Good afternoon and welcome to the MannKind Corporation First Quarter 2026 financial results earnings call. As a reminder, this call is being recorded on May 6th, 2026, and will be available for replay on the MannKind Corporation website shortly after this call for approximately 90 days. This call will contain forward-looking statements. Such forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from these expectations. For further information on the company's risk factors, please see the Form 10-Q for the period ended March 31st, 2026, the earnings release, and the slides prepared for this presentation. Joining us today from MannKind are Chief Executive Officer Michael Castagna and Chief Financial Officer Christopher Prentiss. I'd now like to turn the conference over to Mr. Castagna. Please go ahead, sir.
Thanks operator. Good afternoon, everyone. Thank you for joining us for our Q1 2026 earnings call. Here's today's agenda. I'll start with some opening remarks. In the first quarter, we continued to execute our strategy to evolve MannKind into a diversified company positioned to deliver sustained long-term growth. The company is fundamentally different than it was even a few years ago. We are excited about the near-term milestones that will further advance the company's evolution. Today, we will discuss the recent positive developments with United Therapeutics and articulate our growth plans that we expect will drive significant shareholder value over the coming years. Let's begin with our announcement earlier today that MannKind 1501 has been unveiled as ralinepag DPI, which United Therapeutics optioned into back in August last year.
Our formulation team has been moving ralinepag DPI forward expeditiously, and we recently received a $5 million payment to prioritize the continued rapid advancement of this program. We have the potential to receive up to $35 million in development milestones plus a 10% royalty on net sales. Of those milestones, we expect about $15 million to be earned over the next 12 months. This expanded collaboration is significant for a few reasons. First, it deepens an already productive partnership with United Therapeutics. Second, ralinepag DPI has the potential to be used across pulmonary arterial hypertension, pulmonary hypertension associated with interstitial lung disease, idiopathic pulmonary fibrosis, and progressive pulmonary fibrosis, collectively impacting more than 250,000 patients and representing a substantial opportunity to improve the outcomes across these conditions. Third, it continues to validate our unique Technosphere platform.
In addition to ralinepag DPI, we've also confirmed MannKind as the sole manufacturer of Tyvaso DPI under a supply agreement that includes contractual minimums. This provides us with a solid foundation as we continue to scale our Danbury, Connecticut facility for our own pipeline, including a manufacturing build-out to support the growth of FUROSCIX ReadyFlow. Let's move on to Q1 performance. We delivered quarterly revenues of $90 million, a 15% increase over the prior year as this now includes the addition of FUROSCIX. Q1 was a challenging quarter for several reasons. Number 1 is structural. We see each year as Q1 typically declines relative to Q4 due to annual deductible resets. As patients face higher out-of-pocket costs at the start of the year, we see both fewer fills and lower doses per prescription.
For FUROSCIX, doses per prescription were down roughly 20% in Q1 compared to Q4. Number two is transitional. As we prepared for our upcoming launches of Afrezza Pediatrics and the FUROSCIX ReadyFlow auto-injector, we reorganized its field teams, leading to customer disruptions in Q1 as we didn't want to disrupt the field in Q4 or the upcoming next two quarters given the potential launches. Additionally, we reallocated marketing resources away from Afrezza Adult, which slowed the growth year-over-year as we thought it'd be more prudent to shift these investments towards the pediatric Afrezza launch and FUROSCIX nephrology opportunity. We have made the adjustments, and the field teams in place today are talented, highly experienced in their therapeutic areas, and have the right resources to deliver quarterly growth the balance of the year.
Number three, as we prepare for the launch in Q3 of the auto-injector, we want to ensure an efficient conversion. We transitioned our inventory levels to minimize volatility and inventory stocking of the current on-body infuser at the specialty pharmacies. As this adjustment is now behind us, we expect future product outflows to better reflect underlying prescriber demand, which will help us accelerate the transition upon FDA approval. When you put these three things together, Q1 came in lighter on the revenue side, but even so, the underlying indicators were more encouraging than the top-line quarter may suggest. We saw growth in both overall writers and repeat writers of FUROSCIX hitting a record number of prescribers in Q1, and demand momentum improved as the quarter progressed. Doses dispensed are up nearly 60% through April compared to the same period last year.
Chris will walk through the quarter in more detail, but we are confident the underlying business is moving in the right direction, and we remain on track to meet our full year 2026 FUROSCIX revenue target of $110 million-$120 million. Now let's walk through the Q1 highlights. The FDA approved the updated Afrezza label, which now provides clearer starting dose guidance. That's an important enabler for the pediatric launch, as this was the dosing used for the pivotal trial. We've also completed our launch build-out for Afrezza Pediatrics ahead of the May 29th PDUFA date. We completed the pilot phase enrollment in our Inhale First pediatric trial evaluating Afrezza in youth with newly diagnosed type 1 diabetes. That's the long-term goal I've talked about for years. Additionally, we settled the convertible notes, which strengthens the balance sheet.
Finally, on the SC Pharm integration, we are now approximately 7 months post-close, and I'm very pleased with how the integration has progressed. For most functions, integration is substantially complete, and we've identified synergies that exceeded our $20 million annual target we previously set. I want to thank both teams for the way they came together. These integrations are always challenging, and ours is going exceptionally well. I now take a step back to talk about strategic evolution because this slide tells a really important story. Until 2022, we were essentially a single product company with Afrezza. Since then, United Therapeutics and Tyvaso DPI specifically has played a critical role in funding our transformation, including enabling the SC Pharma acquisition last year. With the acquisition of scPharmaceuticals, we added FUROSCIX, which brought an incredible team with deep cardiology experience.
That has expanded our portfolio and our commercial infrastructure in a meaningful way. As we look at 2026 and beyond, we are now a diversified cardiometabolic and orphan lung company with multiple FDA-approved products, 2 near-term regulatory catalysts, and a potentially transformative pipeline opportunity with inhaled nintedanib DPI advancing into phase II. The UT partnership will remain a reliable pillar of the business, providing stability and significant growth potential. It also gives us flexibility to advance the pipeline, reduce debt, and pursue business development opportunities. The MannKind story is increasingly about the products and development candidates we own and the brands we are building for the long term. Turning to the major catalyst for 2026 and beyond, we have 2 regulatory catalysts and 1 clinical catalyst stacked up in a narrow window over the next 3 to 4 months. First is the Afrezza pediatric indication.
If approved, Afrezza will be the first and only needle-free mealtime option for children and adolescents in more than a century and would address a long-standing unmet need with a highly differentiated value proposition. This opportunity compounds over time as adolescents initiate therapy early and continue into adulthood, supporting durable long-term growth for the brand. Second is the FUROSCIX ReadyFlow autoinjector. If approved, this changes the administration profile of FUROSCIX from several hours to just seconds, which has real implications for patient convenience, training, and widespread adoption. It supports broader use and would significantly reduce our cost of goods. Third is the MannKind 201 nintedanib DPI program. There remains an urgent need for more new effective therapies in IPF, where current options are limited by tolerability.
Our lung-targeted delivery approach is designed to address those barriers, and we are on track to report phase I-B top-line data in the third quarter, a key clinical de-risking step. In parallel, we are advancing MannKind 201 into a global phase II trial this quarter. Each of these catalysts would be significant on its own. Having all three in a single calendar year is a powerful testament to our progress and execution over the last 10 years. Together, these milestones strengthen our foundation and position us to potentially deliver meaningful growth in the years ahead. We have two near-term regulatory events, a growing commercial business, a strong revenue base from UT, and a pipeline approaching important data milestones. Let's go deeper on the upcoming commercial expansion opportunities for our products, starting with Afrezza.
The pediatric opportunity is a well-defined new population entry point with the ability to expand across an even broader populations over time. There are roughly 360,000 people between 8 and 22 years old living with type 1 diabetes in the U.S., with about 30,000 newly diagnosed each year. While our launch focus is type 1 in children and adolescents, when you look at the broader picture where Afrezza is already indicated, the long-term opportunity for inhaled insulin is significant at over 38 million patients that were indicated for today. The pediatric opportunity is one of the most important milestones for Afrezza since its initial approval, and our extensive research highlights why. Despite decades of technology and drug innovation in diabetes, A1C control is still not meeting goals, largely because of mealtime challenges that exist in the everyday life of patients. Afrezza is the solution.
After more than a decade on the market, Afrezza is poised to finally live up to its potential. Managing mealtime insulin in children and adolescents often means multiple daily injections, rigid meal timing, and significant burden on both parents and caregivers. Afrezza directly addresses those challenges by eliminating mealtime injections through a novel route of administration, providing greater flexibility around meals and easier timing for kids. When you think about what it means for a child with type 1 diabetes to not have to take a shot at lunch or wear a pump while playing sports or count carbs at a birthday party or even forgo the cake, that's a really big deal to the average life of a child. This is a therapy backed by more than a decade of real-world data and now a completed phase III pediatric trial.
The American Diabetes Association now positions inhaled insulin as an equivalent option to multiple daily injections and insulin pumps, including AID, in their guidelines. This guideline support puts Afrezza on equal footing with the standards of care, a significant milestone that recently happened. The evidence base has never been stronger. Families and physicians continue to highlight the significant daily burden of diabetes management and are telling us that Afrezza has the potential to fundamentally change that experience. With peak share potential in the range of 23%-37% and each 10% share representing approximately $150 million in net revenue, the opportunity is significant and will continue to compound over the coming years. Pediatric represents a fundamentally different dynamic as we look at our key areas at launch. We're continuing to be very disciplined.
We're directly addressing the mealtime challenge where about 35% of patients have real friction with insulin at mealtime today, compounded by the fact that 25%-35% intentionally miss their mealtime injections or pump boluses. We're engaging consumers through highly targeted outreach. About 93% of families are motivated to speak to their HCP to request a change in the child's diabetes management. Patient requests matter. We're targeting roughly 60-plus prioritized academic medical centers with about 20 key account managers. That's where the highest volume pediatric prescribers are. In parallel, the broader Afrezza sales team will extend coverage by engaging community-based healthcare providers as well as these academic centers to ensure comprehensive reach and frequency at launch. We're enhancing the customer experience through ease of access, with commercial or Medicaid patients able to get on Afrezza for $35 or less.
In parallel, we've engaged in a number of payer discussions to ensure formularies are positioned to support the pediatric launch, and we're seeing receptivity to expand the access for children and adolescents as we approach approval. The pediatric approval for Afrezza offers the brand a new beginning, new patients, eager physicians, and a clear unmet need. If approved, we are ready to launch. Now let's turn our attention to FUROSCIX. As we look at the addressable opportunity, there are roughly 700,000 fluid overload events we can address outside the hospital setting. There are multiple intervention points along the patient journey. Since launch, we were historically targeting when fluid first presented at home and oral diuretics weren't enough. We are moving to address the post-discharge setting where it can impact length of stay and thirty-day readmissions.
With the FUROSCIX ReadyFlow, we believe we can unlock several additional intervention points both earlier and later in the treatment paradigm where FUROSCIX can break this cycle of admissions and readmissions. Next, let's talk about ReadyFlow auto-injector and why we are so excited about it. We consistently hear from HCPs that the current FUROSCIX on-body infuser, while effective, can be a 1 barrier to adoption in certain patient segments. With the PDUFA date of July 26th, if the ReadyFlow auto-injector is approved, it will reduce the administration time of FUROSCIX from 5 hours to just seconds. That could broaden use among prescribers who have been more selective with the current presentation. Our research also supports this. 65% of HCPs anticipate they would expand their FUROSCIX use with the ReadyFlow auto-injector. Patients are already familiar with the auto-injector type of delivery formats through other therapies.
It's a simple, reliable delivery system with minimal training required. It has comparable efficacy and safety to IV and the current on-body infuser. The auto-injector allows earlier intervention and enhanced patient independence because there's less hesitancy to use it. Importantly, the ReadyFlow auto-injector would significantly reduce our cost of goods, which improves our margins and frees up capital to reinvest. On FUROSCIX ReadyFlow launch readiness, we are building from a position of strength. To support the launch, we've identified four key tactics. Number 1, approximately 60% of FUROSCIX patients require prior authorizations today. Simplifying access and reducing friction in the onboarding process is critical to ensuring patients can start therapy without delay.
Based on recent payer conversations, they are receptive to removing access hurdles, given the overall cost benefits of FUROSCIX and trying to reduce the number of patients going into the ER related to fluid overload. Number 2, from an adoption standpoint, our market research is encouraging. Roughly 85% of existing FUROSCIX patients are expected to convert to the ReadyFlow auto-injector, reflecting strong confidence in the ReadyFlow profile. 65% of healthcare providers anticipate expanding their use, enables earlier and more productive intervention. Number 3, we have a clear focus on accelerating time to patient start. We are exploring alternative distribution partners that will improve our ability to get FUROSCIX in the hands of the patient the same day. Lastly, we've deployed our key account manager team to deepen integrated delivery networks or IDN relationships and continue to integrate FUROSCIX into hospital discharge protocols.
That's where the post-discharge intervention opportunity lives, and it's where we believe we can make the most meaningful difference in reducing hospital readmissions. We've prioritized more than 60 key accounts supported by our entire sales force in addition to our newly established key account managers who completed training in March. This approach should drive consistent uptake and appropriate utilization, which we expect will accelerate in the second half. Taken together, these tactics position ReadyFlow for rapid adoption by accelerating patient starts, establishing earlier use in the treatment pathway, and ensuring focused, disciplined execution across the accounts that matter most. Moving on now to nintedanib DPI, our MNKD-201 program. IPF is a devastating disease. These patients cough up to 1,000 times per day, and with the poor tolerability of current treatments, their quality of life is significantly compromised.
8 out of 10 patients die from this disease within 5 years, and many would rather forgo treatment than endure the side effects of today's standards of care. Our approach is to bypass the GI tract through targeted pulmonary delivery. The Technosphere platform is a proven platform. We have two FDA-approved products with less than a 3% discontinuation rate due to instances of cough and demonstrated safety and tolerability in patients with underlying lung disease. When you combine a proven molecule like nintedanib with direct lung targeting and consider our phase I healthy volunteer observation showing no GI tolerability issues and our phase I-B in actual IPF patients showing no discontinuations due to cough or serious adverse events in the first 12 patients, we have strong confidence in the potential to improve tolerability while maintaining or potentially enhancing efficacy. On to our 201 program updates.
We've completed enrollment of cohort 1 in our phase I-B InFlow study, which is in active IPF patients. Our top-line data are expected to be shared during Q3. That's a key de-risking point as we generate safety and tolerability data in these patients. Simultaneously, we're initiating enrollment in our global phase II study now that we have received our first country approval. We are advancing both programs in parallel to accelerate data generation and development timelines. Here are the key things that differentiate MannKind 201. A 2-second inhalation, a proven delivery platform with no cleaning required, and the potential to dramatically reduce side effects while meeting or beating the efficacy of oral nintedanib. Each step further de-risks a program that we believe has tremendous potential to target a disease with limited treatment options.
Taken together, our inhaled nintedanib DPI program, along with the United Therapeutics Tyvaso DPI and ralinepag DPI, gives us three differentiated shots on goal in IPF. Importantly, nintedanib DPI is not only well-positioned to serve as the backbone of therapy, but also opens the door to combination use alongside other current and emerging IPF therapies, which is increasingly how we expect this market to evolve, is with combination use. Together, these programs reinforce the potential for inhaled delivery to improve tolerability and play a central role in redefining how IPF is treated.
Before I turn it over to Chris, I want to highlight some of the key upcoming scientific conferences we'll be at, including the Respiratory Innovation Summit, where we have a small presentation at ATS, the American Diabetes Association, where I have almost 10 presentations at the scientific sessions, and the American Association of Heart Failure Nurses in San Diego in late June. These are exciting times with lots of data dissemination and hopefully upcoming FDA approvals. I will now turn it over to Chris to review our first quarter 2026 financial results.
Thanks, Mike. Good afternoon, everyone. For a summary of our financials, please review our press release issued before this call and our Form 10-Q, which is now on file with the SEC. Let's start with FUROSCIX. For Q1 2026, FUROSCIX net sales were $15.5 million. As a reminder, the acquisition closed on October 7th of last year, and only post-acquisition results are included in MannKind financials. Underneath the revenue number, the demand metrics for the brand remain strong. We had a record number of writers in the first quarter, and 75% of those writers are repeat writers, which is a really good signal. Doses dispensed grew 64% year-over-year, and our IDN business grew 97% year-over-year, reflecting the early traction of our key account manager team.
If you look at 2025, approximately 14% of annual dispenses was generated in Q1. If you apply this to our Q1 units dispensed, we remain on track to achieve our annual target and are reaffirming our 2026 FUROSCIX revenue range of $110 million-$120 million. Turning to Afrezza global sales, Q1 2026 net sales were $15.3 million, up 3% year-over-year. As we discussed earlier, we have shifted our marketing efforts toward our two anticipated launches this year and transitioned nephrology sales responsibility to the legacy Afrezza sales team. As expected with a new call point, this created some near-term disruption, which we expect to improve steadily over the remainder of 2026. Tyvaso DPI-related revenues provide a durable revenue base.
Our collaboration and services revenue is driven primarily by manufacturing revenue based on volumes sold through to UT, plus the recognition of deferred revenue. For the quarter, C&S revenue was $23.5 million compared to $29.4 million for the prior year quarter. As we've noted previously, this revenue stream may fluctuate between periods depending on production scheduling at our Danbury facility across Afrezza, development programs, and Tyvaso DPI. It is important to note that the amendment to our Tyvaso DPI supply agreement we signed earlier this quarter established annual minimum quantities, effectively fixing our annual manufacturing revenue for Tyvaso DPI. As a result, period-to-period fluctuations are driven primarily by manufacturing planning and scheduling requirements, and to a lesser extent by the timing of revenue recognition from other collaboration activities. One such collaboration is our development of ralinepag DPI with UT.
We recently received $5 million to accelerate its development. We will begin to recognize this in Q2. An additional $35 million of development milestones remain, of which we expect to earn $15 million over the next 12 months. Q1 2026 royalties reflect a year-over-year growth of 9% to $32.7 million. In 2026, royalty revenue will support key capital priorities, including funding the March retirement of our senior convertible notes, our CVR obligations, and our pipeline programs. Turning to the bottom line, for the first quarter of 2026, we reported a GAAP net loss of $16.6 million or $0.05 per share. On a non-GAAP basis, we reported a net loss of $6.9 million or $0.02 per share.
For comparison, in Q1 2025, we reported GAAP net income of $13.2 million or $0.04 per share and non-GAAP net income of $21.6 million or $0.07 per share. The year-over-year change reflects the planned increase in commercial investment associated with the potential FUROSCIX ReadyFlow auto-injector and Afrezza Pediatrics launches, as well as the incremental cost structure associated with the scPharmaceuticals acquisition, including amortization of acquired intangible assets, which is non-cash. For the full details on non-GAAP adjustments, please refer to our press release and 10-Q filing. On the expense side, R&D expenses increased over the prior year period, driven by ongoing enrollment in the phase I-B study and preparations to begin enrollment for the phase II study of MNKD-201.
We expect R&D spending to remain at this level as we advance the MNKD-201 program and as well as our pipeline programs, such as our inhaled bumetanide program, MNKD-701. Selling, general, and administrative expenses increased compared to the prior year quarter, primarily driven by the expanded commercial infrastructure supporting the anticipated pediatric Afrezza and ReadyFlow auto-injector launches, as well as the full quarter impact of the sc Pharma commercial team and operating structure. Having two PDUFAs within months of each other is unusual for a company of our size and makes 2026 a deliberate investment year. We're investing to ensure both potential launches are properly supported across the field and in promotion, which is reflected in SG&A this quarter. Going forward, we'll continue to evaluate commercial performance and adjust investment levels with discipline as we execute on these launches.
Turning to our balance sheet, we ended Q1 with a solid liquidity position after settling the remaining balance of our senior convertible notes. We believe we have sufficient capital to support our planned commercial launches and continue advancing our pipeline. In addition, our credit facility provides financial flexibility if needed, and we remain focused on deploying capital in a manner that maximizes long-term value for our shareholders. Before I turn it back over to Mike, I want to mention that we'll be at the Jefferies Global Healthcare Conference in New York in June. We look forward to engaging with many of you there. With that, I will turn the call back over to Mike.
Thank you, Chris. Let me close by summarizing why we believe MannKind is well-positioned for the next phase of growth. Number one, as we look at the remainder of 2026, we are in the middle of a meaningful corporate transformation. Since 2022, we've evolved from a single product company into one with multiple FDA-approved products and a more diversified growth profile. United Therapeutics revenue continues to provide a strong foundation while our revenue mix is shifting steadily toward MannKind owned brands, with owned revenue moving from roughly 40% just prior to the SC acquisition to over 65% with the anticipated FDA approvals as we exit 2026. That represents a fundamentally different company than one we just experienced a few quarters ago. Number two is FUROSCIX.
We have a clear line of sight to achieving our $110 million-$120 million revenue range for 2026. The ReadyFlow auto-injector, pending its July 26 PDUFA date, represents a meaningful opportunity to extend and accelerate the brand's growth trajectory. The fact that 65% of healthcare providers indicate they would expand the use with FUROSCIX ReadyFlow auto-injector reinforces our confidence in its potential. Number 3 is Afrezza. A pediatric approval would unlock a significant growth opportunity and represent the most important milestone since the approval of Afrezza in 2014. Pediatric demand indicators are strong, the value proposition is clear, and we are launch-ready with disciplined targeted investment. If approved, our team is ready to execute. Number 4 is our partnership with United Therapeutics. The Tyvaso DPI franchise continues to deliver durable economics with the potential for expansion of the IPF.
An addition of ralinepag DPI extends the partnership into multiple indications, reinforcing both the strategic depth and long-term value of this relationship. Number 5 is nintedanib DPI. Completion of the Phase I-B in IPF patients, where we expect top-line data in Q3, and the planned first patient enrollment in the global Phase II program this quarter represent important de-risking milestones and position this asset for the next meaningful pipeline value driver. When we put all these together, a durable revenue base from UT, two near-term regulatory catalysts, and a pipeline with meaningful upside, our priorities are clear, our team is focused, and MannKind is poised to capitalize on some of the most fundamental and transformational moments in the history of the company. We look forward to seeing many of you at the upcoming events and share more updates as we approach the Afrezza Pediatrics and ReadyFlow auto-injector PDUFA date.
With that, operator, we'll open the call for questions. You know, see a bigger gap there. I think in general, I would see an evolution of a combination market evolving, and that's one of the reasons we're running a QID arm in our phase II, so that if you were on QID Tyvaso DPI or Tyvaso nebulizer, you could look at a QID, nintedanib DPI as well. We're hoping to show in that trial whether using 4 milligrams twice a day or 2 milligrams four times a day, that your outcomes are comparable. If one's better, that's great. We'll lead with that. That's one of the things we're exploring in that phase II.
Great. Last one from me on FUROSCIX. Any extra color on some of the trends you saw in the quarter? I noticed you reiterated your guide, which is encouraging. I was curious also, anything interesting that you're watching for in the next couple quarters in terms of underlying demand?
I think the first is we know 2 competitors launched last October. Obviously, we're keeping an eye on that, not much activity out there. I think maybe 40, 50 scripts since launch. Nothing of significance. We did hear anecdotal reports of people switching back. You know, some of them had tried the nasal and may not have gotten the efficacy they wanted and went back to FUROSCIX. That's an early indicator of patient satisfaction or physician satisfaction for us that we felt more confident as we go forward. We're moving our inhaled bumetanide program forward as well, just so we make sure we have, you know, simple inhalation in that space if people wanna go that route. On the FUROSCIX side, you know, great prescribers. neph picked up a lot in March as we closed out the quarter.
We see that. We think the transition of the sales force caused a pretty big disruption in January, February. As they get those relationships reestablished, lunches on calendars, et cetera, dinner events are now taking place. We think neph will continue to accelerate throughout the year. We think FUROSCIX overall, especially with the auto-injector, will grow a lot faster in Q3 and Q4. Otherwise the When you look at the volume, the % of units that shipped in Q1 of last year and the % of units that shipped in Q1 of this year, you kinda get to a pretty close number to our reported number. I think that's what we see in Q1 because of co-pay resets and there's nothing more to read into that.
We listened to a few other companies' calls. We heard the same thing in Medicare. These co-pays and insurance designs are really slowing down the January, February performance of a lot of products. You start to see the March and April pick back up, which gives you the confidence for the rest of the year. We feel pretty good in all the feedback, and anecdotal evidence we hear from FUROSCIX is very positive.
Great. Thanks a lot.
Our next question comes from Benjamin Burnett with Wells Fargo. Please go ahead with your question.
Hey, good evening, and thank you. I also wanted to ask about the ralinepag DPI that was disclosed this morning. I just curious, just kinda going back to sort of what you were saying just a minute ago, how far along in this process are you? I guess, really, what gives you the confidence that you can actually formulate this as a DPI? I believe there's also some discussion in the disclosure that, you know, QD is on the table, once-daily is on the table. What's sort of the confidence around that as well?
I can't comment on the pharmacokinetics cause I'm gonna have to defer to UT and their modeling and all the work that they've done and what they know about the ralinepag. I'll stand by their statements, and I think we don't know the real answer till we get into a human and we see some of the pharmacology there. Hypothetically what they, what they believe is probably is best we have today. In terms of my confidence, I feel pretty confident we have a lead powder that can go forward into human trials and animals trials now, to move us forward. You know, the good news is the amount of power we have to make for those things is not very significant, that's going ahead of schedule.
UT's doing an excellent job on moving this as quickly as humanly possible, and we're doing the best job we can to keep up and keep ahead of them. I think overall there's a lot of energy to make sure we accelerate this as quickly as possible, and I think there'll be some interesting, good dialogues and updates throughout the year next year.
Okay. Excellent. Also excited to see that there are two PDUFs coming up with Afrezza and FUROSCIX. I guess the question for you is when you know, assuming these are both successful and both approved, how soon after those approvals would you anticipate sort of the adoption curve for those drugs being impacted?
I think on peds, the approval should come the week before American Diabetes Association. If that timeline works, that'll be ideal because we have 10, 9 or 10 presentations and poster clinical updates as well as an evening event that will be there. I think that'd be a good blast off for there, not just for the U.S. but also India. There was a lot of Indian doctors attending ADA, just a lot of positive news at ADA will ultimately help just spread the word of Afrezza across the conference, that's exciting for us.
We have a plan to go into really the first 30, 60, 90 days to get into the top 10, 15 and set up the best practices, take those best practices and go to the next 15, the next 15. We're kind of doing a staged rollout and making sure we have advocates and processes and we're actually updating the reimbursement hub, which will be a big part of the launch. We're using the FUROSCIX hub actually, and that's had really good feedback from their customers, and we think that as a more of a white glove service to really make sure these patients get through the system nicely. I think on the Afrezza side, we should see it, you know, a little bit in Q2 because there's only about one month.
I'd say we'll be watching that very closely in Q3 and over the summer will be. The question I have for the summer is it all vacations and excuses, or is it people are coming in and we're seeing adoption and people wanna maybe have, you know, opportunities as they get ready for sports or summer vacations to have something different and take the time to try something different. That's important. The last thing I'll add is our Inhale First trial. We got the first I think 9 or 10 patients done and the anecdotal feedback coming out of that is really positive.
Being able to have a first insulin in children and newly diagnosed is really exciting and that could really be a game changer if that continues to pick momentum in the trial in real world.
Would you expect to see FUROSCIX impact in Q3?
Yeah, sorry. FUROSCIX, yeah, I think, assuming the approval comes July, we'll be launching in August is our expectation here. You know, we'd see a little bit of impact in Q3, but a full impact in Q4. That one should go 'Cause it's, that one's in Q use, so I think we'll see that much faster in terms of adoption and direction.
Okay. Excellent. Thanks so much for the color.
All right. Thank you, Ben.
Our next question will come from Prakesh Patel with Cantor Fitzgerald. Please go ahead with your question.
Hey, guys. This is Sam on for Olivia. Piggybacking on some FUROSCIX questions, I think it's encouraging you guys said that you're still confident, hitting $110-$120 in sales for this year in FUROSCIX. Is that including both the on-body and the auto-injector? You mentioned that this is weighted more towards 3Q and 4Q. Is this due to the potential approval of the auto-injector, and do you expect the auto-injector to like cannibalize the on-body infuser quite quickly?
The forecast for the year is basically looking at how the units came out in 2025 and kind of proportionately, you know, as we look at our demand and our curves, they look like they're consistent with 2025. I'd say the auto-injector is a small portion of that range, but not the reason we expect to hit 110. We believe the on-body infuser should be able to get in that direction, and that the auto-injector will just bring it there faster. Depending on when that launch is, when that gets out there, and how fast we get everything moving, that'll be a great opportunity.
One of the challenges in the first half so far is we actually don't have samples this year, and that's just due to the nature of how we're preparing for auto-injector and managing our inventory supply. That is another key thing that we're really gearing up to sample the auto-injector and get that out there to get the adoption faster.
Thank you, guys, and congrats on the ralinepag DPI.
Thank you.
Our next question will come from Gregory Renza with Truist Securities. Please go ahead with your question.
Hi, guys. It's Anish on for Greg. Congrats on the progress this quarter and for taking our question. One from us on the RAL DPI update. Maybe if you could just remind us on the relative positioning of prostacyclins to prostanoid-based drugs and the treatment paradigm for PAH, namely on patient applicability and doc choice, and how that's framing your views on commercial and royalty opportunities to MannKind. Thanks so much.
Yeah. I think it's a little too early to speculate on that. I mean, you know, to me, we got Tyvaso DPI and United has Tyvaso nebulizer. Really over the next two, three years will be the major focus of continuing to penetrate IPF and hopefully PPF for the DPI scenario. I think overall Tyvaso is going to be a growth driver over the next couple of years as a DPI. I think as ralinepag launches, you know, that's probably gonna go earlier just due to the convenience, is my guess if I had to forecast out where that's gonna be going. That, you know, typically the nebulizer, the DPIs are being used second and third line is my rough estimate here. That's really UT's positioning and UT's expertise for that.
I think the question will be I think you heard in UT's call today that in IPF ralinepag DPI will be the predominant formulation that gets used in that development program. We expect that from an IPF perspective to become the dominant driver overall.
Great. Thanks so much.
Okay. Thank you.
Our next question will come from Brandon Folkes with H.C. Wainwright. Please unmute your line and ask your question.
Hi, thanks for taking my question. Maybe just on Afrezza, on Afrezza Pediatrics, do you have to do anything on the contracting side post the Afrezza peds label expansion, or does that fall into the current coverage contracts that you have? Secondly, can you just talk about some of the, you know, how do you assess the success of the peds ramp early on? You know, what are some of your objectives that would drive you to invest further behind the peds launch versus sort of, you know, maybe keep investment where it is or pull back? Thank you.
Sure. I think on the contracting, because it'll be the same SKUs, there's not like we have to add another SKU to the contract. I think from that perspective, there's not updates. We've had a couple presentations to the large PBMs and some regionals, and we are exploring how do you free up prior authorizations and simplicity for parents and patients around pediatrics. It does feel like there's an appetite to free up that friction that happens in the adult side for kids at least, and then depending on the conversations could go into adults. We're really focused on making sure Medicaid access exists for kids and the big 3 PBM commercial lives have access for kids.
I don't think it all happened July 1st, but I think as we get throughout the year going into January next year, I would expect updated clinical guidelines at most of the payers to support the use of Afrezza. Even adult because the clinical guidelines, what we're finding is people weren't aware and are not aware of the ADA guidelines putting Afrezza equal to an AID system and multiple daily injections. For them to cause, you know, 2, 3 step edits is against the standards of care now. From that perspective, I actually expect with ped's approval guidelines to get updated and payer criteria to get updated in a positive way going into 2027. So far all indicators are positive.
In terms of ped success, I think the key things we'll be looking for is not as much on the revenue side. Obviously we want revenue to grow, but how many prescribers do we have? How many institutions have tried? How many times have they repeated that trial? How many patients do we see coming into our referral hub? Those are gonna be the key metrics we're looking at every week, and we will share those as they come out in the quarters. We think that's really important is look at breadth and depth of prescribing and how many patients could uptake and we will have access programs for those patients to make sure nobody goes without the option of Afrezza.
That's our commitment as we look through 2026 is to make sure that payer friction is not one of the reasons to not prescribe, we'll do everything we can to minimize that. Really maximize the opportunity to help parents, children, and doctors experience Afrezza because we believe what we see in the adult side, when somebody has a great experience and they use it in more than 10 patients, they really become adopters. The ones that never really adopt it are ones who tried it in one person and never really figured out how to dose it due to PA, et cetera.
We think it's really important to go wide and deep in these accounts, and then we just made a decision that our sales force will be covering the 20 key account managers we have, will be having local coverage to help with the reach and frequency and share of voice in the beginning of launch here. That's going to be important as well. Okay. Thank you, Brandon.
Our next question will come from Yun Zhong with Wedbush. Please unmute your line and ask your question.
Hi, good afternoon. Thank you very much for taking my question. My questions are about the MNKD-201 program. It's very encouraging to hear that good safety tolerability, no patient discontinuation. Given that we're going to enroll the first patient in 2Q without waiting for the top line data in 3Q, just want to confirm, do you plan to confirm anything else besides safety and tolerability from the phase I study? I believe United Therapeutics this morning confirmed that talked about the plan for the bridging study for Tyvaso DPI for IPF. Looks like it's going to start from a healthy volunteer, but there will be a patient study. Do you expect any potential impact on, for example, the pace of patient enrollment and overall the program?
The last question, well, including metapack, eventually there will likely be 3 different products in DPI formulation for IPF. Do you think just a patient taking different inhalations with the same DPI, or is it reasonable to think about potential co-formulation to increase the, or improve the convenience? Thank you very much.
Yeah, several questions in here. I'll try to take 'em one at a time here. On the MNKD-201, you know, we did a phase I-A last year with healthy volunteers, and in that study we were particularly looking at cough-related incidence, as well as FEV1, FVC, followed by diarrhea and GI side effects. We can confirm in that trial cough was not a major concern, and that GI side effects did not come up even in the highest doses. That, that gave us there. On the FEV1, FVC there was no significant issues. We obviously see variability in the test. We see variability patient to patient, but nothing that was a showstopper. In the I-B study, we're looking in IPF patients and taking that stepwise approach and showing that you can dose a dry powder inhalation in IPF safely and effectively.
I'm happy to see after the first 12 that we did get, This was using 2 milligrams 3 times a day, so they're getting about, you know, about 30 milligrams of powder to get 6 milligrams of nintedanib. We can see in that, in those patients that the tolerability, cough, discontinuation in IPF patients, there was no concerns in the first 12 of cohort 1. That cohort is now closed. The DSMB will meet next week, and hopefully, post that meeting we'll open up cohort 2. We're already screening for cohort 2, so we fully expect to enroll that much faster than cohort 1 and hopefully have top-line data here in Q3.
The top-line data in Q3 is just gonna probably show you whether you give it twice a day at 8 milligrams or 3 times a day at 2 milligrams, TID, you're not gonna see a difference in tolerability or cough or acceptance of the product. What that will do is it'll wrap it up to answer any questions the FDA may have had as we expand to phase II. To your next question on Tyvaso bridging, remember Utis focused on Tyvaso DPI for the U.S. market, any work they do will predominantly be based in the U.S. in IPF. In our case with our phase II trial, we are, as of today, 100% ex-U.S. focused on that trial. We are considering adding a few sites in the U.S., but that'll be pending some additional FDA negotiations.
We have submitted the protocol to the FDA and received back comments. We kind of know what it would take to get the FDA sites added if we wanted to. We're much more focused on accelerating the European enrollment and other markets outside of Europe, including Canada and Australia. We think getting this trial done ex-U.S. will be a similar patient population to the U.S., and that'll minimize any potential impact of Tyvaso accelerating the IPF side. In your last comments, co-formulation, and I would say our technology, given the doses of the product and the common excipient here, there obviously is potential for co-formulation of these assets. I've worked on fixed-dose combos in my previous lives.
I think first we gotta see that these dosing regimens are tolerable, and I think that's the first step to any fixed-dose combo. You have to have two parties willing to come together to figure those things out. Stay tuned. I think we're all moving in the same direction to help patients hopefully live a longer, healthier life relative to what they have today. Thank you.
Our next question will come from Anthony Petrone with Mizuho Financial Group. Please go ahead with your question.
Anthony? Okay. He may have dropped.
No problem. Our final question will come from Douglas Miehm with RBC Capital Markets. Please go ahead with your question.
Good afternoon. Question I have, Michael, just has to do with those discharge protocols and the ability to integrate the product into those 60 key accounts. Could you walk us through the process involved in opening those accounts or having those changes made to the discharge protocols and how long they may take?
Yeah, they take time unfortunately. I mean, obviously if this was a fast process, we would be blowing out the numbers right now. These are long-term process, meaning long-term being 6-15 months I'll say, not 3 months. The reason is every health system is different, and I've met probably 5 or 6 by now at the C-suite level and cardiac surgery departments and discharge quality teams. What we consistently hear is that there are patient navigators in many of these institutions who are responsible to make sure these 30-day readmissions do not come back. You gotta get the quality team, you gotta get the pharmacist, you gotta get the local contract set up, and you gotta get the adoption and the protocols. That all takes time.
There are places like Cleveland Clinic already doing it. Kaiser's running a big experiment right now in Northern California that looks pretty good. We have trial results that should come out later this year looking at early discharge. That's some of the data people wanna see is, can I get people out a day or two early? Then you have other clinics who, you know, really are focused on, they wanna make sure the patient gets discharged when they get discharged, but they leave with FUROSCIX so that they are not coming back within the 30-day window, right? It's a hodgepodge of systems, and it's You know, like I was talking to Kaiser, and I didn't realize, for example, that they don't, they accept non-Kaiser patients.
In that system, you know, they have to have a protocol for Kaiser patients and then a separate one for non-Kaiser because they don't have maybe access to patient navigators or that population. Each system's a little bit different, but I think as we start to find the commonalities, we'll get those across the finish line. Cleveland Clinic shares their protocol with our other customers, which is great.
Okay, great.
We feel good about it. All right, Doug.
Okay, excellent. The second question.
Go ahead.
My last question is just,
Doug, you're going out.
Can you hear me now?
Yep, I hear you now.
Yeah.
What's your second question?
You do. Okay. My other question just had to do with the 60 priority accounts on the Afrezza side. What would they represent in terms of that targeted market share that you're hoping for, that 23% to 37%? They'd represent perhaps over 50%, I imagine, but can you fine-tune that for me?
I'm gonna bet roughly they represent about 75%-80% of the target opportunity we believe is out there. There's about 20, depending on which way you cut the data, but about 20% of the patients fall in the community setting and 80% roughly fall in the key account setting. It's very concentrated.
Thank you.
Thank you. Great questions.
Our final question comes from Anthony Petrone with Mizuho Financial Group. Please go ahead and ask your question.
Hi, just wanna make sure you can hear us. Can you hear me?
We hear you now, Andy. Yep.
Nice. All right. Thanks a lot. Maybe just FUROSCIX, the PDUFA date, July 26. I think we're in the window, but are you expecting a panel meeting on the auto-injector? That'll be the first question, and a quick follow-up on FUROSCIX. This is, you know, moving from a hospital, you know, almost, you know, patient setting infusion clinic, you're going from a 5-hour infusion cycle to under 10 seconds. Patient has to use this in the home setting. Just what does that transition look like? How long do you think it takes to get adopted in the home and, you know, what level of, like, patient training is there gonna be? It just strikes us that this can be pretty seamless and is pretty much a kind of a game changer for these patients.
Just trying to frame up that transition from, you know, infusion to auto-injector in the home setting. Thanks.
Yeah. The first answer is no, we don't expect a panel. We have had various information requests from the FDA, nothing that looks like a showstopper at this point, so we believe we're on track for that PDUFA date, and hopefully that continues to go in the right direction. We're working on labeling, manufacturing, all that as we speak, so we'll be ready when the FDA gives us the green light.
On the transition, because it's an acute use drug, meaning, you know, every cycle is a new cycle, every patient, every day is a new patient, that conversion can happen very quickly, and today probably 90% of the use is preventing people from going into the hospital, the ER, and about 10%, I'll say, is on the discharge and the readmission of 30 days, and that's just rough estimates. I could be off by 50% on those, but I don't think I am. The auto-injector I think really helps get those patients on the hospital discharge faster because it's just much easier.
We're gonna get probably more local distribution there, same day to the patient, and we think that's one of the key barriers of when someone's suffering from fluid overload, you know, they want that product as soon as possible and we believe that's an important dynamic. With the auto-injector that can happen versus the COGS you deal with the auto infuser are quite high and that's something you don't want laying around in many different places. Otherwise I think you will see a pretty quick transition. There'll be a group of people who still wanna use the on-body infuser and we'll be prepared to hopefully make it available for them. We believe the preponderance of growth will come from the auto-injector.
Thank you.
That concludes the question and answer portion of today's call. I will now hand the call back to Michael Castagna for closing remarks.
Thank you for joining our call today. Apologize for the technical difficulties. We appreciate your continued support and look forward to keeping you updated as we execute on the multiple regulatory and clinical catalysts expected in the months ahead. Lot of exciting times. We've never been busier here at MannKind, and stay tuned. Every week we'll have hopefully updates coming as we go. Thank you.
That concludes today's call. You may now disconnect.