MannKind Corporation

Good morning and welcome to the Mankind Corporation 3rd Quarter 2025 Financial Results Earnings Call. As a reminder, this call is being recorded on November 5th 2025 and will be available for playback on the Mankind Corporation website shortly after the conclusion of this call and available 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 10Q for the quarterly period ended September 30th, 2025, the earnings release, and the slides prepared for this presentation. Joining us today for Mankind are Chief Executive Officer Michael Castagna and Chief Financial Officer Chris Prentice. I'd now like to turn the conference over to Mr. Castagna. Please go ahead, sir.

Good morning and thank you for joining our Q3 2025 earnings call. Let me start with the Q3 highlights. We delivered a record revenue of a quarter of $82 million. We also strengthened our portfolio with the acquisition of SC Pharmaceuticals. On the pipeline side, Afrez's supplemental BLA was accepted for review with a PDUFA date of Q2, 2026. We also saw strong performance from Tyveso DPI, which contributed $59 million in royalty and manufacturing-related revenue, reinforcing the durability of our revenue streams. Christopher will review the details of our third quarter results shortly. We're excited to have completed the acquisition of SC Pharmaceuticals and are pleased to welcome their talented team to Mankind. Together, we're focused on unlocking the full potential of Firo6 as well as the advancement of inhaled Bumetanide, AKA Mankind 701 for fluid overload and CKD and heart failure as our target indications. We are encouraged by the momentum across our clinical development programs that we've been working on the past five plus years in terms of Mankind 101 and 201, which I'll discuss at the end of our call. Now let me bridge to our near-term growth catalysts. Building on the hard work and dedication of the entire Mankind team, we have a unique near-term opportunity to accelerate growth and deliver meaningful value through catalysts across our commercial products and pipeline programs. I'll point to a few of these milestones. The SNDA-306 auto-injector was submitted to the FDA in Q3 as planned, with an expected PUDUFA date of Q3 26. The IFRESA SPLA was accepted for review and, if approved, would be the first new insulin for pediatric patients in 100 plus years of diabetes therapy. We've also completed enrollment into our midterm target for ICON1 NTM Phase III ahead of schedule, allowing us to confirm the sizing of the trial mid-next year. Now I want to bridge over to our commercial highlights, starting with Tyvasiv DPI and our collaboration with United Therapeutics. In Q3, we recorded our highest revenue quarter for Tyvasiv DPI, earning $33 million in royalties and $26 million in manufacturing-related revenue. As UT noted on its call, we have developed and produced an 80-microgram cartridge, which allows patients to take 15 nebulizer-equivalent breaths in a single dose, improving convenience for patients. Following UT's positive Teton2 data, we anticipate that the company will pursue a DPI bridging study in IPF, which would have the potential to expand the Tyveser DPI label to include IPF and or PPF contingent upon FDA approval. Additionally, UT recently exercised their option to expand our collaboration, and we've begun formulating a second investigational molecule as a dry powder platform using mankind's proprietary technosphere technology. In Q3, Afrezza grew 31% in new prescriptions and 27% in total prescriptions year over year. As we shifted our focus to type 1 diabetes in preparation for pediatrics, our units per script have declined by about 15% year over year, as the average person with type 1 diabetes requires less insulin than the average type 2. The impact you can start to see it reflected in the difference between our net revenue growth being lower than our TRX growth. On the revenue side, Afreza grew 23% in Q3 2025 compared to Q3 2024. We're focused on driving prescribing among top prescribers and continue to see strong engagement from healthcare providers, especially with the potential to expand into pediatrics if approved. Ahead of that opportunity, we've enhanced our messaging and expanded our field force, which includes medical science liaisons, local field salespeople, as well as key account managers who will be focused on the top 50 pediatric centers. I'll now turn to Furo6, a product we're very excited about. Furo6 is a high-potential brand that expands our footprint into cardiorenal medicine, and we now have the opportunity to merge SC Pharma's experience team with the Mankind team. This addition enhances our commercial scale, accelerates growth, and aligns with our strategy to expand into adjacent therapeutic areas while delivering innovative patient-focused solutions. Fluid overload remains a significant burden, and Furosix addresses a critical gap in care by helping break the cycle of hospital admissions and readmissions. SC Farm invested heavily in building a high-performing sales organization, expanding from about 40 representatives to more than 80 by early 2025. Establishing a sales force is a substantial undertaking that requires a significant financial and operational commitment. That investment laid the foundation for the strong adoption we've seen in 2025. The expanded sales team, combined with more focused territories and stronger engagement with health care providers, is driving broader coverage and deeper prescriber interactions. These strong results are reflected in Q3 performance with over 27,000 doses dispensed, up 153% from the same quarter last year, reflecting continued prescribing adoption and growing confidence in 406. With the demand continuing to rise, let's turn to the financial impact. For the year-to-date period, Furosix revenue reached $47.1 million, a 95% increase over the same period in 2024, indicating the investment and driving share voice is accelerating product adoption. For the third quarter of 2025, unaudited Furosix revenue was $19.3 million, Ferocix revenues will be included in Mankind's financial results commencing with the close of the acquisition, i.e. Q4. Now I want to focus on a large unmet medical need in heart failure and CKD, which is what we saw as we evaluated the SC Pharmaceutical acquisition. To put the growth we're seeing in perspective, let's look at the size of opportunity in heart failure and CKD, areas with significant unmet need. Heart failure is a large unmet need, and market research shows 80% of heart failure costs are tied directly to hospitalization. There are 2.1 million addressable heart failure episodes in the U.S., mostly driven by congestion from worsening heart failure. And for patients 65 and older, heart failure is one of the top reasons for hospital admission. This represents a large addressable market and a significant portion of the Medicare Part A and Part B spend. This is where furosix makes a difference. Its key feature is to allow patients to treat edema at home and reduce hospital admission time and or readmissions. Now I'd like to talk about the furosix opportunity for intervention. SC Pharma achieved success in furosix by focusing on community physicians who treat CKD and heart failure often before a patient shows up to the ER, which is on the left side of this slide. By intervening early, physicians have the potential to reduce hospitalizations and break the cycle of hospital readmissions. As we look post-integration, we're now expanding our focus to the post-discharge period where readmissions risk is the highest, creating a significant opportunity for furosics to improve outcomes and reduce costs. This approach aligns with CMS's proposed ambulatory specialty model for heart failure care, which begins in January, 2027. and introduces mandatory two-sided risk for cardiologists in select regions with performance tied to quality, cost, and care coordination. These changes underscore the importance of early intervention and strengthen Furo6's role as a key enabler for providers to meet quality and cost targets under CMS's new risk-based payment model. Beyond revenue growth, we remain focused on innovation to enhance patient experience and drive long-term value. Building on Furo6's momentum, we will expand our hospital strategy by adding key account managers critical to helping ensure discharge protocols will include Furo6 and enable local access within major health systems through meds-to-bed programs. This position Furo6 for far gradualization in hospitals and post-discharge settings. We're also planning to increase our share of voice in cardiology and nephrology to raise awareness amongst clinicians and patients supporting sustained adoption in the community prescribing level. A key milestone this quarter was the S-NDA submission for the 406 ReadyFlow Auto Injector. If approved, this device will simplify admissions, expand treatment options, and reduce cost of goods significantly, freeing up capital to reinvest in growth, strengthen our portfolio, and improving margins. Additionally, we're advancing Bumetanide DPI Mankind 701 into preclinical development, another example of our commitment to innovation and long-term growth, as we believe furosics will be the standard of care, but a subpopulation may prefer to inhale versus inject. Our technosphere technology should provide comparable bioavailability based on our historical development programs in insulin, tropostinol, and migraine, where we get IV-like onset and sustained efficacy in the short term. A DPI formulation of Bumetanide could offer a rapid, non-invasive, and highly portable solution, enabling patients and providers to manage fluid overload without hospitalization. I'll now turn the call over to Chris to review our third quarter results.

Thank you, Mike, and good morning, everyone. In the third quarter, total revenues grew 17% over the prior year to $82 million, driven primarily by royalties earned on Tyveso DPI. These royalties increased 23% to $33 million, reflecting the continued strong performance of Tyveso DPI under our collaboration with United Therapeutics. Collaboration and services revenue was $27 million, up 14% from the prior year, and consists primarily of manufacturing revenue based on production volume sold through to UT, as well as the recognition of deferred revenue. During the quarter, we announced a new collaboration with United Therapeutics and received a $5 million upfront payment. We will begin to recognize revenue related to this agreement in the fourth quarter as the development activities progress over the next several quarters. Afreza net revenue rose 23% to 18.5 million while Vigo contributed 3.8 million down 19% over the prior year period. The performance of Vigo is consistent with our expectations as we no longer actively promote the product. On the expense side, quarterly research and development expenses increased 1.1 million or 9% over the prior year period, driven by the enrollment ahead of plan in the ICON1 trial of inhaled clofazamine and preparations for the inflow phase two IPF study, which is expected to begin enrolling in Q1, 2026. These increases were partially offset by the completion of the INHALE-3 and Mankind 201 Phase 1 studies in 2024. Selling, general and administrative expenses increased 5.2 million or 22% in the third quarter versus the prior year period. As we continue to invest in AFREZA to support the potential pediatric launch, we have higher headcount and personnel related costs, including the deployment of the medical science liaison team, as well as additional sales reps. SG&A for this quarter also included 3.7 million of acquisition related expenses. Q4 SG&A expenses will include costs related to our October key account manager team build out to support the Afrezza pediatric call point. Additionally, transaction costs associated with the close of the acquisition of SC Pharmaceuticals will be reflected in the fourth quarter. As a reminder, our fourth quarter results for our commercial product sales will include sales of Ferosix as of the deal close, as well as expenses incurred in their respective categories. Related to the transaction, I'd like to note that we utilized $133 million of our $286 million of cash and investments as of September 30th to fund the transaction and have borrowed an aggregate of $325 million on our five-year term loan facility with Blackstone. For the year-to-date period of 2025, total revenues reached 237 million, representing 14% growth compared to the same period last year. Our commercial product sales, consisting of Afrezza and Vigo, account for 27% of our total revenues for the year-to-date period. With the addition of Ferosix in Q4, our commercial product sales will be a more meaningful component of our growth. On a pro forma basis, if Ferosix was included for the year-to-date period, commercial product sales would have been 39% of our total revenues. Considering the continued growth we anticipate in royalties we earn on Tyveso DPI, as well as meaningful and stable revenues from our collaboration and services, we have never been more excited about our revenue growth potential. I'd like to finish with GAAP net income for Q3, which was 8 million compared to 11.6 million in the prior year. After adjusting for non-cash and one-time items, our non-GAAP net income was 22.4 million up from 15.4 million last year and non-GAAP EPS of 7 cents up from 6 cents in Q3 of 2024. This reflects strong operational performance of our business lines, even as we are making significant investments in future growth drivers. I'll now hand it over to Mike to discuss clinical updates, starting with our FREZA pediatric indication. Mike.