Summary of Avalo Therapeutics Conference Call Company Overview - **Company**: Avalo Therapeutics (NasdaqCM:AVTX) - **Event**: 2026 Conference on February 11, 2026 - **Focus**: Discussion on the upcoming phase 2b data from the LOTUS trial for AVTX-009, a monoclonal antibody targeting IL-1 beta Key Points Industry and Product Insights - **Product**: AVTX-009, a high-affinity anti-IL-1 beta monoclonal antibody - **Trial**: LOTUS trial, over 250 patients, placebo-controlled, focusing on moderate to severe hidradenitis suppurativa (HS) [2][36] - **Expected Data Release**: Phase 2b data anticipated in Q2 2026 [2][60] Mechanism of Action - **IL-1 Beta Role**: Principal driver of inflammation in HS, with higher concentrations than other inflammatory markers [6][14] - **Comparison with Other Drugs**: IL-1 beta is considered more effective than IL-1 alpha in treating HS, as evidenced by the failure of anti-IL-1 alpha drugs like bermekimab [13][14] Trial Design and Execution - **Trial Structure**: Three-arm study comparing two dosing regimens of AVTX-009 against placebo [34][35] - **Patient Population**: Over 250 patients enrolled, including a significant number of biologically experienced patients [37][42] - **Placebo Response**: Historical placebo response rates in HS trials range from 13% to 18% [35] Safety and Efficacy Considerations - **Safety Profile**: Expected increase in bacterial infections and potential for neutropenia, but generally manageable [47] - **Efficacy Expectations**: Aiming for a response rate of 20% or higher beyond placebo, with a potential "home run" at 25% [49][50] Future Directions - **Next Steps**: Plans for two pivotal phase III trials following the LOTUS study data [52] - **Potential Indications**: Interest in expanding into dermatology, rheumatology, and gastrointestinal diseases due to the potency of AVTX-009 [53] Financial Position - **Cash Reserves**: $100 million reported at the end of the previous year, with a burn rate of $50 million [68] Additional Considerations - **Quality of Life Metrics**: Focus on pain relief and quality of life improvements as key endpoints in the trial [54][55] - **Data Release Timeline**: Complete data set expected to include a 6-week safety follow-up, with final patient visits concluding in March 2026 [62][64] This summary encapsulates the critical insights from the Avalo Therapeutics conference call, highlighting the company's strategic focus, product development, and market positioning within the biotech industry.

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]

Financial Performance and Growth Strategy - Incyte aims to transition into a high-growth Hematology-Oncology-IAI company[4] - The company targets a 15%-20% 5-year CAGR with a diversified franchise and minimal LOE exposure, targeting a $7-8 billion cash balance by 2030[14] - Incyte's core business (excluding Jakafi) is projected to grow to $3-4 billion by 2030[11, 14] - The core business (ex-Jakafi) experienced a 45% year-over-year revenue growth from 2024 to 2025[19, 23] Pipeline and Product Development - Incyte anticipates launching Jakafi XR, Opzelura (mAD), povorcitinib, and Monjuvi (1L DLBCL)[11] - The company has seven high-value pipeline assets with a potential peak net sales opportunity of over $10 billion[11, 25] - Fourteen pivotal trials across seven assets are expected by the end of the year[12] - Povorcitinib is projected to achieve over $1 billion in sales across three indications[56] Jakafi Performance - 2025 Jakafi net product revenue guidance is between $3050 million and $3075 million[18] - Jakafi volume increased 10% compared to the prior year[70, 71] Opzelura Performance - 2025 Opzelura net revenue guidance is between $630 million and $670 million[18]

Core Insights - Palvella Therapeutics has appointed Dr. Vimal Patel as Senior Vice President of Medical Affairs, bringing over 25 years of experience in dermatology and immunology to the role [1][2][3] - Dr. Patel will lead the Medical Affairs organization to enhance scientific engagement, KOL collaboration, and disease state awareness for the QTORIN™ programs targeting serious, rare skin diseases [1][2] Company Overview - Palvella Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative therapies for serious, rare skin diseases without FDA-approved treatments [5][6] - The company is developing a pipeline based on its patented QTORIN™ platform, with lead candidates including QTORIN™ 3.9% rapamycin anhydrous gel and QTORIN™ pitavastatin [6][7] Leadership Experience - Dr. Patel previously served at Incyte as Dermatology Therapeutic Area Head, where he led medical strategy for various dermatological conditions and contributed to the launch of therapies like OPZELURA and povorcitinib [2][3] - His prior experience includes senior roles at Sun Pharma and Johnson & Johnson, where he contributed to the success of multiple high-impact therapies in dermatology and immunology [3] Strategic Vision - Dr. Patel emphasizes the importance of rigorous science and strong clinical evidence in advancing therapies for rare skin diseases, aligning with Palvella's mission-driven approach [4] - The QTORIN™ platform is seen as a pioneering solution with the potential to transform treatment paradigms for rare skin diseases by addressing their underlying pathobiology [4]

Core Viewpoint - China Medical System Holdings Limited's subsidiary, Dermavon Holdings Limited, has obtained licensing rights for the innovative oral JAK1 inhibitor povorcitinib, which is aimed at treating non-segmental vitiligo and has been recognized as a Breakthrough Therapeutic Drug by the NMPA, potentially expediting its development and review process in China [1][6]. Group 1: Product Development and Clinical Trials - Povorcitinib is currently undergoing Phase 3 clinical trials for non-segmental vitiligo, moderate to severe hidradenitis suppurativa, and prurigo nodularis in various countries outside China, with a Phase 2 trial for asthma also in progress [2]. - In March 2023, Incyte reported that povorcitinib met the primary endpoint in a global Phase 2b trial for non-segmental vitiligo, showing significant improvement in total body repigmentation after 24 weeks of treatment [3]. - Dermavon received approval from the NMPA in August 2025 to conduct clinical trials for povorcitinib in China, with plans to explore additional indications for skin-related diseases in the future [4]. Group 2: Market Potential and Patient Impact - Vitiligo affects approximately 10.3 million patients in China, with around 8.2 million suffering from non-segmental vitiligo, highlighting a significant unmet medical need for effective treatments [5]. - If approved, povorcitinib could offer a differentiated treatment option for non-segmental vitiligo patients, particularly those with moderate to severe forms of the disease [5]. - The inclusion of povorcitinib in the Breakthrough Therapeutic Drugs list is expected to enhance its clinical and commercial value, potentially benefiting patients with skin diseases through synergy with other Dermavon products [6]. Group 3: Collaboration and Licensing - Dermavon entered into a Collaboration and License Agreement with Incyte on March 31, 2024, granting exclusive rights to develop and commercialize povorcitinib in several regions, including Mainland China and Southeast Asia [7].

Incyte FY Conference Summary Company Overview - **Company**: Incyte (NasdaqGS: INCY) - **Focus**: Transitioning from Jakafi to a hematology-oncology (Heme-Onc) and immunology (I&I) company, aiming for high growth and durable revenue post-2029 [2][3] Core Business and Pipeline - **Core Business**: Includes Jakafi and a growth portfolio with Opzelura, Niktimvo, Monjuvi, and Zynyz, performing well [2] - **Pipeline**: Seven priority projects identified, focusing on hematology and solid tumors, with several programs moving into phase three in 2026 [3] - **Hematology**: Focus on 989 and V617F - **Solid Tumors**: Programs in pancreatic, colorectal, and ovarian cancers - **I&I**: Developing povorcitinib for hidradenitis, prurigo nodularis, and vitiligo, with NDA submission planned for Q1 2026 [3] Anemia and Treatment Efficacy - **Anemia Improvement**: 55% of patients showed improvement in anemia, with 15% achieving major improvement, indicating the drug's potential to shift blood cell production from malignant to benign cells [12][15] - **Jakafi Comparison**: Jakafi improves symptoms and shrinks the spleen but worsens anemia, while 989 addresses all three issues effectively [15][16] Regulatory Considerations - **FDA Discussions**: Proposing spleen and anemia as co-primary endpoints for regulatory approval, which is a significant shift in treatment evaluation [17][18] - **Development Strategy**: Staggered approach for second-line and first-line treatments in myelofibrosis (MF), with ongoing patient enrollment for true first-line data [19] V617F Program and Prelude Collaboration - **V617F Inhibitor**: Ongoing studies with a focus on improving solubility and exposure of the molecule, with backup programs in place [24] - **Prelude Asset**: Collaboration with Prelude to explore a different chemical space for V617F inhibitors, with an option to acquire the asset based on clinical data [25] Commercial Strategy - **Jakafi XR**: Expected approval in mid-2026, with a potential switch rate from twice a day to once a day estimated between 15%-20%, preserving approximately $750 million of Jakafi revenue through the transition [30] - **Niktimvo Performance**: Anticipated strong fourth quarter with annualized sales exceeding $200 million, showing effectiveness post-Jakafi use [31] Market Potential - **TAFA Expansion**: The first-line DLBCL study could significantly expand the addressable market, potentially increasing the value of Incyte's offerings [29] Conclusion - Incyte is strategically positioning itself for future growth through a robust pipeline, innovative treatment approaches, and a focus on regulatory advancements, while maintaining strong performance in its core business segments [2][3][31]

Financial Data and Key Metrics Changes - The company expects to transition its business model post-Jakafi, aiming for a five-year compound annual growth rate (CAGR) of 15%-20% with multiple products projected to generate over $1 billion in revenue [7][19] - Jakafi sales are anticipated to be preserved with the launch of a once-daily formulation, expected to convert 15%-30% of patients, potentially maintaining nearly $750 million in sales through 2029 [9][10] Business Line Data and Key Metrics Changes - The core business, excluding Jakafi, is projected to grow significantly, potentially matching Jakafi's revenue by 2029 [5] - The company has seven late-stage pipeline projects, including targeted treatments for hematological conditions and solid tumors, which are expected to enhance the core business [6][19] Market Data and Key Metrics Changes - Opzelura finished the year with approximately $650 million in sales, with a potential 10% CAGR over the next five years, driven by increased market penetration and new indications [27][28] - The company anticipates significant growth in the HS market, estimating a potential market size of over $1 billion across HS, PN, and vitiligo [44] Company Strategy and Development Direction - The company is focused on transitioning to a Hematology/Oncology and Immunology (I&I) company, with a strategy to build a sustainable growth curve post-2029 [5] - Business development efforts will aim to extend the core in hematology, oncology, and immunology [6][86] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the pipeline's potential, emphasizing the importance of execution and the ability to replicate positive clinical data [7][26] - The company is optimistic about the competitive positioning of its products, particularly in the context of ongoing clinical trials and market dynamics [26][80] Other Important Information - The company is preparing for the EU submission of Tropovo and anticipates a U.S. submission for povorcitinib in early 2026, with potential approval timelines extending into late 2026 or early 2027 [40][42] - The company is actively pursuing combination therapies to enhance treatment efficacy and expand market opportunities [66][70] Q&A Session Summary Question: What is the expected growth for Jakafi and its new formulation? - The once-daily formulation is expected to launch in mid-2026, with a conversion rate of 15%-30% of patients, preserving significant sales [9][10] Question: Can you elaborate on the 989 mutant CalR antibody and its significance? - The 989 antibody shows promising results in normalizing platelet counts in patients with essential thrombocythemia and has potential disease-modifying effects [14][17] Question: What is the growth outlook for Opzelura? - Opzelura is projected to grow at a 10% CAGR, with significant contributions from increased market penetration and new indications [27][28] Question: How does the company plan to address competition in the market? - The company acknowledges competition but believes its strong prescriber base and clinical data will support its market position [35][36] Question: What are the timelines for upcoming clinical trials? - The company plans to implement multiple phase III trials in 2026 for various indications, with specific timelines dependent on data availability [24][68]

Financial Data and Key Metrics Changes - The company expects to transition its business model post-Jakafi, aiming for a five-year compound annual growth rate (CAGR) of 15%-20% with multiple products projected to generate over $1 billion in revenue each [6][20][21] - Jakafi sales are anticipated to be preserved with the launch of a once-daily formulation, potentially maintaining nearly $750 million in sales through 2029 [7][8] Business Line Data and Key Metrics Changes - The core business, excluding Jakafi, is projected to grow significantly, potentially matching Jakafi's revenue by 2029 [4][6] - Opzelura finished the year with approximately $650 million in sales, with expectations of a 10% CAGR, potentially doubling by 2030 [21][22] - The company has seven late-stage pipeline projects that could enhance its core business in hematology, oncology, and immunology [4][6] Market Data and Key Metrics Changes - The U.S. market is experiencing a shift from topical corticosteroids to nonsteroidal topicals, with Opzelura positioned to benefit from this trend [21][22] - The company anticipates approval for Opzelura in moderate atopic dermatitis in Europe by mid to late 2026, which could significantly drive growth [23][24] Company Strategy and Development Direction - The company aims to establish a targeted therapy for every patient with myeloproliferative neoplasms (MPNs) by the end of the decade, with a focus on executing clinical trials efficiently [18][19] - Business development efforts will focus on extending the core in hematology, oncology, and immunology [4][61] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the pipeline's potential, emphasizing the importance of execution and the favorable positioning of their products in competitive markets [6][20] - The company is aware of competition but believes it has a strong lead in several therapeutic areas, particularly with its G12D inhibitor and other oncology programs [20][55] Other Important Information - The company is preparing for the submission of povorcitinib in the U.S. in early 2026, with expectations of a launch by late 2026 or early 2027 [31][32] - The company has a robust consumer campaign for vitiligo treatment, aiming to increase diagnosis and treatment rates [26] Q&A Session Summary Question: Can you discuss the growth potential of Opzelura? - Opzelura is expected to grow at a 10% CAGR, potentially reaching $1.3 billion by 2030, driven by increased market penetration and new indications [21][22] Question: What is the timeline for the submission of povorcitinib? - The submission for povorcitinib is planned for early 2026, with potential approval by late 2026 or early 2027 [31][32] Question: How does the company view its competitive positioning in the market? - The company believes it has a strong lead in the market, particularly with its G12D inhibitor, and is focused on executing its clinical trials effectively [20][55] Question: What are the expectations for the upcoming data presentations? - The company is preparing to present data at ASH, which will provide further insights into its pipeline and product efficacy [62]