FLORHAM PARK, N.J., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today reported financial results for the second quarter of 2024, and provided recent business updates.
“Our impressive progress through the second full quarter of launch highlights the strong and growing demand for VOQUEZNA, an innovative treatment now approved across the entire GERD market,” said Terrie Curran, President and CEO of Phathom. “Following our recent FDA approval and the expanded label for VOQUEZNA last month, we immediately began promotional efforts to ensure millions of Non-Erosive GERD sufferers, and their physicians, are informed about this powerful new treatment option. We are very excited by the growth across all key metrics and the positive feedback from those who have experienced the benefits of VOQUEZNA. Additionally, with commercial coverage secured for over 116 million estimated lives, we are in a strong position to expand our patient base and ensure broad access to our first-in-class therapy. We remain dedicated to building VOQUEZNA into a potential blockbuster and are committed to our mission to change the treatment landscape for acid-related disorders."
Recent Business Highlights and Second Quarter 2024 Results:
VOQUEZNA Launch Progress:
Recent Business and Regulatory Highlights:
Second Quarter Financial Results:
Conference Call and Webcast
Phathom will host a conference call and webcast to discuss its second quarter financial results and business highlights today, August 8, 2024, at 8:30 am ET. A live webcast will be available on the investors page of Phathom’s website under Events & Presentations. A replay of the webcast will be available following the completion of the event and will be archived for up to 90 days.
Non-GAAP Financial Measures
This press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP), and also certain non-GAAP financial measures. In particular, Phathom has provided non-GAAP adjusted net loss and adjusted net loss per share, adjusted to exclude the items below. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, Phathom believes the presentation of non-GAAP adjusted net loss and adjusted net loss per share, when viewed in conjunction with GAAP results, provides investors with a more meaningful understanding of ongoing operating performance. These measures exclude (i) non-cash stock-based compensation, which is substantially dependent on changes in the market price of common shares, (ii) interest expense related to the accounting for our revenue interest financing liability, which are in excess of the actual interest owed, and (iii) interest expense related to the amortization of debt discount on our term loan.
Phathom believes the presentation of these non-GAAP financial measures provides useful information to management and investors regarding Phathom's results of operations. When GAAP financial measures are viewed in conjunction with these non-GAAP financial measures, investors are provided with a more meaningful understanding of Phathom's ongoing operating performance and are better able to compare Phathom's performance between periods. In addition, these non-GAAP financial measures are among those indicators Phathom uses as a basis for evaluating performance, and planning and forecasting future periods. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation between these non-GAAP measures and the most directly comparable GAAP measures is provided later in this press release.
About Phathom Pharmaceuticals, Inc.
Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases. Phathom has in-licensed the exclusive rights to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB) that is currently marketed in the United States as VOQUEZNA® (vonoprazan) tablets for the treatment of heartburn associated with Non-Erosive GERD in adults, the healing and maintenance of healing of Erosive GERD in adults and associated heartburn, in addition to VOQUEZNA® TRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules) for the treatment of H. pylori infection in adults. For more information about Phathom, visit the company’s website at www.phathompharma.com and follow on LinkedIn and X.
Forward-Looking Statements
This 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 commencement of the Phase 3 As Needed dosing Non-Erosive GERD and Phase 2 EoE trials, the availability of additional funds under our term loan agreement, future growth in demand and our ability to secure additional commercial coverage for our products, 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, VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK, 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; we may use our capital resources sooner than expected, or our operating plan may overestimate our expected product revenues, which could require us to reduce expenses or raise additional capital sooner than expected; 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 obtain and maintain intellectual property protection and non-patent regulatory exclusivity for vonoprazan; Phathom’s estimates regarding patient population and commercial coverage could prove to be inaccurate; 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 most recent 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 CONTACT
Nick Benedetto
1-877-742-8466
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INVESTOR CONTACT
Eric Sciorilli
1-877-742-8466
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Selected Condensed Balance Sheets (in thousands) (unaudited) | ||||||||
June 30, 2024 | December 31, 2023 | |||||||
Assets | ||||||||
Cash and cash equivalents | $ | 276,237 | $ | 381,393 | ||||
Total assets | $ | 319,376 | $ | 413,842 | ||||
Total liabilities | $ | 553,205 | $ | 486,601 | ||||
Total stockholders’ deficit | $ | (233,829 | ) | $ | (72,759 | ) | ||
Statements of Operations and Comprehensive Loss (in thousands, except share and per share amounts) (unaudited) | ||||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||||||
Product revenue, net | $ | 7,324 | $ | - | $ | 9,236 | $ | - | ||||||||
Cost of revenue | 1,376 | - | 1,802 | - | ||||||||||||
Gross profit | 5,948 | - | 7,434 | - | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 7,376 | 12,764 | 16,806 | 24,242 | ||||||||||||
Selling, general and administrative | 75,872 | 18,937 | 137,882 | 37,536 | ||||||||||||
Total operating expenses | 83,248 | 31,701 | 154,688 | 61,778 | ||||||||||||
Loss from operations | (77,300 | ) | (31,701 | ) | (147,254 | ) | (61,778 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Interest income | 3,624 | 348 | 7,937 | 1,808 | ||||||||||||
Interest expense | (17,764 | ) | (9,615 | ) | (34,932 | ) | (18,832 | ) | ||||||||
Other (expense) income, net | (6 | ) | 3 | (49 | ) | 23 | ||||||||||
Total other expense | (14,146 | ) | (9,264 | ) | (27,044 | ) | (17,001 | ) | ||||||||
Net loss and comprehensive loss | $ | (91,446 | ) | $ | (40,965 | ) | $ | (174,298 | ) | $ | (78,779 | ) | ||||
Net loss per share, basic and diluted | $ | (1.56 | ) | $ | (0.84 | ) | $ | (2.98 | ) | $ | (1.73 | ) | ||||
Weighted-average shares of common stock outstanding, basic and diluted | 58,558,145 | 48,500,516 | 58,464,813 | 45,444,496 | ||||||||||||
Reconciliation of GAAP to Non-GAAP Financial Measures (in thousands, except share and per share amounts) (unaudited) | |||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||||
Reconciliation of GAAP to Non-GAAP adjusted net loss: | |||||||||||||||
GAAP net loss | ($91,446 | ) | ($40,965 | ) | ($174,298 | ) | ($78,779 | ) | |||||||
Stock-based compensation expense (A) | 6,099 | 7,253 | 11,725 | 14,301 | |||||||||||
Non-cash interest on revenue interest financing liability | 11,553 | 5,397 | 23,509 | 10,550 | |||||||||||
Interest expense related to amortization of debt discount | 499 | 523 | 974 | 1,019 | |||||||||||
Non-GAAP adjusted net loss | ($73,295 | ) | ($27,792 | ) | ($138,090 | ) | ($52,909 | ) | |||||||
Reconciliation of GAAP to Non-GAAP adjusted net loss per share — basic and diluted: | |||||||||||||||
GAAP net loss per share — basic and diluted | ($1.56 | ) | ($0.84 | ) | ($2.98 | ) | ($1.73 | ) | |||||||
Stock-based compensation expense (A) | 0.10 | 0.15 | 0.20 | 0.31 | |||||||||||
Non-cash interest on revenue interest financing liability | 0.20 | 0.11 | 0.40 | 0.23 | |||||||||||
Interest expense related to amortization of debt discount | 0.01 | 0.01 | 0.02 | 0.02 | |||||||||||
Non-GAAP net loss per share — basic and diluted | ($1.25 | ) | ($0.57 | ) | ($2.36 | ) | ($1.17 | ) | |||||||
(A) Stock-based compensation consists of the following: | |||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||
Research and development | 1,331 | 1,803 | 2,580 | 3,580 | |||||||
Selling, general and administrative | 4,768 | 5,450 | 9,145 | 10,721 | |||||||
© 2024 Phathom Pharmaceuticals. All rights reserved. VOQUEZNA, VOQUEZNA DUAL PAK, VOQUEZNA TRIPLE PAK, Phathom Pharmaceuticals, and their respective logos are registered trademarks of Phathom Pharmaceuticals, Inc.
Last Trade: | US$18.27 |
Daily Change: | 0.85 4.88 |
Daily Volume: | 1,019,453 |
Market Cap: | US$1.250B |
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