Regeneron Pharmaceuticals (REGN) FY 2025 Annual General Meeting June 13, 2025 10:30 AM ET Speaker0 Good morning, and welcome to the twenty twenty five Annual Shareholder Meeting of Regeneron Pharmaceuticals. The meeting will begin after the following message. Speaker1 At Regeneron, we've always pursued bold science to drive our purpose, transforming lives through groundbreaking innovation. That principle is just as strong today as it was when the company was founded. Speaker2 We committed to not just treati ...

Scholar Rock Holding (SRRK) FY 2025 Conference June 11, 2025 09:20 AM ET Speaker0 Joining us, I'm Salveen Richter, biotechnology analyst at Goldman Sachs, and it's a pleasure to have, with us David Halal, the CEO of ScholarRock. So, David, to to start here, you recently took over as the CEO of ScholarRock after after serving as the Chairman of the Board of Directors since 2017, and you were previously the CEO of Alexion. Can you discuss your decision to step into this role, and your vision for the company, ...

Core Insights - The European Commission has approved the subcutaneous formulation of Opdivo (nivolumab) for multiple solid tumor indications, making it the first PD-1 inhibitor approved for subcutaneous use in the EU [1][3]. Approval Details - The approval applies to all 27 EU member states, as well as Iceland, Norway, and Liechtenstein [1]. - Nivolumab for subcutaneous use is co-formulated with recombinant human hyaluronidase and is indicated for various adult solid tumors, either as monotherapy or in combination with other therapies [2][4]. Clinical Study Findings - The approval was supported by data from the CheckMate -67T clinical study, which demonstrated that the subcutaneous formulation has a pharmacokinetics and safety profile comparable to the intravenous version [4]. - The study showed that the subcutaneous formulation met primary pharmacokinetic noninferiority endpoints, with a geometric mean ratio for Cavgd28 of 2.10 and for Cminss of 1.77 [7]. - The objective response rate was 24% in the subcutaneous group compared to 18% in the intravenous group, indicating comparable efficacy [7]. Market Performance - Bristol Myers' shares have declined by 17% year to date, while the industry has seen a decline of 5.4% [3].

Scholar Rock Holding (SRRK) Q1 2025 Earnings Call May 14, 2025 08:15 AM ET Company Participants Rushmie Nofsinger - Vice President of Corporate Affairs & Investor RelationsDavid Hallal - CEO & ChairmanAkshay Vaishnaw - President, R&DKeith Woods - COOVikas Sinha - CFOMichael Yee - Managing DirectorDavid Nierengarten - Managing Director - Equity ResearchGary Nachman - Managing Director - Equity ResearchMalcolm Hoffman - Senior BioPharma Equity Research AssociateAndres Maldonado - Vice President Conference Cal ...

Scholar Rock Holding (SRRK) Q1 2025 Earnings Call May 14, 2025 08:15 AM ET Company Participants Rushmie Nofsinger - Vice President of Corporate Affairs & Investor RelationsDavid Hallal - CEO & ChairmanAkshay Vaishnaw - President, R&DKeith Woods - COOVikas Sinha - CFOMichael Yee - Managing DirectorDavid Nierengarten - Managing Director - Equity ResearchGary Nachman - Managing Director - Equity ResearchMalcolm Hoffman - Senior BioPharma Equity Research AssociateAndres Maldonado - Vice President Conference Cal ...

Scholar Rock Holding (SRRK) Q1 2025 Earnings Call May 14, 2025 08:15 AM ET Speaker0 Ladies and gentlemen, thank you for standing by and welcome to ScholarRock's First Quarter Financial Results and Business Update Call. At this time, all participants are in a listen only mode. Following the presentation, we will conduct a question and answer session. To ask a question during the session, you will need to press 11 on your telephone. You would then hear an automated message advising your hand is raised. To wit ...

Core Insights - Sandoz has signed a global collaboration agreement with Shanghai Henlius Biotech to commercialize a biosimilar of ipilimumab, with a total consideration of up to USD 301 million, including an upfront payment of USD 31 million, targeting net reference-medicine sales of USD 2.5 billion [2][3][7] Company Overview - Sandoz is a global leader in generic and biosimilar medicines, with a strategic ambition to occupy the leading position in the US biosimilars market, having recently moved up to third position [5][9] - The company has a robust biosimilars pipeline comprising 28 molecules and around 450 generic pipeline medicines, supporting its goal of sustainable long-term growth [5][9] - In 2024, Sandoz recorded net sales of USD 10.4 billion [9] Collaboration Details - Under the agreement, Sandoz has exclusive commercial rights for the biosimilar of ipilimumab in Australia, Canada, Europe, Japan, and the US, with the core sequence patent for ipilimumab having expired in March 2025 in the US and set to expire no later than February 2026 in the EU [3][4] - Henlius is developing its own proposed biosimilar of ipilimumab in an integrated Phase I/III trial targeting 656 patients [4] Market Potential - The combination therapy of ipilimumab and nivolumab is used in 95% of eligible patients, indicating a significant market opportunity for Sandoz's biosimilar [7] - The agreement aims to address considerable unmet medical needs and increase worldwide access to cancer treatments, reinforcing Sandoz's commitment to expanding patient access and driving sustainable savings for healthcare systems [7]