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Regeneron (REGN) Q2 Earnings Gain From Eylea HD, Dupixent
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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) reported better-than-expected second-quarter results despite lower sales from its lead drug Eylea. The stock rose 1.3% following the results but was trading lower a day later.
Revenues climbed 12% to $3.6 billion, driven by growth in Eylea HD sales, profits from blockbuster asthma drug Dupixent and oncology drug Libtayo.
Higher revenues drove the bottom line as well. Adjusted earnings per share (EPS) of $11.56 beat the Zacks Consensus Estimate of $10.57 and were up 13% from the year-ago quarter’s level.
Regeneron’s shares have risen 22% year to date against the industry’s decline of 2.2%.
Image Source: Zacks Investment Research
Strong Eylea HD Uptake
Eylea HD generated $304 million in its third full quarter in the United States market and continues to outperform recent launches in the anti-VEGF category. Total combined product sales for Eylea HD and Eylea were $1.53 billion, up 2.3% year over year. The figure also beat the Zacks Consensus Estimate of $1.52 billion.
In August 2023, the FDA approved Eylea HD (higher dose of Eylea) for the treatment of patients with wet age-related macular degeneration, diabetic macular edema (DME) and diabetic retinopathy.
However, on a standalone basis, Eylea sales declined 18% to $1.2 billion due to increased competition resulting in lower volumes and a reduced net selling price.
Eylea HD has witnessed a strong uptake maintaining momentum for REGN as patients transition from Eylea. The company is now focused on bringing a pre-filled syringe of Eylea HD in the U.S. market. A tentative launch is targeted for early 2025.
Dupixent Marches Ahead
Collaboration revenues from partner Sanofi (SNY - Free Report) increased 21% to $1.1 billion, driven by profits associated with higher Dupixent sales. Sanofi records global net product sales of Dupixent and Kevzara, while Regeneron records its share of profits/losses in connection with the global sales of both drugs.
Dupixent’s sales increased 27% year over year to $3.5 billion, reflecting strong growth across all approved indications (atopic dermatitis, asthma and nasal polyps), age groups and geographies. In June 2024, the European Commission approved Dupixent as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. This also represents the first biologic approved to treat COPD.
Libtayo Gains Traction
Total Libtayo sales came in at $297.4 million, up 42% year over year. The figure beat the Zacks Consensus Estimate of $285 million. Libtayo is witnessing growth in demand for the indication of skin cancer while making impressive inroads in non-small cell lung cancer (NSCLC) indication.
Cost & Margin Analysis
Adjusted R&D expenses jumped 10% year over year to $1.1 billion due to the advancement of the company's late-stage oncology programs and higher headcount and headcount-related costs. Adjusted SG&A expenses increased 19% to $667 million due to higher commercialization-related expenses to support the launch of Eylea HD and higher headcount and headcount-related costs.
Pipeline Progress
The biologics license application (BLA) for linvoseltamab was earlier accepted for Priority Review for the treatment of relapsed/refractory (R/R) multiple myeloma by the FDA with a target action date of Aug 22, 2024.
However, during its review of the BLA, the FDA informed REGN that the third-party fill-finish manufacturer for linvoseltamab had unresolved findings from a pre-approval inspection for another company's product candidate. Consequently, a reinspection will be required and the FDA is likely to delay its decision from the earlier set target action date.
A phase II study for fianlimab, an antibody to LAG-3, in combination with Libtayo, for perioperative NSCLC was initiated. A phase II/III study for fianlimab, in combination with Libtayo, for perioperative melanoma was also initiated.
However, in May 2024, the FDA extended the target action date of its priority review of the supplemental biologics license application (sBLA) for Dupixent as an add-on maintenance treatment in certain adult patients with uncontrolled COPD by three months. The revised target action date is Sep 27, 2024.
A phase II study was initiated for trevogrumab, an antibody to myostatin (GDF8), in combination with semaglutide, with and without garetosmab, for the treatment of obesity.
Regeneron Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
While the second-quarter results were good and the uptake of Eylea HD was impressive, recent pipeline setbacks are a concern.
Eylea sales continue to be under pressure due to competition from Roche’s (RHHBY - Free Report) Vabysmo. Roche has designed Vabysmo to block pathways involving Ang-2 and VEGF-A. The drug raked in CHF 1.8 billion in the first half of 2024 on strong demand in all regions.
Roche has already obtained FDA approval for Vabysmo prefilled syringe for people living with wet age-related macular degeneration, DME and retinal vein occlusion.
Nonetheless, Dupixent maintains its stellar performance and profits from this drug, which has helped REGN in offsetting the declining Eylea sales. Recent launches in eosinophilic esophagitis and prurigo nodularis indications have shown encouraging uptake. Approval of the COPD indication should further boost sales.
Image: Bigstock
Regeneron (REGN) Q2 Earnings Gain From Eylea HD, Dupixent
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) reported better-than-expected second-quarter results despite lower sales from its lead drug Eylea. The stock rose 1.3% following the results but was trading lower a day later.
Revenues climbed 12% to $3.6 billion, driven by growth in Eylea HD sales, profits from blockbuster asthma drug Dupixent and oncology drug Libtayo.
Higher revenues drove the bottom line as well. Adjusted earnings per share (EPS) of $11.56 beat the Zacks Consensus Estimate of $10.57 and were up 13% from the year-ago quarter’s level.
Regeneron’s shares have risen 22% year to date against the industry’s decline of 2.2%.
Image Source: Zacks Investment Research
Strong Eylea HD Uptake
Eylea HD generated $304 million in its third full quarter in the United States market and continues to outperform recent launches in the anti-VEGF category. Total combined product sales for Eylea HD and Eylea were $1.53 billion, up 2.3% year over year. The figure also beat the Zacks Consensus Estimate of $1.52 billion.
In August 2023, the FDA approved Eylea HD (higher dose of Eylea) for the treatment of patients with wet age-related macular degeneration, diabetic macular edema (DME) and diabetic retinopathy.
However, on a standalone basis, Eylea sales declined 18% to $1.2 billion due to increased competition resulting in lower volumes and a reduced net selling price.
Eylea HD has witnessed a strong uptake maintaining momentum for REGN as patients transition from Eylea. The company is now focused on bringing a pre-filled syringe of Eylea HD in the U.S. market. A tentative launch is targeted for early 2025.
Dupixent Marches Ahead
Collaboration revenues from partner Sanofi (SNY - Free Report) increased 21% to $1.1 billion, driven by profits associated with higher Dupixent sales. Sanofi records global net product sales of Dupixent and Kevzara, while Regeneron records its share of profits/losses in connection with the global sales of both drugs.
Dupixent’s sales increased 27% year over year to $3.5 billion, reflecting strong growth across all approved indications (atopic dermatitis, asthma and nasal polyps), age groups and geographies. In June 2024, the European Commission approved Dupixent as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. This also represents the first biologic approved to treat COPD.
Libtayo Gains Traction
Total Libtayo sales came in at $297.4 million, up 42% year over year. The figure beat the Zacks Consensus Estimate of $285 million. Libtayo is witnessing growth in demand for the indication of skin cancer while making impressive inroads in non-small cell lung cancer (NSCLC) indication.
Cost & Margin Analysis
Adjusted R&D expenses jumped 10% year over year to $1.1 billion due to the advancement of the company's late-stage oncology programs and higher headcount and headcount-related costs. Adjusted SG&A expenses increased 19% to $667 million due to higher commercialization-related expenses to support the launch of Eylea HD and higher headcount and headcount-related costs.
Pipeline Progress
The biologics license application (BLA) for linvoseltamab was earlier accepted for Priority Review for the treatment of relapsed/refractory (R/R) multiple myeloma by the FDA with a target action date of Aug 22, 2024.
However, during its review of the BLA, the FDA informed REGN that the third-party fill-finish manufacturer for linvoseltamab had unresolved findings from a pre-approval inspection for another company's product candidate. Consequently, a reinspection will be required and the FDA is likely to delay its decision from the earlier set target action date.
A phase II study for fianlimab, an antibody to LAG-3, in combination with Libtayo, for perioperative NSCLC was initiated. A phase II/III study for fianlimab, in combination with Libtayo, for perioperative melanoma was also initiated.
However, in May 2024, the FDA extended the target action date of its priority review of the supplemental biologics license application (sBLA) for Dupixent as an add-on maintenance treatment in certain adult patients with uncontrolled COPD by three months. The revised target action date is Sep 27, 2024.
A phase II study was initiated for trevogrumab, an antibody to myostatin (GDF8), in combination with semaglutide, with and without garetosmab, for the treatment of obesity.
Regeneron Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Regeneron Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Regeneron Pharmaceuticals, Inc. Quote
While the second-quarter results were good and the uptake of Eylea HD was impressive, recent pipeline setbacks are a concern.
Eylea sales continue to be under pressure due to competition from Roche’s (RHHBY - Free Report) Vabysmo. Roche has designed Vabysmo to block pathways involving Ang-2 and VEGF-A. The drug raked in CHF 1.8 billion in the first half of 2024 on strong demand in all regions.
Roche has already obtained FDA approval for Vabysmo prefilled syringe for people living with wet age-related macular degeneration, DME and retinal vein occlusion.
Nonetheless, Dupixent maintains its stellar performance and profits from this drug, which has helped REGN in offsetting the declining Eylea sales. Recent launches in eosinophilic esophagitis and prurigo nodularis indications have shown encouraging uptake. Approval of the COPD indication should further boost sales.
Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.