Webcast and Conference Call today at 4:30
p.m. ET
- Royalty revenue for the quarter
increased to $44.0 million due to increase in AbbVie’s MAVYRET™
sales
- Net income for the quarter was $12.6
million, or $0.61 per diluted common share
- Fast Track designation granted to
EDP-938 for Respiratory Syncytial Virus (RSV) Infection
- Cash and marketable securities totaled
$288.9 million at March 31, 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 second quarter ended
March 31, 2018.
Enanta’s results for the quarter benefited from $44 million of
royalty revenue on AbbVie’s $919 million in sales of its HCV
regimens that contain either of the two protease inhibitor products
developed through Enanta’s collaboration with AbbVie. Enanta earns
its annually tiered, per product royalties on a portion of AbbVie’s
net sales allocated to Enanta’s protease inhibitor product in each
HCV regimen. In the case of MAVYRET™ (U.S.)/ MAVIRET™ (ex-U.S.)
(glecaprevir/pibrentasvir), Enanta’s royalty is based on 50% of
AbbVie’s net sales of that combination.
“Our strong financial results this quarter were driven by
royalty revenue earned on AbbVie’s sales of MAVYRET, which reached
$850 million in sales in the quarter,” commented Jay R. Luly.
Ph.D., President and Chief Executive Officer, Enanta. “This royalty
revenue supports our three clinical-stage programs in NASH, PBC and
RSV, all of which have now been granted Fast Track designation by
the U.S. FDA. We are looking forward to having preliminary data
from our Phase 1 study of EDP-938 next quarter and initiating our
planned Phase 2 RSV challenge study of EDP-938 in the last quarter
of calendar 2018. We also plan to designate a candidate compound
for HBV later this year.”
Enanta’s cash, cash equivalents and short-term and long-term
marketable securities totaled $288.9 million at March 31, 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.
Fiscal Second Quarter Ended March 31, 2018 Financial
Results
Total revenue for the three months ended March 31, 2018 was
$44.0 million, compared to $9.0 million for the three months ended
March 31, 2017. The increase in revenue was due to an increase in
royalties earned on AbbVie’s worldwide net sales of HCV regimens as
a result of the launch of MAVYRET™/MAVIRET™ in major markets in the
second half of 2017. For the three months ended March 31, 2017,
revenue consisted exclusively of royalties earned on AbbVie’s
worldwide net sales of HCV regimens containing
paritaprevir. Royalties have varied significantly from period
to period, and that variability may continue in the future.
Research and development expenses totaled $21.5 million for the
three months ended March 31, 2018, compared to $13.0 million for
the three months ended March 31, 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 non-alcoholic steatohepatitis
(NASH), primary biliary cholangitis (PBC), respiratory syncytial
virus (RSV) and hepatitis B virus (HBV).
General and administrative expenses totaled $5.7 million for the
three months ended March 31, 2018, which was consistent with the
$5.5 million of such expenses for the three months ended March 31,
2017.
Enanta recorded income tax expense of $5.4 million for the three
months ended March 31, 2018, compared to an income tax benefit of
$3.6 million for the three months ended March 31, 2017. During the
three months ended March 31, 2018, income tax expense reflected the
significant increase in pre-tax income during the quarter as well
as an increase in Enanta’s estimated annual effective tax rate for
fiscal 2018. Enanta’s estimated annual effective tax rate for
fiscal 2018 of 27.1 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.
Net income for the three months ended March 31, 2018 was $12.6
million, or $0.61 per diluted common share, compared to a net loss
of $5.4 million, or $(0.28) per diluted common share, for the
corresponding period in 2017.
Development Programs and Business Review
Respiratory Syncytial Virus
- The U.S. Food and Drug administration
has granted EDP-938 Fast Track designation for respiratory
syncytial virus (RSV).
- A Phase 1 clinical study of EDP-938 is
ongoing. In the third quarter of calendar 2018, topline Phase 1
data is expected to be announced and a Phase 2 proof-of-concept
challenge study in RSV-infected humans is expected to begin in the
following quarter.
Hepatitis B Virus
- New data on EP-027367, one of several
core inhibitors Enanta is evaluating for hepatitis B virus was
presented at the International Liver Congress™ (ILC) 2018 in April.
The data demonstrated that in a chimeric SCID mouse model with
human liver cells, EP-027367 reduced viral DNA and RNA levels by up
to 3.0 logs from baseline with 4 weeks of treatment and
demonstrated a favorable tolerability and pharmacokinetic profile.
EP-027367 has also demonstrated potent, pan-genotypic, anti-HBV
activity capable of preventing the establishment of cccDNA in
vitro.
NASH and PBC
- Three posters on EDP-305, Enanta’s FXR
agonist currently in a Phase 2 study for NASH and a Phase 2 study
for PBC, were presented at the ILC. Two posters focused on
additional preclinical safety and efficacy data and a third
presented data from Enanta’s previously released Phase 1 study
highlighting the pharmacokinetics, pharmacodynamics and safety of
EDP-305 in healthy and presumptive NAFLD subjects.
Upcoming Events and Presentations
- June 12, 2018 – 38th NASDAQ Investor
Conference, London
- June 20-21, 2018 – JMP Securities Life
Sciences Conference, New York
- Enanta plans to issue its fiscal third
quarter financial results press release, and hold a conference call
regarding those results, on August 7, 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 May 8, 2018, through 11:59 p.m. ET on May 11, 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 3238478. 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 has used its robust,
chemistry-driven approach and drug discovery capabilities to become
a leader in the discovery 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 in
jurisdictions around the world as part of AbbVie’s direct-acting
antiviral (DAA) regimens for the treatment of hepatitis C virus
(HCV) infection, including the regimens marketed as 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 the
prospects 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 December 31, 2017 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
OPERATIONSUNAUDITED
(in thousands, except per share
amounts)
Three Months EndedMarch 31, Six
Months EndedMarch 31, 2018 2017
2018 2017 Revenue $ 44,049 $ 8,959 $ 82,158 $
19,376 Operating expenses Research and development 21,484 13,004
39,446 25,530 General and administrative 5,706
5,461 11,476 10,398 Total
operating expenses 27,190 18,465
50,922 35,928 Income (loss) from operations
16,859 (9,506 ) 31,236 (16,552 ) Other income, net 1,066
549 2,026 1,073
Income (loss) before income taxes 17,925 (8,957 ) 33,262 (15,479 )
Income tax (expense) benefit (5,370 ) 3,565
(9,014 ) 5,107 Net income (loss) $ 12,555
$ (5,392 ) $ 24,248 $ (10,372 ) Net income (loss) per
share Basic $ 0.65 $ (0.28 ) $ 1.27 $ (0.54 ) Diluted $ 0.61 $
(0.28 ) $ 1.20 $ (0.54 ) Weighted average common shares outstanding
Basic 19,206 19,047 19,167 19,042 Diluted 20,601 19,047 20,256
19,042
ENANTA PHARMACEUTICALS,
INC.CONDENSED CONSOLIDATED BALANCE
SHEETSUNAUDITED
(in thousands)
March 31,2018 September
30,2017 Assets Current assets Cash and cash equivalents
$ 66,926 $ 65,675 Short-term marketable securities 189,797 157,994
Accounts receivable 44,049 10,614 Prepaid expenses and other
current assets 4,905 3,536 Total current assets
305,677 237,819 Long-term marketable securities 32,186 70,038
Property and equipment, net 8,616 8,049 Deferred tax assets 7,567
10,123 Restricted cash 608 608 Total assets $ 354,654
$ 326,637 Liabilities and Stockholders' Equity Current liabilities
Accounts payable $ 4,696 $ 3,714 Accrued expenses and other current
liabilities 7,041 7,970 Income taxes payable 5,380
9,298 Total current liabilities 17,117 20,982 Warrant liability -
807 Series 1 nonconvertible preferred stock 1,528 762 Other
long-term liabilities 2,607 2,410 Total liabilities
21,252 24,961 Total stockholders' equity
333,402 301,676 Total liabilities and stockholders' equity $
354,654 $ 326,637
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version on businesswire.com: https://www.businesswire.com/news/home/20180508006390/en/
Investor ContactEnanta PharmaceuticalsCarol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
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