Webcast and Conference Call today at 4:30
p.m. ET
- Royalty revenue for the quarter
increased to $67.2 million
- Net income was $27.4 million, or $1.30
per diluted common share
- Cash and marketable securities totaled
$325.1 million
- Phase 2a study initiated with EDP-938
against respiratory syncytial virus (RSV) infection in a human
challenge study
- Hepatitis B virus (HBV) candidate
EDP-514 selected for clinical development in 2019
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 fourth quarter and year
ended September 30, 2018.
“Enanta has never been in a stronger position from both a
financial and clinical development perspective,” said Jay R. Luly,
Ph.D. President and CEO, Enanta Pharmaceuticals. “With the recent
start of our Phase 2a study in RSV, we now have three Phase 2
studies ongoing in our wholly-owned development programs. Our
momentum will continue into 2019, when we plan to initiate clinical
testing of EDP-514, our first candidate to treat hepatitis B virus,
and we expect Phase 2 data readouts in our other programs, starting
with NASH and RSV studies.”
Fiscal Fourth Quarter and Year Ended September 30, 2018
Financial Results
Total revenue for the three months ended September 30, 2018
consisted of $67.2 million of royalty revenue, compared to total
revenue of $75.9 million for the three months ended September 30,
2017, which consisted of $10.9 million of royalty revenue and $65.0
million in milestone payment revenue for the approvals of
MAVYRET™/MAVIRET™ (glecaprevir/pibrentasvir) in the U.S. and the
EU. For the twelve months ended September 30, 2018, total revenue
was $206.6 million, compared to $102.8 million for the same period
in 2017.
The increase in royalty revenue for the recent quarter was due
to an increase in royalties earned on AbbVie’s worldwide net sales
of MAVYRET™/MAVIRET™. For the twelve months ended September 30,
2018, revenue consisted of $191.6 million in royalties earned on
AbbVie’s worldwide net sales of HCV regimens containing glecaprevir
or paritaprevir, as well as the final $15.0 million milestone
payment for glecaprevir, which we earned upon the November 2017
reimbursement approval of MAVIRET™ in Japan. For the 2017
twelve-month period, revenue consisted of the $65.0 million in
milestone payments, as well as $37.8 million in royalties earned on
AbbVie’s worldwide net sales of HCV regimens containing
paritaprevir or glecaprevir.
Research and development expenses totaled $26.9 million for the
three months ended September 30, 2018, compared to $16.5 million
for the three months ended September 30, 2017. For the twelve
months ended September 30, 2018, research and development expenses
totaled $94.9 million compared to $57.5 million for the same period
in 2017. 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), and respiratory syncytial virus (RSV),
as well as research efforts in hepatitis B virus (HBV).
General and administrative expenses totaled $5.8 million for the
three months ended September 30, 2018, compared to $5.1 million for
the three months ended September 30, 2017. For the twelve months
ended September 30, 2018, general and administrative expenses
totaled $23.4 million, compared to $20.7 million for the same
period in 2017. The increase in general and administrative expenses
in both periods was primarily due to increases in compensation
expense driven by increased headcount to support Enanta’s
wholly-owned R&D programs.
Enanta recorded income tax expense of $8.5 million for the three
months ended September 30, 2018 compared to an income tax expense
of $18.4 million for the same period in 2017. Enanta recorded
income tax expense of $21.2 million for the year ended September
30, 2018 compared to income tax expense of $9.2 million for the
same period in 2017. The Company’s effective tax rate for fiscal
2018 was approximately 23% compared to approximately 34% in fiscal
2017. Enanta’s effective tax rate for fiscal 2018 reflects the
impact of a non-cash revaluation charge against deferred tax assets
due to the reduced federal corporate income tax rate in the U.S.
Tax Cuts and Jobs Act enacted in December 2017.
Net income for the three months ended September 30, 2018 was
$27.4 million, or $1.30 per diluted common share, compared to a net
income of $36.5 million, or $1.86 per diluted common share, for the
corresponding period in 2017. For the twelve months ended September
30, 2018, net income was $72.0 million, or $3.48 per diluted common
share, compared to net income of $17.7 million, or $0.91 per
diluted common share, for the corresponding period in 2017.
Enanta’s cash, cash equivalents and short-term and long-term
marketable securities totaled $325.1 million at September 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, as well as its continuing royalty revenue,
will be sufficient to meet the anticipated cash requirements of its
existing business and development programs for the foreseeable
future.
Financial Guidance for Fiscal 2019
- Research and Development Expense: $135
to $155 million
- General and Administrative Expense: $27
to $33 million
Development Programs and Business Review
Respiratory Syncytial Virus (RSV)
- Phase 1 results for EDP-938, Enanta’s
non-fusion N-inhibitor candidate, were presented at the 11th
International Respiratory Syncytial Virus Symposium in Asheville,
North Carolina on November 1. Additional preclinical results of
EDP-938 were also presented in an oral presentation demonstrating
that EDP-938 has a high barrier to resistance in vitro.
- Dosing began in October in a Phase 2a
study to evaluate the safety, pharmacokinetics and antiviral
activity of multiple doses of orally administered EDP-938 against
respiratory syncytial virus infection in a human challenge study.
Initial data is expected in the third quarter of calendar
2019.
Hepatitis B Virus (HBV)
- Enanta’s HBV program continues to move
ahead as Enanta announces that it has selected EDP-514, a promising
inhibitor of the HBV core protein, as its first development
candidate in this program. A Phase 1 study of EDP-514, consisting
of evaluation of single and multiple doses of drug in healthy
volunteers and incorporating a Phase 1b arm in chronic HBV
patients, is planned to begin in 2019.
Non-Alcoholic Steatohepatitis (NASH) and Primary Biliary
Cholangitis (PBC)
- Two preclinical posters titled “The
Farnesoid X Receptor (FXR) Agonist EDP-305 Reduces Ascites and
Hepatocellular Carcinoma Development in a Rat Model of Cirrhosis”
and “The Farnesoid X Receptor (FXR) Agonist EDP-305 Inhibits
Fibrosis Progression in a Rat Model of Non-alcoholic
Steatohepatitis Cirrhosis” were presented at The Liver Meeting®
2018 in November.
- Enrollment continues in the ARGON-1
study for non-alcoholic steatohepatitis (NASH), and in the INTREPID
study for primary biliary cholangitis (PBC) patients. Enrollment
will continue through the remainder of 2018 and into 2019. Initial
data is expected starting in mid-2019.
Hepatitis C Virus (HCV)
- Enanta’s HCV collaboration partner,
AbbVie, presented data for its pan-genotypic chronic HCV treatment,
MAVYRET™(glecaprevir/pibrentasvir), in treatment-naïve patients
with compensated cirrhosis, as a late-breaking oral presentation at
The Liver Meeting® 2018 on November 13, 2018. Results from the
Phase 3 EXPEDITION-8 study showed that with 8 weeks of MAVYRET, 100
percent (n=273/273) of genotypes 1, 2, 4, 5 and 6 patients achieved
a sustained virologic response 12 weeks after treatment
(SVR12).
Upcoming Events and Presentations
- 37th Annual J.P. Morgan Healthcare
Conference, January 7-10, 2019
- Enanta plans to issue its fiscal first
quarter financial results press release, and hold a conference call
regarding those results, on February 6, 2019.
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 26, 2018, through 11:59 p.m. ET on November 28,
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 9952167. 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 Enanta Pharmaceuticals, Inc.Enanta 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. Glecaprevir, a protease inhibitor discovered by
Enanta, has been developed by AbbVie, and is now approved and sold
in numerous countries as part of AbbVie’s newest treatment for
chronic hepatitis C virus (HCV) infection. This leading HCV regimen
is sold under the tradenames MAVYRET™ (U.S.) and MAVIRET™ (ex-U.S.)
(glecaprevir/pibrentasvir).
Royalties from the AbbVie collaboration are helping to fund
Enanta’s research and development efforts, which are currently
focused on the following disease targets: respiratory syncytial
virus (RSV), non-alcoholic steatohepatitis (NASH), primary biliary
cholangitis (PBC), and hepatitis B virus (HBV). Please visit
www.enanta.com for more information.
FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements,
including statements with respect to the prospects for advancement
of Enanta’s clinical programs in NASH/PBC and RSV and its
preclinical program in HBV, as well as Enanta’s projections of its
expenses in fiscal 2019 and the prospects for AbbVie’s
MAVYRET™/MAVIRET™ regimen for HCV and future royalty revenue to
Enanta from sales of that regimen. 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
regimen MAVYRET™/MAVIRET™; competitive pricing, market acceptance
and reimbursement rates for MAVYRET™/MAVIRET™ compared to
competitive HCV products on the market; the discovery and
development risks of early stage discovery and clinical 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
research and development 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
June 30, 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
OPERATIONSUNAUDITED(in thousands, except per share
amounts)
Three Months EndedSeptember
30,
Year EndedSeptember 30, 2018 2017
2018 2017 Revenue $ 67,205 $ 75,927 $ 206,625
$ 102,814 Operating expenses Research and development 26,923 16,514
94,856 57,451
General and administrative
5,830 5,118 23,441
20,749 Total operating expenses 32,753
21,632 118,297 78,200 Income
from operations 34,452 54,295 88,328 24,614 Other income, net
1,429 660 4,793
2,333 Income before income taxes 35,881 54,955 93,121 26,947
Income tax expense (8,461 ) (18,447 ) (21,165
) (9,237 ) Net income $ 27,420 $ 36,508 $
71,956 $ 17,710 Net income per share Basic $ 1.41 $
1.91 $ 3.74 $ 0.93 Diluted $ 1.30 $ 1.86 $ 3.48 $ 0.91 Weighted
average common shares outstanding Basic 19,380 19,097 19,255 19,066
Diluted 21,066 19,611 20,650 19,407
ENANTA
PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED BALANCE
SHEETSUNAUDITED(in thousands)
September
30,2018 September 30,2017 Assets Current
assets Cash and cash equivalents $ 63,902 $ 65,675 Short-term
marketable securities 244,828 157,994 Accounts receivable 67,205
10,614 Prepaid expenses and other current assets 4,454
3,536 Total current assets 380,389 237,819 Long-term
marketable securities 16,389 70,038 Property and equipment, net
8,374 8,049 Deferred tax assets 8,375 10,123 Restricted cash 608
608 Other long-term assets 92 - Total assets $
414,227 $ 326,637 Liabilities and Stockholders' Equity Current
liabilities Accounts payable $ 4,745 $ 3,714 Accrued expenses and
other current liabilities 9,892 7,970 Income taxes payable
1,388 9,298 Total current liabilities 16,025 20,982 Warrant
liability - 807 Series 1 nonconvertible preferred stock 1,628 762
Other long-term liabilities 2,895 2,410 Total
liabilities 20,548 24,961 Total stockholders' equity
393,679 301,676 Total liabilities and stockholders'
equity $ 414,227 $ 326,637
View source
version on businesswire.com: https://www.businesswire.com/news/home/20181126005548/en/
Investor Contact:Carol
Miceli617-607-0710cmiceli@enanta.comMedia Contact:Kari
WatsonMacDougall Biomedical
Communications781-235-3060kwatson@macbiocom.com
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