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, 2013.
Fiscal Fourth Quarter and Year Ended September 30, 2013
Financial Results
Revenue for the three months ended September 30, 2013 was $1.3
million compared to $1.9 million for the three months ended
September 30, 2012. For the year ended September 30, 2013 revenue
was $32.1 million compared to $41.7 million for the year ended
September 30, 2012. The changes in revenue for the three and
twelve-month periods are primarily related to the timing and amount
of milestone and other payments from collaborations, which have
varied significantly from period to period and are expected to
continue to do so.
Research and development expenses totaled $4.3 million for both
the three months ended September 30, 2013 and for the three months
ended September 30, 2012. For the year ended September 30, 2013,
research and development expenses were $16.8 million compared to
$15.1 million for the year ended September 30, 2012. The increase
in research and development expenses is primarily due to increases
in preclinical expenses for our early stage drug discovery
programs.
General and administrative expenses totaled $1.7 million for
both the three months ended September 30, 2013 and the three months
ended September 30, 2012. For the year ended September 30, 2013,
general and administrative expenses were $6.2 million compared to
$5.3 million for the year ended September 30, 2012. The increase is
primarily due to higher stock-based compensation expense related to
grants of additional employee stock options, as well as additional
expenses incurred as a result of operating as a public company.
Net loss for the three months ended September 30, 2013 was $4.4
million compared to a net loss of $4.1 million for the same period
in 2012. Net income for the year ended September 30, 2013 was $9.6
million compared to net income of $21.4 million for the same period
in 2012.
Cash, cash equivalents and marketable securities totaled $112.2
million at September 30, 2013. This compares to $45.4 million at
September 30, 2012. The increase in cash, cash equivalents and
marketable securities is primarily due to our March 2013 initial
public offering that resulted in $59.9 million in net proceeds to
the company. 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.
“2013 was a transformational year for Enanta,” stated Jay R.
Luly, Ph.D., President and Chief Executive Officer. “Our initial
public offering in March further strengthened our cash position,
and we ended the year with three HCV compounds in the clinic and we
have progressed our internal programs and pipeline candidates.”
Pipeline and Business Review
- Enanta recently announced results from
the SAPPHIRE-I study, one of six phase 3 registrational studies
being conducted by AbbVie for the treatment of hepatitis C virus
(HCV) genotype 1 (GT1) infection, using a regimen containing
Enanta’s lead protease inhibitor ABT-450. Results demonstrated a
sustained virologic response at 12 weeks post-treatment (SVR12) of
96 percent in treatment-naive adult patients chronically infected
with GT1 HCV. Results from the remaining five ABT-450 containing
studies will be available in the coming months, supporting
regulatory submissions starting in the second quarter of 2014.
- Data from AbbVie’s PEARL-1 study was
presented at the AASLD meeting on November 3, 2013. In an
intent-to-treat analysis, a two-direct acting antiviral HCV regimen
which included ABT-450, produced SVR12 results of 95% in GT 1b,
treatment-naïve HCV patients and SVR12 results of 90% in prior null
responders, without the use of interferon or ribavirin
- The National Institute of Allergy and
Infectious Diseases (NIAID) awarded Enanta an additional $9.2
million to further fund development of Enanta’s new class of
bridged bicyclic antibiotics known as Bicyclolides.
- Bicyclolide EDP-788 is targeted to
begin phase 1 clinical studies in the first half of calendar
2014.
Upcoming Events and Presentations
Enanta management will participate at the Deutsche Bank BioFest
investor conference in Boston, MA on December 3, 2013.
Conference Call and Webcast Information
Enanta will host a conference call and webcast today at 8:30
a.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 11:30 a.m. Eastern time on
November 25, 2013, through 11:59 p.m. Eastern time on November 29,
2013 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 10354107. A live audio webcast of the call will be
accessible at www.enanta.com. Please visit the Investor home page
of our website and search for calendar of events. A replay of the
webcast will be available on www.enanta.com approximately two hours
following the live webcast.
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 (partnered with Novartis) and
nucleotide polymerase – as well as a host-targeted antiviral (HTA)
inhibitor class targeted against cyclophilin. Additionally, Enanta
has created a new class of antibiotics, called Bicyclolides, for
the treatment of multi-drug resistant bacteria, with a focus on
developing an intravenous and oral treatment for hospital and
community MRSA (methicillin-resistant Staphylococcus aureus)
infections.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements,
including statements with respect to the prospects for further
clinical development of ABT-450 and EDP-788, the expected timeline
for announcement of results of Phase III studies of regimens that
include ABT-450, and the projected sufficiency of Enanta’s cash
equivalent resources. 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 the
development and commercialization efforts of AbbVie for treatment
regimens containing ABT-450 or any additional collaboration
protease inhibitor and on the efforts of NIAID for the early
clinical development of EDP-788; regulatory actions affecting
clinical development or treatment regimens containing ABT-450 or
any additional protease inhibitors; clinical development of
competitive product candidates of others for HCV and other viruses
or for MRSA and other bacteria; Enanta’s lack of clinical
development experience; Enanta’s need to attract and retain senior
management and key scientific personnel; Enanta’s lack of resources
and experience commercializing drugs, including any future
proprietary drug candidates it may develop; 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-Q and other periodic
reports filed 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 Year Ended
September 30, September 30, 2013 2012
2013 2012 Revenue $ 1,349 $ 1,858 $ 32,053 $
41,706 Operating expenses Research and development 4,300 4,255
16,841 15,115 General and administrative 1,750
1,699 6,183 5,302 Total
operating expenses 6,050 5,954
23,024 20,417 Income (loss) from operations
(4,701 ) (4,096 ) 9,029 21,289 Other income, net 258
44 598 110 Net income
(loss) (4,443 ) (4,052 ) 9,627 21,399 Liabilities, Preferred
Stock and Stockholders' Equity (Deficit) to redemption value -
(1,332 ) (2,526 ) (5,367 ) Net income attributable to participating
securities - - (13,670 )
(14,663 ) Net income (loss) attributable to common stockholders $
(4,443 ) $ (5,384 ) $ (6,569 ) $ 1,369 Net
income (loss) per share attributable to common stockholders Basic $
(0.25 ) $ (4.78 ) $ (0.67 ) $ 1.26 Diluted $ (0.25 ) $ (4.78 ) $
(0.67 ) $ 1.13 Weighted average common shares outstanding Basic
17,904 1,127 9,788 1,089 Diluted 17,904 1,127 9,788 2,475
ENANTA PHARMACEUTICALS, INC. CONDENSED
CONSOLIDATED BALANCE SHEETS (in thousands)
September 30, September 30, 2013 2012
Assets Current assets Cash and cash equivalents $ 8,859 $
10,511 Short-term marketable securities 92,621 33,251 Accounts
receivable 808 1,049 Unbilled receivables 784 1,893 Prepaid
expenses and other current assets 1,641 604
Total current assets 104,713 47,308 Property and equipment, net
1,121 611 Long-term marketable securities 10,703 1,656 Restricted
cash 436 436 Other assets - 2,151 Total assets
$ 116,973 $ 52,162
Liabilities, Preferred Stock and
Stockholders' Equity (Deficit) Current liabilities Accounts
payable $ 1,481 $ 1,851 Accrued expenses 3,035 3,866 Deferred
revenue 10 17 Total current liabilities 4,526
5,734 Warrant liability 1,620 2,001 Other long-term liabilities
359 498 Total liabilities 6,505
8,233 Redeemable convertible preferred stock - 158,955
Convertible preferred stock - 327 Total stockholders' equity
(deficit) 110,468 (115,353 ) Total liabilities,
preferred stock and stockholders' equity (deficit) $ 116,973 $
52,162
InvestorEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMediaMacDougall Biomedical
CommunicationsKari Watson, 781-235-3060kwatson@macbiocom.com
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