On May 11, 2021 Dynavax Technologies Corporation ("Dynavax") (Nasdaq: DVAX) reported the pricing of $200.0 million aggregate principal amount of 2.50% convertible senior notes due 2026 (the "notes") in a private placement to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Dynavax Technologies, MAY 11, 2021, View Source [SID1234579684]). Dynavax also granted the initial purchasers of the notes an option to purchase up to an additional $30.0 million aggregate principal amount of notes. The sale of the notes is expected to close on May 13, 2021, subject to customary closing conditions.

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The notes will be general unsecured obligations of Dynavax and will accrue interest payable semiannually in arrears on May 15 and November 15 of each year, beginning on November 15, 2021, at a rate of 2.50% per year. The notes will mature on May 15, 2026, unless earlier converted, redeemed or repurchased. The initial conversion rate of the notes will be 95.5338 shares of Dynavax’s common stock per $1,000 principal amount of notes (equivalent to an initial conversion price of approximately $10.47 per share of Dynavax’s common stock). The initial conversion price of the notes represents a premium of approximately 32.5% over the last reported sale price of Dynavax’s common stock on May 10, 2021. The notes will be convertible by the holders thereof into cash, shares of Dynavax’s common stock or a combination of cash and shares of Dynavax’s common stock, at Dynavax’s election.

Dynavax may redeem for cash all or any portion of the notes, at its option on or after May 20, 2024 and prior to the 31st scheduled trading day immediately preceding the maturity date, if the last reported sale price of Dynavax’s common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which Dynavax provides notice of redemption, at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

If Dynavax undergoes a "fundamental change" (as defined in the indenture governing the notes), subject to certain conditions and exceptions, noteholders may require Dynavax to repurchase for cash all or any portion of their notes at a fundamental change repurchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. In addition, following certain corporate events that occur prior to the maturity date or if Dynavax delivers a notice of redemption, Dynavax will, in certain circumstances, increase the conversion rate for a noteholder who elects to convert its notes in connection with such a corporate event or convert its notes called (or deemed called) for redemption in connection with such notice of redemption, as the case may be.

Dynavax estimates that the net proceeds from the offering of the notes will be approximately $195.1 million (or approximately $224.4 million if the initial purchasers exercise their option to purchase additional notes in full), after deducting the initial purchasers’ discounts and commissions and estimated offering expenses payable by Dynavax. Dynavax expects to use the net proceeds from the offering of the notes, together with cash on hand, to repay in full the outstanding debt and other obligations under Dynavax’s term loan agreement and to pay the costs of the capped call transactions described below. Dynavax expects that approximately $190.2 million will be needed to repay the outstanding debt and other obligations under the term loan agreement and approximately $24.2 million will be needed to pay the cost of the capped call transactions.

If the initial purchasers exercise their option to purchase additional notes in full, Dynavax expects to use approximately $3.6 million of the net proceeds from the sale of such additional notes to enter into additional capped call transactions. Dynavax expects to use any remaining net proceeds from the sale of such additional notes for general corporate purposes.

In connection with the pricing of the notes, Dynavax entered into capped call transactions with one of the initial purchasers and other financial institutions (the "option counterparties"). The capped call transactions will cover, subject to customary adjustments, the number of shares of Dynavax’s common stock that initially underlie the notes. The capped call transactions are expected to offset the potential dilution to Dynavax’s common stock as a result of any conversion of notes, with such offset subject to a cap initially equal to $15.80 (which represents a premium of 100% over the last reported sale price of Dynavax’s common stock on May 10, 2021).

In connection with establishing their initial hedges of the capped call transactions, Dynavax has been advised that the option counterparties and/or their respective affiliates expect to enter into various derivative transactions with respect to Dynavax’s common stock concurrently with or shortly after the pricing of the notes and/or purchase shares of Dynavax’s common stock concurrently with or shortly after the pricing of the notes. This activity could increase (or reduce the size of any decrease in) the market price of Dynavax’s common stock or the trading price of the notes at that time.

In addition, the option counterparties and/or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Dynavax’s common stock and/or purchasing or selling Dynavax’s common stock or other securities of Dynavax in secondary market transactions following the pricing of the notes and prior to the maturity of the notes (and are likely to do so on each exercise date of the capped call transactions, which are expected to occur during the 30 trading day period beginning on the 31st scheduled trading day prior to the maturity date of the notes, or following any termination of any portion of the capped call transactions in connection with any repurchase, redemption or early conversion of the notes). This activity could also cause or avoid an increase or a decrease in the market price of Dynavax’s common stock or the notes, which could affect a noteholder’s ability to convert its notes and, to the extent the activity occurs during any observation period related to a conversion of notes, it could affect the amount and value of the consideration that a noteholder will receive upon conversion of such notes.

Neither the notes, nor any shares of Dynavax’s common stock issuable upon conversion of the notes, have been registered under the Securities Act or any state securities laws, and unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.

This press release is neither an offer to sell nor a solicitation of an offer to buy any securities, nor shall it constitute an offer, solicitation or sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On May 11, 2021 Applied Therapeutics, Inc. (Nasdaq: APLT) ("Applied Therapeutics" or the "Company"), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, reported financial results for the first quarter ended March 31, 2021 (Press release, Applied Therapeutics, MAY 11, 2021, View Source [SID1234579683]).

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"In the first quarter we continued to progress our late stage programs towards commercialization in Galactosemia and Diabetic Cardiomyopathy, while advancing our additional rare disease programs in SORD and PMM2-CDG," said Shoshana Shendelman, PhD, Founder, CEO and Chair of the Board of Applied Therapeutics. "We are looking forward to our planned NDA submission in Galactosemia in the third quarter of this year, and continue to focus on our primary objective – bringing drugs to patients in desperate need of treatment."

Recent Highlights

Initiated Phase 2 Study of AT-007 in Patients with SORD Deficiency. The Phase 2 pilot study of AT-007 in patients with Sorbitol Dehydrogenase Deficiency (SORD Deficiency), a progressive, debilitating hereditary neuropathy that affects peripheral nerves and motor neurons, has been initiated. Preclinical findings demonstrate that AT-007 has the potential to be the first disease-modifying therapy for SORD, targeting the underlying cause of disease.
Presented Data on Galactosemia Disease Progression at the 2021 Annual Clinical Genetics Meeting of the American College of Medical Genetics and Genomics. In April 2021, the Company presented data featuring a cross-sectional analysis of nineteen pediatric patients with Classic Galactosemia, providing meaningful insight on the progressive worsening of the central nervous system phenotype with age.
Hosted Virtual Rare Disease Forum. In March 2021, the Company hosted a virtual forum highlighting its AT-007 development programs in Galactosemia, SORD Deficiency, and PMM2-CDG. A replay of the presentation, which featured several rare disease key opinion leaders, is available at View Source
Announced Restart of Pediatric Galactosemia Study. In February 2021, the Company announced that the FDA lifted the clinical hold on the AT-007 ACTION-Galactosemia Kids pediatric clinical study, and the study resumed immediately. Applied Therapeutics worked closely with FDA to modify the trial, with the shared goal of ensuring that all patients have the opportunity to receive clinical benefit, and remains on target to submit an NDA no later than Q3 2021.

Closed Approximately $75 million Public Offering. In February 2021, the Company completed an underwritten public offering of 3,450,000 shares of its common stock, including the exercise in full of the underwriters’ option to purchase 450,000 additional shares of common stock at a price of $23.00 per share, resulting in aggregate net proceeds of approximately $74.4 million.
Financial Results

Cash and cash equivalents and short-term investments totaled $148.1 million as of March 31, 2021, compared with $96.8 million at December 31, 2020.

Research and development expenses for the three months ended March 31, 2021 were $14.4 million, compared to $7.3 million for the three months ended March 31, 2020. The increase of $7.2 million was primarily related to an increase in clinical and pre-clinical expense of $1.3 million, related to the progression of the AT-007 ACTION-Galactosemia adult extension study, the AT-007 ACTION-Galactosemia Kids pediatric registrational study and the AT-001 Phase 3 ARISE-HF clinical study; an increase in drug manufacturing and formulation costs of $5.2 million related to the progression of the manufacturing campaigns and the completion and release of AT-001 and AT-007 drug product batches; an increase in personnel expenses of $0.3 million due to the increase in headcount in support of our clinical program pipeline; an increase in stock-based compensation of $0.2 million due to new stock option and restricted stock unit grants; and an increase in regulatory and other expenses of $0.2 million relating to an increase in clinical consulting fees during the three months ended March 31, 2021.

General and administrative expenses were $9.8 million for the three months ended March 31, 2021, compared to $5.2 million for the three months ended March 31, 2020. The increase of approximately $4.6 million was primarily related to an increase of $1.9 million related to the establishment of a commercial department; an increase in stock-based compensation of $1.5 million and increase in personnel expenses of $0.9 million related to an increase in headcount; an increase of $0.2 million related to increased insurance costs; an increase of $0.4 million in other expenses relating to increased costs of rent and other office expenses; and a $0.4 million decrease in legal and professional fees due to lower external legal fees.
Net loss for the first quarter of 2021 was $24.2 million, or $1.00 per basic and diluted common share, compared to a net loss of $12.4 million, or $0.59 per basic and diluted common share, for the first quarter 2020.

On May 11, 2021 Schrödinger, Inc. (Nasdaq: SDGR), whose physics-based software platform is transforming the way therapeutics and materials are discovered, reported financial results for the quarter ended March 31, 2021, and provided an update on the company (Press release, Schrodinger, MAY 11, 2021, View Source [SID1234579682]).

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"We had strong execution across multiple facets of our business during the quarter," stated Ramy Farid, Ph.D., chief executive officer at Schrödinger. "We are continuing to advance our internal drug discovery pipeline and recently selected a development candidate for our MALT1 inhibitor program. Progress on our internal programs, coupled with our collaborators’ successes with molecules we’ve helped discover, are powerful examples that our platform and approach generates high-quality development candidates. We look forward to seeing the full impact of our technology as pharmaceutical, biotechnology and materials companies adopt our platform on a larger scale."

Today the company announced an expanded collaboration with AstraZeneca to deploy Schrödinger’s computational platform to help accelerate drug discovery. The collaboration is an expansion of the agreement announced in September 2019, which was a pilot project across an initial small number of programs. Under the expanded agreement, AstraZeneca will fully deploy Schrödinger’s platform across all its structurally-enabled small molecule discovery programs.

First Quarter 2021 Financial Results

Revenue was $32.1 million for the first quarter of 2021, a 23 percent increase compared to the first quarter of 2020.
Software revenue was $26.3 million for the first quarter of 2021, an 11 percent increase compared to the first quarter of 2020.
Drug discovery revenue was $5.8 million for the first quarter of 2021, compared to $2.4 million in the first quarter of 2020.
Gross profit was $16.2 million in the first quarter of 2021, up three percent over the first quarter in 2020. Software gross margin was 78 percent in the first quarter of 2021, compared to 83 percent for the same period in the prior year.
Operating expenses for the first quarter of 2021 were $40.1 million, compared to $27.4 million in the first quarter of 2020.
Other income, which included losses on equity investments, changes in fair value of such investments and interest income, was $23.5 million in the first quarter of 2021 compared to a loss of $2.4 million for the first quarter of 2020. Other income for the first quarter of 2021 included a $24.8 million non-cash gain from the change in fair value of Schrödinger’s equity stake in Morphic Therapeutic. Additionally, in the first quarter of 2021, Schrödinger sold its equity stake in Relay Therapeutics, Inc. for cash proceeds of $15.7 million, which resulted in a non-cash loss of $1.8 million as a result of the fair value based on the share price of the Relay Therapeutics common stock at the sales date.
Net loss, after adjusting for non-controlling interests, was $0.0 million for the first quarter of 2021, compared to a net loss of $13.8 million in the first quarter of 2020.
Recent Business Highlights

Continued revenue growth and strategic execution

Reported 23 percent total revenue growth in the first quarter of 2021, driven by significant increase in drug discovery revenue in addition to continued uptake of Schrödinger’s core technologies including FEP+ and its enterprise solution, LiveDesign, as well as growth in new customers.
Ended the first quarter of 2021 with cash, cash equivalents, restricted cash and marketable securities of $649.0 million, compared to $643.2 million as of December 31, 2020.
Progressed internal pipeline

Selected a development candidate for the company’s MALT1 inhibitor program. Targeting MALT1 is emerging as a potential therapeutic strategy to treat certain relapsed or resistant B-cell lymphomas and chronic lymphocytic leukemia.
Continued to advance multiple programs toward IND-enabling studies; subject to completion of the preclinical data packages, the company expects to submit up to three IND applications in 2022, with the first submission to the FDA expected in the first half of next year.
Presented preclinical data on the company’s CDC7 inhibitor program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Virtual Meeting. The data showed that Schrödinger’s picomolar CDC7 inhibitors were highly selective and inhibited tumor cell growth alone and in combination with several approved and investigational cancer treatments.
Advanced discovery efforts to allow addition of new programs to the company’s internal pipeline in 2021.
Continued investment in Schrödinger’s computational platform

Formed a strategic partnership with NVIDIA to further optimize Schrödinger’s software platform for the NVIDIA DGX SuperPODTM, an enterprise system that can be scaled to enable any organization to reach supercomputing speed and power. Optimizing Schrödinger’s platform for the NVIDIA GPU framework is designed to give customers access to an all-in-one supercomputing solution for in silico drug and materials discovery.
Further expanded the domain of applicability for Schrödinger’s software platform. Recently published research provided rationale for applying Schrödinger’s free energy calculation technology, FEP+, to ion channels using structures generated by cryo-electron microscopy (cryo-EM). The company’s scientists also published research describing a highly accurate method to predict the binding modes of small molecule inhibitors binding to protein targets with flexible binding sites, which have historically been challenging targets for structure-based drug design. Additionally, Schrödinger scientists co-authored a white paper describing how recent advances in protein production and cryo-EM can rapidly facilitate the structural enablement of drug targets.
Full-Year 2021 Financial Outlook

As of May 11, 2021, Schrödinger continues to expect total revenue to range from $124 million to $142 million, with software revenue expected to range from $102 million to $110 million and drug discovery revenue expected to range from $22 million to $32 million for the fiscal year ending December 31, 2021. Additional details are as follows:

Software revenue growth is expected to be higher in the second half of the year with the majority of second half growth in the fourth quarter of 2021.
Drug discovery revenue is expected to be highly variable quarter to quarter based on the timing of potential milestones related to collaborative agreements.
Schrödinger continues to aggressively fund R&D to advance its technology and drug discovery pipeline. The company expects operating expense growth to be higher than the 42% annual growth rate reported in 2020 and expects software gross margin to be lower than the 81% reported in 2020.
Webcast and Conference Call Information

Schrödinger will host a conference call to discuss its first quarter financial results on Tuesday, May 11, 2021, at 8:30 a.m. ET. The conference call can be accessed live by dialing (833) 727-9520 (domestic) or +1 (830) 213-7697 (international) and referring to conference ID 3297222. The webcast can also be accessed under "News & Events" in the investors section of Schrödinger’s website, View Source The archived webcast will be available on Schrödinger’s website following the event.

On May 11, 2021 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported financial results for the first quarter ended March 31, 2021, and highlighted recent corporate accomplishments (Press release, Galera Therapeutics, MAY 11, 2021, View Source [SID1234579681]).

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"Galera is off to a strong start in 2021, as we continue to progress our clinical oncology programs in radiation-induced severe oral mucositis (SOM), locally advanced pancreatic cancer (LAPC) and non-small cell lung cancer (NSCLC) with our dismutase mimetics," said Mel Sorensen, M.D., President and CEO of Galera. "We recently reported updated data from our placebo-controlled Phase 1/2 pilot trial, in which a near doubling of median overall survival was observed in patients with pancreatic cancer. Building on the positive results from this trial, we anticipate initiating a Phase 2b trial in the first half of 2021 in patients with LAPC, with overall survival as the primary endpoint. Importantly, we look forward to announcing topline data in the pivotal Phase 3 trial in SOM and potential regulatory approval and commercialization of avasopasem, our lead dismutase mimetic product candidate."

Recent Corporate Highlights

Severe Oral Mucositis (SOM)

Continued enrollment in the pivotal Phase 3 ROMAN trial of avasopasem for the treatment of SOM in patients with locally advanced head and neck cancer (HNC) undergoing standard-of-care radiotherapy. The Company remains on track to report topline data in the second half of 2021.

The Company expects to report topline data from the Phase 2a EUSOM multi-center trial of avasopasem in Europe in patients with HNC undergoing standard-of-care radiotherapy in the second half of 2021.
Locally Advanced Pancreatic Cancer (LAPC)

Reported updated data from the placebo-controlled Phase 1/2 pilot trial of Galera’s dismutase mimetic in patients with LAPC who are also undergoing stereotactic body radiation therapy (SBRT). As of the data analysis, median overall survival (OS) in the treatment arm (20.1 months) was nearly twice as long as observed in the placebo arm (10.9 months); 29% of patients in the treatment arm achieved a partial response compared to 11% of patients in the placebo arm; and positive results were also observed in local tumor control, time to metastases and progression-free survival. The Company expects to report final results from the trial with at least one year of follow-up on all patients in the second half of 2021.
Non-Small Cell Lung Cancer (NSCLC)

Continued enrollment in the Phase 1/2 GRECO-1 trial of GC4711, Galera’s second dismutase mimetic product candidate, in combination with SBRT in patients with NSCLC. The Company remains on track to report initial data in the first half of 2022.
Esophagitis

Continued enrollment in the Phase 2a AESOP trial of avasopasem evaluating its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer. The Company expects to report topline data in the first half of 2022.
First Quarter 2021 Financial Highlights

Research and development expenses were $12.4 million in the first quarter of 2021, compared to $14.3 million for the same period in 2020. The decrease was primarily attributable to avasopasem development costs, due to decreased expenses related to the ROMAN trial and a decrease in preclinical expenses.

General and administrative expenses were $5.1 million in the first quarter of 2021, compared to $3.6 million for the same period in 2020. The increase was primarily attributable to employee-related costs from increased headcount and share-based compensation expense, and increased expenses related to pre-commercial activities for avasopasem.

Galera reported a net loss of $(18.7) million, or $(0.75) per share, for the first quarter of 2021, compared to a net loss of $(18.4) million, or $(0.74) per share, for the same period in 2020.

As of March 31, 2021, Galera had cash, cash equivalents and short-term investments of $57.5 million. Galera expects that its existing cash, cash equivalents and short-term investments, together with the expected payments from Blackstone in the amount of $57.5 million upon the achievement of certain clinical enrollment milestones in the ROMAN trial and the anti-cancer program in combination with SBRT under the amended royalty agreement, will enable Galera to fund its operating expenses and capital expenditure requirements into the second half of 2022. The Company expects to achieve these clinical enrollment milestones in the first half of 2021.

On May 11, 2021 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, reported corporate updates and financial results for the fourth fiscal quarter and fiscal year ended March 31, 2021 (Press release, Myovant Sciences, MAY 11, 2021, View Source [SID1234579680]).

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"The ORGOVYX launch is off to a strong start and its differentiated clinical profile has the potential to redefine care for men with advanced prostate cancer. ORGOVYX demand accelerated over the course of the quarter, reflecting our ongoing efforts to educate urologists and medical oncologists about ORGOVYX while improving access and reimbursement for patients. In partnership with Pfizer, we continue to execute on our long-term goal of establishing ORGOVYX as the new standard of care androgen deprivation therapy," said David Marek, Chief Executive Officer of Myovant Sciences, Inc. "I am also pleased with the progress we have made in preparing for the U.S. launch of relugolix combination tablet in women with uterine fibroids, which is expected this June. In addition, we have advanced relugolix combination tablet toward a U.S. regulatory submission in endometriosis and our European regulatory submission for relugolix monotherapy for the treatment of advanced prostate cancer was validated by the European Medicines Agency."

Fourth Fiscal Quarter 2020 and Recent Corporate Updates

ORGOVYX

ORGOVYX was launched in the U.S. and authorized specialty distribution channels were fully stocked in early January 2021. Fourth fiscal quarter 2020 net product revenues for ORGOVYX in the U.S. were $3.6 million.
More than 800 treatment centers have prescribed ORGOVYX to over 2,000 patients, estimated through April 30, 2021.
Through April 30, 2021, Myovant achieved 43% commercial coverage and 51% Medicare Part D coverage for ORGOVYX. Myovant continues to engage in coverage negotiations with key commercial and Medicare Part D payors and remains on track to achieve its goal of broad coverage at the end of calendar year 2021.
Relugolix Monotherapy

On March 29, 2021, Myovant announced that the European Medicines Agency (EMA) validated its Marketing Authorization Application (MAA) for relugolix for the treatment of advanced prostate cancer. The validation of the application confirmed that the submission is sufficiently complete for the EMA to begin the review process.
Relugolix Combination Tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg)

Uterine Fibroids
On March 24, 2021, Myovant and Pfizer announced positive safety and efficacy data from the Phase 3 LIBERTY randomized withdrawal study in women with uterine fibroids. The study met its primary endpoint and all three key secondary endpoints. Bone mineral density was maintained through two years in the subset of women continuously treated with relugolix combination therapy (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.
Endometriosis
On January 26, 2021, Myovant and Pfizer announced that the Phase 3 SPIRIT long-term extension study in women with endometriosis reported clinically meaningful reductions in dysmenorrhea (menstrual pain) and non-menstrual pelvic pain over one year with minimal and stable bone mineral density loss. The data are consistent with the efficacy and safety profile observed through 24 weeks in the Phase 3 SPIRIT 1 and SPIRIT 2 studies. These results will be included in the regulatory submission to the U.S. Food and Drug Administration (FDA) for relugolix combination tablet for the treatment of women with endometriosis, expected in the second quarter of calendar year 2021.
Prevention of Pregnancy
On April 12, 2021, Myovant and Pfizer announced that the first patient was dosed in the Phase 3 SERENE study evaluating the contraceptive efficacy of relugolix combination tablet in healthy women ages 18-35 years who are at risk for pregnancy. The SERENE study is designed to enroll 900 sexually active, healthy women ages 18-35 years with presumed normal fertility. The primary efficacy endpoint is the at-risk Pearl Index, defined as the number of on-treatment pregnancies per 100 women-years of treatment. Safety data will also be collected during the study. Results of the SERENE study could support a potential indication of pregnancy prevention for women treated with relugolix combination tablet, if approved.
Executive Appointments

On January 4, 2021, Myovant announced the appointment of David Marek as Chief Executive Officer of Myovant Sciences, Inc. Concurrent with this appointment, Mr. Marek was also appointed Principal Executive Officer of Myovant Sciences Ltd. and a member of its Board of Directors.
On April 5, 2021, Myovant announced the appointment of Lauren Merendino as Chief Commercial Officer of Myovant Sciences, Inc. Ms. Merendino is also a member of Myovant’s Executive Committee.
Expected Upcoming Milestones

FDA decision for relugolix combination tablet for the treatment of uterine fibroids is expected by the June 1, 2021 target action date. If approved, Myovant and Pfizer expect to launch in the U.S. in June 2021. Upon FDA approval, Myovant will receive a $100.0 million regulatory milestone payment from Pfizer.
U.S. regulatory submission to the FDA for relugolix combination tablet for the treatment of women with endometriosis-associated pain is expected in the second quarter of calendar year 2021.
Pfizer’s decision regarding its exclusive option to acquire development and commercialization rights to relugolix in oncology outside of the U.S. and Canada (excluding certain Asian markets) is expected in mid-calendar year 2021. If Pfizer exercises this option, Myovant will receive a $50.0 million payment and will be eligible to receive double-digit royalties on net sales.
European Commission (EC) decision on the uterine fibroids MAA is expected in mid-calendar year 2021. If approved, this launch will be executed by Gedeon Richter Plc. (Richter), Myovant’s commercialization partner for relugolix combination tablet for the uterine fibroids and endometriosis indications in Europe and certain other international markets.
MAA submission to the EMA for relugolix combination tablet for the treatment of women with endometriosis-associated pain is expected in calendar year 2021. Richter will be the MAA sponsor.
EC decision on the advanced prostate cancer MAA is expected in calendar year 2022.
Fourth Fiscal Quarter and Fiscal Year Ended March 31, 2021 Financial Summary

Total revenues for the three months and year ended March 31, 2021, were $24.6 million and $59.3 million, respectively. There were no revenues recorded in the comparable prior year periods.

Product revenue, net from sales of ORGOVYX in the U.S. for the three months and year ended March 31, 2021 were $3.6 million.
Collaboration revenue for the three months and year ended March 31, 2021 was $21.0 million and $22.4 million, respectively, and represents partial amortization of the upfront payment received from Pfizer pursuant to the Pfizer Collaboration and License Agreement.
License and milestone revenue for the year ended March 31, 2021 was $33.3 million and represents the partial recognition of revenue associated with the $40.0 million upfront payment and a $10.0 million regulatory milestone payment received from Richter under the Richter Development and Commercialization Agreement.
Cost of product revenue for the three months and year ended March 31, 2021, was $0.3 million related to the cost of goods sold and royalty expense payable to Takeda pursuant to the Takeda License Agreement. There were no such expenses for the comparable prior year periods.

Collaboration expense to Pfizer for the three months and year ended March 31, 2021, was $1.7 million, reflecting Pfizer’s 50% share of net profits from sales of ORGOVYX in the U.S., pursuant to the Pfizer Collaboration and License Agreement. There were no such expenses for the comparable prior year periods.

Research and development (R&D) expenses for the three months ended March 31, 2021, were $21.6 million compared to $41.7 million for the comparable prior year period. R&D expenses for the year ended March 31, 2021, were $136.7 million compared to $192.6 million for the prior fiscal year. The decrease in R&D expenses reflects a reduction in clinical study costs as a result of the wind down of Myovant’s Phase 3 LIBERTY, HERO, and SPIRIT studies and cost share reimbursements from Pfizer for certain R&D expenses in the fiscal 2020 periods. This decrease was partially offset primarily by an increase in personnel expenses, mainly driven by the continued expansion of Myovant’s medical affairs organization to support the U.S. commercial launch of ORGOVYX and the potential U.S. commercial launches of relugolix combination tablet for the women’s health indications, if approved, as well as regulatory expenses and incremental spend on new relugolix development programs.

Selling, general and administrative (SG&A) expenses for the three months ended March 31, 2021, were $78.0 million compared to $22.4 million for the comparable prior year period. SG&A expenses in the year ended March 31, 2021, were $181.4 million compared to $82.3 million for the prior fiscal year. The increase was primarily due to higher expenses related to commercial activities to support the ORGOVYX U.S. launch and commercial readiness activities for the potential U.S. launch of relugolix combination tablet, higher personnel-related costs primarily due to the hiring of Myovant’s commercial operations, marketing, and market access teams, as well as the oncology sales force, higher share-based compensation expense, and general overhead expenses to support Myovant’s organizational growth. Share-based compensation expense for the three months and year ended March 31, 2021 includes incremental expense of $25.7 million related to the acceleration, modification, and remeasurement of our former Principal Executive Officer’s outstanding equity awards. SG&A expenses for the year ended March 31, 2020 included $10.2 million in share-based compensation expense related to the accelerated vesting of certain equity awards as well as a $3.6 million capital tax accrual.

Interest expense was $3.5 million for the three months ended March 31, 2021, compared to $1.4 million for the comparable prior year period. Interest expense was $10.4 million for the year ended March 31, 2021, compared to $12.7 million for the prior fiscal year. The decrease in interest expense, despite higher outstanding loan balances, was primarily driven by the significantly lower interest rates associated with the Sumitomo Dainippon Pharma Loan Agreement as compared to Myovant’s previously outstanding debt obligations, which were repaid in December 2019.

There was no loss on extinguishment of debt for the year ended March 31, 2021. For the year ended March 31, 2020, Myovant recorded a $4.9 million loss resulting from the early repayment of Myovant’s previously outstanding debt obligations in December 2019.

Interest income for the three months ended March 31, 2021, was less than $0.1 million compared to $0.2 million for the comparable prior year period. Interest income for the year ended March 31, 2021, was $0.2 million compared to $2.6 million for the prior fiscal year. The decrease was primarily due to decreases in interest rates.

Foreign exchange loss (gain) for the three months ended March 31, 2021, was a loss of less than $0.1 million compared to a gain of $0.5 million for the comparable prior year period. Foreign exchange gain for the year ended March 31, 2021, was $16.2 million compared to $1.6 million for the prior fiscal year. The increase for the year ended March 31, 2021 was primarily due to a larger foreign currency exchange gain on Myovant’s outstanding balance under the Sumitomo Dainippon Pharma Loan Agreement during the year ended March 31, 2021 compared to the prior year.

Net loss for the three months ended March 31, 2021, was $81.4 million compared to $64.9 million for the comparable prior year period. Net loss for the year ended March 31, 2021, was $255.1 million compared to $289.0 million for the prior fiscal year. On a per common share basis, net loss was $0.89 and $0.73 for the three months ended March 31, 2021 and 2020, respectively, and $2.83 and $3.37 for the year ended March 31, 2021 and 2020, respectively.

Capital resources: Cash, cash equivalents, marketable securities, and amounts available under the Sumitomo Dainippon Pharma Loan Agreement totaled $726.2 million as of March 31, 2021, and consisted of $684.9 million of cash, cash equivalents, and marketable securities and $41.3 million of available borrowing capacity under the Sumitomo Dainippon 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 11, 2021, to discuss corporate updates and financial results for its fourth fiscal quarter and fiscal year ended March 31, 2021. 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 1-800-532-3746 in the U.S. or +1-470-495-9166 from outside the U.S. The webcast will be archived on Myovant’s Investor Relations website following the call.

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. Relugolix monotherapy (120 mg) is FDA-approved as ORGOVYX for the treatment of adult patients with advanced prostate cancer and is under regulatory review in Europe for the treatment of men with advanced prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in the U.S. and Europe for women with uterine fibroids, has completed Phase 3 registration-enabling studies for women with endometriosis, and is being assessed for contraceptive efficacy in healthy women ages 18-35 years who are at risk for pregnancy.