Myovant Sciences (NYSE:
MYOV), a
clinical-stage healthcare company focused on developing and
commercializing innovative therapies for women’s health and
prostate cancer, today announced recent corporate updates and
reported financial results for the first fiscal quarter ended
June 30, 2019.
“Myovant Sciences recently announced positive top-line data for
the LIBERTY 1 and LIBERTY 2 studies evaluating relugolix
combination therapy in women with uterine fibroids, as well as the
positive results from a separate bioequivalence study supporting a
potential one pill, once-a-day dosing regimen of relugolix
combination therapy,” said Lynn Seely, M.D., President and Chief
Executive Officer of Myovant Sciences. “These results confirm the
potential of relugolix to offer a constellation of attributes in a
single pill, taken once-a-day and we are now focused on preparing
for the New Drug Application (NDA) submission to the U.S. Food and
Drug Administration (FDA), which we plan to file by the end of this
calendar year. We also look forward to reporting data from our
Phase 3 prostate cancer study later this calendar year and results
from our two Phase 3 endometriosis studies in the first and second
quarters of calendar year 2020.”
First Fiscal Quarter 2019 and Recent Business
Highlights
Relugolix Phase 3 Clinical Programs
- On May 14, 2019, Myovant Sciences announced positive top-line
results from the LIBERTY 1 Phase 3 study evaluating relugolix
combination therapy (relugolix 40 mg plus estradiol 1.0 mg and
norethindrone acetate 0.5 mg) once-a-day in women with uterine
fibroids and heavy menstrual bleeding. The study met its
primary endpoint with a p-value of <0.0001 and achieved six key
secondary endpoints with a well-tolerated safety profile.
- On July 23, 2019, Myovant Sciences announced positive top-line
results from the LIBERTY 2 Phase 3 study evaluating relugolix
combination therapy in women with uterine fibroids and heavy
menstrual bleeding. This study also met its primary endpoint
with a p-value of <0.0001 and achieved six key secondary
endpoints with a well-tolerated safety profile.
- On July 23, 2019, Myovant Sciences also announced that the
single-tablet relugolix combination therapy met all required FDA
criteria in a separate bioequivalence study supporting a potential
one-pill, once-a-day dosing regimen of relugolix.
- Based on the positive top-line results for LIBERTY 1 and
LIBERTY 2, Myovant Sciences currently plans to submit an NDA for
one-pill, once-a-day relugolix combination therapy for the
treatment of heavy menstrual bleeding and uterine fibroids to the
FDA in the fourth quarter of calendar year 2019 and the Marketing
Authorisation Application to the European Medicines Agency in the
first quarter of calendar year 2020.
- Enrollment of approximately 130 additional men with metastatic
prostate cancer in the Phase 3 HERO study was completed in July
2019. The objective of enrolling these men was 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.
MVT-602 Clinical Program
- Myovant Sciences completed a successful dose-finding
pharmacokinetic/pharmacodynamic Phase 2a study of MVT-602, a
kisspeptin-1 receptor agonist, in healthy women undergoing a
minimal controlled ovarian stimulation protocol. Top-line results
were presented at the European Society of Human Reproduction in
Vienna, Austria in June 2019. The study demonstrated that MVT-602
was generally well-tolerated and produced the desired luteinizing
hormone surge associated with high and dose-dependent rates of
ovulation in healthy women following a minimal controlled ovarian
stimulation protocol.
Corporate
- On June 4, 2019, Myovant Sciences completed an underwritten
public equity offering, receiving net proceeds of approximately
$134.5 million.
- In the first quarter of fiscal year 2019, Myovant Sciences
received aggregate net proceeds of $2.5 million pursuant to the
issuance of common shares under its “at-the-market” equity offering
program.
First Fiscal Quarter 2019 Financial Summary
Research and development (R&D) expenses for
the quarter ended June 30, 2019, were $51.1 million compared
to $51.3 million for the comparable prior year period. The
composition of R&D expenses in both periods is similar, and
primarily includes expenses related to Myovant Sciences’ Phase 3
clinical studies as well as personnel-related expenses for
employees engaged in R&D activities. R&D expenses for the
quarter ended June 30, 2018 reflected a ramp up in relugolix
Phase 3 study costs primarily related to study enrollment, whereas
R&D expenses for the quarter ended June 30, 2019 reflect
lower relugolix Phase 3 study costs as certain studies are in the
process of winding down. The decrease in relugolix Phase 3 study
costs were partially offset by increases in other R&D spending
related to Myovant Sciences’ preparations to seek regulatory
approval for its product candidates.
General and administrative (G&A) expenses
for the quarter ended June 30, 2019, were $14.2 million
compared to $8.7 million for the comparable prior year period. The
increase primarily reflects increases in personnel-related
expenses, professional service fees, share-based compensation, and
other general overhead and administrative expenses to support
Myovant Sciences’ headcount growth and expanding operations.
Interest expense for the quarter ended
June 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 the
financing agreements as compared to the prior year period.
Interest income for the quarter ended
June 30, 2019, was $0.8 million. There was no interest income
for the quarter ended June 30, 2018. During the quarter ended
June 30, 2019, a portion of Myovant Sciences’ cash was
invested in a combination of money market funds and commercial
paper. There were no such investments during the prior year
period.
Net loss for the quarter ended June 30,
2019, was $67.9 million, compared to $62.1 million for the
comparable prior year period. On a per common share basis, net loss
was $0.89 and $0.98 for the quarters ended June 30, 2019, and
2018, respectively. The increase in the net loss for the quarter
was driven primarily by the increase in costs outlined above.
Capital resources: Cash and cash equivalents
totaled $226.7 million as of June 30, 2019. During the quarter
ended June 30, 2019, Myovant Sciences raised net proceeds of
approximately $134.5 million from an underwritten public
equity offering and approximately $2.5 million from its
“at-the-market” equity offering program. Myovant Sciences currently
has approximately $10.4 million of capacity available under the
“at-the-market” equity offering program that it initiated in April
2018.
About Relugolix
Relugolix is a once-a-day, oral gonadotropin-releasing hormone
(GnRH) receptor antagonist that reduces ovarian estradiol and
progesterone production, hormones known to stimulate uterine
fibroids and endometriosis. Myovant Sciences has successfully
completed two Phase 3 clinical studies (LIBERTY 1 and LIBERTY 2)
evaluating relugolix combination therapy (relugolix 40 mg plus 1.0
mg estradiol with 0.5 mg norethindrone acetate) in women with heavy
menstrual bleeding and uterine fibroids and is studying relugolix
combination therapy in two Phase 3 clinical studies (SPIRIT 1 and
SPIRIT 2) in women with endometriosis-associated pain. Data from
SPIRIT 2 and SPIRIT 1 are expected in the first and second
quarters, respectively, of calendar year 2020. Relugolix also
lowers testosterone in men, an androgen known to drive the growth
of prostate cancer. Myovant Sciences is evaluating relugolix, 120
mg once-a-day, in the Phase 3 HERO study in men with advanced
prostate cancer. Top-line results from the HERO study are expected
in the fourth quarter of calendar year 2019.
About MVT-602
MVT-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 Sciences
Myovant Sciences aspires to be the leading healthcare company
focused on innovative treatments for women’s health and prostate
cancer. Myovant Sciences’ lead product candidate is relugolix, an
oral, once-a-day small molecule that acts as a GnRH receptor
antagonist. Myovant Sciences has three late-stage clinical programs
for relugolix ongoing in uterine fibroids, endometriosis and
prostate cancer. Myovant Sciences 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
granted Myovant Sciences 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. Over time,
Myovant Sciences intends to expand its development pipeline to
include other potential treatments for women’s health and prostate
cancer. For more information, please visit Myovant Sciences’
website at www.myovant.com. Follow @Myovant on Twitter and
LinkedIn (https://linkedin.com/company/myovant-sciences/).
Forward-Looking Statements
This 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, Myovant
Sciences’ intentions to expand its development pipeline to include
other potential treatments for women’s health and prostate cancer,
Myovant Sciences’ plans to submit the uterine fibroids NDA to the
FDA in the fourth quarter of calendar year 2019 and the Marketing
Authorisation Application to the European Medicines Agency in the
first quarter of calendar year 2020, to report data from its Phase
3 prostate cancer study later this calendar year and the results
from its two Phase 3 endometriosis studies in the first and second
quarters of calendar year 2020.
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’ Annual Report on Form 10-K filed with
the SEC on May 24, 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 August 6, 2019, as such risk factors may
be amended, supplemented or superseded from time to time by other
reports Myovant Sciences files with the SEC. 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 June 30, |
|
2019 |
|
2018 |
Operating
expenses: |
|
|
|
Research and development (1) |
$ |
51,117 |
|
|
$ |
51,341 |
|
General and administrative (1) |
14,152 |
|
|
8,742 |
|
Total operating expenses |
65,269 |
|
|
60,083 |
|
Interest expense |
3,793 |
|
|
1,617 |
|
Interest income |
(766 |
) |
|
— |
|
Other (income) expense,
net |
(705 |
) |
|
289 |
|
Loss before income taxes |
(67,591 |
) |
|
(61,989 |
) |
Income tax expense |
313 |
|
|
145 |
|
Net loss |
$ |
(67,904 |
) |
|
$ |
(62,134 |
) |
Net loss per common
share — basic and diluted |
$ |
(0.89 |
) |
|
$ |
(0.98 |
) |
Weighted average
common shares outstanding — basic and diluted |
76,468,347 |
|
|
63,310,177 |
|
|
|
|
|
|
|
(1) Includes the following
share-based compensation expenses: |
|
|
|
|
|
Research and development |
$ |
2,548 |
|
|
$ |
1,561 |
|
General and
administrative |
$ |
3,904 |
|
|
$ |
2,683 |
|
MYOVANT SCIENCES
LTD.Condensed Consolidated Balance
Sheets(Unaudited, in thousands)
|
June 30, 2019 |
|
March 31, 2019 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
226,734 |
|
|
$ |
156,074 |
|
Prepaid expenses and other current assets |
8,693 |
|
|
10,194 |
|
Income tax receivable |
331 |
|
|
524 |
|
Total current assets |
235,758 |
|
|
166,792 |
|
Property and equipment,
net |
2,057 |
|
|
2,071 |
|
Operating lease right-of-use
asset |
9,181 |
|
|
— |
|
Other assets |
3,877 |
|
|
4,114 |
|
Total assets |
$ |
250,873 |
|
|
$ |
172,977 |
|
Liabilities and
Shareholders’ Equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
10,004 |
|
|
$ |
11,019 |
|
Interest payable |
758 |
|
|
1,077 |
|
Accrued expenses |
46,258 |
|
|
53,614 |
|
Operating lease liability |
813 |
|
|
— |
|
Due to Roivant Sciences Ltd., Roivant Sciences, Inc., and Roivant
Sciences GmbH |
196 |
|
|
121 |
|
Current maturities of long-term debt |
10,867 |
|
|
6,142 |
|
Total current liabilities |
68,896 |
|
|
71,973 |
|
Deferred rent |
— |
|
|
1,157 |
|
Deferred interest payable |
3,790 |
|
|
2,273 |
|
Long-term operating lease
liability |
9,550 |
|
|
— |
|
Long-term debt, less current
maturities |
89,070 |
|
|
93,240 |
|
Total liabilities |
171,306 |
|
|
168,643 |
|
Total shareholders’ equity |
79,567 |
|
|
4,334 |
|
Total liabilities and
shareholders’ equity |
$ |
250,873 |
|
|
$ |
172,977 |
|
Investor Contact:Frank KarbeChief Financial
OfficerMyovant Sciencesinvestors@myovant.com
SOURCE: Myovant Sciences
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