BASEL, Switzerland,
Feb. 7, 2019 /PRNewswire/
-- Myovant Sciences (NYSE: MYOV), a clinical-stage
biopharmaceutical company focused on developing and commercializing
innovative therapies for the treatment of women's health and
endocrine diseases, today announced corporate updates and reported
financial results for the third fiscal quarter ended
December 31, 2018.
"As we enter this new year, we look forward to our first Phase 3
data from our LIBERTY program in uterine fibroids. The recent
approval by Takeda for Relumina® (relugolix 40 mg tablets) for the
treatment of uterine fibroids in Japan, further validates our belief in
relugolix as a critical treatment for people with uterine fibroids
in the U.S. and Europe," said
Lynn Seely, M.D., President and
Chief Executive Officer of Myovant Sciences. "We continue to be on
track to deliver data from both our LIBERTY and HERO programs this
year, however enrollment for our SPIRIT endometriosis studies has
taken longer than anticipated. While we remain confident that
enrollment will be completed in 2019, we now anticipate top-line
data for SPIRIT will be available in the first quarter of next
year."
Recent Business Highlights and Upcoming Milestones
Relugolix Phase 3 Clinical Programs
- Completed patient enrollment in the Phase 3 LIBERTY 2 trial
evaluating relugolix in combination with estradiol and a progestin
in women with heavy menstrual bleeding associated with uterine
fibroids.
- Expect top-line data from LIBERTY 1 and LIBERTY 2 Phase 3
trials evaluating the safety and efficacy of relugolix in
combination with estradiol and a progestin in women with heavy
menstrual bleeding associated with uterine fibroids in Q2 and Q3 of
2019, respectively, and assuming positive data, submission of the
New Drug Application (NDA) to the U.S. Food and Drug Administration
(FDA) in Q4 of 2019.
- Expect top-line data from the HERO Phase 3 trial evaluating the
safety and efficacy of relugolix in men with advanced prostate
cancer in Q4 2019, and assuming positive data, submission of the
NDA to the FDA in early 2020.
- Expect completion of enrollment in both SPIRIT 1 and SPIRIT 2
Phase 3 trials evaluating the safety and efficacy of relugolix in
women with pain associated with endometriosis this year, with
top-line data expected in Q1 2020.
- On January 8, 2019, Takeda
Pharmaceutical Company Limited and ASKA Pharmaceutical Co., Ltd.
announced that Takeda has obtained marketing authorization in
Japan from the Ministry of Health,
Labour and Welfare for Relumina® Tablets 40 mg (generic name:
relugolix) for the improvement of symptoms of uterine fibroids
(heavy menstrual bleeding, lower abdominal pain, lower back pain,
and anemia).
MVT-602 Clinical Program
- Completed enrollment in the dose-finding
pharmacokinetic/pharmacodynamic Phase 2a study of MVT-602, a
kisspeptin-1 receptor agonist, in healthy women undergoing a
controlled ovarian stimulation protocol. Top-line results are
expected to be reported in the first half of 2019.
Corporate
- Raised proceeds of $92.0 million
pursuant to our existing financing arrangement with NovaQuest in
late December 2018.
Third Fiscal Quarter 2018 Financial Summary
Research and development (R&D) expenses for the
quarter ended December 31, 2018, were $58.4 million compared to $34.9 million for the comparable period in 2017.
The increase for the quarter primarily reflects the progress of
Myovant's ongoing Phase 3 clinical trials of relugolix, which were
initiated in 2017, as well as additional personnel-related expenses
and MVT-602 clinical trial expenses.
General and administrative (G&A) expenses for the
quarter ended December 31, 2018, were $10.7 million compared to $6.6 million for the comparable period in 2017.
The increase for the quarter primarily reflects increases in
personnel-related expenses, professional service fees, and other
administrative expenses to support Myovant's headcount growth and
expanding operations.
Net interest expense for the quarter ended
December 31, 2018, was $1.6
million compared to $0.9
million in the comparable prior year period. Net interest
expense consists of interest expense related to financing
agreements with NovaQuest and Hercules Capital, Inc., as well as
the associated non-cash amortization of debt discount and issuance
costs, partially offset by interest income earned on cash
equivalents.
Net loss for the quarter ended December 31, 2018,
was $70.6 million, compared to
$41.8 million for the comparable
period in 2017. On a per common share basis, net loss was
$1.04 and $0.70 for the quarters ended December 31,
2018, and 2017, respectively. The increases in the net loss and net
loss per common share for the quarter were driven primarily by the
increase in costs outlined above.
Capital resources: Cash and cash equivalents totaled
$183.0 million at December 31,
2018. An additional $40.6
million of capacity remains available under the
"at-the-market" equity offering program that Myovant initiated in
April 2018.
About Relugolix
Relugolix is an oral, once-daily, small molecule that acts as a
gonadotropin-releasing hormone, or GnRH, receptor antagonist.
More than 2,150 study participants have received treatment with
relugolix in Phase 1, Phase 2 and Phase 3 clinical trials. In
completed trials, relugolix was generally well tolerated and
suppressed estrogen and progesterone levels in women and
testosterone levels in men. Common side effects observed were
consistent with suppression of these hormones.
In the ongoing Phase 3 LIBERTY clinical trials in women with
heavy menstrual bleeding associated with uterine fibroids and the
ongoing Phase 3 SPIRIT clinical trials in women with pain
associated with endometriosis, relugolix is undergoing evaluation
in combination with estradiol and norethindrone acetate, a
progestin, and as monotherapy. Myovant is studying whether
the combination optimizes estradiol levels to the range required to
treat the signs and symptoms of endometriosis and uterine fibroids
while minimizing the side effects associated with low estrogen
levels, which include bone mineral density loss and hot flashes.
The ongoing Phase 3 HERO study is evaluating relugolix monotherapy
in men with advanced prostate cancer.
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 trial in healthy female volunteers to characterize the
dose-response curve in the controlled ovarian stimulation setting
has completed enrollment.
About Myovant Sciences
Myovant Sciences is a clinical-stage biopharmaceutical company
focused on developing and commercializing innovative therapies for
the treatment of women's health and endocrine diseases. Myovant's
lead product candidate is relugolix, an oral, once-daily, small
molecule that acts as a GnRH receptor antagonist. Myovant has
initiated three clinical programs for relugolix consisting of five
international Phase 3 clinical trials, two in women with heavy
menstrual bleeding associated with uterine fibroids (LIBERTY 1
& 2), two in women with pain associated with endometriosis
(SPIRIT 1 & 2), and one in men with advanced prostate cancer
(HERO). Myovant is also developing MVT-602, an oligopeptide
kisspeptin-1 receptor agonist, that is in Phase 2a development for
the treatment of female infertility as part of assisted
reproduction. Takeda Pharmaceuticals International AG granted
Myovant an exclusive, worldwide license to develop and
commercialize relugolix (excluding Japan and certain
other Asian countries where Takeda retains exclusive rights) and an
exclusive license to develop and commercialize MVT-602 in all
countries worldwide. Over time, Myovant intends to expand its
development pipeline to include other potential treatments for
women's health and endocrine diseases. For more information, please
visit Myovant's website at www.myovant.com.
Forward-Looking Statements
This press-release contains forward-looking statements,
including without limitation, statements related to: Myovant's
focus on developing and commercializing innovative therapies for
the treatment of women's health and endocrine diseases and its
intent to expand its development pipeline to include other
potential treatments for women's health and endocrine diseases; the
statements and Dr. Seely's quotes regarding the expected timelines
for announcing patient enrollment and top-line safety and efficacy
data for relugolix in 2019 and 2020 in three distinct indications;
other statements relating to the timing of reporting clinical trial
results, including the expected timeline for top-line results of
the Phase 2a study of MVT-602 in the first half of 2019; and the
announcement by Takeda that it has obtained marketing authorization
in Japan from the Ministry of
Health, Labour and Welfare for Relumina® (Relugolix 40 mg Tablets)
for the improvement of symptoms of uterine fibroids (heavy
menstrual bleeding, lower abdominal pain, lower back pain, and
anemia) and Dr. Seely's quote that the marketing authorization
further validates our belief in relugolix as a critical treatment
for people with uterine fibroids in the U.S. and Europe. Forward-looking statements can be
identified by words such as "anticipate," "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. Myovant 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. Such forward-looking statements 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. Factors that could
cause or contribute to such differences include, but are not
limited to, risks relating to those discussed in the section titled
"Risk Factors" set forth in Part II, Item 1A of Myovant's
Quarterly Report on Form 10-Q filed with the United States
Securities and Exchange Commission, or the SEC, on November 8,
2018, and in Myovant's future filings with the SEC including
without limitation, Myovant's Quarterly Report on Form 10-Q
expected to be filed with the SEC on or about February 7,
2019, and other filings that Myovant makes with the SEC from time
to time. These risks are not exhaustive. New risk factors
emerge from time to time and it is not possible for its management
to predict all risk factors, nor can Myovant 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.
These statements are inherently uncertain and investors are
cautioned not to unduly rely upon these statements. Except as
required by law, Myovant undertakes no obligation to update any
forward-looking statements to reflect events or circumstances after
the date of such statements.
Investor Contact:
Frank
Karbe
Chief Financial Officer
Myovant Sciences
investors@myovant.com
MYOVANT SCIENCES
LTD.
|
Condensed
Consolidated Statements of Operations
|
(Unaudited, in
thousands, except share and per share data)
|
|
|
Three Months Ended
December 31,
|
|
Nine Months Ended
December 31,
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development(1)
|
$
|
58,434
|
|
|
$
|
34,875
|
|
|
$
|
163,588
|
|
|
$
|
76,753
|
|
General and
administrative(2)
|
10,686
|
|
|
6,640
|
|
|
29,738
|
|
|
16,963
|
|
Total operating
expenses
|
69,120
|
|
|
41,515
|
|
|
193,326
|
|
|
93,716
|
|
|
|
|
|
|
|
|
|
Interest expense,
net
|
1,634
|
|
|
904
|
|
|
4,831
|
|
|
904
|
|
Other (income)
expense, net
|
(121)
|
|
|
(429)
|
|
|
147
|
|
|
(225)
|
|
Loss before income
taxes
|
(70,633)
|
|
|
(41,990)
|
|
|
(198,304)
|
|
|
(94,395)
|
|
Income tax (benefit)
expense
|
—
|
|
|
(213)
|
|
|
233
|
|
|
607
|
|
Net loss
|
$
|
(70,633)
|
|
|
$
|
(41,777)
|
|
|
$
|
(198,537)
|
|
|
$
|
(95,002)
|
|
Net loss per common
share — basic and diluted
|
$
|
(1.04)
|
|
|
$
|
(0.70)
|
|
|
$
|
(3.01)
|
|
|
$
|
(1.60)
|
|
Weighted average
common shares outstanding — basic
and diluted
|
67,616,419
|
|
|
59,629,486
|
|
|
65,873,779
|
|
|
59,446,140
|
|
|
|
(1) Includes the following
share-based compensation expense:
|
|
Research and
development
|
$
|
1,840
|
|
|
$
|
1,041
|
|
|
$
|
5,247
|
|
|
$
|
2,580
|
|
General and
administrative
|
$
|
2,954
|
|
|
$
|
2,252
|
|
|
$
|
8,516
|
|
|
$
|
5,663
|
|
MYOVANT SCIENCES
LTD.
|
Condensed
Consolidated Balance Sheets
|
(Unaudited, in
thousands)
|
|
|
December 31,
2018
|
|
March 31,
2018
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
|
183,003
|
|
|
$
|
108,624
|
|
Prepaid expenses and
other current assets
|
12,396
|
|
|
5,139
|
|
Income tax
receivable
|
767
|
|
|
1,000
|
|
Total current
assets
|
196,166
|
|
|
114,763
|
|
|
|
|
|
Property and
equipment, net
|
1,693
|
|
|
1,273
|
|
Other
assets
|
3,811
|
|
|
3,065
|
|
Total
assets
|
$
|
201,670
|
|
|
$
|
119,101
|
|
|
|
|
|
Liabilities and
Shareholders' Equity
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
|
5,471
|
|
|
$
|
4,578
|
|
Interest
payable
|
429
|
|
|
282
|
|
Accrued
expenses
|
48,388
|
|
|
30,265
|
|
Due to RSL, RSI and
RSG
|
66
|
|
|
1,960
|
|
Current maturities of
long-term debt
|
1,520
|
|
|
—
|
|
Total current
liabilities
|
55,874
|
|
|
37,085
|
|
|
|
|
|
Deferred
rent
|
1,132
|
|
|
408
|
|
Deferred interest
payable
|
773
|
|
|
255
|
|
Long-term debt, less
current maturities
|
97,156
|
|
|
43,624
|
|
Total
liabilities
|
154,935
|
|
|
81,372
|
|
|
|
|
|
Total shareholders'
equity
|
46,735
|
|
|
37,729
|
|
Total liabilities and
shareholders' equity
|
$
|
201,670
|
|
|
$
|
119,101
|
|
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SOURCE Myovant Sciences