MannKind (NASDAQ:MNKD) executives highlighted accelerating revenue growth, pipeline priorities, and commercialization plans during a discussion at Oppenheimer’s 36th Annual Healthcare Life Sciences Conference, held following the company’s fourth-quarter and full-year 2025 earnings release.
Oppenheimer Senior Biotech Analyst Andreas Argyrides noted that MannKind reported total revenue of nearly $350 million for 2025, representing 46% annual growth. Management also pointed to a framework in which 2026 revenue could climb above $450 million, citing multiple drivers including Afrezza’s pediatric expansion, potential approval of an auto-injector for FUROSCIX, and royalties from Tyvaso DPI.
MNKD-201 (nintedanib DPI) enters clinical execution
Castagna said the Phase 1 study is a two-cohort design in IPF patients and is intended to answer a key question for regulators and clinicians: whether a dry powder is safe and tolerable in the IPF population. He stated the company had four patients enrolled and 10 in screening at the time of the discussion, and expects to complete the first 12-person cohort within roughly 30 to 45 days. A second cohort will evaluate a higher dose regimen, which Castagna described as two cartridges twice a day.
He framed the commercial rationale around current oral nintedanib tolerability challenges, describing significant discontinuation rates and difficult side effects. Castagna said MannKind is optimistic that delivering nintedanib as a dry powder directly to the lungs could improve tolerability and potentially demonstrate an effect size “equal or better” than oral nintedanib, though he emphasized this is the “big question” that remains unknown.
For Phase 2, Castagna said the company expects to begin enrolling early in the second quarter, with initial activity occurring ex-U.S. while Phase 1 is U.S.-focused to address FDA questions. He added that MannKind has submitted the Phase 2 protocol to the FDA and would consider adding U.S. sites if the design is agreed. The Phase 2 trial is described as 12 weeks with a six-month rollover; management expects to look for early separation from placebo by week 12, based on prior industry data in the category. Castagna said MannKind is “fully funded” to complete Phase 2.
Afrezza: pediatric pathway, INHALE-1ST execution, and dosing options
On Afrezza, Castagna discussed the INHALE-1ST study as a build on the prior INHALE-1 trial. He characterized INHALE-1ST as focused on enabling newly diagnosed pediatric patients to receive inhaled insulin as their first post-discharge insulin, with the goal of avoiding long-term mealtime injections or pump use. Castagna said the company’s main focus is not efficacy concerns, but rather the logistics and protocol changes required in hospital systems for insulin-naïve pediatric patients, including titration, training, and workflow adjustments.
He also described the trial’s site rollout approach: the first two sites must enroll approximately 10 patients before expanding to additional sites. Castagna said the first two sites were progressing well and had enrolled “3 or 4” patients in the prior several weeks.
Regarding dosing, Castagna said investigators have provided feedback about the jump from 4-unit to 8-unit dosing and interest in a 2-unit cartridge to enable intermediate titration steps (such as 6 or 10 units). He said the 2-unit cartridge has not yet been studied in a “meaningful way,” and that the company is evaluating the concept in the context of the trial and may discuss options with the FDA if results support it.
Castagna also referenced new data the company plans to submit showing Afrezza’s glucose-lowering profile early after dosing, saying Afrezza achieves the majority of its glucose-lowering effect within the first 90 to 120 minutes, contrasting that with injectable insulin’s earlier effect profile. He tied these dynamics to a recent label change, which he described as aligned with modern mealtime control expectations in the CGM era.
PDUFA timing and market awareness in pediatric endocrinology
Castagna said the pediatric approval decision date (PDUFA) is May 29 and described ongoing FDA inquiries similar to those addressed during the recent label update, including dosing and hypoglycemia-related analyses. He said the company is aiming to meet the May 29 timeline and noted the timing is the week before the American Diabetes Association meeting, which would be “great” for launch planning.
He also said pediatric endocrinology awareness of Afrezza remains low, which he characterized as a positive in the sense that the product can be introduced as “brand new” to that audience, despite more than a decade of market history in adults. He pointed to two published lung safety studies and reiterated confidence in lung safety for adults and children. Castagna listed three factors he believes have limited broader Afrezza adoption historically:
- Share of voice
- Lung safety perceptions
- Managed care access
He said the company believes it can address lung safety perceptions with long-term data and managed care hurdles through cash-pay programs or improved prior authorization criteria, while “share of voice” remains a strategic investment decision. He added that MannKind has begun digital promotion and is collecting patient research to inform future patient activation efforts.
FUROSCIX: hospital protocols, nephrology opportunity, and auto-injector lifecycle plans
Turning to FUROSCIX, Castagna emphasized the cost burden of heart failure admissions and said a significant portion of hospitalizations occur to administer IV Lasix when oral diuretics fail. He argued that, historically, the hospital segment was not broadly aware FUROSCIX existed, and he described the hospital channel as a longer-term sell requiring protocol changes and engagement across quality, finance, and pharmacy functions.
Castagna said MannKind has invested in building that hospital effort, including hiring 10 key account managers and a team leader, with the possibility of adding more as the approach proves out. He also pointed to chronic kidney disease as another avenue, saying nephrologists are aggressive in treating fluid overload and represent “huge upside,” though they can be difficult to reach due to split time across dialysis centers and offices. He suggested early feedback has been positive and said he expects increased impact over the coming quarters, particularly in Q2 and Q3, with further hospital opportunity in the second half.
On the product lifecycle, Castagna contrasted the existing on-body infuser with the company’s interest in an auto-injector, saying the auto-injector could reduce training burden and fit more naturally into provider and caregiver workflows. He also said an auto-injector could improve stocking, storage, and shipping convenience, while MannKind continues evaluating which care settings (including hospitals and nursing homes) could benefit most.
Tyvaso DPI royalties and management’s view of recent stock volatility
The conversation also addressed investor reaction to an announcement related to United Therapeutics and the potential for a soft mist inhaler. Castagna described United Therapeutics as a “phenomenal partner” historically, while emphasizing that MannKind’s growth strategy is increasingly centered on assets it controls. He said the company has tried to communicate that, even under certain downside scenarios, it expects substantial cash flow over the next several years from Tyvaso-related royalties, and that the key question for investors is how MannKind deploys that cash flow into its own launches and pipeline.
Castagna said MannKind does not build internal models with significant dependency “beyond this year” on the Tyvaso opportunity, citing uncertainties such as pricing, discounts, and market dynamics outside the company’s control. He argued that near-term execution drivers for MannKind remain strong and suggested that some investors may have owned MannKind primarily as a hedge tied to United Therapeutics, contributing to recent stock moves. He reiterated that the company’s focus is to deliver on its stated plans, particularly around relaunching Afrezza for pediatrics, building FUROSCIX, and advancing MNKD-201.
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.
