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Phathom Pharmaceuticals(PHAT) - 2024 Q1 - Quarterly Report
2024-05-09 20:06
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(PHAT) - 2024 Q1 - Quarterly Results
2024-05-09 12:05
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 ...
Phathom Pharmaceuticals(PHAT) - 2023 Q4 - Annual Report
2024-03-07 21:01
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].
Phathom Pharmaceuticals(PHAT) - 2023 Q4 - Earnings Call Transcript
2024-03-07 19:11
Phathom Pharmaceuticals, Inc. (NASDAQ:PHAT) Q4 2023 Earnings Conference Call March 7, 2024 8:30 AM ET Company Participants Eric Sciorilli - Head of Investor Relations Terrie Curran - President & Chief Executive Officer Martin Gilligan - Chief Commercial Officer Molly Henderson - Chief Financial Officer Azmi Nabulsi - Chief Operating Officer Conference Call Participants Yatin Suneja - Guggenheim Joseph Stringer - Needham & Company Paul Choi - Goldman Sachs Umer Raffat - Evercore Matthew Caufield - H.C. Wainw ...
Phathom Pharmaceuticals(PHAT) - 2023 Q4 - Annual Results
2024-03-07 13:06
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 ...
Phathom Pharmaceuticals(PHAT) - 2023 Q3 - Quarterly Report
2023-11-09 13:05
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 ...
Phathom Pharmaceuticals(PHAT) - 2023 Q2 - Quarterly Report
2023-08-10 12:06
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 ...
Phathom Pharmaceuticals(PHAT) - 2023 Q1 - Quarterly Report
2023-05-10 12:19
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 ...
Phathom Pharmaceuticals(PHAT) - 2022 Q4 - Annual Report
2023-02-28 13:06
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | | | Commission file number: 001-39094 PHATHOM PHARMACEUTICALS, INC. (Exact name of Registrant as specified in its charter) Delaware 82-4151574 (State or Other Jurisdiction of Incorporation or ...
Phathom Pharmaceuticals(PHAT) - 2022 Q3 - Quarterly Report
2022-11-08 20:31
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, 2022 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) Delaware 82-4151574 (State or other juris ...