Analyst Conference Summary

Biotechnology

conference date: August 3, 2022 @ 5:30 AM Pacific Time
for quarter ending: June 30, 2022 (Q2, second quarter 2022)

Forward-looking statements

Overview:

Basic data (GAAP):

Revenue was $ billion, down % sequentially from $2.97 billion but up % from $ billion in the year-earlier quarter.

Net income was $ billion, down % sequentially from $0.97 billion, and down % from $ billion year-earlier.

Diluted Earnings Per Share (EPS) was $, down % sequentially from $8.61 and down % from $ year-earlier.

Guidance:

Conference Highlights:

Leonard S. Schleifer, CEO, said ""

In April 2022, Regeneron entered into an agreement to acquire Checkmate Pharmaceuticals, Inc. at a total equity value of approximately $250 million. The transaction is expected to close, subject to the satisfaction of customary closing conditions including regulatory approvals, in mid-2022. This is the first time Regeneron has ever acquired an entire company.

In April 2022, the European Commission approved Dupixent for the treatment of severe asthma in children aged 6 to 11 years.

In Q1 the FDA accepted for priority review the sBLA for Dupixent for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis, with a PDUFA date of June 9, 2022. A regulatory application was also submitted in the European Union (EU). The FDA accepted for priority review the sBLA for Dupixent for adults and adolescents aged 12 years and older with eosinophilic esophagitis (EoE), with a target action date of August 3, 2022. A regulatory application was also submitted in the EU.

In Q1 2022 a supplemental Biologics License Application (sBLA) for Eylea for an every-16-weeks dosing regimen in patients with non-proliferative diabetic retinopathy was submitted to the FDA.

In Q4 2021 the FDA accepted the sBLA for Libtayo in combination with chemotherapy to treat patients with advanced non-small cell lung cancer (NSCLC). The PDUFA date is September 19, 2022. A regulatory application was also submitted in the EU.

Dupixent for prurigo nodularis Phase 3 trial met is endpoints, with a regulatory submission expected 1H 2022.

Future growth will be fueled by the breadth and depth of the pipeline. Genetic medicines portfolio pipeline has high potential future value.

The company continued to advance its bispecific antibodies for cancers in early stage trials. The first data readout from a prostate cancer bispecific is expected later this year. Many anti-cancer agents are being tested in combination with Libtayo. In all it has 30 product candidates in clinical development.

Revenue by type: product sales $ billion. Collaboration revenue $ billion. Other income $ million.

Non-GAAP results: net income $ billion, down % sequentially from $1.32 billion and up % from $ billion year earlier. Diluted EPS $, down % sequentially from $11.49 and up % from $ year-earlier.

In Q1 2022 Fianlimab, a LAG-3 agonist, initiated a Phase 3 study in first-line metastatic melanoma.

See also the Regeneron Pipeline.

Cash and equivalents balance ended at $ billion, up sequentially from $ billion. $ billion long-term debt. Cash from operations was $ billion, free cash flow $ billion. $ million shares repurchased in the quarter.

GAAP expenses of $ billion consisted of: cost of goods sold $ million; research and development $ million; selling, general and administrative $ million; collaboration manufacturing costs $ million; other operating income $ million. Leaving income from operations of $ billion. Other expense was $ million. Income tax was $ million.

Q&A selective summary:

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