It was an extremely busy week in the biotech sector, with several companies making important presentations at the J.P. Morgan Healthcare Conference. Among these, Moderna MRNA and Regeneron Pharmaceutical REGN were in the limelight on financial updates. Meanwhile, Intellia Therapeutics NTLA was down after it announced a strategic update and workforce reduction.
Recap of the Week’s Most Important Stories:
MRNA Stock Down on Updates for 2025
Moderna provides updates on its business and pipeline progress at the J.P. Morgan Healthcare Conference.
Moderna reported preliminary product sales between $3 billion and $3.1 billion for 2024. This includes more than $3 billion in COVID-19 vaccine sales and minimal sales from the RSV vaccine mResvia. This figure was mainly toward the lower end of the company’s previously issued guidance of $3.0-$3.5 billion. Cash, cash equivalents and investments at year-end 2024 were approximately $9.5 billion.
However, Moderna cut its previously announced sales guidance for 2025 by $1 billion. It now forecasts total revenues to be in the range of $1.5-$2.5 billion, mainly from product sales of its COVID-19 and RSV vaccines. Management expects to generate the majority of this figure in the second half of the year. Shares of Moderna were down due to the guidance cut.
Moderna reiterated its stance to launch 10 new marketed products over the next three years. To achieve this goal, management submitted three regulatory filings seeking the FDA’s approval.
NTLA Stock Down on Strategic Updates
Intellia Therapeutics announced its strategic priorities and key anticipated milestones for 2025. However, investors were disappointed and the stock fell following the announcement.
As part of this portfolio reorganization, NTLA is planning to prioritize the development of its investigational in vivo genome-editing candidate, Nexiguran ziclumeran (nex-z, also known as NTLA-2001), which is being studied for two indications, ATTR amyloidosis with polyneuropathy (ATTRv-PN) and ATTR amyloidosis with cardiomyopathy.
Intellia is developing another pipeline candidate, NTLA-2002, for the treatment of hereditary angioedema. Intellia has decided to discontinue the development of its in vivo gene insertion candidate, NTLA-3001, for the treatment of alpha-1 antitrypsin deficiency associated lung disease.
Also, with the strategic reorganization, NTLA plans to reduce its current workforce by almost 27% over the course of 2025.
NTLA had approximately $862 million in cash, cash equivalents and investments at the end of the fourth quarter of 2024. Per the company, the existing cash balance and the anticipated cost savings from the above-mentioned strategic reorganization are expected to provide the cash runway into the first half of 2027.
NTLA currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Regeneron's Pipeline Updates
Regeneron provided business and pipeline updates at the 43rd Annual J.P. Morgan Healthcare Conference.
On a preliminary basis, lead drug Eylea and Eylea HD (higher dose of Eylea) recorded $6 billion in sales in 2024 in the United States. Sales for the fourth quarter amounted to $1.5 billion in the United States. On a standalone basis, Eylea sales totaled $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.
REGN filed an application with the FDA for the use of the Eylea HD pre-filled syringe. A potential approval and launch are expected by mid-2025. Longer-term data in wet age-related macular degeneration and diabetic macular edema are under FDA review, with a target action date of April 20, 2025. 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 maximize dosing flexibility and address more retinal diseases.
Among other updates, an application for expanding the Dupixent’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.
Oncology drug 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.
Regeneron also 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.
SAGE Stock Up on Biogen’s Offer
Sage Therapeutics SAGE announced that its partner Biogen made an unsolicited, non-binding proposal offer to acquire the former’s shares (that it does not already own) for $7.22 per share. The offer price represents a premium of 30% on Sage Therapeutics’ closing price of $5.55 on Jan. 10.
According to an SEC filing by the company, Biogen currently owns a 10.2% stake in SAGE. SAGE stock was up in response to the news. Sage Therapeutics’ board will review and evaluate the offer and make a final decision.
Sage Therapeutics and Biogen have a collaboration deal for the commercialization of Zurzuvae, which was approved for treating postpartum depression in August 2023.
GSK to Acquire IDRx, Inc.
GSK plc GSK announced an agreement to acquire clinical-stage private biotech IDRx, which makes precision therapeutics for treating gastrointestinal stromal tumors (GIST). IDRx’s key pipeline candidate is IDRX-42, a highly selective KIT tyrosine kinase inhibitor (TKI), which has shown the potential to address all key KIT mutations in GIST that drive tumor growth.
Per the terms of the acquisition, GSK will make an upfront payment of $1 billion, along with potential milestone payments of $150 million in cash. The acquisition adds to GSK’s growing portfolio in gastrointestinal (GI) cancers, including ongoing trials with dostarlimab and GSK5764227.
Performance
The Nasdaq Biotechnology Index has lost 0.97% in the past four trading sessions and MRNA’s shares have lost 19.46%. In the past six months, shares of MRNA have plunge 71.38%. (See the last biotech stock roundup here: Biotech Stock Roundup: NMRA Plunges on Study Failure, HOTH, VIR Soar on Study Data & More)
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for more pipeline updates.
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Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report
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Moderna, Inc. (MRNA) : Free Stock Analysis Report
Sage Therapeutics, Inc. (SAGE) : Free Stock Analysis Report
Intellia Therapeutics, Inc. (NTLA) : Free Stock Analysis Report
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