FLORHAM PARK, N.J., May 28, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, announced today that members of its management team are scheduled to participate in the following investor conferences in June: Jefferies Global Healthcare Conference in New York, NY Date: Wednesday, June 5, 2024 Live Webcast: 12:30 p.m. ET Management to participate in one-on-one meetings ...

Financial Data and Key Metrics Changes - For Q1 2024, the company reported net revenues of $1.9 million, representing a 180% sequential quarterly increase, attributed to growing demand in filled prescriptions and inventory restocking by wholesalers [2] - Gross profit for the quarter was $1.5 million, equating to a gross margin of 78%, with a sequential quarterly increase of about 220 basis points [3] - Non-GAAP adjusted net loss was $64.8 million, or $1.11 loss per share, compared to a loss of $46 million, or $0.80 loss per share in Q4 2023 [7] - Cash and cash equivalents were $322 million, with an additional $150 million available via a debt facility [7][8] Business Line Data and Key Metrics Changes - Non-GAAP R&D spend was $8.2 million, a 16% reduction compared to Q1 2023, primarily due to lower clinical trial costs [4] - Non-GAAP SG&A expenses were $57.6 million, an increase of over 330% compared to the same period in 2023, driven by the build-out of commercial infrastructure and marketing activities [5] Market Data and Key Metrics Changes - The company reported over 43,000 prescriptions written and over 17,500 prescriptions filled for VOQUEZNA, with filled prescriptions increasing by 361% [77] - Approximately 72 million commercially insured lives now have access to VOQUEZNA following its addition to major formularies [66][83] Company Strategy and Development Direction - The company aims to establish widespread commercial coverage throughout 2024 and is focused on the potential approval and label expansion of VOQUEZNA for nonerosive GERD, which represents a significant market opportunity [12][68] - The strategy includes a direct-to-consumer campaign to increase brand awareness and drive demand [65][84] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the financial position, expecting a cash runway through the end of 2026 based on current operating plans and anticipated product revenues [8] - The company is optimistic about the potential for VOQUEZNA to displace PPIs in a large market, with a focus on executing its launch strategy effectively [13][73] Other Important Information - The company is planning to initiate a Phase III trial for as-needed dosing in nonerosive GERD and a Phase II trial for eosinophilic esophagitis later this year [70][71] - The anticipated approval for nonerosive GERD is set for July 19, 2024, which could serve as a significant catalyst for growth [69] Q&A Session Summary Question: Update on fill rate for BlinkRx - Management confirmed that the fill rate has improved to nearly 41%, up from approximately 27% previously reported, indicating increased access and utilization [16][18] Question: Expectations for gross to net improvement - Management noted that while the first quarter saw better-than-expected gross to net due to a temporary issue, they are not providing specific projections for the rest of the year as negotiations with payers are ongoing [21][22] Question: Clarification on prescription split between Blink and IQVIA - Management confirmed that approximately 60% of scripts are now going through retail channels, indicating a shift from cash support to covered scripts as access improves [30][31] Question: Insights on refill rates and patient retention - Management indicated that over 50% of prescribers have written multiple prescriptions, suggesting positive patient experiences and retention [80] Question: Future dynamics of BlinkRx and payer coverage - Management stated that while there may always be some level of coverage through Blink, they expect overall coverage to grow as negotiations with payers progress [45][46]

Sales and Market Performance - Vonoprazan generated approximately $850 million in net sales in its seventh full year on the market since its approval in Japan in late 2014[132]. - As of April 26, 2024, over 43,000 prescriptions for VOQUEZNA tablets, VOQUEZNA Triple Pak, and VOQUEZNA Dual Pak have been written, with over 17,500 prescriptions filled[136]. - Approximately 72 million, or an estimated 48 percent, of U.S. commercial lives now have access to VOQUEZNA tablets[136]. - Product revenue for the three months ended March 31, 2024, was $1.9 million, attributed to the sales of VOQUEZNA launched in Q4 2023[155]. Financial Performance - The net loss for the three months ended March 31, 2024, was $82.9 million, compared to $37.8 million for the same period in 2023[139]. - As of March 31, 2024, the accumulated deficit was $1.0 billion[139]. - The company has incurred significant operating losses since inception and expects to continue doing so for the foreseeable future[139]. - The company anticipates continued net losses and negative cash flows from operations for the foreseeable future[161]. - Net cash used in operating activities was approximately $69.0 million for the three months ended March 31, 2024, compared to $39.7 million for the same period in 2023[189]. - The company incurred approximately $61.9 million in research and development and administrative expenses for the three months ended March 31, 2024[189]. Research and Development - The company plans to initiate a Phase 3 trial for a novel dosing regimen of vonoprazan as an "as-needed" treatment for episodic heartburn relief in 2024[135]. - Research and development expenses decreased to $9.4 million from $11.5 million year-over-year, a reduction of $2.1 million[157]. Cash and Financing - The company has cash and cash equivalents of $322.2 million as of March 31, 2024, and believes this is sufficient to fund operations through the end of 2026[138]. - The company expects to fund operations for at least the next twelve months and through the end of 2026 with existing cash, cash equivalents, and remaining $150 million under the Loan Agreement[184]. - The Loan Agreement with Hercules allows for term loans up to $300 million, with various tranches available based on milestones[166]. - The cash interest rate under the Fourth Loan Amendment is capped at 10.35%, with a variable rate starting at 9.85%[167]. - The company generated net proceeds of approximately $14.1 million from the sale of 1,514,219 shares under the 2020 ATM Offering for the year ended December 31, 2023[182]. - The company completed an underwritten public offering, selling 12,793,750 shares at a price of $11.75 per share, generating net proceeds of $141.8 million[183]. Expenses and Liabilities - Cost of revenue for the same period was $0.4 million, with prior manufacturing costs related to VOQUEZNA already expensed[156]. - Selling, general and administrative expenses increased significantly to $62.0 million from $18.6 million, an increase of $43.4 million[159]. - Interest income rose to $4.3 million for the three months ended March 31, 2024, compared to $1.5 million in the same period of 2023[160]. - Interest expense increased to $17.2 million for the three months ended March 31, 2024, from $9.2 million in the prior year[160]. - The company is obligated to pay a 10% royalty on net sales of products containing vonoprazan to the Initial Investors until aggregate payments equal 200% of the Investment Amount[178]. - The company recorded a $1.3 million fair value of the warrant and $9.7 million in final interest payment fees as debt discount, amortized over the term of the Term Loan[176]. Regulatory and Market Considerations - The FDA has assigned a PDUFA target action date of July 19, 2024, for the NDA seeking approval of vonoprazan for Non-Erosive GERD[135]. - The company plans to evaluate commercial partnerships for vonoprazan in Europe and Canada and expand development into other indications and formulations[137]. - The company remains an emerging growth company until it meets certain criteria, including total annual gross revenue of at least $1.235 billion[196]. - The market value of the company's common stock held by non-affiliates must exceed $700 million to be deemed a "large accelerated filer"[196]. - There are no off-balance sheet arrangements currently in place as defined under SEC rules[198]. - As of March 31, 2024, there have been no material changes in market risk, including interest rate risk, foreign currency exchange risk, and inflation risk[199].

Phathom Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Business Update Exhibit 99.1 "Phathom is quickly establishing VOQUEZNA as the first and only FDA-approved treatment of its kind for Erosive GERD and we are thrilled with the promising strides made in our first full quarter post-launch," said Terrie Curran, President and CEO of Phathom. "We're pleased that prescribers are embracing VOQUEZNA as a powerful new treatment option and that demand is rapidly growing. The positive feed ...

Financial Performance - The company incurred a net loss of $201.6 million for the year ended December 31, 2023, compared to a net loss of $197.7 million for 2022, with an accumulated deficit of $928.7 million as of December 31, 2023[311]. - The company expects to continue incurring significant operating losses for the foreseeable future, with uncertainty regarding achieving profitability[311][312]. - The company anticipates that existing cash and cash equivalents, along with a remaining $160 million drawdown under its loan agreement, will fund operations for at least the next 12 months and through the end of 2026[316]. Product Development and Commercialization - The company relies entirely on the success of its recently launched products: VOQUEZNA, VOQUEZNA TRIPLE PAK, and VOQUEZNA DUAL PAK, which were introduced in Q4 2023[308]. - The successful commercialization of its products will depend on obtaining adequate reimbursement and favorable pricing policies from governmental authorities and health insurers[310]. - The commercialization of VOQUEZNA, VOQUEZNA TRIPLE PAK, and VOQUEZNA DUAL PAK is dependent on the company's marketing, sales, and distribution capabilities, which were only developed in late 2023 due to prior delays[322]. - The company has limited experience in commercializing products, which may hinder its ability to successfully market its product candidates[308]. - The company faces uncertainty regarding third-party payer coverage and reimbursement, which is essential for patient access to products like VOQUEZNA[335]. Regulatory and Compliance Risks - The company faces risks related to regulatory approvals and the potential for delays in clinical trials, which could impact its product pipeline[310][318]. - The FDA and other regulatory authorities may impose ongoing requirements for post-approval studies and surveillance, leading to significant additional expenses for the company[323]. - The company must comply with the Medicaid Drug Rebate Program, which imposes extensive reporting obligations and penalties for non-compliance[342]. - The ongoing review of EU pharmaceutical legislation may significantly impact the company's business and regulatory environment in the long term[327]. - The company must comply with various regulatory requirements for drug approval in foreign markets, which may pose additional risks[361]. Financial Obligations and Funding - The company is required to make milestone and royalty payments to Takeda, which could impact its financial position and operational capabilities[314]. - The company has entered into a Loan Agreement with Hercules, borrowing $100 million initially and an additional $40 million in December 2023, with a total borrowing capacity of up to $260 million[434]. - Under the Revenue Interest Financing Agreement, the company can receive up to $300 million in funding, with $175 million received following FDA approval of vonoprazan for Erosive GERD treatment[438]. - Investors under the Revenue Interest Financing Agreement are entitled to a 10% royalty on net sales of products containing vonoprazan, with a step-down on exceeding certain annual thresholds[439]. Market Competition - The company faces significant competition from larger pharmaceutical firms and research institutions, which may adversely affect its ability to develop and commercialize products[349]. - The company expects VOQUEZNA to compete primarily with generic PPIs in both prescription and OTC markets, as well as with Talicia for H. pylori infection treatment[350]. - The company is aware of multiple competitors developing similar products, including Daewoong and Cinclus, which may launch products in the near future[351]. Clinical Trials and Development Challenges - The company faces risks related to delays in clinical trials, regulatory approvals, and potential adverse events that could impact the commercialization of vonoprazan[366]. - The timeline for recruiting patients and conducting trials may be significantly delayed if a sufficient number of patients cannot be enrolled[384]. - The company must conduct extensive clinical trials to demonstrate the safety and efficacy of vonoprazan for new indications before obtaining marketing approvals[375]. - Delays in clinical trials could increase costs and hinder the ability to generate revenue from vonoprazan and future product candidates[380]. Intellectual Property and Licensing - The company relies on the Takeda License for exclusive rights to develop and commercialize vonoprazan in the United States, Europe, and Canada, with potential termination risks impacting business prospects[411]. - The company has in-licensed patents related to vonoprazan from Takeda, but currently does not own any issued patents or pending patent applications[479]. - There is uncertainty regarding the ability to enforce pending patent applications, which may not result in issued patents providing sufficient protection[480]. - The patent position of biopharmaceutical companies is highly uncertain, affecting the commercial value of patent rights[492]. Legal and Regulatory Compliance - The company is subject to the U.S. federal Anti-Kickback Statute and other laws that impose strict penalties for non-compliance, which could include exclusion from government healthcare programs[446]. - The company may face civil and criminal penalties for noncompliance with healthcare and data privacy laws, impacting operations and profitability[475]. - The company is subject to the EU GDPR, which imposes fines of up to €20 million or 4% of annual global revenues for noncompliance[469]. Operational Risks - The company faces risks related to epidemic diseases, such as COVID-19, which could disrupt business activities and supply chains, impacting clinical trials and commercialization efforts[432]. - The company anticipates challenges in managing growth due to limited experience in handling significant operational expansion[444]. - The company must maintain certain financial covenants under its Loan Agreement, which could limit operational flexibility and expose it to default risks[436].

Financial Data and Key Metrics Changes - For Q4 2023, the company reported net revenues of $682,000, reflecting initial stocking of wholesalers in December, with VOQUEZNA becoming commercially available on November 28 [11][24] - Gross profit for Q4 2023 was $515,000, resulting in a gross margin of approximately 76% [11] - GAAP net loss for Q4 2023 was $79.6 million, or $1.39 loss per share, compared to a loss of $55 million, or $1.33 loss per share in Q4 2022 [12] - Non-GAAP adjusted net loss for Q4 2023 was $46 million, or $0.80 loss per share, compared to $42.2 million, or $1.02 loss per share in the same period of 2022 [12] - As of December 31, 2023, cash and cash equivalents were $381 million, including $175 million received from a revenue interest financing agreement [12][41] Business Line Data and Key Metrics Changes - The company reported over 3,800 filled prescriptions for VOQUEZNA as of February 23, 2024, with an estimated total of 14,000 prescriptions written since launch [8][18] - The sales force's efforts have resulted in over 1,200 unique prescribers writing VOQUEZNA scripts, with repeat prescribing observed [8][10] Market Data and Key Metrics Changes - VOQUEZNA's total commercial coverage now reflects an estimated 60 million commercially covered lives, following its addition to Express Scripts' national formularies [22][51] - The company anticipates that the gap between total demand and filled scripts will narrow significantly as payer access improves [6][9] Company Strategy and Development Direction - The company aims to become the number one prescribed acid suppressant in the U.S. and is focused on expanding market access and driving demand for VOQUEZNA [7][34] - The FDA has accepted the NDA for non-erosive GERD daily dosing, with a target action date of July 19, 2024, which could significantly broaden VOQUEZNA's addressable population [6][34] - A new branded consumer campaign targeting Erosive GERD patients is set to launch, including TV commercials on popular streaming services [23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong demand for VOQUEZNA, citing positive feedback from physicians and patients [5][34] - The company believes that the successful launch and ongoing negotiations with payers will lead to increased filled prescriptions throughout 2024 [55][56] - Management highlighted the potential for VOQUEZNA to achieve annual peak revenues exceeding $3 billion, supported by a significant addressable market and unmet patient needs [34] Other Important Information - The company reported non-GAAP R&D expenses of $6.1 million for Q4 2023, down from $14.3 million in Q4 2022, while SG&A expenses increased to $39.7 million from $25.7 million in the same period [40][58] - The company has access to a total of $160 million via its debt facility, providing a solid financial position to support its launch and development strategies [41] Q&A Session Summary Question: What is the company's comfort level with the consensus revenue estimates? - Management indicated that they expect normalized gross-to-net (GTN) dynamics to be between 50% and 65% [15][16] Question: Can you discuss the reasons for prescriptions not being filled? - Management noted that early on, some prescriptions were sent to long-established retail pharmacies, leading to a portion of VOQUEZNA prescriptions not being filled [54] Question: How does the company view the uptake of VOQUEZNA across different regions? - Management reported that they are seeing similar upticks in demand across the U.S., with positive feedback from physicians [69] Question: What is the expected trend for the split between BlinkRx and retail prescriptions? - Management expects the utilization of BlinkRx to grow over time, with a shift towards retail as more payer access is secured [88][91] Question: How is the company planning to approach the Eosinophilic Esophagitis Phase II trial? - The company intends to target a first-line treatment population, focusing on broader segments in the Phase II study [92]

Exhibit 99.1 Phathom Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update FLORHAM PARK, N.J., March 7, 2024 — 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, 2023, and provided recent business highlights. "Last year was transformative for Phathom, with ke ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 001-39094 PHATHOM PHARMACEUTICALS, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorpora ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (State or other jurisdiction of incorporation or organization) Delaware 82-4151574 (I.R.S. Employer Identification No.) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 001-39094 PHATHOM PHA ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 001-39094 PHATHOM PHARMACEUTICALS, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation ...