Syndax Pharmaceuticals (NasdaqGS:SNDX) Q4 2025 Earnings call February 26, 2026 04:30 PM ET Speaker10Good day, everyone. Welcome to the Syndax fourth quarter 2025 earnings conference call. Today's call is being recorded. If you would like to ask a question following the company's prepared remarks, please press star five during the call. At this time, I would like to turn the call over to Sharon Klahre, Head of Investor Relations at Syndax Pharmaceuticals.Speaker13Thank you, operator. Welcome, and thank you a ...

Core Viewpoint - China Medical System Holdings Limited's subsidiary, Dermavon Holdings Limited, has received acceptance from the National Medical Products Administration of China for the New Drug Application of ruxolitinib phosphate cream for treating mild to moderate atopic dermatitis, which is expected to accelerate the marketing approval process [1][4]. Group 1: Product Development and Approval - Ruxolitinib phosphate cream has been approved for marketing by the NMPA for the treatment of vitiligo and is now expanding its indications to atopic dermatitis, marking a significant milestone in its therapeutic applications [2]. - The NDA for ruxolitinib phosphate cream has been included in the Priority Review List, reducing the review timeline from 200 days to 130 days, which is anticipated to expedite the product's availability to patients [4]. Group 2: Clinical Trial Results - The product demonstrated robust efficacy in a Phase III clinical trial, achieving a significantly higher proportion of subjects reaching an Investigator's Global Assessment score of 0 or 1 compared to placebo (63.0% vs 9.2%, P < 0.001) [6]. - For the secondary endpoint, 78.0% of subjects treated with ruxolitinib phosphate cream achieved at least a 75% improvement in the Eczema Area and Severity Index score compared to 15.4% in the placebo group (P < 0.001) [6]. Group 3: Market Potential and Strategic Positioning - Atopic dermatitis affects over 54 million patients in China, with mild to moderate cases accounting for 98% of these, indicating a substantial market opportunity for ruxolitinib phosphate cream [5]. - Dermavon is developing a comprehensive "treatment + care" solution for atopic dermatitis, which includes ruxolitinib phosphate cream and other therapeutic options, enhancing its leadership in dermatology [6][7]. - The acceptance of the NDA for atopic dermatitis is expected to strengthen Dermavon's strategic positioning in skin treatments and create synergies with its existing product portfolio, potentially enhancing market competitiveness [8].

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其 準確性或完整性亦不發表任何聲明，並表明概不就因本公告全部或任何部分內容而產生 或因倚賴該等內容而引致的任何損失承擔任何責任。 CHINA MEDICAL SYSTEM HOLDINGS LIMITED 康哲藥業控股有限公司* （於開曼群島註冊成立的有限公司） 磷酸蘆可替尼乳膏已在輕中度AD的一項隨機、雙盲、安慰劑對照中國三期藥物臨床研 究成功達到主要終點，即使用產品治療8周，達到研究者整體評估（IGA）評分為0或1 分，且較基線改善≥2分的受試者比例，顯著高於安慰劑（63.0% vs 9.2%，P<0.001）。 關鍵次要終點，磷酸蘆可替尼乳膏治療8周達到濕疹面積及嚴重程度指數評分較基線至 少改善75%（EASI 75）的受試者比例亦顯著優於安慰劑（78.0% vs 15.4%，P<0.001）。 安全性方面，治療期出現的不良事件（TEAE）的嚴重程度大多數為輕度或中度，未發 生導致研究藥物用藥終止的TEAE，整體安全耐受性良好。 （香港股份代號：867） （新加坡股份代號：8A8） 自願性及業務進展公告 創新藥磷酸蘆可替尼乳膏增加 ...

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Core Viewpoint - Knight Therapeutics Inc. has submitted a marketing authorization application for NIKTIMVO (axatilimab) in Brazil for treating chronic graft-versus-host disease (GVHD) after failure of at least two prior systemic therapies in patients aged 6 years and older [1] Company Developments - Knight Therapeutics expanded its agreement with Incyte for exclusive distribution rights of retifanlimab and axatilimab in Latin America, with Incyte responsible for development and supply, while Knight handles regulatory approvals and distribution [2] - NIKTIMVO received FDA approval in August 2024 for chronic GVHD treatment in patients weighing at least 40 kg after failure of two prior systemic therapies [3] - The CEO of Knight emphasized the importance of new treatment options for chronic GVHD patients, highlighting the company's commitment to improving patient access to effective therapies [4] Industry Context - Chronic GVHD is a significant complication following allogeneic stem cell transplantation, affecting 30%-70% of recipients globally, with approximately 1,400 to 1,800 allogeneic transplants reported annually in Brazil [5] - The cumulative incidence of chronic GVHD after two years is reported to be 29.5% based on recent analyses [5] - NIKTIMVO is a first-in-class CSF-1R-blocking antibody, with ongoing studies for its efficacy in combination therapies for chronic GVHD and other conditions [6][8]

Core Insights - Syndax Pharmaceuticals is experiencing significant growth driven by its products Revuforj and Niktimvo, with a strong commercial performance expected to continue into 2026 [4][7]. Product Performance - Revuforj has shown a 38% growth in the fourth quarter, attributed to its use in KMT2A-rearranged acute myeloid leukemia (AML) and new momentum in NPM1-mutant AML following recent guideline inclusion and approval [2][3]. - Niktimvo has generated $152 million in net sales within its first 11 months on the market for chronic graft-versus-host disease (GVHD), indicating strong uptake [3][7]. - The company anticipates Revuforj's average treatment duration to increase from 4-6 months to 6-12 months as maintenance adoption rises from 35-40% to an expected 70-80% [6][12]. Market Opportunities - The U.S. market for Niktimvo in the third-line-plus setting is estimated at approximately 6,500 patients, with a frontline opportunity of around 17,000 patients, suggesting a potential approach to $1 billion in sales [5][15]. - Syndax expects to dominate the market share in NPM1-mutant AML, although it is currently too early to quantify [8]. Financial Outlook - The company has guided flat operating expenses at $400 million for 2026 and is fully funded, indicating no immediate need for additional cash [23]. - Syndax's collaboration with Incyte involves a 50/50 profit split, with expectations that 25-30% of Incyte's reported net sales will contribute to Syndax's revenue [16][17]. Clinical Development - Syndax is advancing a Phase II trial in idiopathic pulmonary fibrosis (IPF) with results expected in the second half of 2026, and a Phase II trial combining Niktimvo with Jakafi is anticipated to read out in early 2027 [18][20]. - The company is also exploring myelofibrosis treatment options, with preclinical work showing promising results [13][14].

Summary of Syndax Pharmaceuticals Conference Call Company Overview - **Company**: Syndax Pharmaceuticals (NasdaqGS:SNDX) - **Date**: February 12, 2026 - **Key Speakers**: Michael Metzger (CEO), Nick Botwood (CMO, Head of R&D), Keith Goldan (CFO) Core Points and Arguments Financial Performance - **Revuforj**: Achieved $125 million in annual net sales, with a quarter-over-quarter growth of 38% in Q4 2025, indicating strong market performance and expansion in its labeled indications [2][4] - **Niktimvo**: Generated $152 million in sales within the first 11 months of launch for chronic GVHD, also showing significant quarter-over-quarter growth [2] Product Development and Market Strategy - **Revuforj**: - Focused on KMT2A and NPM1 indications, with new NCCN guidelines and approvals driving growth [4][5] - Anticipated to capture a dominant market share in NPM1, similar to its established position in KMT2A [9] - Current maintenance therapy uptake for KMT2A is 35%-40%, with expectations to grow to 70%-80% over time [10][13] - **Niktimvo**: - Currently approved for later-line chronic GVHD, with a potential market of approximately 6,500 patients in the U.S. for third-line treatment, and an estimated peak opportunity approaching $1 billion [23][24] - Collaboration with Incyte involves a 50/50 profit split, with expectations for long-term growth in revenue share [24][26] Research and Development - **IPF Phase II Trial**: - Expected to read out in the second half of 2026, with a well-designed study focusing on forced vital capacity as the primary endpoint [30][34] - Strong preclinical data supports the role of CSF1R inhibition in IPF, with significant improvements noted in related conditions [32][40] - **Future Opportunities**: - Plans to explore the role of revumenib in myeloproliferative neoplasms (MPN), with promising preclinical results [20][21][22] Path to Profitability - Syndax aims for profitability potentially by 2027, supported by strong revenue from both Revuforj and Niktimvo, while maintaining flat operating expenses at $400 million [46] Additional Important Insights - The company is fully funded and does not require additional cash, positioning it well for future growth [46] - The collaboration with Incyte extends to future trials, including potential IPF studies, with shared costs and responsibilities [45] This summary encapsulates the key points discussed during the conference call, highlighting the financial performance, product development strategies, research initiatives, and the company's path to profitability.

Core Insights - Incyte (INCY) reported mixed Q4 earnings results, with non-GAAP EPS falling short of expectations while revenue exceeded them [1] - The significant market-moving factor was the 2026 guidance provided by management [1] Financial Performance - Non-GAAP EPS did not meet market expectations [1] - Revenue for the quarter surpassed expectations [1] Future Outlook - Management provided guidance for 2026, which was a key focus for investors [1]

Financial Performance and Projections - Revenues from JAKAFI currently constitute the substantial majority of total revenues, but a decline is anticipated post-patent exclusivity expiration in 2028[255]. - The company expects to continue incurring significant expenses in drug discovery and development, which may hinder sustained profitability in the future[255]. - Future funding requirements may necessitate raising additional capital, which could be challenging if market conditions are unfavorable[259]. - The company derives a significant portion of revenues from royalties and milestone payments, primarily from collaborations, with JAKAVI and OLUMIANT being key contributors[269]. Drug Development and Research Risks - The company anticipates increased expenditures on drug discovery and development as it expands focus on preclinical tests and clinical trials[256]. - The company may face risks related to intellectual property, including potential litigation and claims that could disrupt drug development efforts[270]. - The company may need to scale back operations or eliminate research programs if additional capital is not raised under favorable terms[261]. - The company may need to participate in opposition proceedings to determine the validity of its patents, which could result in substantial costs and resource diversion[282]. - Changes in U.S. patent laws could create uncertainty regarding the validity and scope of the company's patent protection, potentially impacting its competitive position[280]. Financial and Market Risks - The company is subject to risks associated with marketable securities and equity investments, which could impact overall financial position[262]. - The company is subject to interest rate risk, and a uniform increase of 10% in market interest rates could lead to a decline in the fair value of its investments, although the decline would not be material[379]. - Changes in tax laws, such as the One Big Beautiful Bill Act and the Inflation Reduction Act, could adversely affect the company's financial condition and effective tax rate[267][268]. Information Technology and Data Security - The company faces significant risks related to information technology systems, including potential disruptions and data security breaches that could adversely affect its business and reputation[283]. - The company is continuously evaluating and enhancing its IT systems to support planned growth, which involves inherent costs and risks, including potential delays and additional operating expenses[284]. - Data security breaches could lead to the loss of confidential information and reputational harm, with malicious cyber attacks becoming increasingly sophisticated[285]. - Compliance with evolving data privacy laws, such as the EU's General Data Protection Regulation, may impose large fines and complicate the company's operations[288]. - The company may incur significant remediation costs and face enforcement actions due to potential violations of data privacy laws[286]. Social Media and Technology Risks - The increasing use of social media and new technologies, including artificial intelligence, presents risks that could lead to liability and reputational damage[290].

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