Dupixent Approved in EU for CSU Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 16 2024
0mins
Should l Buy REGN?
Source: Business Insider
Regeneron Pharmaceuticals and Sanofi have received approval for Dupixent in the EU as the first innovative treatment for chronic spontaneous urticaria (CSU). This approval fills a significant gap in treatment options that has persisted for over a decade, promising to enhance the quality of life for approximately 270,000 patients in the region.
The approval is based on the successful LIBERTY-CUPID Phase 3 clinical trials, which demonstrated significant reductions in urticaria activity over 24 weeks. This positions Dupixent as a first-line treatment option for patients who have not adequately responded to standard antihistamine therapies.
With the introduction of Dupixent, Regeneron and Sanofi are poised to capture a substantial share of the market, addressing the needs of patients who have been underserved by existing treatments. The safety profile of Dupixent aligns with known characteristics, ensuring its acceptability in clinical use.
This development not only represents a breakthrough for patients but also signals potential revenue growth for Regeneron as they expand their market presence in chronic inflammatory diseases.
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Analyst Views on REGN
Wall Street analysts forecast REGN stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for REGN is 808.50 USD with a low forecast of 637.00 USD and a high forecast of 1057 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
22 Analyst Rating
16 Buy
6 Hold
0 Sell
Moderate Buy
Current: 766.630
Low
637.00
Averages
808.50
High
1057
Current: 766.630
Low
637.00
Averages
808.50
High
1057
About REGN
Regeneron Pharmaceuticals, Inc. is a fully integrated biotechnology company. The Company invents, develops, manufactures, and commercializes medicines for people with serious diseases. Its products and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. The Company is accelerating drug development using its proprietary technologies, such as VelociSuite, which produces optimized fully human antibodies and new classes of bispecific antibodies. VelociSuite consists of VelocImmune, VelociGene, VelociMouse, VelociMab, Veloci-Bi, VelociT, VelociHum, and other related technologies. Its marketed products include EYLEA (aflibercept); Dupixent (dupilumab); Libtayo (cemiplimab); Ordspono (odronextamab); Kevzara (sarilumab); Itepekimab; Linvoseltamab, and others.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Regeneron Reports Strong Q4 2024 Earnings with Key Growth Drivers
- Significant Revenue Growth: Regeneron achieved a 10% revenue growth in Q4 2024, reaching $3.8 billion, primarily driven by strong performances from Dupixent, Libtayo, and EYLEA, demonstrating the company's sustained competitiveness in the biopharmaceutical sector.
- Expansion of Dupixent Patient Base: Over 1 million patients are currently on Dupixent treatment globally, with significant future growth potential anticipated from new indications like COPD, further solidifying its market leadership.
- EYLEA HD Market Performance: EYLEA HD reported net sales of $305 million in Q4, and despite competitive pressures, upcoming launches of a prefilled syringe and label expansions are expected to position it as the new standard in the anti-VEGF category.
- Capital Return Strategy: Regeneron announced the initiation of a quarterly cash dividend program at $0.88 per share and an additional $3 billion share repurchase authorization, reflecting confidence in future cash flows while maintaining ongoing investments in R&D.
See More
Regeneron Reports 11% Revenue Growth in Q3 2024 Earnings Call
- Revenue Growth Highlight: Regeneron reported total revenues of $3.72 billion for Q3, reflecting an 11% year-over-year increase, primarily driven by higher collaboration revenues with Sanofi, showcasing the company's robust performance in the biopharmaceutical sector.
- Dupixent Sales Milestone: Dupixent achieved global sales of $3.8 billion, a 24% increase, with over 1 million patients currently on treatment, and is expected to continue driving revenue growth, particularly with new indications like COPD.
- EYLEA HD Market Performance: Combined net sales for EYLEA HD and EYLEA reached $1.54 billion, up 3% year-over-year, maintaining a 44% market share despite competitive pressures, indicating strong trust from physicians and patients.
- Pipeline Outlook: Regeneron has approximately 40 programs in clinical development, with several pivotal data readouts anticipated in the next 12 to 18 months, further enhancing the company's potential for medium- to long-term shareholder value growth.
See More
Cardinal Health Shares Surge Following Earnings Report as CEO Discusses Success Factors.
- Fiscal-Year Outlook Increase: Cardinal Health has raised its fiscal-year outlook for the second time in less than a month.
- Positive Financial Performance: The company’s recent adjustments indicate strong financial performance and confidence in future growth.
See More
Merck's Stock Outlook Remains Positive Despite Price Repricing
- Strong Stock Performance: Merck's shares have risen over 30% in the past three months, reflecting market confidence in its future performance despite pressures on drug pricing and valuation concerns.
- Optimistic Earnings Forecast: Wall Street analysts predict Merck will achieve earnings of $2.01 per share with revenues of $16.2 billion in the fourth quarter, indicating robust performance and profitability in the market.
- Drug Pricing Adjustment: Merck agreed last year to reduce the price of its diabetes medication Januvia from $330 to $100, which, while potentially impacting short-term revenue, may enhance patient accessibility and market share in the long run.
- Industry Dynamics: Despite the collapse of talks to acquire biotech firm Revolution Medicines last month, Terranova continues to add investments in other biotech and pharmaceutical companies, demonstrating confidence in the sector, particularly as the S&P 500 Health Care index has risen 8% over the past three months.
See More
Regeneron Reports Strong Q4 Earnings, Beats Expectations
- Strong Earnings Performance: Regeneron reported adjusted earnings of $11.44 per share for Q4, a 5% year-over-year decline, yet surpassing the market expectation of $10.71, demonstrating resilience in a competitive pharmaceutical landscape.
- Stable Sales Growth: The company achieved sales of $3.88 billion, a 3% increase year-over-year, exceeding the consensus estimate of $3.79 billion, indicating robust demand for its four blockbuster drugs.
- Optimistic Future Outlook: Regeneron expects a GAAP gross margin of 79%-80% and an adjusted gross margin of 83%-84% for fiscal 2026, reflecting ongoing improvements in cost control and profitability.
- Increased R&D Investment: The company forecasts adjusted R&D expenses between $5.9 billion and $6.1 billion for 2026, with non-GAAP SG&A expenditures projected between $2.5 billion and $2.65 billion, underscoring its commitment to future product development.
See More
Regeneron Pharmaceuticals Announces 6.8% Dividend Increase
- Dividend Increase: Regeneron Pharmaceuticals declares a quarterly dividend of $0.94 per share, marking a 6.8% increase from the previous $0.88, demonstrating the company's ongoing commitment to stable cash flow and shareholder returns.
- Yield Metrics: The forward yield of this dividend stands at 0.51%, reflecting the company's attractiveness in the current market environment, which may draw in more investors seeking stable income.
- Payment Schedule: The dividend is payable on March 5, with a record date of February 20 and an ex-dividend date also set for February 20, ensuring shareholders receive their earnings promptly.
- Future Outlook: Regeneron anticipates double-digit growth in 2026 and plans to initiate 18 new Phase III studies, expecting four FDA approvals, indicating a proactive approach in research and market expansion.
See More
Regeneron Reports Strong Q4 2024 Earnings with Key Growth Drivers
- Significant Revenue Growth: Regeneron achieved a 10% revenue growth in Q4 2024, reaching $3.8 billion, primarily driven by strong performances from Dupixent, Libtayo, and EYLEA, demonstrating the company's sustained competitiveness in the biopharmaceutical sector.
- Expansion of Dupixent Patient Base: Over 1 million patients are currently on Dupixent treatment globally, with significant future growth potential anticipated from new indications like COPD, further solidifying its market leadership.
- EYLEA HD Market Performance: EYLEA HD reported net sales of $305 million in Q4, and despite competitive pressures, upcoming launches of a prefilled syringe and label expansions are expected to position it as the new standard in the anti-VEGF category.
- Capital Return Strategy: Regeneron announced the initiation of a quarterly cash dividend program at $0.88 per share and an additional $3 billion share repurchase authorization, reflecting confidence in future cash flows while maintaining ongoing investments in R&D.
See More
Regeneron Reports 11% Revenue Growth in Q3 2024 Earnings Call
- Revenue Growth Highlight: Regeneron reported total revenues of $3.72 billion for Q3, reflecting an 11% year-over-year increase, primarily driven by higher collaboration revenues with Sanofi, showcasing the company's robust performance in the biopharmaceutical sector.
- Dupixent Sales Milestone: Dupixent achieved global sales of $3.8 billion, a 24% increase, with over 1 million patients currently on treatment, and is expected to continue driving revenue growth, particularly with new indications like COPD.
- EYLEA HD Market Performance: Combined net sales for EYLEA HD and EYLEA reached $1.54 billion, up 3% year-over-year, maintaining a 44% market share despite competitive pressures, indicating strong trust from physicians and patients.
- Pipeline Outlook: Regeneron has approximately 40 programs in clinical development, with several pivotal data readouts anticipated in the next 12 to 18 months, further enhancing the company's potential for medium- to long-term shareholder value growth.
See More
Cardinal Health Shares Surge Following Earnings Report as CEO Discusses Success Factors.
- Fiscal-Year Outlook Increase: Cardinal Health has raised its fiscal-year outlook for the second time in less than a month.
- Positive Financial Performance: The company’s recent adjustments indicate strong financial performance and confidence in future growth.
See More
Merck's Stock Outlook Remains Positive Despite Price Repricing
- Strong Stock Performance: Merck's shares have risen over 30% in the past three months, reflecting market confidence in its future performance despite pressures on drug pricing and valuation concerns.
- Optimistic Earnings Forecast: Wall Street analysts predict Merck will achieve earnings of $2.01 per share with revenues of $16.2 billion in the fourth quarter, indicating robust performance and profitability in the market.
- Drug Pricing Adjustment: Merck agreed last year to reduce the price of its diabetes medication Januvia from $330 to $100, which, while potentially impacting short-term revenue, may enhance patient accessibility and market share in the long run.
- Industry Dynamics: Despite the collapse of talks to acquire biotech firm Revolution Medicines last month, Terranova continues to add investments in other biotech and pharmaceutical companies, demonstrating confidence in the sector, particularly as the S&P 500 Health Care index has risen 8% over the past three months.
See More
Regeneron Reports Strong Q4 Earnings, Beats Expectations
- Strong Earnings Performance: Regeneron reported adjusted earnings of $11.44 per share for Q4, a 5% year-over-year decline, yet surpassing the market expectation of $10.71, demonstrating resilience in a competitive pharmaceutical landscape.
- Stable Sales Growth: The company achieved sales of $3.88 billion, a 3% increase year-over-year, exceeding the consensus estimate of $3.79 billion, indicating robust demand for its four blockbuster drugs.
- Optimistic Future Outlook: Regeneron expects a GAAP gross margin of 79%-80% and an adjusted gross margin of 83%-84% for fiscal 2026, reflecting ongoing improvements in cost control and profitability.
- Increased R&D Investment: The company forecasts adjusted R&D expenses between $5.9 billion and $6.1 billion for 2026, with non-GAAP SG&A expenditures projected between $2.5 billion and $2.65 billion, underscoring its commitment to future product development.
See More
Regeneron Pharmaceuticals Announces 6.8% Dividend Increase
- Dividend Increase: Regeneron Pharmaceuticals declares a quarterly dividend of $0.94 per share, marking a 6.8% increase from the previous $0.88, demonstrating the company's ongoing commitment to stable cash flow and shareholder returns.
- Yield Metrics: The forward yield of this dividend stands at 0.51%, reflecting the company's attractiveness in the current market environment, which may draw in more investors seeking stable income.
- Payment Schedule: The dividend is payable on March 5, with a record date of February 20 and an ex-dividend date also set for February 20, ensuring shareholders receive their earnings promptly.
- Future Outlook: Regeneron anticipates double-digit growth in 2026 and plans to initiate 18 new Phase III studies, expecting four FDA approvals, indicating a proactive approach in research and market expansion.
See More
