This week, Roche RHHBY announced its third-quarter and nine-month results. Sanofi SNY confirmed that it is holding exclusive talks with U.S. private equity company CD&R to sell a controlling stake in its consumer healthcare (“CHC”) business, Opella.
The FDA approved Pfizer’s PFE respiratory syncytial virus (RSV) Abrysvo for adults under the age of 60. Novo Nordisk’s NVO cardiovascular outcomes study on its popular drug, oral semaglutide, met its primary endpoint. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of AstraZeneca’s AZN Wainzua in the EU.
Here's a recap of the week’s most important stories.
Roche Releases Q3 and 9-Month Results
Roche’s performance in the third quarter and the first nine months of 2024 was strong, driven by high demand for its drugs and diagnostic tests. Roche’s sales rose 9% at a constant exchange rate (CER) in the third quarter.
Sales in the Pharmaceuticals Division grew 7% in the first nine months to CHF 34.3 billion. Vabysmo (eye diseases) was the biggest growth driver of sales, with Phesgo (breast cancer), Ocrevus (multiple sclerosis), Hemlibra (hemophilia) and Polivy (blood cancer) being the other significant contributors. The Diagnostics division’s sales rose 5% year over year.
Roche maintained its sales growth guidance for 2024 in the mid-single-digit range (at CER). Core earnings per share are expected to grow in the high single-digit range, excluding the impact of the resolution of tax disputes in 2023.
Sanofi in Exclusive Talks With CD&R for Opella Stake Sale
Sanofi provided an update on its exclusive negotiations with CD&R to sell a 50% controlling stake in Opella. Sanofi announced its intention to separate its CHC unit last year through the creation of a publicly listed entity headquartered in Paris called Opella. Sanofi will remain a significant shareholder of Opella. The deal values Opella at an enterprise value of almost 16 billion euros or 14 times EBITDA for 2024. The transaction is not expected to close before the second quarter of 2025.
The company raised its earnings growth expectations for 2024, including Opella. It expects its earnings to be stable to up by a low single-digit percentage from the previous expectation of being stable at a constant exchange rate (CER). Excluding Opella, Sanofi expects its EPS to grow by at least a low-single-digit percentage at CER in 2024.
FDA Approves Pfizer’s RSV Jab, Abrysvo for Younger Adults
The FDA approved the expanded use of Pfizer’s FDA RSV vaccine, Abrysvo, for adults 18 to 59 years. The vaccine is approved for adults in this age group who are at an increased risk of developing severe RSV-associated lower respiratory tract disease (LRTD), like those with certain underlying chronic conditions such as asthma, obesity, diabetes, heart failure, chronic kidney disease, and chronic obstructive pulmonary disease.
Abrysvo becomes the only RSV vaccine approved for adults younger than 50. The approval was based on data from a phase III study called MONeT. Abrysvo was approved and launched to help protect older adults (aged more than 60), as well as infants, through maternal immunization in the United States, EU and some other countries in 2023
The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practice (ACIP) recommended expanding the use of pneumococcal vaccines of Pfizer and Merck, Prevnar 20 and Capvaxive, respectively, for all adults aged 50 and older. Until now these vaccines were recommended by ACIP for use in adults aged 65 and above. For adults 19-49 years of age, these vaccines are recommended only for those with certain underlying conditions or risk factors. This recommendation is pending final approval by the CDC and the Department of Health and Human Services.
NVO’s Cardiovascular Study on Semaglutide Meets Goal
Novo Nordisk announced positive data from the SOUL cardiovascular outcomes study evaluating oral semaglutide for the prevention of major adverse cardiovascular events (MACE) such as cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. Novo Nordisk markets oral semaglutide by the name of Rybelsus.
The study achieved its primary endpoint by demonstrating a statistically significant and superior reduction in MACE of 14% in adults with type II diabetes compared to placebo. Novo Nordisk plans to file regulatory applications in both the United States and EU to seek expanded use of Rybelsus for the cardiovascular indication toward the end of the year.
CHMP Nod to AstraZeneca’s Wainzua for TTR Amyloidosis
The CHMP gave a positive opinion recommending approval of AstraZeneca’s Wainzua (eplontersen) for treating hereditary transthyretin-mediated amyloidosis, commonly referred to as ATTRv-PN. It is a debilitating disease, which leads to peripheral nerve damage. The CHMP opinion was based on data from the NEURO-TTRansform study. Wainzua was approved by the name of Wainua in the United States in December last year.
AstraZeneca and Ionis are commercializing the drug in the United States. Eplontersen is also being evaluated as a treatment for cardiomyopathy caused by hereditary TTR amyloidosis in the phase III CARDIO-TTRansform study, which is on track for a data readout in first-half 2025.
The NYSE ARCA Pharmaceutical Index declined 2.4% 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, AbbVie rose the most (0.6%), while Novo Nordisk declined the most (3.6%).
In the past six months, while Lilly rose the most (21.5%), Merck declined the most (19.3%).
(See the last pharma stock roundup here: JNJ’s Q3 Earnings, FDA Nod to Some New Drugs)
What's Next in the Pharma World?
Watch this space for Lilly, Pfizer, Merck and AbbVie’s third-quarter earnings update and regular pipeline and regulatory updates next week.
Pfizer, Novo Nordisk Roche and Sanofi have a Zacks Rank #3 (Hold) each, while AstraZeneca has a Zacks Rank of 2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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