Key Takeaways MRK faces major headwinds as Keytruda, its top revenue driver, nears the loss of exclusivity in 2028.Gardasil sales are sliding in China and Japan, with further weakness projected in 2H 2025.MRK eyes $3B in savings by 2027 as new drug approvals look to offset upcoming headwinds.Merck (MRK) is likely to face several headwinds over the next few years that could impact its sales and profits, with the most significant being the upcoming loss of exclusivity for its blockbuster PD-L1 inhibitor, Keyt ...

PresentationTerence FlynnEquity Analyst Good afternoon, everybody. We're going to get started here. But I'm Terence Flynn, Morgan Stanley's U.S. biopharma analyst. I'm very pleased to be hosting Merck this afternoon. From the company, we have Rob Davis, the company's Chairman and CEO; and Dr. Eliav Barr, who is the company's Head of Global Clinical Development and also CMO. Thank you both so much for joining us today this afternoon. Looking forward to chatting. Just quickly, for important disclosures, pleas ...

Summary of Merck & Co., Inc. Conference Call Company Overview - **Company**: Merck & Co., Inc. - **Industry**: Biopharmaceuticals Key Points and Arguments Transformation and Growth Strategy - Merck is transitioning from being primarily known for KEYTRUDA to becoming a diversified launch company with multiple upcoming product launches [2][3] - The company has identified over $50 billion in commercial opportunities by the mid-2030s, excluding recent deals with Verona Pharma and iBio, which are also multi-billion dollar opportunities [2][3] Pipeline and Product Launches - Merck is focused on launching over 20 new molecular entities, most of which have blockbuster potential [3] - The company is committed to investing in its internal pipeline and pursuing business development opportunities [3][4] Pricing and Regulatory Environment - Merck is preparing for potential tariff impacts by managing inventory and shifting manufacturing to the U.S. [6] - The company is engaged in discussions with the administration regarding the Most Favored Nation (MFN) pricing model, aiming to lower out-of-pocket costs for patients [7][8] - Merck believes capturing the middle dollar in pricing could significantly reduce costs for patients [9] Direct-to-Consumer (DTC) Strategy - Current DTC discussions are more focused on existing products rather than new launches, with potential for DTC in pharmacy benefit drugs [12] - The company is open to exploring DTC opportunities for certain products, including HIV and diabetes drugs [12] International Market and Pricing Strategy - Merck is actively engaging with governments in the UK and EU to address pricing disparities and is changing its pricing strategy for new product launches [14][15] - The company believes that the best time to address pricing imbalances is during the launch of new products [14] Business Development and Acquisitions - Merck has invested over $50 billion in business development since the current CEO took over, focusing on science-driven opportunities [21] - The company is open to commercial deals but emphasizes the importance of scientific basis and sustainability [22] Opportunities in China - Merck is exploring opportunities in China but maintains that it will pursue the best science globally, not limited to any specific region [23] Winrevair Launch and Market Dynamics - The launch of Winrevair is progressing well, with strong access and increasing physician prescriptions [25] - The company anticipates significant growth in international markets, particularly in Europe and Japan, by 2026 [26] Oncology Pipeline - Merck has a robust oncology pipeline with 80 phase 3 studies underway, including 60 in oncology, which could drive significant revenue [50] - The company highlights the potential of its antibody-drug conjugate portfolio and precision molecular targeting agents [50][51] Emerging Therapeutic Areas - Merck is excited about opportunities in HIV, ophthalmology, and animal health, with significant potential for growth in these areas [62][64][65] - The company is developing next-generation treatments in HIV and has accelerated its ophthalmology program through acquisitions [64] Conclusion - Merck is positioned for sustainable long-term growth through a diversified pipeline, strategic pricing, and ongoing engagement with regulatory bodies [4][14][15] - The company is optimistic about its future prospects across various therapeutic areas and markets, emphasizing the importance of innovation and patient care [3][4][22]

Summary of Key Points from the Conference Call Industry Overview - The conference call focuses on the **Biopharma** industry in **North America** with a comprehensive analysis of the **US drug market** as per **IQVIA Rx** data [1][6]. Core Insights - The **Total Prescription Year-over-Year (YoY) growth** for the week ending **August 29, 2025**, was reported at **+1.7%**, a decrease from **+2.3%** the previous week and **+2.6%** over the past 12 weeks [1][2]. - The **rolling 4-week TRx YoY** change was **+2.3%**, while the **rolling 12-week TRx YoY** was **+2.6%** [2]. - The **Extended Unit (EUTRx)** weekly YoY growth was **+2.0%**, indicating stronger performance compared to the overall TRx YoY [2]. Company-Specific Developments - **Bristol Myers Squibb (BMY)**: The drug **Cobenfy** for schizophrenia was approved on **September 26, 2024**. The current weekly scripts are approximately **2,210**, up from **2,160** the previous week. To meet the 2025 consensus expectations, Cobenfy needs to achieve **~129K TRx** at a net price of **~$1,200** [3]. - **Vertex Pharmaceuticals (VRTX)**: The drug **Journavx** for acute pain was approved on **January 30, 2025**. Current scripts are around **7,280**, with hospital scripts making up about **35%** of total scripts. To achieve projected sales of **$78 million**, approximately **349K total scripts** are needed [4]. - **Gilead Sciences (GILD)**: The drug **Yeztugo** was approved on **June 18, 2025**. The latest total TRx is approximately **470**, up from **390** the previous week. Projections for achieving consensus estimates for the second half of 2025 are discussed, with a focus on gross-to-net pricing adjustments [5]. Market Trends and Comparisons - A comparison of launches between **GILD's Yeztugo**, **Descovy**, and **Apretude** is provided, highlighting the uptake among different patient groups and the anticipated growth trajectory [5][9]. - The **GLP-1 franchise** from **Eli Lilly** shows significant growth, with **Mounjaro** and **Zepbound** experiencing **+66%** and **+233%** YoY growth respectively [20][23]. Additional Insights - The call includes a detailed analysis of **key products** and their respective YoY performance, with notable declines in some established drugs like **Humira** (-39%) and growth in others like **Skyrizi** (+44%) [20]. - The **COVID vaccine** tracking and **biosimilar adoption** analysis are also mentioned, indicating ongoing trends in the pharmaceutical landscape [12][28]. Conclusion - The conference call provides a comprehensive overview of the current state of the biopharma industry in North America, highlighting both challenges and opportunities for key players in the market. The data reflects a mixed performance across various drugs, with some experiencing significant growth while others face declines.

Core Insights - The session features the Merck management team, highlighting their expertise and focus on the company's pipeline development [2]. Company Overview - Caroline Litchfield serves as the Executive Vice President and Chief Financial Officer of Merck, indicating a strong leadership presence [2]. - Eliav Barr, the Senior Vice President and Chief Medical Officer, is responsible for managing all pipeline development at Merck, showcasing the company's commitment to advancing its product offerings [2].

Financial Data and Key Metrics Changes - Merck is in a transformation phase with a diversified set of growth drivers, aiming for over $50 billion in revenues by the mid-2030s from its pipeline [3][4] - The company is launching 20 products, most of which have blockbuster potential [3][4] Business Line Data and Key Metrics Changes - KEYTRUDA continues to show strong growth with 42 approved indications in the U.S. across 18 tumor types, with expectations for continued growth from new indications [6][7] - The subcutaneous formulation of KEYTRUDA is anticipated to achieve 30% to 40% adoption within 18 to 24 months post-launch [9][11] Market Data and Key Metrics Changes - The company is well-positioned to manage the impact of tariffs and has a diverse supply chain footprint [41][42] - The impact of the Most Favored Nation (MFN) policy is expected to be manageable, as it only accounts for less than 10% of revenues [42][43] Company Strategy and Development Direction - Merck is focused on innovation and expanding its pipeline, with plans to increase R&D investments due to a strong pipeline of 80 Phase III clinical programs [51][52] - Business development remains a priority, with a focus on bringing in innovative science that addresses unmet medical needs [67][68] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating the loss of exclusivity for KEYTRUDA and emphasized the importance of their pipeline in driving future growth [5][6] - The company is optimistic about the readouts from its oncology and HIV pipelines in the coming year [80][81] Other Important Information - The company is preparing for the launch of its oral PCSK9 inhibitor, which is expected to democratize access to this treatment [60][62] - Merck is also excited about its cancer vaccine program, focusing on early-stage cancers with potential curative opportunities [39][40] Q&A Session Summary Question: What are the growth avenues for KEYTRUDA? - Management expects continued growth from new indications, including early-stage lung cancer and women's cancers [7][8] Question: How will the adoption of the subcutaneous formulation of KEYTRUDA be affected? - Factors such as pricing, access, and the J code will influence adoption rates, with expectations of 30% to 40% adoption within 18 to 24 months [10][11] Question: What is the confidence level in the TROP-two ADC program? - Management expressed confidence based on early signals and extensive clinical trials, highlighting its unique properties and potential in maintenance settings [17][18] Question: How does Merck plan to address macroeconomic headwinds like tariffs? - The company has a diverse supply chain and is well-positioned to manage tariff impacts, focusing on innovation and product launches [41][42] Question: What is the outlook for Gardasil in China? - Gardasil is not expected to drive significant growth in China, with future growth anticipated from international markets and new product launches [69][70] Question: What are the expectations for the cancer vaccine program? - The program is focused on early-stage cancers, with positive readouts expected in the next couple of years [39][40]

Financial Data and Key Metrics Changes - The company is in a transformation phase with a diversified set of growth drivers, expecting over $50 billion in revenues by the mid-2030s from its pipeline [3][4][5] - The company is launching 20 products, most of which have blockbuster potential [3][4] Business Line Data and Key Metrics Changes - KEYTRUDA continues to show strong growth with 42 approved indications across 18 tumor types, with new indications expected to drive future growth [6][7][8] - The subcutaneous formulation of KEYTRUDA is anticipated to achieve 30% to 40% adoption within 18 to 24 months post-launch [9][11] - The company has 24 oncology assets in clinical trials, focusing on immune stimulation, chemotherapy improvements, and specific targeting agents [13][15] Market Data and Key Metrics Changes - The company is well-positioned to manage tariff impacts due to a diverse supply chain and manufacturing footprint [42][43] - The impact of the Most Favored Nation (MFN) policy is expected to be manageable, with less than 10% of revenues affected [43][44] Company Strategy and Development Direction - The company is focused on innovation and expanding its pipeline, with a commitment to reinvest $3 billion in annual cost savings into R&D [51][52] - Business development remains a priority, with a focus on bringing in innovative science that addresses unmet medical needs [66][67] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating the loss of exclusivity for KEYTRUDA and emphasized the importance of new product launches [5][6] - The company is optimistic about the future, with expectations for positive readouts from its pipeline and successful product launches [78][79] Other Important Information - The company is excited about the potential of its oral PCSK9 inhibitor, which showed a 60% reduction in LDL cholesterol in Phase II trials [59][60] - The company is also exploring opportunities in the GLP-1 space, with an oral formulation expected to enter Phase I trials [62][64] Q&A Session Summary Question: What are the growth avenues for KEYTRUDA? - Management highlighted new indications in lung cancer and women's cancers as key growth opportunities [6][7] Question: How does the company plan to handle tariff impacts? - The company has a diverse supply chain and believes the impact of tariffs is manageable [42][43] Question: What is the strategy for the new PD-1 VEGF bispecifics? - The company is focusing on specific patient strata and therapeutic indications to differentiate from existing treatments [32][33] Question: How will the company approach pricing in light of MFN? - The company plans to price products based on the value they bring, ensuring broad access while being mindful of MFN implications [44][46] Question: What is the outlook for the cancer vaccine program? - Management is optimistic about the enthusiasm from investigators and the potential for early-stage cancer treatments [39][40] Question: How does the company view the future of Gardasil in China? - Gardasil is not expected to drive significant growth in China, with focus shifting to international markets [68][69]

Summary of Arcus Biosciences Conference Call - September 03, 2025 Company Overview - **Company**: Arcus Biosciences (RCUS) - **Focus**: Development of innovative cancer therapies, particularly in the area of HIF-2 alpha inhibitors Key Points and Arguments Product Pipeline and Clinical Trials - **Casdatafan**: - Positioned as a best-in-class HIF-2 alpha inhibitor, with compelling data from 120 patients indicating superior efficacy compared to Merck's belzutafan [6][17] - Total addressable market estimated at $10 billion [7] - Phase 3 studies initiated, including a combination with cabozantinib (cabo) and a collaboration with AstraZeneca for frontline settings [8][10] - Expected rapid enrollment due to investigator enthusiasm [7][11] - **Domzim**: - An anti-TIGIT, anti-PD-1 combination therapy, with data to be presented at ESMO [9][10] - **Quemly**: - A CD73 inhibitor in pancreatic cancer, fully enrolled ahead of schedule, with results expected in the next 12-18 months [12][97] Competitive Landscape - **Comparison with Merck's Belzutafan**: - Casdatafan shows a lower rate of primary progression (15% vs. 35% for belzutafan) and better overall response rates (over 30% vs. just over 20%) [17][18] - Arcus believes their development strategy is superior, focusing on combining with cabo, which is more widely used and easier to manage than Merck's lenvatinib [22][24] Strategic Advantages - **Development Strategy**: - Arcus employs a cleaner statistical analysis plan with a single primary endpoint of progression-free survival (PFS) [30] - Two-to-one randomization in trials to enhance patient enrollment [32] - **Collaboration with AstraZeneca**: - Cost-sharing arrangement for a phase 1b/3 study combining Casdatafan with AstraZeneca's bispecific anti-PD-1/CTLA-4 [40][41] Upcoming Data and Events - **Investor Event**: - Scheduled for October 6, 2025, to present updated data on Casdatafan and other therapies [8] - **Data Readouts**: - Continuous flow of data expected from various studies, including OS data from the Edge Gastric study and the phase 3 study for upper GI cancers [10][66] Market Positioning - **TKI-Sparing Regimen**: - Arcus aims to shift the use of TKIs to later lines of therapy, enhancing patient quality of life by avoiding early toxicities associated with TKIs [49] Other Important Insights - **Safety Profile**: - Casdatafan is expected to have minimal overlapping toxicity with other treatments, which could make it a backbone agent in clear cell renal cell carcinoma (CCRCC) [60] - **Regulatory Landscape**: - No competing phase 3 studies currently exist for Casdatafan, positioning Arcus favorably in the market [35] Conclusion - Arcus Biosciences is in a transformative phase with multiple late-stage clinical trials and a strong competitive position against Merck's belzutafan. The company is focused on delivering innovative therapies with a favorable safety profile and robust efficacy data, aiming to capture significant market share in the oncology space.

Core Insights - Merck (MRK) is experiencing growth driven by new products and a robust pipeline, particularly in oncology, vaccines, and infectious diseases [1][2] - The company's phase III pipeline has nearly tripled since 2021, positioning it to launch around 20 new vaccines and drugs in the coming years, many of which have blockbuster potential [2][10] Pipeline and Product Development - Promising late-stage candidates include enlicitide decanoate/MK-0616 for hypercholesterolemia, tulisokibart for ulcerative colitis, and bomedemstat for blood disorders [3][6] - The CORALreef Lipids study demonstrated that enlicitide decanoate significantly reduced LDL cholesterol levels compared to placebo, meeting all primary and key secondary endpoints [4][5][10] - If approved, enlicitide decanoate could be the first oral PCSK9 inhibitor, potentially transforming LDL management [6][10] Competitive Landscape - The cholesterol management market is competitive, with existing PCSK9 inhibitors like Amgen's Repatha and Regeneron's Praluent, as well as AstraZeneca's developing oral PCSK9 inhibitor, AZD0780 [7][8] Long-Term Growth Strategy - Merck is focusing on new drug approvals to sustain growth, especially as its blockbuster Keytruda faces loss of exclusivity in 2028 [11] - New products like the 21-valent pneumococcal conjugate vaccine Capvaxive and pulmonary arterial hypertension drug Winrevair are expected to generate significant revenues [11][12] Financial Performance and Valuation - Year-to-date, Merck's shares have decreased by 14.1%, contrasting with a 0.5% decline in the industry [13] - Merck's price/earnings ratio is currently at 9.12, lower than the industry average of 14.78, indicating attractive valuation [14] - The Zacks Consensus Estimate for 2025 earnings has slightly increased, while the estimate for 2026 has decreased [15]

Core Viewpoint - Merck (MRK.US) announced positive results from the Phase III CORALreef Lipids study for Enlicitide, a treatment for hypercholesterolemia, marking the largest Phase III study completed for this drug [1] Group 1: Study Results - The CORALreef Lipids study is the largest Phase III trial completed for Enlicitide, which has previously successfully completed two other Phase III studies [1] - Enlicitide (MK-0616) is an oral cyclic peptide PCSK9 inhibitor developed by Merck [1] Group 2: Mechanism of Action - PCSK9 (proprotein convertase subtilisin/kexin type 9) is primarily expressed in the liver and is a contributor to elevated levels of "bad cholesterol" LDL-C [1] - PCSK9 binds to receptors on liver cells responsible for clearing LDL-C, resulting in a significant portion of LDL-C being unable to be absorbed [1]