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MYOV Myovant Sciences

Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Myovant Sciences has one FDA-approved medicine, ORGOVYX™ (relugolix), for adult patients with advanced prostate cancer. Its lead product candidate, relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg), is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis. Myovant Sciences is also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, which has completed a Phase 2a study for female infertility as part of assisted reproduction. Sumitovant Biopharma, Ltd., a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is its majority shareholder.

Company profile

Ticker
MYOV
Exchange
Website
CEO
Lynn Seely
Employees
Incorporated
Location
Fiscal year end
SEC CIK
Subsidiaries
Myovant Sciences, Inc. • Myovant Holdings Ltd. • Myovant Sciences GmbH • Myovant Sciences Ireland Limited • Myovant Treasury, Inc. • Myovant Treasury Holdings, Inc. ...

MYOV stock data

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Press releases

Pro users get this 30m faster
Enzyvant Receives FDA Approval for RETHYMIC® (allogeneic processed thymus tissue-agdc), a One-Time Regenerative Tissue-Based Therapy for Pediatric Congenital Athymia
8 Oct 21
RETHYMIC is the first and only FDA-approved treatment indicated for immune reconstitution in pediatric patients with congenital athymia Children with congenital athymia are born without a thymus causing severe
Urovant Sciences Presents Positive Ambulatory Blood Pressure Data Showing That GEMTESA® (vibegron) 75 mg in Overactive Bladder Was Not Associated with Statistically Significant or Clinically Meaningful Effects on Blood Pressure or Heart Rate
13 Sep 21
New data from dedicated ambulatory blood pressure study of patients with overactive bladder (OAB) showed once-daily treatment with GEMTESA® was not associated with statistically significant or clinically
Myovant Sciences and Pfizer Announce FDA Acceptance of Supplemental New Drug Application for MYFEMBREE® for the Management of Moderate to Severe Pain Associated With Endometriosis
9 Sep 21
Filing in endometriosis is supported by data from the Phase 3 SPIRIT programFDA PDUFA target action date is May 6, 2022 BASEL, Switzerland and NEW YORK, Sept. 09, 2021 (GLOBE NEWSWIRE) -- Myovant
Urovant Sciences to Present New Ambulatory Blood Pressure Data in Patients Dosed With GEMTESA® (vibegron) 75 mg for Overactive Bladder at the Virtual 2021 Annual Meeting of the American Urological Association
3 Sep 21
Myovant Sciences Appoints Uneek Mehra as Chief Financial and Business Officer
12 Aug 21

Calendar

28 Jul 21
16 Oct 21
31 Mar 22
Quarter (USD)
Jun 21 Mar 21 Dec 20 Sep 20
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD)
Mar 21 Mar 20 Mar 19 Mar 18
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS

Financial data from company earnings reports.

Cash burn rate (estimated) Burn method: Change in cash Burn method: Operating income/loss Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 494.05M 494.05M 494.05M 494.05M 494.05M 494.05M
Cash burn (monthly) 61.14M (positive/no burn) 20.25M 24.28M 37.73M (positive/no burn)
Cash used (since last report) 216.8M n/a 71.8M 86.08M 133.76M n/a
Cash remaining 277.25M n/a 422.25M 407.97M 360.28M n/a
Runway (months of cash) 4.5 n/a 20.9 16.8 9.6 n/a

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
5 Oct 21 Lang Matthew Common Shares Sell Dispose S No No 21.62 6,671 144.23K 179,839
5 Oct 21 Arjona Ferreira Juan Camilo Common Shares Sell Dispose S No No 21.62 2,738 59.2K 168,591
28 Sep 21 Sumitomo Chemical Common Stock Buy Acquire P Yes Yes 22.8458 20,677 472.38K 50,041,181
27 Sep 21 Arjona Ferreira Juan Camilo Common Shares Sell Dispose S No Yes 24.32 7,000 170.24K 171,329
27 Sep 21 Arjona Ferreira Juan Camilo Common Shares Option exercise Acquire M No No 7.78 7,000 54.46K 178,329
27 Sep 21 Arjona Ferreira Juan Camilo Stock Option Common Shares Option exercise Dispose M No No 7.78 7,000 54.46K 159,100
27 Sep 21 Sumitomo Chemical Common Stock Buy Acquire P Yes Yes 24.8594 2,232 55.49K 50,020,504
27 Sep 21 Sumitomo Chemical Common Stock Buy Acquire P Yes Yes 24.1851 45,768 1.11M 50,018,272
24 Sep 21 Sumitomo Chemical Common Stock Buy Acquire P Yes Yes 23.4041 36,000 842.55K 49,972,504

Data for the last complete 13F reporting period. To see the most recent changes to ownership, click the ownership history button above.

91.8% owned by funds/institutions
13F holders
Current Prev Q Change
Total holders 108 105 +2.9%
Opened positions 22 27 -18.5%
Closed positions 19 29 -34.5%
Increased positions 40 39 +2.6%
Reduced positions 27 19 +42.1%
13F shares
Current Prev Q Change
Total value 2.25B 1.39B +61.9%
Total shares 84.5M 82.26M +2.7%
Total puts 1.36M 1.35M +0.7%
Total calls 319.3K 230.7K +38.4%
Total put/call ratio 4.3 5.9 -27.2%
Largest owners
Shares Value Change
SOMMY Sumitomo Chemical 48.64M $1.03B +0.4%
Wellington Management 6.52M $148.51M +15.3%
JHG Janus Henderson 5.42M $123.43M +3.5%
BLVGF Bellevue 5.27M $119.98M +1.4%
BBBOF BB Biotech 4.76M $131.39M 0.0%
STT State Street 2.29M $52.25M +1137.0%
Partner Fund Management 1.91M $43.54M -6.9%
BLK Blackrock 1.06M $24.1M +10.8%
Vanguard 774.32K $17.63M +2.1%
Cormorant Asset Management 542.5K $12.35M -45.8%
Largest transactions
Shares Bought/sold Change
STT State Street 2.29M +2.11M +1137.0%
Lord, Abbett & Co. 534.02K -1.31M -71.1%
Wellington Management 6.52M +867.33K +15.3%
Cormorant Asset Management 542.5K -457.5K -45.8%
Tri Locum Partners 0 -321.1K EXIT
Pier Capital 300.62K -254.16K -45.8%
Opaleye Management 0 -249.8K EXIT
Schroder Investment Management 246.53K +246.53K NEW
Renaissance Technologies 227K +227K NEW
Millennium Management 219.46K +219.46K NEW

Financial report summary

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Competition
Neurocrine BiosciencesAbbvieAllerganObsEva
Risks
  • Our success depends in part on the successful commercialization of our drug products. To the extent our drug products are not commercially successful, our business, financial condition and results of operations will be materially harmed.
  • Our drug products may fail to achieve the degree of market acceptance by physicians, patients, third-party payers or others in the medical community necessary for commercial success, which would negatively impact our business.
  • Failure to successfully obtain coverage and reimbursement for ORGOVYX and MYFEMBREE in the United States, or the availability of coverage only at limited levels, would diminish our ability to generate net product revenue.
  • We face substantial competition in the commercialization of ORGOVYX and MYFEMBREE, and our operating results will suffer if we fail to compete effectively.
  • If manufacturers obtain approval for generic versions of ORGOVYX, MYFEMBREE, or of products with which they compete, our business may suffer.
  • If patient safety issues were to arise for any of our drug products, our future sales of our drug products may be reduced, adversely affecting our results of operations.
  • If we or our collaboration partner, Pfizer, are found to have improperly promoted unapproved uses of our drug products, we may be subject to restrictions on the sale or marketing of our drug products and significant fines, penalties, sanctions and product liability claims, and our image and reputation within the industry and marketplace could be harmed.
  • If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs in the U.S., we could be subject to additional reimbursement requirements, fines, sanctions and exposure under other laws which could have a material adverse effect on our business, results of operations and financial condition.
  • Our drug products are complex to manufacture, and manufacturing disruptions may occur that could cause us to experience disruptions in the supply of our drug products.
  • Risks Related to Commercialization of our Drug Products Outside the U.S. and for Product Candidates
  • Our success relies on the successful commercialization of drug products outside the U.S. or the development or commercialization of our product candidates. If we are successful in obtaining regulatory approval for the drug products in jurisdictions outside the U.S. or for the product candidates, we will be subject to the same or similar commercialization risks as described above for our approved drug products.
  • Risks Related to Our Financial Position and Capital Requirements
  • We are required to meet certain terms and conditions to draw down funds under the Sumitomo Dainippon Pharma Loan Agreement. If we are unable to meet such terms and conditions, we may not be able to access funding from the Sumitomo Dainippon Pharma Loan Agreement. Further, we may be obligated to repay the loans prior to their scheduled maturity date under certain circumstances.
  • We may never achieve or maintain profitability.
  • Risks Related to Our Business Operations
  • The terms of the Sumitomo Dainippon Pharma Loan Agreement place restrictions on our operating and financial flexibility.
  • We may not be successful in our efforts to identify and acquire or in-license additional product candidates, which may limit our growth potential.
  • We do not have our own manufacturing capabilities and rely on third parties to produce clinical and commercial supplies of drug substance and drug product. If these third parties do not perform as we expect, do not maintain their regulatory approvals, or become subject to other negative circumstances, it may result in delay in our ability to develop and commercialize our products.
  • Our or our affiliates’ employees, independent contractors, third-party manufacturers, principal investigators, consultants, commercial collaboration partners, service providers, and other vendors, may engage in misconduct or other improper activities, including noncompliance with regulatory or legal standards and requirements, which could have an adverse effect on our results of operations.
  • Business interruptions resulting from effects of pandemics or epidemics, such as the COVID-19 pandemic, may materially and adversely affect our business and financial condition.
  • International expansion of our business exposes us to business, legal, regulatory, political, operational, financial, economic, and other risks associated with conducting business outside of the U.S., which could interrupt our business operations and harm our future international expansion and, consequently, negatively impact our financial condition, results of operations, and cash flows.
  • The withdrawal of the United Kingdom (the “U.K.”) from the European Union (the “EU”), commonly referred to as “Brexit,” may adversely impact our ability to obtain regulatory approvals of our product candidates in the EU, result in restrictions or imposition of taxes and duties for importing our product candidates into the EU, and may require us to incur additional expenses in order to develop, manufacture and commercialize our product candidates in the EU.
  • Our internal computer systems, and those of our third-party collaborators, consultants or contractors, may fail or suffer cybersecurity breaches and data leakage, which could result in a material disruption of our business and operations or liabilities that adversely affect our financial performance.
  • If we fail to comply with applicable U.S. and foreign privacy and data protection laws and regulations, we may be subject to liabilities that adversely affect our business, operations and financial performance.
  • The failure to successfully expand and maintain our enterprise resource planning (“ERP”) system and other information technology systems could adversely affect our business and results of operations or the effectiveness of internal control over financial reporting.
  • The phase-out of the London Interbank Offered Rate (“LIBOR”), or the replacement of LIBOR with an alternative reference rate, may adversely affect interest rates on our outstanding variable rate indebtedness with Sumitomo Dainippon Pharma.
  • Risks Related to Clinical Development and Regulatory Approval
  • Clinical studies are very expensive, time-consuming, difficult to design and implement, and involve uncertain outcomes. Clinical study failures can occur at any stage of clinical studies, and we could encounter problems that cause us to suspend, abandon or repeat clinical studies. We cannot predict with any certainty the timing for commencement or completion of current or future clinical studies.
  • We are dependent on the research and development of relugolix and MVT-602 previously conducted by Takeda. If Takeda did not conduct this research and development in compliance with applicable requirements, it could result in increased costs and delays in our development of these product candidates.
  • Recruitment, enrollment and retention of patients in clinical studies is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control.
  • The results of our clinical studies may not support our proposed claims for our product candidates. The results of previous clinical studies may not be predictive of future results, and interim or top-line data may be subject to change or qualification based on the complete analysis of data.
  • Reported data or other clinical development announcements by Takeda, its partners or sublicensees, or by our collaboration partners, including Pfizer and Richter may adversely affect our commercialization of our drug products and our clinical development plans.
  • The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming, and inherently unpredictable. If we are not able to obtain required regulatory approvals for our product candidates, our ability to generate net product revenue will be materially impaired.
  • Even if we obtain approval for a product candidate in one country or jurisdiction, we may never obtain approval for or commercialize it in any other jurisdiction which would limit our ability to realize our product candidates’ full market potential.
  • Even though we have obtained regulatory approval for ORGOVYX and MYFEMBREE in the U.S. and RYEQO in Europe, or even if we obtain regulatory approval for any of our product candidates, we face or will still face extensive regulatory requirements and our products may face future development risks and regulatory difficulties.
  • Our current and future relationships with investigators, healthcare professionals, consultants, third-party payers, and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties.
  • Changes in legislation may increase the difficulty and cost for us to obtain marketing approval for and commercialize our drug products or product candidates and affect the prices we may obtain.
  • Risks Related to Our Dependence on Third Parties
  • We are dependent upon our relationships with collaboration partners to further develop, fund, manufacture and commercialize our drug products and our product candidates. If such relationships are unsuccessful, or if a collaboration partner terminates its collaboration agreement with us, it could negatively impact our ability to conduct our business and generate net product revenue. Failure by a collaboration partner to perform its duties under its collaboration agreement with us (e.g. financial reporting or internal control compliance) may negatively affect us.
  • Regulatory requirements or manufacturing disruptions may make it difficult for us to be able to obtain materials or supplies necessary to conduct clinical studies or to manufacture and sell any of our product candidates, if approved.
  • We are reliant on third parties to conduct, manage, and monitor our clinical studies, and if those third parties perform in an unsatisfactory manner, it may harm our business.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain and maintain patent protection for our technology and products, or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets.
  • If we fail to comply with our obligations under any license, collaboration or other agreements, we may be required to pay damages and could lose intellectual property rights that are necessary for developing and protecting our product candidates.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.
  • Third party claims or litigation alleging infringement of patents or other proprietary rights, or seeking to invalidate our patents or other proprietary rights, may delay or prevent the development of our product candidates and commercialization of our drug products and any future product candidate.
  • We may become involved in lawsuits to protect or enforce our patents, the patents of our licensors or our other intellectual property rights, which could be expensive, time consuming, and unsuccessful.
  • Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • We may not be able to protect our intellectual property rights throughout the world, which could impair our business.
  • Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
  • Risks Related to Our Being a Controlled Company
  • We have agreements with Sumitovant, our majority shareholder, and with Sumitovant’s parent, Sumitomo Dainippon Pharma, and their affiliates, including Sunovion, that may be perceived to create conflicts of interest which, if other investors perceive that Sumitovant or Sumitomo Dainippon Pharma will not act in the best interests of all of our shareholders, may affect the price of our common shares and have other effects on our company.
  • We are a “controlled company” within the meaning of the applicable rules of the NYSE and, as a result, qualify for exemptions from certain corporate governance requirements. If we rely on these exemptions, our shareholders will not have the same protections afforded to shareholders of companies that are subject to such requirements.
  • Risks Related to Us and Our Shareholders Related to Our Being a Foreign Corporation
  • We are an exempted company limited by shares incorporated under the laws of Bermuda and it may be difficult for our shareholders to enforce judgments against us or our directors and executive officers.
  • Bermuda law differs from the laws in effect in the U.S. and may afford less protection to our shareholders.
  • There are regulatory limitations on the ownership and transfer of our common shares.
  • Legislation enacted in Bermuda as to economic substance may affect our operations.
  • We may become subject to unanticipated tax liabilities and higher effective tax rates.
  • The intended tax effects of our corporate structure and intercompany arrangements depend on the application of the tax laws of various jurisdictions and on how we operate our business.
  • Changes in our effective tax rate may reduce our net income in future periods.
  • U.S. holders that own 10 percent or more of the vote or value of our common shares may suffer adverse tax consequences because we and our non-U.S. subsidiaries are expected to be characterized as “controlled foreign corporations” (“CFCs”), under Section 957(a) of the U.S. Internal Revenue Code of 1986, as amended (the “Code”).
  • U.S. holders of our common shares may suffer adverse tax consequences if we are characterized as a passive foreign investment company.
  • Raising additional funds may cause dilution to existing shareholders and/or may restrict our operations.
  • Our future success depends on our ability to attract and retain key personnel.
  • We plan to expand our organization, and we may experience difficulties in managing this growth, which could disrupt our operations.
  • Potential product liability lawsuits against us could cause us to incur substantial liabilities and could impact ongoing and planned clinical studies as well as limit commercialization of any products that we may develop.
  • Use of social media platforms presents risks of inappropriate or harmful disclosures which could harm our business.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of their former employers or other third parties.
  • Our operating results may fluctuate significantly and our future operating results could fall below expectations. The market price of our common shares has been and is likely to continue to be highly volatile, and you may lose some or all of your investment.
  • Volatility in our share price could subject us to securities class action litigation.
  • Because we do not anticipate paying any cash dividends on our common shares in the foreseeable future, capital appreciation, if any, would be your sole source of gain.
Management Discussion
  • We began generating product revenue from sales of ORGOVYX and MYFEMBREE in the U.S. in January 2021 and June 2021, respectively. We record product revenue net of estimated discounts, chargebacks, rebates, product returns, and other gross-to-net revenue deductions.
  • Pfizer collaboration revenue for the three months ended June 30, 2021, consists of the partial recognition of the upfront payment we received from Pfizer in December 2020 and of the regulatory milestone payment due from Pfizer that was triggered upon the FDA approval of MYFEMBREE for the treatment for heavy menstrual bleeding associated with uterine fibroids on May 26, 2021. There were no such amounts recognized for the three months ended June 30, 2020.
  • There was no Richter license and milestone revenue for the three months ended June 30, 2021. Richter license and milestone revenue for the three months ended June 30, 2020 consists of the partial recognition of the upfront payment we received from Richter in March 2020 and the regulatory milestone payment we received from Richter in April 2020.
Content analysis
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Positive
Negative
Uncertain
Constraining
Legalese
Litigous
Readability
H.S. senior Avg
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Patents

APP
Utility
Treatment of Prostate Cancer
8 Jul 21
Methods for treating prostate cancer, including advanced prostate cancer, in a subject in need thereof, include administering once-daily to the subject, at least 80 mg of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea, or a corresponding amount of a pharmaceutically acceptable salt thereof.
GRANT
Utility
Methods of treating uterine fibroids
15 Jun 21
Methods for treating uterine fibroids, endometriosis, adenomyosis, or heavy menstrual bleeding in a subject, which include administering to the subject from 10 mg to 60 mg per day of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea, and from 0.01 mg to 5 mg per day of a hormone replacement medicament.
GRANT
Utility
Methods of treating female infertility
25 May 21
Further according to the present disclosure, there are methods for promoting egg maturation in assisted reproductive technologies, such as in in vitro fertilization (IVF) or in an embryo transfer (ET) process.
GRANT
Utility
Treatment of prostate cancer
28 Sep 20
Methods for treating prostate cancer, including advanced prostate cancer, in a subject in need thereof, include administering once-daily to the subject, at least 80 mg of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea, or a corresponding amount of a pharmaceutically acceptable salt thereof.