Johnson & Johnson (NYSE: JNJ) will host a conference call to review third-quarter results on Tuesday, October 13, at 8:30 am Eastern Time.

The call will be led by Joaquin Duato, Chairman and Chief Executive Officer, and Joseph J. Wolk, Executive Vice President and Chief Financial Officer. Ryan Koors, Vice President of Investor Relations, will also participate. Additional executive team members will join the question-and-answer session.

Accessing the Conference Call

Investors can access the webcast and presentation materials via the company’s investor relations website at www.investor.jnj.com . A replay of the webcast will be available approximately three hours after the call concludes.

Telephone access is available for both listen-only participants and analysts joining the Q&A segment:

• U.S. dial-in number: 877-869-3847
• International dial-in number: 201-689-8261

A replay of the conference call will be available until approximately 12:00 am on October 27. The replay dial-in numbers are:

• U.S.: 877-660-6853
• International: 201-612-7415

The conference ID for all callers is 13762207.

Press Release Timing

The official press release detailing the financial results will be issued at approximately 6:45 am Eastern Time on the morning of the conference call.

Future Earnings Schedule

The company has scheduled its fourth-quarter earnings webcast for Tuesday, January 26, 2027. A complete list of planned earnings calls is available on the investor relations website.

The US Food and Drug Administration approved Johnson & Johnson (NYSE: JNJ) on August 24, 2026, for IMAAVY (nipocalimab-aahu) to treat warm autoimmune hemolytic anemia (wAIHA). This marks the first therapy proven safe and effective specifically for this rare, life-threatening disease in adults and pediatric patients aged 12 and older.

The approval extends to patients who currently receive or previously received corticosteroids. In wAIHA, pathogenic immunoglobulin G (IgG) autoantibodies attach to and destroy healthy red blood cells, causing severe anemia, profound fatigue, and an elevated risk of morbidity and mortality.

Clinical Efficacy and Trial Data

The approval follows an FDA Priority Review and is based on the Phase 2/3 ENERGY study. The trial evaluated 115 adults randomized to receive nipocalimab at two dose schedules or placebo.

Key efficacy outcomes from the study include:

Patients receiving the approved dose of 30 mg/kg every 4 weeks achieved durable hemoglobin levels significantly more often than those on placebo. A durable response is defined as a hemoglobin concentration of ≥10 g/dL and an increase from baseline of ≥2 g/dL for at least 28 days without rescue therapy.

What the Numbers Show

The clinical data indicates a rapid onset of effect combined with sustained durability. Patients saw a mean hemoglobin increase of 1 g/dL within just one week of treatment. This early physiological improvement correlated with patient-reported outcomes, where the treatment group recorded a 3.5-point higher mean FACIT-Fatigue score versus placebo by Week 24. The divergence between the rapid hemoglobin rise and the later fatigue score improvement suggests that while red blood cell counts normalize quickly, the alleviation of debilitating fatigue—a primary symptom of wAIHA—manifests over a longer therapeutic horizon.

Safety Profile and Mechanism

IMAAVY is an immunoselective FcRn blocker designed to reduce pathogenic IgG autoantibodies while preserving B-cell function. The safety profile in wAIHA was consistent with its established profile in generalized myasthenia gravis (gMG), for which it was previously approved in April 2025 for patients 12 years and older who are acetylcholine receptor or muscle-specific kinase antibody positive.

Common adverse reactions (≥10%) in wAIHA patients included:

• Peripheral edema
• Diarrhea
• Fever (pyrexia)

Serious risks include infections and allergic reactions. Patients are advised to report symptoms such as fever, chills, or trouble breathing immediately.

Market Context

Warm autoimmune hemolytic anemia affects approximately 1-3 new people per 100,000 annually, with about 1 in 8,000 individuals living with the condition. Prior to this approval, treatment options were limited to corticosteroids and immunosuppressants, which suppress the entire immune system rather than targeting specific autoantibodies.

David M. Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head at Johnson & Johnson, stated that IMAAVY has the potential to redefine the management of wAIHA, particularly for patients with uncontrolled disease.

Stock Performance

JNJ shares were down 0.33% at $270.81 during premarket trading on Tuesday. The stock is approaching its 52-week high of $276.47.