Myovant Sciences (NYSE: MYOV), a biopharmaceutical company
that aspires to redefine care for women and for men through
purpose-driven science, empowering medicines, and transformative
advocacy, today announced financial results for the second quarter
of fiscal year 2022 and provided other corporate updates.
“With the recently announced merger agreement,
we believe the expertise and resources of Sumitovant will best
support Myovant and our employees, which will enable us to expand
the impact of our differentiated therapies, accelerate clinical
programs, and work to remove barriers to access quality care for
the patients we serve,” said David Marek, Chief Executive Officer
of Myovant Sciences, Inc. Mr. Marek added, “With the FDA approval
for endometriosis, we are excited MYFEMBREE is now positioned to
redefine care for more women as the first and only once daily oral
GnRH antagonist treatment indicated for both uterine fibroids and
endometriosis. In addition, ORGOVYX continues to gain momentum and
is now the most prescribed GnRH antagonist for men with advanced
prostate cancer.”
Second Fiscal
Quarter 2022 and Recent Corporate
Updates
Corporate
- On October 23, 2022, Myovant
announced that it entered into a merger agreement with Sumitovant
and Sumitomo under which Sumitovant has agreed to acquire the
remaining shares of Myovant that Sumitovant does not currently
hold. Subject to the terms and conditions set forth in the
agreement, in the event the merger is consummated, holders of
Myovant common shares will be entitled to receive $27.00 per share
in cash.
ORGOVYX (relugolix 120 mg)
- Second fiscal
quarter 2022 net product revenues for ORGOVYX in the U.S. were
$43.3 million, reflecting 20% sequential growth compared to the
first fiscal quarter 2022. ORGOVYX commercial demand volume grew
20% quarter-over-quarter driven by accelerating new patient starts
and continued expansion across all treatment settings.
- Approximately 4,000
new patients started treatment with ORGOVYX in the second fiscal
quarter of 2022, reaching approximately 22,000 cumulative patients
since launch.
- ORGOVYX is now the
leading GnRH antagonist therapy for advanced prostate cancer with a
55% share based on months of therapy.
- Since launching in
January 2021, ORGOVYX drove a 133% volume increase of the GnRH
antagonist market for products FDA-approved for the treatment of
advanced prostate cancer.
- In October 2022,
Myovant’s commercialization partner, Accord Healthcare, Ltd.
(Accord), launched ORGOVYX for the treatment of advanced
hormone-sensitive prostate cancer in Europe. Pursuant to the Accord
License Agreement, the first commercial sale of ORGOVYX in Europe
triggered a $5.0 million milestone payment due from Accord.
- Myovant and Pfizer
are initiating a new Phase 3 randomized open label clinical study,
the REPLACE-CV study, to assess the risk of major adverse
cardiovascular events (MACE) associated with ORGOVYX compared with
leuprolide. The REPLACE-CV study design was agreed upon with the
U.S. Food and Drug Administration (FDA). The study could further
differentiate ORGOVYX by potentially adding additional data to the
prescribing information concerning MACE events versus leuprolide,
if approved by the FDA.
MYFEMBREE (relugolix 40 mg, estradiol 1.0 mg,
and norethindrone acetate 0.5 mg)
- Second fiscal
quarter 2022 net product revenues for MYFEMBREE in the U.S. were
$6.4 million, reflecting 60% sequential growth compared to first
fiscal quarter 2022. MYFEMBREE commercial demand volume grew 40%
quarter-over-quarter driven by strong growth in new patient starts
and prescribers.
- On August 5, 2022,
the FDA approved MYFEMBREE for the management of moderate to severe
pain associated with endometriosis, establishing it as the first
and only once-daily oral GnRH treatment approved for both uterine
fibroids and endometriosis. MYFEMBREE was launched in the U.S. for
this indication by Myovant and Pfizer in August 2022. Pursuant to
the terms of the Pfizer Collaboration and License Agreement, this
approval triggered a $100.0 million regulatory milestone payment
from Pfizer, which Myovant received in September 2022.
- Approximately 3,200
new patients started treatment with MYFEMBREE in the second fiscal
quarter 2022, resulting in 55% sequential quarterly growth in the
number of patients treated since launch.
- MYFEMBREE expanded
its leadership in new-to-brand prescription (NBRx) and total
prescription (TRx) share among GnRH antagonist therapies
FDA-approved for the treatment of uterine fibroids with 67% and 54%
share in July 2022, respectively, prior to launching in
endometriosis.
- In the overall GnRH
antagonist class for uterine fibroids and endometriosis, MYFEMBREE
drove 23% TRx growth since its initial launch and reached 32% NBRx
share in September 2022.
- Significant
progress has been made in the five weeks since MYFEMBREE’s
endometriosis launch with over 22,000 health care professional
(HCP) calls conducted, reaching 66% of high and medium target HCPs.
As of October 1, 2022, 30% commercial coverage has been obtained,
covering approximately 50 million lives.
- In September 2022
and October 2022, Myovant and Pfizer completed New Drug Submissions
to Health Canada seeking marketing approval in Canada for MYFEMBREE
for heavy menstrual bleeding associated with uterine fibroids and
MYFEMBREE for the treatment of endometriosis-associated pain,
respectively.
RYEQO (relugolix 40 mg, estradiol 1.0 mg, and
norethindrone acetate 0.5 mg)
- In September 2022,
Myovant’s commercialization partner, Gedeon Richter Plc. (Richter)
submitted a Type II variation application to the United Kingdom
Medicines and Healthcare products Regulatory Agency (MHRA) seeking
approval for RYEQO for moderate to severe pain associated with
endometriosis in adult women of reproductive age with a history of
previous medical or surgical treatment for their
endometriosis.
- In October 2022,
Richter submitted a Type II variation application to the European
Medicines Agency (EMA) seeking approval for RYEQO for the treatment
of moderate to severe pain associated with endometriosis in adult
women of reproductive age with a history of previous medical or
surgical treatment for their endometriosis. The acceptance of the
Type II variation submission is pending validation by the EMA.
Pursuant to the Richter Development and Commercialization
Agreement, the acceptance of the Type II variation application by
the EMA would trigger a $4.0 million milestone payment due from
Richter.
Expected Upcoming
Milestones
- Myovant expects to
submit a New Drug Submission to Health Canada seeking marketing
approval for ORGOVYX for advanced prostate cancer by the end of
calendar year 2022.
- Myovant expects the
FDA decision for the MYFEMBREE supplemental New Drug Application
(sNDA) proposing updates to MYFEMBREE’s U.S. Prescribing
Information based on the safety and efficacy data from the Phase 3
LIBERTY randomized withdrawal study of MYFEMBREE in premenopausal
women with heavy menstrual bleeding associated with uterine
fibroids for up to two years by the January 29, 2023 Prescription
Drug User Fee Act goal date.
- Myovant expects to
submit an sNDA to the FDA for the SPIRIT 2-year long-term extension
study for MYFEMBREE in women for the management of pain associated
with endometriosis in the first half of calendar year 2023.
Second Fiscal Quarter
2022 Financial Summary
Total revenues for the three
months ended September 30, 2022, and 2021 were $104.8 million and
$77.9 million, respectively.
- Product
revenue, net for the three months ended September 30,
2022, and 2021 was $49.9 million and $21.1 million, respectively.
Product revenue, net consisted primarily of the following:
- Product revenue,
net from sales of ORGOVYX in the U.S. for the three months ended
September 30, 2022 was $43.3 million compared to $18.7 million for
three months ended September 30, 2021.
- Product revenue,
net from sales of MYFEMBREE in the U.S. for the three months ended
September 30, 2022 was $6.4 million compared to $0.6 million for
the three months ended September 30, 2021.
- Pfizer
collaboration revenue for the three months ended September
30, 2022, and 2021 was $54.6 million and $25.2 million,
respectively. Pfizer collaboration revenue for both the three
months ended September 30, 2022 and 2021 consists of the partial
recognition of the upfront payment Myovant received from Pfizer in
December 2020 and of the $100.0 million regulatory milestone
payment Myovant received 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 three months ended September 30, 2022
also includes the partial recognition of the $100.0 million
regulatory milestone payment Myovant received from Pfizer that was
triggered upon the FDA approval of MYFEMBREE for the management of
moderate to severe pain associated with endometriosis on August 5,
2022.
- Richter
license and milestone revenue for the three months ended
September 30, 2022 was $0.3 million compared to $31.7 million in
the three months ended September 30, 2021. Richter license and
milestone revenue for the three months ended September 30, 2021
included the recognition of $16.7 million of previously deferred
revenue as a result of Myovant’s delivery of the remaining
substantive relugolix combination tablet data packages to Richter
pursuant to the Richter Development and Commercialization
Agreement, and a $15.0 million regulatory milestone payment that
was triggered upon the European Commission approval of RYEQO for
the treatment of moderate to severe symptoms of uterine fibroids in
adult women of reproductive age.
Cost of product revenue for the
three months ended September 30, 2022 was $4.9 million compared to
$2.6 million for the three months ended September 30, 2021 related
to the cost of goods sold and royalty expense payable to Takeda
pursuant to the Takeda License Agreement. The increase in cost of
product revenue in the three months ended September 30, 2022 was
due to an increase in cost of goods sold and royalty expense
payable to Takeda as a result of higher sales of ORGOVYX and
MYFEMBREE in the U.S., as compared to the year ago period.
Collaboration expense to Pfizer
for the three months ended September 30, 2022, was $22.4 million,
compared to $8.6 million for the three months ended September 30,
2021, reflecting Pfizer’s 50% share of net profits from sales of
ORGOVYX and MYFEMBREE in the U.S. The increase in collaboration
expense to Pfizer in the three months ended September 30, 2022 was
due to an increase in net profits generated from sales of ORGOVYX
and MYFEMBREE in the U.S., as compared to the year ago period.
Selling, general and administrative
(SG&A) expenses for the three months ended September
30, 2022, and 2021 were $84.3 million and $58.8 million,
respectively. The increase in SG&A expenses primarily reflects
higher expenses to support the ORGOVYX and MYFEMBREE
commercialization activities in the U.S, including higher
personnel-related costs and patient activation costs, particularly
for MYFEMBREE.
Research and development
(R&D) expenses for the three months ended September
30, 2022, and 2021 were $26.9 million and $26.3 million,
respectively.
Interest expense for the three
months ended September 30, 2022, and 2021 was $4.8 million and $3.5
million, respectively, and was primarily related to the Sumitomo
Pharma Loan Agreement. Interest expense related to the Sumitomo
Pharma Loan Agreement increased $1.9 million, as a result of an
increase in 3-month LIBOR as compared to the year ago period.
Income tax expense (benefit)
for the three months ended September 30, 2022, and 2021 was $8.1
million and $(0.1) million, respectively. Myovant’s tax expense
currently relates principally to profits earned in the U.S. The
increase in income tax expense was driven principally by the
changed requirement under Internal Revenue Code Section 174,
effective for years beginning after December 31, 2021, to
capitalize and subsequently amortize R&D expenditures, pursuant
to changes enacted in the Tax Cuts and Jobs Act of 2017. For
periods beginning prior to December 31, 2021, R&D expenses were
allowed to be expensed as incurred.
Net loss for the three months
ended September 30, 2022 was $45.6 million compared to $21.6
million for the year ago period. On a per common share basis, net
loss was $0.47 and $0.23 for the three months ended September 30,
2022 and 2021, respectively.
Capital resources: Cash, cash
equivalents, marketable securities, and amounts available under the
Sumitomo Pharma Loan Agreement totaled $412.6 million in the
aggregate as of September 30, 2022, and consisted of $371.3
million of cash, cash equivalents, and marketable securities and
$41.3 million of available borrowing capacity under the Sumitomo
Pharma Loan Agreement.
About Relugolix
Relugolix is a once-daily, oral
gonadotropin-releasing hormone (GnRH) receptor antagonist that
reduces testicular testosterone, a hormone known to stimulate the
growth of prostate cancer, and ovarian estradiol, a hormone known
to stimulate the growth of uterine fibroids and endometriosis.
ORGOVYX® (relugolix, 120 mg) was approved in the U.S. by the FDA in
December 2020 as the first and only oral GnRH receptor antagonist
for the treatment of adult patients with advanced prostate cancer.
In April and June 2022, respectively, the European Commission (EC)
and the United Kingdom (U.K.) Medicines and Healthcare products
Regulatory Agency (MHRA) approved ORGOVYX® (relugolix, 120 mg) as
the first and only oral GnRH receptor antagonist for the treatment
of adult patients with advanced hormone-sensitive prostate cancer
in Europe and the U.K. MYFEMBREE® (relugolix 40 mg, estradiol 1.0
mg, and norethindrone acetate 0.5 mg) was approved in the U.S. by
the FDA in May 2021 as the first and only once-daily oral GnRH
treatment for the management of heavy menstrual bleeding associated
with uterine fibroids in premenopausal women, with a treatment
duration of up to 24 months; and in August 2022 as the first and
only once-daily oral GnRH antagonist combination treatment for the
management of moderate to severe pain associated with
endometriosis, with a treatment duration of 24 months. In July
2021, the EC, and in August 2021, the U.K. MHRA, approved RYEQO®
(relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5
mg) for the treatment of moderate to severe symptoms of uterine
fibroids in adult women of reproductive age, with no limitation for
duration of use. In June 2022, the FDA accepted to review Myovant’s
supplemental New Drug Application (sNDA) for updates to the United
States Prescribing Information (USPI) based on safety and efficacy
data from the Phase 3 LIBERTY randomized withdrawal study (RWS) of
MYFEMBREE in premenopausal women with heavy menstrual bleeding due
to uterine fibroids for up to two years. The FDA set a Prescription
Drug User Fee Act (PDUFA) goal date of January 29, 2023 for this
sNDA. MYFEMBREE is also being assessed for contraceptive efficacy
in women with endometriosis or uterine fibroids who are 18 to 50
years of age and at risk for pregnancy.
About Myovant Sciences
Myovant Sciences aspires to redefine care for
women and men through purpose-driven science, empowering medicines,
and transformative advocacy worldwide. Founded in 2016, Myovant has
executed multiple successful Phase 3 clinical trials across
hormone-sensitive oncology and women’s health leading to five
regulatory approvals in the United States and Europe. Myovant and
its partners continue to file for additional indications of its
lead products as well as continue further development of pipeline
assets. Sumitovant Biopharma Ltd., a wholly owned subsidiary of
Sumitomo Pharma Co., Ltd., is Myovant’s majority shareholder. For
more information, please visit www.myovant.com.
About Sumitovant Biopharma
Ltd.
Sumitovant is a technology-driven
biopharmaceutical company accelerating development and
commercialization of new potential therapies for patients with rare
conditions and other diseases. Through its proprietary computing
and data platforms, scientific expertise and diverse company
portfolio, Sumitovant has supported development of multiple
FDA-approved products and a robust pipeline of early- through
late-stage investigational assets addressing unmet patient needs in
pediatrics, urology, oncology, women’s health, specialty
respiratory and infectious diseases. Sumitovant, a wholly owned
subsidiary of Sumitomo Pharma, is also the majority-shareholder of
Myovant. Please visit Sumitovant’s website at www.sumitovant.com
for more information on Sumitovant and its portfolio.
About Sumitomo Pharma Co.,
Ltd.
Sumitomo Pharma is among the top-ten listed
pharmaceutical companies in Japan, operating globally in major
pharmaceutical markets, including Japan, the U.S., China, and other
Asian countries with more than 7,000 employees worldwide. Sumitomo
Pharma defines its corporate mission as “To broadly contribute to
society through value creation based on innovative research and
development activities for the betterment of healthcare and fuller
lives of people worldwide.” Additional information about Sumitomo
Pharma is available through its corporate website at
https://www.sumitomo-pharma.com.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. In this press release, forward-looking
statements include, but are not limited to, all statements
reflecting Myovant Sciences’ expectations, including: statements
regarding Myovant’s aspiration to redefine care for women and for
men; statements regarding expectations about the proposed
transaction involving Myovant and Sumitovant, including the
statements that with the proposed transaction, the expertise and
resources of Sumitovant will best support Myovant and its employees
and enable Myovant to expand the impact of its differentiated
therapies, accelerate clinical programs, and work to remove
barriers to access quality care for the patients it serves in Mr.
Marek’s quote; Myovant’s expectation that the REPLACE-CV study
could further differentiate ORGOVYX by potentially adding
additional data to the prescribing information concerning MACE
events versus leuprolide, if approved by the FDA; the potential
milestone payment to Myovant that would be triggered by the
acceptance of the Type II variation application to EMA for RYEQO
that was submitted by Richter, Myovant’s commercialization partner;
statements regarding the timing of Myovant’s regulatory
submissions, anticipated regulatory review results, as well as
other statements under the caption “Expected Upcoming Milestones.”
In addition, risks and uncertainties related to the proposed
transaction include, but are not limited to, the risk that the
parties may be unable to achieve expected synergies and operating
efficiencies in the merger within the expected timeframes or at all
and to successfully integrate Myovant’s operations into those of
Sumitovant; such integration may be more difficult, time consuming
or costly than expected, the risk that the proposed transaction
does not close, due to the failure of one or more conditions to
closing or otherwise; the risk that required Myovant shareholder
approvals of the proposed transaction will not be obtained or that
such approvals will be delayed or conditioned beyond current
expectations; the risk that the necessary regulatory approvals may
not be obtained or may be obtained subject to conditions that are
not anticipated; the occurrence of any event, change or other
circumstances that could give rise to the termination of the merger
agreement; uncertainty as to the timing of completion of the
proposed transaction; risks related to the disruption of management
time from ongoing business operations due to the proposed
transaction and possible difficulties in maintaining customer,
supplier, key personnel and other strategic relationships; and
potential litigation relating to the proposed transaction that
could be instituted against Myovant, Sumitovant or their respective
directors or officers, including the effects of any outcomes
related thereto; and the possibility of unexpected costs and
liabilities related to the proposed transaction.
Myovant Sciences’ forward-looking statements are
based on management’s current expectations and beliefs and are
subject to a number of risks, uncertainties, assumptions, and other
factors known and unknown that could cause actual results and the
timing of certain events to differ materially from future results
expressed or implied by the forward-looking statements, including
unforeseen circumstances or other disruptions to normal business
operations arising from or related to the COVID-19 pandemic and the
conflict in Ukraine. Myovant Sciences cannot assure you that the
events and circumstances reflected in the forward-looking
statements will be achieved or occur, and actual results could
differ materially from those expressed or implied by these
forward-looking statements. Factors that could materially affect
Myovant Sciences’ operations and future prospects or which could
cause actual results to differ materially from expectations
include, but are not limited to, the risks and uncertainties listed
in Myovant Sciences’ filings with the United States Securities and
Exchange Commission (SEC), including under the heading “Risk
Factors” in Myovant Sciences’ Quarterly Report on Form 10-Q to be
filed on October 26, 2022, as such risk factors may be
amended, supplemented, or superseded from time to time. These risks
are not exhaustive. New risk factors emerge from time to time and
it is not possible for Myovant Sciences’ management to predict all
risk factors, nor can Myovant Sciences assess the impact of all
factors on its business or the extent to which any factor, or
combination of factors, may cause actual results to differ
materially from those contained in any forward-looking statements.
You should not place undue reliance on the forward-looking
statements in this press release, which speak only as of the date
hereof, and, except as required by law, Myovant Sciences undertakes
no obligation to update these forward-looking statements to reflect
events or circumstances after the date of such statements.
Additional Information and Where to Find
It
This communication may be deemed to be
solicitation material in respect of the proposed transaction
involving Myovant and Sumitovant. Myovant intends to file with the
SEC relevant materials, including a proxy statement on Schedule 14A
in connection with the proposed transaction with Sumitovant, and
Myovant and certain other persons, including Sumitovant, intend to
file a Schedule 13E-3 transaction statement with the SEC. The
definitive proxy statement and Schedule 13E-3 transaction statement
will be sent to Myovant’s shareholders and will contain important
information about the proposed transaction and related matters.
MYOVANT’S SECURITYHOLDERS ARE URGED TO READ THE PROXY STATEMENT,
THE SCHEDULE 13E-3 TRANSACTION STATEMENT AND ANY AMENDMENTS OR
SUPPLEMENTS THERETO, AND ANY OTHER RELEVANT DOCUMENTS FILED OR TO
BE FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY
BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION
ABOUT THE PROPOSED TRANSACTION. The proxy statement, Schedule
13E-3, any amendments or supplements thereto and other relevant
materials (when they become available), and any other documents
filed by Myovant with the SEC, may be obtained free of charge at
the SEC’s website at www.sec.gov. In addition, securityholders of
Myovant will be able to obtain free copies of the proxy statement
and Schedule 13E-3 through the Investor Relations page of Myovant’s
website, www.myovant.com.
Participants in the
Solicitation
Myovant and its directors, executive officers
and other members of management and certain other persons may be
deemed to be participants in the solicitation of proxies in
connection with the proposed transaction. Information about
Myovant’s directors and executive officers, including a description
of their direct or indirect interests, by security holdings or
otherwise, is contained in Myovant’s proxy statement for its 2022
annual meeting of shareholders, filed with the SEC on July 28,
2022. Additional information regarding these persons and their
interests in the Merger will be included in the proxy statement on
Schedule 14A and Schedule 13E-3 relating to the proposed
transaction when they are filed with the SEC. These documents, when
available, can be obtained free of charge from the sources
indicated above.
MYOVANT SCIENCES
LTD.Condensed Consolidated Statements of
Operations and Comprehensive Loss(Unaudited, in thousands,
except share and per share data)
|
Three Months Ended September 30, |
|
Six Months Ended September 30, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Revenues: |
|
|
|
|
|
|
|
Product revenue, net |
$ |
49,947 |
|
|
$ |
21,063 |
|
|
$ |
91,298 |
|
|
$ |
32,617 |
|
Pfizer collaboration revenue |
|
54,577 |
|
|
|
25,172 |
|
|
|
79,718 |
|
|
|
54,681 |
|
Accord license revenue |
|
— |
|
|
|
— |
|
|
|
50,000 |
|
|
|
— |
|
Richter license and milestone revenue |
|
300 |
|
|
|
31,667 |
|
|
|
300 |
|
|
|
31,667 |
|
Total revenues |
|
104,824 |
|
|
|
77,902 |
|
|
|
221,316 |
|
|
|
118,965 |
|
Operating costs and
expenses: |
|
|
|
|
|
|
|
Cost of product revenue(1) |
|
4,942 |
|
|
|
2,622 |
|
|
|
9,857 |
|
|
|
3,654 |
|
Collaboration expense to Pfizer |
|
22,418 |
|
|
|
8,565 |
|
|
|
40,434 |
|
|
|
13,826 |
|
Selling, general and administrative(1) |
|
84,259 |
|
|
|
58,781 |
|
|
|
163,291 |
|
|
|
119,993 |
|
Research and development(1) |
|
26,916 |
|
|
|
26,280 |
|
|
|
50,806 |
|
|
|
57,160 |
|
Total operating costs and expenses |
|
138,535 |
|
|
|
96,248 |
|
|
|
264,388 |
|
|
|
194,633 |
|
Loss from operations |
|
(33,711 |
) |
|
|
(18,346 |
) |
|
|
(43,072 |
) |
|
|
(75,668 |
) |
Interest expense |
|
4,813 |
|
|
|
3,494 |
|
|
|
9,013 |
|
|
|
6,999 |
|
Interest income |
|
(1,018 |
) |
|
|
(100 |
) |
|
|
(1,504 |
) |
|
|
(178 |
) |
Loss before income taxes |
|
(37,506 |
) |
|
|
(21,740 |
) |
|
|
(50,581 |
) |
|
|
(82,489 |
) |
Income tax expense
(benefit) |
|
8,113 |
|
|
|
(149 |
) |
|
|
16,277 |
|
|
|
762 |
|
Net loss and comprehensive
loss |
$ |
(45,619 |
) |
|
$ |
(21,591 |
) |
|
$ |
(66,858 |
) |
|
$ |
(83,251 |
) |
Net loss per common share —
basic and diluted |
$ |
(0.47 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.70 |
) |
|
$ |
(0.90 |
) |
Weighted average common shares
outstanding — basic and diluted |
|
96,211,190 |
|
|
|
92,355,150 |
|
|
|
95,801,991 |
|
|
|
92,019,987 |
|
(1) Includes the following share-based compensation:
Selling, general and administrative |
$ |
7,744 |
|
|
$ |
6,803 |
|
|
$ |
13,716 |
|
|
$ |
13,958 |
|
Research and development |
|
3,832 |
|
|
|
4,884 |
|
|
|
7,498 |
|
|
|
8,841 |
|
Cost of product revenue |
|
141 |
|
|
|
15 |
|
|
|
209 |
|
|
|
18 |
|
Total share-based compensation |
$ |
11,717 |
|
|
$ |
11,702 |
|
|
$ |
21,423 |
|
|
$ |
22,817 |
|
Revenue components are as follows:
Product revenue, net: |
|
|
|
|
|
|
|
ORGOVYX |
$ |
43,319 |
|
|
$ |
18,663 |
|
|
$ |
79,353 |
|
|
$ |
29,142 |
|
MYFEMBREE |
|
6,403 |
|
|
|
629 |
|
|
|
10,402 |
|
|
|
1,704 |
|
Richter product supply and royalties |
|
225 |
|
|
|
1,771 |
|
|
|
1,543 |
|
|
|
1,771 |
|
Total product revenue, net |
|
49,947 |
|
|
|
21,063 |
|
|
|
91,298 |
|
|
|
32,617 |
|
Pfizer collaboration
revenue: |
|
|
|
|
|
|
|
Amortization of upfront payment |
|
20,974 |
|
|
|
20,974 |
|
|
|
41,948 |
|
|
|
41,948 |
|
Amortization of regulatory milestones |
|
33,603 |
|
|
|
4,198 |
|
|
|
37,770 |
|
|
|
12,733 |
|
Total Pfizer collaboration revenue |
|
54,577 |
|
|
|
25,172 |
|
|
|
79,718 |
|
|
|
54,681 |
|
Accord license revenue |
|
— |
|
|
|
— |
|
|
|
50,000 |
|
|
|
— |
|
Richter license and milestone
revenue |
|
300 |
|
|
|
31,667 |
|
|
|
300 |
|
|
|
31,667 |
|
Total revenues |
$ |
104,824 |
|
|
$ |
77,902 |
|
|
$ |
221,316 |
|
|
$ |
118,965 |
|
MYOVANT SCIENCES
LTD.Condensed Consolidated Balance
Sheets(Unaudited, in thousands)
|
September 30, 2022 |
|
March 31, 2022 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
341,960 |
|
|
$ |
406,704 |
|
Accounts receivable, net |
|
33,762 |
|
|
|
23,296 |
|
Marketable securities |
|
29,330 |
|
|
|
27,483 |
|
Inventories |
|
23,047 |
|
|
|
7,584 |
|
Prepaid expenses and other current assets |
|
31,868 |
|
|
|
22,498 |
|
Amount due from related party |
|
943 |
|
|
|
580 |
|
Total current assets |
|
460,910 |
|
|
|
488,145 |
|
Property and equipment,
net |
|
2,708 |
|
|
|
2,944 |
|
Operating lease right-of-use
asset |
|
7,026 |
|
|
|
7,961 |
|
Other assets |
|
13,330 |
|
|
|
20,961 |
|
Total assets |
$ |
483,974 |
|
|
$ |
520,011 |
|
Liabilities and
Shareholders’ Deficit |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
8,215 |
|
|
$ |
12,250 |
|
Accrued expenses and other current liabilities |
|
84,081 |
|
|
|
68,594 |
|
Deferred revenue |
|
117,231 |
|
|
|
100,564 |
|
Amounts due to Pfizer |
|
38,939 |
|
|
|
32,563 |
|
Cost share advance from Pfizer |
|
— |
|
|
|
33,818 |
|
Operating lease liability |
|
2,374 |
|
|
|
2,148 |
|
Amounts due to related parties |
|
851 |
|
|
|
393 |
|
Total current liabilities |
|
251,691 |
|
|
|
250,330 |
|
Deferred revenue,
non-current |
|
379,321 |
|
|
|
375,706 |
|
Long-term operating lease
liability |
|
5,788 |
|
|
|
7,041 |
|
Long-term debt, less current
maturities (related party) |
|
358,700 |
|
|
|
358,700 |
|
Other liabilities |
|
1,723 |
|
|
|
1,711 |
|
Total liabilities |
|
997,223 |
|
|
|
993,488 |
|
Total shareholders’ deficit |
|
(513,249 |
) |
|
|
(473,477 |
) |
Total liabilities and
shareholders’ deficit |
$ |
483,974 |
|
|
$ |
520,011 |
|
Investor Contact: Uneek MehraChief Financial
OfficerMyovant Sciences, Inc.investors@myovant.com
Media Contact:Noelle Cloud DuganVice President,
Corporate CommunicationsMyovant Sciences, Inc.media@myovant.com
Myovant Sciences (NYSE:MYOV)
과거 데이터 주식 차트
부터 1월(1) 2025 으로 2월(2) 2025
Myovant Sciences (NYSE:MYOV)
과거 데이터 주식 차트
부터 2월(2) 2024 으로 2월(2) 2025