It has been a busy week for the biotech sector as quite a few big companies came out with fourth-quarter results. Other pipeline and regulatory updates were also in focus.

Recap of the Week’s Most Important Stories:

Q4 Earnings by AMGN, BMY, GILD, REGN:  Amgen AMGN reported strong fourth-quarter results, topping earnings and sales estimates. However, the outlook for 2023 disappointed investors. Key products like Repatha, Prolia and Evenity posted solid growth.

Bristol Myers BMY reported better-than-expected results for the fourth quarter of 2022. Revenues of $11.4 billion surpassed the Zacks Consensus Estimate of $11.1 billion but decreased 5% from the year-ago period due to generic competition for multiple myeloma (MM) drug, Revlimid, and foreign exchange impacts, partially offset by in-line products (primarily Opdivo) and new product portfolios (primarily Opdualag and Abecma). The company reported adjusted earnings per share of $1.82, which beat the Zacks Consensus Estimate of $1.71 but was down from the $1.84 reported in the year-ago quarter.

Gilead Sciences GILD reported better-than-expected fourth-quarter results due to continued solid demand for its HIV portfolio with further share growth for flagship therapy Biktarvy and oncology revenues driven by the cell therapy franchise and Trodelvy. The company reported earnings of $1.67 per share in the quarter, which easily beat the Zacks Consensus Estimate of $1.50. Total revenues of $7.4 billion surpassed the Zacks Consensus Estimate of $6.6 billion.

Regeneron REGN posted better-than-expected fourth-quarter 2022 results even though Eylea sales were hurt by a short-term shift to off-label use of Avastin (bevacizumab), a temporary closing in the fourth quarter of a not-for-profit fund that provides patient co-pay assistance and an increase in sales-related deductions. Fourth-quarter earnings of $12.56 per share comfortably beat the Zacks Consensus Estimate of $9.68.  Regeneron records its share of profits/losses in connection with global sales of Dupixent, which maintained its stellar performance.

Gilead Gets FDA Nod for Trodelvy:  Gilead obtained FDA approval for Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. The approval is based on statistically significant and clinically meaningful progression-free survival and overall survival data from the phase III TROPiCS-02 study. The drug is already approved for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.

Label Expansion of Regeneron’s Eylea:  Regeneron announced that the FDA has approved the label expansion of the ophthalmology drug Eylea (aflibercept) for treating preterm infants with retinopathy of prematurity (ROP).

The FDA approval is supported by data from two randomized, global phase III studies – FIREFLEYE (n=113) and BUTTERFLEYE (n=120) – evaluating Eylea 0.4 mg versus laser photocoagulation (laser) in infants with ROP. Data from both trials showed approximately 80% of EYLEA-treated infants achieved an absence of both active ROP and unfavorable structural outcomes at 52 weeks of age, which is better than would have been expected without treatment.

Both trials were conducted pursuant to FDA Pediatric Written Request. In October 2022, the FDA granted pediatric exclusivity to Eylea, extending the U.S. market exclusivity of the drug by an additional six months through May 17, 2024. Eylea is now indicated to treat five retinal conditions caused by ocular angiogenesis following the first pediatric approval.

Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Kiora Surges on Regulatory Update: Shares of Kiora Pharmaceuticals, Inc. KPRX surged after it announced that it received investigational new drug application approval for a mid-stage study of KIO-101 for the treatment of the Ocular Presentation of Rheumatoid Arthritis and other autoimmune diseases (OPRA+). KIO-101 is part of a class of non-steroidal autoimmune disease drugs called DHODH inhibitors, which reduce T-cell proliferation and ongoing proinflammatory cytokine release. The phase II study will enroll approximately 120 patients in a multi-center, controlled, randomized, double-masked trial assessing the safety and efficacy of KIO-101 eye drops in patients with autoimmune disease who have signs and symptoms of the ocular surface disease. The study is expected to begin enrolling patients in Australia in the first half of 2023.

The study will evaluate two concentrations of KIO-101, 0.15% and 0.30%. The efficacy endpoints will evaluate a number of established ocular signs and symptoms, including but not limited to corneal staining and changes in Schirmer's test score at 12 weeks. The study will also evaluate several safety and tolerability measures.

Performance

The Nasdaq Biotechnology Index has lost 2.91% in the past five trading sessions. Among the biotech giants, Vertex has lost 7.55% during the period. Over the past six months, shares of Gilead have soared 41.81%. (See the last biotech stock roundup here: Biotech Stock Roundup: BLUE Down on Share Issuance, CPRX Falls on Generic Filing & More)

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What's Next in Biotech?

Stay tuned for other updates.

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Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report

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