Enanta Pharmaceuticals Reports Financial Results for its Fiscal First Quarter and Three Months Ended December 31, 2018

Webcast and Conference Call today at 4:30 p.m. ET

  • Royalty revenue for the quarter increased to $69.9 million
  • Research and development programs progressing well with clinical
    milestones expected in 2019 in our RSV, NASH, and HBV programs
  • Cash and marketable securities totaled $357.3 million at December
    31, 2018

WATERTOWN, Mass.–(BUSINESS WIRE)–lt;a href=”https://twitter.com/search?q=%24ENTA&src=ctag” target=”_blank”gt;$ENTAlt;/agt; lt;a href=”https://twitter.com/hashtag/ENTA?src=hash” target=”_blank”gt;#ENTAlt;/agt;–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 first quarter ended December 31, 2018.

“Enanta’s research and development programs are progressing well and we
have many clinical goals that we expect to achieve this year,” said Jay
R. Luly, Ph.D. President and CEO, Enanta Pharmaceuticals. “By mid-year,
we expect to announce top-line data from our Phase 2a human challenge
study of EDP-938 for RSV, followed by Phase 2a data from our NASH study.
We also expect to initiate a Phase 1 study with our new HBV core
inhibitor candidate EDP-514 in the second half of 2019.”

Fiscal First Quarter Ended December 31, 2018 Financial Results

Total revenue for the three months ended December 31, 2018 was $69.9
million and consisted entirely of royalty revenue from worldwide net
sales of AbbVie’s hepatitis C virus (HCV) regimens MAVYRET™/MAVIRET™, as
well as its HCV regimens containing paritaprevir. For the three months
ended December 31, 2017, total revenue was $38.1 million which consisted
of a $15.0 million milestone payment for the reimbursement approval of
MAVIRET™ in Japan and royalty revenue primarily earned on AbbVie’s
global net sales from the launch of MAVYRET™/MAVIRET™ in major markets
in the second half of 2017.

Research and development expenses totaled $34.9 million for the three
months ended December 31, 2018, compared to $18.0 million for the three
months ended December 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
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 $7.2 million for the three
months ended December 31, 2018, compared to $5.8 million for the three
months ended December 31, 2017. The increase in general and
administrative expenses was primarily due to increases in compensation
expense driven by increased headcount.

Enanta recorded income tax expense of $3.7 million for the three months
ended December 31, 2018 compared to an income tax expense of $3.6
million for the same period in 2017. Enanta’s effective tax rate for the
December 31, 2018 quarter was approximately 13%.

Net income for the three months ended December 31, 2018 was $26.0
million, or $1.25 per diluted common share, compared to net income of
$11.7 million, or $0.59 per diluted common share, for the corresponding
period in 2017.

Enanta’s cash, cash equivalents and short-term and long-term marketable
securities totaled $357.3 million at December 31, 2018. This compares to
a total of $325.1 million at September 30, 2018. 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.

Development Programs and Business Review

EDP-938, N-Protein Inhibitor for Respiratory Syncytial Virus:

  • Dosing is ongoing in a Phase 2a human challenge study to evaluate the
    safety, pharmacokinetics and antiviral activity of multiple doses of
    EDP-938 orally administered to healthy subjects infected with a strain
    of respiratory syncytial virus. The trial is advancing well, and
    topline data is now expected mid-2019.

EDP-514, Core Inhibitor for Hepatitis B Virus:

  • In January, Enanta announced positive preclinical data on EDP-514, a
    promising inhibitor of the HBV core protein. Data demonstrated potent
    inhibition of HBV replication in vitro accompanied by a greater
    than 4-log viral load reduction in a humanized liver mouse model after
    12 weeks of dosing.
  • A Phase 1 study of EDP-514, is planned to begin in the second half of
    2019. The study will evaluate single and multiple doses of drug in
    healthy volunteers and will incorporate a Phase 1b arm in patients
    with chronic HBV infection.

EDP-305, FXR agonist for NASH:

  • Enrollment in the 12-week Phase 2a NASH trial is expected to conclude
    in the first quarter of 2019, allowing Enanta to report preliminary
    top line data in the third quarter of calendar 2019.
  • Enanta also expects to identify a follow-on FXR clinical candidate in
    calendar 2019.

Upcoming Events and Presentations

  • 31st Annual Roth Conference, March 17-19, 2019, Dana Point,
    CA
  • Oppenheimer’s 29th Annual Healthcare Conference, March
    19-20, 2019, New York
  • Preclinical data presentations from our NASH and HBV programs at The
    International Liver Congress, Vienna, Austria, April 10-14, 2019
  • Enanta plans to issue its fiscal second quarter financial results
    press release, and hold a conference call regarding those results, on
    May 7, 2019.

Conference Call and Webcast Information
Enanta 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 February 6, 2019,
through 11:59 p.m. ET on February 8, 2019 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 1190228. 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. Enanta’s research and development efforts 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).

Enanta’s research and development activities are currently funded by
royalties from HCV products developed under its collaboration with
AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is now
sold by AbbVie in numerous countries as part of its 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). 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 RSV and
NASH/PBC and its preclinical program in HBV, as well as the prospects
for future royalty revenue to Enanta from sales of AbbVie’s
MAVYRET™/MAVIRET™ regimen for HCV. 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
continued success of AbbVie’s commercialization of its MAVYRET™/MAVIRET™
HCV regimen; the impact of development, regulatory and marketing efforts
of others with respect to competitive treatments for RSV, NASH, PBC and
HBV; competitive pricing, market acceptance and reimbursement rate
actions affecting MAVYRET™/MAVIRET™ compared to competitive HCV products
on the market; the discovery and development risks of Enanta’s programs
in RSV, NASH, PBC, and HBV; the competitive impact of development,
regulatory and marketing efforts of others in those 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-K for
the fiscal year ended September 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 OPERATIONS

UNAUDITED
(in
thousands, except per share amounts)
                 
 
Three Months Ended
December 31,
2018 2017
 
Revenue $ 69,886 $ 38,109
Operating expenses
Research and development 34,878 17,962
General and administrative   7,152     5,770  
Total operating expenses   42,030     23,732  
Income from operations 27,856 14,377
Other income, net   1,885     960  
Income before income taxes 29,741 15,337
Income tax expense   (3,730 )   (3,644 )
Net income $ 26,011   $ 11,693  
 
 
Net income per share
Basic $ 1.34 $ 0.61
Diluted $ 1.25 $ 0.59
Weighted average common shares outstanding
Basic 19,426 19,130
Diluted 20,810 19,918
 
 

ENANTA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED
BALANCE SHEETS

UNAUDITED
(in thousands)

               
December 31,
2018
September 30,
2018
Assets
Current assets
Cash and cash equivalents $ 74,365 $ 63,902
Short-term marketable securities 271,423 244,828
Accounts receivable 69,886 67,205
Prepaid expenses and other current assets   7,636   4,454
Total current assets 423,310 380,389
Long-term marketable securities 11,465 16,389
Property and equipment, net 9,493 8,374
Deferred tax assets 9,248 8,375
Restricted cash 608 608
Other long-term assets   92   92
Total assets $ 454,216 $ 414,227
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable $ 5,622 $ 4,745
Accrued expenses and other current liabilities 11,152 9,892
Income taxes payable   5,858   1,388
Total current liabilities 22,632 16,025
Series 1 nonconvertible preferred stock 1,628 1,628
Other long-term liabilities   3,121   2,895
Total liabilities   27,381   20,548
Total stockholders’ equity   426,835   393,679
Total liabilities and stockholders’ equity $ 454,216 $ 414,227

Contacts

Investor Contact:
Carol Miceli
617-607-0710
cmiceli@enanta.com

Media
Contact:
Kari Watson
MacDougall Biomedical Communications
781-235-3060
kwatson@macbiocom.com

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