Summary of Key Points from the Conference Call Industry Overview - **Industry**: Biopharma in North America - **Market Analysis**: The latest weekly Total Prescription (TRx) year-over-year (YoY) growth for the week ending March 28, 2025, was +2.1%, a decrease from +2.5% the previous week and +3.1% over the past 12 weeks [1][2] Core Insights - **TRx Growth**: For the week ended March 28, the US total market weekly TRx YoY change was +2.1%, compared to +0.4% a year ago. The rolling 4-week TRx YoY was +2.9%, and the rolling 12-week TRx YoY was +3.1% [2] - **Extended Unit Growth**: Extended unit (EUTRx) weekly YoY growth was +0.7%, which is below the TRx YoY growth [2] - **Sequential Growth**: Sequential weekly TRx growth was -1.8%, compared to -1.5% the week before [2] Company-Specific Developments - **Bristol Myers Squibb (BMY)**: - Cobenfy, approved for schizophrenia on September 26, 2024, had approximately 1,570 scripts for the week, up from ~1,440 the previous week. To meet 2025 consensus expectations, Cobenfy TRx needs to track at ~2-3 times the volumes from recent schizophrenia launches [3] - The consensus estimate for Cobenfy has declined to $160 million from $196 million, implying ~125K TRx are required to meet this estimate [3] - **Vertex Pharmaceuticals (VRTX)**: - Journavx, approved for acute pain on January 30, 2025, recorded approximately 2,230 scripts for the week, up from ~1,760 the previous week. To achieve the 2025 sales estimate of $87 million, approximately 229K and 441K total scripts are needed for 14-day and 7-day script durations, respectively [4] Competitive Landscape - **Biosimilars**: The TRx share chart for Stelara biosimilars was added, with Amgen's Wezlana launched on January 17, 2025, and Teva/Alvotech's Selarsdi launched on February 21, 2025 [5] - **Launch Comparisons**: A comparison chart for Descovy vs. Apretude was added, with anticipation for FDA approval of GILD's Lenacapavir [8] Seasonal Trends - **Vaccine Tracking**: Seasonal respiratory vaccine tracking exhibits were added, noting that RSV vaccine volumes are tracking ~65% below last year's levels, and COVID vaccine volumes are also down year-over-year [9] Notable Drug Performance - **Key Products**: - Mounjaro and Zepbound from Eli Lilly are being tracked, with Mounjaro showing significant growth [10] - The oral psoriasis market is being monitored, particularly BMY's Sotyktu launch against AMGN's Otezla [10] Pricing and Market Dynamics - **Immunology Pricing Analysis**: Updated charts for 4Q24 show how volume from additional indications impacts price per script for various drugs [11] - **Biosimilar Adoption**: Comprehensive analysis of biosimilar adoption across various branded drugs was presented [12] Additional Insights - **Market Trends**: The IQVIA databases differentiate between prescription and sales trends, with TRx representing total prescriptions dispensed, including refills [27] - **Sales Dynamics**: The report emphasizes that IQVIA sales dollars reflect list prices and do not account for rebates or discounts, indicating a need for careful interpretation of sales data [43] This summary encapsulates the key points from the conference call, highlighting industry trends, company-specific developments, and competitive dynamics within the biopharma sector.

Core Viewpoint - Amgen's drug Uplizna has received FDA approval for a new indication to treat immunoglobulin G4-related disease (IgG4-RD), marking it as the first and only FDA-approved treatment for this condition [1][2]. Group 1: Drug Approval and Market Impact - Uplizna is now approved for treating adults with IgG4-RD, a chronic disease with significant unmet medical needs [2]. - The approval is based on the phase III MITIGATE study, which demonstrated an 87% reduction in the risk of flares compared to placebo [3][4]. - Year to date, Amgen's shares have increased by 18.9%, outperforming the industry average rise of 1.2% [2]. Group 2: Clinical Study Insights - The MITIGATE study's primary endpoint was to assess the time to first flare in patients with IgG4-RD [3]. - In the study, 58.8% of Uplizna-treated participants achieved flare-free, corticosteroid-free, and complete remission at week 52, compared to 22.4% in the placebo group [4]. Group 3: Future Developments - Amgen is also exploring Uplizna for generalized myasthenia gravis (gMG) and plans to submit a regulatory filing for this indication by the first half of 2025 [5][6]. - Uplizna generated sales of $379 million in 2024, and further label expansions are expected to drive sales growth in future quarters [6].

Core Viewpoint - The Trump administration's recent tariffs have significantly impacted the stock market, with pharmaceuticals and biotech being relatively less affected compared to other sectors [1][2]. Industry Impact - The stock market experienced one of its worst trading days, with the S&P 500 dropping by 4.8%, while Catalyst Pharmaceuticals and Veeva Systems saw smaller declines of 1.5% and 2%, respectively. Notably, Amgen and AstraZeneca reported gains of 1.5% and 2.4% [2]. - The pharmaceutical sector was notably absent from the list of tariffs, which had initially included a proposed 25% duty on foreign pharmaceutical manufacturers [3][4]. Future Considerations - The exemption from tariffs is temporary, and there are indications that the administration may soon impose tariffs specifically targeting pharmaceutical exports [4][5]. - The pharmaceutical industry has powerful lobbyists advocating for reduced tariffs, which may have influenced the temporary exemption [5][6]. Regulatory Developments - Despite the looming threat of tariffs, the pharmaceutical industry continues to announce positive developments, such as Amgen's FDA approval for its Uplizna drug to treat IgG4-related disease, marking a significant advancement for patients [9][10]. - The approval of Uplizna is expected to reduce reliance on long-term steroid use for patients, highlighting the industry's ongoing commitment to regulatory approvals and medication development [10].

Core Insights - Amgen's UPLIZNA has received FDA approval as the first and only treatment for adults with Immunoglobulin G4-related disease (IgG4-RD), addressing a significant unmet medical need in this chronic and debilitating condition [1][2][8] Company Developments - The approval of UPLIZNA is a pivotal moment for patients and healthcare providers, offering a proven treatment that targets a key driver of IgG4-RD, thereby reducing the risk of flares and reliance on long-term steroid use [2][3] - UPLIZNA's efficacy is supported by data from the MITIGATE trial, which demonstrated an 87% reduction in the risk of IgG4-RD flares compared to placebo [9] - UPLIZNA is also indicated for the treatment of AQP4-IgG+ Neuromyelitis Optica Spectrum Disorder (NMOSD) and has received Orphan Drug Designation for generalized myasthenia gravis (gMG), with regulatory filings for gMG expected to be completed in H1 2025 [1][8] Clinical Trial Insights - The MITIGATE trial was the first randomized, double-blind, placebo-controlled trial for IgG4-RD, showing significant reductions in disease activity and flares among patients treated with UPLIZNA [4][5] - Key findings from the trial include that 57.4% of UPLIZNA-treated participants achieved flare-free, treatment-free, and complete remission at Week 52, compared to 22.4% in the placebo group [9] - UPLIZNA-treated patients experienced a ten-fold reduction in mean total glucocorticoid use for disease control compared to those on placebo [9] Disease Background - IgG4-RD is a chronic, systemic, immune-mediated disease that can affect multiple organs and lead to fibrosis and permanent organ damage [6] - The disease is characterized by unpredictable inflammatory flares and can mimic other conditions, complicating timely diagnosis [6][7] - The prevalence of IgG4-RD is estimated at 20,000 people in the U.S., with a higher incidence in men and typical onset between ages 50 and 70 [6]

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Summary of Key Points from the Conference Call Industry Overview - **Industry**: Biopharma in North America - **Market Analysis**: Comprehensive analysis of the US drug market conducted by IQVIA Rx Key Market Metrics - **Total Prescription Year-over-Year (YoY) Growth**: - Latest weekly growth (week ending March 14, 2025) was +4.0%, up from +3.0% the previous week and +2.3% over the past 12 weeks [1][2] - For the week ended March 14, the total market weekly TRx YoY change was +4.0% compared to +1.2% a year ago [2] - Rolling 4-week TRx YoY was +3.1% and rolling 12-week TRx YoY was +2.3% [2] - Extended unit (EUTRx) weekly YoY growth was +2.2%, which is below the TRx YoY growth [2] Company-Specific Insights - **Bristol Myers Squibb (BMY)**: - Cobenfy, approved for schizophrenia on September 26, 2024, had approximately 1,340 scripts for the week, an increase from ~1,300 the previous week [3] - To meet 2025 consensus expectations, Cobenfy TRx needs to track at ~2-3x the volumes from recent schizophrenia launches, with an estimated requirement of ~125K TRx to reach consensus estimates of $160 million [3] - **Vertex Pharmaceuticals (VRTX)**: - Journavx, approved for acute pain on January 30, 2025, recorded ~1,150 scripts for the week, up from ~610 the previous week [4] - To achieve a sales estimate of $87 million, approximately 229K and 441K total scripts are needed for 14-day and 7-day script durations, respectively [4] Competitive Landscape - **Biosimilars**: - Updates on biosimilar launches including Amgen's Wezlana and Teva's Selarsdi, with respective launch dates of January 17, 2025, and February 21, 2025 [5] - **Seasonal Vaccines**: - RSV vaccine volumes are tracking ~65% below last year's levels, while COVID vaccine volumes are also down year-over-year [9] Notable Drug Performance - **Eli Lilly (LLY)**: - Mounjaro and Zepbound launches are being tracked, with Mounjaro showing significant growth [10] - **AbbVie**: - Humira is experiencing a decline of -41% YoY, while Rinvoq and Skyrizi are showing growth rates of 43% and 49% respectively [22][23] Additional Insights - **Market Dynamics**: - The analysis indicates that extended unit data trends were more positive than prescription trends, suggesting a shift towards longer-duration prescriptions [33] - **Sales Trends**: - The IQVIA databases differentiate between prescription and sales trends, with TRx representing total prescriptions dispensed including refills [29] This summary encapsulates the critical insights from the conference call, highlighting the current state of the biopharma industry, specific company performances, and market dynamics.

Group 1 - Amgen's stock closed at $314.38, showing a decrease of -0.53% from the previous day, while the S&P 500 gained 1.77% [1] - Over the past month, Amgen's shares increased by 4.3%, outperforming the Medical sector's decline of -1.17% and the S&P 500's drop of -5.73% [1] Group 2 - Amgen's upcoming earnings report is expected to show earnings per share (EPS) of $4.18, a 5.56% increase year-over-year, with projected quarterly revenue of $8.01 billion, up 7.52% from the previous year [2] - For the entire year, Zacks Consensus Estimates forecast earnings of $20.63 per share and revenue of $35 billion, reflecting increases of +3.98% and +4.72% respectively compared to the previous year [3] Group 3 - Recent analyst estimate revisions for Amgen indicate a positive outlook for the company's business trends [4] - The Zacks Rank system, which incorporates estimate changes, currently ranks Amgen at 3 (Hold), with a Forward P/E ratio of 15.32, lower than the industry average of 18.52 [6] Group 4 - Amgen has a PEG ratio of 2.63, compared to the industry average PEG ratio of 1.51, indicating a higher valuation relative to projected earnings growth [7] - The Medical - Biomedical and Genetics industry, which includes Amgen, holds a Zacks Industry Rank of 74, placing it in the top 30% of over 250 industries [7][8]

Core Viewpoint - Amgen's stock has outperformed the industry, rising 21.7% this year compared to a 7% increase for the industry, driven by strong sales from key drugs and a robust pipeline [1][4]. Financial Performance - Amgen's total revenues increased by 19% in 2024, reaching $33.4 billion, with expectations for continued growth in 2025 from key drugs and biosimilars [4][23]. - Sales from biosimilars reached $2.2 billion in 2024, marking a 16% year-over-year increase [13]. Key Drugs and Pipeline - Key drugs driving revenue include Repatha, Evenity, Tezspire, and rare disease drugs from the Horizon acquisition, while older products like Prolia and Xgeva are expected to decline due to biosimilar competition [4][6][17]. - Amgen is evaluating several drugs for additional indications, with regulatory applications planned for Uplizna in 2025 [7]. - The company is developing MariTide, a GIPR/GLP-1 receptor, with promising phase II data showing up to 20% weight loss over 52 weeks [9][16]. Challenges and Setbacks - Amgen faces pricing headwinds and competitive pressures affecting sales of key brands like Otezla and Lumakras [5][6]. - Recent setbacks in the obesity pipeline include a clinical hold on AMG 513 and lower-than-expected weight loss results from MariTide [15][16]. Valuation and Estimates - Amgen's shares trade at a price/earnings ratio of 15.26, slightly below the industry average of 16.85, and above its five-year mean of 13.83 [18]. - The Zacks Consensus Estimate for earnings per share for 2025 has increased from $20.36 to $20.63 over the past 60 days [25].

Group 1: Amgen - Amgen is positioned for growth with key products like Tezspire for asthma and Tepezza for thyroid eye disease, with ongoing clinical trials and international launches [3][4] - The company reported a 19% year-over-year revenue increase to $33.4 billion, with a solid 7% organic growth [4] - Amgen's pipeline includes promising candidates like MariTide for weight loss and rocatinlimab for eczema, indicating strong long-term performance potential [5] - The company offers a forward dividend yield of about 3%, significantly higher than the S&P 500 average of 1.3%, and has increased its payouts by 201% over the past decade [6] Group 2: Intuitive Surgical - Intuitive Surgical leads in robotic-assisted surgery with its da Vinci surgical system, recently launching the fifth generation of this device, which has seen strong demand [7][9] - The da Vinci 5 features improvements such as greater precision and efficiency, and a Force Feedback technology that enhances surgical accuracy [8] - The company experienced a 25% year-over-year revenue increase to $2.41 billion, with adjusted earnings per share rising from $1.60 to $2.21 [9] - Intuitive Surgical has treated 16 million patients with its systems, with a compound annual growth rate of 17% in procedure volume over the past five years, indicating sustained growth potential [10][11]