Phathom Pharmaceuticals(PHAT)
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Phathom Pharmaceuticals(PHAT) - 2024 Q4 - Earnings Call Transcript
2025-03-06 14:32
Financial Data and Key Metrics Changes - For Q4 2024, the company reported net revenues of $29.7 million, representing an 81% sequential increase quarter-over-quarter [40] - For the full year 2024, net revenues totaled $55.3 million, with strong revenue growth observed in each quarter [40] - Gross profit for Q4 2024 was $25.8 million, equating to a gross margin of 87%, an increase of 155 basis points over Q3 [41] - The company reported a GAAP net loss of $74.5 million for Q4 2024, compared to a loss of $79.6 million in Q4 2023 [46] Business Line Data and Key Metrics Changes - The company has filled over 300,000 prescriptions for its product, with approximately 118,000 filled in Q4 2024, reflecting over 70% growth compared to Q3 [24] - The refill rate among patients continuing therapy was about 70%, indicating strong patient retention [26] - The number of physicians writing prescriptions increased to over 20,000, with 75% of these writers prescribing more than once [28] Market Data and Key Metrics Changes - The company secured commercial coverage for over 120 million lives, with access typically requiring only one generic prescription step [32] - The awareness of the product among primary care physicians has nearly doubled since the product launch [30] - The company anticipates a soft Q1 due to typical seasonal trends but expects growth to resume thereafter [58] Company Strategy and Development Direction - The company plans to enhance brand awareness through a new consumer campaign and increase focus on primary care physicians [11][38] - The company is exploring new indications for its product, including a Phase II trial for eosinophilic esophagitis [12][44] - The company aims to position its product as a first-line therapy alternative to PPIs, leveraging its unique profile [14][35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the product's potential to reach blockbuster status and emphasized the importance of commercial execution [9][51] - The company is optimistic about the ongoing launch and development goals, with a focus on driving growth in 2025 [10][21] - Management acknowledged the challenges of the current operating environment but remains committed to leveraging their strong foundation for future success [48] Other Important Information - The company submitted a citizen petition to the FDA for a ten-year exclusivity period for its products, with a response expected by June 2025 [20][56] - The company has a strong patent position, with expectations for extensions under the Hatch-Waxman Act [20] Q&A Session Summary Question: Can you clarify the timeline for the citizen petition and what happens if the decision is unfavorable? - Management confirmed the FDA is required to respond within 180 days and expressed confidence in their legal position if the outcome is not favorable [55][56] Question: What are the expectations for Q1 growth relative to Q4? - Management indicated that Q1 is expected to be softer than Q4 due to industry dynamics but anticipates growth to resume after the initial months [58] Question: When will there be enough data for the Phase III on-demand trial decision? - Management expects to have enough information by mid-year to make a decision regarding the trial [62] Question: Is the DTC campaign driving the increase in prescribing physicians? - Management confirmed that the DTC campaign is effectively motivating patients to request prescriptions, contributing to the increase in prescribers [66] Question: What are the refill trends and usage metrics for the product? - Management reported that refill rates are consistent with expectations and are tracking similarly to PPIs, indicating strong patient adherence [73] Question: How important is the BlinkRx program now that coverage has improved? - Management emphasized that BlinkRx remains important for supporting patients and increasing refill rates [82]
Phathom Pharmaceuticals(PHAT) - 2024 Q4 - Annual Results
2025-03-06 13:05
Financial Performance - VOQUEZNA generated $55.3 million in net revenues for 2024, with $29.7 million in Q4, representing an 81% increase from Q3[4] - Product revenue for Q4 2024 reached $29.664 million, a significant increase from $682 thousand in Q4 2023[22] - Gross profit for the year ended December 31, 2024, was $47.279 million, compared to $515 thousand in 2023[22] - Non-GAAP adjusted net loss for the full year 2024 was $262.3 million, compared to $129.7 million for 2023[9] - The net loss for Q4 2024 was $74.451 million, compared to a net loss of $79.569 million in Q4 2023[22] - The company reported a total stockholders' deficit of $253.580 million as of December 31, 2024, compared to $72.759 million in 2023[20] - Non-GAAP adjusted net loss for the year ended December 31, 2024, was $262.316 million, compared to $129.713 million in 2023[24] Expenses - SG&A expenses for Q4 2024 were $76.7 million, an increase of $19.7 million compared to Q4 2023[9] - R&D expenses for Q4 2024 were $8.6 million, a decrease of $4.8 million compared to Q4 2023[9] - Total operating expenses for the year ended December 31, 2024, were $324.746 million, up from $167.827 million in 2023[22] - Research and development expenses for the year ended December 31, 2024, were $34.082 million, down from $49.899 million in 2023[22] - Selling, general and administrative expenses for the year ended December 31, 2024, were $290.664 million, significantly higher than $117.928 million in 2023[22] Market Engagement - Over 300,000 filled prescriptions for VOQUEZNA products, a 110% increase since the last earnings report[5] - The number of VOQUEZNA prescribers grew to over 20,000, an increase of over 47% since the last quarterly earnings report[7] - The direct-to-consumer campaign "VOQUEZNA Can Kick Some Acid" has reached millions of GERD sufferers, driving strong patient engagement[7] Research and Development - Phase 2 EoE trial for VOQUEZNA is nearing initiation, with first patient enrollment planned for Q2 2025[4] Cash Position - Cash and cash equivalents as of December 31, 2024, were $297.3 million, with an additional $100 million available under the term loan[15] Risks - The company faces risks related to the commercialization of its products, including potential delays in regulatory approvals and competition[16]
Phathom Pharmaceuticals(PHAT) - 2024 Q4 - Annual Report
2025-03-06 13:05
Financial Performance - The company incurred a net loss of $334.3 million and $201.6 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $1.3 billion as of December 31, 2024[289]. - The company expects to continue incurring significant operating losses for the foreseeable future, with no assurance of achieving profitability[289]. - The company anticipates that existing cash and cash equivalents, along with a $100 million drawdown under its Loan Agreement, will fund operations for at least the next 12 months[295]. - The company must generate sufficient cash flow from operations to service its current and future indebtedness, which may be impacted by its ability to execute its business strategy[409]. Product Development and Commercialization - The company launched VOQUEZNA, VOQUEZNA TRIPLE PAK, and VOQUEZNA DUAL PAK in the fourth quarter of 2023, which are critical for its future revenue generation[286]. - The company relies on the success of its new products and may require additional financing to support commercialization efforts, which could limit operational capabilities if not secured[294]. - The company has limited experience in commercializing products and may face challenges in successfully marketing VOQUEZNA and its future candidates[286]. - The commercialization success of VOQUEZNA and its future products will depend on effective marketing, sales, and distribution capabilities, which require significant investment and time[305]. - The company faces significant competition from larger pharmaceutical firms and research institutions, which may hinder its ability to develop and commercialize products[326]. - The company is aware of multiple PCABs in development that may compete with vonoprazan, including fexuprazan and tegoprazan, with various stages of approval in different regions[329][330]. - The company is focusing on specific indications for vonoprazan due to limited resources, which may result in missed opportunities for more profitable product candidates[374]. Regulatory and Compliance Risks - The company is subject to various regulatory and compliance obligations that could delay or prevent the commercialization of its products[286]. - The FDA and other regulatory authorities may impose significant restrictions on the indicated uses or marketing of VOQUEZNA and future products, leading to additional expenses[306]. - The company faces uncertainty regarding third-party payer coverage and reimbursement for newly approved products, which is crucial for patient affordability[312]. - The company must comply with the Medicaid Drug Rebate Program, which imposes extensive drug price reporting and payment obligations, with penalties for non-compliance[319]. - The company is subject to various healthcare laws and regulations, and failure to comply could adversely affect its financial condition and operations[419]. - The lengthy and unpredictable approval process for drugs means that only a small percentage of candidates successfully complete the regulatory approval process, posing a risk to the company's financial condition[372]. Clinical Trials and Development Challenges - Clinical drug development is lengthy and expensive, with uncertain outcomes, and may take many years to complete[344]. - The Phase 3 clinical trial for H. pylori infection faced challenges due to the inability to double-blind the dual therapy arm, which may affect regulatory interpretations[345]. - The company may face difficulties in enrolling patients for clinical trials, which could delay or adversely affect clinical development activities[358]. - Any delays in clinical trials could increase costs and jeopardize the ability to generate product revenues[356]. - The company may need to conduct additional costly clinical trials as a condition for regulatory approval, which could delay commercialization[373]. Intellectual Property and Patent Risks - The company currently owns a pending patent application but does not own any issued patents at this time[454]. - There is uncertainty regarding the protection of intellectual property rights, which could adversely affect the company's competitive position[456]. - The company may face challenges in patent validity and enforceability, which could allow competitors to commercialize similar products[469]. - The potential loss of patent rights or exclusivity could materially and adversely impact the company's business and competitive position[471]. - The company faces risks related to potential patent infringement claims from third parties, which could delay or prevent commercialization efforts[482]. Financial and Operational Dependencies - Three major customers accounted for approximately 69% of product sales for the year ended December 31, 2024, with individual contributions ranging from 22% to 25%[400]. - As of December 31, 2024, three customers represented 81% of accounts receivable, with individual contributions between 25% and 31%, exposing the company to significant credit risk[400]. - The company is dependent on third parties for clinical trials and manufacturing, which increases the risk of delays and regulatory compliance issues[389][393]. - The company has no plans to build its own manufacturing facilities and relies on third-party manufacturers, increasing the risk of supply chain disruptions[393]. Competition and Market Dynamics - VOQUEZNA will compete with generic PPIs and other therapies for H. pylori infection and erosive esophagitis, including Talicia launched in March 2020[328]. - The company faces significant competition in establishing collaborations for product development and commercialization, which may impact the success of future product candidates[401]. - Future growth may depend on successful entry into foreign markets, subject to additional regulatory burdens and risks[337]. Financial Agreements and Funding - The company has entered into a Loan Agreement with Hercules, borrowing a total of $100 million initially, with additional borrowings of $40 million in December 2023, $10 million in March 2024, $25 million in June 2024, and $25 million in December 2024, potentially eligible for an additional $100 million[408]. - Under the Revenue Interest Financing Agreement, the company can receive up to $300 million in funding, with $100 million received at the initial closing and an additional $175 million following FDA approval of vonoprazan in November 2023[412][413]. - 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 net sales exceeding certain thresholds[414]. Cybersecurity and Data Protection - Cybersecurity risks are increasing due to reliance on internet technology and remote work, potentially disrupting product development programs[448]. - The company may incur significant costs related to cybersecurity breaches, including legal expenses and remediation costs[449]. - The company faces challenges in maintaining compliance with evolving data protection laws, which could impact operations and financial results[442].
Phathom Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
Newsfilter· 2025-03-06 13:00
Core Insights - Phathom Pharmaceuticals reported strong financial results for 2024, with net revenues of $55.3 million, primarily driven by the successful launch of VOQUEZNA [4][8] - The company is experiencing significant commercial momentum, with over 300,000 filled prescriptions for VOQUEZNA, reflecting a 110% increase since the last earnings report [5][4] - Phathom plans to expand its direct-to-consumer marketing efforts to further increase brand awareness and consumer demand for VOQUEZNA [6][5] Business Updates - VOQUEZNA generated $55.3 million in net revenues for 2024, with $29.7 million in Q4 alone, marking an 81% increase from Q3 [4][8] - The number of prescribers for VOQUEZNA has grown to over 20,000, a 47% increase since the last quarterly earnings report [5][4] - A Phase 2 trial for VOQUEZNA as a treatment for eosinophilic esophagitis (EoE) is set to begin in Q2 2025 [9][4] Financial Performance - Q4 2024 net revenues were $29.7 million, a significant increase from $0.7 million in Q4 2023 [8][10] - R&D expenses decreased to $8.6 million in Q4 2024 from $13.4 million in Q4 2023, while SG&A expenses increased to $76.7 million from $57.0 million [10][8] - The net loss for Q4 2024 was $74.5 million, compared to $79.6 million in Q4 2023, with a full-year net loss of $334.3 million [10][8] Market Strategy - The "VOQUEZNA Can Kick Some Acid" direct-to-consumer campaign has been launched to enhance patient engagement and drive prescription requests [6][5] - The campaign is being promoted across various platforms, including streaming services and social media, reaching millions of potential GERD sufferers [5][6] - Phathom aims to further invest in DTC efforts with a new campaign set to launch by the end of March 2025 [6][5] Regulatory and Development Updates - Phathom submitted a Citizen Petition to the FDA to correct the Orange Book listings for VOQUEZNA, seeking a full 10-year NCE exclusivity period through May 3, 2032 [9][4] - The company is also working on developing an orally disintegrating tablet (ODT) formulation for VOQUEZNA, which could extend its intellectual property protection [9][4] - Data from multiple studies presented in 2024 highlighted VOQUEZNA's effectiveness in providing rapid symptom relief for GERD patients [9][4]
Phathom Pharmaceuticals to Report Fourth Quarter and Full Year 2024 Financial Results and Provide Business Update on Thursday, March 6, 2025
Newsfilter· 2025-02-24 13:00
Core Viewpoint - Phathom Pharmaceuticals, Inc. will host a conference call on March 6, 2025, to discuss its fourth quarter and full year 2024 financial results and provide a business update [1]. Company Overview - Phathom Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases [3]. - The company has in-licensed exclusive rights to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB) [3]. - Vonoprazan is marketed in the U.S. as VOQUEZNA® for treating heartburn associated with Non-Erosive GERD and for the healing and maintenance of Erosive GERD [3]. - The company also offers VOQUEZNA® TRIPLE PAK® and VOQUEZNA® DUAL PAK® for the treatment of H. pylori infection in adults [3]. Event Information - A live webcast of the conference call will be available on the Phathom website, with a recording accessible for 90 days post-meeting [2].
Phathom Pharmaceuticals (PHAT) Conference Transcript
2025-02-06 16:00
Summary of Phathom Pharmaceuticals (PHAT) Conference Call - February 06, 2025 Company Overview - **Company Name**: Phathom Pharmaceuticals (PHAT) - **Established**: May 2019 - **Key Product**: Venoprazan, licensed from Takeda, launched in late 2023 - **Indications**: Approved for H. Pylori in combination with antibiotics, GERD (gastroesophageal reflux disease) in both erosive and non-erosive forms [3][4] Core Points and Arguments Product Performance and Market Position - Venoprazan has shown superiority over traditional PPIs (Proton Pump Inhibitors) in clinical trials, leading to a positive commercial trajectory [4][5] - The company has achieved over 80% commercial coverage, indicating strong market acceptance despite initial skepticism regarding physician adoption and payer coverage [13][34] - The launch has been successful, with approximately 6,000 prescriptions per week, and expectations for significant growth in 2025 [15][16] Future Plans and Studies - Phathom is pursuing life cycle management for Venoprazan, including studies for eosinophilic esophagitis (EOE), with plans to start Phase II trials in the first half of 2025 [6][10] - The Phase II study will focus on symptom improvement and resolution of fibrotic effects in the esophagus, with results expected in about two years [9][10] - The company is also exploring the potential for an over-the-counter (OTC) version of Venoprazan, which would require long-term safety data and additional studies [73][76] Regulatory and Exclusivity Issues - Phathom is currently addressing an exclusivity issue with the FDA regarding the application of GAIN exclusivity to multiple indications of Venoprazan [5][46] - The company has received patent protection until February 1930 and is pursuing regulatory exclusivity that could extend this to February 1932 [46][50] - A citizen petition has been filed to expedite the FDA's decision on the exclusivity issue, with an expected response by mid-2025 [55][56] Additional Important Insights - The company has a robust commercial team of 320 sales representatives targeting high-volume prescribers, with no plans for expansion in 2025 [39][40] - The refill rates for Venoprazan are tracking similarly to those of traditional PPIs, indicating strong patient retention [27][28] - The market for H. Pylori treatment is limited, with under 1 million patients treated annually, but Phathom is actively engaging prescribers in this area [44][45] Conclusion Phathom Pharmaceuticals is positioned for growth with its innovative product Venoprazan, backed by strong clinical data and a solid commercial strategy. The company is actively addressing regulatory challenges while exploring new market opportunities, including EOE and OTC formulations. The upcoming years are critical for the company's trajectory, particularly in resolving exclusivity issues and expanding its market presence.
Phathom Pharmaceuticals to Present at the Guggenheim Securities SMID Cap Biotech Conference
Newsfilter· 2025-01-29 13:00
Company Overview - Phathom Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases [3] - The company has in-licensed exclusive rights to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB) [3] - Vonoprazan is marketed in the U.S. as VOQUEZNA® for treating heartburn associated with Non-Erosive GERD and for the healing and maintenance of Erosive GERD [3] Upcoming Events - Members of the management team will participate in a fireside chat at the Guggenheim Securities SMID Cap Biotech Conference on February 6, 2025, at 10:00 am ET [1] - The conference will take place from February 5-6, 2025, in New York, NY, and will include one-on-one meetings [2] - A live webcast and archived recording of the event will be available on the Phathom website for 90 days following the meeting [2]
Phathom Pharmaceuticals (PHAT) Upgraded to Buy: Here's What You Should Know
ZACKS· 2024-11-19 18:01
Core Viewpoint - Phathom Pharmaceuticals, Inc. (PHAT) has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Ratings - The Zacks rating system is primarily based on a company's changing earnings picture, specifically tracking the Zacks Consensus Estimate for EPS from sell-side analysts [2]. - The Zacks rating upgrade for Phathom Pharmaceuticals indicates a positive outlook on its earnings, which could positively affect its stock price [4][6]. Impact of Earnings Estimates on Stock Prices - Changes in a company's future earnings potential, reflected in earnings estimate revisions, are strongly correlated with near-term stock price movements, influenced by institutional investors [5]. - Rising earnings estimates for Phathom Pharmaceuticals suggest an improvement in the company's underlying business, likely leading to an increase in stock price as investors respond to this trend [6]. Importance of Earnings Estimate Revisions - Empirical research shows a strong correlation between earnings estimate revisions and near-term stock movements, making tracking these revisions beneficial for investment decisions [7]. - The Zacks Rank stock-rating system effectively utilizes earnings estimate revisions to classify stocks, with a proven track record of performance [8]. Current Earnings Estimates for Phathom Pharmaceuticals - For the fiscal year ending December 2024, Phathom Pharmaceuticals is expected to earn -$4.34 per share, reflecting a year-over-year change of -71.5% [9]. - Over the past three months, the Zacks Consensus Estimate for Phathom Pharmaceuticals has increased by 21.5%, indicating a positive trend in earnings estimates [9]. Zacks Rating System Overview - The Zacks rating system maintains a balanced distribution of 'buy' and 'sell' ratings across its universe of over 4000 stocks, with only the top 5% receiving a 'Strong Buy' rating [10]. - Phathom Pharmaceuticals' upgrade to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [12].
Phathom Pharmaceuticals(PHAT) - 2024 Q3 - Earnings Call Transcript
2024-11-10 08:54
Financial Data and Key Metrics Changes - The company reported net revenues of $16.4 million for Q3 2024, representing over a 120% sequential quarter-over-quarter increase [36] - Gross profit for the quarter was $14 million, equating to a gross margin of 86%, an increase of about 440 basis points over the previous quarter [38] - The company ended the quarter with cash and cash equivalents of $335 million, bolstered by a $130 million equity financing [43][44] Business Line Data and Key Metrics Changes - VOQUEZNA achieved over 143,000 prescriptions filled since launch, with approximately 69,000 filled prescriptions recorded in Q3, nearly doubling the amount from Q2 [25][36] - The number of physicians writing filled prescriptions increased to over 13,600, up from over 8,200 in the previous report, indicating strong adoption [27] - The 10 mg dose for non-Erosive GERD saw an increase in filled prescriptions by over 230% between Q2 and Q3 [25] Market Data and Key Metrics Changes - VOQUEZNA's commercial access now covers over 120 million lives, or more than 80% of all U.S. commercial lives [30] - The company secured FDA approval for VOQUEZNA as a treatment for non-Erosive GERD, significantly expanding its addressable market to roughly 22 million U.S. adults [11] Company Strategy and Development Direction - The company aims to enhance brand awareness and commercial access for VOQUEZNA, focusing on primary care physicians as a key prescriber group [31][82] - The strategy includes expanding direct-to-consumer campaigns to increase patient awareness and drive prescriptions [33][48] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving a blockbuster opportunity with VOQUEZNA, citing strong market interest and positive feedback from physicians and patients [22][23] - The company plans to continue monitoring trends and evaluating data before providing future revenue guidance [77][86] Other Important Information - The company reported a non-GAAP adjusted net loss of $67.9 million for Q3 2024, an improvement from a loss of $73.3 million in Q2 [41] - The company is in the final stages of obtaining FDA alignment for a Phase 2 program investigating VOQUEZNA as a potential treatment for Eosinophilic Esophagitis, planned to initiate in the first half of 2025 [20] Q&A Session Summary Question: Coverage uptake and prescription increase - Management indicated that the growth in prescriptions is a mix of increased access and demand tied to the non-Erosive GERD launch [52] Question: Duration of prescriptions - Most prescriptions are written for 30 days, with some for 60 or 90 days, depending on health plans [55] Question: Gross to net discount expectations - The company expects to remain within the pre-launch discount range of 50% to 65% [62] Question: Regulatory exclusivity for VOQUEZNA - Management confirmed that the exclusivity for VOQUEZNA should protect it from generic entries until 2032 [64] Question: Refill rates and comparison to PPIs - Refill rates are healthy and consistent with expectations for prescription PPIs, indicating a positive trend [68] Question: Primary care awareness and demand - Awareness among primary care physicians is growing, and new prescribers from this group have overtaken gastroenterologists [82] Question: Guidance for 2025 - The company will monitor trends before providing guidance for 2025, ensuring confidence in any projections made [86]
Phathom Pharmaceuticals(PHAT) - 2024 Q3 - Quarterly Report
2024-11-07 21:05
Financial Performance - Product revenue for the three months ended September 30, 2024, was $16.352 million, compared to $0 for the same period in 2023[9] - Gross profit for the nine months ended September 30, 2024, was $21.430 million, with a gross margin reflecting a significant increase from previous periods[9] - The net loss for the three months ended September 30, 2024, was $85.577 million, compared to a net loss of $43.243 million for the same period in 2023[9] - The company reported a net loss of $259,875,000 for the nine months ended September 30, 2024, compared to a net loss of $122,022,000 for the same period in 2023, indicating a significant increase in losses[18] - The company reported a net loss of $85.6 million for the three months ended September 30, 2024, compared to a net loss of $43.2 million for the same period in 2023, indicating a worsening financial performance[9] Operating Expenses - Total operating expenses for the three months ended September 30, 2024, were $84.792 million, up from $35.659 million in the same period last year, indicating increased investment in R&D and SG&A[9] - The total operating expenses for the nine months ended September 30, 2024, were $239.5 million, significantly higher than $97.4 million for the same period in 2023, reflecting an increase in research and development and selling, general, and administrative expenses[9] - Research and development expenses for the nine months ended September 30, 2024, totaled $25.499 million, down from $36.505 million in the same period last year, indicating a potential shift in focus[9] - Stock-based compensation for the nine months ended September 30, 2024, was $17,360,000, down from $20,441,000 for the same period in 2023[18] - Advertising and marketing costs for the three and nine months ended September 30, 2024 were approximately $17.5 million and $41.0 million, respectively[63] Cash and Liquidity - Cash and cash equivalents decreased to $334.678 million as of September 30, 2024, down from $381.393 million at the end of 2023[7] - Cash and cash equivalents at the end of the period were $337,540,000, up from $216,535,000 at the end of September 2023[18] - The company has sufficient working capital to fund operations for at least the next twelve months, but future funding success is uncertain[22] - The company has incurred net losses and negative cash flows from operating activities since inception, with net proceeds from equity offerings totaling approximately $543.3 million as of September 30, 2024[21] Liabilities and Stockholders' Equity - Total liabilities increased to $574.156 million as of September 30, 2024, compared to $486.601 million at the end of 2023, reflecting higher long-term debt[7] - The company’s stockholders' deficit increased to $1.188 billion as of September 30, 2024, from $1.102 billion at the end of 2023[11] - The total additional paid-in capital increased to $1,001,442 thousand as of September 30, 2024, from $869,149 thousand at June 30, 2024[11] Revenue Recognition - The company recognizes revenue when a customer obtains control of promised goods or services, following a five-step model as per ASC 606[43] - Revenues from product sales are recorded at the net sales price, which includes estimates of variable consideration such as discounts and rebates[45] - The company estimates variable consideration for net product revenues based on market events, industry data, and customer payment patterns, which may lead to adjustments in revenue recognition[47] Customer Concentration - As of September 30, 2024, three customers accounted for 90% of the accounts receivable balance, with each customer representing 28% to 31% of the total[35] - For the three and nine months ended September 30, 2024, three customers accounted for 70% and 68% of product sales, respectively[35] Inventory Management - The company recorded approximately $0.3 million and $0.7 million in charges for inventory not expected to be sold prior to expiration for the three and nine months ended September 30, 2024, respectively[37] - The company states its inventory at the lower of cost or net realizable value, using a first-in, first-out basis for measurement[37] Financing Activities - The company generated net proceeds of approximately $121.8 million from an underwritten public offering in August 2024, contributing to total net proceeds of approximately $543.3 million since inception[21] - The Company entered into a Fourth Amendment to the Loan Agreement, increasing the aggregate principal amount of term loans from $200 million to $300 million, with various tranches available subject to milestones[93] - The Revenue Interest Financing Agreement allows the Company to receive up to $260 million, with $100 million received at the initial closing and an additional $160 million upon FDA approval of VOQUEZNA[103] Stock and Shareholder Information - The company reported a weighted-average share count of 64.628 million for the three months ended September 30, 2024, compared to 56.782 million for the same period in 2023[9] - The company has a total of 14,191,348 common stock reserves available for future issuance as of September 30, 2024[121] - The company filed a shelf registration statement on Form S-3 in November 2023, allowing for the potential sale of up to $150 million of common stock[118] Regulatory Approvals and Product Launches - The FDA approved the NDA for VOQUEZNA tablets on November 1, 2023, and the commercial launch for VOQUEZNA began in Q4 2023[20] - The company initiated the commercial launch of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK for H. pylori treatment in Q4 2023[20]