MannKind (MNKD) investor relations material

IPF pipeline and clinical outlook

• Inhaled nintedanib entered Phase II; INFLO-2 is enrolling ~140 patients across 12–13 countries and testing two doses.

• Across 60–70 healthy volunteers and IPF patients, dosing showed no diarrhea signal or cough-related discontinuations; efficacy remains the key question.

• Expects an efficacy-focused Phase III trial for a TYVASO DPI IPF label, with the FDA cautious about mechanism and lung deposition; potential PPF extrapolation remains a question.

• Combination therapy is a focus: the nintedanib trial allows JASCAYD, TYVASO nebulizer and pirfenidone; TETON-1 and TETON-2 showed greater benefit with TYVASO plus combination therapy than TYVASO monotherapy.

• GenRALD, an inhaled ralinepag program, could enter human testing by end-2026 and Phase II IPF testing late 2027.

Commercial performance and diversification

• Analyst cited Q2 revenue concentration of ~60% from United Therapeutics royalties and manufacturing, and Afrezza sales down 7% YoY; half of adult Afrezza sales-force effort shifted to nephrology.

• Afrezza pediatric market share surpassed adult share within 90 days of launch; management expects continued revenue diversification.

• FUROSCIX ReadyFlow launched late in the quarter; 90% of new prescriptions in its first three weeks were for the auto-injector, and Q4 is expected to be strong.

• The on-body infuser is expected to remain available for another year; plans to accelerate FUROSCIX growth into 2027.

• Following a United Therapeutics settlement, expects TYVASO DPI to return to accelerated growth; TYVASO DPI and FUROSCIX are both expected to grow next year.

Further pipeline and investment plans

• Inhaled bumetanide has FDA clearance to proceed, but investment and trial timing await market assessment; management sees ReadyFlow as addressing the current need.

• Last year’s scPharmaceuticals acquisition added heart-failure exposure; FUROSCIX ReadyFlow launched near quarter-end and the acquisition was described as meeting expectations and delivering cost savings.

• Current investments include two launches and the nintedanib Phase II trial; management said cash can fund innovation and growth, with profitability possible next year if prioritized and no need to raise funds.