Analyst Conference Summary

biotechnology

Amgen
AMGN

conference date: May 1, 2025 @ 1:30 PM Pacific Time
for quarter ending: March 31, 2025 (first quarter, Q1)


Forward-looking statements

Overview: Strong quarter.

Basic data (GAAP):

Revenue was $8.15 billion, down 10% sequentially from $9.09 billion and up 9% from $7.45 billion in the year-earlier quarter.

Net income was $1.73 billion, up 176% sequentially from $627 million, and up from negative $113 million year-earlier.

Earnings Per Share (diluted EPS) were $3.20, up 176% sequentially from $1.16 and down % from negative $0.21 year-earlier.

Guidance:

Full year 2025 revenue $34.3 to $35.7 billion. GAAP EPS $12.21 to 13.46; non-GAAP EPS $20.00 to $21.20. Cap ex about $2.3 billion. Share repurchase max $500 million.

Conference Highlights:

Robert A. Bradway, CEO said "Demand for our products was strong globally in the first quarter. Ongoing new product launches and successful Phase 3 trial results for several products make us feel confident in our long-term growth prospects." Does not expect any significant impacts from possible tariffs. Highly invested in U.S. manufacturing, increasing investment in North Carolina and Ohio.

MariTide (AMG 133) for obesity rolls ahead. Nov. 2024 data from Part 1 of Phase 2 showed robust weight loss. Only requires 1 dose per month. A Phase 2 study of MariTide for Type 2 diabetes completed enrollment of adults living with and without obesity in Q1 2025; data expected in H2 2025. Two Phase 3 studies, ofr obesity with or without diabetes, are now enrolling.

Repatha is in a Phase 3 cardiovascular outcomes study, with data expected in 2H 2025.

As of Q1 2025, a Phase 3, open-label study of Tavneos in combination with rituximab or a cyclophosphamide-containing regimen is enrolling patients 6 to 18 years of age with active ANCA-associated vasculitis.

Krystexxa for uncontrolled gout study data was presented in November 2024. A regulatory filing is underway.

Lumakras, combined with Vectibix, for CRC patients with KRAS G12C mutations was approved by the FDA in January 2025. Other combination trials are underway.

In April 2025 Uplinza was approved by the FDA. On June 5, 2024 Amgen had announced positive Phase 3 results for Uplinza for IgG4-RD (immunoglobulin G4-related disease). In January 2025 the FDA granted Orphan Drug designation for Myasthenia Gravis, with filing expected in 1H 2025.

Rocatinlimab is a first-in-class T-cell rebalancing monoclonal antibody targeting the OX40 receptor to treat atopic dermatitis. Seven of eight Phase 3 studies have completed enrollment. Data readouts from 3 Phase 3 studies were released in March 2025: Eczema, Atopic Dermatitis, and in combination with topical corticosteroids or calcineurin inhibitors.

AMG 513 is in a Phase 1 study for obesity following removal of a clinical hold.

Olpasiran (AMG 890) is in a Phase 3 trial for cardiovascular outcomes. The Phase 3 study for patients with high Lp(a) should start late in 2025 or early in 2026.

In April 2025 Uplizna was approved by the FDA for Immunoglobulin G4 Related Disease. The Phase 3 data for myasthenia gravis was positive so the PDUFA is December 14, 2025.

Imdelltra Phase 3 trial for SCLC after progression from platinum reported postive results in April 2025. A much broader program in multiple indications continues.

Tezspire Phase 3 data for chronic rhinosinusitis with nasal polyps data in Q4 2024 was positive. PDUFA is October 19, 2025. In severe asthma, the WAYFINDER Phase 3b study is complete. Also a Phase 3 study of eosinophilic esophagitis is enrolling.

Many other studies are ongoing.

Non-GAAP numbers: net income was $2.65 billion, down 8% sequentially from $2.88 billion, and up 24% from $2.14 billion year-earlier. EPS was $4.90, down 8% sequentially from $5.31 and up 24% from $3.96 year-earlier.

Product sales were $7.87 billion, up % sequentially from $na billion, and up 11% y/y from $7.12 billion. Non-product revenue was $276 million, up % sequentially from $na million, and down 16% from $329 million year-earlier.

Product sales
$ millions
Q1 2025
Q4 2024
Q1 2024
y/y %
Prolia
$1,099
$1,165
$999
10%
Repatha
656
606
517
27%
Evenity
442
431
342
29%
Lumakras
85
85
82
4%
Neulasta
129
98
118
9%
Otezla
437
624
394
11%
Wezlana
150
na
1
na%
Pavblu
99
na
0
na%
Enbrel
510
1,015
567
-10%
Arenesp
340
308
349
-3%
Vectibix
267
246
247
8%
Nplate
313
337
317
-1%
Xgeva
566
561
561
1%
Kyprolis
324
372
376
%
Blincyto
370
381
244
52%
Parsabiv
88
75
105
-16%
Tezspire
285
296
173
65%
Tepezza
381
460
424
-10%
Krystexxa
236
346
235
0%
Uplizna
91
101
80
14%
Tavneos
90
81
51
76%
Amgevita
136
294
168
-19%
Imdelltra
81
67
0
na%
Mvasi
179
173
202
-11%
ultra rares
179
214
169
6%
other
340
361
397
-14%

Cash and equivalents balance ended at $8.8 billion, down sequentially from $12.0 billion. Operating cash flow $1.39 billion. Capital expenditures $411 million. Free cash flow was $0.98 billion. Long-term debt was $54 billion, reduced $2.8 billion in the quarter. $0 billion in shares were repurchased in the quarter. Dividend payments were $1.3 billion.

See also the Amgen pipeline.

GAAP cost of sales was $2.97 billion. Research and development expense was $1.49 billion; selling general and administrative expense $1.69 billion; and other operating expense $830 million, for total operating expenses of $6.97 billion. Operating income was $1.18 billion. Interest expense was $723 million, other income $1.52 billion, income taxes $243 million.

Q&A selective summary:

MariTide presentation at ADA? Shared salient data from the Phase 1 study. Strong efficacy, monthly dose well tolerated. Will add some mechanistic data, other details at ADA. Will have an investor relations call afterwards. But we are already in Phase 3, which is designed to deliver efficacy and tolerability.

Uplizna in IgG4 commercial strategy? Exciting opportunity. It is a recently diagnosed disease, usually by rheumatologists. We have good presense with key prescribers, field force is deployed. About 20,000 patients in the U.S. In GMG (myasthenia gravis) Uplizna has a very different mechanism than the current therapies.

Repatha competition? Yes, there is competition. We believe we have best profile in PCSK9 category. We have shown lower LDL and event reduction. Also the class is underserved, it is large, it can stand competition. We are working to open up access and affordability for Repatha.

Uplizna GMG pricing, competition? We believe market will be determined by efficacy and convenience. Positive feedback from physicians. We expect fairly broad access from payers.

Tepezza lack of growth? We are broadening the prescribing base. We need to activate non-specialist, general endocrinologists. We are seeing more intent to prescibe. We don't see a rapid change in the trajectory. Yes, subcutaneous product would help. Also got an approval recently in Japan, got a positive opinion in EU.

Talked about potential of the new KRAS therapy. Notes the space is competitive.

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Disclaimer: My analyst call summaries may include both condensations of statements made by company representatives and my own analysis. They are not covered by any warranty. I cannot guarantee anything said by company representatives is true. I try not to make errors, but it is possible. These are my personal notes that I use as the basis for my Seeking Alpha articles. They are not advice.

Copyright 2025 William P. Meyers