Conference Call and Webcast Today at 4:30
p.m. ET
- Royalty revenue was $14.0
million
- R&D expense increased to $10.8
million in support of pipeline development
- Cash and marketable securities
totaled $244.7 million at June 30, 2016
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, 2016.
Enanta’s cash, cash equivalents and short-term and long-term
marketable securities totaled $244.7 million at June 30, 2016. This
compares to a total of $209.4 million in such accounts at September
30, 2015. Enanta expects that its current cash, cash equivalents
and marketable securities will be sufficient to meet the
anticipated cash requirements of its existing business for the
foreseeable future.
Fiscal Third Quarter Ended June 30, 2016 Financial
Results
Revenue for the three months ended June 30, 2016 was $14.0
million, compared to $11.6 million for the three months ended June
30, 2015. The increase in revenue in 2016 was attributable to
higher royalties earned from AbbVie as a result of higher sales of
its hepatitis C virus (HCV) treatment regimens outside of the U.S.
For the nine months ended June 30, 2016, revenue was $75.4 million
compared to revenue of $146.5 million for the same period in 2015.
The decrease in revenue in the year-to-date 2016 period was due
primarily to a reduction in milestone payments versus the
comparable period in 2015. Enanta earned $125.0 million in
milestone payments from AbbVie in 2015 compared to $30.0 million in
2016 based on timing of achievement of commercialization regulatory
approvals of its HCV treatment regimens in the U.S. and Europe
(2015) and Japan (2016). In 2016, the decrease in milestone
payments was partially offset by higher royalties earned from
AbbVie’s worldwide net sales of its HCV regimens. Enanta’s
milestone payments, royalties and other payments received from
collaborations have varied significantly from period to period, and
are expected to continue to do so.
Research and development expenses totaled $10.8 million for the
three months ended June 30, 2016, compared to $6.3 million for the
three months ended June 30, 2015. For the nine months ended June
30, 2016, research and development expenses were $29.0 million,
compared to $16.1 million for the same period in 2015. The increase
in the three and nine month periods was primarily due to increased
pre-clinical and clinical costs due to the progression of Enanta’s
wholly-owned R&D programs in HCV cyclophilin, non-alcoholic
steatohepatitis (NASH), respiratory syncytial virus (RSV) and
hepatitis B virus (HBV).
General and administrative expenses totaled $4.3 million for the
three months ended June 30, 2016, compared to $3.6 million for the
three months ended June 30, 2015. For the nine months ended June
30, 2016, general and administrative expenses were $12.5 million
compared to $9.9 million for the same period in 2015. The increase
in the three and nine month periods primarily reflects increases in
stock-based compensation expense driven by increased headcount.
Income tax (expense) benefit for the three months ended June 30,
2016 was ($0.4) million compared to $0.4 million for the
corresponding period in 2015. During the three months ended June
30, 2016, Enanta increased its estimate of its annual effective tax
rate for fiscal 2016, which resulted in an income tax provision
despite a pre-tax loss for the quarter. Income tax (expense) for
the nine months ended June 30, 2016 was ($11.7) million compared to
($48.1) million for the corresponding period in 2015, representing
annual effective tax rates of 33.3% and 39.7%, respectively, for
those periods.
Net loss for the three months ended June 30, 2016 was ($1.1)
million, or ($0.06) per diluted common share, compared to net
income of $2.4 million or $0.13 per diluted common share, for the
corresponding period in 2015. Net income for the nine months ended
June 30, 2016 was $23.5 million, or $1.22 per diluted common share,
compared to net income of $73.2 million or $3.80 per diluted common
share, for the corresponding period in 2015.
“Enanta is fortunate to be in a position to fund substantial
R&D programs to build shareholder value without dilution. Our
diverse, wholly-owned pipeline is progressing well and as
expected,” commented Jay R. Luly, Ph.D., President and Chief
Executive Officer. “EDP-305, our FXR agonist candidate for
non-alcoholic steatohepatitis and primary biliary cholangitis, is
on track to be in the clinic in the coming months, and we have
several promising leads in RSV and HBV which we are evaluating to
move forward in 2017.”
Development Program and Business Review
- Enanta is planning to initiate phase 1
clinical development in the second half of calendar 2016 for
EDP-305, Enanta’s wholly-owned Farnesoid X Receptor (FXR) agonist
candidate for non-alcoholic steatohepatitis (NASH) and Primary
Biliary Cholangitis (PBC).
- Several abstracts regarding Enanta’s
wholly-owned pipeline programs in HCV and NASH have been accepted
for presentation at The Liver Meeting® in November 2016.
- The U.S. Food and Drug Administration
granted marketing approval for AbbVie’s VIEKIRA XR™ for the
treatment of genotype 1 hepatitis C virus. VIEKIRA XR, which
includes paritaprevir, is a once-daily dosing regimen of the three
direct-acting antivirals (DAAs) in VIEKIRA PAK®.
- Enanta initiated a phase 1
proof-of-concept study in HCV using EDP-494, Enanta’s cyclophilin
inhibitor targeted to treat resistance-associated variants, DAA
failures and other hard to treat populations with HCV
infection.
Upcoming Events and Presentations
- September 7-8, 2016 – Baird 2016 Global
Healthcare Conference, New York
- September 12-14, 2016 – Morgan Stanley
Global Healthcare Conference, New York
- Enanta plans to issue its fourth
quarter financial results press release, and hold a conference call
regarding those results, during the week of November 21, 2016.
Conference Call and Webcast Information
Enanta 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
August 8, 2016, through 11:59 p.m. Eastern time on August 12, 2016
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 46602812. 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 Enanta
Enanta 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 is currently focused on four disease targets:
Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), Non-alcoholic
Steatohepatitis (NASH) and Respiratory Syncytial Virus (RSV).
Enanta has developed direct-acting-antiviral (DAA) inhibitors
designed for use against HCV. Enanta’s protease inhibitors,
developed through its collaboration with AbbVie, include
paritaprevir, which is contained in AbbVie’s marketed DAA regimens
for HCV, and ABT-493, Enanta’s second protease inhibitor, which
AbbVie is developing in phase 3 studies in combination with
ABT-530, AbbVie’s NS5A inhibitor. Enanta has also discovered a
cyclophilin inhibitor, EDP-494, a novel, host-targeting mechanism
for HCV, which is now in phase 1 clinical development, and EDP-305,
an FXR agonist, which Enanta plans to advance into clinical
development for NASH later in 2016. In addition, Enanta has early
lead candidates for HBV and RSV in preclinical testing. Please
visit www.enanta.com for more information on Enanta’s programs and
pipeline.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements,
including statements with respect to the prospects for further
clinical development of Enanta’s cyclophilin inhibitor for the
treatment of HCV, the prospects for advancing EDP-305 for the
treatment of NASH into clinical development, the prospects for
advancement of another program in HBV or RSV, and the projected
sufficiency of Enanta’s cash-equivalent resources and marketable
securities. 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
planned clinical development, regulatory approval and
commercialization of its investigational HCV treatment regimen
containing ABT-493; competitive pricing, market acceptance and
reimbursement rates of AbbVie’s treatment regimens containing
paritaprevir or ABT-493 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 new disease areas such as HBV, NASH and RSV; potential
competition from the development efforts of others in those new
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, 2015 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.
ENANTA PHARMACEUTICALS, INC. CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except
per share amounts) Three Months
Ended Nine Months Ended June 30,
June 30, 2016 2015
2016 2015
Revenue $ 13,978 $ 11,599 $ 75,427 $ 146,464 Operating expenses
Research and development 10,785 6,253 28,961 16,140 General and
administrative 4,282 3,643 12,526
9,850 Total operating expenses 15,067
9,896 41,487 25,990
Income (loss) from operations (1,089 ) 1,703 33,940 120,474 Other
income, net 447 287 1,248
798 Income (loss) before income taxes (642 ) 1,990 35,188
121,272 Income tax (expense) benefit (434 ) 428
(11,720 ) (48,092 ) Net income (loss) $ (1,076 ) $
2,418 $ 23,468 $ 73,180 Net income
(loss) per share Basic $ (0.06 ) $ 0.13 $ 1.24 $ 3.92 Diluted $
(0.06 ) $ 0.13 $ 1.22 $ 3.80 Weighted average common shares
outstanding Basic 18,983 18,697 18,893 18,660 Diluted 18,983 19,278
19,223 19,277
ENANTA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands)
June 30,2016
September 30,2015 Assets Current assets Cash and cash
equivalents $ 24,789 $ 21,726 Short-term marketable securities
193,676 123,479 Accounts receivable 13,978 15,289 Unbilled
receivables - 433 Deferred tax assets 1,147 1,447 Prepaid expenses
and other current assets 8,200 8,267 Total current
assets 241,790 170,641 Property and equipment, net 7,499 5,886
Long-term marketable securities 26,194 64,238 Deferred tax assets
5,843 4,640 Restricted cash 608 608 Total assets $
281,934 $ 246,013 Liabilities and Stockholders' Equity Current
liabilities Accounts payable $ 2,044 $ 1,543 Accrued expenses and
other current liabilities 4,583 3,962 Income taxes payable
2,942 1,199 Total current liabilities 9,569 6,704 Warrant
liability 1,237 1,276 Series 1 nonconvertible preferred stock 158
163 Other long-term liabilities 1,963 1,713 Total
liabilities 12,927 9,856 Total stockholders' equity
269,007 236,157 Total liabilities and stockholders'
equity $ 281,934 $ 246,013
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version on businesswire.com: http://www.businesswire.com/news/home/20160808006032/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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