MannKind Corp Phase 3 INHALE-1 study of Afrezza Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Olivia Brayer - Cantor Fitzgerald & Co. - Analyst : Hi, good morning. Thank you for the questions. Is there anything more you can tell us about that one patient who is excluded from the modified analysis and what their A1c levels were at baseline and at 26 weeks? And then on safety, how many patients have actually hit that 12-month safety mark? And how many will actually have 12 months' worth of safety data by the first half of 2025? And then I've got one follow-up.

Question: Olivia Brayer - Cantor Fitzgerald & Co. - Analyst : Okay. Understood. And then, Mike, can you frame the growth opportunity a bit more? I think you all have previously talked about being able to realize around $150 million in sales for every 10% of the market. Is that still how you're thinking about Afrezza's potential in peds? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.

Question: Olivia Brayer - Cantor Fitzgerald & Co. - Analyst : Great. Thank you both.

Question: Faisal Khurshid - Leerink Partners - Analyst : Hey, good morning guys. Congrats on the update. Question on how should we think about the potential commercial strategy in a pediatric indication? And also, how should investors think about the level of incremental investment needed to unlock that opportunity?

Question: Faisal Khurshid - Leerink Partners - Analyst : Got it. That's helpful. And then could you describe a little bit more of this promotional agreement you guys announced and sort of what that means overall to the strategy?

Question: Faisal Khurshid - Leerink Partners - Analyst : That's fine. Thanks and congratulations. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.

Question: Brandon Folkes - Rodman & Renshaw - Analyst : Hi, thanks for taking my questions.Congrats on the results. Maybe just following on from an earlier question. Just if you do get the INHALE-3 data in the label, how do we think about the rollout of a new promotion efforts and focus with perhaps the pediatric approval coming not too long after that INHALE-3 label expansion, especially if it's sort of the longer 10-month review? How should we think about where there's perhaps greater potential to then than a further curve early on between in INHALE-3 and one and maybe where we would see the focus? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.

Question: Brandon Folkes - Rodman & Renshaw - Analyst : Thanks. And one more if I may. Can you just help us think about perhaps the prescribing hierarchy in practice here for the pediatrics? And what I mean by that is what do you think is going to drive initial conversion? Is it going to be just route of administration? Obviously, we've seen good safety or could some physicians look at sort of incremental A1c control? Just how do we think about sort of what are going to be the fast movers, and then maybe sort of what portions are going to maybe take a little bit longer?

Question: Brandon Folkes - Rodman & Renshaw - Analyst : Great. Thanks for taking my questions and congrats on the results.

Question: Oren Livnat - H.C. Wainwright - Analyst : Hey guys. Thanks for taking my questions. Actually I have several if you'll accommodate me. But just to start, can you just give us a little more context on in this study, in particular, on average, how long are these patients already on multiple daily injections? How stable are they going into the study? And how long do they have to train on Afrezza before going into the observation period? I guess you sort of touched on that issue in the real world just now. And I'm essentially trying to gauge if Afrezza was almost disadvantaged even in this study versus MDIs. And also, you mentioned earlier that some patients didn't do well on this when talking about parental feedback. So I'm actually just curious, you gave us an average non-inferiority result. But can you talk a little bit more about whether some patients did much better on inhalable potentially on A1c even if the average came out the same? And then I have a follow-up.

Question: Oren Livnat - H.C. Wainwright - Analyst : Okay. And as we think about the patients in general, you mentioned that these were maybe less well controlled than your typical study. I'm just curious how pediatric patients tend to do in general over 6 months just based on real-world epidemiological experience? Would we expect this population to generally be stable like we saw in MDI in the real world? Or do they tend to actually get worse and maybe what we saw here with flat A1c in the control arm is probably better than what you'd expect in the real world? And then I have one last follow-up, sorry.

Question: Oren Livnat - H.C. Wainwright - Analyst : Okay. And just lastly -- sorry, I appreciate it. The 6-month extension phase, can you just remind us what you would even hope or expect to see there, given your prior experience of running trials where control arms than switching over? And what portion of patients did switch over -- both from the MDI group or carryover from Afrezza? I'm just curious how important is this data beyond just a formal label expansion on the population, but how important might this data be that you'll presumably publish later to drive commercial uptake?

Question: Oren Livnat - H.C. Wainwright - Analyst : Got it. Thanks so much. I look forward to talking later.