This week, AstraZeneca AZN and AbbVie ABBV announced their fourth-quarter results, with both companies beating estimates for earnings but missing on sales, like most of their counterparts. Bayer BAYRY announced the appointment of Bill Anderson as its new chief executive officer (CEO). Roche RHHBY and J&J JNJ announced positive data from clinical studies on pipeline candidates for rare diseases.
Recap of the Week’s Most Important Stories
AstraZeneca and AbbVie’s Mixed Q4 Results: AstraZeneca’s fourth-quarter results were mixed as it beat estimates for earnings but missed the same for sales. Total revenues rose 1% in the quarter at constant exchange rates (CER). Higher sales of key medicines like Tagrisso, Lynpaza and Farxiga were offset by a steep decline in sales of AstraZeneca’s COVID vaccine, Vaxzevria. Excluding Vaxzevria, total revenues in the quarter increased 17%.
However, AstraZeneca’s sales outlook for 2023 looked encouraging as it expects sales, excluding COVID products, to rise by a double-digit percentage.
AbbVie too beat estimates for earnings but missed the same for sales. Sales rose 3.8% as higher sales of key drugs like Rinvoq, Skyrizi and Vraylar were partially offset by lower sales of Juvederm and Imbruvica. AbbVie issued a fresh EPS guidance for 2023. The company expects adjusted EPS in the range of $10.70-$11.10, suggesting a year-over-year decline of 19.4-22.3%.
Bayer Gets a New CEO: Bayer announced the appointment of Bill Anderson, Roche’s former CEO of Pharmaceuticals Division, as its new CEO, effective from Jun 1, 2023. Bill replaces Bayer’s present CEO, Werner Baumann, whose service ends in May 2023. Bayer’s board was under a lot of investor pressure to change its CEO who had served the company for 35 years reportedly due to the failure of its 2018 Monsanto acquistion. Bayer said the selection process began in mid-2022.
J&J’s Phase II Study on Nipocalimab Meets Primary Goal: J&J’s proof-of-concept phase II study, evaluating nipocalimab for treating pregnant individuals at high risk of severe hemolytic disease of the fetus and newborn (HDFN), met the primary endpoint. In the study, the majority of pregnant women who were given nipocalimab achieved a live birth at or after the gestational age (GA) of 32 weeks, without the need for an intrauterine transfusion (IUT) throughout their entire pregnancy. HDFN is a rare condition in which life-threatening anemia can occur in the fetus when the blood types of a pregnant individual and their fetus are incompatible
Nipocalimab was added to J&J’s pipeline with the 2020 acquisition of Momenta Pharmaceuticals. Nipocalimab is being evaluated in mid-and late-stage development for autoantibody-driven rare diseases and has the potential to create a pipeline in a product
AstraZeneca’s Forxiga Gets Europe Nod for a Broader Indication: The European Commission approved the label expansion of AstraZeneca’s Forxiga for the treatment of symptomatic chronic heart failure with mildly reduced or preserved ejection fraction, (HFmrEF, HFpEF). At present, Forxiga is already approved in the EU for the treatment of symptomatic chronic heart failure with reduced ejection fraction (HFrEF) in adults with and without type-II diabetes. With approval for the broader indication in heart failure, Forxiga will be the first heart failure therapy indicated across the full ejection fraction range in Europe. The approval was based on positive results from the DELIVER phase III study. A regulatory application for a broader indication in HF is under review in the United States.
Roche’s Pivotal Study on PNH Drug Meets Goals: Roche’s global phase III COMMODORE 2 study, evaluating the efficacy and safety of crovalimab for paroxysmal nocturnal hemoglobinuria (PNH), a rare, life-threatening blood condition, met its co-primary efficacy endpoints by showing that crovalimab achieved disease control in patients with PNH who have not been previously treated with complement inhibitors. In the study, crovalimab was also non-inferior to eculizumab, a current standard-of-care medicine, which is given intravenously every two weeks. The study’s co-primary efficacy endpoints were transfusion avoidance and control of hemolysis.
Roche also announced efficacy and safety data from the phase III COMMODORE 1 study conducted on PNH patients switching from currently approved C5 inhibitors to crovalimab. The study supported crovalimab’s favorable benefit-risk profile as seen in the pivotal COMMODORE 2 study. Results from both studies will be submitted to regulatory authorities soon.
The NYSE ARCA Pharmaceutical Index rose 0.9% 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, AstraZeneca rose the most (6.8%), while J&J declined the most (2.4%).
In the past six months, Merck has risen the most (19.7%), while Pfizer declined the most (13.1%).
(See the last pharma stock roundup here: MRK, LLY, PFE Q4 Results, J&J’s Loss in Talc Lawsuits)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report