All eyes on GSK Q3 outcomes as RSV vaccine brings silver lining amid Zantac woes

GSK (NYSE:GSK) is scheduled to announce Q3 earnings outcomes on Wednesday, November 2nd, earlier than market open.

The British drugmaker’s inventory rose +2.40% on July 27 after its Q2 outcomes which noticed gross sales develop +19% Y/Y to ~£6.93B, pushed by progress in Specialty Medicines, and shingles vaccine Shingrix.

GSK had additionally raised its full 12 months 2022 gross sales progress outlook to between 6% to eight%, from a variety of 5% to 7%.

In the course of the begin of Q3, GSK lastly spun off its shopper well being unit Haleon and it began buying and selling on the London Inventory Change on July 18, marking the largest European itemizing in a decade.

Nevertheless, in August, shares of GSK, Haleon and Sanofi got here beneath stress after analysts flagged issues over litigations associated to recalled heartburn drug Zantac (ranitidine).

GSK and Sanofi, nevertheless, defended their stance on Zantac (ranitidine) noting that since 2019 researches carried out by totally different companies and the businesses have proven that there was no proof of ranitidine inflicting most cancers.

Zantac was withdrawn from the U.S. market in 2020 amid issues over the unacceptable ranges of potential human carcinogen, N-nitrosodimethylamine (NDMA).

Whereas Citi noticed restricted affect on the businesses, citing a court docket ruling in Florida. Jefferies downgraded GSK in September on uncertainty associated to the continuing lawsuits.

Credit score Suisse too was involved over Zantac litigation however upgraded GSK noting that pharma’s respiratory syncytial virus (RSV) vaccine candidate may very well be higher than that of Pfizer’s.

YTD, GSK shares have shed ~24%, see chart right here, and has an SA Quant Ranking of Maintain. The common Wall Avenue Analysts’ Ranking differs with a Purchase ranking on the inventory.

Prior to now few months, GSK made inroads to get into the untapped market of RSV vaccines for older adults. Presently there are not any RSV vaccines for older adults accredited anyplace on the planet, in accordance with the corporate.

GSK, which is tightly competing with Pfizer on this area, filed for regulatory approval of its RSV older grownup vaccine candidate within the EU and Japan in October.

The vaccine had proven general efficacy of 82.6% in opposition to RSV decrease respiratory tract illness (RSV-LRTD) in adults aged 60 years and above in a part 3 trial.

Earlier right now (Nov. 1) Pfizer mentioned that its maternal RSV vaccine to guard infants confirmed reveals 81.8% efficacy verus extreme illness in a trial.

In September, GSK named Julie Brown as its first feminine CFO who will take part April 2023 from luxurious style model Burberry the place she serves as Chief Working and Monetary Officer. With CEO Emma Walmsley on the helm, GSK would turn out to be an all-female-led firm.

Regulatory Information:

GSK’s single-vial presentation of meningococcal vaccine Menveo acquired FDA approval in October.

The FDA additionally accredited Boostrix vaccine for pregnant girls of their third trimester to stop pertussis, or whooping cough, in infants.

In August, A panel of the European Medicines Company (EMA) started evaluation for a conditional advertising and marketing authorization of GSK and SK bioscience’s COVID-19 vaccine Skycovion.