Webcast and Conference Call today at 4:30
p.m. ET
- Cash and marketable securities totaled
$293.7 million at September 30, 2017
- Total revenue for the quarter was $75.9
million
- Milestone payments totaling $65.0
million received following AbbVie’s U.S. approval of MAVYRET™
(glecaprevir/pibrentasvir) and EU approval of MAVIRET™
(glecaprevir/pibrentasvir)
- Positive Phase 1 results for EDP-305
support further clinical evaluation in PBC and NASH patients
- Fast Track designation granted to
EDP-305 by the U.S. FDA for the treatment of patients with primary
biliary cholangitis.
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a chemistry-driven
biotechnology company dedicated to creating and developing small
molecule drugs for viral infections and liver diseases, today
reported financial results for its fiscal fourth quarter and year
ended September 30, 2017.
Enanta’s cash, cash equivalents and short-term and long-term
marketable securities totaled $293.7 million at September 30, 2017.
This compares to a total of $242.2 million in such accounts at
September 30, 2016. 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.
“Enanta has made great progress this past year and has delivered
on several key clinical and financial milestones,” stated Jay R.
Luly, Ph.D., President and Chief Executive Officer of Enanta.
“Enanta is on track this quarter to earn the final regulatory
milestone in our eleven year HCV collaboration with AbbVie, which
would mean we would have successfully earned all clinical and
regulatory milestones under the collaboration. To date, this
collaboration has provided us with a total of approximately $500
million to fund and advance our internal pipeline. With these
resources, we expect to initiate two clinical studies by the end of
2017: a Phase 2 study of our lead FXR agonist EDP-305 in PBC, and a
Phase 1 study of our direct-acting antiviral inhibitor EDP-938 for
RSV.”
Fiscal Fourth Quarter and Year Ended September 30, 2017
Financial Results
Total revenue for the three months ended September 30, 2017 was
$75.9 million, compared to $12.8 million for the three months ended
September 30, 2016. For the twelve months ended September 30, 2017,
total revenue was $102.8 million, compared to $88.3 million for the
same period in 2016. The increase in revenue for the quarter was
due to $65.0 million in milestone payments for the U.S. and EU
approvals of AbbVie’s new HCV regimen under the tradenames MAVYRET™
and MAVIRET™, respectively. For the twelve months ending September
30, 2017, revenue also included $37.8 million in royalties earned
on AbbVie’s worldwide net sales of HCV regimens containing
paritaprevir or glecaprevir. For the 2016 twelve-month period,
revenue consisted primarily of $57.7 million of royalty revenues
earned on AbbVie’s worldwide net sales of HCV regimens containing
paritaprevir, as well as a $30.0 million milestone payment for
the reimbursement approval of one of those regimens,
VIEKIRAX®, in Japan in November 2015. Milestone payments and
royalties have varied significantly from period to period, and we
expect that variability to continue in the future.
Research and development expenses totaled $16.5 million for the
three months ended September 30, 2017, compared to $11.5 million
for the three months ended September 30, 2016. For the twelve
months ended September 30, 2017, research and development expenses
totaled $57.5 million compared to $40.5 million for the same period
in 2016. The increase in research and development expenses in both
periods 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 $5.1 million for the
three months ended September 30, 2017, compared to $4.4 million for
the three months ended September 30, 2016. For the twelve months
ended September 30, 2017, general and administrative expenses
totaled $20.7 million, compared to $17.0 million for the same
period in 2016. For the three-month period, the increase in general
and administrative expenses was primarily due to increases in
compensation expense driven by increased headcount. For the
twelve-month period, the increase was due to increased headcount as
well as achievement of milestones under existing performance-based
equity awards.
Enanta recorded income tax expense of $18.4 million for the
three months ended September 30, 2017 compared to an income tax
benefit of $0.8 million for the same period in 2016. Enanta
recorded income tax expense of $9.2 million for the year
ended September 30, 2017 compared to income tax expense of
$10.9 million for the same period in 2016. The Company’s effective
tax rate for fiscal 2017 was approximately 34%.
Net income for the three months ended September 30, 2017 was
$36.5 million, or $1.86 per diluted common share, compared to a net
loss of $1.8 million, or $(0.09) per diluted common share, for the
corresponding period in 2016. For the twelve months ended September
30, 2017, net income was $17.7 million, or $0.91 per diluted common
share, compared to net income of $21.7 million, or $1.13 per
diluted common share, for the corresponding period in 2016.
Development Program and Business Review
- On October 23, Enanta announced
positive results from its Phase 1 clinical study of EDP-305,
Enanta’s lead FXR agonist for non-alcoholic steatohepatitis (NASH)
and primary biliary cholangitis (PBC). In this study of single
ascending doses (SAD) and multiple doses at ascending dose levels
per subject cohort (MAD), EDP-305 was generally safe and well
tolerated over a broad range of single and multiple doses with
pharmacokinetic (PK) data supporting once daily oral dosing.
EDP-305 also exhibited strong engagement of the FXR receptor as
evidenced by increased FGF19 levels and reduced C4 levels. These
results support the ability to administer EDP-305 in future trials
at doses that neither elicited clinically significant changes in
lipids nor resulted in pruritus (itching).
- Enanta expects to initiate two clinical
studies by the end of 2017: a Phase 2 clinical study of EDP-305 in
patients with primary biliary cholangitis (PBC) and a Phase 1 study
of respiratory syncytial virus (RSV) development candidate EDP-938
in healthy volunteers. A Phase 2 clinical study of EDP-305 in
patients with NASH is expected to begin in early 2018.
- The U.S. Food and Drug Administration
(FDA) has granted Enanta’s drug candidate EDP-305, an FXR agonist,
Fast Track designation for the treatment of patients with primary
biliary cholangitis.
- Bryan Goodwin, Ph.D., has recently
joined Enanta as Vice President of Biology. Dr. Goodwin will
provide senior leadership to the virology and NASH biology
groups.
- During the quarter, Enanta received
milestone payments of $65.0 million for the U.S. and European
approvals of AbbVie’s new MAVYRET™/MAVIRET™
(glecaprevir/pibrentasvir) regimen. Glecaprevir, Enanta’s second
protease inhibitor product, is part of this new HCV treatment
regimen that will earn royalties for Enanta.
- On September 27, Enanta announced that
AbbVie also received approval in Japan for MAVIRET™
(glecaprevir/pibrentasvir). Enanta will earn a $15.0 million
milestone payment from AbbVie upon price reimbursement approval of
MAVIRET™ in Japan, which is expected in the quarter ending December
31, 2017.
Financial Guidance for Fiscal Year Ending September 30,
2018
- Research and development expense
between $90 million and $110 million
- General and administration expense
between $22 million and $28 million
Upcoming Events and Presentations
- 36th Annual J.P. Morgan Healthcare
Conference, January 7-11, 2018
- Enanta plans to issue its fiscal first
quarter financial results press release, and hold a conference call
regarding those results, on February 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 November 20, 2017, through 11:59 p.m. ET on November 23,
2017 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 6197609. 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,
paritaprevir and glecaprevir, 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 U.S.-marketed regimens MAVYRET™
(glecaprevir/pibrentasvir) and VIEKIRA PAK®
(paritaprevir/ritonavir/ombitasvir/dasabuvir).
Royalties and milestone payments 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 and RSV, as well as Enanta’s projections of its expenses
in 2018. 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 in the short-term are dependent
upon the success of AbbVie’s continuing commercialization efforts
for its HCV treatment regimens containing paritaprevir and 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-K for the fiscal year ended September 30, 2016 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 EndedSeptember 30, Year
EndedSeptember 30,
2017
2016
2017
2016
Revenue $ 75,927 $ 12,841 $ 102,814 $ 88,268 Operating
expenses Research and development 16,514 11,500 57,451 40,461
General and administrative 5,118 4,440
20,749 16,966 Total operating expenses
21,632 15,940 78,200
57,427 Income (loss) from operations 54,295 (3,099 )
24,614 30,841 Other income, net 660 471
2,333 1,719 Income (loss) before income
taxes 54,955 (2,628 ) 26,947 32,560 Income tax (expense) benefit
(18,447 ) 826 (9,237 ) (10,894 )
Net income (loss) $ 36,508 $ (1,802 ) $ 17,710 $
21,666 Net income (loss) per share Basic $ 1.91 $
(0.09 ) $ 0.93 $ 1.14 Diluted $ 1.86 $ (0.09 ) $ 0.91 $ 1.13
Weighted average common shares outstanding Basic 19,097 19,036
19,066 18,929 Diluted 19,611 19,036 19,407 19,224
ENANTA PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED
BALANCE SHEETSUNAUDITED(in thousands)
September 30,2017 September
30,2016 Assets Current assets Cash and cash equivalents
$ 65,675 $ 16,577 Short-term marketable securities 157,994 193,507
Accounts receivable 10,614 12,841 Prepaid expenses and other
current assets 3,536 9,231 Total current assets
237,819 232,156 Property and equipment, net 8,049 8,004 Long-term
marketable securities 70,038 32,119 Deferred tax assets 10,123
8,390 Restricted cash 608 608 Total assets $ 326,637
$ 281,277 Liabilities and Stockholders' Equity Current
liabilities Accounts payable $ 3,714 $ 3,377 Accrued expenses and
other current liabilities 7,970 4,512 Income taxes payable
9,298 - Total current liabilities 20,982 7,889 Warrant
liability 807 1,251 Series 1 nonconvertible preferred stock 762 159
Other long-term liabilities 2,410 2,042 Total
liabilities 24,961 11,341 Total stockholders' equity
301,676 269,936 Total liabilities and stockholders'
equity $ 326,637 $ 281,277
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version on businesswire.com: http://www.businesswire.com/news/home/20171120005993/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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