Analyst Conference Summary

biotechnology

conference date: October 30, 2024 @ 1:30 PM Pacific Time
for quarter ending: September 30, 2024 (third quarter, Q3)

Forward-looking statements

Overview: Strong quarter.

Basic data (GAAP):

Revenue was $8.50 billion, up 1% sequentially from $8.39 billion and up 23% from $6.90 billion in the year-earlier quarter.

Net income was $2.83 billion, up 279% sequentially from $746 million, and up 63% from $1.73 billion year-earlier.

Earnings Per Share (diluted EPS) were $5.22, up 278% sequentially from $1.38 and up 62% from $3.22 year-earlier.

Guidance:

New full year 2024 guidance: Revenue $33.0 to $33.8 billion. GAAP EPS $8.71 to $9.56. Non-GAAP $19.20 to $20.00. Cap ex $1.3 billion.

Conference Highlights:

Robert A. Bradway, CEO said "Strong growth in sales and earnings this quarter reflects the momentum we're building throughout our business. We continue to invest heavily in our rapidly advancing pipeline, with a focus on delivering innovative therapies across our core therapeutic areas." Excluding sales from the Horizon acquisition, product sales grew 8% y/y.

Mark-to-market gains in BeiGene investment added to the GAAP EPS increase.

MariTide GLP-activator for obesity in ongoing Phase 2 study. Also Phase 2 for Type 2 diabetes. Planning Phase 3 for a variety of indications.

Horizon acquisition is going well and while it caused a y/y increase in expenses, those will be reduced over time due to synergies.

In June 2024 Blyncyto was approved in the U.S. for CD19-positive Philadelphia chromosome negative B -cell precursor acute lymphoblastic leukemia. Submissions are underway outside the US.

Lumakras continues Phase 3 enrollment, combined with Vectibix and Folfiri, for CRC patients with KRAS G12C mutations. A regulatory submission is on track for Lumakras with Vectibix. Other combination trials are underway.

On June 5, 2024 Amgen announced positive Phase 3 results for Uplinza for IgG4-RD (immunoglobulin G4-related disease).

Imdelltra is a DLL3 targeting BiTE in three ongoing trials: second-line extensive-stage small cell lung cancer; first line ES-SCLC; limited stage SCLC. A Phase 2 study in ES-SCLC reported postive results in September 2024.

Xaluritamig (AMG 509) was in two Phase 1 studies for mCRPC (metastatic castrate resistant prostate cancer). Results in September 2024 were positive. A Phase 3 study in post-taxane metastatic castrate resistant prostate cancer should initiate in Q4 2024.

The Olpasiran (AMG 890) Phase 3 study of ASCVD with elevated Lp(a) completed enrollment in Q2 2024. The Phase 3 cardiovascular outcomes for patients with atherosclerotic disease and elevated Lp(a) is ongoing.

In August 2024, the FDA approved Pavblu (aflibercept-ayyh) (ABP 938), a biosimilar candidate to Eylea (aflibercept), for the treatment of retinal conditions, including neovascular age-related macular degeneration (wet AMD), macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

Tezspire Phase 3 data for chronic rhinosinusitis with nasal polyps data expected before the end of 2024.

Many other studies are ongoing.

Non-GAAP numbers: net income was $3.02 billion, up 12% sequentially from $2.69 billion, and up 13% from $2.67 billion year-earlier. EPS was $5.58, up 12% sequentially from $4.97 and up 13% from $4.96 year-earlier.

Product sales were $8.15 billion, up 1% sequentially from $8.04 billion, and up 24% y/y from $6.55 billion. Non-product revenue was $352 million, up 1% sequentially from $347 million, and down 1% from $355 million year-earlier.

Cash and equivalents balance ended at $9.0 billion, down sequentially from $na billion. Operating cash flow $3.6 billion. Capital expenditures $300 million. Free cash flow was $3.3 billion. At the end of quarter long-term debt was $60.4 billion. No shares were repurchased in the quarter. Dividend payments were $1.2 billion.

See also the Amgen pipeline.

GAAP cost of sales was $3.31 billion. Research and development expense was $1.45 billion; selling general and administrative expense $1.63 billion; and other operating expense $71 million, for total operating expenses of $6.46 billion. Operating income was $2.05 billion. Interest expense was $776 million, other income $1.83 billion, income taxes $271 million.

Q&A selective summary:

Maritide data, what will be shared? Should have Phase 2 diabetes data by end of year.

Spend on Phase 3 Maritide program? It will be broad, obesity, diabetes, obesity related conditions. Global trial. Planning is on track. When we give future guidance on expenditures. This will be a significant investment.

We are interested in producing oral medicines for obesity.

Growth path for Tepezza? Rose 8% y/y. Looking to expand from high patients to low patients. Expect momentum in the next several quarters. Expansion to Japan (approved in September) will lead to a launch early in 2025.

Biosimilars? Excited about new launches. It is important to be first or in the first wave. We expect strong interest. Receptivity has been high for Pavblu.

Enbrel no Q3 bounce? Impacted by the decline in net price and a 30% adjustment, but volume was up 4% in the quarter. We expect continued price declines.

Biosimilars to Prolia? Serves to source patients for Evenity. Could help with market presence in the face of biosimilar competition in the future.

Search

More Analyst Conference Pages: