BASEL, Switzerland,
June 7, 2018 /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, or Myovant,
today announced corporate updates and reported financial results
for the fourth fiscal quarter and full fiscal year ended
March 31, 2018.
"I am proud of the Myovant team and our fiscal 2017 clinical and
corporate accomplishments. Our energy continues to be focused
on completing patient enrollment for our ongoing global Phase 3
clinical development programs of relugolix for the treatment of
heavy menstrual bleeding associated with uterine fibroids,
endometriosis-associated pain and advanced prostate cancer," stated
Lynn Seely, M.D., President and
Chief Executive Officer of Myovant Sciences. "With our recent
capital raise and corporate progress, we believe we are well
positioned to execute and advance our corporate mission."
Fourth Fiscal Quarter 2017 and Recent Business
Highlights
- On March 26, 2018, an additional
$15.0 million of Myovant's financing
commitments from Hercules Capital, Inc., or Hercules, was funded
prior to the March 31, 2018, term
commitment termination date, resulting in $40.0 million total principal amount outstanding
under the loan and security agreement.
- On April 2, 2018, Myovant entered into a share purchase
agreement with Roivant Sciences Ltd., or RSL, Myovant's majority
shareholder, pursuant to which Myovant issued and sold to RSL
1,110,015 common shares at a purchase price of $20.27 per common share in a private placement,
or the Private Placement. Myovant received gross proceeds of
$22.5 million at the closing of the
Private Placement.
- On April 2, 2018, Myovant also entered into a Sales
Agreement with Cowen and Company, LLC, to sell common shares having
an aggregate offering price of up to $100.0
million through an "at-the-market," or ATM, equity offering
program. In the first quarter of fiscal 2018, Myovant issued
and sold 2,767,129 common shares under this program at a
weighted-average-price of $21.47 per
common share for aggregate net proceeds of approximately
$57.6 million, after deducting
commissions.
- On April 20, 2018, Myovant
announced a partnership with PERIOD, Inc., a youth-led non-profit
organization focused on menstrual equity, to elevate the
conversation around period health, including an Ask Me About
Periods campaign on college campuses around the country.
- On May 30, 2018, Myovant entered
into a Commercial Manufacturing and Supply Agreement with Takeda
Pharmaceutical Company Ltd., or Takeda, pursuant to which Takeda
will manufacture and supply Myovant with relugolix drug substance
to support the commercial launch of relugolix, if marketing
authorization is granted. Takeda has agreed to assist with
the transfer of technology and manufacturing know-how to a second
contract manufacturing organization of
Myovant.
- In May 2018, following the
completion of a Phase 1 study, Myovant initiated a Phase 2a
clinical trial in healthy female volunteers to characterize the
dose response curve in the controlled ovarian stimulation setting
prior to studying MVT-602 in infertile woman seeking
pregnancy.
Fourth Fiscal Quarter and Full Fiscal Year 2017 Financial
Summary
Research and development (R&D) expenses for the
quarter ended March 31, 2018, were $40.1 million compared to $19.0 million for the comparable period in 2017.
R&D expenses for the fiscal year ended March 31, 2018,
were $116.8 million, compared to
$43.5 million for the prior fiscal
year. The increase for both the quarter and the year primarily
reflects the progress of Myovant's ongoing five Phase 3 clinical
trials of relugolix, which were initiated in 2017, and additional
personnel-related expenses as a result of an increased number of
R&D employees.
General and administrative (G&A) expenses for the
quarter ended March 31, 2018, were
$7.3 million, compared to
$3.9 million for the comparable
period in 2017. G&A expenses for the fiscal year ended
March 31, 2018, were $24.2
million, compared to $12.4
million for the prior fiscal year. The increase for both the
quarter and the year primarily reflects increases in
personnel-related expenses, professional service fees, and other
administrative expenses to support Myovant's headcount growth and
expanding operations.
Interest expense for the quarter and year ended
March 31, 2018, was $1.1 million
and $2.0 million, respectively, while
there was no interest expense in the comparable prior year
periods. Interest expense for both the quarter and the year
consisted of interest expense related to financing agreements with
NovaQuest Pharma Opportunities Fund IV L.P., or NovaQuest, and
Hercules as well as the associated non-cash amortization of debt
discount and issuance costs.
Net loss for the quarter ended March 31, 2018, was
$48.3 million, compared to
$21.7 million for the comparable
period in 2017. Net loss for the fiscal year ended March 31,
2018, was $143.3 million, compared to
$83.4 million for the prior fiscal
year. On a per common share basis, net loss was $0.81 and $0.37 for
the quarters ended March 31, 2018 and 2017, respectively, and
$2.41 and $1.70 for the fiscal years ended March 31,
2018 and 2017, respectively. The increase in the net loss and net
loss per common share for both the quarter and the year were driven
primarily by the increase in costs associated with Myovant's
ongoing Phase 3 clinical trials, which were initiated in 2017, as
well as increased personnel-related expenses. The net loss
for the prior fiscal year of $83.4
million included $27.5 million
of non-cash expense resulting from changes in the fair value of the
Takeda warrant liability, which expired on April 30, 2017.
Capital resources: Cash and committed
funding totaled $200.6 million
at March 31, 2018, consisting of $108.6
million of cash and $92.0
million of remaining financing commitments available from
NovaQuest under the NovaQuest Securities Purchase Agreement and the
NovaQuest Equity Purchase Agreement. In the first quarter of
fiscal year 2018, Myovant further strengthened its balance sheet,
raising $22.5 million with the
completion of the Private Placement of 1,110,015 common shares to
RSL and raising net proceeds of approximately $57.6 million, after deducting commissions, from
the issuance and sale of 2,767,129 common shares pursuant to its
ATM program. Approximately $40.6
million of capacity remains available under the ATM
program.
About Relugolix
Relugolix is an oral, once-daily, small molecule that acts as a
gonadotropin-releasing hormone, or GnRH, receptor antagonist that
has been evaluated in over 1,600 study participants in Phase 1,
Phase 2 and Phase 3 clinical trials. In these trials, relugolix has
been shown to be generally well tolerated and to suppress 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 SPIRIT clinical trials in
women with endometriosis-associated pain and the ongoing Phase 3
LIBERTY clinical trials in women with heavy menstrual bleeding
associated with uterine fibroids, relugolix is undergoing
evaluation with and without low-dose hormonal add-back therapy, the
addition of which is expected to decrease potential relugolix side
effects such as bone mineral density loss and hot flashes. The
ongoing Phase 3 HERO study is evaluating relugolix alone in men
with advanced prostate cancer.
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
goal is to be the leading global biopharmaceutical company focused
on treating women's health and endocrine diseases in areas of high
unmet medical need. 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 and 2), two in women with
endometriosis-associated pain (SPIRIT 1 and 2), and one in men with
advanced prostate cancer (HERO). Myovant is also developing
MVT-602, a kisspeptin agonist, for the treatment of female
infertility as part of assisted reproduction. Takeda
Pharmaceuticals International AG has 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; Dr. Seely's
quotes regarding patient enrollment for Myovant's ongoing global
Phase 3 clinical development programs of relugolix for the
treatment of heavy menstrual bleeding associated with uterine
fibroids, endometriosis-associated pain and advanced prostate
cancer; and the remaining available financing commitments.
Forward-looking statements can be identified by the words
"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. The
forward-looking statements appearing in a number of places
throughout this press release, include, but are not limited to,
statements regarding Myovant's intentions, beliefs, projections,
outlook, analyses or current expectations concerning, among other
things: the success and anticipated timing of Myovant's clinical
trials for relugolix and MVT-602; the anticipated start dates,
durations and completion dates of its ongoing and future
nonclinical studies and clinical trials; the anticipated designs of
its future clinical trials; anticipated future regulatory
submissions and the timing of, and its ability to, obtain and
maintain regulatory approvals for relugolix, MVT-602 and any future
product candidates; its plans to commercialize relugolix, if
approved; its ability to launch commercial sales of any approved
products, whether alone or in collaboration with others; the rate
and degree of market acceptance and clinical utility of any
approved product candidate; its ability to initiate and continue
relationships with third-party manufacturers; its ability to
quickly and efficiently identify and develop product candidates;
its ability to hire and retain its key scientific or management
personnel; its ability to obtain, maintain and enforce intellectual
property rights for its product candidates; the anticipated receipt
of the remaining funding available to Myovant under the NovaQuest
Securities Purchase Agreement and the NovaQuest Equity Purchase
Agreement; its estimates regarding its results of operations,
financial condition, liquidity, capital requirements, access to
capital, prospects, growth and strategies; developments and
projections relating to its competitors or its industry; and the
success of competing drugs that are or may become available. 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,
those identified herein, and those discussed in the section titled
"Risk Factors" set forth in Part I, Item 1A of Myovant's
Quarterly Report on Form 10-Q filed with the United States
Securities and Exchange Commission, or the SEC, on February 13, 2018, and in Myovant's future
filings with the SEC including without limitation, Myovant's Annual
Report on Form 10-K expected to be filed with the SEC on or about
June 7, 2018, 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. In addition, statements that "we
believe," "Myovant believes," and similar statements reflect its
beliefs and opinions on the relevant subject. These statements are
based upon information available to Myovant as of the date of this
press release, and while Myovant believes such information forms a
reasonable basis for such statements, such information may be
limited or incomplete, and its statements should not be read to
indicate that it has conducted an exhaustive inquiry into, or
review of, all potentially available relevant information. 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.
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,
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development (1)
|
$
|
40,079
|
|
|
$
|
19,016
|
|
|
$
|
116,832
|
|
|
$
|
43,500
|
|
General and
administrative (1)
|
7,268
|
|
|
3,930
|
|
|
24,231
|
|
|
12,357
|
|
Total operating
expenses
|
47,347
|
|
|
22,946
|
|
|
141,063
|
|
|
55,857
|
|
|
|
|
|
|
|
|
|
Changes in the fair
value of the Takeda warrant liability
|
—
|
|
|
(1,297)
|
|
|
—
|
|
|
27,518
|
|
Interest
expense
|
1,142
|
|
|
—
|
|
|
2,046
|
|
|
—
|
|
Other expense
(income)
|
158
|
|
|
139
|
|
|
(67)
|
|
|
139
|
|
Loss before income
taxes
|
(48,647)
|
|
|
(21,788)
|
|
|
(143,042)
|
|
|
(83,514)
|
|
Income tax (benefit)
expense
|
(394)
|
|
|
(114)
|
|
|
213
|
|
|
(74)
|
|
Net loss
|
$
|
(48,253)
|
|
|
$
|
(21,674)
|
|
|
$
|
(143,255)
|
|
|
$
|
(83,440)
|
|
|
|
|
|
|
|
|
|
Net loss per common
share — basic and diluted
|
$
|
(0.81)
|
|
|
$
|
(0.37)
|
|
|
$
|
(2.41)
|
|
|
$
|
(1.70)
|
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding — basic and diluted
|
59,748,711
|
|
|
59,132,476
|
|
|
59,520,747
|
|
|
49,184,668
|
|
|
|
(1) Includes the following
share-based compensation expenses:
|
|
Research and
development
|
$
|
1,094
|
|
|
$
|
1,044
|
|
|
$
|
3,674
|
|
|
$
|
3,893
|
|
General and
administrative
|
$
|
2,246
|
|
|
$
|
892
|
|
|
$
|
7,909
|
|
|
$
|
4,824
|
|
MYOVANT SCIENCES
LTD.
|
Condensed
Consolidated Balance Sheets
|
(Unaudited, in
thousands)
|
|
|
March 31,
2018
|
|
March 31,
2017
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash
|
$
|
108,624
|
|
|
$
|
180,838
|
|
Prepaid expenses and
other current assets
|
5,139
|
|
|
3,221
|
|
Income tax
receivable
|
1,000
|
|
|
105
|
|
Total current
assets
|
114,763
|
|
|
184,164
|
|
|
|
|
|
Deferred tax
assets
|
—
|
|
|
208
|
|
Furniture and
equipment, net
|
1,273
|
|
|
906
|
|
Other
assets
|
3,065
|
|
|
—
|
|
Total
assets
|
$
|
119,101
|
|
|
$
|
185,278
|
|
|
|
|
|
Liabilities and
Shareholders' Equity
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
|
4,578
|
|
|
$
|
3,329
|
|
Interest
payable
|
282
|
|
|
—
|
|
Accrued
expenses
|
30,265
|
|
|
11,978
|
|
Due to Roivant
Sciences Ltd., Roivant Sciences, Inc. and Roivant Sciences
GmbH
|
1,960
|
|
|
3,030
|
|
Total current
liabilities
|
37,085
|
|
|
18,337
|
|
|
|
|
|
Takeda warrant
liability
|
—
|
|
|
52
|
|
Deferred
rent
|
408
|
|
|
113
|
|
Deferred interest
payable
|
255
|
|
|
—
|
|
Long-term
debt
|
43,624
|
|
|
—
|
|
Total
liabilities
|
81,372
|
|
|
18,502
|
|
|
|
|
|
Total shareholders'
equity
|
37,729
|
|
|
166,776
|
|
Total liabilities and
shareholders' equity
|
$
|
119,101
|
|
|
$
|
185,278
|
|
Investor Contact:
Frank
Karbe
Chief Financial Officer
Myovant Sciences
investors@myovant.com
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