MannKind Corp Q4 2024 Earnings Call Transcript

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

Question: Olivia Brayer - Cantor Fitzgerald - Analyst : Hi. Good afternoon, guys. Thank you for the question and congrats on all the progress. Appreciate the updates on on all the pipeline programs there. Chris, can you talk a little bit about how we should be thinking about margins over the next few quarters? But also just the coming years, just given some of the investments you all plan to make in the FRSA business later this year, and then have a couple follow ups on Tyvaso.

Question: Olivia Brayer - Cantor Fitzgerald - Analyst : Okay, got it. And then on DPI, can you guys give any more granularity or put some numbers around the gross to net discounting and rebates that happened this quarter and whether that's the new norm going forward? And then also we are getting closer to those TETON readouts and IPF. So what's your base case right now in terms of when a DPI bridging study could actually happen and just what the next steps and and timelines might be for DPI and IPF?

Question: Olivia Brayer - Cantor Fitzgerald - Analyst : Okay, great. Thank you.

Question: Faisal Khurshid - Leerink Partners - Analyst : Hey guys, thanks for the question. Just want to ask, how are you thinking about sort of like the balance of, like defending operational profitability versus investment in the potential like pediatric launch for Afrezza?

Question: Faisal Khurshid - Leerink Partners - Analyst : Got it. Okay. And then how are you thinking about like potential pipeline expansion opportunities? Is that a priority? And where does that sit, kind of relative to these other goals, and also kind of like again, like cash ability?

Question: Faisal Khurshid - Leerink Partners - Analyst : Yes, sounds good. All right, cool, thanks for taking the questions.

Question: Anisha Nihalani - RBC - Analyst : Hi guys, it's Anisha for Greg. Congrats on the progress this quarter in through '24. And thanks for taking our questions. Just a couple from us on Afrezza. First, as you think about a potential launch in Peds, how are you thinking about the plotting of the launch trajectory and uptake? What hurdles do you anticipate along the way? And second, maybe just on the agreement with Cipla in India, how should we be thinking about the relative contribution to a Afrezza's topline over the next couple of years? Thanks so much.

Question: Anisha Nihalani - RBC - Analyst : Great. Thanks so much.

Question: Andreas Argyrides - Oppenheimer & Co. - Analyst : Good afternoon. And thanks for taking our questions and providing all these updates. Congrats also on a solid year. Just wanted to follow up on a question that was asked earlier, if you could just elaborate a little bit more on the contracting dynamics, whether this was a kind of a one-time change during the quarter and is there potential for a catch up in Q1. And then quickly, thinking about the updates that we're going to get on 201 later this year. You plan to meet with the FDA in the first half. What are some of the safety advocacy and points that you guys are considering? And what could a phase 1, sorry, I did a trial look like, off the phase 1, yeah?

Question: Andreas Argyrides - Oppenheimer & Co. - Analyst : Okay. Fantastic. Thanks for the update and looking forward to all the progress the remainder of the year. Appreciate it.

Question: Brandon Folkes - Rodman & Renshaw - Analyst : Hi. thanks for taking my questions. And congratulations on all the progress. Maybe just first up from me. If TETON is successful, how should we think about the potential for a manufacturing element there for Mannkind as well? What are you willing to kind of say at this stage? Is it on the table? Should we model just the royalty? How should we think about it in our models if we do see successful TETON data over the next few or 18 odd months?

Question: Brandon Folkes - Rodman & Renshaw - Analyst : Great. Thanks very much. And then maybe just a follow up for me on the $200 million-plus on a freezer, can you just talk about the timeline there? Is this just sort of -- should we just think about that being in line with the label updates that should come online, post INHALE-3 and INHALE-1? Thank you.

Question: Brandon Folkes - Rodman & Renshaw - Analyst : Great. Thank you very much.

Question: Yun Zhong - Wedbush Securities - Analyst : Hi, good afternoon. Thank you very much for taking your questions and congratulations on the progress. First question on Afrezza, you shared anecdotal feedback on pediatric use. And I was curious, have you heard anything from adult subjects in light of the INHALE-3 data. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 26, 2025 / 9:30PM, MNKD.OQ - Q4 2024 MannKind Corp Earnings Call And the second question on 101 interim analysis and assume we'll be blinded to the company, but is that interim analysis going to look at both co-primary endpoints? And in case you have to increase the study size, do you have any idea by how many patients you're going to increase? Thank you very much.

Question: Yun Zhong - Wedbush Securities - Analyst : Interim analysis 101, yes.

Question: Yun Zhong - Wedbush Securities - Analyst : Great, thank you.