JNJ beat Q4 estimates for both earnings and sales, with earnings of $2.04 per share and $22.5 billion in sales.
The FDA granted approval to AstraZeneca/Daiichi's Dato-DXd for previously treated breast cancer.
SNY, ABBV, RHHBY and NVS will announce Q4 results and regular pipeline and regulatory updates next week.
This week, J&J JNJ announced fourth-quarter and full-year 2024 results, starting the earnings season for the drug and biotech sector. The FDA granted approval to AstraZeneca AZN and partner Daiichi’s novel TROP2-directed antibody-drug conjugate (“ADC”), datopotamab deruxtecan or Dato-DXd for breast cancer. The European Commission (”EC”) approved the expanded use of Sanofi’s SNY Sarclisa in multiple myeloma. AbbVie ABBV announced yet another collaboration deal, this time with small biotech Neomorph, to develop molecular glue degraders for oncology and immunology.
Here's a recap of the week’s most important stories.
J&J’s Q4 Earnings Beat but 2025 Outlook Dull
J&J beat fourth-quarter estimates for both earnings and sales. Sales of $22.52 billion rose 5.3% from the year-ago quarter. Earnings of $2.04 per share declined 10.9% from the year-ago period.
Its Innovative Medicines unit once again outperformed expectations, while the MedTech unit’s sales missed estimates.
Sales in Innovative Medicines segment rose 4.4% year over year to $14.33 billion. Higher sales of key products such as Darzalex, Tremfya, Uptravi and Erleada drove the segment’s growth. New drugs like Carvykti, Tecvayli and Spravato also contributed to growth. The sales growth was partially dampened by lower sales of Stelara, Imbruvica and generic/biosimilar competition to drugs like Zytiga and Remicade. MedTech segment sales came in at $8.19 billion, up 6.7% from the year-ago period.
J&J issued its financial guidance for 2025. The company expects sales in the range of $89.2 billion-$90.0 billion in 2025, which falls short of the Zacks Consensus Estimate. Adjusted earnings per share are expected in the range of $10.50-$10.70.
J&J announced that the FDA approved Spravato as a monotherapy for adults living with treatment-resistant depression (TRD). The approval was based on data from the phase IV TRD4005 study. At present, Spravato is approved in combination with an oral antidepressant to treat adults with TRD and depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior. With the latest approval, Spravato becomes the first and only monotherapy approved for treating MDD in adults who have had an inadequate response to at least two oral antidepressants and are considered to have TRD.
FDA Approves AZN & Daiichi’s Dato-DXd for Breast Cancer
The FDA granted approval to AstraZeneca/Daiichi’s Dato-DXd for previously treated unresectable or metastatic HR+ HER2- breast cancer. The drug will be marketed by the name of Datroway. The approval is based on data from the TROPION-Breast01 phase III study. Dato-DXd is also under review for the breast cancer indication in the EU, China and some other countries.
This is the first approval for Datroway in the United States. A biologics license application (BLA) seeking accelerated approval of Dato-DXd for previously treated advanced EGFR-mutated non-small cell lung cancer (“NSCLC”) is also under review with the FDA. The BLA was based on data from the TROPION-Lung05 phase II study. The FDA’s decision is expected during the third quarter of 2025.
The FDA also granted approval to AstraZeneca’s another BTK inhibitor Calquence in combination with standard-of-care chemoimmunotherapy for previously untreated mantle cell lymphoma. The approval is based on data from the ECHO phase III study. Calquence is presently approved for treating MCL in patients who have received at least one prior therapy.
EU Approval for SNY’s Sarclisa in First-Line Multiple Myeloma
Sanofi announced that the EC has granted approval to Sarclisa in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. The approval was based on data from the IMROZ phase III study. This is the third approved indication for Sarclisa in the EU. Sarclisa is approved in several countries for two indications in relapsed or refractory multiple myeloma. The FDA had approved Sarclisa for a similar first-line use in the United States in September 2024.
AbbVie’s Option-to-License Deal With Neomorph
AbbVie announced an option-to-license agreement with Neomorph to develop novel molecular glue degraders for multiple targets across oncology and immunology, leveraging the latter’s molecular glue discovery platform. Per the deal, Neomorph will receive an undisclosed upfront payment while also being entitled to up to $1.64 billion in aggregate option fees and milestone payments.
The NYSE ARCA Pharmaceutical Index declined 1.6% 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
In the last five trading sessions, AstraZeneca rose the most (4.4%), while Merck declined the most (3.5%).
In the past six months, all stocks were in the red. Novo Nordisk declined the most (36.6%).
(See the last pharma stock roundup here: Pharma Stock Roundup: J&J’s ITCI Buyout, LLY’s Weak Q4 Preliminary Sales)
What's Next in the Pharma World?
Watch this space for SNY, ABBV, RHHBY and NVS’ fourth-quarter results and regular pipeline and regulatory updates next week.
J&J, AbbVie and AstraZeneca have a Zacks Rank #3 (Hold) each, while Sanofi has a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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