MannKind NASDAQ: MNKD reported second-quarter revenue of $109.4 million, up 43% from the prior-year period, as growth in its commercial products and collaboration revenue helped offset increased spending tied to product launches and development programs.
The company recorded a GAAP net loss of $19 million for the quarter, compared with net income of $700,000 a year earlier. Non-GAAP net loss was $2.7 million, versus non-GAAP net income of $13.9 million in the second quarter of 2025. Chief Financial Officer Chris Prentiss said the year-over-year change reflected planned investments in FUROSCIX, the pediatric launch of Afrezza, development of MNKD-201, and costs associated with MannKind’s scPharma acquisition.
Commercial products drive revenue mix shift
Chief Executive Officer Michael Castagna said MannKind’s three major 2026 catalysts had all been achieved: pediatric approval for Afrezza, FDA approval for the FUROSCIX ReadyFlow autoinjector, and positive Phase 1b data for inhaled nintedanib in idiopathic pulmonary fibrosis, or IPF.
Afrezza generated $17 million in net sales during the quarter. FUROSCIX generated $22.2 million in net sales, rising 43% from the first quarter, supported by a 49% increase in units sold. Prentiss said higher gross-to-net adjustments, which reached 29% during the quarter, partially offset the increase in units.
Castagna said marketed-product revenue grew 27% sequentially from the first quarter, while royalties declined 1% over the same period. Excluding collaboration and service revenue, marketed products grew 111% year over year, he said. MannKind’s two commercial products also exceeded royalty revenue as a portion of its underlying revenue mix during the quarter.
Royalty revenue from United Therapeutics rose 4% year over year to $32.4 million. Collaboration and services revenue increased 53% to $35 million, primarily due to greater volumes of products sold through to United Therapeutics. MannKind also recognized $4.9 million in ralinepag DPI development milestone revenue.
Prentiss said manufacturing-related collaboration revenue can fluctuate with production schedules at MannKind’s Danbury facility. Based on current plans, he expects the second quarter to be the company’s highest quarter for manufacturing-related revenue, while full-year revenue should remain in line with the prior year.
Afrezza pediatric launch gains early traction
Afrezza received pediatric approval on May 29, meaning the second quarter contained a limited period of launch activity. Castagna said all 20 of MannKind’s priority pediatric accounts had written at least one prescription, while one-third of the top 100 pediatric rapid-acting insulin prescribers had prescribed the product.
The company has emphasized the pediatric diabetes market as a more concentrated and institutionally based opportunity than the adult market. Castagna said approximately 1,000 pediatric prescribers account for 80% of prescriptions in the segment, compared with roughly 60,000 adult prescribers accounting for 80% of rapid-acting insulin prescriptions.
He also pointed to support from caregivers, diabetes educators, school nurses, advocacy organizations and social-media communities, as well as more than a decade of Afrezza safety data and recent clinical evidence. MannKind said its $35 access program is intended to reduce barriers to starting treatment.
Castagna said more than half of pediatric prescriptions were being filled through cash-pay channels, with the remainder fully paid. The company is pursuing prior authorizations, appeals and payer discussions, and expects its cash-pay program to run through the end of 2026. He said pediatric approval rates have been consistent with adult approval rates.
Early prescription activity has included refills and repeat prescribers, according to management. Castagna said more than 30% of customers had written three or more prescriptions based on the company’s available data, though he cautioned that it remains early to assess refill trends. He added that MannKind had seen roughly 450 new prescribers since launch, including about 200 pediatric and 250 adult prescribers.
Looking ahead, MannKind expects to introduce a 2-unit Afrezza cartridge in 2027 and is targeting a Bluetooth-connected InhaleIQ device integrated with continuous glucose monitoring. The company also expects higher-concentration Afrezza formulations around 2028, which Castagna said could support larger doses with lower powder loads.
FUROSCIX ReadyFlow launch planned for August
MannKind’s FUROSCIX ReadyFlow autoinjector was recently approved by the FDA and is expected to become available later this month. Castagna described ReadyFlow as the only IV-equivalent diuretic delivered through an autoinjector and said the product could support earlier treatment of fluid overload, post-hospital discharge protocols and efforts to reduce readmissions.
The product will initially be made available to key institutions and community prescribers. MannKind expects its field teams to complete ReadyFlow training during the week of Aug. 10, with promotion beginning the following week and product shipments occurring in August.
Castagna said FUROSCIX growth during the quarter included a 36% increase in institutional delivery network engagement and a 67% sequential increase in nephrology sales. MannKind separated cardiology and nephrology sales-force efforts earlier this year, a move that management said caused some disruption in the first quarter but began contributing to growth in the second quarter.
Prentiss said the transition from the on-body infuser to ReadyFlow is expected to improve FUROSCIX margins by about 70%. He said the company anticipates that ReadyFlow will account for a large majority of FUROSCIX volume in 2027. The on-body product could also face tariff effects in future periods, he said.
MannKind maintained its $110 million to $120 million annual FUROSCIX revenue outlook. Castagna said second-half demand historically exceeds first-half demand, in part because patient out-of-pocket costs tend to decline later in the year as Medicare coverage dynamics change. He added that inventory movements between ReadyFlow and the on-body infuser could affect quarterly revenue timing in the second half.
Nintedanib DPI advances into Phase 2
MannKind also highlighted positive Phase 1b findings for its inhaled nintedanib DPI program in patients with IPF. The company said the seven-day, multiple-ascending-dose study showed no serious adverse events, no bronchospasms, and no discontinuations or dose reductions related to safety or tolerability.
Cough occurred in approximately 39% of participants, though Castagna said 60% experienced no cough after inhalation and about 30% reported mild cough. No patients discontinued treatment due to cough, according to the company.
The first patient has been dosed in MannKind’s Phase 2 study, and the company expects to activate sites globally throughout 2026. Management has submitted the Phase 2 protocol to the FDA for potential U.S. sites and expects feedback in the fall. Castagna said the eventual registrational path, including the number of required trials and potential expansion into related pulmonary conditions, remains to be determined with the FDA.
At quarter-end, MannKind announced a $50 million private investment in public equity financing, giving it a pro forma cash position of $161 million. The company expects to pay a $45 million contingent value right in the third quarter associated primarily with ReadyFlow approval, with approximately $16 million of expense recorded during the quarter.
About MannKind (NASDAQ:MNKD)
MannKind Corporation, a biopharmaceutical company, focuses on the development and commercialization of inhaled therapeutic products for endocrine and orphan lung diseases in the United States. It offers Afrezza, an inhaled insulin used to improve glycemic control in adults with diabetes, and the V-Go wearable insulin delivery device, which provides continuous subcutaneous infusion of insulin in adults. The company's product pipeline also includes Tyvaso DPI (Treprostinil), an inhalation powder for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease; MNKD-101, a nebulized formulation of clofazimine, for the treatment of severe chronic and recurrent pulmonary infections, including nontuberculous mycobacterial lung disease; MNKD-201, a dry-powder formulation of nintedanib, for the treatment of idiopathic pulmonary fibrosis (IPF).
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