Q3 2024 Earnings Summary
| Metric | Period | Guidance | Actual | Performance |
|---|---|---|---|---|
R&D Year-over-Year | Q3 2024 | Increase more than 25% year-over-year | 34% increase (R&D was 1,450M in Q3 2024Vs. 1,079M in Q3 2023) | Surpassed |
| Topic | Previous Mentions | Current Period | Trend |
|---|---|---|---|
Obesity pipeline (MariTide / AMG 133) | Consistently emphasized MariTide’s potential, with late 2024 readout of Phase II data noted in Q2 and Q1. Phase I data shared in Q4 2023 showed promising efficacy. The focus has been on monthly or less-frequent dosing, plus preparing for broad registrational studies. | Amgen reiterated confidence in MariTide’s Phase II study, with top-line 52-week data expected in late 2024, and discussed broad Phase III planning across obesity, related conditions, and type 2 diabetes. They also highlighted differentiation in dosing frequency. | Remains a major strategic priority, with continued confidence in its differentiated profile and expanded indications. |
TEPEZZA for Thyroid Eye Disease | Showed steady growth in Q2 ($479M) and Q1 ($424M), with significant potential in low CAS patients. Subcutaneous and international expansions (including Japan) appeared consistently. Q4 2023 also highlighted international approvals and a chronic disease Phase III study. | Reported Q3 sales of $488M (up 8% YoY), with a reorganized field force targeting low and high CAS patients. Approved in Japan in September, launch expected by early 2025. Subcutaneous formulation is in Phase III planning. | Continues to expand globally and address broader TED patient segments, with a focus on new formulations and geographies. |
BLINCYTO in Oncology | Has been a consistent growth driver with label expansions (frontline consolidation) noted in Q2, Q1, and Q4. Subcutaneous formulations and earlier-line use have been recurring themes. | Sales grew 49% YoY to $327M, driven by broader indications in B-cell ALL and a focus on subcutaneous formulation. Amgen also noted extension into autoimmune disease applications. | Maintains strong momentum and broadening usage, especially from label expansions and new formulation development. |
Enbrel Sales Performance | Consistently pressured by lower net selling prices in Q2 (−15%), Q1 (−2%), and Q4 (−8%). Volume has remained relatively flat to slightly positive. | Sales declined 20% YoY due to lower net selling price, partially offset by +4% volume. Amgen expects continued net price declines but stable volume. | Ongoing net price erosion, though volumes remain relatively steady. |
Increased R&D and Pipeline Investments | Previously highlighted a 30% YoY R&D increase in Q2, ~25% in Q1, and ~16% in Q4 2023. Consistent emphasis on Phase III trials (e.g., olpasiran), new indications, and advanced manufacturing capacities. | R&D spending rose 35% YoY to $1.4B, focused on late-stage programs like meratide and Horizon-acquired assets. Amgen sees further investment in areas such as obesity, oncology, and cardiovascular outcomes. | Sustained pipeline funding supporting multiple late-stage assets, reflecting high confidence in future growth drivers. |
Horizon Acquisition & Rare Disease | Q2 showed over $1B in Horizon rare disease sales, highlighting TEPEZZA, KRYSTEXXA, UPLIZNA, TAVNEOS. Similar synergy targets and expanded global reach were discussed in Q1 and Q4. | Horizon integration is on track, contributing $1.2B in Q3 sales (+21% YoY). Amgen expects $500M in pretax cost synergies by year 3, with over half by the end of 2024. TEPEZZA, KRYSTEXXA, UPLIZNA, TAVNEOS saw strong volume growth. | Continues to enhance rare disease presence. Synergies on schedule, with strong product performance fueling growth. |
AMG 786 (no longer mentioned) | In Q1, Amgen noted discontinuing AMG 786 due to its profile not meeting expectations. In Q4 2023, it was still described as an oral candidate in early study; by Q2, it was scarcely referenced. | No mention in Q3. | Development discontinued; no further updates. |
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Mirati Phase II Data and Phase III Plans
Q: What can you share about Mirati Phase II data and Phase III plans?
A: Amgen is excited about Mirati's prospects. They've begun a Phase II study in type 2 diabetes, which is progressing well, and expect to have data by the end of the year. They look forward to sharing these results with investors when available. They're actively planning a broad Phase III program, including obesity and type 2 diabetes, anticipating a large global trial to fully explore the molecule. -
Investment in Mirati and R&D Spending
Q: How will the Phase III Mirati program affect your spending?
A: Amgen's investment in the Phase III trial will reflect their view of Mirati as a differentiated molecule. They raised their CapEx guidance to about $1.3 billion, being thoughtful about this increase. Research and development spending is up 35% quarter-over-quarter and expected to rise over 25% for the year, emphasizing their commitment to innovation with Mirati at the forefront. -
TEPEZZA Growth and Sales Force Expansion
Q: What's the growth plan for TEPEZZA and impact of sales team?
A: TEPEZZA grew 8% year-over-year. Amgen is focusing on both high CAS patients and approximately 80,000 low CAS patients. They've expanded their sales force to reach comprehensive ophthalmologists, ocular specialists, and endocrinologists, aiming to optimize coverage and enable better access to TEPEZZA. This change occurred in the third quarter, and they expect momentum to build over the next several quarters. -
Competitive Position in Obesity Treatment Portfolio
Q: Do you have a competitive obesity treatment portfolio?
A: Amgen is pleased with MariTide's progress and is fully focused on setting up a broad Phase III program. They're actively investigating additional obesity medicines, both preclinically and clinically, including program 513. While they haven't disclosed 513's mechanism of action, they're exploring both injectable and oral medicines, targeting incretin and non-incretin pathways to serve all patients with obesity and related conditions. -
TEZSPIRE in COPD Competitive Landscape
Q: How does TEZSPIRE fit into the COPD treatment landscape?
A: Amgen, with AstraZeneca, reported positive Phase II results for TEZSPIRE in moderate to very severe COPD, showing a 17% numerical reduction in exacerbation rates over 52 weeks. They've learned which patient subsets benefit most and plan to initiate Phase III studies. TEZSPIRE's unique mechanism addresses a broader patient population, and they feel confident about competing in the COPD market. -
Biosimilar Launch Strategy and Supply Advantages
Q: How are you approaching the launch of biosimilars like Path Blue amid supply issues?
A: Amgen is excited about launching Path Blue and other biosimilars. Being among the first is crucial, and they expect strong interest early in the launch phase. While permanent Q codes are important, there's significant interest even with temporary reimbursement codes. They've benefited from shortages of other biosimilars, including Avastin, due to their reliable supply chain and world-class manufacturing. -
Subcutaneous BLINCYTO Development
Q: What's the status of subcutaneous BLINCYTO's development?
A: Developing subcutaneous BLINCYTO is a major priority. Previous studies showed encouraging efficacy, with a 67% complete remission rate within one cycle among 21 patients. Further data revealed an 85% complete remission rate, with 75% achieving MRD negativity, all without grade 4 CRS. The registrational study is progressing, and there's nothing significant about the timing change. -
Impact of GLP-1 Receptor Agonist Development
Q: Will you adjust titration schedules for MariTide's Phase III?
A: Amgen is on track with Phase III planning for MariTide but isn't sharing specifics on dosing approaches now. They are confident their strategy will be informed by the ongoing Phase II study, with data expected later this year. -
Insights into Anti-Diabetic Activity from Phase II
Q: Can you assess A1C effects in your Phase II obesity trial?
A: Amgen hopes to gain insights into anti-diabetic activity from the Phase II study, as type 2 diabetes often accompanies obesity. However, they acknowledge the need for a dedicated Phase II study in patients without obesity to draw definitive conclusions, expecting to share more later this year. -
Enbrel Performance and Expectations
Q: Is Enbrel's Q3 performance indicative of future trends?
A: Enbrel faced two negative trends: the regular decline in net price and a 30% adjustment this quarter, making results softer than usual. Despite this, volume grew by 4%, showing continued prescriber support. Amgen anticipates continued net price declines moving forward.