- Initiated a Phase 2a Challenge Study of EDP-323, an L-Protein
Inhibitor, in Development as an Oral, Once-Daily Treatment for
Respiratory Syncytial Virus (RSV); Expect to Report Data in Q3
2024
- Streamlined Business and Significantly Lowered 2024 R&D and
G&A Spending Guidance to Support Ongoing Operations
- Cash and Marketable Securities Totaled $370 Million at
September 30, 2023
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage
biotechnology company dedicated to creating small molecule drugs
with an emphasis on treatments for viral infections, today reported
financial results for its fiscal fourth quarter and year ended
September 30, 2023.
“Throughout fiscal 2023, Enanta remained focused on advancing
our two RSV clinical stage programs of best-in-class antivirals
with different mechanisms of action. We are pleased to announce the
initiation of our Phase 2a challenge study of EDP-323, an L-protein
inhibitor, in development as an oral, once-daily treatment for RSV,
and look forward to reporting data in the third quarter of 2024,”
said Jay R. Luly Ph.D., President and Chief Executive Officer of
Enanta Pharmaceuticals. “Further, we are advancing RSVPEDs and
RSVHR, our ongoing Phase 2 trials of EDP-938, our N-protein
inhibitor, with a data readout from at least one of these studies
in the third quarter of 2024, assuming this winter is a normal
Northern Hemisphere RSV season. We have also made important
adjustments to significantly reduce our 2024 spending and extend
our cash runway through fiscal 2027. As a result, we are well
positioned financially as we look forward to readouts across our
RSV pipeline in 2024 and advancements in new non-virology
programs.”
Fiscal Fourth Quarter and Year Ended September 30, 2023
Financial Results
Total revenue was $18.9 million for the three months ended
September 30, 2023, which consisted of royalty revenue derived from
worldwide net sales of AbbVie’s hepatitis C virus (HCV) regimen
MAVYRET®/MAVIRET®, compared to royalty revenue of $20.3 million for
the three months ended September 30, 2022. For the twelve months
ended September 30, 2023, total revenue was $79.2 million compared
to $86.2 million for the same period in 2022. The decrease in the
quarter and in year-over-year revenue is due to a decline in
AbbVie’s sales of MAVYRET®/MAVIRET®.
Beginning with the quarter ended September 30, 2023, 54.5% of
Enanta’s ongoing royalties from AbbVie’s net sales of
MAVYRET®/MAVIRET® are being paid to OMERS, one of Canada’s largest
defined benefit pension plans, pursuant to a royalty sale
transaction in April 2023. For financial reporting purposes, the
transaction was treated as debt, with the upfront purchase payment
of $200.0 million recorded as a liability. Enanta will continue to
record 100% of the royalty earned as revenue and will then amortize
the debt liability proportionally as 54.5% of the cash royalty
payments are paid to OMERS, until a cap of 1.42 times the purchase
payment is met, after which point 100% of the cash royalty payments
will be retained by Enanta. Non-cash interest expense was $3.2
million for the three months ended September 30, 2023 and $5.1
million for the twelve months ended September 30, 2023.
Research and development expenses were $36.2 million for the
three months ended September 30, 2023, compared to $34.8 million
for the three months ended September 30, 2022. The increase was due
to the timing of clinical trial costs, offset by a decrease in
preclinical and manufacturing costs. For the twelve months ended
September 30, 2023, research and development expenses were $163.5
million compared to $164.5 million in 2022.
General and administrative expenses totaled $13.8 million for
the three months ended September 30, 2023, compared to $12.6
million for the three months ended September 30, 2022. For the
twelve months ended September 30, 2023, general and administrative
expenses were $52.9 million compared to $45.5 million in 2022. The
increases in both periods were primarily due to an increase in
legal fees related to the company’s patent infringement suit
against Pfizer.
Other income, net, totaled $4.7 million for the three months
ended September 30, 2023, compared to $0.7 million for the three
months ended September 30, 2022. For the twelve months ended
September 30, 2023, other income, net, totaled $11.4 million
compared to $1.7 million in 2022. The increases in both periods
were primarily due to an increase in investment income due to an
increase in Enanta’s average invested cash balance from the receipt
in April 2023 of $200 million from the sale of the company’s
MAVYRET®/MAVIRET® royalty, as well as increases in interest rates
year-over-year.
Enanta recorded an income tax benefit of $1.4 million for the
three months ended September 30, 2023, compared to income tax
expense of less than $0.1 million for the three months ended
September 30, 2022. Enanta recorded income tax expense of $2.8
million for the twelve months ended September 30, 2023, compared to
an income tax benefit of $0.4 million for the three months ended
September 30, 2022. Despite recording a loss before taxes during
the twelve months ended September 30, 2023, Enanta recorded tax
expense driven by the receipt of the $200.0 million from the
royalty sale agreement, which is treated as income for Federal and
State income tax purposes. This taxable income and its related
income tax expense was substantially offset by net operating loss
carryforwards, research and development tax credit carryforwards
and a deduction for foreign derived intangible income.
Net loss for the three months ended September 30, 2023, was
$28.1 million, or a loss of $1.33 per diluted common share,
compared to a net loss of $26.3 million, or a loss of $1.27 per
diluted common share, for the corresponding period in 2022. For the
twelve months ended September 30, 2023, net loss was $133.8
million, or a loss of $6.38 per diluted common share, compared to a
net loss of $121.8 million, or loss of $5.91 per diluted common
share for the corresponding period in 2022.
Enanta’s cash, cash equivalents and marketable securities
totaled $370.0 million at September 30, 2023. Enanta expects that
its current cash, cash equivalents and short-term marketable
securities, as well as its continuing retained portion of royalty
revenue, will continue to be sufficient to meet the anticipated
cash requirements of its existing business and development programs
through fiscal 2027.
Financial Guidance for Fiscal Year 2024
- Research and Development Expense: $100 million to $120 million
(reduced from $163.5 million of actual expense in 2023)
- General and Administrative Expense: $45 million to $50 million
(reduced from $52 million of actual expense in 2023; guidance
includes an increase in legal fees associated with the company’s
patent infringement lawsuit)
Pipeline Update and Business Review
Virology
RSV
- Enanta is progressing multiple clinical programs aimed at
treating populations at high-risk for serious outcomes from RSV
infection, and is evaluating EDP-938, an N-protein inhibitor, with
two ongoing Phase 2 clinical trials, RSVPEDS and RSVHR.
- RSVPEDs is a Phase 2 randomized, double-blind,
placebo-controlled study in hospitalized and non-hospitalized
pediatric RSV patients. The study, which will enroll approximately
90 patients aged 28 days to 36 months, is being conducted in two
parts. Because this is the first time the drug is being dosed in
pediatrics, the objective of the first part of the study is to
evaluate the safety and pharmacokinetics of EDP-938 in multiple
ascending doses to select the optimal dose for each age group. The
second part of the study will evaluate the antiviral activity of
EDP-938 at the selected dose, and symptom scores will be assessed
throughout the treatment duration. This part is designed as a small
cohort to show a trend toward improved virology metrics for EDP-938
compared to placebo and to give confidence to move forward
efficiently into registrational studies.
- RSVHR is a Phase 2b randomized, double-blind,
placebo-controlled study in approximately 180 adults with RSV
infection who are at high risk of complications, including the
elderly and those with congestive heart failure, chronic
obstructive pulmonary disease or asthma. The primary endpoint of
RSVHR is time to resolution of RSV lower respiratory tract disease
symptoms as assessed by the Respiratory Infection Intensity and
Impact Questionnaire (RiiQ™) symptom scale. Secondary endpoints
include additional clinical efficacy measures and antiviral
activity compared to placebo, pharmacokinetics, and safety of
EDP-938.
- RSVTx, a Phase 2b, randomized, double-blind, placebo-controlled
study in adult hematopoietic cell transplant recipients with RSV
infection and symptoms of upper respiratory tract infection, was
discontinued in September and resources were reallocated to the
enrollment and completion of the other ongoing Phase 2 RSV
trials.
- Enanta expects to complete enrollment in one or both of its
ongoing Phase 2 studies of EDP-938 and to report data in the third
quarter of 2024, assuming this winter is a normal pre-pandemic RSV
season in the Northern Hemisphere. Enanta has expanded its global
footprint and has over 75 sites across 15 countries for RSVPEDs and
over 130 sites across 16 countries for RSVHR.
- In October, Enanta presented data at IDWeek™ 2023 highlighting
EDP-938’s high barrier to the development of clinical resistance as
demonstrated in the human challenge study. This is in contrast to
the lower barrier to resistance that has been observed for other
mechanisms, thereby supporting further development of this
first-in-class N-protein inhibitor.
- Enanta today announced the initiation of a Phase 2a human
challenge study of EDP-323, an oral, L-protein inhibitor in
development for the treatment of RSV. The advancement of EDP-323
into a challenge study is supported by positive Phase 1 data which
demonstrated favorable safety, tolerability, and pharmacokinetics
(PK) supportive of once-daily dosing, with good exposure multiples.
In this randomized, double-blind, placebo-controlled, human
challenge study, up to 114 healthy adult subjects will be infected
with RSV-A Memphis 37b virus. Primary and secondary outcome
measures include safety, changes in viral load measurements and
changes in baseline symptoms. Enanta plans to report data from this
Phase 2a study in the third quarter of 2024.
- In September, Enanta presented data for EDP-323 at the 9th
European Scientific Working Group on Influenza (ESWI) Conference.
These data detailed the positive results observed in the Phase 1
study of healthy subjects.
- Enanta hosted an RSV Key Opinion Leader event in October which
highlighted the ongoing need for RSV treatments despite the
availability of new vaccines and prophylactic monoclonal
antibodies. Guest speakers included Jaime Fergie, MD, FAAP, FIDSA,
FSHEA, Medical Director of the Global Institute for Hispanic
Health, Professor of Pediatrics at Texas A&M University, and
Director of Infectious Diseases at Driscoll Children’s Hospital in
Texas; and Tom Wilkinson, MA (Cantab), MBBS, PhD, FRCP, FERS,
Professor of Respiratory Medicine and Associate Dean at the
University of Southampton and a member of the Faculty of Medicine
at Southampton General Hospital, United Kingdom. To view the
webcast, visit here.
COVID-19 (SARS-CoV-2)
- Enanta plans to pursue any future COVID-19 efforts in the
context of a collaboration, including the development of EDP-235,
an oral, once-daily, Phase 3 ready 3CL protease inhibitor which has
been granted Fast Track designation by the FDA.
Human Metapneumovirus (hMPV)/RSV
- Enanta paused development of its research program targeting
both hMPV and RSV with a single agent. Despite promising
preclinical data, the company does not plan to move a third RSV
candidate into the clinic as long as EDP-938 and EDP-323 continue
to progress.
Hepatitis B Virus (HBV)
- Enanta continues to seek an additional mechanism for
development in a combination regimen with a nucleoside reverse
transcriptase inhibitor and EDP-514, its potent core inhibitor
which has Fast Track designation from the FDA, as a functional cure
for HBV.
Non-Virology
- Enanta is advancing discovery programs focused on non-virology
indications that have a high unmet need and leverage the company’s
expertise in preclinical small molecule drug discovery and
development. The company will announce new therapeutic programs
beginning in early 2024.
Upcoming Events and Presentations
- Evercore Healthcare Conference, November 29, 2023
- 42nd Annual JP Morgan Healthcare Conference, January 10,
2024
- Enanta plans to issue its fiscal 2024 first quarter press
release, and hold a conference call regarding those results, on
February 7, 2024.
Conference Call and Webcast Information
Enanta will host a conference call and webcast today at 4:30
p.m. ET. The live webcast can be accessed under "Events &
Presentations" in the investors section of Enanta’s website. To
join by phone, participants can register for the call here. It is
recommended that participants register a minimum of 15 minutes
before the call. Once registered, participants will receive an
email with the dial-in information. The archived webcast will be
available on Enanta’s website for approximately 30 days following
the event.
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 with an emphasis on treatments
for viral infections. Enanta’s research and development programs
include clinical candidates for the following disease targets:
respiratory syncytial virus (RSV), SARS-CoV-2 (COVID-19) and
hepatitis B virus (HBV).
Glecaprevir, a protease inhibitor discovered by Enanta, is part
of one of the leading treatment regimens for curing chronic
hepatitis c virus infection and is sold by AbbVie 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 clinical programs in RSV, SARS-CoV-2 and HBV and its
preclinical dual-inhibitor program in hMPV/RSV. 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, SARS-CoV-2 and HBV;
the discovery and development risks of Enanta’s programs in RSV,
SARS-CoV-2, HBV 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; and
other risk factors described or referred to in “Risk Factors” in
Enanta’s Form 10-K for the fiscal year ended September 30, 2022,
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
Twelve Months Ended September 30, September
30,
2023
2022
2023
2022
Revenue
$
18,932
$
20,317
$
79,204
$
86,160
Operating expenses Research and development
36,167
34,796
163,524
164,522
General and administrative
13,795
12,569
52,887
45,482
Total operating expenses
49,962
47,365
216,411
210,004
Loss from operations
(31,030
)
(27,048
)
(137,207
)
(123,844
)
Interest expense
(3,151
)
—
(5,148
)
—
Other income, net
4,664
714
11,360
1,656
Loss before income taxes
(29,517
)
(26,334
)
(130,995
)
(122,188
)
Income tax benefit (expense)
1,410
(14
)
(2,821
)
433
Net loss
$
(28,107
)
$
(26,348
)
$
(133,816
)
$
(121,755
)
Net loss per share Basic
$
(1.33
)
$
(1.27
)
$
(6.38
)
$
(5.91
)
Diluted
$
(1.33
)
$
(1.27
)
$
(6.38
)
$
(5.91
)
Weighted average common shares outstanding Basic
21,057
20,755
20,969
20,603
Diluted
21,057
20,755
20,969
20,603
ENANTA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED
BALANCE SHEETS UNAUDITED (in thousands)
September 30, September 30,
2023
2022
Assets Current assets Cash and cash equivalents
$
85,388
$
43,994
Short-term marketable securities
284,522
205,238
Accounts receivable
8,614
20,318
Prepaid expenses and other current assets
13,263
13,445
Income tax receivable
31,004
28,718
Total current assets
422,791
311,713
Long-term marketable securities
—
29,285
Property and equipment, net
11,919
6,173
Operating lease, right-of-use assets
22,794
23,575
Restricted cash
3,968
3,968
Other long-term assets
803
696
Total assets
$
462,275
$
375,410
Liabilities and Stockholders' Equity Current liabilities Accounts
payable
$
4,097
$
6,000
Accrued expenses and other current liabilities
18,339
20,936
Liability related to the sale of future royalties
35,076
—
Operating lease liabilities
5,275
2,891
Total current liabilities
62,787
29,827
Liability related to the sale of future royalties, net of current
portion
159,429
—
Operating lease liabilities, net of current portion
21,238
22,372
Series 1 nonconvertible preferred stock
1,423
1,423
Other long-term liabilities
663
454
Total liabilities
245,540
54,076
Total stockholders' equity
216,735
321,334
Total liabilities and stockholders' equity
$
462,275
$
375,410
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231120256071/en/
Media and Investors: Jennifer Viera 617-744-3848
jviera@enanta.com
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