MYOVANT SCIENCES LTD. Management's Discussion and Analysis of Financial Condition and Results of Operations (form 10-K)

May 11, 2022 at 09:05 am EDT

Objective



The purpose of the following discussion and analysis is to provide material
information relevant to an assessment of our financial condition and results of
operations from management's perspective, including to describe and explain key
trends, events, and other factors that impacted our reported results for the
periods presented and that are reasonably likely to impact our future
performance.

The discussion and analysis below is organized as follows:



•executive summary, including a description of our business and significant
events that are important to understand our results of operations and financial
condition;

•a description of the components of our results of operations and a discussion
of our results of operations, including an explanation of significant changes
between the periods presented in the specific line items of our statements of
operations;

•financial condition addressing our liquidity position, sources and uses of cash, capital resources and requirements, and commitments; and

•critical accounting policies and significant judgments and use of estimates which are most important to our financial condition and results of operations.



This Management's Discussion and Analysis of Financial Condition and Results of
Operations ("MD&A") should be read in conjunction with our audited consolidated
financial statements and accompanying notes included elsewhere in this Annual
Report on Form 10-K ("Annual Report"). The following discussion contains
forward-looking statements and should also be read in conjunction with the
cautionary statement set forth at the beginning of this Annual Report.

This section generally discusses our financial results for the fiscal years
ended March 31, 2022, and 2021 and comparisons between these fiscal years. A
discussion of our financial results for the fiscal year ended March 31, 2020 and
a comparison between the fiscal year ended March 31, 2021 and the fiscal year
ended March 31, 2020 that are not included in this Annual Report can be found
under Item 7 of Part II of our Annual Report on Form 10-K for the year ended
March 31, 2021, filed with the United States Securities and Exchange Commission
("SEC") on May 11, 2021, which is available free of charge on the SEC's website
at www.sec.gov and our investor relations website at investors.myovant.com.

Business Overview



We are 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, we have two FDA-approved products: (1) ORGOVYX®
(relugolix 120 mg), which was approved in the U.S. by the U.S. Food and Drug
Administration ("FDA") 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. by the FDA 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, and norethindrone
acetate 0.5 mg) as the first and only long-term, once-daily oral treatment in
the European Union ("EU") and United Kingdom ("U.K."), respectively, for
moderate to severe symptoms of uterine fibroids in adult women of reproductive
age. In April 2022, the EC approved ORGOVYX (relugolix 120 mg) as the first and
only oral androgen deprivation therapy for advanced hormone-sensitive prostate
cancer in Europe. In September 2021, the FDA accepted to review our supplemental
New Drug Application ("sNDA") for MYFEMBREE for the management of moderate to
severe pain associated with endometriosis. On May 6, 2022, we and Pfizer
announced that the FDA extended the Prescription Drug User Fee Act ("PDUFA")
goal date for this sNDA to August 6, 2022. MYFEMBREE is 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. We are 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 our inception, we have funded our operations primarily from the issuance
and sale of our common shares, from debt financing arrangements, and more
recently from the upfront and milestone payments we have received from our
collaboration and commercialization partners, as well as net revenues generated
from sales of ORGOVYX and MYFEMBREE in the U.S.,

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and to a lesser extent from revenues generated from sales of product supply to
Gedeon Richter Plc. ("Richter") as well as royalties on net sales of RYEQO in
Richter's Territory.

Our 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 March 31, 2022, Sumitovant directly, and Sumitomo Pharma indirectly, own
50,041,181, or approximately 52.8%, of our outstanding common shares.

Year Ended March 31, 2022 Financial Highlights and Recent Business Updates

In this section, we summarize certain of our year ended March 31, 2022 financial highlights and recent regulatory, clinical and business updates. Additional information about our business, our approved products, and our product candidates is included in Part I, Item 1., "Business," of this Annual Report.

Financial Highlights

•Total revenues for the year ended March 31, 2022, were $231.0 million compared to $59.3 million for the year ended March 31, 2021.



•Product revenue, net for the year ended March 31, 2022, was $94.3 million,
compared to $3.6 million for the year ended March 31, 2021. Net revenue from
sales of ORGOVYX and MYFEMBREE were $83.0 million and $6.4 million,
respectively, for the year ended March 31, 2022.

•Selling, general, and administrative ("SG&A") expenses for the year ended March
31, 2022, were $259.4 million, compared to $181.4 million for the year ended
March 31, 2021.

•Research and development ("R&D") expenses for the year ended March 31, 2022,
were $107.4 million, compared to $136.7 million for the year ended March 31,
2021.

•Net loss for the year ended March 31, 2022, was $206.0 million, or $2.22 per common share, compared to a net loss of $255.1 million, or $2.83 per common share, for the year ended March 31, 2021.

•Cash, cash equivalents, and marketable securities were $434.2 million at March 31, 2022, compared to $684.9 million at March 31, 2021.

See "Results of Operations" below for a discussion of our results of operations for the year ended March 31, 2022, as compared to the year ended March 31, 2021.



Recent Business Updates

Regulatory

•On May 6, 2022, we and Pfizer announced that the FDA extended the PDUFA goal
date to August 6, 2022 for the sNDA for MYFEMBREE for the management of moderate
to severe pain associated with endometriosis to allow time to review additional
analyses related to bone mineral density submitted in response to the FDA's
information request. No new clinical data was requested by the FDA. The
submission of the additional analyses has been determined by the FDA to
constitute a Major Amendment to the sNDA, resulting in an extension of the PDUFA
goal date.

•On April 29, 2022, the EC approved ORGOVYX as the first and only oral androgen deprivation therapy for advanced hormone-sensitive prostate cancer in Europe.



•On March 29, 2022, one of our subsidiaries, Myovant Sciences GmbH ("MSG"),
submitted an sNDA to the FDA that included the two-year data from the Phase 3
LIBERTY randomized withdrawal study.

•On July 16, 2021, the EC, and on August 9, 2021, the MHRA, approved RYEQO for
the treatment of moderate to severe symptoms of uterine fibroids in adult women
of reproductive age in the EU and U.K., respectively. RYEQO is the first and
only long-term, once-daily oral treatment for uterine fibroids with no
limitation on its duration of use approved in the EU and the U.K. Richter, our
commercialization partner for RYEQO in Europe and certain other international
markets, has launched RYEQO in 17 countries since these regulatory approvals.
The approval of RYEQO in the EU triggered a $15.0 million regulatory milestone
payment from Richter, which we received in the three months ended September 30,
2021.

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•On May 26, 2021, the FDA approved MYFEMBREE as the first and only once-daily
oral GnRH treatment for the management of heavy menstrual bleeding associated
with uterine fibroids. MYFEMBREE was launched in the U.S. for this indication by
us and our collaboration partner, Pfizer, in June 2021. The FDA approval of
MYFEMBREE for this indication triggered a $100.0 million regulatory milestone
payment from Pfizer, which we received in the three months ended September 30,
2021.

Clinical

•In October 2021, we and Pfizer presented data from clinical studies of
MYFEMBREE at the American Society for Reproductive Medicine ("ASRM") 2021
Congress, including results of the Phase 3 LIBERTY randomized withdrawal study,
which was designed to evaluate the efficacy and safety of relugolix combination
therapy for up to two years in women with heavy menstrual bleeding associated
with uterine fibroids, and was designated an ASRM Prize Paper. Additional data
presentations at the ASRM 2021 Congress included data from the SPIRIT 1 and
SPIRIT 2 studies of women with pain associated with endometriosis as well as
pooled safety and tolerability data from the LIBERTY and SPIRIT clinical
programs.

•In May 2021, the FDA informed us that they placed a partial clinical hold on
the Phase 3 SERENE study evaluating MYFEMBREE for the prevention of pregnancy,
pending certain study protocol modifications. In August 2021, the FDA informed
us that the partial clinical hold for the Phase 3 SERENE study was lifted
following study protocol amendments. The primary analysis of the study,
prevention of pregnancy, remains unchanged, but now the SERENE study will only
evaluate women with a confirmed diagnosis of uterine fibroids or endometriosis.
Bone mineral density monitoring will occur throughout the treatment period as
well as after treatment is discontinued to gain additional insights into bone
health, which will augment the safety profile observed in the LIBERTY and SPIRIT
programs. The enrollment target was increased to 1,020 patients who are 18 to 50
years of age and at risk for pregnancy, enhancing the power of the study.
Patient screening with this updated protocol began in September 2021, with
initial patients dosed in October 2021.

•Data from the SPIRIT long-term extension study demonstrated clinically
meaningful improvements in dysmenorrhea (84.8% of patients) and non-menstrual
pain (75.8% of patients) over two years in women with endometriosis-associated
pain. The safety profile during the second year of treatment, including bone
mineral density, was consistent with that observed during the first year with no
new safety signals identified.

Intellectual Property



•On June 15, 2021, the United States Patent and Trademark Office ("USPTO")
granted U.S. Patent. No. 11,033,551 to Myovant. This patent covers the unique
and innovative method of treating patients for heavy menstrual bleeding
associated with uterine fibroids with MYFEMBREE. This patent will expire in
September of 2037 and is listed in the FDA's Approved Drug Products with
Therapeutic Equivalence Evaluations (the "Orange Book"). This patent term
matches that of two methods patents (U.S. Patent. Nos. 10,786,501 and
10,449,191) previously granted by the USPTO for ORGOVYX that cover methods of
treating advanced prostate cancer with relugolix.

Business Development



•On May 5, 2022, one of our subsidiaries, MSG, entered into an exclusive license
agreement (the "Accord License Agreement") with Accord Healthcare, Ltd.
("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, with the right of first
negotiation if we decide to enter into licensing arrangements in countries in
the Middle East, Africa, and India. We are entitled to receive an upfront
payment of $50.0 million, which we expect to receive in the three months ending
June 30, 2022. We are also eligible to receive up to $90.5 million in commercial
launch, sales-based, and other milestones. In addition, we are eligible to
receive tiered royalties from the high-teens to mid-twenties on net sales of
ORGOVYX in Accord's territories. See section titled "Our Key Agreements" set
forth in Part I. Item 1. for additional information about the Accord License
Agreement.

Management and Board of Director Appointments



•Effective on November 5, 2021, Dr. Nancy Valente, M.D. was appointed by
Myovant's Board as an independent director following Ms. Kathleen Sebelius'
retirement from Myovant's Board. Dr. Valente also became a member of the Audit
Committee and the Chair of the Nominating and Corporate Governance Committee of
Myovant's Board.

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•On September 7, 2021, Uneek Mehra was appointed Chief Financial and Business
Officer of Myovant Sciences, Inc. Concurrent with this appointment, Mr. Mehra
was also appointed Principal Financial Officer of Myovant Sciences Ltd. Mr.
Mehra succeeds Frank Karbe, who left our company in August 2021.

•On April 5, 2021, we announced the appointment of Lauren Merendino as Chief Commercial Officer of Myovant Sciences, Inc.

Expected Upcoming Milestones

The following is a summary of certain of our expected upcoming milestones.



•We expect the FDA decision for the MYFEMBREE sNDA seeking approval for the
management of moderate to severe pain associated with endometriosis by its
extended PDUFA goal date of August 6, 2022. FDA approval would trigger a $100.0
million milestone payment from Pfizer. If approved by the PDUFA goal date, we
and Pfizer expect to launch MYFEMBREE in the U.S. in endometriosis in August
2022. This indication would utilize the same dosage, formulation,
administration, and branding as MYFEMBREE that was previously approved by the
FDA in May 2021 for the management of heavy menstrual bleeding associated with
uterine fibroids.

•We expect to present additional details around two-year data from the SPIRIT long-term extension study at a scientific conference in mid-calendar year 2022.



•We expect our commercialization partner, Accord, to launch ORGOVYX for the
treatment of advanced hormone-sensitive prostate cancer in Europe in the second
half of calendar year 2022.

•We expect the European Medicines Agency regulatory submission for RYEQO for the
treatment of women with endometriosis-associated pain in calendar year 2022.
Richter will be the sponsor.

•We expect to submit New Drug Submissions to Health Canada seeking marketing
approval for ORGOVYX for advanced prostate cancer, MYFEMBREE for heavy menstrual
bleeding associated with uterine fibroids, and MYFEMBREE for the treatment of
endometriosis-associated pain in Canada in calendar year 2022.

Effects of the COVID-19 Pandemic on our Business



We continue to closely monitor the impact of the COVID-19 pandemic on all
aspects of our business. Our priorities during the COVID-19 pandemic have been
to protect the health and safety of our employees, patients and healthcare
providers while continuing our mission to redefine care through differentiated
solutions in high unmet need areas within women's health and hormone-sensitive
oncology. We believe the safety measures we have taken in response to the
COVID-19 pandemic meet or exceed the guidelines established by government and
public health officials. Most of our employees worked remotely during much of
2020 and 2021, and many of our employees continue to do so on a part-time or
full-time basis, which required us to devise new ways of working and
collaborating, including adopting remote working tools to minimize the
disruption to our business activities. In April 2022, we reopened our offices,
and our employees began to return to work onsite on a voluntary basis with
specific safety protocols, including requiring vaccination as a condition of
employment, subject to medical and religious exemptions, or as required by law.
We have a distributed workforce, and our employees have become accustomed to
working remotely and working with others who are working remotely for the past
two years. However, as we reopen our offices, we may face operational or other
challenges as we and our partners, customers, suppliers, vendors and other
parties with whom we do business continue to adjust to a hybrid model of remote
and onsite work. These challenges may result in operational inefficiencies,
employee dissatisfaction, and distractions to management related to such
transition, any of which could harm our business.

As of the date of this Annual Report, we do not believe that the COVID-19
pandemic has disproportionately impacted us relative to other companies in which
we compete on our ability to advance our clinical studies, our regulatory
activities, and our U.S. commercial launch activities for ORGOVYX and MYFEMBREE.
We and our collaboration partner, Pfizer, commercially launched ORGOVYX and
MYFEMBREE in the U.S. in January 2021 and June 2021, respectively. To date, our
partner, Richter, has launched RYEQO in 17 countries.

We believe that the COVID-19 pandemic continues to have an impact on our
commercialization activities that is consistent with other companies in our
industry. As a result of the COVID-19 pandemic, there have been changes in the
practice of medical care and medical education. For example, many healthcare
providers initially expanded their utilization of telemedicine to conduct
patient visits, and in many regions of the U.S., the ability of commercial and
medical affairs field teams to call on healthcare providers was restricted or
converted to virtual access. Our oncology sales and medical affairs field teams
resumed in-person interactions with healthcare providers in January 2021 and our
women's health sales and medical affairs field teams began in-person
interactions with healthcare providers in June 2021. Despite this, some
physician's offices and many hospitals

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continue to have limited on-site access for pharmaceutical representatives in
order to reduce exposure risk for their patients or staff. Conducting these
interactions virtually could reduce the number of medical professionals we are
able to engage with, limit our ability to engage with important staff members
and virtual meetings have been shown to be less impactful than in-person
meetings. The cancellation, postponement or virtual formats for medical
conferences also limit access to physicians and reduce awareness of information
shared at conferences (medical and promotional). In response to the COVID-19
pandemic, healthcare professionals may also reduce staffing and reduce or
postpone appointments with patients, or patients may delay, cancel or miss
appointments, resulting in fewer prescriptions. Reduced access to healthcare
providers may impact or require adjustments to our planned commercialization
activities, including the manner in which our field teams engage with healthcare
providers and facilities and supplementing field activities with additional
marketing spend.

The COVID-19 pandemic also resulted in fewer opportunities for our medical
affairs team to present scientific data as multiple medical conferences were
canceled, postponed, or moved to virtual formats during 2020 and 2021, and for
our regional medical advisors to engage potential prescribers in scientific
exchange. Many conferences are planning to conduct in-person meetings in 2022,
while continuing to offer virtual participation as an option. To date, we have
not experienced supply constraints, and we believe we have procured sufficient
quantities of relugolix drug substance to meet our U.S. ORGOVYX and MYFEMBREE
launch plans.

Future developments regarding COVID-19 remain uncertain and the extent to which
the COVID-19 pandemic ultimately impacts our business, financial condition or
results of operations will depend on numerous factors, including the magnitude
and duration of the pandemic, the distribution, acceptance and effectiveness of
COVID-19 vaccines and treatments, the impact of new and potentially more
virulent or transmissible variants of the coronavirus (e.g., the Delta and
Omicron variants, respectively), the duration of governmental measures to
mitigate the pandemic and how quickly and to what extent normal economic and
operating conditions can resume, all of which remain uncertain and difficult to
predict. Additionally, even after normalcy resumes, there will likely be some
permanent changes to how healthcare is provided, how healthcare providers engage
with our industry and perhaps how conferences are conducted. None of these
changes can be anticipated at this point, nor can the potential impact on our
business. As such, it is uncertain as to the full magnitude that the COVID-19
pandemic will have on our financial condition, liquidity, and future results of
operations.

Refer to the risk factor titled "Business interruptions resulting from effects
of pandemics or epidemics, such as the COVID-19 pandemic, may materially and
adversely affect our business and financial condition," as well as other risk
factors included in the section titled "Risk Factors" set forth in Part I. Item
1A.

Effects of the Russian Federation-Ukraine Conflict on our Business



The uncertain nature, magnitude, and duration of hostilities stemming from the
conflict in Ukraine, including the potential effects of sanctions, retaliatory
cyber-attacks on the world economy and markets, and potential shipping delays,
have contributed to increased market volatility and uncertainty, which could
have an adverse impact on macroeconomic factors that affect our business. As a
result of the conflict in Ukraine, the U.S., U.K., and the EU governments, among
others, have developed and coordinated economic and financial sanctions. As the
conflict in Ukraine continues, there could be no certainty regarding whether
such governments or other governments will impose additional sanctions, or other
economic or military measures against the Russian Federation.

The impact the conflict in Ukraine, including economic sanctions or additional
war or military conflict, as well as potential responses to them by the Russian
Federation, is currently unknown and they could adversely affect our business,
supply chain, clinical studies, suppliers or customers. In addition, the
continuation of the conflict in Ukraine by the Russian Federation could lead to
other disruptions, instability and volatility in global markets and industries
that could negatively impact our operations. It is not possible to predict the
broader consequences of this conflict, which could include further sanctions,
embargoes, regional instability, geopolitical shifts and adverse effects on
macroeconomic conditions, the availability and cost of raw materials and fuel,
supplies, freight and labor, inflation, and fluctuations in currency exchange
rates, all of which could impact our business, financial condition and results
of operations.

Refer to the risk factor titled "The conflict between the Russian Federation and
Ukraine and other government policies and actions could negatively affect our
clinical trial sites in Ukraine. We and/or our collaboration partners may not be
able to launch our commercial products in the Russian Federation, Ukraine or
other regions which may negatively affect our or our collaboration partners'
financial results. The uncertain nature, magnitude, and duration of hostilities
stemming from such conflict may result in changes in the world's macroeconomic
conditions which negatively affect our business operations."

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Certain Components of our Results of Operations

Revenues



We have two FDA-approved products that generate product revenue in the U.S:
ORGOVYX and MYFEMBREE. We record product revenue net of estimated discounts,
chargebacks, rebates, product returns, and other gross-to-net revenue
deductions. For the year ended March 31, 2022, the gross-to-net deduction for
ORGOVYX was approximately 40%, and we expect it to be in the low-to-mid 40%'s
for the foreseeable future. Product revenue, net also includes revenues related
to product supply to Richter as well as royalties on net sales of RYEQO in
Richter's Territory.

Our Pfizer collaboration revenue consists of the partial recognition of the
upfront payment and of the regulatory milestone payment that was triggered upon
the FDA approval of MYFEMBREE for the management of heavy menstrual bleeding
associated with uterine fibroids.

Our Richter license and milestone revenue consists of the recognition of the
regulatory milestone payment that was triggered upon the EC approval of RYEQO
for the treatment of moderate to severe symptoms of uterine fibroids in adult
women of reproductive age and the recognition of revenue associated with upfront
and regulatory milestone payments we received from Richter pursuant to the terms
of the Richter Development and Commercialization Agreement.

See Note 13 to our audited consolidated financial statements included elsewhere in this Annual Report for additional information regarding the Pfizer Collaboration and License Agreement and the Richter Development and Commercialization Agreement.

Cost of Product Revenue



Our cost of product revenue is composed of the cost of goods sold and royalty
expense payable to Takeda. Our cost of goods sold consists of raw materials,
third-party manufacturing costs to manufacture the raw materials into finished
product, freight, and indirect overhead costs associated with sales of ORGOVYX
and MYFEMBREE in the U.S. and sales of product supply to Richter. The cost of
inventories written down as a result of excess, obsolescence, or other reasons
is also charged to cost of goods sold. Our royalty expense consists of royalties
on net sales of relugolix payable to Takeda pursuant to the terms of the Takeda
License Agreement (see Note 14(D) to our audited consolidated financial
statements included elsewhere in this Annual Report).

As a result of the FDA approvals of ORGOVYX and MYFEMBREE, we subsequently began
capitalizing inventories manufactured or purchased for each product after its
respective approval date. As a result, we expensed certain manufacturing costs
of ORGOVYX and MYFEMBREE as R&D expenses prior to FDA approval and, therefore,
these costs are not included in cost of goods sold.

Collaboration Expense to Pfizer

Our collaboration expense to Pfizer consists of Pfizer's 50% share of net profits from sales of ORGOVYX and MYFEMBREE in the U.S. (see Note 13(B) to our audited consolidated financial statements included elsewhere in this Annual Report).

Selling, General and Administrative Expenses



Our SG&A expenses consist primarily of personnel costs, including salaries,
sales incentive compensation, bonuses, fringe benefits, and share-based
compensation for our executive, finance, human resources, legal, information
technology, commercial operations, marketing, market access, sales, and other
administrative functions. Our SG&A expenses also include marketing programs,
patient assistance and support programs for qualified uninsured and underinsured
patients, promotion and advertising, conferences, congresses, travel expenses,
professional fees for legal, accounting, auditing and tax services, and costs
related to rent and facilities, insurance, information technology, commercial
operations, and general overhead. Our SG&A expenses also include related party
expenses pursuant to our agreements with Sunovion and Sumitovant (see Note 6 to
our audited consolidated financial statements included elsewhere in this Annual
Report).

SG&A expenses in fiscal year 2022 are expected to increase as compared to fiscal
year 2021 due to increased marketing and promotional expenses to support the
ongoing commercialization of ORGOVYX and MYFEMBREE in the U.S., including
annualization of the MYFEMBREE marketing and promotional spend and targeted
patient activation for both brands. The timing and magnitude of our SG&A
expenses are primarily dependent on our commercial success and sales growth of
ORGOVYX and MYFEMBREE, as well as the timing of any new indications or product
launches and other potential business and operational activities. We expect that
certain SG&A expenses will be shared equally with Pfizer pursuant to the Pfizer
Collaboration and License Agreement (see Note 13(B) to our audited consolidated
financial statements included elsewhere in this Annual Report).

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Research and Development Expenses



R&D activities have been, and will continue to be, central to our business
model. Our R&D expenses to date have been primarily attributable to the clinical
development of our product candidates including the conduct of multiple Phase 3
and earlier clinical studies, the expansion of our team, and the initiation of
activities in preparation for our anticipated commercial launches such as the
establishment of our medical affairs function, as well as regulatory and certain
manufacturing activities. Our R&D expenses include program-specific costs, as
well as costs that are not allocated to a specific program.

Our program-specific costs primarily include third-party costs, which include
expenses incurred under agreements with CROs and CMOs, the cost of consultants
who assist with the development of our product candidates on a program-specific
basis, investigator grants, sponsored research, manufacturing costs in
connection with producing materials for use in conducting nonclinical and
clinical studies, as well as costs related to pre-commercial manufacturing
activities and regulatory submissions, and other third-party expenses directly
attributable to the development of our product candidates.

Our unallocated R&D costs primarily include employee-related expenses, such as
salaries, share-based compensation, fringe benefits and travel for employees
engaged in R&D activities including clinical operations, biostatistics,
regulatory, and medical affairs, and the cost of contractors and consultants who
assist with R&D activities not specific to a program, and costs associated with
nonclinical studies.

The duration, costs and timing of clinical studies and development of our
product candidates will depend on a variety of factors that include, but are not
limited to: the number of studies required for approval; the per patient study
costs; the number of patients who participate in the studies; the number of
sites included in the studies; the countries in which the studies are conducted;
the length of time required to recruit and enroll eligible patients; the number
of patients who fail to meet the study's inclusion and exclusion criteria; the
number of study drug doses that patients receive; the drop-out or
discontinuation rates of patients; the potential additional safety monitoring or
other studies requested by regulatory agencies; the duration of patient
follow-up; the timing and receipt of regulatory approvals; the costs of clinical
study materials; and the efficacy and safety profile of the product candidate.

In addition, the probability of commercial success for ORGOVYX, MYFEMBREE or for
any of our current or potential future product candidates, if approved, will
depend on numerous factors, including competition, manufacturing capability and
commercial viability. Our R&D activities may be subject to change from time to
time as we evaluate our priorities and available resources.

We expect our R&D expenses in fiscal year 2022 to increase as compared to fiscal
year 2021, driven largely by spending on relugolix lifecycle opportunities, such
as the Phase 3 SERENE study, as well as on post-marketing requirements as agreed
upon with the FDA. We expect that certain R&D expenses will be shared equally
with Pfizer pursuant to the Pfizer Collaboration and License Agreement (see Note
13(B) to our audited consolidated financial statements included elsewhere in
this Annual Report).

Interest Expense

Our interest expense consists of related party interest expense pursuant to the
Sumitomo Pharma Loan Agreement, which bears 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 (see Note 6(A) to our audited consolidated financial statements
included elsewhere in this Annual Report), and the accretion of the financing
component of the cost share advance from Pfizer (see Note 13(B) to our audited
consolidated financial statements included elsewhere in this Annual Report).
Fluctuations in 3-month LIBOR could negatively impact our financial results.

Interest Income

Our interest income consists primarily of interest earned and the accretion of discounts to maturity for cash equivalents and marketable securities.

Foreign Exchange Gain



Our foreign exchange gain for the year ended March 31, 2021, consists of the
impact of changes in foreign currency exchange rates on our foreign exchange
denominated liabilities, relative to the U.S. dollar. The impact of foreign
currency exchange rates on our results of operations fluctuates period over
period based on our foreign currency exposures resulting from changes in
applicable exchange rates associated with our foreign denominated liabilities.
Our primary foreign currency exposure has historically been the exchange rate
between the Swiss franc and the U.S. dollar.

In December 2020, we changed the functional currency of our wholly-owned
subsidiary in Switzerland, MSG, from the Swiss franc to the U.S. dollar. This
change in functional currency was accounted for prospectively. As a result of
this change, we

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currently expect that future impacts of changes in foreign currency exchange
rates on our results of operations will not be significant. See Note 2 to our
audited consolidated financial statements included elsewhere in this Annual
Report.

Results of Operations

The following table summarizes our results of operations for the years ended March 31, 2022, and 2021 (in thousands):



                                                         Year Ended March 31,
                                                                         2022            2021
     Revenues:
     Product revenue, net                                            $   94,309      $    3,630
     Pfizer collaboration revenue

104,996 22,354


     Richter license and milestone revenue

31,667 33,333


     Total revenues

230,972 59,317

Operating costs and expenses:


     Cost of product revenue                                             11,510             301
     Collaboration expense to Pfizer                                     40,041           1,664
     Selling, general and administrative

259,364 181,423


     Research and development

107,403 136,713


     Total operating costs and expenses                                 418,318         320,101
     Loss from operations                                              (187,346)       (260,784)
     Interest expense                                                    13,971          10,401
     Interest income                                                       (384)           (211)
     Foreign exchange gain                                                    -         (16,176)
     Loss before income taxes                                          (200,933)       (254,798)
     Income tax expense                                                   5,048             336
     Net loss                                                        $ (205,981)     $ (255,134)


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Revenues

The following table provides information about our revenues for the years ended March 31, 2022, and 2021 (in thousands):




                                            Year Ended March 31,
                                             2022            2021
Revenues:
Product revenue, net:
ORGOVYX                                 $     82,959      $  3,630
MYFEMBREE                                      6,355             -
Richter product supply and royalties           4,995             -
Total product revenue, net                    94,309         3,630
Pfizer collaboration revenue:
Amortization of upfront payment               83,897        22,354
Amortization of regulatory milestone          21,099             -
Total Pfizer collaboration revenue           104,996        22,354

Richter license and milestone revenue 31,667 33,333 Total revenues

$    230,972      $ 59,317


We began generating product revenue from sales of ORGOVYX and MYFEMBREE in the
U.S. in January 2021 and June 2021, respectively. We record product revenue net
of estimated discounts, chargebacks, rebates, product returns, and other
gross-to-net revenue deductions. There was no product revenue from sales of
MYFEMBREE for the year ended March 31, 2021

For the year ended March 31, 2022, product revenue, net also includes revenues
related to product supply to Richter to support their European launches of RYEQO
of $4.7 million, as well as royalties on net sales of RYEQO in Richter's
Territory of $0.3 million. There were no such revenues for the year ended March
31, 2021.

Pfizer collaboration revenue for the year ended March 31, 2022, consists of the
partial recognition of the upfront payment we 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. Pfizer collaboration revenue for the year
ended March 31, 2021, consists of the partial recognition of the upfront payment
received from Pfizer.

Richter license and milestone revenue for the year ended March 31, 2022 was
$31.7 million, consisting of the recognition of a $15.0 million regulatory
milestone payment from Richter that was triggered upon the EC approval of RYEQO
for the treatment of moderate to severe symptoms of uterine fibroids in adult
women of reproductive age and $16.7 million of previously deferred revenue that
was recognized upon the completion of our delivery of the remaining substantive
relugolix combination tablet data packages to Richter. Richter license and
milestone revenue for the year ended March 31, 2021, consists of the recognition
of $33.3 million of the upfront and regulatory milestone payments we received
from Richter in March 2020 and April 2020, respectively.

Product revenue, net by geography for the years ended March 31, 2022 and 2021 consisted of the following (in thousands):



                                    Year Ended March 31,
                                     2022              2021
United States                 $     89,314           $ 3,630
Europe                               4,995                 -
Total product revenue, net    $     94,309           $ 3,630


For the year ended March 31, 2022, compared to the year ago period, product
revenue, net in the U.S. increased by $85.7 million as a result of higher
ORGOVYX net revenues, as well as net revenues generated from sales of MYFEMBREE,
for which there were no such MYFEMBREE net revenues for the year ended March 31,
2021.

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For the year ended March 31, 2022, product revenue, net in Europe consisted of
revenues related to product supply to Richter to support their European launches
of RYEQO of $4.7 million, as well as royalties on net sales of RYEQO in
Richter's Territory of $0.3 million. There were no such revenues for the year
ended March 31, 2021.

Cost of Product Revenue

For the year ended March 31, 2022, our cost of product revenue was $11.5
million, consisting of $4.6 million of cost of goods sold and $6.9 million of
royalty expense to Takeda. For the year ended March 31, 2021, our cost of
product revenue was $0.3 million, which consisted primarily of royalty expense
to Takeda. The $11.2 million increase in our cost of product revenue for the
year ended March 31, 2022 compared to the year ago period was due to an increase
in cost of goods sold and royalty expense to Takeda as a result of higher sales
of ORGOVYX during the year ended March 31, 2022, as well as sales of MYFEMBREE
in the U.S., which began in the three months ended June 30, 2021, and sales of
product supply to Richter that began in the three months ended September 30,
2021.

As a result of the FDA approvals of ORGOVYX and MYFEMBREE, we subsequently began
capitalizing the cost of inventories manufactured or purchased for each product
after its respective approval date. Previously, costs to manufacture ORGOVYX and
MYFEMBREE were expensed as incurred as R&D expenses. We expect our cost of goods
sold to increase in future periods as quantities of previously expensed ORGOVYX
and MYFEMBREE inventories are depleted from our inventory stock.

Collaboration Expense to Pfizer



For the years ended March 31, 2022, and 2021, our collaboration expense to
Pfizer was $40.0 million and $1.7 million, respectively, and represents Pfizer's
50% share of net profits from the sales of ORGOVYX and MYFEMBREE in the U.S.
Collaboration expense to Pfizer increased by approximately $38.4 million for the
year ended March 31, 2022, compared to the year ago period, primarily due to an
increase in net profits generated from sales of ORGOVYX in the U.S., as well as
net profits generated from sales of MYFEMBREE in the U.S., for which there were
no such MYFEMBREE net profits in the year ended March 31, 2021.

Selling, General and Administrative Expenses



SG&A expenses increased $77.9 million, to $259.4 million, in the year ended
March 31, 2022 compared to $181.4 million in the year ago period, primarily due
to higher costs related to commercial activities to support our U.S launches of
ORGOVYX and MYFEMBREE. SG&A expenses are presented net of cost sharing with
Pfizer pursuant to the terms of the Pfizer Collaboration and License Agreement.

The most significant components of the $77.9 million net increase in SG&A expenses include the following:



•$58.2 million increase in personnel expense primarily driven by costs
associated with our commercial operations, marketing, and market access teams,
and our oncology and women's health sales forces, which were hired to support
our U.S. commercial launches of ORGOVYX and MYFEMBREE;

•$21.4 million increase in commercial operations expenses, net of cost sharing with Pfizer, to support our U.S. commercial launches of ORGOVYX and MYFEMBREE;

•$13.4 million increase in general overhead, administrative and information technology expenses to support our organizational growth; partially offset by



•$16.7 million decrease in shared-based compensation, as the year ended March
31, 2021 included incremental share-based compensation related to the
acceleration, modification, and remeasurement of our former Principal Executive
Officer's equity awards as further discussed in Note 10(H) to our audited
consolidated financial statements included elsewhere in this Annual Report.

Research and Development Expenses


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For the years ended March 31, 2022, and 2021, our R&D expenses consisted of the following (in thousands):



                               Year Ended March 31,
                               2022            2021          Change
Program-specific costs:
Relugolix                  $    20,549      $  59,835      $ (39,286)
MVT-602                            318            241             77
Unallocated costs:
Personnel expenses              57,522         48,460          9,062

Share-based compensation 16,010 14,049 1,961 Other expense

                   13,004         14,128         (1,124)

Total R&D expenses $ 107,403 $ 136,713 (29,310)




R&D expenses decreased $29.3 million, to $107.4 million, in the year ended March
31, 2022, compared to $136.7 million in the year ended March 31, 2021. The most
significant components of the $29.3 million net decrease in R&D expenses include
the following:

•$39.2 million decrease in program-specific costs related to CRO, drug supply
and other study, regulatory, and manufacturing-related costs primarily due to
the wind down of our Phase 3 LIBERTY, HERO and SPIRIT studies and higher cost
sharing with Pfizer for certain R&D expenses in the year ended March 31, 2022.
In addition, program-specific costs for the year ended March 31, 2021, include
fees of approximately $5.8 million related to our initial NDA submissions for
MYFEMBREE for the management of heavy menstrual bleeding associated with uterine
fibroids and ORGOVYX for adult patients with advanced prostate cancer, which did
not recur during the year ended March 31, 2022; partially offset by

•$11.0 million increase in personnel expenses and share-based compensation
primarily due to an increase in medical affairs and other personnel to support
the U.S. launches of ORGOVYX and MYFEMBREE.

Interest Expense



Interest expense was $14.0 million and $10.4 million for the years ended March
31, 2022, and 2021, respectively, and was primarily related to the Sumitomo
Pharma Loan Agreement. Interest expense for the years ended March 31, 2022, and
2021 also includes $2.4 million and $0.6 million, respectively, of accretion of
the financing component of the cost share advance from Pfizer. The increase in
interest expense was primarily driven by a higher outstanding balance under the
Sumitomo Pharma Loan Agreement during year ended March 31, 2022, as well as
higher accretion of the financing component of the cost share advance from
Pfizer, which began in the fourth quarter of the year ended March 31, 2021.

Interest Income



Interest income was approximately $0.4 million and $0.2 million for the years
ended March 31, 2022, and 2021, respectively, derived from our investments in
marketable securities and cash equivalents.

Foreign Exchange Gain



For the year ended March 31, 2021, we recorded a foreign exchange gain of $16.2
million, primarily as a result of the impact of fluctuations in the foreign
currency exchange rate between the Swiss franc and the U.S. dollar on our
outstanding balance under the Sumitomo Pharma Loan Agreement. There were no such
amounts for the year ended March 31, 2022.

Income Tax Expense



Our income tax expense was $5.0 million and $0.3 million for the years ended
March 31, 2022, and 2021, respectively. Our effective tax rate for the years
ended March 31, 2022, and 2021 was (2.51)% and (0.13)%, respectively, and is
driven by our jurisdictional earnings by location and a valuation allowance that
eliminates our global net deferred tax assets. The increase in income tax
expense was primarily driven by income earned by the Company's U.S. entity,
Myovant Sciences, Inc.

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Liquidity and Capital Resources



We have incurred losses since our inception and have an accumulated deficit of
$1.25 billion as of March 31, 2022, compared to $1.05 billion as of March 31,
2021.

Sources of Liquidity

Since our inception, we have funded our operations primarily from the issuance
and sale of our common shares, from debt financing arrangements, and more
recently from upfront and milestone payments we have received from Pfizer and
Richter, as well as net revenues generated from sales of ORGOVYX and MYFEMBREE
in the U.S. We began generating net product revenue from sales of ORGOVYX and
MYFEMBREE in the U.S. in January 2021 and June 2021, respectively.

As of March 31, 2022, we had cash, cash equivalents, marketable securities, and
amounts available to us under the Sumitomo Pharma Loan Agreement of $475.5
million, consisting of $434.2 million of cash, cash equivalents, and marketable
securities and $41.3 million of borrowing capacity available to us under the
Sumitomo Pharma Loan Agreement. We maintain our cash deposits and cash
equivalents in highly-rated, federally-insured financial institutions in excess
of federally insured limits. We have established guidelines relative to
diversification and maturities with respect to our marketable securities to
maintain safety and liquidity. Additional funds under the Sumitomo Pharma Loan
Agreement may be drawn down by us no more than once per calendar quarter,
subject to certain terms and conditions, including consent of our board of
directors.

We are eligible to earn additional payments from our collaboration and commercialization partners, including:



•up to $3.6 billion of additional milestone payments from Pfizer, including a
regulatory milestone of $100.0 million upon the FDA approval of MYFEMBREE for
endometriosis, 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. We and Pfizer equally share
profits and certain expenses in the Co-Promotion Territory;

•up to $122.5 million of additional milestone payments, including regulatory
milestones of up to $15.0 million and tiered sales milestones of up to $107.5
million upon reaching certain thresholds of annual net sales in Richter's
Territory, and tiered royalties on net sales in Richter's Territory; and

•an upfront payment of $50.0 million from Accord, which we expect to receive in the three months ending June 30, 2022, additional commercial launch, sales-based, and other milestones totaling up to $90.5 million, and tiered royalties from the high-teens to mid-twenties on net sales of ORGOVYX in Accord's territories.

Funding Requirements



We believe that our existing cash, cash equivalents, and marketable securities
will be sufficient to fund our anticipated operating expenses and capital
expenditure requirements for at least the next 12 months from the date of
issuance of this Annual Report. This estimate is based on our current
assumptions, including assumptions related to our ability to manage our spend,
that might prove to be wrong, and we could use our available capital resources
sooner than we currently expect. In future periods, if our cash, cash
equivalents, marketable securities, and amounts that we expect to generate from
product sales and/or third-party collaboration payments, are not sufficient to
enable us to fund our operations, we may need to raise additional funds in the
form of equity, debt, or from other sources. In addition, we may choose to raise
additional funds in the form of equity, debt, or from other sources due to
market conditions or strategic considerations even if we believe we have
sufficient funds for our current and future operating plans. To the extent that
we raise additional capital through the sale of equity or convertible debt
securities, our common shareholders' ownership interest may experience
substantial dilution, and the terms of these securities may include liquidation
or other preferences that adversely affect our common shareholders' rights. The
Sumitomo Pharma Loan Agreement involves, and any agreements for future debt or
preferred equity financings, if available, may involve, covenants limiting or
restricting our ability to take specific actions, such as incurring additional
debt, raising capital through equity offerings, making capital expenditures or
declaring dividends.

We expect our operating expenses, net of costs that are expected to be shared
with Pfizer pursuant to the Pfizer Collaboration and License Agreement, to
increase as we continue to commercialize ORGOVYX and MYFEMBREE in the U.S.,
prepare for additional potential regulatory approvals, initiate life cycle
management activities as well as conduct post-marketing requirements as agreed
upon with the FDA for our relugolix franchise, and potentially further develop
our product candidates and expand our pipeline. However, while we expect our
future capital requirements and operating expenses to continue to be
significant, we expect our net cash burn to gradually decrease as our net
product revenues increase. Our operating expenses and

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operating cash flows may fluctuate significantly from quarter-to-quarter and
year-to-year and our future funding requirements, both near and long-term, will
depend on many factors, including, but not limited to:

•the price, level of demand and net product revenues generated from commercial sales of our drug products and from any product candidates that may receive marketing approval in the future;

•the achievement of regulatory milestones, sales milestones, and/or royalties that we are eligible to earn pursuant to our collaboration and license agreements;



•the timing, shared costs, and level of investment in our and our collaboration
partners' activities related to sales, marketing, market access, manufacturing,
and distribution for our drug products and for any product candidates that may
receive marketing approval in the future;

•the timing, shared costs, and level of investment in our and our collaboration partners' research and development activities involving ORGOVYX, MYFEMBREE, RYEQO, and any product candidates;

•costs, timing, and outcomes of regulatory submissions and regulatory reviews of our product candidates;

•costs to expand our chemistry, manufacturing, and control and other manufacturing related activities;

•costs to identify, acquire, develop, and commercialize additional product candidates;

•costs to integrate acquired technologies into a comprehensive regulatory and product development strategy;

•costs to maintain, expand, and protect our patent claims and other intellectual property rights;



•costs to hire additional commercial operations, sales and marketing,
scientific, clinical, regulatory, quality, and other personnel to support our
commercialization, sales and marketing, regulatory, and clinical development
efforts;

•costs to implement or enhance operational, accounting, finance, quality, commercial, and management information systems;

•costs to service our debt obligations and associated interest payments; and

•costs to operate as a public company.



Until such time, if ever, as we can generate positive cash flows as a result of
increased sales of ORGOVYX, MYFEMBREE, or any product candidate, we expect to
fund our operations through a combination of cash, cash equivalents, and
marketable securities currently on hand and amounts available to us under the
Sumitomo Pharma Loan Agreement, subject to the consent of our board of
directors, as well as potential payments we are eligible to receive from Pfizer,
Richter, and Accord pursuant to the terms of our agreements with them.

Cash Flows

The following table summarizes our cash flows for the years ended March 31, 2022, and 2021 (in thousands):



                                                          Year Ended March

31,

2021

Net cash (used in) provided by operating activities $ (268,559) $ 370,628 Net cash used in investing activities

$   (18,022)     $

(9,211)


Net cash provided by financing activities             $    25,905      $ 238,045


Operating Activities

Net cash used in operating activities was $268.6 million for the year ended
March 31, 2022, and consisted of our net loss of $206.0 million (see "Results of
Operations" above) and changes in operating assets and liabilities of $107.0
million (see below), partially offset by adjustments for non-cash operating
items of $44.4 million. The non-cash operating items included share based
compensation of $38.9 million, accretion of the implied financing component of
the cost share advance from Pfizer of $2.4 million, amortization of operating
lease right of use asset of $1.7 million, and depreciation expense of $1.4
million.

The changes in operating assets and liabilities included the following:

•$90.5 million decrease in cost share advance from Pfizer due to the application of shared Allowable Expenses (see Note 13(C) to our audited consolidated financial statements included elsewhere in this Annual Report);


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•$30.6 million increase in amounts due to Pfizer as a result of an increase in
profit share and reimbursement of Allowable Expenses incurred by Pfizer (see
Note 13(B) to our audited consolidated financial statements included elsewhere
in this Annual Report);

•$21.7 million net decrease in deferred revenue as a result of the recognition
of $105.0 million of Pfizer collaboration revenue and $16.7 million of Richter
license and milestone revenue, partially offset by a $100.0 million regulatory
milestone payment from Pfizer (see Note 13 to our audited consolidated financial
statements included elsewhere in this Annual Report);

•$24.0 million increase in accrued expenses and other current liabilities, primarily driven by increases in accrued sales discounts, rebates, and allowances due to an increase in product revenue, net, accrued compensation-related expenses, and accrued royalties payable to Takeda, partially offset by a decrease in accrued R&D expenses;

•$19.7 million increase in accounts receivable, net as a result of an increase in net product revenues, mainly driven by sales of ORGOVYX in the U.S.;

•$9.0 million increase in prepaid expenses and other current assets primarily due to prepayments related to commercial manufacturing activities;



•$6.4 million increase in other assets primarily due to prepayments related to
commercial manufacturing activities, partially offset by a reduction in prepaid
clinical study costs;

•$5.6 million decrease in accounts payable, primarily driven by the timing of vendor invoice payments;

•$5.0 million increase in inventories, driven by the capitalization of inventory manufactured or purchased after the FDA approvals of ORGOVYX and MYFEMBREE; and

•$3.8 million net change in other operating assets and liabilities.



Net cash provided by operating activities was $370.6 million for the year ended
March 31, 2021, and consisted of changes in operating assets and liabilities of
$584.6 million (see below), partially offset by our net loss of $255.1 million
(primarily due to our ongoing development and clinical studies, activities
related to our preparation for potential regulatory approvals and
commercialization of our product candidates, and the expansion of our company),
adjusted for non-cash operating items of $41.2 million. The non-cash operating
items included share-based compensation of $53.7 million (which included
$25.7 million related to the acceleration, modification, and remeasurement of
our former Principal Executive Officer's equity awards), foreign currency
transaction gain of $16.2 million primarily related to the Sumitomo Pharma debt
outstanding, and other items of $3.7 million.

The changes in operating assets and liabilities included the following:



•$457.9 million net increase in deferred revenue, which was driven by the
upfront payment of $503.6 million received from Pfizer in December 2020
(including a $3.6 million implied financing component of a cost share advance)
and a regulatory milestone payment of $10.0 million received from Richter in
April 2020, partially offset by the recognition of $33.3 million of Richter
license and milestone revenue and $22.4 million of Pfizer collaboration revenue
(see Note 13 to our audited consolidated financial statements included elsewhere
in this Annual Report);

•$121.2 million net increase in cost share advance from Pfizer, consisting of
the cost share advance received from Pfizer of $150.0 million (discounted to a
present value of $146.4 million), partially offset by the application of $25.2
million of shared Allowable Expenses (see Note 13(B) to our audited consolidated
financial statements included elsewhere in this Annual Report);

•$15.6 million increase in accrued expenses and other current liabilities primarily due to an increase in accrued commercial and compensation-related expenses, partially offset by a decrease in accrued R&D expenses; and



•$10.1 million net change in other operating assets and liabilities primarily
related to increases in accounts receivable, inventories, and prepaid expenses
and other current assets, partially offset by an increase in accounts payable.

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Investing Activities



For the year ended March 31, 2022, we used $18.0 million of cash in investing
activities, of which $17.0 million was for the purchase of marketable
securities, net of maturities, and $1.0 million was for the purchase of property
and equipment.

For the year ended March 31, 2021, we used $9.2 million of cash in investing
activities, of which $7.4 million was for the purchase of marketable securities,
net of maturities and sales, and $1.8 million was for the purchase of property
and equipment.

Financing Activities

For the year ended March 31, 2022, $25.9 million of cash was provided by financing activities, which was primarily due to proceeds of $24.6 million from the exercise of stock options.

For the year ended March 31, 2021, $238.0 million of cash was provided by financing activities. This was primarily due to proceeds of $245.0 million borrowed under the Sumitomo Pharma Loan Agreement and proceeds of $6.7 million from the exercise of stock options, partially offset by payment of tax withholding obligations on net settlement of share awards of $13.7 million.

Contractual Obligations and Other Cash Needs



We have entered into arrangements that contractually obligate us to make
payments that will affect our liquidity and cash flows in future periods. Our
most significant contractual obligations as of March 31, 2022 are summarized
below.

Sumitomo Pharma Loan Agreement



We, and one of our subsidiaries, MSG, entered into a loan agreement with
Sumitomo Pharma on December 27, 2019, pursuant to which Sumitomo Pharma agreed
to make revolving loans to us in the aggregate principal amount of up to $400.0
million. As of March 31, 2022, the outstanding loan balance was $358.7 million
and $41.3 million of borrowing capacity remains available to us, subject to the
terms of the Sumitomo Pharma Loan Agreement. 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 our outstanding
common shares, it may become unlawful under Japanese law for Sumitomo Pharma to
fund loans to us, and in which case we 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.
See Note 6(A) to our audited consolidated financial statements included
elsewhere in this Annual Report for additional information about the Sumitomo
Pharma Loan Agreement.

Operating Leases

We have certain lease agreements for office space under which we are obligated
to make minimum lease payments. As of March 31, 2022, we had $3.1 million of
minimum lease payments due in one year and $8.4 million due over the remaining
lease terms. See Note 12 to our audited consolidated financial statements
included elsewhere in this Annual Report for additional information about our
operating leases.

Contingent Payments

Pursuant to the Takeda License Agreement, we have committed to paying 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 our territory, all
subject to certain agreed reductions. We cannot, at this time, determine when or
if royalty payments will be required or what the total amount of such payments
may be. See Note 14(D) to our audited consolidated financial statements included
elsewhere in this Annual Report for additional information about the Takeda
License Agreement.

Contract Service Providers



In the normal course of business, we enter into agreements with certain vendors
for the provision of goods and services, which includes manufacturing services
with CMOs, development services with respect to CROs, and other services and
products for operating purposes. These agreements may include certain provisions
for purchase obligations and termination obligations that could require payment
for the cancellation of committed purchase obligations or for early termination
of the agreements. The amounts of the cancellation or termination payments vary
and are based on the timing of the cancellation or termination and the specific
terms of the agreements and are considered cancellable contracts.

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Critical Accounting Policies and Significant Judgments and Estimates



Our management's discussion and analysis of our financial condition and results
of operations is based on our audited consolidated financial statements, which
have been prepared in accordance with U.S. generally accepted accounting
principles ("U.S. GAAP"). The preparation of these audited consolidated
financial statements requires us to make estimates, judgments and assumptions
that affect the reported amounts of assets, liabilities, revenues and expenses,
and disclosures of contingent liabilities. We have based our estimates on
historical experience and on various other assumptions that we believe to be
reasonable under the circumstances. Management periodically reviews our
estimates and makes adjustments when facts and circumstances dictate. To the
extent there are material differences between these estimates and actual
results, our financial condition or results of operations will be affected.
Changes in estimates and assumptions are reflected in reported results in the
period in which they become known.

An accounting policy is considered to be critical if it requires an accounting
estimate to be made based on assumptions about matters that are highly uncertain
at the time the estimate is made, and if different estimates that reasonably
could have been used, or changes in the accounting estimates that are reasonably
likely to occur periodically, could materially impact the consolidated financial
statements.

While our significant accounting policies are described in more detail in Note 2
to our audited consolidated financial statements included elsewhere in this
Annual Report, we believe the that the following accounting policies are those
most critical to the judgments and estimates used in the preparation of our
consolidated financial statements.

Revenue Recognition



Under Accounting Standards Codification 606, Revenue from Contracts with
Customers, or ASC 606, we recognize revenue when our customers obtain control of
promised goods or services, in an amount that reflects the consideration that we
expect to receive in exchange for those goods or services. To determine revenue
recognition for arrangements that have been determined to be within the scope of
ASC 606, we perform the following five steps: (i) identify the contract(s) with
a customer; (ii) identify the performance obligations in the contract; (iii)
determine the transaction price; (iv) allocate the transaction price to the
performance obligations in the contract; and (v) recognize revenue when (or as)
we satisfy a performance obligation. We only apply the five-step model to
contracts when it is probable that we will collect the consideration we are
entitled to in exchange for the goods or services we transfer to the customer.

Once the contract is determined to be within the scope of ASC 606, we assess the
goods or services promised within each contract and determine those that are
performance obligations, and assess whether each promised good or service is
distinct. We then recognize as revenue the amount of the transaction price that
is allocated to the respective performance obligation when (or as) the
performance obligation is satisfied.

Product Revenue, Net



We sell our products in the U.S. principally through wholesale and specialty
distribution and pharmacy channels (collectively, "customers"). These customers
subsequently resell our products to healthcare providers and patients. In
addition to distribution agreements with customers, we enter into arrangements
with healthcare providers and payors that provide for government-mandated and/or
privately-negotiated rebates, chargebacks, and discounts with respect to the
purchase of our products. We recognize revenue from product sales when our
customer obtains control of our products, which occurs at a point in time,
typically upon delivery to the customer.

We record revenues from product sales at the net sales price, or transaction
price, which includes estimates of variable consideration for which reserves are
established that result from (a) invoice discounts for prompt payment and
specialty distributor and specialty pharmacy service fees, (b) government and
private payer rebates, chargebacks, discounts and fees, (c) group purchasing
organization ("GPO") discounts, performance rebates and administrative fees, (d)
product returns and (e) costs of co-pay assistance programs for patients
(collectively, "sales deductions"). The variability in the net transaction price
for our products arises primarily from the aforementioned sales deductions. We
use significant judgment in estimating certain sales deductions. Where
appropriate, we utilize the expected value method to determine the appropriate
amount for estimates of variable consideration. The estimates of reserves
established for variable consideration reflect current contractual and statutory
requirements, our historical experience, specific known market events and
trends, industry data and forecasted customer buying and payment patterns. The
amount of variable consideration that is included in the transaction price may
be constrained and is included in net product revenues only to the extent that
it is probable that a significant reversal in the amount of the cumulative
revenue recognized will not occur in a future period. Actual amounts of
consideration ultimately received may differ from our estimates. If actual
results vary from our estimates, we adjust these estimates, which would affect
net product revenue and earnings in the period such variances become known.

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More specifically, our significant adjustments include the following:



•Prompt Pay Discounts: We generally provide our customers with prompt payment
discounts that are explicitly stated in the contracts and are recorded as a
reduction of gross product revenues and accounts receivable in the period the
related product revenue is recognized. Our provision for cash discounts was $2.4
million for the year ended March 31, 2022. A hypothetical 10% change in our cash
discount provision would have had an approximate $0.2 million impact on our net
revenue for the year ended March 31, 2022.

•Product Returns: We estimate the amount of our product sales that may be
returned by our customers and record this estimate in the period the related
product revenue is recognized. We estimate product return liabilities based on
historical product returns, the underlying product demand, and industry specific
data. Our provision for product returns was $2.9 million for the year ended
March 31, 2022. A hypothetical 10% change in our product return provision would
have had an approximate $0.3 million impact on our net revenue for the year
ended March 31, 2022.

•Chargebacks: Chargebacks for discounts represent our estimated obligations
resulting from contractual commitments to sell product to Public Health Service
institutions, Federal government entities purchasing via the Federal Supply
Schedule, GPOs, and health maintenance organizations at a discounted price. The
specialty distributor, in turn, charges back to us the difference between the
price initially paid by the specialty distributor and the discounted price paid
to the specialty distributor by the customer. The allowance for chargebacks is
based on actual chargebacks received and an estimate of sales to contracted
customers. Our provision for chargebacks was $13.4 million for the year ended
March 31, 2022. A hypothetical 10% change in our chargeback provision would have
had an approximate $1.3 million impact on our net revenue for the year ended
March 31, 2022.

•Rebates: Rebates consist of the Medicaid Drug Rebate Program and the Medicare
Part D prescription drug benefit. These reserves are recorded in the same period
the related revenue is recognized. Rebates are amounts owed after the final
dispensing of the product to a benefit plan participant and are based upon
contractual agreements with, or statutory requirements pertaining to, Medicaid
and Medicare benefit providers. The allowance for rebates is based on statutory
discount rates, estimate payor mix, and expected utilization. Our estimates for
expected utilization of rebates are based on historical data received from
specialty pharmacies and specialty distributors since launch, as well as analog
data for similar products. We monitor sales trends and adjust the allowance on a
regular basis to reflect the most recent rebate experience. Our liability for
these rebates consists of invoices received for claims for prior quarters that
have not been paid or for which an invoice has not yet been received, estimates
of claims for the current quarter, and estimated future claims that will be made
for our products that has been recognized as revenue, but remains in the
distribution channel inventories at the end of each reporting period. Our
provision for rebates was $33.4 million for the year ended March 31, 2022. A
hypothetical 10% change in our rebate provision would have had an approximate
$3.3 million impact on our net revenue for the year ended March 31, 2022.

•Co-payment Assistance: We offer co-payment assistance to commercially insured
patients meeting certain eligibility requirements. Co-payment assistance is
accrued based on actual program participation and estimates of program
redemption using data provided by third-party administrators. Our provision for
co-payment assistance was $5.5 million for the year ended March 31, 2022. A
hypothetical 10% change in our co-payment assistance provision would have had an
approximate $0.6 million impact on our net revenue for the year ended March 31,
2022.

•Customer Fees: We pay fees to our customers for account management, data management, and other administrative services. To the extent the services received are distinct from sales of products to the customer, we record these payments in SG&A expenses.



We have adjusted our allowances in the past based on actual experience, and we
may be required to adjust these allowances and accruals in the future. The
historical adjustments have not been significant to our operations. We
continually monitor our allowances and accruals and make adjustments when we
believe actual experience may differ from our estimates.

The following table provides a summary of activity for each significant category of discounts and allowances for the year ended March 31, 2022 (in thousands).


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                               Reserve
                           -government and           Chargebacks and
                           other incentives        administrative fees         Returns          Sales discounts            Total
Balance as of March 31,
2021                      $           843          $             363          $   109          $            79          $  1,394
Provision related to
sales in the current year          38,910                     13,384            2,919                    2,377            57,590
Adjustments related to
prior year sales                     (305)                      (124)               -                        -              (429)
Credits and payments made
during the current year           (25,714)                   (10,995)               -                   (1,970)          (38,679)
Balance as of March 31,
2022                      $        13,734          $           2,628          $ 3,028          $           486          $ 19,876

License, Milestone, and Other Revenue



For units of account under ASC 606, we apply significant judgment when
evaluating whether contractual obligations represent distinct performance
obligations, allocating transaction price to performance obligations within a
contract, determining when performance obligations have been met, assessing the
recognition and future reversal of variable consideration, and determining and
applying appropriate methods of measuring progress for performance obligations
satisfied over time. These judgments are discussed in more detail below:

•Licenses of intellectual property: If the licenses to intellectual property are
determined to be distinct from the other performance obligations identified in
the arrangement, we recognize revenues from non-refundable, upfront fees
allocated to the license when the license is transferred to the licensee and the
licensee is able to use and benefit from the license. For licenses that are not
distinct from other promises, we apply judgment to assess the nature of the
combined performance obligation to determine whether the combined performance
obligation is satisfied over time or at a point in time and, if over time, the
appropriate method of measuring progress for purposes of recognizing revenue
from non-refundable, upfront fees. We evaluate the measure of progress each
reporting period and, if necessary, adjusts the related revenue recognition
accordingly.

•Milestone payments: At the inception of each arrangement that includes
research, development or regulatory milestone payments, we evaluate whether the
milestones are considered probable of being reached and estimate the amount to
be included in the transaction price using the most likely amount method. If it
is probable that a significant revenue reversal would not occur, we include the
associated milestone value in the transaction price. We do not consider
milestone payments that are not within our control or the licensee, such as
regulatory approvals, probable of being achieved until those approvals are
received. We then allocate the transaction price to each performance obligation
on a relative standalone selling price basis, for which we recognize revenue as
or when the performance obligations under the contract are satisfied. At the end
of each subsequent reporting period, we re-evaluate the probability of
achievement of such milestones and any related constraint, and if necessary,
adjust our estimate of the overall transaction price on a cumulative catch-up
basis in earnings in the period of the adjustment.

•Royalties and commercial milestone payments: For arrangements that include
sales-based royalties, including sales-based milestone payments based on
pre-specified level of sales, we recognize revenue at the later of (i) when the
related sales occur, or (ii) when the performance obligation to which some or
all of the royalty has been allocated has been satisfied (or partially
satisfied).

Collaboration Arrangements



We analyze our collaboration arrangements to assess whether they are within the
scope of ASC 808, Collaborative Arrangements, to determine whether such
arrangements involve joint operating activities performed by the parties that
are both active participants in the activities and exposed to significant risks
and rewards dependent on the commercial success of such activities. We perform
this assessment throughout the life of the arrangement based on changes in
responsibilities of all parties in the arrangement. For collaboration
arrangements within the scope of ASC 808 that contain multiple units of account,
we first determine which units of account of the collaboration are deemed to be
within the scope of ASC 808 and those that are reflective of a vendor-customer
relationship and, therefore, within the scope of ASC 606, Revenue from Contracts
with Customers.

While ASC 808 defines collaboration arrangements and provides guidance on income
statement presentation, classification, and disclosures related to such
arrangements, it does not address recognition and measurement matters, such as
(1) determining the appropriate unit of account or (2) when the recognition
criteria are met. Therefore, the accounting for these arrangements is

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either based on an analogy to other accounting literature, such as ASC 606, or an accounting policy election by management. For units of account within collaboration arrangements that are accounted for pursuant to ASC 808, we determine an appropriate revenue recognition method and apply it consistently.



We evaluate the presentation of amounts due from our collaborative partners
associated with activities in the collaborative arrangements based on the nature
of each activity. We record the amounts received prior to satisfying the revenue
recognition criteria as deferred revenue on our consolidated balance sheets. If
we expect the related efforts underlying the deferred revenue to be satisfied
within the next twelve months, we classify the deferred revenue in current
liabilities, otherwise we classify it as a non-current liability.

For collaboration arrangements that are within the scope of ASC 808, the
recognition of collaboration revenue (expense) requires management judgement due
to the fact that the terms of collaboration arrangements may be complicated, and
the nature of the collaborative activities may change over time. Management
exercises judgement in determining the units of account within a collaboration
arrangement and in allocating consideration to those units, estimating the
collaboration revenue to be recognized, including estimating an appropriate term
over which we expect the collaboration revenue to be recognized, as well as in
determining the amortization method. For example, judgement is required in
identifying material rights and performance obligations, and in estimating the
stand-alone selling price of identified performance obligations and material
rights, the estimates of which may include forecasted revenue, development
timelines, discount rates and probabilities of technical and regulatory success.

There is also judgement involved in the identification of costs that we incur
related to the collaboration activities, evaluating the nature of these costs
(for example, whether the costs relate to a particular geography or territory or
whether the costs relate to clinical or commercial activities), and applying the
terms of the respective collaborative arrangement to determine the portion of
such costs that are the responsibility of the collaboration partner, which in
certain circumstances requires significant judgement.

In addition, we are dependent on collaborative partners to provide us with
information in a timely and accurate manner for use in preparing our
consolidated financial statements and related disclosures. Certain of this
information may also be subject to estimates. Should our collaborative partners
fail to provide us with any such information in a timely manner, or should any
estimates upon which such financial information was based, prove to be
inaccurate, we could be required to record such adjustments in future periods.

Research and Development Expenses and Accruals



R&D expenses primarily include personnel-related costs for employees engaged in
R&D activities and costs of third parties who conduct clinical study and
clinical manufacturing activities on our behalf, and are expensed as incurred
unless there is an alternative future use in other R&D projects. We expense
payments for a product license prior to regulatory approval of the product and
payments for milestones achieved prior to regulatory approval of the product in
the period incurred as R&D.

We consider regulatory approval of product candidates to be uncertain and
products manufactured prior to regulatory approval may not be sold unless
regulatory approval is obtained. As such, we do not capitalize the manufacturing
costs for product candidates incurred prior to regulatory approval as inventory,
but rather expense them as R&D expenses when incurred.

Our accruals for clinical studies and other R&D activities are based on
estimates of the services received and efforts expended pursuant to contracts
with numerous clinical study sites, CROs, and CMOs. The financial terms of these
agreements are subject to negotiation and vary from contract to contract and may
result in uneven payment flows. Generally, these agreements set forth the scope
of work to be performed at a fixed fee, unit price, upon achievement of a
milestone event, or on a time and materials basis. Payments under these
agreements depend on factors such as the achievement of certain events, the
successful enrollment of patients, and the completion of portions of the
clinical study or similar conditions. The objective of our accrual policy is to
match the recording of expenses in our consolidated financial statements to the
actual services received and efforts expended. As such, we recognize expense
accruals related to clinical studies and other R&D activities based on our
estimate of the degree of completion of the event or events specified in the
agreements.

Our accrual estimates are dependent upon the timeliness and accuracy of data
provided by third parties regarding the status and cost of studies, and may not
match the actual services performed by these organizations. During the course of
a clinical study, we adjust our rate of clinical study expense recognition if
actual results differ from our estimates. We make estimates of our clinical
study expense as of each balance sheet date based on facts and circumstances
known at that time. Although we do not expect our estimates to be materially
different from amounts actually incurred, our understanding of the status and
timing of services performed relative to the actual status and timing of
services performed may vary and result in us reporting amounts that are too high
or too low for any particular period. This could result in adjustment to our R&D
expense in future periods.

                                       91
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Share-Based Compensation



We account for share-based compensation plans using the fair value recognition
and measurement provisions under U.S. GAAP. We measure share-based compensation
cost at the grant date, based on the fair value of the award, and recognize that
fair value as expense on a straight-line basis over the requisite service
period, which is generally the vesting period of the respective award. We
recognize forfeitures in the period in which such forfeiture occurs and record
share-based compensation as though all awards are expected to vest.

We estimate the grant date fair value of stock options, and the resulting share-based compensation, using the Black-Scholes option-pricing model, which requires the use of subjective assumptions, including:



•Expected Term. The expected term represents the period that our share-based
awards are expected to be outstanding and is determined using the simplified
method in accordance with the Securities and Exchange Commission, Staff
Accounting Bulletins No. 107 and No. 110 (based on the mid-point between the
vesting date and the end of the contractual term).

•Expected Volatility. The expected volatility considers our historical
volatility and the weighted average measures of volatility of a peer group of
companies for a period equal to the expected term of the stock options. Our peer
group of publicly traded biopharmaceutical companies was chosen based on their
similar size, stages in the life cycle, or area of specialty.

•Risk-Free Interest Rate. The risk-free interest rate is based on the U.S.
treasury yield curve in effect at the time of grant for the expected term on the
stock options.

•Expected Dividend. We have never paid, and do not anticipate paying, cash dividends on our common shares. Therefore, the expected dividend yield was assumed to be zero.



We base share-based compensation associated with restricted stock units ("RSU")
and performance share units ("PSU") on the fair value of our common shares on
the grant date, which equals the closing market price of our common shares on
the grant date. We recognize share-based compensation related to RSUs on a
straight-line basis over the requisite service period, which is generally the
vesting period of the respective award. We recognize share-based compensation
related to PSUs if the performance criteria are deemed probable of being met. We
remeasure share-based compensation liabilities at fair value each reporting
period until the common share awards are settled or become mature, with the
change in the fair value recorded as share-based compensation.

No tax benefits for share-based compensation have been recognized in the
consolidated statements of shareholders' deficit or consolidated statements of
cash flows. We have not recognized, and do not expect to recognize in the near
future, any tax benefits related to share-based compensation as a result of our
full valuation allowance on net deferred tax assets and net operating loss
carryforwards.

Recently Issued and Adopted Accounting Pronouncements



For information regarding the impact of recently adopted accounting
pronouncements and the expected impact of recently issued accounting
pronouncements not yet adopted on our consolidated financial statements, see
Note 2 to our audited consolidated financial statements included elsewhere in
this Annual Report.

Sumitomo Pharma Unit Closes $1.7 Billion Purchase of Myovant Sciences	23-03-14	MT
Myovant Sciences Ltd.(NYSE:MYOV) dropped from S&P Biotechnology Select Industry Index	23-03-10	CI
Myovant Sciences Ltd.(NYSE:MYOV) dropped from S&P TMI Index	23-03-10	CI
Myovant Sciences Ltd.(NYSE:MYOV) dropped from S&P Global BMI Index	23-03-10	CI
Sumitovant Biopharma Ltd. completed the acquisition of remaining 47.83% stake in Myovant Sciences Ltd..	23-03-09	CI
Myovant Sciences Ltd. Reports Earnings Results for the Third Quarter and Nine Months Ended December 31, 2022	23-01-26	CI
Earnings Flash (MYOV) MYOVANT SCIENCES Reports Q3 Revenue $100.2M	23-01-26	MT
Insider Sell: Myovant Sciences	23-01-20	MT
Lyell Immunopharma Names Lynn Seely as Chief Executive	22-12-15	MT
Myovant Sciences Appoints Ann Tomlin as Senior Vice President of Human Resources	22-11-16	CI
Evercore ISI Downgrades Myovant Sciences to In Line From Outperform With $27 Price Target	22-10-26	MT
Myovant Sciences Fiscal Q2 Loss Widens, Revenue Rises	22-10-26	MT
Myovant Sciences Ltd. Reports Earnings Results for the Second Quarter and Six Months Ended September 30, 2022	22-10-26	CI
Earnings Flash (MYOV) MYOVANT SCIENCES Reports Q2 Revenue $104.8M	22-10-26	MT
SVB Securities Downgrades Myovant Sciences to Market Perform From Outperform, Adjusts Price Target to $27 From $23	22-10-25	MT
Buying Spree Pulls Up Japanese Stocks; Sumitomo Pharma Unit to Buy Remaining 48% of Myovant Sciences for $1.7 Billion	22-10-25	MT
Sumitomo Pharma Unit to Acquire Remaining 48% of Myovant Sciences for $1.7 Billion	22-10-25	MT
Myovant Sciences Share Rise After Agreement to be Fully Acquired by Sumitovant Biopharma	22-10-24	MT
Baird Downgrades Myovant Sciences to Neutral From Outperform, Raises Price Target to $27 From $20	22-10-24	MT
Japan's Sumitomo Pharma to buy rest of Myovant in sweetened deal	22-10-24	RE
Myovant Sciences to be Fully Acquired by Sumitovant Biopharma	22-10-24	MT
Japan's Sumitomo Pharma to buy rest of Myovant for $27 per share	22-10-24	RE
Sumitovant Biopharma to buy Myovant for $27 per share	22-10-23	RE
Sumitovant Biopharma Ltd. signed an agreement to acquire a 47.83% stake in Myovant Sciences Ltd for $1.2 billion.	22-10-22	CI
Myovant Sciences Ltd. Appoints Shigeyuki Nishinaka as Director	22-10-21	CI

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MEDPACE HOLDINGS, INC.	+21.36%	11.6B
UNITED THERAPEUTICS CORPORATION	+8.20%	11.15B

Myovant Sciences Ltd.

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Biotechnology & Medical Research

MYOVANT SCIENCES LTD. Management's Discussion and Analysis of Financial Condition and Results of Operations (form 10-K)

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