Regeneron said U.S. net product sales of EYLEA HD and EYLEA both increased from the prior year for the three and six months ended June 30, 2024. The company cited the transition of patients to EYLEA HD (FDA-approved in August 2023) and lower volumes and a lower net selling price as factors in the decline in U.S. EYLEA net sales.

1. 01

   Regeneron said U.S. net product sales of EYLEA HD and EYLEA both increased from the prior year for the three and six months ended June 30, 2024. The company cited the transition of patients to EYLEA HD (FDA-approved in August 2023) and lower volumes and a lower net selling price as factors in the decline in U.S. EYLEA net sales.

2. 02

   The company said the FDA extended the target action date of the priority review of the Dupixent sBLA for COPD by 3 months in May 2024. It said the FDA requested additional efficacy analyses from the BOREAS and NOTUS trials, determined them to be a major amendment, and that the revised target action date is September 27, 2024.

3. 03

   Regeneron said the FDA informed it that the third-party fill/finish provider for linvoseltamab had unresolved findings from a pre-approval inspection and that a re-inspection is required. The company said it believes any potential FDA approval of the linvoseltamab BLA will be delayed beyond the August 22, 2024 target action date. It said the FDA has not informed it of any approvability issues for linvoseltamab related to safety, efficacy, or the status of its confirmatory trial.

4. 04

   Regeneron said its board approved, on April 2024, an additional share repurchase program of up to $3.0 billion of common stock on terms substantially similar to the existing program. The company said that as of June 30, 2024, the total remaining amount available for repurchase under the two programs was $3.631 billion.

Key figures

Quarter ended June 30, 2024

Revenue

$3.5B

Operating income

$1.1B

Net income

$1.4B

EPS

$12.41

Analysis scope · Management's discussion (MD&A)We analyzed excerpts of the Management's Discussion and Analysis (MD&A) section (with omissions). Other sections of the report, such as the notes to the financial statements and risk factors, were not reviewed.

AI summarized the filing and translated the summary into English; it may differ from the original. For reference only, not investment advice. AI translated the published Korean report into English. Figures are copied as filed, not recalculated.

Original filing

The filing as submitted to SEC EDGAR. You can check the figures and statements of this summary against it.