Myovant Sciences Announces Financial Results for Third Quarter of Fiscal Year 2021 and Corporate Updates
- Third fiscal quarter 2021 total revenues of
$54.4 million, including net product revenue of $29.3 million
- Net product revenue from
U.S.sales of ORGOVYX® of $24.4 million, reflecting 40% sequential volume growth compared to second fiscal quarter 2021, partially offset by a lower net price
- Net product revenue from
U.S.sales of MYFEMBREE® of $2.4 million; New-to-brand prescription (NBRx) share among GnRH antagonist therapies FDA-approved for the treatment of uterine fibroids grew to 45% in December 2021, six months following launch
- Estimated 11,000 cumulative patients treated with ORGOVYX through
December 2021; Approximately 1,800 treatment centers have prescribed ORGOVYX since launch
- Estimated 1,400 cumulative patients treated with MYFEMBREE through
November 2021; Over 800 unique prescribers through December 2021since launch
- FDA review of MYFEMBREE supplemental New Drug Application for the management of moderate to severe pain associated with endometriosis remains on track for a decision by
May 6, 2022target action date; U.S.launch planned for May 2022, if approved Myovantremains well-capitalized with cash, cash equivalents, and marketable securities of $527.8 millionas of December 31, 2021
“Our third fiscal quarter 2021 financial results reflect the continued strong momentum for the ORGOVYX and MYFEMBREE launches. ORGOVYX volume grew 40% sequentially, reflecting steadily increasing patient and clinician demand for its differentiated clinical profile compared to other androgen deprivation therapy alternatives. By
Third Fiscal Quarter 2021 and Recent Corporate Updates
ORGOVYX (relugolix 120 mg)
- Third fiscal quarter 2021 net product revenues for ORGOVYX in the
U.S.were $24.4 million, reflecting 40% sequential volume growth compared to second fiscal quarter 2021, partially offset by a lower net price due to higher gross-to-net discounts. There were no material changes in inventory for ORGOVYX over the course of third fiscal quarter 2021.
- Over 1,800 treatment centers prescribed ORGOVYX to approximately 11,000 patients on free and commercial drug, from launch through
December 2021, excluding patients utilizing product samples. The cumulative number of estimated patients initiating ORGOVYX therapy has continued to increase steadily in each successive month since launch.
- As of
January 2022, Myovantachieved 81% commercial coverage and 99% Medicare Part D coverage for ORGOVYX. Myovantcontinues to engage with key commercial and Part D payers to maintain coverage as well as to potentially expand coverage with payers yet to make a coverage decision.
MYFEMBREE (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg)
- Third fiscal quarter 2021 net product revenues for MYFEMBREE in the
U.S.were $2.4 million. There were no material changes in inventory for MYFEMBREE over the course of third fiscal quarter 2021.
- New-to-brand prescription share among gonadotropin-releasing hormone (GnRH) antagonists approved by the
U.S. Food and Drug Administration(FDA) for the treatment of uterine fibroids was 45% in December 2021compared to 20% in September 2021, reflecting steadily increasing demand for the differentiated clinical profile of MYFEMBREE while growing the class.
- Approximately 1,400 patients have been treated with MYFEMBREE from launch through
November 2021, including patients on commercial drug and free drug programs, excluding patients utilizing product samples.
- From launch through
December 2021, over 800 unique providers had prescribed MYFEMBREE, of which 58% had not previously prescribed a GnRH antagonist FDA-approved for the treatment of uterine fibroids.
- As of
January 2022, Myovantachieved 83% commercial coverage for MYFEMBREE. Myovantcontinues to engage with key commercial payers to maintain coverage as well as to potentially expand coverage with payers yet to make a coverage decision.
RYEQO (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg)
- Since regulatory approvals for RYEQO by the
European Commission(EC) in July 2021and Medicines and Healthcare products Regulatory Agency in August 2021, Gedeon Richter(Richter), Myovant’s commercialization partner in certain other international markets, has launched RYEQO in 12 countries.
- Third fiscal quarter 2021 net product revenues for RYEQO were
$2.4 million, composed of $2.3 millionrelated to product supply to Richter and $0.1 millionroyalties on net sales of RYEQO in Richter’s Territory.
Myovantis continuing to assess partnership opportunities with multiple interested parties for international commercialization and development rights (excluding Canadaand certain Asian countries) to relugolix in oncology. Myovant’s goal is to reach agreement with a partner by the anticipated EC approval of relugolix for prostate cancer, expected in mid-calendar year 2022.
Board of Director Appointment
- Effective on
November 5, 2021, Dr. Nancy Valente, M.D. was appointed by Myovant’s Board as an independent director following Ms. Kathleen Sebelius’ retirement from Myovant’s Board. Dr. Valentealso became a member of the Audit Committee and the Chair of the Nominating and Corporate Governance Committeeof Myovant’s Board.
Expected Upcoming Milestones
- FDA submission of the Phase 3 LIBERTY randomized withdrawal study results for MYFEMBREE in women with uterine fibroids is expected in the first quarter of calendar year 2022.
- Two-year data from the SPIRIT long-term extension study of MYFEMBREE in women with endometriosis-associated pain is expected in the first quarter of calendar year 2022.
- FDA decision for the MYFEMBREE sNDA seeking approval for the management of moderate to severe pain associated with endometriosis is expected by its
May 6, 2022target action date. FDA approval of MYFEMBREE for this indication would trigger a $100.0 millionregulatory milestone payment from Pfizer. If approved by May 6, 2022, Myovantand Pfizer expect to launch MYFEMBREE in the U.S.for this indication in May 2022. If approved, this indication would utilize the same dosage, formulation, administration, and branding as MYFEMBREE, which was previously approved by the FDA in May 2021for the management of heavy menstrual bleeding associated with uterine fibroids.
- EC decision on the advanced prostate cancer Marketing Authorisation Application is expected in mid-calendar year 2022.
European Medicines Agencyregulatory submission for RYEQO for the treatment of women with endometriosis-associated pain is expected in calendar year 2022. Richter will be the sponsor.
Third Fiscal Quarter 2021 Financial Summary
Total revenues for the three months ended
- Product revenue, net from sales of ORGOVYX and MYFEMBREE in the
U.S.for the three months ended December 31, 2021were $24.4 millionand $2.4 million, respectively. For the three months ended December 31, 2021product revenue, net also includes revenues related to product supply to Richter of $2.3 million, as well as royalties on net sales of RYEQO in Richter’s Territory of $0.1 million. There was no such revenue recorded in the comparable prior year period.
- Pfizer collaboration revenue for the three months ended
December 31, 2021was $25.2 million, reflecting the partial recognition of the upfront payment Myovantreceived from Pfizer upon entering into the Pfizer Collaboration and License Agreement in December 2020and of the regulatory milestone payment from Pfizer that was triggered upon the FDA approval of MYFEMBREE for the management of heavy menstrual bleeding associated with uterine fibroids in May 2021. Pfizer collaboration revenue in the three months ended December 31, 2020was $1.4 million, reflecting the partial recognition of the upfront payment received from Pfizer.
Cost of product revenue for the three months ended
Collaboration expense to Pfizer for the three months ended
Research and development (R&D) expenses for the three months ended
Selling, general and administrative (SG&A) expenses for the three months ended
Interest expense was
Foreign exchange gain for the three months ended
Net loss for the three months ended
Capital resources: Cash, cash equivalents, marketable securities, and amounts available under the Sumitomo Dainippon Pharma Loan Agreement totaled
As previously announced,
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces testicular testosterone, a hormone known to stimulate the growth of prostate cancer, and ovarian estradiol, a hormone known to stimulate the growth of uterine fibroids and endometriosis. ORGOVYX® (relugolix 120 mg) was approved in the
About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in
Sumitovant is a global biopharmaceutical company leveraging data-driven insights to rapidly accelerate development of new potential therapies for unmet patient conditions. Through its unique portfolio of companies—wholly-owned Urovant, Enzyvant, Spirovant, Altavant, plus majority-owned
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In this press release, forward-looking statements include, but are not limited to, all statements reflecting Myovant Sciences’ expectations, including but not limited to: Myovant’s belief that ORGOVYX and MYFEMBREE have the potential to become standard of care therapies in advanced prostate cancer and uterine fibroids, respectively; Myovant’s anticipation that 2022 will be a significant growth year with several important milestones that will support its mission of redefining care and position
Myovant Sciences’ forward-looking statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties, assumptions, and other factors known and unknown that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by the forward-looking statements, including unforeseen circumstances or other disruptions to normal business operations arising from or related to the COVID-19 pandemic.
Condensed Consolidated Statements of Operations
(Unaudited, in thousands, except share and per share data)
|Three Months Ended
||Nine Months Ended
|Product revenue, net||$||29,268||$||—||$||61,885||$||—|
|Pfizer collaboration revenue||25,172||1,379||79,853||1,379|
|Richter license and milestone revenue||—||—||31,667||33,333|
|Operating costs and expenses:|
|Cost of product revenue||4,243||—||7,897||—|
|Collaboration expense to Pfizer||12,086||—||25,912||—|
|Research and development (1)||25,726||30,453||82,886||115,160|
|Selling, general and administrative (1)||72,125||49,243||192,118||103,387|
|Total operating costs and expenses||114,180||79,696||308,813||218,547|
|Loss from operations||(59,740||)||(78,317||)||(135,408||)||(183,835||)|
|Foreign exchange gain||—||(5,891||)||—||(16,178||)|
|Loss before income taxes||(63,149||)||(75,003||)||(145,638||)||(174,387||)|
|Income tax expense (benefit)||296||(1,154||)||1,058||(616||)|
|Net loss per common share — basic and diluted||$||(0.68||)||$||(0.82||)||$||(1.59||)||$||(1.94||)|
|Weighted average common shares outstanding — basic and diluted||93,474,985||90,096,557||92,514,657||89,715,160|
|(1) Includes the following share-based compensation:|
|Selling, general and administrative||$||4,173||$||3,699||$||18,131||$||10,686|
|Research and development||3,026||3,311||12,193||11,060|
|Total share-based compensation||$||7,199||$||7,010||$||30,324||$||21,746|
Revenue components are as follows:
|Product revenue, net:|
|Richter product supply and royalties||2,446||—||4,217||—|
|Total product revenue, net||29,268||—||61,885||—|
|Pfizer collaboration revenue:|
|Amortization of upfront payment||20,974||1,379||62,922||1,379|
|Amortization of regulatory milestone||4,198||—||16,931||—|
|Total Pfizer collaboration revenue||25,172||1,379||79,853||1,379|
|Richter license and milestone revenue||—||—||31,667||33,333|
Condensed Consolidated Balance Sheets
(Unaudited, in thousands)
|Cash and cash equivalents||$||457,742||$||674,493|
|Accounts receivable, net||18,910||3,570|
|Prepaid expenses and other current assets||20,795||13,536|
|Amount due from related party||550||—|
|Total current assets||574,754||704,645|
|Property and equipment, net||2,952||3,300|
|Operating lease right-of-use asset||8,405||9,655|
|Liabilities and Shareholders’ Deficit|
|Accrued expenses and other current liabilities||58,423||44,612|
|Share-based compensation liabilities||2,724||21,636|
|Amounts due to Pfizer||37,727||1,954|
|Cost share advance from Pfizer||55,026||92,415|
|Operating lease liability||2,052||1,807|
|Amounts due to related parties||391||543|
|Total current liabilities||269,037||281,340|
|Deferred revenue, non-current||400,849||397,369|
|Cost share advance from Pfizer, non-current||—||29,447|
|Long-term operating lease liability||7,618||9,189|
|Long-term debt, less current maturities (related party)||358,700||358,700|
|Total shareholders’ deficit||(432,283||)||(353,965||)|
|Total liabilities and shareholders’ deficit||$||604,292||$||725,027|
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+1 (650) 410-3055
Source: Myovant Sciences, Inc.