It was a busy week for the biotech sector as quite a few companies were out with preliminary results. Meanwhile, collaborations again take center stage in the sector, primarily for coronavirus treatments. Other regulatory and pipeline updates too grabbed the spotlight.
Recap of the Week’s Most Important Stories:
Gilead Updates Guidance for 2020: Gilead Sciences, Inc. GILD increased its annual sales guidance for 2020 as the worsening of the coronavirus pandemic drove sales for Veklury (remdesivir). Total product sales are now projected to be $24.3-$24.35 billion for 2020, up from the previous guidance of $23-$23.5 billion. Veklury sales witnessed growth as hospitalization and treatment rates were higher than expected, given the most recent COVID-19 surge. Veklury sales are estimated at $2.8-$2.825 billion.
Total product sales, excluding Veklury, are projected to be $21.5-$21.525 billion, considering the underlying strong Biktarvy uptake, partially offset by the loss of exclusivity of Truvada in the United States and the impact of COVID-19 primarily on Gilead’s pre-exposure prophylaxis (“PrEP”) franchise and chronic hepatitis C virus (“HCV”) franchise. R&D expenses are now expected to grow 20% (previous guidance: mid-teens percentage growth) to reflect the increase in expenses for obligations under the new commercialization and development agreement for Jyseleca (filgotinib) with Galapagos NV. The guidance also reflects higher clinical trial and manufacturing ramp-up expenses related to Gilead’s COVID-19 treatment, remdesivir. Non-GAAP EPS is now projected at $6.98-$7.08, up from the earlier estimated range of $6.25-$6.60.
Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Regeneron Announces Agreement With the Government: Regeneron Pharmaceuticals, Inc. REGN announced that the U.S. Department of Health and Human Services (HHS) and the Department of Defense (DOD) will purchase an additional supply of its antibody cocktail of casirivimab and imdevimab for use in non-hospitalized COVID-19 patients to meet the federal government's Operation Warp Speed goals. Per the agreement, the government will purchase all finished doses of the casirivimab and imdevimab antibody cocktail delivered by Jun 30, 2021. Regeneron is already supplying doses to treat approximately 300,000 people, bringing the total potential purchase to more than 1.5 million doses.
The cocktail is being evaluated in clinical studies for the treatment of COVID-19 in certain hospitalized and non-hospitalized patients, including the open-label RECOVERY trial of hospitalized patients in the U.K. and a trial for the prevention of COVID-19 in household contacts of infected individuals.
CureVAc Up on Bayer Deal: CureVac CVAC shares surged after it announced a collaboration and services agreement with pharma giant, Bayer. Per the agreement, Bayer will support CureVac for further development, supply and key territory operations of the latter’s COVID-19 vaccine candidate, CVnCoV. Bayer will lend its arm in areas such as clinical operations, regulatory affairs, pharmacovigilance, medical information, supply-chain performance and support in selected countries.
While CureVac will be the Marketing Authorization Holder for the product, Bayer will support it with country operations within the European Union (EU) and selected additional markets. Bayer also has the option to become the Marketing Authorization Holder in other markets outside of Europe. The rationale of the deal is to facilitate CureVac to be in a position to supply hundreds of millions of CVnCoV doses around the world, once it obtains approvals.
Vir Biotechnology & Glaxo Announce Agreement for Study: Vir Biotechnology, Inc. VIR and partner GlaxoSmithKline plc GSK announced an agreement with the U.K.-based AGILE initiative to evaluate a second monoclonal antibody, VIR-7832, in patients with mild-to-moderate COVID-19 in a phase Ib/IIa clinical study.
The dose-escalation phase Ib part of the study will evaluate the safety and tolerability of a single dose of VIR-7832, given by intravenous (IV) infusion, and determine the dose for evaluation in the phase IIa part of the study. A total of 24 study participants will be randomized 3:1 to VIR-7832 or placebo. The phase II part of the study will include three treatment arms — 50 patients randomized to VIR-7832, 50 patients to VIR-7831 and 25 patients to placebo. The co-primary endpoints are safety and virologic activity of VIR-7832 as assessed by a change in SARS-CoV-2 viral load from baseline to day 8. The phase II part of the study will also assess the T cell responses to SARS-CoV-2 of VIR-7832 and VIR-7831.
Separately, Vir Biotechnology announced a collaboration with Gilead for developing a functional cure for chronic hepatitis B virus (HBV).
bluebird bio to Separate Oncology Business: bluebird bio, Inc. BLUE plans to spin-off its oncology business into a new company. The company intends to separate its severe genetic disease (SGD) and oncology businesses into differentiated and independent publicly-traded companies. The move is designed to unlock value through improved operational execution, organizational focus, tailored capital allocation and enhanced strategic optionality. The SGD business will focus on the delivery of three core therapies in β-thalassemia, cerebral adrenoleukodystrophy and sickle cell disease in the United States and Europe. The oncology business will support the commercial success of investigational B-cell maturation antigen (BCMA) directed chimeric antigen receptor (CAR) T cell therapy, idecabtagene vicleucel (ide-cel), in multiple myeloma and the continued development of the investigational bb21217 product candidate.
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index gained 5% in the last five trading sessions. Among the biotech giants, Incyte gained 9.83% during this period. Over the past six months, shares of Alexion have rallied 45.37%. (See the last biotech stock roundup here: Biotech Stock Roundup: MRNA’s COVID-19 Vaccine Updates & Other Pipeline Updates)
What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates.
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