MannKind (NASDAQ:MNKD) reported record fourth-quarter revenue and outlined key regulatory and clinical catalysts for 2026 during its Q4 and full-year 2025 earnings call held Feb. 26. Management emphasized that the company’s growth strategy is increasingly diversified beyond its United Therapeutics collaboration, while also highlighting continued cash flow expectations tied to Tyvaso DPI.
Management frames United Therapeutics relationship and cash flow outlook
Chief Executive Officer Michael Castagna opened by placing Tyvaso DPI in historical context, noting that Tyvaso was a “$450 million brand” when the partnership began in 2018 and that Tyvaso DPI grew to a “billion-dollar franchise” within 36 months of launch. Castagna said the success helped fund MannKind’s diversification efforts, including the acquisition and scaling of FUROSCIX, investment in Afrezza’s growth and pediatric development, and pipeline programs such as MNKD-201 (nintedanib DPI) in idiopathic pulmonary fibrosis (IPF).
Chief Financial Officer Chris Prentiss provided additional detail on the amended supply agreement with United Therapeutics, which now includes minimum annual quantities and volume-based pricing. Prentiss said Tyvaso DPI manufacturing revenues were about $100 million in 2025 and that the company expects the next two years to be generally in line with 2025, with the remainder of the contract term through 2031 providing “a revenue floor of approximately $50 million per year.”
Prentiss also discussed MannKind’s exposure to changes in Tyvaso DPI sales, noting that MannKind earns a “net 9%” royalty after a royalty sale transaction completed two years ago, which he said dampens the impact of Tyvaso DPI top-line variability relative to products MannKind commercializes directly.
Q4 and full-year 2025 financial results
MannKind reported total Q4 2025 revenue of $112 million, up 46% year-over-year. Castagna said the company delivered “record quarterly revenue” in the period. For the full year 2025, total revenue was $349 million, up 22% from the prior year.
Prentiss broke out fourth-quarter revenue categories, including contributions from the scPharmaceuticals acquisition, which closed Oct. 7 and brought FUROSCIX into MannKind’s cardiometabolic segment.
- FUROSCIX: $23 million of product sales in Q4.
- Afrezza: $23 million in Q4 sales, up 25% year-over-year, including $600,000 of product sold to Cipla to support an initial launch in India.
- V-Go: $4 million in Q4, a slight year-over-year decline; the company said it is not actively promoting the product.
- Collaboration and services: $28 million in Q4, up 5% year-over-year; $26 million was United Therapeutics-related.
- Royalty revenue: $34 million in Q4, up 24% year-over-year, reflecting Tyvaso DPI performance.
For the full year, Prentiss said royalty revenue rose 25% to $128 million. Afrezza global net sales grew 16% to about $75 million, and FUROSCIX, which MannKind only included after the Q4 acquisition close, was described as adding a high-growth stream; management also cited FUROSCIX brand growth of 93% year-over-year based on total annual revenues.
On profitability, MannKind reported a GAAP net loss of $15.9 million for Q4 and non-GAAP adjusted net income of $1.5 million. For full-year 2025, the company posted GAAP net income of $5.9 million and non-GAAP adjusted net income of $59.5 million. Prentiss said key adjustments included professional services tied to the scPharmaceuticals acquisition and non-cash amortization of acquired intangibles.
FUROSCIX growth, commercialization investments, and upcoming PDUFA
Castagna said FUROSCIX posted “an outstanding Q4,” with net sales of $23.3 million, up 91% year-over-year. For full-year 2025, FUROSCIX generated $70.4 million in net sales. He added that nephrology represented approximately 15% of FUROSCIX sales and that the company experienced minimal sales force turnover during acquisition integration.
Management outlined initiatives intended to accelerate FUROSCIX growth, including: expanding hospital “pull-through” via key account managers to integrate FUROSCIX into discharge protocols; refocusing the legacy team on cardiology and activating the endocrine team to cover nephrology; and increasing marketing spend ahead of a potential ReadyFlow Autoinjector launch. Castagna said these moves increased the sales rep footprint from about 80 to 160.
The company highlighted a PDUFA date of July 26 for the FUROSCIX ReadyFlow Autoinjector. Castagna said healthcare providers have indicated an autoinjector could expand the market due to convenience and ease of use, and that, if approved, it would deliver an “IV equivalent diuretic in under 10 seconds.” He also said the ReadyFlow could reduce cost of goods sold and free up cash for brand investment.
Prentiss told analysts the current on-body infusor has a slightly lower gross margin than Afrezza, and that MannKind could see a modest margin decline before an autoinjector launch, followed by improvement afterward. He also noted acquired intangible amortization flows through cost of goods sold as a non-cash item.
Afrezza performance, guidelines update, and pediatric catalyst
Afrezza generated $22.3 million in Q4 net U.S. sales, up 22% year-over-year, according to Castagna. For the full year, the company reported $74.6 million in global net sales, including what Castagna described as the first commercial shipment to Cipla for India.
Castagna said MannKind had previously managed Afrezza “for profitability” but is shifting to a “growth mindset” in 2026 as it prepares for a potential pediatric launch. He pointed to updated American Diabetes Association guidelines released in December that position inhaled insulin as an “equivalent option” to injectable insulins or automated delivery systems, and said this change creates a more level playing field for Afrezza.
He also referenced a recently approved FDA label change clarifying the starting bolus dose when switching from multiple daily injections or insulin pumps, citing dose-trial data showing a 58% reduction in postprandial glucose excursions at two hours with a higher Afrezza dose compared with the original label.
The company’s key near-term Afrezza regulatory milestone is a PDUFA date of May 29 for a pediatric indication. Castagna called the pediatric opportunity an “underappreciated catalyst,” arguing that, if approved, Afrezza would be the first needle-free mealtime insulin option for pediatric patients “in more than a century.” He shared market research findings, including that two out of three pediatric endocrinologists indicated they would likely prescribe Afrezza and that about one in four healthcare providers would consider it in newly diagnosed Type 1 patients. Castagna said the company estimates pediatric share potential of 23% to 37%, while noting that historically every 10% share represented about $150 million in net revenue opportunity.
MNKD-201 (nintedanib DPI) progresses toward Phase 2
Castagna highlighted MNKD-201, MannKind’s nintedanib dry powder inhaler program for IPF, calling it a major strategic priority with “blockbuster potential.” The company expects to enroll the first patient in a global Phase 2 study next quarter, while the U.S. Phase 1b study is enrolling with top-line data expected in the second half of 2026.
In Q&A, Castagna described the Phase 1 study as a two-part design with 12 patients per part, and said the company is focused on tolerability measures such as cough and lung function (including FEV1). He added that the Phase 1 effort was initiated in response to an FDA request from a prior meeting and may support potential future U.S. Phase 2 activity depending on FDA feedback.
Looking to 2026, Prentiss said MannKind expects to invest up to an additional $40 million in commercial resources and marketing to support potential Afrezza pediatric and FUROSCIX ReadyFlow launches, while noting the company can adjust the timing of investments based on performance.
About MannKind (NASDAQ:MNKD)
MannKind Corporation is a biopharmaceutical company specialized in the development and commercialization of inhaled therapeutic products. The company’s core business revolves around its proprietary Technosphere® drug‐delivery platform, which is designed to enable rapid absorption of small‐molecule drugs through pulmonary administration. MannKind’s lead product, Afrezza®, is an inhaled insulin therapy intended for adults with type 1 and type 2 diabetes, offering users a rapid‐acting alternative to traditional injectable insulins.
Afrezza received U.S.
