Clarithromycin

RedHill has received its first Talicia sales milestone payment as well as royalties and other payments, totaling $1.1 million, following the first ex-U.S. commercial launch of Talicia in 2024 Talicia is the first FDA-approved rifabutin-based product specifically designed to treat Helicobacter pylori (H. pylori), a bacterial infection with high and rising resistance rates that affects over 50% of the world's adult population[1] and is the strongest risk factor for gastric cancer and peptic ulcer disease Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists[2] for treatment of H. pylori infection and was granted a Qualified Infectious Disease Product (QIDP) designation by the FDA, providing eligibility for a total of eight years of U.S. market exclusivity; Talicia is patent protected through 2042 RALEIGH, N.C., Aug. 18, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has received its first Talicia[3] ex-U.S. sales milestone, royalties and other payments totaling approximately $1.1 million. "The presence of H. pylori infection is the strongest risk factor for gastric cancer and peptic ulcer disease and there is a significant global medical need for a highly effective first-line H. pylori therapy," said Rick Scruggs, President, RedHill Biopharma Inc. & Chief Commercial Officer. "H. pylori is a major public health concern, with over 50% of the world's adult population infected. Talicia offers the best hope for patients and physicians in an era of increased resistance with clarithromycin-based therapies[4],[5]. As we work to bring Talicia to more patients globally, we continue our discussions with potential partners and expect to secure additional non-dilutive ex-US licensing revenue streams. Clarithromycin-based triple therapy continues to wane in effectiveness. A 2021 study demonstrated only 68.5% eradication with traditional clarithromycin-based triple therapy, which declined further to 32% in patients harboring resistant H. pylori organisms[6]. Clarithromycin-based treatment efficacy has also been reported to be negatively impacted by patient obesity or diabetic status, neither of which impacts Talicia's safety or efficacy, according to data from post-approval post-hoc analysis [7],[8]. In contrast, in the pivotal Phase 3 study, Talicia demonstrated up to 90% eradication of H. pylori infection in adherent patients (p<0.0001) with minimal to zero antibiotic resistance to rifabutin, a key component of Talicia, detected[9]. About H. pylori H. pylori is a bacterial infection that affects approximately 35%[10] of the U.S. population, with an estimated 1.6 million patients treated annually[11]. Worldwide, more than 50% of the population has H. pylori infection, which is classified by the WHO as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer[12] and a major risk factor for peptic ulcer disease[13] and gastric mucosa-associated lymphoid tissue (MALT) lymphoma[14]. More than 27,000 Americans are diagnosed with gastric cancer annually[15]. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics – especially clarithromycin – which is still commonly used in standard combination therapies[16]. About Talicia Talicia is the only low-dose rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria seen with other antibiotics. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapies and are a strong public health concern, as highlighted by the ACG and FDA in recent years. Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In the pivotal Phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia, was detected in RedHill's pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent to their therapy had response rates of 90.3% in the Talicia® arm vs. 64.7% in the active comparator arm. Talicia is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2042 with additional patents and applications pending and granted in various territories worldwide. Talicia is approved and commercialized in the United States and the United Arab Emirates. TALICIA: INDICATION AND IMPORTANT SAFETY INFORMATION Talicia is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial­­, indicated for the treatment of Helicobacter pylori infection in adults. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs, Talicia should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. IMPORTANT SAFETY INFORMATION Talicia contains omeprazole, a proton pump inhibitor (PPI), amoxicillin, a penicillin-class antibacterial and rifabutin, a rifamycin antibacterial. It is contraindicated in patients with known hypersensitivity to any of these medications, any other components of the formulation, any other beta-lactams or any other rifamycin. Talicia is contraindicated in patients receiving rilpivirine-containing products. Talicia is contraindicated in patients receiving delavirdine or voriconazole. Serious and occasionally fatal hypersensitivity reactions have been reported with omeprazole, amoxicillin and rifabutin. Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of Talicia. Severe cutaneous adverse reactions (SCAR) (e.g., Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN)) have been reported with rifabutin, amoxicillin, and omeprazole. Additionally, drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with rifabutin. Acute Tubulointerstitial Nephritis has been observed in patients taking PPIs and penicillins. Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range from mild diarrhea to fatal colitis. Talicia may cause fetal harm. Talicia is not recommended for use in pregnancy. Talicia may reduce the efficacy of hormonal contraceptives. An additional non-hormonal method of contraception is recommended when taking Talicia. Talicia should not be used in patients with hepatic impairment or severe renal impairment. Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. These events have occurred as both new onset and exacerbation of existing autoimmune disease. The most common adverse reactions (≥1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis. To report SUSPECTED ADVERSE REACTIONS, contact RedHill Biopharma INC. at 1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or . Full prescribing information for Talicia is available at About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA-approved gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults3. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anti-inflammatory, antiviral, and anticancer activity, targeting multiple indications with U.S. government and academic collaborations for development for radiation and chemical exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 study in prostate cancer in combination with darolutamide; (ii) RHB-204, a next-generation optimized formulation of RHB-104, with a planned Phase 2 study for Crohn's disease (based on RHB-104's positive Phase 3 Crohn's disease study results) and Phase 3-stage for pulmonary nontuberculous mycobacteria (NTM) disease; (iii) RHB-107 ( upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19 and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; and (iv) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a U.S. Phase 3 study for acute gastroenteritis and gastritis and positive results from a U.S. Phase 2 study for IBS-D. RHB-102 is partnered with Hyloris Pharma (EBR: HYL) for worldwide development and commercialization outside North America. More information about the Company is available at / X.com/RedHillBio. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements, including, but not limited to, statements regarding the intended use of net proceeds from the offering, may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include statements regarding the risk that the Company will not comply with the listing requirements of the Nasdaq Capital Market ("Nasdaq") to remain listed for trading on Nasdaq, the addition of new revenue generating products, out-licensing of the Company's development pipeline assets, timing of opaganib's development for Acute Radiation Syndrome, non-dilutive development funding from RHB-107 and its inclusion in a key platform study. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, market and other conditions, the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that acceptance onto the RNCP Product Development Pipeline will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for opaganib for any indication, the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials; the risk that the FDA pre-study requirements will not be met and/or that the Phase 3 study of RHB-107 in COVID-19 outpatients will not be approved to commence or if approved, will not be completed or, should that be the case, that we will not be successful in obtaining alternative non-dilutive development funding for RHB-107, the risk that HB-107's late-stage development for non-hospitalized COVID-19 will not benefit from the resources redirected from the terminated RHB-204 Phase 3 study, that the Phase 2/3 COVID-19 study for RHB-107 may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib and RHB-107 are likely to be required, as well as risks and uncertainties associated with the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 8, 2024. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. Logo: Company contact: Adi Frish Chief Corporate & Business Development Officer RedHill Biopharma [email protected] +972-54-6543-112 Category: Commercial 1. Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429. 2. IQVIA XPO Data on file. 3. Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: . 4. Savoldi, A., et al., Prevalence of Antibiotic Resistance in Helicobacter pylori: A Systematic Review and Meta-analysis in World Health Organization Regions. Gastroenterology, 2018. 155(5): p. 1372-1382 e17. 5. Park, J.Y., et al., Helicobacter pylori Clarithromycin Resistance and Treatment Failure Are Common in the USA. Dig Dis Sci, 2016. 61(8): p. 2373-2380. 6. Chey, W.D., et al., Vonoprazan Triple and Dual Therapy for Helicobacter pylori Infection in the United States and Europe: Randomized Clinical Trial. Gastroenterology, 2022. 163(3): p. 608-619. 7. Diabetes Data on File. 8. Kao, J.Y., Helicobacter pylori eradication by low-dose rifabutin triple therapy (RHB-105) is unaffected by high body mass index. GastroHep, 2021. 3(7): p. 426-434. 9. Graham DY, Canaan Y, Maher J, Wiener G, Hulten KG, Kalfus IN. Rifabutin-based triple therapy (RHB-105) for Helicobacter pylori eradication: a double-blind, randomized, controlled trial. Ann Intern Med. 2020;172(12):795-802. 10. Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429. 11. IQVIA Custom Study for RedHill Biopharma, 2019. 12. Lamb A et al. Role of the Helicobacter pylori–Induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497. 13. NIH – Helicobacter pylori and Cancer, September 2013. 14. Hu Q et al. Gastric mucosa-associated lymphoid tissue lymphoma and Helicobacter pylori infection: a review of current diagnosis and management. Biomarker research 2016;4.1:15. 15. National Cancer Institute, Surveillance, Epidemiology, and End Results Program (SEER). 16. Malfertheiner P. et al. Management of Helicobacter pylori infection - the Maastricht IV/ Florence Consensus Report, Gut 2012;61:646-664; O'Connor A. et al. Treatment of Helicobacter pylori Infection 2015, Helicobacter 20 (S1) 54-61; Venerito M. et al. Meta-analysis of bismuth quadruple therapy versus clarithromycin triple therapy for empiric primary treatment of Helicobacter pylori infection. Digestion 2013;88(1):33-45. SOURCE RedHill Biopharma Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Over 580,000 VOQUEZNA® prescriptions filled to date, reflecting 49% growth since last earnings reportNet revenues of $39.5 million reported for Q2Full-year 2025 revenue guidance of $165 million to $175 millionCompany remains focused on path to profitability in 2026Management to host conference call today, August 7, 2025, at 8:00 a.m. ET FLORHAM PARK, N.J., Aug. 07, 2025 (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 ended June 30, 2025, and provided business updates. “The second quarter marked a significant step forward in Phathom’s journey toward becoming a growth-oriented and profitable GI company,” said Steve Basta, President and Chief Executive Officer of Phathom. “We delivered strong sequential revenue growth, implemented strategic cost reductions, and shifted our commercial strategy to focus on high-value prescribers. With over 580,000 VOQUEZNA prescriptions filled to date and extended market exclusivity, we believe we are well-positioned to accelerate VOQUEZNA’s adoption and achieve profitability in 2026.” Recent Business Highlights and Second Quarter 2025 Results: VOQUEZNA Commercial Progress: Phathom surpassed 580,000 filled prescriptions for VOQUEZNA tablets, VOQUEZNA TRIPLE PAK®, and VOQUEZNA DUAL PAK® through July 25, 2025, reflecting a 49% increase since the last earnings report on May 1, 2025.In the second quarter of 2025, approximately 173,000 VOQUEZNA prescriptions were filled, representing 36% sequential growth from Q1.Prescriber adoption continues to expand with over 29,300 unique healthcare providers (HCPs) having written a filled VOQUEZNA prescription as of July 18, 2025, a 24% increase since the last quarterly update. In early July, Phathom began reprioritizing GIs in its sales strategy, while de-emphasizing primary care physicians (PCPs) who have not yet prescribed VOQUEZNA. This more targeted approach aims to deepen prescriber engagement and move HCPs up the adoption ladder. Currently, GIs account for approximately 70% of all filled VOQUEZNA prescriptions to-date.Commercial access for VOQUEZNA remains robust, with coverage for over 120 million lives. More than half of these commercial lives require only one prior proton pump inhibitor (PPI) step. In Q2 2025, approximately 68% of prescriptions were filled through the retail pharmacy channel, with the remainder filled on a cash-pay basis through BlinkRx. Recent Business and Regulatory Updates: In June 2025, the FDA updated the Orange Book to reflect 10-year New Chemical Entity (NCE) exclusivity for VOQUEZNA 10 mg and 20 mg tablets through May 2032—the earliest date when an Abbreviated New Drug Application (ANDA) may be filed with the FDA if no patents are listed in the Orange Book one year prior. Based on typical regulatory review timelines for ANDA submissions, Phathom believes generic entry is unlikely before 2033.In June, Phathom strengthened its leadership team with the appointment of Anne Marie Cook, J.D., as Chief Legal Officer and Corporate Secretary. Anne Marie has over 30 years of legal leadership experience, including prior roles at Sage Therapeutics, Aegerion, and Biogen. Second Quarter 2025 Financial Results: Revenue: Net revenues for the second quarter 2025 were $39.5 million, an increase of $32.2 million compared to $7.3 million for the second quarter 2024. The increase was due to continued momentum with Phathom’s second year of commercial launch of VOQUEZNA, VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK following the initial launch of VOQUEZNA products late in the fourth quarter of 2023.Research and development (R&D) expenses: R&D expenses for the second quarter 2025 were $9.1 million, an increase of $1.7 million compared to $7.4 million for second quarter 2024. The increase was primarily due to one-time personnel-related restructuring charges, partially offset by a decrease in consulting expenses.Selling, general and administrative (SG&A) expenses: SG&A expenses for the second quarter 2025 were $85.3 million, an increase of $9.4 million compared to $75.9 million for second quarter 2024. The increase was primarily due to higher personnel-related costs associated with one-time restructuring charges and continued commercial investment in support of the VOQUEZNA launch.Operating expenses: Operating expenses for the second quarter 2025 were $94.4 million, compared to $83.2 million for the second quarter 2024 and $103.7 million during the first quarter 2025. The sequential decrease compared to the first quarter 2025 was attributable to cost savings associated with Phathom’s restructuring. Second quarter 2025 operating expense included a non-cash charge related to stock-based compensation of $8.3 million compared to $6.1 million for the second quarter 2024 and $5.5 million for the first quarter 2025. Non-GAAP operating expenses for the second quarter 2025 were $86.1 million, compared to $77.1 million for the second quarter 2024 and $98.1 million during the first quarter 2025. Based on our restructuring efforts, Phathom expects non-GAAP operating expenses to be less than $60 million for the third quarter 2025 and less than $55 million for the fourth quarter 2025.Net loss: Net loss for the second quarter 2025 was $75.8 million, compared to $91.4 million for the second quarter 2024. Non-GAAP adjusted net loss for the second quarter 2025 was $56.5 million compared to $73.3 million for the same period in 2024. These non-GAAP adjusted net loss amounts, as more fully described below under "Non-GAAP Financial Measures," exclude non-cash share-based compensation charges, non-cash interest expense related to the accounting for our revenue interest financing liability, which are in excess of the actual interest owed, and interest expense related to the amortization of debt discount on our term loan. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the tables below.Cash and cash equivalents: As of June 30, 2025, cash and cash equivalents were $149.6 million. Based on its current operating plan and projected product revenues, Phathom believes these resources will be sufficient to fund operations and achieve profitability from operations in 2026, excluding stock-based compensation.2025 full year revenue guidance: Based on strong VOQUEZNA prescription trends to date and a refined commercial strategy, Phathom expects full-year 2025 revenue to be in the range of $165 million to $175 million. Conference Call and WebcastPhathom will host a conference call and webcast to discuss its second quarter 2025 financial results and business highlights today, August 7, 2025, at 8:00 a.m. EDT. 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 call and will be archived for up to 90 days. Non-GAAP Financial MeasuresThis 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 operating expense, 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 operating expense, 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 relief of heartburn associated with Non-Erosive GERD in adults, the healing and maintenance of healing of Erosive GERD in adults and relief of 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 StatementsThis press release contains forward-looking statements, including without limitation statements regarding: our plans, expectations and goals for commercialization of VOQUEZNA and potential results of our commercialization efforts; our expectations regarding operating expenses and revenues; our goals and beliefs with respect to potential profitability; our expectations regarding non-patent regulatory exclusivity and the potential timeline for entry of a generic; our development plans and potential timelines; our business strategy, goals, mission and vision; and our other expectations, forecasts and predictions as to future performance, results and likelihood of success. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including the risk that: we may not be able to successfully commercialize VOQUEZNA or to achieve results or revenues at the levels we expect; the market opportunity for VOQUEZNA may be significantly smaller than our expectations; market acceptance for VOQUEZNA from healthcare professionals, patients, and payors in the indications for which it is approved may be significantly lower than we anticipate; we may encounter coverage, reimbursement, market access, or other issues in the course of our commercialization efforts that may negatively impact our efforts and results; the unmet need for new treatment options in GERD may not be as high as we anticipate; estimates of the number of patients with the disorders for which VOQUEZNA is approved, now or in the future, and our estimates of potential market size may not be accurate; our decisions as to where to allocate our resources and focus our efforts may not lead to the results we expect; we may not seek, achieve or maintain the patent and regulatory exclusivity we expect or that could be available to us and may encounter generic competition sooner than we anticipate; our results may be negatively impacted by the launch of other competitive products; we may experience adverse impact as the result of our dependence on third parties in connection with commercialization, product manufacturing, research and preclinical and clinical testing; we may be negatively impacted by regulatory developments or other governmental actions in the United States and foreign countries, including government healthcare reform; we may encounter unexpected adverse side effects or inadequate efficacy of VOQUEZNA that may limit or impair market acceptance or impair current or future development or regulatory approvals, or may result in recalls, withdrawals or product liability claims; we may not be able to obtain and maintain intellectual property protection important to our business, including patent term extensions; if we were to breach our license agreement with Takeda for vonoprazan, Takeda might take action, including termination, that would significantly impair our business; our operating expenses may be higher than we anticipate, including if we decide to engage in activities not currently in our plan or if we face unexpected, or higher than anticipated, expenses, including as the result of unexpected events such as litigation; depending on our results and activities, we may not achieve profitability on the timelines we expect or at all; in the future, we may not have sufficient cash to fund our operations at the levels we expect or to meet our obligations under certain of our agreements or to enable us to achieve profit from operations; we may need to or decide to raise additional capital; we may not be able to raise capital on acceptable terms; and any of the foregoing or other factors may negatively impact our ability to achieve our plans, goals, mission, vision and potential. For additional discussion of these and other risks, see the risk disclosure in our filings with the Securities and Exchange Commission (SEC), including our 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 we undertake no obligation to revise or update this presentation to reflect events or circumstances 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 © 2025 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. Selected Condensed Balance Sheets(in thousands)(unaudited) June 30,2025 December 31,2024Assets Cash and cash equivalents$149,569 $297,263 Total assets$250,220 $378,318 Total liabilities$656,054 $631,898 Total stockholders' deficit$(405,834) $(253,580) Condensed Statements of Operations and Comprehensive Loss(in thousands, except share and per share amounts)(unaudited) Three Months EndedJune 30, Six Months EndedJune 30, 2025 2024 2025 2024 Product revenue, net$39,503 $7,324 $68,023 $9,236 Cost of revenue 5,038 1,376 8,762 1,802 Gross profit 34,465 5,948 59,261 7,434 Operating expenses: Research and development 9,076 7,376 18,260 16,806 Selling, general and administrative 85,313 75,872 179,787 137,882 Total operating expenses 94,389 83,248 198,047 154,688 Loss from operations (59,924) (77,300) (138,786) (147,254)Other (expense) income: Interest income 1,787 3,624 4,427 7,937 Interest expense (17,518) (17,764) (35,588) (34,932)Other expense, net (155) (6) (179) (49)Total other expense (15,886) (14,146) (31,340) (27,044)Net loss and comprehensive loss$(75,810) $(91,446) $(170,126) $(174,298)Net loss per share, basic and diluted$(1.05) $(1.56) $(2.36) $(2.98)Weighted-average shares of common stock outstanding, basic and diluted 72,466,203 58,558,145 72,219,179 58,464,813 Reconciliation of GAAP to Non-GAAP Financial Measures(in thousands, except share and per share amounts)(unaudited) Three Months EndedJune 30, Six Months EndedJune 30, 2025 2024 2025 2024 Reconciliation of GAAP to Non-GAAP adjusted net loss: GAAP net loss$(75,810) $(91,446) $(170,126) $(174,298)Stock-based compensation expense (A) 8,272 6,099 13,812 11,725 Non-cash interest on revenue interest financing liability 10,306 11,553 21,309 23,509 Interest expense related to amortization of debt discount 734 499 1,430 974 Non-GAAP adjusted net loss$(56,498) $(73,295) $(133,575) $(138,090)Reconciliation of GAAP to Non-GAAP adjusted net loss per share — basic and diluted: GAAP net loss per share — basic and diluted$(1.05) $(1.56) $(2.36) $(2.98)Stock-based compensation expense (A) 0.11 0.10 0.19 0.20 Non-cash interest on revenue interest financing liability 0.14 0.20 0.30 0.40 Interest expense related to amortization of debt discount 0.01 0.01 0.02 0.02 Non-GAAP net loss per share — basic and diluted$(0.79) $(1.25) $(1.85) $(2.36)Weighted-average shares of common stock outstanding, basic and diluted 72,466,203 58,558,145 72,219,179 58,464,813 (A) Stock-based compensation consists of the following: Three Months EndedJune 30, Six Months EndedJune 30, 2025 2024 2025 2024 Research and development 1,650 1,331 2,980 2,580 Selling, general and administrative 6,622 4,768 10,832 9,145