MannKind NASDAQ: MNKD executives used the company’s first-quarter 2026 earnings call to highlight a strengthening collaboration with United Therapeutics, two near-term FDA decision dates, and continued investment in commercial infrastructure following the scPharmaceuticals acquisition.
United Therapeutics collaboration expands with ralinepag DPI
Chief Executive Officer Michael Castagna said MannKind 1501 has been “unveiled as ralinepag DPI,” a dry powder inhaler program optioned by United Therapeutics (UT) in August of last year. Castagna said MannKind recently received a $5 million payment to prioritize rapid development of the program and could receive up to $35 million in development milestones along with a 10% royalty on net sales. Castagna added the company expects about $15 million of those milestones to be earned over the next 12 months.
Castagna said the expanded collaboration is meaningful because it deepens MannKind’s partnership with UT, supports multiple potential pulmonary indications, and further validates MannKind’s Technosphere platform. He also noted the company has “confirmed MannKind as the sole manufacturer of Tyvaso DPI under a supply agreement that includes contractual minimums,” which management said provides a foundation as MannKind scales its Danbury, Connecticut manufacturing site for its own pipeline and for the planned FUROSCIX ReadyFlow build-out.
During Q&A, Castagna said he could not comment on ralinepag pharmacokinetics and deferred to UT’s modeling, but he said MannKind is “pretty confident we have a lead powder that can go forward into human trials and animals trials now.”
Q1 revenue growth, but management points to seasonal and operational headwinds
Castagna reported quarterly revenue of $90 million, up 15% from the prior year, reflecting the addition of FUROSCIX following the scPharmaceuticals acquisition. He described Q1 as challenging due to:
- Seasonality: annual deductible resets that typically reduce prescriptions and dosing compared with Q4.
- Transition in field teams: reorganization ahead of the expected launches of Afrezza Pediatrics and FUROSCIX ReadyFlow, which management said caused customer disruption.
- Inventory adjustments: steps to manage specialty pharmacy inventory ahead of a potential conversion from the current FUROSCIX on-body infuser to the ReadyFlow auto-injector.
Despite the softer top-line quarter, Castagna said underlying indicators improved as the quarter progressed. He said FUROSCIX reached a record number of prescribers in Q1 and that doses dispensed were up nearly 60% through April versus the same period last year.
FUROSCIX: Q1 sales and reaffirmed 2026 outlook ahead of ReadyFlow decision
Chief Financial Officer Christopher Prentiss reported FUROSCIX net sales of $15.5 million in Q1 2026, noting MannKind only includes post-acquisition results. He said demand metrics remained strong, including a record number of prescribers, with 75% categorized as repeat writers. Prentiss also said doses dispensed grew 64% year-over-year and the company’s integrated delivery network (IDN) business grew 97% year-over-year, which he attributed to early traction from the key account manager team.
MannKind reaffirmed its 2026 FUROSCIX revenue target of $110 million to $120 million. Castagna said the guidance is not dependent on ReadyFlow, describing the auto-injector as “a small portion of that range” and something that could help the brand reach the target “faster.” He also said MannKind did not have FUROSCIX samples this year due to inventory planning ahead of the auto-injector, and that the company is preparing to sample ReadyFlow to accelerate adoption.
The FUROSCIX ReadyFlow auto-injector PDUFA date is July 26. Castagna said that if approved, the device would reduce administration time “from 5 hours to just seconds,” potentially broadening prescriber adoption and lowering cost of goods. In response to an analyst question, he said the company does not expect an FDA advisory panel for ReadyFlow and described FDA information requests to date as not indicating a “showstopper.” He added that MannKind expects to launch in August if approval arrives in July, with “a little bit of impact in Q3, but a full impact in Q4.”
Castagna also discussed the pace of adoption and conversion, noting that because FUROSCIX is used acutely, the shift to the auto-injector could happen quickly, while some patients may continue using the on-body infuser.
Afrezza: FDA label update and preparations for pediatric launch
Management said the FDA approved an updated Afrezza label that provides clearer starting dose guidance, which Castagna called an enabler for the planned pediatric launch. MannKind has completed its launch build-out for Afrezza Pediatrics ahead of the May 29 PDUFA date.
Prentiss reported Afrezza global net sales of $15.3 million in Q1, up 3% year-over-year. He said marketing efforts have been shifted toward the anticipated pediatric Afrezza and ReadyFlow launches, and nephrology sales responsibility was transitioned to the legacy Afrezza sales team, creating near-term disruption that management expects to improve through 2026.
Castagna outlined launch strategy focused on a targeted set of academic centers, noting MannKind is prioritizing “roughly 60+” academic medical centers and deploying about 20 key account managers, supported by the broader Afrezza sales team. He said commercial or Medicaid patients would be able to access Afrezza for “$35 or less,” and that payer discussions suggest receptivity to expanding access for children and adolescents.
In Q&A, Castagna said the pediatric label expansion would use the same SKUs and therefore would not require adding new SKUs to existing contracts. He said the company is exploring how to reduce prior authorization friction for pediatric patients, with a particular focus on Medicaid access and the largest PBM commercial lives.
When asked how MannKind will gauge early success, Castagna said management will focus less on immediate revenue and more on metrics such as the number of pediatric prescribers and institutions trying Afrezza, repeat usage, and patient referrals into the company’s hub.
Tyvaso DPI economics, manufacturing minimums, and Q1 profitability
Prentiss said MannKind’s collaboration and services revenue, driven primarily by Tyvaso DPI manufacturing volumes sold through to UT plus deferred revenue recognition, was $23.5 million in Q1, down from $29.4 million in the prior-year quarter. He said this line can fluctuate based on production scheduling across Afrezza, development programs, and Tyvaso DPI, but noted that an amended Tyvaso DPI supply agreement signed earlier in the quarter established annual minimum quantities, which management said “effectively” fixes annual manufacturing revenue for Tyvaso DPI.
Prentiss reported royalty revenue of $32.7 million, up 9% year-over-year. He said royalty revenue in 2026 will support capital priorities including retirement of senior convertible notes, contingent value rights (CVR) obligations, and pipeline funding.
On the bottom line, MannKind posted a GAAP net loss of $16.6 million, or $0.05 per share, and a non-GAAP net loss of $6.9 million, or $0.02 per share. A year earlier, the company reported GAAP net income of $13.2 million and non-GAAP net income of $21.6 million. Prentiss attributed the year-over-year change to increased commercial investment for the potential launches, and to incremental costs from the scPharmaceuticals acquisition, including non-cash amortization of acquired intangibles.
Prentiss said R&D expenses increased due to MNKD-201’s phase I-B enrollment and preparations for phase II, and he expects R&D to remain at that level as the program advances, along with other pipeline efforts such as inhaled bumetanide (MNKD-701). SG&A also increased due to expanded commercial infrastructure and the full-quarter impact of the scPharmaceuticals commercial team.
He added that the company ended Q1 with “a solid liquidity position” after settling the remaining balance of its senior convertible notes and believes it has sufficient capital to support planned launches and pipeline advancement.
Looking ahead, Castagna emphasized a near-term cluster of catalysts: the Afrezza pediatric FDA decision, the FUROSCIX ReadyFlow PDUFA date, and expected MNKD-201 phase I-B top-line data in Q3, while the company initiates enrollment in a global phase II study. “We’ve never been busier here at MannKind,” he said, pointing to multiple expected updates in the coming months.
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.
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