Pharma Stock Roundup: JNJ's Q3 Earnings, FDA Nod to Some New Drugs

This week, Johnson & Johnson JNJ began the third-quarter earnings season for the drug and biotech sector. The FDA granted approval to a few new drugs, which included Pfizer’s PFE gene therapy for hemophilia, Roche’s RHHBY breast cancer drug and AbbVie’s ABBV Parkinson’s treatment. Sanofi SNY said it is considering selling a 50% stake in its consumer healthcare business (“CHC”), which it intends to separate.

Here's a recap of the week’s most important stories.

JNJ Begins Q3 Earnings Season

Johnson & Johnson’s third-quarter results were strong as it beat estimates for both earnings and sales. JNJ’s Innovative Medicines segment outperformed expectations while MedTech underperformed. Sales in Innovative Medicines segment rose 4.9% year over year to $14.58 billion.  MedTech segment sales came in at $7.89 billion, up 5.8% from the year-ago period.

Johnson & Johnson’ raised its total revenue expectation for the year as it expects an improved performance in the rest of the year. However, the company lowered its adjusted earnings expectation as its expectation of a better operational performance was partially offset by costs associated with the recent acquisition of private medical device company V-Wave.

Total revenues are expected in the range of $88.4 billion-$88.8 billion for 2024, up from $88.0 billion-$88.4 billion expected previously. The adjusted earnings per share guidance was lowered from a range of $9.97-$10.07 to $9.88-$9.98 per share.

FDA Approves Pfizer’s New Hemophilia Gene Therapy

The FDA granted approval to Pfizer’s anti-TFPI inhibitor, marstacimab, for the treatment of hemophilia A and B. The drug will be marketed by the name of Hympavzi as a prophylactic treatment to prevent or reduce the frequency of bleeding episodes in adults and adolescents with hemophilia A or B without inhibitors. Hympavzi’s approval was based on positive data from the phase III BASIS study.

A marketing authorization application (MAA) for marstacimab is also under review in the EU. The European Commission’s decision on the MAA is expected by the first quarter of 2025. Hympavzi is Pfizer’s second hemophilia treatment to be approved this year. Beqvez/Durveqtix (fidanacogene elaparvovec), a one-time gene therapy for hemophilia B, was approved by the FDA in April 2024.

FDA Approves AbbVie’s New Parkinson’s Drug

The FDA approved AbbVie’s Vyalev (foscarbidopa and foslevodopa) for the treatment of motor fluctuations in adults with advanced Parkinson's disease (PD). Vyalev is the first-and-only subcutaneous 24-hour infusion of levodopa-based therapy for advanced Parkinson's disease, which allows continuous delivery of levodopa in the morning, day and night. The approval was based on data from a pivotal phase III study, which compared the subcutaneous infusion of Vyalev to oral immediate-release carbidopa/levodopa.

The study data showed that patients who were treated with Vyalev experienced superior improvement in "on" time without troublesome dyskinesia versus oral medications. "On" time refers to the periods of time when patients are experiencing optimal motor symptom control. AbbVie said that Medicare is expected to cover the drug from the second half of 2025. Vyalev was launched by the name of Produodopa in the European Union in January.

FDA Approves Roche’s New Breast Cancer Drug

The FDA also approved Roche’s investigational breast cancer drug, inavolisib, to be sold under the brand name Itovebi. It is approved in combination with Pfizer’s Ibrance (palbociclib) and fulvestrant for treating advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation. Itovebi is Roche’s first targeted therapy approved for people with HR-positive disease, which is the most prevalent breast cancer subtype. The approval was based on data from the phase III INAVO120 study.

Sanofi Considering Sale of 50% Stake in Opella

Sanofi announced that it is in discussion to sell a 50% controlling stake in Opella, its CHC business. 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 is in negotiations with a U.S-based investment company, CD&R, for the potential sale of a controlling stake and an update will be provided when a final decision is made. With the separation of its consumer health unit, Sanofi joins several other large drugmakers like J&J, GSK and Pfizer, which have also sold off their consumer health units to focus on their core pharmaceuticals business.

The NYSE ARCA Pharmaceutical Index declined 0.5% in the last five trading sessions.

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, Johnson & Johnson rose the most (2.4%), while AbbVie declined the most (3.0%).

In the past six months, while Lilly rose the most (26.3%), Merck declined the most (12.7%).

(See the last pharma stock roundup here: FDA Approves SNY’s Dupixent for COPD & More)

What's Next in the Pharma World?

Watch this space for Sanofi and Roche’s third-quarter earnings update and regular pipeline and regulatory updates next week.

Pfizer, AbbVie, JNJ, Roche and Sanofi have a Zacks Rank #3 (Hold) each. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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Sanofi (SNY): Free Stock Analysis Report
 
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