Conference Transcript - MNKD 2026-09-15

Speaker 2

Good morning, everyone. Thank you very much for joining us at the H.C. Wainwright Global Investment Conference. My name is Brandon Foulkes. I'm one of the equity research analysts here at H.C. Wainwright. Next up, we have a fireside chat with Mankind, and joining me from Mankind is CFO Chris Prentice. Chris, thank you very much.

Christopher Prentiss, CFO

Brandon, thanks so much for having us. Likewise.

Speaker 2

All right. So, you know, Mankind's evolved pretty significantly over the last five years, but I'd say, you know, exponentially over the last 12 months as well. So, you know, But with three very significant catalysts in 2026, can you just talk about where mankind is today and then where mankind is going over the next 24 months?

Christopher Prentiss, CFO

So just to remind everybody, our three catalysts as we came into this year is one, we've had an approval with AFRESA 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 Fresa is now available for those who are six and older. The second was last year we acquired SC Pharma, and with that the product Ferosix that has an on-body infuser, and we just got approval in an auto-injector form factor, and happy to say that that is now starting to be dispensed to patients beginning this week, so that's very exciting. And then the third was related to our 201 program, which is an IPF. And so we just released Phase 1B data over the last few weeks. We were very encouraged by that data. And now we're moving into phase two. So those were the three big catalysts that kind of set up this year. So 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. So it really is about generating net sales in Afrezzo overall on Ferozix. And I think people really want to see what are those run rates?

Speaker 2

What is that going to look like? what's the peak potential for those brands which are all very fair questions and then third is on our development program side continuing to to expand there what are those timelines look like when are we going to be able to generate the next phase two data fantastic I'm going to start on Furo 6 right because it's very it's a very interesting product right and I think it's a very the ready flow you had the approval there is guidance out there for this year how do we think about the impact of the ready flow approval on 2026 versus perhaps the tailwind coming later in 27 so the the ready flow has been approved for a couple of weeks so it's now been

Christopher Prentiss, CFO

available to order and what has been surprising to us but very exciting is that physicians have been submitting cost and coverage submissions to our hub for the ready flow and so they're trying to understand you know what's the copay going to be for their patient the fact that they are submitting those orders you know several times fold of what the run rate was for obi demonstrates that there's great awareness about the ready flow and that people are very excited to get this in the hands of their patients so we'll see how the next couple of weeks play out but the early signs are very very encouraging so we're excited about that piece fantastic and what are some of the

Speaker 2

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?

Christopher Prentiss, CFO

I mean, this is about demand, right? And so as we think about our current physicians, you know, 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, right? And the market research that we looked at with Ferosix with the on-body infuser was as great of a product this is and to be able to avoid, you know, an IV and a hospital stay, it's a complicated device. And that is the view that physicians have, 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 ready flow. And again, that's what we're seeing in these early days. So we're having our current physicians who prescribe OBI are now submitting for ready flow. And it seems like in pretty impressive numbers. And then we also, even in these early days, have seen physicians who've never prescribed OBI are already submitting, you know, scripts for ReadyFlow. So those two pieces are very exciting. That's both in cardiology and nephrology. And then later, we'll make ReadyFlow available in the IDN space.

Speaker 2

Fantastic. And I do want to talk about the IDN space and the hospital discharge setting. You know, just given how large that opportunity could be, you know, what are the principal remaining or principal barriers to getting ReadyFlow embedded in that early discharge or post-discharge pathway? How important is any real-world evidence or additional evidence that you may need to generate?

Christopher Prentiss, CFO

Yeah, so just to remind folks, the community setting was really the focus of SC Pharma. And so we've really started to focus on the IDN opportunity beginning with this year. And we always knew that it was going to be a relatively longer sales cycle. And we're seeing that, right? I think the enthusiasm and, you know, 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. And what we're finding is each hospital organization works a little bit differently, needs different And so we are trying to bring, you know, a consolidated team to help figure that out. The punchline is if, you know, 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. You know, we needed the ready flow to be approved. That's the appropriate device to do these studies on. And so that is all in flight. We'll be able to give folks some better understanding that as we close out the year.

Speaker 2

Fantastic. second. I'm going to move on to Efresa, you know, with the recent pediatric launch, you know, 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?

Christopher Prentiss, CFO

You know, 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 Efresa and they're having a great overall experience. that's going to lead to them broadening this in their patient population so 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 and you know half of these physicians were involved in our clinical trial and so they already have some real-world experience with Afrezza already. So 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.

Speaker 2

Fantastic. And how do we think about the addressable market in those 50 academic institutions versus broadening out into the community?

Christopher Prentiss, CFO

You know, you're looking at 80% of the pediatric endocrinologists is about less than 1,000 physicians. And 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. And so, again, we have a key account manager team who's able to work with those folks. And so it's much more concentrated and able to get them an experience with the FRESA early.

Speaker 2

Fantastic. And what about reimbursement, right? How are you seeing reimbursement or access in the pediatric population? Any different to the adult situation?

Christopher Prentiss, CFO

Yeah, there's no change right now from the adult situation. You know, we are working with payers. Now that we have furosics, now that we have ready flow, 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 to a fresa and so that's a great way to make sure that you know this doesn't cause any friction to get that first experience and then the hope is by the second or the third script you know 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 the Fresa, and then they're transitioning pretty quickly to PaidScript.

Speaker 2

Fantastic. And I want to move to MNKD 201 next. We obviously saw good data in the 1B. What specifically are you looking to see in Phase 2 that will give you confidence to move that asset forward into Phase 3?

Christopher Prentiss, CFO

Yeah, so we just publicly announced last week that based on the Phase 1B data, we have made some changes to the design of the Phase 2 trial. so that's now going to be 153 patients there's there's two there's a two milligram twice a day and a four milligram twice a day arm against placebo it's a 12-week trial with an open label extension and so 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 so we'll be moving that forward as quickly as possible at the end of the day you know the phase Days 1B 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. And as we've seen with everyone on Afreza and Tyvasa, DPI, et cetera, that cough typically resolves over the first couple of weeks of experiencing the drug. So 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. And then certainly being able to figure out what is the best dose for us as we move into phase three.

Speaker 2

Fantastic. And 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?

Christopher Prentiss, CFO

Yeah. Well, and it's interesting because through our relationship with United Therapeutics, we really have three shots on goal as it relates to IPF. So Tyveso DPI is being pursued for IPF, Relenopeg DPI will be pursued, and then our own 201 program. So we're certainly very excited about the IPF space overall. You know, Nintentative 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 Nintentative is going to be able to have 201 be a new background replacement therapy, then certainly the space seems to be involving to combination. And so that could then be combined with any number of therapies, ones which we are involved in or not.

Speaker 2

All right. And how do you think about 201 in terms of partnering versus go-it-alone commercial strategy?

Christopher Prentiss, CFO

You know, you've obviously done both successfully um as a company both you know gone and had a good partnership with ut but also you know had success with um ifreza and now potentially good success with furosix as well yeah yeah i 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 commercial infrastructure and footprint that you know would work for a company of our size and I think IPF is certainly represents all of those things right it's a very robust opportunity the development plan while the phase three program will will be significant you know we believe it would be one pivotal trial and it's something that certainly we could afford it at our size and you You know, IPF requires a sales force that is in our wheelhouse. So, you know, there's no reason that, you know, we wouldn't be able to continue to pursue 201 on our own.

Speaker 2

How do you think about broader capital allocation as a company, right? You know, 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?

Christopher Prentiss, CFO

Yeah, we kind of like that strategy and that setup and how it's played out so far. I think going back to some of my earlier comments, you know, our catalyst, we delivered on our catalyst. So now we need to go execute from a commercial standpoint. point. We need to generate significant revenues and see what those trend lines are on both Afresa as well as Furosix. And continue to move our 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 helped to fund SC, as well as help us go into new BD opportunities. So the setup is good for us as we think about what comes next.

Speaker 2

Just coming back to Fresa, but staying on capital allocation, as you begin to see success with the Fresa in the pediatric population. How do you think about your investment behind that product on the Salesforce side of things, but maybe also expanding it into limited DTC? Is there anything sort of that you think really could move the needle on the pediatric side of a Fresa?

Christopher Prentiss, CFO

You know, we've been working on a Fresa for so long, right? And have had different approaches along the way, but certainly the pediatric indication in that market is just so much more concentrated. 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. So 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 27 and beyond in terms of how do we realign our approach with Afreza. But again, early days are encouraging.

Speaker 2

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 and as we see mankind continually continue to evolve you know how do you think about the depth of a pipeline you would like to have as well right so especially if you move to a one and you do have success there does that validate that you're also you know a very capable r d organization and may look at a deeper pipeline as well mankind has been around for 35 years right And for us to be around for the next iteration of 35 and the next from that, you know, I think you need to be a full-fledged pharmaceutical company.

Christopher Prentiss, CFO

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 know, 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.

Speaker 2

All right. Fantastic. And, you know, so we opened this discussion with the three very significant catalysts of 2026. Now, if we look to 2027, you know, what do you view as the most successful, the most key milestones or catalysts that you need to execute against for mankind to have another very successful year?

Christopher Prentiss, CFO

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 catalyst. 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? And then, again, you know, 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? Tyveso DPI seems to be on the heels of Tyveso Nebulize. What does that mean? Is that 28, 29? You know, how does that math work? and then the same for both our 201 program as well as Relenepeg DPI. So I think it's milestone-based from a development timeline standpoint as well as what do the revenues look like.

Speaker 2

And just following up on that revenue question and obviously not asking for guidance in 2027, but do you feel we will be able to judge the success of the Ephraza Pediatric Commercial Opportunity in 2027 or do you think it's still a we will see growth but it's still an awareness building you freza has been a long story that you've been involved in for many years as well so um i'm gonna punt on uh on that one since football season has started but uh you know we like the early metrics it's it's still small numbers right so it needs to get more robust before we can answer those questions definitively but we like the trajectory we're on yeah no and i i thought that'd be on the answer but you know i appreciate the insight and appreciate the discussion today thanks so much thanks for having us