Johnson & Johnson (JNJ) investor relations material

Icotrokinra development and launch plans

• Icotrokinra is a first-in-class targeted oral peptide for IL-23, showing transformative efficacy and safety in psoriasis, with robust phase 3 data in adults and adolescents, and special area studies.

• Head-to-head studies demonstrate superiority over leading oral and biologic therapies, with a US regulatory submission in July and a confident 2026 launch target.

• Development is expanding into Crohn's and colitis, with pivotal studies launched and momentum continuing.

• Manufacturing capabilities are well established to meet anticipated global demand for both psoriasis and IBD launches.

• Market opportunity is seen as underappreciated, with 5 million eligible US patients not on biologics and consensus estimates viewed as too low.

Market impact and patient insights

• Introduction of Icotrokinra is expected to expand the market by reducing trade-offs between efficacy, safety, and convenience, leading to broader adoption.

• Encompass study revealed a strong patient preference for oral therapies, with over 90% of injectable users willing to switch if efficacy and safety are maintained.

• Food effect for Icotrokinra is minimal, requiring only a 30-minute wait before eating, with no significant impact on adherence or efficacy in trials.

• Commercial strategies will leverage broad immunology experience and community connections to address unmet needs and ensure a successful launch.

Tremfya performance and expansion

• Tremfya continues to grow in psoriasis and psoriatic arthritis, driven by durable skin clearance, robust safety, and unique inhibition of structural damage.

• Over 50% of new ulcerative colitis starts in the IL-23 class are with Tremfya, with rapid adoption in Crohn's Disease due to subcutaneous induction options.

• Head-to-head studies against Stelara and Skyrizi focus on demonstrating tissue-level remission, with commercial significance tied to showing superiority.