Summary of RAPT Therapeutics Conference Call (October 20, 2025) Company Overview - **Company**: RAPT Therapeutics (NasdaqGM:RAPT) - **Focus**: Development of innovative therapies for chronic spontaneous urticaria (CSU) and other IgE-driven disorders Key Points from the Call Industry and Product Development - **Product**: RPT-nine zero four (also known as JYB-nineteen oh four) - **Indication**: Chronic spontaneous urticaria (CSU) - **Clinical Trial**: Phase II trial conducted in China, comparing RPT-nine zero four to omalizumab - **Results**: Top line data showed RPT-nine zero four demonstrated comparable efficacy to omalizumab with potential for superior durability and less frequent dosing [5][6][7][10][38] Efficacy and Safety Data - **Efficacy**: - RPT-nine zero four showed a 22.1 improvement in UAS7 at week twelve compared to 18.5 for omalizumab [21] - At week sixteen, RPT-nine zero four arms showed improvements of 23.2 and 22.2, while omalizumab showed 19.1 [21] - Complete response (UAS7=0) at week twelve was 37% and 39% for RPT-nine zero four compared to 24.4% for omalizumab [23] - **Safety**: - No serious adverse events or anaphylaxis reported [24] - Treatment emergent adverse events were similar across groups, indicating a favorable safety profile [24] Competitive Landscape - **Current Standard of Care**: Omalizumab, which requires monthly dosing and has limitations in durability and convenience [10][11] - **Market Research**: Survey of allergists indicated that the advantages of RPT-nine zero four would likely drive it to become the preferred treatment option for CSU patients [13] Future Development Plans - **Phase III Trials**: Plans to engage with regulatory authorities to discuss registrational pathways for RPT-nine zero four in CSU [8][39] - **Food Allergy Trials**: Anticipated initiation of Phase IIb trial for food allergies before the end of the year, with top line data expected in 2027 [39][40] - **Asthma Trials**: Smaller Phase II study in moderate to severe asthma expected to read out data by the end of the year [42] Market Potential - **Market Opportunity**: RPT-nine zero four is positioned to address unmet needs in CSU and food allergies, with a focus on less frequent dosing and broader efficacy in patients who are ineligible for omalizumab [39][40] Regulatory Considerations - **FDA Discussions**: Plans to discuss data with the FDA to align on Phase III study designs, with confidence in the translatability of data from Asian populations to Western populations [117] Expert Commentary - **Dr. Ana Maria Jimenez Arnaud**: Highlighted the unmet need for effective treatments in CSU and the potential of RPT-nine zero four to improve patient compliance due to less frequent dosing [28][32][34] Conclusion RAPT Therapeutics is advancing RPT-nine zero four as a promising treatment for CSU, demonstrating comparable efficacy to the current standard of care, omalizumab, with a favorable safety profile and potential for improved patient adherence through less frequent dosing. The company is preparing for Phase III trials and exploring additional indications, including food allergies and asthma.

Core Insights - RAPT Therapeutics and Shanghai Jeyou Pharmaceutical announced positive topline data from a Phase 2 trial of RPT904 for chronic spontaneous urticaria, showing comparable efficacy and safety to omalizumab [1][4][5] Study Design and Results - The Phase 2 study enrolled 137 adult patients with chronic spontaneous urticaria inadequately controlled by H1 antihistamines, randomized into three arms: RPT904 Q8W, RPT904 Q12W, and omalizumab Q4W [2] - The primary endpoint was the change in the seven-day urticaria activity score (UAS7) at Weeks 8, 12, and 16, with key secondary endpoints including the proportion of patients achieving UAS7=0 [2] - RPT904 demonstrated numerically greater improvements in UAS7 scores and a higher proportion of patients achieving UAS7=0 compared to omalizumab at all time points [3] Efficacy Data - Mean baseline UAS7 scores were similar across treatment arms, with RPT904 Q8W showing a least squares mean change from baseline of -20.51 at Week 8, -22.14 at Week 12, and -23.20 at Week 16 [3] - The proportion of patients with UAS7=0 at Week 16 was 45.65% for RPT904 Q8W and 43.48% for Q12W, compared to 33.33% for omalizumab [3] Safety Profile - RPT904 was well tolerated, with no serious adverse events related to the study drug and no treatment-related discontinuations [3][4] Future Development Plans - Jeyou plans to advance RPT904 to Phase 3 development in China, while RAPT will discuss the Phase 3 development path with the FDA [4][5] - RAPT also aims to initiate a Phase 2b trial in food allergies by the end of the year [5] Background Information - Chronic spontaneous urticaria is characterized by sudden onset hives and intense itch, with a need for therapies targeting the underlying IgE-autoantibody pathology [7] - RPT904 is a novel anti-IgE monoclonal antibody designed to provide extended pharmacokinetics compared to omalizumab, targeting the same epitope [8]

Financial Data and Key Metrics Changes - In Q4 2024, revenues reached $731 million, growing 18% year-over-year, with adjusted EBITDA of $155 million, reflecting a 9% increase [42][45][49] - For the full year 2024, total revenues were $2.8 billion, a 17% increase from the previous year, and adjusted EBITDA was $627 million, up 12% [47][49] - Net leverage decreased to 3.9 times, down from 4.8 times at the end of 2023, and significantly reduced from 7.4 times at the end of 2019 [40][49] Business Line Data and Key Metrics Changes - The affordable medicine segment grew 21% in Q4 to $439 million, with full-year growth of 15% [42][47] - Specialty revenues increased 16% in Q4 to $121 million, driven by branded products, including $3 million from the newly launched Crexent [44][47] - The RevCare segment saw a 14% growth in Q4 to $170 million, with expectations for continued double-digit growth [22][45] Market Data and Key Metrics Changes - The specialty business is projected to grow to over $500 million by 2027, driven by Crexent and other branded products [10] - The global biosimilar market is expected to grow from $33 billion today to $75 billion by 2030, with significant opportunities due to expiring patents [18][19] Company Strategy and Development Direction - The company aims to enhance its long-term growth profile through strategic initiatives, including the launch of Crexent and expansion into the biosimilars market [8][11] - A collaboration with Medcera in the weight loss and obesity space is expected to drive innovation and growth, with plans to commercialize products in 20 emerging markets [12][13] - The company is focused on becoming vertically integrated in biosimilars and expanding its injectable portfolio [37][39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving continued top and bottom-line growth in 2025, despite the anticipated loss of exclusivity for Rytary [41][50] - The company is optimistic about the early success of Crexent and its potential to become a leading therapy for Parkinson's disease [44][68] - Management highlighted the importance of maintaining a strong cash flow and reducing debt while investing in growth areas [52][54] Other Important Information - The company fulfilled over 162 million prescriptions annually in the U.S. and is the largest U.S. manufacturer of affordable medicines [24] - The company is targeting to become a top player in the U.S. injectables and biosimilars markets in the coming years [24] Q&A Session Summary Question: Can you elaborate on the launch of Crexent? - Management reported strong early adoption and positive patient testimonials, with formulary access currently at about 30% and expected to rise to 50% [60][65] Question: What are the expectations for GLP-1 launches by 2028? - Management indicated that the launches could include products like Trulicity and involve contract manufacturing, with a manageable CapEx of $100 to $150 million over three years [80] Question: Any updates on naloxone contracts? - Management noted that progress is being made with several states, aiming to provide about 2.5 million kits this year, increasing to 4 million by 2026 [92] Question: What is the long-term opportunity for Unithroid? - Management sees consistent growth potential for Unithroid, similar to Synthroid, as it provides stable therapy for patients [94] Question: What is the target for debt reduction in 2025? - Management aims to reduce net debt to EBITDA to around 3.6% to 3.7% in 2025, with a gross debt reduction target of $80 to $100 million [95][96]

Financial Data and Key Metrics Changes - In Q4 2024, revenues reached $731 million, growing 18% year-over-year, with double-digit growth across all segments [30] - Full year 2024 total revenues were $2.8 billion, up $400 million or 17% year-over-year, exceeding guidance [32] - Adjusted EBITDA for Q4 was $155 million, reflecting a 9% increase, while full year adjusted EBITDA was $327 million, growing 12% [31][32] - Net leverage decreased to 3.9 times compared to 4.8 times at the end of 2023, with a target to reduce it further [29][33] Business Line Data and Key Metrics Changes - The Affordable Medicines segment grew 21% in Q4 to $439 million, with new product launches contributing $54 million [30] - Specialty revenues increased 16% to $121 million, driven by branded products including Krexant [31] - The AvCare segment grew 14% to $170 million, reflecting strong performance across distribution and government channels [31] - Biosimilars generated $39 million in Q4, growing 49% year-over-year [30] Market Data and Key Metrics Changes - The specialty business is projected to exceed $500 million by 2027, driven by products like Krexant and upcoming launches [8] - The global weight loss market is expected to exceed $150 billion by 2030, presenting a significant growth opportunity for the company [11] - The biosimilars market is projected to grow from $33 billion today to $75 billion by 2030, with a significant opportunity for cost savings in the U.S. [15] Company Strategy and Development Direction - The company aims to enhance its long-term growth profile through strategic initiatives such as launching Krexant and expanding its biosimilars pipeline [6][10] - A collaboration with MedCera focuses on developing next-generation therapies, positioning the company as a preferred supplier in the U.S. and Europe [10][22] - The company is committed to becoming vertically integrated, leveraging its manufacturing and R&D capabilities to drive growth in biosimilars and specialty products [26][37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving continued top and bottom line growth in 2025, despite anticipated territory loss of exclusivity [29] - The company is focused on driving execution across development, manufacturing, and commercialization to support its diversified business [28] - Management highlighted the importance of maintaining a strong cash flow and reducing debt levels while investing in growth areas [37] Other Important Information - The company plans to launch 20 to 30 new products each year, with a focus on complex generics and injectables [24] - The first three biosimilars generated $126 million in revenue in 2024, with plans for additional filings and launches in the coming years [14][27] - The company is the largest U.S. manufacturer of affordable medicines, fulfilling over 162 million prescriptions annually [18] Q&A Session Summary Question: Can you elaborate on the launch of Krexant and its market dynamics? - Management reported strong initial adoption and positive patient testimonials, with market share reaching about 1% in four months, aiming for over 3% by year-end [7][41] Question: What is the current status of formulary access for Krexant? - The company is pleased with a 30% coverage rate and anticipates it to increase to around 50% this year, aiming to surpass Rytary's coverage [44] Question: How does the company plan to balance long-term investments with top-line growth? - The company has a solid organic pipeline and plans to allocate capital towards biosimilars and specialty portfolio additions while maintaining a focus on debt reduction [50][52] Question: What is the outlook for GLP-1 launches by 2028? - The company envisions a combination of U.S. and ex-U.S. products, including potential contract manufacturing opportunities [56] Question: Can you provide updates on naloxone contracts and Unithroid's long-term opportunity? - Naloxone contracts are progressing slowly, with expectations to provide 2.5 million kits this year, while Unithroid is expected to maintain a consistent growth profile [67] Question: What are the deleveraging targets for 2025? - The company aims to reduce net debt to EBITDA to approximately 3.6% to 3.7% in 2025, continuing its focus on debt reduction [70]