MannKind (MNKD) investor relations material

Key catalysts and strategic focus

• Three major catalysts: pediatric approval for Afrezza, FUROSCIX autoinjector launch, and positive phase I-B data for MNKD-201, with execution on these as the main focus for the next 12–24 months.

• ReadyFlow launch has generated strong early demand, with both existing and new prescribers showing interest, especially in cardiology and nephrology.

• Expansion into the IDN and hospital discharge market for ReadyFlow is underway, with operationalization and real-world evidence studies in progress.

• Afrezza's pediatric launch is concentrated in about 50 academic centers, leveraging prior clinical trial experience among prescribers.

• MNKD-201 phase II trial design has been updated, aiming for data by the first half of 2028, with a focus on tolerability and dose optimization.

Commercial execution and market expansion

• Early ReadyFlow adoption is driven by simplified device use, expanding the eligible patient base and attracting new prescribers.

• Real-world evidence for ReadyFlow is being generated to support broader adoption in hospital settings.

• Afrezza's pediatric market is highly concentrated, allowing targeted engagement and early positive feedback.

• A bridge program ensures initial access to Afrezza for pediatric patients, with a smooth transition to paid coverage.

• Revenue growth and trend lines for Afrezza and FUROSCIX are key metrics for evaluating commercial success in 2027.

Development pipeline and capital allocation

• MNKD-201 is positioned as a potential new backbone therapy for IPF, with a focus on tolerability and combination potential.

• The company is prepared to advance MNKD-201 independently, given the manageable development plan and commercial fit.

• Capital allocation prioritizes self-sustainability, with royalties supporting profitability, debt reduction, and business development.

• Flexibility in commercial strategy for Afrezza pediatric, including potential DTC efforts, is under consideration for future growth.

• Pipeline depth and ongoing R&D, both organic and inorganic, are seen as essential for long-term sustainability.