Q4 2024 Earnings Summary
- Strong Growth Across Key Products: Amgen reported significant year-over-year growth in several key products. Repatha sales increased 36%, reaching over $2.2 billion, driven by volume growth and improved access worldwide. EVENITY sales increased 35%, reaching almost $1.6 billion, addressing the significant unmet need in fracture prevention. TEZSPIRE sales grew 71%, nearing $1 billion, indicating robust growth potential given the need to treat 2.5 million patients worldwide with severe, uncontrolled asthma. These products are expected to continue driving growth in 2025 and beyond.
- Successful Integration of the Horizon Acquisition: The acquisition of Horizon Therapeutics has added high-growth products to Amgen's portfolio. KRYSTEXXA sales grew 23%, UPLIZNA grew 40%, and TAVNEOS grew 111% year-over-year. These products are early in their lifecycle with more data and indications to come, suggesting significant growth potential moving forward.
- Strong International Growth, Particularly in China: Amgen's Asia-Pacific business is rapidly growing, with China being a significant contributor. Repatha and Prolia are performing well in China, both listed on the national reimbursement drug list and experiencing rapid growth. The partnership with BeiGene has exceeded expectations, strengthening Amgen's presence and providing a platform for further expansion in the Chinese market.
- Upcoming biosimilar competition for denosumab (Prolia and XGEVA) could lead to significant erosion in sales, especially in the latter part of the year, affecting Amgen's revenue growth.
- Challenges in Amgen's obesity pipeline, including the clinical hold on AMG 513 and the discontinuation of another obesity asset, raise concerns about the robustness of their pipeline beyond MariTide.
- TEPEZZA's modest growth of only 5% and the mention of competitive pressures in its market may limit its future growth potential.
| Metric | YoY Change | Reason |
|---|---|---|
Total Revenue | 11% increase (from $8,196M in Q4 2023 to $9,086M in Q4 2024) | Revenue growth was driven by strong improvements in product sales, both in the U.S. and ROW, reflecting persistent volume gains and renewed pricing leverage compared to prior periods where growth had been building gradually. |
U.S. Product Sales | Approximately 11–12% increase | U.S. product sales climbed to $6,509M thanks to continued domestic volume gains and improved market penetration observed in previous quarters, reinforcing momentum developed during earlier periods. |
ROW Product Sales | Approximately 11–12% increase | ROW sales reached $2,207M as international markets continued to expand with volume growth and geographic diversification, echoing trends seen in prior periods where key regions were gaining traction. |
TEPEZZA | Over 90% drop (from $488M in Q3 2024 to $46M in Q4 2024) | TEPEZZA’s dramatic decline appears to reflect a rebalancing effect post–Horizon acquisition, possibly due to strategic reprioritization or market reclassification, diverging sharply from the strong performance seen in Q3 2024. |
Operating Income | 13% sequential increase | Operating income improved to $2,311M in Q4 2024 as revenue leverage and cost initiatives began to offset operating expenses that had escalated in the previous quarter, highlighting better cost management and operational efficiencies. |
Net Income | Approximately 12% sequential increase | Net income rose to $3,174M driven by the higher revenue base, effective control of expenses, and a favourable reduction in the tax rate, thus continuing the positive momentum established in Q3 2024. |
Net Change in Cash | Turned positive at $2,701M | A marked improvement in cash flow was achieved in Q4 2024, with operating cash flows increasing and investing outflows declining, reversing prior financing challenges and strengthening liquidity compared to earlier periods. |
| Metric | Period | Previous Guidance | Current Guidance | Change |
|---|---|---|---|---|
Total Revenues | FY 2024 | no prior guidance | $33.0B to $33.8B | no prior guidance |
Non-GAAP EPS | FY 2024 | no prior guidance | $19.20 to $20.00 | no prior guidance |
Q4 Non-GAAP EPS | Q4 2024 | no prior guidance | Lower than Q3 Non-GAAP EPS | no prior guidance |
Non-GAAP Operating Expenses | FY 2024 | no prior guidance | Expected to grow ~25% year-over-year | no prior guidance |
Non-GAAP R&D Growth | FY 2024 | no prior guidance | More than 25% year-over-year | no prior guidance |
OI&E | FY 2024 | no prior guidance | $2.4B to $2.5B | no prior guidance |
Non-GAAP Tax Rate | FY 2024 | no prior guidance | 14% to 15% | no prior guidance |
Capital Expenditures | FY 2024 | no prior guidance | $1.3B | no prior guidance |
New Asset Sales | FY 2024 | no prior guidance | $400M | no prior guidance |
Other Revenue | FY 2024 | no prior guidance | $1.4B | no prior guidance |
Total Revenues | FY 2025 | no prior guidance | $34.3B to $35.7B | no prior guidance |
Non-GAAP EPS | FY 2025 | no prior guidance | $20.00 to $21.20 | no prior guidance |
Non-GAAP Operating Margin | FY 2025 | no prior guidance | ~46% | no prior guidance |
Non-GAAP Cost of Sales | FY 2025 | no prior guidance | 18% to 19% | no prior guidance |
Non-GAAP R&D Expense | FY 2025 | no prior guidance | Mid-teens % growth year-over-year | no prior guidance |
Non-GAAP SG&A Expense | FY 2025 | no prior guidance | Decline by 1–2 pts year-over-year | no prior guidance |
Non-GAAP Tax Rate | FY 2025 | no prior guidance | 15% to 16% | no prior guidance |
Non-GAAP Other Income/Expense | FY 2025 | no prior guidance | ~$2.4B | no prior guidance |
Capital Expenditures | FY 2025 | no prior guidance | ~$2.3B | no prior guidance |
Free Cash Flow | FY 2025 | no prior guidance | Similar to 2023 levels, slight decline | no prior guidance |
Share Repurchases | FY 2025 | no prior guidance | Not to exceed $500M | no prior guidance |
Other Revenue | FY 2025 | no prior guidance | ~$1.4B | no prior guidance |
Share Count | Q1 2025 | no prior guidance | Expected flat vs. Q4 2024 | no prior guidance |
Q1 2025 Non-GAAP Operating Margin | Q1 2025 | no prior guidance | ~42% (lowest of the year) | no prior guidance |
| Metric | Period | Guidance | Actual | Performance |
|---|---|---|---|---|
Total Revenues | FY 2024 | $33.0B to $33.8B | $33.4B (sum of Q1: 7,447, Q2: 8,388, Q3: 8,503, Q4: 9,086) | Met |
Capital Expenditures | FY 2024 | $1.3B | $1.10B (sum of Q1: 230, Q2: 238, Q3: 257, Q4: 371) | Missed |
Other Revenue | FY 2024 | $1.4B | $1.07B (sum of Q1: 329, Q2: 347, Q3: 352, Q4: 37) | Missed |
| Topic | Previous Mentions | Current Period | Trend |
|---|---|---|---|
Repatha | In Q1 and Q2 earnings calls, Repatha was described with strong sales growth (33% in Q1, 25% in Q2), volume increases, expanded access through improved formulary coverage and prescriber engagement | In Q4, Repatha’s performance was highlighted with even stronger sales growth (36% increase), significant prescriber engagement improvements, and an optimistic future outlook with less price erosion anticipated | Consistent bullish momentum with enhanced focus on access and global growth |
TEZSPIRE | Q1 and Q2 discussions centered on TEZSPIRE’s strong revenue growth, robust year‐over‐year increases (up to 76% in Q2) and promising Phase II/III data for COPD and other indications | Q4 emphasized TEZSPIRE’s nearly $1 billion in sales, its 71% YoY increase, and detailed plans for Phase III studies in COPD and submissions for additional indications | Steady acceleration with expanding indication opportunities |
EVENITY | In Q1, record sales growth and market-leading position were noted; Q2 reiterated 39% YoY growth supported by expanded prescriber base and strong market share | Q4 focused on the unmet need in osteoporosis, noting that only 210,000 U.S. patients have been treated versus millions at risk, creating a large growth opportunity in future periods | Bullish long-term potential despite current low market penetration |
Horizon Acquisition & Portfolio Expansion | Q1 and Q2 calls detailed smooth integration of the Horizon acquisition with the achievement of synergy targets (around $500 million over three years) and robust sales growth for KRYSTEXXA, UPLIZNA, and TAVNEOS | Q4 continued to underscore the effective integration, emphasizing synergy achievements and strong year-over-year sales growth across the expanded portfolio | Consistently positive integration yielding a diversified, high-growth portfolio |
International Expansion & Strategic Partnerships | Earlier calls (Q1 and Q2) did not mention any details on international expansion in China or related strategic partnerships [no info] | Q4 introduced detailed commentary on robust performance in China and a highly successful partnership with BeiGene delivering strong results for multiple oncology products | New emphasis on global markets—especially China—as a key growth driver |
Biosimilar Competition | There was no mention of biosimilar competition risks in Q1 and Q2 earnings calls [no info] | Q4 introduced concerns over biosimilar erosion for denosumab products (Prolia and XGEVA), though Amgen remains confident in its market leadership | Emerging risk factor that could impact revenue, though defensible due to incumbency |
TEPEZZA | In Q1, TEPEZZA was noted for its steady sales (e.g., $424 million in Q1) and efforts to expand access, while Q2 highlighted modest growth with improved reimbursement coverage | Q4 reported continued modest 5% YoY growth alongside a detailed focus on reimbursement challenges and strategic efforts to broaden prescriber engagement globally | Maintaining steady performance but with an increased focus on overcoming access and reimbursement hurdles |
Obesity Pipeline | Q1 discussions underscored the promise of MariTide while also noting the discontinuation of AMG 786; Q2 focused exclusively on MariTide’s progress and upcoming Phase III initiatives | Q4 again mentioned MariTide’s advancement but reintroduced setbacks with AMG 513 being placed on clinical hold | Mixed signals: enduring commitment to MariTide despite intermittent setbacks in related programs |
R&D Innovations & Breakthrough Approvals | Q1 featured several pipeline innovations including BLINCYTO, tarlatimab, and early-stage CD3 bispecifics along with promising data from CD19 approaches | Q4 concentrated on breakthrough approvals and impressive sales for BLINCYTO along with the advancement of IMDELLTRA into earlier lines of therapy | Continually robust innovation with a sharpening focus on high-impact breakthrough therapies |
CD3 BiTE & CD19 Therapeutics | In Q1, the company conveyed strong expertise in both CD3 bispecific T‐cell engaging therapies and CD19‐directed therapeutics, highlighting early progress in each area | In Q4, the emphasis was predominantly on the bispecific T‐cell engager platform (e.g., BLINCYTO and IMDELLTRA) with little to no mention of CD19-directed therapeutics | Shifted focus toward CD3 bispecifics while CD19-directed programs have become less emphasized |
Tax Litigation & Regulatory Challenges | Q1 mentioned an $800 million tax deposit to mitigate interest accrual on uncertain tax positions, and Q2 referenced specific tax litigation with confidence in their legal position | Q4 did not discuss tax litigation or related regulatory challenges at all [no info] | Decreased focus, suggesting either resolution or lower priority of these issues in current period messaging |
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2025 Growth Drivers
Q: Where is growth underappreciated in your 2025 sales guidance?
A: We believe The Street underappreciates our growth potential in several areas. We have 10 products with double-digit growth in 2024 over 2023, 14 products at blockbuster status of $1 billion or more, and 21 that were records in 2024. Repatha, with 100 million people worldwide needing treatment, is poised for continued growth, especially with upcoming Vesalius CV trial results. Evenity has low single-digit penetration, with over 90% of high-risk patients in the U.S. untreated, representing significant unmet need. TEZSPIRE grew 71% in 2024, approaching $1 billion in sales. Our innovative oncology and rare disease portfolios are early in their life cycles, offering additional growth opportunities. Biosimilars grew 16% to $2.2 billion in 2024, with more launches coming. Overall, we expect to bring more medicines to more patients in 2025 and beyond. -
Obesity Pipeline and MariTide
Q: What's your strategic view on obesity assets beyond MariTide?
A: We are confident in our obesity pipeline and do not view recent developments as slip-ups. Our early clinical investigation has a high bar, and while the next medicine after MariTide didn't meet that bar, we have a strong pipeline targeting both incretins and non-incretins, including oral and subcutaneous medicines. We're open to partnerships through external innovation. MariTide's Phase II Part 2 study is ongoing, with data expected late this year. We look forward to presenting Phase II Part 1 data at the ADA meeting in June. The MARITIME Phase III program will focus on chronic weight management and related indications, and we anticipate initiating it in the second half of this year or early next year. -
Repatha and Competition
Q: How will you position Repatha amid competition from oral PCSK9s?
A: We are pleased with Repatha's strong performance in 2024, with significant growth in volume and revenues globally. There are millions of patients who have not optimized their LDL cholesterol levels, and Repatha is an ideal solution that is now perceived as easy to access and affordable. We have removed barriers to access, leading to an inflection point in Repatha's performance. Repatha has demonstrated benefits in secondary prevention of heart attacks and strokes, and with the upcoming Vesalius CV trial reading out later this year, we aim to show risk reduction in primary prevention as well. We will monitor evidence from competitors, but Repatha remains a key growth driver for us. -
TEPEZZA Growth Outlook
Q: What is the growth outlook for TEPEZZA in the U.S. and internationally?
A: In Japan, with an estimated 25,000 patients, we expect steady penetration due to the care model reducing friction in accessing treatment. Early data shows over 550 patients identified and steady momentum. We plan to launch in 7 other markets pending regulatory approvals, leveraging our global footprint to bring TEPEZZA to more patients. In the U.S., we are broadening the prescriber base to general ophthalmology and endocrinology to diagnose Graves' disease and thyroid eye disease. While the first quarter may be lower due to insurance reverification and purchasing patterns, long-term growth looks very good with international approvals and planned momentum in the U.S. -
Denosumab Biosimilar Erosion
Q: How should we think about the biosimilar erosion of denosumab?
A: With settlements reached, we have clarity on the timing of biosimilar entry, which will be more back-end loaded. Biosimilar erosion slopes may differ between XGEVA, used in oncology, and Prolia, used in postmenopausal osteoporosis. Our participation in the biosimilar market positions us well to defend our innovator products. We have a strong incumbency and a large team of account executives with longstanding relationships, helping us defend against biosimilar competition. -
Biosimilars Business Potential
Q: Can your biosimilar be a significant product in a large market?
A: We are pleased with the launch of our biosimilar, being the only one available in the market currently. Feedback from retina specialists has been enthusiastic, appreciating our high-quality biosimilar in an easy-to-use prefilled syringe, which is important given their high volume of administrations. We have built an industry-leading biosimilar franchise, leveraging our manufacturing and operations to deliver attractive returns. With $10 billion in cumulative biosimilar sales through 2024, we are on track to double 2021 sales to over $4 billion by the end of the decade. -
Horizon Products Growth
Q: Thoughts on growth runway for KRYSTEXXA and TEPEZZA's competitive landscape?
A: Including Horizon's performance, KRYSTEXXA was up 23%, UPLIZNA up 40%, TAVNEOS up 111%, and TEPEZZA up 5%. These products are early in their life cycles with more data to come, such as UPLIZNA's IgG4 data and additional GMG data at 52 weeks. For KRYSTEXXA, severe uncontrolled gout is not rare, and with immunomodulation data, we see robust growth opportunities. We are also developing additional pipeline assets to further support growth. -
olpasiran Phase III Trial Plans
Q: Why announce a new olpasiran Phase III trial now if initiation is later?
A: We have already announced our intention to initiate a Phase III trial of olpasiran in primary prevention, targeting patients with elevated Lp(a), a genetically defined cardiovascular risk. We plan to start this study in the second half of this year or the first half of next year. Our commitment is to benefit patients at risk, and early announcement reflects our strategic planning to address unmet needs. -
China Growth and BeiGene Partnership
Q: How does China factor into your growth and BeiGene partnership?
A: Our Japan and Asia Pacific region is the most rapidly growing, with China performing well. Our Amgen affiliate business in China, primarily Repatha and Prolia, is growing nicely, both listed on the national reimbursement drug list. Our partnership with BeiGene (B1) has exceeded expectations, with strong execution across KYPROLIS, BLINCYTO, and XGEVA. We continue to collaborate on R&D projects, reinforcing our long-term goals in the region. -
Business Development and M&A
Q: What's your appetite for international M&A post-Horizon acquisition?
A: Our business development focus remains consistent; we seek molecules where we can add value, regardless of origin. We maintain an active global search for licensing and acquisition opportunities and are open for business in pursuing such prospects. -
ROCKET Program in Atopic Dermatitis
Q: What are you looking for in the ROCKET program readouts?
A: The ROCKET program for rocatinlimab, targeting OX40 receptor, involves 8 studies with over 3,300 patients, providing granularity on the product profile, safety, and efficacy in atopic dermatitis. Upcoming readouts include SHUTTLE and IGNITE studies in the first half of the year, focusing on combination therapy and monotherapy in adults. In the second half, ASCEND will assess maintenance in adults and adolescents, and ASTRO will study adolescents. We aim to generate comprehensive data to inform our competitive positioning in this market. -
Repatha-Vesalius CV Study Lessons
Q: How will Vesalius CV results influence your portfolio?
A: The Vesalius CV trial, a Phase III study with over 12,000 patients, will provide valuable data on improving cardiovascular outcomes in high-risk patients without prior MI or stroke. We have leveraged insights from Repatha to design the olpasiran Phase III program, which is an event-driven outcome study expected to read out in the second half of next year. Synergies are significant, as our leadership in LDL lowering applies to Lp(a) lowering with olpasiran. Since Lp(a) levels cannot be modified by lifestyle, pharmacotherapy offers a unique opportunity. -
MariTide Phase III Design
Q: Will MariTide Phase III include head-to-head trials against incumbents?
A: The MARITIME Phase III program will focus on chronic weight management, cardiovascular disease, kidney disease, type 2 diabetes, sleep apnea, heart failure, and possibly additional indications. As discussions with regulators are mature, it's premature to discuss specific design principles, including potential head-to-head comparisons. -
Obesity Pipeline Confidence
Q: How confident are you in your obesity pipeline amid setbacks?
A: We do not consider recent developments as setbacks; our rigorous early clinical process ensures only medicines meeting high standards advance. Our obesity efforts align with our strengths in cardiovascular and metabolic diseases. We have a strong pipeline with both incretin and non-incretin targets, including oral and subcutaneous options, and we're open to external partnerships.