Webcast and Conference Call today at 4:30
p.m. ET
- Royalty revenue for the quarter
increased to $57.3 million, a quarter-to-quarter increase of
30%
- Net income was $20.3 million, or $0.97
per diluted common share
- Preliminary Phase 1 results demonstrate
that RSV candidate EDP-938 was generally safe and well tolerated
and support its progression to Phase 2
- Cash and marketable securities totaled
$295.5 million at June 30, 2018
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, 2018.
“Enanta continues to benefit from the increasing royalty income
from AbbVie’s net sales of MAVYRET, the best-selling drug for
hepatitis C, which is funding development of our wholly owned
programs in RSV, NASH, PBC and HBV,” commented Jay R. Luly, Ph.D.,
President and Chief Executive Officer, Enanta. “With net sales of
MAVYRET in the first half of calendar and royalty year 2018
reaching over $1.75 billion, our royalties on 50% of those sales
have moved into higher royalty rate tiers this quarter. In
addition, in RSV we have completed dosing our Phase 1 trial of
EDP-938, and expect to report final results later this year.”
Fiscal Third Quarter Ended June 30, 2018 Financial
Results
Total revenue for the three months ended June 30, 2018 was $57.3
million, compared to $7.5 million for the three months ended June
30, 2017. The increase in revenue was due to an increase in
royalties earned on AbbVie’s worldwide net sales of
MAVYRET™/MAVIRET™ (glecaprevir/pibrentasvir), in major markets. For
the three months ended June 30, 2017, revenue consisted exclusively
of royalties earned on AbbVie’s worldwide net sales of HCV regimens
containing paritaprevir.
Research and development expenses totaled $28.5 million for the
three months ended June 30, 2018, compared to $15.4 million for the
three months ended June 30, 2017. The increase in research and
development expenses was primarily due to increased preclinical and
clinical costs associated with the progression of Enanta’s
wholly-owned R&D programs in respiratory syncytial virus (RSV),
non-alcoholic steatohepatitis (NASH) and primary biliary
cholangitis (PBC), as well as research efforts in hepatitis B virus
(HBV).
General and administrative expenses totaled $6.1 million for the
three months ended June 30, 2018, compared to $5.2 million for the
three months ended June 30, 2017. The increase in general and
administrative expenses was primarily due to an increase in
headcount.
Enanta recorded income tax expense of $3.7 million for the three
months ended June 30, 2018, compared to an income tax benefit of
$4.1 million for the three months ended June 30, 2017. During the
three months ended June 30, 2018, income tax expense reflected
the significant increase in pre-tax income during the quarter,
offset by the impact of excess tax benefits from employee stock
award activity. Enanta’s estimated annual effective tax rate
for fiscal 2018 of 22.2 percent includes the impact of a non-cash
revaluation charge against deferred tax assets to reflect the
reduced federal corporate income tax rate as a result of the
enactment of the U.S. Tax Cuts and Jobs Act in December 2017,
during the first quarter of Enanta’s current fiscal year.
Net income for the three months ended June 30, 2018 was $20.3
million, or $0.97 per diluted common share, compared to a net loss
of $8.4 million, or $(0.44) per diluted common share, for the
corresponding period in 2017.
Enanta’s cash, cash equivalents and short-term and long-term
marketable securities totaled $295.5 million at June 30, 2018. This
compares to a total of $293.7 million at September 30, 2017. Enanta
expects that its current cash, cash equivalents and marketable
securities, will be sufficient to meet the anticipated cash
requirements of its existing business and development programs for
the foreseeable future.
Development Programs and Business Review
Respiratory Syncytial Virus
- Preliminary Phase 1 results demonstrate
that EDP-938 was generally safe and well tolerated over a broad
range of single and multiple doses with good pharmacokinetic (PK)
data. Final results will be presented in the fourth calendar
quarter of 2018.
- A Phase 2 proof-of-concept challenge
study in healthy adults inoculated with RSV is expected to begin in
the fourth calendar quarter of 2018.
NASH and PBC
- Enrollment continues in the ARGON-1
study for non-alcoholic steatohepatitis (NASH), and in the INTREPID
study for primary biliary cholangitis (PBC) patients. We expect
enrollment to continue throughout the year and into 2019.
Hepatitis B Virus
- Enanta’s HBV program continues to move
ahead and has generated promising inhibitors of the core protein.
Enanta is targeting the selection of an HBV candidate in the fourth
calendar quarter of 2018.
Upcoming Events and Presentations
- September 5-6, Baird 2018 Global
Healthcare conference, New York
- September 12-14, Morgan Stanley 16th
Annual Global Healthcare Conference, New York
- Enanta plans to issue its fiscal fourth
quarter financial results press release, and hold a conference call
regarding those results, on November 26, 2018.
Conference Call and Webcast InformationEnanta 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 7:30
p.m. ET on August 7, 2018, through 11:59 p.m. ET on August 9, 2018
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 7278673. A live audio webcast of the call and replay can
be accessed by visiting the “Events and Presentation” section on
the “Investors” page of Enanta’s website at www.enanta.com.
About EnantaEnanta Pharmaceuticals is using its robust,
chemistry-driven approach and drug discovery capabilities to become
a leader in the discovery and development of small molecule drugs
for the treatment of viral infections and liver diseases. Two
protease inhibitors, glecaprevir and paritaprevir, discovered and
developed through Enanta’s collaboration with AbbVie, have now been
approved around the world as part of AbbVie’s regimens for the
treatment of hepatitis C virus (HCV) infection, sold under the
tradenames MAVYRET™ (U.S.) and MAVIRET™ (ex-U.S.)
(glecaprevir/pibrentasvir) and VIEKIRA PAK®
(paritaprevir/ritonavir/ombitasvir/dasabuvir) (U.S.) and VIEKIRAX®
(paritaprevir/ritonavir/ombitasvir) (ex-U.S.).
Royalties from the AbbVie collaboration are helping to fund
Enanta’s research and development efforts, which are currently
focused on the following disease targets: non-alcoholic
steatohepatitis (NASH), primary biliary cholangitis (PBC),
respiratory syncytial virus (RSV) and hepatitis B virus (HBV).
Please visit www.enanta.com for more information.
Forward Looking StatementsThis press release contains
forward-looking statements, including statements with respect to
the prospects for AbbVie’s MAVYRET/MAVIRET regimen in HCV and
Enanta’s resulting royalty revenues, as well as the prospects and
timelines for advancement of Enanta’s earlier stage programs in
NASH, PBC, RSV and HBV. 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 continuing commercialization
efforts for its HCV treatment regimens, primarily its new
MAVYRET/MAVIRET regimen; competitive pricing, market acceptance and
reimbursement rates for AbbVie’s HCV treatment regimens compared to
competitive HCV products on the market; the discovery and
development risks of early stage discovery efforts in other disease
areas such as NASH, PBC, RSV and HBV; potential competition from
the development efforts of others in those other 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-Q for the quarter ended March 31, 2018 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
UNAUDITED
(in thousands, except per share
amounts)
Three Months Ended Nine Months Ended
June 30, June 30, 2018
2017 2018 2017
Revenue $ 57,262 $ 7,511 $ 139,420 $ 26,887 Operating
expenses Research and development 28,487 15,407 67,933 40,937
General and administrative 6,135 5,233
17,611 15,631 Total operating expenses
34,622 20,640 85,544
56,568 Income (loss) from operations 22,640 (13,129 )
53,876 (29,681 ) Other income, net 1,338 600
3,364 1,673 Income (loss) before
income taxes 23,978 (12,529 ) 57,240 (28,008 ) Income tax (expense)
benefit (3,690 ) 4,103 (12,704 )
9,210 Net income (loss) $ 20,288 $ (8,426 ) $ 44,536
$ (18,798 ) Net income (loss) per share Basic $ 1.05 $ (0.44
) $ 2.32 $ (0.99 ) Diluted $ 0.97 $ (0.44 ) $ 2.17 $ (0.99 )
Weighted average common shares outstanding Basic 19,303 19,081
19,212 19,055 Diluted 21,017 19,081 20,509 19,055
ENANTA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED
BALANCE SHEETS UNAUDITED
(in thousands)
June 30, September 30, 2018 2017
Assets Current assets Cash and cash equivalents $ 42,477 $ 65,675
Short-term marketable securities 230,750 157,994 Accounts
receivable 57,262 10,614 Prepaid expenses and other current assets
9,404 3,536 Total current assets 339,893 237,819
Long-term marketable securities 22,272 70,038 Property and
equipment, net 8,383 8,049 Deferred tax assets 7,929 10,123
Restricted cash 608 608 Total assets $ 379,085 $
326,637 Liabilities and Stockholders' Equity Current liabilities
Accounts payable $ 4,902 $ 3,714 Accrued expenses and other current
liabilities 9,127 7,970 Income taxes payable - 9,298
Total current liabilities 14,029 20,982 Warrant liability - 807
Series 1 nonconvertible preferred stock 1,528 762 Other long-term
liabilities 2,627 2,410 Total liabilities
18,184 24,961 Total stockholders' equity 360,901
301,676 Total liabilities and stockholders' equity $ 379,085
$ 326,637
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version on businesswire.com: https://www.businesswire.com/news/home/20180807005796/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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