Bristol-Myers Squibb Company (BMY) FY Conference June 11, 2025 10:00 AM ET Speaker0 All right. We're just right about at time. So let's get started. Welcome to day three of our Healthcare Conference. My name is Assad Haidar. I'm The U. S. Pharmaceutical Analyst here at Goldman Sachs. I'm very, very pleased and privileged to have the Bristol Myers team over here, Chris Boerner, Chairman and CEO and Adam Wenkowski, Chief Commercial Officer. Chris and Adam, welcome, and thank you for being with us. It's great ...

Financial Data and Key Metrics Changes - The company is anticipating over $50 billion in revenue by the early to mid-2030s, driven by a diversified set of therapeutic areas including cardiometabolic, immunology, ophthalmology, vaccines, and HIV [4][5] - The company has invested over $12 billion in manufacturing strategy from 2018 to 2024, with an additional $9 billion planned to bring more manufacturing back to the U.S. [16][18] Business Line Data and Key Metrics Changes - The company has nearly 20 new assets and product launches planned over the next few years, marking a significant period of transformation and growth [3][4] - The oral PCSK9, enlicitide, has shown promising results in Phase III studies, with ambitions to be the most potent LDL cholesterol-lowering pill [3][50] Market Data and Key Metrics Changes - The U.S. market for cholesterol management shows that 70% of individuals are not at their cholesterol goals, indicating a significant opportunity for the company's PCSK9 products [49] - The company continues to see elevated inventories in the Chinese market for Gardasil, with expectations for future growth once market conditions improve [36] Company Strategy and Development Direction - The company is focused on executing its pipeline and leveraging its R&D capabilities across both human and animal health sectors, with a strong emphasis on operational synergies [71][72] - The company is committed to addressing drug pricing issues and is engaged in constructive dialogue with the administration regarding the MFN executive order [9][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the safety and efficacy of their vaccines, particularly klezrovimab, despite regulatory uncertainties [23][24] - The company is optimistic about its growth trajectory, with more product launches planned than ever before in a five-year window [47] Other Important Information - The company is actively pursuing business development opportunities, with a focus on identifying strategic assets that align with its scientific goals [40][41] - The company is expanding its immunology focus, particularly around the TL1A class, which is seen as a significant therapeutic target [42][43] Q&A Session Summary Question: What are the expectations regarding the political environment and MFN pricing? - Management indicated ongoing constructive dialogue with the administration and a willingness to collaborate on drug pricing solutions [7][9] Question: How is the company addressing the manufacturing shift for KEYTRUDA? - The company is bringing back KEYTRUDA manufacturing to the U.S. through a phased approach, with significant investments in infrastructure [18][19] Question: What is the outlook for Gardasil sales in the U.S.? - Management acknowledged potential headwinds from discussions around lower dosing recommendations but remains confident in the vaccine's value [26][34] Question: What is the company's strategy for business development? - Management emphasized that the recent slowdown in business development activity is due to timing rather than a change in strategy or urgency [40][41] Question: How does the company view the competitive landscape in oncology? - The company is focused on advancing its broad ADC program and is committed to moving quickly in the oncology space [62][64]

Summary of Regeneron Conference Call Company Overview - **Company**: Regeneron Pharmaceuticals - **Key Speakers**: - Marianne McCourt, Executive Vice President of Commercial - Ryan Crow, Senior Vice President, Investor Relations and Strategic Analysis Industry Context - **Industry**: Biopharmaceuticals - **Key Products**: EYLEA, DUPIXENT, Libtayo Core Points and Arguments Financial Performance - **EYLEA**: Experienced challenges in the retina space, with Q1 sales impacted by seasonality and inventory issues. Sales dropped from $6 billion last year to an expected $4 billion this year due to biosimilar competition [3][29]. - **DUPIXENT**: Grew 19% globally, leading in prescription share across approved indications, except for Chronic Spontaneous Urticaria (CSU) which was recently approved [3][50]. - **Libtayo**: Grew 21% in the US, now second in new to brand share in advanced lung cancer [4]. Pipeline Developments - Upcoming pivotal readouts include: - Itapakimab for COPD in former smokers [4]. - Combination of LAG-three antibody fianlimab with Libtayo for advanced melanoma [5]. - Pivotal readout for semdisiran in generalized myasthenia gravis [5]. - PDUFA dates for limboceltimab and rotranextamab in July [5]. Capital Allocation - Regeneron is investing approximately $7 billion in R&D and manufacturing capabilities in the US. A dividend program was initiated to return capital to shareholders alongside a buyback program [6]. Regulatory Environment - The company is assessing the impact of the Most Favored Nation (MFN) executive order and potential tariffs on its operations. Regeneron aims to engage with the administration to navigate these changes [8][9]. - The company emphasizes the importance of innovation and patient access to medicines amidst regulatory changes [13][14]. Mergers and Acquisitions (M&A) - Regeneron does not plan to change its conservative approach to M&A, focusing on organic growth and partnerships rather than transformative acquisitions [11][12]. EYLEA Challenges - EYLEA faces competition from biosimilars and affordability issues, leading to increased prescribing of Avastin. Despite a disappointing Q1, EYLEA HD showed a 5% increase in demand [31][32]. - The upcoming approval of a prefilled syringe and new indications are expected to enhance EYLEA's market position [33]. DUPIXENT Launch and Market Dynamics - DUPIXENT is performing well with strong uptake in COPD, achieving 85-90% payer access. The product is expected to reach $20 billion in sales by 2030 [50][52]. - The company is optimistic about the upcoming itapacumab product, which targets a different COPD patient population [53][55]. Competitive Landscape - Regeneron acknowledges competition in the atopic dermatitis market, particularly from Lilly's new product, but maintains confidence in DUPIXENT's established position [61][62]. Additional Important Insights - The company is adapting its copay assistance strategy, moving towards a matching donation model to support patient access [45][46]. - Regeneron is focused on maintaining its commitment to innovation while navigating the complexities of the US healthcare system [14][22]. This summary encapsulates the key points discussed during the Regeneron conference call, highlighting the company's current performance, pipeline developments, regulatory challenges, and strategic direction.