Q1 2025 Earnings Summary
- MariTide's compelling Phase II results suggest a robust weight management opportunity with strong efficacy (up to 20% weight loss) and competitive tolerability driven by a proven dose-escalation design, setting the stage for an extensive Phase III program and potential cardiovascular outcomes trials.
- UPLIZNA’s dual indication in rare diseases offers a differentiated market advantage; its approval for IgG4‐related disease and promising data in myasthenia gravis provide a new standard of care with convenient 6‑month dosing, addressing significant unmet clinical needs.
- A diversified pipeline in oncology and biosimilars bolsters the bull case, as assets like Repatha continue to gain traction through improved access and growing market penetration, while upcoming readouts for bemarituzumab and advances in KRAS inhibitor AMG 410 highlight Amgen’s potential to capture large addressable markets in tough‑to‑treat cancers.
- Uncertainty around MariTide's long‐term data: Several analysts questioned the absence of extended efficacy and safety results beyond the initial 52‑week Phase II data, leaving investors exposed to risks if longer‑term outcomes (as well as potential competitive challenges from emerging oral obesity therapies) do not meet expectations.
- Increasing competitive and payer pressures: Questions about the competitive landscape—such as intensifying competition in the PCSK9 space and concerns over aggressive payer dynamics in the incretin and obesity segments—suggest that pricing pressures and reimbursement challenges could negatively impact future margins.
- Reliance on new formulations and international uptake: Concerns remain over TEPEZZA’s growth trajectory, as slow uptake without a subcutaneous formulation and delays in international market launches could dampen revenue growth prospects in a highly competitive treatment area.
| Metric | YoY Change | Reason |
|---|---|---|
Total Revenues | +9% (from US$7,447M in Q1 2024 to US$8,149M in Q1 2025) | **Revenues increased due to robust domestic product sales growth (14% rise in U.S. Product Sales) combined with modest gains in international markets (3% increase in ROW Product Sales), building on the momentum from previous periods. ** |
U.S. Product Sales | +14% (from US$4,973M in Q1 2024 to US$5,662M in Q1 2025) | **The strong 14% gain in U.S. Product Sales reflects healthy domestic demand, driven by volume and market penetration improvements in key products such as Repatha and EVENITY compared to the prior period, reinforcing the company's strategic focus on its core markets. ** |
ROW Product Sales | +3% (to US$2,211M in Q1 2025) | **Growth in ROW Product Sales was modest at 3%, indicating that while there was some volume gain internationally, challenges such as pricing pressures and variable market conditions continued to constrain growth relative to the stronger domestic market performance. ** |
Repatha | +27% (from US$517M in Q1 2024 to US$656M in Q1 2025) | **A 27% increase in Repatha sales was driven by significant volume growth and improved market access compared to Q1 2024, reflecting both stronger physician adoption and enhanced patient outreach initiatives that built on its previous quarter’s momentum. ** |
EVENITY | +29% (from US$342M in Q1 2024 to US$442M in Q1 2025) | **EVENITY sales surged by 29%, fueled by robust volume expansion and strategic investments that solidified its leadership in the bone-builder market, reflecting continued progress from its strong FY 2024 performance. ** |
TEPEZZA | -10% (from US$424M in Q1 2024 to US$381M in Q1 2025) | **TEPEZZA experienced a 10% decline which may be attributed to market adjustments following its initial post-acquisition growth phase in earlier periods, along with competitive dynamics affecting its pricing and uptake. ** |
ENBREL | -10% (from US$567M in Q1 2024 to US$510M in Q1 2025) | **The 10% drop in ENBREL sales continued a downward trend from previous periods, likely driven by persistent pricing pressures, increased discounting (e.g., via the 340B Program), and overall market share challenges in a competitive therapeutic segment. ** |
Operating Income | +19% (from US$991M in Q1 2024 to US$1,178M in Q1 2025) | **Operating income improved by nearly 19% due to higher revenues and more efficient cost management, reflecting a better mix in the operating portfolio compared to Q1 2024, including gains from both organic improvements and possible benefits from operational leverage. ** |
Net Income | Rebounded from a Q1 2024 loss of US$113M to a gain of US$1,730M in Q1 2025 | **The turnaround in net income, from a loss of US$113M to US$1,730M, was primarily driven by improved operating performance, a significant positive swing in other income from equity adjustments (notably the BeiGene investment), and lower net interest expense, building on corrective measures taken in the previous quarter. ** |
Basic EPS | Shifted from a negative US$0.21 in Q1 2024 to a positive US$3.22 in Q1 2025 | **Basic EPS recovered sharply due to the net income rebound and stable share dilution, largely reflecting both the reversal of previous unrealized losses and the improved operational and financial performance in Q1 2025 relative to Q1 2024. ** |
| Metric | Period | Previous Guidance | Current Guidance | Change |
|---|---|---|---|---|
Total Revenues | FY 2025 | $34.3 billion to $35.7 billion | $34.3 billion to $35.7 billion | no change |
Non-GAAP EPS | FY 2025 | Between $20.00 and $21.20 | Between $20.00 and $21.20 | no change |
Non-GAAP Operating Margin | FY 2025 | Approximately 46% | Roughly 46% | no change |
Non-GAAP Tax Rate | FY 2025 | 15% to 16% | Between 14.5% and 16% | lowered |
Non-GAAP Other Income & Expense | FY 2025 | Approximately $2.4 billion | Approximately $2.3 billion | lowered |
Capital Expenditures | FY 2025 | Approximately $2.3 billion | $2.3 billion | no change |
Free Cash Flow | FY 2025 | Similar to 2023 levels, with some decline due to working capital favorability and incremental capex | Roughly comparable to FY 2023, with a decline primarily driven by FY 2024 working capital favorability and incremental capex | no change |
Share Repurchases | FY 2025 | Not expected to exceed $500 million in 2025 | Not expected to exceed $500 million in FY 2025 | no change |
Non-GAAP R&D Expense Growth | FY 2025 | Expected to grow in the mid-teens percentage | Approximately 20% | raised |
Other Revenue | FY 2025 | Approximately $1.4 billion | Approximately $1.4 billion | no change |
WEZLANA Sales | Q2 2025 | no prior guidance | Quarterly sales expected to fluctuate, with no sales anticipated in Q2 2025 | no prior guidance |
| Topic | Previous Mentions | Current Period | Trend |
|---|---|---|---|
Pipeline Innovation | Extensively detailed in Q4 2024 and Q2 2024 with multiple programs (e.g., MariTide, Olpasiran, TEZSPIRE, IMDELLTRA) driving innovation, with strong clinical readouts and new Phase III study plans | Q1 2025 continued to emphasize a broad innovation portfolio with further updates on multiple Phase III studies, positive Phase II data and additional investment in late‐stage assets | Recurring topic with consistent strategic focus. Slight increased emphasis on advanced-stage data and strategic execution. |
New Product Approvals | Q4 2024 and Q2 2024 discussed regulatory approvals in oncology, rare disease, and biosimilars, including launches of TEPEZZA and regulatory filings for UPLIZNA | Q1 2025 highlighted new approvals for UPLIZNA and TEPEZZA, with launch updates and robust market uptake for biosimilars | Consistently prioritized with sustained momentum in approvals and launches. |
MariTide Development in Obesity Management | Q2 2024 described Phase II progress, differentiated profile, convenient dosing, and plans for a broad Phase III program; Q4 2024 reiterated unique attributes and upcoming data presentations | Q1 2025 detailed initiation of two Phase III studies, confirmed Phase II results (including dose‐escalation benefits) and competitive positioning against oral therapies | Recurring with evolving clarity – increasing emphasis on clinical data and competitive advantages over emerging oral treatments. |
UPLIZNA's Dual Indication in Rare Diseases | Q2 2024 and Q4 2024 communicated strong Phase III data for IgG4-related disease and dual potential in GMG, supported by FDA filings and priority reviews | Q1 2025 reinforced dual indication with new 52-week Phase III data in GMG and the first FDA approval for IgG4-related disease, underscoring expanding clinical impact | Steady progression with enhanced data supporting dual indications. Seen as a key future growth driver in rare diseases. |
TEPEZZA Market Performance and International Expansion | Q4 2024 presented robust 2024 sales figures, strong U.S. performance, detailed Japan launch and plans for further international expansion; Q2 2024 emphasized regulatory filings and early-stage focus on Japan, with no mention of China in Q2 | Q1 2025 focused on U.S. market performance (impact from wholesaler inventory adjustments), positive uptake in Japan as the sole international market mentioned, with no reference to China | Recurring with some shifts – continued international focus but a narrowing mention to Japan in Q1, omitting earlier China-related commentary. |
Repatha Performance and Competitive Dynamics | Q2 2024 and Q4 2024 highlighted strong sales, volume growth, improved access/reimbursement, and detailed competitive positioning versus entrants including oral PCSK9 therapies | Q1 2025 continued to show robust growth with clear improvements in payer access and a positive volume trend, maintaining its differentiation in lowering LDL cholesterol | Consistent strong performance with positive sentiment around competitive positioning. |
Biosimilar Competition for Denosumab (Prolia/XGEVA) | Q4 2024 provided detailed commentary on anticipated back‐loaded biosimilar erosion for Prolia/XGEVA and Amgen’s defensive positioning due to market leadership and longstanding account relationships | Q1 2025 contained no specific discussion regarding Denosumab biosimilar competition | No current period mention; topic appears to have been dropped from the latest discussion. |
Acquisition Integration Impact (Horizon Acquisition) | Q2 2024 detailed integration efforts including sales and expense impacts, increased SG&A, debt retirement, and projected $500 million in pretax synergies by Year 3; Q4 2024 also emphasized synergy realization and EPS accretion | Q1 2025 reported continued strong integration progress, substantial debt reduction (with multiple retirements) and reaffirmation of $500 million synergies by end-2025 | Recurring with a maturing integration that is delivering expected cost synergies and debt reduction, reinforcing long‑term financial benefits. |
Tax Litigation Concerns | Q2 2024 included explicit discussion by Peter Griffith affirming confidence with an upcoming tax court date and stable reserves ; Q4 2024 did not mention tax issues [—] | Q1 2025 revisited tax-related topics focusing on tax policy, repatriation tax impact, and lower non‑GAAP tax rate, with less focus on litigation specifics compared to Q2 2024 | Recurring but with shifted emphasis – earlier detailed litigation discussions now integrated within broader tax policy and financial planning updates. |
Emerging Oral Obesity Therapies Competition | Q2 2024 acknowledged the potential of oral obesity therapies, while reinforcing MariTide’s differentiated profile and monthly dosing convenience; Q4 2024 reiterated strategic confidence in obesity portfolio and noted areas where the bar was not met for certain assets | Q1 2025 reaffirmed that although emerging oral therapies exist, they have not achieved the same weight loss efficacy as MariTide, underscoring its competitive advantage | Recurring with consistent sentiment – strong confidence remains in the efficacy and strategic positioning of MariTide against emerging oral options. |
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TEPEZZA Growth
Q: What drives TEPEZZA’s market progress?
A: Management stressed that TEPEZZA is broadening its prescribing base beyond specialized surgeons. They noted a gradual increase in awareness coupled with expectations that a subcutaneous formulation will simplify administration and accelerate uptake, further bolstered by strong international expansion ( ). -
UPLIZNA Strategy
Q: How is UPLIZNA positioned commercially?
A: The team is focused on targeting rheumatologists and related specialists to serve the roughly 20,000 US patients with IgG4-related disease, while also planning to expand its role in myasthenia gravis through differentiated dosing and robust clinical data ( ). -
Repatha Competition
Q: How is Repatha faring against competitors?
A: Despite rising competition from alternative PCSK9 products, management emphasized that Repatha’s strong efficacy, proven cardiovascular event reduction, and expanded patient access underscore its best‐in-class profile ( ). -
MG Market Dynamics
Q: What is the competitive edge in myasthenia gravis?
A: UPLIZNA is highlighted for its durable efficacy and convenient 6‑month dosing schedule, potentially offering a cost advantage compared to FcRn therapies, which may translate into significant market share in the MG arena ( ). -
Obesity Program
Q: What supports the obesity weight-loss program?
A: Management expressed strong confidence in MariTide’s robust weight-loss efficacy and dose-escalation strategy, which drives competitive tolerability and positions it well against emerging oral agents ( ). -
MariTide Data
Q: What key data will ADA present on MariTide?
A: The ADA presentation will focus on 52‑week Phase II results showing consistent weight loss and excellent tolerability, reinforced by mechanistic data that validate its dual-action approach ( ). -
MariTide Trials
Q: Are additional MariTide studies planned?
A: Beyond the ADA update, management plans to initiate comprehensive Phase III programs, including trials assessing switching from existing weight-loss medications, with more details to follow as they mature ( ). -
Bemarituzumab Readout
Q: What is expected from bemarituzumab’s Phase III data?
A: The forthcoming Phase III readout, expected next quarter, aims to demonstrate a meaningful survival benefit in gastric cancer, targeting a significant patient population both domestically and overseas ( ). -
KRAS Strategy
Q: How promising is AMG 410 for KRAS inhibition?
A: AMG 410 is presented as a promising, low–molecular weight pan-KRAS inhibitor with over 100‑fold selectivity over HRAS and NRAS, aiming to address unmet needs in KRAS-driven cancers despite a competitive landscape ( ). -
TEZSPIRE CRS
Q: What is TEZSPIRE’s role in CRS treatment?
A: TEZSPIRE is positioned to significantly reduce the need for surgery in chronic rhinosinusitis with nasal polyps, addressing an estimated 1–2 million US patients, particularly those overlapping with severe asthma cases ( ). -
PAVBLU Uptake
Q: How is PAVBLU performing in the market?
A: PAVBLU has been well received by retina specialists, who appreciate the high-quality biosimilar and its prefilled syringe device, supporting steady uptake as broader contracting efforts continue ( ). -
Incretin Payer
Q: What’s the outlook on payer dynamics in obesity?
A: Management remains focused on navigating evolving payer environments to ensure broad access to obesity therapies, emphasizing collaborative approaches with PBMs and timely policy adjustments ( ). -
AD Market Split
Q: What is the expectation for atopic dermatitis market share?
A: While specifics remain uncertain, management is confident that rocatinlimab will be competitive within an expanding atopic dermatitis space, even as its market share against future entrants is still evolving ( ).