MannKind Corp Q2 2024 Earnings Call Transcript

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

Question: Olivia Brayer - Cantor Fitzgerald & Co. - Analyst : Hey, good morning, guys. Thank you for the questions. How are you thinking about IP and just revenue runway for your two pipeline candidates? And can you just remind us how well protected your Technosphere technology is? And then on the 201 update that we'll get in the fourth quarter, can you give any more color on how many patients worth of data you expect to have and just how you're thinking about next steps once you do have those healthy volunteer data in hand?

Question: Olivia Brayer - Cantor Fitzgerald & Co. - Analyst : Yeah. Why don't we start with IP, Mike, and then I can follow up with 201.

Question: Olivia Brayer - Cantor Fitzgerald & Co. - Analyst : Okay, understood. And then, yeah, just second question was around 201, and the data that we get in 4Q, just any color on how many patients worth of data that you guys will have? And then obviously, just thoughts around next steps for that program going into 2025.

Question: Thomas Smith - Leerink Partners LLC - Analyst : Hey, guys. Good morning. Thanks for taking the questions. Just with respect to the ICoN-1 Phase 3 design, just wondering if you could comment on the powering assumptions for the six month primary endpoint and then for the interim analysis. It sounds like this is mostly a sample size re-estimation, but can you comment on whether there's any early stopping criteria built into this interim either for futility or superiority?

Question: Thomas Smith - Leerink Partners LLC - Analyst : Yes. Just asking about the power and assumptions on the six month end point, what you've assumed in terms of placebo response and treatment effect?

Question: Thomas Smith - Leerink Partners LLC - Analyst : Got it. That makes sense. And then just one on Afrezza. I was wondering if you could just comment on some of the feedback you've been hearing coming out of ADA with the INHALE-3 results, I guess, reception to the dataset and how you think about translating these data and INHALE-1 data to sales growth. Are these data sets you think could potentially impact 2025 prescribing? Or is that more of a longer-term dynamic? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 07, 2024 / 1:00PM, MNKD.OQ - Q2 2024 MannKind Corp Earnings Call

Question: Gregory Renza - RBC Capital Markets LLC - Analyst : Great. Good morning, Mike and Chris. Congrats on the -- on the quarter. Thanks for taking my question. Mike, maybe just keeping with 101, clofazimine inhalation, just curious as you and the team activate sites and stand up the trial, if you had any feedback, and maybe touch on how sort of the activation and the entrenchment of sites is shaping your confidence in the program and the value proposition that you see with 101?

Question: Gregory Renza - RBC Capital Markets LLC - Analyst : Got it. I think at the top of the call Mike you mentioned expanded access and maybe more to come. Just touch a little bit about that, maybe some of the timing, and some of the inputs there. Thanks and congrats again on the quarter.

Question: Brandon Folkes - Rodman & Renshaw LLC - Analyst : Maybe just two for me, Mike, I know you said you can't talk too much about the potential Phase 2/3 trial in 201, but would you be able to just talk about maybe if you're considering multiple dose levels there, and just elaborate on what is first prize for you in this program? Is it something that's comparable on efficacy with better GI side effects? Or would you prioritize, perhaps, sort of a potentially more efficacious drug here? And then secondly, just maybe on Tyvaso DPI, can you just talk about the manufacturing capacity where you're at today, what needs to be done if TETON is successful? And just how much investment does that take? Thank you.