- On Track to Initiate Phase 1b Study of EDP-514 in Viremic
Hepatitis B Patients in 2Q 2020 and Phase 1 Study of EDP-297 in 3Q
2020
- Royalty Revenue for the Quarter was $27.6 Million
- Cash and Marketable Securities Totaled $435.4 Million at March
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 second quarter ended March 31, 2020.
“Enanta is fortunate to have advanced several of its programs in
the recent quarter and it continues to have a strong balance sheet
and ongoing royalty funding to support its business plans going
forward,” said Jay R. Luly, President and Chief Executive Officer
of Enanta Pharmaceuticals. “The current pandemic has underscored
our commitment as a company to bring forth novel anti-viral
therapies for respiratory viruses and liver infections, and we
remain highly dedicated to the clinical advancement of our
innovative small molecule pipeline. We are on schedule to initiate
our Phase 1b study of EDP-514 in viremic hepatitis B patients this
quarter, and we also expect to initiate a first-in-human study of
our follow-on Farnesoid X receptor agonist, EDP-297, next quarter.
Additionally, we have plans for two additional studies of EDP-938
for respiratory syncytial virus to start by year-end, one in
pediatric patients and one in adult transplant patients. With these
catalysts in mind, we continue to monitor any impact of COVID-19 on
all of our clinical studies.”
Fiscal Second Quarter Ended March 31, 2020 Financial
Results
Total revenue for the three months ended March 31, 2020 was
$27.6 million and consisted of royalty revenue derived primarily
from worldwide net sales of AbbVie’s hepatitis C virus (HCV)
regimen MAVYRET®/MAVIRET® (glecaprevir/pibrentasvir). For the three
months ended March 31, 2019, total revenue was $39.6 million, which
consisted of royalty revenue earned on AbbVie’s global net sales of
its HCV regimens. AbbVie has reported that the decrease in its
first quarter 2020 HCV sales was due to lower patient volumes in
select international markets where patients are treated in
hospitals affected by COVID-19, as well as increased competition
affecting pricing and market share within the U.S. Managed Medicaid
segment.
Research and development expenses totaled $32.6 million for the
three months ended March 31, 2020, compared to $34.2 million for
the three months ended March 31, 2019. The decrease in research and
development expenses was primarily due to a decrease in clinical
trial expense due to timing of Phase 2 studies in non-alcoholic
steatohepatitis (NASH)/primary biliary cholangitis (PBC) conducted
in the prior year.
General and administrative expenses totaled $6.9 million for the
three months ended March 31, 2020, compared to $6.8 million for the
three months ended March 31, 2019.
Enanta recorded an income tax benefit of $3.9 million for the
three months ended March 31, 2020 compared to an income tax benefit
of $3.2 million for the same period of 2019. The income tax benefit
for the three months ended March 31, 2020 was due to a pre-tax loss
and increased research and development tax credits. In the prior
year, Enanta recorded an income tax benefit despite reporting
pre-tax income due to tax deductions from employee stock
award-related activity during the quarter.
Net loss for the three months ended March 31, 2020 was $6.0
million, or a loss of $0.30 per diluted common share, compared to
net income of $4.1 million, or $0.20 per diluted common share, for
the corresponding period in 2019.
Enanta’s cash, cash equivalents and short-term and long-term
marketable securities totaled $435.4 million at March 31, 2020.
This compares to a total of $400.3 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.
Pipeline Programs and Near-term Milestones
- Respiratory Syncytial Virus (RSV): N-Protein Inhibitor
EDP-938, Human Metapneumovirus (hMPV) and SARS-CoV-2
- Continue with plans to broaden the RSVP study into the Southern
Hemisphere, and to expand to trials sites in Europe and North
America in the fall and winter RSV season, with the goal of having
data in the third quarter of 2021
- Plan to initiate Phase 2 dose ranging study in pediatric
patients with RSV in 4Q 2020
- Plan to initiate Phase 2 study in adult transplant patients
with RSV in 4Q 2020
- Perform optimization of Enanta’s current nanomolar hMPV
inhibitor leads
- Advance efforts for discovery of direct-acting antiviral
compounds for SARS-CoV-2
- Hepatitis B (HBV): Core Inhibitor EDP-514
- Initiate Phase 1b study in viremic HBV patients in 2Q 2020
- Resume recruitment in Phase 1b study in nuc-suppressed HBV
patients, currently paused
- Non-Alcoholic Steatohepatitis (NASH): Farnesoid X Receptor
(FXR) Agonists EDP-305 and EDP-297
- Resume recruitment and dosing in ARGON-2 Phase 2b study of
EDP-305 in NASH, currently paused
- Plan to initiate Phase 1 study of EDP-297 (follow-on FXR for
NASH) in 3Q 2020
- Advance efforts for discovery of non-FXR compounds for
NASH
- Hepatitis C (HCV) Collaboration with AbbVie
- AbbVie announced that the European Commission approved a change
to the marketing authorization for MAVIRET®
(glecaprevir/pibrentasvir) to shorten once-daily treatment duration
from 12 to 8 weeks in treatment-naïve, compensated cirrhotic,
chronic HCV patients with genotype (GT) 3 infection. The decision
makes MAVIRET the only pan-genotypic (GTs 1-6) 8-week treatment
option for treatment-naïve, chronic HCV patients, without cirrhosis
or with compensated cirrhosis.
Upcoming Events and Presentations
- May 19, 2020 – RBC Capital Markets Global Healthcare
Conference, Virtual
- June 18, 2020 – Raymond James Healthcare Conference,
Virtual
- Enanta plans to issue its fiscal third quarter financial
results press release, and hold a conference call regarding those
results, on August 4, 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 May 6, 2020, through 11:59 p.m. ET
on May 8, 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 4261269. 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 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 emerging
coronaviruses, including SARS-CoV-2.
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 and now marketed by AbbVie as part of its
leading treatment for chronic HCV infection, is sold under the
brand names 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
discovery programs in hMPV and SARS-CoV-2, and prospects for future
royalty revenue from sales of AbbVie’s MAVYRET®/MAVIRET® HCV
regimen. 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 level 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, 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, HBV, hMPV,
SARS-CoV-2; 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-Q for the quarter ended December 31, 2019, 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 Six
Months Ended March 31, March 31,
2020
2019
2020
2019
Revenue
$ 27,619
$ 39,631
$ 80,189
$ 109,517
Operating expenses Research and development
32,610
34,155
65,388
69,033
General and administrative
6,884
6,780
13,805
13,932
Total operating expenses
39,494
40,935
79,193
82,965
Income (loss) from operations
(11,875)
(1,304)
996
26,552
Other income, net
1,950
2,245
4,026
4,130
Income (loss) before income taxes
(9,925)
941
5,022
30,682
Income tax (expense) benefit
3,920
3,204
2,416
(526)
Net income (loss)
$ (6,005)
$ 4,145
$ 7,438
$ 30,156
Net income (loss) per share Basic
$ (0.30)
$ 0.21
$ 0.37
$ 1.55
Diluted
$ (0.30)
$ 0.20
$ 0.36
$ 1.44
Weighted average common shares outstanding Basic
19,922
19,549
19,836
19,487
Diluted
19,922
21,084
20,692
20,946
ENANTA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED
BALANCE SHEETS UNAUDITED(in thousands)
March 31, September 30,
2020
2019
Assets
Current assets
Cash
and cash equivalents
$
74,338
$
51,230
Short-term marketable securities
280,917
284,006
Accounts receivable
27,619
51,313
Prepaid expenses and other current assets
19,835
15,299
Total current assets
402,709
401,848
Long-term marketable securities
80,099
65,013
Property and equipment, net
9,738
10,927
Deferred tax assets
12,418
11,341
Operating lease, right-of-use assets
7,837
— Restricted cash
608
608
Other long-term assets
92
92
Total assets
$
513,501
$
489,829
Liabilities and Stockholders' Equity
Current liabilities
Accounts payable
$
5,945
$
6,689
Accrued expenses and other current liabilities
9,807
15,920
Operating lease liabilities
3,764
— Total current liabilities
19,516
22,609
Operating lease liabilities, net of current portion
5,330
— Series 1 nonconvertible preferred stock
1,628
1,628
Other long-term liabilities
1,036
3,100
Total liabilities
27,510
27,337
Total stockholders' equity
485,991
462,492
Total liabilities and stockholders' equity
$
513,501
$
489,829
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200506005569/en/
Media and Investors: Jennifer Viera 617-744-3848
jviera@enanta.com
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