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 second quarter ended March 31, 2014.
Fiscal Second Quarter Ended March 31, 2014 Financial Results
Revenue for the three months ended March 31, 2014 was $2.2 million,
compared to $1.2 million for the three months ended March 31, 2013. For
the six months ended March 31, 2014, revenue was $3.1 million, compared
to revenue of $29.1 million for the same period in 2013. The changes in
revenue for the three and six-month periods were 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 $4.7 million for the three
months ended March 31, 2014, compared to $3.7 million for the three
months ended March 31, 2013. For the six months ended March 31, 2014,
research and development expenses were $9.0 million, compared to $8.5
million for the same period in 2013. The increase in the three and six
month periods is primarily due to increased spending on Enanta’s
proprietary research programs.
General and administrative expenses totaled $2.6 million for the three
months ended March 31, 2014, compared to $1.5 million for the three
months ended March 31, 2013. For the six months ended March 31, 2014,
general and administrative expenses totaled $4.7 million, compared to
$2.6 million for the same period in 2013. The increase in the three and
six month periods is primarily due to an increase in stock-based
compensation expense as well as additional expenses incurred as a result
of operating as a public company.
Net loss for the three months ended March 31, 2014 was $5.2 million,
compared to a net loss of $3.7 million for the same period in 2013. For
the six months ended March 31 2014, net loss was $10.6 million, compared
to net income of $18.2 million for the same period in 2013.
Cash, cash equivalents and marketable securities totaled $102.0 million
at March 31, 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.
“There have been significant developments in Enanta’s partnered and
proprietary programs for hepatitis C in recent months,” commented Jay R.
Luly, Ph.D. President and Chief Executive Officer. “The recent U.S. NDA
and MAA submissions by our partner AbbVie for its genotype 1 HCV regimen
is an important step toward Enanta being part of the first wave of
all-oral, interferon-free HCV treatments. In addition, our internal
programs are advancing and we continue to explore new infectious disease
areas for which we can apply our internal chemistry expertise.”
Program and Business Review
-
AbbVie submitted a New Drug Application (NDA) to the U.S. Food and
Drug Administration in April and Marketing Authorization Applications
(MAA) to the European Medicines Agency in May, for its hepatitis C
virus (HCV) regimen containing the Enanta/AbbVie collaboration’s
protease inhibitor ABT-450. Enanta earned a $20 million milestone
payment for each submission.
-
This quarter, Enanta’s NS5A inhibitor EDP-239, is expected to advance
into drug combination studies in healthy volunteers with alisporivir,
Novartis’s cyclophilin inhibitor. EDP-239 is being studied in
collaboration with Novartis on NS5A inhibitors for the treatment of
HCV infection.
-
Detailed data from several phase 3 studies that include the
Enanta/AbbVie collaboration’s protease inhibitor ABT-450 were
presented at the International Liver Congress in London and at
Digestive Disease Week in Chicago.
-
Pre-clinical data on ABT-493, a next-generation HCV NS3/4A protease
inhibitor identified within the Enanta/AbbVie collaboration, was
presented at the 21st Conference on Retroviruses and
Opportunistic Infections in Boston. The data demonstrates that ABT-493
has a substantially improved in vitro profile compared to
earlier generation HCV NS3/4A protease inhibitors and displays potent
and broad genotypic activity in genotypes 1a, 1b, 2a, 3a, 4a and 6a.
Upcoming Events and Presentations
Enanta management will participate in the following upcoming investor
conferences:
-
Jefferies 2014 Global Healthcare Conference, June 2-5, 2014
-
Wells Fargo 2014 Healthcare Conference, June 17-18, 2014
-
JMP Securities Healthcare Conference, June 24-25, 2014
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 May 12, 2014,
through 11:59 p.m. Eastern time on May 16, 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 31914722. A live audio
webcast of the call and replay will be accessible on our website 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 approval of AbbVie’s HCV
treatment regimen containing ABT-450 for use in the U.S., the prospects
for EDP-239 and Enanta’s internal programs, 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 AbbVie’s planned regulatory submissions
and commercialization efforts for its treatment regimens containing
ABT-450 or any additional collaboration protease inhibitor; regulatory
actions affecting approval of treatment regimens containing ABT-450 or
any additional protease inhibitors; clinical and commercial development
of competitive product candidates of others for HCV and other viruses;
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 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
|
|
Six Months Ended
|
|
|
|
|
March 31,
|
|
March 31,
|
|
|
|
|
|
2014
|
|
|
|
2013
|
|
|
|
2014
|
|
|
|
2013
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
|
$
|
2,160
|
|
|
$
|
1,196
|
|
|
$
|
3,053
|
|
|
$
|
29,055
|
|
Operating expenses
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
4,722
|
|
|
|
3,704
|
|
|
|
8,985
|
|
|
|
8,502
|
|
|
General and administrative
|
|
|
2,565
|
|
|
|
1,493
|
|
|
|
4,652
|
|
|
|
2,645
|
|
|
|
Total operating expenses
|
|
|
7,287
|
|
|
|
5,197
|
|
|
|
13,637
|
|
|
|
11,147
|
|
Income (loss) from operations
|
|
|
(5,127
|
)
|
|
|
(4,001
|
)
|
|
|
(10,584
|
)
|
|
|
17,908
|
|
Other income (expense), net
|
|
|
(76
|
)
|
|
|
252
|
|
|
|
11
|
|
|
|
300
|
|
Net income (loss)
|
|
|
(5,203
|
)
|
|
|
(3,749
|
)
|
|
|
(10,573
|
)
|
|
|
18,208
|
|
|
|
|
|
|
|
|
|
|
|
|
Accretion of redeemable convertible
|
|
|
|
|
|
|
|
|
preferred stock to redemption value
|
|
|
-
|
|
|
|
(1,244
|
)
|
|
|
-
|
|
|
|
(2,526
|
)
|
Net income attributable to participating securities
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(13,670
|
)
|
Net income (loss) attributable to common stockholders
|
|
$
|
(5,203
|
)
|
|
$
|
(4,993
|
)
|
|
$
|
(10,573
|
)
|
|
$
|
2,012
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share attributable to common stockholders
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
(0.28
|
)
|
|
$
|
(2.28
|
)
|
|
$
|
(0.58
|
)
|
|
$
|
1.21
|
|
|
Diluted
|
|
$
|
(0.28
|
)
|
|
$
|
(2.28
|
)
|
|
$
|
(0.58
|
)
|
|
$
|
1.09
|
|
Weighted average common shares outstanding
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
18,354
|
|
|
|
2,192
|
|
|
|
18,149
|
|
|
|
1,670
|
|
|
Diluted
|
|
|
18,354
|
|
|
|
2,192
|
|
|
|
18,149
|
|
|
|
3,084
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ENANTA PHARMACEUTICALS, INC.
|
CONDENSED CONSOLIDATED BALANCE SHEETS
|
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
September 30,
|
|
|
|
|
|
2014
|
|
|
2013
|
Assets
|
|
|
|
|
|
Current assets
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
18,101
|
|
$
|
8,859
|
|
Short-term marketable securities
|
|
|
76,669
|
|
|
92,621
|
|
Accounts receivable
|
|
|
998
|
|
|
808
|
|
Unbilled receivables
|
|
|
1,604
|
|
|
784
|
|
Prepaid expenses and other current assets
|
|
|
1,977
|
|
|
1,641
|
|
|
Total current assets
|
|
|
99,349
|
|
|
104,713
|
Property and equipment, net
|
|
|
1,377
|
|
|
1,121
|
Long-term marketable securities
|
|
|
7,184
|
|
|
10,703
|
Restricted cash
|
|
|
436
|
|
|
436
|
|
|
Total assets
|
|
$
|
108,346
|
|
$
|
116,973
|
Liabilities, Preferred Stock and Stockholders' Equity
|
|
|
|
|
Current liabilities
|
|
|
|
|
|
Accounts payable
|
|
$
|
2,041
|
|
$
|
1,481
|
|
Accrued expenses
|
|
|
2,327
|
|
|
3,035
|
|
Deferred revenue
|
|
|
51
|
|
|
10
|
|
|
Total current liabilities
|
|
|
4,419
|
|
|
4,526
|
Warrant liability
|
|
|
1,617
|
|
|
1,620
|
Series 1 nonconvertible preferred stock
|
|
|
206
|
|
|
-
|
Other long-term liabilities
|
|
|
389
|
|
|
359
|
|
|
Total liabilities
|
|
|
6,631
|
|
|
6,505
|
Total stockholders' equity
|
|
|
101,715
|
|
|
110,468
|
|
|
Total liabilities, preferred stock and stockholders' equity
|
|
$
|
108,346
|
|
$
|
116,973
|
|
|
|
|
|
|
|
|
|
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