MannKind Closes 2026 Catalysts With Two FDA Approvals

The Tip Desk · August 6, 2026 · 3 min read

Second-quarter revenue reached $109.4 million as Furoscix net sales hit $22.2 million and the company booked a $19.0 million GAAP loss.

MannKind Corporation (MNKD), a biopharmaceutical company focused on cardiometabolic and orphan lung diseases, said it delivered the three catalysts it had set for 2026: FDA approval of a pediatric indication for Afrezza, approval of the Furoscix ReadyFlow autoinjector, and positive Phase 1b data for nintedanib DPI in idiopathic pulmonary fibrosis.

Second-quarter total revenues were $109.4 million, up 43% from a year earlier. Sequential growth had been slower: first-quarter revenue was $90.2 million, up 15% from the year-ago period. The year-over-year increase reflected the October 2025 addition of Furoscix through the scPharma acquisition, higher collaborations and services revenue, and royalties.

Revenue from marketed products, Afrezza and Furoscix, grew 27% from the first quarter to the second. Furoscix net sales were $22.2 million. Doses purchased in integrated delivery networks increased 36% over the first quarter, and nephrology units dispensed increased 67%. On July 23, the FDA approved Furoscix ReadyFlow, the first and only autoinjector delivering IV-equivalent diuretic therapy for edema in adults with heart failure or chronic kidney disease. Commercial availability is expected in late August.

Afrezza net sales were $17.0 million, down 7% from $18.3 million a year earlier. On May 29, the FDA approved Afrezza for children and adolescents ages 6 and older with diabetes. One in three of the top 100 pediatric insulin writers had prescribed the product. The company also received a Breakthrough T1D grant supporting INHALE-1ST, a pediatric trial in youth with newly diagnosed type 1 diabetes.

Collaborations and services revenue was $35.0 million, up 53% from $22.8 million a year earlier, after a 20% year-over-year decline in the first quarter. The increase was primarily attributable to product sold to United Therapeutics and revenue related to ralinepag DPI development. Royalties were $32.4 million, up 4% from a year earlier. V-Go revenue was $2.8 million.

Commercial product sales were $42.0 million. Cost of goods sold for commercial products, excluding amortization of acquired intangible assets, was $14.4 million. Gross margin percentage decreased because Furoscix has a lower gross margin percentage than Afrezza. Research and development expenses were $18.0 million, up 32% from $13.7 million a year earlier, primarily due to Furoscix ReadyFlow formulation development, higher personnel costs after the scPharma acquisition, and increased MNKD-201 development costs. Selling, general and administrative expenses were $58.3 million, up 84% from $31.6 million a year earlier, due to promotion of Furoscix and expanded field teams for the Afrezza pediatric and ReadyFlow launches.

GAAP net loss was $19.0 million, or $0.06 a share, versus net income of $0.7 million, or $0.00 a share, a year earlier. Non-GAAP adjusted net loss was $2.7 million, or $0.01 a share. Interest expense was $11.9 million.

Cash, cash equivalents and investments totaled $111 million as of June 30, down from $134 million at March 31. On July 24, the company closed a $50 million private placement; proceeds will fund a $45 million CVR payment triggered by FDA approval of Furoscix ReadyFlow. A $5 million payment from United Therapeutics supported ralinepag DPI, which is on track for an IND filing by year end.

Topline U.S. Phase 1b INFLO-1 data for nintedanib DPI (MNKD-201) demonstrated safety and tolerability in IPF patients. Site activation and enrollment are underway in the global Phase 2 INFLO-2 study. Chief Executive Officer Michael Castagna said the two recent FDA approvals are expected to fuel near-term growth opportunities and that the INFLO-1 results reduce development risk for MNKD-201.