Next Catalysts on Horizon More details on the study are available at http://www.hoththerapeutics.com. About Hoth Therapeutics, Inc. Accessibility StatementSkip Navigation NEW YORK. Sevt. 10. 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical innovator, today announced it has submitted its Clinical Trial Application (CTA) to the European Medicines Agency (EMA) to expand its ongoing Phase II trial of HT-001, a novel topical therapeutic for skin toxicities associate ...

Financial Data and Key Metrics Changes - The company reported $8.8 million in top-line revenue for the most recent quarter, showing growth from $8 million in the previous quarter [40][41] - To achieve cash flow breakeven, the company needs to reach a normalized revenue run rate of approximately $8.5 million to $9 million per quarter, aligning with annual cash operating expenses of roughly $33 million to $35 million [41][42] Business Line Data and Key Metrics Changes - The product Pedmark, sodium thiosulfate, is the first FDA-approved treatment for ototoxicity risk due to cisplatin in pediatric patients, with recent NCCN guidelines expanding its recommendation to patients aged 15 to 39 [5][6] - The company has seen two consecutive quarters of growth, attributed to improved marketing strategies and a focus on the adolescent and young adult (AYA) population [16][22] Market Data and Key Metrics Changes - The AYA segment presents a significant market opportunity, with approximately 20,000 patients in the AYA space receiving cisplatin, compared to about 3,000 pediatric patients [17][18] - The partnership with Norgene for European markets includes an upfront fee of approximately $43 million and royalties starting in the mid-teens, with potential milestones exceeding $200 million [44][45] Company Strategy and Development Direction - The company aims to enhance its commercial execution and has focused on increasing the competency of its medical team to engage with key opinion leaders [23][25] - Future growth strategies include targeting high prescribers of cisplatin and potentially introducing additional complementary products in oncology supportive care [56][58] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of increasing awareness of Pedmark among prescribers and improving execution in sales and marketing efforts [35][36] - The company is optimistic about achieving profitability and is exploring opportunities in Japan, where a trial for Pedmark has been completed and is under review [58][59] Other Important Information - The company has approximately $23 million in cash as of March 31, with a convertible note of $19.5 million remaining, which they plan to address as profitability increases [50][51] - Recent approvals for Pedmark in Scotland and ongoing efforts to expand into additional EU countries are part of the company's growth strategy [48][47] Q&A Session Summary Question: What is the revenue run rate needed for cash flow breakeven? - The company needs to achieve a revenue run rate of approximately $8.5 million to $9 million per quarter to reach cash flow breakeven [41][42] Question: Can you describe the partnership with Norgene? - The partnership includes an upfront fee of approximately $43 million, royalties starting in the mid-teens, and potential milestones exceeding $200 million [44][45] Question: What are the plans regarding the convertible debt? - The company has retired $13 million of the convertible note, which currently stands at $19.5 million, and plans to explore options for further retirement as profitability improves [51][52]

Financial Data and Key Metrics Changes - The company recorded net product sales of approximately $8.8 million in Q1 2025, reflecting an 18% growth compared to $7.4 million in Q1 2024 and an 11% increase over Q4 2024 [15][16] - Selling and marketing expenses decreased to $2.9 million in Q1 2025 from $5.2 million in Q1 2024, primarily due to the elimination of European pre-commercialization expenses [17] - General and administrative expenses were $6.1 million in Q1 2025, consistent year-over-year but increased from $4.1 million in Q4 2024 [18] - Cash and cash equivalents stood at $22.6 million as of March 31, 2025, with a cash burn of approximately $4 million in Q1 2025 [18] Business Line Data and Key Metrics Changes - The company has made significant progress in targeting prescribers for Pedmark, particularly in the adolescent and young adult (AYA) patient population, which is expected to have a larger market potential than the pediatric market [9][10] - The targeting model implemented has shown early traction, with tier one targets prescribing Pedmark and integrating it into treatment plans [7][10] Market Data and Key Metrics Changes - The AYA segment is estimated to have approximately 20,000 cisplatin chemotherapy patients treated annually in the U.S., with a favorable reimbursement profile [9] - The product has launched commercially in Germany and the UK, with recent acceptance for use in Scotland [12] Company Strategy and Development Direction - The company is focused on enhancing field execution and supporting sustainable growth across key segments, particularly through a data-driven targeting model [5][6] - There is a strategic emphasis on deepening relationships with key accounts and expanding adoption among existing customers [14] - The company is exploring additional strategic opportunities in oncology supportive care, with ongoing discussions about potential synergies [66] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory, anticipating significant quarterly growth in net product sales as foundational initiatives take effect [17] - The company remains optimistic about the impact of its strategic focus and disciplined execution, expecting continued progress throughout the year [14][71] Other Important Information - The company does not anticipate that proposed tariffs will materially impact gross margins or overall financial performance, as Pedmark is manufactured in the U.S. [19] Q&A Session Summary Question: Average number of vials per patient and adherence rates - The average is about 30 vials per patient, with approximately 50% adherence to the full treatment course [21][23] Question: Improvements in the FENICHERS program - The program has been redesigned to enhance home administration capabilities, which is critical for improving adherence [26][27] Question: Operating expenses and future revenue expectations - Operating expenses are expected to be front-end loaded, with a potential decrease in the second half of the year [30][31] - The company aims for revenue growth to reach breakeven, targeting approximately $8.5 to $9 million in sales [47][48] Question: Expansion into ex-U.S. markets - The company is focusing on major European markets, with Spain, Italy, and France as potential future opportunities for Pedmark [62][63] Question: Strategic opportunities in oncology supportive care - The company is open to exploring strategic opportunities and partnerships that could enhance its offerings in supportive care [66]

Financial Data and Key Metrics Changes - The company generated total net revenues of approximately $39 million for Q1 2025, achieving a record quarterly adjusted EBITDA of $6.2 million and reporting net income of $2.6 million, compared to a net loss of $3.2 million in the same period in 2024 [8][17] - Product gross profit for the three months ended March 31, 2025, was $30.4 million or 78%, an increase from 76% for the same period in 2024, attributed to lower cost per unit due to production efficiencies [16] - Cash and short-term investments as of March 31, 2025, were $50.7 million, with adjusted EBITDA guidance revised to a range of $4 million to $12 million [17] Business Line Data and Key Metrics Changes - The oncology franchise, including CINVONTI and SUSTAL, generated combined net revenues of $28.6 million for the quarter, maintaining market share in a competitive environment [9] - Aponvi and Xenalev experienced significant growth in Q1 2025, with increases of over 43% and 26% respectively compared to the same period last year [11][12] - The company is focusing on product growth and execution, with a goal to optimize commercial performance and selectively expand the team to support high return growth opportunities [6][14] Market Data and Key Metrics Changes - Zeneralev's formulary status now covers approximately 19% of all orthopedic procedures, with expectations for deeper adoption in the market [6] - The company is onboarding new accounts, which are expected to drive sales momentum in the second half of the year [22][46] Company Strategy and Development Direction - The company aims to focus on disciplined execution, optimizing commercial performance, and expanding the team selectively to support growth opportunities [7][14] - The management is actively exploring strategies to drive continued growth in the oncology supportive care market [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving consensus numbers and anticipates a significant inflection in sales as new accounts are onboarded and partnerships are optimized [23][47] - The company is optimistic about the growth potential of Aponvi, projecting it to be a multi-hundred million dollar drug due to its unique safety profile and mechanism of action [42] Other Important Information - A settlement agreement with Mylan Pharmaceuticals regarding Cymbonte and Aponvi products was reached, avoiding costly litigation fees [8] - The company is focused on integrating the CrossLink partnership to enhance sales efforts and improve product adoption [41] Q&A Session Summary Question: Can you provide qualitative comments on the Cimanti litigation settlements and implications for near-term financials? - Management indicated that the settlement allows for continued growth of Cymbonte and Aponvi [20] Question: What should be expected in terms of sales momentum in the back half of the year? - Management noted that unit demand was up 2% while the market was down 5.3%, indicating positive trends and onboarding of new accounts [21][22] Question: Can you discuss overall Q1 trends and any changes to guidance? - Management confirmed that trends were consistent with past years, and they are optimistic about future growth due to new account onboarding and partnerships [28][30] Question: How do you expect gross profit margin to progress through the year? - Management expects gross margin to remain in the mid-seventies range, despite some fluctuations due to production sources [36][37] Question: What is the near-term to long-term potential for Aponvi? - Management believes Aponvi has significant growth potential, aiming to be the first choice for third-line agents in PONV therapy [42] Question: When might Zeneralev start achieving sequential revenue growth? - Management anticipates a significant inflection in Zeneralev's sales as new accounts are onboarded around mid-year [47]