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.

Headquartered in Wilmington, Delaware, Incyte Corporation (INCY) discovers, develops, and commercializes innovative therapies that confront some of medicine’s toughest challenges. Commanding a market cap of roughly $19.6 billion, the company targets blood cancers, solid tumors, immune-mediated disorders, and dermatological diseases. Over the past 52 weeks, INCY stock has surged 49%, comfortably eclipsing the S&P 500 Index ($SPX) 14.4% gain during the same period. Year-to-date (YTD), INCY stock remains ma ...

Jakafi delivered fourth quarter sales of $828 million (up 7% ) and full-year sales of $3.093 billion (up 11% ). Bill said prescriptions increased 11% in the fourth quarter and 9% for the full year despite competition, with demand up across all three indications. He added that polycythemia vera (PV) is expected to be the “largest and fastest growing indication” in 2026, citing an estimated PV penetration rate of about 30% compared with 60%–70% in frontline myelofibrosis (MF). Formulary coverage was described ...

Financial Data and Key Metrics Changes - In Q4 2025, total revenues reached $1.51 billion, a 28% increase year-over-year, while full-year revenues totaled $5.14 billion, up 21% from the previous year [5][31] - Net sales for Q4 were $1.22 billion, representing a 20% increase year-over-year, and full-year net sales were $4.35 billion, also up 20% year-over-year [6][31] - R&D expenses for Q4 were $611 million, a 31% increase from the prior year, with full-year R&D expenses at $2.05 billion [31] - SG&A expenses for Q4 were $390 million, increasing 19% year-over-year, with full-year SG&A expenses at $1.38 billion, up 11% year-over-year [31] Business Line Data and Key Metrics Changes - Core business sales excluding Jakafi totaled $1.26 billion in 2025, a 53% increase compared to 2024, with significant contributions from OPZELURA, Niktimvo, and MONJUVI [6][10] - Jakafi sales in Q4 were $828 million, a 7% increase year-over-year, with full-year sales at $3.093 billion, an 11% increase [7] - OPZELURA's Q4 net sales were $207 million, up 28%, with full-year sales at $678 million, a 33% increase [9] - Hematology and oncology product sales in Q4 were $187 million, up 121% year-over-year, with full-year sales at $583 million, an 83% increase [10] Market Data and Key Metrics Changes - The U.S. market for OPZELURA in atopic dermatitis and vitiligo is expanding, with pediatric launches contributing to a strong start, annualizing around $30 million [9][46] - The international sales for OPZELURA in vitiligo doubled to $130 million in 2025, with expectations for continued growth [9] - The hematology and oncology business is projected to generate $800 million-$880 million in 2026, representing a 40%-50% increase compared to 2025 [13] Company Strategy and Development Direction - The company aims to transition its core business and pipeline, with multiple assets moving from early to late-stage development, targeting MPNs, pancreatic cancer, colorectal cancer, and hidradenitis suppurativa [4][5] - The long-term goal is to nearly double the size of the core business excluding Jakafi by 2030, with significant growth expected from upcoming product launches [10][13] - The company is focused on expanding its pipeline with 14 pivotal trials across seven assets by the end of 2026, indicating a robust growth strategy [14][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, highlighting a strong foundation for an inflection point in 2026 and beyond [5][6] - The company anticipates continued revenue growth driven by strong commercial performance and an increase in milestone and contract revenue [5][6] - Management emphasized the importance of execution in orchestrating product launches and managing multiple Phase III trials [35] Other Important Information - Regulatory applications for Jakafi XR, OPZELURA, and povorcitinib were submitted on time, enhancing visibility into the company's growth profile [5][6] - The company is exploring business development opportunities to extend and strengthen its core, with a focus on strategic fit and potential for durable revenue [15] Q&A Session Summary Question: Thoughts on CALR pivotal programs and dosing strategies - Management is discussing dosing strategies with the FDA and is confident in their approach to address differential potency across mutations [39][40] Question: OPZELURA uptake and modeling sales - The AD business is growing at nearly 20% year-over-year, with significant contributions from pediatric launches and international markets [45][46] Question: MONJUVI's opportunity in front-line DLBCL - MONJUVI is positioned as an addition to R-CHOP, with a focus on addressing a broader patient population and competitive PFS benefits [52][54] Question: OPZELURA in prurigo nodularis and FDA recommendations - The FDA recommended an additional trial for OPZELURA in PN due to mixed results from previous studies, with no implications for HS [64][66] Question: mCALR bispecific and V617F program conviction - The mCALR bispecific program is accelerating, with a focus on differentiating it from current programs, while the V617F program is expected to generate promising data [73][75]

Financial Data and Key Metrics Changes - Total revenues for Q4 2025 reached $1.51 billion, a 28% increase year-over-year, while full-year revenues totaled $5.14 billion, up 21% year-over-year [5][30] - Net sales in Q4 were $1.22 billion, representing a 20% increase compared to the prior year, with full-year net sales at $4.35 billion, also up 20% year-over-year [6][30] - GAAP R&D expenses for Q4 were $611 million, a 31% increase from the prior year, with full-year R&D expenses at $2.05 billion [30] - GAAP SG&A expenses for Q4 were $390 million, increasing 19% year-over-year, with full-year SG&A expenses at $1.38 billion, up 11% year-over-year [30] Business Line Data and Key Metrics Changes - Core business sales excluding Jakafi totaled $1.26 billion, a 53% increase versus 2024, with significant contributions from Opzelura, Niktimvo, and Monjuvi [6][10] - Jakafi sales in Q4 were $828 million, a 7% increase year-over-year, with full-year sales at $3.093 billion, an 11% increase [7] - Opzelura's Q4 net sales were $207 million, up 28%, with full-year sales at $678 million, a 33% increase [9] - Hematology and oncology product sales in Q4 were $187 million, up 121% year-over-year, with full-year sales at $583 million, an 83% increase [10] Market Data and Key Metrics Changes - The U.S. market for Opzelura in atopic dermatitis (AD) is growing at nearly 20% year-over-year, while the vitiligo market is growing in the mid-teens [46] - The pediatric launch of Opzelura AD is annualizing around $30 million, indicating strong market uptake [9][46] - The international sales for Opzelura in vitiligo doubled to $130 million in 2025, with expectations for continued growth [9] Company Strategy and Development Direction - The company aims to transition its core business and pipeline, with multiple assets moving from early to late-stage development, targeting MPNs, pancreatic cancer, colorectal cancer, and hidradenitis suppurativa (HS) [4][5] - The company anticipates significant growth in its core business, potentially matching Jakafi's current size by 2030, driven by upcoming product launches [13] - The company is focused on expanding its hematology portfolio and advancing novel therapies in myeloproliferative neoplasms [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, highlighting a strong foundation for an inflection point in 2026 and beyond [5] - The company expects total revenues for 2026 to be between $4.77 billion and $4.94 billion, representing a 10%-13% increase from the prior year [32] - Management emphasized the importance of execution in orchestrating product launches and managing multiple phase three trials [35] Other Important Information - The company has submitted regulatory applications for Jakafi XR, Opzelura for moderate AD, and povorcitinib for HS in Europe [5] - The company plans to initiate 14 pivotal trials across seven assets by the end of 2026, reflecting a robust pipeline [14][17] Q&A Session Summary Question: Thoughts on CALR pivotal programs and dosing strategies - Management is discussing dosing strategies with the FDA to address differential potency across CALR mutations and is confident in their approach [39][40] Question: Opzelura uptake and average usage - The AD business is growing at nearly 20% year-over-year, with significant contributions from the pediatric launch and international markets [46][47] Question: Monjuvi's opportunity in front-line DLBCL - Monjuvi is positioned as an addition to R-CHOP, with a focus on a broad patient population, and management is optimistic about its competitive edge [54][55] Question: Opzelura in PN and FDA recommendations - The FDA recommended an additional trial for Opzelura in PN due to mixed results from previous studies, but there is no read-through to HS [62][66] Question: Updates on mCALR bispecific and V617F programs - The mCALR bispecific program is accelerating, and management is optimistic about the V617F program's potential to address a significant patient population [72][75]

Financial Data and Key Metrics Changes - In Q4 2025, total revenues reached $1.51 billion, a 28% increase year-over-year, while full-year revenues totaled $5.14 billion, up 21% from the previous year [4][29] - Net sales for Q4 were $1.22 billion, representing a 20% increase compared to the prior year, with full-year net sales at $4.35 billion, also up 20% year-over-year [5][29] - R&D expenses for Q4 were $611 million, a 31% increase from the prior year, with full-year R&D expenses at $2.05 billion [29][30] - SG&A expenses for Q4 were $390 million, increasing 19% year-over-year, with full-year SG&A expenses at $1.38 billion, up 11% [29][30] Business Line Data and Key Metrics Changes - Core business sales excluding Jakafi totaled $1.26 billion, a 53% increase from 2024, with expectations for over 30% growth in 2026 [5][12] - Jakafi sales in Q4 were $828 million, an increase of 7% year-over-year, with full-year sales at $3.093 billion, representing an 11% increase [6][29] - Opzelura's Q4 net sales were $207 million, up 28%, with full-year sales at $678 million, a 33% increase [9][29] - Hematology and oncology product sales in Q4 were $187 million, up 121% year-over-year, with full-year sales at $583 million, an 83% increase [10][29] Market Data and Key Metrics Changes - The pediatric launch of Opzelura for atopic dermatitis is performing well, with annualized sales around $30 million [9] - International sales for Opzelura in vitiligo doubled to $130 million in 2025 [9] - The hematology and oncology business is expected to generate $800-$880 million in 2026, representing a 40%-50% increase compared to 2025 [12][29] Company Strategy and Development Direction - The company aims to transition its core business and pipeline, with multiple assets moving from early to late-stage development [3][4] - The focus is on expanding the core business, with expectations for product launches in late 2026 and early 2027 [12][14] - The company views business development as a multiplier to strengthen its core, with a focus on strategic fit and potential for durable revenue [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, with a revenue guidance for 2026 set at $4.77 billion-$4.94 billion, a 10%-13% increase from the prior year [31][32] - The company anticipates a significant increase in core business growth, with expectations for Jakafi sales to be between $3.22 billion and $3.27 billion in 2026 [31] - Management emphasized the importance of execution in orchestrating product launches and managing multiple phase three trials [32] Other Important Information - The company has submitted regulatory applications for Jakafi XR, Opzelura, and povorcitinib in Europe [4] - The pipeline has reached a new level of maturity, with 14 pivotal trials expected to be underway by the end of 2026 [15][16] Q&A Session Summary Question: Thoughts on CALR pivotal programs and dosing strategies - Management indicated that they will discuss dosing strategies with the FDA and are confident in their approach [36][39] Question: Opzelura uptake and average usage - Management noted that the AD business is growing at nearly 20% year-over-year, with significant growth expected in the pediatric segment [42][45] Question: Monjuvi's opportunity in front-line DLBCL - Management highlighted that Monjuvi is positioned as an addition to R-CHOP, with a competitive PFS benefit [47][51] Question: Opzelura in PN and FDA recommendations - Management clarified that the FDA recommended an additional trial for Opzelura in PN due to mixed results from previous studies, with no implications for HS [59][62] Question: mCALR bispecific and V617F program - Management expressed confidence in the mCALR bispecific program and the potential of the V617F program to deliver transformative clinical effects [64][68]

Incyte周二公布的年度销售额预期低于华尔街预估，其主要增长动力Opzelura药物预计表现不佳，这加 剧了外界对这家制药商能否抵消其最畅销药物Jakafi即将到来的专利到期影响的担忧。 这家总部位于特拉华州威尔明顿的公司，股价在盘前交易中下跌超过4%。 公司预计Opzelura在2026年实现营收7.5亿至7.9亿美元，低于分析师预估的8.015亿美元。 尽管第四季度表现强劲——Opzelura销售额大涨28%至2.073亿美元，高于预期的1.956亿美元——但公司 仍给出了谨慎展望。 蒙特利尔银行（BMO）分析师Evan Seigerman表示："Opzelura的预期偏弱，意味着2026年仍有不少工作 要做。"投资者正密切关注，在Jakafi专利到期后，这款增长型药物能否填补收入缺口。 Opzelura用于治疗12岁及以上患者的白癜风和特应性皮炎。公司预计今年下半年将获得监管审批结果， 计划2026年底在美国以外市场推出其中重度特应性皮炎适应症。 Jakafi是Incyte用于治疗骨髓纤维化、真性红细胞增多症等血液癌症的旗舰药物，目前仍是公司最畅销产 品。Incyte预计2026年Jakafi销售额为 ...

Incyte forecast annual sales below Wall Street estimates on Tuesday with its key growth driver Opzelura expected to underperform, raising concerns about the drugmaker's ability to offset looming patent losses on top-seller Jakafi. ...

03 R&D Highlights Pablo Cagnoni, MD | Head of R&D Alexis Smith | VP, Investor Relations 04 Financial Results Tom Tray | Principal Financial Officer 06 Q&A Fourth Quarter & Full-Year 2025 Financial & Corporate Update FEBRUARY 10, 2026 Agenda 01 Introduction Bill Meury | Chief Executive Officer 05 Closing Remarks Bill Meury | Chief Executive Officer Steven Stein, MD | EVP, Chief Medical Officer Dave Gardner | EVP, Chief Strategy Officer Mohamed Issa | EVP, Head of US Oncology 02 Opening Remarks Matteo Trotta ...

Core Insights - The fourth-quarter earnings season is ongoing, with major pharmaceutical companies set to announce their results, including AstraZeneca, Incyte, Gilead Sciences, Vertex Pharmaceuticals, and Moderna [1] Industry Overview - Several large pharmaceutical companies such as Johnson & Johnson, Lilly, AbbVie, Biogen, Merck, and Amgen reported better-than-expected fourth-quarter results, surpassing estimates for both earnings and revenues. In contrast, Novartis and Sanofi had mixed results, with earnings exceeding estimates but revenues falling short [2] - As of February 4, 40% of companies in the Medical sector, representing 73.9% of the sector's market capitalization, reported quarterly earnings. Among these, 87.5% exceeded earnings estimates, and 75% surpassed revenue estimates. Year-over-year, earnings increased by 3.3%, while revenues rose by 9.5%. Overall, fourth-quarter earnings for the Medical sector are expected to decline by 1.5%, while sales are projected to increase by 9.1% compared to the previous year [3] Company-Specific Insights AstraZeneca - AstraZeneca's performance has been mixed, with earnings beating estimates in two of the last four quarters, meeting once, and missing once, resulting in an average surprise of 3.81%. The consensus estimate for fourth-quarter sales is $15.78 billion, with earnings expected at $2.18 per share [5] - Key medicines, particularly cancer drugs and diabetes medicine, are expected to drive fourth-quarter sales, supported by strong demand trends [7] - AstraZeneca is scheduled to report its fourth-quarter and full-year 2025 results on February 10 [8] Incyte - Incyte has a mixed history of earnings surprises, beating estimates in three of the last four quarters, with an average surprise of 14.35%. The consensus estimate for fourth-quarter sales is $1.35 billion, with earnings expected at $1.94 per share [9] - Strong sales of Jakafi and expected growth in Opzelura sales are likely to contribute to revenue growth in the fourth quarter [11][12] - Incyte is also set to report its fourth-quarter and full-year 2025 earnings on February 10 [12] Gilead Sciences - Gilead Sciences has a mixed earnings surprise history, beating estimates in three of the last four quarters, with an average surprise of 7.80%. The consensus estimate for fourth-quarter sales is $7.57 billion, with earnings expected at $1.83 per share [13] - Increased sales from Biktarvy and Descovy, along with growth in the Liver Disease portfolio, are anticipated to drive top-line growth [14] - Gilead is scheduled to report its fourth-quarter and full-year 2025 results on February 10 [15] Vertex Pharmaceuticals - Vertex has a mixed earnings surprise history, beating estimates in two of the last four quarters, with an average surprise of 2.01%. The consensus estimate for fourth-quarter sales is $3.17 billion, with earnings expected at $5.07 per share [16] - Revenue growth is likely to be driven by higher sales of its cystic fibrosis medicine, Trikafta, and contributions from newer drugs [18] - Vertex is set to report its fourth-quarter and full-year 2025 results on February 12 [19] Moderna - Moderna has a strong earnings surprise history, beating estimates in all of the last four quarters, with an average surprise of 31.45%. The consensus estimate for fourth-quarter sales is $661.4 million, with expected earnings showing a loss of $2.60 per share [20] - Revenue is expected to be primarily driven by sales of COVID-19 vaccines, although demand has declined recently [22] - Moderna is scheduled to report its fourth-quarter and full-year 2025 earnings on February 13 [23]