Phathom Pharmaceuticals Reports Second Quarter 2023 Results
August 10 2023 - 8:01AM
Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical
company focused on developing and commercializing novel treatments
for gastrointestinal diseases, today reported financial results for
the second quarter of 2023 and provided updates on recent
regulatory and business progress.
“We made great progress advancing key regulatory, financial, and
commercial priorities during the second quarter, highlighted by our
regulatory submissions for both Erosive GERD and H. pylori
convenience packs, the successful execution of a capital raise
resulting in $141.4 million in net proceeds, and commencement of
our salesforce recruiting in anticipation of our product launches
in the fourth quarter,” said Terrie Curran, President and Chief
Executive Officer of Phathom. “Our manufacturing and regulatory
teams have worked diligently to address the impurity cited by the
FDA in the complete response letters we received in February, and
we are pleased that our regulatory applications have been assigned
PDUFA action dates later this year. We remain focused on onboarding
a high-performing field force and completing the final preparations
for our anticipated commercial launches.”
Clinical, Regulatory, and Business Updates:
- In June 2023, Phathom submitted a PAS to the FDA for both
VOQUEZNA TRIPLE PAK (vonoprazan, amoxicillin, clarithromycin) and
VOQUEZNA DUAL PAK (vonoprazan, amoxicillin). The submission of
these supplements signifies a full response to the February 2023
complete response letter (CRL) and, subject to filing, the FDA has
assigned a PDUFA goal date of October 30, 2023. The PAS contained
three months of stability data supporting both VOQUEZNA-based
convenience packs, which includes reformulated vonoprazan tablets,
to support the commercial shelf life of vonoprazan. Phathom plans
to provide six-month stability data during the regulatory review as
previously agreed with the FDA.
- In June 2023, Phathom announced that the FDA acknowledged the
New Drug Application (NDA) resubmission for vonoprazan for the
treatment of Erosive GERD (gastroesophageal reflux disease)
constitutes a complete response to the February 2023 CRL and
assigned a PDUFA goal date of November 17, 2023.
- In May 2023, Phathom recorded $141.4
million in net proceeds from the completed public offering of its
common stock. The total gross proceeds to Phathom from the offering
were approximately $150.3 million, before deducting the
underwriting discounts and commissions and other offering expenses.
Phathom intends to use the net proceeds from the offering to fund
the clinical development of vonoprazan, pre-commercial activities
and commercialization expenses, and for working capital and general
corporate purposes.
- In its Phase 3 PHALCON-NERD-301
trial for Non-Erosive GERD, Phathom successfully completed the
20-week blinded extension period where patients were administered
vonoprazan 10 mg or 20 mg once-daily for further safety and
efficacy evaluation. Topline results from the extension period are
expected to be shared by the end of 2023. A regulatory submission
remains on track for the second half of 2023 seeking approval of
vonoprazan as a daily (QD) treatment for Non-Erosive GERD, the
largest subcategory of GERD with an estimated U.S. population of
over 45 million people.
- Phathom has currently secured
coverage for 65% of commercial lives for first-in-class PCAB-based
H. pylori infection treatments, VOQUEZNA TRIPLE PAK and VOQUEZNA
DUAL PAK.
- Phathom is in the process of recruiting and onboarding a
national salesforce in advance of the planned fourth quarter 2023
commercial launches for H. pylori and Erosive GERD.
Second Quarter 2023 Financial Results:
- Net loss for the second quarter ended June 30, 2023, was $41.0
million, compared to $50.9 million for second quarter 2022. Second
quarter 2023 net loss included a non-cash charge related to
stock-based compensation of $7.3 million compared to $5.9 million
for second quarter 2022.
- Research and development expenses for the second quarter 2023
were $12.8 million, a decrease of $6.0 million compared to $18.8
million for second 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 second quarter 2023
were $18.9 million, a decrease of $7.6 million compared to $26.5
million for second quarter 2022. The decrease was primarily due to
a reduction in professional services, partially offset by increased
personnel costs.
- As of June 30, 2023, cash and cash equivalents were $248.8
million. An additional $100.0 million is available under Phathom’s
term loan with Hercules Capital, Inc. (Hercules) on October 1,
2023, and $175.0 million will be paid to Phathom upon FDA approval
of VOQUEZNA for Erosive GERD under the terms of its revenue
interest financing agreement.
- 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 following 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 StatementsPhathom cautions you that statements
contained in this press release regarding matters that are not
historical facts are forward-looking statements. These statements
are based on the Company’s current beliefs and expectations. Such
forward-looking statements include, but are not limited to,
statements regarding Phathom’s expectations of generating and
submitting to the FDA stability data necessary to support the
proposed shelf life of vonoprazan; the potential approval of its
Erosive GERD NDA and prior approval supplements for its H. pylori
convenience pack NDAs, and anticipated product launches in H.
pylori and Erosive GERD; a potential regulatory submission seeking
approval of vonoprazan as a daily treatment for Non-Erosive GERD;
and that Phathom will have sufficient capital to fund operations
through the end of 2025. 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: Phathom may be unable to generate the required data to
meet the acceptable intake of its nitrosamine impurity, or may be
unable to reduce the impurity to an acceptable level throughout the
shelf life of the product, to obtain approval for its Erosive GERD
NDA or to bring vonoprazan to market for patients with Erosive
GERD, if approved, or for patients with H. pylori; future
nitrosamine data may be inconsistent with data generated to date;
the FDA may not accept for review the H. pylori convenience pack
supplements; risks associated with product manufacturing or
formulation changes required to be made in connection with
achieving the acceptable daily intake limit of the nitrosamine
detected in vonoprazan drug product; the FDA may disagree that the
existing safety and efficacy data, together with additional data,
is sufficient to approve the Erosive GERD NDA or supplements to the
H. pylori NDAs; 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.
|
Selected Condensed Balance Sheets |
(Unaudited) |
(in thousands) |
|
|
June 30,2023 |
|
December 31,2022 |
Assets |
|
|
|
Cash and cash equivalents |
$ |
248,847 |
|
$ |
155,385 |
Total assets |
$ |
265,039 |
|
$ |
164,810 |
Total liabilities |
$ |
247,439 |
|
$ |
239,624 |
Total stockholders’ equity
(deficit) |
$ |
17,600 |
|
$ |
(74,814) |
|
|
|
|
|
|
Statements of Operations and Comprehensive
Loss |
(Unaudited) |
(in thousands, except share and per share
amounts) |
|
|
Three Months
EndedJune 30, |
|
Six Months
EndedJune 30, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
12,764 |
|
|
$ |
18,815 |
|
|
$ |
24,242 |
|
|
$ |
36,475 |
|
General and administrative |
|
18,937 |
|
|
|
26,548 |
|
|
|
37,536 |
|
|
|
46,795 |
|
Total operating expenses |
|
31,701 |
|
|
|
45,363 |
|
|
|
61,778 |
|
|
|
83,270 |
|
Loss from operations |
|
(31,701 |
) |
|
|
(45,363 |
) |
|
|
(61,778 |
) |
|
|
(83,270 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
348 |
|
|
|
112 |
|
|
|
1,808 |
|
|
|
119 |
|
Interest expense |
|
(9,615 |
) |
|
|
(5,667 |
) |
|
|
(18,832 |
) |
|
|
(8,426 |
) |
Other income (expense) |
|
3 |
|
|
|
(2 |
) |
|
|
23 |
|
|
|
(8 |
) |
Total other expense |
|
(9,264 |
) |
|
|
(5,557 |
) |
|
|
(17,001 |
) |
|
|
(8,315 |
) |
Net loss and comprehensive
loss |
$ |
(40,965 |
) |
|
$ |
(50,920 |
) |
|
$ |
(78,779 |
) |
|
$ |
(91,585 |
) |
Net loss per share, basic and
diluted |
$ |
(0.84 |
) |
|
$ |
(1.33 |
) |
|
$ |
(1.73 |
) |
|
$ |
(2.40 |
) |
Weighted-average shares of common
stock outstanding, basic and diluted |
|
48,500,516 |
|
|
|
38,272,044 |
|
|
|
45,444,496 |
|
|
|
38,155,151 |
|
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