Webcast and Conference Call Today at 4:30
p.m. ET
- Positive results from part 1 of the Phase 1a/b clinical study
of EDP-514 in healthy subjects - Part 2 initiated in nuc-suppressed
chronic hepatitis B virus patients
- Research and development programs progressing well -- several
milestones expected in 2020 from our RSV, NASH, and HBV
programs
- Royalty revenue for the quarter was $52.6 million
- Cash and marketable securities totaled $414.7 million at
December 31, 2019
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and
development-focused 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, 2019.
“We achieved the first of our 2020 milestones with today’s
announcement of positive data in healthy subjects with EDP-514, our
core inhibitor for HBV. EDP-514 was found to be safe and
well-tolerated in healthy adults, with a pharmacokinetic profile
that demonstrated good blood levels to support once daily dosing.
These results support further clinical evaluation, so we have
initiated part 2 of the study in nuc-suppressed chronic HBV
patients,” stated Jay R. Luly, Enanta President and CEO. “We look
forward to reporting further clinical results and updates from our
other wholly-owned clinical programs in RSV, NASH and PBC in
2020.”
Fiscal First Quarter Ended December 31, 2019 Financial
Results
Total revenue for the three months ended December 31, 2019 was
$52.6 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, 2018, total royalty revenue
was $69.9 million.
Research and development expenses totaled $32.8 million for the
three months ended December 31, 2019, compared to $34.9 million for
the three months ended December 31, 2018. The decrease was
primarily due to the timing of clinical trial costs associated with
the progression of Enanta’s wholly owned clinical programs in
respiratory syncytial virus (RSV), non-alcoholic steatohepatitis
(NASH), primary biliary cholangitis (PBC), and hepatitis B virus
(HBV).
General and administrative expenses totaled $6.9 million for the
three months ended December 31, 2019 compared to $7.2 million for
the three months ended December 31, 2018.
Enanta recorded income tax expense of $1.5 million for the three
months ended December 31, 2019 compared to an income tax expense of
$3.7 million for the same period in 2018. Enanta’s effective tax
rate for the December 31, 2019 quarter was approximately 10 percent
compared to approximately 12.5 percent for the corresponding period
in 2018. The decrease quarter over quarter was due primarily to
increased research and development tax credits and a federal income
tax benefit from foreign-derived royalty income.
Net income for the three months ended December 31, 2019 was
$13.4 million, or $0.65 per diluted common share, compared to net
income of $26.0 million, or $1.25 per diluted common share, for the
corresponding period in 2018.
Enanta’s cash, cash equivalents and short-term and long-term
marketable securities totaled $414.7 million at December 31, 2019.
This compares to a total of $400.2 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.
Phase 1 data for core inhibitor EDP-514 for HBV
The Phase 1 randomized, double-blind, placebo-controlled,
first-in-human study of EDP-514 was conducted to evaluate the
safety, tolerability, and pharmacokinetics (PK) of single- and
multiple- (14 days) ascending doses of EDP-514 in healthy
subjects.
Overall, EDP-514 in healthy subjects dosed for up to 14 days was
well tolerated with a favorable safety profile; treatment emergent
adverse events were infrequent and mild in intensity; no one
discontinued EDP-514 due to adverse events; and there were no
significant individual lab data findings or pattern of lab
abnormalities. Additionally, the pharmacokinetic (blood level)
profile was fully supportive of once daily dosing.
Following these results, which support further clinical
evaluation of EDP-514 in HBV patients, Enanta has initiated a study
in patients with chronic HBV infection that is being suppressed
with nucleos(t)ide-reverse-transcriptase treatment (nuc-suppressed
patients). A further study is planned in patients with chronic HBV
infection who are not on therapy and have high levels of virus in
their blood (viremic patients).
Further details of results from this Phase 1a study will be
presented at the International Liver Congress™, April 15-20,
2020.
Near-term Milestones
- RSV: N-inhibitor EDP-938 and human metapneumovirus (hMPV)
Inhibitor Leads
- Due to an apparent December peak in the RSV season in North
America, continue enrollment in RSVP study of EDP-938 in adult RSV
outpatients, including in the Southern Hemisphere, with the goal of
having data in the first half of 2021.
- Initiate Phase 2 dose ranging study in pediatric RSV patients
in 4Q 2020
- Initiate Phase 2 study in adult transplant patients with RSV in
4Q 2020
- Perform optimization of Enanta’s current nanomolar hMPV
inhibitor leads
- HBV: Core Inhibitor EDP-514
- Initiate Phase 1b in viremic HBV patients in 2Q 2020
- Data from Phase 1b study in nuc-suppressed HBV patients in 1Q
2021
- NASH / PBC: FXR Agonists EDP-305 and EDP-297
- Initiate ARGON-2 Phase 2b study of EDP-305 in NASH by early 2Q
2020
- Phase 2 data from INTREPID study of EDP-305 in PBC by early 2Q
2020
- Initiate Phase 1 study of EDP-297 (follow-on FXR) in
mid-2020
- Advance discovery of non-FXR compounds for NASH
Upcoming Events and Presentations
- Enanta Annual Shareholder Meeting, February 26, 2020,
Cambridge, MA
- EDP-514, EDP-297, and EDP-305 abstracts at the International
Liver Congress™, April 15-20, 2020
- Enanta plans to issue its fiscal second quarter financial
results press release, and hold a conference call regarding those
results, on May 6, 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 February 6, 2020, through 11:59 p.m. ET on February 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 3972249. 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 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)/ primary biliary cholangitis
(PBC), and hepatitis B virus (HBV). Enanta’s research and
development activities are funded by royalties from HCV products
developed under its collaboration with AbbVie. Glecaprevir, a
protease inhibitor discovered by Enanta, is now sold by AbbVie in
numerous countries as part of its leading treatment for chronic
hepatitis C virus (HCV) infection sold 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/PBC and HBV, as well as Enanta’s 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, PBC and HBV; 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, PBC, 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; and
other risk factors described or referred to in “Risk Factors” in
Enanta’s most recent Form 10-K for the year ended, 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
OPERATIONSUNAUDITED(in thousands, except per share amounts)
Three Months Ended December
31,
2019
2018
Revenue
$
52,570
$
69,886
Operating expenses Research and development
32,778
34,878
General and administrative
6,921
7,152
Total operating expenses
39,699
42,030
Income from operations
12,871
27,856
Other income, net
2,076
1,885
Income before income taxes
14,947
29,741
Income tax expense
(1,504
)
(3,730
)
Net income
$
13,443
$
26,011
Net income per share Basic
$
0.68
$
1.34
Diluted
$
0.65
$
1.25
Weighted average common shares outstanding Basic
19,751
19,426
Diluted
20,773
20,810
ENANTA PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED BALANCE
SHEETSUNAUDITED(in thousands)
December 31, 2019
September 30, 2019
Assets Current assets Cash and cash equivalents
$
27,558
$
51,230
Short-term marketable securities
346,227
284,006
Accounts receivable
52,570
51,313
Prepaid expenses and other current assets
14,153
15,299
Total current assets
440,508
401,848
Long-term marketable securities
40,941
65,013
Property and equipment, net
10,407
10,927
Deferred tax assets
10,656
11,341
Operating lease, right-of-use assets
7,762
— Restricted cash
608
608
Other long-term assets
92
92
Total assets
$
510,974
$
489,829
Liabilities and Stockholders' Equity Current liabilities Accounts
payable
$
6,596
$
6,689
Accrued expenses and other current liabilities
9,411
15,920
Operating lease liabilities
3,132
— Total current liabilities
19,139
22,609
Operating lease liabilities, net of current portion
5,987
— Series 1 nonconvertible preferred stock
1,628
1,628
Other long-term liabilities
1,933
3,100
Total liabilities
28,687
27,337
Total stockholders' equity
482,287
462,492
Total liabilities and stockholders' equity
$
510,974
$
489,829
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200206005778/en/
Investor Contact: Paul Mellett pmellett@enanta.com
Media Contact: Kari Watson MacDougall Biomedical
Communications 781-235-3060 kwatson@macbiocom.com
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