Conference Call and Webcast Today at 4:30
p.m. ET
- Royalty revenue for paritaprevir
containing regimens was $17.9 million
- $30 million milestone payment
received from AbbVie for reimbursement approval in Japan for
VIEKIRAX®
- Cash and marketable securities
totaled $236.6 million at December 31, 2015
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 first quarter ended
December 31, 2015.
Enanta’s cash, cash equivalents and short-term and long-term
marketable securities totaled $236.6 million at December 31, 2015.
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 First Quarter Ended December 31, 2015 Financial
Results
Revenue for the three months ended December 31, 2015 was $48.4
million, compared to $77.5 million for the three months ended
December 31, 2014. For the 2015 period, revenue consisted primarily
of a $30 million milestone payment earned and received from AbbVie
for reimbursement approval of VIEKIRAX® in Japan, as well as
royalties earned on contractually specified portions of AbbVie’s
worldwide net sales of hepatitis C virus (HCV) treatment regimens
containing paritaprevir, Enanta’s lead protease inhibitor
identified within the ongoing AbbVie-Enanta collaboration. Revenue
in the 2014 period consisted primarily of a $75 million milestone
payment received in the period ended December 31, 2014 for the
initial commercialization regulatory approval of VIEKIRA PAK® in
the U.S. Milestone payments, royalties and other payments from
collaborations have varied significantly from period to period, and
are expected to continue to do so.
Research and development expenses totaled $9.0 million for the
three months ended December 31, 2015, compared to $4.5 million for
the three months ended December 31, 2014. The increase in the three
month period over the prior year period was primarily due to
increased pre-clinical and clinical costs associated with Enanta’s
wholly-owned R&D programs in NASH, RSV, HBV and HCV
cyclophilin.
General and administrative expenses totaled $3.8 million for the
three months ended December 31, 2015, compared to $2.8 million for
the three months ended December 31, 2014. The increase in the 2015
period primarily reflects increases in stock-based compensation
expense, as well as additional expenses incurred as Enanta expands
its operations.
Net income for the three months ended December 31, 2015 was
$26.2 million, or $1.36 per diluted common share, compared to net
income of $42.0 million or $2.18 per diluted common share, for the
corresponding period in 2014.
“Sustained by Enanta’s financial resources generated by our HCV
collaboration product, 2016 will be a year in which Enanta
continues to diversify beyond our partnered and wholly-owned HCV
programs and advances its internal programs in NASH, hepatitis B
virus and respiratory syncytial virus,” commented Jay R. Luly,
Ph.D., President and Chief Executive Officer. “We expect to advance
our NASH program into clinical development this year and look
forward to sharing updates on these new programs in the coming
months.”
Development Program and Business Review
- In January Enanta dosed the first
subject in its phase 1 clinical study of EDP-494, Enanta’s
wholly-owned cyclophilin inhibitor being developed for the
treatment of hepatitis C virus (HCV).
- In January, Enanta announced that it
has expanded its research and development programs within the
company’s core focus areas of virology and liver disease to include
new programs to treat hepatitis B virus (HBV) and Respiratory
Syncytial Virus (RSV) infections. Preclinical candidate selection
is ongoing with a goal to initiate clinical studies for at least
one of these programs in 2017.
- Enanta is on track to initiate a phase
1 clinical trial in the second half of 2016 with EDP-305, Enanta’s
wholly-owned Farnesoid X Receptor (FXR) agonist candidate for
non-alcoholic steatohepatitis (NASH) and Primary Biliary
Cholangitis (PBC).
- AbbVie has initiated six global phase 3
clinical studies of its next-generation HCV treatment regimen,
which includes ABT-493, Enanta’s next-generation protease
inhibitor.
Revenue Guidance
For the quarter ending March 31, 2016, which marks the beginning
of a new year for the calculation of Enanta’s annually tiered
royalties, Enanta expects its royalty revenue to be at least 3%
percent of AbbVie’s reported VIEKIRA sales. The actual percentage
will depend primarily on the amounts and portions of those sales
that are 2-DAA or 3-DAA regimen sales. Under its agreement with
AbbVie, Enanta is entitled to receive annually tiered, double-digit
royalties on specified portions of sales that are allocated to
paritaprevir using 30% of 3-DAA sales (VIEKIRA PAK™ or VIEKIRAX® +
EXVIERA®) and 45% of 2-DAA sales (TECHNIVIE® or VIEKIRAX®) for the
allocation.
Upcoming Events and Presentations
- February 10, 2016 - Leerink Partners
5th Annual Global Healthcare Conference, New York, NY
- February 11, 2016 at 4:00 p.m. ET -
Enanta 2016 Annual Meeting of Stockholders, Boston, MA
- March 17, 2016 - Barclays Global Health
Care Conference, Miami, FL
- Enanta plans to issue its fiscal second
quarter financial results press release, and hold a conference call
regarding those results, in the week of May 9, 2016.
Conference Call and Webcast Information
Enanta 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 6:30 p.m. Eastern time on February 8, 2016,
through 11:59 p.m. Eastern time on February 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
36743436. 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 novel protease inhibitors and NS5A
inhibitors that are members of the direct-acting-antiviral (DAA)
inhibitor classes designed for use against the hepatitis C virus
(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
next-generation protease inhibitor, which AbbVie is developing in
phase 3 studies in combination with ABT-530, AbbVie’s
next-generation 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. 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 future
royalties on sales of AbbVie’s HCV treatment regimens containing
paritaprevir, the prospects for AbbVie’s development of a
next-generation regimen containing ABT-493, the prospects for
further clinical development of Enanta’s cyclophilin inhibitor for
the treatment of HCV, the prospects for advancing an FXR agonist
for the treatment of NASH into clinical trials, 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 are dependent upon the success
of AbbVie’s planned regulatory approval and 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 and commercialization of
next-generation regimens containing ABT-493; regulatory actions
affecting any approval of an HCV treatment regimen containing
ABT-493; the pricing, market acceptance and reimbursement rates of
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
December 31, 2015 2014
Revenue $ 48,445 $ 77,498 Operating expenses Research
and development 9,033 4,519 General and administrative 3,818
2,769 Total operating expenses 12,851
7,288 Income from operations 35,594 70,210
Other income, net 329 301 Income before
income taxes 35,923 70,511 Income tax expense (9,734 )
(28,502 ) Net income $ 26,189 $ 42,009
Net income per share Basic $ 1.39 $ 2.26 Diluted $ 1.36 $
2.18 Weighted average common shares outstanding Basic 18,776 18,603
Diluted 19,269 19,283
ENANTA PHARMACEUTICALS,
INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in
thousands) December 31, September
30, 2015 2015 Assets Current assets
Cash and cash equivalents $ 46,233 $ 21,726 Short-term marketable
securities 133,786 123,479 Accounts receivable 17,869 15,289
Unbilled receivables 1,009 433 Deferred tax assets 1,581 1,447
Prepaid expenses and other current assets 8,543 8,267
Total current assets 209,021 170,641 Property and equipment, net
7,872 5,886 Long-term marketable securities 56,618 64,238 Deferred
tax assets 4,260 4,640 Restricted cash 608 608 Total
assets $ 278,379 $ 246,013 Liabilities and Stockholders' Equity
Current liabilities Accounts payable $ 2,767 $ 1,543 Accrued
expenses and other current liabilities 3,165 3,962 Income taxes
payable 4,940 1,199 Total current liabilities 10,872
6,704 Warrant liability 1,290 1,276 Series 1 nonconvertible
preferred stock 164 163 Other long-term liabilities 1,774
1,713 Total liabilities 14,100 9,856 Total
stockholders' equity 264,279 236,157 Total
liabilities and stockholders' equity $ 278,379 $ 246,013
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version on businesswire.com: http://www.businesswire.com/news/home/20160208005836/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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