Mannkind Corporation H.C. Wainwright 28th Annual Global Investment Conference
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Good morning, everyone. Thank you very much for joining us at the H.C. Wainwright Global Investment Conference. My name is Brandon Folkes. I am one of the equity research analysts here at H.C. Wainwright. Next up, we have a fireside chat with MannKind, and joining me from MannKind is CFO, Chris Prentiss. Chris, thank you very much.
Brandon, thanks so much for having us.
No worries. All right. MannKind has evolved pretty significantly over the last five years, but I would say exponentially over the last 12 months as well. With the three very significant catalysts in 2026, can you just talk about where MannKind is today and then where MannKind is going over the next 24 months?
Yeah. Just to remind everybody, our three catalysts as we came into this year is, one, we have had an approval with Afrezza for many years now. It was approved in 2014, and after many years of working through a development program, we just got approval in the pediatric indications. So Afrezza is now available for those who are six and older. The second was last year, we acquired scPharmaceuticals and with that the product FUROSCIX that has an on-body infuser, and we just got approval in an autoinjector form factor, and happy to say that that is now starting to be dispensed to patients beginning this week. So that is very exciting. The third was related to our MNKD-201 program, which is an IPF, and so we just released phase I-B data over the last few weeks.
We were very encouraged by that data, and now we're moving into phase II. Those were the three big catalysts that set up this year. 2026 was a huge investment year for us. As we think about the next 12 and 24 months, it's really executing on those three prongs. It really is about generating net sales in Afrezza overall, on FUROSCIX, and I think people really want to see what are those run rates, what is that going to look like, what's the peak potential for those brands, which are all very fair questions. Then third is on our development program side, continuing to expand there. What do those timelines look like? When are we going to be able to generate the next phase II data?
Fantastic. I'm going to start on FUROSCIX, because it's a very interesting product. I think it's a very, the ReadyFlow, you had the approval. There is guidance out there for this year. How do we think about the impact of the ReadyFlow approval on 2026 versus perhaps the tailwind coming later in 2027?
The ReadyFlow has been approved for a couple of weeks, so it's now been available to order. What has been surprising to us, but very exciting, is that physicians have been submitting cost and coverage submissions to our hub for the ReadyFlow. They're trying to understand what's the copay going to be for their patient. The fact that they are submitting those orders several times fold of what the run rate was for On-body Infusor demonstrates that there's great awareness about the ReadyFlow, and that people are very excited to get this in the hands of their patients. We'll see how the next couple of weeks play out, but the early signs are very encouraging. We're excited about that piece.
Fantastic. What are some of the key metrics that you're going to look at over the first 6 to 12 months of that ReadyFlow launch that you think is really changing and expanding that market?
This is about demand. As we think about our current physicians, are they making the transition to ReadyFlow and do they see a broader patient group within their practice who's an appropriate patient for ReadyFlow? That's really the feedback overall. The market research that we looked at with FUROSCIX, with the on-body infuser, was as great of a product this is and to be able to avoid an IV and a hospital stay, it's a complicated device. That is the view that physicians had, that this was a narrow patient who could handle the complexity of the device. Those friction points, that barrier goes away when you think about the ReadyFlow. That's what we're seeing in these early days. We're having our current physicians who prescribe OBI are now submitting for ReadyFlow, and it seems like in pretty impressive numbers.
We also, even in these early days, have seen physicians who've never prescribed OBI are already submitting scripts for ReadyFlow. So those two pieces are very exciting. That's both in cardiology and nephrology. Then later we'll make ReadyFlow available in the IDN space.
Fantastic. I do want to talk about the IDN space and the hospital discharge setting. Just given how large that opportunity could be, what are the principal remaining or principal barriers to getting ReadyFlow embedded in that early discharge or post-discharge pathway? How important or is any real-world evidence or additional evidence that you may need to generate?
Yeah. Just to remind folks, the community setting was really the focus of scPharmaceuticals, and so we've really started to focus on the IDN opportunity beginning with this year. We always knew that it was going to be a relatively longer sales cycle. We're seeing that. I think the enthusiasm and understanding how this could fit into their practice, I think everyone gets, and so it's just a matter of how do you actually get them to operationalize that within the hospital organization. What we're finding is each hospital organization works a little bit differently, needs different things, and so we are trying to bring a consolidated team to help figure that out.
The punchline is, if they are able to operationalize that, we think this is a great opportunity for them to get onto the early discharge protocols, get people out of the hospital earlier, as well as avoid readmissions. Going to real-world evidence, that's certainly a comment that we get. We needed the ReadyFlow to be approved. That's the appropriate device to do these studies on, and so that is all in flight, and we'll be able to give folks some better understanding of that as we close out the year.
Fantastic. I'm going to move on to Afrezza. With the recent pediatric launch, as we move past the initial launch phase here, what's going to give you confidence in these early adopters and that they're going to grow their depth of prescribing?
I think it is about that early experience with a patient. Are they able to get to the right therapeutic dose for them, and therefore they're refilling Afrezza, and they're having a great overall experience? That's going to lead to them broadening this in their patient population. The early signs are very encouraging. The energy enthusiasm around the pediatric launch is just very different from what we experienced on the adult side. A lot of this has to do with this is focused on about 50 academic centers, so it's a more concentrated physician base. Half of these physicians were involved in our clinical trial, and so they already have some real-world experience with Afrezza already. Early signs are very encouraging, but it really is going to be about how those first patients really experience Afrezza, and therefore more patients will get on it.
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