UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

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

For the Quarterly Period Ended ~~March 31, 2018~~June 30, 2019

~~[ ]~~ ☐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 001-37569

Strongbridge Biopharma plc

(Exact name of Registrant as specified in its charter)

Ireland

98-1275166

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification Number)

900 Northbrook Drive

Suite 200

Trevose, PA 19053

(Address of principal executive offices)

Registrant’s Telephone Number, Including Area Code: +1 610‑254‑9200

Securities Registered Pursuant to Section 12(b) of the Exchange Act:


Title of each class:	Trading Symbol	Name of each exchange on which registered:
Ordinary shares, par value $0.01 per share	SBBP	The Nasdaq Global Select Market

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 ~~[X]~~☒ No ~~[ ]~~☐

Indicate by check mark whether the registrant has submitted electronically ~~and posted on its corporate Web site, if any,~~ every Interactive Data File required to be submitted ~~and posted~~ pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit ~~and post~~ such files). Yes ~~[X]~~☒ No ~~[ ]~~☐

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 filer,” “smaller reporting company,” and emerging growth company in Rule 12b-2 of the Exchange Act. ~~(Check one):~~


Large Accelerated Filer	~~[ ]~~☐	Accelerated Filer	~~[X]~~☒

Non-Accelerated Filer	~~[ ]~~☐	Smaller Reporting Company	~~[ ]~~☒
~~(Do not check if a smaller reporting company)~~
		Emerging Growth Company	~~[X]~~☒

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. ~~[X]~~☒

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

As of ~~May 4, 2018,~~July 29, 2019, there were ~~45,534,665~~54,186,268 ordinaryshares of the registrant issued and ~~outstanding.~~

outstanding.

Table of Contents

TABLE OF CONTENTS


		Page
PART I.	Financial Information	31

Item 1.	Financial Statements	31
	Consolidated Balance Sheets as of ~~March 31, 2018~~June 30, 2019 (unaudited) and December 31, ~~2017~~2018	31
	Consolidated Statements of Operations ~~and Comprehensive Loss~~ for the Three and Six Months Ended ~~March 31,~~June 30, 2019 and 2018 ~~and 2017~~ (unaudited)	42
	Consolidated Statements of Stockholders’ Equity (Deficit) (unaudited)	53
	Consolidated Statements of Cash Flow for the ~~Three~~Six Months Ended ~~March 31,~~June 30, 2019 and 2018 ~~and 2017~~ (unaudited)	64
	Notes to the Unaudited Consolidated Financial Statements	75

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	1915
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	2823
Item 4.	Controls and Procedures	2823

PART II.	Other Information	2824

Item 1.	Legal Proceedings	2824
Item 1A.	Risk Factors	2924
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	2926
Item 3.	Defaults Upon Senior Securities	2926
Item 4.	Mine Safety ~~Data~~Disclosures	2926
Item 5.	Other Information	2926
Item 6.	Exhibits	2926

SIGNATURES		3027

Solely for convenience, the trademarks and trade names in this Quarterly Report on Form 10-Q (this “Quarterly Report”) are referred to without the ® and ™ symbols, but absence of such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. The trademarks, trade names and service marks appearing in this ~~Annual~~Quarterly Report are the property of their respective owners.

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PART I – FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

STRONGBRIDGE BIOPHARMA plc

Consolidated Balance Sheets

(In thousands, except share and per share data)

(unaudited)


	March 31,		December 31,		June 30,		December 31,
	2018		2017		2019		2018
ASSETS
Current assets:
Cash and cash equivalents	$	92,405	$	57,510	$	86,167	$	122,490
Accounts receivable		2,016		1,584		6,343		1,626
Inventory		1,661		511		3,218		3,946
Prepaid expenses and other current assets		1,776		1,208		2,454		4,236
Total current assets		97,858		60,813		98,182		132,298
Property and equipment, net		12		15		291		294
Intangible assets, net		58,041		35,155
Right of use assets, net						934		—
Intangible asset, net						27,621		30,132
Goodwill		7,256		7,256		7,256		7,256
Other assets		360		686		872		305
Total assets	$	163,527	$	103,925	$	135,156	$	170,285
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	2,168	$	1,247	$	1,469	$	1,184
Accrued liabilities		8,837		11,232
Accrued liabilities and other current liabilities						17,035		16,065
Total current liabilities		11,005		12,479		18,504		17,249
Long-term debt		76,142		37,794
Warrant liability		51,008		41,308		8,636		15,513
Supply agreement liability, noncurrent		23,519		24,258		15,454		24,568
Other long-term liabilities						1,273		—
Total liabilities		161,674		115,839		43,867		57,330
Commitments and contingencies (Note 8)
Stockholders’ equity (deficit):
Deferred shares, $1.098 par value, 40,000 shares authorized, issued and outstanding at March 31, 2018 and December 31, 2017		44		44
Ordinary shares, $0.01 par value, 600,000,000 shares authorized at March 31, 2018 and December 31, 2017; 45,531,827 and 40,149,812 shares issued and outstanding at March 31, 2018 and December 31, 2017		455		401
Commitments and contingencies (Note 7)
Stockholders’ equity:
Deferred shares, $1.098 par value, 40,000 shares authorized, issued and outstanding at June 30, 2019 and December 31, 2018						44		44
Ordinary shares, $0.01 par value, 600,000,000 shares authorized at June 30, 2019 and December 31, 2018; 54,186,268 and 54,122,074 shares issued and outstanding at June 30, 2019 and December 31, 2018						542		541
Additional paid-in capital		272,960		230,524		328,416		323,402
Accumulated deficit		(271,606)		(242,883)		(237,713)		(211,032)
Total stockholders’ equity (deficit)		1,853		(11,914)
Total liabilities and stockholders’ equity (deficit)	$	163,527	$	103,925
Total stockholders’ equity						91,289		112,955
Total liabilities and stockholders’ equity					$	135,156	$	170,285

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

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STRONGBRIDGE BIOPHARMA plc

Consolidated Statements of Operations ~~and Comprehensive Loss~~

(In thousands, except share and per share data)

(unaudited)


	Three Months Ended				Three Months Ended				Six Months Ended
	March 31				June 30				June 30
	2018		2017		2019		2018		2019		2018
Revenues:
Net product sales	$	3,870	$	—	$	6,073	$	4,296	$	10,406	$	8,166
Royalty revenues						6		—		16		—
Total revenues		3,870		—		6,079		4,296		10,422		8,166

Cost and expenses:
Cost of sales (excluding amortization of intangible assets)	$	667	$	—	$	1,022	$	753	$	1,835	$	1,420
Selling, general and administrative		12,362		7,442		12,182		15,210		24,282		27,572
Research and development		4,881		3,481		8,739		5,453		15,322		10,334
Amortization of intangible assets		1,769		1,256		1,255		1,872		2,511		3,641
Total cost and expenses		19,679		12,179		23,198		23,288		43,950		42,967
Operating loss		(15,809)		(12,179)		(17,119)		(18,992)		(33,528)		(34,801)
Other expense, net:
Unrealized loss on fair value of warrants		(9,700)		(14,928)
Other income, net:
Income from field services agreement						1,725		—		3,741		—
Expense from field services agreement						(1,758)		—		(3,987)		—
Unrealized gain on fair value of warrants						8,697		19,017		6,877		9,317
Interest expense		(2,874)		(737)		—		(3,289)		—		(6,163)
Foreign exchange loss		(20)		(12)
Loss on extinguishment of debt		(500)		—		—		—		—		(500)
Other income (expense), net		180		(35)
Total other expense, net		(12,914)		(15,712)
Other income, net						608		342		1,293		502
Total other income, net						9,272		16,070		7,924		3,156
Loss before income taxes		(28,723)		(27,891)		(7,847)		(2,922)		(25,604)		(31,645)
Income tax expense		—		(1,594)		(400)		(1)		(1,077)		(1)
Net loss	$	(28,723)	$	(29,485)	$	(8,247)	$	(2,923)		(26,681)		(31,646)

Net loss attributable to ordinary shareholders:
Basic					$	(8,247)	$	(2,923)	$	(26,681)	$	(31,646)
Diluted					$	(16,944)	$	(21,940)	$	(33,558)	$	(40,963)
Net loss per share attributable to ordinary shareholders:
Basic and diluted	$	(0.66)	$	(0.83)
Basic					$	(0.15)	$	(0.06)	$	(0.49)	$	(0.69)
Diluted					$	(0.30)	$	(0.43)	$	(0.60)	$	(0.81)
Weighted-average shares used in computing net loss per share attributable to ordinary shareholders:
Basic and diluted		43,620,746		35,335,026
Basic						54,175,731		45,829,600		54,165,439		45,728,793
Diluted						55,781,078		50,437,716		56,262,936		50,363,801

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

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STRONGBRIDGE BIOPHARMA plc

Consolidated Statement of Stockholders’ Equity (Deficit) ~~Equity~~

(In thousands, except share amounts)

(unaudited)


							Additional				Total								Additional				Total
	Ordinary Shares			Deferred Shares			Paid-In		Accumulated		Shareholders’		Ordinary Shares			Deferred Shares			Paid-In		Accumulated		Shareholders’
													Shares	Amount		Shares	Amount		Capital		Deficit		(Deficit) Equity
Balance—March 31, 2018													45,531,827	$	455	40,000	$	44	$	272,960	$	(271,606)	$	1,853
Net loss													—		—	—		—		—		(2,923)		(2,923)
Stock-based compensation													—		—	—		—		1,985		—		1,985
Ordinary shares issued, net of shares withheld for employee taxes													2,826		—	—		—		(13)		—		(13)
Exercise of stock options													2,838		*	—		—		—		—		*
Issuance of shares in connection with at-the-market facility, net of costs													1,172,557		12	—		—		7,949		—		7,961
Balance—June 30, 2018													46,710,048	$	467	40,000	$	44	$	282,881	$	(274,529)	$	8,863
	Shares	Amount		Shares	Amount		Capital		Deficit		(Deficit) Equity
Balance—December 31, 2017	40,149,812	$	401	40,000	$	44	$	230,524	$	(242,883)	$	(11,914)	40,149,812	$	401	40,000	$	44	$	230,524	$	(242,883)	$	(11,914)
Net loss	—		—	—		—		—		(28,723)		(28,723)	—		—	—		—		—		(31,646)		(31,646)
Stock-based compensation	—		—	—		—		1,688		—		1,688	—		—	—		—		3,673		—		3,673
Issuance of shares, net of offering costs	5,255,683		53	—		—		33,455		—		33,508	5,255,683		53	—		—		33,455		—		33,508
Common stock issued, net of shares withheld for employee taxes	89,163		1	—		—		(429)		—		(428)
Ordinary shares issued, net of shares withheld for employee taxes													91,989		1	—		—		(442)		—		(441)
Exercise of stock options	37,169		*	—		—		59		—		59	40,007		*	—		—		59		—		59
Issuance of shares in connection with at-the-market facility, net of costs													1,172,557		12	—		—		7,949		—		7,961
Issuance of warrants related to loan agreements	—		—	—		—		7,663		—		7,663	—		—	—		—		7,663		—		7,663
Balance—March 31, 2018	45,531,827	$	455	40,000	$	44	$	272,960	$	(271,606)	$	1,853
Balance—June 30, 2018													46,710,048	$	467	40,000	$	44	$	282,881	$	(274,529)	$	8,863

Balance—March 31, 2019													54,167,948	$	542	40,000	$	44	$	325,863	$	(229,466)	$	96,983
Net loss													—		—	—		—		—		(8,247)		(8,247)
Stock-based compensation													—		—	—		—		2,572		—		2,572
Exercise of stock options													4,113		*	—		—		12		—		12
Ordinary shares issued, net of shares withheld for employee taxes													14,207		*	—		—		(31)		—		(31)
Balance—June 30, 2019													54,186,268	$	542	40,000	$	44	$	328,416	$	(237,713)	$	91,289

Balance—December 31, 2018													54,122,074	$	541	40,000	$	44	$	323,402	$	(211,032)	$	112,955
Net loss													—		—	—		—		—		(26,681)		(26,681)
Stock-based compensation													—		—	—		—		4,895		—		4,895
Exercise of stock options													43,841		1	—		—		178		—		179
Ordinary shares issued, net of shares withheld for employee taxes													20,353		*	—		—		(59)		—		(59)
Balance—June 30, 2019													54,186,268	$	542	40,000	$	44	$	328,416	$	(237,713)	$	91,289

* Represents an amount less than $1.

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

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STRONGBRIDGE BIOPHARMA plc

Consolidated Statements of Cash Flow

(In thousands)

(unaudited)


	Three Months Ended				Six Months Ended
	March 31,				June 30,
	2018		2017		2019		2018
Cash flows from operating activities:
Net loss	$	(28,723)	$	(29,485)	$	(26,681)	$	(31,646)
Adjustments to reconcile net loss to net cash used in operating activities:
Change in fair value of warrant liability		9,700		14,928		(6,877)		(9,317)
Stock-based compensation		1,688		1,169		4,895		3,673
Amortization of intangible assets		1,769		1,256		2,511		3,641
Interest and related guarantee fees paid in kind		766		—		—		1,813
Amortization of debt discounts and debt issuance costs		314		140		—		697
Loss on extinguishment of debt		500		—		—		500
Deferred income tax expense		—		1,599
Depreciation		3		3		36		10
Changes in operating assets and liabilities:
Accounts receivable		(432)		—		(4,717)		(792)
Inventory		(1,150)		—		393		(675)
Prepaid expenses and other current assets		(567)		(198)		1,782		(1,870)
Other assets		325		(1)		(1,166)		368
Accounts payable		921		791		285		1,164
Accrued liabilities and other liabilities		(3,133)		509		(6,872)		(114)
Net cash used in operating activities		(18,019)		(9,289)		(36,411)		(32,548)
Cash flows from investing activities:
Payment for acquisitions		(24,655)		(7,500)		—		(24,655)
Purchases of property and equipment						(33)		(310)
Net cash used in investing activities		(24,655)		(7,500)		(33)		(24,965)
Cash flows from financing activities:
Proceeds from long-term debt, net		44,930		—		—		44,930
Payment for loss on extinguishment of debt		(500)		—		—		(500)
Payment for amendment of long-term debt		—		(150)
Proceeds from issuance of ordinary shares, net		33,508		—		—		33,508
Proceeds from issuance of ordinary shares in connection with at-the-market offering						—		7,961
Proceeds from exercise of stock options		59		—		180		59
Payments related to tax withholding for net-share settled equity awards		(428)		—		(59)		(441)
Net cash provided by (used in) financing activities		77,569		(150)
Net increase (decrease) in cash and cash equivalents		34,895		(16,939)
Net cash provided by financing activities						121		85,517
Net (decrease) increase in cash and cash equivalents						(36,323)		28,004
Cash and cash equivalents—beginning of period		57,510		66,837		122,490		57,510
Cash and cash equivalents—end of period	$	92,405	$	49,898	$	86,167	$	85,514
Supplemental disclosures of cash flow information:
Cash paid during the year for:
Interest	$	1,642	$	295	$	—	$	3,501
Income taxes other, net of refunds	$	—	$	255
Supplemental non-cash financing activities:
Issuance of shares from vested restricted share units	$	1,016	$	—

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

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STRONGBRIDGE BIOPHARMA plc

Notes to Unaudited Consolidated Financial Statements

1. Organization

We are a global, commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs.

Our first commercial product is Keveyis (dichlorphenamide), the first and only treatment approved by the U.S. Food and Drug Administration (the “FDA”) for hyperkalemic, hypokalemic, and related variants of primary periodic paralysis (“PPP”), a group of rare hereditary disorders that cause episodes of muscle weakness or paralysis.

Our second commercial product, Macrilen (macimorelin) is an oral growth hormone secretagogue receptor agonist, and is the first and only oral drug approved by the FDA for the diagnosis of patients with adult growth hormone deficiency (“AGHD”). In January 2018, we acquired the U.S. and Canadian rights to Macrilen and we expect to launch Macrilen in the United States in mid-2018.

~~In addition to our two commercial products, we~~We have two clinical-stage product candidates for rare endocrine diseases, Recorlev and veldoreotide. Recorlev (levoketoconazole) is a cortisol synthesis inhibitor currently being studied for the treatment of endogenous Cushing's syndrome. Veldoreotide is a next-generation somatostatin analog being investigated for ~~the treatment of acromegaly and~~ potential ~~additional~~ applications in ~~other~~ conditions amenable to somatostatin receptor ~~activation.~~activation, such as acromegaly. Both Recorlev and veldoreotide have received orphan designation from the FDA and the European Medicines Agency (“EMA”).

~~Given~~In January 2018, Strongbridge Ireland Ltd., one of our wholly-owned subsidiaries, acquired the ~~well-identified~~U.S. and ~~concentrated prescriber base addressing our target markets, we intend~~Canadian rights to ~~continue to use a small, focused sales force to market Keveyis,~~ Macrilen (macimorelin), the first and ~~any future products,~~only oral drug approved by the FDA for the diagnosis of patients with adult growth hormone deficiency. We launched Macrilen in the United States in July 2018. In December 2018, we sold Strongbridge Ireland Ltd. to Novo Nordisk Healthcare AG (“Novo”) for $145 million plus the ~~European Union and other key global markets. We believe that our ability~~right to ~~execute~~receive tiered royalties on ~~our strategy is enhanced by the significant commercial and clinical development experience~~net sales of ~~key members~~Macrilen through 2027. In addition, Strongbridge U.S. Inc, another of our ~~management team.~~

~~Since~~wholly-owned subsidiaries, entered into an agreement with Novo Nordisk Inc., subsidiary of Novo (“NNI”), pursuant to which NNI will fund the ~~introduction~~costs of 23 of our ~~new management team~~field-based employees to provide full-time ongoing services to NNI, including the promotion of Macrilen in ~~August 2014, we have been building~~the United States, for a ~~rare disease, franchise-based business model focused on expansion through a disciplined in-licensing and acquisition strategy. In pursuit~~period of our growth strategy, we have raised over $275 million in equity and debt financings since December 2014. We will continue to identify and evaluate the acquisition of products and product candidates for licensing or acquisition that would be complementary to our existing rare neuromuscular and endocrine franchises or that would form the basis for new rare disease franchises. We believe this approach will enable us to maximize our commercial potential by further leveraging our existing resources and expertise.three years.

Liquidity

We believe that our cash resources of ~~$92.4~~$86.2 million at ~~March 31, 2018~~June 30, 2019 will be sufficient to allow us to fund planned operations for at least 12 months beyond the issuance date of these unaudited consolidated financial statements, which is after the expected receipt of data from the Recorlev SONICS and LOGICS Phase 3 clinical trials. We expect our funding requirements for operating activities to increase in 2018 and possibly beyond due to expenses associated with the commercialization of Keveyis and Macrilen, the execution of the Phase 3 SONICS and LOGICS clinical trials for Recorlev, and selling, general and administrative expenses. We also expect our cash needs to increase to fund potential in‑licenses, acquisitions or similar transactions as we pursue our strategy. These expenses may be offset only in part by sales of Keveyis and ~~Macrilen. In addition, beginning in March 2021, we may be required to make quarterly principal payments to repay amounts borrowed under our credit facility.~~statements.

We may never achieve profitability, and unless and until we do, we will continue to need to raise additional capital. We plan to continue to fund our operations and capital funding needs through equity or debt financing along with revenues from Keveyis and royalty revenues from Macrilen. There can be no assurances, however, that additional funding will be available on terms acceptable to us.

~~Table of Contents~~

Our loan and security agreement, under which outstanding borrowings were $86.5 million at March 31, 2018 contains financial and non-financial covenants including minimum amounts of net revenue in 2018 and beyond. Failure to comply with the covenants could result in the lenders declaring the loan immediately due and payable. Our liquidity requirements are predicated on maintaining compliance with the debt covenants and repaying outstanding borrowings in accordance with the loan term (see Note 7).

2. Summary of significant accounting policies and basis of presentation

Basis of presentation

These unaudited consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States (“U.S. GAAP”). The unaudited consolidated financial statements reflect all adjustments, which include only normal recurring adjustments that are, in the opinion of management, necessary to present a fair statement of the operating results and financial position for the periods presented.

The preparation of the unaudited consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect reported amounts and disclosures in the consolidated financial statements. Actual results could differ from those estimates. Results for the ~~three~~six months ended ~~March 31, 2018~~June 30, 2019 are not necessarily indicative of the results that may be expected for the year ending December 31, ~~2018.~~2019.

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These unaudited consolidated financial statements should be read in conjunction with the accounting policies and notes to the audited consolidated financial statements included in our ~~annual report~~Annual Report on Form 10-K for the fiscal year ended December 31, ~~2017~~2018 filed with the U.S. Securities and Exchange Commission on ~~March 12, 2018~~February 27, 2019 (the ~~“2017~~“2018 Annual Report”). Our significant accounting policies are described in Note 2 of the notes to the audited consolidated financial statements included in our ~~2017~~2018 Annual Report. Since the date of those financial statements, there have been no changes to our significant accounting policies.

~~Revenue recognition~~Royalty Revenues

Royalty revenues are from commercial sales of Macrilen by Novo Nordisk Healthcare AG, based on net sales.

Leases

We ~~follow~~account for leases in accordance with Accounting Standards Codification ~~(“ASC”)~~ Topic ~~606,~~842, ~~Revenue from Contracts with Customers,~~ Leases~~effective April 1, 2017. Topic 606 applies~~, (“ASC 842”). We determine if an arrangement is a lease at contract inception. A lease exists when a contract conveys to ~~all contracts with customers, except~~us the right to control the use of identified property, plant, or equipment for ~~contracts that are within the scope~~a period of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Under Topic 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration the entity expects to receivetime in exchange for ~~those goods or services. To determine revenue recognition for arrangements that~~consideration. The definition of a lease embodies two conditions: (1) there is an ~~entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations~~identified asset in the ~~contract; (iii) determine~~contract that is land or a depreciable asset (i.e., property, plant, and equipment), and (2) we have the ~~transaction price; (iv) allocate~~right to control the ~~transaction price~~use of the identified asset.

Operating leases where we are the lessee are included in Right of use (“ROU”) assets and Other current liabilities and Other long-term liabilities on our Consolidated Balance Sheets. The lease liabilities are initially and subsequently measured at the present value of the unpaid lease payments at the lease commencement date.

Key estimates and judgments include how we determined (1) the discount rate we use to discount the unpaid lease payments to present value, (2) lease term and (3) lease payments.

ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. Because our leases do not provide an implicit rate, we use our incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. Our incremental borrowing rate for a lease is the rate of interest we would have to pay on a collateralized basis to borrow an amount equal to the ~~performance obligations~~lease payments under similar terms.

The lease term for all of our leases includes the noncancellable period of the lease. Lease payments included in the ~~contract; and (v) recognize revenue when (or as)~~measurement of the ~~entity satisfies~~lease asset or liability are comprised of our fixed payments

The ROU asset is initially measured at cost, which comprises the initial amount of the lease liability adjusted for lease payments made at or before the lease commencement date less any lease incentives received.

For operating leases, the ROU asset is subsequently measured throughout the lease term at the carrying amount of the lease liability, plus (minus) any prepaid (accrued) lease payments, less the unamortized balance of lease incentives received. Lease expense for lease payments is recognized on a ~~performance obligation.~~ straight-line basis over the lease term.

We ~~apply~~monitor for events or changes in circumstances that require a reassessment of a lease. If a reassessment results in the ~~five-step model to contracts only when it~~remeasurement of a lease liability, a corresponding adjustment is ~~probable that we will collect the consideration we are entitled to receive in exchange for the goods or services we transfer~~made to the ~~customer. At contract inception, once~~carrying amount of the ~~contract is determined~~corresponding ROU asset unless doing so would reduce the carrying amount of the ROU asset to ~~be within the scope of Topic 606, we assess the goods or services promised within each contract and determine those~~an amount less than zero. In that ~~are performance obligations, and assess whether each promised good or service is distinct. We then recognize as revenue~~case, the amount of the ~~transaction price~~adjustment that would result in a negative ROU asset balance is ~~allocated~~recorded in profit or loss.

We have elected not to recognize ROU assets and lease liabilities for all short-term leases that have a lease term of 12 months or less. We recognize the ~~respective performance obligation when (or as)~~lease payments associated with our short-term leases as an expense on a straight-line basis over the ~~performance obligation is satisfied. For a complete discussion of accounting~~lease term. Variable lease payments associated with these leases are recognized and presented in the same manner as for ~~net product revenue, see Note 3, "Revenue recognition".~~

~~Inventoryand cost of sales~~

~~Inventory is stated at the lower of cost or market where cost is determined using the first-in, first-out method. Our inventory consists of only finished goods.~~ ~~Cost of sales includes the cost of inventory sold, which includes third-party acquisition costs, third-party warehousing and product distribution charges.~~all our other leases.

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~~Foreign currency translation~~

~~The consolidated~~We adopted ASC 842 using a modified retrospective transition approach as of the effective date, as permitted by the amendments in ASU 2018-11. As a result, we were not required to adjust our comparative period financial ~~statements are reported in United States dollars, which is our functional currency, including each~~information for effects of ~~our consolidated subsidiaries. Transactions in foreign currencies are remeasured into our functional currency at~~ the ~~rate of exchange prevailing at~~standard or make the new required lease disclosures for periods before the date of adoption (i.e., January 1, 2019). We have elected to adopt the ~~transaction. Any monetary assets~~package of transition practical expedients and, ~~liabilities arising from these transactions are remeasured into our functional currency at exchange rates prevailing~~therefore, have not reassessed (1) whether existing or expired contracts contain a lease, (2) lease classification for existing or expired leases or (3) the accounting for initial direct costs that were previously capitalized. We did not elect the practical expedient to use hindsight for leases existing at the ~~balance sheet date or~~adoption date. Further, we do not expect the amendments in ASU 2018-01: Land Easement Practical Expedient to have an effect on ~~settlement. Resulting gains~~us because we do not enter into land easement arrangements.

Income and ~~losses~~Expense from Field Services Agreement

For our field services agreement with NNI, our income and expense are being recorded ~~in foreign exchange loss in our consolidated statements of operations.~~

~~Use of estimates~~

~~The preparation of financial statements in conformity with U.S. GAAP requires us to make estimates~~as non-operating income and assumptions that affect the reported amounts in the financial statements and accompanying notes. We must apply significant judgment in this process. Actual results could materially differ from those estimates.expense, respectively.

Segment information

Operating segments are identified as components of an enterprise ~~about~~for which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision making group, in making decisions on how to allocate resources and assess performance. We view our operations and manage our business in one operating segment. ~~Prior to March 31, 2018, our material long‑lived assets reside in Ireland, Sweden and the Cayman Islands. Effective March 31, 2018 all of our material long-lived assets reside in Ireland.~~ ~~For the three months ended March 31, 2018, revenues from product sales were derived entirely from theUnited States.~~

Net loss per share

Basic net loss per share is calculated by dividing the net loss attributable to shareholders by the weighted average number of ordinary shares outstanding during the period. Diluted net loss per share is calculated by dividing the net loss attributable to shareholders by the weighted‑average number of ordinary shares outstanding for the period, including any dilutive effect from outstanding stock options or other equity-based awards. Shares used in the diluted net loss per share calculations exclude anti‑dilutive ordinary share equivalents, which currently consist of outstanding stock options, unvested restricted stock units (“RSUs”) and equity-classified warrants.

The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as of ~~March 31,~~June 30, 2019 and 2018, ~~and 2017,~~ as they would be anti-dilutive:


	Three Months Ended
	March 31,				June 30,
	2018		2017		2019		2018
Warrants		8,803,253		7,428,571		1,803,253		1,803,253
Stock options issued and outstanding		7,960,469		5,291,986		10,241,158		8,661,560
Unvested restricted stock units		173,400		194,000
Unvested RSUs						964,850		173,400

Recent accounting pronouncements – not yet adopted

In January 2017, the ~~Financial Accounting Standards Board (FASB)~~ FASB issued ~~Accounting Standards Update (ASU)~~ASU 2017-04, Intangibles - Goodwill and Other: Simplifying the Accounting for Goodwill Impairment. ASU 2017-04 removes Step 2 of the goodwill impairment test, which requires a hypothetical purchase price allocation. A goodwill impairment will now be the amount by which a reporting unit’s carrying value exceeds its fair value, not to exceed the carrying amount of goodwill. This standard, which will be effective for us beginning in the first quarter of fiscal year ~~2021,~~2020, is required to be applied prospectively. Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017. We ~~are currently evaluating the~~do not expect any impact from this ~~new accounting guidance will have on our consolidated financial statements.~~standard.

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~~In August 2016, the FASB issued ASU 2016-15,~~ ~~Classification of Certain Cash Receipts and Cash Payments~~, which clarifies how certain cash receipts and cash payments are presented and classified in the statement of cash flows in order to reduce diversity in practice. The guidance is effective for us beginning in the first quarter of fiscal year 2018. Early adoption is permitted. We have adopted this effective January 1, 2018.

~~In February 2016, the FASB issued ASU No. 2016-02,~~ ~~Leases~~, that discusses how an entity should account for lease assets and lease liabilities. The guidance specifies that an entity who is a lessee under lease agreements should recognize lease assets and lease liabilities for those leases classified as operating leases under previous FASB guidance. Accounting for leases by lessors is largely unchanged under the new guidance. The guidance is effective for us beginning in the first quarter of fiscal year 2019. Early adoption is permitted. In transition, lessees and lessors are required to recognize and measure leases at the beginning of the earliest period presented using a modified retrospective approach. We are currently evaluating the impact this new accounting guidance will have on our consolidated financial statements.

3. Revenue recognition

Product ~~Revenue, Net~~

sales, net

We sell Keveyis to one specialty pharmacy provider (the “Customer”), who is the exclusive distributor of Keveyis in the United States. The Customer subsequently resells Keveyis to patients, ~~which~~most of whom are covered by payors that may provide for government-mandated or privately negotiated rebates with respect to the purchase of Keveyis.

Revenues from sales of Keveyis are recognized when we satisfy a performance obligation by transferring control of ~~Keveyis~~the product to the Customer. Transfer of control occurs upon receipt of ~~Keveyis~~the product by the Customer. We expense incremental costs related to the set-up of ~~the contract~~contracts with the Customer when incurred, as these costs ~~did~~do not meet the criteria for capitalization.

Reserves for ~~Variable Consideration~~variable consideration

Revenues from sales of Keveyis are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established and ~~which~~that result from rebates, co-pay assistance and other allowances that are offered between us and the patients’ payors. There is no variable consideration reserve for returns as we do not accept returns of Keveyis. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the Customer) or a current liability (if the amount is payable to a party other than the Customer). Where appropriate, these estimates may take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as our historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Overall, these reserves reflect our best estimates of the amount of consideration to which we are entitled based on the terms of the contract. The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from our estimates. We reassess our estimates on an ongoing basis. If actual results in the future vary from our estimates, we will adjust our estimates. Any such adjustments would affect net product revenue and earnings in the period such variances become known.

Trade Discount: We provide the Customer with a discount that is explicitly stated in our contract and is recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, we receive sales order management, data and distribution services from the Customer. To the extent the services received are distinct from our sale of Keveyis to the Customer, these payments are classified in selling, general and administrative expenses in our consolidated statement of operations and comprehensive loss.

Funded Co-pay Assistance Program: We contract with a third-party to manage the co-pay assistance program intended to provide financial assistance to qualified insured patients. The calculation of the accrual for co-pay assistance

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is based on an estimate of claims and the cost per claim that we expect to receive associated with Keveyis that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. These payments are consideration payable to the ~~customer~~Customer and the related reserve is recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses on the consolidated balance sheet.

Government Rebates: We are subject to discount obligations under state Medicaid programs and Medicare. We estimate our Medicaid and Medicare rebates based upon a range of possible outcomes that are probability-weighted for the estimated patient mix. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability, which is included in accrued expenses on the consolidated balance sheet. For Medicaid, accruals are based on estimates of future Medicaid beneficiary utilization applied to the Medicaid unit rebate formula established by the Center for Medicaid and Medicare Services. Effective January 1, 2011, manufacturers of pharmaceutical products are responsible for 50% of the patient’s cost of branded prescription drugs related to the Medicare Part D Coverage Gap. In order to estimate the cost to us of this Medicare

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coverage gap responsibility, we estimate the number of patients in the prescription drug coverage gap for whom we will owe an additional liability under the Medicare Part D program. Our liability for these rebates consists of estimates of claims for the current quarter and estimated future claims that will be made for Keveyis that ~~has~~have been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period.

Temporary Supply and Patient Assistance Programs: We provide free Keveyis to uninsured patients who satisfy pre-established criteria for either the Temporary Supply Program or the Patient Assistance Program. Patients who meet the Temporary Supply Program eligibility criteria may receive a temporary supply of free Keveyis for no more than sixty days while ~~we are determining~~there is a determination of the patient’s third-party insurance, prescription drug benefit or other third-party coverage for Keveyis. The Patient Assistance Program provides free Keveyis for up to twelve months to uninsured patients ~~that~~who satisfy pre-established criteria for financial need. We do not recognize any revenue related to these free products and the associated costs are classified in selling, general and administrative expenses in our consolidated statements of operations and comprehensive loss.

Royalty Revenues

Royalty revenues are from commercial sales of Macrilen by Novo, based on net sales.

4. Fair value measurement

We follow FASB accounting guidance on fair value measurements for financial assets and liabilities measured on a recurring basis. Because of their short-term nature, the amounts reported in the balance sheet for cash and ~~cash equivalents, and~~ accounts payable approximate fair value.

The guidance requires fair value measurements to maximize the use of “observable inputs.” The three-level hierarchy of inputs to measure fair value are as follows:

Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities. Because of their short-term nature, the amounts reported in the balance sheet for cash ~~and cash equivalents,~~ and accounts payable approximate fair value.

Level 2: Significant observable inputs other than Level 1 prices such as quoted prices in markets that are not active, or inputs that are observable, either directly or indirectly, for substantially the full term of the asset or liability

Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable ~~(i.e.~~(i.e., supported by little or no market activity). The fair values of the outstanding warrants were measured using the Black-Scholes option-pricing model. Inputs used to determine estimated fair value of the warrant liabilities include the estimated fair value of the underlying stock at the valuation date, the estimated term of the warrants, risk-free interest rates, expected dividends and the expected volatility of the underlying stock. The significant unobservable inputs used in the fair value measurement of the warrant liabilities were the volatility rate and the estimated term of the warrants. Generally, increases (decreases) in the fair value of the underlying stock and estimated term would result in a directionally similar impact to the fair value measurement.

We did not have any transfers between the different levels.

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The following table presents our assets and liabilities that are measured at fair value on a recurring basis for the periods presented (in thousands):


	As of March 31, 2018								As of June 30, 2019
	Level I		Level II		Level III		Total		Level I		Level II		Level III		Total
Cash equivalents		92,148		—		—		92,148		85,759		—		—		85,759
Total assets	$	92,148	$	—	$	—	$	92,148	$	85,759	$	—	$	—	$	85,759
Warrant liability		—		—		51,008		51,008		—		—		8,636		8,636
Total liabilities	$	—	$	—	$	51,008	$	51,008	$	—	$	—	$	8,636	$	8,636


	As of December 31, 2017								As of December 31, 2018
	Level I		Level II		Level III		Total		Level I		Level II		Level III		Total
Cash equivalents		57,024		—		—		57,024		122,300		—		—		122,300
Total assets	$	57,024	$	—	$	—	$	57,024	$	122,300	$	—	$	—	$	122,300
Warrant liability		—		—		41,308		41,308		—		—		15,513		15,513
Total liabilities	$	—	$	—	$	41,308	$	41,308	$	—	$	—	$	15,513	$	15,513

The following table presents a reconciliation of our level 3 Warrant liability (in thousands):


		As of June 30, 2019
Balance as of December 31, 2018	$	15,513
Unrealized gain on fair value of warrants for the six months ended June 30, 2019		(6,877)
Balance as of June 30, 2019	$	8,636

5. Intangible assets and goodwill

The following represents the balance of our intangible assets as follows (in thousands):

As of March 31, 2018

Beginning of Period

Additions

Impairment

Amortization

End of Period

Keveyis

35,155

—

—

(1,256)

33,899

Macrilen

—

24,655

—

(513)

24,142

Goodwill

7,256

—

—

—

7,256

Total

$
42,411

$
24,655

$
—

$
(1,769)

$
65,297


	As of December 31, 2017										As of June 30, 2019
	Beginning of Period		Additions		Impairment		Amortization		End of Period		Beginning of Period		Amortization		End of Period
IPR&D	$	20,723	$	—	$	(20,723)	$	—	$	—
Keveyis		40,177		—		—		(5,022)		35,155	$	30,132	$	(2,511)	$	27,621
Goodwill		7,256		—		—		—		7,256		7,256		—		7,256
Total	$	68,156	$	—	$	(20,723)	$	(5,022)	$	42,411	$	37,388	$	(2,511)	$	34,877

Our finite lived intangible assets ~~consists~~consist of acquired developed product rights obtained from our ~~acquisitions~~acquisition of Keveyis (dichlorphenamide) from a subsidiary of Taro Pharmaceutical Industries Ltd. (“Taro”) ~~and Macrilen from~~ ~~Aeterna Zentaris GmbH~~.

Pursuant to the terms of the Asset Purchase Agreement and Supply Agreement that we entered into with Taro in December 2016, we paid Taro an upfront payment in two installments of $1 million in December 2016 and $7.5 million in March 2017. We concluded that the supply price payable by us exceeds fair value and, therefore, used a discounted cash flow method with a probability assumption to value the payments in excess of fair value at $29.3 million, for which we have recorded an intangible asset and corresponding liability. This liability will be reduced as we purchase inventory over the term of the Supply ~~Agreement.~~Agreement that we entered into with Taro in December 2016. In addition, we incurred transaction costs of $2.4 million. The overall recording of the transaction resulted in the recording of an intangible asset of $40.2 million. This asset is being amortized over an eight-year period using the straight-line method.

We entered into a License and Assignment Agreement in 2018 with Aeterna Zentaris GmbH, pursuant to which we acquired the U.S. and Canadian rights to manufacture and commercialize Macrilen (macimorelin) for $24 million and incurred transaction costs of $0.7 million, resulting in an intangible of $24.7. This asset is being amortized over a ten-year period using the straight-line method.

We recorded amortization expense of ~~$1.8~~$1.3 million and ~~$1.3~~$2.5 million for the three and six months ended ~~March 31,~~June 30, 2019, respectively, compared to $1.9 million and $3.6 million for the three and six months ended June 30, 2018, ~~and 2017,~~ respectively.

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6. Accrued liabilities and other current liabilities

Accrued liabilities and other current liabilities consist of the following (in thousands):


	March 31,		December 31,		June 30,		December 31,
	2018		2017
					2019		2018
Supply agreement - current portion					$	5,375	$	1,638
Consulting and professional fees	$	3,082	$	3,207		4,077		4,145
Supply agreement - current portion		4,191		4,237
Employee compensation		1,342		3,668		2,816		5,717
Accrued sales allowances						1,863		2,233
Accrued taxes						1,596		535
Accrued royalties						577		802
Lease liability - current portion						330		—
Other		222		120		401		995
Total accrued liabilities	$	8,837	$	11,232	$	17,035	$	16,065

7. ~~Long-term debt~~

~~On January 16, 2018 (the “Loan Amendment Effective Date”), we and our subsidiaries, Strongbridge U.S. Inc., Strongbridge Ireland Limited~~, Cortendo AB (publ) and Cortendo Cayman Ltd., entered into an amendment (the “Loan Amendment”), to the Term Loan Agreement (the “Loan Agreement”), dated July 14, 2017, with CRG Servicing LLC (“CRG”), as administrative agent and collateral agent, and the lenders named therein (the “Lenders”).

The primary purpose of the Loan Amendment was to increase the total potential borrowing under the Loan Agreement from $50 million to $100 million. The Loan Amendment provides for (i) an additional disbursement of $45.0 million (the “Second Tranche”), to the Company on the Loan Amendment Effective Date, and (ii) an additional disbursement of $5.0 million (the “Fourth Tranche”), to us at our election, contingent upon our achievement of certain revenue milestones and a market capitalization condition on or before December 31, 2018, as described in the Loan Amendment. We continue to be eligible to borrow up to an additional $10.0 million (the “Third Tranche”), contingent upon our achievement of certain revenue milestones on or before June 30, 2018, as previously provided in the Loan Agreement; provided, however, that under the Loan Agreement, as amended, the Third Tranche is now subject to market capitalization condition, as described in the Loan Amendment.

The term of the Loan Agreement, as amended, remains six years, although the interest-only period was extended by six months to December 31, 2020. We retained the option to extend the interest-only period to six years based upon the achievement of certain milestones during the interest-only period. ~~The Loan Agreement provides for interest payable at an annual rate of 12.5% and a final payment fee of 5% of the principal balance.~~

The Loan Agreement includes a payment-in-kind (“PIK”) provision, which allows us to defer 4.0% of the 12.5% annual interest payable under the loan during the first three years of the term of the loan (which may be extended for the entire term of the loan, subject to the satisfaction of certain conditions) by adding such amount to the principal loan amount. We have elected to PIK each period so far, resulting in an additional $0.5 million added to our outstanding principal balance as of March 31, 2018. We have granted a security interest in substantially all of our existing assets and assets acquired by us in the future, including intellectual property. The Loan Agreement contains facility and prepayment fees, and customary affirmative and negative covenants, including a financial covenant regarding minimum amounts of net revenue and restrictions on our ability to pay cash dividends, and a list of events that will constitute “events of default” under the loan agreement, and permit the lenders to declare all amounts under the Loan Agreement immediately due and payable, including a material adverse change in our business, operations or financial condition. We recorded $10.6 million in debt discounts and $0.2 million of debt issuance costs relating to this loan agreement which have been recorded as a reduction to the long-term debt. These amounts will be amortized over the outstanding period of the debt to interest expense using the effective interest rate method.

As a condition to the Second Tranche under the Loan Agreement, as amended, we issued to the Lenders on the Loan Amendment Effective Date warrants to purchase an aggregate of 1,248,250 of our ordinary shares, at an exercise price of $10.00 per share. If we borrow the Third Tranche, we must issue to the Lenders, or their designees, one or more additional warrants to purchase a number of our ordinary shares equal to an aggregate of 0.20% of our ordinary shares outstanding following such issuance on a fully diluted basis (inclusive of the ordinary shares underlying all such

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warrants issued), at an exercise price equal to 110% of the closing price of our ordinary shares on the date immediately preceding the Third Tranche disbursement date. If we borrow the Fourth Tranche, we must issue to the Lenders, or their designees, one or more additional warrants to purchase a number of our ordinary shares equal to an aggregate of 0.25% of our ordinary shares outstanding following such issuance on a fully diluted basis (inclusive of the ordinary shares underlying all such warrants issued), at an exercise price equal to 140% of the 10-day volume weighted average price (“VWAP”) per ordinary share for the consecutive 10-day trading period ending on the trading day immediately prior to the Fourth Tranche disbursement date. Each of these warrants will be exercisable at any time prior to seven years following its issue date and will contain customary provisions for assumption or exchange upon a change of control or a sale of all or substantially all of our assets. The warrants were valued using the Black-Scholes Model resulting in a fair value of $7.7 million which was recorded as equity.

~~Due to a greater than 10% change in cash flows as compared to the original debt instrument, the loan amendment was accounted for as a debt extinguishment, which resulted in a~~ ~~$0.5 million loss during the three months ended March 31, 2018.~~

~~Future principal payments due under the Loan Agreement are as follows~~ ~~(in thousands)~~:

Principal

Payments

2018

$
—

2019

—

2020

—

2021

34,611

2022

34,611

2023

17,305

Total future payments

$
86,527

8. Commitments and contingencies

~~Lease obligations~~

On April 22, 2014, we entered into a 48‑month building lease for approximately 3,000 square feet of space in Radnor, Pennsylvania. The lease has annual rent escalations. We obtained access to this leased space on August 1, 2014, and this was considered the lease commencement date for accounting purposes. Thus, rent expense began on this date and is recognized on a straight‑line basis over the subsequent 48 months.

In March 2015, we entered into a 52‑month building sublease agreement for 14,743 square feet of office space in Trevose, Pennsylvania. The lease has annual rent escalations and is recognized on a straight‑line basis over the term of the lease. In November 2017, the Company entered into a 60‑month building lease agreement for an additional 7,326 square feet of office space in the same building in Trevose, Pennsylvania. The lease has annual rent escalations. We obtained access to this newly leased space on November 27, 2017, and this was considered the lease commencement date for accounting purposes. Thus, rent expense began on this date and is recognized on a straight‑line basis over the term of the lease. The lease provides for us the ability to continue leasing its currently subleased office space upon expiration of the sublease described above.

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~~As of March 31, 2018, future minimum commitments under facility operating leases were as follows (in thousands):~~

Operating

leases

2018

278

2019

439

2020

470

2021

481

2022

492

2023

207

Total minimum lease payments

$
2,367

~~Rent expense recognized under our operating lease was approximately $175,000 and $68,000 for the three months ended March 31, 2018 and 2017, respectively.~~

(a) Commitments to Taro Pharmaceuticals Industries Ltd.

In December 2016, we acquired the ~~United States~~ U.S. marketing rights to Keveyis (dichlorphenamide) from ~~a subsidiary of~~ Taro. Under the terms of ~~the~~an Asset Purchase Agreement, we paid Taro an upfront payment in two installments of $1 million in December 2016 and $7.5 million in March 2017, and will pay an aggregate of $7.5 million in potential milestones upon the achievement of certain product sales targets. Taro has agreed to continue to manufacture Keveyis for us under an exclusive supply agreement through the orphan exclusivity period. We are obligated to purchase certain annual minimum amounts of product totaling approximately $29 million over a six-year period. ~~The~~As of June 30, 2019, our remaining obligation was $22.1 million. Our Supply Agreement with Taro may extend beyond the orphan exclusivity period unless terminated by either party pursuant to the terms of the agreement. If terminated by Taro at the conclusion of the orphan exclusivity period, we have the right to manufacture the product on our own or have the product manufactured by a third party on our behalf. We are also required to reimburse Taro for their royalty obligation resulting from their sale of Keveyis to us.

~~Commitments~~(b) Indemnifications

In the ordinary course of business and in connection with the sale of assets and businesses and other transactions, we often indemnify our counterparties against certain liabilities that may arise in connection with the transaction or that are related to ~~Aeterna Zentaris GmbH~~

~~In January 2018, we acquired~~events and activities prior to or following a transaction, such as breaches of contracts, unfavorable tax consequences and employee liabilities. If the ~~U.S. and Canadian rights~~indemnified party were to ~~Macrilen (macimorelin) from~~ ~~Aeterna Zentaris GmbH.~~ ~~Under~~make a successful claim pursuant to the terms of the ~~License~~indemnification, we may be required to reimburse the loss and ~~Assignment Agreement, we paid Aeterna Zentaris GmbH $24 million, and will pay tiered royalties~~such amount could be material to our financial statements. Where appropriate, the obligation for such indemnifications is recorded as a liability. Because the amount of ~~15%-18% on net sales as well as an aggregate~~these types of $174 million in potential milestones upon achievement of certain product sales targets. Additionally, Aeterna Zentaris will remain responsible for a pediatric development program to support regulatory submission for approval with Strongbridge sharing oversight and paying for 70 percentindemnifications generally is not specifically stated, the overall maximum amount of the obligation under such indemnifications cannot be reasonably estimated. However, we believe that the likelihood of a material liability being triggered under these indemnification obligations is not probable at this time.

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8. Leases

We lease office space under operating leases. Our leases have initial lease terms ranging from one to five years. Our lease agreements contain provisions for future rent increases.

As of June 30, 2019, future minimum commitments under facility operating leases were as follows (in thousands):


	Operating
	leases

2019		207
2020		470
2021		481
2022		492
2023		207
Total minimum lease payments	$	1,857

The components of lease cost offor the ~~program, or approximately $4 million over a three-year period~~quarter ended June 30, 2019 are as ~~well as $5 million upon the regulatory approval for use in pediatric patients~~follows (in thousands):


		Six Months
		Ended
		June 30, 2019
Lease costs
Amortization of right of use assets	$	221
Interest on lease liabilities		64
Total lease cost	$	285

Amounts reported in the ~~U.S. and Canada. We~~Consolidated Balance Sheets for leases where we are ~~obligated to purchase certain amounts~~the lessee as of ~~product totaling $1.3 million over the next nine months.~~June 30, 2019 were as follows (in thousands):


		June 30, 2019
Operating Leases
Right of use asset	$	934
Lease liability	$	1,603

Remaining lease term
Operating leases		4 years

Discount rate
Operating leases		7.69%

9. Income taxes

Deferred tax assets and liabilities are recognized for the future tax consequences of differences between the carrying amounts and tax bases of assets and liabilities and operating loss carryforwards and other attributes using enacted rates expected to be in effect when those differences reverse. Valuation allowances are provided against deferred tax assets that are not more likely than not to be realized.

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We assess our ability to realize deferred tax assets. Changes in future earnings projections, among other factors, may cause us to adjust our valuation allowance on deferred tax assets. Any such adjustments would impact our income tax expense in the period in which it is determined that these factors have changed.

~~For~~We recorded income tax expense of $1.1 million for the six months ended June 30, 2019 and $0.4 million for the three months ended ~~March 31, 2018, we recorded full valuation allowances against our deferred tax asset and deferred tax liability, resulting in no income tax expense.~~

~~On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to~~June 30, 2019, as the Tax Cuts and Jobs Act (the “Tax Act”). The Tax Act makes broad and complex changes to the U.S. tax code, including, but not limited to, reducing the top U.S. federal corporate tax rate from 35 percent to 21 percent; requiring

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companies to pay a onetime transition tax on certain un-repatriated earnings of foreign subsidiaries; generally eliminating U.S. federal income taxes on dividends from foreign subsidiaries; requiring a current inclusion in U.S. federal taxable income of certain earnings of controlled foreign corporations; eliminating the corporate alternative minimum tax (AMT) and changing how existing AMT credits can be realized; creating the base erosion anti-abuse tax (BEAT), a new minimum tax; creating a new limitation on deductible interest expense; and changing rules related to uses and limitations of net operating loss carryforwards created in tax years beginning after December 31, 2017.

The Tax Act reduces our U.S. corporate income tax rate from 34% to 21%, effective January 1, 2018. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to reverse. As a result of tax liability expected in connection with the ~~reduction in the U.S. corporate income tax rate from 34% to 21% under the Tax Act, we revalued our ending net deferred tax assets and liabilities at December 31, 2017.~~

~~The Tax Act provided for a one-time transition tax on the deemed repatriation~~intercompany transfer of post-1986 undistributed foreign subsidiary earnings and profits (“E&P”). We did not have to recognize any income tax expense related to the transition tax as they own no controlled foreign corporations.intellectual property.

The global intangible low-taxed income tax and base erosion provisions are effective for taxable years beginning after December 31, 2017. We do not currently expect these provisions to have a material impact on ~~its~~our tax rate as ~~they~~we do not own any controlled foreign corporations and they are currently below the gross receipts threshold for purposes of the base erosion provisions.

10. ~~Ordinary shares~~

~~Equity transactions~~

On January 30, 2018, we sold 5,000,000 ordinary shares in a public offering at a price to the public of $6.75 per ordinary share for net proceeds of approximately $31.8 million, after deducting underwriting discounts and commissions and offering expenses payable by us.

On February 27, 2018, we sold an additional 255,683 ordinary shares to the underwriters of our January 2018 public offering in connection with their partial exercise of their option to purchase additional shares to cover over-allotments at a price of $6.75 per ordinary share for net proceeds of approximately $1.7 million, after deducting underwriting discounts and commissions and offering expenses payable by us.Warrants

Warrants

During the three months ended March 31, 2018, in connection with the CRG loan amendment, we issued warrants with a seven-year term to CRG to purchase 1,248,250 of our ordinary shares at an exercise price of $10.00.

Our outstanding warrants as of ~~March 31, 2018~~June 30, 2019 are as follows:


							Warrants							Warrants
							Outstanding							Outstanding
		Exercise		Expiration	Warrants	Warrants	March 31,		Exercise		Expiration	Warrants	Warrants	June 30,
	Classification	Price		Date	Issued	Exercised	2018	Classification	Price		Date	Issued	Exercised	2019
Warrants in connection with private equity placement	Liability	$	2.50	6/28/2022	7,000,000	—	7,000,000	Liability	$	2.50	6/28/2022	7,000,000	(1,970,000)	5,030,000
Warrants in connection with Horizon and Oxford loan agreement	Equity	$	2.45	12/28/2026	428,571	(267,857)	160,714	Equity	$	2.45	12/28/2026	428,571	(267,857)	160,714
Warrants in connection with CRG loan agreement	Equity	$	7.37	7/14/2024	394,289	—	394,289	Equity	$	7.37	7/14/2024	394,289	—	394,289
Warrants in connection with CRG loan amendment in January 2018	Equity	$	10.00	1/16/2025	1,248,250	—	1,248,250	Equity	$	10.00	1/16/2025	1,248,250	—	1,248,250
					9,071,110		8,803,253					9,071,110		6,833,253

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11. Stock‑based compensation

Our board of directors has adopted the 2017 Inducement Plan (the “Inducement Plan”). The Inducement Plan provides for the grant of equity-based awards to new employees. The purpose of the Inducement Plan is to attract valued employees by offering them a greater stake in our success and a closer identity with us, and to encourage ownership of our ordinary shares by such employees. The Inducement Plan became effective on February 23, 2017. As of ~~March 31, 2018, 1,147,200~~June 30, 2019, 688,887 shares are available for issuance pursuant to the Inducement Plan.

Our board of directors has adopted, and our shareholders have approved, the 2015 Equity Compensation Plan (the “2015 Plan”). The 2015 Plan provides for the grant of incentive stock options to our employees and any parent or subsidiary ~~corporations’~~corporation’s employees, and for the grant of nonstatutory stock options, stock awards, and ~~restricted stock units~~RSUs to our employees, directors and consultants and our parent or subsidiary corporations’ employees and consultants. The 2015 Plan became effective on September 3, 2015. As of ~~March 31, 2018, 203,006~~June 30, 2019, 274,542 shares are available for issuance pursuant to the 2015 Plan.

Our board of directors has adopted, and our shareholders have approved, the Non‑Employee Director Equity Compensation Plan (the “Non‑Employee Director Plan”). The Non‑Employee Director Plan provides for the grant of nonstatutory stock options, stock awards, and ~~restricted stock units~~RSUs to our non‑employee directors. The Non‑Employee Director Plan became effective on September 3, 2015. As of ~~March 31, 2018, 201,541~~June 30, 2019, 32,151 shares are available for issuance pursuant to the Non‑Employee Director Plan.

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A summary of our outstanding stock options as of ~~March 31, 2018~~June 30, 2019 is as follows:


	Options Outstanding						Options Outstanding
				Weighted-						Weighted-
				Average						Average
		Weighted-		Remaining				Weighted-		Remaining
		Average		Contractual				Average		Contractual
	Number of	Exercise		Term	Aggregate		Number of	Exercise		Term	Aggregate
	Shares	Price		(Years)	Intrinsic Value		Shares	Price		(Years)	Intrinsic Value
					(in thousands)						(in thousands)
Outstanding—January 1, 2018	6,104,715	$	7.50	7.70	$	14,021
Outstanding—January 1, 2019							8,579,511	$	7.35	7.57	$	3,281
Granted	1,943,255	$	6.69				1,989,900	$	4.52
Forfeited and cancelled	(62,556)	$	12.22				(284,412)	$	6.07
Exercised	(24,945)	$	2.39				(43,841)	$	4.12
Outstanding—March 31, 2018	7,960,469	$	7.28	8.08	$	24,837
Vested and exercisable—March 31, 2018	2,423,543	$	10.41	5.74	$	5,172
Outstanding—June 30, 2019							10,241,158	$	6.85	7.55	$	469
Vested and exercisable—June 30, 2019							5,004,978	$	8.31	6.39	$	224

Included in the stock options outstanding at March 31, 2018 are unvested stock options to purchase 88,908 shares at a weighted average exercise price of $18.80 per share for which the vesting of certain tranches will accelerate if the fair value per share of our stock reaches $31.46. In addition, the options outstanding as of March 31, 2018 include 97,652 shares that vest upon a market appreciation event, so long as it occurs prior to the date specified in the applicable award agreement and 97,652 shares that will vest upon the one year anniversary of the market appreciation event. The market appreciation event, which had not yet occurred as of March 31, 2018, is defined as the last trading day in the period in which our closing stock price on each of 20 consecutive trading days reported on Nasdaq has been at least $30.14 or $33.66 for the respective grantee.

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Stock‑based compensation expense

We recognized stock‑based compensation expense for employees and directors for stock options and RSUs as follows (in thousands):


	Three Months Ended				Three Months Ended				Six Months Ended
	March 31,				June 30,				June 30,
	2018		2017		2019		2018		2019		2018
Selling, general and administrative	$	1,280	$	216	$	1,966	$	1,521	$	3,764	$	2,801
Research and development		408		953		606		464		1,131		872
Total stock-based compensation	$	1,688	$	1,169	$	2,572	$	1,985	$	4,895	$	3,673

As of ~~March 31, 2018,~~June 30, 2019, the total unrecognized compensation expense related to unvested stock options, net of estimated forfeitures, is ~~$17.9~~$16.9 million, which we expect to recognize over an estimated weighted‑average period of ~~3.23~~2.82 years.

In determining the estimated fair value of our service-based awards, we use the Black‑Scholes option‑pricing model and assumptions discussed below. Each of these inputs is subjective and generally requires significant judgment. The fair value of our service-based awards that were granted during the years was estimated with the following assumptions:


	Three Months Ended		Six Months Ended
	March 31,		June 30,
	2018	2017	2019	2018
Expected term (in years)	6.08	6.09	6.10	6.12
Risk-free interest rate	2.25% - 2.71%	1.98% - 2.26%	1.98% - 2.61%	2.25% - 2.96%
Expected volatility	85.00%	81.1% - 81.8%	78.70% - 80.85%	78.19% - 85%
Dividend rate	—%	—%	—%	—%

Restricted ~~Stock Units~~stock units

Our board of directors have approved grants of ~~restricted stock units (“RSUs”)~~RSUs to employees. These RSUs vest two years from the date of issuance, provided that the employee is employed by us on such vesting date. All RSUs will fully vest upon a change of control of our company. If and when the RSUs vest, we will issue one ordinary share for each whole RSU that has vested, subject to satisfaction of the executive’s tax withholding obligations. The RSUs will cease to be outstanding upon such issuance of ordinary shares. We recorded expense, which is included in the stock-based compensation table above, of ~~$149,000~~$533,000 and ~~$88,000~~$115,000 for the three months ended ~~March 31,~~June 30, 2019 and 2018, respectively, and ~~2017,~~$771,000 and $264,000

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for the six months ended June 30, 2019 and 2018, respectively. As of ~~March 31, 2018,~~June 30, 2019, the total unrecognized compensation expense related to unvested RSUs is ~~$0.7~~$3.2 million, which we expect to recognize over an estimated weighted‑average period of ~~1.58~~1.4 years.

A summary of our unvested RSUs as of ~~March 31, 2018~~June 30, 2019 is as follows:


		Number of
		Shares
Outstanding—January 1, ~~2018~~2019		~~267,250~~143,100
Granted		~~60,150~~891,000
Forfeited		—(32,250)
Vested		~~(154,000)~~(37,000)
Unvested—~~March 31, 2018~~June 30, 2019		~~173,400~~964,850

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

The following discussion and analysis should be read in conjunction with our interim unaudited consolidated financial statements and related notes for the three and six months ended ~~March 31, 2018~~June 30, 2019 included elsewhere in this Quarterly Report on 10-Q (this “Quarterly Report”) and the audited financial statements and related notes for the year ended December 31, ~~2017~~2018 and related Management’s Discussion and Analysis of Financial Condition and Results of Operations that are included in our Annual Report on Form 10-K for the fiscal year ended December 31, ~~2017~~2018 (the ~~“2017~~“2018 Annual Report”) filed with the Securities and Exchange Commission (“SEC”) on ~~March 12, 2018.~~February 27, 2019. As used in this Quarterly Report, unless the context suggests otherwise, “we,” “us,” “our,” or “Strongbridge” refer to Strongbridge Biopharma plc.

Special Note Regarding Forward-Looking Statements

This Quarterly Report contains forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, prospective products, size or market or patient population, plans, objectives of management and expected market growth are forward-looking statements. The words “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.

By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics, and healthcare, regulatory and scientific developments and depend on the economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this Quarterly Report. In addition, even if our results of operations, financial condition and liquidity, and the development of the industry in which we operate are consistent with the forward-looking statements contained in this Quarterly Report, they may not be predictive of results or developments in future periods.

Any forward-looking statement that we make in this Quarterly Report speaks only as of the date of such statement, and we undertake no obligation to update such statements to reflect events or circumstances after the date of

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this Quarterly Report except as required by law. You should also read carefully the factors described in the “Risk Factors” section of our ~~2017~~2018 Annual Report and this Quarterly Report to better understand the risks and uncertainties inherent in our business and underlying any forward-looking statements.

Overview

We are a global, commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs.

Our first commercial product is Keveyis (dichlorphenamide), the first and only treatment approved by the U.S. Food and Drug Administration ~~(the “FDA”~~(“FDA”) for hyperkalemic, hypokalemic, and related variants of primary periodic paralysis (“PPP”), a group of rare hereditary disorders that cause episodes of muscle weakness or paralysis.

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~~deficiency (“AGHD”). In January 2018, we acquired the U.S. and Canadian rights to Macrilen and we expect to launch Macrilen in the United States in mid-2018.~~

We are building a rare disease, franchise-based business model focused on expansion through a disciplined in-licensing and acquisition strategy. ~~In pursuit of our growth strategy, we have raised over $275 million in equity and debt financings since December 2014.~~ We will continue to identify and evaluate the acquisition of products and product candidates for licensing or acquisition that would be complementary to our existing rare neuromuscular and endocrine franchises or that would form the basis for new rare disease franchises. We believe this approach will enable us to maximize our commercial potential by further leveraging our existing resources and expertise.

In December 2017, we received letters from the offices of ~~United States~~U. S. Senators Amy Klobuchar, Susan Collins and Tammy Baldwin, and Senator Claire McCaskill, Ranking Member of the Homeland Security and Governmental Affairs Committee, ~~requesting~~that requested information relating to the marketing and sales of ~~Keveyis. The letters request information~~Keveyis principally relating to the pricing of ~~Keveyis, among other things.~~Keveyis. We ~~are cooperating~~have cooperated with these voluntary requests for ~~information.~~information, as well as additional follow-up requests in 2018.

Recent Developments

In March 2019, we conducted a Type C meeting with the Division of Metabolic and Endocrine Products (DMEP) of the FDA. DMEP stated in its meeting minutes that the FDA generally requests that a sponsor conduct two adequate and well-controlled clinical studies for the proposed indication of a drug candidate under 21 CFR 314.126(b)(2). DMEP also noted that the FDA recognizes situations when a single trial may be sufficient. DMEP reiterated that the characteristics of an “adequate and well-controlled” investigation under 21 CFR 314.126 include the use of a control group (e.g., placebo concurrent control, dose-comparison concurrent control), randomization and evaluation of primary endpoints that directly measure clinical benefits, or supported by evidence of clinical benefit. For this reason, while DMEP indicated that it would consider, as a review issue, the adequacy of a New Drug Application (NDA) submission with data from the SONICS trial as the sole Phase 3 evidence supporting the efficacy of RECORLEV, DMEP nonetheless recommended that we complete the LOGICS trial (which is double-blinded, randomized and placebo-controlled) and include the results from the LOGICS trial in addition to data from the SONICS trial in our NDA submission. We currently expect to receive LOGICS top-line data at the end of the first quarter of 2020

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and, if supported by the data, submit an NDA for Recorlev in the third quarter of 2020 that will include data from each of the SONICS and LOGICS trials. In addition, the DMEP stated in its meeting minutes that our clinical pharmacology program for Recorlev, as described to them, appears reasonable to support an NDA filing for Recorlev provided that the data generated are found to be suitable.

Financial Operations Overview

The following discussion sets forth certain components of our statements of operations as well as factors that impact those items.

Net ~~Revenue~~Product Sales

We sell Keveyis to one specialty pharmacy provider (the “Customer”), who is the exclusive distributor of Keveyis in the United States. The Customer subsequently resells Keveyis to patients, which are covered by payors that may provide for government-mandated or privately negotiated rebates with respect to the purchase of the Keveyis.

~~We recognize revenues~~Revenues from sales of ~~Keveyis when we satisfy~~our products are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established and that result from rebates, co-pay assistance and other allowances that are offered by us and the patients’ payors. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to our customer) or a ~~performance obligation by transferring control~~current liability (if the amount is payable to a party other than our customer). Where appropriate, these estimates may take into consideration a range of ~~Keveyis to the Customer. Transfer of control occurs upon receipt of Keveyis by the Customer. We expense incremental costs related to the set-up~~possible outcomes that are probability-weighted for relevant factors such as our historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Overall, these reserves reflect our best estimates of the ~~contract with~~amount of consideration to which we are entitled based on the ~~Customer when incurred, as these costs did not meet~~terms of the ~~criteria~~contract. For a complete discussion of accounting for ~~capitalization.~~net product revenue, see Note 3, "Revenue recognition" to our consolidated financial statements.

~~We expect to launch~~Royalty Revenues

Royalty revenues are from commercial sales of Macrilen ~~in the United States in mid-2018 and will recognize revenue in~~ ~~accordance with the Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 606,~~ ~~Revenue Recognition.~~by Novo, based on net sales.

Cost of Sales

Cost of sales includes third-party acquisition costs, third-party warehousing and product distribution charges.

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Selling, General and Administrative Expenses

Selling, general and administrative expenses include personnel costs, costs for outside professional services and other allocated expenses. Personnel costs consist of salaries, bonuses, benefits, travel and stock‑based compensation. Outside professional services consist of legal, accounting and audit services, commercial evaluation and strategy services, sales, marketing and other consulting services. ~~We expect to incur additional selling, general and administrative costs as a result of our initial and on-going commercial activities in support of Keveyis and our commercial launch of Macrilen.~~

Research and Development Expenses

Our research and development expenses consist primarily of costs incurred in connection with the development of our product candidates, including:

personnel‑related costs, such as salaries, bonuses, benefits, travel and other related expenses, including stock‑based compensation;

expenses incurred under our agreements with contract research organizations, ~~(“CROs”),~~ clinical sites, contract laboratories, medical institutions and consultants that plan and conduct our preclinical studies and clinical trials, including, in the case of consultants, stock‑based compensation;

costs associated with regulatory filings;

upfront and milestone payments under in‑license or acquisition agreements with third parties;

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costs of acquiring preclinical study and clinical trial materials, and costs associated with formulation and process development; and

depreciation, maintenance and other facility‑related expenses.

We expense all research and development costs as incurred. Clinical development expenses for our product candidates are a significant component of our current research and development expenses as we progress our product candidates into and through clinical trials. Product candidates in later ~~stage~~stages of clinical development generally have higher research and development costs than those in earlier stages of development, primarily due to increased size and duration of the clinical trials. We recognize costs for each grant project, preclinical study or clinical trial that we conduct based on our evaluation of the progress to completion, including the use of information and data provided to us by clinical sites and our external research and development vendors.

We expect our research and development expenses to increase in absolute dollars in the future as we continue to in‑license or acquire product candidates and as we advance our existing and any future product candidates into and through clinical trials and pursue regulatory approval ofto market our product candidates. The process of conducting the necessary clinical research to obtain regulatory marketing approval of a product candidate is costly and time consuming. The probability that any of our product candidates receives regulatory marketing approval and eventually is able to generate revenue depends on a variety of factors, including the quality of our product candidates, early clinical data, investment in our clinical program, competition, manufacturing capability and commercial viability. As a result of these uncertainties, we are unable to determine the duration and completion costs of our research and development projects or if, when and to what extent we will generate revenue from the commercialization and sale of any of our product candidates, if approved. We may never succeed in achieving regulatory approval for any of our product candidates.

We do not allocate personnel‑related research and development costs, including stock‑based compensation or other indirect costs, to specific programs, as they are deployed across multiple projects under development.

~~Interest Expense~~

~~Interest expense represents interest paid to our lender, amortization of our debt discount, and issuance costs associated with loan and security agreements.~~

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Amortization of Intangible Assets

Amortization of intangible ~~asset~~assets relates to the amortization of our product rights to ~~Keveyis and Macrilen. Both~~Keveyis. This intangible ~~assets are~~asset is being amortized over an eight-year period using the straight-line ~~method, using an amortization period of eight-years for Keveyis and ten-years for Macrilen.~~method.

Other ~~Expense,~~Income, Net

Other ~~expense,~~income, net, consists of unrealized loss on the remeasurement of the fair value of warrant liability, interest ~~expense recognized on our long-term debt, the loss on the extinguishment of our pre-existing long-term debt, interest~~ income generated from our cash and cash equivalents, foreign exchange gains, ~~and~~ losses and gains and losses on investments.

~~Our consolidated financial statements are reported~~ We record income and expenses relating to NNI service agreement to fund the costs of 23 of our field-based employees to provide full-time ongoing services to NNI, including the promotion of Macrilen in ~~U.S. dollars, which is also our functional currency. Transactions in foreign currencies are remeasured into our functional currency at~~ the ~~rate~~United States, for a period of exchange prevailing at the date of the transaction. Any monetary assets and liabilities arising from these transactions are remeasured into our functional currency at exchange rates prevailing at the balance sheet date or on settlement. Resulting gains and losses are recorded in foreign currency loss in other income (expense) in our consolidated statements of operations.three years beginning December 2018.

Critical Accounting Policies and Significant Judgments and Estimates

This management’s discussion and analysis ~~operating and financial review~~ of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The preparation of these consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the 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.

We believe there have been no significant changes in our critical accounting policies and significant judgments and estimates as discussed in “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” ~~included in~~of our ~~2017~~2018 Annual Report.

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Results of Operations

Comparison of the Three and Six Months Ended ~~March 31, 2018~~June 30, 2019 and ~~2017~~2018.

The following table sets forth our results of operations for the three and six months ended ~~March 31, 2018~~June 30, 2019 and ~~2017.~~2018.


	Three Months Ended						Three Months Ended						Six Months Ended
	March 31,				Change		June 30,				Change		June 30,				Change
	2018		2017		$		2019		2018		$		2019		2018		$
	(in thousands)						(in thousands)						(in thousands)
Revenues:
Net product sales	$	3,870	$	—	$	3,870	$	6,073	$	4,296	$	1,777	$	10,406	$	8,166	$	2,240
Royalty revenues								6		—		6		16		—		16
Total revenues		3,870		—		3,870		6,079		4,296		1,783		10,422		8,166		2,256

Cost and operating expenses:
Cost of sales (excluding amortization of intangible assets)	$	667	$	—	$	667	$	1,022	$	753	$	269	$	1,835	$	1,420	$	415
Selling, general and administrative		12,362		7,442		4,920		12,182		15,210		(3,028)		24,282		27,572		(3,290)
Research and development		4,881		3,481		1,400		8,739		5,453		3,286		15,322		10,334		4,988
Amortization of intangible assets		1,769		1,256		513		1,255		1,872		(617)		2,511		3,641		(1,130)
Total cost and expenses		19,679		12,179		7,500		23,198		23,288		(90)		43,950		42,967		983
Operating loss		(15,809)		(12,179)		(3,630)		(17,119)		(18,992)		1,873		(33,528)		(34,801)		1,273
Other expense, net		(12,914)		(15,712)		2,798
Other income, net								9,272		16,070		(6,798)		7,924		3,156		4,768
Loss before income taxes		(28,723)		(27,891)		(832)		(7,847)		(2,922)		(4,925)		(25,604)		(31,645)		6,041
Income tax expense		—		(1,594)		1,594		(400)		(1)		(399)		(1,077)		(1)		(1,076)
Net loss	$	(28,723)	$	(29,485)	$	762	$	(8,247)	$	(2,923)	$	(5,324)	$	(26,681)	$	(31,646)	$	4,965

~~Net Revenue~~Revenues and Cost of Sales

Net revenue ~~of $3.9~~was $6.1 million ~~for the three ended March 31, 2018~~ and cost of sales ~~of $0.7~~were $1.0 million for the three months ended ~~March 31, 2018, resulted from commercial~~June 30, 2019, an increase of $1.8 million and $0.3 million, respectively, compared to the three months ended June 30, 2018. The increase was due to the continued sales growth of Keveyis, which wewas launched in April 2017.

Net revenue was $10.4 million and cost of sales were $1.8 million for the six months ended June 30, 2019, an increase of $2.2 million and $0.4 million, respectively, compared to the six months ended June 30, 2018. The increase is was to the continued sales growth of Keveyis, which was launched in April 2017.

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Selling, General and Administrative Expenses

The following table summarizes our selling, general and administrative expenses during the three and six months ended ~~March 31, 2018~~June 30, 2019 and ~~2017:~~2018:


	Three Months Ended						Three Months Ended						Six Months Ended
	March 31,				Change		June 30,				Change		June 30,				Change
	2018		2017		$		2019		2018		$		2019		2018		$
	(in thousands)						(in thousands)						(in thousands)
Compensation and other personnel costs	$	5,572	$	1,902	$	3,670	$	6,133	$	6,443	$	(310)	$	11,996	$	12,015	$	(19)
Outside professional and consulting services		5,241		4,502		739		3,841		7,039		(3,198)		8,001		12,280		(4,279)
Stock-based compensation expense		1,280		952		328		1,981		1,521		460		3,792		2,801		991
Facility costs		269		86		183		227		207		20		493		476		17
Total selling, general and administrative expenses	$	12,362	$	7,442	$	4,920	$	12,182	$	15,210	$	(3,028)	$	24,282	$	27,572	$	(3,290)

Selling, general and administrative expenses were ~~$12.4~~$12.2 million for the three months ended ~~March 31, 2018, an increase~~June 30, 2019, a decrease of ~~$4.9~~$3.0 million compared to the three months ended ~~March 31, 2017. Compensation~~June 30, 2018. Outside professional and ~~related personnel costs increased by $3.7~~consulting services decreased $3.2 million during the three months ended ~~March 31, 2018,~~June 30, 2019, primarily due to ~~increased headcount of commercial personnel for commercialization of Keveyis and planned~~Macrilen launch preparation activities during the three months ended June 30, 2018 in connection with the launch of ~~Macrilen.~~Macrilen in July 2018.

Selling, general and administrative expenses were $24.3 million for the six months ended June 30, 2019, a decrease of $3.3 million compared to the six months ended June 30, 2018. Outside professional and consulting services ~~increased $0.7 million due to expenses relating to the commercialization of Keveyis and planned launch of Macrilen. Stock-based compensation expense increased by $0.3~~decreased $4.3 million during the ~~2018 period~~six months ended June 30, 2019, primarily due to ~~granting~~Macrilen pre-launch preparation activities in the first half of ~~new awards to new employees and facility costs increased due to the new lease entered into in November 2017.~~

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2018.

Research and Development Expenses

The following table summarizes our research and development expenses during the three and six months ended ~~March 31, 2018~~June 30, 2019 and ~~2017:~~2018:


	Three Months Ended						Three Months Ended						Six Months Ended
	March 31,				Change		June 30,				Change		June 30,				Change
	2018		2017		$		2019		2018		$		2019		2018		$
	(in thousands)						(in thousands)						(in thousands)
Product development and supporting activities	$	3,223	$	2,486	$	737	$	6,652	$	3,828	$	2,824	$	11,387	$	7,051	$	4,336
Compensation and other personnel costs		1,250		778		472		1,495		1,162		333		2,831		2,412		419
Stock-based compensation expense		408		217		191		592		463		129		1,104		871		233
Total research and development expenses	$	4,881	$	3,481	$	1,400	$	8,739	$	5,453	$	3,286	$	15,322	$	10,334	$	4,988

Research and development expenses were ~~$4.9~~$8.7 million for the three months ended ~~March 31, 2018,~~June 30, 2019, an increase of ~~$1.4~~$3.3 million compared to the three months ended ~~March 31, 2017.~~June 30, 2018. The ~~$0.7~~$2.8 million increase in expenses for product development and supporting activities was primarily due to additional clinical development expenses for Recorlev. ~~Compensation~~

Research and ~~other personnel costs increased by $0.5~~development expenses were $15.3 million for the ~~three~~six months ended ~~March 31, 2018 as~~June 30, 2019, an increase of $5.0 million compared to the ~~same period~~six months ended June 30, 2018. The $4.3 million increase in ~~2017~~expenses for product development and supporting activities was primarily due to ~~increased headcount in research and development. Stock-based compensation expense increased by $0.2 million~~additional clinical development expenses for ~~the three months ended March 31, 2018 as compared to the same period in 2017 due to the granting~~Recorlev.

Table of ~~new awards.~~ Contents

Amortization of Intangible Assets

Amortization of intangible assets was ~~$1.8~~$1.3 million ~~an increase of $0.5~~and $2.5 million for the three and six months ended ~~March 31, 2018 compared to the three months ended March 31, 2017,~~June 30, 2019, respectively, a decrease of $0.6 million and $1.1 million respectively, due to the ~~commencement of~~prior year including amortization of the intangible asset related to Macrilen, ~~product~~the rights ~~that~~to which we ~~acquired~~sold in ~~January~~December 2018.

Other ~~Expense,~~Income, Net

The following table summarizes our other ~~expense,~~income, net, during the three and six months ended ~~March 31, 2018~~June 30, 2019 and ~~2017:~~2018:

Three Months Ended


March 31,

Change

2018

2017

$

(in thousands)

Unrealized loss on fair value of warrants

$
(9,700)

$
(14,928)

$
5,228

Interest expense

(2,874)

(737)

(2,137)

Foreign exchange loss

(20)


(12)


(8)

Loss on extinguishment of debt

(500)

—

(500)

Other income (expense), net

180

(35)

215

Total other expense, net

$
(12,914)

$
(15,712)

$
2,798


	Three Months Ended						Six Months Ended
	June 30,				Change		June 30,				Change
	2019		2018		$		2019		2018		$
	(in thousands)						(in thousands)
Income from field services agreement	$	1,725	$	—	$	1,725	$	3,741	$	—	$	3,741
Expense from field services agreement		(1,758)		—		(1,758)		(3,987)		—		(3,987)
Unrealized gain on fair value of warrants		8,697		19,017		(10,320)		6,877		9,317		(2,440)
Interest expense		—		(3,289)		3,289		—		(6,163)		6,163
Loss on extinguishment of debt		—		—		—		—		(500)		500
Other income, net		608		342		266		1,293		502		791
Total other income, net	$	9,272	$	16,070	$	(6,798)	$	7,924	$	3,156	$	4,768

Other ~~expense,~~income, net, decreased by ~~$2.8~~$6.8 million for the three months ended ~~March 31, 2018~~June 30, 2019 as compared to the three months ended ~~March 31, 2017.~~June 30, 2018. The decrease was primarily due to a ~~$5.2~~$10.3 million change in the unrealized gain on the fair value of our warrant liability in ~~2018~~2019, offset in part by a $3.3 million change in interest expense in 2019. In addition, during 2019, we incurred $1.8 million of expenses relating to our field-based service agreement with NNI and recorded $1.7 million of related income.

Other income, net, increased by $4.8 million for the six months ended June 30, 2019 as compared to ~~$14.9~~the six months ended June 30, 2018. The increase was primarily due to a $6.2 million decrease in interest expense, offset in part by a $2.4 million change in the unrealized gain on the fair value of our warrant liability ~~for the three months ended March 31, 2017. The change~~ in ~~the warrant liability is primarily due to changes in our stock price, offset in part by a $2.1 million increase in interest expense and $0.5~~2019. In addition, we incurred $4.0 million of ~~expense~~expenses relating to ~~the loss on the extinguishment~~our field based service agreement with NNI and recorded $3.7 million of ~~debt.~~

~~Income Tax~~

~~We recorded no income tax expense for the three months ended March 31, 2018 as a result of recording full valuation allowances against our deferred tax asset and deferred tax liability.~~related income.

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Income Tax

We recorded income tax expense of $1.1 million for the six months ended June 30, 2019 and $0.4 million for the three months ended June 30, 2019, as a result of tax liability expected in connection with the intercompany transfer of intellectual property.

Cash Flows

Comparison for the ~~Three~~Six Months Ended ~~March 31, 2018~~June 30, 2019 and ~~2017:~~2018:


	Three Months Ended				Six Months Ended
	March 31				June 30
	2018		2017		2019		2018
	(in thousands)				(in thousands)
Net cash provided by (used in):
Net cash (used in) provided by:
Operating activities	$	(18,019)	$	(9,289)	$	(36,411)	$	(32,548)
Investing activities		(24,655)		(7,500)		(33)		(24,965)
Financing activities		77,569		(150)		121		85,517
Net increase (decrease) in cash and cash equivalents	$	34,895	$	(16,939)
Net (decrease) increase in cash and cash equivalents					$	(36,323)	$	28,004

Operating Activities

Net cash used in operating activities was ~~$18.0~~$36.4 million for the ~~three~~six months ended ~~March 31, 2018~~June 30, 2019 compared to ~~$9.3~~$32.5 million for the ~~three~~six months ended ~~March 31, 2017. The increase in net cash used in operating activities resulted primarily from investments during 2018 to support the commercialization of Keveyis and the launch of Macrilen.~~June 30, 2018.

Investing Activities

~~Net cash used in investing activities was $24.7 million for the three months ended March 31, 2018 compared to $7.5 million for the three months ended March 31, 2017.~~ The ~~increase~~decrease in net cash used in investing activities resulted from the ~~$24~~$24.7 million payment made to Aeterna Zentaris GmbH in 2018 for our acquisition of Macrilen and other expenses incurred with the acquisition.

Financing Activities

Net cash provided by financing activities was $77.6 million for the three months ended March 31, 2018 compared to net cash used in financing activities for the three months ended March 31, 2017 of $0.2 million. The ~~increase~~decrease in net cash provided by financing ~~activity~~activities resulted primarily from our receipt of ~~$44.9~~$44.4 million in proceeds from the amendment to our senior credit facility with CRG Servicing LLC (“CRG”) and ~~$33.5~~$41.1 million in proceeds from our issuance of ordinary ~~shares.~~shares for the six months ended June 30, 2018.

Liquidity and Capital Resources

~~Our~~We believe that our cash resources of $86.2 million at June 30, 2019 will be sufficient to allow us to fund planned operations ~~have been financed primarily by net proceeds from~~for at least 12 months beyond the issuance date of ordinary shares and the issuance of debt. Our primary uses of capital have been costs incurred in connection with the acquisition of marketing rights for Keveyis and Macrilen, third‑party expenses associated with the commercialization of Keveyis, the planning and conduct of clinical trials, costs of process development services and manufacturing of our product candidates, and compensation‑related expenses. We expect our funding requirements for operating activities to increase in 2018 and possibly beyond due to expenses associated with the commercialization of Keveyis and Macrilen, the execution of our Phase 3 SONICS and LOGICS clinical trials for Recorlev, and selling, general and administrative expenses. We also expect our cash needs to increase to fund potential in‑licenses, acquisitions or similar transactions as we pursue our business strategy. These expenses may be offset in part by sales of Keveyis and Macrilen. In addition, beginning March 2021, we may be required to make quarterly principal payments to repay amounts borrowed under our credit facility.these financial statements.

Cash used to fund operating expenses is affected by the timing of when we ~~pay expenses,~~are invoiced by our vendors, as reflected in the change in our outstanding accounts payable and accrued expenses set forth in the financial statements, included in this Quarterly Report. We believe that our cash resources will be sufficient to allow us to fund planned operations for at least 12 months beyond the issuance date of the financial statements, which is after the expected receipt of data from the Recorlev SONICS and LOGICS Phase 3 clinical trials.

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Our future funding requirements will depend on many factors, including the following:

the amount of revenue that we receive from sales of Keveyis and royalty revenues from Macrilen;

the cost and timing of establishing sales, marketing, distribution and administrative capabilities;

the scope, rate of progress, results and cost of our clinical trials testing and other related activities for Recorlev and veldoreotide;

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~~whether we borrow any additional amounts under our credit facility;~~

the number and characteristics of product candidates that we pursue, including any additional product candidates we may in‑license or acquire;

the cost of filing, prosecuting, defending and enforcing 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 product candidates;

the cost, timing and outcomes of regulatory approvals;

the terms and timing of any collaborative, licensing and other arrangements that we may establish, including any required milestone and royalty payments thereunder; and

the emergence of competing technologies and their achieving commercial success before we do or other adverse market developments.

~~As of March 31, 2018, we held cash and cash equivalents of $92.4 million.~~

The loan and security agreement contains financial and non-financial covenants including minimum amounts of net revenue we must achieve in 2017 and beyond. Failure to comply with the covenants could result in the lenders declaring the loan immediately due and payable. Our liquidity requirements are predicated on maintaining compliance with the debt covenants and repaying outstanding borrowings in accordance with the loan agreement. See Note 7 of the financial statements included in this Quarterly Report for additionally information concerning the Loan Agreement, as amended.

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~~Our ability to achieve and maintain profitability is dependent upon the successful commercialization of Keveyis~~ ~~and Macrilen, the development, regulatory approval and commercialization of our product candidates and achieving a level of revenues adequate to support our cost structure.~~ We may never achieve profitability, and unless and until we do, we will continue to need to raise additional capital. ~~If we need to raise additional capital to fund our operations and complete our ongoing and planned clinical trials, funding may not be available to us on acceptable terms, or at all.~~

We plan to continue to fund our operations and capital funding needs through equity or debt financing along with revenues from Keveyis and royalty revenues from ~~and~~ Macrilen. The sale of additional equity would result in additional dilution to our shareholders. The incurrence of debt financing would result in debt service obligations and the instruments governing such debt could provide for operating and financing covenants There can be no assurances, however, that ~~would restrict our operations. If we are not able to secure adequate~~ additional funding ~~we may~~will be ~~forced~~available on terms acceptable to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible or suspend or curtail planned programs. In addition, lack of funding would limit any strategic initiatives to in‑license or acquire additional product candidates or programs.us.

~~Contractual Obligations and Other Commitments~~

~~The following table summarizes our future minimum commitments at March 31, 2018:~~

Payments due by period


Less than





More than


1 year

1 to 3 years

3 to 5 years

5 years

Total

(in thousands)

Minimum contract purchases pursuant to supply agreement

$
3,293

$
13,820

$
7,835

$
—

$
24,948

Debt payments

$
—

$
34,611

$
51,916

$
—

$
86,527

Operating leases

$
390

$
1,399

$
578

$
—

$
2,367

Total contractual obligations

$
3,683

$
49,830

$
60,329

$
—

$
113,842

We enter into agreements in the normal course of business with vendors for clinical trials, preclinical studies, and other services and products for operating purposes. Future payment obligations under these agreements, which are cancelable at any time by us, generally upon 30 days prior written notice, are not included in this table of contractual obligations.

We are obligated to make future payments to third parties due to payments that become due and payable upon the achievement certain commercialization milestones. As the amount and timing of these milestones are not probable and estimable, such commitments have not been included on our consolidated balance sheets or in the contractual obligations table above.

Off‑Balance Sheet Arrangements

We do not have variable interests in variable interest entities or any off‑balance sheet arrangements.

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ITEM 3. Quantitative and Qualitative Disclosures about Market Risk

~~We are exposed~~There have been no material changes to ~~certain~~our market ~~risks in the ordinary course of our business. These risks primarily include interest rate sensitivities as follows:~~

~~Interest Rate Risk~~

~~We had cash and cash equivalents of $92.4 million as March~~risk exposures since December 31, 2018. Our cash and cash equivalents are held in a variety of interest‑earning instruments, including money market funds. Such interest‑earning instruments carry a degree of interest rate risk. To date, fluctuations in interest income have not been significant. We also had total outstanding long-term debt principal of $86.5 million as of March 31, 2018, none of which was due within 12 months. The interest rate of our borrowings under the term loan agreement with CRG is fixed. A hypothetical 10% change in interest rates during any of the periods presented would not have had a material impact on our financial statements.

ITEM 4. Controls and Procedures

Evaluation of Disclosure 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 Securities Exchange Act of 1934, as amended (the “Exchange ~~Act’~~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.

Our management, under the supervision and with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures as of ~~March~~June 30, ~~2018,~~2019, the end of the period covered by this Quarterly Report. Based on ~~their~~that evaluation, ~~we believe~~our principal executive officer and principal financial officer concluded that our disclosure controls and procedures as of ~~March~~June 30, ~~2018~~2019 were effective to provide reasonable assurance that the information required to be disclosed by us in reports filed or submitted under the Exchange Act, 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 timely decisions regarding required disclosure.

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Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting that occurred during the fiscal quarter ended ~~March 31, 2018~~ June 30, 2019 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II – OTHER INFORMATION

ITEM 1. Legal Proceedings

The Company is not currently involved in any legal matters arising in the normal course of business. From time to time, the Company could become involved in disputes and various litigation matters that arise in the normal course of business. These may include disputes and lawsuits related to intellectual property, licensing, contract law and employee relations matters.

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ITEM 1A. Risk Factors

The risks described in Item 1A. Risk Factors of our ~~2017~~2018 Annual Report could materially and adversely affect our business, financial condition and results of operations. The risk factors discussed in our ~~2017~~2018 Annual Report do not identify all risks that we face because our business operations could also be affected by additional factors that are not presently known to us or that we currently consider to be immaterial to our operations. ~~There~~The following is an update to our risk factors.

The regulatory approval process of the FDA, EMA or any comparable foreign regulatory agency may be lengthy, time consuming and unpredictable.

We cannot be certain that any of our product candidates will be successful in clinical trials or receive regulatory approval. The FDA, EMA and other comparable foreign regulatory agencies have ~~been no material changes~~substantial discretion in the ~~risk factors discussed~~approval process and in determining when or whether regulatory approval will be obtained for any of our product candidates. Even if we believe the data collected from clinical trials of our product candidates are promising, such data may not be sufficient to support approval by the FDA, EMA or any comparable foreign regulatory agency. Many companies that believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain regulatory approval for the product candidates.

Furthermore, while certain of our employees have prior experience with submitting marketing applications to the FDA, EMA and comparable foreign regulatory agencies, we, as a company, have not submitted such applications for our product candidates. Applications for any of our product candidates could fail to receive regulatory approval for many reasons, including, but not limited to, the following:

the FDA, EMA or any comparable foreign regulatory agency may disagree with the design or implementation of our clinical trials or our interpretation of data from nonclinical trials or clinical trials;

the population studied in the clinical program may not be sufficiently broad or representative to assure safety in the full population for which we seek approval, including reliance on foreign clinical data;

the data collected from clinical trials of our product candidates may not be sufficient to support a finding that has statistical significance or clinical meaningfulness or support the submission of an NDA or other submission, or to obtain regulatory approval in the United States or elsewhere;

we may be unable to demonstrate to the FDA, EMA or any comparable foreign regulatory agency that a product candidate’s risk‑benefit ratio for its proposed indication is acceptable;

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the FDA, EMA or any comparable foreign regulatory agency may fail to approve the manufacturing processes, test procedures and specifications or facilities of third‑party manufacturers with which we contract for clinical and commercial supplies; and

the approval policies or regulations of the FDA, EMA or any comparable foreign regulatory agency may significantly change in a manner rendering our clinical data insufficient for approval.

In communications we had with the FDA, they recommended use of a concurrent control group in our ~~2017 Annual Report.~~SONICS Phase 3 clinical trial. However, SONICS utilizes an open-label, single-arm design because use of a placebo control in a parallel-arm monotherapy design was considered unethical or infeasible to enroll, depending on the specific country or clinical trial site under consideration. Studies lacking an active control group are more likely to be subject to unanticipated variability in study results that can potentially lead to flawed conclusions because they do not allow for discrimination of patient outcomes. In August 2018, we announced statistically significant positive top-line results from our SONICS Phase 3 clinical trial. However, even if we achieve the clinical trial’s endpoints for this clinical trial, the FDA or other regulatory authorities could view our study results as potentially biased due to our lack of an active control group.

Our LOGICS study, which is a second Phase 3 clinical trial of Recorlev for the treatment of endogenous Cushing’s syndrome, will supplement the long-term efficacy and safety data from the ongoing SONICS trial via a double-blind, placebo-controlled, randomized-withdrawal design that will randomize approximately 54 patients. The addition of a concurrent control group in LOGICS is an attempt to address FDA’s request for such a control group that was lacking in SONICS. There can be no assurances, however, that the FDA or other regulatory authorities will view the LOGICS study results as sufficient.

In March 2019, we conducted a Type C meeting with the Division of Metabolic and Endocrine Products (DMEP) of the FDA. DMEP stated in its meeting minutes that the FDA generally requests that a sponsor conduct two adequate and well-controlled clinical studies for the proposed indication of a drug candidate under 21 CFR 314.126(b)(2). DMEP also noted that the FDA recognizes situations when a single trial may be sufficient. DMEP reiterated that the characteristics of an “adequate and well-controlled” investigation under 21 CFR 314.126 include the use of a control group (e.g., placebo concurrent control, dose-comparison concurrent control), randomization and evaluation of primary endpoints that directly measure clinical benefits, or supported by evidence of clinical benefit. For this reason, while DMEP indicated that it would consider, as a review issue, the adequacy of an NDA submission with data from the SONICS trial as the sole Phase 3 evidence supporting the efficacy of RECORLEV, DMEP nonetheless recommended that we complete the LOGICS trial (which is double-blinded, randomized and placebo-controlled) and include the results from the LOGICS trial in addition to data from the SONICS trial in our NDA submission. We currently expect to receive LOGICS top-line data at the end of the first quarter of 2020 and, if supported by the data, submit an NDA for Recorlev in the third quarter of 2020 that will include data from each of the SONICS and LOGICS trials. In addition, the DMEP stated in its meeting minutes that our clinical pharmacology program for Recorlev, as described to them, appears reasonable to support an NDA filing for Recorlev provided that the data generated are found to be suitable.

In addition, following FDA consultation, we have determined that the 505(b)(2) approval pathway, which permits an NDA applicant to rely on data from studies that were not conducted by or for the applicant and for which the applicant has not obtained a right of reference, is the appropriate pathway for a Recorlev NDA. We intend to rely on published literature and the FDA’s prior findings concerning the safety and/or effectiveness of ketoconazole in our NDA for Recorlev and on similar processes in other jurisdictions. There can be no assurances, however, that the 505(b)(2) approval pathway in the United States, or similar approval pathways outside of the United States, will be available for Recorlev or that the FDA or other regulatory authorities will approve Recorlev through an application based on such pathways.

We generally plan to seek regulatory approval to commercialize our product candidates in the United States, the European Union and other key global markets. To obtain regulatory approval in other countries, we must comply with regulatory requirements of such other countries regarding safety, efficacy, chemistry, manufacturing and controls, clinical trials, commercial sales, pricing and distribution of our product candidates. Even if we are successful in

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obtaining approval in one jurisdiction, we cannot ensure that we will obtain approval in any other jurisdictions. Failure to obtain marketing authorization for our product candidates in any jurisdiction will result in our being unable to market and sell such products. Similarly, regulatory agencies may not approve the labeling claims that are necessary or desirable for the successful commercialization of our product candidates.

Any of our current or future product candidates could take a significantly longer time to gain regulatory approval than we expect or may never gain regulatory approval. This could delay or eliminate any potential product revenue by delaying or terminating the potential commercialization of our product candidates.

ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds

None

ITEM 3. Defaults Upon Senior Securities

None.

ITEM 4. Mine Safety Disclosures

Not applicable.

ITEM 5. Other Information

None.

ITEM 6. Exhibits

EXHIBIT INDEX


31.1		Certificate of principal executive officer pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2		Certificate of principal financial officer pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1		Certificate of principal executive officer and principal financial officer pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS		XBRL Instance Document
101.SCH		XBRL Taxonomy Extension Schema Document
101.CAL		XBRL Taxonomy Extension Calculation Linkbase Document
101.LAB		XBRL Taxonomy Extension Label Linkbase Document
101.PRE		XBRL Taxonomy Extension Presentation Linkbase Document
101.DEF		XBRL Taxonomy Extension Definitions Linkbase Document

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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.



	STRONGBRIDGE BIOPHARMA PLC

	By:		/s/ A. BRIAN DAVIS
	Name:		A. Brian Davis
	Title:		Chief Financial Officer

Date: ~~May 10, 2018~~

July 31, 2019

3027


	Principal
	Payments

2018	$	—
2019		—
2020		—
2021		34,611
2022		34,611
2023		17,305
Total future payments	$	86,527


	Payments due by period
	Less than						More than
	1 year		1 to 3 years		3 to 5 years		5 years		Total
	(in thousands)

Minimum contract purchases pursuant to supply agreement	$	3,293	$	13,820	$	7,835	$	—	$	24,948
Debt payments	$	—	$	34,611	$	51,916	$	—	$	86,527
Operating leases	$	390	$	1,399	$	578	$	—	$	2,367
Total contractual obligations	$	3,683	$	49,830	$	60,329	$	—	$	113,842