Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused
biopharmaceutical company that is developing somavaratan, a novel,
long-acting form of recombinant human growth hormone (rhGH) for
growth hormone deficiency (GHD), today announced financial results
for the second quarter ended June 30, 2017, and provided an update
on its clinical development programs.
“This is a time of tremendous excitement for Versartis as we
approach our most significant milestone to date: the topline
results from our Phase 3 VELOCITY trial of somavaratan in pediatric
GHD patients,” said Jay Shepard, Chief Executive Officer of
Versartis. “With our last patient visits expected in late August,
we anticipate topline results around the end of September. Our
confidence in somavaratan is supported by three years of data
suggesting a solid safety profile and efficacy comparable to U.S.
registries on the key parameters, as well as baseline
characteristics in our VELOCITY trial arms that are well balanced
and in line with our Phase 2 patient population. We look forward to
reporting the trial outcome in the very near future, as we continue
our work to prepare a strong regulatory package for submission to
the U.S. Food and Drug Administration.”
“Adding to this excitement is the enthusiasm we are experiencing
at clinical trial sites participating in VISTA,” continued Mr.
Shepard. “Through our ongoing dialogue with physicians, patients
and advocacy groups, we recognize the burden of daily rhGH
injections and the desire for less frequent dosing. By expanding
enrollment in our VISTA study, we are increasing the overall number
of pediatric patients treated with twice-monthly somavaratan while
also collecting ‘real world’ data that will be valuable to
physicians and patients if approved.”
Corporate Highlights & Milestones
- Expanded enrollment of the ongoing VISTA
(Versartis Long-Term Safety
Study of Somavaratan) study of somavaratan in
pediatric GHD to accommodate additional patients who will initiate
twice-monthly somavaratan therapy
- Exceeded the initial target of enrolling 300 patients in the
study; expect to have over 400 children exposed to the 3.5 mg/kg
twice-monthly dose of somavaratan by Q3 2017, 300 of which are
expected to have 6 months or more of continuous exposure at the
time of BLA filing
- Additions will include patients newly diagnosed with GHD as
well as those switching from daily rhGH therapy
- Three abstracts featuring somavaratan data through three years
of treatment in the VERTICAL/VISTA pediatric GHD studies accepted
for presentation at the 10th Annual International Joint Meeting of
Pediatric Endocrinology (IMPE), to be held September 14-17 in
Washington D.C.; VELOCITY data will not be available for
presentation at IMPE
- Appointed Eric Dobmeier, current Chief Operating Officer of
Seattle Genetics, to the Board of Directors, adding further depth
to the board with his executive and board member experience at
biotech companies
Upcoming Anticipated Milestones and Other
Events
- Report topline data from the pediatric Phase 3 VELOCITY trial
around the end of September
- Complete enrollment of Phase 3 Japan trial in H2 2017
- Observe a corporate quiet period beginning August 11 and
leading up to the VELOCITY trial results; external communications
expected to be limited primarily to announcements relating to
planned IMPE presentations
Second Quarter 2017 Financial Results
For the second quarter ended June 30, 2017, Versartis reported a
net loss of approximately $36.6 million, or $1.04 per share, basic
and diluted, compared to a net loss for the quarter ended June 30,
2016 of $22.1 million, or $0.75 per share, basic and diluted. Net
cash used during the quarter ended June 30, 2017 was $21.7
million.
Total operating expenses for the quarter ended June 30, 2017
were $36.2 million, compared to $22.3 million for the quarter ended
June 30, 2016.
Research and development (R&D) expenses for the quarter
ended June 30, 2017 were $28.6 million, compared to $16.4 million
for the quarter ended June 30, 2016. The increase in R&D
expenses was primarily due to an increase in clinical and
manufacturing costs to support our ongoing global VELOCITY
pediatric trial and our Phase 2/3 trial of somavaratan in pediatric
patients in Japan.
General and administrative (G&A) expenses for the quarter
ended June 30, 2017 were $7.6 million, compared to $5.9 million for
the quarter ended June 30, 2016. The increase in G&A expenses
was primarily due to additional payroll, consulting, and
professional services expenses as we continue to increase our
headcount and expand our infrastructure to support our growth.
Total operating expenses for the quarter ended June 30, 2017
include non-cash stock-based compensation expense of $3.7 million,
compared to $3.0 million of non-cash stock-based compensation
expense for the quarter ended June 30, 2016.
Total operating expenses for the six months ended June 30, 2017
were $65.8 million, compared to $46.4 million for the six months
ended June 30, 2016. R&D expenses for the six months ended June
30, 2017 were $50.6 million, compared with $34.6 million for the
six months ended June 30, 2016, reflecting the increase in
manufacturing and clinical costs to support our ongoing Phase 2 and
3 clinical trials for somavaratan noted above. G&A expenses for
the six months ended June 30, 2017 were $15.2 million, compared to
$11.8 million for the six months ended June 30, 2016. The increase
was attributable to additional payroll, consulting, and
professional services expenses as noted above to support our
continued growth.
Total operating expenses for the six months ended June 30, 2017
include non-cash stock-based compensation expense of $7.5 million,
compared to $5.4 million of non-cash stock-based compensation
expense for the six months ended June 30, 2016.
Cash and cash equivalents were $143.4 million as of June 30,
2017.
About Versartis, Inc.
Versartis, Inc. is an endocrine-focused biopharmaceutical
company initially developing somavaratan, a novel, long-acting form
of recombinant human growth hormone in late-stage clinical trials
for the treatment of GHD in children and adults. Somavaratan is
intended to reduce the burden of daily injection therapy by
requiring significantly fewer injections, potentially improving
adherence and, therefore, treatment outcomes.
For more information on Versartis, visit www.versartis.com.
Cautionary Note on Forward-Looking
Statements
This press release contains forward-looking statements for
purposes of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements include
statements regarding our intentions or current expectations
concerning, among other things, plans and timing of our clinical
trials and the potential for eventual regulatory approval of
somavaratan. Forward-looking statements are not guarantees of
future performance and are subject to risks and uncertainties that
could cause actual results and events to differ materially from
those anticipated, including, but not limited to, risks and
uncertainties related to: our success being heavily dependent on
somavaratan; somavaratan being a new molecular entity; the risk
that somavaratan may not have favorable results in clinical trials
or receive regulatory approval; potential delays in our clinical
trials due to regulatory requirements or difficulty identifying
qualified investigators or enrolling patients; the risk that
somavaratan may cause serious side effects or have properties that
delay or prevent regulatory approval or limit its commercial
potential; the risk that we may encounter difficulties in
manufacturing somavaratan; if somavaratan is approved, risks
associated with its market acceptance, including pricing and
reimbursement; potential difficulties enforcing our intellectual
property rights; our reliance on our license of intellectual
property from Amunix Operating, Inc. and our need for
additional funds to support our operations. We discuss many of
these risks in greater detail under the heading "Risk Factors"
contained in our Annual Report on Form 10-K for the year
ended December 31, 2016, which is on file with
the Securities and Exchange Commission (SEC).
Forward-looking statements are not guarantees of future
performance, and our actual results of operations, financial
condition and liquidity, and the development of the industry in
which we operate, may differ materially from the forward-looking
statements contained in this press release. Any forward-looking
statements that we make in this press release speak only as of the
date of this press release. We assume no obligation to update our
forward- looking statements whether as a result of new information,
future events or otherwise, after the date of this press
release.
Versartis, Inc. |
Condensed Consolidated Statement of
Operations |
(Unaudited) |
(in thousands, except per share amounts) |
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
June 30, |
|
|
June 30, |
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
$ |
28,618 |
|
|
$ |
16,397 |
|
|
$ |
50,622 |
|
|
$ |
34,589 |
|
General and
administrative |
|
7,572 |
|
|
|
5,909 |
|
|
|
15,228 |
|
|
|
11,823 |
|
Total
operating expenses |
|
36,190 |
|
|
|
22,306 |
|
|
|
65,850 |
|
|
|
46,412 |
|
Loss from
operations |
|
(36,190 |
) |
|
|
(22,306 |
) |
|
|
(65,850 |
) |
|
|
(46,412 |
) |
Interest income |
|
242 |
|
|
|
129 |
|
|
|
441 |
|
|
|
234 |
|
Other income (expense),
net |
|
(521 |
) |
|
|
59 |
|
|
|
(782 |
) |
|
|
(171 |
) |
Net loss before
provision for income taxes |
|
(36,469 |
) |
|
|
(22,118 |
) |
|
|
(66,191 |
) |
|
|
(46,349 |
) |
Provision for income
taxes |
|
128 |
|
|
|
- |
|
|
|
128 |
|
|
|
- |
|
Net loss |
|
(36,597 |
) |
|
|
(22,118 |
) |
|
|
(66,319 |
) |
|
|
(46,349 |
) |
Net loss per share-
basic and diluted |
$
|
(1.04 |
) |
|
$
|
(0.75 |
) |
|
$
|
(1.89 |
) |
|
$
|
(1.57 |
) |
Weighted-average common shares used to compute basic and
diluted net loss per share |
|
35,316 |
|
|
|
29,489 |
|
|
|
35,001 |
|
|
|
29,455 |
|
|
Versartis, Inc. |
Condensed Consolidated Balance
Sheet |
(Unaudited) |
(in thousands, except per share amounts) |
|
|
|
June 30, |
|
|
December 31, |
|
2017 |
|
|
2016 |
Assets: |
|
|
|
|
|
|
Cash and cash
equivalents |
$ |
143,358 |
|
|
$ |
201,153 |
Other assets |
|
14,591 |
|
|
|
4,417 |
Build-to-suit lease
asset |
|
9,975 |
|
|
|
- |
Total
assets |
$ |
167,924 |
|
|
$ |
205,570 |
Liabilities and
stockholders' equity: |
|
|
|
|
|
|
Accounts payable and
other current liabilities |
$ |
24,731 |
|
|
$ |
14,503 |
Upfront payment from
collaboration partner |
|
40,000 |
|
|
|
40,000 |
Build-to-suit lease
obligation |
|
8,174 |
|
|
|
- |
Total liabilities |
|
72,905 |
|
|
|
54,503 |
Total stockholders'
equity |
|
95,019 |
|
|
|
151,067 |
Total
liabilities and stockholders’
equity |
$ |
167,924 |
|
|
$ |
205,570 |
|
Contacts:
Corporate Communications:
Christine Labaree
Corporate Affairs
(650) 600-1697
clabaree@versartis.com
Investors:
David Burke
Director, Investor Relations
(650) 516-2703
dburke@versartis.com
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