It was a busy week for the biotech sector with updates from most bigwigs. Both Bristol-Myers (BMY - Free Report) and Regeneron (REGN - Free Report) reported better-than-expected second-quarter results. Apart from this, other regulatory and pipeline updates were in the spotlight.
Recap of the Week’s Most Important Stories:
Bristol-Myers Beats on Earnings, Ups View: Bristol-Myers reported better-than-expected results for the second quarter of 2020 as blood thinner drug, Eliquis, and addition of sales from Celgene’s drugs (acquired in November 2019) maintained momentum. Second-quarter 2020 earnings of $1.63 per share, easily beat the Zacks Consensus Estimate of $1.46 and increased from the year-ago quarter’s $1.18.
Total revenues of $10.12 billion beat the Zacks Consensus Estimate of $10.1 billion and surged 61% from $6.3 billion in the year-ago period. Strong growth was mainly driven by the addition of Celgene’s products. However, weak Opdivo sales are concerning. The company lifted its earnings guidance for 2020 in hope of a possible recovery in the second half of 2020.
Regeneron Fires All Cylinders in Q2: Regeneron Pharmaceuticals reported better-than-expected results for the second quarter of 2020, wherein both earnings and sales beat estimates. Regeneron reported earnings of $7.16 per share in the second quarter, comfortably beating the Zacks Consensus Estimate of $6.23 and increasing from $6.02 in the year-ago quarter.
Total revenues in the reported quarter increased 24% year over year to $1.9 billion and comfortably beat the Zacks Consensus Estimate of $1.8 billion. The year-over-year growth was driven by strong Dupixent sales. However, lead drug Eylea’s sales in the United States were negatively impacted by the COVID-19 pandemic.
Regeneron currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Gilead Submits Application for Coronavirus Drug: Gilead Sciences, Inc. (GILD - Free Report) announced that it has submitted a New Drug Application (NDA) for Veklury (remdesivir) to the FDA. The drug is an investigational antiviral for the treatment of patients with COVID-19. Veklury is currently available in the United States under an Emergency Use Authorization for the treatment of hospitalized patients with severe COVID-19. The filing is the final tier of the rolling NDA submission that was initiated on Apr 8, 2020. It has also been approved by multiple regulatory authorities around the world, including in the European Union and Japan.
Additionally, the China National Medical Products Administration (NMPA) has approved a pre-exposure prophylaxis indication for HIV medicine Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, FTC/TDF).
Biogen’s Application for AD Drug Accepted: Biogen (BIIB - Free Report) and partner Eisai announced that the FDA has accepted the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer’s disease. The BLA has been granted Priority Review by the agency with a target action date of Mar 7, 2021. The agency plans to act early on this application under an expedited review. A potential approval will make aducanumab the first therapy to reduce the clinical decline of Alzheimer’s disease and also the first therapy to demonstrate that removing amyloid beta results in better clinical outcomes.
Meanwhile, Biogen has collaborated with Denali Therapeutics Inc. to co-develop and co-commercialize the latter’s small molecule inhibitors of leucine-rich repeat kinase 2 (LRRK2) for Parkinson’s disease. Biogen will also receive rights to opt into two programs and a right of first negotiation for two additional programs, for each case of neurodegenerative diseases leveraging Denali’s Transport Vehicle (TV) technology platform to cross the blood-brain barrier (BBB).
Seres Therapeutics Surges on Data From Phase III Study: Shares of Seres Therapeutics, Inc. (MCRB - Free Report) surged significantly after it announced that the phase III ECOSPOR III study evaluating its investigational oral microbiome therapeutic SER-109 for recurrent C. difficile infection (CDI) met the primary endpoint. The primary efficacy endpoint of ECOSPOR III was the proportion of patients with recurrent CDI at up to eight weeks following administration of SER-109 or placebo. SER-109 achieved the primary endpoint, showing a highly statistically significant 30.2% absolute reduction in the rate of C. difficile infection recurrence compared to placebo. SER-109 was well tolerated, with a safety profile comparable to placebo. The study’s efficacy results exceeded the statistical threshold previously provided in consultation with the FDA that could allow this single clinical study to fulfill efficacy requirements for a Biologics License Application (BLA).
Moderna Soars on Vaccine Deal With The Government: Moderna Inc. (MRNA - Free Report) surged after it announced a supply agreement with the U.S. government, which has secured 100 million doses of mRNA-1273 as part of the U.S. government’s goal of securing early access to safe and effective COVID-19 vaccines for the Americans. mRNA-1273 is an mRNA vaccine against COVID-19, which was developed by Moderna and investigators from the National Institute of Allergy and Infectious Disease’s (NIAID) Vaccine Research Center. The government has awarded up to $1.525 billion for 100 million doses. With the previous award of up to $955 million from BARDA for the development of mRNA-1273 to licensure, the company has received up to $2.48 billion for its experimental vaccine candidate. Per the terms, the government, as part of Operation Warp Speed, will also have the option to purchase up to an additional 400 million doses of mRNA-1273 from Moderna.
The Nasdaq Biotechnology index lost 4.21% in the last five trading sessions. Among the biotech giants, Bristol-Myers gained 6.15% during this period. Over the past six months, shares of Regeneron have gained 50.94%. (See the last biotech stock roundup here: Biotech Stock Roundup: Amgen Reports Q2, GILD's CAR T Therapy Gets Approval & More)
What's Next in Biotech?
Stay tuned for more pipeline and earnings updates.
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