Webcast and Conference Call Today at 4:30 p.m.
ET
- On track to initiate a Phase 2b study in adult transplant
patients with respiratory syncytial virus by year-end and a Phase 2
study in pediatric patients with respiratory syncytial virus in
early 2021
- Readouts from two clinical trials in hepatitis B virus program
expected in the second quarter of 2021
- Initiated Phase 1 study of EDP-297, a highly potent and
targeted follow-on farnesoid X receptor agonist for the treatment
of non-alcoholic steatohepatitis; initial clinical data expected in
the second quarter of 2021
- Royalty revenue for the quarter was $23.6 million
- Cash and marketable securities totaled approximately $419
million at September 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 fourth quarter and year ended September 30,
2020.
“2020 was marked by significant progress for Enanta. We
initiated four clinical trials between our hepatitis B and
non-alcoholic steatohepatitis programs, and we announced two new
discovery programs for respiratory viruses – SARS-CoV-2 and human
metapneumovirus. Additionally, we remain on schedule to initiate
our adult transplant Phase 2b study in RSV by year-end 2020, which
will be followed shortly thereafter with the initiation of our
pediatric Phase 2 study in RSV in early 2021,” commented Jay R.
Luly, Ph.D., President and Chief Executive Officer of Enanta. “I am
grateful to the entire Enanta team for rising to the challenges
presented by the COVID-19 pandemic and advancing our existing
pipeline. Our commitment has laid the groundwork for a strong 2021,
with multiple catalysts anticipated next year, including clinical
data in our lead disease areas. If positive, these data will
strengthen Enanta as a leader in the discovery and development of
small molecule drugs for viral infections and liver diseases, and
position us well to progress further our wholly-owned pipeline of
clinical and preclinical programs to bring meaningful new
treatments to patients.”
FISCAL FOURTH QUARTER AND YEAR ENDED SEPTEMBER 30, 2020
FINANCIAL RESULTS
Total revenue of $23.6 million for the three months ended
September 30, 2020 consisted of royalty revenue derived primarily
from worldwide net sales of AbbVie’s hepatitis C virus (HCV)
regimen MAVYRET®/MAVIRET® (glecaprevir/pibrentasvir). Total revenue
for the three months ended September 30, 2019, was $51.3 million.
For the twelve months ended September 30, 2020, total revenue was
$122.5 million compared to $205.2 million for the same period in
2019. The decrease in royalty revenue quarter over quarter was
driven by lower HCV product sales as treated patient volumes have
remained below pre-COVID levels, as reported by AbbVie.
Research and development expenses were $36.7 million for the
three months ended September 30, 2020, compared to $38.7 million
for the three months ended September 30, 2019. For the twelve
months ended September 30, 2020, research and development costs
were $136.8 million compared to $142.2 million in 2019. The
decrease in research and development expenses was primarily due to
the timing of the company’s clinical studies year over year and
COVID-19-related delays in two clinical studies that are now
ongoing.
General and administrative expenses totaled $6.7 million for the
three months ended September 30, 2020, compared to $6.2 million for
the three months ended September 30, 2019. For the twelve months
ended September 30, 2020, general and administrative costs were
$27.4 million compared to $26.2 million in 2019.
Enanta recorded income tax expense of $10.7 million for the
three months ended September 30, 2020, despite a net operating
loss, compared to an income tax benefit of $0.5 million for the
same period in 2019. For the twelve months ended September 30,
2020, Enanta recorded income tax expense of $1.1 million, compared
to an income tax benefit of $0.8 million for the twelve months
ended September 30, 2019. 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. This is a non-cash charge based on an
assessment that it is more likely than not that Enanta’s deferred
tax assets will not be fully realized. The tax valuation allowance
charge, which is recorded in income tax expense, was partially
offset by a federal net operating loss carryback under the CARES
Act, research and development credits generated during the year,
and a release of an uncertain tax position reserve related to the
close of a Massachusetts Department of Revenue Audit. In 2019, the
company’s income tax benefit was the result of a federal tax
benefit on foreign derived royalty income and tax deductions from
employee stock-award-related activity during 2019.
Net loss for the three months ended September 30, 2020 was $29.3
million, or a loss of $1.46 per diluted common share, compared to
net income of $9.2 million, or $0.44 per diluted common share, for
the corresponding period in 2019. For the twelve months ended
September 30, 2020, net loss was $36.2 million, or a loss of $1.81
per diluted common share, compared to net income of $46.4 million,
or $2.21 per diluted common share for the twelve months ended
September 30, 2019. The decrease in net income in both 2020 periods
was due to a decrease in HCV royalties earned under the AbbVie
agreement and a non-cash tax valuation allowance charge of $18.3
million recorded in the three months ended September 30, 2020.
Enanta’s cash, cash equivalents and marketable securities
totaled approximately $419 million at September 30, 2020. This
compares to a total of approximately $400 million at September 30,
2019. 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 YEAR 2021
- Research and Development Expense: $145 million to $165
million
- General and Administrative Expense: $27 million to $33
million
PIPELINE PROGRAMS AND BUSINESS REVIEW
Virology
Respiratory Syncytial Virus (RSV)
Enanta is evaluating EDP-938, its N-protein inhibitor, in a
broad clinical development program, consisting of three planned or
ongoing trials: RSVP, RSVTx and RSVPEDs. Together, these studies
are designed to evaluate the effect of EDP-938 in a range of
pediatric and adult patient populations:
- RSVP, an ongoing Phase 2b study in adult outpatients with
community-acquired RSV infection, is anticipated to readout data in
3Q 2021, subject to the impact of the ongoing COVID-19 pandemic on
levels of community RSV infection and activities at trial
sites.
- RSVTx, a Phase 2b study in adult hematopoietic cell transplant
recipients with acute RSV infection of the upper respiratory tract,
is expected to initiate in 4Q 2020.
- RSVPEDs, a Phase 2 study in hospitalized and non-hospitalized
pediatric patients with RSV, is expected to initiate in early
2021.
Human Metapneumovirus (hMPV)
In January, Enanta announced a new program to develop nanomolar
inhibitors of hMPV, a pathogen that causes upper and lower
respiratory tract infections in young children and the elderly, as
well as in immunocompromised patients or those with COPD or asthma.
Enanta’s goal is to finalize a clinical candidate in 2021.
SARS-CoV-2 (COVID-19)
In March, Enanta initiated a program to discover direct-acting
antiviral drug candidates, with a focus on polymerase and protease
inhibitors, for the treatment of patients infected with the novel
coronavirus COVID-19, also known as SARS-CoV-2. Enanta’s goal is to
finalize a clinical candidate in 2021.
Hepatitis B Virus (HBV)
EDP-514, Enanta’s novel class II core inhibitor with Fast Track
Designation from the FDA, is being developed in two Phase 1b
studies for the treatment of HBV across different patient
populations: subjects treated with a nucleos(t)ide reverse
transcriptase inhibitor (NUC-suppressed patients), and chronic HBV
subjects with high viral loads and not currently on therapy
(viremic patients):
- In February, Enanta announced positive results from Part 1 of a
Phase 1a/1b clinical study, informing the company’s decision to
initiate a Phase 1b study in NUC-suppressed patients in March. The
Phase 1b study is currently ongoing with preliminary data expected
in 2Q 2021.
- Subsequently, in July, Enanta initiated a randomized,
double-blind, placebo-controlled Phase 1b study in viremic chronic
HBV subjects not currently on therapy, with preliminary data
expected in 2Q 2021.
Non-Alcoholic Steatohepatitis
(NASH)
EDP-305, Enanta’s lead farnesoid X receptor (FXR) agonist, is
currently being evaluated for the treatment of NASH with
fibrosis:
- In May, Enanta announced that it was no longer pursuing an
indication for EDP-305 in primary biliary cholangitis and would
remain focused on NASH for this compound.
- In August, Enanta began enrollment for ARGON-2, its Phase 2b
randomized, double-blind, placebo-controlled 72-week study of
EDP-305 in approximately 340 patients with biopsy-confirmed NASH
with fibrosis, using doses of 1.5 mg and 2.0 mg.
EDP-297, Enanta’s highly potent and targeted follow-on FXR
agonist is currently being developed for the treatment of NASH with
fibrosis:
- A Phase 1 randomized, double-blind, placebo-controlled,
first-in-human clinical trial of EDP-297 is ongoing. Enanta expects
to report safety, tolerability and pharmacokinetics data in 2Q
2021.
Around mid-year Enanta expects that the EDP-297 data, together
with an interim analysis at 12 weeks of treatment on a subset of
patients in ARGON-2, will enhance Enanta’s ability to prioritize
its FXR agonist compounds and seek opportunities for development of
one or both of them in combinations with other mechanisms for NASH
with fibrosis.
UPCOMING EVENTS AND PRESENTATIONS
- Piper Sandler 32nd Annual Virtual Healthcare Conference,
November 30 - December 3, 2020
- Evercore ISI 3rd Annual Virtual HealthCONx Conference, December
1 - 3, 2020
- 39th Annual JP Morgan Virtual Healthcare Conference, January 11
- 14, 2021
- Enanta plans to issue its fiscal first quarter 2021 financial
results press release, and hold a conference call regarding those
results, on February 8, 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 November 23, 2020, through 11:59
p.m. ET on November 25, 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 5436807. 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
Enanta’s projections of its expenses in fiscal 2021, and its
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
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 discovery
and development risks of Enanta’s programs in RSV, NASH, HBV, hMPV
and SARS-CoV-2; the competitive impact of development, regulatory
and marketing efforts of others in those disease areas; any
continuing impact of the COVID-19 pandemic on Enanta’s HCV
royalties, 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-Q for the quarter ended June 30, 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.
Tables to Follow
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,
2020
2019
2020
2019
Revenue
$
23,631
$
51,313
$
122,473
$
205,197
Operating expenses Research and development
36,686
38,719
136,756
142,213
General and administrative
6,728
6,163
27,356
26,246
Total operating expenses
43,414
44,882
164,112
168,459
Income (loss) from operations
(19,783
)
6,431
(41,639
)
36,738
Other income, net
1,149
2,274
6,620
8,819
Income (loss) before income taxes
(18,634
)
8,705
(35,019
)
45,557
Income tax (expense) benefit
(10,707
)
486
(1,149
)
826
Net income (loss)
$
(29,341
)
$
9,191
$
(36,168
)
$
46,383
Net income (loss) per share Basic
$
(1.46
)
$
0.47
$
(1.81
)
$
2.37
Diluted
$
(1.46
)
$
0.44
$
(1.81
)
$
2.21
Weighted average common shares outstanding Basic
20,074
19,686
19,940
19,584
Diluted
20,074
20,876
19,940
20,968
ENANTA PHARMACEUTICALS, INC. CONDENSED
CONSOLIDATED BALANCE SHEETS UNAUDITED (in
thousands)
September 30,
September 30,
2020
2019
Assets Current assets Cash and cash equivalents
$
87,131
$
51,230
Short-term marketable securities
299,518
284,006
Accounts receivable
23,492
51,313
Prepaid expenses and other current assets
26,696
15,299
Total current assets
436,837
401,848
Long-term marketable securities
32,634
65,013
Property and equipment, net
8,596
10,927
Deferred tax assets
345
11,341
Operating lease, right-of-use assets
7,020
-
Restricted cash
608
608
Other long-term assets
92
92
Total assets
$
486,132
$
489,829
Liabilities and Stockholders' Equity Current liabilities Accounts
payable
$
5,737
$
6,689
Accrued expenses and other current liabilities
14,159
15,920
Operating lease liabilities
4,261
-
Total current liabilities
24,157
22,609
Operating lease liabilities, net of current portion
3,838
-
Series 1 nonconvertible preferred stock
1,479
1,628
Other long-term liabilities
1,078
3,100
Total liabilities
30,552
27,337
Total stockholders' equity
455,580
462,492
Total liabilities and stockholders' equity
$
486,132
$
489,829
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201123006215/en/
Investors and Media: Jennifer Viera 617-744-3848
jviera@enanta.com
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