Earnings results, along with important regulatory and pipeline updates, continue to keep the biotech sector in focus.
: Recap of the Week’s Most Important Stories : Updates From Regeneron Regeneron Pharmaceuticals ( REGN Quick Quote REGN - Free Report) reported better-than-expected third-quarter 2022 results. It beat estimates for both earnings and sales, driven by growth in Eylea and Dupixent and progress on launches in pediatric atopic dermatitis, eosinophilic esophagitis and prurigo nodularis. Third-quarter earnings of $11.14 per share comfortably beat the Zacks Consensus Estimate of $9.65. The year-ago quarter recorded earnings per share of $15.37 due to higher sales. Total revenues in the reported quarter were down 15% year over year to $2.9 billion but beat the Zacks Consensus Estimate of $2.8 billion. Excluding REGEN-COV (a cocktail of two monoclonal antibodies — casirivimab and imdevimab) for COVID-19, sales increased 11%.
Regeneron also obtained FDA approval for the label expansion of PD-1 inhibitor Libtayo (cemiplimab-rwlc) for another indication. The drug has been approved 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. The drug has been approved for patients who either have metastatic or locally advanced tumors that are not candidates for surgical resection or definitive chemoradiation. Patients may be treated with this combination irrespective of PD-L1 expression or histology. The latest approval is the second advanced NSCLC indication that expands the patient population eligible for a Libtayo-based regimen to include combination treatment with chemotherapy irrespective of PD-L1 expression levels.
Regeneron currently carries a Zacks Rank #3 (Hold). You can see
. the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here : Amgen & Moderna’s Q3 Earnings Amgen ( AMGN Quick Quote AMGN - Free Report) reported third-quarter 2022 earnings of $4.70 per share, which beat the Zacks Consensus Estimate of $4.43 and were up from $4.08 in the year-ago quarter. Lower operating expenses and share count boosted earnings in the quarter. Total revenues of $6.65 billion also beat the Zacks Consensus Estimate of $6.57 billion. However, revenues declined 1% year over year due to lower product sales as higher volumes were offset by lower selling prices of several drugs and currency headwinds. The company now expects revenues in the range of $26.0 billion to $26.3 billion versus the prior expectation of $25.5 billion to $26.4 billion. Earnings are expected in the range of $17.25 to $17.85 (earlier projection: $17.00 to $18.00). Moderna ( MRNA Quick Quote MRNA - Free Report) reported earnings of $2.53 per share in the third quarter, missing the Zacks Consensus Estimate of $3.04 and down from $7.70 in the year-ago quarter. The year-over-year decline in the bottom line was due to lower revenues and higher operating expenses incurred during the third quarter. Revenues in the quarter were $3.36 billion, which also beat the Zacks Consensus Estimate of $3.33 billion. Total revenues were down 32.3% year over year due to declining COVID-19 vaccine sales during the quarter.
Following the delay of certain deliveries of its bivalent COVID-19 vaccine doses due to short-term supply-related issues, Moderna cut its annual sales forecast for its COVID-19 vaccine. Management now expects revenue from advanced purchase agreements in the range of $18-$19 billion, down from the previous guidance of nearly $21 billion. The company deferred deliveries worth $2-$3 billion to next year. Shares were down in response to the same.
: Shares of clinical-stage biotechnology company Verve Tanks on Update Verve Therapeutics, Inc. ( VERV Quick Quote VERV - Free Report) tanked after the FDA placed a hold on its investigational new drug (IND) application to conduct a study evaluating VERVE-101 in patients with heterozygous familial hypercholesterolemia (HeFH), a prevalent and potentially life-threatening subtype of atherosclerotic cardiovascular disease (ASCVD), in the United States.
Verve submitted its IND application for VERVE-101 to the regulatory body last month. VERVE-101 is a novel, investigational gene editing medicine designed to be a single-course treatment to permanently turn off the PCSK9 gene in the liver to reduce disease-driving low-density lipoprotein cholesterol (LDL-C). Verve expects to receive an official letter with the FDA’s questions within 30 days.
The Nasdaq Biotechnology Index gained 0.20% in the past five trading sessions. Among the biotech giants, Amgen has gained 7.47% during the period. Over the past six months, shares of Biogen have soared 52.59%. (See the last biotech stock roundup here:
) Biotech Stock Roundup: BIIB & BMYs Q3 Earnings, TCDA Down on Study Update Image Source: Zacks Investment Research What's Next in Biotech?
Stay tuned for other updates.