United Therapeutics (UTHR) Morgan Stanley 23rd Annual Global Healthcare Conference summary

Clinical trial and regulatory updates

• TETON-2 clinical trial delivered the most successful IPF pivotal results to date, with nebulized TYVASO showing significant FVC improvement over placebo at week 52 (p<0.0001).

• Statistically significant improvements were observed in most secondary endpoints, with positive trends in others.

• Orphan designation for nebulized TYVASO in IPF is secured with both FDA and EMA, providing a long competitive runway.

• TETON-1 results are expected in the first half of next year, with plans to expedite regulatory filings after data readout.

• Ongoing dialogue with the FDA aims to explore accelerated review pathways, including the STAR pilot program.

Commercial strategy and market opportunity

• IPF represents a multibillion-dollar market with an estimated 100,000 U.S. patients, and potential for higher prevalence.

• Plans are underway to establish a dedicated IPF/ILD Salesforce, potentially doubling the current ILD team.

• Treatment duration for IPF is expected to be similar to PAH and ILD, pending further data.

• No revenue guidance will be provided for 2025 or 2026, but double-digit revenue growth is expected.

Capital allocation and business development

• A $1 billion share repurchase program was initiated in August, reflecting confidence in business strength and share price.

• Capital allocation priorities remain internal R&D, corporate development, and returning cash to shareholders.

• No urgent need to acquire new assets; focus remains on rare lung disease, cardiopulmonary, and oncology opportunities.