Johnson & Johnson - JNJ STOCK NEWS

Johnson & Johnson (NYSE: JNJ) reported Q3 2024 results with sales growth of 5.2% to $22.5 billion. Operational growth was 6.3% and adjusted operational growth was 5.4%. Earnings per share (EPS) decreased by 34.3% to $1.11 due to a one-time special charge and acquired IPR&D. Adjusted EPS decreased by 9.0% to $2.42.

The company highlighted significant pipeline progress, including approvals for TREMFYA and RYBREVANT, and the submission of an IDE for the OTTAVA robotic system. JNJ increased its full-year 2024 operational sales guidance but updated its adjusted operational EPS guidance to reflect the acquisition of V-Wave.

Innovative Medicine worldwide operational sales grew 6.3%, driven by products like DARZALEX and TREMFYA. MedTech worldwide operational sales grew 6.4%, with growth in cardiovascular, vision, and general surgery products.

Johnson & Johnson (NYSE: JNJ) announces its participation in the Stifel 2024 Healthcare Conference on Monday, November 18th, at the Lotte New York Palace in New York. Michael Bodner, Group President of Heart Recovery & Circulatory Restoration, will represent the company in a session scheduled for 10:55 a.m. (Eastern Time).

The event will feature a live audio webcast accessible to investors and interested parties through the Johnson & Johnson website at www.investor.jnj.com. An audio replay will be available approximately 48 hours after the webcast concludes.

Johnson & Johnson (NYSE: JNJ) announced impressive results for TREMFYA® (guselkumab) in treating Crohn's disease (CD) and ulcerative colitis (UC). Key findings include:

1. TREMFYA® showed superior endoscopic remission rates compared to ustekinumab in CD patients and placebo in UC patients, for both biologic-naïve and biologic-refractory groups.

2. In CD, 44-46.1% of biologic-naïve patients achieved endoscopic remission with TREMFYA® vs 29.8% with ustekinumab.

3. In UC, 38.1-41.7% of biologic-naïve patients achieved endoscopic remission with TREMFYA® vs 20.4% with placebo.

4. TREMFYA® is now FDA-approved for UC and under review for CD in the U.S. and Europe.

These results suggest TREMFYA® could offer a differentiated treatment option for CD and UC patients, including those new to biologics and those who have failed prior therapies.

Johnson & Johnson (NYSE: JNJ) has successfully completed the acquisition of V-Wave , a privately-held company specializing in innovative heart failure treatments. V-Wave will operate under Johnson & Johnson MedTech, strengthening the company's position in cardiovascular disease management. The acquisition brings V-Wave's Ventura® Interatrial Shunt, a novel minimally invasive device, into JNJ's portfolio.

This strategic move aims to address heart failure, a critical unmet medical need, and accelerates JNJ's expansion into high-growth markets. It complements JNJ's existing platforms for coronary and peripheral artery diseases, heart recovery, and atrial fibrillation. The transaction, accounted for as an asset acquisition, will result in an in-process research and development charge of approximately $600 million in Q4 2024 and is expected to dilute adjusted EPS by $0.24 in 2024 and $0.06 in 2025.

Johnson & Johnson (NYSE: JNJ) has announced its participation in the Guggenheim Global Healthcare Conference on Tuesday, November 12th, at the InterContinental Boston. Biljana Naumovic, President of Solid Tumor, U.S. Oncology, and Mark Wildgust, Vice President of Global Medical Affairs Oncology, will represent the company in a session scheduled for 10:30 a.m. (Eastern Time).

A live audio webcast of the session will be available to investors and interested parties on the Johnson & Johnson website at www.investor.jnj.com. An audio replay will be accessible approximately 48 hours after the webcast. This event provides an opportunity for stakeholders to gain insights into JNJ's oncology initiatives and healthcare strategies.

Johnson & Johnson (NYSE: JNJ) announced results from a landmark real-world study showing ERLEADA® (apalutamide) provided a statistically significant overall survival benefit compared to enzalutamide in patients with metastatic castration-sensitive prostate cancer (mCSPC). The study, presented at the 6th European Congress of Oncology Pharmacy, analyzed nearly 4,000 patients and demonstrated:

- A 23% reduction in risk of death at 24 months for ERLEADA® initiators compared to enzalutamide initiators (HR 0.77; 95% CI, 0.62-0.96; P<0.019)

- 87.6% of ERLEADA® patients were alive at 24 months, consistent with the Phase 3 TITAN trial results

The study applied FDA real-world evidence guidance and employed robust methodology to ensure validity. This real-world evidence offers insights on overall survival that can inform prescribers when choosing an androgen receptor pathway inhibitor (ARPI) for mCSPC treatment.

Johnson & Johnson (NYSE:JNJ) has submitted a supplemental Biologics License Application (sBLA) to the FDA for a new indication of DARZALEX FASPRO® in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for newly diagnosed multiple myeloma patients ineligible for or deferring autologous stem cell transplant. The submission is based on the Phase 3 CEPHEUS study, which showed:

• 60.9% of patients achieved minimal residual disease (MRD)-negativity with D-VRd
• 43% reduction in risk of progression or death
• Overall MRD-negativity rate of 60.9% vs 39.4% for VRd alone
• Sustained MRD-negativity rate of 48.7% vs 26.3% for VRd
• Complete response rate of 81.2% vs 61.6% for VRd

The safety profile was consistent with known profiles for DARZALEX FASPRO® and VRd. This could potentially be the first FDA-approved treatment regimen for newly diagnosed multiple myeloma based on MRD-negativity as the primary endpoint.

Johnson & Johnson has expanded the rollout of its latest TECNIS Odyssey intraocular lens (IOL) in the U.S. This new full visual range IOL offers cataract patients precise vision at every distance in any lighting. Key features include:

- Exceptional distance vision and 14% smaller readable print size compared to PanOptix
- 93% of patients become glasses-free at all distances
- Higher tolerance to residual refractive errors
- Two-times better contrast in low lighting than PanOptix
- 93% of patients reported no or mild halos, glare, or starbursts one month after surgery

The TECNIS Odyssey IOL aims to provide continuous, uninterrupted vision at all distances, minimizing the need for glasses. It has already benefited over 14,000 eyes and has received regulatory approval in several countries.

Johnson & Johnson announced long-term results from the Phase 3 CARTITUDE-4 study, showing that CARVYKTI® (ciltacabtagene autoleucel) significantly extended overall survival in patients with relapsed or lenalidomide-refractory multiple myeloma. The study demonstrated a 45 percent reduction in risk of death with CARVYKTI® compared to standard therapies after three years of follow-up.

Key findings include:

• Median overall survival was not reached for both CARVYKTI® and standard therapies arms
• 30-month overall survival rates were 76% for CARVYKTI® vs 64% for standard therapies
• Median progression-free survival was not reached for CARVYKTI® vs 11.79 months for standard therapies
• CARVYKTI® showed higher complete response rates (77%) and overall response rates (85%) compared to standard therapies

The safety profile was consistent with previous analyses, with cytopenia being the most common grade 3/4 treatment-emergent adverse event in both arms.