Core Insights - The combination of evorpacept, rituximab, and lenalidomide achieved a complete response (CR) rate of 92% in patients with untreated indolent non-Hodgkin lymphoma (iNHL), significantly higher than the historical CR rate of approximately 50% for rituximab alone [1][2] - The treatment regimen was well-tolerated and demonstrated impressive anti-tumor activity in the frontline setting, with a one-year progression-free survival (PFS) rate of 91% and a one-year overall survival (OS) rate of 100% [2] Study Details - The Phase 2 investigator-sponsored trial enrolled 24 patients, including 14 with follicular lymphoma and 10 with marginal zone lymphoma, and met the primary objective of achieving a CR rate above 80% [2] - The trial was led by Dr. Paolo Strati from The University of Texas MD Anderson Cancer Center, and the results were presented at the American Society of Hematology (ASH) Annual Meeting 2025 [3] Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment, with evorpacept as its lead candidate [4] - The company is also advancing a second pipeline candidate, ALX2004, which is an EGFR-targeted antibody-drug conjugate currently in Phase 1 trials [5]

Core Insights - Genmab A/S announced positive results from the Phase 3 EPCORE® FL-1 study, demonstrating that the combination of EPKINLY® (epcoritamab) with rituximab and lenalidomide significantly reduces the risk of disease progression or death by 79% compared to standard care [2][3] - The overall response rate (ORR) for patients treated with EPKINLY + R2 was 95%, compared to 79% for those receiving R2 alone, indicating a substantial improvement in treatment efficacy [2][3] - The U.S. FDA has approved the EPKINLY + R2 combination for patients with relapsed or refractory follicular lymphoma after one or more lines of systemic therapy, marking a significant advancement in treatment options [4][5] Study Results - The EPCORE FL-1 study included patients with relapsed or refractory follicular lymphoma, showing that 83% of patients achieved a complete response (CR) with EPKINLY + R2, compared to 50% with R2 alone [3][5] - The duration of response (DOR) at 12 months was 89% for EPKINLY + R2 versus 49% for R2, highlighting the long-term benefits of the new treatment [3][5] - The safety profile of EPKINLY + R2 was consistent with known safety profiles, with 90.1% of patients experiencing Grade 3 or 4 treatment-emergent adverse events (TEAEs) [3][4] Industry Context - Follicular lymphoma is a common form of non-Hodgkin lymphoma, accounting for 20-30% of all NHL cases, with approximately 15,000 new diagnoses in the U.S. annually [7] - Current standard treatments are often ineffective over time, leading to relapses and shorter remission periods, which underscores the need for innovative therapies like EPKINLY [7] - Epcoritamab, developed using Genmab's DuoBody technology, is designed to target both T cells and B cells, enhancing the immune response against cancer cells [8][9] Future Developments - Genmab and AbbVie are continuing to explore the use of epcoritamab in various hematologic malignancies, with multiple ongoing Phase 3 trials assessing its efficacy as a monotherapy and in combination with other treatments [9] - The companies aim to expand regulatory approvals for epcoritamab in additional indications, including relapsed/refractory diffuse large B-cell lymphoma (DLBCL) [8][9] - Genmab's vision is to transform cancer treatment through innovative antibody medicines, with a focus on improving patient outcomes [10]

-Â Â EPKINLY plus rituximab and lenalidomide (EPKINLY + R2) Â is now the first and only bispecific antibody combination therapy available for patients with relapsed or refractory follicular lymphoma after at least one line of systemic therapy -Â Â In the Phase 3 EPCORE® FL-1 trial, EPKINLY + R2 demonstrated significantly superior progression-free survival and overall response rates compared to standard of care R2 with approximately 3 out of 4 patients achieving a complete response -Â Â Approval marks third ...

Core Insights - Genmab A/S announced FDA approval for EPKINLY (epcoritamab-bysp) in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma, based on the Phase 3 EPCORE FL-1 study results [2][7][9] Group 1: Study Results - EPKINLY + R reduced the risk of disease progression or death by 79% compared to standard treatment R, with a hazard ratio of 0.21 [3] - The median progression-free survival (PFS) was not reached for EPKINLY + R, while it was 11.2 months for R [3] - Among patients treated with EPKINLY + R, 89% responded to treatment and 74% achieved a complete response, compared to 74% overall response rate and 43% complete response rate for R [3] Group 2: Safety Profile - The safety profile of EPKINLY + R was consistent with known safety profiles of the individual components, with common adverse reactions including rash, upper respiratory infections, and fatigue [4] - Cytokine release syndrome (CRS) occurred in 24% of patients, primarily low grade, with a single event of immune effector cell-associated neurotoxicity syndrome (ICANS) reported [4][21] Group 3: Industry Impact - The approval of EPKINLY + R represents a significant advancement for patients with follicular lymphoma, providing a chemotherapy-free treatment option that can be administered in outpatient settings [5][6] - Follicular lymphoma is a slow-growing form of non-Hodgkin lymphoma affecting approximately 15,000 new patients annually in the U.S., with current therapies considered incurable [5][26] Group 4: Future Prospects - EPKINLY + R is the first bispecific-based therapy approved by the FDA for follicular lymphoma in the second-line setting, marking the third indication for EPKINLY [7] - Genmab and AbbVie are continuing to evaluate epcoritamab in various hematologic malignancies, with multiple ongoing Phase 3 trials [29][28]

Core Insights - Viatris Inc. (VTRS) reported third-quarter 2025 adjusted earnings per share (EPS) of 67 cents, exceeding the Zacks Consensus Estimate of 63 cents, but down from 75 cents in the same quarter last year [1][7] - Total revenues for the quarter were $3.76 billion, a 2% decline year over year on an operational basis, yet surpassing the Zacks Consensus Estimate of $3.6 billion [1][7] Revenue Breakdown - Total sales reached $3.7 billion, down 2% year over year, with a 1% decline on a divestiture-adjusted operational basis [3] - Sales from Developed Markets were $2.25 billion, down 5% on a divestiture-adjusted operational basis, but slightly above the Zacks Consensus Estimate of $2.20 billion [3] - Emerging Markets generated $570.4 million in sales, reflecting a 7% increase on a divestiture-adjusted operational basis, beating the Zacks Consensus Estimate of $550 million [4] - Sales from Japan, Australia, and New Zealand (JANZ) totaled $306.3 million, down 9% on a divestiture-adjusted operational basis, yet exceeding the Zacks Consensus Estimate of $303 million [4] - Greater China sales amounted to $615.2 million, up 9% on a divestiture-adjusted operational basis, surpassing the Zacks Consensus Estimate of $579 million [4] Product Category Performance - Revenues from Brands increased by 3% to $2.4 billion, with a 1% rise on a divestiture-adjusted operational basis, driven by strong performance in Greater China and Emerging Markets [5] - Key branded products included Lipitor with sales of $396.1 million, Norvasc at $179.7 million, and EpiPen at $157.2 million, while Lyrica sales decreased to $126.5 million [8] Generics Performance - Generics revenue was $1.31 billion, down 5%, with a 6% decline on an operational change basis, primarily due to the impact from the Indore facility [9][10] - The decline in generics was offset by growth in complex products in North America and strong performance in key European markets [9] Financial Guidance and Shareholder Returns - Viatris raised its 2025 revenue guidance to a range of $13.9-$14.3 billion, up from the previous guidance of $13.5-$14 billion, and adjusted EPS guidance to $2.25-$2.35 from $2.16-$2.30 [12] - The company has returned over $920 million to shareholders year to date, including more than $500 million in share repurchases, and is on track to return over $1 billion in 2025 [11] Strategic Developments - Viatris acquired Aculys Pharma, gaining exclusive rights in Japan for pitolisant and plans to file two new drug applications in Japan [13] - The acquisition also includes rights for Spydia Nasal Spray, approved in Japan for treating status epilepticus [14]

Core Insights - Genmab A/S has released results from the Phase 3 EPCORE FL-1 trial, showing that subcutaneous epcoritamab in combination with rituximab and lenalidomide (R2) significantly improves outcomes for adult patients with relapsed or refractory follicular lymphoma [1][2] Study Results - The trial met its dual primary endpoints of overall response rate (ORR) and progression-free survival (PFS), demonstrating a 79% reduction in the risk of disease progression or death [2] - Results will be presented at the 67th Annual Meeting and Exposition of the American Society of Hematology (ASH) and will support global regulatory submissions [3] Regulatory Developments - The U.S. FDA has accepted for priority review the supplemental Biologics License Application (sBLA) for epcoritamab plus R2, based on significant ORR and PFS improvements from interim analysis [4] - The FDA has set a target action date of November 30, 2025, for the sBLA [5] Market Performance - Genmab reported revenue of $1.64 billion for the first half of 2025, up from $1.38 billion year-over-year, with second-quarter sales of $925 million exceeding consensus estimates [6] - The 19% revenue increase was driven by higher royalties from collaborations and increased sales of Epkinly [7] - The company raised its fiscal year 2025 sales guidance to between $3.5 billion and $3.7 billion, surpassing consensus expectations [7]

Core Insights - Genmab A/S announced positive results from the Phase 3 EPCORE FL-1 trial for subcutaneous epcoritamab in combination with rituximab and lenalidomide, showing significant improvements in overall response rate (ORR) and progression-free survival (PFS) for patients with relapsed or refractory follicular lymphoma [2][6][4] - The U.S. FDA has accepted the supplemental Biologics License Application (sBLA) for epcoritamab plus rituximab, with a target action date of November 30, 2025, which could make it the first bispecific antibody combination available in the U.S. for second-line treatment of this condition [3][6] - Epcoritamab is designed to target CD3 on T cells and CD20 on B cells, facilitating T-cell-mediated killing of malignant B cells, and has received regulatory approval in various lymphoma indications [8][9] Trial Results - The EPCORE FL-1 trial met its dual primary endpoints, achieving an ORR of 95.7% (p-value < 0.0001) and a PFS hazard ratio of 0.21 (p-value < 0.0001), indicating a 79% reduction in the risk of disease progression or death [2][6][4] - The safety profile of epcoritamab in combination with rituximab was consistent with known safety profiles, with no new safety signals observed [4][6] Industry Context - Follicular lymphoma (FL) is a slow-growing form of non-Hodgkin's lymphoma, accounting for 20-30% of all NHL cases, with approximately 15,000 new cases annually in the U.S. [5] - Current treatment options for R/R FL often lead to declining response rates and shorter remission periods, with over 25% of patients potentially transforming to aggressive large-cell lymphoma [5][4] Company Overview - Genmab is an international biotechnology company focused on developing innovative antibody therapeutics, with a vision to transform cancer treatment by 2030 [11][12] - The company is co-developing epcoritamab with AbbVie, sharing commercial responsibilities in the U.S. and Japan, while pursuing additional international regulatory approvals [9][10]

Core Insights - Knight Therapeutics Inc. has launched Minjuvi® (tafasitamab) in Mexico through its affiliate Grupo Biotoscana de Especialidad S.A. de C.V. [1] - Minjuvi® is indicated for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT) [2][4]. Company Overview - Knight Therapeutics Inc. is a pan-American specialty pharmaceutical company focused on acquiring and commercializing pharmaceutical products in Canada and Latin America [12]. - The company entered a supply and distribution agreement with Incyte for exclusive rights to distribute tafasitamab in Latin America [7]. Product Details - Minjuvi® is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, demonstrating a 60% objective response rate (ORR) in clinical trials [4][8]. - The L-MIND trial showed a complete response rate (CR) of 43% and a disease control rate (DCR) of 74% for Minjuvi® in combination with lenalidomide [4]. Clinical Significance - DLBCL is the most common subtype of non-Hodgkin lymphoma, with many patients facing poor prognosis due to refractory disease or relapse [3]. - Approximately 57% of patients responding to Minjuvi® remained in remission at 5 years, highlighting its effectiveness as a treatment option [5]. Regulatory Approval - Minjuvi® received marketing authorization in Mexico based on the L-MIND trial data and was recognized as an orphan medicine by COFEPRIS [4][7]. - The product has also received accelerated approval in the United States and conditional marketing authorization in Europe for similar indications [9].

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 2024, the company reported total revenues of approximately $14.7 billion, reflecting a 2% growth on a divestiture adjusted operational basis compared to 2023 [7][36] - Adjusted EBITDA for 2024 was approximately $4.7 billion, with adjusted gross margins of 58% [7][36] - Free cash flow for 2024 was approximately $2.6 billion, excluding divestiture-related taxes and transaction costs [8][36] - The company anticipates a negative impact of approximately $500 million on total revenues and $385 million on adjusted EBITDA for 2025 due to the remediation efforts at the Indore facility [12][40] Business Line Data and Key Metrics Changes - New product revenues increased to $582 million in 2024, setting a target range of $450 million to $550 million for 2025 [6][17] - The global generics business grew by 2% in 2024, driven by new product launches and complex products [37] Market Data and Key Metrics Changes - North America is expected to decline year over year due to the impact of the Indore facility and expected competition on certain generics [31] - Emerging markets are projected to grow year over year, primarily driven by the expansion of the cardiovascular portfolio in Latin America and key markets such as Turkey and India [32][33] Company Strategy and Development Direction - The company aims to balance capital return and business investment over the next three to five years, with a focus on returning capital to shareholders in 2025 [14][45] - The company is prioritizing new product launches and expects several notable launches in 2025, including complex injectables [12][28] - An enterprise-wide initiative has been launched to review global infrastructure and identify additional cost savings, expected to deliver operational expense savings in 2026 and beyond [15][39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to drive base business growth and execute on the pipeline, despite challenges from the Indore facility [15][39] - The company is committed to quality and is making progress on the remediation plan at the Indore facility, with expectations for completion in a few months [10][40] Other Important Information - The company has engaged independent third-party experts to support remediation efforts at the Indore facility [10] - The company expects to maintain a strong focus on advancing its innovative pipeline, with several Phase III readouts anticipated in 2025 [19][26] Q&A Session Summary Question: Concerns about quality control at other facilities - Management confirmed that only the Indore facility received a warning letter, while other facilities are in compliance [50][52] Question: Timing of Phase III data for Sinerimod and Solatogrel - Management indicated that data is expected in late 2026, but enrollment is progressing well [56] Question: Long-term vision for the company - Management stated that the capital allocation plan remains unchanged, with a focus on returning capital to shareholders while also pursuing business development opportunities [53][54] Question: Impact of Indore facility issues on revenues outside the U.S. - Management explained that remediation efforts could cause supply issues for certain products, affecting revenues in other markets [73] Question: Gross margin expectations and factors affecting them - Management noted that the primary impact on gross margins is from the Indore facility, along with normal price erosion and increased supply costs [68][70]