Conference Call and Webcast today at 8:30 am
ET
Enanta Pharmaceuticals, Inc., (NASDAQ:ENTA), a research and
development-focused biotechnology company dedicated to creating
small molecule drugs in the infectious disease field, today
reported financial results for its fiscal fourth quarter and year
ended September 30, 2014.
Fiscal Fourth Quarter and Year Ended September 30, 2014
Financial Results
Revenue for the three months ended September 30, 2014 was $2.6
million, compared to $1.3 million for the three months ended
September 30, 2013. For the year ended September 30, 2014, revenue
was $47.7 million, compared to $32.1 million for the prior year.
The increase in revenue for fiscal 2014 year was primarily due to
milestone payments totaling $40 million received from AbbVie for
the U.S. and European regulatory filings for AbbVie’s
investigational hepatitis C virus (HCV) treatment regimen
containing the protease inhibitor ABT-450, which was developed in
the Enanta-AbbVie collaboration. Enanta’s milestone 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 $5.2 million for the
three months ended September 30, 2014, compared to $4.3 million for
the three months ended September 30, 2013. For the year ended
September 30, 2014, research and development expenses were $18.7
million, compared to $16.8 million for the corresponding period in
2013. The increases in the three and twelve-month periods are
primarily due to increased spending on Enanta’s proprietary
research programs.
General and administrative expenses totaled $2.8 million for the
three months ended September 30, 2014, compared to $1.8 million for
the three months ended September 30, 2013. For the year ended
September 30, 2014, general and administrative expenses totaled
$10.0 million, compared to $6.2 million for the corresponding
period in 2013. The increases in the three and twelve-month periods
primarily reflect increases in stock-based compensation expense,
due principally to increases in Enanta’s stock price, as well as
additional expenses incurred as a result of operating as a public
company.
There was no income tax benefit for the three months ended
September 30, 2014 and 2013. For the year ended September 30, 2014,
income tax benefit was $15.2 million as compared to $0.0 million
for the same period in 2013. The tax benefit during fiscal 2014 is
due to Enanta’s reversal of the entire valuation allowance related
to its deferred tax assets.
Net loss for the three months ended September 30, 2014 was $5.0
million, compared to a net loss of $4.4 million for the
corresponding period in 2013. For the year ended September 30,
2014, net income was $34.4 million, compared to net income of $9.6
million for the 2013 year. The increase in net income during the
twelve-month period ended September 30, 2014 was primarily due to
the $40 million in milestone payments received from AbbVie and the
$15.2 million income tax benefit from the reversal of the tax
valuation allowance.
Cash, cash equivalents and short-term and long-term marketable
securities totaled $131.8 million at September 30, 2014. This
compares to $112.2 million at September 30, 2013. Enanta expects
that its current cash, cash equivalents and marketable securities
will be sufficient to meet its anticipated cash requirements for at
least the next 24 months.
“We ended our fiscal year in a strong financial position to
advance our development pipeline,” commented Jay R. Luly, Ph.D.,
President and Chief Executive Officer. “With over $131 million in
cash and securities, as well as pending U.S. and European
regulatory approvals that are anticipated to generate milestone
payments and then royalties for us, the company will be well funded
to advance our wholly-owned HCV programs and our other internal
programs. We will also continue to invest in additional new disease
areas for which we can apply our internal chemistry expertise.”
Program and Business Review
- The European Committee for Medicinal
Products for Human Use of The European Medicines Agency has granted
positive opinions for AbbVie’s investigational, all-oral,
interferon-free treatment of VIEKIRAX™ (a combination of
ombitasvir, paritaprevir (ABT-450) and ritonavir) plus EXVIERA™
(dasabuvir), with or without ribavirin (RBV), for patients with
genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, and
VIEKIRAX™ only, with RBV, for patients with genotype 4 (GT4) HCV
infection.
- AbbVie announced that U.S. regulatory
approval for AbbVie’s 3-direct-acting-antiviral regimen containing
ABT-450 is expected by calendar year end. Enanta is entitled to up
to $155 million in commercial regulatory approval milestones as
well as annually tiered, double-digit royalties on the portion of
AbbVie’s worldwide net sales allocable to ABT-450. AbbVie and
Enanta are collaborative partners on HCV protease inhibitors for
HCV, including ABT-450 and ABT-493, our next-generation protease
inhibitor.
- Enanta announced that it did not
exercise its co-development option on ABT-493 in order to invest
its resources in other assets in its pipeline. Enanta is eligible
to receive up to $80 million in regulatory approval milestones as
well as annually tiered, double-digit royalties on the portion of
AbbVie’s worldwide net sales allocable to ABT-493.
- Under an amendment to its agreement
with Novartis, Enanta will regain all rights to EDP-239, an NS5A
inhibitor for HCV which was discovered by Enanta and was being
developed by Novartis. The new agreement provides for the
completion or transition back to Enanta of specified clinical
studies currently underway with EDP-239, including a
proof-of-concept study. The transition is expected to be completed
effective as of December 15, 2014. Novartis has indicated that HCV
is no longer a strategic focus for Novartis.
- 25 abstracts presenting results from
regimens containing ABT-450 or ABT-493 were presented during The
Liver Meeting (AASLD) earlier this month.
- AbbVie has initiated a phase 2b
clinical study with ABT-493 to evaluate the safety and efficacy of
ABT-493 co-administered with ABT-530, AbbVie's next generation NS5A
inhibitor, in HCV patients.
Upcoming Events and Presentations
Enanta management will participate in the following upcoming
investor conferences:
- Deutsche Bank BioFest, Dec. 1, 2014,
Boston
- JP Morgan 33rd Annual Healthcare
Conference, Jan. 12-15, San Francisco
Conference Call and Webcast Information
Enanta will host a conference call and webcast today at 8:30
a.m. Eastern Time to discuss these results and provide an update on
its research and development pipeline. 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 11:30 a.m. Eastern Time
on November 24, 2014, through 11:59 p.m. Eastern Time on December
1, 2014 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 3020290. A live webcast and replay of the call can be
accessed by visiting the “Calendar of Events” section on the
“Investors” page of Enanta’s website at www.enanta.com. The replay
webcast will be available following the presentation and will be
archived for approximately 30 days.
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 in the infectious disease field. Enanta is discovering, and
in some cases developing, novel inhibitors designed for use against
the hepatitis C virus (HCV). These inhibitors include members of
three direct acting antiviral (DAA) inhibitor classes – protease
(partnered with AbbVie), NS5A and nucleotide polymerase – as well
as a host-targeted antiviral (HTA) inhibitor class targeted against
cyclophilin. Additionally, Enanta has a Bicyclolide antibiotic in
early clinical development with the National Institutes of Allergy
and Infectious Diseases (NIAID) for the potential treatment of
multi-drug resistant bacterial infections.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements,
including statements with respect to the prospects for approval of
AbbVie’s HCV treatment regimen containing ABT-450 for use in the
U.S. and Europe and any resulting milestone payments and subsequent
royalties, the prospects for EDP-239 and Enanta’s internal
programs, 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
reliance on AbbVie’s planned regulatory approval and
commercialization efforts for its treatment regimens containing
ABT-450 or ABT-493; regulatory actions affecting approval of
treatment regimens containing ABT-450 or ABT-493; the pricing,
market acceptance and reimbursement rates of such treatment
regimens compared to competitive HCV product candidates of other
companies; 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, 2013 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 EndedSeptember
30,
Year EndedSeptember 30,
2014 2013 2014
2013
Revenue $ 2,637 $ 1,349 $ 47,741 $ 32,053
Operating expenses Research and development 5,202 4,300 18,740
16,841 General and administrative 2,761 1,750
10,016 6,183 Total operating expenses
7,963 6,050 28,756 23,024
Income (loss) from operations (5,326 ) (4,701 ) 18,985 9,029
Other income, net 236 258 283
598 Income (loss) before income taxes (5,090 ) (4,443
) 19,268 9,627
Income tax benefit 48 - 15,170
-
Net income (loss) (5,042 ) (4,443 ) 34,438 9,627
Accretion of redeemable convertible
preferred stock to redemption value
- - - (2,526 )
Net income attributable to participating securities -
- - (13,670 )
Net income (loss) attributable to common stockholders $ (5,042 ) $
(4,443 ) $ 34,438 $ (6,569 )
Net income (loss) per share attributable to common stockholders
Basic $ (0.27 ) $ (0.25 ) $ 1.88 $ (0.67 ) Diluted $ (0.27 ) $
(0.25 ) $ 1.80 $ (0.67 ) Weighted average common shares outstanding
Basic 18,589 17,904 18,355 9,788 Diluted 18,589 17,904 19,185 9,788
ENANTA PHARMACEUTICALS,
INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in
thousands)
September 30,2014
September 30,2013
Assets Current assets Cash and cash equivalents $ 30,699 $
8,859 Short-term marketable securities 60,065 92,621 Accounts
receivable 1,724 808 Unbilled receivables 2,770 784 Deferred tax
assets 11,123 - Prepaid expenses and other current assets
1,594 1,641 Total current assets 107,975 104,713 Property
and equipment, net 1,803 1,121 Long-term marketable securities
41,003 10,703 Deferred tax assets 4,198 - Restricted cash
436 436 Total assets $ 155,415 $ 116,973
Liabilities,
Preferred Stock and Stockholders' Equity Current liabilities
Accounts payable $ 1,874 $ 1,481 Accrued expenses 2,872 3,035
Deferred revenue - 10 Total current liabilities 4,746
4,526 Warrant liability 1,584 1,620 Series 1 nonconvertible
preferred stock 202 - Other long-term liabilities 229
359 Total liabilities 6,761 6,505 Total stockholders'
equity 148,654 110,468 Total liabilities, preferred
stock and stockholders' equity $ 155,415 $ 116,973
Investor ContactEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
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