Mannkind Corp Q4 FY2025 Earnings Call

Good morning, and welcome to the MannKind Corporation Fourth Quarter and Full Year 2025 Financial Results Earnings Call. As a reminder, this call is being recorded on February 26, 2026, and will be available for replay on the MannKind Corporation website shortly after this call and 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-K for the annual period ended December 31, 2025, 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, Chris Prentiss. I'd now like to turn the conference over to Mr. Castagna. Please go ahead, sir.

Thanks, operator, and good morning, everyone. Thank you for joining us for our Q4 and year-end 2025 earnings call. Here is today's agenda, and I'll start with some opening remarks. I want to start by taking a step back and putting our relationship with United Therapeutics into context. Tyvaso DPI has transformed both United Therapeutics and MannKind's future to fund our respective innovation and growth. Tyvaso was a $450 million brand when we entered the collaboration in 2018, and Tyvaso DPI quickly grew within 36 months of launch to a $1 billion franchise by delivering a highly impactful therapy that has helped thousands of patients. This success has funded our diversification, setting us up for 3 important milestones. First, the opportunity to acquire and scale Furoscix and invest in inhaled Bumetanide dry powder inhalation. Second, it funded our growth of Afrezza over the past 6 years as well as the investment in our pediatric indication. While simultaneously third, investing in our pipeline programs, such as MNKD-201, which has blockbuster potential. When we signed the UT agreement in Q3 of 2018, MannKind was generating approximately $3.8 million in quarterly revenue and had a market cap of roughly $300 million. Today, we are a very different company. Excluding Tyvaso DPI, we have a $200 million-plus annual run rate and a market cap of approximately $1 billion. Our long-range plan is not dependent on future growth from UT-related revenues. And yesterday's announcement from United Therapeutics does not change our strategic direction or long-term plan, as the next 36 months should deliver over $350 million in royalties that have no cost against them. And our long-term supply agreement has 6 years left with minimum orders that should deliver over $400 million in revenue. Just as UT did not convert the entire market to Tyvaso DPI, alternative delivery formats will continue to coexist. We've seen this dynamic play out before. Despite being the most widely adopted soft mist inhaler, Spiriva Respimat never achieved more than 50% market share versus the DPI 8 years post launch. Clinical experience with Tyvaso DPI supports this durability. The BREEZE study enrolled over 50 PAH patients, and less than 4% of patients dropped out as the cough generally subsides with time, and we've seen that in our Afrezza studies as well. This has enabled Tyvaso DPI to become a $1 billion brand. Competition in the PAH will continue to evolve, and it's reasonable to expect a company facing loss of IP on the nebulized product to pursue replacement options with soft mist inhalers being a likely path. Now I want to step back even further and highlight our revenue trajectory over the past 5 years. We exited 2025 with nearly $350 million in total revenue, representing a compound annual growth rate of approximately 46%. That growth reflects exactly what we set out to accomplish, moving from a company largely dependent on a single revenue stream to a diversified commercial stage organization with 4 FDA-approved products. We remain grateful to United Therapeutics and fully expect Tyvaso DPI to continue benefiting patients for years to come. At the same time, we believe there will always be a meaningful market for dry powder inhalers even as delivery formats evolve. We see a clear path to over $450 million revenue run rate in 2026 alone, and look forward to discussing our growth drivers the rest of today. As we turn our attention back to Q4, which was a transformative quarter for MannKind, we completed the acquisition of scPharmaceuticals, which strengthens our cardiometabolic franchise with the incredible team from scPharma and Furoscix. We delivered record quarterly revenue of $112 million in Q4. And on the regulatory front, we have 2 important PDUFA dates coming up with the acceptances of our files. First, the Afrezza pediatric indication with a PDUFA date of May 29; and second, the Furoscix ReadyFlow Autoinjector with a PDUFA date of July 26. These milestones represent years of work and position us to potentially deliver meaningful growth in the years ahead. Now I'm going to turn to Furoscix performance. Furoscix had an outstanding Q4 with net sales of $23.3 million, up 91% year-over-year. And for the full year 2025, Furoscix generated $70.4 million in net sales. What's impressive to me is that the team shipped nearly as many units in Q4 as they did in all of 2024. As you can see, Furoscix has grown consistently since launch with clear acceleration in 2025. Q1 is typically soft as deductibles reset and patients face higher out-of-pocket costs, particularly for Medicare. But momentum continues to build throughout the year. If you focus on the last 2 quarters, I'm very impressed that the team remained focused during the acquisition and integration and continue to deliver record growth with nephrology accounting for approximately 15% of our sales. We've experienced minimal turnover within the salesforce. And as we get past Q1, we expect significant year-over-year growth in the quarters ahead. Since we acquired scPharma, we've taken a hard look where the opportunities are to accelerate growth. Let me walk you through 3 key areas. Number one is hospital pull-through. We've deployed a key account manager team to deepen our IDN relationships and get Furoscix integrated into the hospital discharge protocols. This is critical because the post-discharge period is when readmission risk is the highest. Number 2 is our salesforce focus. We refocused the legacy sc team on cardiology and activated our endocrine team to cover nephrology. That gives us a sharper specialty focus and increased our sales rep footprint from approximately 80 to 160 reps, doubling our share of voice. Number 3 is our marketing investment. We've increased our marketing spend to prepare for the potential ReadyFlow Autoinjector launch and to build broader awareness of Furoscix to treat fluid overload from the convenience at home. We believe our investments in these strategic initiatives will support Furoscix's growth to achieve a CVR range of $110 million to $120 million in 2026. Now let me talk about the Furoscix ReadyFlow Autoinjector. We have consistently heard from HCPs that an autoinjector could expand the Furoscix market given the ease of use and convenience of a once-daily injection. If approved, it would deliver an IV equivalent diuretic in under 10 seconds. Beyond the convenience of the patient, the ReadyFlow Autoinjector has the potential to significantly reduce our COGS and free up cash to invest in the brand. Now turning to our Afrezza performance for 2025. In Q4, Afrezza generated $22.3 million in net U.S. sales, up 22% year-over-year. For the full year, we had $74.6 million in global net sales, which included our first commercial shipment to Cipla, our commercialization partner for India. This shipment marks an important milestone as we look to expand Afrezza growth internationally. Over the past couple of years, we've been very deliberate about managing Afrezza for profitability, but we're now in a growth mindset as we prepare for the potential pediatric launch and increase our commercial investments in 2026. I want to highlight an important development for Afrezza. The new ADA guidelines that came out in December position inhaled insulin as an equivalent option to injectable insulins or automated delivery systems, which are considered the standard of care. For years, Afrezza has not been on an even playing field, but now guidelines recommend HCPs should evaluate the need for a modification of administration at every visit for patients who are not at goal. That's a meaningful improvement based on the scientific data we've generated recently. We believe our shift to a growth mindset supported by investments in guidelines and a potential new indication will set up Afrezza growth in the years ahead. We are excited about the recent FDA approval of our label change, which clarifies the starting bolus dose when switching from MDI or insulin pumps. This graph from our dose trial shows that there was a 58% reduction in postprandial glucose excursions at 2 hours with the higher Afrezza dose compared to the original label. That's a meaningful improvement in post-mealtime glucose control, which is when the patients struggle most. We expect that this label update will help support health care providers by providing clearer starting dose guidance when transitioning patients to Afrezza and will support the pediatric launch, if approved. Now I'm going to spend some time on the pediatric opportunity because I think it is one of the most underappreciated catalysts in our pipeline. If approved, Afrezza will be the first needle-free mealtime insulin option for pediatric patients in more than a century. We recently completed new market research, and I'd like to share what we're hearing from healthcare providers. The daily burden of diabetes management remains high for children and their families. Carb counting, rigid school schedules, and social dynamics create real friction with current mealtime options, especially for adolescents who are constantly snacking and are highly active and don't always want to be attached to things. In fact, our research shows that 93% of families request a change in the child's diabetes management. This tells us there's a significant dissatisfaction with current options and a real desire for innovation. Afrezza has the potential to address these challenges by removing the need for mealtime injections, reducing reliance on carb counting, and offering greater flexibility around meals. For children and their families, that flexibility can reduce daily stress and improve the quality of life while giving providers a tool that better aligns with how kids and their families actually live. Four important data points stood out to us that signal a meaningful opportunity in pediatric diabetes. And please remember, this is an entirely new segment that has never been marketed to or prescribed Afrezza historically. First, approximately 50% of HCPs cite eliminating mealtime injections as their primary driver of adoption. Second, 2 out of 3 pediatric endocrinologists indicate they'd be likely to prescribe Afrezza. That's a strong signal of potential underlying demand. We're also encouraged by how early Afrezza could be used in the treatment journey. Nearly 1 in 4 HCPs indicate they would consider using Afrezza in newly diagnosed type 1 patients. This has helped support our decision to launch the inhale-first pediatric study, which is now currently enrolling. Finally, based on this research, we see share potential in the range of 23% to 37%. And importantly, every 10% share historically represented approximately $150 million in net revenue opportunity. When you put all 4 of these signals together, the opportunity in pediatric is both substantial and well supported. I will now turn it over to Chris to review our fourth quarter and full-year financial results.

Thanks, Mike, and good morning, everyone. For a summary of our financials, please review our press release issued before this call and our Form 10-K, which is now on file with the SEC. Now let me walk through our Q4 2025 revenues by category based on total revenues of $112 million, up 46% from the prior year quarter. As our acquisition of scPharmaceuticals closed on October 7, Furoscix is now included in our cardiometabolic revenues and contributed $23 million of product sales. We recorded sales of $23 million for Afrezza, an increase of 25% over the prior year quarter, which includes $600,000 of products sold to Cipla to support their initial launch of Afrezza in India. We are excited that the Cipla team is now able to bring a differentiated treatment option to people with diabetes in India and look forward to supporting their execution on the launch. Lastly, V-Go was $4 million for the quarter, a slight decline from the prior year period and in line with expectations, as we are not actively promoting the product. Collaboration and services revenue increased 5% over the prior year quarter to $28 million. Within collaboration and services revenue, $26 million of revenue was UT-related. This was primarily for the production of Tyvaso DPI and the recognition of deferred revenue, as well as recognition of a portion of the upfront milestone we received related to the second investigational molecule as part of our collaboration with UT. Recently, we amended our supply agreement with UT to add minimum annual quantities and volume-based pricing. This provides us better predictability as we prepare our Danbury facility to scale our development programs over the next few years. To give this context, our 2025 Tyvaso DPI manufacturing revenues were approximately $100 million. Based on our revised supply agreement, we expect the next 2 years to be generally in line with 2025 and for the balance of the committed contract terms through 2031 to provide a revenue floor of approximately $50 million per year. Lastly, Q4 royalty revenue was $34 million, up 24% from the prior year period, which reflects continued strong performance of Tyvaso DPI in the market. I wanted to provide some color about the sensitivity of our financials to potential changes in Tyvaso DPI sales by UT. It's important to remember that our economics are driven by a royalty structure where we earn a net 9% following the royalty sale transaction we completed 2 years ago. What that means in practical terms is that even if United Therapeutics were to see variability or a decline in Tyvaso DPI sales, the impact to MannKind is significantly dampened relative to the products we commercialize ourselves. We're exposed to a fraction of the Tyvaso DPI top-line change. We expect Tyvaso DPI to continue to provide meaningful cash flows even in the event of evolving competitive dynamics in future years. So while we obviously care about the success of Tyvaso DPI, our overall business today is far less dependent on United Therapeutics than it has been historically. For the full year 2025, total revenue was up 22% to $349 million, fueled by our 2 commercial growth drivers of Afrezza and Furoscix. Afrezza grew 16% over the prior year to $75 million. And now with the addition of Furoscix in Q4, we have added a high-growth revenue stream. As a brand, Furoscix grew 93% year-over-year based on total annual revenues. When we look out at our commercial product portfolio, it is now more diversified and represents a significant portion of our expected growth going forward. Lastly, royalty revenue was up 25% year-over-year to $128 million, driven by the performance of Tyvaso DPI. On the expense side, R&D increased year-over-year as we progressed enrollment in our clinical programs and prepared to initiate clinical trials for our MNKD-201 program in IPF. SG&A increased primarily due to acquisition-related expenses and commercial investments ahead of the potential pediatric launch and the ReadyFlow Autoinjector launch. For Q4 2025, we reported a GAAP net loss of $15.9 million and a non-GAAP adjusted net income of $1.5 million. For the full year 2025, we reported GAAP net income of $5.9 million and a non-GAAP adjusted net income of $59.5 million. The adjustments for the fourth quarter and the year were primarily related to professional services costs incurred as part of our acquisition of scPharma, as well as amortization of intangible assets acquired, which is noncash and will continue to be amortized over the life of the Furoscix IP. Lastly, I'd like to make a couple of comments about our outlook for 2026. United Therapeutics noted on their earnings call yesterday that they expect durable double-digit growth of Tyvaso DPI in 2026. This will directly correspond to the growth of our royalty revenue. As we compare the pre-acquisition expense run rate for Afrezza and Furoscix to our commercial spend expectations for 2026, we anticipate investing up to an additional $40 million to support these brands' potential launches. This is based on making the significant investments in resources we highlighted earlier on the call today, including key account managers, patient navigators, and expanded field force, as well as increasing marketing spend. We expect both of these brands to be important contributors to our future growth over the next several years. We will have the ability to modulate these investments and adjust timing during the year as we evaluate how our tactics are impacting performance. Regarding research and development, our efforts will be focused on advancing our MNKD-201 program as well as progressing our other development and life cycle management programs. Additionally, manufacturing-related costs to get ReadyFlow Autoinjector available for distribution upon its potential approval will be recorded to R&D this year. Before I turn it back to Mike, I want to mention that we'll be presenting virtually at the Oppenheimer Emerging Growth Conference later today. Next month, we will be attending the Leerink Partners and the Barclays Global Healthcare Conferences. We look forward to engaging with many of you at those meetings. With that, I will turn the call back over to Mike.

Thank you, Chris. Now let me bridge to the major catalysts driving this year. As we've discussed earlier, there are several exciting commercial catalysts between now and July for Afrezza and Furoscix. We continue working on early programs like inhaled Bumetanide and other undisclosed programs. But today, I want to focus on our clinical stage program, MNKD-201, which has blockbuster potential. On the clinical side, we anticipate enrolling the first patient in our Nintedanib DPI global Phase II study next quarter. And the U.S. Phase Ib study in IPF is enrolling nicely with top-line data expected in the second half of 2026. IPF is a progressive and fatal disease with problematic therapies available today. Only a minority of patients with IPF are on approved therapy. And why is that? Because patients can't tolerate these drugs. So they stop taking them, or they never even start. This is a disease where we believe patients are desperate for better options, and we believe Nintedanib DPI can fill this unmet medical need by delivering Nintedanib deep into the lungs. As we look at the competitive landscape, lung target delivery is emerging as a winning strategy in IPF. Systemic oral delivery has not translated into meaningful antifibrotic impact because it's difficult to achieve high lung exposure without compromising tolerability. Inhaled delivery changes this equation, and our Technosphere-based DPIs have demonstrated safety and tolerability in numerous patients with underlying lung disease. Nintedanib DPI pairs a proven molecule with direct lung targeting and gives us high confidence in its potential to reduce the GI-related adverse events seen with oral Nintedanib while maintaining or even enhancing efficacy. It also opens the door to combination use alongside current and future IPF therapies, which is increasingly how we see the market evolving. We believe Nintedanib will be the backbone of IPF therapy for years to come, and we look forward to hopefully bringing this opportunity to patients in the future. Before we close, I want to highlight some upcoming scientific conferences next month. We'll be at the THT conference in Boston, and we're also excited about our participation in the ATTD conference in Barcelona. These are important forums for us to share our clinical data and engage with the medical community as we prepare for upcoming potential launches later this year. As we look ahead, our key pillars are clear. Afrezza is at an inflection point and positioned for growth with the potential for the 2026 pediatric approval. Furoscix is a high-growth revenue stream addressing a significant unmet need in heart failure and chronic kidney disease. And if the ReadyFlow Autoinjector is approved, it would expand the market opportunity and improve the cost structure. Tyvaso DPI remains the backbone of PAH and PH-ILD, and we expect a solid 2026 performance. And Nintedanib DPI is progressing into Phase II in IPF, and we believe this program has blockbuster potential to improve treatment options for a disease with very limited options. These pillars give us multiple shots on goal and a diversified growth profile over the years ahead. As I reflect on 2025, I'm incredibly proud of what this team has accomplished. We completed the transformative acquisition of scPharma, and the integration has gone extremely smooth. We delivered record revenue, advanced our pipeline and built the commercial infrastructure needed to support multiple product launches in 2026. I want to thank you for everyone's attention today, and I'll now open up for Q&A.

Our first question comes from Olivia Brayer with Cantor.

Can you guys hear me now?

Yes.

Okay. Perfect. Sorry about that. Mike, you made some intro comments around minimum supply agreement with United. Can you just maybe help contextualize some of those numbers to help give us a sense of what the real downside risk here is? How are you thinking about that $350 million number over the next 36 months? And Chris, I know you mentioned a minimum floor of $50 million through 2031. So is that the annual minimum supply agreement that UT is contractually obligated to...

Sorry about that. But maybe just to kick it off about the minimum supply agreement. So this is a schedule that was just attached to our 10-K that was issued this morning. It is redacted, so you can't see the quantities or dollar amounts, but it is a volume-based agreement. And so we were just trying to put that in dollar terms. So if you think about 2025, it was approximately $100 million. That will be in line for the next 2 years. And then after that, when we get to minimum quantities, you're looking at about half that amount, so approximately $50 million for the out years.

And those are minimum, Olivia. And I think on the royalty, I think you heard yesterday, UT talk about the robustness and double-digit growth of Tyvaso DPI. So if you were to just take a conservative approach and look at that number for this year, and bridge to next year, which we don't expect any major competition. I think you get 2 years there, and you at least get to the third year and get a decent number as well. So we wanted to get some context around what this means and how much cash flow it still is going to bring in, not just in the near term, but the longer term, and that it's our job to deploy that capital in an appropriate way.

Okay. Very helpful. And then on MNKD-201, how big of a strategic priority is that program at this point? And when will we actually see those Phase Ib data? I know it's later this year, but maybe beyond the timelines, like what will we actually see from that data set that could help drive confidence in the profile of a DPI and IPF patients?

Yes. A couple of things. MNKD-201 is critical — we are spending a lot of energy, money, and people on this program, so it is a major priority. The team is actively kicking off and enrolling a Phase I trial in the U.S. and activating a Phase II trial globally right now. A tremendous amount of resources is being applied to move as quickly as possible. The Phase I is a two-part study with 12 patients in each part. We already have four enrolled in Part 1 and 10 in screening, so we hope to wrap up Part 1, hopefully in the next month. There will be a second part with the next dosing after completing Part 1, and that should be in Q2. I flagged the readout in the second half to give the team time to analyze the data. What we expect to get from the study is tolerability and any changes in FEV1. It’s a seven-day study, so we don’t expect big efficacy signals, but tolerability, cough, and related effects in IPF patients are our main focus. The same dose administered in the clinic will be used in the Phase II, so we will collect comparable data there. This Phase I was designed to satisfy the FDA request from our meeting last year and could allow us to consider moving the Phase II to the U.S. Right now, Phase II is entirely ex-U.S. We have submitted the Phase II protocol to the FDA and are awaiting feedback; they may or may not agree to certain parameters, but we tried to incorporate everything they were looking for into Phase II as we did in Phase I. We expect that data to emerge earlier in the second half of this year. On conviction, the Phase II is intended to show an initial impact on FEV1. When you look at treatments like nintedanib or Tyvaso in TETON 2, those curves begin to separate after about six to 12 weeks. We expect to see a similar separation in INFLO-2. The study is not powered for statistical significance — that will be addressed in Phase III — but it should provide early conviction that this candidate has blockbuster potential in IPF, with nintedanib remaining the backbone of treatment.

Our next question comes from Roanna Ruiz with Leerink Partners.

So another question about the UT supply contracts for DPI. I just wanted to check, could they be updated again in future years depending on DPI's ramp? And then as a positive counterbalance to that, I also wanted to ask what tailwinds could be driving future revenue growth, both from Afrezza and Furoscix this year and into later years, especially how you're thinking about the new guideline updates and the Autoinjector launch for Furoscix.

Yes. On the supply agreement, it was important for us. We never had minimums originally because at the start of the launch, which Roanna missed, it took off much faster than expected and created capacity constraints. As the product matured and uptake increased, and with additional work underway, we needed to include minimums so we could operate Danbury for the long term rather than the short term. Looking back, we were in manufacturing hell for a couple of years. That agreement is in place. I would not say nothing can be modified, but any changes would require mutual agreement. We do think there is a minimum production level, and any long-term brand will require ongoing supply. We believe we will be the sole supplier for Tyvaso for a while. For Afrezza over the last two to three years, we focused on reducing expenses and running it for profitability rather than for growth. That is important context when people ask why Afrezza did not grow faster. We believed pediatric safety and efficacy data would be the inflection point, and until we had that we could not make significant investments. We tried various adult-segment initiatives, but with GLP therapies gaining traction, debating type 2 usage and insulin needs was not the best use of resources. We wanted to maintain and modestly grow Afrezza, but we did not expect a high return from increased investment compared with our other priorities. Last year we brought in a new team, received the data readout, and met with the FDA. Our conviction in the pediatric opportunity grew significantly and that is our future focus. Our President, Nick, has built the team and infrastructure, and we conducted advisory boards to validate the research and prepare for launch, including starting INHALE-1. You will see increased investment in the second half. If FDA approval occurs in May as planned, we expect Afrezza to show additional growth in Q3 and Q4 and by year-end. For Furoscix, we place high value on the autoinjector deal. The growth trends for the on-body infusor are strong, but physicians tell us that an autoinjector greatly eases patient and caregiver burden, including mental burden and training. We expect this to be a meaningful transformation. The autoinjector timeline targets July, about four to five months away, and we should be preparing for launch and engaging with the FDA on labeling. Both programs are on track. We have received some information requests from the FDA, but nothing that appears to be a showstopper. We feel good about these assets and expect them to hit their PDUFA dates.

Our next question comes from Gregory Renza with Truist Securities.

It's Anish on for Greg. First, just for Chris. How should we be thinking about the evolution of gross margins and operating margins over 2026 as you take the reins with Furoscix and have Afrezza potentially going into peds this year? And second, for Mike, maybe if you could just give us more color and remind us on how MannKind leverages FDKP to enhance the delivery, efficacy, and tolerability of dry powders and how doc and patient fees have evolved over the years in PAH and PH-ILD, and how this might translate to IPF?

Thanks, Anish. To talk about gross margin dynamics: the on-body infusor has a slightly lower gross margin than Afrezza historically. So before the autoinjector is approved and launched, there will be a slight decline in gross margin. That will then improve significantly as the autoinjector is launched later this year. I think you'll see a little bit of a hit in 2026 and then a significant improvement in 2027 and beyond. Another thing to note is that, as a result of the purchase accounting, we now have an intangible asset, which is the on-body infusor and, when approved, the autoinjector. Those intangible assets are amortized. You saw $4 million in Q4. That will obviously play out over the year. That amortization is technically part of cost of goods sold. If you look at our COGS and margin disclosures in the 10-K, you'll see a more significant impact to margin. That is a noncash item, but it will be included in margin going forward.

And then your question on FDKP, if I heard it correctly, is just how is that critical? Why is that important? And FDKP is really what founded the formulation behind Afrezza and the scalability in the company and the moat that we have around our technology. It really is used to deliver drug deep into the lungs by either protecting the molecule, make sure it gets there, and making sure the molecule can fly there. As you may or may not know, many dry powders and nebulizers have wide variability in their delivery. And so it's not just the FDKP and the powder, it's also the device platform we have. And those 2 things go hand-in-hand to deliver deep lung penetration and consistent lung penetration. And we see that in Afrezza and the 3D imaging studies we did, that's important. And so we believe, as you look at the various molecules we've already worked on and got approved as well as what's in the pipeline, 80% to 99% of that powder is FDKP. So it's a critical ingredient in everything that we do and the formulations that we make. And you continue to see that help, whether it's in the Bumetanide work that we're doing, the IPF for MNKD-201 and Nintedanib as well as Afrezza and that Furoscix and treprostinil. So we think it's important. We think it helps shape the particle size, and there is a barrier to access this molecule. And we think there's more innovation as we look out that we can start to think about with FDKP and continuing to take that to the next level as well.

Our last question comes from Brandon Folkes with H.C. Wainwright.

Maybe just 2 from me. Firstly, on the Afrezza pediatric opportunity, can you just talk about the market research you did? What did this sort of return and where the opportunity lies initially, versus new patient starts versus switch patients? And then should we think about any bolus of switch patients upfront, looking to go needle-free or pump-free? And then maybe secondly, for me, just a quick one. Coming back to UT, which is taking a different approach. In your press release, you continue to include the second molecule, 1505, that collaboration. So is there anything molecule-specific on 1501 that give you confidence that they would move forward on a dry powder on that molecule?

Yes. On the Afrezza pediatric market research, this is new research that came in over the last few weeks. We wanted to update the prior research that gave us conviction, so we felt it was important to share. This is recent data and was gathered from a group of physicians in a quantitative way; it was not interactive or a sales exercise, just presenting the data and the product profile. We were encouraged by the results, since they reflect opinions before any medical education or rep detailing. That suggests a large opportunity. One surprise was the percentage of naive patients who might potentially try the product, which wasn't in our original framework. As we were planning INHALE-1, the results reconfirmed that it was the right study to do and scale. The study is enrolling nicely; we've just started the first ten patients, after which we'll evaluate and then open the remaining 90. It's well underway and will be important to understand dynamics in endocrinology practice and children's hospitals: how they create teaching protocols, what they have to change for onboarding patients, how they train patients on basal versus mealtime control, when they give doses, and school nurse programs. There's a lot we're learning daily from that trial that will apply to the launch. Will there be a bolus of switch patients? I think the majority in the initial launch will come from switching, and over time, as experience grows, from naive patients. But I don't expect a rapid influx from day one because we are not turning on a large DTC campaign at launch. We're taking a methodical approach: getting the key account team across the 50 to 70 centers we're targeting, which will treat the majority of the kids, and the community salesforce will target the rest. We want to walk before we run and avoid spending a ton of money. There is upside, though, and when the consumer research that's just coming back is available we'll determine how quickly consumer activation should start and when, because there is clearly a consumer component with families and kids. On the UT second-molecule collaboration, the teams are working well together day to day and the program is progressing nicely. What UT decides is up to them, but under the agreement we're completing the first part, which should wrap up shortly. We hope it moves forward. We think it could help a lot of patients and potentially be blockbuster, but that decision is UT's. Does that answer your questions, Brandon?

That concludes the questions.

Thank you, operator. I see no other questions here in the queue. So I want to thank our employees for their dedication and hard work. I want to thank the patients and families who are participating and continue to participate in our trials and use our products every day. Everything we focus on is about helping people live life more human. We remain committed to our mission, and we look forward to moving our company forward in 2026. Thank you.