MannKind (MNKD) Q2 FY26 earnings call: guidance and Q&A

What proportion of pediatric Afrezza scripts are coming through the cash program, and when are these patients expected to convert to standard channels?

A good portion of dispensed scripts are fully paid, with about half going through as cash. It's too early to tell the conversion rate, but the company is pursuing prior authorizations and appeals. The cash program will run through the end of 2026, with hopes of working through payer coverage by then. Pediatric approval rates are consistent with adult rates.

“more than half grown through is cash, but that we expect many of those to convert to paid.”

asked by Ben Burnett · answered by Michael Castagna

What is the regulatory path for the IPF program, what feedback has been received from the FDA, and is PPF being considered for the long-term portfolio?

The company met with the FDA last year and submitted the Phase II protocol for US sites. The underlying assumption is that one pivotal trial for IPF will be required, with potential for additional data in other target populations like PPF or ILD. The FDA's stance on indication extrapolation is still evolving, and the effect size from Phase II will be key. PPF and ILD are being considered, but the focus is on establishing dosing in Phase II for IPF first.

“I think you've seen the FDA kind of indicate probably one trial is probably all will be required in addition to the Phase II, and that's our underlying assumption.”

asked by Olivia Brayley · answered by Michael Castagna

What is the pace of script trends for pediatric Afrezza, and how is the mix of adult and pediatric scripts expected to trend in the future?

Initial weeks saw a bolus of patients, followed by consistent, steady referral patterns, with momentum building in the last two weeks and new peaks being hit weekly. The company is adding 1,000 pediatric targets for its reps. For adults, resources were pulled back, leading to some softness, but the adult business appears to have hit a nadir in Q2/Q3, with new patients growing 30% over June. The pediatric response is expected to continue building momentum, and the adult segment is expected to grow with pediatrics.

“I think we had our highest week 1.5 weeks ago of the last 8 weeks. So it is growing, and we are hitting new peaks every week, and that's exciting.”

asked by Unknown Analyst · answered by Michael Castagna

For Afrezza, how much of the 23-37% peak share range assumes conversion from pumps/pods versus MDI patients? For nintedanib DPI, what is the shortest credible route to approval, and does it require FVC benefit or non-inferiority?

For Afrezza, roughly half of patients are expected to come from MDI, 20-30% from pumps (or added to pumps), and 15-20% from insulin-naive patients. Early data supports this breakdown. For nintedanib DPI, the initial goal was a biosimilar-like pathway (non-inferiority with indication extrapolation), but Phase II data is needed to show effect size. An add-on design trial with placebo is likely preferred by the FDA, especially with the success of other therapies like Jascayd making add-on patients more available.

“we would expect roughly half our patients to come from MDI, and maybe 20%, 30% to come off pumps or added to pumps and then the remaining 15%, 20% be insulin-naive patients.”

asked by Anish Nikhanj · answered by Michael Castagna

Any color on pediatric Afrezza refills and repeat prescriptions? Is the titration/dosing data resonating with prescribers, or is there a learning curve similar to the adult launch?

Refills are already being seen in month 2, which is a good sign, but it's too early for full data. Over 30% of customers have written three or more scripts. The company applied lessons from the adult launch to address perceived objections. Cost is not seen as a barrier ($35), and lung safety/testing are being worked through. The new label and dose conversion data are giving prescribers confidence to start and titrate, which should reduce dropouts.

“Over 30% of our customers have written three or more scripts from what we can see.”

asked by Brandon Folkes · answered by Michael Castagna

For Afrezza, why have the other 2/3 of top pediatric insulin writers not prescribed yet? For ReadyFlow, why the 3-week delay after FDA approval?

For Afrezza, the other 2/3 of top writers are likely due to summer vacations, academic institution access, and scheduled in-services in August/September. There are no major objections, and prescribers are engaged in learning how to use the product. For ReadyFlow, the delay is due to outsourced supply chain logistics, including labeling, packaging, and fitting into provider queues. The product is manufactured, and inventory is expected to ship in August.

“There's nothing specific that I would sit here and say today other than time of why the other 2/3 have not written. There's no major objections happening, and I think that's what's most important.”

asked by Yun Zhong · answered by Michael Castagna

When will additional Afrezza doses (upper end) be available, and what will be the mix and gross margin contribution? How will ReadyFlow's transition from on-body infusor impact product gross margin in 2027?

High-dose Afrezza work will take 12-18 months for approval. The 2-unit cartridge work is done and submitted to FDA, expected in 2027, which is more important in the short term. Gross margin change between doses is not expected to be significant, but smaller doses will help international markets. For Furoscix, the margin increases by about 70% with the transition from OBI to ReadyFlow, which will significantly help in 2027, especially as OBI is impacted by tariffs.

“the margin increases by about 70% when we think about the transition from OBI to the ReadyFlow.”

asked by Anthony Petrone · answered by Michael Castagna

Given $38 million in H1, how will the $110-120 million FY guidance be achieved, implying a doubling in H2, especially with the ReadyFlow launch in late August?

The H2 ramp is consistent with historical trends (2/3 of units in H2) due to patient affordability and co-pay dynamics (donut hole). The $38 million in H1 represents roughly 35% of the expected full-year range, which is good given headwinds. The main factor influencing the range will be inventory shifts between the autoinjector and on-body infusor and how fast the conversion happens.

“if you look at 2025, 1/3 of the units came in the first half and 2/3 of the units came into the second half of last year. I think that trend is probably what we expect...”

asked by Douglas Miehm · answered by Michael Castagna