- Initiated Phase 1b Study of EDP-514 in Viremic HBV Patients and
Resumed Phase 1b Study of EDP-514 in NUC-Suppressed HBV Patients;
Preliminary Data Expected in 1H 2021 and 2Q 2021, Respectively
- Plans to Initiate Two Phase 2 Studies of EDP-938 in Pediatric
and Adult Transplant Patients with RSV in 4Q 2020
- Initiated ARGON-2 Phase 2b Study of EDP-305 in Patients with
NASH, On Track to Initiate Phase 1 Study of EDP-297 for NASH in 3Q
2020
- Royalty Revenue for the Quarter was $18.7 Million
- Cash and Marketable Securities Totaled $435.4 Million at June
30, 2020
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage
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, 2020.
“During the past quarter, Enanta made progress in our clinical
development programs, laying the groundwork for several
catalyst-rich quarters to come. Our virology programs, developed
from years of antiviral drug discovery expertise, continue to
advance with the initiation of our Phase 1b clinical trial in
viremic HBV patients and the resumption of our Phase 1b study in
HBV patients currently treated with nucleos(t)ide reverse
transcriptase inhibitors, which was previously paused due to the
COVID-19 pandemic,” said Jay R. Luly, Ph.D., President and Chief
Executive Officer of Enanta Pharmaceuticals. “In addition, our
Phase 2b RSVP trial in RSV is ongoing, and we are on schedule to
initiate two additional studies for the condition, one in pediatric
patients and a second in adult transplant patients, by year end.
Finally, we are also excited about advancing our candidates in NASH
this quarter, starting with the initiation of the ARGON-2 trial of
EDP-305, our potent FXR agonist candidate, and the planned
initiation later this quarter of the Phase 1 study of EDP-297, our
highly potent and targeted follow-on FXR agonist.”
Fiscal Third Quarter Ended June 30, 2020 Financial
Results
Total revenue of $18.7 million for the three months ended June
30, 2020 consisted of royalty revenue derived primarily from
worldwide net sales of AbbVie’s hepatitis C virus (HCV) regimen
MAVYRET®/MAVIRET®. For the three months ended June 30, 2019, total
revenue was $44.4 million, which consisted of royalty revenue
earned on AbbVie’s global net sales of its HCV regimens. AbbVie has
stated that the decrease in royalty revenue in the three months
ended June 30, 2020 was mainly driven by declining treated patient
volumes due to the COVID-19 pandemic.
Research and development expenses increased slightly to $34.7
million for the three months ended June 30, 2020, compared to $34.5
million for the three months ended June 30, 2019.
General and administrative expenses totaled $6.8 million for the
three months ended June 30, 2020, compared to $6.2 million for the
three months ended June 30, 2019. The slight increase was due to an
increase in compensation expense.
Enanta recorded an income tax benefit of $7.1 million for the
three months ended June 30, 2020 compared to an income tax benefit
of $0.9 million for the same period in 2019. The income tax benefit
in 2020 was driven by the company’s net loss for the period,
federal research and development tax credits, and a federal net
operating loss carry back.
Net loss for the three months ended June 30, 2020 was $14.3
million, or a loss of $0.71 per diluted common share, compared to
net income of $7.0 million, or $0.33 per diluted common share, for
the corresponding period in 2019.
Enanta’s cash, cash equivalents and marketable securities
totaled $435.4 million at June 30, 2020. This compares to a total
of $400.2 million at September 30, 2019, its fiscal year end.
Enanta expects that its current cash, cash equivalents and
short-term and long-term marketable securities, as well as its
continuing royalty revenue, will continue to be sufficient to meet
the anticipated cash requirements of its existing business and
development programs for the foreseeable future.
Pipeline Programs and Near-term Milestones
- Virology
- Respiratory Syncytial Virus (RSV): N-Protein Inhibitor
EDP-938
- Phase 2b RSVP trial is ongoing at sites in the Southern
Hemisphere and will expand to trial sites in Europe and North
America for the fall and winter RSV season, with the goal of
reporting data in 3Q 2021
- Initiate Phase 2 dose-ranging study in pediatric patients with
RSV in 4Q 2020
- Initiate Phase 2 study in adult transplant patients with RSV in
4Q 2020
- Hepatitis B (HBV): Core Inhibitor EDP-514
- Initiated Phase 1b study in viremic HBV patients, with
preliminary data expected in 1H 2021
- Resumed Phase 1b study in NUC-suppressed HBV patients, with
preliminary data expected in 2Q 2021
- Human Metapneumovirus (hMPV)
- Perform optimization of Enanta’s current nanomolar hMPV
inhibitor leads
- SARS-CoV-2 (COVID-19)
- Continue to advance efforts for discovery of direct-acting
antiviral compounds for SARS-CoV-2
- Non-Alcoholic Steatohepatitis (NASH)
- Farnesoid X Receptor (FXR) Agonist EDP-305
- Recruitment and dosing in ARGON-2 Phase 2b study of EDP-305 in
NASH ongoing
- FXR Agonist EDP-297
- Initiate Phase 1 study of EDP-297 in 3Q 2020, with data
expected in 2Q 2021
- Advance efforts for discovery of non-FXR compounds for
NASH
- Corporate
- Announced the appointment of Mark G. Foletta to Enanta’s Board
of Directors where he will serve as the Chair of the Audit
Committee as well as a member of the Nominating and Corporate
Governance Committee
Upcoming Events and Presentations
- August 10, 2020 – BTIG Virtual Biotechnology Conference
2020
- September 9-10, 2020 – Baird 2020 Global Healthcare
Conference
- September 21-23, 2020 – Oppenheimer Fall Healthcare Life
Sciences & MedTech Summit
- Enanta plans to issue its fiscal fourth quarter financial
results press release, and hold a conference call regarding those
results, on November 23, 2020.
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 August 4, 2020, through 11:59 p.m.
ET on August 6, 2020 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 7561838. A live audio webcast of the
call and replay can be accessed by visiting the “Events and
Presentations” section on the “Investors” page of Enanta’s website
at www.enanta.com.
About Enanta Pharmaceuticals, Inc.
Enanta 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 have produced clinical candidates for the following disease
targets: respiratory syncytial virus (RSV), non-alcoholic
steatohepatitis (NASH) and hepatitis B virus (HBV). Enanta is also
conducting research in human metapneumovirus (hMPV) and SARS-CoV-2
(COVID-19).
Enanta’s research and development activities are funded by
royalties from hepatitis C virus (HCV) products developed under its
collaboration with AbbVie. Glecaprevir, a protease inhibitor
discovered by Enanta, is sold by AbbVie in numerous countries as
part of its leading treatment for chronic HCV infection 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, NASH and HBV, as well as the
prospects for advancing research in hMPV and SARS-CoV-2 and 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: the dependence of Enanta’s revenues in the
short-term upon the continued success of AbbVie’s sales of its
MAVYRET/MAVIRET HCV regimen; the impact of development, regulatory
and marketing efforts of others with respect to competitive
treatments for RSV, NASH, HBV, hMPV and SARS-CoV-2; treatment
rates, competitive pricing, and reimbursement rate actions
affecting MAVYRET/MAVIRET compared to competitive HCV products on
the market; the impact COVID-19 could have on number of patient
treatments which could impact MAVYRET/MAVIRET sales; the discovery
and development risks of Enanta’s programs in RSV, NASH 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; the realizability of our deferred tax
assets; 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, 2020, 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,
2020
2019
2020
2019
Revenue
$
18,653
$
44,367
$
98,842
$
153,884
Operating expenses
Research and development
34,682
34,461
100,070
103,494
General and administrative
6,823
6,151
20,628
20,083
Total operating expenses
41,505
40,612
120,698
123,577
Income (loss) from operations
(22,852
)
3,755
(21,856
)
30,307
Other income, net
1,445
2,415
5,471
6,545
Income (loss) before income taxes
(21,407
)
6,170
(16,385
)
36,852
Income tax benefit
7,142
866
9,558
340
Net income (loss)
$
(14,265
)
$
7,036
$
(6,827
)
$
37,192
Net income (loss) per share
Basic
$
(0.71
)
$
0.36
$
(0.34
)
$
1.90
Diluted
$
(0.71
)
$
0.33
$
(0.34
)
$
1.77
Weighted average common shares outstanding
Basic
20,020
19,673
19,897
19,549
Diluted
20,020
21,105
19,897
20,999
ENANTA PHARMACEUTICALS,
INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
UNAUDITED
(in thousands)
June 30,
September 30,
2020
2019
Assets
Current assets
Cash and cash equivalents
$
99,855
$
51,230
Short-term marketable securities
270,145
284,006
Accounts receivable
18,653
51,313
Prepaid expenses and other current assets
24,728
15,299
Total current assets
413,381
401,848
Long-term marketable securities
65,404
65,013
Property and equipment, net
9,285
10,927
Deferred tax assets
15,289
11,341
Operating lease, right-of-use assets
7,645
—
Restricted cash
608
608
Other long-term assets
92
92
Total assets
$
511,704
$
489,829
Liabilities and Stockholders' Equity
Current liabilities Accounts payable
$
6,074
$
6,689
Accrued expenses and other current liabilities
13,576
15,920
Operating lease liabilities
4,264
—
Total current liabilities
23,914
22,609
Operating lease liabilities, net of current portion
4,547
—
Series 1 nonconvertible preferred stock
1,628
1,628
Other long-term liabilities
1,058
3,100
Total liabilities
31,147
27,337
Total stockholders' equity
480,557
462,492
Total liabilities and stockholders' equity
$
511,704
$
489,829
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200804005969/en/
Media and Investor Contact: Jennifer Viera Tel:
617-744-3848 jviera@enanta.com
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