BASEL, Switzerland,
Feb. 13, 2018 /PRNewswire/
-- Myovant Sciences (NYSE: MYOV), a clinical-stage
biopharmaceutical company focused on developing and commercializing
innovative therapies for women's health and endocrine diseases,
today announced corporate updates and reported financial results
for the third fiscal quarter ended December
31, 2017.
"We continue to execute on each of our ongoing global Phase 3
development programs of relugolix for the treatment of
endometriosis-associated pain, heavy menstrual bleeding associated
with uterine fibroids, and advanced prostate cancer with the goal
of completing enrollment in each program this year," stated
Lynn Seely, M.D., President and
Chief Executive Officer of Myovant Sciences. "In addition, in
October, we secured flexible financing commitments of up to
$140 million, which will help support
the continued advancement of our Phase 3 programs."
Third Fiscal Quarter 2017 Business Highlights
Positive results in two Phase 3 clinical studies conducted by
Takeda Pharmaceutical Company Limited ("Takeda") to evaluate the
efficacy and safety of relugolix for the treatment of uterine
fibroids.
- On October 2, 2017, Myovant
announced that Takeda reported positive top-line results from a
Phase 3 study in Japan evaluating
the efficacy and safety of relugolix compared with leuprorelin for
the treatment of women with heavy menstrual bleeding associated
with uterine fibroids. Relugolix met the study's primary endpoint,
the proportion of patients achieving a pre-defined reduction in
menstrual bleeding, demonstrating an 82.2% response rate, and was
observed to be statistically non-inferior to leuprorelin (p =
0.0013). The incidence of adverse events in the study was generally
similar between treatment groups and consistent with the mechanism
of action of the study medications.
- On November 9, 2017, Myovant
announced that Takeda reported positive top-line results from a
Phase 3 study in Japan evaluating
the efficacy and safety of relugolix compared with placebo for the
treatment of pain associated with uterine fibroids. Of the women
treated with relugolix, 57.6% achieved a marked improvement in pain
symptoms compared to 3.1% treated with placebo (p < 0.0001).
Adverse events in the study were consistent with the mechanism of
action of relugolix and adverse events observed in previous
clinical studies.
- Takeda plans to submit the data from both studies to regulatory
authorities in Japan for marketing
authorization of relugolix for the treatment of uterine fibroids.
Myovant will be solely responsible for obtaining FDA approval for
relugolix in the United
States.
Secured flexible financing commitments of up to $140 million. On October 16, 2017, Myovant announced that it had
secured up to $140 million in
flexible financing commitments from NovaQuest Capital Management
("NovaQuest") and Hercules Capital, Inc. ("Hercules"). The
NovaQuest financing is comprised of a note purchase commitment of
up to $60 million and an equity
purchase commitment of up to $40
million. An additional $40
million of debt financing capacity is committed in the form
of a term loan facility from Hercules. Myovant plans to use the net
proceeds from both financings to fund the ongoing Phase 3
development of relugolix in uterine fibroids, endometriosis and
advanced prostate cancer. Pursuant to the agreements, upon closing,
Myovant issued notes and shares of common stock of approximately
$33 million under the financing
commitments.
Third Fiscal Quarter 2017 Financial Summary
Research and development (R&D) expenses for the
quarter ended December 31, 2017 were
$34.9 million, compared to
$6.2 million for the comparable
period in 2016. The increase over the prior year period is
primarily due to costs associated with the progress in our five
ongoing Phase 3 clinical trials of relugolix which were initiated
in 2017. R&D expenses for the three months ended
December 31, 2017 consisted primarily of clinical
trial-related costs of $28.4 million,
personnel expenses of $3.2 million,
share-based compensation expense of $1.0
million, and costs billed to us under the services
agreements with Roivant Sciences Ltd. and Roivant Sciences, Inc.
("the Services Agreements") of $1.9
million, including personnel expenses and third-party costs
associated with our ongoing clinical trials and other research
programs.
General and administrative (G&A) expenses for the
quarter ended December 31, 2017 were
$6.6 million, compared to
$2.9 million for the same period in
2016. G&A expenses for the three months ended December 31, 2017 consisted primarily of
personnel-related and general overhead expenses of $2.7 million, share-based compensation expense of
$2.3 million, legal and professional
fees of $0.6 million and costs of
$1.0 million billed to us under the
Services Agreements, including personnel expenses, overhead
allocations and third-party costs.
Interest Expense for the quarter ended December 31, 2017 was $0.9
million and consisted of interest expense accrued and paid
under the financing agreements with NovaQuest and Hercules as well
as the associated amortization of debt discount and issuance
costs. There was no interest expense for the comparable prior
year period.
Net loss for the quarter ended December 31, 2017 was
$41.8 million, or $0.70 per share, compared to a net loss of
$8.1 million or $0.15 per share for the same period in 2016. The
increase in net loss was driven by the increase in costs associated
with our ongoing LIBERTY 1 and LIBERTY 2, SPIRIT 1 and SPIRIT 2,
and HERO Phase 3 clinical studies which were initiated in 2017, as
well as increased personnel expenses to support Myovant's growing
operations.
Cash and committed funding totaled $235.9 million at December
31, 2017 consisting of $128.9
million of cash and financing commitments totaling
$107.0 million available under our
financing agreements with NovaQuest and Hercules.
About Relugolix
Relugolix is an oral, once-daily, small molecule
gonadotropin-releasing hormone (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 are 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 will be evaluated with and without
low-dose hormonal add-back therapy, the addition of which is
expected to decrease potential side effects such as bone mineral
density loss and hot flashes. The ongoing Phase 3 HERO study is
evaluating relugolix 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
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 endometriosis-associated pain (SPIRIT 1 & 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, the company intends to expand its development
pipeline to include other potential treatments for women's health
and endocrine diseases. For more information, please visit the
company'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 building Myovant into a leading women's health company;
Myovant's ability to advance the clinical development of relugolix
through the LIBERTY 1, LIBERTY 2, SPIRIT 1, SPIRIT 2 and HERO
clinical trials; Myovant's ability to expand its development
pipeline; Takeda's reported results from its Phase 3 studies of
relugolix and any support those data may have for Myovant's Phase 3
studies of relugolix; Myovant's business strategies, financial
condition and trends, competitive position, potential growth
opportunities, use of proceeds and the effects of competition; and
the financing commitments of up to $140
million from NovaQuest and Hercules. Forward-looking
statements can be identified by the words "believe," "anticipate,"
"continue", "estimate", "project," "expect," "plan," "potential,"
"intends," "will," "would", "could", "should" or the negative or
plural of these words or other similar expressions that are
predictions or indicate future events, trends or prospects but the
absence of these words does not necessarily mean that a statement
is not forward-looking. In addition, any statements that refer to
expectations, projections or other characterizations of future
events or circumstances are forward-looking statements.
Forward-looking statements are subject to risks and uncertainties
that could cause actual results to differ materially and reported
results should not be considered as an indication of future
performance. Actual results and the timing of events could differ
materially from those anticipated in the forward-looking statements
as a result of these risks and uncertainties, which include,
without limitation: risks associated with the success, cost and
timing of our product development activities and clinical trials;
the approval and commercialization of our product candidates
relugolix and MVT-602; and increased regulatory requirements. These
statements are subject to the risk that clinical trial data are
subject to differing interpretations, and regulatory agencies,
medical and scientific experts and others may not share Myovant's
views of the clinical study data. There can be no assurance
that the clinical programs for relugolix or MVT-602 will be
successful in demonstrating safety and/or efficacy, that we will
not encounter problems or delays in clinical development, or that
any of our product candidates will ever receive regulatory approval
or be successfully commercialized. For a further description
of the risks and uncertainties that could cause actual results to
differ from those expressed in these forward-looking statements, as
well as risks relating to Myovant's business in general, see the
"Risk Factors" section of our quarterly report on Form 10-Q filed
with the Securities and Exchange Commission on November 13, 2017, 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 13, 2018, and
other filings that Myovant makes with the SEC from time to time.
These forward-looking statements are based on information available
to Myovant as of the date of this presentation and speak only as of
the date of this presentation. Myovant disclaims any obligation to
update these forward-looking 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
December 31,
|
|
Nine Months Ended
December 31,
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development (includes $1,041 and $1,060 of share-based compensation
expense for the three months ended December 31, 2017 and 2016 and
$2,580 and $2,849 for the nine months ended December 31, 2017 and
2016, respectively)
|
$
|
34,875
|
|
|
$
|
6,158
|
|
|
$
|
76,753
|
|
|
$
|
24,484
|
|
General and
administrative (includes $2,252 and $950 of share-based
compensation expense for the three months ended December 31, 2017
and 2016 and $5,663 and $3,932 for the nine months ended December
31, 2017 and 2016, respectively)
|
6,640
|
|
|
2,898
|
|
|
16,963
|
|
|
8,427
|
|
Total operating
expenses
|
41,515
|
|
|
9,056
|
|
|
93,716
|
|
|
32,911
|
|
|
|
|
|
|
|
|
|
Changes in the fair
value of the Takeda warrant liability
|
—
|
|
|
(1,002)
|
|
|
—
|
|
|
28,815
|
|
Interest
expense
|
904
|
|
|
—
|
|
|
904
|
|
|
—
|
|
Other
income
|
(429)
|
|
|
—
|
|
|
(225)
|
|
|
—
|
|
Loss before provision
for income taxes
|
(41,990)
|
|
|
(8,054)
|
|
|
(94,395)
|
|
|
(61,726)
|
|
Income tax (benefit)
expense
|
(213)
|
|
|
29
|
|
|
607
|
|
|
40
|
|
Net loss
|
$
|
(41,777)
|
|
|
$
|
(8,083)
|
|
|
$
|
(95,002)
|
|
|
$
|
(61,766)
|
|
Net loss per common
share — basic and diluted
|
$
|
(0.70)
|
|
|
$
|
(0.15)
|
|
|
$
|
(1.60)
|
|
|
$
|
(1.34)
|
|
Weighted average
common shares outstanding — basic and diluted
|
59,629,486
|
|
|
54,447,203
|
|
|
59,446,140
|
|
|
45,929,021
|
|
MYOVANT SCIENCES
LTD.
|
Condensed
Consolidated Balance Sheets
|
(Unaudited, in
thousands)
|
|
|
December 31,
2017
|
|
March 31,
2017
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash
|
$
|
128,873
|
|
|
$
|
180,838
|
|
Prepaid expenses and
other current assets
|
5,279
|
|
|
3,221
|
|
Income tax
receivable
|
607
|
|
|
105
|
|
Total current
assets
|
134,759
|
|
|
184,164
|
|
|
|
|
|
Deferred tax
assets
|
—
|
|
|
208
|
|
Furniture and
equipment, net
|
1,120
|
|
|
906
|
|
Other
assets
|
2,098
|
|
|
—
|
|
Total
assets
|
$
|
137,977
|
|
|
$
|
185,278
|
|
|
|
|
|
Liabilities and
Shareholders' Equity
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
|
2,091
|
|
|
$
|
3,329
|
|
Accrued
expenses
|
20,953
|
|
|
11,978
|
|
Due to Roivant
Sciences Ltd. and Roivant Sciences, Inc.
|
3,683
|
|
|
3,030
|
|
Total current
liabilities
|
26,727
|
|
|
18,337
|
|
|
|
|
|
Takeda warrant
liability
|
—
|
|
|
52
|
|
Deferred
rent
|
372
|
|
|
113
|
|
Deferred interest
payable
|
105
|
|
|
—
|
|
Long-term
debt
|
28,575
|
|
|
—
|
|
Total
liabilities
|
55,779
|
|
|
18,502
|
|
|
|
|
|
Total shareholders'
equity
|
82,198
|
|
|
166,776
|
|
Total liabilities and
shareholders' equity
|
$
|
137,977
|
|
|
$
|
185,278
|
|
Investor Contacts:
Frank
Karbe
Chief Financial Officer
Myovant Sciences
DeDe Sheel
Investor Relations
Myovant Sciences
investors@myovant.com
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