Webcast and Conference Call today at 4:30
p.m. ET
- Cash and marketable securities
totaled $235.3 million at June 30, 2017
- Royalty revenue for the quarter was
$7.5 million
- Milestone payments totaling $65
million earned following AbbVie’s EU approval of MAVIRET™
(glecaprevir/pibrentasvir) in July, and U.S. approval of MAVYRET™
(glecaprevir/pibrentasvir) in August
- RSV and NASH/PBC clinical programs
continue to advance toward new stages next quarter
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and
development-focused biotechnology company dedicated to creating
small molecule drugs for viral infections and liver diseases, today
reported financial results for its fiscal third quarter ended June
30, 2017.
Enanta’s cash, cash equivalents and short-term and long-term
marketable securities totaled $235.3 million at June 30, 2017. This
compares to a total of $242.2 million in such accounts at September
30, 2016. Enanta expects that its current cash, cash equivalents
and marketable securities will be sufficient to meet the
anticipated cash requirements of its existing business and
development programs for the foreseeable future.
Fiscal Third Quarter Ended June 30, 2017 Financial
Results
Total revenue for the three months ended June 30, 2017 was $7.5
million, compared to $14.0 million for the three months ended June
30, 2016. For the nine months ended June 30, 2017, total revenue
was $26.9 million, compared to $75.4 million for the same period in
2016. For the three and nine month periods ended June 30, 2017,
revenue consisted exclusively of royalties earned on AbbVie’s
worldwide net sales of HCV regimens containing paritaprevir. For
the 2016 nine month period, revenue consisted primarily of royalty
revenues as well as a $30.0 million milestone payment for the
reimbursement approval of VIEKIRAX® in Japan in November 2015.
Milestone payments and royalties have varied significantly from
period to period, and we expect that variability to continue in the
future.
Research and development expenses totaled $15.4 million for the
three months ended June 30, 2017, compared to $10.8 million for the
three months ended June 30, 2016. For the nine months ended June
30, 2017, research and development expenses totaled $40.9 million
compared to $29.0 million for the same period in 2016. The increase
in research and development expenses in both periods was primarily
due to increased preclinical and clinical costs associated with the
progression of Enanta’s wholly-owned R&D programs in
non-alcoholic steatohepatitis (NASH)/primary biliary cholangitis
(PBC), respiratory syncytial virus (RSV) and hepatitis B virus
(HBV).
General and administrative expenses totaled $5.2 million for the
three months ended June 30, 2017, compared to $4.3 million for the
three months ended June 30, 2016. For the nine months ended June
30, 2017, general and administrative expenses totaled $15.6
million, compared to $12.5 million for the same period in 2016. For
the three month period, the increase in general and administrative
expenses was primarily due to increases in compensation expense
driven substantially by increased headcount. For the nine month
period, the increase was due to increased headcount as well as
achievement of milestones under existing performance-based stock
awards.
Enanta recorded an income tax benefit for the three months
ended June 30, 2017 of $4.1 million compared to an income
tax expense of $0.4 million for the same period in 2016. The
Company’s estimated annual effective tax rate for fiscal 2017 of
approximately 33% was slightly below the statutory rate of 35% due
to the availability of research and development tax credits.
The net loss for the three months ended June 30, 2017 was $8.4
million, or $(0.44) per diluted common share, compared to a net
loss of $1.1 million, or $(0.06) per diluted common share, for the
corresponding period in 2016. For the nine months ended June 30,
2017, net loss was $18.8 million, or $(0.99) per diluted common
share, compared to net income of $23.5 million, or $1.22 per
diluted common share, for the corresponding period in 2016.
“Enanta continues to make great progress from a research and
development perspective,” stated Jay R. Luly, Ph.D., President and
Chief Executive Officer of Enanta. Our second commercialized
protease inhibitor product, glecaprevir, is one of the two new DAAs
in AbbVie’s new pan-genotypic treatment regimen for HCV, which was
recently approved in the EU and in the U.S. under the names
MAVIRET™ and MAVYRET™, respectively. Additionally, data from the
Phase 1 clinical study on our NASH candidate EDP-305 will be
available soon, and, with our strong cash resources of over $235
million, we are well funded to continue to advance our clinical
programs in NASH, PBC, RSV and HCV.”
Development Program and Business Review
- On June 25 at the XIX International
Symposium on Respiratory Viral Infections in Berlin, Germany,
Enanta presented data on its respiratory syncytial virus inhibitor
candidate EDP-938, which demonstrated a greater than 4-log
reduction in viral load in an animal model challenged with RSV.
Enanta expects to initiate a Phase 1 clinical study with EDP-938
during the fourth quarter of calendar 2017.
- On July 28, the European Commission
granted AbbVie marketing authorization for MAVIRET
(glecaprevir/pibrentasvir), and on August 3, the U.S. Food and Drug
Administration (FDA) granted AbbVie marketing approval for MAVYRET
(glecaprevir/pibrentasvir), sometimes referred to as the G/P
regimen, AbbVie’s new pan-genotypic treatment for patients with
chronic hepatitis C virus (HCV) infection. Glecaprevir is Enanta’s
second protease inhibitor being developed and commercialized by
AbbVie and is one of the two new direct-acting antivirals in G/P.
Enanta earned a total of $65 million in milestone payments
following the EU and U.S. approvals. Enanta is eligible to earn the
remaining $15 million milestone payment upon G/P receiving
commercial regulatory approval in Japan, which is anticipated next
quarter. Additionally, Enanta is eligible to receive annually
tiered, double digit, per product royalties on 50% of the net sales
of G/P.
- Enanta expects to announce clinical
data from its ongoing Phase 1 clinical study of EDP-305 in healthy
volunteers and presumed NAFLD subjects1 at the AASLD meeting in
October and is conducting NASH-enabling studies during the second
half of this year. A Phase 2 study in PBC is also expected to begin
in the next quarter, and a Phase 2 study in NASH is expected to
begin in early 2018.
Upcoming Events and Presentations
- September 6, 2017 − Baird 2017 Global
Healthcare Conference, New York
- September 11-13, 2017 – Morgan Stanley
15th Annual Global Healthcare Conference, New York
- September 25-27, 2017 − Cantor
Fitzgerald Global Healthcare Conference, New York
- Enanta plans to issue its fiscal fourth
quarter financial results press release, and hold a conference call
regarding those results, on November 20, 2017.
Conference Call and Webcast InformationEnanta will host a
conference call and webcast today at 4:30 p.m. ET. To participate
in the live conference call, please dial (855) 840-0595 in the U.S.
or (518) 444-4814 for international callers. A replay of the
conference call will be available starting at approximately 7:30
p.m. ET on August 7, 2017, through 11:59 p.m. ET on August 10, 2017
by dialing (855) 859-2056 from the U.S. or (404) 537-3406 for
international callers. The passcode for both the live call and the
replay is 47670579. A live audio webcast of the call and replay can
be accessed by visiting the “Events and Presentation” section on
the “Investors” page of Enanta’s website at www.enanta.com.
About EnantaEnanta Pharmaceuticals is a research and
development-focused biotechnology company that uses its robust
chemistry-driven approach and drug discovery capabilities to create
small molecule drugs for viral infections and liver diseases.
Enanta’s research and development efforts are currently focused on
the following disease targets: non-alcoholic steatohepatitis
(NASH)/ primary biliary cholangitis (PBC), respiratory syncytial
virus (RSV) and hepatitis B virus (HBV). Enanta has also discovered
novel protease inhibitors that have been developed as part of
AbbVie’s hepatitis C virus (HCV) treatment regimens under a
collaboration that now provides Enanta a payment stream, which it
is using to fund its research and development programs. Please
visit www.enanta.com for more information on Enanta’s programs and
pipeline.
Forward Looking StatementsThis press release contains
forward-looking statements, including statements with respect to
the prospects for AbbVie’s G/P regimen in HCV and the prospects for
advancement of Enanta’s earlier stage programs in NASH/PBC and RSV.
Statements that are not historical facts are based on management’s
current expectations, estimates, forecasts and projections about
Enanta’s business and the industry in which it operates and
management’s beliefs and assumptions. The statements contained in
this release are not guarantees of future performance and involve
certain risks, uncertainties and assumptions, which are difficult
to predict. Therefore, actual outcomes and results may differ
materially from what is expressed in such forward-looking
statements. Important factors and risks that may affect actual
results include: Enanta’s revenues in the short-term are dependent
upon the success of AbbVie’s continuing commercialization efforts
for its HCV treatment regimens containing paritaprevir and its
efforts to obtain additional regulatory approvals for G/P and
commercialize that regimen; competitive pricing, market acceptance
and reimbursement rates of AbbVie’s treatment regimens containing
paritaprevir or its G/P combination compared to competitive HCV
products on the market and product candidates of other companies
under development; the discovery and development risks of early
stage discovery efforts in other disease areas such as NASH, PBC,
RSV and HBV; potential competition from the development efforts of
others in those other disease areas; Enanta’s lack of clinical
development experience; Enanta’s need to attract and retain senior
management and key scientific personnel; Enanta’s need to obtain
and maintain patent protection for its product candidates and avoid
potential infringement of the intellectual property rights of
others; and other risk factors described or referred to in “Risk
Factors” in Enanta’s most recent Form 10-K for the fiscal year
ended September 30, 2016 and other periodic reports filed more
recently with the Securities and Exchange Commission. Enanta
cautions investors not to place undue reliance on the
forward-looking statements contained in this release. These
statements speak only as of the date of this release, and Enanta
undertakes no obligation to update or revise these statements,
except as may be required by law.
1 Presumed NAFLD subjects in this study are obese subjects, with
or without pre-diabetes or type-2 diabetes.
ENANTA
PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS UNAUDITED (in thousands, except per share
amounts) Three Months Ended Nine Months
Ended June 30, June 30, 2017 2016
2017 2016 Revenue $ 7,511 $ 13,978 $ 26,887 $
75,427 Operating expenses Research and development 15,407 10,785
40,937 28,961 General and administrative 5,233 4,282
15,631 12,526 Total operating expenses 20,640
15,067 56,568 41,487 Income (loss) from
operations (13,129) (1,089) (29,681) 33,940 Other income, net
600 447 1,673 1,248 Income (loss)
before income taxes (12,529) (642) (28,008) 35,188 Income tax
(expense) benefit 4,103 (434) 9,210
(11,720) Net income (loss) $ (8,426) $ (1,076) $ (18,798) $ 23,468
Net income (loss) per share Basic $ (0.44) $ (0.06) $ (0.99)
$ 1.24 Diluted $ (0.44) $ (0.06) $ (0.99) $ 1.22 Weighted
average common shares outstanding Basic 19,081 18,983 19,055 18,893
Diluted 19,081 18,983 19,055 19,223
ENANTA PHARMACEUTICALS,
INC. CONDENSED CONSOLIDATED BALANCE SHEETS
UNAUDITED (in thousands) June 30,
September 30, 2017 2016 Assets Current assets
Cash and cash equivalents $ 22,263 $ 16,577 Short-term marketable
securities 169,752 193,507 Accounts receivable 7,511 12,841 Prepaid
expenses and other current assets 6,589 9,231 Total
current assets 206,115 232,156 Property and equipment, net 8,070
8,004 Long-term marketable securities 43,321 32,119 Deferred tax
assets 17,723 8,390 Restricted cash 608 608 Total
assets $ 275,837 $ 281,277 Liabilities and Stockholders'
Equity Current liabilities Accounts payable $ 5,488 $ 3,377 Accrued
expenses and other current liabilities 5,634 4,512
Total current liabilities 11,122 7,889 Warrant liability 1,291
1,251 Series 1 nonconvertible preferred stock 164 159 Other
long-term liabilities 2,394 2,042 Total liabilities
14,971 11,341 Total stockholders' equity
260,866 269,936 Total liabilities and stockholders' equity $
275,837 $ 281,277
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version on businesswire.com: http://www.businesswire.com/news/home/20170807005934/en/
Investor ContactEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
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