Phathom Pharmaceuticals Reports Third Quarter 2023 Results and Recent Business Updates
November 09 2023 - 8:00AM
Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical
company focused on developing and commercializing novel treatments
for gastrointestinal diseases, today reported financial results for
the third quarter of 2023 and provided updates on recent regulatory
and business progress.
“Our recent FDA approval of VOQUEZNA makes 2023 another
significant year for Phathom and marks a pivotal moment in our
journey to bring a new class of treatment options to millions of
patients in the U.S. with acid related disorders,” said Terrie
Curran, President and Chief Executive Officer of Phathom. “We are
completing the buildout and onboarding of our sales team to execute
our highly anticipated launch and have already begun branded
promotion in advance of VOQUEZNA’s expected commercial availability
in December. Our organization also continues to make important
regulatory progress to maximize the full commercial potential of
vonoprazan, evidenced by our September NDA submission seeking
approval of vonoprazan as a daily treatment for Non-Erosive GERD,
the largest subcategory of GERD. With an additional $175 million in
cash provided under our non-dilutive revenue interest financing
agreement this quarter, we believe we are well capitalized to
support the blockbuster potential of VOQUEZNA.”
Recent Clinical, Regulatory, and Business
Updates:
- In November 2023, Phathom announced the FDA approval of
VOQUEZNA® (vonoprazan) tablets 10 mg and 20 mg, a novel
potassium-competitive acid blocker (PCAB), as a treatment for
adults for the healing of all grades of Erosive Esophagitis, also
known as Erosive GERD (gastroesophageal reflux disease),
maintenance of healing of all grades of Erosive GERD, and relief of
heartburn associated with Erosive GERD. This approval provides
healthcare providers with a first-in-class therapeutic option that
has demonstrated superiority over a standard-of-care proton pump
inhibitor (PPI) in the healing of patients with moderate-to-severe
disease after two weeks, and in the maintenance of healing of all
patients. Commercial availability of VOQUEZNA is expected in
December 2023.
- In October 2023, the FDA approved Phathom’s prior approval
supplements for reformulated vonoprazan tablets packaged in
VOQUEZNA TRIPLE PAK (vonoprazan tablets, amoxicillin capsules,
clarithromycin tablets) and VOQUEZNA DUAL PAK (vonoprazan tablets,
amoxicillin capsules), for the treatment of Helicobacter pylori (H.
pylori) infection in adults. VOQUEZNA-based treatment regimens
contain antibiotics conveniently packaged with vonoprazan.
- In September 2023, Phathom announced the submission of an NDA
to the FDA seeking approval for vonoprazan as a daily treatment for
Non-Erosive GERD (NERD), the largest subcategory of GERD and is
characterized by reflux-related symptoms in the absence of
esophageal mucosal erosions. Phathom expects a 10-month regulatory
review with FDA action expected in the third quarter of 2024. If
approved, a U.S. commercial launch for the expanded indication is
planned for the same quarter.
- Phathom shared the top-line results
from the 20-week extension period of its positive Phase 3
PHALCON-NERD-301 trial which evaluated the efficacy and safety of
vonoprazan for the daily treatment of adults with Non-Erosive GERD.
In the trial, vonoprazan (10 mg and 20 mg) controlled heartburn
symptoms through the entire 6 months of the study with a safety
profile consistent with prior vonoprazan studies.
- Phathom plans to commence a separate Phase 3 Non-Erosive GERD
trial in 2024 studying the As Needed dosing of vonoprazan for
active heartburn episodes, a dosing regimen for which proton pump
inhibitors (PPIs) are not approved in the U.S. The Company hopes to
confirm the positive results from its previous Phase 2 As Needed
study of vonoprazan in Non-Erosive GERD to support an application
for regulatory approval of this novel dosing regimen.
- Phathom has completed the onboarding of its sales leadership
team and is finalizing the hiring and onboarding of an experienced
national salesforce to support its upcoming commercial
launches.
Third Quarter 2023 Financial Results:
- Net loss for the third quarter ended September 30, 2023, was
$43.2 million, compared to $51.1 million for third quarter 2022.
Third quarter 2023 net loss included a non-cash charge related to
stock-based compensation of $6.1 million compared to $5.8 million
for third quarter 2022.
- Research and development expenses for the third quarter 2023
were $12.3 million, a decrease of $6.7 million compared to $19.0
million for third quarter 2022. The decrease was a result of
decreased clinical trial costs, partially offset by increased
chemistry, manufacturing and controls costs, and personnel
costs.
- General and administrative expenses for the third quarter 2023
were $23.4 million, a decrease of $0.1 million compared to $23.5
million for third quarter 2022. The decrease was primarily due to a
reduction in professional services, partially offset by increased
personnel costs in anticipation of the planned commercial launches
in December.
- As of September 30, 2023, cash and cash equivalents were $213.7
million. Following the FDA approval of VOQUEZNA for Erosive GERD,
$175.0 million will be paid to Phathom under the terms of its
revenue interest financing agreement. An additional $100.0 million
is also available under Phathom’s term loan with Hercules Capital,
Inc. (Hercules).
- Phathom anticipates a $19.3 million non-cash charge in the
fourth quarter 2023 related to the immediate vesting of performance
share units (PSUs) related to the approval of VOQUEZNA for Erosive
GERD.
- Based on its current operating plan, including expected product
revenues, the funds available under its existing term loan with
Hercules and cash to be paid under our royalty interest financing
agreement based on the recent approval of VOQUEZNA for Erosive
GERD, Phathom believes it will have sufficient capital to fund
operations through the end of 2025.
About Phathom PharmaceuticalsPhathom
Pharmaceuticals is a biopharmaceutical company focused on the
development and commercialization of novel treatments for
gastrointestinal diseases. Phathom has in-licensed the exclusive
rights in the United States, Europe, and Canada to vonoprazan, a
first-in-class potassium-competitive acid blocker (PCAB). For more
information about Phathom, visit the Company’s website
at www.phathompharma.com and follow the
Company on LinkedIn and Twitter.Forward-Looking
StatementsThis press release contains forward-looking
statements. Investors are cautioned not to place undue reliance on
these forward-looking statements, including statements about the
timing of a U.S. commercial launch for vonoprazan for Erosive GERD,
the timing of regulatory review and commercial launch of vonoprazan
as a daily treatment for Non-Erosive GERD, the timing of
commencement of our Phase 3 Non-Erosive GERD trial, and our cash
runway. The inclusion of forward-looking statements should not be
regarded as a representation by Phathom that any of its plans will
be achieved. Actual results may differ from those set forth in this
press release due to the risks and uncertainties inherent in
Phathom’s business, including, without limitation: we may not be
able to successfully commercialize VOQUEZNA which will depend on a
number of factors including coverage and reimbursement levels from
governmental authorities and health insurers as well as market
acceptance by healthcare providers; future data generated from our
stability program may be different from the data submitted to the
FDA to date and may not demonstrate that our mitigation efforts
will continue to maintain the level of the nitrosamine impurity
below the acceptable intake (AI) level throughout the shelf life of
products containing vonoprazan, which could result in market action
or shelf life reduction; risks associated with product
manufacturing or formulation changes required to be made in
connection with achieving the AI; the inherent risks of clinical
development of vonoprazan; Phathom’s dependence on third parties in
connection with product manufacturing, research and preclinical and
clinical testing; regulatory developments in the United States and
foreign countries; unexpected adverse side effects or inadequate
efficacy of vonoprazan that may limit its development, regulatory
approval and/or commercialization, or may result in recalls or
product liability claims; Phathom’s ability to access additional
capital under its term loan facility and royalty interest finance
agreements is subject to certain conditions; Phathom’s ability to
obtain and maintain intellectual property protection for
vonoprazan; Phathom’s ability to comply with its license agreement
with Takeda; and other risks described in the Company’s prior press
releases and the Company’s filings with the Securities and Exchange
Commission (SEC), including under the heading “Risk Factors” in the
Company’s Annual Report on Form 10-K and any subsequent filings
with the SEC. You are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
hereof, and Phathom undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date hereof. All forward-looking statements are qualified
in their entirety by this cautionary statement, which is made under
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995.
MEDIA CONTACTNick
Benedetto1-877-742-8466media@phathompharma.com
INVESTOR CONTACTEric
Sciorilli1-877-742-8466ir@phathompharma.com
© 2023 Phathom Pharmaceuticals. All rights reserved.
VOQUEZNA, VOQUEZNA TRIPLE PAK, VOQUEZNA DUAL PAK, Phathom
Pharmaceuticals, and their respective logos are registered
trademarks or trademarks of Phathom Pharmaceuticals, Inc.
Selected Condensed Balance
Sheets (Unaudited)(in
thousands)
|
|
September 30,2023 |
|
|
December 31,2022 |
|
Assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
213,677 |
|
|
|
$ |
155,385 |
|
|
Total
assets |
|
$ |
236,992 |
|
|
|
$ |
164,810 |
|
|
Total
liabilities |
|
$ |
254,765 |
|
|
|
$ |
239,624 |
|
|
Total
stockholders’ deficit |
|
$ |
(17,773 |
) |
|
|
$ |
(74,814 |
) |
|
Statements of Operations and
Comprehensive Loss (Unaudited)(in
thousands, except share and per share amounts)
|
|
Three Months
EndedSeptember 30, |
|
Nine Months
EndedSeptember 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
12,263 |
|
|
$ |
19,020 |
|
|
$ |
36,505 |
|
|
$ |
55,495 |
|
General and administrative |
|
|
23,396 |
|
|
|
23,509 |
|
|
|
60,932 |
|
|
|
70,303 |
|
Total
operating expenses |
|
|
35,659 |
|
|
|
42,529 |
|
|
|
97,437 |
|
|
|
125,798 |
|
Loss
from operations |
|
|
(35,659 |
) |
|
|
(42,529 |
) |
|
|
(97,437 |
) |
|
|
(125,798 |
) |
Other
income (expense): |
|
|
|
|
|
|
|
|
Interest income |
|
|
2,720 |
|
|
|
726 |
|
|
|
4,528 |
|
|
|
845 |
|
Interest expense |
|
|
(10,107 |
) |
|
|
(9,277 |
) |
|
|
(28,939 |
) |
|
|
(17,703 |
) |
Other (expense), net |
|
|
(197 |
) |
|
|
(11 |
) |
|
|
(174 |
) |
|
|
(20 |
) |
Total
other expense |
|
|
(7,584 |
) |
|
|
(8,562 |
) |
|
|
(24,585 |
) |
|
|
(16,878 |
) |
Net loss
and comprehensive loss |
|
$ |
(43,243 |
) |
|
$ |
(51,091 |
) |
|
$ |
(122,022 |
) |
|
$ |
(142,676 |
) |
Net loss
per share, basic and diluted |
|
$ |
(0.76 |
) |
|
$ |
(1.32 |
) |
|
$ |
(2.48 |
) |
|
$ |
(3.72 |
) |
Weighted-average shares of common stock outstanding, basic and
diluted |
|
|
56,782,379 |
|
|
|
38,820,266 |
|
|
|
49,265,321 |
|
|
|
38,379,292 |
|
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