Myovant Sciences (NYSE:
MYOV), a healthcare
company focused on developing innovative treatments for women’s
health and prostate cancer, today announced recent corporate
updates and reported financial results for the second fiscal
quarter ended September 30, 2019.
“Myovant continues to make great progress
towards our milestones and is poised for a strong commercial launch
of relugolix if approved, with two positive Phase 3 studies
evaluating relugolix combination therapy in women with uterine
fibroids and approximately $500 million in total cash and committed
financing, including the Sumitomo Dainippon Pharma term loan
facility,” said Lynn Seely, M.D., President and CEO of Myovant
Sciences. “Bringing a new treatment to the millions of women who
suffer from uterine fibroids and endometriosis has been the key
vision for the development of Myovant’s relugolix combination
tablet. The use of a priority review voucher enables us to expedite
the review of our NDA while strengthening the data package in the
submission to support this objective.”
Second Fiscal Quarter
2019 and Recent Business Highlights
Relugolix Phase 3 Clinical Programs
- In July 2019, Myovant announced
positive top-line data from LIBERTY 2, the second of two Phase 3
studies evaluating relugolix combination therapy (relugolix 40 mg
plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women
with uterine fibroids and heavy menstrual bleeding. Results from a
separate bioequivalence study support submission to the FDA of a
potential one tablet, once-daily dosing regimen of relugolix
combination therapy. In addition, the 12-month safety data from the
LIBERTY open-label extension study are expected in the first
quarter of calendar year 2020.
- Roivant Sciences and Sumitomo
Dainippon Pharma have committed to Myovant a priority review
voucher (PRV) expected to become available in early December 2019.
Myovant plans to use the PRV in conjunction with its NDA submission
for a once-daily, relugolix combination tablet for the treatment of
heavy menstrual bleeding and uterine fibroids, potentially
decreasing the standard FDA review time. Myovant has decided to
defer its NDA submission for a once-daily, relugolix combination
tablet for the treatment of heavy menstrual bleeding and uterine
fibroids until April 2020, which would allow inclusion of the
complete 12-month safety data from the LIBERTY open-label extension
study, key data that may positively impact the labeled duration of
use of the combination tablet. The terms regarding how the PRV will
be transferred to Myovant will be determined in connection with the
closing of the Roivant-Sumitomo Dainippon Pharma transaction. The
transfer is expected to be a related-party transaction and will not
involve the issuance of Myovant shares. Myovant still plans to
submit a Marketing Authorisation Application (MAA) to the European
Medicines Agency in the first quarter of calendar year
2020.
- In July 2019, Myovant completed
enrollment of an additional cohort of 139 men with metastatic
prostate cancer in the Phase 3 HERO study in order to assess the
secondary objective of demonstrating that relugolix can delay the
time to progression of the lethal state of the disease,
castration-resistant prostate cancer, as compared to leuprolide.
Myovant expects the top-line data readout for the HERO study by the
end of calendar year 2019, with results from this additional
cohort, including the castration resistance-free survival endpoint,
expected in the third quarter of calendar year 2020. Myovant also
anticipates submitting its NDA for its once-daily, oral relugolix
monotherapy tablet for men with advanced prostate cancer in the
second quarter of calendar year 2020.
- In August and October 2019, Myovant
completed patient recruitment for the Phase 3 SPIRIT 2 and SPIRIT 1
studies, respectively, evaluating the safety and efficacy of
relugolix combination therapy in women with pain associated with
endometriosis. Myovant expects to report top-line results from
SPIRIT 2 and SPIRIT 1 in the first and second quarters of calendar
year 2020, respectively.
Corporate
- In October 2019, Myovant entered
into a landmark agreement with Sumitomo Dainippon Pharma to secure
a $350 million low-interest, five-year term loan facility, with no
payments due until the end of the term, and an Investors Rights
Agreement, which is intended to provide safeguards to minority
shareholders. The term loan facility and Investors Rights Agreement
are expected to become effective in connection with the closing of
Sumitomo Dainippon Pharma’s transaction with Roivant.
Second Fiscal Quarter 2019 Financial
Summary
Research and development
(R&D) expenses for the quarter ended
September 30, 2019, were $50.8 million compared to $53.8
million for the comparable prior year period. R&D expenses in
both periods primarily include expenses related to Myovant’s Phase
3 clinical studies, manufacturing expenses as well as
personnel-related expenses for employees engaged in R&D
activities. R&D expenses related to Myovant’s clinical studies
have continued to decline driven primarily by the wind down of
Myovant’s LIBERTY Phase 3 studies. The decrease in study costs were
partially offset by increases in other R&D expenses related
predominantly to Myovant’s manufacturing activities in connection
with preparations for Myovant’s anticipated commercial launches and
regulatory submissions for relugolix in multiple indications and
jurisdictions, as well as increases in personnel expenses,
share-based compensation expense, and other R&D expenses.
General and administrative
(G&A) expenses for the quarter ended
September 30, 2019, were $16.6 million compared to $10.3
million for the comparable prior year period. The increase
primarily reflects increases in personnel-related expenses,
share-based compensation, professional service fees, expenses
related to commercial operations activities in advance of potential
regulatory approvals of relugolix, and other general overhead and
administrative expenses to support Myovant’s headcount growth and
expanding operations which was in part driven by the assumption of
activities previously provided by Roivant.
Interest expense for the
quarter ended September 30, 2019, was $3.8 million compared to
$1.6 million in the comparable prior year period. The increase for
the quarter was primarily the result of higher outstanding debt
balances under Myovant’s financing agreements as compared to the
prior year period.
Interest income for the quarter
ended September 30, 2019, was $0.9 million. There was no
interest income for the quarter ended September 30, 2018.
During the quarter ended September 30, 2019, a portion of
Myovant’s cash was invested in a combination of money market funds,
commercial paper, and short-term corporate bonds. There were no
such investments during the comparable prior year period.
Net loss for the quarter ended
September 30, 2019, was $70.6 million, compared to $65.8
million for the comparable prior year period. The increase in the
net loss for the quarter was driven primarily by the increase in
costs outlined above. On a per common share basis, net loss was
$0.79 and $0.99 for the quarters ended September 30, 2019, and
2018, respectively. The decrease in the net loss per common share
for the quarter was due to an increase in the weighted-average
common shares outstanding primarily as a result of Myovant’s
underwritten public equity offering in June 2019.
Capital resources: Cash, cash
equivalents, and marketable securities totaled $157.6 million as of
September 30, 2019. Myovant’s term loan facility to be entered
into with Sumitomo Dainippon Pharma, which is expected to become
effective in connection with the close of the Sumitomo-Roivant
transaction, is expected to provide an additional $350.0 million of
capital to support Myovant’s operations. 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 Sciences is developing a relugolix
combination tablet (relugolix 40 mg plus estradiol 1.0 mg and
norethindrone acetate 0.5 mg) for women with heavy menstrual
bleeding associated with uterine fibroids and for women with
endometriosis-associated pain. Myovant is also evaluating relugolix
monotherapy (120 mg once daily) in 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 innovative treatments for women’s health and prostate cancer.
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, granted the company an
exclusive, 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. For more information, please visit the
company’s website at www.myovant.com.
Follow @Myovant on Twitter and LinkedIn.
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 regarding Myovant Sciences’ aspirations to
become the leading healthcare company focused on innovative
treatments for women’s health and prostate cancer; the expected
timing and terms of agreements with Sumitomo Dainippon Pharma,
including an anticipated loan facility and Investors Rights
Agreement; the expected timing of announcements of data from
Myovant’s clinical studies, including the Phase 3 HERO and SPIRIT
studies; the expected timing of Myovant Sciences’ uterine fibroids
NDA submission to the FDA and Marketing Authorisation Application
to the European Medicines Agency; the potential for Myovant
Sciences to obtain a priority review voucher from Roivant Sciences
and Sumitomo Dainippon Pharma and the likelihood and timing of when
such priority review voucher is expected to be available and
transferred to Myovant Sciences.
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. 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 with the SEC on August 6, 2019,
and in Myovant Sciences’ future filings with the SEC including
without limitation, Myovant Sciences’ Quarterly Report on Form 10-Q
expected to be filed with the SEC on or about November 12,
2019, as such risk factors may be amended, supplemented or
superseded from time to time by other reports Myovant Sciences
files with the SEC. In addition, the terms of the term loan
facility, the Investors Rights Agreement and the priority review
voucher transfer with Sumitomo Dainippon Pharma, although agreed to
be entered into, have not yet been fully negotiated, and are
expected to be negotiated, entered into and become effective in
connection with the closing of Sumitomo Dainippon Pharma’s
transaction with Roivant Sciences. As a result, unexpected
disagreements may arise in the negotiations of these agreements
that may delay or prevent the entering into of these agreements;
further, these agreements will only become effective upon closing
of Sumitomo Dainippon Pharma’s transaction with Roivant Sciences,
which if the closing does not occur will cause these agreements not
to become effective. 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, except as may be required by law.
MYOVANT SCIENCES
LTD.Condensed Consolidated Statements of
Operations(Unaudited, in thousands, except share and per
share data)
|
Three Months Ended September 30, |
|
Six Months Ended September 30, |
|
2019 |
|
2018 |
|
2019 |
|
2018 |
Operating
expenses: |
|
|
|
|
|
|
|
Research and development (1) |
$ |
50,803 |
|
|
$ |
53,813 |
|
|
$ |
101,920 |
|
|
$ |
105,154 |
|
General and administrative (1) |
16,603 |
|
|
10,310 |
|
|
30,755 |
|
|
19,052 |
|
Total operating expenses |
67,406 |
|
|
64,123 |
|
|
132,675 |
|
|
124,206 |
|
Interest expense |
3,788 |
|
|
1,580 |
|
|
7,581 |
|
|
3,197 |
|
Interest income |
(942 |
) |
|
— |
|
|
(1,708 |
) |
|
— |
|
Other expense (income),
net |
121 |
|
|
(21 |
) |
|
(584 |
) |
|
268 |
|
Loss before income taxes |
(70,373 |
) |
|
(65,682 |
) |
|
(137,964 |
) |
|
(127,671 |
) |
Income tax expense |
195 |
|
|
88 |
|
|
508 |
|
|
233 |
|
Net loss |
$ |
(70,568 |
) |
|
$ |
(65,770 |
) |
|
$ |
(138,472 |
) |
|
$ |
(127,904 |
) |
Net loss per common
share — basic and diluted |
$ |
(0.79 |
) |
|
$ |
(0.99 |
) |
|
$ |
(1.68 |
) |
|
$ |
(1.97 |
) |
Weighted average
common shares outstanding — basic and diluted |
88,798,398 |
|
|
66,666,876 |
|
|
82,667,061 |
|
|
64,997,698 |
|
(1) Includes the following share-based compensation
expenses:
Research and development |
$ |
3,618 |
|
$ |
1,846 |
|
$ |
6,166 |
|
$ |
3,407 |
|
General and
administrative |
$ |
4,313 |
|
$ |
2,879 |
|
$ |
8,217 |
|
$ |
5,562 |
|
MYOVANT SCIENCES
LTD.Condensed Consolidated Balance
Sheet(Unaudited, in thousands)
|
September 30, 2019 |
|
March 31, 2019 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
130,373 |
|
|
$ |
156,074 |
|
Marketable securities |
27,220 |
|
|
— |
|
Prepaid expenses and other current assets |
9,969 |
|
|
10,194 |
|
Income tax receivable |
17 |
|
|
524 |
|
Total current assets |
167,579 |
|
|
166,792 |
|
Property and equipment,
net |
2,288 |
|
|
2,071 |
|
Operating lease right-of-use
asset |
8,973 |
|
|
— |
|
Other assets |
5,162 |
|
|
4,114 |
|
Total assets |
$ |
184,002 |
|
|
$ |
172,977 |
|
Liabilities and
Shareholders’ Equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
5,819 |
|
|
$ |
11,019 |
|
Interest payable |
305 |
|
|
1,077 |
|
Accrued expenses |
44,380 |
|
|
53,614 |
|
Operating lease liability |
853 |
|
|
— |
|
Due to Roivant Sciences Ltd., Roivant Sciences, Inc., and Roivant
Sciences GmbH |
271 |
|
|
121 |
|
Current maturities of long-term debt |
8,402 |
|
|
6,142 |
|
Total current liabilities |
60,030 |
|
|
71,973 |
|
Deferred rent |
— |
|
|
1,157 |
|
Deferred interest payable |
5,323 |
|
|
2,273 |
|
Long-term operating lease
liability |
9,320 |
|
|
— |
|
Long-term debt, less current
maturities |
92,075 |
|
|
93,240 |
|
Total liabilities |
166,748 |
|
|
168,643 |
|
Total shareholders’ equity |
17,254 |
|
|
4,334 |
|
Total liabilities and
shareholders’ equity |
$ |
184,002 |
|
|
$ |
172,977 |
|
Investor Contact:Frank KarbeChief Financial
OfficerMyovant Sciences, Inc. investors@myovant.com
SOURCE: Myovant Sciences
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