Myovant Sciences (NYSE:
MYOV), a healthcare
company focused on redefining care for women and for men, today
announced recent corporate updates and reported financial results
for the fourth fiscal quarter and full fiscal year ended
March 31, 2020.
“I am tremendously proud of the many
accomplishments of the Myovant team over the last year, with four
positive Phase 3 studies, multiple regulatory submissions, and a
strategic partnership with Gedeon Richter to accelerate the
potential commercialization of relugolix combination tablet,” said
Lynn Seely, M.D., chief executive officer of Myovant Sciences. “We
look forward to submitting our NDA in uterine fibroids this month
and sharing the SPIRIT 1 results later this quarter, as we continue
to realize our vision of redefining care for the millions of women
and men with uterine fibroids, endometriosis, and prostate
cancer.”
Fourth Fiscal Quarter 2019 and Recent
Business Highlights
Relugolix Clinical Programs
- In March 2020, Myovant announced the submission of a Marketing
Authorization Application (MAA) to the European Medicines
Agency (EMA) for once-daily, oral relugolix combination tablet
(relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5
mg) for the treatment of women with moderate to severe symptoms
associated with uterine fibroids. The MAA submission has completed
validation and is now under evaluation by the EMA. The MAA
submission was supported by efficacy and safety data from the Phase
3 LIBERTY program which consisted of two multinational, replicate
pivotal clinical studies, LIBERTY 1 and 2, as well as data from a
long-term extension study of relugolix combination therapy. Myovant
expects to submit an NDA for relugolix combination tablet in
uterine fibroids in May 2020.
- In April 2020, Myovant announced that the Phase 3 SPIRIT 2
study evaluating the safety and efficacy of relugolix combination
therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone
acetate 0.5 mg) over 24 weeks in 623 women with endometriosis met
its co-primary efficacy endpoints with a 75.2% response rate for
dysmenorrhea (menstrual pain) and a 66.0% response rate for
non-menstrual pelvic pain, while achieving six key secondary
endpoints and demonstrating minimal bone mineral density loss.
Myovant expects to report top-line results from a replicate Phase 3
study, SPIRIT 1, in the second quarter of calendar year 2020.
- In April 2020, Myovant also announced that in an ovulation
inhibition study relugolix combination therapy achieved 100%
ovulation inhibition in 67 healthy women with no women ovulating
during the 84-day treatment period, as evaluated by the
Hoogland-Skouby assessment scale (score < 5). Furthermore, 100%
of women resumed ovulation or menses upon discontinuation of
treatment with an average time to ovulation of 23.5 days.
- In April 2020, Myovant announced the submission of a New Drug
Application (NDA) to the U.S. Food and Drug
Administration (FDA) for once-daily, oral relugolix
monotherapy tablet (120 mg) for the treatment of men with advanced
prostate cancer. The NDA submission was supported by efficacy
and safety data from the Phase 3 HERO study, a randomized pivotal
study comparing relugolix monotherapy tablet versus leuprolide
acetate. Myovant will present new efficacy and cardiovascular
safety data from the HERO study in an oral presentation at the
American Society of Clinical Oncology (ASCO)’s ASCO20 Virtual
Scientific Program on May 29, 2020. Myovant expects to report
additional data from the HERO study measuring castration
resistance-free survival in approximately 430 men in the third
quarter of calendar year 2020.
Corporate
- In March 2020, Myovant and Gedeon Richter Plc. (Richter),
a major pharmaceutical company in Central Eastern
Europe focused on women’s health, entered into an exclusive
license agreement for Richter to commercialize relugolix
combination tablet for uterine fibroids and endometriosis
in Europe, the Commonwealth of Independent States
including Russia, Latin America, Australia, and New
Zealand. Under the agreement, Myovant received an upfront
payment of $40 million and is eligible to receive up
to $40 million in regulatory milestones (of which $10
million was received in April 2020) and $107.5 million in
sales-related milestones, and tiered royalties on net sales
following regulatory approval. Myovant retains all rights
to relugolix combination tablet in the U.S. and Canada, as
well as rights to relugolix in other therapeutic areas outside of
women’s health.
COVID-19 Pandemic Environment
- To date the impact of the COVID-19 pandemic on Myovant’s
ability to advance its clinical studies, regulatory activities, and
preparation for the potential commercialization of its product
candidates has been limited and all of Myovant’s publicly announced
milestones remain on track. However, if the COVID-19 pandemic
persists, and depending on the further evolution of the pandemic
and its effects on Myovant’s activities, Myovant may experience
more significant impacts on its business operations.
Fourth Fiscal Quarter and Full Fiscal Year
2019 Financial Summary
Research and development (R&D)
expenses for the quarter ended March 31, 2020, were $41.7
million compared to $59.0 million for the comparable prior year
period. R&D expenses for the fiscal year ended March 31,
2020, were $192.6 million, compared to $222.6 million for the prior
fiscal year. R&D expenses for the periods presented primarily
include expenses related to Myovant’s Phase 3 clinical programs,
manufacturing expenses, as well as personnel-related expenses for
employees engaged in R&D activities. R&D expenses related
to Myovant’s clinical programs have continued to decline, driven
primarily by the wind down of Myovant’s Phase 3 studies. The
decrease in relugolix Phase 3 study costs were partially offset by
increases in other R&D expenses related predominantly to
regulatory activities in connection with regulatory submissions for
relugolix combination tablet and relugolix monotherapy tablet in
multiple indications and jurisdictions and the build out of
Myovant’s medical affairs organization in connection with
preparations for Myovant’s anticipated commercial launches, as well
as increases in personnel expenses, share-based compensation, and
other R&D expenses. For the year ended March 31, 2020,
R&D expenses include $1.8 million of share-based compensation
related to the accelerated vesting of certain equity awards as a
result of a change in control in Myovant in connection with the
closing of a transaction between Roivant and Sumitomo Dainippon
Pharma.
General and administrative
(G&A) expenses for the quarter ended March 31,
2020, were $22.4 million compared to $12.5 million for the
comparable prior year period. G&A expenses for the fiscal year
ended March 31, 2020, were $82.3 million, compared to $42.2
million for the prior fiscal year. The increase in G&A expenses
for the quarter and the fiscal year ended March 31, 2020 were
primarily due to increases in expenses related to commercial
operations activities in advance of potential future regulatory
approvals of relugolix combination tablet and relugolix monotherapy
tablet, personnel-related expenses, and share-based compensation
expenses, as well as professional services fees, and other general
overhead, administrative and information technology expenses to
support Myovant’s headcount growth and expanding operations. For
the year ended March 31, 2020, G&A expenses include
certain one-off increases as a result of the change in control in
Myovant, namely $10.2 million in share-based compensation expense
related to the accelerated vesting of certain equity awards as well
as a $3.6 million capital tax accrual.
Interest expense for the quarters
ended March 31, 2020 and 2019, was $0 and $3.9 million,
respectively. On December 31, 2019, Myovant repaid all of its
outstanding debt obligations to NovaQuest and Hercules and as a
result there was no interest expense during the quarter ended
March 31, 2020. For the year ended March 31, 2020,
interest expense was $11.2 million, compared to $8.8 million for
the comparable prior year period, reflecting higher outstanding
debt balances with NovaQuest and Hercules until the debt repayment
on December 31, 2019.
Loss on extinguishment of debt for
the year ended March 31, 2020, was $4.9 million, which
resulted from the early retirement of Myovant’s outstanding
obligations to NovaQuest and Hercules. There were no such amounts
in the other periods presented.
Interest expense (related party)
for the quarter and year ended March 31, 2020, was $1.4
million in relation to Myovant’s outstanding debt of $113.7 million
to Sumitomo Dainippon Pharma, which did not exist in the year ended
March 31, 2019.
Interest income for the quarter
and year ended March 31, 2020, was $0.2 million and $2.6
million, respectively. There was interest income of $0.8 million
and $0.9 million for the quarter and year ended March 31,
2019, respectively.
Net loss for the quarter ended
March 31, 2020, was $64.9 million, compared to $75.0 million
for the comparable prior year period. Net loss for the fiscal year
ended March 31, 2020, was $289.0 million, compared to $273.6
million for the prior fiscal year. On a per common share basis, net
loss was $0.73 and $1.07 for the quarters ended March 31, 2020
and 2019, respectively, and $3.37 and $4.09 for the years ended
March 31, 2020 and 2019, respectively.
Capital resources: Cash, cash
equivalents, marketable securities, and committed funding totaled
$365.9 million as of March 31, 2020, and consisted of $79.6
million of cash, cash equivalents, and marketable securities and
$286.3 million of available borrowing capacity under the Sumitomo
Dainippon Pharma Loan Agreement. Additional funds may be drawn down
by Myovant once per calendar quarter, subject to certain terms and
conditions, including consent of Myovant’s Board of Directors. In
April 2020, Myovant borrowed an additional $80.0 million under the
Sumitomo Dainippon Pharma Loan Agreement. In April 2020, Myovant
received a $10.0 million regulatory milestone payment from
Richter.
About RelugolixRelugolix is a
once-daily, oral gonadotropin-releasing hormone (GnRH) receptor
antagonist that reduces ovarian estradiol production, a hormone
known to stimulate the growth of uterine fibroids and
endometriosis, and testicular testosterone production, a hormone
known to stimulate the growth of prostate cancer. Myovant is
developing a relugolix combination tablet (relugolix 40 mg,
estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for women with
uterine fibroids and for women with endometriosis. Myovant is also
developing a relugolix monotherapy tablet (120 mg once daily) for
men with advanced prostate cancer.
About MVT-602MVT-602 is an
oligopeptide kisspeptin-1 receptor agonist. Kisspeptin, the ligand,
is a naturally-occurring peptide that stimulates GnRH release and
is required for puberty and maintenance of normal reproductive
function, including production of sperm, follicular maturation and
ovulation, and production of estrogen and progesterone in women and
testosterone in men. A Phase 2a clinical study in healthy female
volunteers to characterize the dose-response curve in a minimal
controlled ovarian stimulation setting has been completed.
About Myovant SciencesMyovant
Sciences aspires to be the leading healthcare company focused on
redefining care for women and for men. The company’s lead product
candidate is relugolix, a once-daily, oral GnRH receptor
antagonist. The company has three late-stage clinical programs for
relugolix in uterine fibroids, endometriosis, and prostate cancer.
The company is also developing MVT-602, an oligopeptide
kisspeptin-1 receptor agonist, that has completed a Phase 2a study
for the treatment of female infertility as part of assisted
reproduction. Takeda Pharmaceuticals International AG, a subsidiary
of Takeda Pharmaceutical Company Limited, the originator of
relugolix, granted the company a worldwide license to develop and
commercialize relugolix (excluding Japan and certain
other Asian countries) and an exclusive license to develop and
commercialize MVT-602 in all countries worldwide. Sumitovant
Biopharma, Ltd., a wholly owned subsidiary of Sumitomo Dainippon
Pharma Co., Ltd., is the majority shareholder of Myovant. For more
information, please visit the company’s website
at www.myovant.com. Follow @Myovant on Twitter and
LinkedIn.
About Sumitovant Biopharma
Ltd.Sumitovant is a global biopharmaceutical company with
offices in New York City and London. Sumitovant is a wholly owned
subsidiary of Sumitomo Dainippon Pharma. Sumitovant is the majority
shareholder of Myovant and Urovant, and wholly owns Enzyvant,
Spirovant and Altavant. Sumitovant’s promising pipeline is
comprised of early- through late-stage investigational medicines
across a range of disease areas targeting high unmet need. For
further information about Sumitovant, please visit
https://www.sumitovant.com.
About Sumitomo Dainippon
PharmaSumitomo Dainippon Pharma is among the top-ten
listed pharmaceutical companies in Japan, operating globally in
major pharmaceutical markets, including Japan, the U.S., China and
the European Union. Sumitomo Dainippon Pharma is based on the
merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and
Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma
has more than 6,000 employees worldwide. Additional information
about Sumitomo Dainippon Pharma is available through its corporate
website at https://www.ds-pharma.com.
Forward-Looking StatementsThis
press-release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements include all statements regarding Myovant
Sciences’ intent, belief, or expectations regarding future events
or results and can be identified by words such as “anticipate,”
“aspire,” “believe,” “can,” “continue,” “could,” “estimate,”
“expect,” “intend,” “likely,” “may,” “might,” “objective,”
“ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “to
be,” “will,” “would,” or the negative or plural of these words or
other similar expressions or variations, although not all
forward-looking statements contain these identifying words. In this
press release, forward-looking statements include, but are not
limited to, statements and quotes regarding Myovant Sciences’
aspiration to redefine care for women and for men; expectations to
submit an NDA for relugolix combination tablet in uterine fibroids
in May 2020; report top-line results from SPIRIT 1, a Phase 3 study
of relugolix combination therapy for the treatment of women with
endometriosis, in the second quarter of calendar year 2020; present
new efficacy and cardiovascular safety data from the HERO study at
the ASCO20 Virtual Scientific Program; and report castration
resistance-free survival results of relugolix for the treatment of
men with advanced prostate cancer in the third quarter of calendar
year 2020, as well as potential business interruptions due to the
COVID-19 pandemic environment.
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.
Myovant Sciences cannot assure you that the events and
circumstances reflected in the forward-looking statements will be
achieved or occur and actual results could differ materially from
those expressed or implied by these forward-looking statements.
Factors that could materially affect Myovant Sciences’ operations
and future prospects or which could cause actual results to differ
materially from expectations include, but are not limited to the
risks and uncertainties listed in Myovant Sciences’ filings with
the United States Securities and Exchange Commission (SEC),
including under the heading “Risk Factors” in Myovant Sciences’
Quarterly Report on Form 10-Q filed on February 10, 2020, as such
risk factors may be amended, supplemented or superseded from time
to time. These risks are not exhaustive. New risk factors emerge
from time to time and it is not possible for Myovant Sciences’
management to predict all risk factors, nor can Myovant Sciences
assess the impact of all factors on its business or the extent to
which any factor, or combination of factors, may cause actual
results to differ materially from those contained in any
forward-looking statements. You should not place undue reliance on
the forward-looking statements in this press release, which speak
only as of the date hereof, and, except as required by law, Myovant
Sciences undertakes no obligation to update these forward-looking
statements to reflect events or circumstances after the date of
such statements.
MYOVANT SCIENCES
LTD.Condensed Consolidated Statements of
Operations(Unaudited, in thousands, except share and per
share data)
|
Three Months Ended March 31, |
|
Years Ended March 31, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Operating
expenses: |
|
|
|
|
|
|
|
Research and development (1) |
$ |
41,713 |
|
|
$ |
59,019 |
|
|
$ |
192,560 |
|
|
$ |
222,607 |
|
General and administrative (1) |
22,430 |
|
|
12,481 |
|
|
82,327 |
|
|
42,219 |
|
Total operating expenses |
64,143 |
|
|
71,500 |
|
|
274,887 |
|
|
264,826 |
|
Interest expense |
— |
|
|
3,913 |
|
|
11,222 |
|
|
8,821 |
|
Loss on extinguishment of
debt |
— |
|
|
— |
|
|
4,851 |
|
|
— |
|
Interest expense (related
party) |
1,425 |
|
|
— |
|
|
1,441 |
|
|
— |
|
Interest income |
(247 |
) |
|
(804 |
) |
|
(2,552 |
) |
|
(881 |
) |
Other (income) expense,
net |
(470 |
) |
|
162 |
|
|
(1,621 |
) |
|
309 |
|
Loss before income taxes |
(64,851 |
) |
|
(74,771 |
) |
|
(288,228 |
) |
|
(273,075 |
) |
Income tax expense |
62 |
|
|
243 |
|
|
761 |
|
|
476 |
|
Net loss |
$ |
(64,913 |
) |
|
$ |
(75,014 |
) |
|
$ |
(288,989 |
) |
|
$ |
(273,551 |
) |
Net loss per common
share — basic and diluted |
$ |
(0.73 |
) |
|
$ |
(1.07 |
) |
|
$ |
(3.37 |
) |
|
$ |
(4.09 |
) |
Weighted average
common shares outstanding — basic and diluted |
89,130,806 |
|
|
70,076,475 |
|
|
85,839,303 |
|
|
66,910,060 |
|
(1) Includes the following share-based compensation
expenses:
Research and development
(2) |
$ |
2,959 |
|
|
$ |
1,914 |
|
|
$ |
14,524 |
|
|
$ |
7,161 |
|
General and administrative
(3) |
$ |
3,114 |
|
|
$ |
3,019 |
|
|
$ |
25,727 |
|
|
$ |
11,535 |
|
(2) For the year ended March 31, 2020,
includes approximately $1.8 million related to the accelerated
vesting of certain equity awards as a result of a change in control
of Myovant.
(3) For the year ended March 31, 2020,
includes approximately $10.2 million related to the accelerated
vesting of certain equity awards as a result of a change in control
of Myovant.
MYOVANT SCIENCES
LTD.Condensed Consolidated Balance
Sheet(Unaudited, in thousands)
|
March 31, |
|
2020 |
|
2019 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
76,644 |
|
|
$ |
156,074 |
|
Marketable securities |
2,997 |
|
|
— |
|
Prepaid expenses and other current assets |
8,269 |
|
|
10,194 |
|
Income tax receivable |
— |
|
|
524 |
|
Total current assets |
87,910 |
|
|
166,792 |
|
Property and equipment,
net |
2,497 |
|
|
2,071 |
|
Operating lease right-of-use
asset |
11,146 |
|
|
— |
|
Other assets |
4,373 |
|
|
4,114 |
|
Total assets |
$ |
105,926 |
|
|
$ |
172,977 |
|
Liabilities and
Shareholders’ (Deficit) Equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
15,334 |
|
|
$ |
11,019 |
|
Interest payable |
— |
|
|
1,077 |
|
Interest payable (related party) |
15 |
|
|
— |
|
Accrued expenses |
29,060 |
|
|
53,735 |
|
Deferred revenue |
40,000 |
|
|
— |
|
Operating lease liability |
1,516 |
|
|
— |
|
Current maturities of long-term debt |
— |
|
|
6,142 |
|
Total current liabilities |
85,925 |
|
|
71,973 |
|
Deferred rent |
— |
|
|
1,157 |
|
Deferred interest payable |
— |
|
|
2,273 |
|
Long-term operating lease
liability |
10,996 |
|
|
— |
|
Long-term debt, less current
maturities |
— |
|
|
93,240 |
|
Long-term debt, less current
maturities (related party) |
113,700 |
|
|
— |
|
Other |
3,582 |
|
|
— |
|
Total liabilities |
214,203 |
|
|
168,643 |
|
Total shareholders’ (deficit) equity |
(108,277 |
) |
|
4,334 |
|
Total liabilities and
shareholders’ (deficit) equity |
$ |
105,926 |
|
|
$ |
172,977 |
|
Investor Contact:Frank KarbePresident and Chief
Financial OfficerMyovant Sciences, Inc.investors@myovant.com
SOURCE: Myovant Sciences
Myovant Sciences (NYSE:MYOV)
Historical Stock Chart
From Mar 2024 to Apr 2024
Myovant Sciences (NYSE:MYOV)
Historical Stock Chart
From Apr 2023 to Apr 2024