It has been a busy week for the biotech sector, with earnings from bigwigs like Gilead Sciences GILD, Bristol Myers BMY and Amgen AMGN, among others. Concurrently, mergers and acquisitions continue to be in the spotlight as pharma and biotech majors look to bolster their product portfolio/pipeline.
Recap of the Week’s Most Important Stories:
Morphysys Up on NVS Deal: Shares of Morphysys MOR surged after pharma giant Novartis announced that it will acquire the company for €68 per share or an aggregate of €2.7 billion. The offer price corresponds to a premium of 94% and 142% on the volume-weighted average price during the last month and three months, as of market close on Jan 25, 2024, respectively - the day before first rumors on a potential takeover surfaced.
The acquisition is expected to close in the first half of 2024. The acquisition will add late-stage candidate pelabresib (CPI-0610) to Novartis’ pipeline. MorphoSys also has an approved drug, Monjuvi (tafasitamab), in its portfolio. However, the drug failed to contribute significantly to the top line. Hence, the deal with Novartis impressed investors. MorphoSys and Incyte collaborated on the development and commercialization of tafasitamab. Separately, MorphoSys entered into a purchase agreement to sell and transfer all rights worldwide related to tafasitamab to Incyte Corporation.
Gilead’s Q4 Results: Gilead Sciences reported mixed results for the fourth quarter, wherein earnings missed expectations but sales surpassed the same. Fourth-quarter adjusted earnings of $1.72 per share missed the Zacks Consensus Estimate of $1.76 but increased from $1.67 in the year-ago quarter. The year-over-year increase was due to lower total costs and expenses. Total revenues of $7.1 billion beat the Zacks Consensus Estimate of $7 billion on better-than-expected Veklury (remdesivir) sales due to an uptick in hospitalizations at the end of 2023. Revenues decreased 4% due to lower Veklury and HIV sales than the year-ago quarter. Lead HIV drug Biktarvy sales also missed estimates. Shares lost following the mixed results.
The guidance for 2024 was dim. Product sales are projected to be between $27.1 billion and $27.5 billion. Total product sales, excluding Veklury, are expected between $25.8 and $26.2 billion.
Updates From BMY: Bristol-Myers reported better-than-expected results for the fourth quarter of 2023 on the back of growth in its new product portfolio. The company reported adjusted earnings per share of $1.70, which beat the Zacks Consensus Estimate of $1.52. In the year-ago quarter, BMY posted adjusted earnings of $1.82. Total revenues of $11.5 billion surpassed the Zacks Consensus Estimate of $11.1 billion. Revenues increased 1% from the year-ago period due to higher sales of new product portfolio, as well as Eliquis and Opdivo.
The guidance for 2024 was encouraging. Bristol-Myers expects adjusted earnings of $7.10-$7.40 per share for 2024. Revenues are anticipated to increase in the low single digits.
BMY also announced that a notice was published in the Federal Register that the FDA will convene a virtual meeting of the Oncologic Drugs Advisory Committee on Mar 15, 2024, to review data supporting the supplemental biologics license application (sBLA) for Abecma (idecabtagene vicleucel). The company has partnered 2seventy bio, Inc for Abecma. The sBLA is seeking label expansion of Abecma for triple-class exposed relapsed or refractory multiple myeloma based on results from the pivotal phase III KarMMa-3 study.
Amgen’s Q4 Results: Amgen reported fourth-quarter 2023 adjusted earnings of $4.71 per share, which beat the Zacks Consensus Estimate of $4.66. Earnings rose 15% year over year on higher revenues, which were partially offset by higher operating costs and higher interest expenses.
Total revenues of $8.2 billion marginally beat the Zacks Consensus Estimate of $8.16 billion. Total revenues rose 20% year over year, driven by higher product sales. Amgen closed the acquisition of Horizon Therapeutics for $27.8 billion on Oct 6, 2023, which added several rare disease drugs like Tepezza, Krystexxa and Uplizna to AMGN’s portfolio.
Tepezza, Krystexxa and Uplizna generated sales of $448 million, $272 million and $65 million from Oct 6 to Dec 31, 2023.
For 2024, the company expects to record revenues in the range of $32.4 billion to $33.8 billion. Adjusted earnings are expected in the range of $18.90 to $20.30. Shares were trading down after the results as investors were not encouraged by the annual guidance.
REGENXBIO Surges on Update: Shares of REGENXBIO Inc. RGNX gained after it announced top-line results from the phase I/II/III CAMPSIITE trial of study of its investigational one-time gene therapy candidate, RGX-121, for the treatment of patients (up to five years old) with Mucopolysaccharidosis Type II (MPS II), also known as Hunter syndrome.
The pivotal phase of the study met its primary endpoint of patients achieving a reduction in cerebrospinal fluid (CSF) biomarker of MPS II disease with statistical significance. MPS II patients treated with RGX-121 achieved decreased cerebrospinal fluid levels of D2S6, a key biomarker of brain disease activity, below maximum attenuated disease levels at 16 weeks (p value of 0.00016). Patients receiving RGX-121 demonstrated an 86% median reduction in D2S6, approaching normal levels. The candidate also demonstrated its potential to significantly improve vital brain function for patients with this disease.
REGENXBIO is currently gearing up to use CSF levels of D2S6 as a surrogate endpoint for accelerated approval of RGX-121. The company is currently completing the remaining activities and expects to file the BLA in the second half of 2024.
Performance
The Nasdaq Biotechnology Index has lost 0.73% in the past five trading sessions. Among the biotech giants, Amgen has lost 5.85% during the period. Over the past six months, shares of Vertex have surged 21.36%. (See the last biotech stock roundup here: Biotech Stock Roundup: GSKs Q4 Results, VRTX Gains on Update, TSVT Up on REGN Deal)
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What's Next in Biotech?
Stay tuned for more earnings and pipeline updates.
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