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Phathom Pharmaceuticals(PHAT) - 2025 Q1 - Quarterly Report

Sales Performance - Vonoprazan generated peak net sales of approximately $850 million and continues to achieve volume growth during its tenth full year on the market since its approval in 2014 [106]. - Product revenue for the three months ended March 31, 2025, was $28.5 million, a significant increase from $1.9 million in the same period of 2024, representing a growth of 1,400% [128]. - Gross profit for the three months ended March 31, 2025, was $24.8 million, compared to $1.5 million in 2024, indicating an increase of 1,570% [128]. - The company has secured broad commercial coverage for VOQUEZNA, with over 120 million, or over 80%, of total U.S. commercial lives having access to VOQUEZNA tablets [109]. Financial Position - The company had cash and cash equivalents of $212.3 million as of March 31, 2025, which is expected to fund operations for at least the next twelve months [112]. - As of March 31, 2025, the company reported a net cash used in operating activities of approximately $84.9 million, an increase from $69.0 million in the same period of 2024 [161]. - The company reported a net decrease in cash of $84.9 million for the three months ended March 31, 2025, compared to a decrease of $59.2 million in the same period of 2024 [160]. - The company has sufficient cash and cash equivalents to fund operations for at least the next twelve months, but future capital requirements will depend on various factors including product revenues and clinical trial costs [156][159]. Expenses and Losses - Net losses for the three months ended March 31, 2025, were $94.3 million, compared to $82.9 million for the same period in 2024, with an accumulated deficit of $1.4 billion [113]. - Selling, general and administrative expenses rose to $94.5 million in Q1 2025 from $62.0 million in Q1 2024, an increase of $32.5 million or 52.6% [131]. - Interest expense for the three months ended March 31, 2025, was $18.1 million, up from $17.2 million in the same period of 2024, reflecting an increase of $0.9 million or 5.2% [132]. - Net loss for the three months ended March 31, 2025, was $94.3 million, compared to a net loss of $82.9 million in 2024, an increase in loss of $11.5 million or 13.9% [128]. Research and Development - Research and development expenses for the three months ended March 31, 2025, totaled $9.184 million, a decrease from $9.430 million in the same period in 2024 [121]. - The company plans to reduce investment in direct-to-consumer promotion and suspend several clinical and product development programs [108]. - The net cash used in operating activities for Q1 2025 included approximately $76.0 million spent on research and development and administrative activities [161]. Financing and Agreements - The Loan Agreement with Hercules allows for term loans up to $300 million, with various tranches available based on milestones [138]. - The cash interest rate under the Loan Agreement was reduced to a variable rate of 9.85%, with a cap at 10.35% [138]. - The company entered into a Revenue Interest Financing Agreement, receiving $100 million initially and an additional $160 million upon FDA approval of vonoprazan for Erosive GERD in Q4 2023 [149]. - The Initial Investors are entitled to a 10% royalty on net sales of products containing vonoprazan, with a cap payment option available after April 30, 2024 [150]. - The company has a shelf registration statement allowing for the sale of up to $150 million of common stock, with no shares sold as of March 31, 2025 [154]. - The company anticipates financing future cash needs through equity offerings, the Revenue Interest Financing Agreement, and potential collaborations [157]. Workforce and Costs - The company expects to incur one-time costs of approximately $7 million to $10 million in connection with a workforce reduction of 28 employees, or approximately 6% [108]. - The company does not expect to meet the revenue threshold to draw the Fifth or Sixth Tranche based on current projections [144]. - The minimum cash covenant requires the company to maintain a minimum cash balance of 20% of the outstanding principal balance at all times [148]. Regulatory Approvals - The FDA approved VOQUEZNA 10 mg tablets for the relief of heartburn associated with Non-Erosive GERD on July 17, 2024 [107].