Full Press Release Details
Phathom Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update
February 28, 2023 Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today reported financial results for
the fourth quarter and full year ended December 31, 2022, and provided a business update.
Over the past year, our teams made significant
progress to advance the development and commercial potential of vonoprazan. We obtained FDA approval of our first products, aligned with the FDA on a near final label for erosive GERD, and delivered our third positive Phase 3 trial for vonoprazan in
a third potential indication, said Terrie Curran, President and Chief Executive Officer of Phathom. While our anticipated commercial launch is on hold pending resolution of the previously announced nitrosamine impurity issue, we are
confident in the progress we have made in generating additional stability data, and based on initial testing results, we believe the mitigation measures put in place are achieving their intended effects. We have a meeting scheduled with the FDA in
March to discuss our proposed resubmission plan and align on potential review timelines to help make vonoprazan available to patients as soon as possible. We look forward to meeting with the FDA and expect to share more details about our progress
once we have obtained additional clarity.
Full Year 2022 and Recent Business Highlights:
Fourth Quarter and Full Year 2022 Financial Results:
About Phathom Pharmaceuticals, Inc.
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.
Phathom 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 stability
data necessary to support the proposed shelf life of vonoprazan and the potential approval of its erosive esophagitis NDA and post approval supplements for its H. pylori NDAs, and anticipated product launches in H. pylori and erosive
esophagitis; the expected timing of topline data from the Phase 3 trial of vonoprazan as a daily treatment for patients with non-erosive GERD; the potential of vonoprazan to provide patients with a rapid
relief agent to treat non-erosive GERD; and that Phathom will have sufficient capital to fund operations through 2024. 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 its erosive esophagitis NDA or to bring
vonoprazan to market for patients with erosive esophagitis, if approved, or for patients with H. Pylori; 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 esophagitis 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.
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
| December 31, 2022 | December 31, 2021 | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 155,385 | $ | 183,259 | ||||
| Total assets | $ | 164,810 | $ | 189,431 | ||||
| Total liabilities | $ | 239,624 | $ | 117,275 | ||||
| Total stockholders equity (deficit) | $ | (74,814 | ) | $ | 72,156 |
Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
| Three Months Ended December 31, | Years Ended December 31, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 15,946 | $ | 13,553 | $ | 71,441 | $ | 72,338 | ||||||||
| General and administrative | 30,695 | 19,487 | 100,999 | 62,742 | ||||||||||||
| Total operating expenses | 46,641 | 33,040 | 172,440 | 135,080 | ||||||||||||
| Loss from operations | (46,641 | ) | (33,040 | ) | (172,440 | ) | (135,080 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 1,286 | 6 | 2,132 | 41 | ||||||||||||
| Interest expense | (9,603 | ) | (2,775 | ) | (27,305 | ) | (6,788 | ) | ||||||||
| Other expense | (89 | ) | (17 | ) | (110 | ) | (2,056 | ) | ||||||||
| Total other expense | (8,406 | ) | (2,786 | ) | (25,283 | ) | (8,803 | ) | ||||||||
| Net loss and comprehensive loss | $ | (55,047 | ) | $ | (35,826 | ) | $ | (197,723 | ) | $ | (143,883 | ) | ||||
| Net loss per share, basic and diluted | $ | (1.33 | ) | $ | (0.95 | ) | $ | (5.05 | ) | $ | (3.89 | ) | ||||
| Weighted-average shares of common stock outstanding, basic and diluted | 41,310,887 | 37,758,061 | 39,118,215 | 37,002,959 |