Over the past year, Apple (AAPL 0.04%) and Amgen (AMGN -0.69%), two well-established companies that are part of the iconic Dow Jones Industrial Average, have faced significant headwinds. Apple is struggling due to the threat that President Donald Trump's trade agenda poses to its business, while Amgen faced a clinical setback late last year. Apple and Amgen have lagged the market over the trailing-12-month period, but despite their issues, both stocks are worth investing in for the long haul. Here's why. An ...

Summary of Viridian Therapeutics (VRDN) 2025 Conference Call Company Overview - **Company**: Viridian Therapeutics (VRDN) - **Event**: Jefferies Global Healthcare Conference - **Date**: June 04, 2025 Key Points Industry and Product Development - Viridian is focused on the treatment of Thyroid Eye Disease (TED) with its lead program involving both intravenous (IV) and subcutaneous (SUBQ) administration methods [2][23] - The company is completing phase three studies and preparing to file with the FDA [2][18] Clinical Trial Results - The main endpoints for the phase three trials include proptosis response (eye bulging), clinical activity score (pain and inflammation), and diplopia (double vision) [4][5] - The results showed significant improvement in both diplopia and proptosis, with a rapid treatment effect observed after just one infusion [6][7] - 70% of patients maintained their response at 40 weeks post-infusion, compared to Amgen's TEPEZZA, which reported a 53% response rate [8][9] Breakthrough Therapy Designation - The FDA granted breakthrough therapy designation based on rapid treatment onset and superior diplopia resolution rates compared to TEPEZZA [3][14] - Viridian's treatment showed a 20% placebo-adjusted complete resolution of diplopia, significantly higher than TEPEZZA's 3% [14][16] Regulatory and Filing Strategy - The company is awaiting the completion of the chronic study follow-up period before filing for approval [18][23] - A priority review could lead to a PDUFA date in 2026 [23][24] Subcutaneous (SUBQ) Program - The SUBQ program is currently enrolling in two phase three studies, with data expected in the first half of 2026 and a BLA filing anticipated by the end of 2026 [27][28] - The SUBQ formulation is designed for self-administration, which could significantly increase patient access and convenience [41][51] Market Dynamics and Competitive Landscape - TEPEZZA, currently the only approved treatment for TED, has seen declining sales due to initial reimbursement challenges and a lengthy treatment regimen [60][64] - Viridian aims to capture market share by offering a more convenient treatment option with fewer infusions (5 vs. 8 for TEPEZZA) and a shorter treatment duration [63][64] Future Opportunities - The company is optimistic about its potential to become a commercial entity in 2026, leveraging its differentiated data and the convenience of its SUBQ administration [73][74] - Viridian is also developing an FcRn program, targeting multiple indications with a focus on IgG suppression, which could further expand its market opportunities [78][79] Conclusion - Viridian Therapeutics is positioned for significant growth with its innovative treatment for TED and ongoing development of its SUBQ program, alongside a promising FcRn initiative. The company is set to capitalize on the current market dynamics and the shortcomings of existing therapies.

Core Viewpoint - Amgen (AMGN) reported strong first-quarter earnings and sales for 2025, with total revenues increasing by 9% year over year and product revenues rising by 11% to $7.87 billion, driven by volume growth despite price declines [1][2][3] Revenue Performance - Total revenues rose 9% year over year, with product revenues increasing 11% to $7.87 billion, reflecting strong volume growth across all areas [1][2] - Sales of key products such as Prolia, Xgeva, Repatha, Blincyto, and Evenity exceeded estimates, with 14 products achieving double-digit volume growth [3][4] Key Drug Performance - Repatha generated $656 million in sales, up 27% year over year, with volume growth of 41% offset by a 9% price decline [4] - Evenity recorded sales of $442 million, a 29% increase year over year, driven by strong demand [5] - Prolia revenues reached $1.1 billion, up 10% from the previous year, as higher volumes mitigated lower pricing impacts [5] Rare Disease Drug Sales - Sales of rare disease drugs rose 3% year over year to $1 billion, with Tepezza and Krystexxa impacted by U.S. wholesaler inventory changes [8][9] - Tepezza sales declined 10% to $381 million, while Krystexxa remained flat at $236 million; Uplizna grew 14% to $91 million, and Tavneos saw a 76% increase to $90 million [9] Oncology Portfolio - Amgen's oncology portfolio grew 10% year over year, generating over $2 billion in sales, with Blincyto as a key driver at $370 million, up 52% [10][11] - Xgeva delivered revenues of $566 million, while Kyprolis saw a 14% decline to $324 million due to competitive pressures [11] Biosimilars Contribution - Biosimilar portfolio sales increased by 35% year over year to $735 million, with new products like Wezlana contributing significantly [12][13] - Wezlana generated $150 million in sales, while Pavblu brought in $99 million [13] Inflammation Drugs - Otezla sales were $437 million, up 11%, while Enbrel revenues declined 10% to $510 million, with both products beating estimates [15] Overall Conclusion - Amgen's key medicines, including Evenity, Repatha, and Blincyto, drove sales growth, offsetting declines from oncology biosimilars and established products like Enbrel [16] - Increased pricing pressures and competition are expected to impact sales of several products, with potential revenue headwinds from brands like Otezla and Lumakras [17]

Financial Data and Key Metrics Changes - Revenue grew 9% year over year, reaching $8.1 billion, with volume growth of 14% reflecting increased patient demand for innovative medicines [4][49] - Non-GAAP operating expenses rose 4%, with R&D expenses increasing by 12% year over year [50] - Non-GAAP operating margin was 45.7%, above previous guidance due to timing of R&D spending [50] Business Line Data and Key Metrics Changes - General Medicine saw Repatha sales increase by 27% year over year, generating $656 million in Q1 [18] - Rare Disease portfolio grew 3% year over year, delivering $1 billion in sales, with TEPEZZA and KRYSTEXXA impacted by U.S. wholesaler inventory changes [23] - Oncology portfolio generated over $2 billion in sales, growing 10% year over year, driven by the bispecific T cell engager platform [28] Market Data and Key Metrics Changes - U.S. product sales grew 14%, with 14 products delivering double-digit growth [17] - Repatha sales outside the U.S. increased by 29% year over year, reaching $442 million [21] - Evenity sales in the U.S. grew 36% year over year, with Prolia sales reaching nearly $1.1 billion [22][23] Company Strategy and Development Direction - The company is focused on addressing large underserved patient populations with multiple products, particularly in general medicine and rare diseases [5][6] - Continued investment in manufacturing and R&D, with nearly $5 billion invested in U.S. capital projects since 2017 [14][58] - The company aims to maintain leadership in biosimilars and innovative therapies while navigating potential tariff and tax changes [13][58] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, citing strong patient demand and ongoing product launches [16] - The company is well-positioned to deliver innovation and growth, despite operating in a volatile environment [16] - Management reaffirmed 2025 revenue guidance of $34.3 billion to $35.7 billion and non-GAAP EPS guidance of $20 to $21.2 [54] Other Important Information - The company generated $1 billion in free cash flow in Q1, reflecting operational momentum [51] - The FDA granted breakthrough therapy designation for blinatumomab for subcutaneous treatment of B-ALL [11][46] - The company is advancing multiple Phase 3 studies across various therapeutic areas, including obesity and rare diseases [36][42] Q&A Session Summary Question: What should be expected at ADA regarding Meritide? - Management highlighted strong efficacy and tolerability data from Phase II studies, with a focus on mechanistic insights and ongoing Phase III trials [62][64] Question: What is the commercial strategy for Aplisna in IgG4? - The company is excited about being the first approved therapy for IgG4, with a focus on engaging rheumatologists and leveraging its experience in autoimmune diseases [68][70] Question: How does the company view competition from oral obesity medications? - Management expressed confidence in Meritide's efficacy and tolerability, noting that while oral medications may enter the market, Meritide's unique dosing schedule provides a competitive advantage [80][84] Question: How is Repatha performing against competitors like Lecvio? - Management acknowledged competition but emphasized Repatha's strong profile and ongoing efforts to improve access and affordability for patients [88][90] Question: What is the expected uptake of Tableau following the Q code implementation? - The company reported positive reception of PABLUE among retina specialists and is working on contracting with larger groups [95] Question: How is the company addressing payer dynamics in the obesity market? - Management is focused on ensuring broad access to obesity medications and is monitoring recent changes in the payer environment [99]

Financial Data and Key Metrics Changes - The company reported revenues of $8.1 billion for Q1 2025, reflecting a 9% year-over-year increase, driven by 14% volume growth from key brands [48] - Non-GAAP operating expenses rose by 4%, with R&D expenses increasing by 12% year-over-year, indicating continued investment in the late-stage pipeline [49] - The non-GAAP operating margin was 45.7%, above previous guidance due to the timing of R&D spending [49] Business Line Data and Key Metrics Changes - Global product sales grew by 11% year-over-year, with the U.S. market showing a 14% increase [18] - Repatha sales increased by 27% year-over-year, reaching $656 million in Q1, driven by improved access and prescriber engagement [19] - The rare disease portfolio grew by 3% year-over-year, generating $1 billion in sales, although sales of TEPEZZA and KRYSTEXXA were impacted by changes in U.S. wholesaler inventory levels [23] Market Data and Key Metrics Changes - The biosimilars portfolio generated $735 million in sales, a 35% increase year-over-year, with PABLUE sales reaching $99 million [31] - Evenity sales grew by 36% in the U.S., highlighting the potential for further market penetration as fewer than 250,000 patients have been treated to date [22] - The oncology portfolio, including products like BLINCYTO and IMDELTRA, grew by 10% year-over-year, generating over $2 billion in sales [29] Company Strategy and Development Direction - The company is focused on addressing large underserved patient populations in general medicine, rare diseases, and oncology, with multiple product launches and positive clinical trial data [5][6] - There is a commitment to innovation, with significant investments in R&D and manufacturing capacity in the U.S. [14][56] - The company aims to adapt to potential changes in tariffs and taxes while maintaining long-term growth strategies [13][55] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, citing strong patient demand for innovative medicines and the successful execution of multiple Phase 3 studies [16] - The company reaffirmed its 2025 total revenue guidance in the range of $34.3 billion to $35.7 billion, along with non-GAAP earnings per share guidance between $20 and $21.2 [52] - Management acknowledged the competitive landscape but emphasized the unique value propositions of their products, particularly in the PCSK9 category [88] Other Important Information - The company has invested nearly $5 billion in U.S. capital projects since 2017 and announced an additional $2 billion in expansions in Ohio and North Carolina [14] - The integration of Horizon is progressing well, with expectations to achieve $500 million in pre-tax cost synergies by the end of the year [49] Q&A Session Summary Question: What should be expected at ADA regarding Meritide? - Management highlighted strong efficacy and tolerability data from Phase II studies, with a focus on new mechanistic data to be presented at ADA [60][62] Question: What is the commercial strategy for Uplenza in IgG4? - The company is excited about being the first approved therapy for IgG4, with a focus on engaging rheumatologists and leveraging its existing presence in inflammation and autoimmune diseases [68][70] Question: How does the company view competition from oral obesity medications? - Management acknowledged the competition but emphasized the unique dosing schedule and efficacy of Meritide, which they believe will maintain its competitive edge [82][84] Question: What is the outlook for Repatha amidst increasing competition? - The company recognizes competition but believes Repatha has the best profile in the PCSK9 category, with ongoing efforts to improve access and affordability for patients [88][90]

Q1 '25 Earnings Call May 1, 2025 Safe Harbor Statement This presentation contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla® (a ...

Amgen (AMGN) will report first-quarter 2025 results on May 1, after market close. In the last reported quarter, the company beat earnings expectations by 5.57%. The Zacks Consensus Estimate for first-quarter sales and earnings is pegged at $7.96 billion and $4.16 per share, respectively. (Find the latest earnings estimates and surprises on Zacks Earnings Calendar.)Factors to Consider for AmgenAmgen’s product sales are expected to have been driven by strong volume growth of products like Evenity, Repatha, Ky ...

Core Viewpoint - The current economic environment presents a favorable opportunity for investors to consider solid dividend stocks, which tend to be more resilient than non-dividend-paying companies amid market volatility and potential recession [1]. Group 1: Dividend Stocks Overview - Four recommended dividend-paying stocks during the current market sell-off are AbbVie, Amgen, Bristol Myers Squibb, and Zoetis [2]. Group 2: AbbVie - AbbVie is recognized for its strong position in immunology, despite facing challenges such as a patent cliff and clinical setbacks [3]. - The company has increased its 2027 revenue guidance for key products Skyrizi and Rinvoq by $4 billion to over $31 billion, indicating strong growth potential [4]. - AbbVie has a robust pipeline and a history of increasing dividends for 53 consecutive years, with a forward yield of 3.9%, significantly above the S&P 500 average of 1.3% [5]. Group 3: Amgen - Amgen's shares faced a decline due to underperformance of its weight loss candidate, MariTide, but the company has a strong portfolio with over 10 blockbuster drugs [6]. - Key growth drivers include asthma medicine Tezspire and FDA-approved Tepezza for thyroid eye disease, supporting a strong revenue outlook [7]. - Since initiating dividends in 2011, Amgen has increased payouts by 750%, with a forward yield exceeding 3.5% [8]. Group 4: Bristol Myers Squibb - Bristol Myers is facing significant patent cliffs, particularly for its best-sellers Opdivo and Eliquis, but has managed to secure new approvals to mitigate revenue loss [9]. - Newer medicines like Reblozyl and Opdualag are expected to drive future sales growth [10]. - The company has increased its dividend by nearly 68% over the past decade, offering a yield of 5.1% [11]. Group 5: Zoetis - Zoetis, a leader in animal health, started the year with disappointing guidance but has a strong portfolio with 15 products generating over $100 million in annual sales [12]. - The company is expected to overcome current challenges with its key product Apoquel and has new approvals in the pipeline to drive growth [13]. - Zoetis has increased its dividends by about 500% over the past decade, although its yield is 1.4% [14].