Conference Call and Webcast Today at 4:30 p.m. ET
-
Cash and marketable securities totaled $212 million at June 30,
2015
-
Existing financial resources and anticipated cash flows to fund
continued operations and advance proprietary pipeline
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 third quarter ended June 30, 2015.
Fiscal Third Quarter Ended June 30, 2015 Financial Results
Cash, cash equivalents and short-term and long-term marketable
securities totaled $212 million at June 30, 2015. This compares to a
total of $132 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 June 30, 2015 was $11.6 million,
compared to $42.1 million for the three months ended June 30, 2014. For
the 2015 quarter, revenue consisted primarily of royalties earned on a
contractually specified portion 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. The higher revenue in the comparable
quarter in 2014, when Enanta had no royalty revenue, consisted primarily
of milestone payments from AbbVie totaling $40 million related to
regulatory filings in the U.S. and EU. For the nine months ended June
30, 2015, revenue was $146.5 million, compared to revenue of $45.1
million for the same period in 2014. The increase in revenue for the
nine months ended June 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.
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 $6.3 million for the three
months ended June 30, 2015, compared to $4.6 million for the three
months ended June 30, 2014. For the nine months ended June 30, 2015,
research and development expenses were $16.1 million, compared to $13.5
million for the same period in 2014. The increases in the three and nine
month periods over the prior year periods were primarily due to
increased spending on Enanta’s proprietary research programs.
General and administrative expenses totaled $3.6 million for the three
months ended June 30, 2015, compared to $2.6 million for the three
months ended June 30, 2014. For the nine months ended June 30, 2015,
general and administrative expenses totaled $9.9 million, compared to
$7.3 million for the same period in 2014. The increases in the three and
nine 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 June 30, 2015 was $2.4 million, or
$0.13 per diluted common share, compared to $50.1 million, or $2.61 per
diluted common share, for the corresponding period in 2014. The net
income in the 2014 quarter reflected not only a total of $40 million in
milestone payments for regulatory filings, but also the reversal of the
entire valuation allowance related to Enanta’s deferred tax assets,
which resulted in an income tax benefit of $15.1 million in the quarter.
For the nine months ended June 30, 2015, net income was $73.2 million,
compared to $39.5 million for the same period in 2014. The increase in
net income during the nine month period ended June 30, 2015 was
primarily due to $125 million in milestone payments received, as well as
royalty revenue earned and payable, from AbbVie.
“Enanta has a solid financial base from milestone payments received and
royalty revenues being earned on AbbVie’s net sales of paritaprevir,”
commented Jay R. Luly, Ph.D., President and Chief Executive Officer. “We
will use these revenues to sustain our business operations, and advance
our wholly-owned, proprietary programs in HCV and NASH, among others.”
Development Program and Business Review
-
The U.S. Food and Drug Administration granted marketing approval on
July 24, 2015 for TECHNIVIE™, the first and only all oral,
interferon-free, two-direct-acting antiviral treatment regimen for
Genotype 4 HCV patients.
-
AbbVie announced interim phase 2b SVR12 results of 100
percent in a study of ABT-493, Enanta’s next-generation HCV protease
inhibitor in combination with ABT-530, AbbVie’s next-generation NS5A
inhibitor.
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In June, Nathalie Adda, MD, was appointed as Senior Vice President and
Chief Medical Officer of Enanta.
-
AbbVie reported results from the TURQUOISE-III study in
treatment-naïve and treatment-experienced patients with GT1b chronic
HCV with compensated liver cirrhosis. These data demonstrated 100
percent SVR12 rates when treated with VIEKIRA without RBV.
-
Results from AbbVie’s GIFT-I study were presented at the Annual
Meeting of the Japan Society for Hepatology. Results demonstrated
sustained virologic response 12 weeks post-treatment (SVR12)
of 95 percent and 91 percent in Japanese patients with genotype 1b
(GT1b) hepatitis C virus (HCV) infection with and without compensated
cirrhosis, respectively.
-
Enanta was added to S&P small cap 600 Index effective July 28.
Revenue Guidance
-
For the quarter ended June 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
September 30, 2015 to continue to be approximately 3 percent of such
sales.
-
Based upon AbbVie’s guidance for regulatory approval in Japan for its
2-DAA hepatitis C virus treatment regimen, we expect to earn a $30
million milestone payment upon reimbursement approval in Japan in the
quarter ending December 31, 2015.
Upcoming Events and Presentations
-
September 10, Baird 2015 Healthcare Conference, New York
-
September 16, 2015 Morgan Stanley Global Healthcare Conference, New
York
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Enanta plans to issue its fiscal fourth quarter and year-end financial
results press release, and hold a conference call regarding those
results, in the week of November 23, 2015.
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 August 6, 2015, through 11:59 p.m. Eastern time on
August 12, 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 82580357. 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. Enanta
also has a program to develop a host-targeted antiviral (HTA) inhibitor
class for HCV targeted against cyclophilin, 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 regulatory approval in
Japan for AbbVie’s HCV treatment regimen 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 milestone payment for Japan, the likely level of Enanta
royalties on AbbVie’s future net sales of paritaprevir-containing
regimens, 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 further approvals of
treatment regimens containing paritaprevir or 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 share and
per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
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Three Months Ended
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Nine Months Ended
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June 30,
|
|
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June 30,
|
|
|
|
|
|
|
2015
|
|
2014
|
|
|
2015
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
|
|
|
$
|
11,599
|
|
$
|
42,051
|
|
|
$
|
146,464
|
|
|
$
|
45,104
|
Operating expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
|
|
6,253
|
|
|
4,553
|
|
|
|
16,140
|
|
|
|
13,538
|
General and administrative
|
|
|
|
|
|
3,643
|
|
|
2,603
|
|
|
|
9,850
|
|
|
|
7,255
|
Total operating expenses
|
|
|
|
|
|
9,896
|
|
|
7,156
|
|
|
|
25,990
|
|
|
|
20,793
|
Income from operations
|
|
|
|
|
|
1,703
|
|
|
34,895
|
|
|
|
120,474
|
|
|
|
24,311
|
Other income, net
|
|
|
|
|
|
287
|
|
|
36
|
|
|
|
798
|
|
|
|
47
|
Income before income taxes
|
|
|
|
|
|
1,990
|
|
|
34,931
|
|
|
|
121,272
|
|
|
|
24,358
|
Income tax (expense) benefit
|
|
|
|
|
|
428
|
|
|
15,122
|
|
|
|
(48,092
|
)
|
|
|
15,122
|
Net income
|
|
|
|
|
$
|
2,418
|
|
$
|
50,053
|
|
|
$
|
73,180
|
|
|
$
|
39,480
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per share
|
|
|
|
|
|
|
|
|
|
|
|
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Basic
|
|
|
|
|
$
|
0.13
|
|
$
|
2.70
|
|
|
$
|
3.92
|
|
|
$
|
2.16
|
Diluted
|
|
|
|
|
$
|
0.13
|
|
$
|
2.61
|
|
|
$
|
3.80
|
|
|
$
|
2.06
|
Weighted average common shares outstanding
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
|
|
|
18,697,104
|
|
|
18,528,833
|
|
|
|
18,659,742
|
|
|
|
18,275,831
|
Diluted
|
|
|
|
|
|
19,277,966
|
|
|
19,203,270
|
|
|
|
19,276,767
|
|
|
|
19,168,368
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ENANTA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED
BALANCE SHEETS (in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
September 30,
|
|
|
|
|
|
|
|
2015
|
|
2014
|
Assets
|
|
|
|
|
|
|
|
Current assets
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
|
|
$
|
19,844
|
|
$
|
30,699
|
Short-term marketable securities
|
|
|
|
|
|
134,442
|
|
|
60,065
|
Accounts receivable
|
|
|
|
|
|
11,724
|
|
|
1,724
|
Unbilled receivables
|
|
|
|
|
|
1,376
|
|
|
2,770
|
Deferred tax assets
|
|
|
|
|
|
1,757
|
|
|
11,123
|
Prepaid expenses and other current assets
|
|
|
|
|
|
3,497
|
|
|
1,594
|
Total current assets
|
|
|
|
|
|
172,640
|
|
|
107,975
|
Property and equipment, net
|
|
|
|
|
|
2,582
|
|
|
1,803
|
Long-term marketable securities
|
|
|
|
|
|
57,657
|
|
|
41,003
|
Deferred tax assets
|
|
|
|
|
|
4,287
|
|
|
4,198
|
Restricted cash
|
|
|
|
|
|
608
|
|
|
436
|
Total assets
|
|
|
|
|
$
|
237,774
|
|
$
|
155,415
|
Liabilities and Stockholders' Equity
|
|
|
|
|
|
|
|
Current liabilities
|
|
|
|
|
|
|
|
Accounts payable
|
|
|
|
|
$
|
1,614
|
|
$
|
1,874
|
Accrued expenses
|
|
|
|
|
|
3,469
|
|
|
2,872
|
Income taxes payable
|
|
|
|
|
|
2,229
|
|
|
-
|
Total current liabilities
|
|
|
|
|
|
7,312
|
|
|
4,746
|
Warrant liability
|
|
|
|
|
|
1,457
|
|
|
1,584
|
Series 1 nonconvertible preferred stock
|
|
|
|
|
|
185
|
|
|
202
|
Other long-term liabilities
|
|
|
|
|
|
538
|
|
|
229
|
Total liabilities
|
|
|
|
|
|
9,492
|
|
|
6,761
|
Total stockholders' equity
|
|
|
|
|
|
228,282
|
|
|
148,654
|
Total liabilities and stockholders' equity
|
|
|
|
|
$
|
237,774
|
|
$
|
155,415
|
|
|
|
|
|
|
|
|
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