Good morning, and welcome to the MannKind Corporation third quarter 2022 earnings call. As a reminder, this call is being recorded on November 8th, 2022, and will be available for playback on the MannKind Corporation website shortly after the conclusion of this call until November 22nd, 2022. This call will contain forward-looking statements. Such forward-looking statements are subject to risks and uncertainty, which could cause actual results to differ materially from these stated expectations. For further information on the company's risk factors, please see their 10-Q report filed with the Securities and Exchange Commission this morning, 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, Steven Binder. I would now like to turn the call over to Mr. Castagna. Go ahead. Good morning. This is Mike Castagna, and I hope you can hear me okay. Okay. Good? Sorry, can you hear us? Okay. Sorry, we were having technical issues. Just wanted to make sure everybody could hear me before I got started. Good morning, and thank you for joining us for our earnings call today. Today marks the beginning of the new MannKind. You can start to see our execution from a single product to a sustainable growth company. We've never been more excited about our future than now. When you look down, you see four sources of revenue growth and 74% growth quarter-over-quarter. Orphan lung business is really starting to shape up as you look at the collaboration and service revenue with Tyvaso, as I'll talk about with clofazimine moving forward. The endocrine business is also doing well at double-digit growth, 28% quarter-over-quarter with Afrezza and V-Go revenue. When you look at the orphan lung, we're well-positioned with Tyvaso DPI growing significantly as we go forward, and clofazimine starting to enter patients hopefully in 2023. Our EBU is growing year-over-year, but in Q3, we made some changes and integrated V-Go. As you'll see in a minute, as those changes took place, we started to grow our market share month-over-month and quarter-over-quarter. On the Tyvaso side, you'll see our first quarter of commercial manufacturing. One of the first questions I get is this full manufacturing? The answer is no. This is just the beginning. The first full quarter commercialized by U.K., our royalties earned were about $6 million, which is significantly higher than Wall Street expected. Our capacity expansion is ongoing and quickly progressing here in Danbury. On our pipeline, we have reported out in September our phase I results that were generally well-tolerated up to 90 mg. No significant adverse events or QT prolongation, and we're planning to meet with the FDA here in late Q4. We're very excited about this program and excited to get this product to patients. On Afrezza, really focused on paid TRxs, which grew 10% year-over-year and 4% Q3 to Q2. On INHALE-1, we're currently on track to hit our goals for enrollment this year, with an expectation of completing enrollment by mid-next year and results six months later. Our capacity expansion is ongoing and quickly progressing here in Danbury. On our pipeline, we have reported out in September our phase I results that were generally well-tolerated up to 90 milligrams. No significant adverse events or QT prolongation. We're planning to meet with the FDA here in late Q4. We're very excited about this program and excited to get this product to patients. On Afrezza, really focused on paid TRxs, which grew 10% year-over-year and 4% Q3 to Q2. On INHALE-1, we're currently on track to hit our goals for enrollment this year, with an expectation of completing enrollment by mid-next year and results six months later. We also will be presenting our ABC results very shortly, which is the Afrezza basal combination trial, where we switched some patients off a pump, we added Afrezza to a pump, or we maintained the people on the pump. On the V-Go side, we feel good that we've stabilized the revenue, and we're ready for growth. Overall, we have $178 million in cash to fund our growth and our five-year plan. Here's a quick picture just to see the team in Danbury working through making our devices 24/7. Not just devices, but also product and dry powder cartridges. It's a very exciting time for people at MannKind and our future. With the purchase of V-Go, we really do become the mealtime solutions company. Let me start off by talking about Afrezza and what we're doing to continue to grow market share there. We pivoted this year to focus on a subset of doctors as well as ultra-acting analog insulin, URAA. That market share, as you look amongst our key targets, has continued to grow after years of decline and watching our competition continue to take ultra-acting market share away from us. We believe they're reaching for a faster insulin, and Afrezza should be the fastest insulin of choice. With that refocus this year, we've continued to grow market share quarter-over-quarter, month-over-month. When you look year-over-year, very excited that the new Rx's are a leading indicator of our TRx's, and you can really see the NRx growth from Q1 to Q2 to Q3, where we hit 18% NRx growth year-over-year, and how that translates to TRx growth quarter-over-quarter, year-over-year. On the V-Go, we gave guidance of $18 million to $22 million when we purchased this asset. We're on the higher end of that expectation with revenue of $5.4 million here in Q3, and we continue to see positive momentum with V-Go here in Q4, and we're planning to implement this into 60 additional sales reps in January of 2023. We stabilized the TRx decline that's been happening for over 18 months and exited Q3 around 1,200 TRx's a week. There's additional business here that does not show up in Symphony, in distributors, as well as some of the TRICARE accounts. V-Go will be in a P2 position in the Afrezza sales force as we exit this year going into next year. People ask me, what does that mean for product segmentation? We just got the ABC results and market research telling us where we need to fix on Afrezza to continue to accelerate the growth. We expect to focus on 2023 on a narrow focus on a set group of providers that write both V-Go and Afrezza, which is around 3,000 providers. Additionally, we want to make this business cash flow break even and really choose to win where we choose to play. On the Afrezza side, you'll continue to see us focus more on type 1, younger population, commercially insured, endocrinology focused. On the V-Go side, continue to focus on type 2 for patients looking for a simple way to deliver their insulin and basal control. Older population, typically Medicare and endo NP/PA PCP. The bottom right corner shows you Afrezza will be a P1 target for our core sales force. Type 2 will be a P3 target. V-Go will be a position 2 target in that sales force. As we go forward, we're very excited about the Endocrine Business Unit. Our pipeline, I'll talk about at the end of today, as well as the impact Tyvaso is going to have on the future of MannKind. I'm going to turn it over to Steve. Thank you. Thanks, Mike. Good morning. I'm pleased to review select third quarter and September year-to-date financial results. Please supplement this call by reading the condensed consolidated financial statements in MD&A contained in our 10-Q, which was filed with the SEC this morning. This is the first full quarter of revenue activity across all four sources of commercial revenue. Afrezza and V-Go for our Endocrine Business and Tyvaso DPI manufacturing and Tyvaso DPI sales royalties for our orphan lung business. Looking at how our business is growing year-on-year, please focus on the bottom of the table, where it shows we had a 48% increase in total revenues, which amounted to $32.8 million for the third quarter of 2022. Breaking down the third quarter by source of revenue, Afrezza net revenue was $10.8 million versus $9.8 million in 2021, a growth rate of 11%. The increase was mainly driven by price, including a more favorable growth to net percentage and higher patient demand with paid TRx growth of 10%, partially offset by wholesale inventory ordering patterns, which resulted in lower channel inventory levels for the third quarter of 2022. Lower channel inventory levels have been a recurring theme this year, as we have seen channel inventories lowered by approximately $1.1 million in the six-month period ended September 30th, and almost $2 million since a year ago at September 30th, 2021, which has adversely impacted our net revenue growth this year. We believe that the Afrezza channel inventory levels have likely hit their minimum maintenance balances and shouldn't lower much more. Year-to-date Afrezza growth came in at plus 13%, which was mainly due to favorable price, including a more favorable gross net percentage, higher product demand, and a more favorable cartridge mix. Next is our net revenue for V-Go, the recently acquired wearable insulin delivery device, where we had $5.4 million in net revenue for the third quarter and $7.5 million for year to date, which represents the four months of June through September. We expect V-Go net revenue for the 12 months post-acquisition to be in the range of $18 million-$22 million, and we are tracking to the mid to high end of that range. Moving to collaboration services, revenue for the third quarter was $10.3 million, versus $12.5 million for 2021. The main driver of collaboration revenue has shifted from the amortization of United Therapeutics milestones in 2021 to Tyvaso DPI manufacturing revenues in 2022. Included in the third quarter 2022 collaboration and services revenue number of $10.3 million is $9.9 million of Tyvaso DPI manufacturing revenue. The September year-to-date revenue of $18.4 million is mainly lower in 2022 versus 2021 because of the prior year UT milestone amortization in the first half 2022 deferral of revenue associated with the delay in the start of commercial manufacturing. In addition to UT-related revenue recognized in 2022, we had $32.2 million of deferred revenue on the September 30, 2022 balance sheet associated with United Therapeutics, which we recognized the income through 2031, which is the remaining term of the commercial supply agreement with United Therapeutics. Lastly, we recorded royalties on sales of TYVASO DPI by United Therapeutics to their customers. The third quarter was the first full quarter of sales of TYVASO DPI by UT, and we earned $6.2 million of royalties for those sales based on a low double-digit royalty. United Therapeutics released third-quarter earnings last week. They said on their earnings call that the physician engagement and enthusiasm around TYVASO DPI is extremely high, and we continue to manufacture on a 24/7 basis to supply UT. I consider MannKind to be a new commercial growth story. The next slide shows our revenue growth quarter-to-quarter for 2022. Moving from the left to the right, we grew total revenues from $12 million in the first quarter to $18.9 million in the second quarter, a 58% increase. Then grew total revenues from $18.9 million in the second quarter to $32.8 million in the third quarter, a 74% increase. Our quarterly revenues grew almost 3x from first quarter to third quarter. Driving the revenue growth are our three new sources of revenue, TYVASO DPI manufacturing revenue, royalties associated with the sales of TYVASO DPI, and sales of V-Go. We're pretty pumped about the future revenue growth potential across all four revenue streams. Now let's look at the profitability of our endocrine products, Afrezza and V-Go. Afrezza gross margin increased from 61% in the third quarter of 2021 to 81% in the third quarter of 2022. The gross profit associated with Afrezza increased to $8.7 million in the quarter. The increase in the third quarter gross margin versus 2021 was due to an increase in Afrezza sales, coupled with a decrease in the cost of goods sold, mainly due to a decrease in excess manufacturing capacity costs. When looking at the profitability for September 2022 year-to-date, Afrezza had a gross margin of 75% and gross profit of $23.6 million, driven by higher sales and lower cost of goods sold, mainly due to a decrease in excess manufacturing capacity costs and a $2 million fee incurred for an amendment of our insulin supply agreement in the second quarter of 2021. Please note that there will always be some variability in Afrezza gross margin between quarters due to the timing of manufacturing spend and activity, as we are not at maximum production capacity. The far right table shows V-Go September year-to-date gross margin of 44%, which is about where we expected the margin to be. Let me conclude with some final comments around liquidity and performance. We ended the third quarter with $178 million in cash equivalents, and investments. With our growth across all four commercial revenue streams, we're able to invest behind our pipeline and strategically behind Afrezza and V-Go. Our collaboration with UT is tight, and the TYVASO DPI launch is off to a strong start. I feel like the company's turned a corner. We are focused on maximizing the potential of our collaboration with UT. We are focused on profitably growing our endocrine business, and we are focused on developing and bringing innovative products to patients from our emerging pipeline. Thank you, and now I'll turn it back over to Mike to review key milestones and provide a pipeline update. Thank you, Steve. Great summary, great future. Looking over the next 18 months, I'm just going to share a couple things. We have a good purview on the endocrine business unit and where we are with Afrezza. First, we launched a quick start program to get patients started quickly here in Q4 to pilot that as we get ready for next year to scale our business. In 2023, we fully expect that Afrezza will be covered in Medicare at $35 under the Inflation Reduction Act bill that was passed. That changes the game as one of the major objections for Afrezza is around access, and we really want to continue to see that patients only have to pay $35 for Afrezza, and if not insured, we'll have a low-cost cash program available. We expect to finally launch BluHale VIS, which is our patient edition integrated with CGM in Q1 as a pilot with a full-scale launch in Q2 next year, assuming that goes well. Sympla is fully enrolled in our type 2 study, and we expect that readout to happen by Q3 next year. INHALE-1 readout [audio distortion] could happen late Q4 or early Q1 at the latest. I'm going to bridge over to our MannKind pipeline. This is a position that we started three years ago when we looked at the orphan lung business. In 2019, we decided to pivot and focus on orphan lung, as we felt that was the best opportunity to help patients. Hearing the patient stories on nontuberculous mycobacterium, as well as TYVASO DPI, are heartbreaking. We are fundamentally going to extend and enhance people's lives as it comes to using our product and our technology to give them the freedom to live their life. With clofazimine, we are fully engaged in getting this ready for FDA submission in terms of a phase II, hopefully III study. That's one study. On nintedanib, we're progressing that rapidly into a phase I. On 301, the team is working hard on the formulation. We're almost ready to go to the next stage there. The TGF-β will be getting a final study report very shortly in the next couple weeks. On the cannabinoid program, RLS just released recent data, and they're going forward with their second trial. On the Fosun, we continue to watch that progress in the oncology space. One of the things I was talking to some investors yesterday was how do we start to help people understand our pipeline and the opportunity that we're going after. I think this slide is a good summary. You look at NTM, pretty much a big unmet need. Most of the drugs are generic and have severe toxicities. Our market value for this is in the $3 billion-$4 billion range. We look at this as about 58,000 patients, ultra orphan here in the U.S., with 15,000 in treatment, as well as Japan as another large market for this opportunity. In the IPF space, the market is littered with failures. A very tough disease. It's called idiopathic pulmonary fibrosis because it's very hard to treat. It's very hard to diagnose, very hard to get a consistent patient population. We believe the only two products approved are nintedanib and pirfenidone give us an opportunity to reformulate nintedanib in an orphan lung delivered product, where we know one of the very limiting side effects from nintedanib is the dose-related adverse events. They cannot dose much higher. We're excited about this as there's 100,000 patients in IPF who need more options. On the cystic fibrosis side, I was actually privileged to be at the CF conference this past weekend, hearing all the great progress and life expectancy that's been extended in this patient population. Despite the life expectancy extension, there's a subset of patients who will continue to be sick, there's a subset of patients who will continue to have exacerbations and infections. One of the conversations there was the fact that people's lungs are getting better are masking the infections because these patients are no longer producing sputum and how do you continue to treat an infection if you can't culture the sputum? These are great opportunities and challenges to develop drugs in this space. I think they point to the unmet need in the CF community and the interest that the Cystic Fibrosis Foundation has in our product pipeline as we go forward. Every year, we lay out all of our milestones. We feel pretty good that we're on track to hit all of them. Nothing here is surprised. In Q2, we've released the 101. Pretty soon, hopefully we'll have ABC results. The MannKind 501 close will be ensured. Q4, we're lined up to have a great quarter, close out the year strong, get ready for 2023. I'll stop there and get ready for questions. To ask a question, you will need to press star 11 on your telephone. Again, to ask a question, you will need to press star 11 on your telephone. Please stand by while we compile the Q&A roster. Our first question comes from Brandon Folkes with Cantor Fitzgerald. Your line is now open. Hi. Thanks for taking my questions, and congratulations on another very good quarter. Maybe just two from me. You talked about the manufacturing on Tyvaso running 24/7. Can you just give us an update in terms of how it's been with staffing? Obviously, we've had staffing challenges across the board in 2022, but do you have the staff there? Do you have the ability to ramp up should this strong ramp on Tyvaso DPI continue? Then maybe just a point of clarification, sir. I think you mentioned 60 additional sales reps that are going to detail V-Go. Are these current reps that you have detailing Afrezza, or are these new hires to the company? Great, Brandon. Thank you for dialing in this morning. Just to answer that one easily, it's our existing infrastructure. When we bought V-Go, it was not to add a ton of more infrastructure to the diabetes business, but to leverage the existing infrastructure we have. We have 60 current Afrezza salespeople across the country, and we'll be dropping V-Go in that bag around late January. That hopefully clarifies that one. On the Tyvaso 24/7 manufacturing, fortunately, we've had a really good year of staffing, very low turnover relatively to the market. On the ramp, the real issue on the ramp is continued production. I think that's the biggest thing is when equipment starts and stops, that's when we have headaches. When equipment's running 24/7, it actually gets more efficient over time. I think that's really where the team is focused on, is making sure as you ramp up production, that the equipment continues to manufacture and fill cartridges at the rate we need. Hopefully we get better on the supply chain in terms of packaging and shipping to the pharmacies. We don't anticipate having to hire more people in the near term for production outside of the scale-up facility. Remember, we're building a major expansion in Danbury, that facility requires some extra employees next year, which will be reimbursed by UT. Currently, we've already worked with UT to anticipate upside demand, we will make sure we're able to supply that demand in 2023. Thank you for both of those. Do you mind if I just sneak one more in? Why not? Just given your strong cash balance, I know you mentioned getting investors to understand your pipeline. How do you think about capital allocation going forward, just given the strong position you've built in the company on your balance sheet now? That's it for me. Thank you. Yeah. I think that's a question we just had with our board last week around the future of the company, the five-year plan, priorities for investment. I think the way we look at the company is continuing to run the diabetes business on a tight leash in terms of budgets and returns for our money that we're spending there. We think the pipeline has a huge amount of opportunity, and we also will look for external innovation. We haven't really decided on which of those focuses will be priority for 2023, but we do believe Afrezza and V-Go are off to a great start. We do believe there's some milestones in that business unit that will give us some information that should we invest more in 2024? Should we invest harder in pediatrics? Let's get the data. Let's let the data drive some of the uptake of Afrezza as we go forward into 2024. We also believe you'll start to see V-Go as a platform. I think that's something I don't want to talk about now, but as we get ready for next year, that's probably where some of that capital can go, which is how do you repurpose V-Go outside of diabetes? We think it's a platform device that can be leveraged for other products. That's an area that we're looking at. Then I think in the future, is there investments in automation? How do we bring down our cost structure across the company, given the inflation, the impact on employees, and the growth we have? We got to get more efficiencies out of the company. Is there ways to invest to bring more efficiencies in the future? For example, one of the decisions we'll make today is around lab automation and manufacturing automation on data and how that transfers from a manual process to a digital process. Things like that bring efficiencies as we continue to scale the company as we go forward. Steve, I don't know if you have any additional comments on that. That's good, Mike. Thank you. Okay. Hopefully I answered your question, Brandon. Thank you. Thank you to you both, and congratulations on all the progress. Thank you. Thank you. Thank you. Our next question comes from Gregory Renza with RBC Capital Markets. Your line is now open. Greg, good morning, Mike and Steve. Congrats on the progress on the quarter, thanks for taking my question. Mike, just to perhaps piggyback on the previous question when it comes to capacity, I'm just curious if you could maybe provide just some additional color or highlights just on that process through which you intend to meet the advancing demand. Any color on the runway through which you can lock down product currently, how that engagement works, and maybe to be direct, you've mentioned the collaboration with UT is healthy and engaging and strong. I'm just curious, do those engagement points change? Are there ongoing touch points that provide that closeness for anticipating the demand and meeting the supply now that the product is launched and underway, say, versus the previous development process? Thank you very much. Yeah. There's really two things when it comes to production. Number one is how much product can you spray dry, and what does that yield? The second one is how quickly can you fill that cartridge per minute? Currently, there's two different rate-limiting steps in that process. As we continue to build efficiencies on the cartridges per minute, one of the production lines next year that'll be coming online hopefully will be the fill-finish part of the cartridges. Then the rate-limiting step could be how much powder can we produce to fill those cartridges. The other part that's shifted a little bit is the dosing. Probably more naive patients than UT expected. On the flip side, higher dose patients also as they titrate off on ILD. We got both ends of those spectrums and a 64-unit cartridge, for example, requires four times as much powder as a 16 unit. Those are some of the things that drive production volume and time and capacity that we continue to balance as we're in this initial launch phase. The good news is, every week we can adjust that production volume. We can adjust that with the packager. There's no limitations in the short-term that we can see as we continue to watch the launch phase every week. We talk to UT weekly. We feel good about where we are, great communication, collaboration, continue to prioritize the most needed packaging, for example, to get this to patients to make sure there's no stockouts. So far, everything is really tight and going very well. On the capacity side, we ordered equipment. The manufacturing build-out is happening as you saw, we continue to see that the rate limiting factor there is really the construction as opposed to equipment, which is what you hear from many other companies buying stuff these days. We feel pretty good about getting the expansion done next year, getting it ready for 2024. When we built the factory, we anticipated high end of demand from where we are and we anticipated ILD and PH. We have enough production capacity to supply the market from where we are today that we can see. I think that answers the questions there. Absolutely. Thanks so much. Helpful color and congratulations again. Thank you. Thank you, Greg, for coming to business. Thank you. Our next question comes from Steven Lichtman with Oppenheimer. Your line is now open. Hi, this is Ron for Steve Richman. I just wanted to ask if you think you guys can give a bit more of an update on the BluHale launch. Are you seeing any easing on the chip shortages that you spoke about in the past? You gave a new timing for Q2 2023. If you can please remind us about the opportunity you see for BluHale. Thanks. Congrats. Thank you, Ron. I want to make sure I heard your question properly. Sorry. I think you asked for any shortages on Afrezza launch and- No an update on BluHale? Sorry. An update on BluHale, and you talked in the past that some of the issues with the launch were because of chip shortages. Are you seeing any easing with that? Because we heard from other companies that the shortages have been easing up a little bit. I wondered if that affects you as well, and if you can remind us about the opportunity you see for BluHale. Sure. Yeah. BluHale, in terms of large scale production, was limited by chips in the short term. The main chip that we were using became obsolete. We had to reprogram the motherboard and redo all the Bluetooth technology around that. We're on our next iteration that's almost done or should be wrapping up shortly. We have enough units we'll be able to make for Q1 launch. By the time we get before Q2 launch, we believe that chip shortage and parts shortage should be behind us, at least in the short term. That should not be our rate limiting factor. Much more worried about the reliability and consistency of the device, the patient feedback, and the patient experience. We feel like that's the most critical part of BluHale. The prototype looks great. The app looks great. The team did an amazing job. I think it's going to be really nice for patients. We're just working through the last-minute device finalization and technical aspects there, otherwise it looks like it should be ready to go in 2022. Thanks. Just a follow-up. Can you please remind us about the opportunity you guys see for BluHale? Opportunity? I think the real opportunity is as we continue to go deeper in type 1s. We know technology and dosing and feedback loops are important. That's really where we're really repositioning Afrezza. We tried for a long time to help type 2s. The type 2 market got really crowded, especially with the Mounjaro launch. We just feel the best place for Afrezza to win is really in that type 1 market. Yes, we'll be up against insulin pumps and Omnipod, but when we think about Omnipod's success with the pay-as-you-go model, Afrezza fits right into that mindset. I think with the data sets that we're seeing, people do want faster insulin. They do want faster control. They see it on their CGM. We think Afrezza's really well-positioned, and with the PEAK study readout, we think that's only going to reinforce a new data set in type 1s. We also know from the market research that the more doctors get used to type 1, they will by default use it in type 2. Now with V-Go, we think that's a natural segue for them. They've already used insulin. They really like the device, and being able to have a nice simple device for type 2s is a nice growth opportunity. We feel really good about the co-positioning of those assets and really providing a solution for customers, which is not something we always had. Can you hear us? I think Oscar said he can't hear you. Thank you, guys. Thank you so much. Congrats again on the progress. Thank you. Thank you. Our next question comes from Robert Hazlett with BTIG. Your line is now open. Thanks. Thank you for taking the question and congrats on all the progress. It's terrific to see. One or two for me. First on gross margins for V-Go. I think 40%-45% was where you said that came in and that was in line with expectations. Is there an opportunity for expansion of gross margin with that product? Love to hear what the potential is there. Yeah, I think there is. We just met with Jeffrey, the head of manufacturing, yesterday. It's going to require some automation investment, but that's when I think the earlier gentleman asked me on capital allocation. These are the types of things we can now do when we have a two to five-year view on capital allocation. In the short term, it's always hard to make any investments in the company because we were just focused on survival. When you think now, we are focused on gross margin, we are focused on profitability, we are focused on advancing a pipeline. We got to make these plans now as they come to fruition. I think when you look back in the last five years, where we made the risk-based decision to bring TYVASO DPI forward, we made the decision to continue to invest in pediatrics and Afrezza. Those decisions are paying off now, I think the same thing is true over the next three to four years, is V-Go will be here. We expect to invest in that product. You're right, the gross margin can be improved through automation of manufacturing. We're also going to look at gross to nets as we go into 2023 and understand, are we getting the value from the payer that we expect in terms of formulary access and restrictions, or are they making it easy for patients to get access? I think these are all really important attributes to continue to help those two products get more profitable. That's terrific. Then just one on the pipeline with regard to clofazimine. If you could just touch on what the goals are for that program. Is it to reduce the AEs, maybe the skin AEs you see with the product in different routes of administration? What are next steps? Are we going to see any data anytime in the near future in terms of publications of the results you have? Thanks. Yeah. Well, first, I just reviewed a publication last night that's getting accepted to one of the journals, so that's exciting. It's our first animal data, and the reviewer comments were really positive around the unmet need that clofazimine nebulization is going to bring to patients. So I thought that was really positive. The phase I data is just wrapping up and coming in with a complete study report. We'll publish that data as well, showing the dose range and effects and what we see in terms of dosing. Then I think the FDA feedback will be critical here in Q4. We have a meeting set up for late December. That should give us the green light to go forward in the phase II-III design that we've laid out. That doesn't mean the FDA is going to agree with it. It doesn't mean all the endpoints are going to be aligned. We hope to be able to find some commonality with the FDA because there's a big difference with clofazimine or any of the NTM assets between how Japan thinks regulatory-wise from a sputum conversion and the FDA on spill, form, and function. We think clofazimine can improve both, but as you know, this disease is very hard to treat, and it takes a while to get those types of results. It doesn't happen in two to three weeks. That we feel good in terms of what we want to improve on clofazimine. I think clofazimine is an incredible drug that's underappreciated. The number 1 thing as you think about it is accumulation of toxicities because of the long half-life. We really will be reducing that through our dosing regimen and our dose into the lung. I think the skin discoloration, you nailed it. That's a big one for patients. We don't foresee that issue so far in our dosing. We haven't seen any complaints. We don't expect that to be an issue. Really just getting deep into the lung and getting a very high concentration above MIC. We feel like that's going to give patients the effectiveness that they want without the systemic side effects. Lastly, the QT prolongation. That's a known side effect of clofazimine. We have not seen that on our highest dosing patients yet after seven days, and we feel really good about that safety profile given our dose. I think clofazimine overall should be a better, safer product for patients that really treats that lung infection at the site. It's very hard to penetrate from the oral route of administration. We'll see. It's a big unmet need, we think this drug will help a lot of these patients. Terrific. Look forward to more progress there. Thanks. Thank you, Rick. Thank you. Our next question comes from Thomas Smith with SVB Securities. Your line is now open. Hi, everyone. This is Mike on for Tom. Thanks for taking our questions and congrats on a really strong quarter. On TYVASO DPI, can you provide any color on the preliminary commercial and manufacturing trends that you're seeing, and if you'd expect some seasonality in the first quarter of 2023? Are there other dynamics that you've got a flag for investors trying to get a sense of the potential ramp here? Yeah. I think one thing I'll say, Mike, is at least from our investors I've talked with a little bit, people are watching Symphony Health data, and I think that's okay to get some direction, but I don't think UT has a very closed distribution network, so not all those scripts probably show up in the framework out there. We can only say so much, right? This is UT's launch. This is their product, their revenue. We are just the manufacturer and trying to make sure we keep up with their demands and their successful launch. We don't anticipate any problems there. We're doing a decent job. The team really looks at the inventory, the demand, the product shipments every week. A lot of constant communication. I think we're on top of it. Things could always happen beyond our control that we can't see. As of now, I think every week we get orders. We look at the demand. We can adjust our supply chain pretty quickly. It takes about 30 days to get through a batch in terms of we make it, and then by the time it's released and packaged, it's about that time. We can adjust pretty quickly on that demand forecast. I think what you heard from UT, which I thought was very encouraging, is of the patient referrals coming in, 50% were for nebulizer, 50% were for DPI. I thought that was a fairly good statistic because we know that this is going to continue to grow. It's going to be a billion-dollar-plus product, and how much of that becomes DPI is the billion-dollar question. Obviously, we feel pretty good about that. If you heard the patient stories and freedom that they're getting, I think it's going to be a no-brainer that more and more people want this. I think the other question I get around this topic is Where do you see the market? I think that the good news is the Medicare Part D, I know that's one of the reasons UT feels there's some limitational conversion, but that hole closes in 2025. Those patient out-of-pocket costs will be capped about $125 a month, roughly. That will create the next leg up. Anyone that doesn't convert that's on Medicare, for example, will have that opportunity in the next 24 months to get there. This is a tough disease. People are going to die, and they don't want to die. They really want to extend their life, enhance their life for the remaining years they have. TYVASO DPI is doing an amazing job changing those lives. I just wish our shareholders and our investors, and our analysts could hear the stories of the patients and the doctors have been extremely motivating and positive, and our team is so encouraged by the feedback that's happening. It just gives that much more motivation for our pipeline because we really are changing lives and extending lives. It's just super exciting times here. Got it. Yeah, really appreciate the helpful commentary there. Just a separate one from me. With respect to Afrezza, you really did a nice job laying out the important milestones that you have coming up there. Is there a certain one in particular, either clinical or regulatory, that you think could be important for seeing that next leg of growth for product sales? I think next year is really an execution year. Every year we try to do something different to try to spike growth on Afrezza, and we just seem to trot along. COVID hits for a couple of years, and I don't think it's fair to investors to keep guessing where Afrezza is going to go. What we really have done for the business is purchasing V-Go, integrating those two next year, and really just focus on execution and alignment. If we have an asset and a franchise that's going to do $80 million-$100 million in growth, 10%, 20% a year for the foreseeable future, that's a good business for MannKind. We will continue to hope that the data readouts demonstrate upside opportunities, but I think being real about where we are, if there's much time of getting this to be a profitable division for the company, helping as many patients as we can, and really placing some strategic bets, and pediatrics is one of them. We believe kids is where you're going to change type 1 care. We think being able to show you're as good as an AID system will be important. Those are the attributes that we're focused on. Those aren't going to happen in the next six months. Those are really the key milestones we're looking at saying, how does Afrezza do in kids? Is that really going to be the game-changing opportunity to transform growth to 2024? The data readout in India will be important, a little less so important, meaning, I think important for India, we're really focused Afrezza on type 1s. The India studies for type 2s, that'll be nice to have as additional data set to support what we think is a great drug for type 2s. Recognizing, there's 1.5 million people live with type 1 diabetes. They're half the insulin market. We got to nail the kids opportunity first to get that really foundation built, work with JDRF a lot more in the patient walks, and raising our awareness out there in the society. There's still too many patients not aware in type 1 especially, that inhaled insulin is an option. We think when we look at next year, it's really about making sure Afrezza is a choice amongst the doctors that we're targeting. I just think we're not in the choice set. We're like number 8 out of the 8 things they could do, we got to move up that ladder a little bit. Year by year, we'll get better from here on out. We have a map, we have a plan, we got the team to do it, I feel very good about 2023 with the team we have. Great. Well, thanks very much again for the color, congrats on the strong quarter. Thank you. Thank you. Nothing. I would now like to turn the conference back over to Michael Castagna, CEO, for closing remarks. Thank you, Daniel. Overall, monumental quarter for the company. Super excited about where we are with Tyvaso. The company is in the best shape it's ever been. We got the best talent we could possibly have. We feel really, really good about our future. We continue to make change and pivot us for the next five years. Afrezza and V-Go will be great in 2023 in terms of pivoting to an endocrine focus, making sure that business is a cash flow positive unit by the end of the year. I think on the pipeline, you're going to see really nice progress over the next 12 months of moving assets from preclinical formulation stage into phase I, phase II, phase III, and we think that's going to be a monumental opportunity for investors to start to really understand that value. Just like Tyvaso, for years, we had signed a deal with UT in 2018. No one really appreciated it until probably 2021. I think when you look at the pipeline, we started this progress in 2019. I don't think we have a lot of value or attributes on the pipeline. I think you're going to start to see that come out over the next couple of quarters, and we think that's a nice upside for investors from where we are and ultimately position the future of the company. Then Tyvaso is just going to continue to rock the world. It's just a great product. It's helping a lot of patients. UT is doing an amazing job, and we will do everything we can to make sure we stay ahead of the demand curve and build that inventory to make sure we can supply the patients. Overall great year. Company's well-positioned for 2023 to be a great year. It's a tough economy, tough biotech investors, but we feel MannKind's well-positioned for investors, that double-digit growth for the foreseeable future. We're very excited about where we are. Thank you. Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.