This week marked the beginning of the third-quarter earnings season for the pharma sector, with J&J JNJ announcing mixed results and raising its earnings guidance. Roche RHHBY announced encouraging sales results for the first nine months of 2021. The FDA authorized a booster dose of J&J’s COVID vaccine. Pfizer PFE and partner BioNTech announced high efficacy of their COVID vaccine booster dose in a phase III study.
In a surprising move, the FDA authorized a heterologous administration of the booster doses of the three approved COVID-19 vaccines made by J&J, Pfizer and Moderna. The heterologous administration will allow inoculation of an individual with any of the three available booster jabs irrespective of the initial COVID-19 vaccine regimen.
Recap of the Week’s Most Important Stories
J&J’s Mixed Q3 Results: J&J reported mixed third-quarter earnings as it beat estimates for earnings but missed the same for sales. Its Pharmaceuticals unit continued to perform above market levels. Though its Medical Devices segment benefited from an ongoing recovery, the COVID Delta-variant impacted its sales to some extent. Sales of the Consumer segment continued to improve.
J&J significantly raised its previously issued guidance range for earnings while slightly increasing the lower end of the sales range for 2021.However, the company kept its COVID-19 vaccine sales outlook of $2.5 billion intact.
Diagnostics Unit Drives Roche’s Sales Growth: Roche’s sales rose 6% in the first nine months of 2021. Sales in the Pharmaceuticals unit were flat in the nine months as the business recovered from the impact of the pandemic and biosimilar competition slowed down. However, the Diagnostics division sales rose 39% due to a surge in demand for COVID-19 diagnostics tests. In the third quarter, the Pharmaceuticals division’s sales grew 5% while the Diagnostics division sales jumped 18%.
Roche now expects sales to grow in the mid-single-digit range compared to the previous expectation of low- to mid-single-digit range in 2021 at constant exchange rates.
FDA Approves J&J’s COVID Booster Dose: J&J announced that the FDA has granted emergency use authorization (EUA) to the booster dose of its single-shot COVID-19 vaccine for adults aged 18 and older and who have completed at least two months after the initial dose. The booster dose has the same formulation and dosage as the primary shot.
The FDA authorization came on the heels of a unanimous recommendation (19-0) by the FDA’s Vaccines and Related Biological Products advisory committee (VRBPAC) for the booster dose of J&J’s vaccine last week. J&J’s EUA amendment request to include a booster dose of its COVID-19 vaccine was backed by data from several clinical studies including the phase III ENSEMBLE 2 study.
The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) also unanimously recommended J&J’s vaccine as a booster for eligible individuals in the United States irrespective of the initial COVID-19 vaccine regimen.
FDA Approves Another Indication for Roche’s Tecentriq: The FDA granted approval to Roche’s cancer drug Tecentriq for a new indication in lung cancer. It is now approved as an adjuvant treatment, following surgery and platinum-based chemotherapy, for adults with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumors express PD-L1≥1%. The approval was based on results from an interim analysis of the phase III IMpower010 study. Tecentriq is already approved for various types of lung cancer and some other cancer indications.
FDA Approves Sanofi/Regeneron’s Dupixent for Asthma in Kids: The FDA granted approval to Sanofi SNY/Regeneron’s blockbuster medicine Dupixent to treat moderate-to-severe asthma in children aged 6 to 11 years. A similar application for children aged 6 to 11 years with moderate-to-severe asthma is under review in Europe. Dupixent is already approved for asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults and for patients aged 6 years and older with uncontrolled moderate-to-severe atopic dermatitis.
Pfizer’s First Data from COVID Booster Study: Pfizer and partner BioNTech announced top-line data from their phase III COVID-19 vaccine booster study. The booster (30-µg) or “third” dose of its COVID-19 vaccine, Comirnaty, led to a relative vaccine efficacy of 95.6% against the disease. Pfizer/BioNTech plan to submit these data to the FDA, European Medicines Agency, and other regulatory agencies
Last month, the FDA granted emergency use authorization (EUA) to Pfizer’s booster dose of Comirnaty for individuals 65 years and older and individuals 18 through 64 years of age in high-risk groups.
CDC’s Advisory Panel Backing for Pfizer, Merck’s Pneumococcal Vaccine: The CDC’s ACIP voted routine use of Pfizer’s Prevnar 20 (pneumococcal 20-valent conjugate vaccine) in adults. Prevnar 20 was approved by the FDA in June this year. The ACIP committee also unanimously voted to provisionally recommend Merck’s MRK new 15-valent pneumococcal conjugate vaccine, Vaxneuvance either with a sequential regimen of Vaxneuvance followed by Pneumovax 23, or with a single dose of 20-valent pneumococcal conjugate vaccine in certain adults. Vaxneuvance was approved by the FDA in July.
The committee also voted unanimously to recommend two doses of Glaxo’s GSK shingles vaccine Shingrix for immunocompromised adults aged 19 and up.
The NYSE ARCA Pharmaceutical Index rose 2.5% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here’s how the eight major stocks performed in the last five trading sessions.
Image Source: Zacks Investment Research
In the last five trading sessions, all the stocks were in the green except AbbVie ABBV, which declined 0.1%. Merck gained the most (3.6%).
In the past six months, Lilly recorded the maximum gain (27.8%) while Novartis declined the most (4.1%)
(See the last pharma stock roundup here: MRK to Buy XLRN, ABBV Gets FDA Nod for Migraine Drug & More)
What's Next in the Pharma World?
Watch out for the results of Merck, Lilly, Glaxo, Sanofi and others and regular pipeline and regulatory updates next week.
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