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Regeneron Reports Eylea Sales, Provides Other Pipeline Updates
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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) provided business and pipeline updates at the 43rd Annual J.P. Morgan Healthcare Conference.
Shares of the company moved up in pre-market trading on Jan. 14.
Shares of REGN have plunged 33.7% in the past six months compared with the industry’s decline of 12.3%.
Image Source: Zacks Investment Research
Updates on REGN’s Eylea Franchise
Regeneron’s lead drug, Eylea (aflibercept), is an anti-vascular endothelial growth factor inhibitor approved for various ophthalmology indications.
To counter the ongoing decline in Eylea sales, Regeneron developed a higher dose (8 mg) of the drug, Eylea HD.
Per Regeneron, on a combined basis, Eylea 2 mg and Eylea HD maintained their leadership position in the anti-VEGF category leader in 2024 in the United States.
On a preliminary basis, Eylea and Eylea HD recorded $6 billion in sales in 2024 in the United States. Sales for the fourth quarter were $1.5 billion in the United States, in line with the Zacks Consensus Estimate.
On a standalone basis, Eylea sales were $1.19 billion in the United States in the fourth quarter of 2024. Eylead HD’s net product sales were $305 million in the fourth quarter of 2024 in the United States.
The total Eylea franchise sales in the United States in the fourth quarter were favorably impacted by approximately $85 million as a result of higher wholesaler inventory levels for Eylea, partially offset by lower wholesaler inventory levels for Eylea HD.
Eylea’s sales have boosted the company’s top line for many years. However, Eylea’s sales have been under pressure in the last couple of years due to competition from Roche’s (RHHBY - Free Report) Vabysmo.
The uptake of Roche’s Vabysmo has been phenomenal. Roche has designed Vabysmo to block pathways involving Ang-2 and VEGF-A.
Biosimilar competition for Eylea is also worrisome.
REGN filed an application with the FDA for the use of the Eylea HD pre-filled syringe (PFS). A potential approval and launch are expected by mid 2025.
Longer-term data in wet age-related macular degeneration (wAMD) and diabetic macular edema are under FDA review with a target action date of April 20, 2025, to potentially extend dosing intervals for Eylea HD up to every 24 weeks.
Regeneron plans to submit a supplemental biologics license application (sBLA) for Eylea HD for every four-week dosing and retinal vein occlusion in the first quarter of 2025 to potentially maximize dosing flexibility and address more retinal diseases.
Regeneron has a collaboration agreement with Bayer (BAYRY - Free Report) for Eylea. Regeneron records the net product sales of Eylea and Eylea HD in the United States, and Bayer records its net product sales outside the country.
Regeneron records its share of profits in connection with Eylea’s sales outside the United States.
REGN Updates on Dupixent
REGN’s top line also comprises its share of profits/losses in connection with the global sales of Dupixent. Partner Sanofi (SNY - Free Report) records global net product sales of Dupixent.
Solid sales of Dupixent (approved for use in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis) have fueled the top line for Sanofi and Regeneron. The initial uptake for the recently approved indication of chronic obstructive pulmonary disease (COPD) is encouraging.
An application for expanding the drug’s label for the indication of chronic spontaneous urticaria is under review in the United States with a target action date of April 18, 2025.
The sBLA seeking label expansion of the drug for bullous pemphigoid was submitted in the fourth quarter of 2024.
REGN’s Focus on Oncology
REGN is looking to strengthen its oncology franchise, which currently comprises Libtayo (cemiplimab-rwlc), indicated in certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma and advanced non-small cell lung cancer.
Libtayo exceeded $1 billion in sales for 2024.
Regeneron announced positive results from the late-stage C-POST study, which demonstrated that adjuvant treatment with PD-1 inhibitor Libtayo led to a statistically significant and clinically meaningful improvement in the primary endpoint of disease-free survival in patients with high-risk cutaneous squamous cell carcinoma after surgery.
More on the REGN Pipeline
REGN has a deep pipeline with many promising candidates: itepekimab (IL-33) for COPD, fianlimab (LAG3) for melanoma, and linvoseltamab (BCMAxCD3) for multiple myeloma.
The BLA for linvoseltamab was resubmitted after the resolution of third-party manufacturing issues, with the launch anticipated in mid 2025.
REGN’s oncology franchise got a boost with the European Commission's approval of odronextamab for treating adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma after two or more lines of systemic therapy. The drug has been approved under the brand name Ordspono.
However, the company’s efforts to get odronextamab approved in the United States suffered a setback. The regulatory body issued complete response letters for its biologics license application (BLA) for odronextamab.
Enrollment is underway for a confirmatory study to support resubmission of the BLA for FL to the FDA in the first quarter of 2025.
Two Factor XI antibodies, REGN7508 (catalytic domain) and REGN9933 (A2 domain) will advance to pivotal trials in 2025 on the basis of positive proof-of-concept data announced last month.
Regeneron is also evaluating various combinations with GLP-based therapies for obesity. A phase II study of trevogrumab and Wegovy (semaglutide) with and without garetosmab is now fully enrolled, and a phase II study testing combinations of tirzepatide and mibavademab is ongoing, with initial data expected from both in the second half of 2025.
REGN Announces Collaboration With Truveta
Regeneron announced a strategic collaboration with Truveta, Inc. and its collective of U.S. health systems to advance innovation and data-driven discovery across the life sciences, public health and healthcare delivery ecosystem.
Image: Bigstock
Regeneron Reports Eylea Sales, Provides Other Pipeline Updates
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) provided business and pipeline updates at the 43rd Annual J.P. Morgan Healthcare Conference.
Shares of the company moved up in pre-market trading on Jan. 14.
Shares of REGN have plunged 33.7% in the past six months compared with the industry’s decline of 12.3%.
Image Source: Zacks Investment Research
Updates on REGN’s Eylea Franchise
Regeneron’s lead drug, Eylea (aflibercept), is an anti-vascular endothelial growth factor inhibitor approved for various ophthalmology indications.
To counter the ongoing decline in Eylea sales, Regeneron developed a higher dose (8 mg) of the drug, Eylea HD.
Per Regeneron, on a combined basis, Eylea 2 mg and Eylea HD maintained their leadership position in the anti-VEGF category leader in 2024 in the United States.
On a preliminary basis, Eylea and Eylea HD recorded $6 billion in sales in 2024 in the United States. Sales for the fourth quarter were $1.5 billion in the United States, in line with the Zacks Consensus Estimate.
On a standalone basis, Eylea sales were $1.19 billion in the United States in the fourth quarter of 2024. Eylead HD’s net product sales were $305 million in the fourth quarter of 2024 in the United States.
The total Eylea franchise sales in the United States in the fourth quarter were favorably impacted by approximately $85 million as a result of higher wholesaler inventory levels for Eylea, partially offset by lower wholesaler inventory levels for Eylea HD.
Eylea’s sales have boosted the company’s top line for many years. However, Eylea’s sales have been under pressure in the last couple of years due to competition from Roche’s (RHHBY - Free Report) Vabysmo.
The uptake of Roche’s Vabysmo has been phenomenal. Roche has designed Vabysmo to block pathways involving Ang-2 and VEGF-A.
Biosimilar competition for Eylea is also worrisome.
REGN filed an application with the FDA for the use of the Eylea HD pre-filled syringe (PFS). A potential approval and launch are expected by mid 2025.
Longer-term data in wet age-related macular degeneration (wAMD) and diabetic macular edema are under FDA review with a target action date of April 20, 2025, to potentially extend dosing intervals for Eylea HD up to every 24 weeks.
Regeneron plans to submit a supplemental biologics license application (sBLA) for Eylea HD for every four-week dosing and retinal vein occlusion in the first quarter of 2025 to potentially maximize dosing flexibility and address more retinal diseases.
Regeneron has a collaboration agreement with Bayer (BAYRY - Free Report) for Eylea. Regeneron records the net product sales of Eylea and Eylea HD in the United States, and Bayer records its net product sales outside the country.
Regeneron records its share of profits in connection with Eylea’s sales outside the United States.
REGN Updates on Dupixent
REGN’s top line also comprises its share of profits/losses in connection with the global sales of Dupixent. Partner Sanofi (SNY - Free Report) records global net product sales of Dupixent.
Solid sales of Dupixent (approved for use in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis) have fueled the top line for Sanofi and Regeneron. The initial uptake for the recently approved indication of chronic obstructive pulmonary disease (COPD) is encouraging.
An application for expanding the drug’s label for the indication of chronic spontaneous urticaria is under review in the United States with a target action date of April 18, 2025.
The sBLA seeking label expansion of the drug for bullous pemphigoid was submitted in the fourth quarter of 2024.
REGN’s Focus on Oncology
REGN is looking to strengthen its oncology franchise, which currently comprises Libtayo (cemiplimab-rwlc), indicated in certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma and advanced non-small cell lung cancer.
Libtayo exceeded $1 billion in sales for 2024.
Regeneron announced positive results from the late-stage C-POST study, which demonstrated that adjuvant treatment with PD-1 inhibitor Libtayo led to a statistically significant and clinically meaningful improvement in the primary endpoint of disease-free survival in patients with high-risk cutaneous squamous cell carcinoma after surgery.
More on the REGN Pipeline
REGN has a deep pipeline with many promising candidates: itepekimab (IL-33) for COPD, fianlimab (LAG3) for melanoma, and linvoseltamab (BCMAxCD3) for multiple myeloma.
The BLA for linvoseltamab was resubmitted after the resolution of third-party manufacturing issues, with the launch anticipated in mid 2025.
REGN’s oncology franchise got a boost with the European Commission's approval of odronextamab for treating adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma after two or more lines of systemic therapy. The drug has been approved under the brand name Ordspono.
However, the company’s efforts to get odronextamab approved in the United States suffered a setback. The regulatory body issued complete response letters for its biologics license application (BLA) for odronextamab.
Enrollment is underway for a confirmatory study to support resubmission of the BLA for FL to the FDA in the first quarter of 2025.
Two Factor XI antibodies, REGN7508 (catalytic domain) and REGN9933 (A2 domain) will advance to pivotal trials in 2025 on the basis of positive proof-of-concept data announced last month.
Regeneron is also evaluating various combinations with GLP-based therapies for obesity. A phase II study of trevogrumab and Wegovy (semaglutide) with and without garetosmab is now fully enrolled, and a phase II study testing combinations of tirzepatide and mibavademab is ongoing, with initial data expected from both in the second half of 2025.
REGN Announces Collaboration With Truveta
Regeneron announced a strategic collaboration with Truveta, Inc. and its collective of U.S. health systems to advance innovation and data-driven discovery across the life sciences, public health and healthcare delivery ecosystem.
REGN’s Zacks Rank
REGN currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.