This week, Sanofi SNY and Roche RHHBY announced their fourth-quarter and full-year 2024 results. Novo Nordisk’s NVO novel obesity medicine, amycretin, showed superior weight loss in a study. Merck MRK announced mixed data from a phase III study on a combination regimen of its blockbuster PD-L1 inhibitor, Keytruda, in gastroesophageal cancer. The FDA granted approval for the expanded use of AstraZeneca AZN and its Japanese partner Daiichi’s antibody-drug conjugate, Enhertu, in breast cancer.
Here's a recap of the week’s most important stories.
Sanofi Q4 Earnings Miss, 2025 Outlook Impresses
Sanofi missed estimates for both earnings and sales in the fourth quarter. Sanofi’s sales rose 10% on a constant currency rate (“CER”) basis, while earnings per share declined 11%. Higher sales of Dupixent and contributions from new products like Altuviiio and Beyfortus were partially offset by lower sales of flu vaccines and Aubagio due to generic competition. Dupixent’s sales rose 16% year over year. Total vaccine sales increased 10.8% to €2.2 billion, driven by Beyfortus sales in Europe.
Sanofi issued a fresh guidance for 2025. It expects its sales to rise by a mid-to-high single-digit percentage at CER. Sanofi also announced a €5 billion ($5.2 billion) buyback program to be executed in 2025. Sanofi expects earnings to rebound strongly in 2025 with the expectation of low double-digit percentage growth versus 4.1% in 2024.
Roche Releases Q4 and 2024 Results
Roche’s performance in the fourth quarter and full-year 2024 was strong, driven by high demand for its drugs and diagnostic tests. In 2024, sales grew 7% year over year at constant exchange rates (CER). Core earnings per share rose 7% in 2024.
In the fourth quarter, sales rose 9% at CER.
Sales in the Pharmaceuticals Division grew 8% in 2024. Vabysmo (eye diseases) was the biggest growth driver of sales, with Phesgo (breast cancer), Ocrevus (multiple sclerosis), and Hemlibra (hemophilia) being the other significant contributors. The Diagnostics division’s sales rose 4% year over year.
Roche expects total sales to grow in the mid-single-digit range (at CER) in 2025. Core earnings per share are expectedto grow in the high single-digit range at CER.
NVO’s Encouraging Data From the Novel Obesity Drug Study
Novo Nordisk announced encouraging data from a phase Ib/IIa study on subcutaneous amycretin, a novel unimolecular GLP-1 and amylin receptor agonist in people who are overweight or obese. Top-line data from the study showed that people treated with amycretin experienced a weight loss of 9.7% for the 1.25 mg dose over 20 weeks. While those treated with 5 mg experienced a weight loss of 16.2% over 28 weeks, the ones given 20 mg lost 22% of their weight over 35 weeks. Patients on placebo experienced an estimated 1.9%, 2.3% and 2.0% body weight gain for the 1.25 mg, 5 mg and 20 mg doses, respectively.
Amycretin works by a different mechanism from NVO’s popular obesity drug, Wegovy. Wegovy mimics the GLP-1 hormone while amycretin mimics both the GLP-1 hormone and a hormone called amylin.
The FDA granted approval to Novo Nordisk’s popular diabetes medicine, Ozempic, to reduce the risk of worsening kidney disease and cardiovascular death in adults with type II diabetes and chronic kidney disease. The approval is based on data from the pivotal FLOW phase IIIb kidney outcomes study. In 2020. Ozempic was approved by the FDA to reduce the risk of major cardiovascular events in patients with type II diabetes and known heart disease.
MRK’s Study on Keytruda Lenvima Combo Misses OS Goal
Merck’s phase III LEAP-015 study, evaluating blockbuster PD-L1 inhibitor, Keytruda and partner Eisai's Lenvima plus chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic gastroesophageal adenocarcinoma, met one of the dual primary endpoints while missing the other.
At the interim analysis, treatment with the Keytruda plus Lenvima-based regimen led to a statistically significant improvement in progression-free survival – one of the study's dual primary endpoints –versus standard-of-care chemotherapy. However, in the final analysis, the study failed to show a statistically significant increase in overall survival, the study’s second primary endpoint.
The Keytruda plus Lenvima combination is currently approved in the United States, Europe, Japan and other countries for treating certain types of advanced endometrial carcinoma and advanced renal cell carcinoma (“RCC”).
Merck also announced the decision to stop the phase III HYPERION study on its new pulmonary arterial hypertension (PAH) drug, Winrevair, due to strong positive interim efficacy data from other Winrevair studies, including the STELLAR and ZENITH studies.
The program’s external steering committee concluded that since the other Winrevair studies have already demonstrated robust efficacy data across a broad spectrum of patients, continuing the placebo-controlled HYPERION study would be unethical, and it was therefore stopped early. Winrevair is approved in the United States and several other countries to treat PAH, WHO Group 1 based on data from the phase III STELLAR study.
The FDA granted priority review to a supplemental new drug application (sNDA) seeking approval for Merck’s oral HIF-2α inhibitor, Welireg for the treatment of patients with advanced pheochromocytoma and paraganglioma. Currently, there are no approved therapies for treating these rare adrenal tumors. The FDA’s decision on the sNDA is expected on May 26, 2025. The NDA was based on data from the phase II LITESPARK-015 study. Welireg is currently approved in the United States for patients with advanced RCC and some von Hippel-Lindau disease-associated tumors.
FDA Approves AZN & Daiichi’s Enhertu for Expanded Breast Cancer Use
The FDA granted approval to AstraZeneca/Daiichi’s Enhertu for treating unresectable or metastatic HER2-low or HER2-ultralow metastatic breast cancer in adult patients whose disease has progressed after one or more endocrine therapies.
The FDA’s approval is based on data from the phase III DESTINY-Breast06 study. The FDA approval will expand the currently approved indication of Enhertu in HER2-low metastatic breast cancer to include use in an earlier disease setting as well as in a broader patient population that includes HER2-ultralow. Following this approval, AstraZeneca will be entitled to make a milestone payment of $175 million to Daiichi.
Enhertu is presently also approved for advanced or metastatic HER2-positive gastric cancer, previously treated HER2-mutant metastatic non-small cell lung cancer and metastatic HER2-positive and HER2-low breast cancer and previously treated HER2-positive solid tumors.
The NYSE ARCA Pharmaceutical Index rose 4.3% in the past five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here’s how the eight major stocks performed in the previous five trading sessions.
Zacks Investment Research
Image Source: Zacks Investment Research
All the stocks were in the green in the last five trading sessions, with Lilly rising the most (7.4%).
In the past six months, all stocks were in the red. Novo Nordisk declined the most (35.7%).
(See the last pharma stock roundup here: JNJ’s Q4 Earnings, FDA Nod to AZN, Daiichi Drug)
What's Next in the Pharma World?
Watch this space for PFE, MRK, LLY and AZN’s fourth-quarter results and regular pipeline and regulatory updates next week.
Merck and AstraZeneca have a Zacks Rank #3 (Hold) each, while Sanofi, Roche and Novo Nordisk have a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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
