Summary of Viatris Conference Call Company Overview - **Company**: Viatris (NasdaqGS: VTRS) - **Event**: UBS Healthcare Conference - **Date**: November 11, 2025 Key Updates and Financial Performance - Viatris reported a positive momentum in business with an expected operational revenue growth of **2-3%** for 2025, excluding Indor [4][80] - The company is on track to return over **$1 billion** to shareholders, including **$500 million** in share repurchases for the year [4][80] New Product Launches - Anticipated new product revenue is projected to be in the range of **$450 million to $550 million** annually, driven by existing products and upcoming launches [6][4] - Key products contributing to this revenue include: - **Iron sucrose** - **Glucagon** - **Paclitaxel** - Upcoming launches: **Liraglutide**, **Effexor GAD**, **Sotagliflozin** [6][4] Geographic Performance - **North America**: - Experienced competition in generic products, particularly **XULANE LO** [17][22] - Decline primarily attributed to the impact of Indor [19][22] - Strong double-digit growth noted in products like **Breyna** and **Uptravi** [22][22] - **Emerging Markets**: - Strong growth driven by established brand business, particularly in **Turkey**, **Mexico**, and **emerging Asia** [23][23] - Stabilization of lower-margin ARV products has supported growth in the generics business [23][23] - **Japan**: - Facing normal price regulations but focusing on adding innovative assets to stabilize and grow the business [26][26] - Recent acquisition of **Pitolisant** and **Spidea** expected to enhance the portfolio [26][26] - **China**: - Achieved **9% operational growth** driven by a diversified commercial model and strong brand demand [28][28] - Over **10,000 customers** across various channels, with expectations for low to mid-single-digit growth over time [31][31] Pipeline and Future Products - Excitement around **fast-acting meloxicam** as a non-opioid alternative for acute pain management, targeting a launch in the second half of **2026** [34][41] - Anticipated FDA filings for several products, including **Effexor GAD** and **Salatogrel**, with enrollment for Salatogrel on track to complete by the end of **2026** [51][52] Indor Remediation and Strategic Review - Progress on remediation efforts for Indor, with operational readiness for reinspection expected in **2026** [54][54] - An enterprise-wide strategic review initiated to ensure sustainable growth, with details expected in **Q1 2026** [60][60] Capital Allocation Strategy - Viatris maintains a balanced capital allocation strategy, focusing on business development and capital return, with a **50/25/25** framework [71][71] - The company is looking for opportunities to invest in durable, higher-margin innovative assets, particularly in the U.S. market [73][73] Conclusion - Viatris is optimistic about its position going into **2026**, with a focus on executing its strategic priorities, enhancing its product pipeline, and addressing challenges in various markets [80][80]

Core Insights - Merck announced the first presentation of results from the pivotal Phase 3 KEYNOTE-B96 trial, evaluating KEYTRUDA® in combination with chemotherapy for platinum-resistant recurrent ovarian cancer [1] Group 1 - The trial, also known as ENGOT-ov65, assesses the efficacy of KEYTRUDA® (pembrolizumab) combined with paclitaxel, with or without bevacizumab [1]

Core Insights - Merck announced that the Phase 3 KEYNOTE-B96 trial met its secondary endpoint of overall survival for patients with platinum-resistant recurrent ovarian cancer [1] Group 1: Trial Details - The KEYNOTE-B96 trial, also known as ENGOT-ov65, studied the efficacy of KEYTRUDA® (pembrolizumab) in combination with chemotherapy (paclitaxel) with or without bevacizumab [1]

Core Insights - ALX Oncology is set to present updated data from its Phase 2 ASPEN-06 trial, focusing on evorpacept as a treatment for HER2-positive gastric cancer, at the SITC 40th Annual Meeting in November 2025 [1][2] - The trial evaluates evorpacept in combination with HERCEPTIN, CYRAMZA, and paclitaxel for patients with advanced gastric cancer who have previously undergone treatment [1][3] Company Overview - ALX Oncology is a clinical-stage biotechnology company dedicated to developing novel cancer therapies aimed at extending patient lives [4] - The lead candidate, evorpacept, is being assessed in various clinical trials across multiple cancer indications, indicating its potential as a cornerstone therapy in immuno-oncology [4] - The second pipeline candidate, ALX2004, is an EGFR-targeted antibody-drug conjugate that began Phase 1 trials in August 2025 [4]

Core Insights - Cardiff Oncology, Inc. announced positive results from a Phase 1b clinical trial evaluating onvansertib in combination with paclitaxel for metastatic triple-negative breast cancer (mTNBC), showing a 40% objective response rate [1][2][5] - The trial demonstrated that the combination was well-tolerated with a manageable toxicity profile, primarily myelosuppression being the most common adverse event [5] Company Overview - Cardiff Oncology is a clinical-stage biotechnology company focused on developing novel therapies leveraging PLK1 inhibition across various cancers, with onvansertib as its lead asset [4] - The company is also exploring onvansertib in combination with standard of care treatments for other indications, including RAS-mutated metastatic colorectal cancer, metastatic pancreatic ductal adenocarcinoma, and small cell lung cancer [4] Clinical Trial Details - The Phase 1b trial was led by Antonio Giordano, MD, PhD, at Dana-Farber Cancer Institute, focusing on the safety, pharmacokinetics, and pharmacodynamics of the drug combination [5] - The study's primary endpoint was to assess safety and determine the recommended Phase 2 dose (RP2D), with secondary endpoints including pharmacokinetics and pharmacodynamics [5] - Patients in the trial had a median of 3 prior lines of chemotherapy, and the highest dose of onvansertib (18 mg/m²) resulted in a 40% objective response rate [5]

Core Insights - Compass Therapeutics announced statistically significant top-line data from the COMPANION-002 trial, indicating the efficacy of tovecimig in combination with paclitaxel for patients with advanced biliary tract cancer (BTC) [1][2][6] Company Overview - Compass Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing proprietary antibody-based therapeutics for oncology [12] - The company aims to address critical biological pathways involved in tumor growth and angiogenesis [12] Clinical Trial Details - The COMPANION-002 trial is a Phase 2/3 randomized study involving 168 adult patients with unresectable advanced BTC, comparing tovecimig plus paclitaxel to paclitaxel alone [4][6] - Patients in the trial were randomized in a 2:1 ratio, with 111 receiving the combination therapy and 57 receiving paclitaxel alone [4] Efficacy Results - The primary endpoint of the trial, overall response rate (ORR), was 17.1% for the combination therapy compared to 5.3% for paclitaxel alone, demonstrating a statistically significant difference (p=0.031) [5][6][7] - The combination therapy also showed a lower progressive disease (PD) rate of 16.2% compared to 42.1% for paclitaxel alone [6][8] Patient Population and Need - Biliary tract cancer affects approximately 23,000 patients annually in the U.S., with 85% of patients lacking FDA-approved second-line treatment options [3] - Current second-line therapies have an ORR of ~5% or less, with a median overall survival of about six months [3] Future Expectations - The company plans to report additional data, including key secondary endpoints, in Q4 2025 [5][13] - Safety data will also be reported alongside the secondary endpoint analyses, with an independent Data Monitoring Committee recommending the continuation of the study without modifications [13]

Core Insights - Compass Therapeutics, Inc. is set to host a webcast on April 1, 2025, to discuss top-line clinical data from its Phase 2/3 COMPANION-002 trial, which evaluates tovecimig in combination with paclitaxel for advanced biliary tract cancer [1][2] Company Overview - Compass Therapeutics is a clinical-stage biopharmaceutical company focused on oncology, developing proprietary antibody-based therapeutics for various diseases [3] - The company's research emphasizes the interplay between angiogenesis, the immune system, and tumor growth, aiming to create therapies that target critical biological pathways for effective anti-tumor responses [3] - Founded in 2014 and headquartered in Boston, Massachusetts, Compass Therapeutics is advancing its product candidates through clinical development as standalone therapies and in combination with other proprietary antibodies [3]