Myovant Sciences Announces Corporate Updates and Financial Results for First Fiscal Quarter 2022

July 27, 2022 at 4:05 PM EDT

BASEL, Switzerland, July 27, 2022 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV), a biopharmaceutical company that aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy, today announced financial results for the first quarter of fiscal year 2022 and provided other corporate updates.

“We’re excited to start fiscal year 2022 with solid performance across both brands,” said David Marek, Chief Executive Officer of Myovant Sciences, Inc. “ORGOVYX delivered double digit volume growth across treatment settings and MYFEMBREE is now the market leader in new and total prescriptions while continuing to grow the class.” Mr. Marek added, “despite the challenging macro-economic environment, we remain well capitalized to build on our commercial momentum and advance our pipeline in women’s health and hormone-sensitive oncology.”

First Fiscal Quarter 2022 and Recent Corporate Updates

ORGOVYX (relugolix 120 mg)

MYFEMBREE (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg)

Expected Upcoming Milestones

First Fiscal Quarter 2022 Financial Summary

Total revenues for the three months ended June 30, 2022, and 2021 were $116.5 million and $41.1 million, respectively.

Cost of product revenue for the three months ended June 30, 2022 was $4.9 million, compared to $1.0 million for the three months ended June 30, 2021 related to the cost of goods sold and royalty expense payable to Takeda pursuant to the Takeda License Agreement. The increase in cost of product revenue in the three months ended June 30, 2022 was primarily due to an increase in cost of goods sold and royalty expense payable to Takeda as a result of higher sales of ORGOVYX and MYFEMBREE in the U.S., as compared to the year ago period.

Collaboration expense to Pfizer for the three months ended June 30, 2022, was $18.0 million, compared to $5.3 million for the three months ended June 30, 2021, reflecting Pfizer’s 50% share of net profits from sales of ORGOVYX and MYFEMBREE in the U.S., pursuant to the Pfizer Collaboration and License Agreement. The increase in collaboration expense to Pfizer in the three months ended June 30, 2022 was due to an increase in net profits generated from sales of ORGOVYX and MYFEMBREE in the U.S., as compared to the year ago period.

Selling, general and administrative (SG&A) expenses for the three months ended June 30, 2022, and 2021 were $79.0 million and $61.2 million, respectively. The increase in SG&A expenses primarily reflects higher expenses to support the ORGOVYX and MYFEMBREE commercialization activities in the U.S, including higher personnel-related costs, patient activation costs particularly for MYFEMBREE, as well as a banker fee associated with the Accord License Agreement.

Research and development (R&D) expenses for the three months ended June 30, 2022, and 2021 were $23.9 million and $30.9 million, respectively. The decrease in R&D expenses primarily reflects a reduction in clinical study costs due to the completion and wind down of Myovant’s Phase 3 LIBERTY, HERO, and SPIRIT studies.

Interest expense for the three months ended June 30, 2022, and 2021 was $4.2 million and $3.5 million, respectively, and was primarily related to the Sumitomo Pharma Loan Agreement. Interest expense related to the Sumitomo Pharma Loan Agreement increased $0.7 million, as a result of an increase in 3-month LIBOR as compared to the year ago period. Interest expense includes $0.6 million of accretion of the financing component of the cost share advance from Pfizer for both the three months ended June 30, 2022, and 2021.

Income tax expense for the three months ended June 30, 2022, and 2021 was $8.2 million and $0.9 million, respectively. The increase in income tax expense was driven principally by the changed requirement under Internal Revenue Code Section 174, effective for years beginning after December 31, 2021, to capitalize and subsequently amortize R&D expenditures, pursuant to changes enacted in the Tax Cuts and Jobs Act 2017. For periods beginning prior to December 31, 2021, R&D expenses were allowed to be expensed as incurred.

Net loss for the three months ended June 30, 2022 was $21.2 million compared to $61.7 million for the year ago period. On a per common share basis, net loss was $0.22 and $0.67 for the three months ended June 30, 2022 and 2021, respectively.

Capital resources: Cash, cash equivalents, marketable securities, and amounts available under the Sumitomo Pharma Loan Agreement totaled $400.0 million as of June 30, 2022, and consisted of $358.7 million of cash, cash equivalents, and marketable securities and $41.3 million of available borrowing capacity under the Sumitomo Pharma Loan Agreement.

Conference Call
As previously announced, Myovant will hold a webcast and conference call to discuss corporate updates and financial results for its first fiscal quarter, ended June 30, 2022. The webcast and conference call will be held at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time on July 27, 2022. Investors and the general public may access the live webcast: https://edge.media-server.com/mmc/p/oi3u5djb. The live webcast can also be accessed by visiting the investor relations page of Myovant’s website at: https://investors.myovant.com/. A replay of the webcast, along with the earnings press release and presentation materials, can be found on Myovant’s investor relations website for a period of one year.

About Relugolix
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 U.S. by the FDA in December 2020 as the first and only oral GnRH receptor antagonist for the treatment of adult patients with advanced prostate cancer. In April and June 2022, respectively, the European Commission and the United Kingdom (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) approved ORGOVYX® (relugolix, 120 mg) as the first and only oral GnRH receptor antagonist for the treatment of adult patients with advanced hormone-sensitive prostate cancer in Europe and the U.K. MYFEMBREE® (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) was approved in the U.S. by the FDA in May 2021 as the first and only once-daily oral treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months. In July 2021, the European Commission, and in August 2021, the U.K. MHRA, approved RYEQO® (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age, with no limitation for duration of use. In September 2021, the FDA accepted to review Myovant’s supplemental New Drug Application (sNDA) for MYFEMBREE for the management of moderate to severe pain associated with endometriosis. On May 6, 2022, Myovant and Pfizer announced that the FDA extended the Prescription Drug User Fee Act (PDUFA) goal date for this sNDA to August 6, 2022. In June 2022, the FDA accepted to review Myovant’s sNDA for updates to the United States Prescribing Information (USPI) based on safety and efficacy data from the Phase 3 LIBERTY randomized withdrawal study (RWS) of MYFEMBREE in premenopausal women with heavy menstrual bleeding due to uterine fibroids for up to two years. The FDA set a PDUFA goal date of January 29, 2023 for this sNDA. MYFEMBREE is also being assessed for contraceptive efficacy in women with endometriosis or uterine fibroids who are 18 to 50 years of age and at risk for pregnancy.

About Myovant Sciences
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Founded in 2016, Myovant has executed five successful Phase 3 clinical trials across oncology and women’s health leading to two regulatory approvals by the U.S. Food and Drug Administration (FDA) for men with advanced prostate cancer and women with heavy menstrual bleeding associated with uterine fibroids, respectively. Myovant also has received regulatory approvals by the European Commission (EC) and the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) for women with symptomatic uterine fibroids and for men with advanced hormone-sensitive prostate cancer. Myovant has supplemental New Drug Applications under review with the FDA for endometriosis-associated pain, and for updates to the United States Prescribing Information (USPI) based on safety and efficacy data from the Phase 3 LIBERTY randomized withdrawal study (RWS) of MYFEMBREE in premenopausal women with heavy menstrual bleeding due to uterine fibroids for up to two years. Myovant also is conducting a Phase 3 study to evaluate the prevention of pregnancy in women with uterine fibroids or endometriosis. Myovant also is developing MVT-602, an investigational 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 Pharma Co., Ltd., is Myovant’s majority shareholder. For more information, please visit www.myovant.com. Follow @Myovant on Twitter and LinkedIn.

About Sumitovant Biopharma Ltd.
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 wholly-owned “Vant” subsidiaries—Urovant, Enzyvant, Spirovant, Altavant—and use of embedded computational technology platforms to generate business and scientific insights, Sumitovant has supported the development of FDA-approved products and advanced a promising pipeline of early through late-stage investigational assets for other serious conditions. Sumitovant, a wholly-owned subsidiary of Sumitomo Pharma, is also the majority-shareholder of Myovant (NYSE: MYOV). For more information, please visit Sumitovant’s website at https://www.sumitovant.com.

About Sumitomo Pharma Co., Ltd.
Sumitomo Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China, and other Asian countries with more than 7,000 employees worldwide. Sumitomo Pharma defines its corporate mission as “To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide.” Additional information about Sumitomo Pharma is available through its corporate website at https://www.sumitomo-pharma.com.

Forward-Looking Statements
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: statements regarding Myovant’s aspiration to redefine care for women and for men; Myovant’s expectations of the success of commercialization of its approved drug products; statements with respect to Myovant’s expectations to remain well capitalized to build on its commercial momentum and advance its pipeline in women’s health and hormone-sensitive oncology in Mr. Marek’s quote; statements regarding the timing of Myovant’s regulatory submissions, anticipated regulatory review results, as well as Myovant’s and its collaboration and commercialization partners’ expected commercial launches of Myovant’s products, including, with no limitations, the timeline and potential outcome of the FDA’s review of the MYFEMBREE sNDA for the management of moderate to severe pain associated with endometriosis and if approved by the FDA, the potential milestone payment from Pfizer and the timing and expected launch of MYFEMBREE for this indication; the timeline and potential outcome of the FDA’s review of the MYFEMBREE sNDA proposing updates to MYFEMBREE’s USPI based on 2-year safety and efficacy data from the Phase 3 LIBERTY RWS of MYFEMBREE in premenopausal women with heavy menstrual bleeding associated with uterine fibroids; the timeline and expectation of launching ORGOVYX for the treatment of advanced hormone-sensitive prostate cancer in Europe by Accord; the timeline and expectation of submitting New Drug Submissions to Health Canada seeking marketing approval for ORGOVYX for advanced prostate cancer, MYFEMBREE for heavy menstrual bleeding associated with uterine fibroids, and MYFEMBREE for the treatment of endometriosis-associated pain in Canada; and other statements under the caption “Expected Upcoming Milestones.”

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 and the conflict in Ukraine. Myovant Sciences cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could materially affect Myovant Sciences’ operations and future prospects or which could cause actual results to differ materially from expectations include, but are not limited to, the risks and uncertainties listed in Myovant Sciences’ filings with the United States Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in Myovant Sciences’ Quarterly Report on Form 10-Q to be filed on July 27, 2022, as such risk factors may be amended, supplemented, or superseded from time to time. These risks are not exhaustive. New risk factors emerge from time to time and it is not possible for Myovant Sciences’ management to predict all risk factors, nor can Myovant Sciences assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof, and, except as required by law, Myovant Sciences undertakes no obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements.

MYOVANT SCIENCES LTD.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited, in thousands, except share and per share data)

 Three Months Ended 
June 30,
Three Months Ended 
June 30,
  20222021
Revenues: 
Product revenue, net$41,351$11,554
Pfizer collaboration revenue 25,14129,509
Accord license revenue 50,000
Total revenues 116,49241,063
Operating costs and expenses: 
Cost of product revenue(1) 4,9151,032
Collaboration expense to Pfizer 18,0165,261
Selling, general and administrative(1) 79,03261,212
Research and development(1) 23,89030,880
Total operating costs and expenses 125,85398,385
Loss from operations (9,361)(57,322)
Interest expense 4,2003,505
Interest income (486)(78)
Loss before income taxes (13,075)(60,749)
Income tax expense 8,164911
Net loss and comprehensive loss$(21,239)$(61,660)
  
Net loss per common share — basic and diluted$(0.22)$(0.67)
  
Weighted average common shares outstanding — basic and diluted 95,388,29491,637,151


(1)
Includes the following share-based compensation:

Selling, general and administrative$5,972$7,155
Research and development3,6663,957
Cost of product revenue683
Total share-based compensation$9,706$11,115


Revenue components are as follows:

Product revenue, net: 
ORGOVYX$36,034$10,479
MYFEMBREE3,9991,075
Richter product supply and royalties1,318
Total product revenue, net41,35111,554
Pfizer collaboration revenue: 
Amortization of upfront payment20,97420,974
Amortization of regulatory milestone4,1678,535
Total Pfizer collaboration revenue25,14129,509
Accord license revenue50,000
Total revenues$116,492$41,063

MYOVANT SCIENCES LTD.
Condensed Consolidated Balance Sheets
(Unaudited, in thousands)

  June 30, 2022March 31, 2022
Assets  
Current assets:  
Cash and cash equivalents$325,535 $406,704
Accounts receivable, net29,648 23,296
Marketable securities31,216 27,483
Inventories21,222 7,584
Prepaid expenses and other current assets18,750 22,498
Amount due from related party458 580
Total current assets426,829 488,145
Property and equipment, net2,681 2,944
Operating lease right-of-use asset7,501 7,961
Marketable securities, non-current1,938 —
Other assets21,181 20,961
Total assets$460,130 $520,011
Liabilities and Shareholders’ Deficit  
Current liabilities:  
Accounts payable$9,552 $12,250
Accrued expenses and other current liabilities65,688 68,594
Deferred revenue100,564 100,564
Amounts due to Pfizer39,244 32,563
Cost share advance from Pfizer8,555 33,818
Operating lease liability2,256 2,148
Amounts due to related parties382 393
Total current liabilities226,241 250,330
Deferred revenue, non-current350,565 375,706
Long-term operating lease liability6,431 7,041
Long-term debt, less current maturities (related party)358,700 358,700
Other liabilities1,717 1,711
Total liabilities943,654 993,488
Total shareholders’ deficit(483,524)(473,477)
Total liabilities and shareholders’ deficit$460,130 $520,011

Investor Contact:
Uneek Mehra
Chief Financial Officer
Myovant Sciences, Inc.
investors@myovant.com

Media Contact:
Noelle Cloud Dugan
Vice President, Corporate Communications
Myovant Sciences, Inc.
media@myovant.com

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The Impact of Urinary Incontinence Related to Overactive Bladder on Long-Term Care Residents and Facilities in the U.S. Highlighted in New Survey

July 13, 2022 at 8:00am PST

IRVINE, Calif. & BASEL, Switzerland – July 13, 2022 – Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., today announced the peer-reviewed journal publication of the findings from a survey of Directors of Nursing (DONs) in U.S. long-term care settings. The results highlight the need for improved awareness, education, and management of urinary incontinence (UI) related to overactive bladder (OAB) in the long-term care population.

The paper is titled “Impact of Urinary Incontinence Related to Overactive Bladder on Long-Term Care Residents and Facilities: A Perspective from  Directors of Nursing,” and was published in the Journal of Gerontological Nursing.

“The survey emphasizes the need for improved OAB awareness and education in the long-term care provider community. A significant unmet need remains among long-term care residents with incontinence related to OAB,” said Sef Kurstjens, M.D., Ph.D., Executive Vice President and Chief Medical Officer of Urovant Sciences. “Urovant remains committed to improving the dignity and quality of life of these residents through the development and commercialization of additional OAB treatment options.”

The survey of 71 DONs revealed that the impact and management of UI related to OAB is a substantial burden to long-term care facilities, as well as to their residents and staff, and it contributes to staff turnover:

Few residents were treated with medication to lessen the impact of their condition, and most were left to cope with their symptoms, using adult hygiene products:

81% of residents with UI used incontinence products

Only 14% of residents with UI were treated with medication

While anticholinergics remain the most-used treatment for residents with incontinence due to overactive bladder, most nursing directors surveyed (75%) were unaware of data suggesting a possible link between anticholinergic therapy and risk of cognitive side effects, signaling a potential opportunity for improved education and training on the appropriate ways to treat the symptoms of OAB in the long-term care community.

The 70-question quantitative online survey – conducted from February 27, 2020, to May 11, 2020 – received 71 complete responses from directors of nursing employed by a wide variety of organizations, who had all worked for one year or more at a skilled nursing facility with 100 or more beds (≥80% LTC beds).

“Our survey suggests that long-term care residents with mobility issues, especially those requiring staff help for toileting, may benefit from safe and efficacious medication to control urgency, allowing more time to access the toilet,” said lead author Richard Stefanacci, D.O., of the Jefferson College of Population Health, Thomas Jefferson University, Philadelphia, Pennsylvania. “For these patients, drug therapy that does not add to anticholinergic burden may be most appropriate.”

About Overactive Bladder
Overactive bladder (OAB) is a clinical condition that occurs when the bladder muscle contracts involuntarily. Symptoms may include urinary urgency (the sudden urge to urinate that is difficult to control), urgency incontinence (unintentional loss of urine immediately after an urgent need to urinate), frequent urination (usually eight or more times in 24 hours), and nocturia (waking up more than two times in the night to urinate).1

Approximately 30 million Americans suffer from bothersome symptoms of OAB, which can have a significant impairment on a patient’s day-to-day activities.1, 2

About Urovant Sciences
Urovant Sciences is a biopharmaceutical company focused on developing and commercializing innovative therapies for areas of unmet need, with a dedicated focus in Urology. The Company’s lead product, GEMTESA®(vibegron), is an oral, once-daily (75 mg) small molecule beta-3 agonist for the treatment of adult patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. GEMTESA was approved by the U.S. FDA in December 2020 and launched in the U.S. in April 2021. GEMTESA is also being evaluated for the treatment of OAB in men with benign prostatic hyperplasia. The Company’s second product candidate, URO-902, is a novel gene therapy being developed for patients with OAB who have failed oral pharmacologic therapy. Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., intends to bring innovation to patients in need in urology and other areas of unmet need. Learn more about us at www.Urovant.com and follow us on LinkedIn and Twitter.

About GEMTESA

GEMTESA is a prescription medicine for adults used to treat the following symptoms due to a condition called overactive bladder:

It is not known if GEMTESA is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Do not take GEMTESA if you are allergic to vibegron or any of the ingredients in GEMTESA.

Before you take GEMTESA, tell your doctor about all your medical conditions, including if you have liver problems; have kidney problems; have trouble emptying your bladder or you have a weak urine stream; take medicines that contain digoxin; are pregnant or plan to become pregnant (it is not known if GEMTESA will harm your unborn baby; talk to your doctor if you are pregnant or plan to become pregnant); are breastfeeding or plan to breastfeed (it is not known if GEMTESA passes into your breast milk; talk to your doctor about the best way to feed your baby if you take GEMTESA).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

What are the possible side effects of GEMTESA?
GEMTESA may cause serious side effects, including the inability to empty your bladder (urinary retention). GEMTESA may increase your chances of not being able to empty your bladder, especially if you have bladder outlet obstruction or take other medicines for treatment of overactive bladder. Tell your doctor right away if you are unable to empty your bladder. The most common side effects of GEMTESA include headache, urinary tract infection, nasal congestion, sore throat or runny nose, diarrhea, nausea, and upper respiratory tract infection. These are not all the possible side effects of GEMTESA. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please click here for full Product Information for GEMTESA.

About Sumitovant Biopharma
Sumitovant is a technology-driven biopharmaceutical company accelerating development of new potential therapies for patients with high unmet medical need. Through our subsidiary portfolio and use of embedded computational technology platforms to generate business and scientific insights, Sumitovant has supported development of FDA-approved products and advanced a promising pipeline of early-through late-stage investigational assets for other serious conditions. Sumitovant’s subsidiary portfolio includes wholly-owned Enzyvant, Urovant, Spirovant and Altavant, and majority-owned Myovant (NYSE: MYOV). Sumitomo Pharma is Sumitovant’s parent company. For more information, please visit www.sumitovant.com.

  1. Reynolds, W. S., Fowke, J., & Dmochowski, R. (2016). The Burden of Overactive Bladder on US Public Health. Current bladder dysfunction reports, 11(1), 8–13. https://doi.org/10.1007/s11884-016-0344-9
  2. Coyne, K. S., Sexton, C. C., Vats, V., Thompson, C., Kopp, Z. S., & Milsom, I. (2011). National community prevalence of overactive bladder in the United States stratified by sex and age. Urology, 77(5), 1081–1087.

UROVANT, UROVANT SCIENCES, the UROVANT SCIENCES logo are trademarks of Urovant Sciences GmbH, registered in the U.S. and in other countries. All other trademarks are the property of their respective owners. © 2022 Urovant Sciences. All rights reserved.

Urovant Sciences
Alana Darden Powell
Vice President, Corporate Communications
949-436-3116
alana.darden@Urovant.com 
media@urovant.com 

Sumitovant Biopharma 
Maya Frutiger
VP, Head of Corporate Communications
media@sumitovant.com

Source: Urovant Sciences, Inc.

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Urovant Sciences® Named One of 2022 “Best Places to Work” in Orange County

July 7, 2022 at 8:07am PST 

IRVINE, Calif. & BASEL, Switzerland – July 7, 2022 (8:07am PST) – Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., has been named for the 2nd year in a row as one of the Best Places to Work by the Orange County Business Journal.

“It’s an honor to be recognized as a Best Place to Work not once, but twice by the Business Journal,” said James Robinson, CEO of Urovant Sciences. “Because the list is largely based on responses from our colleagues, we feel this honor celebrates our deeply-rooted culture, steeped in values of integrity and compassion. Our inclusive and collaborative mindset fuels achievements and bold innovation for all.”

The awards program was created in 2009 and is a project of the Orange County Business Journal and Workforce Research Group. This county-wide survey and awards program work to identify, recognize and honor the best places of employment in Orange County, California, benefiting the county’s economy, its workforce and businesses.  

The recognition by the OCBJ follows on a separate recognition Urovant Sciences received in 2022, the Great Place to Work® Certification™. Great Place to Work certification is the most definitive “employer-of-choice” recognition that companies aspire to achieve. It is the only recognition based entirely on what employees report about their workplace experience – specifically, how consistently they experience a high-trust workplace. Every year, more than 10,000 companies across 60 countries apply to get Great Place to Work-Certified.

About Urovant Sciences
Urovant Sciences is a biopharmaceutical company focused on developing and commercializing innovative therapies for areas of unmet need, with a dedicated focus in Urology. The Company’s lead product, GEMTESA® (vibegron), is an oral, once-daily (75 mg) small molecule beta-3 agonist for the treatment of adult patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. GEMTESA was approved by the U.S. FDA in December 2020 and launched in the U.S. in April 2021. GEMTESA is also being evaluated for the treatment of OAB in men with benign prostatic hyperplasia. The Company’s second product candidate, URO-902, is a novel gene therapy being developed for patients with OAB who have failed oral pharmacologic therapy. Urovant Sciences, a wholly owned subsidiary of Sumitovant Biopharma Ltd., intends to bring innovation to patients in need in urology and other areas of unmet need. To learn more, visit http://www.urovant.com or follow us on Linked InTwitter or Instagram.

About Sumitovant Biopharma
Sumitovant is a technology-driven biopharmaceutical company accelerating development of new potential therapies for patients with high unmet medical need. Through our subsidiary portfolio and use of embedded computational technology platforms to generate business and scientific insights, Sumitovant has supported development of FDA-approved products and advanced a promising pipeline of early-through late-stage investigational assets for other serious conditions. Sumitovant’s subsidiary portfolio includes wholly-owned Enzyvant, Urovant, Spirovant and Altavant, and majority-owned Myovant (NYSE: MYOV). Sumitomo Pharma is Sumitovant’s parent company. For more information, please visit www.sumitovant.com.

About the 2022 Best Places to Work in Orange County
Organizations from across the county entered the two-part process to determine the Best Places to Work in Orange County. The first part consisted of evaluating each employer’s workplace policies, practices, and demographics. This part of the process was worth approximately 20% of the total evaluation. The second part consisted of an employee survey to measure the employee experience. This part of the process was worth approximately 80% of the total evaluation. The combined scores determined the top organizations and the final ranking. Workforce Research Group managed the overall registration and survey process in Orange County and analyzed the data and used their expertise to determine the final ranking. The Best Places to Work in Orange County list was published in the July 4 edition of the Orange County Business Journal. 

About Great Place to Work®
Great Place to Work® is the global authority on workplace culture. Since 1992, they have surveyed more than 100 million employees worldwide and used those deep insights to define what makes a great workplace: trust. Their employee survey platform empowers leaders with the feedback, real-time reporting, and insights they need to make data-driven people decisions. Everything they do is driven by the mission to build a better world by helping every organization become a great place to work For All™.

About GEMTESA®

GEMTESA is a prescription medicine for adults used to treat the following symptoms due to a condition called overactive bladder:

It is not known if GEMTESA is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Do not take GEMTESA if you are allergic to vibegron or any of the ingredients in GEMTESA.

Before you take GEMTESA, tell your doctor about all your medical conditions, including if you have liver problems; have kidney problems; have trouble emptying your bladder or you have a weak urine stream; take medicines that contain digoxin; are pregnant or plan to become pregnant (it is not known if GEMTESA will harm your unborn baby; talk to your doctor if you are pregnant or plan to become pregnant); are breastfeeding or plan to breastfeed (it is not known if GEMTESA passes into your breast milk; talk to your doctor about the best way to feed your baby if you take GEMTESA).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

What are the possible side effects of GEMTESA?
GEMTESA may cause serious side effects including the inability to empty your bladder (urinary retention). GEMTESA may increase your chances of not being able to empty your bladder, especially if you have bladder outlet obstruction or take other medicines for treatment of overactive bladder. Tell your doctor right away if you are unable to empty your bladder. The most common side effects of GEMTESA include headache, urinary tract infection, nasal congestion, sore throat or runny nose, diarrhea, nausea, and upper respiratory tract infection. These are not all the possible side effects of GEMTESA. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please click here for full Product Information for GEMTESA.

UROVANT, UROVANT SCIENCES, GEMTESA and the UROVANT SCIENCES logo are trademarks of Urovant Sciences GmbH, registered in the U.S. and in other countries. All other trademarks are the property of their respective owners. © 2022 Urovant Sciences. All rights reserved.

Urovant Sciences
Alana Darden Powell
Vice President, Corporate Communications
949-436-3116
alana.darden@Urovant.com
media@urovant.com

Sumitovant Biopharma 
Maya Frutiger
VP, Head of Corporate Communications
media@sumitovant.com

Source: Urovant Sciences, Inc.

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Urovant Sciences and Pierre Fabre Médicament Enter into Exclusive License Agreement to Commercialize Vibegron for the Treatment of Overactive Bladder in the European Economic Area, UK, and Switzerland

July 5, 2022 at 8:05am EST

Basel, Switzerland, and Castres, France – July 5, 2022, Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., and Pierre Fabre Médicament today announced they have entered into an exclusive license agreement for Pierre Fabre to register and commercialize vibegron for the treatment of Overactive Bladder (OAB) in the European Economic Area, UK, and Switzerland, with some option territories, which notably include French-speaking countries of Sub-Saharan Africa, Turkey, and certain Eastern European countries. Urovant will retain full rights in the United States and other select markets.

“We are thrilled to partner with Pierre Fabre, a leader in the international biopharmaceutical space,” said Jim Robinson, Chief Executive Officer of Urovant Sciences. “Their experience in the global OAB and Benign Prostatic Hyperplasia (BPH) market make them uniquely suited to deliver vibegron to more patients who need it across Europe and surrounding areas.”

Under the terms of the agreement, Urovant Sciences will receive payments up to USD $75 million, based on upfront, regulatory, and sales milestone payments. Additionally, Urovant will receive royalties based on sales performance.

Urovant Sciences and Pierre Fabre will share responsibility for vibegron clinical trials in the pediatric populations in Europe. As part of the transaction, Urovant Sciences will also provide manufacturing services to Pierre Fabre.

“We are delighted to enter into this partnership with Urovant, which will bring effective treatment and improved quality of life to all patients suffering from Overactive Bladder (OAB) in Europe. This partnership confirms Pierre Fabre’s extensive expertise in urology and in women’s health for five decades and the group’s ambitions to offer therapeutic solutions to chronic diseases that are very disabling in everyday life,” said Eric Ducournau, group CEO at Pierre Fabre.

About Overactive Bladder
Overactive Bladder (OAB) is a clinical condition that occurs when the bladder muscle contracts involuntarily. Symptoms may include urinary urgency (the sudden urge to urinate that is difficult to control), urgency incontinence (unintentional loss of urine immediately after an urgent need to urinate), frequent urination (usually eight or more times in 24 hours), and nocturia (waking up more than two times in the night to urinate).1

While 33 million US adults experience the bothersome symptoms of OAB, approximately 546 million people ≥20 years are affected by OAB worldwide. 1,2

About Urovant Sciences
Urovant Sciences is a biopharmaceutical company focused on developing and commercializing innovative therapies for areas of unmet need, with a dedicated focus in Urology. The Company’s lead product, GEMTESA®(vibegron), is an oral, once-daily (75 mg) small molecule beta-3 agonist for the treatment of adult patients with Overactive Bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. GEMTESA was approved by the U.S. FDA in December 2020 and launched in the U.S. in April 2021. GEMTESA is also being evaluated for the treatment of OAB in men with Benign Prostatic Hyperplasia. The Company’s second product candidate, URO-902, is a novel gene therapy being developed for patients with OAB who have failed oral pharmacologic therapy. Urovant Sciences, a wholly owned subsidiary of Sumitovant Biopharma Ltd., intends to bring innovation to patients in need in urology and other areas of unmet need. Learn about us at www.urovant.com or follow us on Twitter or LinkedIn.

About Sumitovant Biopharma
Sumitovant is a technology-driven biopharmaceutical company accelerating development of new potential therapies for patients with high unmet medical need. Through our company portfolio and use of embedded computational technology platforms to generate business and scientific insights, Sumitovant has supported development of FDA-approved products and advanced a promising pipeline of early-through-late-stage investigational assets for other serious conditions. Sumitovant’s subsidiary portfolio includes wholly owned Enzyvant, Urovant, Spirovant and Altavant, and majority-owned Myovant (NYSE: MYOV). Sumitomo Pharma is Sumitovant’s parent company. For more information, please visit www.sumitovant.com.

About Pierre Fabre Group
Pierre Fabre is the 2nd largest dermo-cosmetics laboratory in the world, the 2nd largest private French pharmaceutical group and the market leader in France for products sold over the counter in pharmacies. Its portfolio includes several medical franchises and international brands including Pierre Fabre Oncology, Pierre Fabre Dermatology, Eau Thermale Avène, Klorane, Ducray, René Furterer, A-Derma, Naturactive, Pierre Fabre Oral Care.  

In 2021, Pierre Fabre generated €2.5 billion in revenues, 66% of which came from international sales.  Established in the South-West of France since its creation, the Group manufactures over 95% of its products in France and employs some 9,500 people worldwide. Its products are distributed in about 115 countries. Pierre Fabre is 86%-owned by the Pierre Fabre Foundation, a government-recognized public-interest foundation, and secondarily by its own employees through an international employee stock ownership plan. 

To learn more, please go to https://www.pierre-fabre.com/en. You can also join us on Twitter at @PierreFabre and Facebook at www.facebook.com/laboratoirespierrefabre.

About GEMTESA® tablets for oral use (US market)
GEMTESA® is a prescription medicine for adults used to treat the following symptoms due to a condition called overactive bladder:

It is not known if GEMTESA is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Do not take GEMTESA if you are allergic to vibegron or any of the ingredients in GEMTESA.

Before you take GEMTESA, tell your doctor about all your medical conditions, including if you have liver problems; have kidney problems; have trouble emptying your bladder or you have a weak urine stream; take medicines that contain digoxin; are pregnant or plan to become pregnant (it is not known if GEMTESA will harm your unborn baby; talk to your doctor if you are pregnant or plan to become pregnant); are breastfeeding or plan to breastfeed (it is not known if GEMTESA passes into your breast milk; talk to your doctor about the best way to feed your baby if you take GEMTESA).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

What are the possible side effects of GEMTESA?
GEMTESA may cause serious side effects including the inability to empty your bladder (urinary retention). GEMTESA may increase your chances of not being able to empty your bladder, especially if you have bladder outlet obstruction or take other medicines for treatment of overactive bladder. Tell your doctor right away if you are unable to empty your bladder. The most common side effects of GEMTESA include headache, urinary tract infection, nasal congestion, sore throat or runny nose, diarrhea, nausea, and upper respiratory tract infection. These are not all the possible side effects of GEMTESA. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Please click here for full Product Information for GEMTESA.

References:

1. Irwin DE, Kopp ZS, Agatep B, Milsom I, Abrams P. Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction. BJU Int. 2011;108(7):‍11‍32‍-11‍38‍. doi:10.1111/j.1464-410X.2010.09993.x 

2. Leron E, Weintraub AY, Mastrolia SA, Schwarzman P. Overactive bladder syndrome: evaluation and management. Curr Urol. 2017;11:117-125. doi:10.1159/000447205

UROVANT, UROVANT SCIENCES, the UROVANT SCIENCES logo are trademarks of Urovant Sciences GmbH, registered in the U.S. and in other countries. All other trademarks are the property of their respective owners. © 2022 Urovant Sciences. All rights reserved.

PIERRE FABRE, the PIERRE FABRE logo are trademarks of Pierre Fabre Médicament SAS, registered in the U.S and in other countries. All other trademarks are the property of their respective owners. © 2022 Pierre Fabre Médicament. All rights reserved.

Urovant Sciences
Alana Darden Powell
Vice President, Corporate Communications
949-436-3116
alana.darden@Urovant.com

Sumitovant Biopharma 
Maya Frutiger
VP, Head of Corporate Communications
media@sumitovant.com

Pierre Fabre
Anne Kerveillant
Media Relations PF Pharmaceuticals Direction
Tél. : +33 (0)6 20 88 54 57
annekerveillant@pierre-fabre.com

Source: Urovant Sciences, Inc.

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Myovant Sciences and Pfizer Announce Publication in The Lancet of Phase 3 SPIRIT 2 and SPIRIT 2 Studies of Once-Daily Relugolix Combination Therapy in Women with Endometriosis-Associated Pain

June 17, 2022 at 6:45 AM EDT

BASEL, Switzerland and NEW YORK, June 17, 2022 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced that results of the Phase 3 SPIRIT 1 and SPIRIT 2 studies of investigational once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in over 1,200 women with moderate to severe pain associated with endometriosis were published in The Lancet.

As previously reported, both studies achieved their co-primary endpoints by demonstrating clinically meaningful reductions in dysmenorrhea (menstrual pain) and non-menstrual pelvic pain in women with endometriosis. SPIRIT 1 and 2 each met their co-primary endpoints with 75% of women in the relugolix combination therapy group in both studies achieving a clinically meaningful reduction in dysmenorrhea compared with 27% and 30% of women in the placebo groups at Week 24, respectively (both p < 0.0001). For non-menstrual pelvic pain, relugolix combination therapy achieved a clinically meaningful reduction in 59% and 66% of women, compared with 40% and 43% of women in the placebo groups (p < 0.0001). In SPIRIT 1, seven key secondary endpoints, and in SPIRIT 2, six key secondary endpoints comparing relugolix combination therapy with placebo at Week 24 achieved statistical significance, including reductions in dyspareunia and opioid use. In addition, more women treated with relugolix combination therapy groups were opioid free at Week 24 compared with placebo (86% and 82% vs 76% and 66%, respectively). In both studies, relugolix combination therapy was associated with a generally well-tolerated safety profile, including bone mineral density loss of <1% over 24 weeks.

“Approximately 7.5 million premenopausal women in the United States have endometriosis and 75-80 percent of them are symptomatic,” said Juan Camilo Arjona Ferreira, M.D., Chief Medical Officer of Myovant Sciences, Inc.1,2,3,4 “The data published in The Lancet underscore the value relugolix combination therapy may provide as a potential new treatment option for women with endometriosis-associated pain.”

“We are excited to see this data published in The Lancet,” said James Rusnak, M.D., Ph.D., Senior Vice President, Chief Development Officer, Internal Medicine and Hospital, Global Product Development at Pfizer. “We continue to look forward to bringing this potential new treatment option to women with endometriosis-associated pain.”

Seven key secondary endpoints in SPIRIT 1 and six key secondary endpoints in SPIRIT 2 comparing relugolix combination therapy with placebo at Week 24 also achieved statistical significance. These endpoints include changes in mean dysmenorrhea, non-menstrual pelvic pain, overall pelvic pain, impact of pain on daily activities as measured by the Endometriosis Health Profile-30 (EHP-30) pain domain, the proportion of women not using opioids, the proportion of women not using analgesics, and change in mean dyspareunia (painful intercourse). While the seventh endpoint for the SPIRIT 2 study – reduction in analgesic use (based on pill count) – did not achieve statistical significance, possibly due to the low number of average pills per day and variability in day-to-day pill consumption, a post-hoc analysis of SPIRIT 2 showed that the percentage of patients who were analgesic-free at end of treatment was greater among women in the combination therapy group than the placebo group.

The most frequently reported adverse events in both relugolix combination treatment and placebo groups were headache, nasopharyngitis, and hot flushes.

In the U.S., relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is currently available as MYFEMBREE® for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months. Data from SPIRIT 1 and SPIRIT 2, in addition to data from an open-label extension study, were included in a supplemental New Drug Application for MYFEMBREE for the management of moderate to severe pain associated with endometriosis, which has a target Prescription Drug User Fee Act (PDUFA) action date of August 6, 2022.

About Endometriosis
Endometriosis is a condition in which tissue similar to the uterine lining is found outside of the uterine cavity, which often causes disruptive symptoms like painful periods, fatigue, pain in the lower back and abdomen, heavy menstrual bleeding, and even painful or difficult sexual intercourse. For endometriosis-associated pain, current treatment options include prescription and over-the-counter pain medications, oral contraceptives, GnRH agonists, and antagonists. There are also surgical options including adhesiolysis, cyst removal, and hysterectomy.

Endometriosis can also impact general physical, mental, and social well-being, requiring a multi-disciplinary approach to care. Almost 200 million women suffer from symptoms of endometriosis globally.5 In the U.S., there are approximately 7.5 million premenopausal women with endometriosis.1,2,3 It can take between four and eleven years to get an endometriosis diagnosis6,7,8 and for some women, current treatment options do not provide relief.9

About MYFEMBREE®
MYFEMBREE (relugolix, estradiol, and norethindrone acetate) is the first and only once-daily oral treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women approved by the U.S. Food and Drug Administration, with a treatment duration of up to 24 months. MYFEMBREE contains relugolix, which reduces the amount of estrogen (and other hormones) produced by ovaries, estradiol (an estrogen) which may reduce the risk of bone loss, and norethindrone acetate (a progestin) which is necessary when women with a uterus (womb) take estrogen.

For full prescribing information including Boxed Warning and patient information, click here.

Indications and Usage
MYFEMBREE is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. Limitations of Use: Use of MYFEMBREE should be limited to 24 months due to the risk of continued bone loss which may not be reversible.

Important Safety Information

BOXED WARNING: THROMBOEMBOLIC DISORDERS AND VASCULAR EVENTS

Estrogen and progestin combination products, including MYFEMBREE, increase the risk of thrombotic or thromboembolic disorders including pulmonary embolism, deep vein thrombosis, stroke and myocardial infarction, especially in women at increased risk for these events.

MYFEMBREE is contraindicated in women with current or a history of thrombotic or thromboembolic disorders and in women at increased risk for these events, including women over 35 years of age who smoke or women with uncontrolled hypertension.

CONTRAINDICATIONS

MYFEMBREE is contraindicated in women with any of the following: high risk of arterial, venous thrombotic, or thromboembolic disorder; pregnancy; known osteoporosis; current or history of breast cancer or other hormone-sensitive malignancies; known hepatic impairment or disease; undiagnosed abnormal uterine bleeding; known hypersensitivity to components of MYFEMBREE.

WARNINGS AND PRECAUTIONS

Thromboembolic Disorders: Discontinue immediately if an arterial or venous thrombotic, cardiovascular, or cerebrovascular event occurs or is suspected. Discontinue at least 4 to 6 weeks before surgery associated with an increased risk of thromboembolism, or during periods of prolonged immobilization, if feasible. Discontinue immediately if there is sudden unexplained partial or complete loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions and evaluate for retinal vein thrombosis as these have been reported with estrogens and progestins.

Bone Loss: MYFEMBREE may cause a decrease in bone mineral density (BMD) in some patients, which may be greater with increasing duration of use and may not be completely reversible after stopping treatment. Consider the benefits and risks in patients with a history of low trauma fracture or risk factors for osteoporosis or bone loss, including medications that may decrease BMD. Assessment of BMD by dual-energy X-ray absorptiometry (DXA) is recommended at baseline and periodically thereafter. Consider discontinuing MYFEMBREE if the risk of bone loss exceeds the potential benefit.

Hormone-Sensitive Malignancies: Discontinue MYFEMBREE if a hormone-sensitive malignancy is diagnosed. Surveillance measures in accordance with standard of care, such as breast examinations and mammography are recommended. Use of estrogen alone or estrogen plus progestin has resulted in abnormal mammograms requiring further evaluation.

Depression, Mood Disorders, and Suicidal Ideation: Promptly evaluate patients with mood changes and depressive symptoms including shortly after initiating treatment, to determine whether the risks of continued therapy outweigh the benefits. Patients with new or worsening depression, anxiety, or other mood changes should be referred to a mental health professional, as appropriate. Advise patients to seek immediate medical attention for suicidal ideation and behavior and reevaluate the benefits and risks of continuing MYFEMBREE.

Hepatic Impairment and Transaminase Elevations: Steroid hormones may be poorly metabolized in these patients. Instruct women to promptly seek medical attention for symptoms or signs that may reflect liver injury, such as jaundice or right upper abdominal pain. Acute liver test abnormalities may necessitate the discontinuation of MYFEMBREE use until the liver tests return to normal and MYFEMBREE causation has been excluded.

Gallbladder Disease or History of Cholestatic Jaundice: Discontinue MYFEMBREE if signs or symptoms of gallbladder disease or jaundice occur. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, assess the risk-benefit of continuing therapy. Studies among estrogen users suggest a small increased relative risk of developing gallbladder disease.

Elevated Blood Pressure: For women with well-controlled hypertension, monitor blood pressure and stop MYFEMBREE if blood pressure rises significantly.

Change in Menstrual Bleeding Pattern and Reduced Ability to Recognize Pregnancy: Advise women to use non-hormonal contraception during treatment and for one week after discontinuing MYFEMBREE. Avoid concomitant use of hormonal contraceptives. MYFEMBREE may delay the ability to recognize pregnancy because it alters menstrual bleeding. Perform testing if pregnancy is suspected and discontinue MYFEMBREE if pregnancy is confirmed.

Risk of Early Pregnancy Loss: MYFEMBREE can cause early pregnancy loss. Exclude pregnancy before initiating and advise women to use effective non-hormonal contraception.

Uterine Fibroid Prolapse or Expulsion: Advise women with known or suspected submucosal uterine fibroids about the possibility of uterine fibroid prolapse or expulsion and instruct them to contact their physician if severe bleeding and/or cramping occurs.

Alopecia: Alopecia, hair loss, and hair thinning were reported in phase 3 trials with MYFEMBREE. Consider discontinuing MYFEMBREE if hair loss becomes a concern. Whether the hair loss is reversible is unknown.

Effects on Carbohydrate and Lipid Metabolism: More frequent monitoring in MYFEMBREE-treated women with prediabetes and diabetes may be necessary. MYFEMBREE may decrease glucose tolerance and result in increased blood glucose concentrations. Monitor lipid levels and consider discontinuing if hypercholesterolemia or hypertriglyceridemia worsens. In women with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations in triglycerides levels leading to pancreatitis. Use of MYFEMBREE is associated with increases in total cholesterol and LDL-C.

Effect on Other Laboratory Results: Patients with hypothyroidism and hypoadrenalism may require higher doses of thyroid hormone or cortisol replacement therapy. Use of estrogen and progestin combinations may raise serum concentrations of binding proteins (e.g., thyroid-binding globulin, corticosteroid-binding globulin), which may reduce free thyroid or corticosteroid hormone levels. Use of estrogen and progestin may also affect the levels of sex hormone-binding globulin, and coagulation factors.

Hypersensitivity Reactions: Immediately discontinue MYFEMBREE if a hypersensitivity reaction occurs.

ADVERSE REACTIONS
Most common adverse reactions for MYFEMBREE (incidence ≥3% and greater than placebo) were hot flush/hyperhidrosis/night sweats, abnormal uterine bleeding, alopecia, and decreased libido. These are not all the possible side effects of MYFEMBREE.

DRUG INTERACTIONS
P-gp Inhibitors:
 Avoid use of MYFEMBREE with oral P-gp inhibitors. If use is unavoidable, take MYFEMBREE first, separate dosing by at least 6 hours, and monitor patients for adverse reactions.

Combined P-gp and Strong CYP3A Inducers: Avoid use of MYFEMBREE with combined P-gp and strong CYP3A inducers.

LACTATION
Advise women not to breastfeed while taking MYFEMBREE.

About Myovant Sciences 
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Founded in 2016, Myovant has executed five successful Phase 3 clinical trials across oncology and women’s health leading to two regulatory approvals by the U.S. Food and Drug Administration (FDA) for men with advanced prostate cancer and women with heavy menstrual bleeding associated with uterine fibroids, respectively. Myovant also has received regulatory approvals by the European Commission (EC) for women with symptomatic uterine fibroids and for men with advanced hormone-sensitive prostate cancer. Myovant has supplemental New Drug Applications under review with the FDA for endometriosis-associated pain, and for updates to the United States Prescribing Information (USPI) based on safety and efficacy data from the Phase 3 LIBERTY randomized withdrawal study (RWS) of MYFEMBREE in premenopausal women with heavy menstrual bleeding due to uterine fibroids for up to two years. Myovant also is conducting a Phase 3 study to evaluate the prevention of pregnancy in women with uterine fibroids or endometriosis. Myovant also is developing MVT-602, an investigational 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 Pharma Co., Ltd., is Myovant’s majority shareholder. For more information, please visit www.myovant.com. Follow @Myovant on Twitter and LinkedIn.

About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com.

In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer NewsLinkedInYouTube and like us on Facebook at Facebook.com/Pfizer.

Myovant Sciences Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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. In this press release, forward-looking statements include, but are not limited to, the statements with respect to providing relugolix combination therapy as a potential new treatment option for women with endometriosis-associated pain.

For a further discussion of factors that could materially affect Myovant Sciences’ operations and future prospects or which could cause actual results to differ materially from expectations, see the risks and uncertainties listed in Myovant Sciences’ filings with the United States Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in Myovant Sciences’ Annual Report on Form 10-K filed on May 11, 2022, as such risk factors may be amended, supplemented, or superseded from time to time. These risks are not exhaustive. New risk factors emerge from time to time and it is not possible for Myovant Sciences’ management to predict all risk factors, nor can Myovant Sciences assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof, and, except as required by law, Myovant Sciences undertakes no obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements.

Pfizer Disclosure Notice
The information contained in this release is as of June 17, 2022. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about MYFEMBREE® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg), including a potential indication in the U.S. for the management of moderate to severe pain associated with endometriosis, including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of MYFEMBREE; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when applications may be filed in any additional jurisdictions for MYFEMBREE for the management of moderate to severe pain associated with endometriosis or in any jurisdictions for any other potential indications for MYFEMBREE; whether and when the FDA may approve the supplemental new drug application for the management of moderate to severe pain associated with endometriosis and whether and when regulatory authorities in any jurisdictions may approve any such other applications for MYFEMBREE that may be pending or filed, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether MYFEMBREE for the management of moderate to severe pain associated with endometriosis will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of MYFEMBREE; whether our collaboration with Myovant Sciences will be successful; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

Myovant Sciences Contacts
Investor Contact:
Uneek Mehra
Chief Financial Officer
Myovant Sciences, Inc.
investors@myovant.com

Media Contact:
Noelle Cloud Dugan
Vice President, Corporate Communications
Myovant Sciences, Inc.
media@myovant.com

Pfizer Contacts
Media Relations:

PfizerMediaRelations@Pfizer.com
+1 (212) 733-1226

Investor Relations:
IR@Pfizer.com
+1 (212) 733-4848

1.   US census 2019 (table 1; approx. 75 million women in the US ages 15-49). Available online at https://data.census.gov/cedsci/table?q=United%20States&t=Age%20and%20Sex
2.   Shafrir. Best Pract Res Clin Obstet Gynaecol. 2018 Aug;51:1-15
3.   Fuldeore Gynecol Obstet Invest. 2017;82:453-461
4.   Bulletti J Asist Reprod Genet 2010
5.   Adamson, G. et al. Journal Endometriosis. 2010; 2:3-6
6.   Zondervan KT, et al. NEJM. 2020;382(13):1244–1256
7.   Nnoaham KE et al. Fertil Steril. 2011;96(2):366.e8–373.e8
8.   Ballard K et al. Fertil Steril. 2006;86:1296–301
9.   Soliman et al. J Women’s Health. 2017. 26(7): 788-797

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Myovant Sciences and Pfizer Announce FDA Acceptance of Supplemental New Drug Application for MYFEMBREE®

June 2, 2022 at 6:50 AM EDT

BASEL, Switzerland and NEW YORK, June 02, 2022 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) accepted for review a supplemental New Drug Application (sNDA) for MYFEMBREE® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg). The sNDA proposes updates to MYFEMBREE’s United States Prescribing Information (USPI) based on safety and efficacy data from the Phase 3 LIBERTY randomized withdrawal study (RWS) of MYFEMBREE in premenopausal women with heavy menstrual bleeding associated with uterine fibroids for up to two years. The FDA set a target action date of January 29, 2023 for this sNDA under the Prescription Drug User Fee Act (PDUFA).

“Heavy menstrual bleeding is the most common symptom affecting women with uterine fibroids that can impact their daily life and activities over a long period of time,” said Juan Camilo Arjona Ferreira, M.D., Chief Medical Officer of Myovant Sciences, Inc. “We are pleased to submit these study results to the FDA as they show the value MYFEMBREE can potentially have on treating women’s uterine fibroid symptoms long term.”

Patients who completed the 24-week pivotal LIBERTY 1 and 2 studies were offered the option to receive MYFEMBREE for an additional 28 weeks in an open-label extension study. After completion of the LIBERTY 1 or LIBERTY 2 and the open-label extension studies, women who met the definition of responder (menstrual blood loss < 80 mL and a reduction from pivotal study baseline > 50%) could participate in an additional 52-week randomized withdrawal study (N=229) designed to provide two-year safety and efficacy data on MYFEMBREE and to evaluate the need for maintenance therapy. Women who entered the RWS were re-randomized to either MYFEMBREE or placebo for 52 additional weeks (N = 229), with the primary endpoint at Week 76. The LIBERTY randomized withdrawal study met its primary endpoint with 78.4% of women who continued on MYFEMBREE achieving the sustained responder rate (menstrual blood loss < 80 mL) through Week 76 compared with 15.1% of women who discontinued treatment and initiated placebo at Week 52 (p < 0.0001). All three key secondary endpoints in the LIBERTY randomized withdrawal study were also achieved, including sustained responder rate through Week 104, time to relapse of heavy menstrual bleeding, and amenorrhea rate (all p < 0.0001).

Bone mineral density remained stable in women who received MYFEMBREE in the randomized withdrawal study. Additionally, bone mineral density was maintained through two years in the subset of women continuously treated with MYFEMBREE (N = 31). The incidence of adverse events over one additional year of treatment was consistent with those observed in prior studies, with no new safety signals observed.

“Data from the MYFEMBREE RWS supports our mission to improve care for women living with uterine fibroids,” said James Rusnak, M.D., Ph.D., Senior Vice President, Chief Development Officer, Internal Medicine and Hospital, Global Product Development at Pfizer. “We look forward to the FDA’s review of the application and potential updates to the MYFEMBREE prescribing information based on these data.”

MYFEMBREE was approved in the U.S. in 2021 for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women with a treatment duration of up to 24 months.

About the Phase 3 LIBERTY Program in Uterine Fibroids 
The Phase 3 clinical program for uterine fibroids consisted of two multi-national, replicate pivotal clinical studies (LIBERTY 1, N=388 and LIBERTY 2, N=382) of MYFEMBREE® in women with heavy menstrual bleeding associated with uterine fibroids for 24 weeks. Eligible women who completed the LIBERTY 1 or LIBERTY 2 studies were offered the opportunity to enroll in an active treatment, open-label extension study in which all women received MYFEMBREE for an additional 28-week period for a total treatment period of 52 weeks (N=477), designed to evaluate the safety and efficacy of longer-term treatment. After completion of the LIBERTY 1 or LIBERTY 2 and open-label extension studies, eligible women could elect to participate in an additional 52-week randomized withdrawal study (N=229) designed to provide two-year safety and efficacy data on MYFEMBREE and to evaluate the need for maintenance therapy. Across the LIBERTY 1, LIBERTY 2 and open-label extension studies, a response was defined as a menstrual blood loss volume of less than 80 mL and a 50% or greater reduction from baseline in menstrual blood loss volume during the last 35 days of treatment measured using the alkaline hematin method.

LIBERTY 1 and LIBERTY 2 met their primary endpoints (p < 0.0001) with 72.1% and 71.2% of women receiving MYFEMBREE achieving the responder criteria compared with 16.8% and 14.7% of women receiving placebo at 24 weeks, respectively. On average, women receiving MYFEMBREE in both studies experienced an 84.3% reduction in menstrual blood loss from baseline at Week 24 (p < 0.0001). The overall incidence of adverse events in the relugolix combination and placebo groups was comparable in both studies. The most common adverse reactions (incidence ≥ 3%) were hot flush, hyperhidrosis or night sweats, uterine bleeding, alopecia, and decreased libido.

In the open-label extension study, changes in bone mineral density through one year, as assessed by DXA every three months, were consistent with LIBERTY 1 and 2. The incidence of adverse events over one year was consistent with that observed in LIBERTY 1 and 2, with no new safety signals observed.

The LIBERTY randomized withdrawal study met its primary endpoint of maintaining sustained responder rate (menstrual blood loss < 80 mL). All three key secondary endpoints in the LIBERTY randomized withdrawal study were also achieved, including sustained responder rate at two years (Week 104), time to relapse of heavy menstrual bleeding, and amenorrhea rate (all p < 0.0001). Bone mineral density was maintained through two years in the subset of women continuously treated with MYFEMBREE (N = 31). The incidence of adverse events over one additional year of treatment was consistent with those observed in prior studies, with no new safety signals observed.

About Uterine Fibroids
Uterine fibroids are noncancerous tumors that develop in or on the muscular walls of the uterus and are among the most common reproductive tract tumors in women. In addition to an individual’s genetic predisposition, estrogens are well known to play an important role in the regulation of fibroid growth.

Although uterine fibroids are benign tumors, they can cause debilitating symptoms such as heavy menstrual bleeding (frequently resulting in anemia and fatigue), pain (including painful periods, abdominal pain, painful intercourse, backache), increased abdominal girth and bloating, urinary frequency or retention, constipation, pregnancy loss, and, in some cases, infertility. These symptoms can also lead to loss of productivity at work, limitations in normal activities of daily living, and social embarrassment.

An estimated five million women in the U.S. suffer from symptoms of uterine fibroids,i and an estimated three million women are inadequately treated by current medical therapy.ii

About MYFEMBREE®
MYFEMBREE (relugolix, estradiol, and norethindrone acetate) is the first and only once-daily oral treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women approved by the U.S. Food and Drug Administration, with a treatment duration of up to 24 months. MYFEMBREE contains relugolix, which reduces the amount of estrogen (and other hormones) produced by ovaries, estradiol (an estrogen) which may reduce the risk of bone loss, and norethindrone acetate (a progestin) which is necessary when women with a uterus (womb) take estrogen.

For full prescribing information including Boxed Warning and patient information, click here.

Indications and Usage
MYFEMBREE is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. Limitations of Use: Use of MYFEMBREE should be limited to 24 months due to the risk of continued bone loss which may not be reversible.

Important Safety Information

BOXED WARNING: THROMBOEMBOLIC DISORDERS AND VASCULAR EVENTS

Estrogen and progestin combination products, including MYFEMBREE, increase the risk of thrombotic or thromboembolic disorders including pulmonary embolism, deep vein thrombosis, stroke and myocardial infarction, especially in women at increased risk for these events.

MYFEMBREE is contraindicated in women with current or a history of thrombotic or thromboembolic disorders and in women at increased risk for these events, including women over 35 years of age who smoke or women with uncontrolled hypertension.

CONTRAINDICATIONS

MYFEMBREE is contraindicated in women with any of the following: high risk of arterial, venous thrombotic, or thromboembolic disorder; pregnancy; known osteoporosis; current or history of breast cancer or other hormone-sensitive malignancies; known hepatic impairment or disease; undiagnosed abnormal uterine bleeding; known hypersensitivity to components of MYFEMBREE.

WARNINGS AND PRECAUTIONS

Thromboembolic Disorders: Discontinue immediately if an arterial or venous thrombotic, cardiovascular, or cerebrovascular event occurs or is suspected. Discontinue at least 4 to 6 weeks before surgery associated with an increased risk of thromboembolism, or during periods of prolonged immobilization, if feasible. Discontinue immediately if there is sudden unexplained partial or complete loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions and evaluate for retinal vein thrombosis as these have been reported with estrogens and progestins.

Bone Loss: MYFEMBREE may cause a decrease in bone mineral density (BMD) in some patients, which may be greater with increasing duration of use and may not be completely reversible after stopping treatment. Consider the benefits and risks in patients with a history of low trauma fracture or risk factors for osteoporosis or bone loss, including medications that may decrease BMD. Assessment of BMD by dual-energy X-ray absorptiometry (DXA) is recommended at baseline and periodically thereafter. Consider discontinuing MYFEMBREE if the risk of bone loss exceeds the potential benefit.

Hormone-Sensitive Malignancies: Discontinue MYFEMBREE if a hormone-sensitive malignancy is diagnosed. Surveillance measures in accordance with standard of care, such as breast examinations and mammography are recommended. Use of estrogen alone or estrogen plus progestin has resulted in abnormal mammograms requiring further evaluation.

Depression, Mood Disorders, and Suicidal Ideation: Promptly evaluate patients with mood changes and depressive symptoms including shortly after initiating treatment, to determine whether the risks of continued therapy outweigh the benefits. Patients with new or worsening depression, anxiety, or other mood changes should be referred to a mental health professional, as appropriate. Advise patients to seek immediate medical attention for suicidal ideation and behavior and reevaluate the benefits and risks of continuing MYFEMBREE.

Hepatic Impairment and Transaminase Elevations: Steroid hormones may be poorly metabolized in these patients. Instruct women to promptly seek medical attention for symptoms or signs that may reflect liver injury, such as jaundice or right upper abdominal pain. Acute liver test abnormalities may necessitate the discontinuation of MYFEMBREE use until the liver tests return to normal and MYFEMBREE causation has been excluded.

Gallbladder Disease or History of Cholestatic Jaundice: Discontinue MYFEMBREE if signs or symptoms of gallbladder disease or jaundice occur. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, assess the risk-benefit of continuing therapy. Studies among estrogen users suggest a small increased relative risk of developing gallbladder disease.

Elevated Blood Pressure: For women with well-controlled hypertension, monitor blood pressure and stop MYFEMBREE if blood pressure rises significantly.

Change in Menstrual Bleeding Pattern and Reduced Ability to Recognize Pregnancy: Advise women to use non-hormonal contraception during treatment and for one week after discontinuing MYFEMBREE. Avoid concomitant use of hormonal contraceptives. MYFEMBREE may delay the ability to recognize pregnancy because it alters menstrual bleeding. Perform testing if pregnancy is suspected and discontinue MYFEMBREE if pregnancy is confirmed.

Risk of Early Pregnancy Loss: MYFEMBREE can cause early pregnancy loss. Exclude pregnancy before initiating and advise women to use effective non-hormonal contraception.

Uterine Fibroid Prolapse or Expulsion: Advise women with known or suspected submucosal uterine fibroids about the possibility of uterine fibroid prolapse or expulsion and instruct them to contact their physician if severe bleeding and/or cramping occurs.

Alopecia: Alopecia, hair loss, and hair thinning were reported in phase 3 trials with MYFEMBREE. Consider discontinuing MYFEMBREE if hair loss becomes a concern. Whether the hair loss is reversible is unknown.

Effects on Carbohydrate and Lipid Metabolism: More frequent monitoring in MYFEMBREE-treated women with prediabetes and diabetes may be necessary. MYFEMBREE may decrease glucose tolerance and result in increased blood glucose concentrations. Monitor lipid levels and consider discontinuing if hypercholesterolemia or hypertriglyceridemia worsens. In women with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations in triglycerides levels leading to pancreatitis. Use of MYFEMBREE is associated with increases in total cholesterol and LDL-C.

Effect on Other Laboratory Results: Patients with hypothyroidism and hypoadrenalism may require higher doses of thyroid hormone or cortisol replacement therapy. Use of estrogen and progestin combinations may raise serum concentrations of binding proteins (e.g., thyroid-binding globulin, corticosteroid-binding globulin), which may reduce free thyroid or corticosteroid hormone levels. Use of estrogen and progestin may also affect the levels of sex hormone-binding globulin, and coagulation factors.

Hypersensitivity Reactions: Immediately discontinue MYFEMBREE if a hypersensitivity reaction occurs.

ADVERSE REACTIONS
Most common adverse reactions for MYFEMBREE (incidence ≥3% and greater than placebo) were hot flush/hyperhidrosis/night sweats, abnormal uterine bleeding, alopecia, and decreased libido. These are not all the possible side effects of MYFEMBREE.

DRUG INTERACTIONS
P-gp Inhibitors:
 Avoid use of MYFEMBREE with oral P-gp inhibitors. If use is unavoidable, take MYFEMBREE first, separate dosing by at least 6 hours, and monitor patients for adverse reactions.

Combined P-gp and Strong CYP3A Inducers: Avoid use of MYFEMBREE with combined P-gp and strong CYP3A inducers.

LACTATION
Advise women not to breastfeed while taking MYFEMBREE.

About Myovant Sciences 
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Founded in 2016, Myovant has executed five successful Phase 3 clinical trials across oncology and women’s health leading to two regulatory approvals by the U.S. Food and Drug Administration (FDA) for men with advanced prostate cancer and women with heavy menstrual bleeding associated with uterine fibroids, respectively. Myovant also has received regulatory approvals by the European Commission (EC) for women with symptomatic uterine fibroids and for men with advanced hormone-sensitive prostate cancer. Myovant has supplemental New Drug Applications under review with the FDA for endometriosis-associated pain, and for updates to the United States Prescribing Information (USPI) based on safety and efficacy data from the Phase 3 LIBERTY randomized withdrawal study (RWS) of MYFEMBREE in premenopausal women with heavy menstrual bleeding due to uterine fibroids for up to two years. Myovant also is conducting a Phase 3 study to evaluate the prevention of pregnancy in women with uterine fibroids or endometriosis. Myovant also is developing MVT-602, an investigational 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 Pharma Co., Ltd., is Myovant’s majority shareholder. For more information, please visit www.myovant.com. Follow @Myovant on Twitter and LinkedIn.

About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com.

In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer NewsLinkedInYouTube and like us on Facebook at Facebook.com/Pfizer.

Myovant Sciences Forward-Looking Statements 
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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. In this press release, forward-looking statements include, but are not limited to, the statements with respect to the value of MYFEMBREE on treating women’s uterine fibroid symptoms, the potential updates to the MYFEMBREE USPI, and the potential outcome of FDA’s review of the sNDA for MYFEMBREE.

For a further discussion of factors that could materially affect Myovant Sciences’ operations and future prospects or which could cause actual results to differ materially from expectations, see the risks and uncertainties listed in Myovant Sciences’ filings with the United States Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in Myovant Sciences’ Annual Report on Form 10-K filed on May 11, 2022, as such risk factors may be amended, supplemented, or superseded from time to time. These risks are not exhaustive. New risk factors emerge from time to time and it is not possible for Myovant Sciences’ management to predict all risk factors, nor can Myovant Sciences assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof, and, except as required by law, Myovant Sciences undertakes no obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements.

Pfizer Disclosure Notice
The information contained in this release is as of June 2, 2022. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about MYFEMBREE® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg), including a sNDA proposing updates to the United States Prescribing Information based on safety and efficacy data from the Phase 3 LIBERTY randomized withdrawal study (RWS) of MYFEMBREE in premenopausal women with heavy menstrual bleeding due to uterine fibroids for up to two years, including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of MYFEMBREE; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when applications may be filed in any additional jurisdictions for MYFEMBREE for the RWS study data or in any jurisdictions for any other potential indications for MYFEMBREE; whether and when regulatory authorities in any jurisdictions may approve any such other applications for MYFEMBREE that may be pending or filed, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether MYFEMBREE will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of MYFEMBREE; whether our collaboration with Myovant Sciences will be successful; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

Myovant Sciences Contacts
Investor Contact:
Uneek Mehra
Chief Financial Officer
Myovant Sciences, Inc.
investors@myovant.com

Media Contact:
Noelle Cloud Dugan
Vice President, Corporate Communications
Myovant Sciences, Inc.
media@myovant.com

Pfizer Contacts
Media Relations:
PfizerMediaRelations@Pfizer.com 
+1 (212) 733-1226

Investor Relations:
IR@Pfizer.com
+1 (212) 733-4848

i Stewart E. Lancet. 2001. 357:293-298
ii Marjoribanks et al. Cochrane Database Syst. Rev. 2006.

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Spirovant Launches State-of-the-Art Laboratory and Headquarters

The facilities are located in the center of Philadelphia’s thriving life sciences corridor

Philadelphia, PA, May 17, 2022 – Spirovant Sciences, a gene therapy company developing treatments for inherited respiratory diseases, including cystic fibrosis (CF), announced today the launch of its new state-of-the-art research laboratory and corporate headquarters in Philadelphia. The new research facilities will allow the company to accelerate development of its lead program targeting CF, support the vector manufacturing process, and build capabilities to grow its platform and pipeline into therapeutic opportunities.

“Our growth and maturity as a leading gene therapy company have propelled us to expand into the new research facilities where we will redouble our efforts to develop promising treatments and cures for patients with inherited respiratory diseases such as CF,” said Joan Lau, CEO of Spirovant Sciences. “Our diverse team of talented researchers and drug development professionals is committed to advancing promising drug candidates as a cornerstone of biotech innovation in Philadelphia.”

“With a first investment and ongoing commercialization support from the Science Center, and the expansion here at uCity Square, we celebrate the success and continued growth of Spirovant Sciences,” said Tiffany Wilson, President & CEO of the University City Science Center. “Spirovant Sciences is a true success story for the Science Center, uCity Square, and Philadelphia’s vibrant life sciences ecosystem.”

The new laboratory space is in the uCity Square district, located in the heart of the University City neighborhood t, surrounded by leading universities, academic medical centers and numerous outstanding technology, life sciences, and healthcare organizations. The laboratory allows the Spirovant scientists to conduct innovative R&D in respiratory biology and within process and analytical sciences. 

“As a company that started here, stayed here and has grown here, Spirovant is a leading example of the success of Philadelphia’s booming cell and gene therapy ecosystem, and we are excited they have chosen to continue growing their team and their therapies here in uCity Square,” said John Grady Senior Vice President and Northeast Region Executive for Wexford Science and Technology, developer of the uCity Square knowledge community.    

“I am thrilled about Spirovant’s move into the new laboratory space and corporate headquarters,” said Myrtle Potter, CEO of Sumitovant, Spirovant’s parent company. “The greater Philadelphia region is well known for its dynamic business environment in the field of gene and cell therapy, and we expect the entrepreneurial spirit of the region to reflect positively on Spirovant’s ambitions and talent.”

About Spirovant Sciences
Spirovant is a gene therapy company focused on changing the course of cystic fibrosis and other respiratory diseases. The company’s current investigational gene therapy technologies are designed to overcome the historical barriers that have prevented effective genetic treatments for cystic fibrosis. Spirovant’s lead programs are in development for cystic fibrosis. Spirovant, a wholly owned subsidiary of Sumitovant Biopharma, is located in Philadelphia, PA. For more information, please visit our website at spirovant.com.

About Sumitovant Biopharma
Sumitovant is a global biopharmaceutical company leveraging data-driven insights to rapidly accelerate development of new potential therapies. Through our unique portfolio of companies—wholly owned Urovant, Enzyvant, Spirovant, Altavant, plus majority-owned Myovant (NYSE: MYOV)—and use of embedded computational technology platforms to generate business and scientific insights, Sumitovant has supported the development of FDA-approved products and advanced a promising pipeline of early-through late-stage investigational assets for other serious conditions. Sumitovant is a wholly owned subsidiary of Sumitomo Pharma. For more information, please visit our website at sumitovant.com.

Media Contacts:

Spirovant Sciences
Jennifer Guinan 
Sage Strategic Marketing
610.410.8111
Jennifer@sagestrat.com

Sumitovant Biopharma
Maya Frutiger
Head of Corporate Communications
media@sumitovant.com

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Urovant Sciences® Presents New Data from EMPOWUR Study, Advancing Knowledge of the Treatment of Overactive Bladder at the 2022 American Urological Association Meeting

May 15, 2022 at 10:00 AM EDT

IRVINE, Calif. and BASEL, Switzerland – May 15, 2022 – Urovant Sciences, a wholly owned subsidiary of Sumitovant Biopharma Ltd., announced new analyses from the phase 3 EMPOWUR study of GEMTESA®, presented Sunday at the 2022 annual meeting of the American Urological Association (AUA2022). The meeting is being held in New Orleans, Louisiana, from May 13-16, 2022.

“The additional analyses of data on our FDA-approved overactive bladder therapy, GEMTESA, further confirm this drug’s potential utility and durability in this patient population,” said Sef Kurstjens, M.D., Ph.D., Executive Vice President and Chief Medical Officer of Urovant Sciences. “This is an additional demonstration of Urovant’s commitment to providing innovative and effective therapies for patients with urologic conditions.”

Two podium presentations at AUA2022 on May 15 featured new analyses of data from the EMPOWUR 40-week extension trial of GEMTESA (vibegron) 75 mg. This was a phase 3, randomized, double blind, active controlled, parallel-group multicenter study to evaluate long-term safety and efficacy in patients with symptoms of OAB. GEMTESA is approved by the U.S. Food and Drug Administration for adults in the treatment of OAB symptoms of UUI, urgency, and urinary frequency.

The first podium presentation, PD38-11, presented at 8:40-8:50 a.m. by Jeffrey Frankel, MD, Medical Director Seattle Urology Research Center, Seattle, Washington, was titled, “Long-Term Efficacy and Safety of Vibegron for Overactive Bladder in Patients ≥65 Years Old: Analysis from the EMPOWUR Extension Trial.” In a subgroup analysis of adults, 65 years old or above with overactive bladder, treatment with GEMTESA was safe and well tolerated. Treatment with GEMTESA was associated with sustained reductions from baseline in average daily micturition, urge urinary incontinence (UUI) episodes and urgency episodes. These results were consistent with the overall EMPOWUR study population.

The second podium presentation, PD38-12, presented at 8:50-9:00 a.m. by David Staskin, MD, Associate Professor of Urology, Tufts University School of Medicine, was titled, “Long-Term Patient-Reported Outcomes of Vibegron for Overactive Bladder: Analyses from the EMPOWUR Extension Trial.” This analysis showed that after 52 weeks of treatment, GEMTESA was associated with sustained and patient-perceived meaningful improvements in OAB questionnaire (OAB-q) and Patient Global Impression (PGI) scores in the EMPOWUR extension trial. This was consistent with GEMTESA’s long-term improvements in OAB symptoms and a favorable safety and tolerability profile during the 52-week treatment period.

Abstracts are available in the Journal of Urology at the following links:

EMPOWUR-EXT older adults: https://www.auajournals.org/doi/10.1097/JU.0000000000002596.11

EMPOWUR-EXT PRO: https://www.auajournals.org/doi/10.1097/JU.0000000000002596.12

About the EMPOWUR Trial
The EMPOWUR trial was an international, randomized, double-blind, placebo and active comparator-controlled phase 3 clinical trial evaluating the safety and efficacy of investigational vibegron in men and women with symptoms of overactive bladder, including frequent micturition, urgency, and UUI. A total of 1,518 patients were randomized across 215 study sites into one of three groups for a 12-week treatment period with a four-week safety follow-up period: vibegron 75 mg administered orally once daily; placebo administered orally once daily; or tolterodine ER 4 mg administered orally once daily.

About the 40-Week EMPOWUR Extension
The EMPOWUR 40-week extension trial was a phase 3, randomized, double blind, active-comparator controlled multicenter study to evaluate the long-term safety and efficacy of vibegron in patients with symptoms of overactive bladder. The extension study enrolled approximately 500 EMPOWUR completers. The primary endpoint was safety, measured by incidence of adverse events. Secondary endpoints were changes from EMPOWUR baseline at week 52 in average daily micturitions, UUI, urgency, and total urinary incontinence. 

About Overactive Bladder
Overactive bladder (OAB) is a clinical condition that occurs when the bladder muscle contracts involuntarily. Symptoms may include urinary urgency (the sudden urge to urinate that is difficult to control), urgency incontinence (unintentional loss of urine immediately after an urgent need to urinate), frequent urination (usually eight or more times in 24 hours), and nocturia (waking up more than two times in the night to urinate).1

Approximately 30 million Americans suffer from bothersome symptoms of OAB, which can have a significant impairment on a patient’s day-to-day activities.1, 2

About GEMTESA®

GEMTESA is a prescription medicine for adults used to treat the following symptoms due to a condition called overactive bladder:

It is not known if GEMTESA is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Do not take GEMTESA if you are allergic to vibegron or any of the ingredients in GEMTESA.

Before you take GEMTESA, tell your doctor about all your medical conditions, including if you have liver problems; have kidney problems; have trouble emptying your bladder or you have a weak urine stream; take medicines that contain digoxin; are pregnant or plan to become pregnant (it is not known if GEMTESA will harm your unborn baby; talk to your doctor if you are pregnant or plan to become pregnant); are breastfeeding or plan to breastfeed (it is not known if GEMTESA passes into your breast milk; talk to your doctor about the best way to feed your baby if you take GEMTESA).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

What are the possible side effects of GEMTESA?

GEMTESA may cause serious side effects including the inability to empty your bladder (urinary retention). GEMTESA may increase your chances of not being able to empty your bladder, especially if you have bladder outlet obstruction or take other medicines for treatment of overactive bladder. Tell your doctor right away if you are unable to empty your bladder.

The most common side effects of GEMTESA include headache, urinary tract infection, nasal congestion, sore throat or runny nose, diarrhea, nausea, and upper respiratory tract infection. These are not all the possible side effects of GEMTESA. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please click here for full Product Information for GEMTESA.

About Urovant Sciences
Urovant Sciences is a biopharmaceutical company focused on developing and commercializing innovative therapies for areas of unmet need, with a dedicated focus in urology. The Company’s lead product, GEMTESA®(vibegron), is an oral, once-daily (75 mg) small molecule beta-3 agonist for the treatment of adult patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. GEMTESA was approved by the U.S. FDA in December 2020 and launched in the U.S. in April 2021. GEMTESA is also being evaluated for the treatment of OAB in men with benign prostatic hyperplasia. The Company’s second product candidate, URO-902, is a novel gene therapy being developed for patients with OAB who have failed oral pharmacologic therapy. Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., intends to bring innovation to patients in need in urology and other areas of unmet need. Learn more about us at www.urovant.com or follow us on Twitter or LinkedIn.

About Sumitovant Biopharma
Sumitovant is a global biopharmaceutical company leveraging data-driven insights to rapidly accelerate development of new potential therapies for unmet patient conditions. Through our unique portfolio of wholly-owned “Vant” subsidiaries—Urovant, Enzyvant, Spirovant, Altavant—and use of embedded computational technology platforms to generate business and scientific insights, Sumitovant has supported the development of FDA-approved products and advanced a promising pipeline of early-through late-stage investigational assets for other serious conditions. Sumitovant, a wholly-owned subsidiary of Sumitomo Pharma, is also the majority-shareholder of Myovant (NYSE: MYOV). For more information, please visit our website at www.sumitovant.com.

  1. Reynolds, W. S., Fowke, J., & Dmochowski, R. (2016). The Burden of Overactive Bladder on US Public Health. Current bladder dysfunction reports, 11(1), 8–13. https://doi.org/10.1007/s11884-016-0344-9
  2. Coyne, K. S., Sexton, C. C., Vats, V., Thompson, C., Kopp, Z. S., & Milsom, I. (2011). National community prevalence of overactive bladder in the United States stratified by sex and age. Urology, 77(5), 1081–1087.

UROVANT, UROVANT SCIENCES, the UROVANT SCIENCES logo, GEMTESA, and the GEMTESA logo are trademarks of Urovant Sciences GmbH, registered in the U.S. and in other countries. All other trademarks are the property of their respective owners. © 2022 Urovant Sciences. All rights reserved.

Urovant Sciences
Alana Darden Powell
Vice President, Corporate Communications
949-436-3116
alana.darden@urovant.com 
media@urovant.com

Sumitovant Biopharma 
Maya Frutiger
Head of Corporate Communications
media@sumitovant.com

Source: Urovant Sciences, Inc.

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Urovant Sciences® Presents Interim Data from Phase 2a Study of Investigational Novel Gene Therapy, URO-902, Supporting Safety, Tolerability, and Efficacy Endpoints at 2022 American Urological Association Meeting

May 13, 2022 at 11:30 PM CDT

IRVINE, Calif. and BASEL, Switzerland – May 13, 2022 – Urovant Sciences, a wholly owned subsidiary of Sumitovant Biopharma Ltd., announced that positive interim results from a Phase 2a trial of its investigational novel gene therapy, URO-902, were presented Friday at the 2022 annual meeting of the American Urological Association (AUA2022). The meeting is being held in New Orleans, from May 13-16, 2022.

Presented as a late-breaker during the plenary session, the interim results support that in women with OAB, not well managed by oral therapies, a single dose of URO-902 was safe and well tolerated. This was a prespecified, 12-week interim analysis of a 48-week multicenter, randomized, double-blind, placebo-controlled, dose-escalation study (NCT04211831). URO-902 was administered via direct intradetrusor injections via cystoscopy under local anesthesia.

“These positive findings indicate that URO-902 has the potential to be a new therapeutic option for overactive bladder patients who have failed oral pharmacologic therapy,” said presenting author Kenneth Peters, MD, Principal Investigator, and Chief of the Department of Urology at Beaumont Hospital, Royal Oak; Medical Director of the Beaumont Women’s Urology and Pelvic Health Center; and Professor and Chair of Urology of the Oakland University William Beaumont School of Medicine in Rochester, Mich.

Of the 80 female patients who were randomized, 68 completed week 12 of the study and 74 were included in the intent-to-treat population. The mean age was 64.7 years.

At week 12, both URO-902 24 mg and 48 mg were associated with clinically relevant improvement compared with placebo in mean daily micturition (urination), urgency episodes, UUI episodes, OAB questionnaire symptom bother score, and proportion of patient global impression of change responders. Treatment-emergent adverse events occurred in 45.5% of patients receiving URO-902 24 mg, 46.2% receiving 48 mg, and 50.0% receiving placebo. The most commonly occurring adverse event was urinary tract infection (0% in individuals receiving the 24 mg dose of URO-902; 15.4% in those receiving the 48 mg dose; and 3.8% in those receiving placebo). One patient in the 48 mg arm of the study had asymptomatic elevated post-void residual urine volume at week 2; this resolved spontaneously and did not require catheterization.

“We are encouraged by these promising interim safety and efficacy findings for URO-902,” said Sef Kurstjens, MD, PhD, Executive Vice President and Chief Medical Officer of Urovant Sciences. “This is in line with our ongoing efforts to develop innovative and effective treatments for patients in need.”

The abstract is available in the Journal of Urology at the following link:

URO-902: https://www.auajournals.org/doi/10.1097/JU.0000000000002671.03

About the Phase 2a Study of URO-902
The 48-week multicenter study was a randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of a single physician administered dose of URO-902, a novel gene therapy being developed for patients with OAB who have not been adequately managed with oral or transdermal pharmacologic therapy. URO-902 is administered via direct intradetrusor injections into the bladder wall under local anesthesia in patients who are experiencing OAB symptoms and urge urinary incontinence (UUI).

The Phase 2a trial enrolled 80 female patients in two cohorts: the first cohort received either a single administration of 24 mg of URO-902 or matching placebo, and the second cohort received 48 mg of URO-902 or matching placebo into the bladder wall. Multiple outcome measures were explored, including the effect on the number of micturitions, urgency episodes, and quality-of-life indicators compared to placebo, 12 weeks post-administration, as well as an assessment of the safety and tolerability of this potential new therapy. Patients were followed for up to 48 weeks after initial administration.

About URO-902
URO-902 has the potential to be the first gene therapy for patients with OAB. If approved, this innovative treatment has the potential to address an unmet need for patients who have failed oral pharmacologic therapies.

About Overactive Bladder
Overactive bladder (OAB) is a clinical condition that occurs when the bladder muscle contracts involuntarily. Symptoms may include urinary urgency (the sudden urge to urinate that is difficult to control), urgency incontinence (unintentional loss of urine immediately after an urgent need to urinate), frequent urination (usually eight or more times in 24 hours), and nocturia (waking up more than two times in the night to urinate).1

Approximately 30 million Americans suffer from bothersome symptoms of OAB, which can have a significant impairment on a patient’s day-to-day activities.1, 2

About Urovant Sciences
Urovant Sciences is a biopharmaceutical company focused on developing and commercializing innovative therapies for areas of unmet need, with a dedicated focus in urology. The Company’s lead product, GEMTESA®(vibegron), is an oral, once-daily (75 mg) small molecule beta-3 agonist for the treatment of adult patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. GEMTESA was approved by the U.S. FDA in December 2020 and launched in the U.S. in April 2021. GEMTESA is also being evaluated for the treatment of OAB in men with benign prostatic hyperplasia. The Company’s second product candidate, URO-902, is a novel gene therapy being developed for patients with OAB who have failed oral pharmacologic therapy. Urovant Sciences, a wholly owned subsidiary of Sumitovant Biopharma Ltd., intends to bring innovation to patients in need in urology and other areas of unmet need. Learn more about us at www.urovant.com or follow us on Twitter or LinkedIn.

About Sumitovant Biopharma
Sumitovant is a global biopharmaceutical company leveraging data-driven insights to rapidly accelerate development of new potential therapies for unmet patient conditions. Through our unique portfolio of wholly-owned “Vant” subsidiaries—Urovant, Enzyvant, Spirovant, Altavant—and use of embedded computational technology platforms to generate business and scientific insights, Sumitovant has supported the development of FDA-approved products and advanced a promising pipeline of early-through late-stage investigational assets for other serious conditions. Sumitovant, a wholly owned subsidiary of Sumitomo Pharma, is also the majority-shareholder of Myovant (NYSE: MYOV). For more information, please visit our website at www.sumitovant.com.

About GEMTESA®

GEMTESA is a prescription medicine for adults used to treat the following symptoms due to a condition called overactive bladder:

It is not known if GEMTESA is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Do not take GEMTESA if you are allergic to vibegron or any of the ingredients in GEMTESA.

Before you take GEMTESA, tell your doctor about all your medical conditions, including if you have liver problems; have kidney problems; have trouble emptying your bladder or you have a weak urine stream; take medicines that contain digoxin; are pregnant or plan to become pregnant (it is not known if GEMTESA will harm your unborn baby; talk to your doctor if you are pregnant or plan to become pregnant); are breastfeeding or plan to breastfeed (it is not known if GEMTESA passes into your breast milk; talk to your doctor about the best way to feed your baby if you take GEMTESA).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

What are the possible side effects of GEMTESA?
GEMTESA may cause serious side effects including the inability to empty your bladder (urinary retention). GEMTESA may increase your chances of not being able to empty your bladder, especially if you have bladder outlet obstruction or take other medicines for treatment of overactive bladder. Tell your doctor right away if you are unable to empty your bladder.

The most common side effects of GEMTESA include headache, urinary tract infection, nasal congestion, sore throat or runny nose, diarrhea, nausea, and upper respiratory tract infection. These are not all the possible side effects of GEMTESA. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please click here for full Product Information for GEMTESA.

Reynolds, W. S., Fowke, J., & Dmochowski, R. (2016). The Burden of Overactive Bladder on US Public Health. Current bladder dysfunction reports, 11(1), 8–13. https://doi.org/10.1007/s11884-016-0344-9

Coyne, K. S., Sexton, C. C., Vats, V., Thompson, C., Kopp, Z. S., & Milsom, I. (2011). National community prevalence of overactive bladder in the United States stratified by sex and age. Urology, 77(5), 1081–1087.

UROVANT, UROVANT SCIENCES, the UROVANT SCIENCES logo, GEMTESA, and the GEMTESA logo are trademarks of Urovant Sciences GmbH, registered in the U.S. and in other countries. All other trademarks are the property of their respective owners. © 2022 Urovant Sciences. All rights reserved.

Urovant Sciences
Alana Darden Powell
Vice President, Corporate Communications
949-436-3116
alana.darden@urovant.com 
media@urovant.com

Sumitovant Biopharma 
Maya Frutiger
Head of Corporate Communications
media@sumitovant.com

Source: Urovant Sciences, Inc.

Back to News & Events

Myovant Sciences Announces Corporate Updates and Financial Results for Fourth Fiscal Quarter and Fiscal Year Ended March 31, 2022

May 10, 2022 at 6:55 AM EDT

BASEL, Switzerland, May 10, 2022 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV), a biopharmaceutical company that aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy, today announced financial results for the fourth fiscal quarter and fiscal year ended March 31, 2022 and provided other corporate updates.

“Fiscal year 2021 was a transformative year for Myovant as we expanded ORGOVYX utilization in the U.S. and successfully launched MYFEMBREE, finishing the year with another quarter of strong demand growth. Our recent approval of ORGOVYX in Europe and partnership with Accord, coupled with our prior approval of RYEQO, will enable more patients than ever to have access to these meaningful and differentiated medicines,” said David Marek, Chief Executive Officer of Myovant Sciences, Inc. Mr. Marek added, “Our strong commercial momentum, advancement of our lifecycle and business development strategies, and our financial strength position Myovant for another exciting year in fiscal year 2022.”

Fourth Fiscal Quarter 2021 and Recent Corporate Updates

ORGOVYX (relugolix 120 mg)

MYFEMBREE (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg)

Expected Upcoming Milestones

Fourth Fiscal Quarter and Fiscal Year Ended March 31, 2022 Financial Summary

Total revenues for the three months ended March 31, 2022, and 2021 were $57.6 million and $24.6 million, respectively. Total revenues for the year ended March 31, 2022, and 2021 were $231.0 million and $59.3 million, respectively.

Cost of product revenue for the three months and year ended March 31, 2022, was $3.6 million and $11.5 million, respectively, compared to $0.3 million for both the three months and year ended March 31, 2021, related to the cost of goods sold and royalty expense payable to Takeda pursuant to the Takeda License Agreement. The increase in cost of product revenue in the fiscal year 2021 periods was due to an increase in cost of goods sold and royalty expense to Takeda as a result of higher sales of ORGOVYX in the U.S. during the fiscal 2021 periods, as well as sales of MYFEMBREE in the U.S., which began in June 2021, and sales of product supply to Richter, which began in the three months ended September 30, 2021.

Collaboration expense to Pfizer for the three months and year ended March 31, 2022, was $14.1 million and $40.0 million, respectively, compared to $1.7 million for both the three months and year ended March 31, 2021, reflecting Pfizer’s 50% share of net profits from sales of ORGOVYX and MYFEMBREE in the U.S., pursuant to the Pfizer Collaboration and License Agreement. The increase in collaboration expense to Pfizer in the fiscal 2021 periods was due to an increase in net profits generated from sales of ORGOVYX in the U.S., as well as net profits generated from sales of MYFEMBREE in the U.S., for which there were no such MYFEMBREE net profits in the year ago periods.

Selling, general and administrative (SG&A) expenses for the three months ended March 31, 2022, and 2021 were $67.2 million and $78.0 million, respectively. The decrease in SG&A expenses primarily reflects lower share-based compensation as the three months ended March 31, 2021 included incremental expense of $25.7 million related to the acceleration, modification, and remeasurement of Myovant’s former Principal Executive Officer’s equity awards, which did not recur in the three months ended March 31, 2022, partially offset by higher expenses to support the ORGOVYX and MYFEMBREE U.S. launches, including higher personnel-related costs due to the hiring of Myovant’s commercial operations, marketing, and market access teams, as well as the oncology and women’s health sales forces. SG&A expenses for the year ended March 31, 2022, and 2021 were $259.4 million and $181.4 million, respectively. The increase in SG&A expenses was primarily due to higher expenses to support the ORGOVYX and MYFEMBREE U.S. launches, including higher personnel-related costs. These costs were partially offset by lower share-based compensation.

Research and development (R&D) expenses for the three months ended March 31, 2022, and 2021 were $24.5 million and $21.6 million, respectively. The increase in R&D expenses primarily reflects an increase in personnel expenses due to an increase in medical affairs and other personnel to support the U.S. launches of ORGOVYX and MYFEMBREE, partially offset by a reduction in clinical study costs due to the completion and wind down of Myovant’s Phase 3 LIBERTY, HERO, and SPIRIT studies. R&D expenses for the year ended March 31, 2022, and 2021 were $107.4 million and $136.7 million, respectively. The decrease in R&D expenses primarily reflects a reduction in clinical study costs as a result of the completion and wind down of Myovant’s Phase 3 LIBERTY, HERO, and SPIRIT studies, as well as higher cost sharing with Pfizer for certain R&D expenses in the year ended March 31, 2022. In addition, the year ended March 31, 2021, included regulatory submission fees for Myovant’s initial NDA filings for ORGOVYX and MYFEMBREE, which did not recur during the year ended March 31, 2022.

Interest expense for both the three months ended March 31, 2022, and 2021 was $3.5 million, and was primarily related to the Sumitomo Pharma Loan Agreement. Interest expense for the year ended March 31, 2022, and 2021 was $14.0 million and $10.4 million, respectively. The increase in interest expense was primarily driven by a higher outstanding balance under the Sumitomo Pharma Loan Agreement during the year ended March 31, 2022, as well as higher accretion of the financing component of the cost share advance from Pfizer, which began in the fourth quarter of the year ended March 31, 2021.

Foreign exchange loss (gain) for the three months ended March 31, 2021, was a loss of less than $0.1 million, and for the year ended March 31, 2021, was a gain of $16.2 million, primarily as a result of the impact of fluctuations in the foreign currency exchange rate between the Swiss franc and the U.S. dollar on Myovant’s outstanding balance under the Sumitomo Pharma Loan Agreement. As a result of a change in the functional currency of Myovant’s wholly-owned subsidiary in Switzerland, Myovant Sciences GmbH, from the Swiss franc to the U.S. dollar in December 2020, Myovant is no longer exposed to significant foreign currency gains or losses.

Net loss for the three months ended March 31, 2022, was $59.3 million compared to $81.4 million for the year ago period. Net loss for the year ended March 31, 2022, was $206.0 million compared to $255.1 million for the year ago period. On a per common share basis, net loss was $0.63 and $0.89 for the three months ended March 31, 2022, and 2021, respectively, and $2.22 and $2.83, for the years ended March 31, 2022, and 2021, respectively.

Capital resources: Cash, cash equivalents, marketable securities, and amounts available under the Sumitomo Pharma Loan Agreement totaled $475.5 million as of March 31, 2022, and consisted of $434.2 million of cash, cash equivalents, and marketable securities and $41.3 million of available borrowing capacity under the Sumitomo Pharma Loan Agreement.

Conference Call
As previously announced, Myovant will hold a webcast and conference call at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) today, May 10, 2022, to discuss financial results for its fourth fiscal quarter and fiscal year ended March 31, 2022 and corporate updates. Investors and the general public may access a live webcast of the call by visiting the investor relations page of Myovant’s website at investors.myovant.com. Institutional investors and analysts may also participate in the conference call by dialing 1-800-891-3840 in the U.S. or +1-785-424-1677 from outside the U.S. and reference password MYOVQ421. A replay of the webcast, along with the earnings press release and presentation materials, can be found on Myovant’s investor relations website for a period of one year.

About Relugolix
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 U.S. by the FDA in December 2020 as the first and only oral GnRH receptor antagonist for the treatment of adult patients with advanced prostate cancer. In April 2022, the European Commission approved ORGOVYX® (relugolix, 120 mg) as the first and only oral GnRH receptor antagonist for the treatment of adult patients with advanced hormone-sensitive prostate cancer in Europe. MYFEMBREE® (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) was approved in the U.S. by the FDA in May 2021 as the first and only once-daily oral treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months. In July 2021, the European Commission, and in August 2021, the United Kingdom (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA), approved RYEQO® (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age, with no limitation for duration of use. In September 2021, the FDA accepted to review Myovant’s supplemental New Drug Application (sNDA) for MYFEMBREE for the management of moderate to severe pain associated with endometriosis. On May 6, 2022, Myovant and Pfizer announced that the FDA extended the Prescription Drug User Fee Act (PDUFA) goal date for this sNDA to August 6, 2022. MYFEMBREE is also being assessed for contraceptive efficacy in women with endometriosis or uterine fibroids who are 18 to 50 years of age and at risk for pregnancy.

About Myovant Sciences
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Founded in 2016, Myovant has executed five successful Phase 3 clinical trials across oncology and women’s health leading to two regulatory approvals by the U.S. Food and Drug Administration (FDA) for men with advanced prostate cancer and women with heavy menstrual bleeding associated with uterine fibroids, respectively. Myovant also has received regulatory approvals by the European Commission (EC) for women with symptomatic uterine fibroids and for men with advanced hormone-sensitive prostate cancer. Myovant has a supplemental New Drug Application in endometriosis-associated pain under review with the FDA. Myovant also is conducting a Phase 3 study to evaluate the prevention of pregnancy in women with uterine fibroids or endometriosis. Myovant also is developing MVT-602, an investigational 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 Pharma Co., Ltd., is Myovant’s majority shareholder. For more information, please visit www.myovant.com. Follow @Myovant on Twitter and LinkedIn.

About Sumitovant Biopharma Ltd.
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 wholly-owned “Vant” subsidiaries—Urovant, Enzyvant, Spirovant, Altavant—and use of embedded computational technology platforms to generate business and scientific insights, Sumitovant has supported the development of FDA-approved products and advanced a promising pipeline of early through late-stage investigational assets for other serious conditions. Sumitovant, a wholly-owned subsidiary of Sumitomo Pharma, is also the majority-shareholder of Myovant (NYSE: MYOV). For more information, please visit Sumitovant’s website at https://www.sumitovant.com.

About Sumitomo Pharma Co., Ltd.
Sumitomo Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China, and other Asian countries with more than 7,000 employees worldwide. Sumitomo Pharma defines its corporate mission as “To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide.” Additional information about Sumitomo Pharma is available through its corporate website at https://www.sumitomo-pharma.com.

Forward-Looking Statements
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 expectations of the success of commercialization of its approved drug products; statements with respect to expectations of patients’ access to Myovant’s medicines and Myovant’s positioning for fiscal year 2022 in Mr. Marek’s quote; Myovant’s expectation to receive from Accord an upfront payment in the first fiscal quarter 2022, commercial launch, sales-based, and other milestones, and tiered royalties from the high-teens to mid-twenties on net sales of ORGOVYX; the commercial launch of ORGOVYX in Europe by Accord in the second half of calendar year 2022; and the statements under the caption “Expected Upcoming Milestones.”

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 and the conflict in Ukraine. Myovant Sciences cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could materially affect Myovant Sciences’ operations and future prospects or which could cause actual results to differ materially from expectations include, but are not limited to, the risks and uncertainties listed in Myovant Sciences’ filings with the United States Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in Myovant Sciences’ Quarterly Report on Form 10-Q filed on January 26, 2022, as such risk factors may be amended, supplemented, or superseded from time to time. These risks are not exhaustive. New risk factors emerge from time to time and it is not possible for Myovant Sciences’ management to predict all risk factors, nor can Myovant Sciences assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof, and, except as required by law, Myovant Sciences undertakes no obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements.

MYOVANT SCIENCES LTD.
Condensed Consolidated Statements of Operations
(Unaudited, in thousands, except share and per share data)

 Three Months Ended 
March 31,
Three Months Ended 
March 31,
Year Ended 
March 31,
Year Ended 
March 31,
 20222021 20222021
Revenues:  
Product revenue, net$32,424$3,630 $94,309$3,630
Pfizer collaboration revenue25,14320,975 104,99622,354
Richter license and milestone revenue 31,66733,333
Total revenues57,56724,605 230,97259,317
Operating costs and expenses:  
Cost of product revenue3,613301 11,510301
Collaboration expense to Pfizer14,1291,664 40,0411,664
Selling, general and administrative(1)67,24678,036 259,364181,423
Research and development(1)24,51721,553 107,403136,713
Total operating costs and expenses109,505101,554 418,318320,101
Loss from operations(51,938)(76,949)(187,346)(260,784)
Interest expense3,4933,493 13,97110,401
Interest income(136)(33)(384)(211)
Foreign exchange loss (gain)2 —(16,176)
Loss before income taxes(55,295)(80,411)(200,933)(254,798)
Income tax expense3,990952 5,048336
Net loss$(59,285)$(81,363)$(205,981)$(255,134)
Net loss per common share — basic and diluted$(0.63)$(0.89)$(2.22)$(2.83)
Weighted average common shares outstanding — basic and diluted94,397,96591,018,204 92,974,88790,036,459
 
(1) Includes the following share-based compensation:
Selling, general and administrative$4,787$28,941$22,918$39,627
Research and development3,8172,98916,01014,049
Total share-based compensation$8,604$31,930$38,928$53,676
Revenue components are as follows:  
   
Product revenue, net:  
ORGOVYX$29,424$3,630$82,959$3,630
MYFEMBREE2,2226,355
Richter product supply and royalties7784,995
Total product revenue, net32,4243,63094,3093,630
Pfizer collaboration revenue:  
Amortization of upfront payment20,97520,97583,89722,354
Amortization of regulatory milestone4,16821,099
Total Pfizer collaboration revenue25,14320,975104,99622,354
Richter license and milestone revenue31,66733,333
Total revenues$57,567$24,605$230,972$59,317



MYOVANT SCIENCES LTD.

Condensed Consolidated Balance Sheets
(Unaudited, in thousands)

 March 31,March 31,
  20222201
Assets 
Current assets: 
Cash and cash equivalents$406,704$674,493
Accounts receivable, net 23,2963,570
Marketable securities 27,48310,435
Inventories 7,5842,611
Prepaid expenses and other current assets 22,49813,536
Amount due from related party 580
Total current assets 488,145704,645
Property and equipment, net 2,9443,300
Operating lease right-of-use asset 7,9619,655
Other assets 20,9617,427
Total assets$520,011$725,027
Liabilities and Shareholders’ Deficit 
Current liabilities: 
Accounts payable$12,250$17,809
Accrued expenses and other current liabilities 68,59444,612
Share-based compensation liabilities —21,636
Deferred revenue 100,564100,564
Amounts due to Pfizer 32,5631,954
Cost share advance from Pfizer 33,81892,415
Operating lease liability 2,1481,807
Amounts due to related parties 393543
Total current liabilities 250,330281,340
Deferred revenue, non-current 375,706397,369
Cost share advance from Pfizer, non-current —29,447
Long-term operating lease liability 7,0419,189
Long-term debt, less current maturities (related party) 358,700358,700
Other liabilities 1,7112,947
Total liabilities 993,4881,078,992
Total shareholders’ deficit (473,477)(353,965)
Total liabilities and shareholders’ deficit$520,011$725,027

Investor Contact: 
Uneek Mehra
Chief Financial Officer
Myovant Sciences, Inc.
investors@myovant.com

Media Contact:
Noelle Cloud Dugan
Vice President, Corporate Communications
Myovant Sciences, Inc.
media@myovant.com

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