Conference Call and Webcast Today at 4:30
p.m. ET
- Royalty revenue of $14.4 million in
fourth quarter brings fiscal year total to $34.1 million
- AbbVie’s phase 3 trial begun for
next-generation HCV treatment containing Enanta’s protease
inhibitor ABT-493
- Enanta’s cyclophilin inhibitor
candidate EDP-494 expected to enter the clinic in the first
calendar quarter of 2016
- Cash and marketable securities
totaled $209 million at September 30, 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 fourth quarter and year
ended September 30, 2015.
Fiscal Fourth Quarter and Year Ended September 30, 2015
Financial ResultsCash, cash equivalents and short-term and
long-term marketable securities totaled $209.4 million at September
30, 2015. This compares to a total of $131.8 million in such
accounts at September 30, 2014. 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.
Revenue for the three months ended September 30, 2015 was $14.4
million, compared to $2.6 million for the three months ended
September 30, 2014. For the 2015 quarter, revenue consisted
primarily of 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. Quarterly royalty revenues are all included in
accounts receivable at quarter end and then collected in a single
payment in the following quarter. For the twelve months ended
September 30, 2015, revenue was $160.9 million, compared to revenue
of $47.7 million for the same period in 2014. The increase in
revenue for the twelve months ended September 30, 2015 was due
primarily to a total of $125 million in payments earned from AbbVie
for the achievement of U.S. and EU commercialization regulatory
approvals of VIEKIRA PAK™ and VIEKIRAX®, respectively, as well as
to royalties earned on those products, compared to $40 million in
milestone payments and other contractual revenue in the comparable
period in 2014. 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 $7.0 million for the
three months ended September 30, 2015, compared to $5.2 million for
the three months ended September 30, 2014. For the twelve months
ended September 30, 2015, research and development expenses were
$23.2 million, compared to $18.7 million for the comparable period
in 2014. The increases in the three and twelve month periods over
the prior year periods were primarily due to increased internal and
external spend on Enanta’s proprietary research programs.
General and administrative expenses totaled $3.7 million for the
three months ended September 30, 2015, compared to $2.8 million for
the three months ended September 30, 2014. For the twelve months
ended September 30, 2015, general and administrative expenses
totaled $13.5 million, compared to $10.0 million for the comparable
period in 2014. The increases in the three and twelve month periods
primarily reflected increases in stock-based compensation expense,
due principally to increases in Enanta’s stock price, as well as
additional expenses incurred as Enanta expands its operations.
Net income for the three months ended September 30, 2015 was
$5.8 million, or $0.29 per diluted common share, compared to a net
loss of $5.0 million, or ($0.27) per diluted common share, for the
corresponding period in 2014. For the twelve months ended September
30, 2015, net income was $79.0 million, or $4.09 per diluted common
share, compared to $34.4 million, or $1.80 per diluted common share
for the comparable period in 2014. The increase in net income
during the twelve month ended September 30, 2015 was primarily due
to $125 million in milestone payments received, as well as royalty
revenue earned from AbbVie. Net income in the 2014 year reflected a
total of $40 million in milestone payments for regulatory filings,
and the reversal of the entire valuation allowance related to
Enanta’s deferred tax assets, which resulted in an income tax
benefit of $15.2 million in 2014.
“We ended our fiscal year in a position of financial strength
and poised for advances in our research pipeline,” commented Jay R.
Luly, Ph.D., President and Chief Executive Officer. “Our cash and
marketable securities balance is strong, and we have royalties on
paritaprevir that were running at an annualized rate of
approximately $57 million at the quarter ending September 30.
Additionally, our second protease inhibitor, ABT-493 has advanced
into Phase 3 trials as part of AbbVie’s next-generation, fixed-dose
combination treatment for HCV, we plan to advance two of our
wholly-owned programs – our cyclophilin inhibitor for HCV and an
FXR agonist for NASH – into the clinic next year, and we are also
advancing other discovery programs.”
Development Program and Business Review
- In November 2015, Enanta earned a $30
million milestone payment for the reimbursement approval of
AbbVie’s VIEKIRAX® in Japan, which will be reflected in Enanta’s
quarter ending December 31, 2015.
- Phase 3 studies have begun on AbbVie’s
next-generation HCV treatment containing a fixed-dose combination
of protease inhibitor ABT-493 and ABT-530, AbbVie’s next generation
NS5A inhibitor.
- Data from AbbVie’s SURVEYOR studies,
its investigational hepatitis C virus (HCV) regimen containing
Enanta’s next-generation protease inhibitor ABT-493 and ABT-530,
AbbVie’s next generation NS5A inhibitor, demonstrated that after 12
weeks of treatment with doses at or closest to the Phase 3 clinical
dose, SVR12 rates were 100 percent in genotype 1 HCV patients, 96
percent in genotype 2, and 93 percent in genotype 3. Additional
late breaking data from SURVEYOR-I showed that non-cirrhotic
genotype 1 HCV patients treated for only 8 weeks with this
combination achieved SVR12 rate of 97 percent.
- Enanta has selected its cyclophilin
inhibitor candidate EDP-494 from its wholly-owned pipeline to
advance into a phase 1 clinical study for HCV, which is scheduled
to commence in the first quarter of calendar 2016. The cyclophilin
inhibitor class may have the highest barrier to resistance of any
class because cyclophilin is a human drug target that is
non-mutating and may prove valuable in treating resistant forms of
HCV.
- AbbVie recently filed a New Drug
Application with the FDA for a once-daily, fixed-dose formulation
of the 3 DAA’s in the VIEKIRA PAK regimen for the treatment of
patients with chronic GT1 HCV infection.
- The U.S. Food and Drug Administration
granted marketing approval on July 24, 2015 for AbbVie’s
TECHNIVIE™, the first all-oral, interferon-free, two-direct-acting
antiviral (2-DAA) treatment regimen approved in the U.S. for GT4
HCV patients.
Financial Guidance
- For the quarter ended September 30,
2015, Enanta’s paritaprevir royalties represented approximately 3%
percent of AbbVie’s reported VIEKIRA sales, and Enanta expects its
royalties in the quarter ending December 31, 2015 to continue to be
approximately 3% percent of such sales, depending 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 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 full fiscal year ending
September 30, 2016, Enanta expects to incur between $40 and $50
million of research and development expenses.
Upcoming Events and Presentations
- 34th Annual J.P. Morgan Healthcare
Conference, January 11-14, 2016, San Francisco
- Enanta plans to issue its fiscal first
quarter financial results press release, and hold a conference call
regarding those results, in the week of February 8, 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 November 23, 2015,
through 11:59 p.m. Eastern time on November 30, 2015 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
58326369. 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 has developed
novel protease 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
partnered 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 recently initiated phase 3
development in combination with ABT-530, AbbVie’s next-generation
NS5A inhibitor. Enanta also has discovered a host-targeted
antiviral (HTA) inhibitor for HCV targeted against cyclophilin,
which Enanta plans to study in a phase 1 clinical trial in the
first quarter of 2016 as well as another DAA program to develop
nucleotide polymerase inhibitors. In addition, Enanta has a
preclinical program in non-alcoholic steatohepatitis, or NASH,
which is a condition that results in liver inflammation and liver
damage caused by a buildup of fat in the liver.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements,
including statements with respect to the prospects for 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 advancement of the NASH
development program, expectations for a commercialization
regulatory approval in Japan milestone payment from AbbVie, the
prospects for Enanta’s cyclophilin inhibitor being valuable in
treating resistance forms of HCV, the prospects for advancing a
cyclophilin inhibitor for the treatment of HCV and an FXR agonist
for the treatment of NASH into clinical trials, 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 treatment regimens containing paritaprevir;
Enanta’s longer term revenues will likely 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 a 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; 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, 2014 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 Year Ended
September 30, September 30, 2015 2014
2015 2014 Revenue $ 14,416 $ 2,637 $ 160,880 $
47,741 Operating expenses Research and development 7,049 5,202
23,189 18,740 General and administrative 3,693 2,761
13,543 10,016
Total operating expenses
10,742 7,963 36,732
28,756 Income (loss) from operations 3,674 (5,326 ) 124,148 18,985
Other income, net 509 236 1,307
283 Income (loss) before income taxes 4,183 (5,090 ) 125,455
19,268 Income tax (expense) benefit 1,629 48
(46,463 ) 15,170 Net income (loss) $ 5,812 $ (5,042 )
$ 78,992 $ 34,438 Net income (loss) per share
Basic $ 0.30 $ (0.27 ) $ 4.23 $ 1.88 Diluted $ 0.29 $ (0.27 ) $
4.09 $ 1.80 Weighted average common shares outstanding Basic 18,714
18,589 18,673 18,355 Diluted 19,337 18,589 19,295 19,185
ENANTA PHARMACEUTICALS, INC. CONDENSED
CONSOLIDATED BALANCE SHEETS (in thousands)
September 30, September 30,
2015 2014 Assets Current assets Cash and cash
equivalents $ 21,726 $ 30,699 Short-term marketable securities
123,479 60,065 Accounts receivable 15,289 1,724 Unbilled
receivables 433 2,770 Deferred tax assets 1,447 11,123 Prepaid
expenses and other current assets 8,267 1,594
Total current assets
170,641 107,975 Property and equipment, net 5,886 1,803 Long-term
marketable securities 64,238 41,003 Deferred tax assets 4,640 4,198
Restricted cash 608 436 Total assets $ 246,013 $
155,415 Liabilities and Stockholders' Equity Current liabilities
Accounts payable $ 1,543 $ 1,874 Accrued expenses and other current
liabilities 3,962 2,872 Income taxes payable 1,199 -
Total current liabilities 6,704 4,746 Warrant liability 1,276 1,584
Series 1 nonconvertible preferred stock 163 202 Other long-term
liabilities 1,713 229 Total liabilities 9,856
6,761 Total stockholders' equity 236,157
148,654 Total liabilities and stockholders' equity $ 246,013 $
155,415
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version on businesswire.com: http://www.businesswire.com/news/home/20151123006222/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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