- Broadened Hepatitis B Virus (HBV) Program with EDP-721, a New
Oral HBV RNA Destabilizer, as a Potential Component of a Functional
HBV Cure Regimen; Plan to Initiate Phase 1 Study Mid-2021
- Initiated RSVTx, a Phase 2b Study of EDP-938 in Adult
Hematopoietic Cell Transplant Recipients with Acute Respiratory
Syncytial Virus (RSV) Infection
- Expanded RSV Program with a Discovery Initiative for Novel RSV
L-Protein Inhibitors
- Royalty Revenue for the Quarter was $31.7 Million
- Cash and Marketable Securities Totaled $404.7 Million at
December 31, 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 first quarter ended December 31, 2020.
“Our first fiscal quarter of 2021 was an especially active time,
as we advanced and expanded our wholly-owned pipeline. In HBV, not
only did we advance our two ongoing Phase 1b trials of EDP-514, but
we also broadened our program with the introduction of EDP-721, a
novel HBV RNA destabilizer. We believe that an all-oral regimen of
EDP-514, EDP-721 and a nucleos(t)ide reverse transcriptase
inhibitor has the potential to lead to a functional cure. We
anticipate having preliminary data in our two existing HBV trials
in the second quarter of 2021, with a Phase 1 study of EDP-721 on
track to initiate mid-year,” stated Jay R. Luly, Ph.D., President
and Chief Executive Officer of Enanta Pharmaceuticals.
“We also made meaningful progress on our RSV franchise,
initiating an RSV L-protein inhibitor discovery effort centered on
potent nanomolar leads active against both RSV-A and RSV-B.
Further, we initiated the Phase 2b RSVTx study evaluating EDP-938
in adult hematopoietic cell transplant recipients with RSV, and
remain on track to initiate the Phase 2 RSVPEDs study of EDP-938 in
pediatric patients with RSV this quarter. Meanwhile, we are in the
process of expanding clinical sites for RSVP in Europe and Asia
Pacific, so that we are ready when RSV re-emerges. Additionally, we
are making significant progress in our discovery efforts in human
metapneumovirus (hMPV) and SARS-CoV-2 (COVID-19), with the goal of
identifying two clinical candidates this year from among our hMPV,
COVID-19 and RSV discovery programs. Importantly, our strategy for
COVID-19 involves targeting mechanisms that should be effective
against emerging spike protein variants,” continued Dr. Luly.
“Finally, our non-alcoholic steatohepatitis (NASH) program is
progressing with the ARGON-2 trial of EDP-305 and the Phase 1 study
of EDP-297 ongoing, and we look forward to having valuable insights
around mid-year to inform next steps for our NASH program. Looking
ahead, we believe the upcoming year will be important for Enanta,
as we progress through numerous milestones across our entire
pipeline.”
Fiscal First Quarter Ended December 31, 2020 Financial
Results
Total revenue for the three months ended December 31, 2020 was
$31.7 million and consisted entirely of royalty revenue from
worldwide net sales of AbbVie’s hepatitis C virus (HCV) regimens.
For the three months ended December 31, 2019, total royalty revenue
was $52.6 million on AbbVie’s higher HCV sales. As reported by
AbbVie, continued lower HCV product sales were due primarily to
lower treated patient volumes during the COVID-19 pandemic.
Research and development expenses totaled $36.7 million for the
three months ended December 31, 2020, compared to $32.8 million for
the three months ended December 31, 2019. The increase was
primarily due to the timing of the company’s clinical trials year
over year.
General and administrative expenses totaled $7.4 million for the
three months ended December 31, 2020, compared to $6.9 million for
the three months ended December 31, 2019. This increase was
primarily due to increased headcount and compensation expense.
Enanta recorded an income tax benefit of $3.3 million for the
three months ended December 31, 2020 compared to income tax expense
of $1.5 million for the same period in 2019. Enanta recorded an
income tax benefit during the three months ended December 31, 2020
due to the provision of the CARES Act of 2020, which enables the
Company to carry back its projected current year tax loss to offset
taxable income in prior years.
Net loss for the three months ended December 31, 2020 was $8.3
million, or a loss of $0.41 per diluted common share, compared to
net income of $13.4 million, or $0.65 per diluted common share, for
the corresponding period in 2019.
Enanta’s cash, cash equivalents and short-term and long-term
marketable securities totaled $404.7 million at December 31, 2020.
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.
Pipeline Programs and Near-Term Milestones
Virology
- RSV: N-Protein Inhibitor EDP-938
- RSVP, a Phase 2b randomized, double-blind,
placebo-controlled study in 70 adult outpatients with
community-acquired RSV infection, is ongoing, but to date the 2021
RSV season in the Northern Hemisphere has not yet begun due to
COVID-19 mitigation measures. Enanta has made extensive efforts to
more than double its clinical sites globally, including sites
across Europe and Asia-Pacific, to be ready when RSV
re-emerges.
- Initiated RSVTx, a Phase 2b randomized,
double-blind, placebo-controlled study in 200 adult hematopoietic
cell transplant recipients with acute RSV infection and symptoms of
upper respiratory tract infection.
- On schedule to initiate RSVPEDs, a Phase 2
randomized, double-blind, placebo-controlled study in 90
hospitalized and non-hospitalized pediatric RSV patients in the
first quarter of calendar 2021.
- HBV: Core Inhibitor EDP-514 and RNA Destabilizer
EDP-721
- Introduced EDP-721, a potent and selective
HBV RNA destabilizer, for use alone or in combination with other
mechanisms, such as EDP-514, with the goal of achieving an all-oral
functional cure. Enanta expects to initiate a Phase 1 clinical
study of EDP-721 in mid-2021.
- Phase 1b study of EDP-514 in viremic HBV
patients is ongoing, with preliminary data expected in the second
quarter of calendar 2021.
- Phase 1b study of EDP-514 in NUC-suppressed
HBV patients is ongoing, with preliminary data expected in the
second quarter of calendar 2021.
- Respiratory Virology Discovery Programs – In 2021,
Enanta expects to identify clinical development candidates for two
of its three programs below:
- RSV L-Protein Inhibitor
° Recently announced an RSV L-inhibitor
discovery initiative with potent nanomolar leads active against
both RSV-A and RSV-B, for potential use alone or in combination
with agents targeting other RSV mechanisms, such as EDP-938.
- COVID-19
° Urgently performing lead optimization on
direct-acting antiviral leads targeting mechanisms that should be
effective against emerging spike protein variants.
- hMPV ° Continue
performing lead optimization on current nanomolar hMPV inhibitor
leads.
NASH
- Farnesoid X Receptor (FXR) Agonist EDP-305
- Continue recruitment and dosing in ARGON-2
Phase 2b study of EDP-305, with a blinded 12-week interim analysis
on a subset of patients, for Enanta’s internal use, expected in
mid-2021.
- Continue recruitment and dosing in a Phase
1 study of EDP-297, with data expected in mid-2021.
Corporate
- Announced the appointment of several key new hires,
including
- Tara Kieffer, Ph.D., Senior Vice President,
New Product Strategy and Development;
- Brendan Luu, Senior Vice President,
Business Development; and
- John DeVincenzo, M.D., Vice President,
Translational Virology.
Upcoming Events and Presentations
- SVB Leerink Global Healthcare Conference (February 23-26, 2021,
Virtual)
- Enanta Annual Shareholder Meeting (March 2, 2021, Virtual)
- H.C. Wainwright Global Life Sciences Conference (March 9-10,
2021, Virtual)
- ROTH Capital Partners Annual Conference (March 15-17, 2021,
Virtual)
- Oppenheimer & Co. Annual Healthcare Conference (March
16-17, 2021, Virtual)
- Enanta Fiscal Second Quarter 2021 Financial Results Webcast and
Conference Call (May 6, 2021)
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 8, 2021, through 11:59 p.m.
ET on February 12, 2021 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 2854627. 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
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), hepatitis B virus (HBV)
and non-alcoholic steatohepatitis (NASH). 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, HBV and NASH, as well as its
discovery programs in SARS-CoV-2 and hMPV and prospects for future
royalty revenue 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 impact of development, regulatory and
marketing efforts of others with respect to competitive treatments
for RSV, HBV, NASH, SARS-CoV-2 and hMPV; the discovery and
development risks of Enanta’s programs in RSV, HBV, NASH,
SARS-CoV-2 and hMPV; the competitive impact of development,
regulatory and marketing efforts of others in those disease areas;
the dependence of Enanta’s revenues in the short-term upon AbbVie’s
sales of its MAVYRET/MAVIRET HCV regimen; any continuing impact of
the COVID-19 pandemic on Enanta’s royalty revenues, business
operations and clinical trials; 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, 2020, and any 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,
2020
2019
Revenue
$
31,743
$
52,570
Operating expenses Research and development
36,665
32,778
General and administrative
7,377
6,921
Total operating expenses
44,042
39,699
Income (loss) from operations
(12,299
)
12,871
Other income, net
677
2,076
Income (loss) before income taxes
(11,622
)
14,947
Income tax (expense) benefit
3,294
(1,504
)
Net income (loss)
$
(8,328
)
$
13,443
Net income (loss) per share Basic
$
(0.41
)
$
0.68
Diluted
$
(0.41
)
$
0.65
Weighted average common shares outstanding Basic
20,093
19,751
Diluted
20,093
20,773
ENANTA PHARMACEUTICALS, INC. CONDENSED
CONSOLIDATED BALANCE SHEETS UNAUDITED (in
thousands)
December 31,
September 30,
2020
2020
Assets Current assets Cash and cash equivalents
$
55,095
$
87,131
Short-term marketable securities
331,101
299,518
Accounts receivable
31,743
23,492
Prepaid expenses and other current assets
28,003
26,696
Total current assets
445,942
436,837
Long-term marketable securities
18,462
32,634
Property and equipment, net
7,788
8,596
Deferred tax assets
345
345
Operating lease, right-of-use assets
7,775
7,020
Restricted cash
608
608
Other long-term assets
92
92
Total assets
$
481,012
$
486,132
Liabilities and Stockholders' Equity Current liabilities Accounts
payable
$
6,305
$
5,737
Accrued expenses and other current liabilities
11,542
14,159
Operating lease liabilities
5,197
4,261
Total current liabilities
23,044
24,157
Operating lease liabilities, net of current portion
3,520
3,838
Series 1 nonconvertible preferred stock
1,479
1,479
Other long-term liabilities
974
1,078
Total liabilities
29,017
30,552
Total stockholders' equity
451,995
455,580
Total liabilities and stockholders' equity
$
481,012
$
486,132
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210208005739/en/
Investors and Media: Jennifer Viera 617-744-3848
jviera@enanta.com
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