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Regeneron Pharmaceuticals

Regeneron Pharmaceuticals, Inc. is a biotechnology company, which engages in the discovery, invention, development, manufacture, and commercialization of medicines. Its product portfolio includes the following brands: EYLEA, Dupixent, Praluent, Kevzara, Libtayo, ARCALYST, and ZALTRAP. The firm accelerates the traditional drug development process through its proprietary VelociSuite technologies such as VelocImmune, which uses unique genetically-humanized mice to produce optimized fully-human antibodies and bispecific antibodies. The company was founded by Alferd G. Gilman, Leonard S. Schleifer, and Eric M. Shooter on January 8, 1988, and is headquartered in Tarrytown, NY.

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Regeneron reports robust Q4 earnings, eyes strategic launches and collaborations

Regeneron Pharmaceuticals showcased strong financial performance and pipeline advancements in Q4 2022.
The company's focus on safety, efficacy, and strategic imperatives positions it for future growth.
Challenges include competitive positioning, trial data anticipation, and managing uncertainties.
Opportunities in market launches, accelerated approvals, and innovative collaborations drive future potential.

Regeneron excels in Q1 with strong revenue growth and pipeline advancements

Regeneron Pharmaceuticals delivered a strong performance in Q1 2023, driven by revenue growth and pipeline advancements in key therapeutic areas like DUPIXENT and EYLEA.
Despite operational challenges in market positioning and regulatory considerations, the company's strengths in research capabilities and strategic planning present growth opportunities.
With a focus on commercialization efforts, expanding indications, and leveraging genetic insights, Regeneron is poised to capitalize on opportunities for sustained success and innovation.
Navigating challenges in market competition and regulatory uncertainties, Regeneron remains proactive in addressing key issues to maintain its position as a leading biopharmaceutical company.

Regeneron reports strong Q2 earnings, eyes aflibercept launch

Regeneron Pharmaceuticals demonstrated strong financial performance and commercial success in Q2 2023.
While facing regulatory challenges, the company remains optimistic about pipeline advancements and potential launches.
Balancing efficacy and safety in treatments, Regeneron aims to capitalize on growth opportunities and strategic partnerships.
Robust cash position and focus on patient well-being position Regeneron for continued success and market expansion.

Regeneron posts robust Q3 results, eyes innovation and market growth

Regeneron's Q3 performance reflects strong revenue growth, financial stability, and promising market potential for key products like Dupixent and EYLEA HD.
While facing legal challenges and competitive pressures, the company's strategic focus on innovation, R&D, and shareholder value management positions it for long-term success.
With a robust pipeline, unique therapeutic targets, and a solid financial foundation, Regeneron is poised for continued growth, market leadership, and innovation in the biopharmaceutical industry.

Regeneron posts strong Q4 results, eyes growth through innovation

Regeneron Pharmaceuticals delivered a strong performance in Q4 2023, driven by successful product launches and financial results in line with expectations.
The company's focus on innovation, strategic leadership, and capital allocation priorities position them well for future growth and market success.
While facing challenges in market dynamics and competition, Regeneron has opportunities to leverage new product approvals and innovative treatment approaches.
Overall, Regeneron's performance highlights their resilience, strategic vision, and commitment to advancing healthcare through groundbreaking therapies.

Regeneron posts solid Q1 results, faces FDA request challenges

Regeneron Pharmaceuticals delivered strong financial performance in Q1 2024, driven by Dupixent and EYLEA HD.
The company's robust pipeline and focus on innovation position it well for future growth.
Challenges include FDA requests for Dupixent efficacy analyses and market entry hurdles for new products.
Opportunities lie in advancing therapies for COPD, severe food allergies, and expanding cancer treatment options.

Regeneron posts robust Q2 earnings, eyes pipeline expansion opportunities

Regeneron Pharmaceuticals demonstrated strong financial performance and product sales growth in Q2.
While facing regulatory challenges, the company's pipeline and market position remain robust.
Opportunities for expansion and innovation present avenues for future growth.
Overall, Regeneron's Q2 results reflect resilience and strategic focus.

Regeneron Pharmaceuticals reports strong Q3 results and eyes innovative growth

Regeneron's Q3 performance reflects solid revenue and earnings growth driven by key products. While facing regulatory challenges and capital allocation decisions, the company's focus on innovation and strategic investments positions it well for future growth.

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Regeneron Pharmaceuticals, Inc. is a biotechnology company, which engages in the discovery, invention, development, manufacture, and commercialization of medicines. Its product portfolio includes the following brands: Dupixent, Evkeeza, Eylea, Inmazeb, and Kevzara. The firm accelerates the traditional drug development process through its proprietary VelociSuite technologies such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies. The company was founded by Alferd G. Gilman, Leonard S. Schleifer, George Damis Yancopoulos, and Eric M. Shooter on January 8, 1988, and is headquartered in Tarrytown, NY.

Recommendation is based on data from two pivotal trials showing Dupixent significantly improved itch, skin lesions and health-related quality of life in adults with prurigo nodularis If approved, Dupixent would be the first and only targeted medicine specifically indicated for prurigo nodularis in the European Union TARRYTOWN, N.Y. and PARIS , Nov. 11, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of Dupixent® (dupilumab) in the European Union (EU) to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.

Dupixent® (dupilumab) Recommended for EU Approval by the CHMP for the Treatment of Prurigo Nodularis

Regeneron (REGN) obtains FDA approval for the second advanced NSCLC indication, which expands the patient population eligible for a Libtayo-based regimen to include combination treatment with chemotherapy, irrespective of PD-L1 expression levels.

Regeneron (REGN) Gets FDA Nod for Libtayo's Label Expansion

Approval based on superior survival outcomes of Libtayo plus chemotherapy, compared to chemotherapy alone, in a patient population with a wide range of disease characteristics Second advanced NSCLC indication expands patient population eligible for a Libtayo-based regimen to include combination treatment with chemotherapy  irrespective of PD-L1 expression levels TARRYTOWN, N.Y. , Nov. 8, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations.

Libtayo® (cemiplimab-rwlc) in Combination with Chemotherapy Approved by the FDA as First-line Treatment for Advanced Non-small Cell Lung Cancer (NSCLC)

Presentations reinforce that aflibercept 8 mg demonstrated non-inferior vision gains to EYLEA at 48 weeks, with 93% and 83% of patients in PHOTON and PULSAR, respectively, maintaining dosing intervals of 12 weeks or longer after initial monthly doses Additional new pre-specified and exploratory analyses showed aflibercept 8 mg led to sustained improvements in certain anatomical measures during the 48-week treatment period for both 12- and 16-week dosing regimens in PHOTON and PULSAR TARRYTOWN, N.Y. , Nov. 4, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced late-breaking presentations of updated results from two positive pivotal trials investigating novel aflibercept 8 mg with 12- and 16-week dosing regimens, compared to EYLEA® (aflibercept) Injection, in patients with diabetic macular edema (DME) and wet age-related macular degeneration (wAMD).

Aflibercept 8 mg Late-breaking Data Presented at Retina Society in Diabetic Macular Edema and Wet Age-related Macular Degeneration

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Regeneron (REGN) tops earnings and sales estimates for the third quarter, driven by its lead drug Eylea and profits from the asthma drug, Dupixent. However, earnings decline year over year.

Regeneron (REGN) Q3 Earnings & Sales Beat on Eylea, Dupixent

Regeneron Pharmaceuticals, Inc. (AAPL) Q3 2022 Earnings Conference Call November 3, 2022 8:30 AM ET Company Participants Ryan Crowe - Vice President, Investor Relations Leonard Schleifer - President, Chief Executive Officer George Yancopoulos - President, Chief Scientific Officer Marion McCourt - Executive Vice President, Head of Commercial Robert Landry - Executive Vice President, Chief Financial Officer Conference Call Participants Evan Seigerman - BMO Tyler Van Buren - Cowen Salveen Richter - Goldman Sachs Matthew Harrison - Morgan Stanley Tim Anderson - Wolfe Research Mohit Bansal - Wells Fargo Christopher Raymond - Piper Sandler Colin Bristow - UBS Brian Abrahams - RBC Carter Gould - Barclays Operator Hello, and welcome to Regeneron Pharmaceuticals' Third Quarter 2022 Earnings Conference Call. My name is Towanda, and I will be your operator for today's call.

Regeneron Pharmaceuticals, Inc. (REGN) Q3 2022 Earnings Call Transcript

Regeneron (REGN) delivered earnings and revenue surprises of 14.85% and 5.08%, respectively, for the quarter ended September 2022. Do the numbers hold clues to what lies ahead for the stock?

Regeneron (REGN) Surpasses Q3 Earnings and Revenue Estimates

First Phase 2 data for odronextamab (CD20xCD3) in diffuse large B-cell lymphoma and follicular lymphoma to be presented in two oral sessions Additional presentations include new data on linvoseltamab (REGN5458; BCMAxCD3) in multiple myeloma Regeneron will host an investor webcast on Wednesday, December 14 at 8:30 AM ET to provide updates across its hematology portfolio TARRYTOWN, N.Y. , Nov. 3, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that new data across its hematology pipeline will be highlighted in 17 presentations at the 2022 American Society of Hematology (ASH) Annual Meeting from December 10-13 in New Orleans, LA.

Regeneron Presents New Data at ASH from Advancing Hematology Pipeline across Multiple Blood Cancers and Disorders

Regeneron Pharma topped third-quarter expectations Thursday, reporting less of a decline than expected. But REGN stock was down early.

Regeneron Pharmaceuticals Tops Quarterly Expectations Despite Covid Shortfall

Regeneron Pharmaceuticals Inc. REGN, -2.56% said Thursday its third-quarter net income fell 19% to $1.32 billion or $11.66 a share, from $1.63 billion or $14.33 a share, in the year-ago period. Adjusted net income fell to $11.14 a share from $15.37 a share.

Regeneron Pharmaceuticals Q3 tops earnings and revenue marks

Third quarter 2022 revenues decreased 15% to $2.94 billion versus third quarter 2021; excluding REGEN-COV ® (a)(b), revenues increased 11% Third quarter 2022 EYLEA® U.S. net sales increased 11% versus third quarter 2021 to a record $1.63 billion Third quarter 2022 Dupixent® global net sales(c)(recorded by Sanofi) increased 40% to $2.33 billion versus third quarter 2021 Third quarter 2022 GAAP diluted EPS of $11.66; non-GAAP diluted EPS(a) of $11.14 Positive results reported in aflibercept 8 mg pivotal trials for diabetic macular edema (DME) and neovascular age-related macular degeneration (wet AMD) EYLEA granted additional six months of pediatric exclusivity by the FDA FDA approved Dupixent for prurigo nodularis Inmazeb® won 2022 Prix Galien USA "Best Biotechnology Product" Award TARRYTOWN, N.Y., Nov. 3, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial results for the third quarter of 2022 and provided a business update.

Regeneron Reports Third Quarter 2022 Financial and Operating Results

Inmazeb is the first FDA-approved treatment for Zaire ebolavirus TARRYTOWN, N.Y. , Oct. 28, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that Inmazeb™ (atoltivimab, maftivimab, and odesivimab-ebgn) has been recognized as the "Best Biotechnology Product" of 2022 by the Galien Foundation, which acknowledges extraordinary scientific innovations that improve the human condition.

Inmazeb™ (atoltivimab, maftivimab, and odesivimab-ebgn) Wins Prestigious 2022 Prix Galien USA Best Biotechnology Product Award

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TARRYTOWN, N.Y. , Oct. 21, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for EYLEA® (aflibercept) Injection.

Regeneron Receives Six Months of U.S. Pediatric Exclusivity for EYLEA® (aflibercept) Injection

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Despite CRISPR stocks' enthusiasm, the risk of potential cures continues to cloud market projections for new gene-editing treatments moving through the pipeline toward FDA approval. The post CRISPR Stocks: Will Concerns Over Risk Inhibit Gene-Editing Cures?

CRISPR Stocks: Will Concerns Over Risk Inhibit Gene-Editing Cures?

Regeneron (REGN) gets a positive recommendation from CHMP for the label expansion of its oncology drug for treating adult patients with recurrent or metastatic cervical cancer.

Regeneron (REGN) Drug Gets Positive CHMP View for Cervical Cancer

While the rest of the market is making moves higher today, Regeneron Pharmaceuticals Inc (NASDAQ:REGN) is static, last seen off 0.1% at $735.31.

Biotech Stock Sitting Out Today's Rally

Immune-Onc Therapeutics Initiates Expansion Cohorts for IO-108 and Enters into Clinical Supply Agreement with Regeneron

Recommendation based on a Phase 3 Libtayo trial that was first and only to demonstrate significantly improved survival compared to chemotherapy in the second-line setting irrespective of PD-L1 expression status or tumor histology TARRYTOWN, N.Y. , Oct. 14, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Libtayo® (cemiplimab) as a monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.

Libtayo® (cemiplimab) Receives Positive CHMP Opinion Recommending Approval to Treat Advanced Cervical Cancer

The FDA accepts and grants priority review to Regeneron's (REGN) sBLA for Eylea injection to treat retinopathy of prematurity in preterm infants. A decision is due on Feb 11, 2023.

Regeneron's (REGN) Eylea sBLA Gets FDA's Priority Review

ROP is a leading cause of childhood blindness worldwide TARRYTOWN, N.Y. , Oct. 12, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection to treat Retinopathy of Prematurity (ROP) in preterm infants.

EYLEA® (aflibercept) Injection sBLA for Treatment of Retinopathy of Prematurity (ROP) Accepted for FDA Priority Review

A majority of children on Dupixent (up to 68% on a higher dose) achieved histological disease remission at week 16 First and only Phase 3 trial to show positive results in this patient population; there are currently no approved treatments specifically indicated for children under 12 years of age with EoE TARRYTOWN, N.Y. and PARIS , Oct. 11, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today presented late-breaking positive results from a Phase 3 trial evaluating the investigational use of Dupixent® (dupilumab) in children aged 1 to 11 years with active eosinophilic esophagitis (EoE).

Dupixent® (dupilumab) Late-Breaking Phase 3 Data Presented at UEG Week 2022 Showed Significant Histological Remission of Eosinophilic Esophagitis (EoE) in Children 1 to 11 Years Old

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Among biotech stocks, there are several established names that have products in markets and deep pipelines. These companies deliver predictable revenue and earnings, and maybe even a dividend for good measure.

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