Conference Call and Webcast Today at 8:30
a.m. ET
- Revenues for the quarter totaled
$57.4 million
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 second quarter ended
March 31, 2015.
Fiscal Second Quarter Ended March 31, 2015 Financial
Results
Cash, cash equivalents and short-term and long-term marketable
securities totaled $226.8 million at March 31, 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 its anticipated
cash requirements for the foreseeable future.
Revenue for the three months ended March 31, 2015 was $57.4
million, compared to $2.2 million for the three months ended March
31, 2014. For the six months ended March 31, 2015, revenue was
$134.9 million, compared to revenue of $3.1 million for the same
period in 2014. The increase in revenue for the most recent quarter
was primarily due to the achievement of a $50.0 million milestone
payable from AbbVie for the European regulatory approval of
VIEKIRAX® as well as $7.0 million in royalty revenue, which was
earned from a contractually specified portion of AbbVie’s worldwide
net sales of HCV treatment regimens containing paritaprevir,
Enanta’s lead hepatitis C virus (HCV) protease inhibitor identified
within the ongoing AbbVie-Enanta collaboration. The increase in
revenue for the six months ended March 31, 2015 was due to the
achievement of a $75.0 million milestone payment as a result of
U.S. regulatory approval of Viekira Pak, in addition to the $50.0
million milestone and royalties earned on paritaprevir. 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 $5.4 million for the
three months ended March 31, 2015, compared to $4.7 million for the
three months ended March 31, 2014. For the six months ended March
31, 2015, research and development expenses were $9.9 million,
compared to $9.0 million for the same period in 2014. 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 $3.4 million for the
three months ended March 31, 2015, compared to $2.6 million for the
three months ended March 31, 2014. For the six months ended March
31, 2015, general and administrative expenses totaled $6.2 million,
compared to $4.6 million for the same period in 2014. The increase
in the three and six month periods primarily reflects 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 March 31, 2015 was $28.8
million, or $1.49 per diluted common share, compared to a net loss
of $5.2 million, or $(0.28) per diluted common share, for the
corresponding period in 2014. For the six months ended March 31
2015, net income was $70.8 million, compared to a net loss of $10.6
million for the same period in 2014. The increase in net income
during the three and six month periods ended March 31, 2015 was
primarily due to milestone payments and royalty revenue earned and
payable from AbbVie.
“Our first approved product paritaprevir, is providing royalty
revenues to help fuel our business operations and internal
pipeline,” commented Jay R. Luly, Ph.D., President and Chief
Executive Officer. “With sustainable cash flows expected for the
foreseeable future, we plan to continue to evergreen our pipeline
and advance our programs throughout the year.”
HCV Program and Business Review
- Preliminary results from the first 10
patients in AbbVie’s RUBY-I study of its paritaprevir-containing
regimen in patients with severe renal impairment demonstrated 100
percent sustained virologic response four weeks after
treatment.
- Preliminary results from AbbVie’s phase
2b study of a combination of ABT-493 (next-generation protease
inhibitor) and ABT-530 (next-generation NS5A inhibitor) for the
treatment of HCV patients demonstrated a sustained virologic
response rate four weeks after treatment of 99 percent.
- A New Drug Application submitted by
AbbVie to the U.S. Food and Drug Administration for the treatment
of Genotype 4 chronic hepatitis C patients was accepted and granted
breakthrough therapy designation and priority review.
- A New Drug Application submitted by
AbbVie to the Japanese Ministry of Health, Labour and Welfare for
the treatment of genotype 1 chronic hepatitis C virus was granted
priority review.
- Enanta received a $50 million milestone
payment from AbbVie for commercialization regulatory approval in
Europe for VIEKIRAX®, a paritaprevir-containing regimen.
Fiscal Third Quarter Revenue Guidance
- For the quarter ended March 31, 2015,
our paritaprevir royalties represented approximately 3 percent of
AbbVie’s reported Viekira regimen sales, and we expect royalties to
Enanta in the quarter ending June 30, 2015 would continue to be
approximately 3 percent of such sales.
Upcoming Events and Presentations
Enanta management will participate in the following upcoming
investor conferences and events:
- May 7, Deutsche Bank 40th Annual
Healthcare Conference, Boston
- June 23-24, JMP Securities Life
Sciences Conference, New York
- Week of August 3, fiscal third quarter
financial results press release
Conference Call and Webcast Information
Enanta will host a conference call and webcast today at 8:30
a.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 11:30 a.m. Eastern time on May 7, 2015, through
11:59 p.m. Eastern time on May 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 28434645. 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 is
discovering, and in some cases developing, novel inhibitors
designed for use against the hepatitis C virus (HCV). These
inhibitors include members of the 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. 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 and the prospects for approval of a similar
regimen in the U.S. for treatment of genotype 4 HCV, the prospects
for AbbVie’s development of a next-generation regimen containing
ABT-493, the prospects for selection of a NASH development
candidate, the likely level of Enanta royalties on for future
revenues generated from products sales and development 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 paritaprevir; Enanta’s
reliance on AbbVie’s planned clinical development of 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 such treatment regimens compared to
competitive HCV product candidates of other companies; the risk of
early stage discovery efforts in 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 Six Months Ended March 31, March 31,
2015 2014
2015 2014 Revenue $
57,367 $ 2,160 $ 134,865 $ 3,053 Operating expenses Research and
development 5,368 4,722 9,887 8,985 General and administrative
3,438 2,565 6,207
4,652 Total operating expenses 8,806
7,287 16,094 13,637 Income
(loss) from operations 48,561 (5,127 ) 118,771 (10,584 ) Other
income (expense), net 210 (76 ) 511
11 Income (loss) before income taxes 48,771
(5,203 ) 119,282 (10,573 ) Income tax expense (20,018 )
- (48,520 ) - Net income (loss)
$ 28,753 $ (5,203 ) $ 70,762 $ (10,573 )
Net income (loss) per share Basic $ 1.54 $ (0.28 ) $ 3.80 $
(0.58 ) Diluted $ 1.49 $ (0.28 ) $ 3.67 $ (0.58 ) Weighted average
common shares outstanding Basic 18,679,898 18,353,628 18,641,060
18,149,330 Diluted 19,268,565 18,353,628 19,275,969 18,149,330
ENANTA PHARMACEUTICALS, INC. CONDENSED
CONSOLIDATED BALANCE SHEETS (in thousands)
March 31, September
30, 2015 2014 Assets Current assets Cash
and cash equivalents $ 25,751 $ 30,699 Short-term marketable
securities 139,721 60,065 Accounts receivable 7,081 1,724 Unbilled
receivables 1,550 2,770 Deferred tax assets 1,451 11,123 Prepaid
expenses and other current assets 2,230 1,594 Total
current assets 177,784 107,975 Property and equipment, net 2,295
1,803 Long-term marketable securities 61,330 41,003 Deferred tax
assets 3,867 4,198 Restricted cash 608 436 Total
assets $ 245,884 $ 155,415
Liabilities and Stockholders'
Equity Current liabilities Accounts payable $ 2,343 $ 1,874
Accrued expenses 2,910 2,872 Income taxes payable 14,537
- Total current liabilities 19,790 4,746 Warrant liability
1,442 1,584 Series 1 nonconvertible preferred stock 185 202 Other
long-term liabilities 252 229 Total liabilities
21,669 6,761 Total stockholders' equity
224,215 148,654 Total liabilities and stockholders' equity $
245,884 $ 155,415
Investor ContactEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
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