Analyst Conference Summary

biotechnology

conference date: February 8, 2022 @ 5:00 AM Pacific Time
for quarter ending: December 30, 2021 (fourth quarter, Q4)

Forward-looking statements

Note this was an over 3 hour meeting. So too long for me to summarize here. Most of the data here is from the press release.

Overview: Not a bad quarter.

Basic data (GAAP):

Revenue was $6.85 billion, up 2% sequentially from $6.71 billion and up 3% from $6.63 billion in the year-earlier quarter.

Net income was $1.90 billion, up 1% sequentially from $1.88 billion, and up 18% from $1.62 billion year-earlier.

Earnings Per Share (diluted EPS) were $3.36, up 2% sequentially from $3.31, and up 22% from $2.76 year-earlier.

Guidance:

na

Conference Highlights:

Robert A. Bradway, CEO said "We realized strong volume growth for many of our key products during last year. These products, combined with our many pipeline opportunities, position us well for long-term growth."

In January 2022, Amgen and Generate Biomedicines announced a research collaboration agreement to discover and create protein therapeutics for five clinical targets across several therapeutic areas and multiple modalities.

In January 2022, Amgen and Arrakis Therapeutics announced a research collaboration focused on the discovery and development of RNA degrader therapeutics against a range of difficult-to-drug targets in multiple therapeutic areas. This new class of targeted RNA degraders consists of small molecule drugs that selectively destroy RNAs encoding disease-causing proteins by inducing their proximity to nucleases. In February 2022, Amgen and Plexium announced a research collaboration and license agreement to identify novel targeted protein degradation therapeutics toward historically challenging drug targets.

Following a priority review by the FDA, Tezspire (tezepelumab) was approved early in December 2021 for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. Regulatory reviews are underway in the EU, Japan, and other jurisdictions.

Expects increased competition to continue to erode results of certain established products like Neulasta and Neupogen.

Non-GAAP numbers: net income was $2.46 billion, down 8% sequentially from $2.66 billion, and up 22% from $2.02 billion year-earlier. EPS was $4.36, down 7% sequentially from $4.67 and up 26% from $3.46 year-earlier.

Product sales were $6.27 billion, down 1% sequentially from $6.32 billion, and down 1% y/y from $6.33 billion. Non-product revenue was $575 million, up from $300 million year-earlier.

Cash and equivalents balance ended at $8.0 billion, down sequentially from $12.9 billion. Operating cash flow $2.8 billion. Free cash flow was $2.5 billion. At the end of quarter long-term debt was $33.3 billion. Capital expenditures $0.3 billion. $1.5 billion worth of shares were repurchased in the quarter. Dividend payments were $1.0 billion.

In December 2021, Otezla was approved by the FDA for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.

In January 2022, the European Commission granted conditional marketing authorization for LUMYKRAS, for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy. Lumakras (AMG 510 or sotorasib) was approved in May 2021 for treating KRAS G12C-mutated NSCLC in the U.S. , following at least one prior systemic therapy. Applications made in EU, Canada, Australia, Brazil and the United Kingdom. Trials in other indications continue. Launch is strong, so far.

In July 2021 the FDA accepted the BLA for tezepelumab. A Phase 3 Study evaluating the efficacy and safety of tezepelumab in adults and adolescents with severe uncontrolled asthma data was presented in February 2021. A Phase 2 study evaluating the efficacy and safety of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease is enrolling patients. Designated a Breakthrough Therapy.

See also the Amgen pipeline.

GAAP cost of sales was $1.72 billion. Research and development expense was $1.35 billion; selling general and administrative expense $1.43 billion; and other expense $51 million, for total operating expenses of $4.54 billion. Operating income was $2.30 billion. Interest expense was $335 million, other income $162 million, income taxes $232 million.

Q&A summary:

not available

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