- Presented First Preclinical Data for EDP-235, an Oral Protease
Inhibitor Specifically Designed for the Treatment of COVID-19;
First-in-Human Study Planned for Early 2022
- Reported Positive Clinical Data from Two Phase 1b Studies of
EDP-514, a Hepatitis B Virus (HBV) Core Inhibitor, in Viremic and
NUC-Suppressed Chronic HBV Patients; Terminated Clinical
Development of EDP-721, an Oral HBV RNA Destabilizer
- Announced Decision to Pursue Combination Approaches with
Farnesoid X Receptor (FXR) Agonists for Non-Alcoholic
Steatohepatitis (NASH) Through an Out-Licensing Strategy
- Royalty Revenue for the Quarter was $23.6 Million
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 fourth quarter and year ended September 30,
2021.
“We ended fiscal 2021 achieving multiple milestones including
presenting positive Phase 1b data of EDP-514 in two major HBV
patient populations,” stated Jay R. Luly, Ph.D., President and
Chief Executive Officer of Enanta Pharmaceuticals. “We were also
excited to present the first preclinical data for EDP-235, our oral
protease inhibitor specifically designed to target SARS-CoV-2, and
we are making meaningful progress with our Phase 2b RSVP study in
RSV. Looking ahead, we expect to make significant advancements
across our pipeline and are on schedule to select a new clinical
development candidate from our RSV L-inhibitor program by year-end
and to report initial data from RSVP in the first half of
2022.”
Fiscal Fourth Quarter and Year Ended September 30, 2021
Financial Results
Total revenue of $23.6 million for the three months ended
September 30, 2021 consisted of royalty revenue derived almost
entirely from worldwide net sales of AbbVie’s hepatitis C virus
(HCV) regimen MAVYRET®/MAVIRET®, which was unchanged from the
royalty revenue of $23.6 million for the three months ended
September 30, 2020. For the twelve months ended September 30, 2021,
total revenue was $97.1 million compared to $122.5 million for the
same period in 2020. Royalty revenue for these periods reflect that
treated patient volumes remain suppressed compared to pre-COVID
levels, as reported by AbbVie.
Research and development expenses were $48.9 million for the
three months ended September 30, 2021, compared to $36.7 million
for the three months ended September 30, 2020. For the twelve
months ended September 30, 2021, research and development expenses
were $174.1 million compared to $136.8 million in 2020. The
increases in both periods were due to the timing of clinical trials
in the company's virology programs.
General and administrative expenses totaled $8.4 million for the
three months ended September 30, 2021, compared to $6.7 million for
the three months ended September 30, 2020. For the twelve months
ended September 30, 2021, general and administrative expenses were
$32.5 million compared to $27.4 million in 2020. The increase was
due to additional headcount and related compensation expense.
Enanta recorded an income tax benefit of $8.8 million for the
three months ended September 30, 2021 compared to an income tax
expense of $10.7 million for the same period in 2020. For the
twelve months ended September 30, 2021, Enanta recorded an income
tax benefit of $28.6 million, compared to income tax expense of
$1.1 million for the twelve months ended September 30, 2020. The
income tax expense in 2020 was due to a tax valuation allowance
charge of $18.3 million recorded against the company’s deferred tax
assets in the three months ended September 30, 2020. The income tax
benefit in the current period was due to the provision of the CARES
Act of 2020, which enables the company to carry back its current
year tax loss to offset taxable income in prior years. This
provision will not apply to periods ending after September 30,
2021.
Net loss for the three months ended September 30, 2021 was $24.6
million, or a loss of $1.22 per diluted common share, compared to a
net loss of $29.3 million, or a loss of $1.46 per diluted common
share, for the corresponding period in 2020. For the twelve months
ended September 30, 2021, net loss was $79.0 million, or a loss of
$3.92 per diluted common share, compared to a net loss of $36.2
million, or loss of $1.81 per diluted common share for
corresponding period in 2020.
Enanta’s cash, cash equivalents and marketable securities
totaled $352.4 million at September 30, 2021. 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
at least the next two years.
Financial Guidance for Fiscal Year 2022
- Research and Development Expense: $150 million to $170
million
- General and Administrative Expense: $35 million to $41
million
Pipeline Programs – Recent Events and Near-Term
Milestones
Virology
- Respiratory Syncytial Virus (RSV): N-Protein Inhibitor
EDP-938
- Evaluating EDP-938, an N-protein inhibitor, in a broad clinical
development program, consisting of three ongoing Phase 2 trials:
RSVP, RSVTx and RSVPEDs.
- Continued to establish additional trial sites worldwide for
RSVP, which is designed to study the effect of EDP-938 on
community-acquired RSV infection in an adult population. While RSV,
like influenza, was significantly suppressed while there were
mitigation measures in place to control COVID-19, more recently
there has been evidence of increased RSV activity in various
regions of the world, including parts of the United States and
Europe. Enanta expects that enrollment in the RSVP study will be
complete during the Northern Hemisphere winter season, if there is
no further significant increase in COVID-19 or mitigation measures
in those regions. Assuming this enrollment occurs, the company
expects data in the first half of 2022.
- For RSVTx and RSVPEDs, which were initiated more recently,
enrollment is expected to require more than one global RSV season,
subject to the uncertainties of the continuing pandemic.
- COVID-19 (SARS-CoV-2): Protease Inhibitor EDP-235
- Presented preclinical data during the International Society for
Influenza and Other Respiratory Virus Diseases (ISIRV)–World Health
Organization (WHO) Virtual Conference 2021 demonstrating that oral
EDP-235 selectively blocked replication of SARS-CoV-2 in multiple
cellular models with nanomolar potency. Further, antiviral activity
was maintained against multiple SARS-CoV-2 variants. Good
distribution to lung cells was observed with optimized
pharmacokinetic properties supporting once-daily, oral dosing
without ritonavir boosting. Enanta plans to move EDP-235 into the
clinic in early 2022.
- HBV: Core Inhibitor EDP-514 and HBV RNA Destabilizer
EDP-721
- Announced positive final data from both Phase 1b studies of
EDP-514 in viremic and NUC-suppressed chronic HBV patients. These
data demonstrated that the 200 mg, 400 mg, and 800 mg doses were
safe and well-tolerated through 28 days of treatment and displayed
pharmacokinetics supportive of once-daily dosing. In viremic
patients, treatment with EDP-514 resulted in mean HBV DNA
reductions of 2.9, 3.3, and 3.5 logs at 28 days for the 200 mg, 400
mg, and 800 mg cohorts, respectively, compared to a 0.2 log
reduction in the placebo group.
- Terminated development of EDP-721, an oral HBV RNA destabilizer
due to adverse safety signals in a Phase 1 healthy volunteer
study.
- Respiratory Virology Discovery Initiatives: Enanta’s
goal in the second half of 2021 is to identify one more clinical
development candidate among the two discovery initiatives below:
- RSV L-Protein Inhibitor
- On schedule to select a clinical candidate with potent
nanomolar activity against both RSV-A and RSV-B by year-end.
- Human Metapneumovirus (hMPV)
- Continuing lead optimization on potent nanomolar hMPV
inhibitors.
Non-Alcoholic Steatohepatitis
(NASH)
- Announced a strategic decision to discontinue internal
development of FXR agonists EDP-305 and EDP-297, to prioritize
combination approaches for NASH through out-licensing.
Corporate
- Announced the election of Yujiro S. Hata to Enanta’s Board of
Directors.
Upcoming Events and Presentations
- Evercore HealthCONx, November 30 – December 2, 2021
- Piper Sandler 33rd Annual Healthcare Conference, November 30 –
December 2, 2021
- 40th Annual JP Morgan Healthcare Conference, January 10 – 13,
2022
- Enanta plans to issue its fiscal 2022 first quarter results
press release, and hold a conference call regarding those results,
on February 8, 2022.
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
844-467-7101 in the U.S. or 270-215-9353 for international callers.
A replay of the conference call will be available starting at
approximately 7:30 p.m. ET on November 22, 2021, through 11:59 p.m.
ET on November 29, 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 1973737. 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 currently in development
for the following disease targets: respiratory syncytial virus
(RSV), hepatitis B virus (HBV) and SARS-CoV-2 (COVID-19). Enanta is
also conducting research in human metapneumovirus (hMPV).
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 part of AbbVie’s leading treatment for
chronic HCV infection that it sells in numerous countries 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 research and development programs in RSV, HBV,
SARS-CoV-2 and hMPV, as well as 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
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,
HBV, SARS-CoV-2 and hMPV; treatment rates, competitive pricing, and
reimbursement rate actions affecting MAVYRET/MAVIRET compared to
competitive HCV products on the market; any continuing impact of
COVID-19 on AbbVie’s MAVYRET/MAVIRET sales; the discovery and
development risks of Enanta’s research and development programs in
RSV, HBV, SARS-CoV-2 and hMPV; 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 June 30, 2021, 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
Twelve Months Ended
September 30,
September 30,
2021
2020
2021
2020
Revenue
$
23,575
$
23,631
$
97,074
$
122,473
Operating expenses Research and development
48,946
36,686
174,111
136,756
General and administrative
8,356
6,728
32,536
27,356
Total operating expenses
57,302
43,414
206,647
164,112
Loss from operations
(33,727
)
(19,783
)
(109,573
)
(41,639
)
Other income, net
333
1,149
1,994
6,620
Loss before income taxes
(33,394
)
(18,634
)
(107,579
)
(35,019
)
Income tax (expense) benefit
8,795
(10,707
)
28,583
(1,149
)
Net loss
$
(24,599
)
$
(29,341
)
$
(78,996
)
$
(36,168
)
Net loss per share Basic
$
(1.22
)
$
(1.46
)
$
(3.92
)
$
(1.81
)
Diluted
$
(1.22
)
$
(1.46
)
$
(3.92
)
$
(1.81
)
Weighted average common shares outstanding Basic
20,221
20,074
20,171
19,940
Diluted
20,221
20,074
20,171
19,940
ENANTA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED
BALANCE SHEETS UNAUDITED (in thousands)
September 30,
September 30,
2021
2020
Assets Current assets Cash and cash equivalents
$
57,206
$
87,131
Short-term marketable securities
186,796
299,518
Accounts receivable
23,576
23,492
Prepaid expenses and other current assets
14,188
13,655
Income tax receivable
37,255
13,041
Total current assets
319,021
436,837
Long-term marketable securities
108,416
32,634
Property and equipment, net
5,943
8,596
Deferred tax assets
—
345
Operating lease, right-of-use assets
4,711
7,020
Restricted cash
608
608
Other long-term assets
92
92
Total assets
$
438,791
$
486,132
Liabilities and Stockholders' Equity Current liabilities Accounts
payable
$
9,540
$
5,737
Accrued expenses and other current liabilities
22,429
14,159
Operating lease liabilities
4,203
4,261
Total current liabilities
36,172
24,157
Operating lease liabilities, net of current portion
1,126
3,838
Series 1 nonconvertible preferred stock
1,506
1,479
Other long-term liabilities
558
1,078
Total liabilities
39,362
30,552
Total stockholders' equity
399,429
455,580
Total liabilities and stockholders' equity
$
438,791
$
486,132
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211122006607/en/
Media and Investors: Jennifer Viera Tel: 617-744-3848
jviera@enanta.com
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