MannKind Corp at RBC Capital Markets Global Healthcare Conference Transcript

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

Question: Greg Renza - RBC Capital Markets - Analyst : Yes, it's the first time, and a lot of virtual, but now is the time to get back to some degree of normalcy. And with that, for those of us who aren't familiar with MannKind, maybe, Mike, we can just start with having you give us a brief introduction to the Company. But also, I think particularly relevant is an announcement today on a deal that you and the team have conducted, so that maybe we could also hear a little bit about that and what you took in this morning.

Question: Greg Renza - RBC Capital Markets - Analyst : Yes.

Question: Greg Renza - RBC Capital Markets - Analyst : That's great. And when it comes to the V-Go deal, is this representative of what you're looking at? I know we've spent a lot of time and you've certainly commented on your approach to the market and the opportunities that could be available to you, given your infrastructure. And certainly, with, I think, your track record of really making those operational improvements that are necessary -- dare I say, even turning around areas of opportunity -- is that a sweet spot for you? Does this deal represent maybe a boilerplate for future?

Question: Greg Renza - RBC Capital Markets - Analyst : Yes. Makes sense. And certainly, as the development goes on in the background -- focus on Afrezza, now V-Go, we've got (inaudible). But really a key point to focus, I know there's limited perspective you can offer. But still we've got the FDA decision coming any day now and you've got your skin in the game. What is the current plan to ramp production to prep for a launch yet again, but upon a potential approval coming up or at least a decision that's coming up?

Question: Greg Renza - RBC Capital Markets - Analyst : Excellent. Excellent.

Question: Greg Renza - RBC Capital Markets - Analyst : Great. And then maybe taking a step back, if you could just remind us of the kind of fits and starts that have happened with the FDA interfaces, the reason for the CRL, and some of the PDUFA delays, and maybe, just weaving in your confidence level. You were mentioning Danbury, of course, around that, that manufacturing part of the application and really the safety profile to DPI.

Question: Greg Renza - RBC Capital Markets - Analyst : Sure.

Question: Greg Renza - RBC Capital Markets - Analyst : Sure.

Question: Greg Renza - RBC Capital Markets - Analyst : Sure.

Question: Greg Renza - RBC Capital Markets - Analyst : And you've commented on looking at the BREEZE, looking at the existing and looking back retrospectively -- or retroactively, even before your time -- and taking a comprehensive look. And your confidence level is maintained, if not increasing, about being able to navigate that. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 17, 2022 / 3:00PM, MNKD.OQ - MannKind Corp at RBC Capital Markets Global Healthcare Conference

Question: Greg Renza - RBC Capital Markets - Analyst : That's great. And just maybe from the collaboration and the milestone with United Therapeutics, what are some of those milestones, maybe laying those out on the financial side, and how to realize those and as we sort of think about the model and garnering that value?

Question: Greg Renza - RBC Capital Markets - Analyst : Okay. And then another (inaudible) influencing the market and at least the view of the out years is just the competitive landscape. What is your view on the potential competitors to Technosphere in the context of Tyvaso DPI, Afrezza, and even your pipeline opportunities?

Question: Greg Renza - RBC Capital Markets - Analyst : Sure.

Question: Greg Renza - RBC Capital Markets - Analyst : Yes.

Question: Greg Renza - RBC Capital Markets - Analyst : Sure.

Question: Greg Renza - RBC Capital Markets - Analyst : And how large do you think that peds market opportunity is for Afrezza?

Question: Greg Renza - RBC Capital Markets - Analyst : That's great. And let's stay with Afrezza, maybe just talking more about the more recent term. So, those initiatives to drive new Rx growth, how that's progressing, tracking, according to your expectations? Certainly some relook at how you're going to market, which was very logical in the last several months and into the new year, but maybe the latest update, Mike, from there.

Question: Greg Renza - RBC Capital Markets - Analyst : Great. And then just keeping with the market and expansion, certainly with peds and certainly the current go to market. What about geographically, just remind us on Afrezza ex-US?

Question: Greg Renza - RBC Capital Markets - Analyst : Fantastic. And then maybe just let me just circle back to Tyvaso and Tyvaso DPI. Helpful to hear about longer term with competitive forces, and now UT keep looking at the indication layering. But maybe when it comes to anticipating the manufacturing needs for DPI with respect to the shift dynamic from Tyvaso to Tyvaso DPI, how are you looking at that, anticipating that how that translates to your readiness, and then certainly, obviously, the revenue generation for the company?

Question: Greg Renza - RBC Capital Markets - Analyst : Right. And maybe why don't we close with just giving us an update on your cash position and the latest guidance on runway, and then maybe some of the specific points of focus even beyond the PDUFA that is near term.

Question: Greg Renza - RBC Capital Markets - Analyst : That's great. [We'll finally] leave it there. Looking forward to the decision (multiple speakers)