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Press Release: Regeneron Reports Fourth Quarter -2-

· 02/05/2021 06:30
Programs Milestones EYLEA - Report results from Phase 2 study for high-dose formulation in neovascular age-related macular degeneration (wet AMD) Dupixent - FDA decision on sBLA and MAA submission for asthma in pediatrics (6--11 years of age) - Report results from Part B of the Phase 3 study in adults and adolescents with eosinophilic esophagitis (EoE) - Report results from Phase 3 study in prurigo nodularis REGEN-COV (casirivimab and - Report additonal data from Phase 3 imdevimab) portion of COVID-19 study in non-hospitalized patients - Report results for lower 1,200 mg dose in Phase 3 portion of COVID-19 study in non-hospitalized patients - Report additional data from Phase 3 portion of COVID-19 prevention study in household contacts - Data to be reported from Phase 3 United Kingdom-based RECOVERY trial in hospitalized patients - Report data from Phase 2 dose-ranging virology study in non-hospitalized patients - Submit BLA and MAA for COVID-19 Libtayo - FDA decision on sBLA (target action date of February 28, 2021) and EC decision on regulatory submission for first-line NSCLC, monotherapy - Interim analysis from Phase 3 study in first-line NSCLC, chemotherapy combination - FDA decision on sBLA (target action date of March 3, 2021) and EC decision on regulatory submission for advanced BCC - Interim analysis from Phase 3 study in cervical cancer REGN5458 (BCMA and CD3 Bispecific - Complete patient enrollment in Antibody) potentially pivotal Phase 2 study in multiple myeloma - Initiate pivotal trials in earlier lines of multiple myeloma therapy Odronextamab (CD20 and CD3 - Complete patient enrollment in Bispecific Antibody) potentially pivotal Phase 2 study in B-NHL - Initiate Phase 3 program Praluent - FDA decision on sBLA for homozygous familial hypercholesterolemia (HoFH) in adults (target action date of April 4, 2021) Evkeeza(TM) (evinacumab) (ANGPTL3 - FDA decision on BLA (target action Antibody) date of February 11, 2021) and EC decision on MAA for HoFH Fasinumab (NGF Antibody) - Report additional longer-term safety results from Phase 3 studies in osteoarthritis pain of the knee or hip - Continue discussions with regulatory authorities and determine next steps for the program-- A Phase 3 study in birch allergy was recently initiated. REGN5713-5714-5715 is designed to treat allergic inflammatory conditions caused by the allergen Betv1, which is the main allergen responsible for birch pollen allergies. Birch pollen allergy is one of the most common causes of seasonal allergies that occur in the spring, and is also believed to trigger "oral allergy syndrome" food reactions to related allergens found in fruits and nuts such as apples, pears, and cherries.-- The Company and Sanofi have initiated a Phase 3 program in chronic obstructive pulmonary disease (COPD).-- In addition to REGN5458 and odronextamab, the Company has advanced two CD3 bispecifics into clinical trials including MUC16xCD3 (REGN4018), which is being studied in ovarian cancer. -- Three costimulatory CD28 bispecifics are now in clinical trials targeting prostate cancer, ovarian cancer, and other solid tumors. -- Also in clinical development is the first of a third class of bispecifics, METxMET (REGN5093), in non-small cell lung cancer driven by MET mutations and/or amplifications.-- In December 2020, updated results from the Phase 1 trial in R/R follicular lymphoma, diffuse large B-cell lymphoma, and other B-cell non-Hodgkin lymphomas were shared in an oral presentation at ASH and included patient follow-up data of up to 3 years. -- In December 2020, the Company announced it was pausing new enrollment of patients with B-cell non-Hodgkin lymphomas (B-NHL) in its trials in compliance with an FDA partial clinical hold. The FDA requested that the Company amend the trial protocols in order to further reduce the incidence of >=Grade 3 cytokine release syndrome (CRS) during step-up dosing. The Company is working with the FDA to amend the protocol, with the goal of resuming patient enrollment within the first half of 2021.-- In December 2020, the Company announced updated data from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. The results continued to show deep and durable responses in patients with heavily-pretreated multiple myeloma and were shared in an oral presentation at the virtual 2020 American Society of Hematology (ASH) Annual Meeting.-- In October 2020, the FDA approved Inmazeb (REGN-EB3) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection.

Inmazeb(TM) (atoltivimab, maftivimab, and odesivimab-ebgn)

REGN5458, a bispecific antibody targeting BCMA and CD3

Odronextamab, a CD20xCD3 bispecific antibody

Additional Bispecific Antibodies

Itepekimab, an antibody to IL-33

REGN5713-5714-5715, a multi-antibody therapy to Betv1

Select 2021 Milestones

Fourth Quarter and Full Year 2020 Financial Results

Effective January 1, 2020, Regeneron implemented changes in the presentation of its financial statements related to certain reimbursements and other payments for products developed and commercialized with collaborators. The Company made these changes in presentation to better reflect the nature of the Company's costs incurred and revenues earned pursuant to arrangements with collaborators and to enhance the comparability of Regeneron's financial statements with industry peers. The change in presentation has been applied retrospectively. See note (4) below for further information.

Revenues

Total revenues increased by 30% to $2.423 billion in the fourth quarter of 2020, compared to $1.864 billion in the fourth quarter of 2019. Full year 2020 total revenues increased 30% to $8.497 billion, compared to $6.558 billion for the full year 2019.

EYLEA(R) net product sales in the United States increased to $1.343 billion in the fourth quarter of 2020, compared to $1.222 billion in the fourth quarter of 2019. Full year 2020 EYLEA net product sales in the United States increased to $4.947 billion, compared to $4.644 billion for the full year 2019. Overall distributor inventory levels for EYLEA in the United States remained within the Company's one-to-two-week targeted range.

Net product sales of REGEN-COV were $146 million in the fourth quarter of 2020 and $186 million for the full year of 2020.

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February 05, 2021 06:30 ET (11:30 GMT)