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MannKind (MNKD) investor relations material
MannKind Morgan Stanley 23rd Annual Global Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Morgan Stanley 23rd Annual Global Healthcare Conference summary10 Sep, 2025
Strategic transformation and recent developments
Diversification beyond diabetes with late-stage programs in cofazamine and nintedanib, and a strong partnership with United Therapeutics for Tyvaso DPI.
Major acquisition of SC Pharmaceuticals to accelerate growth and expand into heart failure and chronic kidney disease markets.
Announced new partnership with United Therapeutics and preparing for a relaunch of Afrezza with a label change and pediatric focus.
Multiple catalysts expected over the next 18 months, including regulatory milestones, product launches, and clinical trial readouts.
Key growth drivers and upcoming milestones
October label change for Afrezza to address dosing issues, with a pediatric file expected to be accepted soon.
SC Pharmaceuticals acquisition expected to close in Q4, with integration aimed at leveraging sales forces and maximizing value in overlapping metabolic and cardiovascular markets.
Anticipated pediatric approval and autoinjector launch in 2025, with interim cofazamine data and continued Tyvaso DPI progress.
Revenue inflection expected as new products and indications come to market, with financial guidance indicating $110–$120 million run rate plus pipeline contributions by 2026.
Clinical pipeline and regulatory strategy
TEPTEN-2 data for Tyvaso DPI in IPF exceeded expectations, supporting confidence in United Therapeutics' commitment and future royalty growth.
Inhaled nintedanib phase 2 trial launching with top-line data expected in H1 2027; design includes multiple dosing regimens and aims to address GI side effects seen with oral therapy.
Regulatory strategy involves adapting to FDA feedback and pursuing ex-US trial designs to expedite development, with plans to return for phase 3 approval.
What are key value drivers for SC Pharma acquisition?
What is the strategy for Afrezza's pediatric launch?
How will clofazimine differentiate from ARIKAYCE?
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Q3 20256 Nov, 2025
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Frequently asked questions
MannKind Corporation is a biopharmaceutical company focused on the development and commercialization of therapeutic products for patients with diabetes and pulmonary diseases. The company’s flagship product is an inhalable insulin used to manage blood sugar levels in adults with diabetes. MannKind is also exploring its proprietary Technosphere platform for the delivery of other therapeutic agents via inhalation, aiming to improve treatment options for various chronic conditions. The company is headquartered in Danbury, Connecticut, and its shares are listed on the NASDAQ.
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