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    Bristol-Myers Squibb Co (BMY)

    Business Description

    Bristol-Myers Squibb Company (BMS) is a global biopharmaceutical company dedicated to discovering, developing, licensing, manufacturing, marketing, distributing, and selling innovative medicines that help patients overcome serious diseases . The company operates in a single business segment, focusing on therapeutic areas such as oncology, hematology, immunology, cardiovascular, and neuroscience . BMS's product portfolio includes in-line products, a new product portfolio, and recent loss of exclusivity (LOE) products .

    1. In-line Products - Comprises well-established brands like Eliquis and Opdivo, contributing significantly to the company's revenue.
    2. New Product Portfolio - Includes rapidly growing drugs such as Reblozyl, Opdualag, and Camzyos, showing substantial growth in recent years.
    3. Recent Loss of Exclusivity (LOE) Products - Consists of products like Revlimid, which have experienced revenue decline due to generic competition.

    Q2 2024 Summary

    Initial Price$54.17April 1, 2024
    Final Price$41.30July 1, 2024
    Price Change$-12.87
    % Change-23.76%

    What went wrong

    • Immunology products like Sotyktu are underperforming expectations due to slower-than-expected market access and intense competition, with performance being "slower than we would like" and challenges in gaining preferred status with PBMs.
    • Key growth drivers are facing increasing competition, with competitors running head-to-head trials that may lead to drugs with better efficacy than BMY's Sotyktu and Opdualag, and the market is becoming "more crowded and competitive over time."
    • The company is moving away from providing long-term targets or floor guidance, potentially indicating uncertainty about future revenue streams, which may concern investors seeking visibility into future performance, especially given upcoming challenges like patent expirations and the impact of the IRA.

    Q&A Summary

    1. IRA Impact on Eliquis
      Q: Any updates on IRA negotiations for Eliquis?
      A: We have received the government's final MFP price for Eliquis and expect CMS to publish it by September 1. Once published, we'll provide more details on the impact. Having seen the final price, we're increasingly confident in our ability to navigate the impact of the IRA on Eliquis, which remains important for patients and the company in the short to medium term.

    2. Sotyktu Performance and Pricing
      Q: How is Sotyktu's pricing and performance outlook?
      A: Sotyktu's performance has been slower than we'd like, but we're focused on improving it. We've increased access from 25% to 65% as of July 1, covering over 100 million lives. Further access improvements are expected in January. While there will be a modest increase in gross to net due to rebates for improved access, this is offset by increased volume. We're committed to making this a big product as we move into 2025.

    3. Business Development Strategy
      Q: What's your capacity and focus for business development?
      A: Business development remains a priority. We're focused on executing recent deals, like preparing for the KarXT launch. Paying down debt is also a top priority. We're interested in deals that make strategic and financial sense, focusing on therapeutic areas where we have a right to win. We plan to pursue bolt-on deals and partnerships. We're monitoring the obesity market but are currently focusing on our highlighted areas.

    4. Opdivo Subcutaneous Launch
      Q: How will the Opdivo subcutaneous version impact the business?
      A: We anticipate the PDUFA date for Opdivo subcutaneous in late December. We aim to convert at least 30%–40% of the total U.S. Opdivo IV business before the 2028 LOE. This new formulation benefits patients with less than 5-minute infusion time and frees up chairs for physicians. We expect both subcutaneous and IV versions to continue into the next decade, extending our leading IO franchise into the early 2030s.

    5. Cendakimab Launch Plans
      Q: When can we expect the cendakimab launch?
      A: We recently had a positive Phase III study for cendakimab in Eosinophilic Esophagitis (EO), meeting both primary endpoints. We've just received the data and are analyzing it. In the U.S., there are about 300,000 treated EO patients with low treatment rates. We expect cendakimab to be positioned behind Dupixent, and we're preparing to share data with regulatory authorities and present at an upcoming meeting.

    6. Breyanzi Performance
      Q: Can you discuss Breyanzi's strong quarter and outlook?
      A: Breyanzi sales increased over 50% versus prior year in Q2. We've expanded manufacturing capacity, putting us in a stronger position to meet demand. Growth will continue, driven by our leading indication in LBCL and recent expanded indications. Breyanzi is increasingly recognized as a best-in-class CD19 therapy.

    7. Operating Margin Outlook
      Q: How should we think about 2025 operating margins?
      A: We remain committed to an operating margin greater than 37%. We saw strength in our gross margins with a favorable mix, and our operational efficiency programs give us flexibility in maintaining those margins.

    8. Part D Redesign Impact
      Q: How will Medicare Part D redesign affect your products?
      A: We'll see favorability with Eliquis due to the Part D redesign, notably the elimination of the coverage gap, partially offset by increased responsibility in the catastrophic phase for products like Revlimid and Pomalyst. Overall, when looking at Part D redesign across the portfolio, we think it offsets and will largely move on.

    9. Milvexian and FXIa Program
      Q: Any concerns with Milvexian after competitor data?
      A: We're confident in our Milvexian program. We chose doses based on prior learnings, including 100 mg BID for single agent. Independent investigators have shown differentiation between asundexian and Milvexian. Enrollment continues well in AF, secondary stroke prevention, and ACS trials, and we're looking forward to readouts.

    10. Camzyos Performance
      Q: Can you discuss Camzyos patient growth trends?
      A: We're seeing steady and consistent growth with approximately 1,300 patients added quarter-over-quarter. Physician and patient feedback remains positive. We're increasing our user base in large COEs and expanding prescribing in smaller institutions and community practices. We're deploying additional community representatives to drive treatment.

    11. PRMT5 Data Expectations
      Q: What will we see from the PRMT5 readout?
      A: We plan to present data from our PRMT5 program this year at a medical conference, including responses across multiple tumor types. This will help as we initiate Phase II studies in selected patients with MTAP deletions.

    12. Radiopharma Strategy
      Q: How do you view the radiopharma opportunity with RayzeBio?
      A: We're excited about the RayzeBio platform, which includes a robust IND engine and a state-of-the-art manufacturing facility. While the lead program Rayze 101 in GAP-NET is a modest opportunity, the actinium-based radiopharmaceutical platform has potential across a host of solid tumors. We look forward to launching Rayze 101 and advancing new INDs in the back half of the decade and beyond.

    13. CELMoDs Positioning
      Q: How will your CELMoDs compete in multiple myeloma?
      A: Our CELMoDs, Iberdomide and Mezigdomide, are in development across four Phase III trials with readouts in 2026. We're focusing on multidrug regimens for better outcomes. Mezigdomide is going head-to-head versus pomalidomide, and Iberdomide is being studied in combinations and as maintenance after transplant versus Revlimid. We believe they will play roles, especially in patients not eligible for cell therapies, providing manageable toxicities and more options for physicians.

    14. Sotyktu Competitive Landscape
      Q: How will Sotyktu fare against new competitors?
      A: We recognize psoriasis is a highly competitive category that will become more crowded over time. Sotyktu has set a high bar for new orals. We're preparing for competition and plan to have several indications, including psoriatic arthritis (PsA) and SLE, which will help accelerate Sotyktu's growth. We're focused on growing this important brand.

    15. CAR NEX-T Data
      Q: Any updates on the CAR NEX-T program?
      A: We have two ongoing studies with our CD19 NEX-T therapy. One enrolls patients with advanced systemic lupus erythematosus and other autoimmune diseases; the other enrolls patients with multiple sclerosis. We aim to achieve remission, allowing patients to discontinue treatments like glucocorticoids and immunosuppressants. We look forward to presenting data and progressing the program.

    Revenue by Segment - in Millions of USDFY 2013Q1 2014Q2 2014Q3 2014Q4 2014FY 2014Q1 2015Q2 2015Q3 2015Q4 2015FY 2015Q1 2016Q2 2016Q3 2016Q4 2016FY 2016Q1 2017Q2 2017Q3 2017Q4 2017FY 2017Q1 2018Q2 2018Q3 2018Q4 2018FY 2018Q1 2019Q2 2019Q3 2019Q4 2019FY 2019Q1 2020Q2 2020Q3 2020Q4 2020FY 2020Q1 2021Q2 2021Q3 2021Q4 2021FY 2021Q1 2022Q2 2022Q3 2022Q4 2022FY 2022Q1 2023Q2 2023Q3 2023Q4 2023FY 2023Q1 2024Q2 2024Q3 2024
    In-Line Products--------
    - Eliquis3,4233,2042,7052,87412,2063,7203,4163,002
    - Opdivo2,2022,1452,2752,3879,0092,0782,3872,360
    - Orencia7649279259853,601798948936
    - Pomalyst/Imnovid832847872893,441865959898
    - Yervoy5085855795662,238583630642
    - Sprycel4294585175261,930374424290
    - Mature and other brands467472476481,895---
    New Product Portfolio--------
    - Reblozyl206234248321,008354425447
    - Opdualag11715416619627206235233
    - Abecma1471329314728295124
    - Zeposia78100123133434110151147
    - Breyanzi7110092101364107153224
    - Camzyos2946688823184139156
    - Sotyktu16256663170445366
    - Onureg34444347168---
    - Inrebic25272929110---
    - Augtyro----16710
    Recent LOE Products--------
    - Revlimid1,7501,4681,4291,456,0971,6691,3531,412
    - Abraxane2392582602471,004217231253
    Other Growth Products-----319341433
    Other Legacy Products-----228222225
    Total Revenue11,33711,22610,96611,47745,00611,86512,20111,892
    Revenue by Geography - in Millions of USDFY 2013Q1 2014Q2 2014Q3 2014Q4 2014FY 2014Q1 2015Q2 2015Q3 2015Q4 2015FY 2015Q1 2016Q2 2016Q3 2016Q4 2016FY 2016Q1 2017Q2 2017Q3 2017Q4 2017FY 2017Q1 2018Q2 2018Q3 2018Q4 2018FY 2018Q1 2019Q2 2019Q3 2019Q4 2019FY 2019Q1 2020Q2 2020Q3 2020Q4 2020FY 2020Q1 2021Q2 2021Q3 2021Q4 2021FY 2021Q1 2022Q2 2022Q3 2022Q4 2022FY 2022Q1 2023Q2 2023Q3 2023Q4 2023FY 2023Q1 2024Q2 2024Q3 2024
    United States8,0337,8917,6288,00331,5558,4768,8018,232
    Europe--------
    Rest of the World--------
    International3,1493,1603,1533,2912,7523,1903,2243,389
    Other155175185184699199176271
    Total Revenue11,33711,22610,96611,47745,00611,86512,20111,892

    Executive Team

    NamePositionStart DateShort Bio
    Christopher BoernerChief Executive OfficerNovember 1, 2023Christopher Boerner, Ph.D., has been serving as the CEO since November 1, 2023. He was previously the Executive Vice President and Chief Operating Officer from April 2023 to October 2023 .
    Giovanni CaforioExecutive Chairman of the BoardNovember 1, 2023Giovanni Caforio, M.D., has been the Executive Chairman since November 1, 2023. He was the CEO from May 2015 to October 2023 and has been a director since 2014 .
    David V. ElkinsExecutive Vice President and Chief Financial Officer2019David V. Elkins has served as EVP and CFO since 2019. He was previously the CFO at Celgene Corporation from 2018 to 2019 .
    Cari GallmanExecutive Vice President, Corporate Affairs2023Cari Gallman has been EVP, Corporate Affairs since 2023. She was previously the Senior Vice President, Chief Compliance Officer from 2021 to 2023 .
    Sharon GreenleesSenior Vice President, Corporate Controller2022Sharon Greenlees has served as SVP, Corporate Controller since 2022. She was previously at AbbVie Inc. as Vice President and Controller, R&D Finance and Operations from 2021 to 2022 .
    Samit HirawatExecutive Vice President, Chief Medical Officer, Head of Development2023Samit Hirawat, M.D., has been EVP, Chief Medical Officer, and Head of Development since 2023. He was previously EVP, Chief Medical Officer, Head of Global Drug Development from 2019 to 2023 .
    Lynelle HochPresident, Cell Therapy Organization2023Lynelle Hoch has been President, Cell Therapy Organization since 2023. She was previously the Senior Vice President, Global Cell Therapy Franchise Lead from 2021 to 2023 .
    Adam LenkowskyExecutive Vice President, Chief Commercialization Officer2023Adam Lenkowsky has served as EVP, Chief Commercialization Officer since 2023. He was previously the Senior Vice President, Head of Major Markets from 2022 to 2023 .
    Sandra LeungExecutive Vice President, General Counsel2015Sandra Leung has been EVP and General Counsel since 2015. She is a member of the Leadership Team .
    Greg MeyersExecutive Vice President, Chief Digital and Technology Officer2022Greg Meyers has served as EVP, Chief Digital and Technology Officer since 2022. He was previously the Group Chief Information and Digital Officer at Syngenta Group from 2018 to 2022 .
    Robert PlengeExecutive Vice President, Chief Research Officer, Head of Research2023Robert Plenge, M.D., Ph.D., has been EVP, Chief Research Officer, and Head of Research since 2023. He joined BMY as part of the acquisition of Celgene Corporation in November 2019 .
    Amanda PooleExecutive Vice President, Chief Human Resources Officer2024 (expected)Amanda Poole has been EVP, Chief Human Resources Officer since 2024. She was previously the Senior Vice President, People Strategy, Solutions & Services from 2022 to 2024 .
    Karin ShanahanExecutive Vice President, Global Product Development & Supply2022Karin Shanahan has served as EVP, Global Product Development & Supply since 2022. She was previously the Senior Vice President of Global Biologics and Sterile Operations at Merck & Co., Inc. from 2018 to 2022 .
    Michael R. McMullenIndependent DirectorJuly 1, 2024Michael R. McMullen has served as an Independent Director since July 1, 2024. There is no specific information available regarding his membership in the Audit Committee .
    Phil HolzerSenior Vice President and ControllerN/APhil Holzer serves as the Senior Vice President and Controller. He is listed as an officer in the company's SEC filings, specifically in a Form 3 document filed on February 23, 2024 .

    Questions to Ask Management

    1. Given the challenges you've faced with Sotyktu and Zeposia in the immunology space, particularly regarding market access and competition from IL-23 inhibitors, can you explain what specific actions you're taking to improve performance and overcome these hurdles?

    2. With the upcoming impact of the Inflation Reduction Act on Eliquis and potential price pressures on non-rebated drugs like Opdivo, how are you strategically preparing for these changes, and what can you share about the negotiations and their implications for your portfolio?

    3. As you've become more aggressive in business development while prioritizing programs to control costs, what is your current capacity for further deals, and are you considering expanding into new areas such as obesity treatments?

    4. Competitors are advancing therapies that claim superior efficacy to your growth drivers like Sotyktu and Opdualag, some even conducting head-to-head trials; how are you positioning your products to maintain market share amid this increasing competition?

    5. With several clinical readouts expected in multiple myeloma by 2026, including your CELMoD agents Iberdomide and Mezigdomide, how do you plan to position these therapies in an increasingly crowded market to ensure they stand out both clinically and commercially?

    Share Repurchase Program

    Program DetailsProgram 1Program 2Program 3Program 4Program 5
    Approval DateMay 2010 February 2020 January 2021 December 2021 December 2023
    End Date/DurationN/AN/AN/AN/AN/A
    Total Additional Amount$3.0 billion $5.0 billion $2.0 billion $15.0 billion $3.0 billion
    Remaining AuthorizationN/AN/AN/AN/A$5.0 billion
    DetailsN/AN/AN/AN/AN/A

    Past Guidance

    Q2 2024 Earnings Call

    • Issued Period: Q2 2024
    • Guided Period: FY 2024
    • Guidance:
      1. Revenue Growth: Full-year revenue expected to achieve low single-digit growth, anticipated at the upper end of this range.
      2. Gross Margin: Raised to reflect the impact of sales mix.
      3. Operating Expenses: Expected at the upper end of a low single-digit percentage increase range.
      4. Operating Margin: Target for the full year remains at least 37%.
      5. Other Income & Expenses (OI&E): Annual expenses expected to be approximately $50 million.
      6. Tax Rate: Estimated underlying tax rate expected to be about 18%.
      7. Non-GAAP EPS: Range raised to between $0.60 and $0.90 .

    Q1 2024 Earnings Call

    • Issued Period: Q1 2024
    • Guided Period: FY 2024
    • Guidance:
      1. Revenue: Expected to increase in the low single-digit range.
      2. Gross Margin: Expected to be approximately 74%.
      3. Operating Expenses: Expected to increase in the low single-digit range.
      4. Operating Margin: Target at least 37%.
      5. Other Income & Expense (OI&E): Expected to be approximately $250 million.
      6. Tax Rate: Full-year underlying tax rate expected to be about 18%.
      7. Non-GAAP EPS Guidance: Range of $7.10 to $7.40.
      8. Cost Savings: Anticipated cost savings of approximately $1.5 billion by the end of 2025 .

    Q4 2023 Earnings Call

    • Issued Period: Q4 2023
    • Guided Period: FY 2024
    • Guidance:
      1. Non-GAAP EPS: Expected to be within the range of $7.10 to $7.40.
      2. Revenue Growth: Expected to increase in a low single-digit range.
      3. Gross Margin: Expected to be approximately 74%.
      4. Operating Expenses: Expected to increase in a low single-digit range.
      5. Operating Margin: Targeted to be at least 37%.
      6. Other Income & Expense (OI&E): Expected to be approximately $250 million.
      7. Tax Rate: Projected to be approximately 17.5% .

    Q3 2024 Earnings Call

    • Issued Period: Q3 2024
    • Guided Period: N/A
    • Guidance: The documents do not contain information about the Q3 2024 earnings call for Bristol-Myers Squibb (BMY). Therefore, I cannot provide the guidance metrics from that specific earnings call.