The paragraph is an introduction to Amgen's Fourth Quarter and Full Year 2024 Financial Results Conference Call, facilitated by Julienne, with opening remarks from Justin Claeys, Vice President of Investor Relations. Bob Bradway, the CEO, describes 2024 as a successful year for Amgen, highlighting the company's consistent supply to patients, quality clinical results, and business growth across various therapeutic areas and geographic regions. Looking forward, Amgen aims to achieve long-term growth amidst challenges such as regulatory changes, declining net prices, and loss of exclusivity. Despite these challenges, Amgen has historically maintained revenue and EPS growth.

The paragraph discusses the company's strategic positioning for growth in the coming decade, highlighting their focus on novel medicines aimed at addressing aging population needs. It mentions the successful market performance of 14 medicines, with specific emphasis on Repatha and EVENITY in general medicine for heart disease and osteoporosis, respectively. The company anticipates 2025 as significant for regulatory approvals of TEPEZZA and new launches for UPLIZNA in rare diseases. In inflammation, TEZSPIRE is expanding into new indications such as COPD and chronic rhinosinusitis. In oncology, their bispecific T-cell engager platform shows growth potential with BLINCYTO, IMDELLTRA, and xaluritamig advancing in treatment areas like B-ALL, small cell lung cancer, and advanced prostate cancer.

The paragraph discusses the company's progress and future plans, highlighting significant developments expected in 2025, including Phase III data readouts in various medical fields and new trials for MariTide in obesity. It emphasizes the role of AI in enhancing innovation and patient access. Reflecting on 2024, the company showed strong business performance and expects continued growth into 2030. Murdo Gordon reports a 19% increase in product sales for the year, with Repatha and EVENITY showing strong growth potential, contributing nearly $1 billion. Repatha's sales alone grew 36% in 2024, addressing a large global unmet need for LDL-C lowering treatments.

The paragraph discusses the growth potential of Repatha and EVENITY. Repatha saw significant sales and volume growth in the U.S. in 2024, driven by increased investment in primary care, improved prescriber numbers, enhanced patient education, and better access and reimbursement. Despite global competition, Repatha is expected to see less price erosion in 2025. EVENITY, which helps build bone and reduce fracture risk in postmenopausal women, also experienced a notable sales increase in 2024. However, many high-risk patients remain untreated, indicating substantial growth opportunities for EVENITY in the future.

The paragraph highlights the company's performance in various medical segments. In the U.S., EVENITY leads the bone-builder market with a 14% rise in new customers and increased prescription volume. The company has also shifted its U.S. bone field force focus to EVENITY. The rare disease portfolio, particularly TEPEZZA, achieved over $4.5 billion in sales, with TEPEZZA generating $1.9 billion and witnessing 5% growth. Efforts to expand TEPEZZA's reach include engagement with a wide prescriber base and securing regulatory approval internationally, with launches in Japan and plans for seven more countries in 2025. In the inflammation segment, TEZSPIRE saw a 71% sales increase to nearly $1 billion, driven by adoption among pulmonologists for severe uncontrolled asthma. Lastly, the oncology portfolio, including several innovative products, contributed nearly $8 billion in sales, marking an 11% increase due to both volume and pricing.

The paragraph highlights the success and growth opportunities of a bispecific T-cell engager platform, focusing on BLINCYTO and IMDELLTRA, which address needs in oncology. BLINCYTO sales increased by 41% to over $1.2 billion, with growth expected in 2025 as it becomes the standard of care for certain B-cell ALL patients. IMDELLTRA, launched for extensive-stage small cell lung cancer, generated $115 million from 2,000 patients in 7 months, with adoption driven by its efficacy. Sales of biosimilar products reached $2.2 billion in 2024, a 16% increase. The successful launch of the EYLEA biosimilar, PAVBLU, saw $31 million in sales in 9 weeks. Further launches in 2025 include WEZLANA and BEKEMV, biosimilars to STELARA and SOLIRIS, respectively.

The paragraph discusses Amgen's anticipated growth and success in 2024 due to their biosimilar portfolio and team coordination across research, development, manufacturing, and commercial operations. This collaboration is expected to help them serve more patients globally and continue expanding in 2025. James Bradner highlights their achievements in 2024, including two U.S. regulatory approvals in oncology, the completion of five positive Phase III studies, and the initiation of three new Phase III trials. The focus is on MariTide, a therapy with a unique profile offering sustained weight loss and improvements in cardiometabolic health, which has garnered strong support from key opinion leaders. Amgen aims to enhance health outcomes with an optimized dosing schedule and fewer injections.

The paragraph discusses several promising medical advancements and studies across different therapeutic areas. MariTide is showing potential as a treatment for obesity and related conditions, with Phase III studies expected in 2025. Key data from ongoing Phase II studies for MariTide and those involving type 2 diabetes and chronic weight management are anticipated in the second half of 2025. Additionally, Repatha's VESALIUS Phase III study is set to release data for cardiovascular primary prevention later this year. The olpasiran OCEAN(a) Phase III trial for cardiovascular outcomes is progressing, with plans for another study targeting individuals with elevated Lp(a) by late 2025 or early 2026. In the rare disease arena, UPLIZNA shows promise for treating rare inflammatory diseases, with its MITIGATE study data under FDA priority review for IgG4-related disease and orphan drug designation for generalized Myasthenia Gravis, based on positive Phase III results.

The paragraph discusses the progress and future potential of several treatments for various inflammatory and autoimmune conditions. UPLIZNA is highlighted for its effectiveness in reducing steroid use and upcoming potential approvals for IgG4-related disease and generalized Myasthenia Gravis. TEZSPIRE is set to begin Phase III studies targeting COPD, and submissions are underway for treating chronic rhinosinusitis. Phase III studies for rocatinlimab are ongoing for atopic dermatitis, with future exploration in asthma and prurigo nodularis. Efforts in B-cell depletion using blinatumomab and inebilizumab are focused on systemic lupus erythematosus. In oncology, key Phase III data readouts are expected in 2025, with significant developments in their BiTE portfolio, particularly BLINCYTO.

The paragraph discusses advancements in cancer therapies led by the Children's Oncology Group and other organizations. It highlights the improved 3-year disease-free survival rate achieved by adding BLINCYTO to chemotherapy for pediatric B-cell acute lymphoblastic leukemia and the development of a subcutaneous formulation for relapsed/refractory B-ALL expected to start trials in 2025. It also details the advancement of IMDELLTRA for small cell lung cancer into Phase III studies and the progress of xaluritamig, a bispecific T-cell engager, for metastatic castrate-resistant prostate cancer. The development of bemarituzumab for frontline gastric cancer therapy is also mentioned, with expected data from a Phase III study in 2025. The paragraph emphasizes the growth potential of their BiTE platform and ongoing clinical trials for these therapies.

The paragraph discusses Amgen's recent developments and financial performance. In the second half of 2025, data is expected from the FORTITUDE-102 Phase III study of bemarituzumab with chemotherapy and nivolumab. Amgen is also advancing Phase III biosimilar programs for OPDIVO, KEYTRUDA, and OCREVUS. The company reported strong execution in 2024, with total revenues of $33.4 billion, a 19% increase from the previous year, driven by strong product sales and volume growth. Non-GAAP operating margin was 47%, with an increase in R&D spending to $5.9 billion, primarily due to late-stage pipeline investments and Horizon-acquired programs. The Horizon integration is progressing well, with expected $500 million pretax cost synergies within three years and the acquisition positively impacting non-GAAP EPS for 2024.

The paragraph details the company's financial performance and strategic initiatives. In the past year, the company saw a $1.1 billion increase in non-GAAP other income and expenses, largely due to interest expenses from acquiring Horizon. They improved their financial position by retiring $4.5 billion in debt in 2024 and reduced their non-GAAP tax rate to 14.5%. The company generated $10.4 billion in free cash flow for the full year, with $4.4 billion in the fourth quarter, benefited by favorable year-end collections. They invested $1.3 billion in capital expenditures in 2024 and deployed artificial intelligence across their operations to enhance innovation. The company rewarded shareholders with a dividend of $2.25 per share, a 6% increase from 2023. Looking ahead to 2025, they anticipate revenues between $34.3 billion and $35.7 billion, with non-GAAP earnings per share ranging from $20 to $21.20, driven by growth in various therapeutic areas and portfolios.

The company anticipates that growth will offset declines due to the denosumab patent expiration and ongoing price reductions in 2025. Quarterly revenue growth rates are expected to be consistent throughout the year, with typically lower sales of Otezla and Enbrel in Q1. Biosimilar sales in the U.S. can vary significantly each quarter, with Q1 2025 AMGEVITA sales expected to match Q3 2024 levels. The company projects $1.4 billion in other revenue for 2025 and plans to boost R&D investments in late-stage projects such as MariTide and olpasiran. The non-GAAP operating margin is expected to be about 46% of product sales, with cost of sales between 18% and 19%. R&D expenses will rise in the mid-teens percentage-wise to support pipeline assets, while SG&A expenses are projected to decrease by 1-2 percentage points due to efficiency improvements and leveraging technology, including their new hub in India.

The paragraph provides a financial outlook for the organization, indicating an operating margin of around 46% and projecting a non-GAAP operating margin to be lowest at 42% in Q1, with growth expected in later quarters. Non-GAAP OI&E is anticipated to reach $2.4 billion in 2025, with a tax rate of 15-16%. Share repurchases will not exceed $500 million, and capital expenditures are estimated at $2.3 billion. The organization aims to maintain strong credit ratings and return to pre-Horizon capital structure by 2025, with free cash flow performance similar to 2023 due to various factors impacting cash flow in 2025. The long-term outlook is positive, and the paragraph concludes with gratitude to colleagues and a transition to the Q&A session.

The paragraph is a transcript from a company earnings call where executives discuss their products' sales performance and future outlook. They highlight strong sales momentum, with 10 products experiencing double-digit growth and 14 products reaching over $1 billion in annual sales. A question-and-answer session follows, where Yaron Werber from TD Cowen inquires about AMG 513, a novel investigational obesity drug in Phase I, for which the mechanism of action has not been disclosed. The conversation also touches on AMGEVITA's performance and potential growth. Courtney Breen from Bernstein asks about Repatha's strong growth and future prospects, especially in primary prevention. The moderator, Justin Claeys, seeks to manage the flow of questions due to a full queue.

Murdo Gordon discusses the positive performance and growth of Repatha in 2024, highlighting its effectiveness and accessibility for treating patients who have not optimized their LDL cholesterol levels. This growth is attributed to successful efforts in making Repatha affordable and accessible through strategic positioning on formularies and reimbursement negotiations. Gordon also addresses the upcoming competition from oral PCSK9s and emphasizes Repatha's proven benefits in preventing secondary cardiovascular events. The readout of the VESALIUS trial later this year is anticipated to further demonstrate Repatha's potential in reducing the risk of initial heart attacks or strokes.

The paragraph discusses the growth potential and market dynamics related to Amgen's cardiovascular product, Repatha, in connection with its future sales guidance for 2025. It emphasizes Repatha's role as a critical growth driver, particularly in light of the Part D redesign, which is anticipated to benefit chronic care products like Repatha by making them more affordable when patients experience capped and smooth out-of-pocket costs. The executives highlight their strong end-market portfolio, including other high-growth products and those nearing or achieving blockbuster status. They express confidence in Repatha's continued success due to its broad global access and stable pricing environment. Additionally, there is mention of the potential growth for EVENITY, indicating its current low market penetration.

The paragraph discusses the significant unmet treatment needs for high-risk patients in the U.S. and highlights the market potential of various medical products. EVENITY addresses the unmet need, while TEZSPIRE is expected to increase by 71% in 2024 with almost $1 billion in sales. The innovative oncology segment is projected to grow by 11% thanks to seven products, and rare disease treatments are expected to reach $4.5 billion, highlighting early product lifecycle potential. Biosimilars are anticipated to grow by 16%, with new launches expected and a continued strong market outlook into 2025. The discussion then shifts to Horizon products, with KRYSTEXXA showing 23% growth, UPLIZNA up 40%, TAVNEOS up 111%, and TEPEZZA up by 5%, highlighting notable growth across these treatments.

The paragraph discusses the growth prospects of a portfolio of products that are early in their life cycle, highlighting upcoming data for UPLIZNA and international expansion with TEPEZZA's approval in Japan. It notes that KRYSTEXXA, despite being part of the rare disease portfolio, addresses the non-rare condition of severe uncontrolled gout and has growth potential. The text also mentions the development of additional pipeline assets. Additionally, during a question-and-answer segment, Michael Yee from Jefferies inquires about the company's obesity asset portfolio, referencing past setbacks and asking about future plans. Robert Bradway and James Bradner respond, rejecting the notion of setbacks and emphasizing their high standards for progressing medicines beyond early clinical investigation.

The paragraph discusses a company's comprehensive efforts and confidence in tackling obesity, leveraging its strengths in cardiovascular disease, nephrology, and primary care. The company has a robust research and development pipeline, exploring both integrin and non-integrin targets, with medicines administered orally and subcutaneously. It aims to foster partnerships through external innovations and shows strong confidence in a product named MariTide. During a conference call, Robert Bradway clarifies a development issue related to another product, while expressing enthusiasm for the obesity program's pipeline. The latter part mentions a discussion about leveraging lessons from the Repatha VESALIUS-CV outcome study to benefit products like olpasiran and MariTide, with contributions in population genetics and epidemiology.

The paragraph discusses the ongoing use and studies related to Repatha for secondary prevention in high cardiovascular risk patients, focusing on the VESALIUS-CV Phase III study involving over 12,000 patients. This study's event-driven results are expected in the year's second half and will provide valuable data for improving cardiovascular outcomes. Insights from Repatha have influenced the design of the olpasiran Phase III program, with results anticipated next year. Murdo Gordon highlights synergies in LDL and Lp(a) lowering efforts, noting Lp(a) cannot be managed by lifestyle changes and lacks other effective treatments. Engage with stakeholders to ensure they understand olpasiran's profile and study design.

In the paragraph, Alex Hammond asks Amgen's Robert Bradway about the company's approach to international opportunities, particularly in China, and its appetite for mergers and acquisitions following its acquisition of Horizon. Bradway responds that Amgen continues to actively seek out valuable molecules for licensing and acquisition worldwide. Terence Flynn from Morgan Stanley expresses sympathy for those affected by wildfires near Amgen's location and inquires about the MariTide Phase II study on obesity, specifically about quarterly dosing and presentation of data. James Bradner confirms the ongoing study and mentions the upcoming presentation of Part 1 data at the ADA meeting in June. Dave Risinger from Leerink Partners then indicates he has a simple question after noting that helpful pipeline updates have been provided.

The paragraph discusses the plans for initiating a Phase III trial of olpasiran, a drug aimed at patients with elevated Lp(a) levels to prevent cardiovascular disease. The trial is expected to start in late 2025 or early 2026, reflecting the company's commitment to patient benefit despite the timeline. It also addresses the growth prospects for TEPEZZA, a drug targeting a significant patient population in Japan, where the healthcare model is expected to support its uptake, potentially mirroring the rapid growth seen in the U.S. market.

The paragraph discusses the positive outlook for TEPEZZA, highlighting its steady market penetration in Japan and its upcoming launch in seven other international markets, subject to regulatory approvals. The expansion is seen as a catalyst for the brand's growth, supported by Amgen's global reach after its acquisition. In the U.S., efforts continue to broaden the prescriber base, focusing on diagnosing and treating thyroid eye disease. The paragraph notes that while the first quarter of the year might show lower sales due to insurance re-verifications and market purchasing patterns, long-term growth looks promising. Additionally, James Shin from Deutsche Bank inquires about the MARITIME trials starting in the first half of 2025, asking about potential head-to-head comparisons with existing treatments like tirzepatide or semaglutide.

The paragraph discusses Amgen's involvement in the MARITIME Phase III program and its biosimilar business. James Bradner talks about the upcoming MARITIME program focused on various health conditions, mentioning that discussions with federal regulators are advanced but details are not yet public. Tim Anderson from Bank of America Merrill Lynch asks about Amgen's EYLEA biosimilar, PAVBLU, suggesting it could achieve significant sales. Robert Bradway acknowledges the question, emphasizing Amgen's leadership in biosimilars and highlighting their strategy to be early entrants in the market. Murdo Gordon adds that while specific sales guidance isn't provided, they are satisfied with PAVBLU's launch as the only biosimilar currently available in the market.

The paragraph discusses Amgen's success and potential with their biosimilar products, highlighting the positive feedback from retina specialists about their new prefilled syringe product. Peter Griffith emphasizes Amgen's leading position in the biosimilar market and their efficient operations, noting a 100% FDA approval success rate and significant sales achievements. The conversation then shifts to a question about the Phase III ROCKET program, where the speaker seeks insights on upcoming readouts and how these will influence Amgen's competitive stance in the atopic dermatitis market.

The paragraph discusses the ongoing research and development of rocatinlimab, a monoclonal antibody targeting the OX40 receptor, for treating atopic dermatitis. The ROCKET program includes multiple studies, such as SHUTTLE for combination therapy and IGNITE for monotherapy, with data expected in the first half of the year. Additional studies, ASCEND and ASTRO, are planned for the latter half to assess maintenance therapy and adolescent treatment. The discussion then shifts to the commercial opportunities in China, highlighting the partnership with BeiGene to expand in oncology markets and the global growth of the business, with a particular focus on rapid growth in the Japan and Asia Pacific region.

The paragraph discusses Amgen's positive performance in Japan and China, highlighting successful collaborations with BeiGene, now called BeOne, particularly in marketing drugs like KYPROLIS, BLINCYTO, and XGEVA. Murdo Gordon and Robert Bradway from Amgen address questions about the potential impact of biosimilar drugs on their denosumab franchise, noting they understand the timing of biosimilar entry due to settlements. They expect erosion to be more pronounced toward the back end, with differences in how XGEVA, used in oncology, and Prolia, used for postmenopausal osteoporosis, may be affected.

The company is confident in its strong position in the biosimilar market, leveraging its experience to effectively compete and defend its innovator products. With a seasoned team managing long-standing accounts for XGEVA and Prolia, they maintain a leadership position in the bone market, which bolsters their ability to withstand incoming biosimilar competition. Robert Bradway concluded the earnings call by expressing gratitude for the interest shown and anticipates future updates after the next quarter.

This summary was generated with AI and may contain some inaccuracies.