UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, ~~2020~~2021

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _______ to _______

Commission file number 001-37929

Myovant Sciences Ltd.

(Exact name of registrant as specified in its charter)


Bermuda						98-1343578
(State or other jurisdiction of incorporation or organization)						(I.R.S. Employer Identification No.)
Suite 1, 3rd Floor
11-12 St. James’s Square
London
SW1Y 4LB
United Kingdom						Not Applicable
(Address of principal executive offices)						(Zip Code)

Registrant’s telephone number, including area code: +44 (207) 400 3351

Securities registered pursuant to Section 12(b) of the Act:

Title of each Class

Trading Symbol

Name of each exchange on which registered

Common Shares, $0.000017727 par value per share

MYOV

New York Stock Exchange

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No o

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” ~~”accelerated~~“accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange ~~Act~~Act.


Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

The number of shares outstanding of the Registrant’s common shares, $0.000017727 par value per share, on ~~November 9, 2020,~~October 22, 2021 was ~~90,593,611.~~

93,309,055.

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MYOVANT SCIENCES LTD.

QUARTERLY REPORT ON FORM 10-Q

FOR THE QUARTER ENDED SEPTEMBER 30, ~~2020~~2021

TABLE OF CONTENTS


			Page
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements:
Condensed Consolidated Balance Sheets as of September 30, 2021 ~~30, 2020~~ and March 31, ~~2020 (Unaudited)~~			20213
~~Condensed Consolidated Statements of Operations for the Three~~ ~~and Six~~ ~~Months Ended~~ ~~September~~ ~~30, 2020 and 2019 (Unaudited)~~			4
~~Condensed Consolidated Statements of Comprehensive Loss for the Three~~ ~~and Six~~ ~~Months Ended~~ ~~September~~ ~~30, 2020 and 2019~~ (Unaudited)			5
Condensed Consolidated Statements of ~~Shareholders~~’ ~~(Deficit) Equity~~Operations for the Three and Six Months~~Six~~ ~~Months~~ Ended September 30, 2021 ~~30, 2020~~ and ~~2019~~2020 (Unaudited)			6
Condensed Consolidated Statements of ~~Cash Flows~~Comprehensive Loss for the Three and Six Months~~Six~~ ~~Months~~ Ended S ~~ept~~e ~~mber~~September 30, 2021 and 2020 (Unaudited)			7
Condensed Consolidated Statements of Shareholders’ Deficit for the Three and Six Months Ended September 30, ~~2020~~2021 and ~~2019~~2020 (Unaudited)			8
Condensed Consolidated Statements of Cash Flows for the Six Months EndedSeptember 30, 2021 and 2020 (Unaudited)			10
Notes to Condensed Consolidated Financial Statements (Unaudited)			911
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations			2526
Item 3. Quantitative and Qualitative Disclosures About Market Risk			4540
Item 4. Controls and Procedures			4540
PART II. OTHER INFORMATION
Item 1. Legal Proceedings			4641
Item 1A. Risk Factors			4641
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds			7977
Item 3. Defaults Upon Senior Securities			7977
Item 4. Mine Safety Disclosures			7977
Item 5. Other Information			7977
Item 6. Exhibits			8077

Signatures			8179

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In this Quarterly Report on Form 10-Q (“Quarterly Report”), “Myovant,” “the Company,” “we,” “us” and “our” refer to Myovant Sciences Ltd. and its wholly-owned subsidiaries.

This report may contain references to our proprietary intellectual property, including among others, trademarks for our products, ORGOVYX® and MYFEMBREE®.

These trademarks and trade names are the property of Myovant or the property of our wholly-owned subsidiaries and are protected under applicable intellectual property laws. Solely for convenience, our trademarks and trade names referred to in this Quarterly Report may appear without the ® or other symbols, but such references are not intended to indicate in any way that the Company will not assert, to the fullest extent under applicable law, its rights to these trademarks and trade names.

Risk Factor Summary

Below is a summary of the material factors that make an investment in our common shares speculative or risky. Importantly, this summary does not address all of the risks and uncertainties that we face. Additional discussion of the risks and uncertainties summarized in this risk factor summary, as well as other risks and uncertainties that we face, can be found under the heading “Risk Factors” in Item 1A of Part II of this Quarterly Report. The below summary is qualified in its entirety by that more complete discussion of such risks and uncertainties. You should consider carefully the risks and uncertainties described under “Risk Factors” in Item 1A of Part II of this Quarterly Report as part of your evaluation of an investment in our common shares.

Risks Related to Commercialization of Our Drug Products

•Our success depends in part on the successful commercialization of our drug products. To the extent our drug products are not commercially successful, our business, financial condition and results of operations will be materially harmed.

•Our drug products may fail to achieve the degree of market acceptance by physicians, patients, third-party payers or others in the medical community necessary for commercial success, which would negatively impact our business.

•If we and our collaboration partners are unable to effectively market and sell our drug products, the commercialization ofour drug products will not be successful and our business will be harmed.

•Failure to successfully obtain coverage and reimbursement for ORGOVYX and MYFEMBREEin the United States, or the availability of coverage only at limited levels, would diminish our ability to generate net product revenue.

•We face substantial competition in the commercialization of our approved drug products, and our operating results will suffer if we fail to compete effectively.

•If we or our collaboration partner, Pfizer, are found to have improperly promoted unapproved uses of our drug products, we may be subject to restrictions on the sale or marketing of our drug products and significant fines, penalties, sanctions and product liability claims, and our image and reputation within the industry and marketplace could be harmed.

Risks Related to Our Financial Position and Capital Requirements

•If we do not have adequate funds to cover our development and commercialization activities, we may have to raise additional capital or curtail or cease operations. We may not be able to obtain funding through public or private offerings of our capital shares, debt financings, collaboration or licensing arrangements, or other sources.

•We may never achieve or maintain profitability.

Risks Related to Our Business Operations

•The terms of the Sumitomo Dainippon Pharma Loan Agreement place restrictions on our operating and financial flexibility.

•We do not have our own manufacturing capabilities and rely on third parties to produce clinical and commercial supplies of drug substance and drug product. If these third parties do not perform as we expect, do not maintain their regulatory approvals, or become subject to other negative circumstances, it may result in a delay in our ability to develop and commercialize our products.

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Risks Related to Clinical Development and Regulatory Approval

•Clinical studies are very expensive, time-consuming, difficult to design and implement, and involve uncertain outcomes. Clinical study failures can occur at any stage of clinical studies, and we could encounter problems that cause us to suspend, abandon or repeat clinical studies. We cannot predict with any certainty the timing for commencement or completion of current or future clinical studies.

•The results of our clinical studies may not support our proposed claims for our product candidates. The results of previous clinical studies may not be predictive of future results, and interim or top-line data may be subject to change or qualification based on the complete analysis of data.

•The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time-consuming, and inherently unpredictable. If we are not able to obtain required regulatory approvals for our product candidates, our ability to generate net product revenue will be materially impaired.

•Adverse events associated with our product candidates could cause us, regulatory authorities, other reviewing entities or clinical study sites to interrupt, delay, request modification of, or halt clinical studies and could result in the denial of regulatory approval.

Risks Related to Our Dependence on Third Parties

•We are dependent upon our relationships with collaboration partners to further develop, fund, manufacture and commercialize our drug products and our product candidates. If such relationships are unsuccessful, or if a collaboration partner terminates its collaboration agreement with us, it could negatively impact our ability to conduct our business and generate net product revenue. Failure by a collaboration partner to perform its duties under its collaboration agreement with us (e.g. financial reporting or internal control compliance) may negatively affect us.

•We are reliant on third parties to conduct, manage, and monitor our clinical studies, and if those third parties perform in an unsatisfactory manner, it may harm our business.

Risks Related to Our Intellectual Property

•If we are unable to obtain and maintain patent protection for our technology and products, or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets.

•If we fail to comply with our obligations under any license, collaboration or other agreements, we may be required to pay damages and could lose intellectual property rights that are necessary for developing and protecting our product candidates.

Risks Related to Our Being a Controlled Company

•We have agreements with Sumitovant, our majority shareholder, and with Sumitovant’s parent, Sumitomo Dainippon Pharma, and their affiliates, including Sunovion, that may be perceived to create conflicts of interest which, if other investors perceive that Sumitovant or Sumitomo Dainippon Pharma will not act in the best interests of all of our shareholders, may affect the price of our common shares and have other effects on our company.

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PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

MYOVANT SCIENCES LTD.

Condensed Consolidated Balance Sheets

(unaudited; in thousands, except share and per share ~~data~~)data)

September 30, 2020 March 31, 2020
Assets
Current assets:
Cash and cash equivalents $ 94,210 $ 76,644
Marketable securities 17,086 2,997
Prepaid expenses and other current assets 5,612 8,269
Total current assets 116,908 87,910
Property and equipment, net 2,808 2,497
Operating lease right-of-use asset 10,423 11,146
Other assets 5,634 4,373
Total assets $ 135,773 $ 105,926
Liabilities and shareholders’ deficit
Current liabilities:
Accounts payable $ 7,008 $ 15,334
Interest payable (related party) 0 15
Accrued expenses 40,141 29,060
Deferred revenue 16,667 40,000
Operating lease liability 1,657 1,516
Amounts due to related parties 1,284 0
Total current liabilities 66,757 85,925
Long-term operating lease liability 10,127 10,996
Long-term debt, less current maturities (related party) 253,700 113,700
Other 4,968 3,582
Total liabilities 335,552 214,203
Commitments and contingencies (Note 11)
Shareholders’ deficit:
Common shares, par value $0.000017727 per share, 564,111,242 shares authorized, 90,581,003 and 89,833,998 issued and outstanding at September 30, 2020 and March 31, 2020, respectively 2 2
Additional paid-in capital 702,695 684,381
Accumulated other comprehensive loss (11,540) (1,646)
Accumulated deficit (890,936) (791,014)
Total shareholders’ deficit (199,779) (108,277)
Total liabilities and shareholders’ deficit $ 135,773 $ 105,926

~~The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.~~

~~Table of Contents~~

~~MYOVANT SCIENCES LTD.~~

~~Condensed Consolidated Statements of Operations~~

(~~unaudited; in thousands, except share and per share data~~)

Three Months Ended September 30, Six Months Ended September 30,
2020 2019 2020 2019
License and milestone revenue $ 0 $ 0 $ 33,333 $ 0
Operating expenses:
Research and development 40,521 50,803 84,707 101,920
General and administrative (1)
31,316 16,603 54,144 30,755
Total operating expenses 71,837 67,406 138,851 132,675
Loss from operations (71,837) (67,406) (105,518) (132,675)
Interest expense 0 3,788 0 7,581
Interest expense (related party) 2,115 0 4,299 0
Interest income (38) (942) (146) (1,708)
Other (income) expense, net (6,718) 121 (10,287) (584)
Loss before income taxes (67,196) (70,373) (99,384) (137,964)
Income tax (benefit) expense (134) 195 538 508
Net loss $ (67,062) $ (70,568) $ (99,922) $ (138,472)
Net loss per common share — basic and diluted $ (0.75) $ (0.79) $ (1.12) $ (1.68)
Weighted average common shares outstanding — basic and diluted 89,744,142 88,798,398 89,523,389 82,667,061

~~(1)~~ Includes $1,291 and $1,405 of expense (inclusive of third-party pass through costs) for the three and six months ended September 30, 2020, respectively, pursuant to the terms of the Company’s agreements with Sumitovant Biopharma Ltd. and Sunovion Pharmaceuticals Inc. (see Note 5).

~~The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.~~

~~Table of Contents~~

~~MYOVANT SCIENCES LTD.~~

~~Condensed Consolidated Statements of Comprehensive Loss~~

~~(unaudited; in thousands)~~

Three Months Ended September 30, Six Months Ended September 30,
2020 2019 2020 2019
Net loss $ (67,062) $ (70,568) $ (99,922) $ (138,472)
Other comprehensive (loss) income:
Foreign currency translation adjustment (6,419) 281 (9,894) (538)
Total other comprehensive (loss) income (6,419) 281 (9,894) (538)
Comprehensive loss $ (73,481) $ (70,287) $ (109,816) $ (139,010)


	September 30, 2021		March 31, 2021
Assets
Current assets:
Cash and cash equivalents	$	518,163	$	674,493
Accounts receivable, net	14,402		3,570
Marketable securities	97,848		10,435
Inventories	6,141		2,611


Prepaid expenses and other current assets	18,112		13,536

Total current assets	654,666		704,645

Property and equipment, net	3,297		3,300
Operating lease right-of-use asset	8,835		9,655
Other assets	12,742		7,427
Total assets	$	679,540	$	725,027
Liabilities and shareholders’ deficit
Current liabilities:
Accounts payable	$	8,642	$	17,809


Accrued expenses and other current liabilities	46,334		44,612
Share-based compensation liabilities	5,769		21,636
Deferred revenue	100,564		100,564
Amounts due to Pfizer	19,957		1,954
Cost share advance from Pfizer	84,768		92,415
Operating lease liability	1,968		1,807
Amounts due to related parties	334		543


Total current liabilities	268,336		281,340

Deferred revenue, non-current	426,021		397,369
Cost share advance from Pfizer, non-current	—		29,447
Long-term operating lease liability	8,159		9,189

Long-term debt, less current maturities (related party)	358,700		358,700
Other liabilities	1,251		2,947
Total liabilities	1,062,467		1,078,992
Commitments and contingencies (Note 9)	0		0
Shareholders’ deficit:
Common shares, $0.000017727 par value, 564,111,242 shares authorized, 93,077,789 and 91,000,869 issued and outstanding at September 30, 2021 and March 31, 2021, respectively	2		2

Additional paid-in capital	763,755		709,466
Accumulated other comprehensive loss	(17,285)		(17,285)
Accumulated deficit	(1,129,399)		(1,046,148)
Total shareholders’ deficit	(382,927)		(353,965)
Total liabilities and shareholders’ deficit	$	679,540	$	725,027

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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MYOVANT SCIENCES LTD.

Condensed Consolidated Statements of ~~Shareholders’ (Deficit) Equity~~Operations

(unaudited; in thousands, except share and per share data)


	Three Months Ended September 30,				Six Months Ended September 30,
	2021		2020		2021		2020
Revenues:
Product revenue, net	$	21,063	$	—	$	32,617	$	—

Pfizer collaboration revenue	25,172		—		54,681		—
Richter license and milestone revenue	31,667		—		31,667		33,333
Total revenues	77,902		—		118,965		33,333
Operating costs and expenses:
Cost of product revenue	2,622		—		3,654		—
Collaboration expense to Pfizer	8,565		—		13,826		—
Research and development	26,280		40,521		57,160		84,707
Selling, general and administrative (1)	58,781		31,316		119,993		54,144
Total operating costs and expenses	96,248		71,837		194,633		138,851
Loss from operations	(18,346)		(71,837)		(75,668)		(105,518)
Interest expense (2)	3,494		2,115		6,999		4,299

Interest income	(100)		(38)		(178)		(146)
Foreign exchange gain	—		(6,718)		—		(10,287)
Loss before income taxes	(21,740)		(67,196)		(82,489)		(99,384)
Income tax (benefit) expense	(149)		(134)		762		538
Net loss	$	(21,591)	$	(67,062)	$	(83,251)	$	(99,922)
Net loss per common share — basic and diluted	$	(0.23)	$	(0.75)	$	(0.90)	$	(1.12)
Weighted average common shares outstanding — basic and diluted	92,355,150		89,744,142		92,019,987		89,523,389

(1) Includes $1,173 and $2,447 of related party expense (inclusive of third-party pass-through costs) for the three and six months ended September 30, 2021, respectively. Includes $1,291 and $1,405 of related party expense (inclusive of third-party pass-through costs) for the three and six months ended September 30, 2020, respectively (see Note 5).

Common Shares Additional
Paid-in Capital Accumulated
Other Comprehensive
Loss Accumulated Deficit Total Shareholders’
(Deficit) Equity
Shares Amount
Balance at March 31, 2020 89,833,998 $ 2 $ 684,381 $ (1,646) $ (791,014) $ (108,277)
Share-based compensation expense — — 7,812 — — 7,812
Issuance of shares upon exercise of stock options and vesting of restricted stock units 303,014 — 2,190 — — 2,190
Foreign currency translation adjustment — — — (3,475) — (3,475)
Net loss — — — — (32,860) (32,860)
Balance at June 30, 2020 90,137,012 2 694,383 (5,121) (823,874) (134,610)
Share-based compensation expense — — 6,924 — — 6,924
Issuance of shares upon exercise of stock options and vesting of restricted stock units and performance share units 443,991 — 1,388 — — 1,388
Foreign currency translation adjustment — — — (6,419) — (6,419)
Net loss — — — — (67,062) (67,062)
Balance at September 30, 2020 90,581,003 $ 2 $ 702,695 $ (11,540) $ (890,936) $ (199,779)
(2) Includes $2,885 and $5,789 of interest expense under the Sumitomo Dainippon Pharma Loan Agreement for the three and six months ended September 30, 2021, respectively. Includes $2,115 and $4,299 of interest expense under the Sumitomo Dainippon Pharma Loan Agreement for the three and six months ended September 30, 2020, respectively (see Note 5).

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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Common Shares Additional
Paid-in Capital Accumulated
Other Comprehensive
Income (Loss) Accumulated
Deficit Total
Shareholders’
(Deficit) Equity
Shares Amount
Balance at March 31, 2019 72,057,490 $ 1 $ 505,851 $ 507 $ (502,025) $ 4,334
Issuance of shares in connection with “at-the-market” equity offering, net of commissions of $79 106,494 — 2,546 — — 2,546
Issuance of shares in connection with public equity offering, net of commissions and offering costs of $9,229 17,424,243 1 134,537 — — 134,538
Share-based compensation expense — — 6,410 — — 6,410
Capital contribution from former controlling shareholder — share-based compensation — — 42 — — 42
Capital contribution from former controlling shareholder — — 106 — — 106
Foreign currency translation adjustment — — — (819) — (819)
Issuance of shares upon exercise of stock options and vesting of restricted stock units 34,399 — 314 — — 314
Net loss — — — — (67,904) (67,904)
Balance at June 30, 2019 89,622,626 2 649,806 (312) (569,929) 79,567
Public equity offering, additional offering costs 0 0 (80) — — (80)
Share-based compensation expense — — 7,879 — — 7,879
Capital contribution from former controlling shareholder — share-based compensation — — 52 — — 52
Capital contribution from former controlling shareholder — — 123 — — 123
Foreign currency translation adjustment — — — 281 — 281
Issuance of shares upon vesting of restricted stock units 938 — 0 — — 0
Net loss — — — — (70,568) (70,568)
Balance at September 30, 2019 89,623,564 $ 2 $ 657,780 $ (31) $ (640,497) $ 17,254
MYOVANT SCIENCES LTD.

Condensed Consolidated Statements of Comprehensive Loss

(unaudited; in thousands)


	Three Months Ended September 30,				Six Months Ended September 30,
	2021		2020		2021		2020
Net loss	$	(21,591)	$	(67,062)	$	(83,251)	$	(99,922)
Other comprehensive loss:
Foreign currency translation adjustment	—		(6,419)		—		(9,894)
Total other comprehensive loss	—		(6,419)		—		(9,894)
Comprehensive loss	$	(21,591)	$	(73,481)	$	(83,251)	$	(109,816)

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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MYOVANT SCIENCES LTD.

Condensed Consolidated Statements of Shareholders’ Deficit

(unaudited; in thousands, except share data)


	Common Shares			Additional Paid-in Capital		Accumulated Other Comprehensive Loss		Accumulated Deficit		Total Shareholders’ Deficit
	Shares	Amount
Balance at March 31, 2021	91,000,869	$	2	$	709,466	$	(17,285)	$	(1,046,148)	$	(353,965)
Share-based compensation	—	—		11,262		—		—		11,262
Share-based compensation liabilities reclassified to equity upon settlement of awards	—	—		1,862		—		—		1,862
Share-based compensation reclassified to current liabilities	—	—		(1,377)		—		—		(1,377)
Issuance of shares upon exercise of stock options and release of restricted stock units	941,774	—		4,252		—		—		4,252
Net loss	—	—		—		—		(61,660)		(61,660)
Balance at June 30, 2021	91,942,643	2		725,465		(17,285)		(1,107,808)		(399,626)
Share-based compensation	—	—		11,863		—		—		11,863
Share-based compensation liabilities reclassified to equity upon settlement of awards	—	—		16,297		—		—		16,297
Share-based compensation reclassified to current liabilities	—	—		(915)		—		—		(915)
Issuance of shares upon exercise of stock options and release of restricted stock units and performance share units	1,135,146	—		11,045		—		—		11,045
Net loss	—	—		—		—		(21,591)		(21,591)
Balance at September 30, 2021	93,077,789	$	2	$	763,755	$	(17,285)	$	(1,129,399)	$	(382,927)

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	Common Shares			Additional Paid-in Capital		Accumulated Other Comprehensive Loss		Accumulated Deficit		Total Shareholders’ Deficit
	Shares	Amount
Balance at March 31, 2020	89,833,998	$	2	$	684,381	$	(1,646)	$	(791,014)	$	(108,277)
Share-based compensation	—	—		7,812		—		—		7,812
Issuance of shares upon exercise of stock options and release of restricted stock units	303,014	—		2,190		—		—		2,190
Foreign currency translation adjustment	—	—		—		(3,475)		—		(3,475)
Net loss	—	—		—		—		(32,860)		(32,860)
Balance at June 30, 2020	90,137,012	2		694,383		(5,121)		(823,874)		(134,610)
Share-based compensation	—	—		6,924		—		—		6,924
Issuance of shares upon exercise of stock options and release of restricted stock units and performance share units	443,991	—		1,388		—		—		1,388
Foreign currency translation adjustment	—	—		—		(6,419)		—		(6,419)
Net loss	—	—		—		—		(67,062)		(67,062)
Balance at September 30, 2020	90,581,003	$	2	$	702,695	$	(11,540)	$	(890,936)	$	(199,779)

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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MYOVANT SCIENCES LTD.

Condensed Consolidated Statements of Cash Flows

(unaudited; in thousands)


		Six Months Ended September 30,					Six Months Ended September 30,
		2020		2019			2021		2020
Cash flows from operating activities:	Cash flows from operating activities:					Cash flows from operating activities:
Net loss	Net loss	$	(99,922)	$	(138,472)	Net loss	$	(83,251)	$	(99,922)

Adjustments to reconcile net loss to net cash used in operating activities:	Adjustments to reconcile net loss to net cash used in operating activities:					Adjustments to reconcile net loss to net cash used in operating activities:
Share-based compensation	Share-based compensation	14,736		14,383		Share-based compensation	23,125		14,736
Depreciation and amortization (1)	Depreciation and amortization (1)	1,146		726		Depreciation and amortization (1)	1,536		1,146
Amortization of debt discount and issuance costs		0		1,095
Non-cash interest expense						Non-cash interest expense	1,210		—

Foreign currency transaction gain	Foreign currency transaction gain	(10,287)		(584)		Foreign currency transaction gain	—		(10,287)
Other	Other	393		215		Other	—		393
Changes in operating assets and liabilities:	Changes in operating assets and liabilities:					Changes in operating assets and liabilities:
Accounts receivable						Accounts receivable	(10,832)		—
Inventories						Inventories	(3,530)		—

Prepaid expenses and other current assets	Prepaid expenses and other current assets	2,657		225		Prepaid expenses and other current assets	(4,414)		2,657

Income tax receivable		0		507
Other assets	Other assets	(648)		(799)		Other assets	1,798		(648)
Accounts payable	Accounts payable	(8,326)		(5,200)		Accounts payable	(9,519)		(8,326)

Interest payable		0		(772)
Interest payable (related party)	Interest payable (related party)	(15)		0		Interest payable (related party)	—		(15)
Accrued expenses		11,081		(9,154)
Accrued expenses and other current liabilities						Accrued expenses and other current liabilities	1,722		11,081
Deferred revenue	Deferred revenue	(23,333)		0		Deferred revenue	28,652		(23,333)
Amounts due to Pfizer						Amounts due to Pfizer	18,003		—
Cost share advance from Pfizer						Cost share advance from Pfizer	(38,304)		—
Operating lease liabilities	Operating lease liabilities	(728)		(368)		Operating lease liabilities	(869)		(728)
Deferred interest payable		0		3,050

Amounts due to related parties	Amounts due to related parties	1,284		0		Amounts due to related parties	(209)		1,284
Other liabilities	Other liabilities	1,386		0		Other liabilities	(1,696)		1,386
Net cash used in operating activities	Net cash used in operating activities	(110,576)		(135,148)		Net cash used in operating activities	(76,578)		(110,576)
Cash flows from investing activities:	Cash flows from investing activities:					Cash flows from investing activities:
Purchases of marketable securities	Purchases of marketable securities	(28,874)		(27,160)		Purchases of marketable securities	(94,448)		(28,874)
Maturities of marketable securities	Maturities of marketable securities	14,785		0		Maturities of marketable securities	7,035		14,785

Purchases of property and equipment	Purchases of property and equipment	(734)		(532)		Purchases of property and equipment	(361)		(734)
Net cash used in investing activities	Net cash used in investing activities	(14,823)		(27,692)		Net cash used in investing activities	(87,774)		(14,823)
Cash flows from financing activities:						Cash flows from financing activities:

Cash flows from financing activities:
Proceeds from issuance of common shares in “at-the-market” equity offering, net of issuance costs paid		0		2,546
Proceeds from issuance of common shares in public equity offering, net of issuance costs paid		0		134,528
Proceeds from related party debt financing	Proceeds from related party debt financing	140,000		0		Proceeds from related party debt financing	—		140,000
Proceeds from stock option exercises	Proceeds from stock option exercises	3,578		314		Proceeds from stock option exercises	15,135		3,578

Net cash provided by financing activities	Net cash provided by financing activities	143,578		137,388		Net cash provided by financing activities	15,135		143,578
Net change in cash, cash equivalents and restricted cash	Net change in cash, cash equivalents and restricted cash	18,179		(25,452)		Net change in cash, cash equivalents and restricted cash	(149,217)		18,179
Cash, cash equivalents and restricted cash, beginning of period	Cash, cash equivalents and restricted cash, beginning of period	78,018		157,199		Cash, cash equivalents and restricted cash, beginning of period	677,480		78,018
Cash, cash equivalents and restricted cash, end of period	Cash, cash equivalents and restricted cash, end of period	$	96,197	$	131,747	Cash, cash equivalents and restricted cash, end of period	$	528,263	$	96,197
Non-cash financing activities:	Non-cash financing activities:					Non-cash financing activities:

Offering costs included in accounts payable and accrued expenses		$	0	$	70
Change in fair value of share-based awards recorded to additional paid-in capital						Change in fair value of share-based awards recorded to additional paid-in capital	$	2,292	$	—
Equipment purchases included in accounts payable						Equipment purchases included in accounts payable	$	352	$	—
Reclassification of share-based compensation liabilities to additional paid-in capital upon settlement of awards						Reclassification of share-based compensation liabilities to additional paid-in capital upon settlement of awards	$	18,159	$	—
Stock options exercised receivable, included in prepaid expenses and other current assets						Stock options exercised receivable, included in prepaid expenses and other current assets	$	162	$	—

(1) Includes amortization of operating lease right-of-use assets.

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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MYOVANT SCIENCES LTD.

Notes to Condensed Consolidated Financial Statements ~~(Unaudited)~~(unaudited)

Note 1—Organization and Summary of Significant Accounting Policies

Description of Business

Myovant Sciences Ltd. (together with its wholly-owned subsidiaries, the “Company”) is a ~~healthcare~~biopharmaceutical company ~~that aspires to redefine~~focused on redefining care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. ~~The Company’s lead product candidate is relugolix, a once-daily,~~Founded in 2016, the Company has two FDA-approved products: (1) ORGOVYX® (relugolix 120 mg), which was approved in the U.S. by the U.S. Food and Drug Administration (“FDA”) in December 2020 as the first and only oral gonadotropin-releasing hormone (“GnRH”) receptor ~~antagonist. Relugolix monotherapy tablet (120 mg) is under regulatory review in~~antagonist for the ~~U.S. for men~~treatment of adult patients with advanced prostate ~~cancer. Relugolix combination tablet~~cancer; and (2) MYFEMBREE® (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg), which was approved in the U.S. by the FDA in May 2021 as the first and only once-daily oral treatment for the management of heavy menstrual bleeding associated with uterine fibroids. In July 2021 and August 2021, the European Commission and the Medicines and Healthcare products Regulatory Agency, respectively, approved RYEQO® (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) as the first and only long-term, once-daily oral treatment in the European Union and the United Kingdom, respectively, for moderate to severe symptoms of uterine fibroids in adult women of reproductive age. In September 2021, the FDA accepted the Company’s supplemental New Drug Application (“sNDA”) for MYFEMBREE for the management of moderate to severe pain associated with endometriosis, setting a target action date of May 6, 2022. MYFEMBREE is also being evaluated for contraceptive efficacy in women with heavy menstrual bleeding associated with uterine fibroids or endometriosis-associated pain who are 18 to 50 years of age and at risk for pregnancy. Relugolix (120 mg) is also under regulatory review in ~~the U.S. and~~ Europe for ~~women~~men with ~~uterine fibroids and is under development for women with endometriosis.~~advanced prostate cancer. The Company is also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, which has completed a Phase 2a study for the treatment of female infertility as a part of assisted reproduction.

Takeda Pharmaceuticals International AG (“Takeda”), a subsidiary of Takeda Pharmaceutical Company Limited, the originator of relugolix, granted the Company a worldwide license to develop and commercialize relugolix (excluding Japan and certain other Asian countries) and an exclusive right to develop and commercialize MVT-602 in all countries worldwide. On March 30, 2020, the Company entered into an exclusive license agreement with Gedeon Richter Plc. (“Richter”) for Richter to commercialize relugolix combination tablet for uterine fibroids and endometriosis in certain territories outside of the U.S. Under this agreement, the Company has retained all of its rights to relugolix combination tablet in the U.S. and Canada, as well as rights to relugolix in other therapeutic areas outside of women’s health.

Since its inception, the Company has ~~devoted substantially all~~funded its operations primarily from the issuance and sale of its ~~efforts to identifying~~common shares, from debt financing arrangements, and ~~in-licensing its~~more recently from the upfront and regulatory milestone payments it received from Pfizer Inc. (“Pfizer”) and Gedeon Richter Plc. (“Richter”). The Company began generating product ~~candidates, organizing~~revenue from the sales of ORGOVYX and ~~staffing~~MYFEMBREE in the ~~Company, raising capital, preparing for~~U.S. in January 2021 and advancing the clinical development of its product candidates, and preparing for potential future regulatory approvals and commercialization of relugolix combination tablet and relugolix monotherapy tablet.June 2021, respectively.

The Company’s majority shareholder is Sumitovant Biopharma Ltd. (“Sumitovant”), a wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. (“Sumitomo Dainippon Pharma”). As of September 30, ~~2020,~~2021, Sumitovant directly, and Sumitomo Dainippon Pharma indirectly, own ~~48,641,181,~~50,041,181, or approximately ~~53.7%~~53.8%, of the Company’s outstanding common shares.

~~Note 2—Summary of Significant Accounting Policies~~

~~(A)~~ Basis of Presentation and Principles of Consolidation

The Company’s fiscal year ends on March 31, and its first three fiscal quarters end on June 30, September 30 and December 31. The Company has determined that it has 1 operating and reporting segment as it allocates resources and assesses financial performance on a consolidated basis.

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for complete financial statements. ~~These~~

In the opinion of management, the accompanying unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q (“Quarterly Report”) reflect all adjustments necessary for a fair presentation of the Company’s condensed consolidated balance sheets as of September 30, 2021 and March 31, 2021, and its condensed consolidated statements of operations, comprehensive loss, and shareholders’ deficit for the three and six months ended September 30, 2021 and 2020, and its condensed consolidated statements of cash flows for the six months ended September 30, 2021 and 2020. The March 31, 2021 condensed consolidated balance sheet was derived from audited consolidated financial statements, but does not include all disclosures required by U.S. GAAP. The results for interim periods are not necessarily indicative of results for the entire year or any other interim period. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the Company’s previously filed audited consolidated financial statements and the related notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, ~~2020,~~2021, filed with the U.S. Securities and Exchange Commission (the “SEC”) on May 18, 2020. The unaudited consolidated balance sheet at March 31, 2020 has been derived from the audited consolidated financial statements at that date. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary to present fairly the financial position of the Company and its results of operations and cash flows for the interim periods presented have been included. Operating results for the three and six months ended September 30, 2020 are not necessarily indicative of the results that may be expected for the fiscal year ending March 31, 2021, for any other interim period or for any other future year. There have been no significant changes in the Company’s accounting policies from those disclosed in its Annual Report on Form 10-K for the fiscal year ended March 31, 2020, filed with the SEC on May 18, 2020.11, 2021.

Any reference in these notes to applicable accounting guidance is meant to refer to the authoritative U.S. GAAP included in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”), issued by the Financial Accounting

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Standards Board (“FASB”). The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. ~~The Company has no unconsolidated subsidiaries.~~ All intercompany balances and transactions have been eliminated in consolidation.

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The Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the unaudited condensed consolidated financial statements are issued. During the six months ended September 30, 2020, the Company incurred net losses of $99.9 million and used $110.6 million of cash and cash equivalents in operations. The Company expects to continue to incur significant and increasing operating losses and negative operating cash flows as it continues to develop its product candidates and prepares for potential future regulatory approvals and commercialization of relugolix combination tablet and relugolix monotherapy tablet. In addition, the Company currently expects that its outstanding debt levels will increase in future periods, which will result in an increase in its quarterly interest payment obligations. The Company has not generated any product revenue to date and does not expect to generate product revenue unless and until it obtains regulatory approval for at least one of its product candidates. Based on its current operating plan, the Company expects that its existing cash, cash equivalents, marketable securities, and its ability to borrow under the terms of the Sumitomo Dainippon Pharma Loan Agreement (See Note 5) will be sufficient to fund its operating expenses and capital expenditure requirements at least through the end of the Company’s fiscal year ending March 31, 2021. This estimate is based on the Company’s current assumptions, including assumptions relating to its ability to manage its spend, that might prove to be wrong, and it could use its available capital resources sooner than it currently expects. Current cash, cash equivalents, marketable securities and amounts available under the Sumitomo Dainippon Pharma Loan Agreement will not be sufficient to enable the Company to complete all necessary development and regulatory activities and commercially launch relugolix combination tablet or relugolix monotherapy tablet. The Company anticipates that it will continue to incur net losses and negative operating cash flows for the foreseeable future.

To continue as a going concern, the Company will need, among other things, additional capital resources. The Company continually assesses multiple options to obtain additional funding to support its operations, including through financing activities in public or private capital markets. Management can provide no assurances that any sources of a sufficient amount of financing will be available to the Company on favorable terms, if at all. Although the Company expects to draw under the Sumitomo Dainippon Pharma Loan Agreement on a quarterly basis, such draws are contingent upon the consent of the Company’s board of directors. In addition, if Sumitomo Dainippon Pharma fails to own at least a majority of the Company’s outstanding common shares, it may become unlawful under Japanese law for Sumitomo Dainippon Pharma to fund loans to the Company, in which case the Company would not be able to continue to borrow under the Sumitomo Dainippon Pharma Loan Agreement. ASC 240-40, ~~Going Concern, does not allow the Company to consider future financing activities that are uncertain in its assessment of the Company’s future cash burn for the purpose of its liquidity assessment.~~

Due to these uncertainties, there is substantial doubt about the Company’s ability to continue as a going concern. The unaudited condensed consolidated financial statements and footnotes have been prepared on the basis that the Company will continue as a going concern, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the possible inability of the Company to continue as a going concern.

~~(B)~~ Use of Estimates

The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires the Company’s management to make estimates and assumptions ~~in certain circumstances~~ that affect the reported amounts ~~reported in the consolidated financial statements and accompanying notes. The Company regularly evaluates estimates and assumptions related to assets and liabilities, and disclosures~~ of ~~contingent~~ assets and liabilities at the ~~dates~~date of the condensed consolidated financial statements and the accompanying notes, and the reported amounts of ~~revenues~~revenue and expenses during the ~~reporting~~reported periods. ~~Determinations~~Actual results could differ materially from those estimates.

On an ongoing basis, management evaluates its estimates, including those related to valuation of inventories, impairment testing for long-lived-assets, variables used in ~~which management uses subjective judgments include, but are not limited to,~~calculating the ~~evaluation~~fair value of the Company’s ~~ability to continue as a going concern,~~equity awards, expected achievement of performance-based vesting criteria for equity awards, variable consideration and other relevant inputs impacting the gross and net revenue recognition, ~~share-based compensation expenses, research~~contingent liabilities, recoverability of deferred tax assets, determination of lease term and ~~development (“R&D”) expenses and accruals, leases, and~~effective income ~~taxes. The Company~~tax rates. Management bases ~~its~~ estimates ~~and assumptions~~ on historical experience and on various other ~~factors~~assumptions that ~~it believes~~are believed to be reasonable, ~~under the circumstances,~~ the results of which form the basis for making judgments about the carrying values of assets and liabilities atas of the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period, that are not readily apparent from other sources. Estimates and assumptions are periodically reviewed in light of changes in circumstances, facts, or experience. Changes in estimates and assumptions are reflected in reported results in the period in which they become known. ~~Actual~~In addition, management’s assessment of the Company’s ability to continue as a going concern involves the estimation of the amount and timing of future cash inflows and outflows.

Summary of Significant Accounting Policies

The accounting policies used by the Company in its presentation of interim financial results ~~could differ~~are consistent with those described in Note 2 to the Company’s audited consolidated financial statements included in its Annual Report on Form 10-K for the fiscal year ended March 31, 2021, filed with the SEC on May 11, 2021. There have been no significant changes in the Company’s significant accounting policies from those ~~estimates.~~disclosed in its Annual Report on Form 10-K for the fiscal year ended March 31, 2021.

~~(C) Risks~~Liquidity and ~~Uncertainties~~Capital Resources

As of September 30, 2021, the Company had approximately $616.0 million in cash, cash equivalents, and marketable securities. The Company ~~is subject~~believes that its existing cash, cash equivalents, and marketable securities will be sufficient to ~~risks common~~fund its anticipated operating expenses and capital expenditure requirements for at least the next 12 months from the date of issuance of this Quarterly Report.

In future periods, if the Company’s cash, cash equivalents, marketable securities, and amounts that it expects to ~~companies~~generate from product sales and/or third-party collaboration payments are not sufficient to enable the Company to fund its operations, the Company may need to raise additional funds in the ~~biotechnology industry, including, but not limited to, risks~~form of ~~failure~~equity, debt, or unsatisfactory results of nonclinical and clinical studies, the need to obtain additional capital to fund the future development of its product candidates and the commercialization of any product candidatesfrom other sources. There can be no assurances that may obtain marketing approval, the need to obtain marketing approval for its product candidates, the need to successfully commercialize and gain market acceptance of its product candidates, dependence on key personnel, protection of proprietary technology, compliance with government regulations, development by competitors of technological innovations, ability to transition from pilot-scale

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~~manufacturing to large-scale production of products, and dependence on third-party service providers~~ such ~~as contract research organizations (“CROs”) and contract manufacturing organizations (“CMOs).~~

~~In March 2020, the World Health Organization declared the COVID-19 outbreak a pandemic. Due~~funding sources will be available at terms acceptable to the ~~COVID-19 pandemic, there~~Company, or at all. If the Company has ~~been uncertainty and disruption in~~insufficient funding to meet its working capital needs, it could be required to delay, limit, reduce, or terminate its drug development programs, commercialization efforts, and/or limit or cease operations.

As of September 30, 2021, the ~~global economy and financial markets. Through November 12, 2020,~~Company had approximately $41.3 million of borrowing capacity available to it under the Sumitomo Dainippon Pharma Loan Agreement (see Note 5(A)). As of the date of issuance of this Quarterly Report, ~~on Form 10-Q,~~ the ~~Company’s results of operations and cash flows have not been significantly impacted by the COVID-19 pandemic. The~~ Company is ~~not aware~~also eligible to earn up to $3.6 billion and $122.5 million of ~~any specific event or circumstance that would require an update~~additional milestone payments from Pfizer and Richter pursuant to ~~its estimates, judgments,~~the Pfizer Collaboration and ~~assumptions or a revision of~~License Agreement and the ~~carrying value of~~Richter Development and Commercialization Agreement, respectively, as well as potential royalty payments on net sales under the ~~Company’s assets or liabilities as of November 12, 2020.~~Richter Development and Commercialization Agreement. See Note 8 for additional information about the Pfizer Collaboration and License Agreement and the Richter Development and Commercialization Agreement.

~~(D)~~ Net Loss per Common Share

Basic net loss per common share is computed by dividing net loss ~~applicable~~available to common shareholders by the weighted-average number of common shares outstanding during the ~~period, reduced, when applicable, for outstanding yet unvested shares of restricted common stock. The computation of diluted~~period. Diluted net loss per common share is ~~based on~~computed by dividing net loss by the weighted-average number of common shares and potentially dilutive shares of common stock outstanding during the ~~period plus, when their effect is~~period. Potential dilutive ~~incremental shares consisting of shares subject to~~securities outstanding include stock options, restricted stock units, ~~restricted stock awards,~~ performance stock units, and warrants. InDuring all periods ~~in which~~presented, the Company ~~reports a~~incurred net ~~loss, all~~losses. Accordingly, the effect of any common share equivalents would be anti-dilutive during those periods and are ~~deemed anti-dilutive such that basic net loss per common share and~~not included in the calculation of diluted net loss per common share are equal. Potentially dilutive common shares have been excluded from the diluted net loss per common share computations in all periods presented because such securities have an anti-dilutive effect on net loss per common share due to the Company’s net loss. There are no reconciling items used to calculate the weighted-average number of ~~total~~ common shares ~~outstanding for basic and diluted net loss per common share.~~

~~As of September 30, 2020, and 2019, potentially dilutive securities were as follows:~~

September 30,
2020 2019
Stock options 8,484,057 7,676,460
Restricted stock awards (unvested) 564,111 775,651
Restricted stock units (unvested) 2,703,287 753,720
Performance stock units (unvested) 722,071 408,510
Warrants 73,710 73,710
Total 12,547,236 9,688,051

~~(E) Cash, Cash Equivalents, and Restricted Cash~~

Cash as reported on the unaudited condensed consolidated statements of cash flows includes the aggregate amounts of cash, cash equivalents, and restricted cash and consists of the following (in thousands):

September 30,
2020 2019
Cash and cash equivalents $ 94,210 $ 130,373
Restricted cash (1)
1,987 1,374
Total cash, cash equivalents and restricted cash $ 96,197 $ 131,747

~~(1)~~ Restricted cash consists of funds held to satisfy the requirements of certain agreements that are restricted in their use and are included in other assets on the unaudited condensed consolidated balance sheets.

~~(F) Marketable Securities~~

Investments in marketable securities are held in a custodial account at a financial institution and managed by the Company’s investment advisor based on the Company’s investment guidelines. The Company considers all highly liquid investments in securities with a maturity of greater than three months at the time of purchase to be marketable securities.

The Company classifies its marketable securities as available-for-sale at the time of purchase and reevaluates such designation at each balance sheet date. Unrealized gains and losses on available-for-sale securities are excluded from earnings and are recorded in accumulated other comprehensive (loss) income until realized. Any unrealized losses are evaluated for other-than-temporary impairment at each balance sheet date. Realized gains and losses are determined based on the specific identification method and are recorded in other (income) expense, net.

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The Company does not intend to sell its securities that are in an unrealized loss position, and it is unlikely that the Company will be required to sell its securities before recovery of their amortized cost basis, which may be maturity. Factors considered in determining whether a loss is temporary include the length of time and extent to which the fair value has been less than the amortized cost basis and whether the Company intends to sell the security or whether it is more likely than not that the Company would be required to sell the security before recovery of the amortized cost basis. See Note 3 for additional information.

~~(G) Fair Value Measurements~~

The Company utilizes fair value measurement guidance prescribed by accounting standards to value its financial instruments. The guidance establishes a fair value hierarchy for financial instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs). Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances.

Fair value is defined as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the reporting date. As a basis for considering market participant assumptions in fair value measurements, the guidance establishes a three-tier fair value hierarchy that distinguishes among the following:

•~~Level 1—Valuations are based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access.~~

•Level 2—Valuations are based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and models for which all significant inputs are observable, either directly or indirectly.

•~~Level 3—Valuations are based on inputs that are unobservable (supported by little or no market activity) and significant to the overall fair value measurement.~~

To the extent the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.

The Company’s financial instruments include cash, cash equivalents, marketable securities, accounts payable, amounts due to related parties, and debt obligations. Cash, cash equivalents, accounts payable, and amounts due to related parties are stated at their respective historical carrying amounts, which approximate fair value due to their short-term nature. Marketable securities are recorded at their estimated fair value and are included in Level 2 of the fair value hierarchy.

~~(H) Revenue Recognition~~

~~In May 2014, the FASB issued ASU 2014-09,~~ ~~Revenue from Contracts with Customers~~ (Topic 606), as subsequently amended, which outlines a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers. The core principle of the revenue model is that an entity recognizes revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those goods or services. The Company was required to adopt ASC 606 on April 1, 2018. As the Company did not have any effective contracts within the scope of this guidance prior to April 1, 2018, ASC 606 had no impact on the Company's consolidated financial statements and related disclosures upon adoption.

In accordance with ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when or as the Company satisfies a performance obligation.

When applying the revenue recognition criteria of ASC 606 to license and collaboration agreements, the Company applies significant judgment when evaluating whether contractual obligations represent distinct performance obligations, allocating transaction price to performance obligations within a contract, determining when performance obligations have been met,outstanding.

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~~assessing the recognition~~As of September 30, 2021 and future reversal of variable consideration, and determining and applying appropriate methods of measuring progress for performance obligations satisfied over time. These judgments are discussed in more detail below.2020 potentially dilutive securities were as follows:

•~~Licenses of intellectual property~~: If the licenses to intellectual property are determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, upfront fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are not distinct from other promises, the Company applies judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, upfront fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the related revenue recognition accordingly.


	September 30,
	2021	2020
Stock options	7,747,596	8,484,057
Restricted stock awards (unvested)	—	564,111
Restricted stock units and performance stock units (unvested)	4,734,445	3,425,358
Warrants	73,710	73,710
Total	12,555,751	12,547,236

•~~Milestone payments~~: At the inception of each arrangement that includes research, development or regulatory milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s control or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative standalone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price on a cumulative catch-up basis in earnings in the period of the adjustment.

•~~Royalties and commercial milestone payments~~: For arrangements that include sales-based royalties, including commercial milestone payments based on pre-specified level of sales, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Achievement of these royalties and commercial milestones may solely depend upon performance of the licensee.

~~(I) Other (Income) Expense, Net~~

Other (income) expense, net consists primarily of the impact of changes in foreign currency exchange rates on the Company’s foreign exchange denominated liabilities, relative to the U.S. dollar. The impact of foreign exchange rates on the Company’s results of operations fluctuates period over period based on its foreign currency exposures resulting from changes in applicable exchange rates associated with its foreign denominated liabilities, such as the outstanding balance under the Sumitomo Dainippon Pharma Loan Agreement. The Company’s primary foreign currency exposure is currently the exchange rate between the Swiss franc and the U.S. dollar.

~~(J)~~ Recently Adopted Accounting Standards

In ~~August 2018,~~December 2019, the FASB issued ASU ~~2018-13,~~2019-12, ~~Fair Value Measurement~~ Simplifying the Accounting for Income Taxes~~(Topic 820): Disclosure Framework – Changes~~ (Topic 740) (“ASU 2019-12”), that eliminates certain exceptions to the ~~Disclosure Requirements~~general principles in ASC 740 related to intra-period tax allocation, deferred tax liability and general methodology for ~~Fair Value Measurement~~ (“calculating income taxes. ASU ~~2018-13”), which~~2019-12 also simplifies U.S. GAAP by making other changes for matters such as, franchise taxes that are partially based on income, transactions with a government that result in a step up in the ~~fair value measurement disclosure requirements.~~tax basis of goodwill, separate financial statements of legal entities that are not subject to tax, and enacted changes in tax laws in interim periods. The Company adopted ~~the new standard~~ASU 2019-12 on April 1, ~~2020. The adoption of ASU 2018-13~~2021, which did not have a material impact on the Company’s unaudited condensed consolidated financial statements and related disclosures.

~~In November 2018, the FASB issued ASU 2018-18,~~ ~~Collaborative Arrangements~~ ~~(Topic 808): Clarifying the Interaction between Topic 808 and Topic 606~~ ~~(“ASU 2018-18”). This guidance is intended to reduce diversity in practice and clarify the interaction between Topic 808,~~ ~~Collaborative Arrangements, and Topic 606,~~ ~~Revenue from Contracts with Customers~~. ASU 2018-18 provided guidance on whether certain transactions between collaborative arrangement participants should be accounted for with revenue under Topic 606. The Company adopted the new standard on April 1, 2020. The adoption of ASU 2018-18 did not have a material impact on the Company’s unaudited condensed consolidated financial statements and related disclosures.

~~In August 2018, the FASB issued ASU 2018-15,~~ ~~Intangibles - Goodwill and Other - Internal-Use Software~~ ~~(Subtopic 350-40) (“ASU 2018-15”), which amends ASU 2015-05,~~ ~~Customers Accounting for Fees in a Cloud Computing Agreement~~, to help entities evaluate the accounting for fees paid by a customer in a cloud computing arrangement (hosting arrangement) by providing guidance for determining when the arrangement includes a software license. The most significant change will align the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software and hosting arrangements that include an internal-use software license. Accordingly, the amendments in ASU 2018-15 require an entity in a hosting arrangement that is a service contract to follow the guidance in Subtopic 350-40 to determine which implementation

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costs to capitalize as assets related to the service contract and which costs to expense. The Company adopted ASU 2018-15 using the prospective method as of April 1, 2020. The adoption of ASU 2018-15 did not have a material impact on the Company’s unaudited condensed consolidated financial statements and related disclosures.

~~(K)~~ Recently Issued Accounting Standards Not Yet Adopted

In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting, which provides optional expedients and exceptions for applying generally accepted accounting principles to contracts, hedging relationships, and other transactions affected by reference rate reform if certain criteria are met. These amendments apply only to contracts, hedging relationships, and other transactions that reference ~~LIBOR~~the London Interbank Offered Rate (“LIBOR”) or another reference rate expected to be discontinued because of reference rate reform. The amendments are effective prospectively for all entities as of March 12, 2020 through December 31, 2022. As of September 30, ~~2020,~~2021, the Company has not modified its contract that will be impacted by reference rate ~~reform.~~reform (Sumitomo Dainippon Pharma Loan Agreement). The Company will continue to assess the impact the adoption of this standard will have on its consolidated financial statements and related disclosures when its contract impacted by reference rate reform is modified.

In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. ASU 2016-13 replaces the existing incurred loss impairment model with an expected loss model that requires the use of forward-looking information to calculate credit loss estimates. It also eliminates the concept of other-than-temporary impairment and requires credit losses on available-for-sale debt securities to be recorded through an allowance for credit losses instead of as a reduction in the amortized cost basis of the securities. ASU 2016-13 iswas effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2019. Early adoption iswas permitted, including adoption in any interim period. In February 2020, the FASB issued ASU 2020-02, Financial Instruments-Credit Losses (Topic 326) and Leases (Topic 842) - Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 119 and Update to SEC Section on Effective Date Related to Accounting Standards Update No. 2016-02, Leases (Topic 842), which ~~amends~~amended the effective date of the original pronouncement for smaller reporting companies. ASC 2016-13 and its amendments will be effective for annual and interim periods beginning after December 15, 2022 for smaller reporting companies. The Company is currently assessing the impact the adoption of this new standard will have on its consolidated financial statements and related disclosures.

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Note 2—Revenue Components

The following table provides information about the ~~FASB issued ASU 2019-12,~~ ~~Simplifying~~Company’s revenues for the ~~Accounting for Income Taxes~~ ~~(Topic 740) (“ASU 2019-12”), that eliminates certain exceptions to~~three and six months ended September 30, 2021 and 2020 (in thousands):


	Three Months Ended September 30,				Six Months Ended September 30,
	2021		2020		2021		2020
Revenues:
Product revenue, net:
ORGOVYX	$	18,663	$	—	$	29,142	$	—
MYFEMBREE	629		—		1,704		—
Richter product supply and royalties	1,771		—		1,771		—
Total product revenue, net	21,063		—		32,617		—
Pfizer collaboration revenue:
Amortization of upfront payment	20,974		—		41,948		—
Amortization of regulatory milestone	4,198		—		12,733		—
Total Pfizer collaboration revenue	25,172		—		54,681		—
Richter license and milestone revenue	31,667		—		31,667		33,333
Total revenues	$	77,902	$	—	$	118,965	$	33,333

The Company began generating product revenue from sales of ORGOVYX and MYFEMBREE in the ~~general principles~~U.S. in ~~ASC 740~~January 2021 and June 2021, respectively. The Company records product revenue net of estimated discounts, chargebacks, rebates, product returns, and other gross-to-net revenue deductions. For the three and six months ended September 30, 2021, product revenue, net also includes revenues related to ~~intra-period tax allocation, deferred tax liability~~product supply to Richter of $1.7 million, as well as royalties on net sales of RYEQO in Richter’s Territory of less than $0.1 million.

Pfizer collaboration revenue for the three and ~~general methodology~~six months ended September 30, 2021 consists of the partial recognition of the upfront payment the Company received from Pfizer in December 2020 and of the regulatory milestone payment from Pfizer that was triggered upon the FDA approval of MYFEMBREE for ~~calculating income taxes. ASU 2019-12 also simplifies U.S. GAAP by making other changes for matters such as, franchise taxes that are partially based~~the management of heavy menstrual bleeding associated with uterine fibroids on ~~income, transactions with a government that result in a step up~~May 26, 2021. There was no Pfizer collaboration revenue in the ~~tax basis~~prior year periods.

Richter license and milestone revenue for the three and six months ended September 30, 2021 consists of ~~goodwill, separate financial statements~~the recognition of ~~legal entities~~a $15.0 million regulatory milestone payment that ~~are not subject~~was triggered upon the European Commission approval of RYEQO for the treatment of moderate to ~~tax,~~severe symptoms of uterine fibroids in adult women of reproductive age and ~~enacted changes~~$16.7 million of previously deferred revenue that was recognized upon the completion of the Company’s delivery of the remaining substantive relugolix combination tablet data packages to Richter. Richter license and milestone revenue for the six months ended September 30, 2020 consists of the recognition of $33.3 million of the upfront and regulatory milestone payments the Company received from Richter in ~~tax laws in interim periods. ASU 2019-12 is effective~~March and April 2020, respectively. There was no Richter license and milestone revenue for ~~annual periods,~~the three months ended September 30, 2020.

See Note 8 for additional information regarding the Pfizer Collaboration and interim periods within those annual periods, beginning after December 15, 2020. Early adoption is permitted, including adoption in any interim period. The Company is currently assessing the impact the adoption of this standard will have on its consolidated financial statements and related disclosures.

~~Other recent accounting pronouncements issued by the FASB, (including its Emerging Issues Task Force), the American Institute of Certified Public Accountants,~~License Agreement and the ~~SEC did not, or are not believed by the Company to, have a material impact on the Company’s unaudited condensed consolidated financial statements~~Richter Development and ~~related disclosures.~~Commercialization Agreement.

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Note 3—~~Investments~~Certain Balance Sheet Components

Cash, Cash Equivalents and Restricted Cash

The following represents a reconciliation of cash and cash equivalents in the unaudited condensed consolidated balance sheets to total cash, cash equivalents and restricted cash as of September 30, 2021 and September 30, 2020, respectively, in the unaudited condensed consolidated statements of cash flows (in thousands):


	September 30,
	2021		2020
Cash and cash equivalents	$	518,163	$	94,210
Restricted cash	10,100		1,987
Total cash, cash equivalents and restricted cash	$	528,263	$	96,197

Cash and cash equivalents include cash deposits in banks and all highly liquid investments that are readily convertible to cash (maturity of three months or less at the time of purchase). Restricted cash consists of funds held or designated to satisfy the requirements of certain agreements that are restricted in their use and are included in other assets on the unaudited condensed consolidated balance sheets. As of September 30, 2021, restricted cash includes approximately $7.1 million that is held in an escrow fund for use by Sunovion Pharmaceuticals Inc. (“Sunovion”), a subsidiary of Sumitomo Dainippon Pharma, to manage payments for rebates, chargebacks, and similar fees pursuant to the Market Access Services Agreement (see Note 5(C)).

Inventories

As of September 30, 2021 and March 31, 2021, inventories consisted of the following (in thousands):


	September 30, 2021		March 31, 2021
Raw materials	$	931	$	1,390
Work in process	1,960		773
Finished goods	3,250		448

Total inventories	$	6,141	$	2,611

Accrued Expenses and Other Current Liabilities

As of September 30, 2021 and March 31, 2021, accrued expenses and other current liabilities consisted of the following (in thousands):



	September 30, 2021		March 31, 2021
Accrued compensation-related expenses	$	17,111	$	20,571
Accrued sales discounts, rebates, and allowances	10,493		1,315
Accrued R&D expenses	7,354		8,544
Accrued commercial expenses	7,226		7,770
Accrued other expenses	3,525		5,315
Accrued professional fees	625		935
Deferred product revenue	—		162
Total accrued expenses and other current liabilities	$	46,334	$	44,612

Note 4—Fair Value Measurements

The preparation of the Company’s unaudited condensed consolidated financial statements in accordance with U.S. GAAP requires certain assets and liabilities to be reflected at their fair value. Fair value is defined as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be

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classified and disclosed into one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:

•Level 1—Valuations are based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access.

•Level 3—Valuations are based on inputs that are unobservable (supported by little or no market activity) and significant to the overall fair value measurement.

For a description of the methods and assumptions that are used to estimate the fair value and determine the fair value hierarchy classification of each class of the Company’s financial instruments, see Note 2, “Summary of Significant Accounting Policies,” and Note 3, “Fair Value Measurements,” to the Company’s audited consolidated financial statements included in its Annual Report on Form 10-K for the fiscal year ended March 31, 2021, filed with the SEC on May 11, 2021.

Financial Instruments Measured at Fair Value ~~Measurements~~on a Recurring Basis

The following table summarizes the Company’s financial assets ~~that require~~and liabilities measured at fair value ~~measurements~~ on a recurring basis and their respective input levels based on the fair value hierarchy (in thousands):

Quoted Market Prices for Identical Assets
(Level 1) Significant Other Observable Inputs
(Level 2) Significant Unobservable Inputs
(Level 3) Total Fair Value
As of September 30, 2020
Money market funds (1)
$ 291 $ 0 $ 0 $ 291
Commercial paper (2)
0 56,159 0 56,159
Corporate bonds (1)
0 3,000 0 3,000
Municipal bonds (3)
0 512 0 512
U.S. Treasury bills (1)
10,000 0 0 10,000
Total assets $ 10,291 $ 59,671 $ 0 $ 69,962
As of March 31, 2020
Money market funds (1)
$ 11,348 $ 0 $ 0 $ 11,348
Commercial paper (4)
0 7,042 0 7,042
Total assets $ 11,348 $ 7,042 $ 0 $ 18,390


	Fair Value Measurement Using:
	Level 1		Level 2		Level 3		Total
As of September 30, 2021
Assets:
Money market funds (1)	$	913	$	—	$	—	$	913
Commercial paper (2)	—		214,829		—		214,829

Corporate bonds (3)	—		4,002		—		4,002

Total assets	$	913	$	218,831	$	—	$	219,744
Liabilities:
Share-based compensation liabilities - stock options (4)	$	—	$	5,769	$	—	$	5,769

Total liabilities	$	—	$	5,769	$	—	$	5,769


	Fair Value Measurement Using:
	Level 1		Level 2		Level 3		Total
As of March 31, 2021
Assets:
Money market funds (1)	$	36,903	$	—	$	—	$	36,903
Commercial paper (2)	—		21,689		—		21,689
U.S. agency securities (1)	—		10,000		—		10,000
Municipal bonds (3)	—		1,417		—		1,417

Total assets	$	36,903	$	33,106	$	—	$	70,009
Liabilities:
Share-based compensation liabilities - stock options (4)	$	—	$	12,113	$	—	$	12,113
Share-based compensation liabilities - common shares (5)	9,523		—		—		9,523
Total liabilities	$	9,523	$	12,113	$	—	$	21,636

(1) Included in cash and cash equivalents.

(2) ~~Includes $39.6~~Includes $121.0 million in cash and cash equivalents and ~~$16.6~~$93.8 million in marketable ~~securities.~~securities as of September 30, 2021. Includes $12.7 million in cash and cash equivalents and $9.0 million in marketable securities as of March 31, 2021.

(3) Included in marketable securities.

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(4)Includes ~~$4.0 million in cash~~573,958 and ~~cash equivalents and $3.0 million in marketable securities.~~

~~There were 0 liabilities measured at fair value on a recurring basis~~1,281,803 outstanding stock options remeasured using the Black-Scholes option-pricing model as of September 30, ~~2020 or~~2021 and March 31, ~~2020.~~2021, respectively. See Note 7(D).

(5) As of March 31, 2021, includes 462,705 common shares remeasured using the Company’s March 31, 2021 closing market price of $20.58 per common share. See Note 7(D).

The following table includes information regarding the Company’s share-based compensation liabilities (a current liability) for the six months ended September 30, 2021 (in thousands):


March 31, 2021	$	21,636

Change in fair value	2,292
Settlements	(18,159)
September 30, 2021	$	5,769

The fair value of the share-based compensation liabilities related to outstanding stock options was estimated as of September 30, 2021 using the Black-Scholes option-pricing model and the following assumptions:



Expected common share price volatility	48.7	%
Expected risk free interest rate	0.04	%
Expected term, in years	0.3
Expected dividend yield	—	%

Financial Instruments Not Measured at Fair Value on a Recurring Basis

The Company recorded the cost share advance from Pfizer, which is included in Level 2 of the fair value hierarchy, at its estimated fair value as of the transaction date. As discussed in Note ~~4—Accrued~~8(B), on the transaction date, the cost share advance from Pfizer was discounted to fair value using the Company’s estimated incremental borrowing rate over the period in which the cost share advance is expected to be utilized. The recorded amount has been and will continue to be reduced each reporting period by the amount of Allowable Expenses

As applied to the cost share advance. There were no non-recurring fair value assets as of September 30, ~~2020,~~2021 and March 31, ~~2020, accrued expenses consisted of the following (in thousands):~~

September 30, 2020 March 31, 2020
Accrued R&D expenses $ 17,911 $ 15,500
Accrued compensation-related expenses 12,330 9,309
Accrued commercial expenses 5,898 818
Accrued professional service fees 1,068 1,126
Accrued other expenses 2,934 2,307
Total accrued expenses $ 40,141 $ 29,060
2021.

Note 5—Related Party Transactions

~~(A) Sumitomo Dainippon Pharma Co., Ltd.~~

On December 27, 2019, the Company’s former controlling shareholder, Roivant Sciences Ltd. (“Roivant”), completed a transaction (the “Sumitomo-Roivant Transaction”) in which all of the Company’s outstanding common shares held directly or indirectly by Roivant and not already held by Sumitovant were transferred to Sumitovant, and Roivant transferred all of the outstanding equity of Sumitovant to Sumitomo Dainippon Pharma, resulting in Sumitovant directly, and Sumitomo Dainippon Pharma indirectly, owning 45,008,604, or approximately 50.2%, of the Company’s outstanding common shares on December 27, 2019. As of September 30, ~~2020,~~2021, Sumitovant directly, and Sumitomo Dainippon Pharma indirectly, own ~~48,641,181,~~50,041,181, or approximately ~~53.7%~~53.8%, of the Company’s outstanding common shares. The Company has agreements with Sumitovant, Sumitomo Dainippon Pharma, and their affiliates, including Sunovion, a subsidiary of Sumitomo Dainippon Pharma. These agreements are described below.

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(A) Sumitomo Dainippon Pharma Co., Ltd.

Sumitomo Dainippon Pharma Loan Agreement

On December 27, 2019, the Company and one of its ~~subsidiary,~~subsidiaries, Myovant Sciences GmbH (“MSG”), entered into a ~~Loan Agreement~~loan agreement with Sumitomo Dainippon Pharma (the “Sumitomo Dainippon Pharma Loan Agreement”). Pursuant to the Sumitomo Dainippon Pharma Loan Agreement, Sumitomo Dainippon Pharma agreed to make revolving loans to the Company in an aggregate principal amount of up to $400.0 million. On December 30, 2019, the Company borrowed an initial amount of $113.7 million under the Sumitomo Dainippon Pharma Loan Agreement, the proceeds of which were used to repay all outstanding obligations of the Company to NovaQuest Capital Management and Hercules Capital, Inc. and to satisfy certain other fees and expenses. Additional fundsFunds may be drawn down by the Company once per calendar quarter, subject to certain terms and conditions, including consent of the Company’s board of directors. In addition, if Sumitomo Dainippon Pharma fails to own at least a majority of the Company’s outstanding common shares, it may become unlawful under Japanese law for Sumitomo Dainippon Pharma to fund loans to the Company, and in which case the Company would not be able to continue to borrow under the Sumitomo Dainippon Pharma Loan Agreement. Interest is due and payable quarterly, and the outstanding principal amounts are due and payable in full on the five-year anniversary of the closing date of the Sumitomo Dainippon Pharma Loan Agreement. Loans under the Sumitomo Dainippon Pharma Loan Agreement are prepayable at any time without premium or penalty upon 10 business days’ prior written notice.

Loans under the Sumitomo Dainippon Pharma Loan Agreement bear interest at a rate per annum equal to 3-month LIBOR plus a margin of 3% payable on the last day of each calendar quarter. LIBOR is currently expected to be phased out by the end of 2021, and if it becomes unavailable, the Company and Sumitomo Dainippon Pharma will negotiate in good faith to select an alternative interest rate and, if applicable as a result of such alternative interest rate, margin adjustment that is consistent with

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industry accepted successor rates for determining a LIBOR replacement. The Company’s obligations under the Sumitomo Dainippon Pharma Loan Agreement are fully and unconditionally guaranteed by the Company and its subsidiaries. The loans and other obligations are senior unsecured obligations of the Company, MSG, and subsidiary guarantees. The Sumitomo Dainippon Pharma Loan Agreement includes customary representations and warranties and affirmative and negative covenants.

The Sumitomo Dainippon Pharma Loan Agreement also includes customary events of default, including payment defaults, breaches of representations and warranties, breaches of covenants following any applicable cure period, cross acceleration to certain other debt, failure to pay certain final judgments, certain events relating to bankruptcy or insolvency, failure of material provisions of the loan documents to remain in full force and effect or any contest thereto by the Company or any of its subsidiaries and certain breaches by the Company under the Investor Rights Agreement. Upon the occurrence of an event of default, a default interest rate of an additional 5.0% will apply to the outstanding principal amount of the loans, Sumitomo Dainippon Pharma may terminate its obligations to make loans to the Company and declare the principal amount of loans to become immediately due and payable, and Sumitomo Dainippon Pharma may take such other actions as set forth in the Sumitomo Dainippon Pharma Loan Agreement. Upon the occurrence of certain bankruptcy and insolvency events, the obligations of Sumitomo Dainippon Pharma to make loans to the Company would automatically terminate and the principal amount of the loans would automatically become due and payable. In addition, if it becomes unlawful for Sumitomo Dainippon Pharma to maintain the loans under the Sumitomo Dainippon Pharma Loan Agreement or within 30 days of a change of control with respect to the Company, the Company would be required to repay the outstanding principal amount of the Loans.

As of September 30, 2020, the outstanding loan balance of $253.7 million is classified as a long-term liability on the Company’s unaudited condensed consolidated balance sheets under the caption long-term debt, less current maturities (related party). As of September 30, 2020,2021, approximately ~~$146.3~~$41.3 million of borrowing capacity remains available to the Company, subject to the terms of the Sumitomo Dainippon Pharma Loan ~~Agreement.~~Agreement and the outstanding loan balance of $358.7 million is classified as a long-term liability on the unaudited condensed consolidated balance sheets under the caption long-term debt, less current maturities (related party). Interest expense under the Sumitomo Dainippon Pharma Loan Agreement was $2.9 million and $5.8 million for the three and six months ended September 30, 2021, respectively, and $2.1 million and $4.3 million for the three and six months ended September 30, 2020, respectively, and is included in interest expense ~~(related party)~~ in the ~~Company’s~~ unaudited condensed consolidated statements of operations. ~~There was 0 interest expense (related party) for the three and six months ended September 30, 2019.~~

~~Sumitomo Dainippon Pharma Loan Commitment~~

On August 5, 2020, the Company obtained a debt commitment letter from Sumitomo Dainippon Pharma, as amended by a letter dated September 29, 2020 (the “2020 Commitment Letter”), pursuant to which, subject to the terms and conditions set forth therein, Sumitomo Dainippon Pharma has committed to provide an additional $200.0 million in unsecured revolving commitments (the “New Credit Facility”), the proceeds of which may be used for business operating expenditures of the Company and its subsidiaries. The commitments are in addition to the commitments made available to the Company and its subsidiaries by Sumitomo Dainippon Pharma under the existing Sumitomo Dainippon Pharma Loan Agreement.

The New Credit Facility described in the 2020 Commitment Letter will not be available to the Company until the Company enters into a definitive agreement with Sumitomo Dainippon Pharma and the New Credit Facility becomes effective. Pursuant to the terms of the 2020 Commitment Letter, the New Credit Facility shall mature on the fifth anniversary of the closing of the

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New Credit Facility. Sumitomo Dainippon Pharma will have the discretion, to require certain prepayments as Sumitomo Dainippon Pharma may request and/or to not allow the Company to draw down any remaining funds under the New Credit Facility, upon the occurrence of certain material business development transactions. In addition, as a condition to entering into the New Credit Facility, the Company shall be required to enter into an information sharing agreement with Sumitovant which will be on terms to be agreed between the Company and Sumitovant. The terms and conditions of the New Credit Facility shall otherwise be substantially identical to the terms of the existing Sumitomo Dainippon Pharma Loan Agreement, including with respect to the interest rate margins, except as otherwise agreed between the Company and Sumitomo Dainippon Pharma.

Investor Rights Agreement

On December 27, 2019, the Company entered into an Investor Rights Agreement with Sumitomo Dainippon Pharma and Sumitovant (the “Investor Rights Agreement”). Pursuant to the Investor Rights Agreement, among other things, the Company agreed, at the request of Sumitovant, to register for sale, under the Securities Act of 1933, common shares beneficially owned by Sumitovant, subject to specified conditions and limitations. In addition, the Company agreed to periodically provide Sumitovant (i) certain financial statements, projections, capitalization summaries and other information and (ii) access to the Company’s books, records, facilities and employees during the Company’s normal business hours as Sumitovant may reasonably request, subject to specified limitations.

The Investor Rights Agreement also contains certain protections for the Company’s minority shareholders for so long as Sumitomo Dainippon Pharma or certain of its affiliates beneficially owns more than 50% of the Company’s common shares. These protections include: (i) a requirement that Sumitovant vote its shares for the election of independent directors in accordance with the recommendation of the Company’s board of directors (the “board”) or in the same proportion as the shareholders not affiliated with Sumitovant vote their shares; (ii) a requirement that the audit committee of the Company’s board be composed solely of 3 independent directors; (iii) a requirement that any transaction proposed by Sumitomo Dainippon Pharma or certain of its affiliates that would increase Sumitomo Dainippon Pharma’s beneficial ownership to over 60% of the outstanding voting power of the Company must be approved by the Company’s audit committee (if occurring prior to December 27, 2022), and be conditioned on the approval of shareholders not affiliated with Sumitovant approving the transaction by a majority of the common shares held by such shareholders; and a requirement that any related person transactions between Sumitomo Dainippon Pharma or certain of its affiliates and the Company must be approved by the Company’s audit committee.

Pursuant to the Investor Rights Agreement, the Company also agreed that at all times that Sumitomo Dainippon Pharma beneficially owns more than 50% of the Company’s common shares, Sumitomo Dainippon Pharma, by purchasing common shares in the open market or from the Company in certain specified circumstances, will have the right to maintain its percentage ownership in the Company’s common shares in the event of a financing event or acquisition event conducted by the Company, or specified other events, subject to specific conditions.

(B) Sumitovant

On May 18, 2020, the Company and Sumitovant entered into a consulting agreement, as amended on November 9, 2020, pursuant to which Sumitovant ~~provides~~provided consulting services to the Company and its subsidiaries to support ~~the Company in~~ commercial planning, commercial launch, ~~activities~~ and ~~implementation.~~implementation activities. Adele Gulfo, Sumitovant’s Chief Business and Commercial

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Development Officer and a member of the Company’s board of directors, ~~provides~~provided services to the Company on behalf of Sumitovant under this agreement. For the three and six months ended September 30, 2020, the Company incurred $0.2 million and $0.3 million, respectively, of expense under this consulting agreement, which isare included in ~~general and administrative (“G&A”)~~SG&A expenses in the ~~accompanying~~ unaudited condensed consolidated statements of operations. The term of the consulting agreement with Sumitovant expired on March 31, 2021.

The Company’s outstanding obligation to Sumitovant was $0.1 million as of March 31, 2021, and is included in amounts due to related parties on the unaudited condensed consolidated balance sheet. No amounts were outstanding to Sumitovant as of September 30, 2021.

Market Access Services Agreement

On August 1, 2020, one of the Company’s ~~subsidiary,~~subsidiaries, MSG, entered into ~~the~~a Market Access Services Agreement, ~~with Sunovion Pharmaceuticals Inc.~~as amended (“~~Sunovion”~~Market Access Services Agreement”), ~~a subsidiary of Sumitomo Dainippon Pharma.~~with Sunovion. Pursuant to the Market Access Services Agreement, among other things, Sunovion agreed to provide to MSG certain market access services with respect to the distribution and sale of ~~relugolix monotherapy (relugolix 120 mg)~~ORGOVYX (“Prostate Cancer Product”) and ~~relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg and norethindrone acetate 0.5 mg)~~MYFEMBREE (“Women’s Health Product,” and collectively with Prostate Cancer Product, the “Products”, and each a “Product”), including, among other things: (i) adding the Products to Sunovion’s agreements with its third party logistics providers; (ii) adding the Women’s Health Product to certain of Sunovion’s contracts with wholesalers, group purchasing organizations and integrated delivery networks and negotiating rates for the Products with certain market access customers; (iii) providing order-to-cash services; (iv) providing certain employees to provide market access account director services; (v) performing activities required in connection with supporting and

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maintaining contracts between the Company and market access customers for the coverage, purchase, or dispensing of the Products; (vi) managing the validation, processing and payment of rebates, chargebacks, and certain administrative, distribution and service fees related to the Products; (vii) providing MSG with price reporting metrics and other information required to allow the Company to comply with applicable government price reporting requirements; (viii) coordinating with MSG and any applicable wholesalers and distributors to address any recalls, investigations, or product holds; (ix) configuring, or causing to be configured, the appropriate software systems to enable Sunovion to perform its obligations under the Market Access Services Agreement; and (x) providing training and certain other ancillary support services to facilitate the foregoing. Pursuant to this agreement, Sunovion will also provide certain services to the Company to enable the Company to comply with its obligations under the State Transparency Laws.

MSG, in turn, appointed Sunovion as the exclusive distributor of the Women’s Health Product and a non-exclusive distributor of the Prostate Cancer Product, each in the United States, including all of its territories and possessions.

In order to facilitate Sunovion’s provision of these services, MSG agreed, among other things, to: (i) grant Sunovion a non-exclusive license under all intellectual property owned or controlled by MSG, solely for Sunovion’s use in connection with its performance of the contemplated services; (ii) provide Sunovion periodic reports of sales projections and estimated volume requirements, as well as such other information as Sunovion reasonably requests or may need to perform the services; (iii) comply with the provisions of any agreements between Sunovion and third parties pursuant to which the Products will be distributed or sold; (iv) cooperate with certain investigations related to orders and audits of MSG’s quality systems solely related, as reasonably determined by Myovant, to Sunovion’s performance of certain regulatory services, at Sunovion’s costs; and (v) promptly notify Sunovion in the event relugolix is recalled.

As consideration for the services, MSG has paid and will continue to pay Sunovion an agreed-upon monthly service charge for each of the first two years of the Market Access Services Agreement term and any agreed regulatory and training service charges. After the second year of the Market Access Services Agreement term, the monthly service charges will be determined by the parties. In addition, MSG also agreed to (x) reimburse Sunovion for any pass-through expenses it incurs while providing the services, and (y) establish an escrow fund for use by Sunovion ~~when managing any~~to manage payments for rebates, chargebacks and similar ~~fees.~~fees (see Note 3). For the three and six months ended September 30, 2021, the Company incurred $1.2 million and $2.4 million of expense under this agreement (inclusive of third-party pass-through costs billed to the Company), which is included in SG&A expenses in the unaudited condensed consolidated statements of operations. For the three and six months ended September 30, 2020, the Company incurred $1.1 million of expense under this agreement (inclusive of third-party ~~pass through~~pass-through costs billed to the Company), which is included in GSG&A ~~expense~~expenses in the ~~accompanying~~ unaudited condensed consolidated statements of operations. As of September 30, 2021 and March 31, 2021, the Company’s outstanding obligation pursuant to this agreement was $0.3 million and $0.4 million, respectively, and are included in amounts due to related parties on the unaudited condensed consolidated balance sheets.

The Market Access Services Agreement also contains customary representations and warranties by the parties and customary provisions related to confidentiality, indemnification and insurance. The initial term of the Market Access Services Agreement

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is three years. Thereafter, the term will be automatically extended for one-year periods, unless either party provides notice of its intent not to renew the Market Access Services Agreement at least nine (9) months prior to the expiration of the applicable term. Either party may also terminate the Market Access Services Agreement prior to the end of its term in the event of an uncured material breach by the other party, if there are certain changes of law, or if such other party becomes insolvent or undergoes a change of control. MSG may also terminate the Market Access Services Agreement with respect to one or both Products if Sunovion fails to satisfy certain market access milestones or for convenience upon payment of a break-up fee.

~~(D) Roivant Sciences Ltd.~~

As a result of the closing of the Sumitomo-Roivant Transaction described above, on December 27, 2019 all of the Company’s outstanding common shares held directly or indirectly by Roivant and not already held by Sumitovant were transferred to Sumitovant, and Roivant transferred all of the outstanding equity of Sumitovant to Sumitomo Dainippon Pharma. As a result of the transfer of these common shares, Roivant no longer beneficially owns any common shares of the Company. On December 27, 2019, the then existing Information Sharing and Cooperation Agreement between the Company and Roivant, the then existing Services Agreements between the Company and certain of its subsidiaries and Roivant and certain of its subsidiaries, and the then existing Option Agreement between the Company and Roivant were terminated. For three and six months ended September 30, 2019, the Company paid or reimbursed Roivant approximately $0.2 million and $0.4 million under the terms of the then existing Services Agreements. In addition, the Company recorded share-based compensation expense allocated from Roivant of less than $0.1 million and $0.1 million for the three and six months ended September 30, 2019, respectively. NaN amounts were incurred during the three and six months ended September 30, 2020.

Roivant purchased 2,424,242 of the Company’s common shares in the Company’s June 4, 2019 underwritten public equity offering at the same price offered to the public of $8.25 per common share, for a total purchase price of $20.0 million ~~(see Note 7).~~

Note 6—Income Taxes

The Company is not subject to taxation under the laws of Bermuda since it was organized as a Bermuda Exempted Limited Company, for which there is no current tax regime. The Company’s income tax expense is primarily based on income taxes in the U.S. for federal, state and local taxes. The Company’s effective tax rate for the three and six months ended September 30, ~~2020~~2021 was 0.69% and

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~~2019 was 0.20% and (0.28)~~ (0.92)%, respectively. The Company’s effective tax rate for the three and six months ended September 30, 2020 was 0.20% and ~~2019 was~~ (0.54)~~% and (0.37)~~%, respectively. The Company’s effective tax rate is driven by the Company’s jurisdictional earnings by location and a valuation allowance that eliminates the Company’s global net deferred tax assets.

The Company assesses the realizability of the deferred tax assets at each balance sheet date based on available positive and negative evidence in order to determine the amount which is more likely than not to be realized and records a valuation allowance as necessary. The evaluation of the need for a valuation allowance is performed on a jurisdiction-by-jurisdiction basis, and includes a review of all available positive and negative evidence. Factors reviewed include projections of pre-tax book income for the foreseeable future, determining of cumulative pre-tax book income after permanent differences, earnings history, and reliability of forecasting. The Company will continue to assess the need for a valuation allowance on its deferred tax assets by evaluating both positive and negative evidence that may exist. Any adjustment to the net deferred tax asset valuation allowance would be recorded in the consolidated statement of operations for the period that the adjustment is determined to be required.

In response to the COVID-19 pandemic, many governments have enacted or are contemplating measures to provide aid and economic stimulus. These measures include deferring the due dates of tax payments and other changes to income and non-income-based-tax laws as well as providing direct government assistance through grants and forgivable loans. On March 27, 2020, the U.S. Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was enacted in response to the COVID-19 pandemic and the negative impacts that it ~~is having~~had on the global economy and U.S. companies. The CARES Act includes measures to assist companies, including temporary changes to income and non-income-based tax laws. The Company ~~has~~ implemented certain provisions of the CARES Act, such as deferring employer payroll taxes through the end of calendar year 2020. As of September 30, ~~2020,~~2021, the Company has deferred ~~$1.2~~$1.8 million of employer payroll taxes, of which 50% are required to be deposited by December 2021 and the remaining 50% by December 2022. The current portion of the deferred payroll tax liability of $0.9 million is included in accrued expenses and other current liabilities, and the non-current portion of the deferred payroll tax liability of $0.9 million is included in other liabilities on the ~~accompanying~~ unaudited condensed consolidated balance ~~sheet.~~sheets.

Note 7—~~Shareholders’ Deficit~~Share-Based Compensation

The Company has 2 share-based compensation plans, the Myovant Sciences Ltd. 2016 Equity Incentive Plan (“Equity Incentive Plan”) and the Myovant Sciences Ltd. 2020 Inducement Plan (“Inducement Plan”) (collectively, the “Equity Plans”). As of September 30, 2021, there were approximately 2.6 million and 0.1 million common shares available for future issuance under the Equity Incentive Plan and the Inducement Plan, respectively. For additional information about the Company’s Equity Plans, see Note 10, “Share-Based Compensation,” to the Company’s audited consolidated financial statements included in its Annual Report on Form 10-K for the fiscal year ended March 31, 2021, filed with the SEC on May 11, 2021.

(A) ~~At-the-Market Equity Offering Program~~Stock Options

In April 2018, the Company entered into a sales agreement (the “Sales Agreement”) with Cowen and Company, LLC (“Cowen”), to sell its common shares having an aggregate offering price of up to $100.0 million from time to time through an “at-the-market” equity offering program under which Cowen acts as the Company’s agent. DuringActivity for stock options for the six months ended September 30, 2019, the Company issued and sold 106,494 of its common shares under the Sales Agreement. The common shares were sold at a weighted-average price of $24.65 per common share for aggregate net proceeds to the Company of approximately $2.5 million after deducting underwriting commissions paid by the Company. No shares were sold under the Sales Agreement during the three and six months ended September 30, 2020 and the three months ended September 30, 2019. As of September 30, 2020, the Company had approximately $10.4 million of capacity available to it under its “at-the-market” equity offering program.

~~(B) Underwritten Public Equity Offering of Common Shares~~

On June 4, 2019, the Company completed an underwritten public equity offering of 17,424,243 of its common shares at a public offering price of $8.25 per common share. After deducting the underwriting discounts and commissions and offering costs paid by the Company, the net proceeds to the Company in connection with the underwritten public equity offering, including from the exercise of the underwriters’ option to purchase additional common shares, were approximately $134.5 million.

~~Note 8—Share-Based Compensation~~

~~(A) Myovant 2016 Equity Incentive Plan~~

~~In June 2016, the Company adopted its 2016 Equity Incentive Plan,~~2021 is as amended (the “2016 Plan”), under which 4.5 million common shares were originally reserved for issuance. Pursuant to the “evergreen” provision contained in the 2016 Plan, the number of common shares reserved for issuance under the 2016 Plan automatically increases on April 1 of each year, commencing on (and including) April 1, 2017 and ending on (and including) April 1, 2026, in an amount equal to 4% of the total number of shares of the Company’s capital stock outstanding on March 31 of the preceding fiscal year, or a lesser number of shares as determined by the Company’s board of directors. On April 1, 2020, the number of common shares authorized for issuance increased automatically by 3.6 million shares in accordance with the evergreen provision of the 2016 Plan. As of September 30, 2020, a total of 1.1 million common shares were available for future issuance under the 2016 Plan.

The Company’s employees, directors, officers and consultants are eligible to receive non-qualified and incentive stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, and other share awards under the 2016 Plan.follows:

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~~(B) Stock Options~~

~~A summary of stock option activity under the Company’s 2016 Plan is as follows:~~

Number of Options

Options outstanding at March 31, ~~2020~~2021

8,293,331

~~7,723,302~~

Granted

~~1,679,338~~1,057,349

Exercised

~~(496,078)~~(1,255,578)

Forfeited

~~(422,505)~~(347,506)

Options outstanding at September 30, ~~2020~~2021

7,747,596

~~8,484,057~~

Options vested and expected to vest at September 30, ~~2020~~2021

~~8,484,057~~7,747,596

Options exercisable at September 30, ~~2020~~2021

4,942,410

~~4,360,312~~

~~(C)~~(B) Restricted Stock ~~Awards~~ and ~~Restricted~~Performance Stock Units

~~A summary of~~Activity for restricted stock ~~award~~units and ~~restricted~~performance stock ~~unit activity under~~units for the ~~Company’s 2016 Plan~~six months ended September 30, 2021 is as follows:


			Number of Shares
~~Unvested balance at March 31, 2020~~			~~1,280,312~~
~~Granted~~			~~2,465,139~~
~~Vested~~			~~(212,079)~~
~~Forfeited~~			~~(265,974)~~
~~Unvested balance at September 30, 2020~~			~~3,267,398~~

~~(D) Performance Stock Units~~

~~A summary of performance stock unit activity under the Company's 2016 Plan is as follows:~~

~~Number of Shares~~

Unvested balance at March 31, ~~2020~~2021

3,571,235

~~299,870~~

Granted

~~568,976~~2,691,005

Vested

~~(109,360)~~(821,342)

Forfeited

~~(37,415)~~(706,453)

Unvested balance at September 30, ~~2020~~2021

4,734,445

~~722,071~~

~~The vesting of performance stock units requires that certain performance conditions are achieved during the performance period and is subject to the employee’s continued service requirements.~~

~~(E)~~(C) Share-Based Compensation ~~Expense~~

Share-based compensation ~~expense~~during the three and six months ended September 30, 2021 and 2020 was as follows (in thousands):

Three Months Ended September 30, Six Months Ended September 30,
2020 2019 2020 2019
Share-based compensation expense recognized as:
R&D expenses $ 3,725 $ 3,618 $ 7,749 $ 6,166
G&A expenses 3,199 4,313 6,987 8,217
Total $ 6,924 $ 7,931 $ 14,736 $ 14,383


	Three Months Ended September 30,				Six Months Ended September 30,
	2021		2020		2021		2020
Share-based compensation recognized as:
R&D expense	$	5,060	$	3,725	$	9,167	$	7,749
SG&A expense	6,803		3,199		13,958		6,987
Total	$	11,863	$	6,924	$	23,125	$	14,736

~~Share-based compensation expense is included in R&D and G&A expenses in the accompanying unaudited condensed consolidated statements of operations consistent with the grantee’s salary.~~ Total unrecognized share-based compensation ~~expense~~ was ~~approximately $65.2~~approximately $109.6 million as of September 30, ~~2020~~2021 and is expected to be recognized over a weighted-average period of approximately ~~2.8~~3.02 years.

(D) Separation Agreement with Former Principal Executive Officer

In January 2021, the Company entered into a Separation and General Release Agreement with its former Principal Executive Officer. Pursuant to the terms of this agreement, all of the former Principal Executive Officer’s then outstanding and unvested equity awards became fully vested. In addition, the post-termination period during which the former Principal Executive Officer may exercise her outstanding stock options was extended to 12 months. The former Principal Executive Officer has granted Sumitovant or any Sumitovant affiliate a right of first refusal to purchase her common shares of the Company under certain circumstances and provide the Company and its affiliates a general release of claims. Share-based compensation included in SG&A expense for the three and six months ended September 30, 2021 includes $0.9 million and $2.3 million, respectively, related to the settlement and remeasurement of these awards.

As a result of the repurchase feature described above, the outstanding awards were reclassified from additional paid-in capital to current liabilities. The share-based compensation liabilities have been and will continue to be remeasured at fair value each reporting period end, with the change in fair value recorded as share-based compensation within SG&A until the stock options are exercised and the common shares are sold to Sumitovant, to the market, or otherwise settled, or the former Principal Executive Officer has held the common shares for a period of at least six months. As of September 30, 2021, a total of 573,958 outstanding stock options remain subject to the right of first refusal. The former Principal Executive Officer’s outstanding stock options remain exercisable through January 11, 2022. As of September 30, 2021 and March 31, 2021, $5.8 million and $21.6 million, respectively, is included in share-based compensation liabilities on the unaudited condensed consolidated balance sheets.

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~~Note 9—Leases~~

At September 30, 2020, the Company has lease agreements, as lessee, for office space in Brisbane, California, which are accounted for as operating leases. The lease agreements do not contain a specified implicit interest rate; therefore, the Company’s estimated incremental borrowing rate was used to determine the present value of future minimum lease payments. The lease terms for the office space includes the non-cancelable period of the lease(E) Separation Agreement with Former Principal Financial and ~~any periods covered by renewal options that the Company is reasonably certain to exercise.~~Accounting Officer

In ~~September 2020,~~August 2021, the Company entered into a ~~vehicle leasing program for certain~~Separation Agreement and General Release with its former Principal Financial and Accounting Officer. Pursuant to the terms of ~~its field-based employees. Each vehicle lease under~~ this ~~program will be executed separately for twelve-month periods~~agreement, 25% of the former Principal Financial and ~~expire at varying times with renewal~~Accounting Officer’s then outstanding and unvested equity awards became fully vested. In addition, the post-termination period during which he may exercise his outstanding stock options ~~for which the Company is not reasonably certain~~was extended to ~~exercise. The rent expense for these short-term leases will be recognized on a straight-line basis over the lease terms.~~

six months. The Company ~~currently has no other significant operating, financing, or short-term leases.~~

~~The components~~recognized share-based compensation expense within SG&A expenses during the three and six months ended September 30, 2021 of ~~the Company’s lease~~approximately $1.3 million, consisting of share-based compensation expense ~~were as follows (in thousands):~~

Three Months Ended September 30, Six Months Ended September 30,
2020 2019 2020 2019
Operating lease cost $ 729 $ 519 $ 1,458 $ 1,038
Variable lease cost (1)
100 46 190 55
Total lease cost $ 829 $ 565 $ 1,648 $ 1,093

~~(1)~~ ~~Variable lease cost includes common area maintenance and utilities costs which are not included in operating lease liabilities and which are expensed as incurred.~~

~~Certain information~~ related to the ~~Company’s operating lease right-of-use assets~~accelerated vesting of these equity awards and ~~operating lease liabilities for its Brisbane, California office space are as follows (in thousands):~~

Three Months Ended September 30, Six Months Ended September 30,
2020 2019 2020 2019
Cash paid for operating lease liabilities $ 734 $ 501 $ 1,463 $ 997
Operating lease right-of-use assets obtained in exchange for new operating lease liabilities $ 0 $ 0 $ 0 $ 9,181

Asincremental share-based compensation expense related to the modification of ~~September 30, 2020,~~ the ~~Company’s operating leases had a weighted average remaining lease term of 5.2 years and a weighted average discount rate of 12.3%.~~

~~As of September 30, 2020, maturities of operating lease liabilities were as follows (in thousands):~~

Years Ended March 31,
2021 (remainder of year) $ 1,476
2022 3,028
2023 3,127
2024 3,053
2025 2,409
Thereafter 2,898
Total lease payments 15,991
Less imputed interest (4,207)
Present value of future minimum lease payments 11,784
Less operating lease liability, current portion (1,657)
Operating lease liability, long-term portion $ 10,127
post-termination exercise period.

Note ~~10—~~8—Collaboration and License Agreements

(A) Richter Development and Commercialization Agreement ~~with Richter~~

On March 30, 2020, the Company entered into an exclusive license agreement for Richter to commercialize relugolix combination tablet for uterine fibroids and endometriosis in Europe, the Commonwealth of Independent States including Russia, Latin

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America, Australia, and New Zealand (the “Richter Development and Commercialization Agreement”). Under the ~~agreement,~~terms of the Richter Development and Commercialization Agreement, the Company received an upfront payment of $40.0 million on March 31, 2020, is eligible to receive up to $40.0 million in regulatory milestone payments (of which ~~$10.0~~$25.0 million ~~was received in April 2020)~~has been received), $107.5 million in sales-related milestones, and tiered royalties on net sales following regulatory approval.

Under the terms of the ~~agreement,~~Richter Development and Commercialization Agreement, the Company will continue to lead global development of relugolix combination tablet. The Company has also agreed to assist Richter in transferring manufacturing technology from the Company’s CMOs to Richter to enable Richter to manufacture relugolix combination tablet. ~~If requested by Richter, the~~The Company has agreed to supply Richter with quantities of relugolix combination tablet for its territories pursuant to the Company’s agreements with its CMOs. Richter will be responsible for local clinical development, manufacturing, and all commercialization activities for its territories. The Company has also granted Richter an option to collaborate with the Company on relugolix combination tablet for future indications in women’s health other than fertility.

The Company determined that the transaction price under the Richter Development and Commercialization Agreement totaled $50.0 million, consisting of the upfront payment of $40.0 million received on March 31, 2020 and a $10.0 million regulatory milestone payment received in April 2020. No other regulatory milestones, sales-related milestones, or royalties on net sales following regulatory approval were included in the transaction price given the substantial uncertainty related to their achievement.

The Company concluded that Richter represented a customer and applied relevant guidance from ASC 606, ~~to evaluate the accounting under the Richter Development and Commercialization Agreement. In accordance~~Revenue from Contracts with ~~this guidance, the~~Customers. The Company identified one material combined performance obligation to grant a license to Richter to certain of its intellectual property and to deliver certain clinical and regulatory data packages for relugolix combination ~~therapy,~~tablet, the drug used for both potential indications of uterine fibroids and endometriosis. The Company determined that its grant of a license to Richter to certain of its intellectual property was not distinct from the delivery of certain clinical and regulatory data packages pertaining to relugolix combination ~~therapy.~~tablet. In evaluating the appropriate measure for the ~~Company's~~Company’s performance under the combined performance obligation, the Company determined that revenues should be recognized as data packages are ~~issued~~delivered to Richter based on the relative value of the data packages delivered to date compared to the totality of the data packages it is obligated to deliver under the Richter Development and Commercialization Agreement. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Based upon the ~~Company's~~Company’s assessment of its progress toward delivering relugolix combination ~~therapy~~tablet clinical and regulatory data packages to Richter, the Company concluded that ~~as of~~during the six months ended September 30, 2020, it ~~had~~ satisfied approximately two-thirds of the combined performance ~~obligation. As a result, the Company~~obligation and recognized $33.3 million of the transaction price as Richter license and milestone revenue during the six months ended September 30, ~~2020~~.2020. There ~~were 0~~was no such ~~amounts~~revenue in the three months ended September 30, ~~2020 or the~~ ~~comparable prior year periods. As the~~2020. The Company ~~currently expects to deliver the remaining substantive relugolix combination therapy data packages to Richter in the fourth quarter of the fiscal year ending March 31, 2021, the Company has recorded~~recognized the remaining $16.7 million of the transaction price as Richter license and milestone revenue during the three and six months ended September 30, 2021, as the Company completed delivery of the remaining substantive relugolix combination tablet data packages to Richter.

On July 16, 2021, the European Commission approved RYEQO as the first and only long-term, once-daily oral treatment in Europe for moderate to severe symptoms of uterine fibroids in adult women of reproductive age. This approval triggered a $15.0 million regulatory milestone payment from Richter, which the Company recorded as Richter license and milestone revenue during the three and six months ended September 30, 2021.

The term of the Richter Development and Commercialization Agreement shall expire on a country-by-country basis upon expiry of the Royalty Term for the Product in a country in the Richter Territory. The Richter Development and Commercialization Agreement may be terminated in its entirety or on a country-by-country basis by mutual consent of the parties, or by either party for the uncured material breach of other party, for bankruptcy of the other party, and for certain other reasons in accordance with the terms of the Richter Development and Commercialization Agreement.

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(B) Pfizer Collaboration and License Agreement

On December 26, 2020, one of the Company’s subsidiaries, MSG, and Pfizer, entered into a collaboration and license agreement (the “Pfizer Collaboration and License Agreement”), pursuant to which the Company and Pfizer will collaborate to jointly develop and commercialize relugolix in oncology and women’s health in the U.S. and Canada (the “Co-Promotion Territory”). In addition, Pfizer also received an option to acquire exclusive commercialization and development rights to relugolix in oncology outside the Co-Promotion Territory, excluding certain Asian countries (the “Pfizer Territory”). Pfizer notified the Company on October 22, 2021 of their decision to decline this option.

In the Co-Promotion Territory, the Company and Pfizer will equally share profits and certain expenses, including certain pre-launch inventory costs incurred by the Company prior to the effective date of the Pfizer Collaboration and License Agreement (the “Allowable Expenses”). The Company will remain responsible for regulatory interactions and drug supply and will continue to lead clinical development for MYFEMBREE in the women’s health indications, while development for ORGOVYX will be shared equally among the parties.

In the Co-Promotion Territory, the Company will be the principal on all sales transactions with third parties and will recognize 100% of product sales to third parties as revenue from contracts with customers. The Company concluded that based on the principal vs. agent guidance in ASC 606, it has primary responsibility for fulfilling customer orders, controls inventory before it is sold to third party customers, assumes the risk of inventory loss, and maintains discretion in establishing product price.

Pursuant to the terms of the Pfizer Collaboration and License Agreement, the Company received an upfront payment of $650.0 million in December 2020, and is eligible to receive up to $3.7 billion of milestone payments, including 2 regulatory milestones of $100.0 million upon each FDA approval for MYFEMBREE in uterine fibroids and endometriosis ($200.0 million in the aggregate), and tiered sales milestones of up to $3.5 billion upon reaching certain thresholds of annual net sales for oncology and the combined women’s health indications in the Co-Promotion Territory. In July 2021, the Company received a $100.0 million regulatory milestone payment from Pfizer that was triggered upon the FDA approval of MYFEMBREE for the management of heavy menstrual bleeding associated with uterine fibroids on May 26, 2021.

Pursuant to the terms of the Pfizer Collaboration and License Agreement, the Company will bear Pfizer’s share of Allowable Expenses, up to a maximum of $100.0 million for calendar year 2021 and up to a maximum of $50.0 million for calendar year 2022. Any unused portion will carry over into the subsequent calendar years until the Company has assumed in aggregate $150.0 million of Pfizer’s share of the Allowable Expenses.

The term of the Pfizer Collaboration and License Agreement continues until no products are sold and all development activities have terminated in the Co-Promotion Territory. The Pfizer Collaboration and License Agreement may be terminated early by either party for the uncured material breach of the other party or for bankruptcy or other insolvency proceeding of the other party. In addition, Pfizer has certain other termination rights and may terminate the Pfizer Collaboration and License Agreement early upon providing written notice to the Company pursuant to the terms of the Pfizer Collaboration and License Agreement.

The Company assessed the Pfizer Collaboration and License Agreement and determined that it meets both criteria to be considered a collaborative agreement within the scope of ASC 808, Collaborative Arrangements: active participation by both parties and exposures to significant risks and rewards dependent on the commercial success of the activities. Although the Company is lead party and will perform many activities, both development and commercialization responsibilities are assigned between parties and both parties participate on joint steering and other committees overseeing the collaboration activities. Both parties are exposed to significant risks and rewards based on the economic outcomes of the collaboration through cost sharing and profit (loss) sharing provisions. Net payments to/from Pfizer for Pfizer’s share of the net profits and Allowable Expenses will be disaggregated and presented in the Company’s consolidated statements of operations according to the nature of the expense (e.g., collaboration expense, R&D expenses, or SG&A expenses).

As discussed above, the Company received a $650.0 million upfront payment from Pfizer in December 2020, of which $150.0 million is Pfizer’s advanced reimbursement for Pfizer’s share of Allowable Expenses (up to $100.0 million for calendar year 2021 and up to $50.0 million for calendar year 2022). The Company concluded that the prepayment by Pfizer of its share of Allowable Expenses represents a significant financing component since the Company received the cash flows at the outset of the arrangement, rather than over a two-year period. Accordingly, the Company reduced the amount of the advanced reimbursement by approximately $3.6 million, representing the implied financing costs based on the Company’s incremental borrowing ratethat was derived based on the Sumitomo Dainippon Pharma Loan Agreement, and recorded the discounted value on the consolidated balance sheet as a deposit liability (cost share advance from Pfizer) as of the transaction date, split between a current and a non-current portion, based on the expected timing of Allowable Expenses subject to cost share. The financing component has been and will continue to be accreted to interest expense utilizing a method that approximates the effective yield method over the period in which the cost share advance is expected to be used. The remainder of the upfront

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payment was recorded as deferred revenue and has been and will continue to be recognized as Pfizer collaboration revenue on a straight-line basis over the estimated term of the agreement of six years, which was estimated by the Company based upon the terms of the Pfizer Collaboration and License Agreement, including the termination provisions contained therein. The Company determined straight-line amortization to be appropriate because the upfront payment represents payment for Pfizer’s right to participate in the collaboration activities, including both commercialization and development activities, which are expected to be realized evenly over this period.

The achievement of regulatory milestones is outside of the Company’s control and therefore was not deemed probable at contract inception. Amounts associated with the regulatory milestones were not initially recognized. Upon achievement of the related regulatory milestones, cumulative catch-up revenue will be recorded as Pfizer collaboration revenue in the period in which the respective regulatory milestone is achieved, and the remainder will be recognized over the remaining contract term. The Company determined that, conceptually, the regulatory milestone payments represent payment for development activities that will continue to benefit the collaboration as the products move toward commercialization. Accordingly, the recognition of revenue associated with the regulatory milestones follows the same amortization model as the upfront payment described above.

Similar to the regulatory milestones, sales-based milestone payments will not initially be recognized due to the uncertainty associated with the future commercial outcomes of ORGOVYX and MYFEMBREE. Upon achievement, the sales-based milestones will be recognized as revenue immediately in the period when the annual sales thresholds are met as the payments represent consideration for past activities that are completed and culminated in the annual sales thresholds being met.

Amounts due to Pfizer as of September 30, 2021 totaling approximately $20.0 million consisted of $8.6 million payable to Pfizer for Pfizer’s 50% share of net profits on sales of ORGOVYX and MYFEMBREE in the U.S. and approximately $11.4 million reimbursement of Allowable Expenses incurred by Pfizer. Amounts due to Pfizer as of March 31, 2021 totaling approximately $1.9 million consisted of $1.8 million payable to Pfizer for Pfizer’s 50% share of net profits on sales of ORGOVYX in the U.S. and approximately $0.1 million reimbursement of Allowable Expenses incurred by Pfizer.

The following table presents changes in the Company’s contract liabilities during the six months ended September 30, 2021 (in thousands):


	Balance at March 31, 2021		Additions		Imputed Interest		Deductions		Balance at September 30, 2021
Contract liabilities:
Deferred revenue (1)	$	497,933	$	100,000	$	—	$	(71,348)	$	526,585
Cost share advance from Pfizer (2)	$	121,862	$	—	$	1,210	$	(38,304)	$	84,768

(1) Includes $100.6 million and $426.0 million presented as current ~~liability,~~and non-current, respectively, on the unaudited condensed consolidated balance sheet as of September 30, ~~2020.~~2021. Includes $100.6 million and $397.4 million presented as current and non-current, respectively, on the unaudited condensed consolidated balance sheet as of March 31, 2021.

~~Contract Balances~~(2) Includes $84.8 million presented as current on the unaudited condensed consolidated balance sheet as of September 30, 2021. Includes $92.4 million and $29.4 million presented as current and non-current, respectively, on the unaudited condensed consolidated balance sheet as of March 31, 2021.

~~Upfront payments and fees are recorded as deferred revenue upon receipt or when due, and may require deferral of revenue recognition to a future period until~~During the Company performs its obligations under these agreements. Amounts payable to the Company are recorded as accounts receivable when the Company's rights to consideration is unconditional. The following table presents changes in the Company’s total contract liabilities during the six months ended September 30, ~~2020~~ ~~(in thousands):~~

Balance at Balance at
March 31, 2020 Additions Deductions September 30, 2020
Contract liabilities:
Deferred revenue, current $ 40,000 $ 10,000 $ (33,333) $ 16,667

~~Deferred~~2021, deferred revenue ~~related to~~increased by $28.7 million. The net increase was the ~~Richter Development and Commercialization Agreement as~~result of ~~September 30, 2020, which was comprised of the $50.0 million transaction price, including~~ a ~~$40.0 million upfront payment received in March, 2020 and a $10.0~~$100.0 million regulatory milestone from Pfizer that was triggered upon the FDA approval of MYFEMBREE for the management of heavy menstrual bleeding associated with uterine fibroids on May 26, 2021. The increase in deferred revenue was partially offset by the recognition of $54.7 million of Pfizer collaboration revenue and $16.7 million of previously deferred revenue associated with the upfront and regulatory milestone payments the Company received from Richter in March and April 2020, ~~less the revenue recognized from the effective date of the contract, will be recognized as revenue as the combined performance obligation is satisfied.~~respectively.

~~The Company had 0 receivables or contract assets as of September 30, 2020 or March 31, 2020.~~ During the six months ended September 30, ~~2020, the Company's contract liabilities, which consisted of deferred revenue,~~2021, cost share advance from Pfizer decreased by ~~$23.3~~$37.1 million. ~~This~~The decrease ~~included deductions~~was the net result of ~~$33.3~~the application of shared Allowable Expenses incurred by the Company and 50% of reimbursement of Allowable Expenses incurred by Pfizer of $38.3 million ~~related~~(comprised of $13.9 million and $24.4 million in reductions to ~~revenue recognized during the~~ ~~six months ended September 30, 2020~~R&D expenses and SG&A expenses, respectively), partially offset by ~~additions~~accretion of ~~$10.0 million related to a regulatory milestone received in April, 2020.~~the implied financing component of $1.2 million.

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Note ~~11—~~9—Commitments and Contingencies

(A) Legal Contingencies

The Company may be, from time to time, a party to various disputes and claims arising from normal business activities. The Company accrues for loss contingencies when available information indicates that it is probable that a liability has been incurred and the amount of such liability can be reasonably estimated. For cases in which the Company believes that a reasonably possible loss exists, the Company discloses the facts and circumstances of the loss contingency, including an estimable range, if possible. The Company is currently not involved in any material legal proceedings.

(B) Contract Service Providers

In the normal course of business, the Company enters into agreements with contract service providers to assist in the performance of its R&D and clinical and commercial manufacturing activities. Subject to required notice periods and the Company’s obligations under binding purchase orders, the Company can elect to discontinue the work under these agreements at any time. The Company expects to enter into additional collaborative research, contract research, clinical and commercial manufacturing, and supplier agreements in the future, which may require upfront payments and long-term commitments of capital resources.

The Company has agreed to indemnify its officers and directors for certain events or occurrences, subject to certain limits, while the officer or director was serving at the Company’s request in such capacity. The maximum amount of potential future indemnification liability is unlimited; however, the Company holds directors’ and officers’ liability insurance which limits the Company’s exposure and may enable it to recover a portion of any future amounts paid. In the normal course of business, the Company also enters into contracts and agreements with service providers and other parties with which it conducts business that contain indemnification provisions pursuant to which the Company has agreed to indemnify the party against certain types of third-party claims. The Company has agreed to indemnify Sumitomo Dainippon Pharma against certain losses, claims, liabilities and related expenses incurred by Sumitomo Dainippon Pharma, subject to the terms of the Sumitomo Dainippon Pharma Loan Agreement and the Investor Rights Agreement. The Company has also agreed to indemnify Sunovion against certain losses, claims, liabilities and related expenses incurred by Sunovion, subject to the terms of the Market Access Services Agreement. The Company has not experienced any material losses related to these indemnification obligations, and no material claims with respect thereto were outstanding. The Company does not expect significant claims related to these indemnification obligations and, consequently, concluded that the fair value of these obligations is negligible, and no related accruals have been established.

(D) Takeda Agreements

~~Under~~On April 29, 2016, Takeda Pharmaceuticals International AG (“Takeda”), a subsidiary of Takeda Pharmaceutical Company Limited, the ~~Company’s~~originator of relugolix, granted the Company a worldwide license to develop and commercialize relugolix (excluding Japan and certain other Asian countries) and an exclusive right to develop and commercialize MVT-602 in all countries worldwide. Pursuant to the license agreement (the “Takeda License Agreement”) ~~with~~, Takeda granted to the Company an exclusive, royalty-bearing license under certain patents and other intellectual property controlled by Takeda to develop and commercialize relugolix and MVT-602, and products containing these compounds for all human diseases and conditions. Under the Takeda License Agreement, the Company will pay Takeda a fixed, high single-digit royalty on net sales of relugolix and MVT-602 products in the Company’s territory, subject to certain agreed reductions. As of September 30, 2021 and March 31, 2021, the Company recorded royalties payable to Takeda of $1.6 million and $0.3 million, respectively, which are included in the caption accrued expenses and other current liabilities on the unaudited condensed consolidated balance sheets. Takeda will pay the Company a royalty at the same rate on net sales of relugolix products for prostate cancer in the Takeda Territory, subject to certain agreed reductions. Royalties are required to be paid, on a product-by-product and country-by-country basis, until the latest to occur of the expiration of the last to expire valid claim of a licensed patent covering such product in such country, the expiration of regulatory exclusivity for such product in such country, or 10 years after the first commercial sale of such product in such country. Under the Takeda License Agreement, there was no upfront payment and there are no payments upon the achievement of clinical development or marketing approval milestones. As the amount and timing of any potential future payments under the Takeda License Agreement are not probable and estimable, no such potential commitments have been included in the unaudited condensed consolidated balance sheet.

If the Takeda License Agreement is terminated in its entirety or with respect to relugolix for prostate cancer, other than for safety reasons or by the Company for Takeda’s uncured material breach, prior to receipt of the first regulatory approval of relugolix for prostate cancer in Japan, then the Company must either reimburse Takeda for its out of pocket costs and expenses directly incurred in connection with Takeda’s completion of the relugolix development for prostate cancer, up to an agreed upon cap, or complete by itself the conduct of any clinical studies of relugolix for prostate cancer that are ongoing as of the effective date of such termination, at its cost and expense.

~~Pursuant to~~

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In May 2018, the Company entered into a Commercial Manufacturing and Supply Agreement ~~entered into~~ with Takeda (the “Takeda Commercial Supply Agreement”), pursuant to which Takeda agreed to supply the Company and the Company agreed to obtain from Takeda certain quantities of relugolix drug substance according to agreed-upon quality specifications. For relugolix drug substance manufactured or delivered on or after December 31, 2019, the Company will pay Takeda a price per kilogram of relugolix drug substance to be agreed upon between the parties at the beginning of each fiscal year.

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The initial term of the Takeda Commercial Supply Agreement began on May 30, 2018 and will continue for five years. At the end of the initial term, the Takeda Commercial Supply Agreement will automatically renew for successive one-year terms, unless either party gives notice of termination to the other at least 12 months prior to the end of the then-current term. The Takeda Commercial Supply Agreement may be terminated by either party upon 90 days’ notice of an uncured material breach of its terms by the other party, or immediately upon notice to the other party of a party’s bankruptcy. Each party will also have the right to terminate the Takeda Commercial Supply Agreement, in whole or in part, for any reason upon 180 days’ prior written notice to the other party, provided that any then-open purchase orders will remain in effect and be binding on both parties. The Takeda Commercial Supply Agreement, including any then-open purchase orders thereunder, will terminate immediately upon the termination of the Takeda License Agreement in accordance with its terms.

Note ~~12—~~10—Subsequent Events

~~(A) Sumitomo Dainippon Pharma Loan Agreement~~

~~Pursuant~~On October 22, 2021, the Company was notified by Pfizer of their decision to decline the ~~terms of~~exclusive option for international commercialization and development rights (excluding Canada and certain Asian countries) to relugolix in oncology, as offered under the ~~Sumitomo Dainippon Pharma Loan~~Pfizer Collaboration and License Agreement (see Note 5), the Company is permitted to draw down funds once per calendar quarter, subject to certain conditions. In October 2020, the Company borrowed $60.0 million under the Sumitomo Dainippon Pharma Loan Agreement. Subsequent to this draw, approximately $86.3 million of borrowing capacity remains available to the Company.

~~(B) 2020 Inducement Plan~~8(B)).

On November 4, 2020, the Compensation Committee of the Board of Directors of the Company adopted the Myovant Sciences Ltd. 2020 Inducement Plan (the “2020 Inducement Plan”), which, subject to the adjustment provisions thereof, reserved 1,000,000 shares of the Company’s common shares for issuance pursuant to equity awards granted under the 2020 Inducement Plan. The 2020 Inducement Plan was adopted without shareholder approval pursuant to the Listed Company Manual Rule 303A.08 (“Rule 303A.08”) of the New York Stock Exchange (the “NYSE”). The 2020 Inducement Plan provides for the grant of restricted stock units and non-qualified stock options, and contains terms and conditions intended to comply with the inducement award exception under the NYSE rules. In accordance with Rule 303A.08, awards under the 2020 Inducement Plan may only be made to individuals not previously employees of the Company, or being rehired following a bona fide period of interruption of employment, as an inducement material to such individuals’ entering into employment with the Company. An award is a right to receive the Company’s common shares pursuant to the 2020 Inducement Plan pursuant to a restricted stock unit award or a non-qualified stock option award. Through November 12, 2020, the date of issuance of this Quarterly Report on Form 10-Q, there have been no grants made pursuant to the terms of the 2020 Inducement Plan.

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

~~The following discussion~~This Management’s Discussion and ~~analysis~~Analysis of ~~our financial condition, results~~Financial Condition and Results of ~~operations and cash flows~~Operations should be read in conjunction with ~~(1) the~~our unaudited condensed consolidated financial statements and ~~the related~~ notes thereto included ~~elsewhere~~ in Part I, Item 1 of this Quarterly Report on Form 10-Q (“Quarterly Report”) and ~~(2) the~~our audited consolidated financial statements and notes thereto ~~and management’s discussion and analysis of financial condition and results of operations~~ for the fiscal year ended March 31, ~~2020~~2021 included in our Annual Report on Form 10-K, filed with the SEC on May ~~18, 2020.~~ 11, 2021.

Unless otherwise indicated, all results presented are prepared in a manner that complies, in all material respects, with U.S. generally accepted accounting principles (“U.S. GAAP”). Additionally, unless otherwise indicated, all changes identified for the ~~context requires otherwise, references in this Quarterly Report on Form 10-Q~~current period results represent comparisons to ~~“Myovant,”~~ the ~~“Company,” “we,” “us,” and “our” refer to Myovant Sciences Ltd. and its wholly-owned subsidiaries.~~results for the corresponding prior year period.

Forward-Looking Statements

This Quarterly Report ~~on Form 10-Q~~ contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”). These statements are often identified by the use of words such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “to be,” “will,” “would,” or the negative or plural of these words, or similar expressions or variations, although not all forward-looking statements contain these words. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those expressed or implied by these forward-looking statements.

The forward-looking statements appearing in a number of places throughout this Quarterly Report ~~on Form 10-Q~~ include, but are not limited to, statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things:

•~~the impact of pandemics, epidemics or outbreaks of infectious diseases, including the effect that the COVID-19 pandemic~~our and ~~related “shelter-in-place” orders~~our collaboration partners’ ability to successfully plan for and ~~other measures will have on our business operations, financial conditions and results of operations;~~commercialize ORGOVYX®, MYFEMBREE®, RYEQO®, as well as any product candidates, if approved;

•the success and anticipated timing of our clinical studies for ~~relugolix combination therapy (relugolix 40 mg, plus estradiol 1.0 mg and norethindrone acetate 0.5 mg), relugolix 120 mg as a monotherapy, and MVT-602;~~our product candidates;

•the anticipated start dates, durations and completion dates of our ongoing and future nonclinical and clinical studies;

•the anticipated designs of our future clinical studies;

•the anticipated future regulatory submissions and the timing of, and our ability to, obtain and maintain regulatory approvals for ~~relugolix combination tablet, relugolix monotherapy tablet, MVT-602 and any future~~our product candidates;

•Table of Contents~~our ability to successfully plan for and commercialize relugolix combination tablet and relugolix monotherapy tablet, if approved;~~

•our ability to procure sufficient quantities of commercial relugolix drug substance and drug product from approved third party CMOs;

•our ability to achieve commercial sales of any approved products, whether alone or in collaboration with others;

•our ability to obtain and maintain reimbursement and coverage from government and private payers for our products if commercialized;

•the rate and degree of market acceptance and clinical utility of any approved products;

•our ability to initiate and continue relationships with third-party clinical research organizations and ~~manufacturers;~~manufacturers and third-party logistics providers;

•our ability to quickly and efficiently identify and develop new product candidates;

•the impact of pandemics, epidemics or outbreaks of infectious diseases, including the effect that the COVID-19 pandemic and related public health measures will have on our business operations, financial conditions and results of operations;

•our ability to hire and retain our management and other key personnel;

•our ability to obtain, maintain and enforce intellectual property rights for our products and product candidates;

•our estimates regarding our results of operations, financial condition, liquidity, capital requirements, access to capital, prospects, growth and strategies;

•our ability to continue to fund our operations with the cash, cash equivalents, and marketable securities currently on hand, including our expectations for how long these capital resources will enable us to fund our operations;

•our expectations regarding potential future payments that we are eligible to receive from Pfizer under the Pfizer Collaboration and License Agreement and Richter under the Richter Development and Commercialization Agreement;

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•our ability to borrow under the Sumitomo Dainippon Pharma Loan ~~Agreement and our ability to effect the new debt facility transaction with Sumitomo Dainippon Pharma pursuant to the 2020 Commitment Letter with Sumitomo Dainippon Pharma;~~Agreement;

•third party collaboration ~~partners'~~partners’ abilities to perform their obligations under our agreements with them;

•our ability to raise additional capital if needed, on acceptable terms to us;

•industry trends;

•developments and projections relating to our competitors or our industry; and

•the success of competing drugs that are or may become available.

Such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors known and unknown that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified herein, particularly in the section titled “Risk Factors” set forth in Part II. Item 1A. of this Quarterly Report, ~~on Form 10-Q,~~ and in our other filings with the SEC. These risks are not exhaustive. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report, ~~on Form 10-Q,~~ and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements.

~~All brand names or trademarks appearing in this Quarterly Report on Form 10-Q are the property of their respective owners.~~

Business Overview

We are a ~~healthcare~~biopharmaceutical company ~~that aspires to redefine~~focused on redefining care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. ~~Our lead product candidate is relugolix, a once-daily, oral GnRH receptor antagonist. Relugolix monotherapy tablet (120~~Founded in 2016, we have two FDA-approved products: (1) ORGOVYX® (relugolix 120 mg) ~~is under regulatory review~~, which was approved in the U.S. by the U.S. Food and Drug Administration (“FDA”) in

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December 2020 as the first and only oral gonadotropin-releasing hormone (“GnRH”) receptor antagonist for ~~men~~the treatment of adult patients with advanced prostate ~~cancer. Relugolix combination tablet~~cancer; and (2) MYFEMBREE® (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg), which was approved in the U.S. by the FDA in May 2021 as the first and only once-daily oral treatment for the management of heavy menstrual bleeding associated with uterine fibroids. In July 2021 and August 2021, the European Commission and the Medicines and Healthcare products Regulatory Agency, respectively, approved RYEQO® (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) as the first and only long-term, once-daily oral treatment in the European Union and the United Kingdom, respectively, for moderate to severe symptoms of uterine fibroids in adult women of reproductive age. In September 2021, the FDA accepted our supplemental New Drug Application (“sNDA”) for MYFEMBREE for the management of moderate to severe pain associated with endometriosis, setting a target action date of May 6, 2022. MYFEMBREE is also being evaluated for contraceptive efficacy in women with heavy menstrual bleeding associated with uterine fibroids or endometriosis-associated pain who are 18 to 50 years of age and at risk for pregnancy. Relugolix (120 mg) is also under regulatory review in ~~the U.S. and~~ Europe for ~~women~~men with ~~uterine fibroids and is under development for women with endometriosis.~~advanced prostate cancer. We are also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, which has completed a Phase 2a study for the treatment of female infertility as a part of assisted reproduction.

Takeda granted us a worldwide license to develop and commercialize relugolix (excluding Japan and certain other Asian countries) and an exclusive right to develop and commercialize MVT-602 in all countries worldwide. On March 30, 2020, we entered into an exclusive license agreement with Richter for Richter to commercialize relugolix combination tablet for uterine fibroids and endometriosis in certain territories outside of the U.S. Under this agreement, we have retained all of our rights to relugolix combination tablet in the U.S. and Canada, as well as rights to relugolix in other therapeutic areas outside of women’s health.

Since our inception, we have ~~devoted substantially all~~funded our operations primarily from the issuance and sale of our ~~efforts to identifying~~common shares, from debt financing arrangements, and ~~in-licensing our~~more recently from the upfront and regulatory milestone payments we received from Pfizer Inc. (“Pfizer”) and Gedeon Richter Plc. (“Richter”). We began generating product ~~candidates, organizing~~revenue from the sales of ORGOVYX and ~~staffing our company, raising capital, preparing for~~MYFEMBREE in the U.S. in January 2021 and advancing the clinical development of our product candidates and preparing for potential future regulatory approvals and commercialization of relugolix combination tablet and relugolix monotherapy tablet.June 2021, respectively.

Our majority shareholder is Sumitovant Biopharma Ltd. (“Sumitovant”), a wholly-owned subsidiary of Sumitomo Dainippon ~~Pharma.~~Pharma Co., Ltd. (“Sumitomo Dainippon Pharma”). As of September 30, ~~2020,~~2021, Sumitovant directly, and Sumitomo Dainippon Pharma indirectly, own ~~48,641,181,~~50,041,181, or approximately ~~53.7%~~53.8%, of our outstanding common shares.

Second Fiscal Quarter Ended September 30, ~~2020~~2021 and Recent ~~Corporate~~Business Updates

~~The following summarizes~~Below is a summary of certain events during our second fiscal quarter ended September 30, ~~2020~~2021 and recent ~~corporate updates, as well as anticipated upcoming milestones.~~business updates. Additional information about our business, our products, and our product candidates is included in Part I. Item 1., “Business,” included in our Annual Report on Form 10-K, filed with the SEC on May 11, 2021.

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~~Relugolix Clinical Programs~~Products and Product Candidates

•~~Prostate Cancer~~:

◦~~Relugolix monotherapy tablet is under Priority Review by~~In October 2021, we and Pfizer presented data from clinical studies of MYFEMBREE at the ~~U.S. Food and Drug Administration~~American Society for Reproductive Medicine (“~~FDA”~~ASRM”) ~~and is on track for a decision by its December 20, 2020 target action date. The NDA is supported by the positive Phase 3 HERO study~~2021 Congress, including results including a 97% responder rate and six positive key secondary endpoints. Relugolix also demonstrated a lower incidence of major adverse cardiovascular events compared to leuprolide acetate, the current standard of care. The Phase 3 HERO study results were published in the ~~New England Journal of Medicine~~ ~~on June 4, 2020.~~

◦On September 29, 2020, we announced results of an additional secondary endpoint of castration resistance-free survival assessed in the subgroup of men with metastatic prostate cancer from the Phase 3 HERO study of relugolix monotherapy in advanced prostate cancer. Relugolix monotherapy had a similar rate of castration resistance-free survival compared to leuprolide acetate (74% vs. 75%, respectively), and did not achieve statistical superiority (p = 0.84).

◦~~On October 19, 2020, we presented an economic analysis~~ of the Phase 3 ~~HERO data at~~LIBERTY randomized withdrawal study, which was designed to evaluate the ~~Academy~~efficacy and safety of Managed Care Pharmacy (“AMCP”) Nexus 2020 Virtual Meeting, demonstrating that treatment with relugolix may prevent one major adverse cardiovascular event for every 31 patients treated versus patients receiving leuprolide injections.

◦We currently expect to submit a Marketing Authorisation Application (“MAA”) to the European Medicines Agency (“EMA”) for relugolix monotherapy tablet for advanced prostate cancer in the first half of calendar year 2021.

•~~Uterine Fibroids~~:

◦~~In August 2020, the FDA accepted our New Drug Application (“NDA”) for~~ relugolix combination ~~tablet~~therapy for ~~the treatment of~~up to two years in women with heavy menstrual bleeding associated with uterine fibroids, and was designated an ASRM Prize Paper. Additional data presentations at ASRM included data from the SPIRIT 1 and 2 studies of women with pain associated with endometriosis as well as pooled safety and tolerability data from the LIBERTY and SPIRIT clinical programs.

•In September 2021, the FDA accepted our sNDA for MYFEMBREE for the management of moderate to severe pain associated with endometriosis, setting a target action date of ~~June 1,~~May 6, 2022. FDA approval of MYFEMBREE for this indication would trigger a $100.0 million regulatory milestone payment from Pfizer.

•In August 2021, the FDA informed us that the partial clinical hold for the Phase 3 SERENE study evaluating MYFEMBREE for the prevention of pregnancy was lifted following study protocol amendments. The primary analysis of the study, prevention of pregnancy, remains unchanged, but now the SERENE study will only evaluate women with a confirmed diagnosis of uterine fibroids or endometriosis. Bone mineral density monitoring will occur throughout the treatment period as well as after treatment is discontinued to gain additional insights into bone health, which will augment the safety profile observed in the LIBERTY and SPIRIT programs. The enrollment target was increased to 1,020 patients who are 18 to 50 years of age and at risk for pregnancy, enhancing the power of the study. Patient screening with this updated protocol began in September 2021, with initial patients dosed in October 2021.

◦•On ~~September 14, 2020, we announced one-year data on bone mineral density (“BMD”) from~~July 16, 2021 and August 9, 2021, the ~~Phase 3 LIBERTY program. The BMD results from~~European Commission and the ~~LIBERTY program demonstrated maintenance of BMD through one year~~Medicines and were consistent with those observed in a separate prospective observational study of untreated, age-matched women with uterine fibroids. These findings were presented at the American Society for Bone and Mineral Research (“ASBMR”) 2020 Annual Meeting Virtual Event, held on September 11-15, 2020.

◦~~On March 9, 2020, we announced the submission of a MAA to the EMA for relugolix combination tablet~~Healthcare products Regulatory Agency, respectively, approved RYEQO for the treatment of ~~women with~~ moderate to severe symptoms ~~associated~~of uterine fibroids in adult women of reproductive age. RYEQO is the first and only long-term, once-daily oral treatment for uterine fibroids with ~~uterine fibroids. The application has completed validation and is now under evaluation by the EMA. We currently expect~~no limitation on its duration of use approved in the European ~~Commission decision~~Union and the United Kingdom. The approval was based on ~~this application in 2021. If approved, this launch will be executed by~~safety and efficacy data from the global Phase 3 LIBERTY program, which consisted of two replicate, 24-week, multinational clinical studies (LIBERTY 1 and LIBERTY 2), a one-year extension study, and supportive bone mineral density data from a randomized withdrawal study. Richter, our commercialization partner for ~~relugolix combination tablet for the uterine fibroids and endometriosis indications~~RYEQO in Europe and certain other international ~~markets.~~

◦~~On October 21, 2020, we announced the presentation of data at the American Society for Reproductive Medicine (“ASRM”) 2020 Virtual Congress, including long-term extension data~~markets, has launched RYEQO in women with symptomatic uterine fibroids. Results indicated that women experienced, on average, a 90% reduction in menstrual blood loss from baseline at one year. Additionally, 87.7% of women achieved the responder criteria for reduction in menstrual blood loss at one year, and lumbar spine and total hip BMD were maintained over one year. A poster presentation also described a validated exposure-response model simulating long-term effects of relugolix combination therapy on BMD at the lumbar spine that projected maintenance of BMD for at least three years. Other data from the LIBERTY program including improvement in quality of life, reduction in menstrual blood loss in the first treatment cycle, and reduction in uterine fibroid-associated pain, were also presented.

◦Additional data from the Phase 1 ovulation inhibition study from 67 healthy women treated with relugolix combination therapy, resulting in 100% ovulation inhibition and 100% return to ovulation or menses after discontinuation of treatment, were also presented at the ASRM 2020 Virtual Congress.

seven countries since these regulatory approvals.

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Corporate

•~~Endometriosis~~:For the three months ended September 30, 2021, we generated net product revenue from sales of ORGOVYX and MYFEMBREE of $18.7 million and $0.6 million, respectively.

◦•~~Data~~In the three months ended September 30, 2021, we received a $100.0 million regulatory milestone payment from Pfizer that was triggered upon the FDA approval of MYFEMBREE on May 26, 2021 as the first and only once-daily oral treatment for the management of heavy menstrual bleeding associated with uterine fibroids in the U.S. In the three months ended September 30, 2021, we also received a $15.0 million regulatory milestone payment from Richter that was triggered upon the European Commission approval of RYEQO for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

•As of September 30, 2021, we had cash, cash equivalents and marketable securities of $616.0 million. We believe that our existing cash, cash equivalents, and marketable securities will be sufficient to fund our anticipated operating expenses and capital expenditure requirements for at least the next 12 months from the ~~replicate~~date of issuance of this Quarterly Report.

•On October 22, 2021, we were notified by Pfizer of their decision to decline the exclusive option for international commercialization and development rights (excluding Canada and certain Asian countries) to relugolix in oncology, as offered under the Pfizer Collaboration and License Agreement. Pfizer’s decision is based on their assessment of their current strategic investment priorities in international markets and does not impact the companies’ collaboration in the U.S. and Canada for ORGOVYX and MYFEMBREE. We are currently assessing partnership opportunities, focusing on potential partners with a European commercial presence in urology or oncology.

•On September 7, 2021, Uneek Mehra was appointed Chief Financial and Business Officer of Myovant Sciences, Inc. Concurrent with this appointment, Mr. Mehra was also appointed Principal Financial Officer of Myovant Sciences Ltd. Mr. Mehra succeeds Frank Karbe who left our company in August 2021.

Expected Upcoming Milestones

The following is a summary of certain of our expected upcoming milestones.

•FDA submission of the Phase 3 ~~SPIRIT 1 and SPIRIT 2 studies were presented at the ASRM 2020 Virtual Congress on October 20, 2020~~LIBERTY randomized withdrawal study results for MYFEMBREE in ~~an oral presentation named the Prize Paper~~women with uterine fibroids is expected by the ~~Endometriosis Special Interest Group. Relugolix combination therapy met both co-primary endpoints and resulted~~end of calendar year 2021 or in ~~significantly more~~the first quarter of calendar year 2022.

•Two-year data from the SPIRIT long-term extension study of MYFEMBREE in women with ~~clinically meaningful reductions in dysmenorrhea and non-menstrual pelvic~~endometriosis-associated pain ~~compared with those on placebo over 24 weeks of therapy (p < 0.0001) in each study. Changes in BMD at the lumbar spine from both studies pooled over 24 weeks were minimal~~is expected in the ~~relugolix combination therapy groups. Specifically~~first quarter of calendar year 2022.

•~~, relugolix combination therapy achieved both co-primary endpoints~~FDA decision for the MYFEMBREE sNDA seeking approval for the management of moderate to severe pain associated with endometriosis is expected by ~~demonstrating 74.5% and 75.2%~~its May 6, 2022 target action date. FDA approval of women with dysmenorrhea (menstrual pain) and 58.5% and 66.0% of women with non-menstrual pelvic pain achieving clinically meaningful reductions in pain, compared to 26.9% and 30.4% of women with dysmenorrhea and 39.6% and 42.6% of women with non-menstrual pelvic pain in the placebo group, in the SPIRIT 1 and SPIRIT 2 studies respectively (all p-values < 0.0001). On average, women receiving relugolix combination therapy hadMYFEMBREE for this indication would trigger a ~~73.3% reduction~~$100.0 million regulatory milestone payment from Pfizer.

•European Commission decision on the ~~11-point (0 to 10) Numerical Rating Scale for dysmenorrhea from 7.3 (severe pain) to 1.8 (mild pain)~~advanced prostate cancer Marketing Authorisation Application is expected in SPIRIT 1 and a 75.1% reduction in SPIRIT 2 with a decrease from 7.2 (severe pain) to 1.7 (mild pain). All seven key secondary endpoints measured at week 24 and compared to placebo achieved statistical significance in SPIRIT 1, including changes in mean dysmenorrhea and overall pelvic pain, impact of pain on daily activities as measured by the Endometriosis Health Profile-30 (“EHP-30”) pain domain, greater proportions of women not using analgesics (p-values < 0.0001), changes in mean non-menstrual pelvic pain (p = 0.0002), greater proportions of women not using opioids (p = 0.0005), and changes in mean dyspareunia (painful intercourse) (p = 0.0149). Six key secondary endpoints measured at week 24 and compared to placebo achieved statistical significance in SPIRIT 2, including changes in mean dysmenorrhea and overall pelvic pain, impact of pain on daily activities as measured by the EHP-30 pain domain, a greater proportion of women not using opioids (all p-values < 0.0001), changes in non-menstrual pelvic pain (p = 0.0012), and dyspareunia (painful intercourse) (p = 0.0489). A seventh key secondary endpoint evaluating change in analgesic use did not achieve statistical significance in SPIRIT 2. Relugolix combination therapy was generally well-tolerated with minimal BMD loss over 24 weeks. The overall incidence of adverse events in the relugolix combination and placebo groups was similar (71.2% vs. 66.0% in SPIRIT 1; 80.6% vs. 75.0% in SPIRIT 2). In the relugolix combination therapy group, 3.8% and 5.3% of women had adverse events leading to discontinuation of treatment versus 1.9% and 3.9% in the placebo group in SPIRIT 1 and SPIRIT 2, respectively. The only reported adverse events in at least 10% of women in the relugolix combination group for SPIRIT 1 were headache and hot flashes and for SPIRIT 2 were headache, nasopharyngitis, and hot flashes.mid-calendar year 2022.

◦•~~We currently expect to submit an NDA with the FDA~~European Medicines Agency regulatory submission for ~~relugolix combination tablet~~RYEQO for the treatment of women with endometriosis-associated pain is expected in ~~the first half of~~ calendar year ~~2021.~~

◦~~We currently expect to submit an MAA to the EMA for relugolix combination tablet for the treatment of women with endometriosis-associated pain in 2021.~~2022. Richter will be the ~~MAA~~ sponsor.

~~Related Party Agreements~~

~~Market Access Services Agreement~~

On August 1, 2020, our subsidiary, MSG, entered into the Market Access Services Agreement with Sunovion Pharmaceuticals Inc. (“Sunovion”), a subsidiary of Sumitomo Dainippon Pharma, pursuant to which, among other things, Sunovion agreed to provide to MSG certain market access services with respect to the distribution and sale of relugolix monotherapy tablet and relugolix combination tablet. MSG, in turn, appointed Sunovion as the exclusive distributor of relugolix combination tablet and a non-exclusive distributor of relugolix monotherapy tablet, each in the United States, including all of its territories and possessions. For the three and six months ended September 30, 2020, we incurred $1.1 million of expense under this agreement (inclusive of third-party pass through costs billed to us), which is included in G&A expense in the accompanying unaudited condensed consolidated statements of operations. Additional information is included in Note 5 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.

~~Sumitomo Dainippon Pharma Loan Commitment~~

On August 5, 2020, we obtained a debt commitment letter from Sumitomo Dainippon Pharma, as amended by a letter dated September 29, 2020 (the “2020 Commitment Letter”), pursuant to which, subject to the terms and conditions set forth therein, Sumitomo Dainippon Pharma has committed to provide us with an additional $200.0 million low-interest, five-year unsecured revolving term loan commitment, the proceeds of which may be used for business operating expenditures of us and our subsidiaries. The commitments are in addition to the commitments made available to us and our subsidiaries by Sumitomo

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Dainippon Pharma under the existing Sumitomo Dainippon Pharma Loan Agreement. Additional information is included in Note 5 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.

~~Manufacturing Update~~

In June 2020, the FDA issued a warning letter to Takeda following a routine inspection of aseptic finished pharmaceuticals (drug product) manufacturing at Takeda’s manufacturing facility located at Takeda 4720, Mitsui, Hikari, Yamaguchi (the “Hikari Facility”). The warning letter indicated that the FDA was not satisfied with Takeda’s response to an FDA Form 483 issued to Takeda following the inspection and cited significant violations of ~~current good manufactur~~ing practice (“cGMP”) for finished pharmaceuticals. The Hikari Facility is one of two CMOs included in our regulatory filings for the manufacture of relugolix drug substance. We will procure the commercial relugolix drug substance needed for our anticipated U.S. launch in advanced prostate cancer solely from Excella GmbH & Co. KG, the second source contract manufacturing organization included in our initial regulatory filings. We do not expect that the issues relating to the Hikari Facility will have an effect on the FDA’s target action dates or EMA approval date for any of our regulatory filings or our launch readiness.

~~COVID-19 Pandemic~~

~~In December 2019, an outbreak of a novel strain of coronavirus, or COVID-19, was identified. Due to the rapid and global spread~~Effects of the ~~virus, in March 2020,~~COVID-19 Pandemic on our Business

We continue to closely monitor the ~~World Health Organization categorized COVID-19 as a pandemic and it continues to spread throughout the U.S. and other countries across the world. To limit the spread~~impact of COVID-19, governments have taken various actions including the issuance of stay-at-home orders, closing schools, restricting travel, and social distancing guidelines and causing some businesses to suspend operations. It remains unclear how long these measures will remain in place and whether these measures will be effective. Further, recently it has been reported that the rate of the reported number of COVID-19 cases in the United States is increasing, which may further impact the effects that the COVID-19 pandemic ~~may have~~ on ~~us.~~

all aspects of our business. Our priorities during the COVID-19 pandemic ~~are protecting~~have been to protect the health and safety of our employees, patients and ~~patients~~healthcare providers while continuing our mission to redefine care for women and for men. We believe the safety measures we ~~are taking~~have taken in response to the COVID-19 pandemic meet or exceed the ~~guidance required from~~guidelines established by government and public health officials. ~~Beginning in mid-March 2020, substantially all~~Most of our ~~workforce began~~employees worked remotely during much of 2020 and 2021, and many of our employees continue to do so on a part-time or full-time basis, which has required that we devised new ways of working ~~from home~~ and ~~we curtailed employee travel. We have adopted~~collaborating, including adopting remote working tools to minimize the disruption to our business activities. At

As of the date of this ~~time,~~Quarterly Report, we ~~have~~do not identified a material change to our productivity as a result of these measures, but this could change, particularly if restricted travel, closed schools, and shelter-in-place orders are not removed or significantly eased.

~~To date,~~believe that the impact of the COVID-19 pandemic has disproportionately impacted us relative to other companies in which we compete on our ability to advance our clinical studies, our regulatory activities, and ~~preparation~~our U.S. commercial launch activities for ~~the potential commercialization~~ORGOVYX and MYFEMBREE. We and our collaboration partner,

Table of ~~our product candidates has been limited~~Contents

Pfizer, commercially launched ORGOVYX and all of our publicly announced milestones remain on track. We submitted our NDA to the FDA for relugolix monotherapy tablet for the treatment of men with advanced prostate cancer in April 2020, which has been accepted by the FDA for Priority Review with a target action date of December 20, 2020. In May 2020, we submitted our NDA to the FDA for relugolix combination tablet for the treatment of women with heavy menstrual bleeding associated with uterine fibroids, which has been accepted by the FDA with a target action date of June 1, 2021. Regulatory agency pre-approval inspections are limited, and it is not clear if virtual inspections are acceptable due to COVID-19 and this may impact the FDA's review process and timing of potential approval of these product candidates. Should relugolix monotherapy tablet or relugolix combination tablet receive regulatory approval, we will likely commercially launch these productsMYFEMBREE in the U.S. in January 2021 and June 2021, respectively. To date, our partner, Richter, has launched RYEQO in seven countries.

We believe that the COVID-19 ~~environment.~~pandemic continues to have an impact on our commercialization activities that is consistent with other companies in our industry. As a result of the COVID-19 pandemic, there have been changes in the practice of medical care and medical education. For example, many health care providers initially expanded their utilization of telemedicine to conduct patient visits, and in many regions of the U.S., the ability of commercial and medical affairs field teams to call on healthcare providers was restricted or converted to virtual access. Our oncology sales and medical affairs field teams resumed in-person interactions with healthcare providers in January 2021 and our women’s health sales and medical affairs field teams began in-person interactions with healthcare providers in June 2021. Despite this, some physician’s offices and many hospitals continue to have limited on-site access for pharmaceutical representatives in order to reduce exposure risk for their patients or staff. Conducting these interactions virtually could reduce the number of medical professionals we are able to engage with, limit our ability to engage with important staff members and virtual meetings have been shown to be less impactful than in-person meetings. The cancellation, postponement or virtual formats for medical conferences also limit access to physicians and reduce awareness of information shared at conferences (medical and promotional). In response to the COVID-19 pandemic, health professionals may also reduce staffing and reduce or postpone appointments with patients, or patients may delay, cancel or miss appointments, resulting in fewer prescriptions. ~~In addition, if~~Reduced access to healthcare providers may impact or require adjustments to our ~~product candidates receive regulatory approval,~~planned commercialization activities, including the manner in which our ~~sales~~field teams ~~would likely have to make presentations to physicians~~engage with healthcare providers and ~~the~~facilities and supplementing field activities with additional marketing spend.

The COVID-19 pandemic has also resulted in fewer opportunities for our medical ~~community solely by virtual means instead of in-person, which could reduce the number of medical professionals we are able~~affairs team to present scientific data as multiple medical conferences have been canceled, postponed, or moved to virtual formats and ~~these virtual meetings may~~for our regional medical advisors to engage potential prescribers in scientific exchange. To date, we have not ~~be as successful as in-person meetings. At this time,~~experienced supply constraints, and we ~~do not anticipate a substantial impact from the~~believe we have procured sufficient quantities of relugolix drug substance to meet our U.S. ORGOVYX and MYFEMBREE launch plans.

Future developments regarding COVID-19 ~~pandemic on our supply chain and ability to launch relugolix monotherapy tablet or relugolix combination tablet.~~

~~The ultimate impact of the COVID-19 pandemic is highly~~remain uncertain and ~~we do not yet know~~ the full extent of potential delays or impacts on our business, our financial results, our clinical trials, our supply chains, our pre-launch commercial readiness activities, end user demand for our products, if approved, healthcare systems or the global economy as a whole. The extent to which the COVID-19 pandemic ultimately impacts usour business, financial condition or results of operations will depend on ~~future developments,~~numerous factors, including the magnitude and duration of the pandemic, the distribution, acceptance and effectiveness of COVID-19 vaccines and treatments, the impact of new and potentially more virulent variants of the coronavirus (e.g., the Delta variant), the duration of governmental measures to mitigate the pandemic and how quickly and to what extent normal economic and operating conditions can resume, all of which ~~are highly~~remain uncertain and ~~cannot~~difficult to predict. Additionally, even after normalcy resumes, there will likely be ~~predicted, including new information which may emerge concerning~~some permanent changes to how healthcare is provided, how healthcare providers engage with our industry and perhaps how conferences are implemented. None of these changes can be anticipated at this point, nor the ~~severity of COVID-19 and the actions to contain COVID-19 or treat its~~potential impact ~~among others.~~on our business. As such, it is uncertain as to the full magnitude that the COVID-19 pandemic will have on our financial condition, liquidity, and future results of operations.

Refer to the risk factor titled “Business interruptions resulting from effects of pandemics or epidemics, such as the ~~novel strain of the coronavirus known as~~ COVID-19 pandemic, may materially and

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adversely affect our business and financial condition,” as well as other risk factors included in the section titled “Risk Factors” set forth in Part II. Item 1A.

On March 27, 2020, the CARES Act was enacted in response to the COVID-19 pandemic and the negative impacts that it is having on the global economy and U.S. companies. The CARES Act includes various financial measures to assist companies, including temporary changes to income and non-income-based tax laws. We have implemented certain provisions

Components of ~~the CARES Act, such as deferring employer payroll taxes through the end~~our Results of calendar year 2020. As of September 30, 2020, we have deferred $1.2 million of employer payroll taxes, of which 50% are required to be deposited by December 2021 and the remaining 50% by December 2022. The deferred payroll tax liability is included in other liabilities on the accompanying unaudited condensed consolidated balance sheet.Operations

~~Financial History~~Revenues

We currently have ~~incurred, and expect to continue to incur, significant operating losses and negative operating cash flows as we continue to develop our product candidates and prepare~~two FDA-approved products, ORGOVYX for the ~~potential future regulatory approvals and commercialization~~treatment of relugolix combination tablet and relugolix monotherapy tablet. To date, we have not generated any product revenue, and we do not expect to generate product revenue unless and until we obtain regulatory approval for one of our product candidates. We have historically funded our operations primarily from the issuance and sale of our common shares and from debt financing arrangements. Additional information about our sources of funding is included under “—Liquidity and Capital Resources—Sources of Liquidity” below.

~~Our Product Candidates~~

~~Relugolix~~

We are currently developing relugolix in three indications: heavy menstrual bleeding associated with uterine fibroids; pain associated with endometriosis; and advanced prostate cancer. Relugolix is an oral, once-daily, small molecule that acts as a GnRH receptor antagonist that binds to and inhibits GnRH receptors in the anterior pituitary gland. Inhibition of GnRH receptors decreases the release of gonadotropins (luteinizing hormone (“LH”) and follicle-stimulating hormone (“FSH”)), thereby decreasing the downstream production of estrogen and progesterone by the ovaries in women and testosterone by the testes in men.

As a GnRH receptor antagonist, relugolix has a clinically-validated mechanism of action in each of our three targeted indications. The direct and rapid action of relugolix on the pituitary-gonadal axis is distinct from approved luteinizing hormone-releasing hormone (“LHRH”) agonists which are administered as depot injections and result in an initial surge in levels of gonadotropins, and estrogen and progesterone or testosterone, before resulting in pituitary desensitization and a fall in hormone levels over weeks. Approved LHRH agonist injections such as leuprolide acetate are used in women to treat the symptoms of uterine fibroids and endometriosis, but the adoption and duration of use is limited due to BMD loss and vasomotor symptoms.

We are developing relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg and norethindrone acetate 0.5 mg) administered orally once-daily, with the goal of maintaining estrogen levels in the low normal range to achieve the long-term benefit of relugolix on symptoms of uterine fibroids and endometriosis, while maintaining bone health and mitigating side effects from a low-estrogen state, such as vasomotor symptoms. We have successfully completed a bioequivalence study, which demonstrated the bioequivalence of our relugolix combination tablet with relugolix combination therapy, the co-administered regimen used in the LIBERTY and SPIRIT clinical programs (one relugolix 40 mg tablet plus one tablet containing estradiol 1.0 mg and norethindrone acetate 0.5 mg). We expect to launch in the women’s health indications with our single-tablet regimen.

Lowering estrogen and progesterone levels has been demonstrated, including in our two replicate Phase 3 LIBERTY studies, to effectively decrease heavy menstrual bleeding and pain in women with uterine fibroids. Similarly, relugolix combination therapy has been demonstrated in our two replicate Phase 3 SPIRIT studies to reduce pelvic pain associated with endometriosis. Relugolix combination therapy achieved these results while maintaining a generally well-tolerated safety profile. We believe our combination approach has the potential to have a better safety and tolerability profile than the currently approved LHRH agonist therapies and has the potential to be used longer-term. We further believe our single tablet combination approach also has certain benefits over other oral GnRH antagonist therapies that are currently approved or in development. The goal of our relugolix combination tablet is to provide women with uterine fibroids and endometriosis a once-daily oral medical alternative to hysterectomy and other invasive procedures often recommended to treat these conditions that is suitable for long-term use.

Decreasing testosterone slows the growth and progression of advanced prostate cancer, such as when the disease recurs or the prostate-specific antigen (“PSA”) is rising following prostatectomy or radiation therapy, when the disease progresses locally in the prostate bed, or when it becomes metastatic. We demonstrated in our Phase 3 HERO program that relugolix can achieve

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~~sustained testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks in 96.7% of~~adult patients with a once-daily oral treatment. Relugolix was compared to the standard-of-care leuprolide injections in the HERO study and demonstrated superiority to leuprolide in the cumulative proportion of patients achieving sustained testosterone suppression (96.7% vs 88.0%). Data from this study are the basis for the NDA submission undergoing Priority Review for relugolix in advanced prostate cancer. We are developing a distinct therapeutic candidate, relugolix monotherapy (120 mg), for men with advanced prostate cancer ~~which, if approved, we expect to commercialize as a separately branded product from our relugolix combination tablet.~~

~~Our Phase 3 Program~~and MYFEMBREE for the ~~Treatment~~management of ~~Heavy Menstrual Bleeding Associated with Uterine Fibroids~~

We initiated a Phase 3 clinical program in January 2017, evaluating relugolix combination therapy in women with heavy menstrual bleeding associated with uterine fibroids. The program consisted of two multinational, replicate pivotal clinical studies (LIBERTY 1 and LIBERTY 2). Women in the LIBERTY 1 and LIBERTY 2 studies underwent a screening period requiring up to two menstrual cycles to document heavy menstrual bleeding and were randomized in a 1:1:1 ratio to one of three groups. Women received treatment either with relugolix combination therapy for 24 weeks, relugolix 40 mg once-daily monotherapy for 12 weeks followed by relugolix combination therapy once-daily for an additional 12 weeks, or placebo once-daily for 24 weeks.

We enrolled 388 women in LIBERTY 1 and 382 women in LIBERTY 2. To be enrolled, women must have had a monthly menstrual blood loss volume of at least 80 mL in two consecutive cycles or 160 mL in one cycle, measured by the alkaline hematin method, a quantitative measure of menstrual blood loss from an assessment of collected menstrual products.

Eligible women who completed the LIBERTY 1 or LIBERTY 2 studies were offered the opportunity to enroll in an active treatment extension study in which all women received relugolix combination therapy for an additional 28-week period for a total treatment period of 52 weeks, designed to evaluate the safety and sustained efficacy of longer-term treatment. Upon completion of this 52-week total treatment period, eligible women could elect to participate in a second 52-week randomized withdrawal study designed to provide two-year safety and efficacy data on relugolix combination therapy, and to evaluate the need for maintenan~~ce therapy. We currently expect to present data from the LIBERTY randomized withdrawal study in the first quarter of calendar year 2021.~~

The primary efficacy endpoint for LIBERTY 1 and LIBERTY 2 was the proportion of all women enrolled who achieved a menstrual blood loss volume of less than 80 mL and at least a 50% reduction in menstrual blood loss volume from baseline during the last 35 days of the 24-week treatment period as measured by the alkaline hematin method. The secondary endpoints included the proportion of women who achieved amenorrhea (defined as no or negligible blood loss) during the last 35 days of treatment, reduction in pelvic pain, reduction in fibroid volume, reduction in uterine volume, percent change from baseline to week 24 in menstrual blood loss, increase in hemoglobin, and an assessment of the impact of therapy on quality-of-life. Safety, including BMD changes as measured by dual-energy x-ray absorptiometry (“DXA”), was also assessed.

On May 14, 2019 and July 23, 2019, we announced positive top-line results for the LIBERTY 1 and LIBERTY 2 studies, respectively. On February 10, 2020, we announced positive safety and efficacy data from the Phase 3 LIBERTY long-term extension study. On September 14, 2020, we announced additional data on BMD in women with uterine fibroids from the LIBERTY program and from a prospective observational study and on October 21, 2020, we presented one-year efficacy and safety data from the LIBERTY long-term extension study at the ASRM 2020 Virtual Congress.

On March 9, 2020, we announced the submission of a MAA to the EMA for relugolix combination tablet for the treatment of women with moderate to severe symptoms associated with uterine fibroids. This application has completed validation and is now under evaluation by the EMA. We currently expect the European Commission decision on this application in 2021. If approved, this launch would be executed by Richter, our commercialization partner for relugolix combination tablet for the uterine fibroids and endometriosis indications in Europe and certain other international markets. In May 2020, we submitted an NDA to the FDA for relugolix combination tablet for the treatment of women with heavy menstrual bleeding associated with uterine fibroids, which generate product revenue in the U.S. We record product revenue net of estimated discounts, chargebacks, rebates, product returns, and other gross-to-net revenue deductions. We expect the ORGOVYX gross-to-net discount will continue to increase in the coming quarters, reflecting the impact of rebates for incremental covered lives before stabilizing in 2022, once commercial and Medicare Part D coverage has been ~~accepted by~~fully implemented. Product revenue, net also includes revenues related to product supply to Richter as well as royalties on net sales of RYEQO in Richter’s Territory.

Our Pfizer collaboration revenue consists of the partial recognition of the upfront payment and of the regulatory milestone payment that was triggered upon the FDA ~~with a target action date~~approval of ~~June 1, 2021.~~

~~LIBERTY 1~~

~~On May 14, 2019, we announced that LIBERTY 1 met its primary efficacy endpoint and six key secondary endpoints. The distribution of the change in BMD, including outliers, was similar~~MYFEMBREE for the ~~relugolix combination therapy and placebo groups at 24 weeks, as assessed by DXA.~~

~~In the primary endpoint analysis, 73.4%~~management of women receiving relugolix combination therapy achieved the responder criteria compared with 18.9% of women receiving placebo (p < 0.0001). On average, women receiving relugolix combination therapy experienced an 84.3% reduction in menstrual blood loss from baseline, a clinically relevant secondary endpoint. A significantly

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greater proportion of women suffering from moderate-to-severe pain from uterine fibroids at baseline experienced no pain or minimal pain during the last 35 days of treatment with relugolix combination therapy compared with women on placebo (p < 0.0001).

LIBERTY 1 achieved six key secondary endpoints with statistical significance compared to placebo, including mean change in menstrual blood loss from baseline to week 24, reduction in pain in women with pain at baseline, improvement in quality of life, amenorrhea (defined as no or negligible blood loss), improvement in anemia in those women with anemia at baseline, and reduction in uterine volume. The seventh key secondary endpoint, reduction in uterine fibroid volume, did not achieve statistical significance.

The overall incidence of adverse events in the relugolix combination therapy and placebo groups was comparable (62% vs. 66%). In the relugolix combination therapy group, 5% of women discontinued treatment early due to adverse events compared with 4% in the placebo group. The only adverse event in the relugolix combination therapy arm occurring in at least 10% of women and more frequently than in the placebo arm was hot flash (11% vs. 8%). There were no pregnancies in the relugolix combination therapy group and one in the placebo group. There were two serious adverse events related to the study drug: one fibroid expulsion and one for pelvic pain.

~~LIBERTY 2~~

On July 23, 2019, we announced that LIBERTY 2 met its primary efficacy endpoint and the same six key secondary endpoints as were achieved in LIBERTY 1. Changes in BMD were comparable between the relugolix combination therapy and placebo groups at the end of treatment as was the distribution of the change in BMD, including outliers.

In the primary endpoint analysis, 71.2% of women receiving relugolix combination therapy achieved the responder criteria compared with 14.7% of women receiving placebo (p < 0.0001). On average, women receiving relugolix combination therapy experienced a highly significant 84.3% reduction in menstrual blood loss from baseline to week 24 (p < 0.0001). In addition, a significantly greater proportion of women suffering from moderate-to-severe pain from uterine fibroids at baseline experienced no pain or minimal pain during the last 35 days of treatment with relugolix combination therapy compared with women on placebo (p < 0.0001).

LIBERTY 2 achieved six key secondary endpoints with statistical significance compared to placebo, including mean change in menstrual blood loss from baseline to week 24, reduction in pain in women with pain at baseline, improvement in quality of life, amenorrhea (defined as no or negligible blood loss), improvement in anemia in those women with anemia at baseline, and reduction in uterine volume. The seventh key secondary endpoint, reduction in uterine fibroid volume, did not achieve statistical significance.

The overall incidence of adverse events in the relugolix combination therapy and placebo groups was comparable (60.3% vs. 58.9%). In the relugolix combination therapy group, 1.6% of women discontinued treatment early due to adverse events compared with 4.7% in the placebo group. There were no adverse events in the relugolix combination therapy group reported by at least 10% of women and more frequently than in the placebo group. The incidence of hot flashes in the relugolix combination therapy group was similar to placebo (5.6% vs. 3.9%). There were no pregnancies in the relugolix combination therapy group and one in the placebo group. There were no serious adverse events related to study drug reported in this study.

~~LIBERTY Long-Term Extension Study~~

~~On February 10, 2020, we announced positive safety and efficacy data from the Phase 3 LIBERTY long-term extension study of relugolix combination therapy in women with~~ heavy menstrual bleeding associated with uterine fibroids.

InOur Richter license and milestone revenue consists of the ~~primary endpoint analysis, 87.7%~~recognition of ~~women achieved~~ the ~~responder criteria. The primary endpoint result in~~regulatory milestone payment that was triggered upon the ~~one-year Phase 3 LIBERTY long-term extension study was consistent with the 24-week primary endpoint data from the pivotal LIBERTY 1 and LIBERTY 2 studies, demonstrating a durability~~European Commission approval of ~~response through one year. In addition, women experienced, on average, an 89.9% reduction in menstrual blood loss from baseline at one year.~~

Changes in BMD through one year, as assessed by DXA every three months, demonstrated maintenance of bone density and were consistent with those in LIBERTY 1 and LIBERTY 2. The adverse events over one year were consistent with those observed in LIBERTY 1 and LIBERTY 2, with no new safety signals. Adverse events reported in more than 10% of women treated with relugolix combination therapy for one-year and more frequently than those reported in the placebo group after 6 months included only hot flashes (11% vs. 6%). There were no pregnancies reported in the relugolix combination therapy group.

In October 2020, we presented a poster at the ASRM 2020 Virtual Congress describing a validated exposure-response model simulating long-term effects of relugolix combination therapy on BMD at the lumbar spine. Simulations from this model were

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~~well correlated with the effect of relugolix combination therapy observed in the Phase 3 LIBERTY program and projected maintenance of BMD for at least three years.~~

~~Observational Bone Mineral Density Study~~

This prospective observational study was designed to characterize the longitudinal natural history of BMD in 262 premenopausal women with uterine fibroids over 52 weeks. Women with documented uterine fibroids by imaging who were not receiving treatment with GnRH agonists ~~or antagonists~~ were enrolled contemporaneously from U.S. centers that participated in the LIBERTY studies. BMD was assessed by DXA at baseline, week 24 and week 52. Mean BMD at the lumbar spine showed minimal changes over the 52-week observational period (0% at week 24 and -0.41% at week 52) and did not appear to be influenced by race or body mass index.

~~Our Phase 3 Program for the Treatment of Pain Associated with Endometriosis~~

We initiated a Phase 3 clinical program in June 2017, evaluating relugolix combination therapy in women with pain associated with endometriosis. The program consisted of two multinational, replicate pivotal clinical studies (SPIRIT 1 and SPIRIT 2). Each study randomized women 1:1:1 to one of three treatment arms. Women received treatment either with relugolix combination therapy for 24 weeks, relugolix 40 mg once-daily monotherapy for 12 weeks followed by relugolix combination therapy once-daily for an additional 12 weeks, or placebo once-daily for 24 weeks.

We enrolled 623 and 638 patients in the SPIRIT 2 and SPIRIT 1 studies, respectively. To be enrolled, women must have had a surgical diagnosis of endometriosis in the last 10 years and moderate-to-severe dysmenorrhea (menstrual pelvic pain) and non-menstrual pelvic pain.

Eligible women who completed the SPIRIT 1 or SPIRIT 2 studies were offered the opportunity to enroll in an active treatment long-term extension study in which all women receive relugolix combination therapy for an additional 80-week period, resulting in a total treatment period of up to 104 weeks, designed to evaluate the safety and sustain~~ed efficacy of longer-term treatment. We currently expect to announce one-year efficacy and safety data from the SPIRIT extension study in the first quarter of calendar year 2021.~~

The co-primary efficacy endpoints for the SPIRIT 1 and SPIRIT 2 studies were the proportion of all women enrolled with reductions in both dysmenorrhea and non-menstrual pelvic pain, as assessed by an endometriosis-specific patient questionnaire based on the Numerical Rating Scale (“NRS”) completed daily on an electronic patient diary, with no increase in background pain medication. The NRS is an 11-point scale with 0 representing “no pain” and 10 representing “the worst pain you can imagine.” Secondary endpoints included additional questionnaires assessing functional changes associated with endometriosis-specific pain and quality of life, and the use of pain medications to treat endometriosis, including opioid medications. Safety, including BMD changes as measured by DXA, was also assessed.

On April 22, 2020 and June 23, 2020, we announced positive top-line results from the SPIRIT 2 and SPIRIT 1 studies, respectively. We currently expect to submit an NDA with the FDA for relugolix combination tabletRYEQO for the treatment of moderate to severe symptoms of uterine fibroids in adult women ~~with endometriosis-associated pain in the first half~~ of calendar year 2021. We currently expect to submit an MAA to the EMA for relugolix combination tablet for the treatment of women with endometriosis-associated pain in 2021. Richter will be the MAA sponsor. Data from these Phase 3 studies were presented at the ASRM 2020 Virtual Congress on October 20, 2020reproductive age and the ~~presentation was named the Prize Paper by the Endometriosis Special Interest Group.~~

~~SPIRIT 1~~

On June 23, 2020, we announced that SPIRIT 1 met its co-primary efficacy endpoints and all seven key secondary endpoints. In addition, relugolix combination therapy was generally well-tolerated and resulted in minimal BMD loss over 24 weeks.

~~Relugolix combination therapy achieved both co-primary endpoints by demonstrating clinically meaningful pain reductions for 74.5%~~recognition of women with dysmenorrhea (menstrual pain) and 58.5% of women with non-menstrual pelvic pain, compared to 26.9% and 39.6% of women in the placebo group, respectively (p < 0.0001). On average, women receiving relugolix combination therapy had a 73.3% reduction on the 11-point (0 to 10) NRS for dysmenorrhea from 7.3 (severe pain) to 1.8 (mild pain).

All seven key secondary endpoints measured at week 24 and compared to placebo achieved statistical significance, including changes in mean dysmenorrhea and overall pelvic pain, impact of pain on daily activities as measured by the EHP-30 pain domain, greater proportions of women not using analgesics (p-values < 0.0001), changes in mean non-menstrual pelvic pain (p = 0.0002), greater proportions of women not using opioids (p = 0.0005), and changes in mean dyspareunia (painful intercourse) (p = 0.0149).

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The overall incidence of adverse events in the relugolix combination and placebo groups was similar (71.2% vs. 66.0%). In the relugolix combination therapy group, 3.8% of women had adverse events leading to discontinuation of treatment versus 1.9% in the placebo group. The only reported adverse events in at least 10% of women in the relugolix combination group were headache and hot flashes. There was one pregnancy in the relugolix combination group and three in the placebo group.

~~SPIRIT 2~~

On April 22, 2020, we announced that SPIRIT 2 met its co-primary efficacy endpoints and six key secondary endpoints. In addition, relugolix combination therapy was generally well-tolerated and resulted in minimal BMD loss over 24 weeks.

In the co-primary endpoint analysis, 75.2% of women achieved a clinically meaningful reduction in dysmenorrhea versus 30.4% of women in the placebo group (p < 0.0001). For non-menstrual pelvic pain, relugolix combination therapy achieved a clinically meaningful reduction in 66.0% of women versus 42.6% of women in the placebo group (p < 0.0001). On average, women receiving relugolix combination therapy had a 75.1% reduction on the 11-point (0 to 10) NRS for dysmenorrhea from 7.2 (severe pain) to 1.7 (mild pain).

Six key secondary endpoints measured at week 24 and compared to placebo achieved statistical significance, including changes in mean dysmenorrhea and overall pelvic pain, impact of pain on daily activities as measured by the EHP-30 pain domain, a greater proportion of women not using opioids (all p-values < 0.0001), changes in non-menstrual pelvic pain (p = 0.0012), and dyspareunia (painful intercourse) (p = 0.0489). An endpoint evaluating change in analgesic use did not achieve statistical significance.

The overall incidence of adverse events in the relugolix combination therapy and placebo groups was similar (80.6% vs. 75.0%). In the relugolix combination therapy group, 5.3% of women discontinued treatment early due to adverse events versus 3.9% in the placebo group. The most frequently reported adverse events, reported in at least 10% of women in the relugolix combination therapy group, were headache, nasopharyngitis, and hot flashes. There were three pregnancies in the relugolix combination therapy group and five in the placebo group.

~~Bioequivalence Study of Relugolix Combination Therapy and Relugolix Combination Tablet~~

On July 23, 2019, we announced that a separate clinical study of our relugolix combination tablet met all required and pre-specified criteria for bioequivalence to the two tablets (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) used in our Phase 3 uterine fibroid and endometriosis clinical studies, providing data necessary to include the once-daily dosing regimen of relugolix combination tablet in our NDA and MAA submissions for the treatment of heavy menstrual bleedingrevenue associated with ~~uterine fibroids and endometriosis. In December 2019, we successfully completed one-year stability studies, which are required for FDA approval of relugolix combination tablet.~~

~~Ovulation Inhibition Study~~

On April 22, 2020, we announced results from an open-label, single-arm ovulation inhibition study consisting of a pre-treatment period to confirm ovulatory status, an 84-day treatment period (three cycles) to assess the effects of relugolix combination therapy on ovulation inhibition, and a post-treatment follow-up period to determine the time to the return of ovulation. Ovulation inhibition was based on the Hoogland-Skouby scale. In this study, relugolix combination therapy achieved 100% ovulation inhibition in 67 healthy women with no women ovulating during the 84-day treatment period, as evaluated by the Hoogland-Skouby assessment scale (score < 5). Furthermore, 100% of women resumed ovulation or menses upon discontinuation of treatment with an average time to ovulation of 23.5 days.

In July 2020, we presented data from the ovulation inhibition study and additional data from the LIBERTY program showing improvement in patient-reported outcomes and in hemoglobin levels in women with anemia during the European Society of Human Reproduction and Embryology (“ESHRE”) virtual 36th Annual Meeting. Additional data from the ovulation inhibition study were also presented at the ASRM 2020 Virtual Congress in October 2020.

~~Our Phase 3 Program for the Treatment of Advanced Prostate Cancer~~

We initiated a Phase 3 clinical study in March 2017, evaluating the safety and efficacy of relugolix monotherapy in men with advanced prostate cancer, which we refer to as the HERO study. The HERO study randomized 934 men with advanced prostate cancer who required medical therapy to lower testosterone serum levels, also known as androgen deprivation therapy, in a 2:1 ratio to treatment with either oral relugolix 120 mg once-daily (after a single oral loading dose of 360 mg) or a depot injection of leuprolide (per national or regional product label) for a period of at least 48 weeks. Based on FDA discussions, we believe that we will be required to conduct only one Phase 3 study with a single relugolix arm to gain approval for relugolix in men with advanced prostate cancer in the U.S. Nonetheless, we designed the study to include a second arm with leuprolide to demonstrate that treatment with relugolix is noninferior to leuprolide in achieving sustained suppression of testosterone to

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~~castrate levels over 48 weeks, an outcome expected to be required for approval in other major markets such as Europe and Japan.~~

We enrolled 934 men in the HERO study for the primary endpoint analysis. To be enrolled, men must have had advanced prostate cancer that required androgen deprivation therapy for at least 48 weeks and included prostate cancer defined as biochemical or clinical relapse, advanced localized disease or newly diagnosed metastatic disease. Screening PSA was > 2.0 ng/mL and serum testosterone levels within the normal range.

The primary efficacy endpoint for HERO accepted by the FDA was testosterone suppression (< 50 ng/dL) from week 5, day 1 through week 48, day 7. Relugolix monotherapy was required to demonstrate that the lower bound of the 2-sided 95% confidence interval for the percent of patients achieving testosterone suppression through 48 weeks was at least 90%. Testosterone suppression is an approvable endpoint in the U.S. and several hormonal therapies have been approved based on this endpoint. The secondary endpoints included rapid suppression of testosterone at Day 4 and Day 15, profound suppression of testosterone at Day 15, rapid suppression of PSA at Day 15, and suppression of FSH at week 24. Testosterone recovery was also evaluated in a subset of men eligible to discontinue ADT at the completion for the 48-week study treatment.

On November 19, 2019, we announced that the Phase 3 HERO study met its primary efficacy endpoint with 96.7% (95% CI: 94.9%, 97.9%) of men achieving sustained testosterone suppression to castrate levels. The study also met the tested key secondary endpoints, while demonstrating a 54% reduction in risk of major adverse cardiovascular events as compared with leuprolide injections administered every 3 months. The incidence of major adverse cardiovascular events was 2.9% in the relugolix group versus 6.2% in the leuprolide group. In men with a reported history of these major adverse cardiovascular events, the relugolix group had 80% fewer major adverse cardiovascular events reported compared to the leuprolide acetate group (3.6% vs. 17.8%, respectively). More than 90% of men in the HERO study had at least one cardiovascular risk factor, including lifestyle risk factors such as tobacco use and obesity, comorbidities such as diabetes and hypertension, and prior history of a major adverse cardiovascular event.

Five key secondary endpoints demonstrated superiority to leuprolide acetate, including rapid suppression of testosterone at Day 4 and Day 15, profound suppression of testosterone at Day 15, rapid suppression of PSA at Day 15, and suppression of FSH at week 24 (all p-values < 0.0001). In addition, relugolix demonstrated non-inferiority to leuprolide acetate on sustained testosterone suppression through 48 weeks (96.7% vs. 88.8%, respectively) with a between-group difference of 7.9% (95% CI: 4.1%, 11.8%), the primary endpoint required for regulatory submissions outside of the U.S. Superiority to leuprolide was also achieved as the lower bound of the 95% confidence interval for the between-group difference was greater than 0 (p-value < 0.0001). In addition, the pharmacodynamic results showed no testosterone flare after initiation of relugolix and mean testosterone levels returned to normal levels within 90 days after treatment discontinuation in a subset of 184 patients.

The overall incidence of adverse events in the relugolix and leuprolide acetate groups was comparable (92.9% vs. 93.5%, respectively). In the relugolix group, 3.5% of men discontinued the study early due to adverse events compared with 2.6% of men in the leuprolide acetate group. The most frequently reported adverse events, reported in at least 10% of men in the relugolix group, were hot flashes, fatigue, constipation, diarrhea, and arthralgia (defined as pain in a joint). Major adverse cardiovascular events were reported in 2.9% of men in the relugolix group versus 6.2% of men in the leuprolide acetate group in a prespecified safety analysis. These events included non-fatal myocardial infarction, non-fatal stroke, and all-cause mortality and were not adjudicated.

We filed an amendment to the HERO study protocol to enroll 139 additional men with metastatic prostate cancer (total cohort of 434 men, including 295 men from the original HERO study) and to add the secondary objective of demonstrating that relugolix can delay the time to progression to the lethal state of the disease, castration-resistant prostate cancer, as compared to leuprolide, that completed enrollment in July 2019. Castration-resistant prostate cancer is defined by disease progression despite achieving testosterone suppression to castrate levels (< 50 ng/dL). On September 29, 2020, we announced that relugolix had a similar rate of castration resistance-free survival in the subgroup of men with metastatic disease compared to leuprolide acetate and did not achieve statistical superiority through 48 weeks. In the subgroup of men with metastatic disease treated with relugolix, 74% were castration resistance-free through 48 weeks compared to 75% of men treated with leuprolide acetate (HR = 1.03 [95% CI: 0.68-1.57]; p = 0.84). In the secondary endpoint analysis, castration resistance-free survival was defined as the time from first dose to PSA progression per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria or death from any cause. PSA progression was defined as a PSA increase ≥ 25% and ≥ 2 ng/mL above the nadir, and confirmed by a second PSA value ≥ 3 weeks later. The incidence of adverse events in the subgroup of men with metastatic disease was consistent with that observed in the primary analysis of HERO with no new safety signals observed.

~~In May 2020, efficacy and safety data from the Phase 3 HERO study were simultaneously published online in the~~ ~~New England Journal of Medicine~~ and presented at the American Society of Clinical Oncology (“ASCO”)’s ASCO20 Virtual Scientific Program. In July 2020, these data were also presented in an oral presentation during the American Urological Association 2020

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Virtual Experience. Detailed secondary endpoint data showed notable differences in the rapid and profound suppression of testosterone, PSA response, and testosterone recovery after discontinuation of treatment. In the relugolix group, testosterone suppression to less than 50 ng/dL was achieved in 56.0% of men by Day 4 and 98.7% by Day 15, compared to 0.0% by Day 4 and 12.1% by Day 15 for men in the leuprolide acetate group. Additionally, in the relugolix group, profound testosterone suppression to less than 20 ng/dL was achieved in 78.4% of men at Day 15, compared to 1.0% at Day 15 for men in the leuprolide acetate group. A higher proportion of men in the relugolix group achieved a 50% reduction in PSA by Day 15 and confirmed at Day 29 compared to those in the leuprolide acetate group (79.4% vs. 19.8%, respectively). Within 90 days of treatment discontinuation, 54% of men in the relugolix group achieved normal testosterone levels (≥ 280 ng/dL) with a mean testosterone level of 288.4 ng/dL, compared to 3% of men in the leuprolide acetate group with a mean testosterone level of 58.6 ng/dL.

On October 19, 2020, we presented an economic analysis of the Phase 3 HERO data at the AMCP Nexus 2020 Virtual Meeting, demonstrating that treatment with relugolix may prevent one major adverse cardiovascular event for every 31 patients treated versus patients receiving leuprolide injections.

On April 21, 2020, we announced the submission of an NDA to the FDA for relugolix monotherapy tablet for the treatment of men with advanced prostate cancer. In June 2020, the FDA accepted for Priority Review this NDA, setting a target action date of December 20, 2020. In its acceptance letter, the FDA also stated that it is currently not planning to hold an advisory committee meeting for this application. If approved, relugolix would be the first and only oral GnRH receptor antagonist treatment for men with advanced prostate cancer. We currently expect to submit a MAA to the EMA for relugolix monotherapy tablet for advanced prostate cancer in the first half of calendar year 2021. We may conduct additional clinical studies to further support the commercial potential of relugolix in prostate cancer in the U.S. and other major markets.

~~MVT-602~~

As part of our license agreement with Takeda, we acquired the worldwide rights to MVT-602, our second product candidate, which previously had been evaluated in over 150 men. MVT-602 is an oligopeptide kisspeptin-1 receptor agonist. Kisspeptin, the ligand, is a naturally occurring peptide that stimulates GnRH release and is required for puberty and maintenance of normal reproductive function, including production of sperm, follicular maturation and ovulation, and production of estrogen and progesterone in women and testosterone in men. MVT-602 is being developed as a potential treatment for female infertility in women as part of assisted reproduction, such as in vitro fertilization.

In October 2018, we presented data from a Phase 1 study of MVT-602 at the American Society for Reproductive Medicine Annual Congress. Results of the study showed that administration of MVT-602 in healthy premenopausal women in the follicular phase produced a dose-related increase in LH concentrations and expected effects on FSH and estradiol. A total of 24 women were randomized to one of three MVT-602 dose groups (0.3 µg, 1 µg or 3 µg) and then subsequently randomized within the assigned group to receive a single subcutaneous dose of MVT-602 or placebo in a 3:1 ratio. Results showed that administration of single subcutaneous doses of MVT-602 demonstrated dose-related increases in LH concentrations and expected post-dose increases in FSH and estradiol concentrations, with little effect observed on progesterone as expected. No serious adverse events were reported, and no subject discontinued from the study due to an adverse event. Adverse events were similar between the placebo and MVT-602 groups with no apparent dose-related effects.

Further assessment of the exposure-response profile of MVT-602 was conducted in a Phase 2a study during the pre-ovulatory phase in 75 fertile women following a minimal controlled ovarian stimulation protocol. After ovarian stimulation, women were randomized to one of four MVT-602 dose groups (0.1 µg, 0.3 µg, 1 µg or 3 µg), to triptorelin, 0.2 mg, or to placebo. Top-line results from this Phase 2a study were presented at the European Society of Human Reproduction and Embryology in Vienna, Austria in June 2019. The study demonstrated that MVT-602 was generally well-tolerated and produced the desired LH surge associated with high and dose-dependent rates of ovulation in healthy women following a minimal controlled ovarian stimulation protocol. This study provides information for dose selection for a future study of MVT-602 in infertile women seeking pregnancy.

~~Financial Operations Overview~~

~~Revenue~~

To date, we have not generated any product revenue, and we do not expect to generate any revenue, from the sale of any products unless and until we obtain regulatory approval of and commercialize relugolix combination tablet, relugolix monotherapy tablet, MVT-602, or a potential future product candidate. Our revenue to date has been solely derived from the upfront and regulatory milestone payments we received from Richter ~~under~~pursuant to the terms of the Richter Development and Commercialization Agreement.

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See Note 8 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information regarding the Pfizer Collaboration and License Agreement and the Richter Development and Commercialization Agreement.

Cost of Product Revenue

Our cost of product revenue is composed of the cost of goods sold and royalty expense. Our cost of goods sold consists of raw materials, third-party manufacturing costs to manufacture the raw materials into finished product, freight, and indirect overhead costs associated with sales of ORGOVYX and MYFEMBREE in the U.S and sales of product supply to Richter. Our royalty expense consists of royalties on net sales of relugolix payable to Takeda pursuant to the terms of the Takeda License Agreement (see Note 9(D) to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report).

In connection with the FDA approvals of ORGOVYX (on December 18, 2020) and MYFEMBREE (on May 26, 2021), we subsequently began capitalizing inventory manufactured or purchased for each product after its respective approval date. As a result, we expensed certain manufacturing costs of ORGOVYX and MYFEMBREE as research and development (“R&D”) expenses prior to FDA approval and, therefore, these costs are not included in cost of goods sold.

Collaboration Expense to Pfizer

Our collaboration expense to Pfizer consists of Pfizer’s 50% share of net profits from sales of ORGOVYX and MYFEMBREE in the U.S. (see Note 8(B) to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report).

Research and Development Expenses

Our R&D expenses to date have been primarily attributable to the clinical development of our product candidates including the conduct of multiple Phase 3 and earlier clinical studies, the expansion of our team, and the initiation of activities in preparation for our anticipated commercial launches such as the establishment of our medical affairs function, as well as regulatory and certain manufacturing activities. Our R&D expenses include program-specific costs, as well as costs that are not allocated to a specific program.

~~Program-specific~~Our program-specific costs primarily include third-party costs, which include expenses incurred under agreements with CROs and CMOs, the cost of consultants who assist with the development of our product candidates on a program-specific basis, investigator grants, sponsored research, manufacturing costs in connection with producing materials for use in conducting nonclinical and clinical studies, as well as costs related to pre-commercial manufacturing activities ~~in connection with preparations for our anticipated commercial launches~~ and regulatory submissions, ~~for relugolix combination tablet and relugolix monotherapy tablet,~~ and other third-party expenses directly attributable to the development of our product candidates.

~~Unallocated~~Our unallocated R&D costs primarily include employee-related expenses, such as salaries, share-based compensation, fringe benefits and travel for employees engaged in R&D activities including clinical operations, biostatistics, regulatory, and medical affairs, and the cost of contractors and consultants who assist with R&D activities not specific to a program and costs associated with nonclinical studies.

R&D activities have been, and will continue to be, central to our business model. We currently expect R&D expenses ~~over~~for the ~~next several~~remaining fiscal 2021 quarters to be ~~at similar levels to our second quarter 2020~~in line with the R&D ~~expenses as~~spend incurred in the three months ended September 30, 2021. Overall, we expect declining spend on our Phase 3 ~~HERO, LIBERTY, and SPIRIT~~ clinical programs ~~which~~that are winding down ~~are expected~~ to be offset primarily by incremental ~~expenses associated~~spend on new relugolix development programs, such as the Phase 3 SERENE study, and certain other lifecycle activities to potentially expand the commercial opportunity for the relugolix franchise, as well as post-marketing requirements as agreed upon with ~~certain life-cycle management activities, including clinical manufacturing expenses,~~ the further build out of our medical affairs function and potential new investments in our pipeline. We also expect to incur additional regulatory expenses which may result in an increase in our R&D expense in periods where potential regulatory submissions for our product candidates occur.FDA.

The duration, costs and timing of clinical studies and development of our product candidates will depend on a variety of factors that include, but are not limited to: the number of studies required for approval; the per patient study costs; the number of patients who participate in the studies; the number of sites included in the studies; the countries in which the studies are conducted; the length of time required to recruit and enroll eligible patients; the number of patients who fail to meet the study’s inclusion and exclusion criteria; the number of study drug doses that patients receive; the drop-out or discontinuation rates of patients; the potential additional safety monitoring or other studies requested by regulatory agencies; the duration of patient follow-up; the timing and receipt of regulatory approvals; the costs of clinical study materials; and the efficacy and safety profile of the product candidate.

In addition, the probability of commercial success for ~~relugolix combination tablet, relugolix monotherapy tablet, MVT-602~~ORGOVYX and MYFEMBREE, or for any ~~other~~of our current or potential future product candidates, if approved, will depend on numerous factors, including competition, manufacturing capability and commercial viability. As a result, we are unable to determine with certainty to what extent we will generate product revenue from commercialization and sale of any of our product candidates that receive regulatory approval. Our R&D activities may be subject to change from time to time as we evaluate our priorities and available resources.

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We expect that certain R&D expenses will be shared equally with Pfizer pursuant to the Pfizer Collaboration and License Agreement. See Note 8(B) to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information regarding the Pfizer Collaboration and License Agreement.

Selling, General and Administrative Expenses

~~G&A~~Our selling, general and administrative (“SG&A”) expenses consist primarily of personnel costs, ~~such as~~including salaries, sales incentive compensation, bonuses, fringe benefits, and share-based compensation ~~and travel expenses~~ for our executive, finance, human resources, legal, information technology, commercial operations, marketing, market access, sales, and other administrative functions. GOur SG&A expenses also include marketing programs, patient assistance and support programs, advertising, conferences, congresses, travel expenses, professional fees for legal, accounting, auditing and tax services, and costs related to rent and facilities, insurance, information technology, commercial operations, and general overhead. GOur SG&A expenses also include ~~costs incurred under~~related party expenses pursuant to our ~~Market Access Services Agreement~~agreements with ~~Sunovion.~~Sunovion and Sumitovant (see Note 5 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report).

We currently expect GSG&A ~~expense~~expenses for the remaining fiscal 2021 quarters to increase modestly from the SG&A spend incurred in ~~future periods~~the three months ended September 30, 2021 as we continue to ~~build out~~expand our ~~commercial~~sales and marketing infrastructure and capabilities particularly driven by the hiring of our oncology and women’s health sales forces. If relugolix combination tablet, relugolix monotherapy tablet, or MVT-602 obtain regulatory approval for marketing, we expect sales, marketing,as well as general administrative functions to support multiple product launches and commercialization ~~costs~~activities. We expect SG&A expenses in future periods to ~~be significant.~~

~~Interest Expense~~

~~Interest expense consists of interest expense~~include certain expenses related to our ~~previously outstanding debt with Hercules Capital, Inc. (“Hercules”)~~patient support programs such as free drug and ~~NovaQuest Capital Management (“NovaQuest”), which we repaid~~patient assistance for qualified uninsured patients. The timing of these increased expenditures and their magnitude are primarily dependent on ~~December 31, 2019,~~our commercial success and sales growth of ORGOVYX and MYFEMBREE, as well as the ~~associated non-cash amortization~~timing of ~~debt discounts~~any new product launches and ~~issuance costs.~~other potential business and operational activities.

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We expect that certain SG&A expenses will be shared equally with Pfizer pursuant to the Pfizer Collaboration and License Agreement. See Note 8(B) to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information regarding the Pfizer Collaboration and License Agreement.

Interest Expense ~~(Related Party)~~

~~Interest~~Our interest expense ~~(related party)~~ consists of related party interest expense pursuant to the Sumitomo Dainippon Pharma Loan Agreement, which bears interest at a rate per annum equal to 3-month LIBOR plus a margin of 3% payable on the last day of each calendar ~~quarter. In October 2020, we borrowed an additional $60.0 million under~~quarter, and accretion of the ~~Sumitomo Dainippon Pharma Loan Agreement. We believe~~financing component of the ~~October 2020 draw down, as well as additional anticipated increases~~cost share advance from Pfizer (see Note 8(B) to our unaudited condensed consolidated financial statements included elsewhere in ~~our outstanding debt under the Sumitomo Dainippon Pharma Loan Agreement, to result in an increase in interest expense (related party) in future periods.~~this Quarterly Report).

Interest Income

~~Interest~~Our interest income consists primarily of interest earned ~~on cash and cash equivalents~~ and the accretion of discounts to maturity for cash equivalents and marketable securities.

~~Other (Income) Expense, Net~~Foreign Exchange Gain

~~Other (income) expense, net~~Our foreign exchange gain in the three and six months ended September 30, 2020 consists ~~primarily~~ of the impact of changes in foreign currency exchange rates on our foreign exchange denominated liabilities, relative to the U.S. dollar. The impact of foreign currency exchange rates on our results of operations fluctuates period over period based on our foreign currency exposures resulting from changes in applicable exchange rates associated with our foreign denominated ~~liabilities, such as our outstanding balance under the Sumitomo Dainippon Pharma Loan Agreement.~~liabilities. Our primary foreign currency exposure ~~is currently~~has historically been the exchange rate between the Swiss franc and the U.S. dollar.

In December 2020, we changed the functional currency of our wholly-owned subsidiary in Switzerland, Myovant Sciences GmbH (“MSG”), from the Swiss franc to the U.S. dollar. This change in functional currency was accounted for prospectively. As a result of this change, we currently expect that future impacts of changes in foreign currency exchange rates on our results of operations will not be significant. See Note 2 to our audited consolidated financial statements included in our Annual Report on Form 10-K for the fiscal year ended March 31, 2021, filed with the SEC on May 11, 2021.

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Results of Operations

The following table summarizes our results of operations for the three and six months ended September 30, ~~2020~~2021 and ~~2019~~2020 (in thousands):


		Three Months Ended September 30,				Six Months Ended September 30,					Three Months Ended September 30,				Six Months Ended September 30,
		2020		2019		2020		2019			2021		2020		2021		2020
License and milestone revenue		$	—	$	—	$	33,333	$	—
Operating expenses:
Revenues:										Revenues:
Product revenue, net										Product revenue, net	$	21,063	$	—	$	32,617	$	—

Pfizer collaboration revenue										Pfizer collaboration revenue	25,172		—		54,681		—
Richter license and milestone revenue										Richter license and milestone revenue	31,667		—		31,667		33,333
Total revenues										Total revenues	77,902		—		118,965		33,333
Operating costs and expenses:										Operating costs and expenses:
Cost of product revenue										Cost of product revenue	2,622		—		3,654		—
Collaboration expense to Pfizer										Collaboration expense to Pfizer	8,565		—		13,826		—
Research and development	Research and development	40,521		50,803		84,707		101,920		Research and development	26,280		40,521		57,160		84,707
General and administrative		31,316		16,603		54,144		30,755
Total operating expenses		71,837		67,406		138,851		132,675
Selling, general and administrative										Selling, general and administrative	58,781		31,316		119,993		54,144
Total operating costs and expenses										Total operating costs and expenses	96,248		71,837		194,633		138,851
Loss from operations	Loss from operations	(71,837)		(67,406)		(105,518)		(132,675)		Loss from operations	(18,346)		(71,837)		(75,668)		(105,518)
Interest expense	Interest expense	—		3,788		—		7,581		Interest expense	3,494		2,115		6,999		4,299

Interest expense (related party)		2,115		—		4,299		—
Interest income	Interest income	(38)		(942)		(146)		(1,708)		Interest income	(100)		(38)		(178)		(146)
Other (income) expense, net		(6,718)		121		(10,287)		(584)
Foreign exchange gain										Foreign exchange gain	—		(6,718)		—		(10,287)
Loss before income taxes	Loss before income taxes	(67,196)		(70,373)		(99,384)		(137,964)		Loss before income taxes	(21,740)		(67,196)		(82,489)		(99,384)
Income tax (benefit) expense	Income tax (benefit) expense	(134)		195		538		508		Income tax (benefit) expense	(149)		(134)		762		538
Net loss	Net loss	$	(67,062)	$	(70,568)	$	(99,922)	$	(138,472)	Net loss	$	(21,591)	$	(67,062)	$	(83,251)	$	(99,922)

~~License and Milestone Revenue~~Revenues

~~License and milestone revenue~~The following table provides information about our revenues for the three and six months ended September 30, ~~2020~~ ~~was $33.3 million~~2021 and ~~represents the partial recognition~~2020 (in thousands):


	Three Months Ended September 30,				Six Months Ended September 30,
	2021		2020		2021		2020
Revenues:
Product revenue, net:
ORGOVYX	$	18,663	$	—	$	29,142	$	—
MYFEMBREE	629		—		1,704		—
Richter product supply and royalties	1,771		—		1,771		—
Total product revenue, net	21,063		—		32,617		—

Pfizer collaboration revenue:
Amortization of upfront payment	20,974		—		41,948		—
Amortization of regulatory milestone	4,198		—		12,733		—
Total Pfizer collaboration revenue	25,172		—		54,681		—
Richter license and milestone revenue	31,667		—		31,667		33,333
Total revenues	$	77,902	$	—	$	118,965	$	33,333

We began generating product revenue from sales of ~~revenue associated with the $40.0 million upfront payment~~ORGOVYX and a $10.0 million regulatory milestone payment under the Richter Development and Commercialization Agreement. We recognize revenue as we satisfy our combined performance obligation to Richter. There were no such amountsMYFEMBREE in the U.S. in January 2021 and June 2021, respectively. For the three and six months ended September 30, ~~2020 or the~~ ~~comparable prior year periods.~~2021, product revenue, net also includes revenues related to product supply to Richter of $1.7 million, as well as royalties on net sales of RYEQO in Richter’s Territory of less than $0.1 million.

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Pfizer collaboration revenue for the three and six months ended September 30, 2021, consists of the partial recognition of the upfront payment and of the regulatory milestone payment that was triggered upon the FDA approval of MYFEMBREE for the management of heavy menstrual bleeding associated with uterine fibroids. There were no such amounts recognized for the three and six months ended September 30, 2020.

Richter license and milestone revenue for the three and six months ended September 30, 2021 consists of the recognition of a $15.0 million regulatory milestone payment that was triggered upon the European Commission approval of RYEQO for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age and $16.7 million of previously deferred revenue that was recognized upon the completion of our delivery of the remaining substantive relugolix combination tablet data packages to Richter. Richter license and milestone revenue for the six months ended September 30, 2020 consists of the recognition of $33.3 million of the upfront and regulatory milestone payments we received from Richter in March and April 2020, respectively. There was no Richter license and milestone revenue for the three months ended September 30, 2020.

Cost of Product Revenue

For the three and six months ended September 30, 2021, our cost of product revenue was $2.6 million and $3.7 million, respectively, which includes the cost of goods sold and royalty expense payable to Takeda. There were no such amounts recognized for the three and six months ended September 30, 2020.

In connection with the FDA approvals of ORGOVYX for adult patients with advanced prostate cancer (on December 18, 2020) and MYFEMBREE for the management of heavy menstrual bleeding associated with uterine fibroids (on May 26, 2021), we subsequently began capitalizing inventory manufactured or purchased for each product after its respective approval date. Previously, costs to manufacture ORGOVYX and MYFEMBREE were expensed as incurred as R&D expenses. We expect our cost of goods sold to increase in future periods as quantities of previously expensed ORGOVYX and MYFEMBREE inventory are depleted from our inventory stock.

Collaboration Expense to Pfizer

For the three and six months ended September 30, 2021, our collaboration expense to Pfizer was $8.6 million and $13.8 million, respectively and represents Pfizer’s 50% share of net profits from the sales of ORGOVYX and MYFEMBREE in the U.S. There were no such amounts recognized for the three and six months ended September 30, 2020.

Research and Development Expenses

For the three months ended September 30, ~~2020~~2021 and ~~2019,~~2020, our R&D expenses consisted of the following (in thousands):


		Three Months Ended September 30,							Three Months Ended September 30,
		2020		2019		Change			2021		2020		Change
Program-specific costs:	Program-specific costs:							Program-specific costs:
Relugolix	Relugolix	$	19,793	$	36,233	$	(16,440)	Relugolix	$	5,524	$	19,793	$	(14,269)
MVT-602	MVT-602	15		255		(240)		MVT-602	50		15		35
Unallocated costs:	Unallocated costs:							Unallocated costs:
Personnel expense								Personnel expense	13,733		11,827		1,906
Share-based compensation	Share-based compensation	3,725		3,618		107		Share-based compensation	5,060		3,725		1,335
Personnel expense		11,827		7,738		4,089

Other expense	Other expense	5,161		2,959		2,202		Other expense	1,913		5,161		(3,248)
Total R&D expenses	Total R&D expenses	$	40,521	$	50,803	$	(10,282)	Total R&D expenses	$	26,280	$	40,521	$	(14,241)

For the six months ended September 30, ~~2020~~2021 and ~~2019,~~2020, our R&D expenses consisted of the following (in thousands):

Six Months Ended September 30,
2020 2019 Change
Program-specific costs:
Relugolix $ 45,686 $ 75,339 $ (29,653)
MVT-602 239 1,075 (836)
Unallocated costs:
Share-based compensation 7,749 6,166 1,583
Personnel expense 23,663 15,050 8,613
Other expense 7,370 4,290 3,080
Total R&D expenses $ 84,707 $ 101,920 $ (17,213)

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	Six Months Ended September 30,
	2021		2020		Change
Program-specific costs:
Relugolix	$	12,715	$	45,686	$	(32,971)
MVT-602	113		239		(126)
Unallocated costs:
Personnel expense	28,497		23,663		4,834
Share-based compensation	9,167		7,749		1,418
Other expense	6,668		7,370		(702)
Total R&D expenses	$	57,160	$	84,707	$	(27,547)

R&D expenses decreased by ~~$10.3~~$14.2 million, to $26.3 million, in the three months ended September 30, 2021 compared to $40.5 million in the three months ended September 30, ~~2020 compared to $50.8 million~~2020. The decrease in ~~the~~R&D expenses reflects cost share reimbursements from Pfizer for certain R&D expenses during three months ended September 30, ~~2019. The decrease in R&D expenses for three months ended September 30, 2020 reflects~~2021, and a ~~decrease~~reduction in clinical study costs as a result of the completion and ~~continued~~ wind down of our Phase 3 LIBERTY, HERO, and SPIRIT studies. This decrease was partially offset ~~primarily~~ by increased expenses by our medical affairs organization in preparation for our anticipated commercial launches, if approved, of relugolix monotherapy tablet for men with advanced prostate cancer and relugolix combination tablet for the women’s health indications, as well as an increase in medical affairs personnel ~~expenses.~~expenses to support the U.S. launches of ORGOVYX and MYFEMBREE.

R&D expenses for the three months ended September 30, 2021 consisted primarily of personnel expenses of $13.7 million, program-specific costs composed of CRO, drug supply and other study, regulatory, and manufacturing related costs of $5.6 million, share-based compensation of $5.1 million and other unallocated costs of $1.9 million.

R&D expenses for the three months ended September 30, 2020 consisted primarily of program-specific costs composed of CRO, drug supply and other study, regulatory, and manufacturing related costs of $19.8 million, personnel expenses of $11.8 million, share-based compensation ~~expense~~ of $3.7 million, and other ~~R&D~~unallocated costs of $5.2 ~~million, which primarily includes contractors, consultants, and information technology costs and other unallocated nonclinical research costs.~~

R&D expenses in the three months ended September 30, 2019 consisted primarily of CRO, drug supply and other study and manufacturing related costs of $33.7 million, personnel expenses of $7.7 million, share-based compensation expense of $3.6 million, and other R&D costs of $5.8 million, which primarily includes contractors and consultants.million.

R&D expenses decreased by ~~$17.2~~$27.5 million, to $57.2 million, in the six months ended September 30, 2021 compared to $84.7 million in the six months ended September 30, ~~2020 compared to $101.9 million~~2020. The decrease in R&D expenses reflects cost share reimbursements from Pfizer for certain R&D expenses during the six months ended September 30, ~~2019. The decrease in R&D expenses for the six months ended September 30, 2020 reflects~~2021 and a ~~decrease~~reduction in clinical study costs as a result of the completion and ~~continued~~ wind down of our Phase 3 LIBERTY, HERO, and SPIRIT studies. The decrease also reflects lower regulatory expenses during the six months ended September 30, 2021, as the prior year period included submission fees for our NDAs for ORGOVYX for advanced prostate cancer and MYFEMBREE for the uterine fibroids indication. This decrease was partially offset ~~primarily~~ by ~~increases~~an increase in ~~expenses by our~~ medical affairs ~~organization in preparation for our anticipated commercial launches and~~ personnel expenses ~~as well as~~to support the U.S. launches of ORGOVYX and MYFEMBREE.

R&D expenses for the six months ended September 30, 2021 consisted primarily of personnel expenses of $28.5 million, program-specific costs composed of CRO, drug supply and other study, regulatory, ~~expenses in connection with regulatory submissions for relugolix combination tablet~~ and ~~relugolix monotherapy tablet, including fees~~manufacturing related ~~to our NDA submissions for relugolix combination tablet for heavy menstrual bleeding associated with uterine fibroids~~costs of $12.8 million, share-based compensation of $9.2 million, and ~~relugolix monotherapy tablet for advanced prostate cancer.~~

~~Table~~other unallocated costs of ~~Contents~~

$6.7 million,

R&D expenses for the six months ended September 30, 2020 consisted primarily of program-specific costs composed of CRO, drug supply and other study, regulatory, and manufacturing related costs of $40.1 million, personnel expenses of $23.7 million, fees related to our NDA submissions for ~~relugolix combination tablet~~MYFEMBREE for the management of heavy menstrual bleeding associated with uterine fibroids and ~~relugolix monotherapy tablet~~ORGOVYX for adult patients with advanced prostate cancer of $5.8 million, share-based compensation ~~expense~~ of $7.7 million, and other ~~R&D~~unallocated costs of $7.4 million.

Selling, General and Administrative Expenses

SG&A expenses increased by $27.5 million, ~~which primarily includes contractors, consultants, and information technology costs and other unallocated nonclinical research costs.~~

~~R&D expenses~~to $58.8 million, in the ~~six~~three months ended September 30, 2019 consisted primarily of CRO, drug supply and other study and manufacturing related costs of $74.2 million, personnel expenses of $15.1 million, share-based compensation expense of $6.2 million, and other R&D costs of $6.5 million, which primarily include contractors and consultants.

~~General and Administrative Expenses~~

~~G&A expenses increased by $14.7 million,~~2021 compared to $31.3 million in the three months ended September 30, 2020, ~~compared~~primarily due to ~~$16.6 million~~higher expenses to support the U.S commercial launches of ORGOVYX and MYFEMBREE, including higher personnel expenses primarily related to the hiring of our commercial operations, marketing, and market access teams, and our oncology and women’s health sales forces, and other general overhead, administrative, and information technology expenses to support our organizational growth.

SG&A expenses in the three months ended September 30, ~~2019,~~2021 consisted primarily ~~due~~of personnel expenses of $27.4 million, commercial expenses of $10.0 million, general overhead, administrative and information technology expenses of $10.7 million, share-based compensation of $6.8 million, professional service fees of $1.7 million, related party expenses of $1.2 million related to ~~increases in~~our Market Access Services Agreement with Sunovion, and rent and other facilities-related costs of $1.0 million. Share-based compensation includes approximately $2.2 million of incremental expenses related to ~~commercial readiness activities, personnel-related~~our former Principal Executive Officer’s and our former Principal Financial Officer’s equity awards as discussed further in Note 7(D) and Note 7(E),

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respectively, to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report. SG&A expenses are presented net of costs shared with Pfizer pursuant to the terms of the Pfizer Collaboration and other general overhead expenses to support our organizational growth and anticipated commercial launches, if approved, of relugolix monotherapy tablet for men with advanced prostate cancer and relugolix combination tablet for the women’s health indications.License Agreement.

GSG&A expenses in the three months ended September 30, 2020 consisted primarily of commercial operations expenses of $10.0 million, personnel expenses of $8.6 million, general overhead, administrative and information technology expenses of $5.4 million, share-based compensation ~~expense~~ of $3.2 million, professional service fees of $2.0 million, and rent and other facilities-related costs of $0.9 million. For the three months ended September 30, 2020, GSG&A expenses also ~~include $0.2~~includes $1.3 million of ~~expense under a consulting agreement~~related party expenses pursuant to our agreements with Sumitovant and ~~$1.1~~Sunovion.

SG&A expenses increased by $65.9 million, to $120.0 million, in the six months ended September 30, 2021 compared to $54.1 million in the six months ended September 30, 2020, primarily due to higher expenses related to commercial activities to support the U.S commercial launches of ~~expense (inclusive~~ORGOVYX and MYFEMBREE as well as higher personnel expenses primarily related to the hiring of ~~third-party pass through costs billed~~our commercial operations, marketing, and market access teams, and our oncology and women’s health sales forces, and other general overhead, administrative, and information technology expenses to ~~us) under~~support our ~~agreement with Sunovion. For additional~~organizational growth.

SG&A expenses in the six months ended September 30, 2021 consisted primarily of personnel expenses of $54.9 million, commercial expenses of $22.7 million, general overhead, administrative and information ~~about these~~technology expenses of $20.5 million, share-based compensation of $14.0 million, legal and professional service fees of $3.5 million, related party expenses ~~see~~of $2.5 million related to our Market Access Services Agreement with Sunovion, and rent and other facilities-related costs of $1.9 million. Share-based compensation includes approximately $3.6 million of incremental expenses related to our former Principal Executive Officer’s and our former Principal Financial Officer’s equity awards as discussed further in Note 57(D) and Note 7(E), respectively, to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly ~~Report on Form 10-Q.~~

GReport. SG&A expenses inare presented net of costs shared with Pfizer pursuant to the ~~three months ended September 30, 2019 consisted primarily~~terms of ~~personnel expenses of $4.5 million, commercial operations expenses of $2.6 million, share-based compensation expense of $4.3 million, general overhead, administrative~~the Pfizer Collaboration and ~~information technology expenses of $3.5 million, professional service fees of $1.1 million, and rent and other facilities-related costs of $0.6 million.~~License Agreement.

G&A expenses increased by $23.4 million, to $54.1 million, in the six months ended September 30, 2020 compared to $30.8 million in the six months ended September 30, 2019, primarily due to increases in expenses related to commercial readiness activities, personnel-related expenses, and other general overhead expenses to support our organizational growth and anticipated commercial launches of relugolix monotherapy tablet for men with advanced prostate cancer and relugolix combination tablet for the women’s health indications.

GSG&A expenses in the six months ended September 30, 2020 consisted primarily of personnel expenses of $16.2 million, commercial operations expenses of $15.6 million, general overhead, administrative and information technology expenses of $9.0 million, shared-based compensation ~~expense~~ of $7.0 million, professional service fees of $3.3 million, and rent and other facilities-related costs of $1.7 million. For the six months ended September 30, 2020, ~~we incurred $0.3~~SG&A expenses also includes $1.4 million of ~~expense under a consulting agreement~~related party expenses pursuant to our agreements with Sumitovant and ~~$1.1 million of expense (inclusive of third-party pass through costs billed to us) under our agreement with~~ Sunovion. ~~For additional information about these related party expenses, see Note 5 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.~~

G&A expenses in the six months ended September 30, 2019 consisted primarily of personnel expenses of $8.4 million, commercial operations expenses of $3.6 million, share-based compensation expense of $8.2 million, general overhead, administrative and information technology expenses of $7.0 million, professional service fees of $2.5 million, and rent and other facilities-related costs of $1.1 million.

Interest Expense

Interest expense was $3.5 million and $7.0 million in the three and six months ended September 30, 2021, respectively, compared to $2.1 million and $4.3 million in the three and six months ended September 30, 2020, respectively, and was primarily related to the Sumitomo Dainippon Pharma Loan Agreement. The increase in interest expense related to the Sumitomo Dainippon Pharma Loan Agreement ~~compared to $3.8 million and $7.6 million~~was primarily driven by a higher balance in the current fiscal year periods. Interest expense in the three and six months ended September 30, ~~2019,~~2021 also includes $0.6 million and $1.2 million, respectively, ~~related to our previously outstanding~~of accretion of the financing ~~arrangements with NovaQuest~~component of the cost share advance from Pfizer. There was no such accretion for the three and Hercules. The decrease in interest expense was driven by lower interest rates associated with the Sumitomo Dainippon Pharma Loan Agreement as compared to the previously outstanding debt obligations to NovaQuest and Hercules, which were repaid in December 2019.

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six months ended September 30, 2020.

Interest Income

Interest income was ~~less than~~ $0.1 million ~~for the three months ended September 30, 2020, approximately $0.1 million for the six months ended September 30, 2020,~~ and ~~$0.9 million and $1.7~~$0.2 million for the three and six months ended September 30, ~~2019,~~2021, respectively. ~~The decreases were primarily due to decreases in interest rates and lower balances in cash equivalents and marketable securities relative to the prior year periods.~~

~~Other (Income) Expense, Net~~

~~For~~Interest income was approximately $0.1 million for both the three ~~months ended September 30, 2020, we recorded a foreign exchange gain of $6.7 million,~~ and ~~for the three months ended September 30, 2019, we recorded a foreign exchange loss of $0.1 million. For the~~ six months ended September 30, ~~2020, we recorded a foreign exchange gain of $10.3 million compared to a foreign exchange gain of $0.6 million for the six months ended September 30, 2019. The foreign exchange gains in~~2020.

Foreign Exchange Gain

For the three and six months ended September 30, 2020, ~~were~~we recorded foreign exchange gains of $6.7 million and $10.3 million, respectively, primarily as the result of the impact of fluctuations in the foreign currency exchange ~~gains~~rate between the Swiss franc and the U.S. dollar on our outstanding balance under the Sumitomo Dainippon Pharma Loan Agreement. There were no such amounts for the three and six months ended September 30, 2021.

Income Tax (Benefit) Expense

Our income tax (benefit) expense was $(0.1) million and ~~$0.2~~$0.8 million for the three and six months ended September 30, ~~2020 and 2019,~~2021, respectively. Our income tax (benefit) expense was $(0.1) million and $0.5 million for ~~both~~ the three and six months ended September 30, 2020, ~~and 2019.~~respectively. Our effective tax rate for the three and six months ended September 30, ~~2020~~2021 was 0.69% and ~~2019 was 0.20% and (0.28)~~(0.92)%, respectively, and for the three and six months ended September 30, 2020 was 0.20% and ~~2019 was~~ (0.54)~~% and (0.37)~~%, ~~respectively, and~~respectively. Our effective tax rates are driven by our jurisdictional earnings by location and a valuation allowance that eliminates our global net deferred tax assets.

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Liquidity and Capital Resources

Sources of Liquidity

Since our inception, we have funded our operations primarily from the issuance and sale of our common shares, ~~and~~ from debt financing ~~arrangements.~~ arrangements, and more recently from upfront and milestone payments we received from Pfizer and Richter. We began generating net product revenue from the sales of ORGOVYX and MYFEMBREE in the U.S. in January 2021 and June 2021, respectively.

As of September 30, ~~2020,~~2021, we had cash, cash equivalents, marketable securities, and amounts available to us under the Sumitomo Dainippon Pharma Loan Agreement of ~~$257.6~~$657.3 million, consisting of ~~$111.3~~$616.0 million of cash, cash equivalents, and marketable securities and ~~$146.3~~$41.3 million of borrowing capacity available to us under the Sumitomo Dainippon Pharma Loan Agreement, as compared to cash, cash equivalents, marketable securities, and amounts available to us under the Sumitomo Dainippon Pharma Loan Agreement of ~~$365.9~~$726.2 million, consisting of ~~$79.6~~$684.9 million of cash, cash equivalents, and marketable securities and ~~$286.3~~$41.3 million of borrowing capacity available to us under the Sumitomo Dainippon Pharma Loan Agreement, as of March 31, ~~2020.~~2021. Additional funds under the Sumitomo Dainippon Pharma Loan Agreement may be drawn down by us no more than once per calendar quarter, subject to certain terms and conditions, including consent of our board of directors. In October 2020, we borrowed an additional $60.0 million under the Sumitomo Dainippon Pharma Loan Agreement. On August 5, 2020, we obtained the 2020 Commitment Letter from Sumitomo Dainippon Pharma (amended September 29, 2020) pursuant to which, subjectdirectors.

Pursuant to the ~~terms~~Pfizer Collaboration and ~~conditions set forth therein, Sumitomo Dainippon Pharma has committed~~License Agreement, we are eligible to ~~provide us with an incremental $200.0~~receive up to $3.6 billion of additional milestone payments, including a regulatory milestone of $100.0 million ~~low-interest, five-year term loan commitment.~~upon the FDA approval for MYFEMBREE in endometriosis, and tiered sales milestones of up to $3.5 billion upon reaching certain thresholds of annual net sales for oncology and the combined women’s health indications in the Co-Promotion Territory. We and Pfizer equally share profits and certain expenses in the Co-Promotion Territory.

Pursuant to the Richter Development and Commercialization Agreement, we ~~received an upfront payment of $40.0 million in March 2020, and~~ are eligible to receive up to ~~$40.0~~$122.5 million inof additional milestone payments, including regulatory milestones ~~(of which $10.0~~of up to $15.0 million ~~was received in April 2020),~~and tiered sales milestones of up to $107.5 million upon reaching certain thresholds of annual net sales in ~~sales-related milestones,~~Richter’s Territory, and tiered royalties on net sales ~~following regulatory approval.~~

~~As of September 30, 2020, we had approximately $10.4 million of capacity available to us under our “at-the-market” equity offering program that we established~~ in ~~April 2018.~~Richter’s Territory.

Capital Requirements

~~For the six months ended September 30, 2020 and 2019, we had net losses of $99.9 million and $138.5 million, respectively. As of September 30, 2020, we had an accumulated deficit of $890.9 million.~~

We have incurred, and expect to continue to incur, significant operating losses and negative operating cash flows as we continue to develop our product candidates and prepare for the potential future regulatory approvals and commercialization of relugolix combination tablet and relugolix monotherapy tablet. We have not generated any product revenue to date and do not expect to generate product revenue unless and until we obtain regulatory approval for one of our product candidates. Our operating losses and negative operating cash flows may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our planned clinical studies, anticipated regulatory filings, pre-commercialization and commercialization efforts and our expenditures on other R&D and G&A activities.

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~~We anticipate~~believe that our ~~capital requirements will be significant as we:~~

•~~submit additional NDAs and other regulatory filings for our product candidates;~~

•~~expand our chemistry, manufacturing, and control and other manufacturing related activities;~~

•~~seek to identify, acquire, develop, and commercialize additional product candidates;~~

•~~integrate acquired technologies into a comprehensive regulatory and product development strategy;~~

•~~maintain, expand, and protect our intellectual property portfolio;~~

•~~hire scientific, clinical, regulatory, quality, and administrative personnel;~~

•~~add operational, accounting, finance, quality, commercial, and management information systems and personnel;~~

•seek regulatory approvals for relugolix monotherapy tablet for the treatment of men with advanced prostate cancer and relugolix combination tablet for the treatment of women with heavy menstrual bleeding associated with uterine fibroids and any other product candidates that successfully complete clinical studies;

•~~establish a medical affairs group with a medical scientific liaison team;~~

•~~establish a sales, marketing, and distribution infrastructure and increase the scale of our external capabilities to commercialize any product candidates for which we may obtain regulatory approval;~~

•~~service our debt obligations and associated interest payments; and~~

•~~operate as a public company.~~

Our primary use of cash has been to fund the development of relugolix combination therapy, relugolix monotherapy, and MVT-602. We expect our operating expenses to continue to increase over the near term as we expand our operations to continue to develop our product candidates and prepare for potential future regulatory approvals and commercialization of relugolix combination tablet and relugolix monotherapy tablet. In addition, we currently expect that our outstanding debt levels will increase in future periods, which will result in an increase in our quarterly interest payment obligations.

~~Based on our current operating plan, we expect that our~~existing cash, cash equivalents, and marketable securities ~~and amounts available to us under the Sumitomo Dainippon Pharma Loan Agreement~~ will be sufficient to fund our anticipated operating expenses and capital expenditure requirements for at least ~~through~~ the ~~end~~next 12 months from the date of ~~our fiscal year ending March 31, 2021.~~issuance of this Quarterly Report. This estimate is based on our current assumptions, including assumptions ~~relating~~related to our ability to manage our spend, that ~~may~~might prove to be wrong, and we could use our available capital resources sooner than we currently expect. ~~Our current~~In future periods, if our cash, cash equivalents, marketable securities, and amounts ~~available~~that we expect to ~~us under the Sumitomo Dainippon Pharma Loan Agreement will~~generate from product sales and/or third-party collaboration payments, are not be sufficient to enable us to complete all necessary development and regulatory activities and commercially launch relugolix combination tablet or relugolix monotherapy tablet. We anticipate that we will continue to incur net losses and negative operating cash flows for the foreseeable future.

To continue as a going concern, we will need, among other things, additional capital resources. We continually assess multiple options to obtain additional funding to support our operations, including through financing activities in public or private capital markets. We can provide no assurances that any sources of a sufficient amount of financing will be available to us on favorable terms, if at all. Although we expect to draw under the Sumitomo Dainippon Pharma Loan Agreement on a quarterly basis, such draws are contingent upon the consent of our board of directors. If Sumitomo Dainippon Pharma fails to own at least a majority of our common shares, it may become unlawful under Japanese law for Sumitomo Dainippon Pharma to fund loans to us, in which case we would not be able to continue to borrow under the Sumitomo Dainippon Pharma Loan Agreement. ASC 240-40, ~~Going Concern~~, does not allow us to consider future financing activities that are uncertain in our assessment of our future cash burn for the purpose of our liquidity assessment. Due to these uncertainties, there is substantial doubt about our ability to continue as a going concern. If we are unable to raise capital in sufficient amounts and on terms acceptable to us, we may have to significantly delay, scale back, or discontinue operations.

Until such time, if ever, as we can generate substantial product revenue from sales of relugolix combination tablet, relugolix monotherapy tablet, MVT-602, or any future product candidate, we expect to fund our operations, ~~through a combination~~we may need to raise additional funds in the form of ~~cash, cash equivalents,~~equity, debt, or from other sources. In addition, we may choose to raise additional funds in the form of equity, debt, or from other sources due to market conditions or strategic considerations even if we believe we have sufficient funds for our current and marketable securities currently on hand, equity offerings, debt financings, structured transactions such as royalty financings, collaboration, license or development agreements, or other collaborations, as well as quarterly draws under the Sumitomo Dainippon Pharma Loan Agreement, subject to the consent of our board of directors.future operating plans. To the extent that we raise additional capital through the sale of equity or convertible debt securities, our common shareholders’ ownership interest may experience substantial dilution, and the terms of these securities may include liquidation or other preferences that adversely affect our common shareholders’ rights. The Sumitomo Dainippon Pharma Loan Agreement involves, and any agreements for

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future debt or preferred equity financings, if available, may involve, covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, raising capital through equity offerings, making capital expenditures or declaring dividends.

~~In addition, if~~We expect our operating expenses, net of costs that are expected to be shared with Pfizer pursuant to the Pfizer Collaboration and License Agreement, to increase as we ~~raise~~continue to commercialize ORGOVYX and MYFEMBREE in the U.S., prepare for additional ~~funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements~~potential regulatory approvals, initiate life cycle management activities as well as conduct post-marketing requirements as agreed upon with ~~third parties, we may be required to relinquish valuable rights to~~the FDA for our ~~technologies, future revenue streams, research programs or~~relugolix franchise, and potentially further develop our product candidates orand expand our pipeline. However, while we expect our future capital requirements and operating expenses to ~~grant licenses~~continue to be significant, we expect our net cash burn to gradually decrease as our net revenues increase. Our operating expenses and operating cash flows may fluctuate significantly from quarter-to-quarter and year-to-year and our future funding requirements, both near and long-term, will depend on ~~terms that may~~many factors, including, but not ~~be favorable to us. If we are unable to raise additional funds when needed, we may be required to delay, limit, reduce or terminate~~limited to:

•the price, level of demand and net product revenues generated from commercial sales of our drug ~~development or future commercialization efforts or grant rights to develop~~products and ~~market~~from any product candidates that may receive marketing approval in the future;

•the achievement of regulatory milestones, sales milestones, and/or royalties that we ~~would otherwise prefer~~are eligible to earn pursuant to our collaboration agreements;

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•the timing, shared costs, and level of investment in our and our collaboration partners’ activities related to sales, marketing, market access, manufacturing, and distribution for our drug products and for any product candidates that may receive marketing approval in the future;

•the timing, shared costs, and level of investment in our and our collaboration partners’ research and development activities involving ORGOVYX, MYFEMBREE, RYEQO, and any product candidates;

•costs, timing, and outcomes of regulatory submissions and regulatory reviews of our product candidates;

•costs to expand our chemistry, manufacturing, and control and other manufacturing related activities;

•costs to identify, acquire, develop, and ~~market ourselves.~~commercialize additional product candidates;

•costs to integrate acquired technologies into a comprehensive regulatory and product development strategy;

•costs to maintain, expand, and protect our patent claims and other intellectual property rights;

•costs to hire additional commercial operations, sales and marketing, scientific, clinical, regulatory, quality, and other personnel to support our commercialization, sales and marketing, regulatory, and clinical development efforts;

•costs to implement or enhance operational, accounting, finance, quality, commercial, and management information systems;

•costs to service our debt obligations and associated interest payments; and

•costs to operate as a public company.

Until such time, if ever, as we can generate substantial net product revenue from sales of ORGOVYX, MYFEMBREE, or any product candidate, we expect to fund our operations through a combination of cash, cash equivalents, and marketable securities currently on hand and amounts available to us under the Sumitomo Dainippon Pharma Loan Agreement, subject to the consent of our board of directors, as well as potential payments we are eligible to receive from Pfizer and Richter pursuant to the terms of our agreements with them.

Cash Flows

The following table sets forth a summary of our cash flows for the six months ended September 30, ~~2020~~2021 and ~~2019~~2020 (in thousands):


		Six Months Ended September 30,					Six Months Ended September 30,
		2020		2019			2021		2020
Net cash used in operating activities	Net cash used in operating activities	$	(110,576)	$	(135,148)	Net cash used in operating activities	$	(76,578)	$	(110,576)
Net cash used in investing activities	Net cash used in investing activities	$	(14,823)	$	(27,692)	Net cash used in investing activities	$	(87,774)	$	(14,823)
Net cash provided by financing activities	Net cash provided by financing activities	$	143,578	$	137,388	Net cash provided by financing activities	$	15,135	$	143,578

Operating Activities

~~For~~Net cash used in operating activities was $76.6 million for the six months ended September 30, 2021 and consisted of our net loss of $83.3 million adjusted for non-cash operating items of $25.9 million, offset by changes in operating assets and liabilities of $19.2 million. The significant non-cash operating items included share-based compensation of $23.1 million, depreciation and amortization expense of $1.5 million, and accretion of the implied financing component of the cost share advance from Pfizer of $1.2 million.

The changes in operating assets and liabilities included the following:

•$38.3 million decrease in cost share advance from Pfizer due to the application of shared Allowable Expenses (see Note 8(B) and Note 8(C) to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report);

•$28.7 million net increase in deferred revenue due to a $100.0 million regulatory milestone payment from Pfizer, partially offset by the recognition of $54.7 million of Pfizer collaboration revenue and $16.7 million of Richter license and milestone revenue (see Note 8 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report);

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•$18.0 million increase in amounts due to Pfizer as a result of an increase in profit share and reimbursement of Allowable Expenses incurred by Pfizer (see Note 8(B) to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report);

•$10.8 million increase in accounts receivable, net as a result of an increase in net product revenues, mainly driven by sales of ORGOVYX in the U.S.;

•$9.5 million decrease in accounts payable, primarily driven by the timing of vendor invoice payments;

•$3.5 million increase in inventories, driven by the capitalization of inventory manufactured or purchased after the FDA approval of ORGOVYX (on December 18, 2020) and MYFEMBREE (on May 26, 2021); and

•$3.7 million net change in other operating assets and liabilities.

Net cash used in operating activities was $110.6 million for the six months ended September 30, 2020, ~~we used $110.6 million in operating activities primarily due to our ongoing development~~ and ~~clinical studies, activities related to our preparation for potential regulatory approvals and commercialization of relugolix combination tablet and relugolix monotherapy tablet, and the expansion~~consisted of our ~~company. This was primarily attributable to a~~ net loss ~~for the period~~ of $99.9 million aadjusted for non-cash operating items of $5.9 million, offset by changes in operating assets and liabilities of $16.6 million. The significant non-cash operating items included share-based compensation of $14.7 million, foreign currency transaction gain of $10.3 million related to the Sumitomo Dainippon Pharma debt outstanding, and depreciation and amortization expense of $1.1 million.

The changes in operating assets and liabilities included the following:

•$23.3 million net decrease ~~of $23.3 million~~ in deferred revenue consisting of the recognition of $33.3 million of ~~previously deferred~~Richter license and milestone revenue, partially offset by an increase in deferred revenue of $10.0 million related to a regulatory milestone payment we received from Richter in April 2020 ~~a non-cash foreign currency transaction gain of $10.3~~(see Note 8(A) to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report);

•$11.1 million primarily related to the Sumitomo Dainippon Pharma debt outstanding, and a decrease of $8.3 million in accounts payable due to the timing of vendor invoice payments. These amounts were partially offset primarily by $14.7 million of non-cash share-based compensation expense and an increase ~~of $11.1 million~~ in accrued expenses primarily due to increases in accrued commercial, compensation-related, and R&D ~~expenses.~~expenses;

~~For the six months ended September 30, 2019, we used $135.1~~•$8.3 million in operating activities primarily due to our ongoing development and clinical studies, activities related to our preparation for potential regulatory approvals and commercialization of relugolix combination tablet and relugolix monotherapy tablet, and the expansion of our company. This was primarily attributable to a net loss for the period of $138.5 million along with a decrease ~~of $9.2 million in accrued expenses resulting primarily from a decrease in accrued R&D expenses and accrued compensation-related expenses and a decrease of $5.2 million~~ in accounts payable due to the timing of vendor invoice ~~payments. These amounts were partially offset by $14.4~~payments; and

•$3.9 million ~~of non-cash share-based compensation expense as a result of an increase~~net change in ~~headcount, an increase of $3.1~~other operating assets and liabilities.

Investing Activities

For the six months ended September 30, 2021, we used $87.8 million in ~~deferred interest payable related to our previously outstanding debt with NovaQuest,~~investing activities, of which $87.4 million was for the purchases of marketable securities, net of maturities, and ~~$1.8~~$0.4 million was for the purchases of ~~total depreciation~~property and ~~amortization expense.~~

~~Investing Activities~~equipment.

For the six months ended September 30, 2020, we used $14.8 million in investing activities, of which $14.1 million was for the ~~purchase~~purchases of marketable securities, net of maturities, and $0.7 million was for the ~~purchase~~purchases of property and equipment.

Financing Activities

For the six months ended September 30, ~~2019, we used $27.7 million in investing activities, of which $27.2~~2021, $15.1 million was ~~for~~provided by financing activities, which was from proceeds from the ~~purchase~~exercise of ~~marketable securities and $0.5 million was for the purchase of property and equipment.~~

~~Financing Activities~~stock options.

For the six months ended September 30, 2020, $143.6 million was provided by financing activities. This was ~~primarily~~ due to proceeds of $140.0 million borrowed under the Sumitomo Dainippon Pharma Loan Agreement and proceeds of $3.6 million from the exercise of stock ~~options under our 2016 Equity Incentive Plan.~~

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For the six months ended September 30, 2019, $137.4 million was provided by financing activities. This was primarily due to the net proceeds of $134.5 million we received from the issuance and sale of 17,424,243 common shares in our underwritten public equity offering and $2.5 million we received from the sale of 106,494 common shares through our “at-the-market” equity offering program.~~In addition, we received proceeds of $0.3 millionfrom the exercise of stock options under our 2016 Equity Incentive Plan.~~options.

Contractual Obligations

During the six months ended September 30, ~~2020,~~2021, there were no material changes to our contractual obligations and commitments described under Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the year ended March 31, 2020, other than additional draws under the Sumitomo Dainippon Pharma Loan Agreement (see Note 5 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q).2021.

Off-Balance Sheet Arrangements

WeDuring the six months ended September 30, 2021, we did not ~~have during the periods presented, and we do not currently~~ have any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.

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Critical Accounting Policies and Significant Judgments and Estimates

~~Our management’s discussion and analysis~~The preparation of ~~our financial condition and results of operations is based on~~ our unaudited condensed consolidated financial statements ~~which have been prepared in accordance with U.S. generally accepted accounting principles, or U.S. GAAP. The preparation of these unaudited condensed consolidated financial statements~~and related notes requires us to make judgments, estimates ~~judgments~~ and assumptions that affect the reported amounts of assets, liabilities, revenues and ~~liabilities,~~expenses, and related disclosures of contingent ~~assets and liabilities as of the dates of the unaudited condensed consolidated financial statements, and the reported amounts of revenues and expenses during the reporting periods.~~liabilities. We ~~base~~have based our estimates on historical experience and on various other ~~information available to us at the time we make the estimates and judgments~~assumptions that we believe ~~are~~to be reasonable under the circumstances. Management periodically reviews our estimates and makes adjustments when facts and circumstances dictate. To the extent that there are material differences between these estimates and actual results, our financial condition or results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. On an ongoing basis, we evaluate our judgments and estimates in light of changes in circumstances, facts, or experience.operations will be affected. Changes in estimates and assumptions are reflected in reported results in the period in which they become known.

An accounting policy is considered to be critical if it requires an accounting estimate to be made based on assumptions about matters that are highly uncertain at the time the estimate is made, and if different estimates that reasonably could have been used, or changes in the accounting estimates that are reasonably likely to occur periodically, could materially impact the consolidated financial statements. We ~~define~~believe that our critical accounting policies ~~as those under U.S. GAAP that require us to make subjective~~reflect the more significant estimates and ~~judgments about matters that are inherently uncertain and are likely to have a material impact on~~assumptions used in the preparation of our consolidated financial ~~condition and results of operations, as well as the specific manner in which we apply those principles.~~statements.

Our critical accounting policies are more fully described in “Critical Accounting Policies and Significant Judgments and Estimates” in Part II. Item 7. “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended March 31, ~~2020,~~2021, filed with the SEC on May ~~18, 2020.~~11, 2021. We believe there have been no material changes to our critical accounting policies and use of estimates as disclosed in our Annual Report on Form 10-K.

Recent Accounting Pronouncements

For information regarding the impact of recently adopted accounting pronouncements and the expected impact of recently issued accounting pronouncements not yet adopted on our consolidated financial statements, see Note 21 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly ~~Report on Form 10-Q.~~

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Item 3. Quantitative and Qualitative Disclosures About Market Risk

Under SEC rules and regulations, ~~because we are considered to be~~as a “smaller reporting company,” we are not required to provide the information otherwise required by this item in this ~~Item 3.~~Quarterly Report.

Item 4. Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports under the Exchange Act, and the rules and regulations thereunder, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow for timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Evaluation of Disclosure Controls and Procedures

Our principal executive officer and principal financial officer, after evaluating the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) and Rule 15d-15(e) promulgated under the Securities Exchange Act of 1934 as amended) as of the end of the period covered by this Quarterly Report, ~~on Form 10-Q,~~ have concluded that, based on such evaluation, our disclosure controls and procedures were effective at the reasonable assurance level. In designing and evaluating the disclosure controls and procedures, our management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Disclosure controls and procedures include, without limitation, controls and procedures designed to provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow for timely decisions regarding required disclosure.

Changes in Internal Control over Financial Reporting

We continually seek to improve the efficiency and effectiveness of our internal control over financial reporting. NoIn the fourth quarter of our fiscal year ended March 31, 2021 and in the six months ended September 30, 2021, we began to generate net product revenue from sales of ORGOVYX and MYFEMBREE, respectively. Commensurate with the evolution of our business operations, we have implemented and continue to optimize new procedures and controls pertaining to the order to cash, including net revenue and inventory accounting processes. These new or enhanced internal controls were designed and implemented to ensure the completeness and accuracy over financial reporting.

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We have not experienced any material impact to our internal controls over financial reporting despite the fact that most of our employees continue to work remotely due to the COVID-19 pandemic. We are continually monitoring and assessing the impact of the COVID-19 situation on our internal controls to minimize the impact on their design and operating effectiveness.

There were no other changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the fiscal quarter ended September 30, ~~2020~~2021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Inherent Limitations on Effectiveness of Controls

Our management, including our principal executive officer and principal financial officer, does not expect that our disclosure controls and procedures, or our internal controls, will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within Myovant Sciences Ltd. have been detected.

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PART II. OTHER INFORMATION

Item 1. Legal Proceedings

From time to time, we may become involved in legal proceedings related to claims arising from the ordinary course of business. We are not currently a party to any material legal proceedings, and we are not aware of any pending or threatened legal proceedings against us that we believe could have a material adverse effect on our business, operating results, or financial condition.

Item 1A. Risk Factors

You should carefully consider the following risk factors, in addition to the other information contained in this Quarterly Report on Form 10-Q (“Quarterly Report”), including the section of this report titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our unaudited condensed consolidated financial statements and related notes. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, may also become important factors that adversely affect our business. If any of the events described in the following risk factors and the risks described elsewhere in this Quarterly Report ~~on Form 10-Q~~ occurs, our business, operating results and financial condition could be seriously harmed and the trading price of our common shares could decline and you could lose all or part of your investment in our common shares.

~~Summary Risk Factors~~Risks Related to Commercialization of Our Drug Products

Our success depends in part on the successful commercialization of our drug products. To the extent our drug products are not commercially successful, our business, financial condition and results of operations will be materially harmed.

We received approval for ORGOVYX (relugolix 120 mg) in December 2020 from the FDA for the treatment of adult patients with advanced prostate cancer, and received approval for MYFEMBREE (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) in May 2021 for the management of heavy menstrual bleeding associated with uterine fibroids. We continue to invest a significant portion of our efforts and financial resources in the commercialization of these drug products in the U.S. The ability for us and/or our collaboration partner, Pfizer, to generate net product revenues from our drug products will depend upon the size of the markets, the number of competitors in such markets and numerous other factors, including:

•successfully establishing and maintaining effective sales, marketing, and distribution systems in jurisdictions in which our drug products are approved for sale;

•successfully establishing and maintaining commercial third-party manufacturers and having adequate commercial quantities of our drug products manufactured at acceptable cost and quality levels, including maintaining current good manufacturing practice (“cGMP”) and quality systems regulation standards required by various regulatory agencies;

•broad acceptance of our drug products by physicians, patients and the healthcare community;

•the acceptance of pricing and placement of our drug products on payers’ formularies and the associated tiers;

•effectively competing with other approved or used medicines and future compounds in development;

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•continued demonstration of safety and efficacy of our drug products in comparison to competing products, including through differentiated approved product labeling; and

•obtaining, maintaining, enforcing, and defending intellectual property rights and claims.

Further, in July 2021 and August 2021, the European Commission and the Medicines and Healthcare products Regulatory Agency, respectively, approved RYEQO® (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) as the first and only long-term, once-daily oral treatment in the European Union and the United Kingdom, respectively, for moderate to severe symptoms of uterine fibroids in adult women of reproductive age, with no limitation for duration of use. The success of Gedeon Richter Plc. (“Richter”) in generating net revenue from RYEQO in Richter’s Territory is also subject to many of these factors. If we and/or our collaboration partners do not achieve one or more of these factors in a timely manner or at all, we and/or our collaboration partners could experience significant delays or an inability to successfully commercialize any of our drug products, which would materially harm our business.

Our drug products may fail to achieve the degree of market acceptance by physicians, patients, third-party payers or others in the medical community necessary for commercial success, which would negatively impact our business.

Our drug products may fail to gain sufficient market acceptance by physicians, patients, third-party payers, or others in the medical community. If any of our drug products do not achieve an adequate level of acceptance, we may not generate significant net product revenue or become profitable. The degree of market acceptance of our drug products is dependent on a number of ~~risks that our shareholders should be aware of before making a decision to invest in our common shares. These risks are more fully described below. These risks include, among others, the following:~~factors, including but not limited to:

•~~Business interruptions resulting from effects~~the efficacy and potential advantages compared to alternative treatments, including the convenience and ease or duration of ~~pandemics or epidemics such as the novel strain of the coronavirus known as COVID-19, may materially and adversely affect our business and financial condition.~~administration;

•~~We believe~~the prevalence and severity of any side effects;

•the acceptability of the price of our drug products relative to other treatments;

•the content of the approved product labels and our ability to make compelling product claims;

•the effectiveness and adequacy of our and our collaboration partner’s sales and marketing efforts;

•the patient out-of-pocket costs in relation to alternative treatments;

•the willingness of the potential patient population to try new therapies and of healthcare providers to prescribe these therapies;

•the breadth and cost of distribution support;

•the effectiveness of our patient assistance and support programs;

•the availability of third-party payer coverage and adequate reimbursement;

•whether diagnosis and treatment rates change in advanced prostate cancer and heavy menstrual bleeding associated with uterine fibroids or other indications for which the drug products were approved; and

•any restrictions on the use of our drug products together with other medications.

The degree of market acceptance of ORGOVYX will also depend on the acceptance and degree of adoption by institutional treatment pathways and institutional, local, and national clinical guidelines such as the National Comprehensive Cancer Networks® Clinical Practice Guidelines in Oncology, or the NCCN Guidelines, the American Urological Association (“AUA”) guidelines, American Society of Clinical Oncology (“ASCO”) Clinical Practice Guidelines, or other country-specific guidelines. This could also be the case for MYFEMBREE in terms of inclusion in practice guidelines such as those from the American College of Gynecology (“ACOG”), American Society for Reproductive Medicine (“ASRM”), American Association of Gynecologic Laparoscopists (“AAGL”), or other country-specific guidelines. In the U.S., healthcare providers may refer to these guidelines related to patient treatment decisions. To the extent that our current ~~cash, cash equivalents, marketable securities,~~or any future approved products are not included or positioned favorably in such treatment guidelines and pathways, the full utilization potential of our products may not be reached, which may harm our ability to successfully commercialize our current ~~borrowing capacity under~~or any future approved products.

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If we and our ~~Sumitomo Dainippon Pharma Loan Agreement~~collaboration partners are unable to effectively market and sell our drug products, the commercialization of our drug products will not be ~~sufficient~~successful and our business will be harmed.

To market our drug products successfully, we must continue to develop and maintain our capabilities in sales, market access, marketing, distribution, and other commercial functions, either on our own or with our third-party collaboration partners. We have made arrangements regarding some of these functions in certain markets with third-party collaboration partners. For example, on August 1, 2020, we entered into a Market Access Services Agreement, as amended, with Sunovion pursuant to which, among other things, Sunovion has agreed to provide to us certain market access services with respect to the distribution and sale of ORGOVYX and MYFEMBREE in the U.S. On December 26, 2020, we entered into the Pfizer Collaboration and License Agreement, pursuant to which we and Pfizer will collaborate to jointly develop and commercialize relugolix in oncology and women’s health in the U.S. and Canada (the “Co-Promotion Territory”). On March 30, 2020, we entered into the Richter Development and Commercialization Agreement pursuant to which Richter will commercialize relugolix combination tablet for uterine fibroids and endometriosis (if approved) in Europe, the Commonwealth of Independent States including Russia, Latin America, Australia, and New Zealand. If Sunovion, Pfizer, Richter, or any other collaboration partners we may engage in the future, fail to perform or satisfy its obligations under their respective agreements with us or terminate their relationship with us, the sales, market access, marketing and/or distribution of our drug products would be delayed or may not occur. In addition to ~~fund~~the third-party collaboration arrangements described above, we continue to develop and maintain our ~~anticipated level~~own sales, market access, marketing, distribution and other commercial capabilities. There are significant expenses and risks involved with maintaining our own sales, market access, marketing, distribution, and other commercial capabilities, including: (i) our ability to recruit, train, and retain adequate numbers of ~~operations until~~qualified and effective sales, market access and marketing personnel; (ii) our ability to attain access to adequate numbers of healthcare professionals to prescribe any approved drugs; (iii) our ability to negotiate coverage and reimbursement for our products with payers at reasonable rebate or discount levels; (iv) our ability to negotiate competitive provider contracts to ensure access in in-office dispensing pharmacies; and (v) unforeseen costs and expenses associated with establishing and maintaining our own sales, market access, marketing, distribution, and other commercial capabilities. The COVID-19 pandemic may negatively impact our and our collaboration partners’ ability to maintain commercial capabilities and may negatively impact our ability to rapidly and effectively educate potential prescribers and, if significant delays result, to commercialize our drug products.

ORGOVYX and MYFEMBREE are both newly approved and marketed drugs in the U.S. We and our collaboration partner, Pfizer, have only begun to promote these drug products in the U.S. this year. In addition, we have only recently established our distribution and reimbursement capabilities in the U.S. together with Sunovion, all of which are necessary to successfully commercialize these drug products. Further, RYEQO is a newly approved and marketed drug in Europe. As a result, we and/or our collaboration partners continue to expend significant time and resources to market, sell, and distribute these drug products to physicians and the medical community in a credible, persuasive, and compliant manner consistent with applicable laws. There is no guarantee that the strategies, tactics and marketing messages, or the distribution and reimbursement capabilities, that we or our collaboration partners have developed will be successful. Specifically, for distribution of these drug products, we are heavily dependent on third-party logistics, pharmacy and distribution partners. If we or our collaboration partners are unable to perform effectively, our ability to realize sales targets, and the return on our investment in developing these drug products will suffer.

Failure to successfully obtain coverage and reimbursement for ORGOVYX and MYFEMBREE in the United States, or the availability of coverage only at limited levels, would diminish our ability to generate net product revenue.

Our and Pfizer’s ability to commercialize ORGOVYX and MYFEMBREE successfully in the U.S. will depend in part on the extent to which coverage and reimbursement for ORGOVYX and MYFEMBREE will be available from third-party payers, including government health administration authorities, Medicare Part D plan sponsors, and private health insurers, such as pharmacy benefit managers, health plans, and self-insured organizations. In the U.S., no uniform policy for coverage for products exists among third-party payers. Third-party payers decide which drugs they will pay for, what steps prescribers must take to obtain authorization for patients to fill their prescriptions, and how much patients must pay out of their own pocket. Payer decisions regarding the extent of coverage to be provided for any of our product candidates that obtain marketing approval will be made on a plan-by-plan basis. Additionally, a third-party payer’s decision to provide coverage for a drug does not imply that an affordable out-of-pocket cost for patients will be established. Each third-party payer determines whether or not it will provide coverage for a drug, what amount it will reimburse for the drug, on what tier of its formulary the drug will be placed, and whether to require step therapy or prior authorizations. The position of a drug on a formulary generally determines out-of-pocket costs that a patient will pay to obtain the drug and can strongly influence the adoption of a drug by patients and physicians. Patients who are prescribed treatments for their conditions, providers prescribing such therapies and pharmacies that dispense drugs generally rely on third-party payers to reimburse all or part of the associated healthcare and drug costs. Coverage from both governmental healthcare programs, such as Medicare Part D and Medicaid, and coverage by private commercial payers are critical to ORGOVYX’s and MYFEMBREE’s commercial success. Coverage decisions may depend

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upon clinical and economic standards that disfavor new drug products when more established or lower cost therapeutic alternatives are already available or subsequently become ~~cash flow positive. If~~available.

Additionally, there have been a number of legislative and regulatory proposals to change the healthcare system that may impact drug coverage, reimbursement for drugs, and patient out-of-pocket costs in the U.S. that could affect our ability to successfully commercialize ORGOVYX and MYFEMBREE. These legislative and regulatory changes may negatively impact the coverage, reimbursement, and patient out-of-pocket costs for ORGOVYX, MYFEMBREE and any future drugs, if approved.

We face substantial competition in the commercialization of our approved drug products and our operating results will suffer if we fail to ~~obtain additional capital, including~~compete effectively.

The commercialization of new pharmaceutical products is highly competitive, and we face substantial competition with respect to our approved drug products. For example, although ORGOVYX is the first and only oral GnRH receptor antagonist for adult patients with advanced prostate cancer approved by the FDA in the U.S., we may face competition from various drugs approved for the treatment of prostate cancer, such as Lupron Depot® (AbbVie Inc.), Eligard® (Tolmar Pharmaceuticals) and Firmagon® (Ferring Pharmaceuticals). In addition, although MYFEMBREE is the first and only once-daily oral treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women approved by the FDA in the U.S., with a treatment duration of up to 24 months, we expect to face competition from ORIAHNN™, an oral GnRH receptor antagonist combination therapy (one capsule (elagolix 300 mg, estradiol 1 mg, norethindrone acetate 0.5 mg) in the morning and one capsule (elagolix 300 mg) in the evening), which was approved by the FDA and launched by AbbVie in June 2020 for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. In addition, ObsEva announced in September 2021 the submission of a new drug application to FDA for linzagolix, an oral GnRH receptor antagonist, for the treatment of uterine fibroids for use with and without add-back therapy.

Many of our current and potential ~~additional capital~~future competitors may have significantly more resources that they can deploy to commercialize drugs and may succeed in developing, acquiring or licensing, on an exclusive basis, drugs that are more effective or less costly than our drug products or any product candidate that we may obtain approval or develop. Our competitors may succeed in obtaining patent protection, discovering, developing, receiving FDA or other regulatory authority approval for or commercializing medicines before we do, which would have an adverse impact on our business and results of operations. The availability and pricing of our competitors’ products could limit the demand, lead to competitors having preferential payer coverage and limit the price we are able to charge for our drug products or any product candidate that we may obtain approval for or develop. Mergers and acquisitions in the pharmaceutical and biotechnology industries could result in even more resources being concentrated among a smaller number of our competitors.

The inability to compete with existing or subsequently introduced drugs would have an adverse impact on our business, financial condition, and prospects.

If manufacturers obtain approval for generic versions of ORGOVYX, MYFEMBREE, or of products with which they compete, our business may suffer.

Under the U.S. Food, Drug and Cosmetic Act (“FDCA”), the FDA can approve an Abbreviated New Drug Application (“ANDA”), for a generic version of a branded drug without the ANDA applicant undertaking the clinical testing necessary to obtain approval to market a new drug. Generally, in place of such clinical studies, an ANDA applicant usually needs only to submit data demonstrating that its product has the same active ingredient(s), strength, dosage form, route of administration and that it is bioequivalent to the branded product.

The FDCA requires that an applicant seeking approval of a generic form of a branded drug certify either that its generic product does not infringe any of the patents listed by the owner of the branded drug in the Orange Book or that those patents are not enforceable. This process is known as a paragraph IV challenge. Upon notice of a paragraph IV challenge, a patent owner has 45 days to bring a patent infringement suit in federal district court against the company seeking ANDA approval of a product covered by one of the owner’s patents. If this type of suit is commenced, the FDCA provides a 30-month stay on the FDA’s approval of the competitor’s application. If the litigation is resolved in favor of the ANDA applicant or the challenged patent expires during the 30-month stay period, the stay is lifted and the FDA may thereafter approve the application based on the standards for approval of ANDAs. Once an ANDA is approved by the FDA, the generic manufacturer may market and sell the generic form of the branded drug in competition with the branded medicine.

The ANDA process can result in generic competition if the patents at issue are not upheld or if the generic competitor is found not to infringe the owner’s patents. If this were to occur with respect to ORGOVYX, MYFEMBREE, or products with which they compete, our business would be materially harmed.

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If patient safety issues were to arise for any of our drug products, our future sales of our drug products may be reduced, adversely affecting our results of operations.

The data supporting the marketing approvals in the U.S. for ORGOVYX and MYFEMBREE and forming the basis for our product labels for ORGOVYX and MYFEMBREE were obtained in controlled clinical studies of limited duration. As ORGOVYX and MYFEMBREE are used over longer periods of time by patients, including those taking other medicines, we may continue to identify new issues such as safety concerns, resistance or drug interactions of these drug products, which may require us to provide additional warnings or contraindications on our product labels or narrow the approved indications, each of which could reduce the market acceptance of our drug products.

Regulatory authorities have been moving towards more active and transparent pharmacovigilance and are making greater amounts of stand-alone safety information directly available to the public through websites and other means, e.g., periodic safety update report summaries, risk management plan summaries and various adverse event data. Safety information, without the appropriate context and expertise, may be misinterpreted and lead to misperception or legal action which may potentially negatively impact sales of our drug products. Further, if serious safety, resistance or drug interaction issues arise with any of our drug products, sales could be limited or halted by us or by regulatory authorities and our results of operations would be adversely affected. In addition, problems with other drugs marketed by third parties that utilize the same therapeutic target or that belong to the same therapeutic class as any of our drug products could adversely affect commercialization of our drug products.

If a safety issue emerges post-approval, we may become subject to costly product liability litigation by our customers, patients or payers. Product liability claims could divert management’s attention from ~~Sumitomo Dainippon Pharma as described~~our core business, be expensive to defend, and result in ~~its 2020 Commitment Letter to~~sizable damage awards against us ~~we will~~that may not be ~~able to complete the development~~covered by our insurance. If we cannot successfully defend ourselves against claims that our drug products caused injuries, we may incur substantial liabilities. Regardless of ~~seek regulatory approval~~merit or eventual outcome, liability claims may result in:

•decreased demand for ~~and commercialize~~ our ~~product candidates.~~drug products;

•~~We are required~~the inability to ~~meet certain terms~~commercialize our drug products;

•injury to our reputation and ~~conditions~~significant negative media attention;

•withdrawal of patients from clinical studies or cancellation of clinical studies of our product candidates;

•significant costs to ~~draw down funds under~~defend the ~~Sumitomo Dainippon Pharma Loan Agreement. If~~related litigation;

•substantial monetary awards to patients; and

•loss of net product revenue.

Our product liability insurance coverage may not be adequate to cover all liabilities that we ~~are unable to meet such terms and conditions, we~~may incur. Insurance coverage is increasingly expensive. We may not be able to ~~access funding~~obtain insurance coverage at a reasonable cost or in amounts adequate to satisfy any liability or associated costs that may arise in the future. These events could harm our business and results of operations and cause our common share price to decline.

If we or our collaboration partner, Pfizer, are found to have improperly promoted unapproved uses of our drug products, we may be subject to restrictions on the sale or marketing of our drug products and significant fines, penalties, sanctions and product liability claims, and our image and reputation within the industry and marketplace could be harmed.

The FDA and other regulatory agencies, including regulatory authorities outside the U.S., strictly regulate the marketing and promotional claims that are made about drug products, such as ORGOVYX and MYFEMBREE. In particular, promotion for a product must be consistent with its labeling approved by the FDA or by regulatory agencies in other countries. For example, in the case of ORGOVYX and MYFEMBREE, physicians may prescribe ORGOVYX or MYFEMBREE for indications or uses that are inconsistent with the approved label while we and our collaboration partner, Pfizer, may not market or promote such off-label uses. If we or our collaboration partner, Pfizer, are found to have promoted such unapproved uses, we may, among other consequences, receive untitled or warning letters and become subject to significant liability, which would materially harm our business. Furthermore, the use of our products for indications other than those approved by the FDA or regulatory authorities outside the U.S. may not effectively treat such conditions, which could harm our reputation in the marketplace among physicians and patients. Both the U.S. federal government and foreign regulatory authorities have levied significant civil and criminal fines against companies and individuals for alleged improper promotion and have entered into settlement agreements with pharmaceutical companies to limit inappropriate promotional activities. If we become the target of such an investigation or prosecution based on our marketing and promotional practices, we could face similar sanctions, which would

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materially harm our business. In addition, management’s attention could be diverted from our business operations, significant legal expenses could be incurred, and our reputation could be damaged.

Physicians’ prescribing our products for unapproved uses may also subject us to product liability claims, to the ~~Sumitomo Dainippon Pharma Loan Agreement. The terms~~extent such uses lead to adverse events, side effects, or injuries. Product liability claims could divert management’s attention from our core business, be expensive to defend, and result in sizable damage awards against us that may not be covered by insurance. Any of these events could harm our business and results of operations and cause our common share price to decline.

If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs in the U.S., we could be subject to additional reimbursement requirements, fines, sanctions and exposure under other laws which could have a material adverse effect on our business, results of operations and financial condition.

We participate in the Medicaid Drug Rebate Program, as administered by the Centers for Medicare and Medicaid Services (“CMS”) and other federal and state government pricing programs in the U.S., and we may participate in additional government pricing programs in the future. These programs generally require us to pay rebates or otherwise provide discounts to government payers in connection with drugs that are dispensed to beneficiaries/recipients of these programs. Pricing requirements and rebate/discount calculations are complex, vary among products and programs, and are often subject to interpretation by governmental or regulatory agencies and the courts. Thus, there can be no assurance that we will be able to identify all factors that may cause our discount and rebate payment obligations to vary from period to period, and our actual results may differ significantly from our estimated allowances for discounts and rebates. Changes in estimates and assumptions may have a material adverse effect on our business, results of operations and financial condition.

In addition, the Office of Inspector General of the ~~Sumitomo Dainippon Pharma Loan Agreement place restrictions~~Department of Health and Human Services and other Congressional enforcement and administrative bodies have increased their focus on pricing requirements for products, including, but not limited to the methodologies used by manufacturers to calculate average manufacturer price (“AMP”), and best price (“BP”), for compliance with reporting requirements under the Medicaid Drug Rebate Program. We are liable for errors associated with our submission of pricing data and for any overcharging of government payers. For example, failure to submit monthly/quarterly AMP and BP data on a timely basis could result in significant civil monetary penalties for each day the submission is late beyond the due date. Failure to make necessary disclosures and/or to identify overpayments could result in allegations against us under the Federal False Claims Act and other laws and regulations. Any required refunds to the U.S. government or responding to a government investigation or enforcement action would be expensive and time-consuming and could have a material adverse effect on our ~~operating~~business, results of operations and financial ~~flexibility.~~condition. In addition, in the event that CMS were to terminate our rebate agreement, no federal payments would be available under Medicaid or Medicare for our covered outpatient drugs.

Our drug products are complex to manufacture, and manufacturing disruptions may occur that could cause us to experience disruptions in the supply of our drug products.

•~~We expect~~Our drug products are complex to ~~incur significant operating losses and negative operating cash flows~~manufacture. Notwithstanding the fact that our third-party manufacturers have validated our processes, manufacturing disruptions may occur. Such problems may prevent the production of lots that meet the specifications required for sale of the ~~foreseeable future,~~product and may ~~never achieve~~be difficult and expensive to resolve. If any such issues were to arise with respect to our drug products or ~~maintain profitability.~~

•We are heavily dependent on the success of relugolix combination tablet for our women’s health indications of uterine fibroids and endometriosis, relugolix monotherapy tablet for men with advanced prostate cancer, and MVT-602. If relugolix combination tablet, relugolix monotherapy tablet or MVT-602 do not receive regulatory approval or are not successfully commercialized,any future products, our business, ~~will~~financial results, or common share price could be ~~harmed.~~

•adversely affected. Also, see the Risk Factor titled, “We do not have our own manufacturing capabilities and rely on third parties to produce clinical and commercial supplies of drug substance and drug product. If these third parties do not perform as we expect, do not maintain their regulatory approvals or become subject to other negative circumstances, it may result in a delay in our ability to develop and commercialize our ~~products.~~

•productsClinical studies are very expensive, time-consuming, difficult to design and implement, and involve uncertain outcomes. Clinical study failures can occur at any stage of clinical studies, and we could encounter problems that cause us to suspend, abandon or repeat clinical studies. We cannot predict with any certainty the timing for commencement or completion of current or future clinical studies.

•We are dependent on the research and development of relugolix and MVT-602 previously conducted by Takeda, and if Takeda did not conduct this research and development in compliance with applicable requirements this could result in increased costs and delays in our development of these product candidates. Reported data or other clinical development announcements by Takeda, its partners or sublicensees, may adversely affect our clinical development plan..”

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•~~The results~~Risks Related to Commercialization of our ~~clinical studies may not support~~Drug Products Outside the U.S. and for our ~~proposed claims for~~Product Candidates

Our success relies on the successful commercialization of drug products outside the U.S. and the development or commercialization of our product candidates. ~~The results of previous clinical studies may not be predictive of future results, and interim or top-line data may be subject to change or qualification based on the complete analysis of data.~~

•~~The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming, and inherently unpredictable.~~ If we are not able to obtain required regulatory approvals, we will not be able to commercialize relugolix combination tablet, relugolix monotherapy tablet, or MVT-602, and our ability to generate product revenue will be materially impaired.

•~~Relugolix combination therapy, relugolix monotherapy and MVT-602 may cause adverse effects or have other properties that could delay or prevent their~~successful in obtaining regulatory approval ~~or limit~~for drug products in jurisdictions outside the ~~scope of any approved label~~U.S. or ~~market acceptance.~~

•~~We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.~~

•If we are unable to establish sales, market access, marketing, and distribution capabilities, either on our own or with third-party collaboration partners, we may not be successful in commercializing our product candidates, if approved.

•~~Coverage and reimbursement may not be available~~ for our product candidates, ~~which could make it difficult~~we will be subject to the same or similar commercialization risks as described above for usour approved drug products.

We expect to ~~sell them profitably, if approved.~~

•~~Regulatory requirements or manufacturing disruptions may make it difficult~~seek other regulatory approvals for ~~us to be able to obtain materials or supplies necessary to conduct clinical studies or to manufacture~~our drug products in jurisdictions outside the U.S. and ~~sell any of~~for our product candidates ~~if approved.~~

•~~We are reliant on third parties to conduct, manage, and monitor our clinical studies, and if those third parties perform~~ in ~~an unsatisfactory manner, it may harm our business.~~

•the U.S. If we receive regulatory approval for any drug products in jurisdictions outside the U.S. or for our product candidates in the U.S., we will be subject to the same or similar risks we currently face with the commercialization of ORGOVYX and MYFEMBREE, as described under “Risks Related to Commercialization of Our Drug Products” above. For example, in July 2021 and August 2021, the European Commission and the Medicines and Healthcare products Regulatory Agency, respectively, approved RYEQO for moderate to severe symptoms of uterine fibroids in adult women of reproductive age for use in the European Union and the United Kingdom, respectively. Our commercialization partner, Richter has launched RYEQO in seven countries since these regulatory approvals. Sufficient coverage and reimbursement are ~~unable~~important for Richter to successfully commercialize RYEQO in Europe, but healthcare reimbursement models and reimbursement requirements vary from country to country in Europe. Although RYEQO has been approved in the E.U., many countries have not decided on pricing and reimbursement models. Some European countries may choose not to reimburse RYEQO at all or only reimburse RYEQO at a comparatively low price. The commercialization opportunities of RYEQO in Europe may be limited if RYEQO fails to obtain ~~and maintain patent protection for our technology and products,~~sufficient coverage or ~~if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively~~reimbursement in ~~our markets.~~

•We have agreements with Sumitovant, our majority shareholder, and with Sumitovant’s parent, Sumitomo Dainippon Pharma, that may be perceived to create conflicts of interest which, if other investors perceive that Sumitovant or Sumitomo Dainippon Pharma will not act in the best interests of all of our shareholders, may affect the price of our common shares and have other effects on our company.

•~~We are a “controlled company” within the meaning of the applicable rules of the NYSE and, as a result, qualify for exemptions from~~ certain ~~corporate governance requirements. If we rely on these exemptions, our shareholders will not have the same protections afforded to shareholders of companies that are subject to such requirements.~~countries.

Risks Related to Our Financial Position and Capital Requirements

We believe our current cash, cash equivalents, marketable securities, and current borrowing capacity under our Sumitomo Dainippon Pharma Loan Agreement will not be sufficient for us to fund our anticipated level of operations until we become cash flow positive. If we ~~fail~~donot have adequate funds to ~~obtain~~cover our development and commercialization activities, we may have toraise additional capital ~~including from the potential additional capital we~~orcurtail or cease operations. We may ~~obtain from Sumitomo Dainippon Pharma as described in its 2020 Commitment Letter to us, we will~~ not be able to ~~complete~~obtain funding through public or private offerings of our capital shares, debt financings, collaboration or licensing arrangements, or other sources.

In the U.S., we began to commercialize ORGOVYX for the treatment of adult patients with advanced prostate cancer in January 2021 and MYFEMBREE for the management of heavy menstrual bleeding associated with uterine fibroids in June 2021. We also seek to advance additional product candidates through research and clinical development ~~of, seek~~to regulatory approval ~~for,~~ and ~~commercialize our product candidates.~~commercialization. These activities will require substantial financial resources.

As of September 30, ~~2020,~~2021, we had cash, cash equivalents ~~marketable securities, and amounts available to us under the Sumitomo Dainippon Pharma Loan Agreement of $257.6 million consisting of $111.3 million of cash, cash equivalents,~~ and marketable securities ~~and $146.3 million~~ of borrowing capacity available to us under our Sumitomo Dainippon Pharma Loan Agreement for which we can draw upon on a quarterly basis subject to certain terms and conditions, including the consent of our board of directors. In October 2020, we borrowed an additional $60.0 million under this agreement.$616.0 million. B ~~Based~~ased on our current operating plan, we believe that our existing cash, cash equivalents, and marketable securities ~~and borrowing capacity currently available to us under the Sumitomo Dainippon Pharma Loan Agreement~~ will be sufficient to fund our operating expenses and capital expenditure requirements for at least ~~through~~ the ~~end~~next 12 months from the date of ~~our fiscal year ending March 31, 2021.~~issuance of this Quarterly Report. This estimate is based on our current assumptions, including assumptions relating to our ability to manage our spend, that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. ~~We anticipate~~In future periods, if our cash, cash equivalents, marketable securities, and amounts that we ~~will continue~~expect to ~~incur~~generate from product sales and/or third-party collaboration payments are not sufficient to enable us to fund our operations, we may need to raise additional funds in the form of equity, debt, or from other sources. In addition, we may choose to raise additional funds in the form of equity, debt, or from other sources due to market conditions or strategic considerations even if we believe we have sufficient funds for our current and future operating plans.

We expect our operating expenses, net ~~losses~~of costs that are expected to be shared with Pfizer pursuant to the Pfizer Collaboration and ~~negative~~License Agreement, to increase and our future capital requirements are expected to be significant. Our operating expenses and operating cash flows ~~for the foreseeable future.~~

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~~We expect to spend substantial amounts to complete the development of, seek regulatory approvals for~~may fluctuate significantly from quarter-to-quarter and ~~commercialize~~year-to-year and our ~~product candidates. Our~~ future funding requirements, both near and long-term, will depend on many factors, including, but not limited to:

•the price, level of demand and net product revenues generated from commercial sales of our drug products, and for any product candidates that may receive marketing approval in the future;

•the achievement of regulatory milestones, sales milestones, and/or royalties that we are eligible to earn pursuant to our collaboration agreements;

•the timing, shared costs, and level of investment in our and our collaboration partners’ research and development activities involving ORGOVYX, MYFEMBREE, RYEQO, and any product candidates;

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•the initiation, progress, timing, costs, and results of our planned and ongoing clinical studies for our product candidates;

•the outcome, timing, and cost of meeting regulatory requirements established by the FDA and comparable foreign regulatory authorities;

•the cost ~~of filing, prosecuting, defending~~to maintain, expand, and ~~enforcing~~protect our patent claims and other intellectual property rights;

•~~the cost of defending potential intellectual property disputes, including patent infringement actions brought by third parties against us or our products or any future product candidates;~~

•the effect of competing technological and market developments;

•the cost of raw materials and ~~timing~~manufacture of ~~completion of commercial-scale manufacturing activities,~~our drug products, including ~~securing regulatory approval for commercial production;~~packaging;

•the ~~cost of establishing~~costs to hire additional commercial operations, sales and marketing, scientific, clinical, regulatory, quality, and ~~distribution capabilities for~~other personnel to support our ~~products in regions where we choose to commercialize our products on our own;~~commercialization, sales and marketing, regulatory, and clinical development efforts; and

•the ~~initiation, progress, timing~~costs to implement or enhance operational, accounting, finance, quality, commercial, and ~~results of our commercialization of our product candidates, if approved for commercial sale.~~management information systems.

~~Our current funds and amounts available to us under~~Under the terms of the Sumitomo Dainippon Pharma Loan Agreement, ~~will~~we may not beraise additional capital without obtaining the consent of Sumitomo Dainippon Pharma. If we do not have sufficient ~~to enable us~~funds to complete ~~all necessary~~the development of, seek regulatory approvals for our product candidates and ~~regulatory activities~~commercialize our drug products and, ~~commercially launch relugolix combination tablet or relugolix monotherapy tablet. These factors raise substantial doubt about~~if approved, our ~~ability to continue as a going concern for the one-year period following the filing of this Quarterly Report on Form 10-Q. We~~product candidates, we may be required to delay, limit, reduce, or terminate our drug development programs, commercialization efforts, and/or limit or cease our operations if we are unable to obtain additional capital ~~including from the potential additional capital Sumitomo Dainippon Pharma may provide to us as described in its 2020 Commitment Letter to us described below,~~ to support our current operating plan. ~~Management’s plans in this regard are described in Note 2~~In addition, attempting to secure additional capital may divert the time and attention of the unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. In the event that these plans cannot be effectively realized, there can be no assurance that we will be able to continue as a going concern.our management from day-to-day activities and harm our product candidate development and commercialization efforts.

We are required to meet certain terms and conditions to draw down funds under the Sumitomo Dainippon Pharma Loan Agreement. If we are unable to meet such terms and conditions, we may not be able to access funding from the Sumitomo Dainippon Pharma Loan Agreement. Further, we may be obligated to repay the loans prior to their scheduled maturity date under certain circumstances.

On December 27, 2019, we, one of our subsidiaries, and Sumitomo Dainippon Pharma entered into the Sumitomo Dainippon Pharma Loan Agreement, pursuant to which Sumitomo Dainippon Pharma agreed to make revolving loans to us in an aggregate principal amount up to $400.0 million. As of September 30, ~~2020,~~2021, approximately ~~$146.3~~$41.3 million of borrowing capacity remained available to us under the Sumitomo Dainippon Pharma Loan Agreement. ~~In October 2020, we borrowed an additional $60.0 million under this agreement.~~ We may draw down additional funds under the Sumitomo Dainippon Pharma Loan Agreement once per calendar quarter, subject to certain terms and conditions, including the consent of our board of directors and no change of control having occurred with respect to us. We may not be able to meet such terms and conditions in the future and may not be able to secure additional funds. The maturity date of the loans under the Sumitomo Dainippon Pharma Loan Agreement is December 27, 2024 or the date the outstanding principal of the loans is declared due and payable due to an event of default pursuant to the terms of the agreement. In addition, if Sumitomo Dainippon Pharma fails to own at least a majority of the outstanding common shares of Myovant, it may become unlawful under Japanese law for Sumitomo Dainippon Pharma to fund loans to us, and in which case we would not be able to continue to borrow under the Sumitomo Dainippon Pharma Loan Agreement. Furthermore, within 30 days of a change of control having occurred with respect to us, we will be obligated to repay the outstanding amount of loans and accrued interest under the Sumitomo Dainippon Pharma Loan Agreement. ~~We may not be able to meet such terms and conditions in the future and may not be able to secure additional funds.~~

~~We may not be able to obtain funding through public or private offerings of our capital shares, debt financings, collaboration or licensing arrangements, or other sources.~~

As discussed above, our current cash, cash equivalents, marketable securities, and amounts currently available to us under the Sumitomo Dainippon Pharma Loan Agreement will not be sufficient for us to complete all necessary development and regulatory activities and commercially launch our product candidates. Accordingly, we will need to raise additional capital to fund our operations. On August 5, 2020, we obtained the 2020 Commitment Letter from Sumitomo Dainippon Pharma, as amended by a letter dated September 29, 2020, pursuant to which, subject to the terms and conditions set forth therein, Sumitomo Dainippon Pharma has agreed to negotiate with us $200.0 million in unsecured revolving commitments (the “New Credit Facility”), the proceeds of which may be used for our business operating expenditures. Such New Credit Facility would be in addition to the commitments made available to us by Sumitomo Dainippon Pharma under the existing Sumitomo

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Dainippon Pharma Loan Agreement. Sumitomo Dainippon Pharma will have the discretion to require certain prepayments as Sumitomo Dainippon Pharma may request and/or to not allow us to draw down any remaining funds under the New Credit Facility, upon the occurrence of certain material business development transactions. In addition, as a condition to entering into the New Credit Facility, we are required to enter into an information sharing agreement with Sumitovant which will be on terms to be agreed between Sumitovant and us. The New Credit Facility described in the 2020 Commitment Letter will not be available to us until we negotiate and enter into a definitive agreement with Sumitomo Dainippon Pharma and the New Credit Facility becomes effective. As a result, if the conditions set forth in the 2020 Commitment Letter are not met or unexpected disagreements arise in the negotiations, that may delay or prevent the entering into an agreement and the New Credit Facility may not become effective. We cannot be certain that additional capital, including the potential additional capital Sumitomo Dainippon Pharma may provide to us as set forth in the 2020 Commitment Letter will be available to us on acceptable terms, or at all.

~~Even if additio~~nal capital is available to us, under the terms of the Sumitomo Dainippon Pharma Loan Agreement and the agreement governing the New Credit Facility, we may not raise additional capital without obtaining the consent of Sumitomo Dainippon Pharma. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, when needed, we may have to significantly delay, scale back, or discontinue the development or commercialization of our product candidates or potentially discontinue operations. In addition, attempting to secure additional capital may divert the time and attention of our management from day-to-day activities and harm our product candidate development and commercialization efforts. Because of the numerous risks and uncertainties associated with the development and potential commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays, operating expenditures and capital requirements associated with our current and anticipated product development programs and commercialization efforts.

~~We expect to incur significant operating losses and negative operating cash flows for the foreseeable future, and~~ may never achieve or maintain profitability.

Investment in pharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that a product candidate ~~will~~may fail to gain regulatory approval or fail to become commercially viable. Since inception, we have incurred significant operating losses and negative operating cash flows. We expect to continue to incur significant operating ~~losses~~expenses as we continue commercialization of ORGOVYX and ~~negative operating cash flows as we~~MYFEMBREE in the U.S., continue to develop our product candidates, and prepare for potential ~~future~~ regulatory ~~approvals~~approval and commercialization of our drug products in the U.S. and other jurisdictions. The timing and magnitude of our net income (loss) will depend on the commercial success of our drug products, as well as the timing and commercial success of any product ~~candidates. If~~launches, as well as other potential business and operational activities. Likewise, any potential future milestone or royalty payments that we ~~obtain~~are eligible to earn under the Pfizer Collaboration and License Agreement and the Richter Development and Commercialization Agreement will depend on the regulatory ~~approval for~~and commercial success of our drug products and product candidates, ~~we expect to incur increased sales, marketing and manufacturing expenses.~~if approved. As a result, we may never achieve or maintain profitability.

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Risks Related to Our Business Operations

We are heavily dependent on the success of relugolix combination tablet for our women’s health indications of uterine fibroids and endometriosis, relugolix monotherapy tablet for men with advanced prostate cancer, and MVT-602. If relugolix combination tablet, relugolix monotherapy tablet or MVT-602 do not receive regulatory approval or are not successfully commercialized, our business will be harmed.

We have invested and expect to continue to invest a substantial portion of our efforts and expenditures in the development and advancement of our product candidates, relugolix combination tablet, relugolix monotherapy tablet, and MVT-602. Our ability to generate product revenue and achieve profitability depends heavily on our ability to complete the development of our product candidates, obtain necessary regulatory approvals for, and have our product candidates manufactured and successfully marketed, which may never occur. The research, testing, manufacturing, labeling, approval, sale, marketing and distribution of products are and will remain subject to extensive regulation by the FDA and other regulatory authorities in the U.S. and other countries. We are not permitted to market our product candidates in the U.S. until we receive approval of NDAs or in any foreign country until we receive the requisite approvals from the appropriate regulatory authorities in such countries.

Obtaining approval of an NDA or similar foreign regulatory approval is an extensive, lengthy, expensive and inherently uncertain process, and the FDA or other foreign regulatory authority may delay, limit or deny approval of our product candidates. The process of responding to the FDA information requests in the review process, potentially preparing for and appearing at a public advisory committee and preparing our manufacturers and investigators to successfully complete inspections by the FDA during the approval process requires significant human and financial resources. Despite efforts at compliance, from time to time, we or our partners may receive notices of manufacturing, quality-related, or other observations following inspections by regulatory authorities, as well as official agency correspondence regarding compliance. For example, in June 2020, the FDA issued a warning letter to Takeda following a routine inspection of aseptic finished pharmaceuticals (drug product) manufacturing at Takeda’s manufacturing facility located at Takeda 4720, Mitsui, Hikari, Yamaguchi (the “Hikari Facility”). The Hikari Facility is one of two contract manufacturing organizations (“CMOs”) included in our regulatory filings for the manufacture of relugolix drug substance (“API”). The warning letter indicated that the FDA was not satisfied

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with Takeda’s response to an FDA Form 483 issued to Takeda following the inspection and cited significant violations of cGMP for finished pharmaceuticals. Although API manufacturing was not included in the scope of the FDA’s inspection that led to the warning letter, the Hikari Facility is classified under one FDA Establishment Identifier and the facility has a common quality system. We now plan to procure the commercial relugolix drug substance needed for our anticipated U.S. launch in advanced ~~prostate cancer~~ solely from Excella GmbH & Co. KG (“Excella”), the second source contract manufacturing organization included in our initial regulatory filings, pursuant to the Commercial Manufacturing and Supply Agreement we have with Excella. Due to the warning letter, we have removed the Hikari Facility as a manufacturing site from our NDA ~~submission for prostate cancer and may remove it from other~~ regulatory filings if required until Takeda corrects the violations noted in the warning letter to the satisfaction of the regulatory authorities. We cannot predict if or when Takeda will correct the violations and deviations to the satisfaction of the FDA or any other regulatory agency or whether the regulatory agencies will be satisfied with Takeda’s responses. The COVID-19 pandemic may also cause delays in the remediation and re-inspection process. We also face the risk that Excella or our other CMOs may face adverse developments, including with respect to adverse findings during regulatory inspections, delays in regulatory approval and/or the COVID-19 pandemic. If Excella or our other CMOs fail to fulfill their obligations to manufacture and supply relugolix drug substance and drug product needed for our anticipated launches, or if any of the materials cannot be utilized due to quality or cGMP concerns, adverse findings during regulatory inspections, process validation, or other reasons, our development plans and commercialization of relugolix, if approved, could be significantly delayed or otherwise adversely affected.

Even if we receive regulatory approval for our product candidates, our ability to generate product revenues from our product candidates will depend upon the size of the markets in the territories for which we gain regulatory approval, the number of competitors in such markets, whether we own the commercial rights for those territories, and our ability to:

•~~set an acceptable price for our product candidates and obtain coverage and adequate reimbursement from third-party payors;~~

•~~establish effective sales, marketing, and distribution systems in jurisdictions around the world for our product candidates;~~

•initiate and continue relationships with third-party manufacturers and have adequate commercial quantities of our product candidates manufactured at acceptable cost and quality levels, including maintaining cGMP and Quality Systems Regulation standards required by various regulatory agencies;

•~~attract and retain experienced management, employees and consultants;~~

•~~achieve broad market acceptance of our products in the medical community and with third-party payors and consumers;~~

•~~launch commercial sales of our products, whether alone or in collaboration with others;~~

•~~establish the safety and efficacy of our product candidates in comparison to competing products, including through differentiated approved labeling; and~~

•~~maintain, expand, and protect our intellectual property rights.~~

~~If we cannot successfully execute any one of the foregoing, our business may not succeed and your investment in us may be adversely affected.~~

The terms of the Sumitomo Dainippon Pharma Loan Agreement place restrictions on our operating and financial flexibility.

Our obligations under the Sumitomo Dainippon Pharma Loan Agreement are senior unsecured obligations ~~including customary representations and warranties as well as affirmative and negative covenants,~~ that are guaranteed on a full and unconditional basis by all our subsidiaries.

The Sumitomo Dainippon Pharma Loan Agreement also includes customary representations and warranties as well as affirmative and negative covenants. The negative covenants include limitations on additional indebtedness, liens, certain corporate changes, certain restricted payments, ~~investments~~investment transactions with affiliates, entry into certain restrictive agreements, change in the nature of business, and use of proceeds. Compliance with these covenants may limit our flexibility in operating our business and our ability to take actions that might be advantageous to us and our shareholders.

Additionally, the Sumitomo Dainippon Pharma Loan Agreement also includes customary events of default, including payment defaults, breaches of representations and warranties and certain covenants following any applicable cure period, cross acceleration to certain debt, other failure to pay certain final judgments, certain events relating to bankruptcy or insolvency, certain breaches by us under our Investor Rights Agreement with Sumitovant and Sumitomo Dainippon Pharma, dated December 27, 2019, and failure of material provisions of the loan documents to remain in full force and effect or any contest thereto by us or any of our subsidiaries. Upon the occurrence of an event of default, a default interest rate of an additional 5.0%

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will apply to the outstanding principal amount of the loans, Sumitomo Dainippon Pharma may terminate its obligations to make loans to us and declare the principal amount of all outstanding loans and other obligations under the Sumitomo Dainippon Pharma Loan Agreement to become immediately due and payable, and Sumitomo Dainippon Pharma may take such other actions as set forth in the Sumitomo Dainippon Pharma Loan Agreement. Upon the occurrence of certain bankruptcy and insolvency events, the obligations of Sumitomo Dainippon Pharma to make loans to us would automatically terminate and the principal amount of all outstanding loans and other obligations due under the Sumitomo Dainippon Pharma Loan Agreement would automatically become due and payable. In addition, if it becomes unlawful for Sumitomo Dainippon Pharma to maintain the loans under the Sumitomo Dainippon Pharma Loan Agreement, we would be required to repay the outstanding principal amount of the loans and if a change of control occurs with respect to us, we would be required to repay the outstanding principal amount of the loans within 30 days of such change of control. We may not have enough available funds or be able to raise additional funds through equity or debt financings to repay these outstanding obligations at the time any event of default occurs. In that case, we may be required to delay, limit, reduce or terminate our clinical development efforts or grant to others rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. Our business, financial condition and results of operations could be substantially harmed as a result of any of these events.

We may not be successful in our efforts to identify and acquire or in-license additional product candidates, which may limit our growth potential.

Part of our strategy involves ~~diversifying our product development risk by~~ identifying and acquiring or in-licensing novel product candidates. We may fail to identify and acquire or in-license product candidates, including for reasons discussed in these risk factors and also:

•the process by which we identify and decide to acquire product candidates may not be successful;

•the competition to acquire or in-license promising product candidates is fierce and many of our competitors are large, multinational pharmaceutical, biotechnology and medical device companies with considerably more financial, development and commercialization resources and experience than we have;

•potential product candidates may, upon further study during the acquisition process, be shown to have harmful side effects or other characteristics that indicate that they are unlikely to be products that will receive marketing approval or achieve market acceptance; and

•potential novel product candidates may prove to be unsuccessful and may not be effective in treating their targeted diseases.

In addition, ~~we may choose to focus our efforts and resources on potential product candidates that ultimately prove to be unsuccessful. Further,~~ time and resources spent searching for, identifying, acquiring, and developing potential product candidates may distract management’s attention from our primary business. If we are unable to identify and acquire or in-license suitable product candidates, we will be unable to diversify our product risk. We believe that any such failure could have a significant negative impact on our prospects ~~because the risk~~for future growth.

Table of ~~failure of any particular development program in the pharmaceutical field is high.~~Contents

We do not have our own manufacturing capabilities and rely on third parties to produce clinical and commercial supplies of drug substance and drug product. If these third parties do not perform as we expect, do not maintain their regulatory approvals, or become subject to other negative circumstances, it may result in a delay in our ability to develop and commercialize our products.

We do not own or operate, and we do not expect to own or operate, facilities for drug substance and drug product manufacturing, storage and distribution, or ~~testing. While relugolix~~testing and ~~MVT-602 were being developed by Takeda, they were also being manufactured by Takeda and third-party CMOs. In~~are subject to the risk that our contract manufacturers become subject to negative circumstances. For example, in June 2016, we and one of Takeda’s affiliates, Takeda Pharmaceutical Company Limited (“Takeda Limited”) entered into an agreement for the manufacture and clinical supply of relugolix pursuant to which Takeda Limited supplied us with, and we obtained from Takeda, all of our requirements for relugolix drug substance and drug product that were used under our development ~~plans for all indications.~~plans. In May 2018, we entered into a Commercial Manufacturing and Supply Agreement with Takeda pursuant to which Takeda agreed to manufacture and supply us with certain commercial relugolix drug substance quantities. In addition, in April 2019, we entered into a Commercial Manufacturing and Supply Agreement with Excella GmbH & Co. KG (“Excella”) pursuant to which Excella agreed to manufacture and supply us with certain commercial relugolix drug substance quantities.

Takeda is no longer developing MVT-602. Additional process development and manufacturing ~~would~~will be required for us to complete further Phase 2 and Phase 3 clinical studies for MVT-602. ~~Third-party vendors may be difficult to identify~~Any third-party vendor that we retain for MVT-602 process and formulation development and manufacturing will need to meet quality standards due to special capabilities required ~~and they may not be able to meet our quality standards.~~

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If we need to replace a third-party manufacturer, or if any of our third-party manufacturers experience adverse developments, including with respect to adverse findings during regulatory inspections, delays in regulatory approvals and/or the COVID-19 pandemic, we could experience a significant delay in the supply of a product candidate, which could result in a considerable delay in completing our clinical studies, product testing, and potential regulatory approval of our product candidates. In addition, the commercial launch of our product candidates could be delayed and there could be a shortage in supply, which would impair our ability to generate revenue from the sale of our product candidates.

The facilities used by our contract manufacturers to manufacture our product candidates must be approved by the regulatory authorities pursuant to inspections that ~~will~~may be conducted after we submit our regulatory applications to such regulatory authorities. We do not control the manufacturing process of, and are completely dependent on, our contract manufacturing partners for compliance with cGMP requirements and other regulations and laws for the manufacture of relugolix drug substance and drug product. If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or comparable foreign regulatory authorities, they ~~will~~may not be able to secure or maintain regulatory ~~approval~~approvals for their manufacturing facilities and any applications that we submit to the FDA or other regulatory authorities that list those manufacturing facilities may be negatively affected. Our third-party contract manufacturing facilities must also be in an acceptable state of cGMP compliance and not be subject to a ~~cGMP related~~cGMP-related regulatory or enforcement action that limits their ability to manufacture drug substance or drug product. If any of the drug substance or drug product supplied by a contract manufacturing partner cannot be utilized due to quality or cGMP concerns, adverse findings during regulatory inspections or other reasons, our development plans and commercialization of relugolix ~~if approved,~~ could be significantly delayed or otherwise adversely affected. The FDA or other regulatory authority may withhold approval of any pending regulatory applications or supplements in which non-complaint manufacturing facilities are listed.

InFor example, in June 2020, Takeda received a warning letter from the FDA which indicated that the FDA was not satisfied with Takeda’s response to an FDA Form 483 issued to Takeda following its routine inspection of aseptic finished pharmaceuticals manufacturing at Takeda’s manufacturing facility located at Takeda 4720, Mitsui, Hikari, ~~Facility.~~ ~~We initially listed both Takeda and Excella as CMOs~~Yamaguchi (“Hikari Facility”). Although this matter was resolved in ~~our regulatory filings for the manufacture of relugolix drug substance.~~ ~~We now plan~~October 2021, this warning letter required us to ~~procure the commercial relugolix drug substance needed for our anticipated U.S. launch in advanced prostate cancer solely from Excella. We have removed~~remove the Hikari Facility as a manufacturing site from our NDA ~~submission for prostate cancer~~submissions and ~~may remove it from other regulatory filings if required until Takeda corrects~~to rely on the ~~violations noted~~alternate contract manufacturing organization (“CMO”) listed in the ~~warning letter~~NDA (i.e. Excella) to the satisfaction of the regulatory authorities. We cannot predict if or when Takeda will correct the violations and deviations to the satisfaction of the FDA or any other regulatory agency or whether the regulatory agencies will be satisfied with Takeda’s responses. The COVID-19 pandemic may also cause delays in the remediation and re-inspection process.a greater extent than we had originally planned. We also face the risk that Excella or our other CMOs may face adverse developments, including with respect to adverse findings during regulatory inspections, delays in regulatory approval and/or the COVID-19 pandemic. If ~~Excella or~~ our ~~other~~ CMOs fail to fulfill their obligations to manufacture and supply relugolix drug substance and drug product needed for any of our ~~anticipated launches,~~approved drug products and any of our product candidates, or if any of the materials cannot be utilized due to quality or cGMP concerns, adverse findings during regulatory inspections, process validation delays, or other reasons, our development plans and commercialization of ~~relugolix, if~~any of our approved drug products and any of our product candidates could be significantly delayed or otherwise adversely affected.

Our product candidates contain highly potent compounds and therefore require specialized manufacturing facilities. Depending on actual commercial demand, additional third-party manufacturing facilities will have to be established to meet the demand through technology transfer, process validation and regulatory approval before product manufactured at the new facilities can

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be marketed. Any delay in the technology transfer and process validation could limit adequate supply to meet our commercial demand.

Further, our reliance on third-party manufacturers entails various risks, ~~to which we would not be subject if we manufactured product candidates ourselves,~~ including:

•delay or inability to manufacture ~~relugolix monotherapy tablet or relugolix combination tablet;~~our drug products;

•failure of the drug substance transferred from a CMO to meet our product specifications and quality requirements;

•delay or inability to procure or expand sufficient manufacturing capacity;

•manufacturing and product quality issues related to scale-up of manufacturing;

•costs and validation of new equipment and facilities required for scale-up;

•failure to comply with applicable laws, regulations, and standards, including cGMP and similar foreign standards;

•deficient or improper record-keeping;

•inability to negotiate manufacturing and quality agreements with third parties under commercially reasonable terms;

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•termination or nonrenewal of manufacturing agreements with third parties in a manner or at a time that is costly or damaging to us;

•reliance on a limited number of sources, and in some cases, single sources for product components, such that if we are unable to secure a sufficient supply of these product components, we will be unable to manufacture and sell ~~relugolix combination tablet, relugolix monotherapy tablet,~~our drug products or ~~MVT-602, if approved, or any future~~ product ~~candidate~~candidates (if approved) in a timely fashion, in sufficient quantities or under acceptable terms;

•lack of qualified backup suppliers for those components that are currently purchased from a sole or single source supplier;

•adverse inspection findings by the FDA or other regulatory authorities at third-party manufacturing facilities and/or failure to remediate such findings;

•cGMP regulatory or enforcement action at our third-party manufacturing facilities that limit their ability to manufacture drug substance or drug product for commercial use;

•operations of our third-party manufacturers or suppliers could be disrupted by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or supplier or other regulatory sanctions related to the manufacture of another company’s products;

•carrier disruptions or increased costs that are beyond our control; and

•failure to deliver our products under specified storage conditions and in a timely manner.

Any of these events could also lead to clinical study delays, cost overruns, delay or failure to obtain regulatory approval or impact our ability to successfully commercialize our products, as well as potential product liability litigation, product recalls or product withdrawals. Some of these events could be the basis for the FDA or other regulatory authority action, including injunction, recall, seizure, or total or partial suspension of production.

Our or our affiliates’ employees, independent contractors, advisers, third-party manufacturers, principal investigators, consultants, commercial collaboration partners, service providers, and other vendors, may engage in misconduct or other improper activities, including noncompliance with regulatory or legal standards and requirements, which could have an adverse effect on our results of operations.

We are exposed to the risk that our employees, independent contractors, advisers, ~~including~~ third-party manufacturers, principal investigators, consultants, commercial collaboration partners, service providers, and other vendors, or those of our affiliates, may engage in fraudulent, illegal activity, or other misconduct. Misconduct by these parties could include intentional, reckless or negligent conduct or other unauthorized activities that violate the laws and regulations of the FDA or other regulatory bodies, including: those laws that require the reporting of true, complete, and accurate information to such regulatory bodies; laws that require manufacturing by cGMP standards; federal, state and foreign healthcare fraud and abuse laws and data privacy laws; or laws and regulations that require the true, complete, and accurate reporting of financial information or data. In particular, sales, marketing and other business arrangements in the healthcare industry are subject to extensive regulations intended to prevent fraud, kickbacks, self-dealing, bribery, corruption, antitrust violations, and other abusive practices. See the Risk Factors titled, ~~“Our~~

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“Our current and future relationships with investigators, healthcare professionals, consultants, third-party ~~payors,~~payers, and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties,” and “International expansion of our business exposes us to business, legal, regulatory, political, operational, financial, economic, and other risks associated with conducting business outside of the U.S., which could interrupt our business operations and harm our future international expansion and, consequently, negatively impact our financial condition, results of operations, and cash flows.” These laws may restrict or prohibit a wide range of business activities, including research, manufacturing, distribution, pricing, discounting, marketing and promotion, sales ~~commission,~~commissions, customer incentive programs, and other business arrangements. Activities subject to these laws also involve the improper use or misrepresentation of information obtained in the course of clinical studies, creating fraudulent data in our nonclinical or clinical studies or illegal misappropriation of drug product, which could result in regulatory sanctions and serious harm to our reputation. We have a Code of Business Conduct and Ethics and other corporate compliance policies, but it is not always possible to identify and deter employee or third-party misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with such laws or regulations.

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Business interruptions resulting from effects of pandemics or epidemics, such as the ~~novel strain of the coronavirus known as~~ COVID-19 pandemic, may materially and adversely affect our business and financial condition.

The ~~majority~~COVID-19 pandemic may materially and adversely affect our business and financial condition. For example, due to the COVID-19 pandemic, most of our employees ~~are located in the U.S., primarily in the San Francisco Bay Area, with the rest~~worked remotely during much of 2020 and 2021, and many of our employees ~~located across~~continue to do so on a part-time or full-time basis. Although we devised new ways of working and collaborating, including adopting remote working tools to minimize the ~~U.S. and in Switzerland. Our~~disruption to our business activities, employees ~~have been subject to “shelter-in-place” orders resulting from the COVID-19 pandemic that require our employees to work from home with limited exceptions. Our business~~ may be ~~negatively impacted from having all employees working remotely. For example, employees may be~~ lessproductive and efficient given competing priorities with home-schooling or caring for sick family members, and employee engagement and productivity may decrease from the stress of the COVID-19 pandemic resulting in delays in the progress of our business. We have recently begun allowing our employees to return to work on-site on a limited, voluntary basis with specific safety protocols. The safety protocols we implemented may not prevent employees from contracting COVID-19. If members of our management and other key personnel in critical functions across our organization are unable to perform their duties or have limited availability due to illness from COVID-19, we may not be able to execute on our business strategy and/or our operations may be negatively impacted.

We believe that the COVID-19 pandemic continues to have an impact on our commercialization activities that is consistent with other companies in our industry. As a result of the COVID-19 pandemic, there have been changes in the practice of medical care and medical education. For example, many health care providers initially expanded their utilization of telemedicine to conduct patient visits, and in many regions of the U.S., the ability of commercial and medical affairs field teams to call on healthcare providers was restricted or converted to virtual access. We and our collaboration partner, Pfizer, launched ORGOVYX in the U.S. in January 2021 and MYFEMBREE in the U.S. in June 2021, and to date, Richter has launched RYEQO in seven countries. Our oncology sales and medical affairs field teams resumed in-person interactions with healthcare providers in January 2021 and our women’s health sales and medical affairs field teams began in-person interactions with healthcare providers in June 2021. Despite this, some physician’s offices and many hospitals continue to have limited on-site access for pharmaceutical representatives in order to reduce exposure risk for their patients or staff. Conducting these interactions virtually could reduce the number of medical professionals we are able to engage with, limit our ability to engage with important staff members and virtual meetings have been shown to be less impactful than in-person meetings. The cancellation, postponement or virtual formats for medical conferences also limit access to physicians and reduce awareness of information shared at conferences (medical and promotional). Reduced access to healthcare providers may impact or require adjustments to our planned commercialization activities, including the manner in which our field teams engage with healthcare providers and facilities and supplementing field activities with additional marketing spend. The COVID-19 pandemic has also resulted in fewer opportunities for our medical affairs team to present scientific data as multiple medical conferences have been canceled, postponed, or moved to virtual formats and for our regional medical advisors to engage potential prescribers in scientific exchange. We and our collaboration partners may launch other approved products in the COVID-19 environment. Travel restrictions may make it more difficult for us and our collaboration partners, such as Sunovion, Pfizer, and Richter, to maximize the effectiveness of third-party market access, marketing, sales, and distribution capabilities.

In addition, we rely on third parties in the U.S. and in various parts of the world to assist in the conduct of our clinical studies and to supply us with sufficient drug supplies. Our ability to ensure continuous clinical drug supply to patients and our ability to ensure continuous patient follow up and data monitoring for our ongoing clinical studies may be adversely impacted. Likewise, while we currently expect that the drug supply we have on hand isor expect to procure will be sufficient to support our ongoing clinical studies, our and ~~anticipated~~our collaboration partners’ commercial ~~launches,~~sales for our approved drug products, our supply chain for raw materials, drug substance and drug product is worldwide, and the ~~continued spread~~duration of the ~~coronavirus~~COVID-19 pandemic and ~~the duration of~~ its impact on the ability of our suppliers to operate could negatively impact our manufacturing supply chain for ~~relugolix combination tablet~~our approved drug products and ~~relugolix monotherapy tablet.~~for our product candidates that may receive regulatory approval, or for clinical study materials. If disruptions to our supply

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chain persist for an extended period of time, our clinical study timelines, our financial condition and our results of operations may be negatively impacted.

In order to successfully commercialize our product candidates, we need to continue to expand our capabilities, including the hiring of qualified employees, engage potential prescribers in scientific exchange, build commercial infrastructure, conduct market research, develop promotional campaigns and resources, and engage payers in scientific exchange to demonstrate the value of our products and negotiate favorable contracts. The COVID-19 pandemic is making this work more difficult and may result in delays. Conducting interviews remotely makes it more difficult to ensure we are recruiting and hiring high-quality employees, and the uncertainty created byaddition, the COVID-19 pandemic ~~makes it less likely~~may impact the FDA’s review process and timing of potential candidates will be willing to leave a stable job to explore a new opportunity. Our medical affairs team needs to ensure our scientific data are presented and published and our regional medical advisors need to engage potential prescribers in scientific exchange. Multiple medical conferences have been canceled and postponed resulting in fewer opportunities to present our scientific data and our medical affairs team members can only communicate virtually making it more difficult to educate and engage in scientific exchange. Travel restrictions may make it more difficult for us to maximize the potentialapproval of ~~our third-party market access, marketing and distribution capabilities, such as our relationships wi~~th Sunovion and Richter and provide adequate collaboration and oversight. The COVID-19 pandemic may negatively impact our ability to attract the human resources required to build out our commercial capabilities and may negatively impact our ability to rapidly and effectively educate potential prescribers and payers and, if significant delays result, commercialize our product candidates. TheRegulatory agency pre-approval inspections are now limited, particularly for sites outside the U.S., and it is not clear if virtual inspections will be required and acceptable.

Future developments regarding COVID-19 remain uncertain and the extent to which the ~~coronavirus and global efforts to contain its spread will impact~~COVID-19 pandemic ultimately impacts our business, financial condition or results of operations will depend on ~~future developments,~~numerous factors, including the magnitude and duration of the pandemic, the distribution, acceptance, and effectiveness of COVID-19 vaccines and treatments, the impact of new and potentially more virulent variants of the coronavirus (e.g., the delta variant), the duration of governmental measures to mitigate the pandemic and how quickly and to what extent normal economic and operating conditions can resume, all of which ~~are highly~~remain uncertain and ~~cannot~~difficult to predict. Additionally, even after normalcy resumes, there will likely be ~~predicted~~some permanent changes to how healthcare is provided, how healthcare providers engage with our industry and perhaps how conferences are implemented. None of these changes can be anticipated at this ~~time,~~point, nor the potential impact on our business. As such, it is uncertain as to the full magnitude that the pandemic will have on our financial condition, liquidity, and ~~include the duration, severity and scope~~future results of the outbreak and the actions taken to contain or treat the coronavirus outbreak. In addition, the current COVID-19 pandemic may also have the effect of heightening many of the other risks described in this “Risk Factors” section.operations.

International expansion of our business exposes us to business, legal, regulatory, political, operational, financial, economic, and other risks associated with conducting business outside of the U.S., which could interrupt our business operations and harm our future international expansion and, consequently, negatively impact our financial condition, results of operations, and cash flows.

Part of our business strategy involves international expansion, including establishing and maintaining operations outside of the U.S., and establishing and maintaining relationships with healthcare providers, ~~payors,~~payers, government officials, distributors, manufacturers and other third parties globally in case any of our product candidates is approved for marketing outside of the U.S.

Conducting business internationally involves a number of risks, including:

•the increased complexity, difficulties and costs inherent in staffing and managing international operations and business practices in different jurisdictions;

•multiple conflicting and changing laws and regulations such as tax laws, trade protection measures, export and import restrictions, employment, immigration and labor laws, privacy and cybersecurity laws, anti-bribery and anti-corruption laws, regulatory requirements and other governmental approvals, permits and licenses;

•different regulatory requirements for drug approvals and rules governing drug commercialization in foreign countries;

•possible failure by us or our distributors to obtain and maintain appropriate licenses or regulatory approvals for the sale or use of our product candidates, if approved, in various countries;

•~~difficulties in managing foreign operations;~~

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•complexities associated with managing multiple ~~payor-reimbursement,~~payer-reimbursement, pricing and insurance regimes or self-pay systems;

•financial risks, such as longer payment cycles, difficulty enforcing contracts and collecting accounts receivable, and exposure to foreign currency exchange rate fluctuations;

•reduced or no protection over intellectual property rights;

•business interruptions resulting from geopolitical actions, economic instability, or natural disasters, including, but not limited to, wars and terrorism, economic weakness, inflation, political instability in particular foreign economies and markets, boycotts, curtailment of trade, labor disputes, unexpected changes in tariffs, and other business restrictions, outbreak of disease (such as the COVID-19 pandemic), fires, earthquakes, hurricane, tornado, severe storm, power outage, system failure, typhoons or floods;

•failure to comply with foreign laws, regulations, standards and regulatory guidance governing the collection, use, disclosure, retention, security and transfer of personal data, including the European Union General Data Protection Regulation (the “GDPR”) which introduced strict requirements for processing personal data of individuals within the ~~EU;~~European Union (“EU”);

•failure to comply with the Foreign Corrupt Practices Act, including its books and records provisions and its anti-bribery provisions, the United Kingdom Bribery Act 2010, and similar antibribery and anticorruption laws in other jurisdictions, for example, by failing to maintain accurate information and control over sales or distributors’ activities;

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•workforce uncertainty in countries where labor unrest is more common than in the U.S.; and

•production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad.

Any of these risks, if encountered, could interrupt our business operations and harm our future international expansion and, consequently, negatively impact our financial condition, results of operations, and cash flows. We have no prior experience in certain countries, and many biopharmaceutical companies have found the process of marketing their products in foreign countries to be very challenging.

The withdrawal of the United Kingdom (the “U.K.”) from the EU, commonly referred to as “Brexit,” may adversely impact our ability to obtain regulatory approvals of our product candidates in the EU, result in restrictions or imposition of taxes and duties for importing our product candidates into the EU, and may require us to incur additional expenses in order to develop, manufacture and commercialize our product candidates in the EU.

OnFollowing the result of a referendum in 2016, the U.K. left the EU on January 31, 2020, ~~the U.K. withdrew from the EU. The U.K.’s withdrawal from the EU is~~ commonly referred to as Brexit. ~~Under~~Pursuant to the formal withdrawal ~~agreement~~arrangements between the U.K. and the EU, the U.K. ~~will be~~was subject to a transition period until December 31, 2020 (the “Transition Period”) during which EU rules ~~will continue~~continued to apply. ~~During~~A trade and cooperation agreement (the “Trade and Cooperation Agreement”) that outlines the ~~Transition Period, negotiations between the U.K. and the EU are expected to continue in relation to the~~ future ~~customs and~~ trading relationship between the U.K. and the EU following the expiration of the Transition Period. Under the formal withdrawal arrangements between the U.K. and the EU, the parties had until June 30, 2020 to agree to extend the Transition Period if required. No such extension was agreed ~~prior~~ to such date. No agreement has yet been reached between the U.K. and the EU and it may be the case that no formal customs and trading agreement will be reached prior to the expiry of the Transition Period onin December ~~31,~~ 2020.

Since a significant proportion of the regulatory framework in the U.K. applicable to our business and certain of our product candidates are derived from EU directives and regulations, Brexit ~~following the Transition Period could materially~~has had, and may continue to have, a material impact upon the regulatory regime with respect to the development, manufacture, importation, approval and commercialization of our product candidates in the U.K. or the EU. For example, ~~as a result of~~ the ~~uncertainty surrounding Brexit, the EMA relocated to Amsterdam from London. Following the Transition Period, the U.K. will~~U.K is no longer be covered by the centralized procedures for obtaining EU-wide marketing authorization from the EMA, and ~~unless a specific agreement is entered into,~~ a separate ~~process for~~marketing authorization ~~of drug products, including certain of~~will be required to market our product candidates ~~will be required~~ in the U.K.~~, the potential process for which~~ It is currently ~~unclear.~~unclear whether the Medicines and Healthcare products Regulatory Agency (“MHRA”) in the U.K. is sufficiently prepared to handle the increased volume of marketing authorization applications that it is likely to receive. Any delay in obtaining, or an inability to obtain, any marketing approvals, as a result of Brexit or otherwise, would prevent us from commercializing our product candidates in the U.K. or the EU and restrict our ability to generate revenue and achieve and sustain profitability. ~~In addition, we~~

While the Trade and Cooperation Agreement provides for the tariff-free trade of medicinal products between the U.K. and the EU, there may be ~~required~~additional non-tariff costs to ~~pay taxes or duties or be subjected~~such trade which did not exist prior to ~~other hurdles in connection with~~ the ~~importation~~end of ~~certain of our product candidates into~~the Transition Period. Further, should the U.K. diverge from the EU ~~or we may incur expenses~~from a regulatory perspective in ~~establishing a manufacturing facility~~relation to medicinal products, tariffs could be put into place in the ~~EU in order to circumvent such hurdles.~~

~~If any of these outcomes occur, we may be forced to restrict or delay efforts to seek regulatory approval~~future. We could therefore, both now and in the ~~U.K. or the EU for certain of our product candidates, or incur~~future, face significant additional expenses (when compared to the position prior to the end of the Transition Period) to operate our business, which could significantly and materially harm or delay our ability to generate revenues or achieve profitability of our business. Any further changes in international trade, tariff and import/export regulations as a result of Brexit or otherwise may impose unexpected duty costs or

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other non-tariff barriers on us. These developments, or the perception that any of them could occur, may significantly reduce global trade and, in particular, trade between the impacted nations and the U.K. It is also possible that Brexit may negatively affect our ability to attract and retain employees, particularly those from the EU.

Our internal computer systems, and those of our third-party collaborators, consultants or contractors, may fail or suffer cybersecurity breaches and data leakage, which could result in a material disruption of our business and operations or liabilities that adversely affect our financial performance.

Our computer systems, as well as those of our ~~CROs,~~contract research organizations (“CROs”), CMOs, third-party logistics providers, third-party collaboration partners, and other contractors, consultants, and law and accounting firms, may sustain damage or data leakage from computer viruses, unauthorized access or disclosure, data breaches, phishing attacks, cybercriminals, natural disasters (including hurricanes and earthquakes), terrorism, war, and telecommunication and electrical failures. We rely on our third-party providers to implement effective security and data recovery measures and identify and correct for any such failures, deficiencies or breaches. The risk of a security breach or disruption, particularly through cyber-attacks or cyber intrusion, including by computer hackers, foreign governments and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased. If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of the commercialization of our drug products and our drug development programs. For example, the loss of commercialization information, nonclinical or clinical study data from completed, ongoing or planned clinical studies could result in delays in our commercialization, regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach were to result in a loss of or damage to our data, access or applications, or inappropriate disclosure of personal, confidential or proprietary information, we could incur liability, suffer reputational damage, and the further development of any current or future product candidate could be delayed.

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If we fail to comply with applicable U.S. and foreign privacy and data protection laws and regulations, we may be subject to liabilities that adversely affect our business, operations and financial performance.

We are subject to federal and state laws and regulations requiring that we take measures to protect the privacy and security of certain information we gather and use in our business. For example, federal and state security breach notification laws, state health information privacy laws and federal and state consumer protection laws impose requirements regarding the collection, use, disclosure and storage of personal information. In addition, California enacted the California Consumer Privacy Act (“CCPA”), which became effective on January 1, 2020. The CCPA gives California residents expanded rights to access and require deletion of their personal information, opt out of certain personal information sharing, and receive detailed information about how their personal information is used.

The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches that may increase data breach litigation. Although the CCPA includes exemptions for certain clinical study data, and ~~HIPAA~~Health Insurance Portability and Accountability Act (“HIPAA”) protected health information, the law may increase our compliance costs and potential liability with respect to other personal information we collect about California residents. The CCPA has prompted a number of proposals for new federal and state privacy legislation that, if passed, could increase our potential liability, increase our compliance costs and adversely affect our business.

We may also be subject to or affected by foreign laws and regulations, including regulatory guidance, governing the collection, use, disclosure, security, transfer and storage of personal data, such as information that we collect about patients and healthcare providers in connection with clinical studies and our other operations in the U.S. and abroad. The global legislative and regulatory landscape for privacy and data protection continues to evolve, and implementation standards and enforcement practices are likely to remain uncertain for the foreseeable future. This evolution may create uncertainty in our business, result in liability or impose additional costs on us. The cost of compliance with these laws, regulations and standards is high and is likely to increase in the future. For example, the EU has adopted the GDPR, which has strict requirements for processing personal data. The GDPR increases our compliance burden with respect to data protection, including by mandating potentially burdensome documentation requirements and granting certain rights to individuals to control how we collect, use, disclose, retain and leverage information about them. The processing of sensitive personal data, such as information about health conditions, entails heightened compliance burdens under the GDPR and is a topic of active interest among foreign regulators. In addition, the GDPR provides for breach reporting requirements, more robust regulatory enforcement and fines of up to the greater of 20 million euros or 4% of annual global revenue. While companies are afforded some flexibility in determining how to comply with the GDPR’s various requirements, significant effort and expense are required to ensure continuing compliance with the GDPR. Moreover, the requirements under the GDPR and guidance issued by different EU member states may change periodically or may be modified, and such changes or modifications could have an adverse effect on our business operations if compliance becomes substantially costlier than under current requirements. It is also possible that each of these privacy laws may be interpreted and applied in a manner that is inconsistent with our practices. Further, Brexit has created uncertainty with regard to data protection regulation in the U.K. In particular, it is unclear whether, post Brexit, the U.K. will enact data protection legislation equivalent to the GDPR and how data transfers to and from the U.K. will be regulated. Any failure or perceived failure by us to comply with federal, state, or foreign laws or self-regulatory standards could result in negative

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publicity, diversion of management time and effort and proceedings against us by governmental entities or others. In many jurisdictions, enforcement actions and consequences for noncompliance are rising. As we continue to expand into other foreign countries and jurisdictions, we may be subject to additional laws and regulations that may affect how we conduct business.

The failure to successfully ~~implement~~expand and maintain anour enterprise resource planning (“ERP”) system and other information technology systems could adversely affect our business and results of operations or the effectiveness of internal ~~controls~~control over financial reporting.

~~We have implemented and continue to optimize~~During our fiscal year 2019, we began the implementation of a company-wide ~~enterprise resource planning (“ERP”)~~ERP system pertaining to certain business, operational, and finance ~~processes~~processes. We have continued to optimize and expand this ERP system and have implemented and continue to ~~ensure our operations are adequately scalable in support~~optimize other systems as a part of our ~~anticipated commercial launches.~~ongoing technology and process improvement initiatives. ERP and other information technology system implementations are complex, expensive and time-consuming projects that require transformations of business, operational, and finance processes. Any such transformation involves risk inherent in the conversion to a new system, including loss of information and potential disruption to normal operations. ~~The implementation and optimization of the ERP system has required, and will continue to require, the investment of significant financial and human resources.~~

Any disruptions, delays, or deficiencies in the design or the ongoing maintenance and optimization of the ERP system and other information technology systems could adversely affect our ability to accurately maintain our books and records, provide accurate, timely and reliable reports on our financial and operating results, or otherwise operate our business. Additionally, if the ERP system ~~does~~and other information technology systems do not operate as intended, the effectiveness of our internal ~~controls~~control over financial reporting could be adversely affected and could cause us to fail to comply with SEC obligations related to our internal control over financial reporting. In addition, if we experience interruptions in service or operational difficulties and are

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unable to effectively manage our business following the implementation or optimization of the ERP system or other information technology systems, our business and results of operations could be harmed.

The phase-out of the London Interbank Offered Rate (“LIBOR”), or the replacement of LIBOR with ~~a different~~an alternative reference rate, may adversely affect interest ~~rates.~~rates on our outstanding variable rate indebtedness with Sumitomo Dainippon Pharma.

On July 27, 2017, the U.K.’s Financial Conduct Authority (the authority that regulates LIBOR) announced that after 2021, it would ~~phase out~~no longer compel banks to submit the rates required to calculate LIBOR. This announcement indicates that the continuation of LIBOR ~~by the end of~~on its current basis cannot and will not be guaranteed after 2021. It is unclear whether new methods of calculating LIBOR will be established such that it continues to exist after 2021, or if a~~lternative~~alternative rates or benchmarks will be adopted. The interest rate under the Sumitomo Dainippon Pharma Loan Agreement is ~~and the interest under the New Credit Facility is expected to be,~~ calculated based on LIBOR and, when ~~this occurs,~~LIBOR is phased out, we ~~may~~will need to agree with Sumitomo Dainippon Pharma toon a new method of calculating the interest rate under the Sumitomo Dainippon Pharma Loan ~~Agreement and, if entered into, the New Credit Facility, which we may not be able to do.~~Agreement. Changes in the method of calculating LIBOR, or the replacement of LIBOR with an alternative rate or benchmark, may adversely affect interest rates and result in higher borrowing costs. This could ~~materially an~~d adversely affect our results of operations, cash flows and liquidity. We cannot predict the effect of the potential changes to LIBOR or the establishment and use of alternative rates or benchmarks.

Risks Related to Clinical Development and Regulatory Approval ~~and Commercialization~~

Clinical studies are very expensive, time-consuming, difficult to design and implement, and involve uncertain outcomes. Clinical study failures can occur at any stage of clinical studies, and we could encounter problems that cause us to suspend, abandon or repeat clinical studies. We cannot predict with any certainty the timing for commencement or completion of current or future clinical studies.

Any product candidate will require extensive clinical testing resulting in sufficiently positive outcomes before we are prepared to submit an NDA or other similar application for regulatory approval. Human clinical studies are very expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. ~~For example, the~~The FDA or other regulatory authorities may not agree with our proposed plans for any clinical studies of ~~relugolix combination tablet, relugolix monotherapy tablet, MVT-602,~~our product candidates, or any other potential future product candidates, which may delay ~~the~~or prevent the approval of an NDA or similar application. For example, on May 18, 2021, the FDA informed us by teleconference that it placed a partial clinical hold on the Phase 3 SERENE study (MVT-601-050) evaluating relugolix combination tablet for the prevention of pregnancy pending amendment of the study protocol. In August 2021, the FDA informed us that the partial clinical hold on such study was lifted following study protocol amendments. The clinical study ~~process~~process is also very time-consuming. The commencement and completion of clinical studies may be delayed or prevented by several factors, including:

•failure to obtain regulatory approval to commence a ~~study;~~study or regulatory actions requiring a hold on any of our clinical studies;

•unforeseen safety issues;

•lack of effectiveness during clinical studies;

•identification of dosing issues;

•inability to reach agreement on acceptable terms with prospective CROs and/or clinical study sites, the terms of which can be subject to extensive negotiations and may vary significantly among different CROs and clinical study sites;

~~Table~~•our determination that the cost of ~~Contents~~completing the clinical trial and obtaining regulatory approval does not warrant the expense and investment of time by management and our other personnel;

•slower than expected rates of patient recruitment and enrollment or failure to recruit suitable patients to participate in a study;

•failure to open a sufficient number of clinical study sites;

•unanticipated impact from changes in or modifications to clinical study design;

•inability or unwillingness of clinical investigators or study participants to follow our clinical and other applicable protocols, including missed assessments or impeded access to study sites due to government or institutional stay-at-home or shelter-in-place measures during the COVID-19 pandemic;

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•premature discontinuation of study participants from clinical studies or missing data, including from patients unable to come to study visits during the COVID-19 pandemic;

•failure to manufacture or release sufficient quantities of relugolix, MVT-602, estradiol, progestin or placebo or failure to obtain sufficient quantities of concomitant medication, that in each case meet our quality standards, for use in clinical studies;

•inability to monitor patients adequately during or after treatment; or

•inappropriate unblinding of study patients or study results.

Clinical study failures can occur at any stage of clinical studies, and we could encounter problems that cause us to suspend, abandon or repeat clinical studies. We, the FDA or an institutional review board or other regulatory authority may suspend our clinical studies at any time if it appears that we or our collaborators are failing to conduct a clinical study in accordance with regulatory requirements, including, the FDA’s current Good Clinical Practices (“cGCP”) or cGMP regulations, that we are exposing participants to unacceptable health risks, or if the FDA or other regulatory authority, as the case may be, finds deficiencies in our Investigational New Drug application or other submissions or the manner in which the clinical studies are conducted. In addition, product candidates in later stages of clinical development may fail to show the desired safety and efficacy outcomes despite having progressed successfully through prior stages of preclinical and clinical testing. Results from clinical studies may require further evaluation, delaying the next stage of clinical development or submission of an ~~NDA.~~ NDA or other similar application for regulatory approval. Further, we may determine to terminate a clinical trial if we determine that the cost and time of management and our other personnel does not warrant further investment in the clinical trial. Therefore, we cannot predict with any certainty the timing for commencement or completion of current or future clinical studies. If we experience delays in the commencement or completion of our clinical studies, or if we terminate a clinical study prior to completion, the commercial prospects of any product candidates could be harmed, and our ability to generate net product revenue from any product candidates may be delayed. In addition, any delays in our clinical studies could increase our costs, cause a decline in our common share price, slow down the regulatory approval process, and jeopardize our ability to commence product sales and generate net product revenue. Any of these occurrences may harm our business, financial condition, and results of operations. In addition, many of the factors that cause or lead to a delay in the commencement or completion of clinical studies may also ultimately lead to the denial of regulatory approval of our product candidates.

Moreover, principal investigators for our clinical studies may serve as scientific advisors or consultants to us from time to time and receive compensation in connection with such services. Under certain circumstances, we may be required to report some of these relationships to the FDA or other regulatory authorities. The FDA or other regulatory authorities may conclude that a financial relationship between us and a principal investigator has created a conflict of interest or otherwise affected the integrity of the study. The FDA or other regulatory authority may therefore question the integrity of the data generated at the applicable clinical study site and the utility of the clinical study itself may be jeopardized. Clinical study sites, CROs, and manufacturing sites may be inspected for compliance with cGCP or cGMP. Any questions about data integrity or significant quality issues could result in a delay in approval, or rejection, of our marketing applications by the FDA or other regulatory authority, as the case may be, and may ultimately lead to the denial of marketing approval of one or more of our product candidates.

We are dependent on the research and development of relugolix and MVT-602 previously conducted by ~~Takeda, and if~~Takeda. If Takeda did not conduct this research and development in compliance with applicable requirements, ~~this~~it could result in increased costs and delays in our development of these product candidates.

Prior to our acquisition of worldwide rights (excluding Japan and certain other Asian countries) to relugolix and worldwide rights to MVT-602, we had no involvement with or control over the nonclinical or clinical development of relugolix or MVT-602. We are dependent on Takeda having conducted such research and development in accordance with the applicable protocols, legal, regulatory, and scientific standards, having accurately reported the results of all clinical studies and other research conducted prior to our acquisition of the rights to relugolix and MVT-602, having correctly collected and interpreted the data from these studies and other research, and having supplied us with complete information, data sets, and reports required to adequately demonstrate the results reported through the date of our acquisition of these assets. Problems related to any of such nonclinical or clinical work could result in increased costs and delays in the development of our product candidates, which could adversely affect our ability to generate any future revenue from these product candidates.

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Recruitment, enrollment and retention of patients in clinical studies is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control.

We may encounter delays in enrolling, or be unable to enroll, a sufficient number of patients to complete any of our clinical studies on our current timelines, or at all, and even once enrolled, we may be unable to retain a sufficient number of patients to satisfactorily complete any of our clinical studies. Enrollment in our clinical studies may be slower than we anticipated, leading

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to delays in our development timelines. Patient enrollment and retention in clinical studies depends on many factors, including the size of the patient population, the nature of the study protocol, our ability to recruit clinical study investigators with the appropriate competencies and experience, the existing body of safety and efficacy data with respect to the study drug, the number and nature of competing treatments and ongoing clinical studies of competing drugs for the same indication, the proximity of patients to clinical sites, the eligibility criteria for the study and the proportion of patients screened that ~~meets~~meet those criteria, our ability to obtain and maintain patient consents, and the risk that patients enrolled in clinical studies will not comply with the protocol or will drop out of the studies before completion. In addition, unforeseen global instability, including political instability or instability from an outbreak of pandemic or contagious disease, such as the COVID-19 pandemic, in or around the countries in which we conduct our clinical studies, could delay the commencement or rate of completion of our clinical studies. Furthermore, any negative results we or ~~Takeda~~a collaboration partner may report in clinical studies of our product candidates may make it difficult or impossible to recruit, enroll, and retain patients in other clinical studies of that same product candidate. ~~Similarly,~~Similarly, negative or positive results reported by our competitors about their ~~drug~~products or product candidates may negatively affect patient recruitment, enrollment or retention in our clinical studies. Also, marketing authorization of competitors in the same class of product candidates may impair our ability to recruit, enroll or retain patients into our clinical studies, delaying or potentially preventing us from completing clinical studies. Delays or failures in planned patient recruitment, enrollment or retention may result in increased costs, program delays or both, which could have a harmful effect on our ability to develop our product candidates, or could render further development impossible.

The results of our clinical studies may not support our proposed claims for our product candidates. The results of previous clinical studies may not be predictive of future results, and interim or top-line data may be subject to change or qualification based on the complete analysis of data.

Even if our clinical studies are completed as planned, we cannot be certain that their results will support the efficacy or safety of our product candidates. For example, product candidates may not meet the criteria for success for their primary endpoint specified in the statistical analysis plan, highlighting the importance of appropriate selection of the primary endpoint, statistical powering of a clinical study, and diligent oversight of the treatment compliance of those patients enrolled into the study. Success in nonclinical testing and early clinical studies does not ensure that later clinical studies will be successful, and we cannot be sure that the results of later clinical studies will replicate the results of prior clinical studies and nonclinical testing. Likewise, promising results in interim analyses or other preliminary analyses do not ensure that the clinical study as a whole will be successful. In addition, the FDA may not agree that clinical study results are sufficient for approval for any product candidate, or even if approved, may not support a label that is capable of competing with existing treatments. A number of companies in the pharmaceutical industry, including biotechnology companies, have suffered significant setbacks in clinical studies, even after having achieved promising results in earlier nonclinical or clinical studies. These setbacks have been caused by, among other things, nonclinical findings made while clinical studies were underway and safety or efficacy observations made in clinical studies, including previously unreported adverse events. Positive results from any of our clinical studies may not be predictive of the results of any of our other ongoing and potential future clinical studies, and there can be no assurance that the results of studies conducted by third parties will be viewed favorably or are indicative of our own future study results. We may publicly disclose top-line or interim data from time to time, which is based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review, audit, and verification of the data related to the particular study. We make assumptions, estimations, calculations, and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the top-line results that we report may differ from future results of the same studies, or different conclusions or considerations may qualify such results once additional data have been received and fully evaluated.

A future failure of a clinical study to meet its ~~predetermined~~primary endpoints would likely cause us to abandon a product candidate and may delay development of ~~any other~~a product ~~candidates.~~candidate. Any delay in, or termination of, our clinical studies will delay the submission of our NDAs to the FDA or other similar applications ~~with~~to other ~~relevant~~ foreign regulatory authorities and, ultimately, our ability to commercialize our product candidates and generate net product revenue.

Reported data or other clinical development announcements by Takeda, its partners or sublicensees, or by our collaboration partners, including Pfizer and Richter, may adversely affect our commercialization of our drug products and our clinical development ~~plan.~~plans.

Takeda, its partners and sublicensees, and our collaboration partners, Pfizer and Richter, may be involved in the further clinical development of relugolix. Favorable announcements by Takeda, Pfizer or Richter do not guarantee that the results of our clinical studies will also be favorable as the designs of our clinical studies may differ from those of Takeda, Pfizer or Richter. Further, if clinical study or post-marketing adverse events regarding relugolix are reported, or subsequent announcements by our partners regarding relugolix are unfavorable, it could negatively impact our commercialization of drug products, and our clinical development plans for or opinions of the FDA or other regulatory authorities with respect to relugolix. For example, Takeda has developed relugolix for the treatment of women with uterine fibroid-associated pain and heavy menstrual bleeding

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in Japan. Takeda reported positive top-line results from its two Phase 3 clinical studies in Japan in women with uterine fibroids

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and has obtained market authorization in Japan from the Ministry of Health, Labor and Welfare for Relumina® ~~Tablets~~tablets 40 mg (generic name: relugolix) for the improvement of symptoms of uterine fibroids, including heavy menstrual bleeding, lower abdominal pain, lower back pain, and anemia. Favorable announcements by Takeda do not guarantee that the results of our clinical studies will also be favorable as the designs of our clinical studies differ from those of Takeda. Further, if clinical study or post-marketing adverse events regarding Relumina® are reported, or subsequent announcements by Takeda, its partners or sublicensees regarding relugolix are unfavorable, it could negatively impact our clinical development plans for or opinions of the FDA or other regulatory authorities with respect to relugolix. We cannot provide assurance that the FDA or other health authorities will allow us to use the data from Takeda’s clinical studies in support of any NDA or marketing authorization application that we may submit, and such data may be interpreted differently by the regulatory authorities and provide contradictory evidence in support of the FDA’s (or other regulatory authority) evaluation. If the FDA or other regulatory authorities do not allow us to use the data from Takeda’s clinical studies, we may be required to perform additional clinical studies.

~~We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.~~

Drug development is highly competitive and subject to rapid and significant technological advancements. As a significant unmet medical need exists for the treatment of each of uterine fibroids, endometriosis, and advanced prostate cancer, as well as infertility in women, there are several large and small pharmaceutical companies focused on delivering therapies for the treatment of these indications. Further, it is likely that additional drugs are being developed or will become available in the future for the treatment of each of our target indications.

We are aware of several companies that are developing and commercializing drugs that would compete against relugolix combination tablet and relugolix monotherapy tablet for the treatment of heavy menstrual bleeding associated with uterine fibroids, pain associated with endometriosis, and/or advanced prostate cancer, and against MVT-602 for the treatment of female infertility as part of assisted reproduction.

Many of our current and potential future competitors have significantly more experience commercializing drugs and may succeed in developing, acquiring or licensing, on an exclusive basis, drugs that are more effective or less costly than any product candidate that we may develop. Our competitors may succeed in obtaining patent protection, discovering, developing, receiving FDA or other regulatory authority approval for or commercializing medicines before we do, which would have an adverse impact on our business and results of operations. Competition may reduce the number and types of patients available to us to participate in our clinical studies, because some patients who might have opted to enroll in our studies may instead opt to enroll in a study being conducted by one of our competitors or opt to take an approved product. The availability and pricing of our competitors’ products could limit the demand and the price we are able to charge for any product candidate we develop. Mergers and acquisitions in the pharmaceutical and biotechnology industries could result in even more resources being concentrated among a smaller number of our competitors.

~~The inability to compete with existing or subsequently introduced drugs would have an adverse impact on our business, financial condition and prospects.~~

The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, ~~time consuming,~~time-consuming, and inherently unpredictable. If we are not able to obtain required regulatory approvals ~~we will not be able to commercialize relugolix combination tablet, relugolix monotherapy tablet, or MVT-602, and~~for our product candidates, our ability to generate net product revenue will be materially impaired.

We have invested and expect to continue to invest a substantial portion of our efforts and expenditures in the development and advancement of our product candidates. The research, testing, manufacturing, labeling, approval, sale, marketing, and distribution of products are and will remain subject to extensive regulation by the FDA and other regulatory authorities in the U.S. and other countries. We and our collaboration partners are not permitted to market our product candidates in the U.S. until we receive approval of NDAs or in any foreign country until we receive the requisite approvals from the appropriate regulatory authorities in such countries. Obtaining approval of an NDA or similar foreign regulatory approval is an extensive, lengthy, expensive and inherently uncertain process, and the FDA or other foreign regulatory authority may delay, limit or deny approval of our product candidates. The time required to obtain approval of an NDA by the FDA or similar regulatory authorities outside of the U.S. is unpredictable but typically takes many years following the commencement of clinical studies and depends upon numerous factors, including the substantial discretion of the regulatory authority. In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approvals may change during the course of a product candidate’s clinical development and may vary among jurisdictions. Obtaining approval of an NDA from the FDA or a regulatory approval from a regulatory authority outside the U.S. is an expensive process. The submission of NDAs is subject to a substantial application user fee, and the manufacturer and/or sponsor under an approved NDA are also subject to annual program user fees. We may incur additional costs in the ~~fiscal year 2020 with the~~future for our anticipated regulatory submissions, including the fees associated with NDA and foreign equivalent submissions.

Securing marketing approvals requires the submission of extensive nonclinical and clinical data and supporting information to regulatory authorities for each therapeutic indication to establish the safety and efficacy of ~~relugolix combination tablet, relugolix monotherapy tablet, and MVT-602~~our product candidates for the specified indication. The process of responding to the FDA or other regulatory authorities’ information requests in the review process, ~~and~~potentially preparing for and appearing at a public advisory committee ~~if required, will require~~or oral hearing, and preparing our manufacturers and investigators to successfully complete inspections by the FDA or other regulatory authorities during the approval process requires significant human and financial resources. If the information from our completed clinical studies ~~are~~is insufficient to support regulatory approvals, we may have to complete ongoing or additional clinical studies. ~~For example, GnRH receptor antagonists,~~

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like relugolix, when taken alone, may cause loss of bone mineral density due to the induced hypoestrogenic state that may limit duration of use. This risk, and a related risk of hot flash or vasomotor symptoms, may be mitigated by the co-administration of relugolix in combination with low-dose estradiol and a progestin. A key part of our relugolix clinical development strategy has been to formulate a single-tablet fixed-dose combination of relugolix with low-dose estradiol and a progestin (relugolix combination tablet) to maintain bone health and mitigate side effects of a low-estrogen state such as vasomotor symptoms, and to facilitate patient convenience and compliance. If the FDA concludes that the data from these studies are insufficient to support regulatory approvals, we may be required to conduct further studies and we could face delays and increased expenses associated with our development programs and our commercial opportunity could be limited. If we are not able to obtain required regulatory approvals for relugolix combination tablet or if our competitors obtain regulatory approval of a fixed-dose combination with hormonal therapy before we do, we would be at a competitive disadvantage and this could limit our commercial opportunity.

We rely on third-party CROs and consultants to assist us in submitting and supporting the applications necessary to gain marketing approvals. Securing marketing approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the regulatory authorities. Delays or errors in the submission of applications for marketing approvals or issues, including those related to gathering the appropriate data and the inspection process, may ultimately delay or affect our ability to obtain regulatory approvals, commercialize our product candidates, and generate net product revenue. ~~Also, see~~Despite efforts at compliance, from time to time, we or our partners may receive notices of manufacturing, quality-related, or other observations following inspections by regulatory authorities, as well as official agency correspondence regarding compliance. For example, in June 2020, Takeda received a warning letter from the ~~Risk Factor titled “We are heavily dependent~~FDA which indicated that the FDA was not satisfied with Takeda’s response to an FDA Form 483 issued to Takeda following its routine inspection of aseptic finished pharmaceuticals manufacturing at Takeda’s manufacturing facility located at Takeda 4720, Mitsui, Hikari, Yamaguchi (“Hikari Facility”). Although this matter was resolved in October 2021, this warning letter required us to remove the Hikari Facility as a manufacturing site from our NDA submissions and to rely on the ~~success of~~alternate contract manufacturing organization (“CMO”) listed in the NDA (i.e., Excella) to a greater extent than we had originally planned. We are procuring the commercial relugolix ~~combination tablet~~drug substance for U.S. ORGOVYX and MYFEMBREE solely from Excella, pursuant to the Commercial Manufacturing and Supply Agreement we have with Excella. We also face the risk that Excella or our women’s health indications of uterine fibroids and endometriosis, relugolix monotherapy tablet for men with advanced prostate cancer, and MVT-602. If relugolix combination tablet, relugolix monotherapy tablet or MVT-602 do not receive regulatory approval or are not successfully commercialized, our business will be harmed.~~” In addition, any~~other CMOs may face adverse developments, including with respect to ~~our CMOs, including~~ adverse findings during regulatory inspections, ~~such as occurred with the Hikari Facility, or~~ delays ~~related to~~in regulatory approval and/or the COVID-19 ~~pandemic may also ultimately delay~~pandemic. If Excella or ~~affect~~ our ~~ability~~other CMOs fail to ~~obtain~~fulfill their obligations to manufacture and supply relugolix drug substance and drug product needed for our commercialization, or if any of the materials cannot be utilized due to quality or cGMP concerns, adverse findings during regulatory ~~approvals, commercialize~~ inspections, process validation, or other reasons, our development plans and commercialization ofour product candidates ~~and generate product revenue.~~could be significantly delayed or otherwise adversely affected.

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Even if we obtain approval for a product candidate in one country or jurisdiction, we may never obtain approval for or commercialize it in any other jurisdiction which would limit our ability to realize our product candidates’ full market potential.

To market any products in any particular jurisdiction, we must establish and comply with numerous and varying regulatory requirements on a country-by-country basis regarding safety and efficacy. Approval for a product candidate by the FDA in the U.S. does not ensure approval by regulatory authorities in any other country or jurisdiction. In addition, clinical studies conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory approval in one country does not guarantee regulatory approval in any other country. Approval processes vary among countries and can involve additional product testing and validation and additional administrative review periods. Seeking regulatory approval could result in difficulties and costs for us and require additional nonclinical studies or clinical studies which could be costly and time consuming. Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of our products in those countries. ~~We do not have any product candidates approved for~~ ~~sale in any jurisdiction, including in international markets, and we do not have experience in obtaining regulatory approval.~~ We are reliant, in part, upon the regulatory expertise of Richter to gain approval for ~~relugolix combination tablet~~certain drug products in the licensed territories and are completely reliant on Richter to generate net product revenue in the territories licensed ~~territories.~~to Richter. For example, in July 2021 and August 2021, the European Commission and the Medicines and Healthcare products Regulatory Agency, respectively, approved RYEQO for moderate to severe symptoms of uterine fibroids in adult women of reproductive age for use in the European Union and the United Kingdom, respectively. We will rely on Richter to successfully commercialize it in Europe. If we or Richter fail to comply with regulatory requirements in international markets or to obtain and maintain required approvals, or if regulatory approvals in international markets are delayed, our target market will be reduced and our ability to realize the full market potential of any product we develop will be unrealized.

Relugolix combination therapy, relugolix monotherapy and MVT-602 may cause adverse effects or have other properties that could delay or prevent their regulatory approval or limit the scope of any approved label or market acceptance.

Adverse events associated with our product candidates could cause us, regulatory authorities, other reviewing entities or clinical study sites to interrupt, delay, request modification of, or halt clinical studies and could result in the denial of regulatory approval.

Adverse events associated with our product candidates, includingrelugolix combination therapy ~~relugolix monotherapy,~~for endometriosis or MVT-602 could cause us, regulatory authorities, other reviewing entities or clinical study sites ~~or regulatory authorities~~ to interrupt, delay, request modification of, or halt clinical studies and could result in the denial of regulatory approval. If an unacceptable frequency or severity of adverse events are reported in our clinical studies for ~~relugolix combination therapy, relugolix monotherapy or MVT-602 or any future~~our product candidates, our ability to obtain regulatory approval or a desirable label for such product candidates may be negatively impacted. Treatment-related side effects could also affect patient recruitment or the ability of enrolled patients to complete the study or result in potential product liability claims. In addition, these side effects may not be appropriately recognized or managed by the treating medical staff. Any of these occurrences may harm our business, financial condition and prospects.

~~In addition,~~We are required to monitor the safety and efficacy of ORGOVYX, MYFEMBREE and RYEQO and any other products candidates that are approved by the FDA ~~has raised concern about a potential increase in the risk of diabetes~~or other regulatory authorities. We are subject to ongoing regulatory requirements to submit safety and ~~certain cardiovascular diseases in men with prostate cancer treated with GnRH receptor agonists. Further, if~~other post-marketing information and reports, including adverse event reporting. Post-marketing adverse events related to ~~Relumina~~® ~~are reported, it~~ORGOVYX and MYFEMBREE could negatively impact our commercialization plans for these products and could negatively impact the clinical development ~~plans for relugolix.~~

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our product candidates.

If any of our approved drug products cause, or any of our product candidates are approved and then cause, serious or unexpected side effects, a number of potentially significant negative consequences could result, including:

•regulatory authorities may withdraw their approval of the product or require a Risk Evaluation and Mitigation Strategy (a “REMS”) (or equivalent outside the U.S.) to impose restrictions on its distribution or other risk management measures;

•we may be required to recall a product;

•additional restrictions may be imposed on the marketing of the particular product or the manufacturing processes for the product or any component thereof;

•we may be required to conduct post-marketing studies or clinical studies;

•regulatory authorities may require the addition of labeling statements, such as warnings or contraindications or limit the duration of use;

•we may be required to change the way the product is administered or to conduct additional clinical studies;

•we may be required to repeat a nonclinical or clinical study or terminate a program, even if other studies or studies related to the program are ongoing or have been successfully completed;

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•we could be sued and held liable for harm caused to patients;

•we could elect to discontinue the sale of our product;

•the product may become less competitive; and

•our reputation may suffer.

Any of these events could prevent us from achieving or maintaining market acceptance of the affected product candidate and could substantially increase the costs of commercializing ~~relugolix combination tablet, relugolix monotherapy tablet~~ORGOVYX, MYFEMBREE, and any of our product candidates, if approved.

Even though we have obtained regulatory approval for ORGOVYX and MYFEMBREE in the U.S. and RYEQO in Europe, or ~~MVT-602.~~

~~Even~~even if we obtain regulatory approval for any of our product candidates, we face or will still face extensive regulatory requirements and our products may face future development risks and regulatory difficulties.

~~Any~~Our drug products and any product candidate for which we obtain marketing approval, along with the manufacturing processes, post-approval clinical data, labeling, packaging, distribution, adverse event reporting, storage, recordkeeping, export, import, advertising, and promotional activities for such product, among other things, are and will be subject to extensive and ongoing requirements of and review by the FDA and other regulatory authorities. These requirements include submissions of safety and other post-marketing information and reports, establishment of registration and drug listing requirements, continued compliance with cGMP requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of records and documents, requirements regarding the distribution of drug product samples to physicians, recordkeeping, and cGCP requirements for any clinical studies that we conduct post-approval.

Even if marketing approval of a product candidate is granted, the approval may be subject to limitations on the indicated uses for which the product may be marketed or to the conditions of approval or the FDA or other regulatory authorities may require that contraindications, warnings or precautions-including in some cases, a boxed warning, be included in the product labeling. Even if ~~relugolix combination tablet, relugolix monotherapy tablet or MVT-602~~any product candidate receives marketing approval, if the indication approved by regulatory authorities is narrower than we expect or the accompanying label limits the approved use of our product, our sales of products could be limited and we may not generate significant revenue from sales of our products.

Regulatory authorities closely regulate the post-approval marketing and promotion of drugs to ensure drugs are marketed only for the approved indications and in accordance with the provisions of the approved labeling. The FDA does not regulate the behavior of physicians in their choice of treatments and physicians may, in their independent medical judgment, prescribe legally available products for off-label uses. However, regulatory authorities, including the FDA, impose stringent restrictions on manufacturers’ communications regarding off-label use of their products, and if regulatory authorities believe that we are in violation of these restrictions, we may be subject to enforcement action for off-label marketing. Violations of the Federal Food, Drug, and Cosmetic Act in the U.S., and other comparable regulations in foreign jurisdictions, relating to the promotion of prescription drugs may lead to enforcement actions and investigations by the FDA, Department of Justice, State Attorney Generals, and other foreign regulatory agencies alleging violations of U.S. federal and state health care fraud and abuse laws, as well as state consumer protection laws and comparable laws in foreign jurisdictions.

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In addition, later discovery of previously unknown adverse events or other problems with our products, manufacturers or manufacturing processes, or failure to comply with regulatory requirements may yield various results, including those discussed in the Risk Factor titled, “Relugolix combination therapy, relugolix monotherapy and MVT-602 may cause adverse effects or have other properties that could delay or prevent their regulatory approval or limit the scope of any approved label or market acceptance.”

~~Even if one of~~“Adverse events associated with our product candidates ~~receives marketing approval, it may fail~~could cause us, regulatory authorities, other reviewing entities or clinical study sites to ~~achieve market acceptance by physicians, patients, third-party payors~~interrupt, delay, request modification of, or ~~others~~halt clinical studies and could result in the ~~medical community necessary for commercial success.~~

~~Even if one~~denial of our product candidates receives marketing approval, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors, and others in the medical community. If it does not achieve an adequate level of acceptance, we may not generate significant product revenue or become profitable. The degree of market acceptance of a product candidate, if approved for commercial sale, will depend on a number of factors, including but not limited to:

•~~the efficacy and potential advantages compared to alternative treatments, including the convenience and ease or duration of administration;~~

•~~the prevalence and severity of any side effects;~~

•~~the content of the approved product label and our ability to make compelling product claims;~~

•~~the effectiveness and adequacy of our marketing efforts, including direct-to-consumer advertising;~~

•~~the effectiveness of sales efforts;~~

•~~the patient out-of-pocket costs in relation to alternative treatments, including any similar generic treatments;~~

•~~our ability to offer our products for sale at competitive prices;~~

•~~the willingness of the potential patient population to try new therapies and of physicians to prescribe these therapies;~~

•~~the breadth and cost of distribution support;~~

•~~the availability of third-party payor coverage;~~

•~~whether diagnosis and treatment rates increase for the diseases our products treat; and~~

•~~any restrictions on the use of our product together with other medications.~~

Because we expect sales of relugolix combination tablet, relugolix monotherapy tablet and MVT-602, if approved, to generate substantially all of our product revenue for the foreseeable future, the failure of these product candidates to obtain market acceptance would harm our business and could require us to seek additional financing.

If we are unable to establish sales, market access, marketing, and distribution capabilities, either on our own or with third-party collaboration partners, we may not be successful in commercializing our product candidates, if approved.

~~To market any product that may be approved, we must develop our capabilities in sales, market access, marketing, distribution, and other commercial functions, either on our own or with third-~~party collaboration partners. We have made arrangements regarding some of these functions in certain markets with third-party collaboration partners. For example, on August 1,2020, we entered into a Market Access Services Agreement with Sunovion pursuant to which, among other things, Sunovion has agreed to provide to us certain market access services with respect to the distribution and sale of relugolix monotherapy for prostate cancer and relugolix combination tablet for uterine fibroids and endometriosis. As another example, on March 30, 2020, we entered into an exclusive license agreement with Richter pursuant to which, among other things, Richter will be responsible for all commercialization activities for relugolix combination tablet for uterine fibroids and endometriosis in certain territories outside of the U.S. If Richter or Sunovion, or any other collaboration partners we may engage in the future, fail to perform or satisfy its obligations under their respective agreements with us or terminate their relationship with us, the sales, market access, marketing and/or distribution of our product candidates would be delayed or may not occur. To the extent our financial returns depend on these collaboration partners’ performance and capabilities, our business and prospects could be materially and adversely affected if our collaboration partner performing such functions fails to perform. We may pursue collaborative arrangements regarding these functions in certain markets with other collaboration partners in the future. However, it might be difficult for us to find third parties in markets that are willing to enter into such transactions on acceptable economic terms, or at all.

In addition to the third-party collaboration arrangements described above, we continue to build sales, market access, marketing, distribution and other commercial activities on our own. We may not have the resources in the foreseeable future to build our own sales, market access, marketing and distribution capabilities in all of the markets that we desire. Even if we are able to

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~~build such functions, there are significant expenses and risks involved with establis~~hing such functions, including: (i) our inability to recruit, train, and retain adequate numbers of qualified and effective sales, market access and marketing personnel; (ii) our inability to attain access to adequate numbers of physicians to prescribe any drugs; (iii) the inability to negotiate with payors regarding reimbursement and formulary access for our products; and (iv) unforeseen costs and expenses associated with creating and sustaining internal sales, market access, marketing and distribution capabilities. The COVID-19 pandemic may negatively impact our ability to attract the human resources required to build out our own commercial capabilities and may negatively impact our ability to rapidly and effectively educate potential prescribers and, if significant delays result, to commercialize our product candidates.

If we are unable to establish or maintain adequate sales, market access, marketing and distribution capabilities, either on our own or in collaboration with third parties, our product launch will be delayed and we will not be successful in commercializing our product candidates and may not become profitable. We will be competing with companies that currently have extensive and well-funded marketing and sales operations. Without sufficient support from an internal team or from third-party collaboration partners to perform these functions, we may be unable to compete successfully against these more established companies.regulatory approval.”

Our current and future relationships with investigators, healthcare professionals, consultants, third-party ~~payors,~~payers, and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties.

Our business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party ~~payors,~~payers, patient support ~~channels,~~service providers, charitable organizations, and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations. These laws regulate the business or financial arrangements and relationships through which we conduct our operations, including how we research, market, sell, and distribute our products for which we obtain marketing approval. Such laws include, among others, the federal Anti-Kickback Statute, the federal false claims laws, HIPAA, the ~~federal Health Insurance Portability~~Patient Protection and ~~Accountability~~Affordable Care Act of ~~1996 (“HIPAA”),~~2010, as amended by the Health Care and Education Reconciliation Act of 2010, the federal Physician Payments Sunshine Act, and analogous state fraud and abuse, data privacy, and transparency laws.

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Efforts to ensure that our current and future business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations, agency guidance or case law involving applicable healthcare laws. If our operations are found to be in violation of any of these or any other health regulatory laws that may apply to us, we may be subject to significant penalties, including the imposition of significant civil, criminal, and administrative penalties, damages, monetary fines, disgorgement, imprisonment, possible exclusion from participation in Medicare Part D, Medicaid, and other federal healthcare programs or similar programs in other countries or jurisdictions, contractual damages, reputational harm, diminished profits and future earnings, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, and curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations. Even the mere issuance of a subpoena or the fact of an investigation alone, regardless of the merit, may result in negative publicity, a drop in our share price, and other harm to our business, financial condition, and results of operations. Defending against any such actions can be costly, ~~time-~~time consuming, and may require significant financial and personnel resources. Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired.

Changes in legislation may increase the difficulty and cost for us to obtain marketing approval for and commercialize ~~relugolix combination tablet, relugolix monotherapy tablet~~our drug products or ~~MVT-602~~product candidates and affect the prices we may obtain.

In the U.S. and some foreign jurisdictions, there have been, and we expect there will continue to be, a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could, among other things, prevent or delay marketing approval of ~~relugolix combination tablet, relugolix monotherapy tablet~~our drug products in other jurisdictions or ~~MVT-602,~~product candidates in the U.S. and other jurisdictions, restrict or regulate post-approval activities, and affect our ability to profitably sell any products for which we obtain marketing approval.

In addition, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products. Such scrutiny has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products. AtFor example, in July 2021, the ~~federal level,~~Biden administration released an executive order, “Promoting Competition in the ~~Trump administration’s budget proposal for fiscal year~~American Economy,” with multiple provisions aimed at prescription drugs. In response to Biden’s executive order, on September 9, 2021, includes a $135 billion allowance to support legislative proposals seeking to reduce drug prices, increase competition, lower out-of-pocket drug costs for patients, and increase patient access to lower-cost generic and biosimilar drugs. On March 10, 2020, the Trump administration sent “principles” for drug pricing to Congress, calling for legislation that would, among other things, cap Medicare Part D beneficiary out-of-pocket pharmacy expenses, provide an option to cap Medicare Part D beneficiary monthly out-of-pocket expenses, and place limits on pharmaceutical price increases. Additionally, President Trump previously released a “Blueprint”

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to lower drug prices and reduce out of pocket costs of drugs, that contained proposals to increase manufacturer competition, increase the negotiating power of certain federal healthcare programs, incentivize manufacturers to lower the list price of their products and reduce the out of pocket costs of drug products paid by consumers. The U.S. Department of Health and Human Services ~~has solicited feedback on some~~released a Comprehensive Plan for Addressing High Drug Prices that outlines principles for drug pricing reform and sets out a variety of potential legislative policies that Congress could pursue to advance these ~~measures and has implemented others under its existing authority. For example, in May 2019, CMS issued a final rule to allow Medicare Advantage plans~~principles. In addition, Congress is considering drug pricing as part of the option to use step therapy for Part B drugs beginning January 1, 2020. This final rule codified CMS’s policy change that was effective January 1, 2019. Although a number of these and other measures may require additional authorization to become effective, Congress and the Trump administration have each indicated that it will continue to seek new legislative and/or administrative measures to control drug costs.budget reconciliation process.

At the state level, individual states in the U.S. have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access, and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

Legislative and regulatory proposals have also been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products. We cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of our product candidates, if any, may be. In addition, increased scrutiny by the U.S. Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing testing and other requirements. It is also possible that additional governmental action is taken in response to ~~address~~ the COVID-19 pandemic.

~~Coverage and reimbursementmay not be available for our product candidates, which could make it difficult for us to sell them profitably, if approved.~~

Market acceptance and sales of any approved product that we develop will depend in part on the extent to which coverage for these products will be available from third-party payors, including government health administration authorities and private health insurers. In the U.S., no uniform policy of coverage for products exists among third-party payors. Third-party payors decide which drugs they will pay for, what steps prescribers must take to obtain authorization for patients to fill their prescriptions, and how much patients must pay out of their own pocket. Payor decisions regarding the extent of coverage to be provided for any product candidates that we develop through approval will be made on a plan-by-plan basis. One payor’s determination to provide coverage for a product does not assure that other payors will also provide coverage for the product. Additionally, a third-party payor’s decision to provide coverage for a drug does not imply that an affordable out-of-pocket cost for patients will be established. Each plan determines whether or not it will provide coverage for a drug, what amount it will pay the manufacturer for the drug, on what tier of its formulary the drug will be placed, and whether to require step therapy or prior authorizations. The position of a drug on a formulary generally determines the co-payment that a patient will need to make to obtain the drug and can strongly influence the adoption of a drug by patients and physicians. Patients who are prescribed treatments for their conditions and providers prescribing such services generally rely on third-party payors to reimburse all or part of the associated healthcare costs. Patients may not use our products unless coverage is provided and out-of-pocket costs for them are affordable. Manufacturers have the ability to lower costs for patients with commercial insurance through various patients’ saving offers such as co-pay cards or coupons. These types of consumer programs are not permissible for patients who participate in government health insurance programs such as Medicare or Medicaid.

Even if a payor places a product on its formulary, it may put in place procedures designed to control the utilization of our drugs, such as step-edits or prior-authorizations. Step edits require that a patient first try and fail to be adequately treated by one or more other prescription or over-the-counter medications. Prior authorizations require a physician to demonstrate with sufficient paperwork that a patient meets one or more criteria, such as having a formal diagnosis of the condition for which the drug is indicated, before the coverage for such drug can be provided. As a result, these additional requirements may deter physicians from prescribing our drugs.

The process for determining whether a third-party payor will provide coverage for a product may be separate from the process for setting the price that such a payor will pay for the product. Even if we do obtain adequate levels of formulary access, third-party payors, such as government or private healthcare insurers, carefully review and increasingly question the coverage of, and challenge the prices charged for, products. A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Increasingly, third-party payors are requiring that pharmaceutical companies provide them with predetermined discounts from list prices and are challenging the prices charged for products. We may also be required to conduct expensive pharmacoeconomic studies to justify the coverage and the amount of reimbursement for particular medications. We cannot be sure that coverage and affordable patient out-of-pocket costs will be available for any product that we commercialize. Inadequate coverage, patient affordability, and drug utilization controls may impact the demand for, or the price of, any product

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for which we obtain marketing approval. If coverage and adequate reimbursement are not available, or are available only to limited levels, we may not be able to successfully commercialize any product candidates that we develop.

Additionally, there have been a number of legislative and regulatory proposals to change the healthcare system in the U.S. and in some foreign jurisdictions that could affect our ability to sell any future drugs profitably. These legislative and regulatory changes may negatively impact the reimbursement for any future drugs, if approved.

Risks Related to Our Dependence on Third Parties

We are dependent upon our relationships with collaboration partners to further develop, fund, manufacture, and commercialize our drug products and our product candidates. If such relationships are unsuccessful, or if a collaboration partner terminates its collaboration agreement with us, it could negatively impact our ability to conduct our business and generate net product revenue. Failure by a collaboration partner to perform its duties under its collaboration agreement with us (e.g. financial reporting or internal control compliance) may negatively affect us.

On December 26, 2020, we entered into the Pfizer Collaboration and License Agreement, pursuant to which we and Pfizer will collaborate to jointly develop and commercialize relugolix in oncology and women’s health in the Co-Promotion Territory. In addition to the Pfizer Collaboration and License Agreement, we have entered into collaboration arrangements with other collaboration partners. On August 1, 2020, we entered into a Market Access Services Agreement, as amended, with Sunovion pursuant to which, among other things, Sunovion has agreed to provide to us certain market access services with respect to the

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distribution and sale of ORGOVYX for prostate cancer, MYFEMBREE for uterine fibroids, and MYFEMBREE for endometriosis, if approved, in the U.S. On March 30, 2020, we entered into the Richter Development and Commercialization Agreement pursuant to which, among other things, Richter will be responsible for all commercialization activities for RYEQO for the treatment of women with uterine fibroids and relugolix combination tablet for endometriosis (if approved) in certain territories outside of the U.S.

We are subject to a number of risks associated with our dependence on our relationships with our collaboration partners, including:

•our collaboration partners may terminate their collaboration agreements with us for reasons specified in the collaboration agreements, including our breach;

•the need for us to identify and secure on commercially reasonable terms the services of third parties to perform key activities, including development and commercialization activities, currently performed by our collaboration partners in the event that a collaboration partner was to terminate its collaboration with us;

•adverse decisions by a collaboration partner regarding the amount and timing of resource expenditures for the commercialization, distribution, and sale of our drug products;

•failure by a collaboration partner to perform its duties under its collaboration agreement with us (e.g., its failure to comply with regulatory requirements which may disrupt its performance of its obligations under the collaboration agreement with us);

•failure by a collaboration partner to timely deliver accurate and complete financial information to us or to maintain adequate and effective internal control over its financial reporting may negatively affect our ability to meet our financial reporting obligations as required by the SEC;

•decisions by a collaboration partner to prioritize other of its current or future products more highly than our drug products or our product candidates when it performs its duties;

•possible disagreements with a collaboration partner as to the timing, nature, and extent of our development plans or distribution and sales and marketing plans; and

•the financial returns to us, if any, under our collaboration agreements with Pfizer and Richter, depend in large part on the achievement of milestones and generation of product sales, and if Pfizer or Richter fail to perform or satisfy their obligations under the collaboration agreements, the development and commercialization of our drug products could be delayed, hindered or may not occur and our business and prospects could be materially and adversely affected.

Due to these factors and other possible disagreements with our collaboration partners, we may be delayed or prevented from further developing, manufacturing or commercializing our drug products or our product candidates or we may become involved in litigation or arbitration, which would be time-consuming and expensive.

If any collaboration partner were to terminate our collaborative relationship with it unilaterally, we would need to undertake development, commercialization or distribution or sale activities for our drug products and product candidates solely at our own expense, and/or seek one or more other partners for some or all of these activities in the U.S. or worldwide. If we pursued these activities on our own, it would significantly increase our capital and infrastructure requirements, might limit the indications we are able to pursue for our drug products and our product candidates, and could prevent us from effectively commercializing our drug products and our product candidates. If we sought to find one or more other pharmaceutical company partners for some or all of these activities, we may not be successful in such efforts, or they may result in collaborations that have us expending greater funds and efforts than our relationships with our current collaboration partners.

Regulatory requirements or manufacturing disruptions may make it difficult for us to be able to obtain materials or supplies necessary to conduct clinical studies or to manufacture and sell any of our product candidates, if approved.

To sustain our business, we need access to sufficient quantities of our product candidates to satisfy our clinical study needs and, if approved, to maintain sufficient commercial inventories of our products. If we are unable to purchase sufficient quantities of these materials or find suitable alternate materials in a timely manner, our development efforts for our product candidates may be delayed or our ability to manufacture commercial products would be limited.

Suppliers of key components and materials must be named in the NDA or marketing authorization application filed with the FDA, the EMA, or other regulatory authority for any product candidate for which we are seeking marketing approval, and significant delays can occur if those suppliers are not approved or the qualification of a new supplier is required. For example,

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the receipt by Takeda of the warning letter described in the ~~risk factor~~Risk Factor titled, “We do not have our own manufacturing capabilities and rely on third parties to produce clinical and commercial supplies of drug substance and drug product. If these third parties do not perform as we expect, do not maintain their regulatory approvals or become subject to other negative circumstances, it may result in a delay in our ability to develop and commercialize our ~~products”~~products,” has caused us to remove the Hikari Facility as a manufacturing site from our NDA submissions and to rely on our Commercial Manufacturing and Supply Agreement with Excella to a greater extent than we had intended, and may require us to remove the Hikari Facility from our regulatory filings until Takeda corrects the violations noted in the warning letter to the satisfaction of the regulatory authorities. We cannot predict if or when Takeda will correct the violations and deviations to t~~he satisfaction of the FDA or any other regulatory agency or whether the regulatory agencies will be satisfied with Takeda’s responses. The COVID-19 pandemic~~ ~~may also cause delays in the remediation and re-inspection process.~~originally planned. Even after a manufacturer is qualified by the regulatory authority, the manufacturer must continue to expend time, money, and effort in the area of production and quality control to ensure full compliance with cGMP. Manufacturers are subject to regular, periodic inspections by the regulatory authorities both prior to and following initial approval. If, as a result of these inspections, a regulatory authority determines that the equipment, facilities, laboratories or processes do not comply with applicable regulations and conditions of product approval, the regulatory authority may suspend the manufacturing operations, issue import restrictions or other cGMP or regulatory action that could affect our ability to obtain materials from such supplier. If the manufacturing operations of any single suppliers for any of our products are adversely affected or suspended, we may be unable to generate sufficient quantities of commercial or clinical supplies of product to meet demand, which could harm our business. In addition, if delivery of materials from our suppliers was interrupted for any reason, we may be unable to ship commercial products that may be approved for marketing or supply our products in development for clinical studies. In addition, some of our products and the materials that we utilize in our operations are made only at one facility, which we may not be able to replace in a timely manner and on commercially reasonable terms, or at all. Problems with any of the single suppliers we depend on, including in the event of a disaster, including an earthquake or a pandemic, equipment failure or other difficulty, may negatively impact our development and commercialization efforts. If we were to encounter any of these difficulties, our ability to provide our products, if approved, and product candidates to patients would be jeopardized.

We are reliant on third parties to conduct, manage, and monitor our clinical studies, and if those third parties perform in an unsatisfactory manner, it may harm our business.

We currently do not have the ability to independently conduct nonclinical studies that comply with Good Laboratory Practice (“GLP”) requirements. ~~We also do not currently have the ability to independently conduct any clinical studies.~~ We rely substantially on CROs and clinical study sites to ensure the proper and timely conduct of our clinical studies, and we have limited influence over their actual performance.

We rely upon CROs to monitor and manage data for our clinical programs, as well as for the execution of nonclinical studies. We control only certain aspects of our CROs’ activities. Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol, legal, regulatory, and scientific standards, and our reliance on the CROs does not relieve us of our regulatory responsibilities.

We and our CROs are required to comply with current GLP and GCP regulations and guidelines enforced by the FDA and are also required by the competent authorities of the member states of the European Economic Area and comparable foreign regulatory authorities to comply with the International Council for Harmonization guidelines for any of our product candidates

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that are in nonclinical and clinical development, respectively. The regulatory authorities enforce GCP regulations through periodic inspections of clinical study sponsors, ~~principal investigators,~~CROs, and clinical study sites. Although we rely on CROs to conduct our GLP-compliant nonclinical studies and GCP-compliant clinical studies, we remain responsible for ensuring that each of our ~~GLP~~ nonclinical studies and ~~GCP~~ clinical studies is conducted in accordance with its investigational plan and protocol and applicable laws and regulations, and our reliance on the CROs does not relieve us of our regulatory responsibilities. If we, or our CROs or clinical study sites fail to comply with current GCP requirements, the clinical data generated in our clinical studies may be deemed unreliable and the FDA or comparable foreign regulatory authorities may reject our marketing applications or require us to perform additional clinical studies before approving our marketing applications. Accordingly, if we or our CROs fail to comply with these regulations or other applicable laws, regulations or standards, or fail to recruit a sufficient number of subjects, we may be required to repeat clinical studies, which would delay the relevant regulatory approval process. Failure by our CROs to properly execute study protocols in accordance with applicable law could also create product liability and healthcare regulatory risks for us as the sponsor of those studies.

While we have agreements governing their activities, our CROs are not our employees, and we do not control whether or not they devote sufficient time and resources to our future clinical and nonclinical programs. These CROs may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical studies, or other drug development activities which could harm our competitive position. We face the risk of potential unauthorized disclosure or misappropriation of our intellectual property by CROs, which may reduce our trade secret and intellectual property protection and allow our potential competitors to access and exploit our proprietary technology. If our CROs do not successfully carry out their contractual duties or obligations, fail to meet expected deadlines or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our (or their own) clinical protocols or regulatory requirements or for any other reasons, our clinical studies may be extended, delayed or terminated, and we may not be able to obtain regulatory approval for, or successfully commercialize any product candidate that we develop. As a result, our financial

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results and the commercial prospects for any product candidate that we develop could be harmed, our costs could increase, and our ability to generate revenue could be delayed.

In addition, we and our CROs are subject to various data privacy laws in the U.S., Europe, and elsewhere that are often uncertain, contradictory, and evolving. It is possible that these data privacy laws may be interpreted and applied inconsistent with our or our CROs practices. If so, this could result in government-imposed fines or orders requiring that we or our CROs change our practices, which could adversely affect our business. Also, see the Risk Factor titled, “If we fail to comply with applicable U.S. and foreign privacy and data protection laws and regulations, we may be subject to liabilities that adversely affect our business, operations and financial performance.”

If our relationships with these CROs terminate, we may not be able to enter into arrangements with alternative CROs or do so on commercially reasonable terms or in a timely manner. Switching or adding additional CROs involves substantial cost and requires management time and focus. In addition, there is a natural transition period when a new CRO commences work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines. Though we carefully manage our relationships with our CROs, there can be no assurance that we will not encounter challenges or delays in the future or that these delays or challenges will not have an adverse impact on our business, financial condition, and prospects.

Risks Related to Our Intellectual Property

If we are unable to obtain and maintain patent protection for our technology and products, or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets.

We rely upon a combination of patents, trademarks, trade secret protection, and confidentiality agreements to protect the intellectual property related to our drug development programs and product candidates. Our success depends in large part on our ability to obtain and maintain patent protection in the U.S. and other countries with respect to relugolix, MVT-602, and any future product candidates. We seek to protect our proprietary position by filing patent applications in the U.S. and abroad related to our development programs and product candidates. The patent prosecution process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner.

The ~~patents and~~ patent applications that we own or have in-licensed may fail to result in issued patents with claims that protect relugolix, MVT-602 or any future product candidate in the U.S. or in other foreign countries. There is no assurance that all of the potentially relevant prior art relating to our patents and patent applications has been found, which can prevent a patent from issuing from a pending patent application or be used to invalidate a patent. Even if patents do successfully issue and even if such patents cover relugolix, MVT-602 or any future product candidate, third parties may challenge their validity, enforceability or scope, which may result in such patents being narrowed, invalidated or held unenforceable. Any successful opposition to these patents or any other patents owned by or licensed to us could deprive us of rights necessary for the

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successful commercialization of any product candidates or companion diagnostic that we may develop. Further, if we encounter delays in regulatory approvals, the period of time during which we could market a product candidate under patent protection could be reduced.

If the patent applications we hold or have in-licensed with respect to our development programs and product candidates fail to issue, if their breadth or strength of protection is threatened, or if they fail to provide meaningful exclusivity for relugolix, MVT-602 or any future product candidate, it could dissuade companies from collaborating with us to develop product candidates, and threaten our ability to commercialize future drugs. Any such outcome could have a materially adverse effect on our business.

The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions, and has been and will continue to be the subject of litigation and new legislation. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the U.S. For example, many countries restrict the patentability of methods of treatment of the human body. Publications of discoveries in scientific literature often lag behind the actual discoveries, and patent applications in the U.S. and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, we cannot know with certainty whether we were the first to make the inventions claimed in our owned or licensed patents or pending patent applications, or that we were the first to file for patent protection of such inventions.

As a result of these and other factors, the issuance, scope, validity, enforceability, and commercial value of our patent rights are highly uncertain. Our pending and future patent applications may not result in patents being issued which protect our technology or products, in whole or in part, or which effectively prevent others from commercializing competitive technologies and products. Changes in either the patent laws or interpretation of the patent laws in the U.S. and other countries may diminish the value of our patents or narrow the scope of our patent protection.

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Moreover, we may be subject to a third-party pre-issuance submission of prior art to the U.S. Patent and Trademark Office (the “USPTO”) or become involved in opposition, derivation, reexamination, inter partes review, post-grant review or interference proceedings challenging our patent rights or the patent rights of others. The costs of defending our patents or enforcing our proprietary rights in post-issuance administrative proceedings and litigation can be substantial and the outcome can be uncertain. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our technology or products and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing ~~third party~~third-party patent rights. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.

The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our owned and licensed patents may be challenged in the courts or patent offices in the U.S. and abroad. Such challenges may result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology and products. Generally, issued patents are granted a term of 20 years from the earliest claimed non-provisional filing date. In certain instances, patent term can be adjusted to recapture a portion of delay by the USPTO in examining the patent application (patent term adjustment) or extended to account for term effectively lost as a result of the FDA regulatory review period (patent term extension), or both. The scope of patent protection may also be limited. Without patent protection for our current or future product candidates, we may be open to competition from generic versions of such products. Given the amount of time required for the development, testing, and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

If we fail to comply with our obligations under any license, collaboration or other agreements, we may be required to pay damages and could lose intellectual property rights that are necessary for developing and protecting our product candidates.

We have licensed certain intellectual property rights covering our current product candidates from Takeda. If, for any reason, the Takeda License Agreement is terminated or we otherwise lose those rights, it could adversely affect our business. The Takeda License Agreement imposes, and any future collaboration agreements or license agreements we enter into are likely to impose various development, commercialization, funding, milestone, royalty, diligence, sublicensing, insurance, patent prosecution and enforcement or other obligations on us. If we breach any material obligations, or use the intellectual property licensed to us in an unauthorized manner, we may be required to pay damages and the licensor may have the right to terminate the license, which could result in us being unable to develop, manufacture, and sell products that are covered by the licensed technology or enable a competitor to gain access to the licensed technology.

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Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.

Periodic maintenance fees on any issued patent are due to be paid to the USPTO and other foreign patent agencies in several stages over the lifetime of the patent. The USPTO and various foreign national or international patent agencies require compliance with a number of procedural, documentary, fee payment, and other similar provisions during the patent application process. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Noncompliance events that could result in abandonment or lapse of patent rights include, but are not limited to, failure to timely file national and regional stage patent applications based on our international patent application, failure to respond to official actions within prescribed time limits, non-payment of fees, and failure to properly legalize and submit formal documents. If we or our licensors fail to maintain the patents and patent applications covering relugolix, MVT-602 or any future product candidate, our competitors might be able to enter the market, which would have an adverse effect on our business.

~~Third party~~Third-party claims or litigation alleging infringement of patents or other proprietary rights, or seeking to invalidate our patents or other proprietary rights, may delay or prevent the development of our product candidates and commercialization of ~~relugolix combination therapy, relugolix monotherapy, MVT-602,~~our drug products and any future product candidate.

Our commercial success depends in part on our avoiding infringement and other violations of the patents and proprietary rights of third parties. There is a substantial amount of litigation, both within and outside the U.S., involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, including patent infringement lawsuits, interferences, derivation, and administrative law proceedings, inter partes review, and post-grant review before the USPTO, as

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well as oppositions and similar processes in foreign jurisdictions. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we and our collaborators are developing product candidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, and as we gain greater visibility and market exposure as a public company, the risk increases that our product candidates or other business activities may be subject to claims of infringement of the patent and other proprietary rights of third parties. Third parties may assert that we are infringing their patents or employing their proprietary technology without authorization.

Also, there may be third-party patents or patent applications with claims to materials, formulations, methods of manufacture or methods for treatment related to the use or manufacture of our product candidates. Because patent applications can take many years to issue, there may be currently pending patent applications which may later result in issued patents that our product candidates may infringe.

In addition, third parties may obtain patent rights in the future and claim that use of our technologies infringes upon rights. If any third-party patents were held by a court of competent jurisdiction to cover the manufacturing process of any of our product candidates, any molecules formed during the manufacturing process or any final product itself, the holders of any such patents may be able to block our ability to commercialize such product candidate unless we obtained a license under the applicable patents, or until such patents expire. Similarly, if any third-party patent were held by a court of competent jurisdiction to cover aspects of our formulations, processes for manufacture or methods of use, including combination therapy, the holders of any such patent may be able to block our ability to develop and commercialize the applicable product candidate unless we obtained a license or until such patent expires. In either case, such a license may not be available on commercially reasonable terms or at all. In addition, we may be subject to claims that we are infringing other intellectual property rights, such as trademarks or copyrights, or misappropriating the trade secrets of others, and to the extent that our employees, consultants or contractors use intellectual property or proprietary information owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions.

Parties making claims against us may obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize one or more of our product candidates. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business. In the event of a successful infringement or other intellectual property claim against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, pay royalties or redesign our affected products, which may be impossible or require substantial time and monetary expenditure. We cannot predict whether any such license would be available at all or whether it would be available on commercially reasonable terms. Furthermore, even in the absence of litigation, we may need to obtain licenses from third parties to advance our research or allow commercialization of our product candidates, and we have done so from time to time. We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all. In that event, we would be unable to further develop and commercialize one or more of our product candidates, which could harm our business significantly. We cannot provide any

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assurances that third-party patents do not exist which might be enforced against our drugs or product candidates, resulting in either an injunction prohibiting our sales, or, with respect to our sales, an obligation on our part to pay royalties or other forms of compensation to third parties.

We may become involved in lawsuits to protect or enforce our patents, the patents of our licensors or our other intellectual property rights, which could be expensive, ~~time consuming,~~time-consuming, and unsuccessful.

Competitors may infringe or otherwise violate our patents, the patents of our licensors or our other intellectual property rights. To counter infringement or unauthorized use, we may be required to file legal claims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that a patent of ours or our licensors is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation or defense proceedings could put one or more of our patents at risk of being invalidated or interpreted narrowly and could put our patent applications at risk of not issuing. The initiation of a claim against a third party may also cause the third party to bring counter claims against us such as claims asserting that our patents are invalid or unenforceable. In patent litigation in the U.S., defendant counterclaims alleging invalidity or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, non-enablement or lack of statutory subject matter. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant material information from the USPTO, or made a materially misleading statement, during prosecution.

Third parties may also raise similar validity claims before the USPTO in post-grant proceedings, such as ex parte reexaminations, inter partes review, or post-grant review, or oppositions or similar proceedings outside the U.S., in parallel with litigation or even outside the context of litigation. The outcome following legal assertions of invalidity and unenforceability is unpredictable. We cannot be certain that there is no invalidating prior art, of which we and the patent examiner were unaware

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during prosecution. For the patents and patent applications that we have licensed, we may have limited or no right to participate in the defense of any licensed patents against challenge by a third party. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of any future patent protection on our current or future product candidates. Such a loss of patent protection could harm our business.

We may not be able to prevent, alone or with our licensors, misappropriation of our intellectual property rights, particularly in countries where the laws may not protect those rights as fully as in the U.S. Our business could be harmed if in litigation the prevailing party does not offer us a license on commercially reasonable terms. Any litigation or other proceedings to enforce our intellectual property rights may fail, and even if successful, may result in substantial costs and distract our management and other employees.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have an adverse effect on the price of our common shares.

Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.

The U.S. has enacted and implemented wide-ranging patent reform legislation. The U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on actions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce patents that we have licensed or that we might obtain in the future. Similarly, changes in patent law and regulations in other countries or jurisdictions, or changes in the governmental bodies that enforce them or changes in how the relevant governmental authority enforces patent laws or regulations may weaken our ability to obtain new patents or to enforce patents that we have licensed or that we may obtain in the future.

We may not be able to protect our intellectual property rights throughout the world, which could impair our business.

Filing, prosecuting, and defending patents covering relugolix, MVT-602, and any future product candidate throughout the world would be prohibitively expensive. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we may obtain patent protection, but where patent enforcement is not as strong as that in the U.S. These products may compete

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with our products in jurisdictions where we do not have any issued or licensed patents and any future patent claims or other intellectual property rights may not be effective or sufficient to prevent them from so competing.

Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.

Because we expect to rely on third parties to manufacture ~~relugolix combination therapy, relugolix monotherapy, MVT-602,~~our drug products and other clinical study materials, and any future product candidates, and we expect to collaborate with third parties on the development of relugolix, MVT-602, and any future product candidates, we must, at times, share trade secrets with them. We also conduct joint ~~R&D~~research and development programs that may require us to share trade secrets under the terms of our ~~R&D~~ partnerships, market access, distribution or similar agreements. We seek to protect our proprietary technology in part by entering into confidentiality agreements and, if applicable, material transfer agreements, consulting agreements or other similar agreements with our advisors, employees, third-party contractors, and consultants prior to beginning research or disclosing proprietary information. These agreements typically limit the rights of the third parties to use or disclose our confidential information, including our trade secrets. Despite the contractual provisions employed when working with third parties, the need to share trade secrets and other confidential information increases the risk that such trade secrets become known by our competitors, are inadvertently incorporated into the technology of others or are disclosed or used in violation of these agreements. Given that our proprietary position is based, in part, on our know-how and trade secrets, a competitor’s discovery of our trade secrets or other unauthorized use or disclosure would impair our competitive position and may have an adverse effect on our business and results of operations.

In addition, these agreements typically restrict the ability of our advisors, employees, third-party contractors, and consultants to publish data potentially relating to our trade secrets, although our agreements may contain certain limited publication rights. Despite our efforts to protect our trade secrets, our competitors may discover our trade secrets, either through breach of our agreements with third parties, independent development or publication of information by any of our third-party collaborators. A competitor’s discovery of our trade secrets would impair our competitive position and have an adverse impact on our business.

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Risks Related to Our Being a Controlled Company

We have agreements with Sumitovant, our majority shareholder, and with Sumitovant’s parent, Sumitomo Dainippon Pharma, and their affiliates, including Sunovion, that may be perceived to create conflicts of interest which, if other investors perceive that Sumitovant or Sumitomo Dainippon Pharma will not act in the best interests of all of our shareholders, may affect the price of our common shares and have other effects on our company.

There are a number of relationships that may give rise to certain conflicts of interest between Sumitovant and Sumitomo Dainippon Pharma, and their affiliates, on the one hand, and the other investors of our common shares and us, on the other hand. We are party to a loan agreement with Sumitomo Dainippon Pharma that creates restrictions, including limiting or restricting our ability to take specific actions, such as raising additional capital, incurring additional debt, making capital expenditures, or declaring dividends. We are also a party to the 2020 Commitment Letter with Sumitomo Dainippon Pharma pursuant to which, subject to the terms and conditions set forth therein, Sumitomo Dainippon Pharma has agreed to negotiate with us $200.0 million in unsecured revolving commitments to us. In addition, we are party to an Investor Rights Agreement with Sumitovant and Sumitomo Dainippon Pharma that, although designed in part to provide protections for our minority shareholders, also provides rights to Sumitovant and Sumitomo Dainippon Pharma, such as the ability of Sumitomo Dainippon Pharma to appoint directors on our board, to maintain their share ownership percentage in our company, and provide Sumitomo Dainippon Pharma with certain information and give them access to certain of our records. ~~We also entered into~~Further, we are a ~~consulting agreement~~party to a Market Access Services Agreement with ~~Sumitovant~~Sunovion, a subsidiary of Sumitomo Dainippon Pharma, pursuant to which ~~Sumitovant~~Sunovion provides ~~consulting~~certain market access services with respect to ~~us to support us~~the distribution and sale of ORGOVYX and MYFEMBREE in commercial planning, commercial launch activities and implementation, pursuant to which Adele Gulfo, Sumitovant’s Chief Business and Commercial Development Officer and a member of our board of directors, provides services to us on behalf of Sumitovant.the U.S. We may enter into additional agreements with Sumitovant or Sumitomo Dainippon Pharma or their affiliates in the future. Sumitovant and Sumitomo Dainippon Pharma and its affiliates may have interests which differ from our interests or those of the minority holders of our common shares. Any material transaction between us and Sumitomo Dainippon Pharma and its affiliates is subject to our related party transaction policy and the Investor Rights Agreement, which requires prior approval of such transaction by our Audit Committee ~~comprised~~composed of three independent directors. To the extent we fail to appropriately deal with any such conflicts of interests, it could negatively impact our reputation and ability to raise additional funds and the willingness of counterparties to conduct business with us, all of which could have an adverse effect on our business, financial condition, results of operations, and cash flows, and on the market price of our common shares. Further, our agreements with Sumitovant, ~~and~~ Sumitomo Dainippon Pharma and Sunovion may result in unanticipated risks or other unintended consequences on our business and on investor perception that could have a significant impact on the market price of our common shares. Further, we are a party to a Market Access Services Agreement with Sunovion, a subsidiary of Sumitomo Dainippon Pharma, pursuant to which Sunovion provides certain market access services with respect to the distribution and sale of our product candidates.

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We are a “controlled company” within the meaning of the applicable rules of the NYSE and, as a result, qualify for exemptions from certain corporate governance requirements. If we rely on these exemptions, our shareholders will not have the same protections afforded to shareholders of companies that are subject to such requirements.

We are currently a “controlled company” within the meaning of the NYSE corporate governance requirements. Under these rules, a “controlled company” may elect not to comply with certain corporate governance requirements. We have elected to use certain of these exemptions and we may continue to use all or some of these exemptions in the future. As a result, you may not have the same protections afforded to shareholders of companies that are subject to all of the NYSE corporate governance requirements.

Risks Related to Us and Our Shareholders Related to Our Being a Foreign Corporation

We are an exempted company limited by shares incorporated under the laws of Bermuda and it may be difficult for our shareholders to enforce judgments against us or our directors and executive officers.

We are an exempted company limited by shares incorporated under the laws of Bermuda. As a result, the rights of our shareholders are governed by Bermuda law and our memorandum of association and bye-laws. The rights of shareholders under Bermuda law may differ from the rights of shareholders of companies incorporated in another jurisdiction. It may be difficult for investors to enforce in the U.S. judgments obtained in U.S. courts against us based on the civil liability provisions of the U.S. securities laws. It is doubtful whether courts in Bermuda will enforce judgments obtained in other jurisdictions, including the U.S., against us or our directors or officers under the securities laws of those jurisdictions or entertain actions in Bermuda against us or our directors or officers under the securities laws of other jurisdictions.

Bermuda law differs from the laws in effect in the U.S. and may afford less protection to our shareholders.

We are incorporated under the laws of Bermuda. As a result, our corporate affairs are governed by the Bermuda Companies Act 1981, as amended, (the “Companies Act”) which differs in some material respects from laws typically applicable to U.S. corporations and shareholders, including the provisions relating to interested directors, amalgamations, mergers and acquisitions, takeovers, shareholder lawsuits, and indemnification of directors. Generally, the duties of directors and officers of a Bermuda company are owed to the company only. Shareholders of Bermuda companies typically do not have rights to take action against directors or officers of the company and may only do so in limited circumstances. Shareholder class actions are not available under Bermuda law. The circumstances in which shareholder derivative actions may be available under Bermuda

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law are substantially more proscribed and less clear than they would be to shareholders of U.S. corporations. The Bermuda courts, however, would ordinarily be expected to permit a shareholder to commence an action in the name of a company to remedy a wrong to the company in which the act complained of is alleged to be beyond the corporate power of the company or illegal, or would result in the violation of the company’s memorandum of association or bye-laws. Furthermore, consideration would be given by a Bermuda court to acts that are alleged to constitute a fraud against the minority shareholders or, for instance, in which an act requires the approval of a greater percentage of the company’s shareholders than those who actually approved it.

When the affairs of a company are being conducted in a manner that is oppressive or prejudicial to the interests of some shareholders, one or more shareholders may apply to the Supreme Court of Bermuda, which may make such order as it sees fit, including an order regulating the conduct of the company’s affairs in the future or ordering the purchase of the shares of any shareholders by other shareholders or by the company. Additionally, under our bye-laws and as permitted by Bermuda law, each shareholder has waived any claim or right of action against our directors or officers for any action taken by directors or officers in the performance of their duties, except for actions involving fraud or dishonesty. In addition, the rights of our shareholders and the fiduciary responsibilities of our directors under Bermuda law are not as clearly established as under statutes or judicial precedent in existence in jurisdictions in the U.S., particularly the State of Delaware. Therefore, our shareholders may have more difficulty protecting their interests than would shareholders of a corporation incorporated in a jurisdiction within the U.S.

There are regulatory limitations on the ownership and transfer of our common shares.

Common shares may be offered or sold in Bermuda only in compliance with the provisions of the Companies Act and the Bermuda Investment Business Act 2003, which regulates the sale of securities in Bermuda. In addition, the Bermuda Monetary Authority must approve all issues and transfers of shares of a Bermuda exempted company. However, the Bermuda Monetary Authority has, pursuant to its statement of June 1, 2005, given its general permission under the Exchange Control Act 1972 and related regulations for the issue and free transfer of our common shares to and among persons who are non-residents of Bermuda for exchange control purposes as long as the shares are listed on an appointed stock exchange, which includes the NYSE. Additionally, we have sought and have obtained a specific permission from the Bermuda Monetary Authority for the issue and transfer of our common shares up to the amount of our authorized capital from time to time, and options, warrants,

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depository receipts, rights, loan notes, debt instruments, and our other securities to persons resident and non-resident for exchange control purposes ~~with~~without the need for prior approval of such issue or transfer. The general permission or the specific permission would cease to apply if we were to cease to be listed on the NYSE or another appointed stock exchange.

Legislation enacted in Bermuda as to economic substance may affect our operations.

Pursuant to the Economic Substance Act 2018 of Bermuda, as amended (the “Economic Substance Act”) that came into force on January 1, 2019, a registered entity other than an entity which is resident for tax purposes in certain jurisdictions outside Bermuda (a “non-resident entity”) that carries on as a business any one or more of the “relevant activities” referred to in the Economic Substance Act must comply with economic substance requirements. The Economic Substance Act may require in-scope Bermuda entities which are engaged in such “relevant activities” to be directed and managed in Bermuda, have an adequate level of qualified employees in Bermuda, incur an adequate level of annual expenditure in Bermuda, maintain physical offices and premises in Bermuda or perform core income-generating activities in Bermuda. The list of “relevant activities” includes carrying on any one or more of: banking, insurance, fund management, financing, leasing, headquarters, shipping, distribution and service centre, intellectual property and holding entities.

Based on the Economic Substance Act currently, for so long as we are a non-resident entity, we are not required to satisfy any such economic substance requirements other than providing the Bermuda Registrar of Companies annually information on the jurisdiction in which it claims to be resident for tax purposes together with sufficient evidence to support that tax residence. We currently do not anticipate material impact on our business or operations from the Economic Substance Act. However, since such legislation is new and remains subject to further clarification and interpretation, it is not currently possible to ascertain the precise impact of the Economic Substance Act on us. If we ceased to be a non-resident entity, we may be unable to comply with the Economic Substance Act or may have to restructure our business to comply with the Economic Substance Act, either of which may have a material adverse effect on our business.

We may become subject to unanticipated tax liabilities and higher effective tax rates.

We are incorporated under the laws of Bermuda, where we are not subject to any income or withholding taxes. We are centrally managed and controlled in the U.K., and under current U.K. tax law, a company which is centrally managed and controlled in the U.K. is regarded as resident in the U.K. for taxation purposes. Accordingly, we expect to be subject to U.K. taxation on our income and gains, and subject to U.K.’s controlled foreign company rules, except when an exemption applies. We may be treated as a dual resident company for U.K. tax purposes. As a result, our right to claim certain reliefs from U.K. tax may be

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restricted, and changes in law or practice in the U.K. could result in the imposition of further restrictions on our right to claim U.K. tax reliefs. We may also become subject to income, withholding or other taxes in certain jurisdictions by reason of our activities and operations, and it is also possible that taxing authorities in any such jurisdictions could assert that we are subject to greater taxation than we currently anticipate. Any such additional tax liability could adversely affect our results of operations.

The intended tax effects of our corporate structure and intercompany arrangements depend on the application of the tax laws of various jurisdictions and on how we operate our business.

We are incorporated under the laws of Bermuda. We currently have subsidiaries in the U.K., Switzerland, Ireland, and the U.S. If we succeed in growing our business, we expect to conduct increased operations through our subsidiaries in various countries and tax jurisdictions, in part through intercompany service agreements between our subsidiaries and us. In that case, our corporate structure and intercompany transactions, including the manner in which we develop and use our intellectual property, will be organized so that we can achieve our business objectives in a tax-efficient manner and in compliance with applicable transfer pricing rules and regulations. If two or more affiliated companies are located in different countries or tax jurisdictions, the tax laws and regulations of each country generally will require that transfer prices be the same as those between unrelated companies dealing at arm’s length and that appropriate documentation be maintained to support the transfer prices. While we believe that we operate in compliance with applicable transfer pricing laws and intend to continue to do so, our transfer pricing procedures are not binding on applicable tax authorities.

Significant judgment is required in evaluating our tax positions and determining our provision for income taxes. During the ordinary course of business, there are many transactions and calculations for which the ultimate tax determination is uncertain. For example, our effective tax rates could be adversely affected by changes in foreign currency exchange rates or by changes in the relevant tax, accounting, and other laws, regulations, principles, and interpretations. In addition, our effective tax rate could be adversely affected if we do not obtain favorable tax rulings from certain taxing authorities. As we intend to operate in numerous countries and taxing jurisdictions, the application of tax laws can be subject to diverging and sometimes conflicting interpretations by tax authorities of these jurisdictions. It is not uncommon for taxing authorities in different countries to have conflicting views, for instance, with respect to, among other things, the manner in which the arm’s length standard is applied for transfer pricing purposes, or with respect to the valuation of intellectual property. If tax authorities in any of these countries were to successfully challenge our transfer prices as not reflecting arm’s length transactions, they could require us to adjust our

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transfer prices and thereby reallocate our income to reflect these revised transfer prices, which could result in a higher tax liability to us. In addition, if the country from which the income is reallocated does not agree with the reallocation, both countries could tax the same income, potentially resulting in double taxation. If tax authorities were to allocate income to a higher tax jurisdiction, subject our income to double taxation or assess interest and penalties, it would increase our consolidated tax liability, which could adversely affect our financial condition, results of operations, and cash flows.

In addition, tax laws are dynamic and subject to change as new laws are passed and new interpretations of the law are issued or applied. We continue to assess the impact of such changes in tax laws on our business and may determine that changes to our structure, practice, tax positions or the manner in which we conduct our business are necessary in light of such changes and developments in the tax laws of other jurisdictions in which we operate. Such changes may nevertheless be ineffective in avoiding an increase in our consolidated tax liability, which could adversely affect our financial condition, results of operations and cash flows.

Changes in our effective tax rate may reduce our net income in future periods.

Our tax position could be adversely impacted by changes in tax rates, tax laws, tax practice, tax treaties or tax regulations or changes in the interpretation thereof by the tax authorities in Europe (including the U.K. and Switzerland), the U.S., Bermuda, and other jurisdictions, as well as being affected by certain changes resulting from the Organization for Economic Co-operation and Development and their action plan on Base Erosion and Profit ~~Shifting. Such changes may become more likely~~Shifting as a result of recent economic trends in the jurisdictions in which we operate, particularly if such trends continue. If such a situation was to arise, it could adversely impact our tax position and our effective tax rate.well as their other initiatives. Failure to manage the risks associated with such changes, or misinterpretation of the laws providing such changes, could result in costly audits, interest, penalties, and reputational damage, which could adversely affect our business, results of our operations, and our financial condition.

Our actual effective tax rate may vary from our expectation and that variance may be material. A number of factors may increase our future effective tax rates, including: (1) the jurisdictions in which profits are determined to be earned and taxed; (2) the resolution of issues arising from any future tax audits with various tax authorities; (3) changes in the valuation of our deferred tax assets and liabilities; (4) increases in expenses not deductible for tax purposes, including transaction costs and impairments of goodwill in connection with acquisitions; (5) changes in the taxation of share-based compensation; (6) changes in tax laws or the interpretation of such tax laws, and changes in U.S. generally accepted accounting principles; and (7) challenges to the transfer pricing policies related to our structure.

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U.S. holders that own 10 percent or more of the vote or value of our common shares may suffer adverse tax consequences because we and our non-U.S. subsidiaries are expected to be characterized as “controlled foreign corporations” (“CFCs”), under Section 957(a) of the U.S. Internal Revenue Code of 1986, as amended (the “Code”).

A non-U.S. corporation is considered a CFC if more than 50 percent of (1) the total combined voting power of all classes of stock of such corporation entitled to vote, or (2) the total value of the stock of such corporation, is owned, or is considered as owned by applying certain constructive ownership rules, by U.S. shareholders (U.S. persons who own stock representing 10% or more of the vote or value of all outstanding stock of such non-U.S. corporation) on any day during the taxable year of such non-U.S. corporation. Certain U.S. shareholders of a CFC generally are required to include currently in gross income such shareholders’ share of the CFC’s “Subpart F income”, a portion of the CFC’s earnings to the extent the CFC holds certain U.S. property, and a portion of the CFC’s “global intangible low-taxed income” (as defined under Section 951A of the Code). Such U.S. shareholders are subject to current U.S. federal income tax with respect to such items, even if the CFC has not made an actual distribution to such shareholders. “Subpart F income” includes, among other things, certain passive income (such as income from dividends, interests, royalties, rents and annuities or gain from the sale of property that produces such types of income) and certain sales and services income arising in connection with transactions between the CFC and a person related to the CFC. “Global intangible low-taxed income” may include most of the remainder of a CFC’s income over a deemed return on its tangible assets.

We believe that we and our non-U.S. subsidiaries will be classified as CFCs in the current taxable ~~year.~~year as a result of certain constructive ownership rules. For any U.S. holders who hold 10% or more of the vote or value of our common shares directly or indirectly, this may result in adverse U.S. federal income tax consequences, such as current U.S. taxation of Subpart F income and of any such shareholder’s share of our accumulated non-U.S. earnings and profits (regardless of whether we make any distributions), taxation of amounts treated as global intangible low-taxed income under Section 951A of the Code with respect to such shareholder, and being subject to certain reporting requirements with the U.S. Internal Revenue Service. Any such U.S. holder who is an individual generally would not be allowed certain tax deductions or foreign tax credits that would be allowed to a U.S. corporation. If you are a U.S. holder who holds 10% or more of the vote or value of our common shares, you should consult your own tax advisors regarding the U.S. tax consequences of acquiring, owning, or disposing our common shares.

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U.S. holders of our common shares may suffer adverse tax consequences if we are characterized as a passive foreign investment company.

Generally, if, for any taxable year, at least 75% of our gross income is passive income, or at least 50% of the value of our assets is attributable to assets that produce passive income or are held for the production of passive income, including cash, we would be characterized as a passive foreign investment company (“PFIC”) for U.S. federal income tax purposes. For purposes of these tests, passive income includes dividends, interest, and gains from the sale or exchange of investment property and rents and royalties other than rents and royalties which are received from unrelated parties in connection with the active conduct of a trade or business. Additionally, a look-through rule generally applies with respect to 25% or more owned subsidiaries. If we are characterized as a PFIC, U.S. holders of our common shares may suffer adverse tax consequences, including having gains realized on the sale of our common shares treated as ordinary income rather than capital gain, the loss of the preferential tax rate applicable to dividends received on our common shares by individuals who are U.S. holders, and having interest charges apply to distributions by us and the proceeds of sales of our common shares. In addition, special information reporting may be required.

Our status as a PFIC will depend on the nature and composition of our income and the nature, composition and value of our assets from time to time. The 50% passive asset test described above is generally based on the fair market value of each asset, with the value of goodwill and going concern value determined in large part by reference to the market value of our common shares, which may be volatile. With respect to the taxable year that ended on March 31, ~~2020,~~2021, we believe that we were not a ~~PFIC; however, with respect to the current taxable year and foreseeable~~PFIC. However, we cannot predict whether we will or will not be classified as a PFIC in future taxable years because the PFIC tests are based upon the value of our assets, including any goodwill and going concern value, and the nature and composition of our income and assets, which cannot be known at this ~~time, we cannot predict whether we will or will not be classified as a PFIC.~~time. Because the determination of whether we are a PFIC for any taxable year is a fact-intensive determination made annually ~~after~~after the end of each taxable year, and because certain aspects of the PFIC rules are uncertain, we cannot provide any assurances regarding our PFIC status for the current or future taxable years.

We have implemented structures and arrangements intended to mitigate the possibility that we will be classified as a PFIC. There can be no assurance that the IRS will not successfully challenge these structures and arrangements, which may result in an adverse impact on the determination of whether we are classified as a PFIC. In addition, recently proposed U.S. Treasury Regulations, which we are continuing to assess the impact of, may also adversely affect the treatment of these structures and arrangements with respect to our PFIC status.

General Risk Factors

Raising additional funds may cause dilution to existing shareholders and/or may restrict our ~~operations or require us to relinquish proprietary rights.~~operations.

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To the extent that we raise additional ~~capital~~funds by issuing equity or convertible debt securities, our existing shareholders’ ownership interest may experience substantial dilution, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of a common shareholder. Any agreements for future debt or preferred equity financings, if available, may involve covenants limiting or restricting our ability to take specific actions, such as raising additional capital, incurring additional debt, making capital expenditures, or declaring dividends.

In addition, if we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us or grant rights to develop and market product candidates that we would otherwise develop and market ourselves.

Our future success depends on our ability to attract and retain key personnel.

We expect to hire additional ~~employees and consultants.~~employees. The market for talent in our industry is very ~~competitive, especially in the San Francisco Bay Area where we have substantial operations.~~competitive. Many of the other pharmaceutical companies we compete against for qualified personnel ~~and consultants~~ have greater financial and other resources, more favorable risk profiles and a longer operating history in the biopharmaceutical industry than we do. They also may provide more diverse opportunities and better chances for career advancement. Some of these opportunities may be more appealing to high-quality candidates ~~and consultants~~ than what we have to offer. It is particularly difficult to recruit and hire new employees during the COVID-19 pandemic as conducting interviews remotely makes it more difficult to ensure we are recruiting and hiring high-quality employees, and the uncertainty created by the COVID-19 pandemic makes it less likely potential candidates will be willing to leave a stable job to explore a new opportunity.

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In addition, our industry has experienced a high rate of turnover of management personnel in recent years. We are highly dependent on the skills and leadership of our management team and key employees. Our senior management and key employees may terminate their positions with us at any time. If we lose one or more members of our senior management team or key employees or unable to attract and retain other personnel to accomplish our business objectives, our ability to successfully implement our business strategies could be seriously harmed.

We plan to expand our organization, and we may experience difficulties in managing this growth, which could disrupt our operations.

We expect to continue to expand our organization and hire additional employees. Our management is expected to have increasing responsibilities to identify, recruit, maintain, motivate, and integrate additional employees, consultants and contractors which may divert a disproportionate amount of its time and attention away from our day-to-day activities. The expected growth may also ~~require significant capital expenditures and~~ divert financial resources from other projects. If our management is unable to effectively manage our growth, our expenses may increase more than expected, our ability to generate or grow net product revenue could be adversely affected, and we may not be able to implement our business ~~strategy.~~strategies. As a result, our future financial performance and our ability to complete clinical development, obtain regulatory approval, and commercialize our product candidates or any potential future product candidate may be adversely affected.

Potential product liability lawsuits against us could cause us to incur substantial liabilities and could impact ongoing and planned clinical studies as well as limit commercialization of any products that we may develop.

The use of any of our product candidates in clinical studies and the sale of any products for which we obtain marketing approval exposes us to the risk of product liability claims. Product liability claims might be brought against us by regulatory or governmental agencies, consumers, healthcare providers, other pharmaceutical companies or others taking or otherwise coming into contact with our ~~products.~~products or product candidates. On occasion, large monetary judgments have been awarded in class action lawsuits in which drugs have had unanticipated adverse effects. If we cannot successfully defend against product liability claims, we could incur substantial ~~liability~~liabilities and costs. In addition, regardless of merit or eventual outcome, product liability claims may result in:

•inability to commercialize our products or any future products;

•impairment of our business reputation and significant negative media attention;

•withdrawal of participants from our clinical studies;

•significant costs to defend related litigation;

•distraction of management’s attention from our primary business;

•substantial monetary awards to patients or other claimants;

•~~inability to commercialize our products or any future product candidates;~~

•product recalls, withdrawals or labeling, marketing or promotional restrictions;

•decreased demand for our products or any future ~~product candidate,~~products, if approved for commercial sale; and

•loss of net product revenue.

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The product liability and clinical study insurance we currently carry, and any additional product liability and clinical study insurance coverage we acquire in the future, may not be sufficient to reimburse us for any expenses or losses we may suffer. Moreover, insurance coverage is becoming increasingly expensive and in the future, we may not be able to maintain insurance coverage at acommercially reasonable ~~cost~~terms or in ~~sufficient~~adequate amounts to protect us against losses due to liability. If we obtain marketing approval for any of our product candidates, we intend to acquire insurance coverage to include the sale of commercial products; however, we may be unable to obtain product liability insurance on commercially reasonable terms or in adequate amounts. A successful product liability claim or series of claims brought against us could cause our common share price to decline and, if judgments exceed our insurance coverage, could adversely affect our results of operations and business, including preventing or limiting the commercialization of any product candidates we develop.

Use of social media platforms presents risks of inappropriate or harmful disclosures which could harm our business.

We believe that our potential patient population is active on social media. Social media practices in the pharmaceutical and biotechnology industries are evolving, which creates uncertainty and risk of noncompliance with regulations applicable to our business. For example, patients may use social media platforms to comment on the effectiveness of, or adverse experiences with, a product or a product candidate, which could result in reporting obligations. In addition, there is a risk of inappropriate disclosure of sensitive information or negative or inaccurate posts or comments about us, our products, or our product candidates on any social ~~networking website.~~media platform. If any of these events were to occur or we otherwise fail to comply with applicable regulations, we could incur liability, face restrictive regulatory actions or incur other harm to our business.

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We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of their former employers or other third parties.

We employ individuals who were previously employed at other biotechnology or pharmaceutical companies. Although we seek to protect our ownership of intellectual property rights by ensuring that our agreements with our employees, collaborators, and other third parties with whom we do business include provisions requiring such parties to assign rights in inventions to us, we may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed confidential information of our employees’ former employers or other third parties. We may also be subject to claims that former employers or other third parties have an ownership interest in our patents. Litigation may be necessary to defend against these claims. There is no guarantee of success in defending these claims, and if we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Even if we are successful, litigation could result in substantial cost and be a distraction to our management and other employees.

Our operating results may fluctuate significantly and our future operating results could fall below expectations. The market price of our common shares has been and is likely to continue to be highly volatile, and you may lose some or all of your investment.

The market price of our common shares has been and is likely to continue to be highly volatile and may be subject to significant fluctuations in response to a variety of factors. Our quarterly and annual operating results may fluctuate significantly in the future. Any future net product revenue will depend on the successful commercialization and sales of our drug products and product candidates that receive marketing approval. Any future regulatory milestones, sales milestones and royalty payments we are eligible to earn from Pfizer under terms of the Pfizer Collaboration and License Agreement and from Richter under the terms of the Richter Development and Commercialization Agreement, or any potential future collaboration and license agreements, if any, will depend on the achievement of the underlying milestone event or level of sales activity. Furthermore, our operating results may fluctuate due to a variety of other factors, ~~including, but not limited~~many of which are outside of our control and may be difficult to predict, including:

•the ~~following:~~price, level of demand, and net revenues for our products, which may vary significantly as they are launched and compete for position in the marketplace;

•the extent to which coverage and adequate reimbursement is available from government and private payers such as Medicare Part D, Medicaid, pharmacy benefit managers, health plans, self-insured organizations, insurance companies and other plan administrators with respect to our drug products and product candidates, if approved, and the competitive response from existing and potential future therapeutic approaches that compete with our approved products and our product candidates;

•inability to obtain additional funding, or investor perception that we may be unable to obtain additional funding, if needed, or funding on desirable terms ~~such as a failure to successfully negotiate an agreement to effect the new debt facility transaction with Sumitomo Dainippon Pharma based on the terms described in the 2020 Commitment Letter with Sumitomo Dainippon Pharma;~~;

•any delay in the commencement, enrollment, and ultimate completion of our clinical studies;

•actual or anticipated results of clinical studies of any of our product candidates or those of our competitors;

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•any delay in submitting an NDA or similar application for any of our product candidates and any adverse development or perceived adverse development with respect to the FDA or other regulatory authority’s review of that NDA or similar application, as the case may be;

•failure to successfully develop and commercialize any of our current or future product candidates;

•regulatory or legal developments in the U.S. or other countries or jurisdictions applicable to any of our products or current or future product candidates;

•adverse regulatory decisions or findings;

•changes in the structure of healthcare payment systems;

•inability to obtain adequate product supply for any of our products or current or future product candidates, or the inability to do so at acceptable prices;

•inability to ~~hire~~maintain a qualified sales ~~force in a timely fashion;~~force;

•inability to establish and maintain commercial capabilities and expertise including product marketing, sales, trade and distribution, pricing, market access, data analytics and insights, and other commercial operations functions;

•adverse developments or perceived adverse developments with respect to ~~our third-party~~ vendors on which we rely, including CMOs, CROs and ~~CROs;~~third-party logistics providers;

•introduction of new products, services or technologies by our competitors;

•failure to meet or exceed financial projections we may provide to the public;

•failure to maintain effective internal control over financial reporting;

•failure to meet or exceed the estimates and projections of the investor community;

•changes in the market valuations of similar companies;

•market conditions in the pharmaceutical and biotechnology sectors, and the issuance of new or changed securities analysts’ reports or ~~recommendations;~~recommendations on us or our competitors;

•announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;

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•adverse developments or perceived adverse developments with respect to our manufacturing, collaboration and alliance partners and affiliates, including Takeda, Excella, Sumitovant, Sumitomo Dainippon Pharma, Sunovion, Pfizer, and/or Richter;

•variations in our financial results or the financial results of companies that are perceived to be similar to us;

•changes in estimates of financial results or investment recommendations by securities analysts;

•significant lawsuits, including patent or shareholder litigation, and disputes or other developments relating to our proprietary rights, including patents, litigation matters, and our ability to obtain patent protection for our technologies;

•additions or departures of our management, or other key personnel;

•short sales of our common shares;

•sales or purchases of a substantial number of our common shares in the public market, by any of our significant shareholders, or the perception in the market that the holders of a large number of our common shares intend to sell or purchase common shares;

•sales or purchases of our common shares by our executive ~~officers;~~officers or members of our board of directors;

•issuance of additional shares of our common shares, or the perception that such issuances may ~~occur, including through our “at-the-market” equity offering program;~~occur;

•negative coverage in the media or securities analyst reports, whether accurate or not;

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•any changes in our relationships with Sumitomo Dainippon Pharma, Sumitovant, Sunovion and/or their respective affiliates, or actions taken or omission of actions with respect to the Sumitomo Dainippon Pharma Loan Agreement, the Investor Rights Agreement, the Market Access Services Agreement or under the other agreements we entered with Sumitomo Dainippon Pharma, ~~(such as the New Credit Facility),~~ Sumitovant, Sunovion and their respective affiliates;

•issuance of subpoenas or investigative demands, or the public fact of an investigation by a government agency, whether meritorious or not;

•trading liquidity of our common shares;

•investors’ general perception of our company, our business, and our majority shareholder;

•general political, economic, industry, and market conditions;

•effects of natural or man-made catastrophic events, including the COVID-19 pandemic; and

•the other factors described in this “Risk Factors” section.

The cumulative effects of these factors could result in large fluctuations and unpredictability in our quarterly and annual operating results. As a result, comparing our operating results on a period-to-period basis may not be meaningful. Investors should not rely on our past results as an indication of our future performance. This variability and unpredictability could also result in our failing to meet the expectations of industry or securities analysts or investors for any period. If our operating results fall below the expectations of analysts or investors or below any forecasts we may provide to the public, or if the forecasts we provide to the public are below the expectations of securities analysts or investors, the price of our common shares could decline substantially. Such a share price decline could occur even when we have met any previously publicly stated operating results and/or earnings guidance that we may provide.

If we are unable to maintain proper and effective internal control over financial reporting and disclosure controls and procedures, investor confidence in our company and, as a result, the value of our common shares, may be adversely affected.

We are required, pursuant to Section 404 of the Sarbanes-Oxley Act, or Section 404, to assess the effectiveness of our internal control over financial reporting annually and disclosure controls and procedures quarterly. In particular, we must perform system and process evaluation and testing of our internal control over financial reporting to allow management to report on the effectiveness of our internal control over financial reporting, as required by Section 404 of the Sarbanes-Oxley Act. This assessment includes disclosure of any material weaknesses identified by our management in our internal control over financial reporting. In addition, we are also required to include in our upcoming Annual Report on Form 10-K an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. If we have a material weakness, we would receive an adverse opinion regarding our internal control over financial reporting from our independent registered public accounting firm, which could severely inhibit our ability to accurately report our financial condition or results of operations. If we are unable to conclude that our internal control over financial reporting is effective, we could lose investor confidence in the accuracy and completeness of our financial reports, the market price of our common shares could decline, and we could be subject to sanctions or investigations by the NYSE, the SEC or other regulatory authorities. Failure to remedy any material weakness in our internal control over financial reporting, or to implement or maintain other effective control systems required of public companies, could also negatively impact our ability to access the capital markets.

In addition, effective disclosure controls and procedures enable us to make timely and accurate disclosure of financial and non-financial information that we are required to disclose. If our disclosure controls and procedures are ineffective in the future, we may be unable to report our financial results or make other disclosures accurately on a timely basis, which could cause our reported financial results or other disclosures to be materially misstated and result in the loss of investor confidence and cause the market price of our common shares to decline.

Volatility in our common share price could subject us to securities class action litigation.

Stock markets have experienced extreme price and volume fluctuations that have affected and continue to affect the market prices of equity securities of many companies. These fluctuations have often been unrelated or disproportionate to the operating performance of those companies. Broad market and industry factors, as well as general economic, political, regulatory, and market conditions, may negatively affect the market price of our common shares, regardless of our actual operating performance.

Additionally, following periods of volatility in the market, securities class-action litigation has often been instituted against companies. This risk is especially relevant for us because biotechnology and pharmaceutical companies have experienced

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significant share price volatility in recent years. Such litigation, if instituted against us, could result in substantial costs and diversion of management’s attention and resources, which could materially and adversely affect our business, financial condition, results of operations, and growth prospects.

Because we do not anticipate paying any cash dividends on our common shares in the foreseeable future, capital appreciation, if any, would be your sole source of gain.

We have never declared or paid any cash dividends on our common shares. We currently anticipate that we will retain future earnings for the development, operation, and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future. We are also subject to Bermuda legal constraints that may affect our ability to pay dividends on our common shares and make other payments. Additionally, our ability to pay dividends is currently restricted by the terms of the Sumitomo Dainippon Pharma Loan ~~Agreement and, we expect, will be under the New Credit Facility.~~Agreement. As a result, capital appreciation, if any, of our common shares would be your sole source of gain on an investment in our common shares for the foreseeable future.

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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

~~Not applicable.~~None.

Item 3. Defaults Upon Senior Securities

None.

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

None.

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Item 6. Exhibits

Exhibit
Number Description of Document Schedule /
Form File
No. Exhibit
No. Filing
Date
3.1
Certificate of Incorporation.
S-1 333-213891 3.1 09/30/2016
3.2
Memorandum of Association.
S-1 333-213891 3.2 09/30/2016
3.3
Fifth Amended and Restated Bye-laws.
10-Q 001-37929 3.3 02/10/2020
10.1†*
Market Access Services Agreement, dated as of August 1, 2020, by and between Sunovion Pharmaceuticals Inc. and Myovant Sciences GmbH.
10.2†*
Commercial Manufacturing and Supply Agreement, dated April 4, 2019, by and between Excella GmbH & Co. KG and Myovant Sciences GmbH.
10.3†*
Commitment Letter, dated August 5, 2020, by and between Sumitomo Dainippon Pharma Co., Ltd. and the Registrant.
10.4†*
Commitment Letter Amendment Letter, dated September 29, 2020, by and between Sumitomo Dainippon Pharma Co., Ltd. and the Registrant.
10.5†
2020 Inducement Plan.
10.6†
Form of Option Grant Notice and Option Agreement under 2020 Inducement Plan.
10.7†
Form of Restricted Stock Unit Grant Notice and R estricted Stock Unit Agre ement under 2020 Inducement Plan.
31.1†
Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2†
Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1††**
Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2††**
Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
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Exhibit
No.

Description of Document

Schedule / Form

File No.

Exhibit No.

Filing Date

3.1

Certificate of Incorporation.

S-1

333-213891

3.1

09/30/2016

3.2

Memorandum of Association.

S-1

333-213891

3.2

09/30/2016

3.3

Fifth Amended and Restated Bye-Laws.

10-Q

001-37929

3.3

02/10/2020

10.1

†+

Employment Agreement, dated as of August 12, 2021, by and between Uneek Mehra and Myovant Sciences, Inc.

10.2

†+

Separation Agreement and General Release, dated as of August 11, 2021, by and between Frank Karbe and Myovant Sciences, Inc.

10.3

†*

Letter Agreement, dated July 27, 2021, by and between Myovant Sciences GmbH and Pfizer, Inc.

31.1

†

Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2

†

Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1

††**

Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2

††**

Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101.INS

Inline XBRL Instance Document- the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.

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Inline XBRL Taxonomy Extension Schema

101.CAL

Inline XBRL Taxonomy Extension Calculation Linkbase

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Inline XBRL Taxonomy Extension Definition Linkbase

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† Filed herewith.

†† Furnished herewith.

+ Indicates management contract or compensatory plan.

* Portions of this exhibit have been omitted from this exhibit (indicated by asterisks) as such portions are both (a) not material and ~~would likely cause competitive harm to~~(b) is the type of information that the Registrant ~~if publicly disclosed.~~treats as private or confidential.

** These certifications are being furnished solely to accompany this Quarterly Report on Form 10-Q pursuant to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the Exchange Act, as amended, and are not to be incorporated by reference into any filing of the Registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

8078

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


			MYOVANT SCIENCES LTD.


			By:			/s/ ~~Frank Karbe~~Uneek Mehra
						~~Frank Karbe~~ Uneek Mehra (Duly Authorized Officer and Principal Financial ~~and Accounting~~ Officer)

Date: ~~November 12, 2020~~October 26, 2021

8179


	September 30, 2020		March 31, 2020
Assets
Current assets:
Cash and cash equivalents	$	94,210	$	76,644
Marketable securities	17,086		2,997
Prepaid expenses and other current assets	5,612		8,269

Total current assets	116,908		87,910

Property and equipment, net	2,808		2,497
Operating lease right-of-use asset	10,423		11,146
Other assets	5,634		4,373
Total assets	$	135,773	$	105,926
Liabilities and shareholders’ deficit
Current liabilities:
Accounts payable	$	7,008	$	15,334


Interest payable (related party)	0		15
Accrued expenses	40,141		29,060
Deferred revenue	16,667		40,000
Operating lease liability	1,657		1,516
Amounts due to related parties	1,284		0


Total current liabilities	66,757		85,925

Long-term operating lease liability	10,127		10,996

Long-term debt, less current maturities (related party)	253,700		113,700
Other	4,968		3,582
Total liabilities	335,552		214,203
Commitments and contingencies (Note 11)
Shareholders’ deficit:
Common shares, par value $0.000017727 per share, 564,111,242 shares authorized, 90,581,003 and 89,833,998 issued and outstanding at September 30, 2020 and March 31, 2020, respectively	2		2

Additional paid-in capital	702,695		684,381
Accumulated other comprehensive loss	(11,540)		(1,646)
Accumulated deficit	(890,936)		(791,014)
Total shareholders’ deficit	(199,779)		(108,277)
Total liabilities and shareholders’ deficit	$	135,773	$	105,926


	Common Shares			Additional Paid-in Capital		Accumulated Other Comprehensive Income (Loss)		Accumulated Deficit		Total Shareholders’ (Deficit) Equity
	Shares	Amount
Balance at March 31, 2019	72,057,490	$	1	$	505,851	$	507	$	(502,025)	$	4,334
Issuance of shares in connection with “at-the-market” equity offering, net of commissions of $79	106,494	—		2,546		—		—		2,546
Issuance of shares in connection with public equity offering, net of commissions and offering costs of $9,229	17,424,243	1		134,537		—		—		134,538
Share-based compensation expense	—	—		6,410		—		—		6,410
Capital contribution from former controlling shareholder — share-based compensation	—	—		42		—		—		42
Capital contribution from former controlling shareholder	—	—		106		—		—		106
Foreign currency translation adjustment	—	—		—		(819)		—		(819)
Issuance of shares upon exercise of stock options and vesting of restricted stock units	34,399	—		314		—		—		314
Net loss	—	—		—		—		(67,904)		(67,904)
Balance at June 30, 2019	89,622,626	2		649,806		(312)		(569,929)		79,567
Public equity offering, additional offering costs	0	0		(80)		—		—		(80)
Share-based compensation expense	—	—		7,879		—		—		7,879
Capital contribution from former controlling shareholder — share-based compensation	—	—		52		—		—		52
Capital contribution from former controlling shareholder	—	—		123		—		—		123
Foreign currency translation adjustment	—	—		—		281		—		281
Issuance of shares upon vesting of restricted stock units	938	—		0		—		—		0
Net loss	—	—		—		—		(70,568)		(70,568)
Balance at September 30, 2019	89,623,564	$	2	$	657,780	$	(31)	$	(640,497)	$	17,254


	Quoted Market Prices for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		Total Fair Value
As of September 30, 2020
Money market funds (1)	$	291	$	0	$	0	$	291
Commercial paper (2)	0		56,159		0		56,159
Corporate bonds (1)	0		3,000		0		3,000
Municipal bonds (3)	0		512		0		512
U.S. Treasury bills (1)	10,000		0		0		10,000
Total assets	$	10,291	$	59,671	$	0	$	69,962

As of March 31, 2020
Money market funds (1)	$	11,348	$	0	$	0	$	11,348
Commercial paper (4)	0		7,042		0		7,042
Total assets	$	11,348	$	7,042	$	0	$	18,390


Years Ended March 31,
2021 (remainder of year)	$	1,476
2022	3,028
2023	3,127
2024	3,053
2025	2,409
Thereafter	2,898
Total lease payments	15,991
Less imputed interest	(4,207)
Present value of future minimum lease payments	11,784
Less operating lease liability, current portion	(1,657)
Operating lease liability, long-term portion	$	10,127


	Balance at						Balance at
	March 31, 2020		Additions		Deductions		September 30, 2020
Contract liabilities:
Deferred revenue, current	$	40,000	$	10,000	$	(33,333)	$	16,667