Seventh paragraph, second sentence of release dated May 8, 2017,
should read: “For the six months ended March 31, 2017, net loss was
$10.4 million, or ($0.54) per diluted common share, compared to net
income of $24.5 million, or $1.28 per diluted common share...”
(instead of $1.28 million per diluted common share).
The corrected release reads:
ENANTA PHARMACEUTICALS REPORTS FINANCIAL
RESULTS FOR ITS FISCAL SECOND QUARTER ENDED MARCH 31, 2017
Webcast and Conference Call today at 4:30
p.m. ET
- Royalty revenue was $9.0
million
- R&D expense increased to
$13.0 million in support of pipeline development
- Cash and marketable securities
totaled $240.9 million at March 31, 2017
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 second quarter ended
March 31, 2017.
Enanta’s cash, cash equivalents and short-term and long-term
marketable securities totaled $240.9 million at March 31, 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 Second Quarter Ended March 31, 2017 Financial
Results
Total revenue for the three months ended March 31, 2017 was $9.0
million, compared to $13.0 million for the three months ended March
31, 2016. For the six months ended March 31, 2017, total revenue
was $19.4 million, compared to $61.4 million for the same period in
2016. For the three and six month periods ended March 31 2017,
revenue consisted exclusively of royalties earned on AbbVie’s
worldwide net sales of HCV regimens containing paritaprevir. For
the 2016 six 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. 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 $13.0 million for the
three months ended March 31, 2017, compared to $9.1 million for the
three months ended March 31, 2016. For the six months ended March
31, 2017, research and development expenses totaled $25.5 million
compared to $18.2 million for the same period in 2016. The increase
in research and development expenses 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 $5.5 million for the
three months ended March 31, 2017, compared to $4.4 million for the
three months ended March 31, 2016. For the six months ended March
31, 2017, general and administrative expenses was $10.4 million,
compared to $8.2 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 stock-based compensation expense
driven by increased headcount. For the six 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 March 31, 2017 of $3.6 million compared
to an income tax expense of $1.6 million for the same period in
2016. The Company’s estimated annual effective tax rate for fiscal
2017 of 33.0 percent was slightly below the statutory rate of 35.0
percent due to the availability of federal research and development
tax credits.
Net loss for the three months ended March 31, 2017 was $5.4
million, or $(0.28) per diluted common share, compared to net loss
of $1.6 million, or ($0.09) per diluted common share, for the
corresponding period in 2016. For the six months ended March 31,
2017, net loss was $10.4 million, or ($0.54) per diluted common
share, compared to net income of $24.5 million, or $1.28 per
diluted common share, for the corresponding period in 2016.
“With our second partnered protease inhibitor product,
glecaprevir, expected to launch starting in August as part of
AbbVie’s new, investigational G/P treatment for HCV, the prospects
for additional milestone and royalty payments to us for G/P are
significant,” stated Jay R. Luly, Ph.D., President and Chief
Executive Officer, Enanta. “Any such payments, coupled with our
existing financial resources, will allow us to advance our clinical
program in NASH/PBC and also fund our additional R&D programs,
including our lead compound EDP-938 for RSV, scheduled to begin
clinical development later this year.”
Development Program and Business Review
- Enanta presented new preclinical data
on EDP-305, its wholly-owned FXR agonist for non-alcoholic
steatohepatitis, at the International Liver Congress™ (ILC) 2017 in
Amsterdam. Data from three poster presentations presented at the
Congress demonstrated that EDP-305 is a potent Farnesoid X receptor
(FXR) agonist that has been shown to reduce expression of
fibrogenic genes, reduce fibrosis progression and improve
non-alcoholic fatty liver disease (NAFLD) activity scores (NAS) in
a variety of preclinical models.
- Enanta expects to present clinical data
from our ongoing Phase 1 clinical study of EDP-305 in healthy
volunteers and presumed NAFLD subjects1 and to initiate
NASH-enabling studies in the second half of this year. A Phase 2
study in PBC is expected to begin in the fourth quarter of calendar
2017 and Phase 2 studies in NASH are expected to begin in early
2018.
- Also at the ILC, AbbVie presented new
data from its investigational, pan-genotypic, ribavirin-free
regimen for hepatitis C virus (HCV) consisting of a combination of
glecaprevir/pibrentasvir (G/P). Data from the EXPEDITION-1 study
demonstrated that 99 percent (n=145/146) of chronic HCV infected
patients with genotype 1, 2, 4, 5 or 6 and compensated cirrhosis
(Child-Pugh A) achieved sustained virologic response at 12 weeks
post-treatment (SVR12) with G/P. This high SVR12 rate was seen
following 12 weeks of G/P treatment without ribavirin. Data were
also presented at the ILC from the ENDURANCE-3 study. In this
study, 95 percent (n=149/157) of genotype 3 (GT3) chronic
HCV-infected patients without cirrhosis and who were new to
treatment, achieved sustained virologic response at 12 weeks
post-treatment (SVR12) following 8 weeks of treatment with
G/P.
- In March, Enanta announced the Japanese
Ministry of Health, Labour and Welfare (MHLW) granted priority
review designation to AbbVie’s G/P combination for the treatment of
all major genotypes (GT1-6) of chronic hepatitis C virus (HCV)
infection. AbbVie had submitted the NDA for the G/P regimen in
Japan in February 2017. The NDAs for G/P in the U.S and Japan have
been granted priority review designation, and the MAA for G/P has
been granted accelerated assessment in the E.U.
Upcoming Events and Presentations
On June 25 at the XIX International Symposium on Respiratory
Viral Infections in Berlin, Germany, Enanta will present data on
EDP-938, its respiratory syncytial virus inhibitor candidate in an
oral presentation titled: “EDP-938, a Novel Non-Fusion Replication
Inhibitor of Respiratory Syncytial Virus, Demonstrates Potent
Antiviral Activities both In Vitro and In Vivo”.
- Enanta plans to issue its fiscal third
quarter financial results press release, and hold a conference call
regarding those results, on August 7, 2017.
Conference Call and Webcast InformationEnanta will host a
conference call and webcast today at 4:30 p.m. Eastern time. 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. Eastern time on May 8, 2017, through 11:59 p.m. Eastern
time on May 12, 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 6851190. A live audio webcast of the
call and replay can be accessed by visiting the “Calendar of
Events” 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 discovered novel protease inhibitors for use against
the hepatitis C virus (HCV). These protease inhibitors, developed
through Enanta’s collaboration with AbbVie, include paritaprevir,
currently marketed in AbbVie’s HCV regimens, and glecaprevir
(ABT-493), Enanta’s second protease inhibitor product, which AbbVie
is developing as part of its investigational, pan-genotypic HCV
regimen of glecaprevir/pibrentasvir (G/P) now in registration in
the U.S., the E.U. and Japan and other jurisdictions. Royalties and
any further milestone payments from this collaboration will provide
additional funding for Enanta’s earlier development programs,
including its Phase 1 FXR agonist program for NASH/PBC, and its
preclinical programs for HBV and RSV. 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 investigational 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; Enanta’s longer-term revenues will be dependent upon
the success of AbbVie’s efforts to obtain 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 Six Months Ended March 31,
March 31, 2017 2016 2017 2016
Revenue $ 8,959 $ 13,004 $ 19,376 $ 61,449 Operating
expenses Research and Development 13,004 9,143 25,530 18,176
General and administrative 5,461 4,426
10,398 8,244 Total operating expenses
18,465 13,569 35,928
26,420 Income (loss) from operations (9,506 ) (565 )
(16,552 ) 35,029 Other income, net 549 472
1,073 801 Income (loss) before
income taxes (8,957 ) (93 ) (15,479 ) 35,830 Income tax (expense)
benefit 3,565 (1,552 ) 5,107
(11,286 ) Net income (loss) $ (5,392 ) $ (1,645 ) $ (10,372
) $ 24,544 Net income (loss) per share Basic $ (0.28
) $ (0.09 ) $ (0.54 ) $ 1.30 Diluted $ (0.28 ) $ (0.09 ) $ (0.54 )
$ 1.28 Weighted average common shares outstanding Basic
19,047 18,921 19,042 18,848 Diluted 19,047 18,921 19,042 19,225
ENANTA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS UNAUDITED
(in thousands) March 31, September 30,
2017 2016 Assets Current assets Cash and cash
equivalents $ 19,211 $ 16,577 Short-term marketable securities
156,362 193,507 Accounts receivable 8,959 12,841 Prepaid expenses
and other current assets 6,059 9,231 Total current
assets 190,591 232,156 Property and equipment, net 8,526 8,004
Long-term marketable securities 65,330 32,119 Deferred tax assets
13,903 8,390 Restricted cash 608 608 Total assets $
278,958 $ 281,277 Liabilities and Stockholders' Equity
Current liabilities Accounts payable $ 4,056 $ 3,377 Accrued
expenses and other current liabilities 5,098 4,512
Total current liabilities 9,154 7,889 Warrant liability 1,276 1,251
Series 1 nonconvertible preferred stock 162 159 Other long-term
liabilities 2,355 2,042 Total liabilities
12,947 11,341 Total stockholders' equity 266,011
269,936 Total liabilities and stockholders' equity $ 278,958
$ 281,277
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version on businesswire.com: http://www.businesswire.com/news/home/20170508006042/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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