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 scPharma 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 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 OBI 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 six 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.
Fantastic. How do we think about the addressable market in those 50 academic institutions versus broadening out into the community?
You're looking at 80% of the pediatric endocrinologists is about less than 1,000 physicians. You contrast to the adult market, and I think to get to 80,000, you're looking at over 60,000 endocrinologists. It's just a very, very different concentration, and the vast majority of those 1,000 are sitting in these academic centers. We have a key account manager team who's able to work with those folks. It's much more concentrated and able to get them an experience with Afrezza early.
Fantastic. What about reimbursement, right? How are you seeing reimbursement or access in the pediatric population any different to the adult situation?
Yeah, there's no change right now from the adult situation. We are working with payers now that we have FUROSCIX, now that we have ReadyFlow, and as well as the pediatric indication, we're able to have much more constructive conversations with payers, and so those conversations are ongoing. We did launch with the pediatric indication a bridge program, so for $35 everyone has access to Afrezza, and so that's a great way to make sure that this doesn't cause any friction to get that first experience, and then the hope is by the second or the third script, they are able to get on paid coverage, and so far that's how it's playing out. So that's been a great program for people to get their first experience with Afrezza, and then they're transitioning pretty quickly to paid script.
Fantastic. I want to move to MNKD-201 next. We obviously saw good data in the phase I-B. What specifically are you looking to see in phase II that will give you confidence to move that asset forward into phase III?
Yeah. We just publicly announced last week that based on the phase I-B data, we have made some changes to the design of the phase II trial. That's now going to be 153 patients. There's a 2 mg twice a day and a 4 mg twice a day arm against placebo. It's a 12-week trial with an open label extension. Based on those changes to the trial design, we would hope that we would have data that we would be able to generate by the first half of 2028. We'll be moving that forward as quickly as possible. At the end of the day, the phase I-B showed that there is not GI distress. We didn't have any issues with cough. Over 90% had no cough or a mild cough, which is what we would expect.
As we've seen with everyone on Afrezza and TYVASO DPI, et cetera, that cough typically resolves over the first couple of weeks of experiencing the drug. All signs are extremely positive. We would want to be able to see a difference between those on drug and placebo at week 12. It's only a 12-week trial. Then certainly being able to figure out what is the best dose for us as we move into phase III.
Fantastic. Just given the IPF landscape is evolving somewhat, how are you thinking about commercial positioning of 201 relative to what's on the market now, but also what could be on the market by the time 201 comes to market?
Yeah. It's interesting because through our relationship with United Therapeutics, we really have three shots on goal as it relates to IPF. TYVASO DPI is being pursued for IPF. Ralinepag DPI will be pursued, and then our own 201 program. We're certainly very excited about the IPF space overall. Nintedanib has really been the backbone of IPF therapy for many years now, and so we think us being able to come with a much more tolerable version of nintedanib is going to be able to have 201 be a new background replacement therapy, and certainly the space seems to be evolving to combination. That could then be combined with any number of therapies, ones which we are involved in or not.
All right. How do you think about 201 in terms of partnering versus go it alone commercial strategy? You've obviously done both successfully as a company, both gone and had a good partnership with United Therapeutics.
Yeah.
But also had success with Afrezza and now potentially good success with FUROSCIX as well.
Yeah. I think in everything that we've gone about, we've really been looking at commercial opportunities that are robust, development programs that we can afford and that require a commercial infrastructure and footprint that would work for a company of our size. I think IPF certainly represents all of those things. It's a very robust opportunity. The development plan, while the phase III program will be significant, we believe it would be one pivotal trial, and it's something that certainly we could afford at our size. IPF requires a sales force that is in our wheelhouse. So, there's no reason that we wouldn't be able to continue to pursue 201 on our own.
Okay. How do you think about broader capital allocation as a company? You've done a very good job on the balance sheet. There is potential additional royalties coming in over the next few years, which could be quite significant. So how do you think about capital allocation, particularly between the fact that you're a commercial organization, you've taken on internal R&D, but you've also been open to business development over the past few years?
Yeah. We like that strategy and that setup and how it's played out so far. I think going back to some of my earlier comments, our catalysts, we delivered on our catalysts.
Now we need to go execute from a commercial standpoint. We need to generate significant revenues and see what those trend lines are on both Afrezza as well as FUROSCIX and continue to move our MNKD-201 program forward. Those things are all within our wheelhouse. I think we want to be opportunistic about BD on things that make sense. But right now these are all things that we can afford and we can do on our own. We are very focused on becoming more self-sustainable and not reliant on the royalties, but have the royalties be a part of our business that helps us to be profitable, helps us to pay down our facility, that help to fund scPharmaceuticals, as well as help us go into new BD opportunities. The setup is good for us as we think about what comes next.
Okay. Just coming back to Afrezza, but staying on capital allocation. As you begin to see success with Afrezza in the pediatric population, how do you think about your investment behind that product on the sales force side of things, but maybe also expanding it into limited DTC? Just anything that you think really could move the needle on the pediatric side of Afrezza?
We've been working on Afrezza for so long.
Yeah.
And have had different approaches along the way. But certainly the pediatric indication in that market is just so much more concentrated.
Okay.
I think it gives you the ability and flexibility to try some different things that we haven't been able to do on the adult side. DTC is certainly something that we always consider. It'll be interesting to see how the next few quarters play out, and all ideas are on the table as we go into 2027 and beyond in terms of how do we realign our approach with Afrezza. But again, early days are encouraging. Things are going in the right direction, but we'll continue to be creative and think about the right way to go to market.
Fantastic. As we see MannKind continue to evolve, how do you think about the depth of a pipeline you would like to have as well? Especially if you move to a one and you do have success there, does that validate that you're also a very capable R&D organization and may look at a deeper pipeline as well?
MannKind has been around for 35 years. For us to be around for the next iteration of 35 and the next from that, I think you need to be a full-fledged pharmaceutical company. So, 201 is really our most significant development program. We have a number of other things both announced and not announced that we continue to think about and work through. But you need to continue to feed the machine, if you will. So, development, both inorganic and organic, is an important part of our next phase.
All right. Fantastic. We opened this discussion with the three very significant catalysts of 2026. If we look to 2027, what do you view as the most successful, the most key milestones or catalysts that you need to execute against for MannKind to have another very successful year?
Yeah, I think folks are going to be paying attention to a few things. First and foremost is going to be what are net sales looking like in 2027? You got your catalysts, you made your investments. How are you delivering upon that? So I think looking out over the next four or five quarters, folks are going to be very focused, thinking about what are those trend lines, what does it mean for peak sales? Then again, on the development side, we're really associated with three different IPF programs. I think folks are going to want to understand what are those development timelines. TYVASO DPI seems to be on the heels of TYVASO nebulized. What does that mean? Is that 2028, 2029? How does that math work? Then the same for both our 201 program as well as ralinepag DPI.
I think it's milestone based from a development timeline standpoint, as well as what do the revenues look like.
Just following up on that revenue question, obviously not asking for guidance in 2027, but do you feel we will be able to judge the success of the Afrezza pediatric commercial opportunity in 2027? Or do you think it's still a we will see growth, but it's still an awareness building year?
Afrezza has been a long story that you've been involved in for many years as well. I'm going to punt on that one since football season has started. We like the early metrics. It's still small numbers. It needs to get more robust before we can answer those questions definitively. We like the trajectory we're on.
Yep. No, I thought that'd be the answer, but yeah. No, I appreciate the insight and I appreciate the discussion today. Thanks so much, Chris.
Absolutely. Thanks for having us.