0001679082-22-000102 | 10-Q | XBRL Viewer

Collaboration expense to Pfizer

$ 116,492

$ 41,063

18,016

5,261

Selling, general and administrative

^[1]

79,032

61,212

Research and development

23,890

30,880

Total operating costs and expenses

125,853

98,385

Loss from operations

(9,361)

(57,322)

Net loss and comprehensive loss

^[2]

4,200

3,505

Interest income

(486)

(78)

Loss before income taxes

(13,075)

(60,749)

Income tax expense

8,164

911

(21,239)

(61,660)

Net loss and comprehensive loss

$ (21,239)

$ (61,660)

Net loss per common share - basic (in USD per share)

$ (0.22)

$ (0.67)

Net loss per common share - diluted (in USD per share)

$ (0.22)

$ (0.67)

Weighted average common shares outstanding - basic (in shares)

95,388,294

91,637,151

Weighted average common shares outstanding - diluted (in shares)

95,388,294

91,637,151

Product revenue, net

Pfizer collaboration revenue

$ 41,351

$ 11,554

Cost of revenue

4,915

1,032

25,141

29,509

Accord license revenue

$ 50,000

$ 0

[1]	Includes $1,163 and $1,323 of related party expense (inclusive of third-party pass-through costs) for the three months ended June 30, 2022 and 2021, respectively (see Note 5).
[2]	Includes $3,632 and $2,904 of interest expense under the Sumitomo Pharma Loan Agreement for the three months ended June 30, 2022 and 2021, respectively (see Note 5).

Condensed Consolidated Statements of Operations and Comprehensive Loss (Parenthetical) - USD ($)
$ in Thousands

3 Months Ended

Jun. 30, 2022

Jun. 30, 2021

$ 1,163

$ 1,323

Sumitomo Pharma, Co., Ltd. | Letter Agreement with Sumitomo Dainippon Pharma, Co., Ltd. | Term Loan

^[1]

4,200

3,505

$ 3,632

$ 2,904

[1]	Includes $3,632 and $2,904 of interest expense under the Sumitomo Pharma Loan Agreement for the three months ended June 30, 2022 and 2021, respectively (see Note 5).

Condensed Consolidated Statements of Shareholders' Deficit - USD ($) $ in Thousands	Total	Common Shares	Additional Paid-in Capital	Accumulated Other Comprehensive Loss	Accumulated Deficit
Beginning balance (in shares) at Mar. 31, 2021		91,000,869
Beginning balance at Mar. 31, 2021	$ (353,965)	$ 2	$ 709,466	$ (17,285)	$ (1,046,148)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Share-based compensation expense	11,262		11,262
Share-based compensation liabilities reclassified to equity upon settlement of awards	1,862		1,862
Share-based compensation reclassified to current liabilities	(1,377)		(1,377)
Issuance of shares upon exercise of stock options and release of share awards (in shares)		941,774
Issuance of shares upon exercise of stock options and release of share awards	4,252		4,252
Net loss	(61,660)				(61,660)
Ending balance (in shares) at Jun. 30, 2021		91,942,643
Ending balance at Jun. 30, 2021	$ (399,626)	$ 2	725,465	(17,285)	(1,107,808)
Beginning balance (in shares) at Mar. 31, 2022	94,858,446	94,858,446
Beginning balance at Mar. 31, 2022	$ (473,477)	$ 2	795,935	(17,285)	(1,252,129)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Share-based compensation expense	$ 10,001		10,001
Issuance of shares upon exercise of stock options and release of share awards (in shares)	164,226	798,586
Issuance of shares upon exercise of stock options and release of share awards	$ 1,191		1,191
Net loss	$ (21,239)				(21,239)
Ending balance (in shares) at Jun. 30, 2022	95,657,032	95,657,032
Ending balance at Jun. 30, 2022	$ (483,524)	$ 2	$ 807,127	$ (17,285)	$ (1,273,368)

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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Total of all stockholders' equity (deficit) items, net of receivables from officers, directors, owners, and affiliates of the entity which are attributable to the parent. The amount of the economic entity's stockholders' equity attributable to the parent excludes the amount of stockholders' equity which is allocable to that ownership interest in subsidiary equity which is not attributable to the parent (noncontrolling interest, minority interest). This excludes temporary equity and is sometimes called permanent equity.

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Organization and Summary of Significant Accounting Policies

Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands	3 Months Ended
	Jun. 30, 2022	Jun. 30, 2021
Cash flows from operating activities:
Net loss and comprehensive loss	$ (21,239)	$ (61,660)
Adjustments to reconcile net loss to net cash used in operating activities:
Share-based compensation	9,706	11,262
Depreciation	335	321
Non-cash interest expense	568	601
Amortization of operating lease right-of-use assets	460	403
Changes in operating assets and liabilities:
Accounts receivable	(6,352)	(7,038)
Inventories	(13,343)	(1,561)
Milestone receivable from Pfizer	0	(100,000)
Prepaid expenses and other current assets	3,748	(3,916)
Amount due from related party	122	0
Other assets	392	112
Accounts payable	(2,698)	(8,676)
Accrued expenses and other current liabilities	(2,906)	(1,674)
Deferred revenue	(25,141)	70,491
Amounts due to Pfizer	6,681	9,071
Cost share advance from Pfizer	(25,831)	(18,285)
Operating lease liabilities	(502)	(425)
Amounts due to related parties	(11)	(504)
Other liabilities	6	(1,699)
Net cash used in operating activities	(76,005)	(113,177)
Cash flows from investing activities:
Purchases of marketable securities	(10,171)	(78,426)
Maturities of marketable securities	4,500	4,035
Purchases of property and equipment	(72)	0
Net cash used in investing activities	(5,743)	(74,391)
Cash flows from financing activities:
Proceeds from stock option exercises	1,191	4,135
Net cash provided by financing activities	1,191	4,135
Net change in cash, cash equivalents and restricted cash	(80,557)	(183,433)
Cash, cash equivalents and restricted cash, beginning of period	416,804	677,480
Cash, cash equivalents and restricted cash, end of period	336,247	494,047
Supplemental Disclosures of Non-Cash Financing Information:
Change in fair value of share-based awards recorded to additional paid-in capital	0	1,377
Reclassification of share-based compensation liabilities to additional paid-in capital upon settlement of awards	0	1,862
Stock options exercised receivable, included in prepaid expenses and other current assets	$ 0	$ 117

Organization and Summary of Significant Accounting Policies

3 Months Ended

Jun. 30, 2022

Accounting Policies [Abstract]

Description of Business

Myovant Sciences Ltd. (together with its wholly-owned subsidiaries, the “Company”) is a biopharmaceutical company that aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Founded in 2016, the Company has executed five successful Phase 3 clinical trials across oncology and women’s health leading to two regulatory approvals by the United States (“U.S.”) Food and Drug Administration (“FDA”): (1) ORGOVYX® (relugolix 120 mg), which was approved in the U.S. in December 2020 as the first and only oral gonadotropin-releasing hormone (“GnRH”) receptor antagonist for the treatment of adult patients with advanced prostate cancer; and (2) MYFEMBREE® (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg), which was approved in the U.S. in May 2021 as the first and only once-daily oral GnRH treatment for the management of heavy menstrual bleeding associated with uterine fibroids. In July 2021, the European Commission (“EC”), 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) as the first and only long-term, once-daily oral treatment in the European Union (“EU”) and U.K., respectively, for moderate to severe symptoms of uterine fibroids in adult women of reproductive age. In April 2022, the EC, and in June 2022, the MHRA, approved ORGOVYX (relugolix 120 mg) as the first and only oral androgen deprivation therapy for advanced hormone-sensitive prostate cancer in the EU and U.K., respectively.

In September 2021, the FDA accepted for review the Company’s supplemental New Drug Application (“sNDA”) for MYFEMBREE for the management of moderate to severe pain associated with endometriosis. On May 6, 2022, the Company 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 for review the Company’s sNDA that proposes updates to the U.S. Prescribing Information based on the 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 evaluated for contraceptive efficacy in women with heavy menstrual bleeding associated with uterine fibroids or endometriosis-associated pain who are 18 to 50 years of age and at risk for pregnancy. The Company is also developing MVT-602, an investigational oligopeptide kisspeptin-1 receptor agonist, which has completed a Phase 2a study for the treatment of female infertility as a part of assisted reproduction.

Since its inception, the Company has funded its operations primarily from the issuance and sale of its common shares, from debt financing arrangements, and more recently from the upfront and milestone payments it has received from its collaboration and commercialization partners, as well as net revenues generated from sales of ORGOVYX and MYFEMBREE in the U.S.

The Company’s majority shareholder is Sumitovant Biopharma Ltd. (“Sumitovant”), a wholly-owned subsidiary of Sumitomo Pharma Co., Ltd. (“Sumitomo Pharma”), the name of which prior to April 1, 2022 was Sumitomo Dainippon Pharma Co., Ltd. As of June 30, 2022, Sumitovant directly, and Sumitomo Pharma indirectly, own 50,041,181, or approximately 52.3%, of the Company’s outstanding common shares.

Basis of Presentation and Principles of Consolidation

The Company’s fiscal year ends on March 31, and its first three fiscal quarters end on June 30, September 30 and December 31. The Company has determined that it has one operating and reporting segment as it allocates resources and assesses financial performance on a consolidated basis.

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for complete financial statements.

In the opinion of management, the accompanying unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q (“Quarterly Report”) reflect all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the Company’s condensed consolidated balance sheets as of June 30, 2022 and March 31, 2022, and its condensed consolidated statements of operations and comprehensive loss, cash flows, and shareholders’ deficit for the three months ended June 30, 2022 and 2021. The March 31, 2022 condensed consolidated balance sheet was derived from audited consolidated financial statements, but does not include all disclosures required by U.S. GAAP. The results for interim periods are not necessarily indicative of results for the entire fiscal year or any other interim period. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the Company’s previously filed audited consolidated financial statements and the related notes thereto included in the Company’s Annual Report on Form 10-K (“Annual Report”) for the fiscal year ended March 31, 2022, filed with the U.S. Securities and Exchange Commission (the “SEC”) on May 11, 2022.

Any reference in these notes to applicable accounting guidance is meant to refer to the authoritative U.S. GAAP included in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”), issued by the Financial Accounting Standards Board (“FASB”). The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.

Dollar amounts reported in millions within this Quarterly Report are computed based on the amounts in thousands, and therefore, the sum of components may not equal the total amount reported in millions due to rounding.

Use of Estimates

The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires the Company’s management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the condensed consolidated financial statements and the accompanying notes, and the reported amounts of revenue and expenses during the reported periods. Actual results could differ materially from those estimates.

On an ongoing basis, the Company’s management evaluates its estimates, including those related to valuation of inventories, impairment testing for long-lived-assets, variables used in calculating the fair value of the Company’s equity awards, expected achievement of performance-based vesting criteria for equity awards, variable consideration and other relevant inputs impacting the gross and net revenue recognition, contingent liabilities, recoverability of deferred tax assets, determination of lease term, research and development (“R&D”) expenses and accruals, and effective income tax rates. Management bases estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities as of the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period, that are not readily apparent from other sources. Estimates and assumptions are periodically reviewed considering changes in circumstances, facts, or experience. Changes in estimates and assumptions are reflected in reported results in the period in which they become known. In addition, management’s assessment of the Company’s ability to continue as a going concern involves the estimation of the amount and timing of future cash inflows and outflows.

Summary of Significant Accounting Policies

The accounting policies used by the Company in its presentation of interim financial results are consistent with those described in Note 2 to the Company’s audited consolidated financial statements included in its Annual Report for the fiscal year ended March 31, 2022, filed with the SEC on May 11, 2022. There have been no significant changes in the Company’s significant accounting policies from those disclosed in its Annual Report for the fiscal year ended March 31, 2022.

Reclassification

Certain reclassification has been made to the unaudited condensed consolidated statements of cash flows for the three months ended June 30, 2021 to place them on a comparable basis with the three months ended June 30, 2022, regarding the presentation of amortization of operating lease right-of-use assets of $0.4 million. The reclassification had no effect on the previously reported results of operations. The reclassification had no effect on previously reported cash flows from operating activities in the unaudited condensed consolidated statements of cash flows.

Liquidity and Capital Resources

As of June 30, 2022, the Company had approximately $358.7 million in cash, cash equivalents, and marketable securities. The Company believes that its existing cash, cash equivalents, and marketable securities will be sufficient to fund its anticipated operating expenses and capital expenditure requirements for at least the next 12 months from the date of issuance of this Quarterly Report.

In future periods, if the Company’s cash, cash equivalents, marketable securities, and amounts that it expects to generate from product sales and/or third-party collaboration payments are not sufficient to enable the Company to fund its operations, the Company may need to raise additional funds in the form of equity, debt, or from other sources. There can be no assurances that such funding sources will be available at terms acceptable to the Company, or at all. If the Company has insufficient funding to meet its working capital needs, it could be required to delay, limit, reduce, or terminate its drug development programs, commercialization efforts, and/or limit or cease operations.

As of June 30, 2022, the Company had approximately $41.3 million of borrowing capacity available to it under the Sumitomo Pharma Loan Agreement (see Note 5(A)). As of June 30, 2022, the Company is also eligible to earn up to $3.6 billion, $122.5 million, and $90.5 million of additional milestone payments from Pfizer Inc. (“Pfizer”), Gedeon Richter Plc. (“Richter”), and Accord Healthcare, Ltd. (“Accord”), respectively, as well as potential royalty payments from Richter and Accord. See Note 8 for additional information about the Pfizer Collaboration and License Agreement, the Richter Development and Commercialization Agreement, and the Accord License Agreement.

Net Loss per Common Share

Basic net loss per common share is computed by dividing net loss available to common shareholders by the weighted-average number of common shares outstanding during the period. Diluted net loss per common share is computed by dividing net loss by the weighted-average number of common shares and potentially dilutive shares of common stock outstanding during the period. Potential dilutive securities outstanding include stock options, restricted stock units, performance stock units, and warrants. During all periods presented, the Company incurred net losses. Accordingly, the effect of any common share equivalents would have been anti-dilutive during those periods and are not included in the calculation of diluted weighted-average number of common shares outstanding.

The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per common share for the periods indicated because their inclusion would have been anti-dilutive:


	June 30,
	2022	2021
Stock options	5,921,227	8,613,006
Restricted stock units and performance stock units (unvested)	8,329,253	5,170,442
Warrants	73,710	73,710
Total	14,324,190	13,857,158

Recently Issued Accounting Standards Not Yet Adopted

In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting, which provides optional expedients and exceptions for applying generally accepted accounting principles to contracts, hedging relationships, and other transactions affected by reference rate reform if certain criteria are met. These amendments apply only to contracts, hedging relationships, and other transactions that reference the London Interbank Offered Rate (“LIBOR”) or another reference rate expected to be discontinued because of reference rate reform. The amendments are effective prospectively for all entities as of March 12, 2020 through December 31, 2022. The Company’s outstanding debt with Sumitomo Pharma bears a variable interest rate that is indexed off of 3-month LIBOR, for which publication is expected to be discontinued on June 30, 2023. In the event that 3-month LIBOR becomes unavailable, the Company and Sumitomo Pharma will negotiate in good faith to select an alternative interest rate in accordance with the Sumitomo Pharma Loan Agreement. The Company has not yet adopted this guidance and is currently evaluating the potential impact the adoption of this standard will have on its consolidated financial statements and related disclosures.

In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. ASU 2016-13 replaces the existing incurred loss impairment model with an expected loss model that requires the use of forward-looking information to calculate credit loss estimates. It also eliminates the concept of other-than-temporary impairment and requires credit losses on available-for-sale debt securities to be recorded through an allowance for credit losses instead of as a reduction in the amortized cost basis of the securities. ASU 2016-13 was effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2019. Early adoption was permitted, including adoption in any interim period. In February 2020, the FASB issued ASU 2020-02, Financial Instruments-Credit Losses (Topic 326) and Leases (Topic 842) - Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 119 and Update to SEC Section on Effective Date Related to Accounting Standards Update No. 2016-02, Leases

(Topic 842), which amended the effective date of the original pronouncement for smaller reporting companies. ASC 2016-13 and its amendments will be effective for annual and interim periods beginning after December 15, 2022 for smaller reporting companies. The Company is currently assessing the impact the adoption of this new standard will have on its consolidated financial statements and related disclosures.

Revenue Components

3 Months Ended

Jun. 30, 2022

Revenue from Contract with Customer [Abstract]

Revenue Components

The following table provides information about the Company’s revenues (in thousands):


	Three Months Ended June 30,
	2022		2021
Revenues:
Product revenue, net:
ORGOVYX	$	36,034	$	10,479
MYFEMBREE	3,999		1,075
Richter product supply and royalties	1,318		—
Total product revenue, net	41,351		11,554
Pfizer collaboration revenue:
Amortization of upfront payment	20,974		20,974
Amortization of regulatory milestone	4,167		8,535
Total Pfizer collaboration revenue	25,141		29,509
Accord license revenue	50,000		—
Total revenues	$	116,492	$	41,063

Product Revenue, net

The Company began generating product revenue from sales of ORGOVYX and MYFEMBREE in the U.S. in January 2021 and June 2021, respectively. The Company records product revenue net of estimated discounts, chargebacks, rebates, product returns, and other gross-to-net revenue deductions.

For the three months ended June 30, 2022, product revenue, net also includes revenues related to product supply to Richter to support their European launches of RYEQO of $1.1 million, as well as royalties on net sales of RYEQO in Richter’s Territory of $0.2 million. There were no such revenues recorded in the three months ended June 30, 2021.

The activities and ending balances for each significant category of discounts and allowances (which constitutes variable consideration) for the three months ended June 30, 2022 were as follows (in thousands):


	Reserve -government and other incentives		Chargebacks and administrative fees		Returns		Sales Discounts		Total
Balance as of March 31, 2022	$	13,734	$	2,628	$	3,028	$	486	$	19,876
Provision related to sales in the current year	23,742		6,469		815		1,146		32,172
Adjustments related to prior year sales	1,785		(389)		—		—		1,396
Credits and payments made during the current year	(21,185)		(5,335)		(2)		(1,074)		(27,596)
Balance as of June 30, 2022	$	18,076	$	3,373	$	3,841	$	558	$	25,848

The total reserves described above are summarized as components of the Company’s unaudited condensed consolidated balance sheets as follows (in thousands):


	June 30, 2022		March 31, 2022
Reduction of accounts receivable, net	$	558	$	486
Component of accrued expenses and other current liabilities	25,290		19,390
Total revenue-related reserves	$	25,848	$	19,876

Pfizer Collaboration Revenue

Pfizer collaboration revenue for the three months ended June 30, 2022 and 2021 consists of the partial recognition of the upfront payment the Company received from Pfizer upon entering into the Pfizer Collaboration and License Agreement in December 2020 and of the regulatory milestone payment from Pfizer that was triggered upon the FDA approval of MYFEMBREE for the management of heavy menstrual bleeding associated with uterine fibroids on May 26, 2021. See Note 8 for additional information regarding the Pfizer Collaboration and License Agreement.

Accord License Revenue

Accord license revenue for the three months ended June 30, 2022 consists of the recognition of the upfront payment the Company received from Accord in May 2022 pursuant to the Accord License Agreement. There was no Accord license revenue for the three months ended June 30, 2021. See Note 8 for additional information regarding the Accord License Agreement.

Certain Balance Sheet Components

3 Months Ended

Jun. 30, 2022

Other Liabilities Disclosure [Abstract]

Certain Balance Sheet Components

Cash, Cash Equivalents and Restricted Cash

The following represents a reconciliation of cash and cash equivalents on the unaudited condensed consolidated balance sheets to total cash, cash equivalents and restricted cash in the unaudited condensed consolidated statements of cash flows (in thousands):


	June 30,
	2022		2021
Cash and cash equivalents	$	325,535	$	484,960
Restricted cash (included in other assets)	10,712		9,087
Total cash, cash equivalents and restricted cash	$	336,247	$	494,047

Cash and cash equivalents include cash deposits in banks and all highly liquid investments that are readily convertible to cash (maturity of three months or less at the time of purchase). Restricted cash consists of funds held or designated to satisfy the requirements of certain agreements that are restricted in their use. As of June 30, 2022 and 2021, restricted cash includes approximately $7.1 million, that is held in an escrow fund for use by Sunovion Pharmaceuticals Inc. (“Sunovion”), a subsidiary of Sumitomo Pharma, to manage payments for rebates, chargebacks, and similar fees pursuant to the Market Access Services Agreement (see Note 5(D)).

Inventories

Inventories consisted of the following (in thousands):


	June 30, 2022		March 31, 2022
Raw materials	$	12,928	$	663
Work in process	6,340		3,737
Finished goods	1,954		3,184

Total inventories	$	21,222	$	7,584

Accrued Expenses and Other Current Liabilities

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



	June 30, 2022		March 31, 2022
Accrued sales discounts, rebates, and allowances	$	25,290	$	19,390
Accrued compensation-related expenses	13,094		26,389
Accrued income tax payable	8,784		720
Accrued R&D expenses	6,029		6,955
Accrued commercial expenses	5,099		7,196
Accrued other expenses	3,192		3,309
Accrued royalties payable to Takeda	3,082		2,470
Accrued professional fees	1,118		1,340
Deferred product revenue	—		825
Total accrued expenses and other current liabilities	$	65,688	$	68,594

Fair Value Measurements

3 Months Ended

Jun. 30, 2022

Fair Value Disclosures [Abstract]

Fair Value Measurements

The preparation of the Company’s unaudited condensed consolidated financial statements in accordance with U.S. GAAP requires certain assets and liabilities to be reflected at their fair value. Fair value is defined as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed into one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable. These levels are as follows:

•Level 1—inputs, which include unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access;

•Level 2—inputs, which include observable inputs other than Level 1 inputs, such as quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the asset or liability; and

•Level 3—inputs, which include unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the underlying asset or liability. Level 3 assets and liabilities include those whose fair value measurements are determined using pricing models, discounted cash flow methodologies, or similar valuation techniques, as well as significant management judgement or estimation.

For a description of the methods and assumptions that are used to estimate the fair value and determine the fair value hierarchy classification of each class of the Company’s financial instruments, see Note 2, “Summary of Significant Accounting Policies,” and Note 4, “Fair Value Measurements,” to the Company’s audited consolidated financial statements included in its Annual Report for the fiscal year ended March 31, 2022, filed with the SEC on May 11, 2022.

Financial Instruments Measured at Fair Value on a Recurring Basis

The following table summarizes the Company’s financial assets measured at fair value on a recurring basis and their respective input levels based on the fair value hierarchy (in thousands):


	Fair Value Measurement Using:
	Level 1		Level 2		Level 3		Total
As of June 30, 2022
Assets:
Money market funds (1)	$	48	$	—	$	—	$	48
Commercial paper (2)	—		218,302		—		218,302
U.S. treasury securities (3)	1,938		—		—		1,938


Total assets	$	1,986	$	218,302	$	—	$	220,288



	Fair Value Measurement Using:
	Level 1		Level 2		Level 3		Total
As of March 31, 2022
Assets:
Money market funds (1)	$	69	$	—	$	—	$	69
Commercial paper (2)	—		219,772		—		219,772



Total assets	$	69	$	219,772	$	—	$	219,841

(1) Included in cash and cash equivalents.

(2) Includes $187.1 million in cash and cash equivalents and $31.2 million in marketable securities as of June 30, 2022. Includes $192.3 million in cash and cash equivalents and $27.5 million in marketable securities as of March 31, 2022.

(3) Included in marketable securities, non-current.

There were no liabilities measured at fair value on a recurring basis as of June 30, 2022 or March 31, 2022.

Financial Instruments Not Measured at Fair Value on a Recurring Basis

The Company recorded the cost share advance from Pfizer, which is included in Level 2 of the fair value hierarchy, at its estimated fair value as of the transaction date. As discussed in Note 8(B), on the transaction date, the cost share advance from Pfizer was discounted to fair value using the Company’s estimated incremental borrowing rate over the period in which the cost share advance is expected to be utilized. The recorded amount has been and will continue to be reduced each reporting period by the amount of Allowable Expenses applied to the cost share advance. There were no non-recurring fair value assets as of June 30, 2022 and March 31, 2022.

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

Related Party Transactions	3 Months Ended
Related Party Transactions	Jun. 30, 2022
Related Party Transactions [Abstract]
Related Party Transactions	Related Party Transactions As of June 30, 2022, Sumitovant directly, and Sumitomo Pharma indirectly, own 50,041,181, or approximately 52.3%, of the Company’s outstanding common shares. The Company has agreements with Sumitovant, Sumitomo Pharma, and their affiliates, including Sunovion, a subsidiary of Sumitomo Pharma. Certain of these agreements are described below. (A) Sumitomo Pharma Loan Agreement On December 27, 2019, the Company and one of its subsidiaries, Myovant Sciences GmbH (“MSG”), entered into a Loan Agreement with Sumitomo Pharma (the “Sumitomo Pharma Loan Agreement”). Pursuant to the Sumitomo Pharma Loan Agreement, Sumitomo Pharma agreed to make revolving loans to the Company in an aggregate principal amount of up to $400.0 million. Funds may be drawn down by the Company once per calendar quarter, subject to certain terms and conditions, including consent of the Company’s board of directors. The maturity date of the loans under the Sumitomo Pharma Loan Agreement is December 27, 2024 or the date the outstanding principal of the loans is declared due and payable due to an event of default pursuant to the terms of the Sumitomo Pharma Loan Agreement. In addition, if Sumitomo Pharma fails to own at least a majority of the Company’s outstanding common shares, it may become unlawful under Japanese law for Sumitomo Pharma to fund loans to the Company, and in which case the Company would not be able to continue to borrow under the Sumitomo Pharma Loan Agreement. Interest is due and payable quarterly, and the outstanding principal amounts are due and payable in full on the five-year anniversary of the closing date of the Sumitomo Pharma Loan Agreement. Loans under the Sumitomo Pharma Loan Agreement are prepayable at any time without premium or penalty upon 10 business days’ prior written notice. Loans under the Sumitomo Pharma Loan Agreement bear interest at a variable rate per annum equal to 3-month LIBOR plus a margin of 3% payable on the last day of each calendar quarter. Publication of 3-month LIBOR is currently expected to be discontinued on June 30, 2023. In the event that 3-month LIBOR becomes unavailable, the Company and Sumitomo Pharma will negotiate in good faith to select an alternative interest rate and, if applicable as a result of such alternative interest rate, margin adjustment that is consistent with industry accepted successor rates for determining a LIBOR replacement. The Company’s obligations under the Sumitomo Pharma Loan Agreement are fully and unconditionally guaranteed by the Company and its subsidiaries. The loans and other obligations are senior unsecured obligations of the Company, MSG, and subsidiary guarantors. The Sumitomo Pharma Loan Agreement includes customary representations and warranties and affirmative and negative covenants. The Sumitomo Pharma Loan Agreement also includes customary events of default, including payment defaults, breaches of representations and warranties, breaches of covenants following any applicable cure period, cross acceleration to certain other debt, failure to pay certain final judgments, certain events relating to bankruptcy or insolvency, failure of material provisions of the loan documents to remain in full force and effect or any contest thereto by the Company or any of its subsidiaries and certain breaches by the Company under the Investor Rights Agreement. Upon the occurrence of an event of default, a default interest rate of an additional 5.0% will apply to the outstanding principal amount of the loans, Sumitomo Pharma may terminate its obligations to make loans to the Company and declare the principal amount of loans to become immediately due and payable, and Sumitomo Pharma may take such other actions as set forth in the Sumitomo Pharma Loan Agreement. Upon the occurrence of certain bankruptcy and insolvency events, the obligations of Sumitomo Pharma to make loans to the Company would automatically terminate and the principal amount of the loans would automatically become due and payable. In addition, if it becomes unlawful for Sumitomo Pharma to maintain the loans under the Sumitomo Pharma Loan Agreement or within 30 days of a change of control with respect to the Company, the Company would be required to repay the outstanding principal amount of the Loans. As of June 30, 2022, approximately $41.3 million of borrowing capacity remains available to the Company, subject to the terms of the Sumitomo Pharma Loan Agreement and the outstanding loan balance of $358.7 million is classified as a long-term liability on the unaudited condensed consolidated balance sheet under the caption long-term debt, less current maturities (related party). Interest expense under the Sumitomo Pharma Loan Agreement was $3.6 million and $2.9 million for the three months ended June 30, 2022 and 2021, respectively, and is included in interest expense in the unaudited condensed consolidated statements of operations and comprehensive loss. (B) Investor Rights Agreement On December 27, 2019, the Company entered into an Investor Rights Agreement with Sumitomo Pharma and Sumitovant (the “Investor Rights Agreement”). Pursuant to the Investor Rights Agreement, among other things, the Company agreed, at the request of Sumitovant, to register for sale, under the Securities Act of 1933, common shares beneficially owned by Sumitovant, subject to specified conditions and limitations. In addition, the Company agreed to periodically provide Sumitovant (i) certain financial statements, projections, capitalization summaries and other information and (ii) access to the Company’s books, records, facilities and employees during the Company’s normal business hours as Sumitovant may reasonably request, subject to specified limitations. The Investor Rights Agreement also contains certain protections for the Company’s minority shareholders for so long as Sumitomo Pharma or certain of its affiliates beneficially owns more than 50% of the Company’s common shares. These protections include: (i) a requirement that Sumitovant vote its shares for the election of independent directors in accordance with the recommendation of the Company’s board of directors (the “board”) or in the same proportion as the shareholders not affiliated with Sumitovant vote their shares; (ii) a requirement that the audit committee of the Company’s board be composed solely of three independent directors; (iii) a requirement that any transaction proposed by Sumitomo Pharma or certain of its affiliates that would increase Sumitomo Pharma’s beneficial ownership to over 60% of the outstanding voting power of the Company must be approved by the Company’s audit committee (if occurring prior to December 27, 2022), and be conditioned on the approval of shareholders not affiliated with Sumitovant approving the transaction by a majority of the common shares held by such shareholders; and a requirement that any related person transactions between Sumitomo Pharma or certain of its affiliates and the Company must be approved by the Company’s audit committee. Pursuant to the Investor Rights Agreement, the Company also agreed that at all times that Sumitomo Pharma beneficially owns more than 50% of the Company’s common shares, Sumitomo Pharma, by purchasing common shares in the open market or from the Company in certain specified circumstances, will have the right to maintain its percentage ownership in the Company’s common shares in the event of a financing event or acquisition event conducted by the Company, or specified other events, subject to specific conditions. (C) Services and Information Sharing Agreement In February 2022, the Company and two of its subsidiaries, MSG and Myovant Sciences, Inc. (“MSI”), entered into a services and information sharing agreement with Sumitovant Biopharma, Inc., a wholly-owned subsidiary of Sumitovant. Under the agreement, for so long as Sumitovant is a majority owner of the Company, the Company agrees to (1) subject to Sumitovant’s reasonable request and on a timeline to be reasonably agreed by the parties, supply certain information summarizing material aspects of the Company’s business to Sumitovant, and with reasonable advanced notice, give Sumitovant and its representatives the reasonable opportunity to discuss such information with the Company’s senior management; and (2) subject to the oversight of the chairperson of the Company’s Audit Committee, provide certain additional, more detailed information on business-essential matters in order to collaborate with Sumitovant or to enable the Company to leverage Sumitovant’s expertise. Under the agreement, Sumitovant also agrees to provide, upon the Company’s election, various administrative and general business support services as well as research and development services to the Company and its subsidiaries, and the Company agrees to reimburse Sumitovant for expenses it, or third parties acting on its behalf, incurs for the Company. For any general and administrative and research and development activities performed by employees of Sumitovant, the agreement provides for Sumitovant to charge the Company based upon the relative percentage of time utilized on matters related to the Company by the respective employee and a mutually agreed upon mark-up on such expenses. Under the agreement, all other third-party pass-through costs are billed to the Company at cost. For the three months ended June 30, 2022, the Company incurred less than $0.1 million under this agreement. (D) Market Access Services Agreement On August 1, 2020, one of the Company’s subsidiaries, MSG, entered into a Market Access Services Agreement, as amended (“Market Access Services Agreement”), with Sunovion. Pursuant to the Market Access Services Agreement, among other things, Sunovion agreed to provide to MSG certain market access services with respect to the distribution and sale of ORGOVYX (“Prostate Cancer Product”) and MYFEMBREE (“Women’s Health Product,” and collectively with Prostate Cancer Product, the “Products”, and each a “Product”), including, among other things: (i) adding the Products to Sunovion’s agreements with its third party logistics providers; (ii) adding the Women’s Health Product to certain of Sunovion’s contracts with wholesalers, group purchasing organizations and integrated delivery networks and negotiating rates for the Products with certain market access customers; (iii) providing order-to-cash services; (iv) providing certain employees to provide market access account director services; (v) performing activities required in connection with supporting and maintaining contracts between the Company and market access customers for the coverage, purchase, or dispensing of the Products; (vi) managing the validation, processing and payment of rebates, chargebacks, and certain administrative, distribution and service fees related to the Products; (vii) providing MSG with price reporting metrics and other information required to allow the Company to comply with applicable government price reporting requirements; (viii) coordinating with MSG and any applicable wholesalers and distributors to address any recalls, investigations, or product holds; (ix) configuring, or causing to be configured, the appropriate software systems to enable Sunovion to perform its obligations under the Market Access Services Agreement; and (x) providing training and certain other ancillary support services to facilitate the foregoing. Pursuant to this agreement, Sunovion will also provide certain services to the Company to enable the Company to comply with its obligations under the State Transparency Laws. MSG, in turn, appointed Sunovion as the exclusive distributor of the Women’s Health Product and a non-exclusive distributor of the Prostate Cancer Product, each in the U.S., including all of its territories and possessions. In order to facilitate Sunovion’s provision of these services, MSG agreed, among other things, to: (i) grant Sunovion a non-exclusive license under all intellectual property owned or controlled by MSG, solely for Sunovion’s use in connection with its performance of the contemplated services; (ii) provide Sunovion periodic reports of sales projections and estimated volume requirements, as well as such other information as Sunovion reasonably requests or may need to perform the services; (iii) comply with the provisions of any agreements between Sunovion and third parties pursuant to which the Products will be distributed or sold; (iv) cooperate with certain investigations related to orders and audits of MSG’s quality systems solely related, as reasonably determined by Myovant, to Sunovion’s performance of certain regulatory services, at Sunovion’s costs; and (v) promptly notify Sunovion in the event relugolix is recalled. As consideration for the services, MSG has paid and will continue to pay Sunovion an agreed-upon monthly service charge for each of the first two years of the Market Access Services Agreement term and any agreed regulatory and training service charges. After the second year of the Market Access Services Agreement term, the monthly service charges will be determined by the parties. In addition, MSG also agreed to (x) reimburse Sunovion for any pass-through expenses it incurs while providing the services, and (y) establish an escrow fund for use by Sunovion to manage payments for rebates, chargebacks and similar fees. For the three months ended June 30, 2022 and 2021, the Company incurred $1.1 million and $1.3 million, respectively, under this agreement (inclusive of third-party pass-through costs billed to the Company) which are included in SG&A expenses, in the accompanying consolidated statements of operations and comprehensive loss. The Market Access Services Agreement also contains customary representations and warranties by the parties and customary provisions related to confidentiality, indemnification and insurance. The initial term of the Market Access Services Agreement is three years. Thereafter, the term will be automatically extended for one-year periods, unless either party provides notice of its intent not to renew the Market Access Services Agreement at least nine (9) months prior to the expiration of the applicable term. Either party may also terminate the Market Access Services Agreement prior to the end of its term in the event of an uncured material breach by the other party, if there are certain changes of law, or if such other party becomes insolvent or undergoes a change of control. MSG may also terminate the Market Access Services Agreement with respect to one or both Products if Sunovion fails to satisfy certain market access milestones or for convenience upon payment of a break-up fee.

Income Taxes	3 Months Ended
Income Taxes	Jun. 30, 2022
Income Tax Disclosure [Abstract]
Income Taxes	Income Taxes The Company is not subject to taxation under the laws of Bermuda since it is organized as a Bermuda Exempted Limited Company, for which there is no current tax regime. It is subject to taxation under the laws of the United Kingdom by virtue of location of central management and control. The income tax expense of the Company and its affiliates currently is primarily attributable to U.S. federal, state and local taxes. The Company’s effective tax rate for the three months ended June 30, 2022 and 2021 was (62.44)% and (1.50)%, respectively. Key determinative factors of the Company’s effective tax rate include the allocation of its earnings by jurisdiction and a valuation allowance that currently eliminates all of the Company’s net deferred tax assets, including in respect of the R&D matter referred to below. Effective for tax years beginning after December 31, 2021, the Tax Cuts and Jobs Act 2017 (“TCJA”) amendments to Internal Revenue Code Section 174 will no longer permit an immediate deduction for R&D expenditures in the tax year that such costs are incurred. For expenses that are incurred for R&D in the U.S., such amounts will be amortized over 5 years (this is currently approximately 90% of the Company’s relevant spend), and expenses that are incurred for R&D expenditures outside the U.S. will be amortized over 15 years. The Company’s effective tax rate for the three months ended June 30, 2022 was impacted accordingly. Although it is understood that Congress is considering legislation that would extend the TCJA relief by one or more years, the possibility that this will happen is uncertain and the Company is required to calculate its income tax liabilities based on the provisions of current law. The Company assesses the realizability of its deferred tax assets at each balance sheet date based on available positive and negative evidence in order to determine the amount which is more likely than not to be realized, and records a valuation allowance as necessary. The evaluation of the need for a valuation allowance is performed on a jurisdiction-by-jurisdiction basis. Factors reviewed include projections of pre-tax book income for the foreseeable future, determination of cumulative pre-tax book income after permanent differences, earnings history, and reliability of forecasting. Future factors may arise at subsequent balance sheet dates that would impact the assessment of the objective and subjective evidence of the Company. Any adjustment to the deferred tax asset valuation allowance would be recorded in the consolidated statement of operations and comprehensive loss for the period that the adjustment is determined to be required. In response to the COVID-19 pandemic, many governments enacted measures to provide aid and economic stimulus. These measures included deferring the due dates of tax payments and other changes to income and non-income-based-tax laws as well as providing direct government assistance through grants and forgivable loans. On March 27, 2020, the U.S. Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was enacted in response to the COVID-19 pandemic and the negative impacts that it had on the global economy and U.S. companies. The CARES Act includes measures to assist companies, including temporary changes to income and non-income-based tax laws. The Company implemented certain provisions of the CARES Act, such as deferring employer payroll taxes through the end of calendar year 2020. As of June 30, 2022, the Company has $0.9 million of employer payroll taxes deferred under the CARES Act, which is included in accrued expenses and other current liabilities on the unaudited condensed consolidated balance sheet.

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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Share-Based Payment Arrangement [Abstract]

Share-Based Compensation

3 Months Ended

Jun. 30, 2022

Share-Based Compensation

Share-Based CompensationThe Company has two share-based compensation plans, the Myovant Sciences Ltd. 2016 Equity Incentive Plan (“Equity Incentive Plan”) and the Myovant Sciences Ltd. 2020 Inducement Plan (“Inducement Plan”) (collectively, the “Equity Plans”). As of June 30, 2022, there were approximately 2.2 million and 0.8 million common shares available for future issuance under the Equity Incentive Plan and the Inducement Plan, respectively. For additional information about the Company’s Equity Plans, see Note 10, “Share-Based Compensation,” to the Company’s audited consolidated financial statements included in its Annual Report for the fiscal year ended March 31, 2022, filed with the SEC on May 11, 2022.

(A) Stock Options

Activity for stock options for the three months ended June 30, 2022 is included in the following table:


			Number of Options








Options outstanding at March 31, 2022			6,130,680
Granted			204,808
Exercised			(164,226)
Forfeited			(250,035)
Options outstanding at June 30, 2022			5,921,227
Options vested and expected to vest at June 30, 2022			5,921,227
Options exercisable at June 30, 2022			3,993,191

(B) Restricted Stock and Performance Stock Units

Activity for restricted stock units and performance share units for the three months ended June 30, 2022 is included in the following table:


			Number of Shares








Unvested balance at March 31, 2022			4,532,619
Granted			5,057,731
Vested			(634,360)
Forfeited			(626,737)
Unvested balance at June 30, 2022			8,329,253

Share-based compensation during the three months ended June 30, 2022 and 2021 was as follows (in thousands):


	Three Months Ended June 30,
	2022		2021
Share-based compensation recognized as:
SG&A expense	$	5,972	$	7,155
R&D expense	3,666		3,957
Cost of product revenue (1)	68		3
Share-based compensation expense	$	9,706	$	11,115

Share-based compensation capitalized into inventory	$	363	$	150

(1) Share-based compensation capitalized into inventory is recognized as cost of product revenue when the related product is sold.

Share-based compensation included in SG&A expense for the three months ended June 30, 2021 includes $1.4 million related to the settlement and remeasurement of the Company’s former Principal Executive Officer’s equity awards. There was no such expense during the three months ended June 30, 2022. Additional information about the Company’s Separation and General Release Agreement with its former Principal Executive Officer is included in Note 10, “Share-Based Compensation,” to the Company’s audited consolidated financial statements included in its Annual Report for the fiscal year ended March 31, 2022, filed with the SEC on May 11, 2022.

Total unrecognized share-based compensation was approximately $112.1 million as of June 30, 2022 and is expected to be recognized over a weighted-average period of approximately 3.1 years.

Collaboration and License Agreements

3 Months Ended

Jun. 30, 2022

Commitments and Contingencies Disclosure [Abstract]

Collaboration and License Agreements

(A) Richter Development and Commercialization Agreement

On March 30, 2020, one of the Company’s subsidiaries, MSG, entered into an exclusive license agreement with Richter for Richter to commercialize relugolix combination tablet for uterine fibroids and endometriosis in Europe, the Commonwealth of Independent States including Russia, Latin America, Australia, and New Zealand (the “Richter Development and Commercialization Agreement”). Under the terms of the Richter Development and Commercialization Agreement, the Company received an upfront payment of $40.0 million on March 31, 2020, is eligible to receive up to $40.0 million in regulatory milestone payments (of which $25.0 million has been received), $107.5 million in sales-related milestones, and tiered royalties on net sales following regulatory approval.

Under the terms of the Richter Development and Commercialization Agreement, the Company continues to lead global development of relugolix combination tablet. The Company also agreed to assist Richter in transferring manufacturing technology from the Company’s CMOs to Richter to enable Richter to manufacture relugolix combination tablet. The Company agreed to supply Richter with quantities of relugolix combination tablet for its territories pursuant to the Company’s agreements with its CMOs. Richter is responsible for local clinical development, manufacturing, and all commercialization activities for its territories. The Company has also granted Richter an option to collaborate with the Company on relugolix combination tablet for future indications in women’s health other than fertility.

The term of the Richter Development and Commercialization Agreement shall expire on a country-by-country basis upon expiry of the Royalty Term (as defined in the Richter Development and Commercialization Agreement) for the respective product in a country in Richter’s Territory. The Richter Development and Commercialization Agreement may be terminated in its entirety or on a country-by-country basis by mutual consent of the parties, or by either party for the uncured material breach of the other party, for bankruptcy of the other party, and for certain other reasons in accordance with the terms of the Richter Development and Commercialization Agreement.

(B) Pfizer Collaboration and License Agreement

On December 26, 2020, one of the Company’s subsidiaries, MSG, and Pfizer, entered into a collaboration and license agreement (the “Pfizer Collaboration and License Agreement”), pursuant to which the Company and Pfizer collaborate to jointly develop and commercialize relugolix in oncology and women’s health in the U.S. and Canada (the “Co-Promotion Territory”). In addition, Pfizer also received an option to acquire exclusive commercialization and development rights to relugolix in oncology outside the Co-Promotion Territory, excluding certain Asian countries (the “Pfizer Territory”). Pfizer notified the Company on October 22, 2021 of its decision to decline this option.

In the Co-Promotion Territory, the Company and Pfizer equally share profits and certain expenses, including certain pre-launch inventory costs incurred by the Company prior to the effective date of the Pfizer Collaboration and License Agreement (the “Allowable Expenses”). The Company remains responsible for regulatory interactions and drug supply and continues to lead clinical development for MYFEMBREE in the women’s health indications, while development for ORGOVYX is shared equally among the parties.

In the U.S., the Company is the principal on all sales transactions with third parties and recognizes 100% of product sales to third parties as revenue from contracts with customers. The Company concluded that based on the principal versus agent guidance in ASC 606, Revenue from Contracts with Customers, it has primary responsibility for fulfilling customer orders, controls inventory before it is sold to third party customers, assumes the risk of inventory loss, and maintains discretion in establishing product price.

Pursuant to the terms of the Pfizer Collaboration and License Agreement, the Company received an upfront payment of $650.0 million in December 2020, and is eligible to receive up to $3.8 billion of milestone payments, including two regulatory milestones of $100.0 million upon each FDA approval for MYFEMBREE in uterine fibroids and endometriosis ($200.0 million in the aggregate), and tiered sales milestones of up to $3.5 billion upon reaching certain thresholds of annual net sales for oncology and the combined women’s health indications in the Co-Promotion Territory. In July 2021, the Company received a $100.0 million regulatory milestone payment from Pfizer that was triggered upon the FDA approval of MYFEMBREE for the management of heavy menstrual bleeding associated with uterine fibroids on May 26, 2021.

Pursuant to the terms of the Pfizer Collaboration and License Agreement, the Company has and will continue to bear Pfizer’s share of Allowable Expenses, up to a maximum of $100.0 million for calendar year 2021 and up to a maximum of $50.0 million for calendar year 2022. Any unused portion will carry over into the subsequent calendar years until the Company has assumed in aggregate $150.0 million of Pfizer’s share of the Allowable Expenses.

The term of the Pfizer Collaboration and License Agreement continues until no products are sold and all development activities have terminated in the Co-Promotion Territory. The Pfizer Collaboration and License Agreement may be terminated early by either party for the uncured material breach of the other party or for bankruptcy or other insolvency proceeding of the other party. In addition, Pfizer has certain other termination rights and may terminate the Pfizer Collaboration and License Agreement early upon providing written notice to the Company pursuant to the terms of the Pfizer Collaboration and License Agreement.

The Company assessed the Pfizer Collaboration and License Agreement and determined that it meets both criteria to be considered a collaborative agreement within the scope of ASC 808, Collaborative Arrangements: active participation by both parties and exposures to significant risks and rewards dependent on the commercial success of the activities. Although the Company is lead party and will perform many activities, both development and commercialization responsibilities are assigned between parties and both parties participate on joint steering and other committees overseeing the collaboration activities. Both parties are exposed to significant risks and rewards based on the economic outcomes of the collaboration through cost sharing and profit (loss) sharing provisions. Net payments to/from Pfizer for Pfizer’s share of the net profits and Allowable Expenses will be disaggregated and presented in the Company’s consolidated statements of operations and comprehensive loss according to the nature of the expense (e.g., collaboration expense, R&D expenses, or SG&A expenses).

As discussed above, the Company received a $650.0 million upfront payment from Pfizer in December 2020, of which $150.0 million is Pfizer’s advanced reimbursement for Pfizer’s share of Allowable Expenses (up to $100.0 million for calendar year 2021 and up to $50.0 million for calendar year 2022). The Company concluded that the prepayment by Pfizer of its share of Allowable Expenses represents a significant financing component since the Company received the cash flows at the outset of the arrangement, rather than over a two-year period. Accordingly, the Company reduced the amount of the advanced reimbursement by approximately $3.6 million, representing the implied financing costs based on the Company’s incremental borrowing rate that was derived based on the Sumitomo Pharma Loan Agreement, and recorded the discounted value of $146.4 million on the consolidated balance sheet as a deposit liability (cost share advance from Pfizer) as of the transaction date, split between a current and a non-current portion, based on the expected timing of Allowable Expenses subject to cost share. The financing component has been and will continue to be accreted to interest expense utilizing a method that approximates the effective yield method over the period in which the cost share advance is expected to be used. The remainder of the upfront payment was recorded as deferred revenue and has been and will continue to be recognized as Pfizer collaboration revenue on a straight-line basis over the estimated term of the agreement of six years, which was estimated by the Company based upon the terms of the Pfizer Collaboration and License Agreement, including the termination provisions contained therein. The Company determined straight-line amortization to be appropriate because the upfront payment represents payment for Pfizer’s right to participate in the collaboration activities, including both commercialization and development activities, which are expected to be realized evenly over this period.

The achievement of regulatory milestones is outside of the Company’s control and therefore was not deemed probable at contract inception. Amounts associated with the regulatory milestones were not initially recognized. Upon achievement of the related regulatory milestones, cumulative catch-up revenue will be recorded as Pfizer collaboration revenue in the period in which the respective regulatory milestone is achieved, and the remainder will be recognized over the remaining contract term. The Company determined that, conceptually, the regulatory milestone payments represent payment for development activities that will continue to benefit the collaboration as the products move toward commercialization. Accordingly, the recognition of revenue associated with the regulatory milestones follows the same amortization model as the upfront payment described above.

Similar to the regulatory milestones, sales-based milestone payments will not initially be recognized due to the uncertainty associated with the future commercial outcomes of ORGOVYX and MYFEMBREE. Upon achievement, the sales-based milestones will be recognized as revenue immediately in the period when the annual sales thresholds are met as the payments represent consideration for past activities that are completed and culminated in the annual sales thresholds being met.

The amount due to Pfizer as of June 30, 2022, was approximately $39.2 million and consisted of $18.0 million payable to Pfizer for Pfizer’s 50% share of net profits on sales of ORGOVYX and MYFEMBREE in the U.S. and approximately $21.2 million for 50% of Pfizer’s reimbursement of Allowable Expenses. 100% of all expenses related to Pfizer under the Pfizer Collaboration and License Agreement are initially expensed and then the full pool of expenses incurred by both the Company and Pfizer are reduced through application of the cost sharing allowance. The amount due to Pfizer as of March 31, 2022 was approximately $32.6 million and consisted of $14.1 million payable to Pfizer for Pfizer’s 50% share of net profits on sales of ORGOVYX and MYFEMBREE in the U.S. and approximately $18.5 million for 50% of Pfizer’s reimbursement of Allowable Expenses.

On May 5, 2022, one of the Company’s subsidiaries, MSG, entered into an exclusive license agreement (the “Accord License Agreement”) with Accord and Intas Pharmaceuticals, Ltd., parent entity of Accord, for Accord to commercialize relugolix for the treatment of advanced hormone-sensitive prostate cancer under the trade name ORGOVYX® (relugolix 120 mg) in the European Economic Area, U.K., Switzerland, and Turkey (“Accord’s Territories”), with the right of first negotiation if the Company decides to enter into licensing arrangements in countries in the Middle East, Africa, and India. Under the terms of the Accord License Agreement, the Company received an upfront payment of $50.0 million in the three months ended June 30, 2022. The Company is also eligible to receive up to $90.5 million in commercial launch, sales-based, and other milestone payments, as well as tiered royalties from the high-teens to mid-twenties on net sales of ORGOVYX in Accord’s Territories.

Under the terms of the Accord License Agreement, the Company retains all rights to relugolix in the U.S. with its collaboration partner, Pfizer, as well as rights to relugolix in other therapeutic areas outside of prostate cancer, uterine fibroids, and endometriosis in Europe. The Company will continue to lead the global development of relugolix and may provide initial product supply to Accord, subject to the parties entering into a separate supply agreement. Accord will be responsible for certain local clinical development and all commercialization for its territories and has the option to manufacture relugolix in the future. In the event that Accord elects to exercise this option, the Company has agreed to assist Accord in transferring manufacturing technology from the Company’s CMOs to Accord to enable Accord to manufacture its own product supply.

The term of the Accord License Agreement shall expire on a country-by-country basis upon expiry of the Royalty Term (as defined in the Accord License Agreement). The Accord License Agreement may be terminated in its entirety or on a country-by-country basis by either party for the uncured material breach or bankruptcy of the other party, and for certain other reasons in accordance with the terms of the Accord License Agreement.

The Company concluded that Accord represents a customer and evaluated the Accord License Agreement under ASC 606. Based on that evaluation, the Company identified a single performance obligation under the Accord License Agreement, consisting of the Company’s promise to grant Accord a license to certain of the Company’s intellectual property. The Company determined that the initial transaction price consisted solely of the non-refundable upfront payment of $50.0 million, which was recognized as revenue upon delivery of the license to Accord during the three months ended June 30, 2022.

The remaining forms of consideration are variable because they are dependent on the achievement of sales-based or other milestones. The Company evaluated the constraint on variable consideration and concluded that the milestone payments are dependent on regulatory approvals and actions of third parties, and thus are highly susceptible to factors outside the Company’s influence. Therefore, at contract inception, the milestones are not included in the transaction price as it is not probable that a significant reversal of revenue would not occur. Furthermore, the sales-based milestones will be recognized as revenue immediately in the period when the related sales threshold is met. All other milestones will be recognized as revenue immediately in the period the underlying milestone is achieved. Any consideration related to sales-based royalties will be recognized when the related sales occur.

(D) Contract Balances

The following table presents changes in the Company’s contract liabilities during the three months ended June 30, 2022 (in thousands):


	Balance at March 31, 2022		Additions		Imputed Interest		Deductions		Balance at June 30, 2022
Contract liabilities:
Deferred revenue (1)	$	476,270	$	—	$	—	$	(25,141)	$	451,129
Cost share advance from Pfizer (2)	$	33,818	$	—	$	568	$	(25,831)	$	8,555

(1) Includes $100.6 million and $350.6 million presented as current and non-current, respectively, on the unaudited condensed consolidated balance sheet as of June 30, 2022. Includes $100.6 million and $375.7 million presented as current and non-current, respectively, on the unaudited condensed consolidated balance sheet as of March 31, 2022.

(2) Includes $8.6 million presented as current on the unaudited condensed consolidated balance sheet as of June 30, 2022. Includes $33.8 million presented as current on the unaudited condensed consolidated balance sheet as of March 31, 2022.

During the three months ended June 30, 2022, deferred revenue decreased by $25.1 million, as a result of the recognition of Pfizer collaboration revenue.

During the three months ended June 30, 2022, cost share advance from Pfizer decreased by $25.3 million. The decrease was the net result of the application of 100% of shared Allowable Expenses incurred by the Company and 50% of reimbursement of Allowable Expenses incurred by Pfizer of approximately $25.8 million (consisting of $8.5 million and $17.3 million in reductions to R&D expenses and SG&A expenses, respectively), partially offset by accretion of the implied financing component of $0.6 million.

Commitments and Contingencies	3 Months Ended
Commitments and Contingencies	Jun. 30, 2022
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies	Commitments and Contingencies (A) Legal Contingencies The Company may be, from time to time, a party to various disputes and claims arising from normal business activities. The Company accrues for loss contingencies when available information indicates that it is probable that a liability has been incurred and the amount of such liability can be reasonably estimated. For cases in which the Company believes that a reasonably possible loss exists, the Company discloses the facts and circumstances of the loss contingency, including an estimable range, if possible. The Company is currently not involved in any material legal proceedings. (B) Contract Service Providers In the normal course of business, the Company enters into agreements with contract service providers to assist in the performance of its R&D and clinical and commercial manufacturing activities. Subject to required notice periods and the Company’s obligations under binding purchase orders, the Company can elect to discontinue the work under these agreements at any time. The Company expects to enter into additional collaborative research, contract research, clinical and commercial manufacturing, and supplier agreements in the future, which may require upfront payments and long-term commitments of capital resources. (C) Indemnification Agreements The Company has agreed to indemnify its officers and directors for certain events or occurrences, subject to certain limits, while the officer or director was serving at the Company’s request in such capacity. The maximum amount of potential future indemnification liability is unlimited; however, the Company holds directors’ and officers’ liability insurance which limits the Company’s exposure and may enable it to recover a portion of any future amounts paid. In the normal course of business, the Company also enters into contracts and agreements with service providers and other parties with which it conducts business that contain indemnification provisions pursuant to which the Company has agreed to indemnify the party against certain types of third-party claims. The Company has agreed to indemnify Sumitomo Pharma against certain losses, claims, liabilities and related expenses incurred by Sumitomo Pharma, subject to the terms of the Sumitomo Pharma Loan Agreement and the Investor Rights Agreement. The Company has also agreed to indemnify Sunovion against certain losses, claims, liabilities and related expenses incurred by Sunovion, subject to the terms of the Market Access Services Agreement, as amended. The Company has not experienced any material losses related to these indemnification obligations, and no material claims with respect thereto were outstanding. The Company does not expect significant claims related to these indemnification obligations and, consequently, concluded that the fair value of these obligations is negligible, and no related accruals have been established. (D) Takeda Agreements On April 29, 2016, Takeda Pharmaceuticals International AG (“Takeda”), a subsidiary of Takeda Pharmaceutical Company Limited, the originator of relugolix, granted the Company a worldwide license to develop and commercialize relugolix (excluding Japan and certain other Asian countries) and an exclusive right to develop and commercialize MVT-602 in all countries worldwide. Pursuant to the license agreement (the “Takeda License Agreement”), Takeda granted to the Company an exclusive, royalty-bearing license under certain patents and other intellectual property controlled by Takeda to develop and commercialize relugolix and MVT-602, and products containing these compounds for all human diseases and conditions. Under the Takeda License Agreement, the Company will pay Takeda a fixed, high single-digit royalty on net sales of certain relugolix products, a low single-digit royalty on net sales of certain other relugolix products, and a high single-digit royalty on net sales of MVT-602 products in the Company’s territory, all subject to certain agreed reductions. For the three months ended June 30, 2022 and 2021, the Company recorded royalty expense to Takeda of $3.1 million and $0.9 million, respectively, which is included in cost of product revenue on the unaudited condensed consolidated statements of operations and comprehensive loss. As of June 30, 2022 and March 31, 2022, the Company recorded royalties payable to Takeda of $3.1 million and $2.5 million, respectively, which are included in accrued expenses and other current liabilities on the unaudited condensed consolidated balance sheets. Takeda will pay the Company a high single-digit royalty on net sales of relugolix products for prostate cancer in the Takeda Territory, subject to certain agreed reductions. Royalties are required to be paid, on a product-by-product and country-by-country basis, until the latest to occur of the expiration of the last to expire valid claim of a licensed patent covering such product in such country, the expiration of regulatory exclusivity for such product in such country, or 10 years after the first commercial sale of such product in such country. Under the Takeda License Agreement, there was no upfront payment and there are no payments upon the achievement of clinical development or marketing approval milestones. If the Takeda License Agreement is terminated in its entirety or with respect to relugolix for prostate cancer, other than for safety reasons or by the Company for Takeda’s uncured material breach, prior to receipt of the first regulatory approval of relugolix for prostate cancer in Japan, then the Company must either reimburse Takeda for its out of pocket costs and expenses directly incurred in connection with Takeda’s completion of the relugolix development for prostate cancer, up to an agreed upon cap, or complete by itself the conduct of any clinical studies of relugolix for prostate cancer that are ongoing as of the effective date of such termination, at its cost and expense. In May 2018, the Company entered into a Commercial Manufacturing and Supply Agreement with Takeda (the “Takeda Commercial Supply Agreement”) pursuant to which Takeda agreed to supply the Company and the Company agreed to obtain from Takeda certain quantities of relugolix drug substance according to agreed-upon quality specifications. The initial term of the Takeda Commercial Supply Agreement began on May 30, 2018 and will continue for five years. At the end of the initial term, the Takeda Commercial Supply Agreement will automatically renew for successive one-year terms, unless either party gives notice of termination to the other at least 12 months prior to the end of the then-current term. The Takeda Commercial Supply Agreement may be terminated by either party upon 90 days’ notice of an uncured material breach of its terms by the other party, or immediately upon notice to the other party of a party’s bankruptcy. Each party will also have the right to terminate the Takeda Commercial Supply Agreement, in whole or in part, for any reason upon 180 days’ prior written notice to the other party, provided that any then-open purchase orders will remain in effect and be binding on both parties. The Takeda Commercial Supply Agreement, including any then-open purchase orders thereunder, will terminate immediately upon the termination of the Takeda License Agreement in accordance with its terms.

Organization and Summary of Significant Accounting Policies (Policies)	3 Months Ended
	Jun. 30, 2022
Accounting Policies [Abstract]
Basis of Presentation and Principles of Consolidation	Basis of Presentation and Principles of Consolidation The Company’s fiscal year ends on March 31, and its first three fiscal quarters end on June 30, September 30 and December 31. The Company has determined that it has one operating and reporting segment as it allocates resources and assesses financial performance on a consolidated basis. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for complete financial statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q (“Quarterly Report”) reflect all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the Company’s condensed consolidated balance sheets as of June 30, 2022 and March 31, 2022, and its condensed consolidated statements of operations and comprehensive loss, cash flows, and shareholders’ deficit for the three months ended June 30, 2022 and 2021. The March 31, 2022 condensed consolidated balance sheet was derived from audited consolidated financial statements, but does not include all disclosures required by U.S. GAAP. The results for interim periods are not necessarily indicative of results for the entire fiscal year or any other interim period. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the Company’s previously filed audited consolidated financial statements and the related notes thereto included in the Company’s Annual Report on Form 10-K (“Annual Report”) for the fiscal year ended March 31, 2022, filed with the U.S. Securities and Exchange Commission (the “SEC”) on May 11, 2022. Any reference in these notes to applicable accounting guidance is meant to refer to the authoritative U.S. GAAP included in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”), issued by the Financial Accounting Standards Board (“FASB”). The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Dollar amounts reported in millions within this Quarterly Report are computed based on the amounts in thousands, and therefore, the sum of components may not equal the total amount reported in millions due to rounding.
Use of Estimates	Use of Estimates The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires the Company’s management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the condensed consolidated financial statements and the accompanying notes, and the reported amounts of revenue and expenses during the reported periods. Actual results could differ materially from those estimates. On an ongoing basis, the Company’s management evaluates its estimates, including those related to valuation of inventories, impairment testing for long-lived-assets, variables used in calculating the fair value of the Company’s equity awards, expected achievement of performance-based vesting criteria for equity awards, variable consideration and other relevant inputs impacting the gross and net revenue recognition, contingent liabilities, recoverability of deferred tax assets, determination of lease term, research and development (“R&D”) expenses and accruals, and effective income tax rates. Management bases estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities as of the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period, that are not readily apparent from other sources. Estimates and assumptions are periodically reviewed considering changes in circumstances, facts, or experience. Changes in estimates and assumptions are reflected in reported results in the period in which they become known. In addition, management’s assessment of the Company’s ability to continue as a going concern involves the estimation of the amount and timing of future cash inflows and outflows.
Reclassification	Reclassification Certain reclassification has been made to the unaudited condensed consolidated statements of cash flows for the three months ended June 30, 2021 to place them on a comparable basis with the three months ended June 30, 2022, regarding the presentation of amortization of operating lease right-of-use assets of $0.4 million. The reclassification had no effect on the previously reported results of operations. The reclassification had no effect on previously reported cash flows from operating activities in the unaudited condensed consolidated statements of cash flows.
Liquidity and Capital Resources	Liquidity and Capital Resources As of June 30, 2022, the Company had approximately $358.7 million in cash, cash equivalents, and marketable securities. The Company believes that its existing cash, cash equivalents, and marketable securities will be sufficient to fund its anticipated operating expenses and capital expenditure requirements for at least the next 12 months from the date of issuance of this Quarterly Report. In future periods, if the Company’s cash, cash equivalents, marketable securities, and amounts that it expects to generate from product sales and/or third-party collaboration payments are not sufficient to enable the Company to fund its operations, the Company may need to raise additional funds in the form of equity, debt, or from other sources. There can be no assurances that such funding sources will be available at terms acceptable to the Company, or at all. If the Company has insufficient funding to meet its working capital needs, it could be required to delay, limit, reduce, or terminate its drug development programs, commercialization efforts, and/or limit or cease operations. As of June 30, 2022, the Company had approximately $41.3 million of borrowing capacity available to it under the Sumitomo Pharma Loan Agreement (see Note 5(A)). As of June 30, 2022, the Company is also eligible to earn up to $3.6 billion, $122.5 million, and $90.5 million of additional milestone payments from Pfizer Inc. (“Pfizer”), Gedeon Richter Plc. (“Richter”), and Accord Healthcare, Ltd. (“Accord”), respectively, as well as potential royalty payments from Richter and Accord. See Note 8 for additional information about the Pfizer Collaboration and License Agreement, the Richter Development and Commercialization Agreement, and the Accord License Agreement.
Net Loss per Common Share	Net Loss per Common Share Basic net loss per common share is computed by dividing net loss available to common shareholders by the weighted-average number of common shares outstanding during the period. Diluted net loss per common share is computed by dividing net loss by the weighted-average number of common shares and potentially dilutive shares of common stock outstanding during the period. Potential dilutive securities outstanding include stock options, restricted stock units, performance stock units, and warrants. During all periods presented, the Company incurred net losses. Accordingly, the effect of any common share equivalents would have been anti-dilutive during those periods and are not included in the calculation of diluted weighted-average number of common shares outstanding.
Recently Adopted and Issued Accounting Standards	Recently Issued Accounting Standards Not Yet Adopted In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting, which provides optional expedients and exceptions for applying generally accepted accounting principles to contracts, hedging relationships, and other transactions affected by reference rate reform if certain criteria are met. These amendments apply only to contracts, hedging relationships, and other transactions that reference the London Interbank Offered Rate (“LIBOR”) or another reference rate expected to be discontinued because of reference rate reform. The amendments are effective prospectively for all entities as of March 12, 2020 through December 31, 2022. The Company’s outstanding debt with Sumitomo Pharma bears a variable interest rate that is indexed off of 3-month LIBOR, for which publication is expected to be discontinued on June 30, 2023. In the event that 3-month LIBOR becomes unavailable, the Company and Sumitomo Pharma will negotiate in good faith to select an alternative interest rate in accordance with the Sumitomo Pharma Loan Agreement. The Company has not yet adopted this guidance and is currently evaluating the potential impact the adoption of this standard will have on its consolidated financial statements and related disclosures. In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. ASU 2016-13 replaces the existing incurred loss impairment model with an expected loss model that requires the use of forward-looking information to calculate credit loss estimates. It also eliminates the concept of other-than-temporary impairment and requires credit losses on available-for-sale debt securities to be recorded through an allowance for credit losses instead of as a reduction in the amortized cost basis of the securities. ASU 2016-13 was effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2019. Early adoption was permitted, including adoption in any interim period. In February 2020, the FASB issued ASU 2020-02, Financial Instruments-Credit Losses (Topic 326) and Leases (Topic 842) - Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 119 and Update to SEC Section on Effective Date Related to Accounting Standards Update No. 2016-02, Leases (Topic 842), which amended the effective date of the original pronouncement for smaller reporting companies. ASC 2016-13 and its amendments will be effective for annual and interim periods beginning after December 15, 2022 for smaller reporting companies. The Company is currently assessing the impact the adoption of this new standard will have on its consolidated financial statements and related disclosures.

Organization and Summary of Significant Accounting Policies (Tables)

3 Months Ended

Jun. 30, 2022

Accounting Policies [Abstract]

Schedule of Antidilutive Securities Excluded from Computation of Diluted Net Loss Per Common Share


	June 30,
	2022	2021
Stock options	5,921,227	8,613,006
Restricted stock units and performance stock units (unvested)	8,329,253	5,170,442
Warrants	73,710	73,710
Total	14,324,190	13,857,158

Revenue Components (Tables)

3 Months Ended

Jun. 30, 2022

Revenue from Contract with Customer [Abstract]

Disaggregation of Revenue

The following table provides information about the Company’s revenues (in thousands):


	Three Months Ended June 30,
	2022		2021
Revenues:
Product revenue, net:
ORGOVYX	$	36,034	$	10,479
MYFEMBREE	3,999		1,075
Richter product supply and royalties	1,318		—
Total product revenue, net	41,351		11,554
Pfizer collaboration revenue:
Amortization of upfront payment	20,974		20,974
Amortization of regulatory milestone	4,167		8,535
Total Pfizer collaboration revenue	25,141		29,509
Accord license revenue	50,000		—
Total revenues	$	116,492	$	41,063

Summary Of Categories Of Discounts And Allowances


	Reserve -government and other incentives		Chargebacks and administrative fees		Returns		Sales Discounts		Total
Balance as of March 31, 2022	$	13,734	$	2,628	$	3,028	$	486	$	19,876
Provision related to sales in the current year	23,742		6,469		815		1,146		32,172
Adjustments related to prior year sales	1,785		(389)		—		—		1,396
Credits and payments made during the current year	(21,185)		(5,335)		(2)		(1,074)		(27,596)
Balance as of June 30, 2022	$	18,076	$	3,373	$	3,841	$	558	$	25,848

The total reserves described above are summarized as components of the Company’s unaudited condensed consolidated balance sheets as follows (in thousands):


	June 30, 2022		March 31, 2022
Reduction of accounts receivable, net	$	558	$	486
Component of accrued expenses and other current liabilities	25,290		19,390
Total revenue-related reserves	$	25,848	$	19,876

Certain Balance Sheet Components (Tables)

3 Months Ended

Jun. 30, 2022

Other Liabilities Disclosure [Abstract]

Schedule of Cash and Cash Equivalents


	June 30,
	2022		2021
Cash and cash equivalents	$	325,535	$	484,960
Restricted cash (included in other assets)	10,712		9,087
Total cash, cash equivalents and restricted cash	$	336,247	$	494,047

Schedule of Inventory

Inventories consisted of the following (in thousands):


	June 30, 2022		March 31, 2022
Raw materials	$	12,928	$	663
Work in process	6,340		3,737
Finished goods	1,954		3,184

Total inventories	$	21,222	$	7,584

Schedule of Accrued Liabilities

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



	June 30, 2022		March 31, 2022
Accrued sales discounts, rebates, and allowances	$	25,290	$	19,390
Accrued compensation-related expenses	13,094		26,389
Accrued income tax payable	8,784		720
Accrued R&D expenses	6,029		6,955
Accrued commercial expenses	5,099		7,196
Accrued other expenses	3,192		3,309
Accrued royalties payable to Takeda	3,082		2,470
Accrued professional fees	1,118		1,340
Deferred product revenue	—		825
Total accrued expenses and other current liabilities	$	65,688	$	68,594

Fair Value Measurements (Tables)

3 Months Ended

Jun. 30, 2022

Fair Value Disclosures [Abstract]

Assets and Liabilities Measured at Fair Value

The following table summarizes the Company’s financial assets measured at fair value on a recurring basis and their respective input levels based on the fair value hierarchy (in thousands):


	Fair Value Measurement Using:
	Level 1		Level 2		Level 3		Total
As of June 30, 2022
Assets:
Money market funds (1)	$	48	$	—	$	—	$	48
Commercial paper (2)	—		218,302		—		218,302
U.S. treasury securities (3)	1,938		—		—		1,938


Total assets	$	1,986	$	218,302	$	—	$	220,288



	Fair Value Measurement Using:
	Level 1		Level 2		Level 3		Total
As of March 31, 2022
Assets:
Money market funds (1)	$	69	$	—	$	—	$	69
Commercial paper (2)	—		219,772		—		219,772



Total assets	$	69	$	219,772	$	—	$	219,841

(1) Included in cash and cash equivalents.

(3) Included in marketable securities, non-current.

Share-Based Compensation (Tables)

3 Months Ended

Jun. 30, 2022

Share-Based Payment Arrangement [Abstract]

Summary of Stock Option Activity

Activity for stock options for the three months ended June 30, 2022 is included in the following table:


			Number of Options








Options outstanding at March 31, 2022			6,130,680
Granted			204,808
Exercised			(164,226)
Forfeited			(250,035)
Options outstanding at June 30, 2022			5,921,227
Options vested and expected to vest at June 30, 2022			5,921,227
Options exercisable at June 30, 2022			3,993,191

Summary of Restricted Share Awards and Restricted Stock Units Activity

Activity for restricted stock units and performance share units for the three months ended June 30, 2022 is included in the following table:


			Number of Shares








Unvested balance at March 31, 2022			4,532,619
Granted			5,057,731
Vested			(634,360)
Forfeited			(626,737)
Unvested balance at June 30, 2022			8,329,253

Schedule of Share-based Compensation

Share-based compensation during the three months ended June 30, 2022 and 2021 was as follows (in thousands):


	Three Months Ended June 30,
	2022		2021
Share-based compensation recognized as:
SG&A expense	$	5,972	$	7,155
R&D expense	3,666		3,957
Cost of product revenue (1)	68		3
Share-based compensation expense	$	9,706	$	11,115

Share-based compensation capitalized into inventory	$	363	$	150

(1) Share-based compensation capitalized into inventory is recognized as cost of product revenue when the related product is sold.

Collaboration and License Agreements (Tables)

3 Months Ended

Jun. 30, 2022

Commitments and Contingencies Disclosure [Abstract]

Collaboration and License Agreements

The following table presents changes in the Company’s contract liabilities during the three months ended June 30, 2022 (in thousands):


	Balance at March 31, 2022		Additions		Imputed Interest		Deductions		Balance at June 30, 2022
Contract liabilities:
Deferred revenue (1)	$	476,270	$	—	$	—	$	(25,141)	$	451,129
Cost share advance from Pfizer (2)	$	33,818	$	—	$	568	$	(25,831)	$	8,555

Organization and Summary of Significant Accounting Policies - Narrative (Details)	3 Months Ended
	Jun. 30, 2022 USD ($) trial segment shares	Jun. 30, 2021 USD ($)
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Number of successful clinical trials \| trial	5
Number of operating segments \| segment	1
Number of reporting segments \| segment	1
Amortization of operating lease right-of-use assets	$ 460,000	$ 403,000
Cash, cash equivalents and marketable securities	$ 358,700,000
Sumitomo Pharma, Co., Ltd. \| Majority Shareholder
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Number of shares owned (in shares) \| shares	50,041,181
Ownership percentage	52.30%
Sumitomo Pharma, Co., Ltd. \| Letter Agreement with Sumitomo Dainippon Pharma, Co., Ltd. \| Term Loan \| Majority Shareholder
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Available borrowing capacity	$ 41,300,000
Pfizer
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Outstanding payment from milestones achieved	3,600,000,000
Richter
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Outstanding payment from milestones achieved	$ 122,500,000

Organization and Summary of Significant Accounting Policies - Schedule of Antidilutive Securities (Details) - shares	3 Months Ended
	Jun. 30, 2022	Jun. 30, 2021
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities (in shares)	14,324,190	13,857,158
Stock options
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities (in shares)	5,921,227	8,613,006
Restricted stock units and performance stock units (unvested)
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities (in shares)	8,329,253	5,170,442
Warrants
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities (in shares)	73,710	73,710

Revenue Components - Disaggregation of Revenue (Details) - USD ($) $ in Thousands	3 Months Ended
	Jun. 30, 2022	Jun. 30, 2021
Disaggregation of Revenue [Line Items]
Total revenues	$ 116,492	$ 41,063
ORGOVYX
Disaggregation of Revenue [Line Items]
Revenues	36,034	10,479
MYFEMBREE
Disaggregation of Revenue [Line Items]
Revenues	3,999	1,075
Richter product supply and royalties
Disaggregation of Revenue [Line Items]
Revenues	1,318	0
Product revenue, net
Disaggregation of Revenue [Line Items]
Revenues	41,351	11,554
Total revenues	41,351	11,554
Pfizer collaboration revenue
Disaggregation of Revenue [Line Items]
Revenue from collaborative arrangement	25,141	29,509
Total revenues	25,141	29,509
Amortization of Upfront Payment
Disaggregation of Revenue [Line Items]
Revenue from collaborative arrangement	20,974	20,974
Amortization of Regulatory Milestone
Disaggregation of Revenue [Line Items]
Revenue from collaborative arrangement	4,167	8,535
Accord license revenue
Disaggregation of Revenue [Line Items]
Revenues	50,000	0
Total revenues	$ 50,000	$ 0

Revenue Components - Narrative (Details) - USD ($) $ in Thousands	3 Months Ended
	Jun. 30, 2022	Jun. 30, 2021
Richter product supply and royalties
Disaggregation of Revenue [Line Items]
Revenues	$ 1,318	$ 0
Richter product supply and royalties \| Richter
Disaggregation of Revenue [Line Items]
Revenues	1,100	0
RYEQO \| Richter \| Maximum
Disaggregation of Revenue [Line Items]
Revenues	200	0
Accord license revenue
Disaggregation of Revenue [Line Items]
Revenues	$ 50,000	$ 0

Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise.

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Revenue Components - Schedule of Discounts and Allowances (Details) $ in Thousands	3 Months Ended
	Jun. 30, 2022 USD ($)
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward]
Beginning balance	$ 19,876
Provision related to sales in the current year	32,172
Adjustments related to prior year sales	1,396
Credits and payments made during the current year	(27,596)
Ending balance	25,848
Reserve -government and other incentives
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward]
Beginning balance	13,734
Provision related to sales in the current year	23,742
Adjustments related to prior year sales	1,785
Credits and payments made during the current year	(21,185)
Ending balance	18,076
Chargebacks and administrative fees
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward]
Beginning balance	2,628
Provision related to sales in the current year	6,469
Adjustments related to prior year sales	(389)
Credits and payments made during the current year	(5,335)
Ending balance	3,373
Returns
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward]
Beginning balance	3,028
Provision related to sales in the current year	815
Adjustments related to prior year sales	0
Credits and payments made during the current year	(2)
Ending balance	3,841
Sales Discounts
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward]
Beginning balance	486
Provision related to sales in the current year	1,146
Adjustments related to prior year sales	0
Credits and payments made during the current year	(1,074)
Ending balance	$ 558

Revenue Components - Schedule of Reserves as Balance Sheet Components (Details) - USD ($) $ in Thousands	Jun. 30, 2022	Mar. 31, 2022
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items]
Total revenue-related reserves	$ 25,848	$ 19,876
Reduction of accounts receivable, net
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items]
Total revenue-related reserves	558	486
Component of accrued expenses and other current liabilities
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items]
Total revenue-related reserves	$ 25,290	$ 19,390

Certain Balance Sheet Components - Cash and Restricted Cash (Details) - USD ($) $ in Thousands	Jun. 30, 2022	Mar. 31, 2022	Jun. 30, 2021	Mar. 31, 2021
Other Liabilities Disclosure [Abstract]
Cash and cash equivalents	$ 325,535	$ 406,704	$ 484,960
Restricted cash (included in other assets)	10,712		9,087
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents, Total	$ 336,247	$ 416,804	$ 494,047	$ 677,480

Certain Balance Sheet Components - Narrative (Details) - USD ($) $ in Thousands	Jun. 30, 2022	Jun. 30, 2021
Cash and Cash Equivalents [Line Items]
Restricted cash (included in other assets)	$ 10,712	$ 9,087
Sunovion Pharmaceuticals, Inc.
Cash and Cash Equivalents [Line Items]
Restricted cash (included in other assets)	$ 7,100	$ 7,100

Certain Balance Sheet Components - Inventory (Details) - USD ($) $ in Thousands	Jun. 30, 2022	Mar. 31, 2022
Other Liabilities Disclosure [Abstract]
Raw materials	$ 12,928	$ 663
Work in process	6,340	3,737
Finished goods	1,954	3,184
Total inventories	$ 21,222	$ 7,584

Certain Balance Sheet Components - Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands	Jun. 30, 2022	Mar. 31, 2022
Other Liabilities Disclosure [Abstract]
Accrued sales discounts, rebates, and allowances	$ 25,290	$ 19,390
Accrued compensation-related expenses	13,094	26,389
Accrued income tax payable	8,784	720
Accrued R&D expenses	6,029	6,955
Accrued commercial expenses	5,099	7,196
Accrued other expenses	3,192	3,309
Accrued royalties payable to Takeda	3,082	2,470
Accrued professional fees	1,118	1,340
Deferred product revenue	0	825
Total accrued expenses and other current liabilities	$ 65,688	$ 68,594

Fair Value Measurements - Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - Fair Value, Recurring - USD ($) $ in Thousands	Jun. 30, 2022	Mar. 31, 2022
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Total assets	$ 220,288	$ 219,841
Money market funds
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Total assets	48	69
Commercial paper
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Total assets	218,302	219,772
Cash and cash equivalents	187,100	192,300
Marketable securities	31,200	27,500
U.S. treasury securities
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Total assets	1,938
Level 1
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Total assets	1,986	69
Level 1 \| Money market funds
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Total assets	48	69
Level 1 \| Commercial paper
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Total assets	0	0
Level 1 \| U.S. treasury securities
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Total assets	1,938
Level 2
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Total assets	218,302	219,772
Level 2 \| Money market funds
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Total assets	0	0
Level 2 \| Commercial paper
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Total assets	218,302	219,772
Level 2 \| U.S. treasury securities
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Total assets	0
Level 3
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Total assets	0	0
Level 3 \| Money market funds
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Total assets	0	0
Level 3 \| Commercial paper
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Total assets	0	$ 0
Level 3 \| U.S. treasury securities
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Total assets	$ 0

Fair Value Measurements - Narrative (Details) - USD ($)	Jun. 30, 2022	Mar. 31, 2022
Fair Value, Recurring
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Liabilities measured at fair value on a recurring basis	$ 0	$ 0
Non-recurring fair value assets	220,288,000	219,841,000
Fair Value, Nonrecurring
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Non-recurring fair value assets	$ 0	$ 0

Related Party Transactions (Details)

1 Months Ended

3 Months Ended

Aug. 01, 2020

Dec. 27, 2019

USD ($)

day

director

Aug. 31, 2020

Jun. 30, 2022

USD ($)

Jun. 30, 2021

USD ($)

^[1]

$ 4,200,000

$ 3,505,000

Majority Shareholder | Sunovion Pharmaceuticals Inc. Market Access Services Agreement

1,163,000

1,323,000

Sumitomo Pharma, Co., Ltd. | Majority Shareholder

$ 1,100,000

1,300,000

Number of shares owned (in shares) | shares

50,041,181

Ownership percentage

52.30%

Ownership threshold for appointment of directors

50.00%

Number of independent directors required for audit committee | director

Ownership threshold for voting rights

60.00%

Ownership threshold for right of ownership percentage maintenance

50.00%

Sumitovant Biopharma, Inc. | Services Information Sharing Agreement

Sumitomo Dainippon Pharma, Co., Ltd. | Majority Shareholder | Sunovion Pharmaceuticals Inc. Market Access Services Agreement

$ 100,000

Agreement term

3 years

Agreement extension term

1 year

Termination notice period

9 months

MSG | Majority Shareholder | Sunovion Pharmaceuticals Inc. Market Access Services Agreement | Selling, General and Administrative Expenses

Agreement term

2 years

Term Loan | Letter Agreement with Sumitomo Dainippon Pharma, Co., Ltd. | Sumitomo Pharma, Co., Ltd.