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Biotech Stock Roundup: REGN Down on Eylea Update, MRNA Gains on Preliminary Results
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It was a busy week for the biotech sector as several companies were out with preliminary results and pipeline updates at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco, CA. Mergers and acquisitions also continue to be in the spotlight as pharma and biotech bigwigs look to bolster their product portfolio/pipeline.
Recap of the Week’s Most Important Stories:
Regeneron Eylea Sales Weak: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) reported disappointing fourth-quarter preliminary sales for the lead drug, Eylea. Shares declined on the same. The company stated that sales of Eylea (aflibercept) and Eylea HD (higher dose of Eylea) came in at $1.46 billion in the United States.
Eylea sales totaled $1.34 billion in the United States, and Eylea HD sales were $123 million in the fourth quarter of 2023. This was the first full quarter for Eylea HD following its launch after obtaining approval in August. Eylea HD is also approved for the treatment of patients with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy under the brand name Eylea HD.
Eylea sales have been under pressure in 2023 due to competition from Roche’s Vabysmo. Competition affected sales in the fourth quarter as well. A decline in sales of the largest drug most likely pulled down REGN’s total sales in 2023.
Moderna Up on Pipeline Updates: Moderna, Inc. (MRNA - Free Report) stock gained after the company announced business updates and progress in its pipeline of transformative mRNA medicines. The company reported preliminary product sales of nearly $6.7 billion for 2023, generated entirely from the sales of its mRNA-based COVID-19 vaccine. This figure was in line with the company’s previously reported guidance, wherein it expected full-year vaccine sales to be at least $6 billion. The reported preliminary product sales figure was higher than what several Wall Street analysts projected, and shares gained on the same.
Concurrently, Moderna reiterated its previously issued financial guidance for 2024 and beyond. It expects the COVID-19 franchise to be profitable from 2024 onward after incurring significant charges on resizing its manufacturing capacity last year.
Moderna expects to generate $4 billion in product revenues, mostly in the second half of the year, driven by sales of its COVID-19 vaccine and the launch of the respiratory syncytial virus (RSV) vaccine. With the plan to launch multiple products and make disciplined investments, it intends to achieve organic sales growth by 2025 and expects to break even in 2026.
Moderna has already initiated regulatory submissions for the mRNA-based RSV vaccine mRNA-1345 for use in older adults (aged 60 years and older) in several markets, including the United States, Europe and Australia. A potential approval is expected in first-half 2024, with a commercial launch later this year.
GSK to Buy Aiolos: GSK (GSK - Free Report) announced that it will acquire clinical-stage biopharmaceutical company, Aiolos, for an upfront payment of $1 billion and up to $400 million in certain success-based regulatory milestone payments. The acquisition will add Aiolos’ AIO-001, a potentially best-in-class, long-acting anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody, to GSK’s growing pipeline of respiratory biologics. The candidate is ready to enter phase II development for the treatment of adult patients with asthma, with the potential for additional indications, including chronic rhinosinusitis with nasal polyps. The TSLP pathway is a clinically validated target in the treatment of asthma.
Adding AIO-001 can help GSK reach a broader population of asthma patients, including those living with asthma regardless of biomarker status and also those with low T2 inflammation.
Sarepta Up on Preliminary Results: Sarepta Therapeutics, Inc. (SRPT - Free Report) announced robust preliminary results for the fourth quarter and full-year 2023. Shares gained on the same. Sarepta’s commercial portfolio includes three approved RNA-based PMO therapies — Exondys 51, Vyondys 53 and Amondys 45 — and the newly approved gene therapy, Elevidys (delandistrogene moxeparvovec-rokl), all targeting the Duchenne muscular dystrophy (DMD) indication.
Total net product revenues are expected to be around $1.14 billion in 2023. Preliminary net product revenues from RNA-based PMO therapies are expected to be about $234.3 million and $945 million for the fourth quarter and full-year 2023, respectively. The net product revenues from RNA-based PMO therapies exceeded the company’s previously issued guidance of $925 million for 2023.
For the fourth quarter and 2023, SRPT anticipates Elevidys net product sales to be approximately $131.3 million and $200.4 million, respectively. Preliminary cash, cash equivalents and investments were almost $1.7 billion as of Dec 31, 2023.
Exelixis To Cut Jobs: Exelixis (EXEL - Free Report) announced preliminary financial results for 2023, the annual outlook for 2024 and other corporate updates.
Revenues for 2023 totaled around $1.83 billion, while product revenues came in at $1.63 million. The Zacks Consensus Estimate for revenues in 2023 was $1.84 billion. For 2024, Exelixis expects revenues to be between $1.825 billion and $1.925 billion, while product revenues are projected to be in the $1.65-$1.75 billion range.
Management will focus on the label expansion of its lead drug Cabometyx in 2024 and accelerate the development of zanzalintinib, XB002 and XL309, and advance three promising preclinical programs into clinical development. Cabometyx (cabozantinib tablets) is approved for advanced renal cell carcinoma and previously treated hepatocellular carcinoma.
Concurrently, the company announced the implementation of corporate restructuring that will prioritize the advancement of its deep pipeline of clinical and near-clinical programs. As a result, EXEL will reduce its headcount by approximately 175 employees or 13%. The firm expects to substantially complete the restructuring in the first quarter of 2024 and incur a restructuring charge of approximately $25 million.
Separately, its board of directors authorized the repurchase of up to an additional $450 million of the company’s common stock in 2024. Exelixis completed its previously announced repurchase of 26.2 million shares of its common stock or 8% of shares outstanding, for a total of $550 million in 2023.
Performance
The Nasdaq Biotechnology Index has gained 2.11% in the past five trading sessions. Among the biotech giants, Vertex has gained 3.18% during the period. Over the past six months, shares of Regeneron have surged 28.83%. (See the last biotech stock roundup here: Biotech Stock Roundup: VYGR Gains From NVS Deal, AGIO Up on Study Data & More)
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for more pipeline updates.
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Biotech Stock Roundup: REGN Down on Eylea Update, MRNA Gains on Preliminary Results
It was a busy week for the biotech sector as several companies were out with preliminary results and pipeline updates at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco, CA. Mergers and acquisitions also continue to be in the spotlight as pharma and biotech bigwigs look to bolster their product portfolio/pipeline.
Recap of the Week’s Most Important Stories:
Regeneron Eylea Sales Weak: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) reported disappointing fourth-quarter preliminary sales for the lead drug, Eylea. Shares declined on the same. The company stated that sales of Eylea (aflibercept) and Eylea HD (higher dose of Eylea) came in at $1.46 billion in the United States.
Eylea sales totaled $1.34 billion in the United States, and Eylea HD sales were $123 million in the fourth quarter of 2023. This was the first full quarter for Eylea HD following its launch after obtaining approval in August. Eylea HD is also approved for the treatment of patients with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy under the brand name Eylea HD.
Eylea sales have been under pressure in 2023 due to competition from Roche’s Vabysmo. Competition affected sales in the fourth quarter as well. A decline in sales of the largest drug most likely pulled down REGN’s total sales in 2023.
Regeneron currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Moderna Up on Pipeline Updates: Moderna, Inc. (MRNA - Free Report) stock gained after the company announced business updates and progress in its pipeline of transformative mRNA medicines. The company reported preliminary product sales of nearly $6.7 billion for 2023, generated entirely from the sales of its mRNA-based COVID-19 vaccine. This figure was in line with the company’s previously reported guidance, wherein it expected full-year vaccine sales to be at least $6 billion. The reported preliminary product sales figure was higher than what several Wall Street analysts projected, and shares gained on the same.
Concurrently, Moderna reiterated its previously issued financial guidance for 2024 and beyond. It expects the COVID-19 franchise to be profitable from 2024 onward after incurring significant charges on resizing its manufacturing capacity last year.
Moderna expects to generate $4 billion in product revenues, mostly in the second half of the year, driven by sales of its COVID-19 vaccine and the launch of the respiratory syncytial virus (RSV) vaccine. With the plan to launch multiple products and make disciplined investments, it intends to achieve organic sales growth by 2025 and expects to break even in 2026.
Moderna has already initiated regulatory submissions for the mRNA-based RSV vaccine mRNA-1345 for use in older adults (aged 60 years and older) in several markets, including the United States, Europe and Australia. A potential approval is expected in first-half 2024, with a commercial launch later this year.
GSK to Buy Aiolos: GSK (GSK - Free Report) announced that it will acquire clinical-stage biopharmaceutical company, Aiolos, for an upfront payment of $1 billion and up to $400 million in certain success-based regulatory milestone payments. The acquisition will add Aiolos’ AIO-001, a potentially best-in-class, long-acting anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody, to GSK’s growing pipeline of respiratory biologics. The candidate is ready to enter phase II development for the treatment of adult patients with asthma, with the potential for additional indications, including chronic rhinosinusitis with nasal polyps. The TSLP pathway is a clinically validated target in the treatment of asthma.
Adding AIO-001 can help GSK reach a broader population of asthma patients, including those living with asthma regardless of biomarker status and also those with low T2 inflammation.
Sarepta Up on Preliminary Results: Sarepta Therapeutics, Inc. (SRPT - Free Report) announced robust preliminary results for the fourth quarter and full-year 2023. Shares gained on the same. Sarepta’s commercial portfolio includes three approved RNA-based PMO therapies — Exondys 51, Vyondys 53 and Amondys 45 — and the newly approved gene therapy, Elevidys (delandistrogene moxeparvovec-rokl), all targeting the Duchenne muscular dystrophy (DMD) indication.
Total net product revenues are expected to be around $1.14 billion in 2023. Preliminary net product revenues from RNA-based PMO therapies are expected to be about $234.3 million and $945 million for the fourth quarter and full-year 2023, respectively. The net product revenues from RNA-based PMO therapies exceeded the company’s previously issued guidance of $925 million for 2023.
For the fourth quarter and 2023, SRPT anticipates Elevidys net product sales to be approximately $131.3 million and $200.4 million, respectively. Preliminary cash, cash equivalents and investments were almost $1.7 billion as of Dec 31, 2023.
Exelixis To Cut Jobs: Exelixis (EXEL - Free Report) announced preliminary financial results for 2023, the annual outlook for 2024 and other corporate updates.
Revenues for 2023 totaled around $1.83 billion, while product revenues came in at $1.63 million. The Zacks Consensus Estimate for revenues in 2023 was $1.84 billion. For 2024, Exelixis expects revenues to be between $1.825 billion and $1.925 billion, while product revenues are projected to be in the $1.65-$1.75 billion range.
Management will focus on the label expansion of its lead drug Cabometyx in 2024 and accelerate the development of zanzalintinib, XB002 and XL309, and advance three promising preclinical programs into clinical development. Cabometyx (cabozantinib tablets) is approved for advanced renal cell carcinoma and previously treated hepatocellular carcinoma.
Concurrently, the company announced the implementation of corporate restructuring that will prioritize the advancement of its deep pipeline of clinical and near-clinical programs. As a result, EXEL will reduce its headcount by approximately 175 employees or 13%. The firm expects to substantially complete the restructuring in the first quarter of 2024 and incur a restructuring charge of approximately $25 million.
Separately, its board of directors authorized the repurchase of up to an additional $450 million of the company’s common stock in 2024. Exelixis completed its previously announced repurchase of 26.2 million shares of its common stock or 8% of shares outstanding, for a total of $550 million in 2023.
Performance
The Nasdaq Biotechnology Index has gained 2.11% in the past five trading sessions. Among the biotech giants, Vertex has gained 3.18% during the period. Over the past six months, shares of Regeneron have surged 28.83%. (See the last biotech stock roundup here: Biotech Stock Roundup: VYGR Gains From NVS Deal, AGIO Up on Study Data & More)
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for more pipeline updates.