MannKind — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenues for Q3 2026 reached $101.9 million, a 24% increase compared to $82.1 million in Q3 2025.
• Commercial product revenue totaled $45.0 million in Q3 2026, up 102% from Q3 2025.
• Afrezza generated $19.3 million in net sales for Q3 2026, a 5% increase year-over-year.
• Furoscix generated $22.4 million in net revenue for Q3 2026, with no prior year comparison as the product was acquired in October 2025.
• V-Go revenue was $3.3 million for Q3 2026, a 14% decrease from $3.8 million in Q3 2025.
• Collaborations and services revenue was $19.4 million for Q3 2026, down 27% from $26.5 million in Q3 2025.
• Royalty revenue was $37.5 million for Q3 2026, a 12% increase from $33.3 million in Q3 2025.
• For the nine months ended September 30, 2026, total revenues were $301.4 million, up 27% from $237.0 million in the prior year period.
• Cost of goods sold (commercial, excluding amortization) was $11.2 million for Q3 2026, up from $4.5 million in Q3 2025, primarily due to the inclusion of Furoscix which has a lower gross margin percentage than Afrezza.
• Research and development expenses were $14.4 million for Q3 2026, a 2% increase from $14.1 million in Q3 2025.
• Selling, general, and administrative expenses were $61.4 million for Q3 2026, a 111% increase from $29.1 million in Q3 2025, driven by Furoscix promotion and launch activities.
• GAAP net loss for Q3 2026 was $23.2 million ($0.07 per share), compared to net income of $8.0 million ($0.03 per share) in Q3 2025.
• Non-GAAP adjusted net loss for Q3 2026 was $3.6 million ($0.01 per share), compared to non-GAAP net income of $22.4 million ($0.07 per share) in Q3 2025.
• Cash, cash equivalents, and investments totaled $96.6 million as of September 30, 2026.
• Total liabilities were $759.9 million as of September 30, 2026, compared to $843.2 million as of December 31, 2025.
• Stockholders' deficit was $37.3 million as of September 30, 2026, improving from a deficit of $51.0 million as of December 31, 2025.

Guidance and Future Outlook:

• Management expects Furoscix to generate more revenue in the fourth quarter of 2026 than in the first half of the year.
• Anticipates earning $15 million in milestone payments from United Therapeutics in 2027 related to Ralinepag DPI.
• Confirms the global Phase 2 trial for nintedanib DPI (MNKD-201) is underway following positive Phase 1b results.

Business Segments and Product Lines:

• Furoscix: Shipments of the new Furoscix ReadyFlow device commenced in mid-September 2026; approximately 75% of weekly Furoscix shipments transitioned to ReadyFlow by late October. Achieved record monthly prescribers and prescriptions in September.
• Afrezza: Pediatric launch drove an approximately 80% increase in average monthly new-to-brand prescriptions in Q3 2026 compared to Q2 2026. Total prescriptions increased approximately 17% compared to Q2 2026. All 60 priority pediatric institutions have prescribed Afrezza, treating approximately 2,000 pediatric patients since launch.
• Nintedanib DPI (MNKD-201): Positive Phase 1b INFLO-1 results demonstrated tolerability and clinical validation of the Technosphere DPI technology in Idiopathic Pulmonary Fibrosis (IPF).
• Ralinepag DPI (MNKD-1501): Formulation work is complete; United Therapeutics plans to pursue clinical development.
• Inhaled GLP-1 Program: Entered into a licensing and collaboration agreement with Rose Pharma to develop an inhaled rapid-acting, short-duration GLP-1 for weight management.
• Acquisition Impact: Furoscix was added to the product portfolio following the October 2025 acquisition of scPharma.

Market and Competitive Landscape:

• Furoscix ReadyFlow is experiencing rapid adoption, accounting for approximately 75% of current weekly Furoscix shipments.
• Afrezza pediatric launch has achieved full coverage of all 60 priority pediatric institutions.
• Royalty revenue growth is driven by United Therapeutics' increase in net revenue from sales of Tyvaso DPI.

Risks and Challenges:

• Forward-looking statements involve risks including delays in clinical trials, safety complications, regulatory review processes, competition, manufacturing risks, and market adoption risks.
• Gross margin decreased in the current period due to the inclusion of Furoscix, which has a lower gross margin percentage than Afrezza.
• Selling, general, and administrative expenses increased significantly due to launch activities and field team expansion.

Management Commentary and Tone:

• CEO Michael Castagna described the third quarter as an "important transition" shifting from delivering on catalysts to executing against them.
• Management stated Furoscix ReadyFlow is "off to an exceptionally strong start" and reinforced conviction that Furoscix can be transformational for the company and patients.
• The tone indicates confidence in scaling two commercial launches (Furoscix and Afrezza pediatric) while supporting three IPF programs.

Other Key Points:

• Closed a $50 million private placement on July 24, 2026; proceeds funded the $45 million CVR payment triggered by the FDA approval of Furoscix ReadyFlow.
• The Company incurred a $45 million CVR payment to scPharma related to the Furoscix ReadyFlow FDA approval.
• The Company discontinued the ICoN-1 clinical study for MNKD-101.
• The Afrezza pediatric study has been completed.
• The Company reported a loss on settlement of debt of $0.9 million for the nine months ended September 30, 2026.
• The Company reported an impairment loss on available-for-sale investment of $6.4 million in Q3 2025, with no such loss in Q3 2026.