MannKind - Q3 2023

Transcript

Moderator (participant)

Good afternoon, and welcome to the MannKind Corporation 2023 third quarter financial results earnings call. As a reminder, this call is being recorded on November 7th, 2023, and will be available for playback on the MannKind Corporation website shortly after the conclusion of this call until November 21st, 2023. 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 afternoon, 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 conference over to Mr. Castagna. Please go ahead, sir.

Michael Castagna (CEO)

Thank you, DeeDee. Thank you all for joining us today. It's been six years since Steve and I became CEO and CFO. We've turned this company from losing well over $100 million a year to our first profitable quarter in our history. We've helped over 20,000 people on a MannKind manufactured product last quarter, and our pipeline is moving faster than ever to help more as we continue to live our mission to help patients live a better life.

As you think about our highlights this quarter, we've made great progress on the clinical and financial aspects of our company. In the orphan lung space, we've seen Tyvaso royalty revenue of over $20 million and manufacturing of $13 million. On the pipeline, MannKind 101 cannot be in a better position.

We came from our last earnings call when we just had learned of a fire in our facility, our partnership in Germany, to successfully moving CMC here in Danbury, and we've manufactured our first clinical batch in record time. On MannKind 201, our nintedanib program has continued to progress towards filing an IND and starting our Phase I trial in the first half of 2024.

Feedback from our thought leaders has been very positive on this program, and we're excited to get this into humans as quickly as possible. On the endocrine business, we've achieved our first quarterly positive contribution. This is one quarter ahead of our expected Q4 goal. We made $500,000 in Q3 of this year. That was driven by our Afrezza 24% growth year-over-year.

As we think about INHALE-1 and INHALE-3, we are super excited on the clinical progress these two trials have made, as they are pivotal for our future in the diabetes business. On INHALE-1, we achieved our pre-specified interim analysis, which was run when we hit 50% enrollment to determine the size of the trial was appropriate or not. We now expect to finish up enrollment and continue to progress this trial for filing, hopefully in 2025.

As we look at INHALE-3, this was an incredibly exciting trial. I'll talk a little bit more about it, but we are two months ahead of plan enrollment and on the financial income, net income of $2 million, and we've also began paying down our MidCap debt. We are continuing to deleverage our company so we can drive greater shareholder value.

This way, we continue to free up cash flow to drive future growth by reducing our interest expense. As we look at Tyvaso, many of you may recall from the last quarter when there were some questions around what happened at the end of Q2 in the inventory and the $30 million number we heard from United Therapeutics.

So what we plotted here was a continued quarter-over-quarter, including that $30 million, now that it's transparent of what our royalty rate is. We can show you the breakdown between what $30 million would mean to MannKind in terms of our royalty rate on those $30 million in sales and when you look, patient demand continues to be very strong quarter-over-quarter since launch of last year.

The next question I often get is around manufacturing, and I would like to hopefully put this to bed as we go forward for shareholders. As we exit 2023, we expect our new fill finish to come online for 2024, improving our ability to build inventory and supply the market growth for many years to come.

As you look out, we expect new bulk capacity to come on in the second half of next year, continuing to bring more efficiency and more upside production as UT gets ready to wrap up their IPF trial, hopefully showing a positive impact for patients. As we look out, you'll see MannKind can make 25,000-35,000 patients a year we can serve with our manufacturing capacity, and we can build that up to 35,000-50,000 through additional efficiencies without any additional manufacturing plans.

As you all know, the IPF market is well over 100,000 patients, and UT will be able to supply to the upside scenarios in addition to what we can manufacture. We're extremely grateful that United is investing over $500 million in CapEx to duplicate our facility there in North Carolina. We look forward to supporting them on that transition.

As we look to turn back to MannKind, MannKind 101, we've made our first batch since the fire. This is amazing work by our team in Danbury, who did this in record time on top of the build-out of Tyvaso, on top of the progress of the pipeline, getting ready for IND. We expect chronic tox data here this quarter, as well as FDA feedback on our final protocol design.

All this will put us on track to start our Phase II/III trial in the second quarter of next year. Here's a nice, beautiful picture of our first 1,000 vials coming off our production line. Thank you to the team in Danbury for incredible work. Now, if I bridge to Afrezza, we hear a lot of noise about GLPs and the impact they may or may not be having on various aspects of the healthcare system and/or consumer.

It's a lot of noise, but you can see not much impact on Afrezza and due to the main change here in Q2 to Q3 was self-driven, but the overall insulin market in the gray line, you can see the insulin market year-over-year is relatively flat to a small single-digit decline.

On Afrezza, year-over-year, we had growth, but in Q2 to Q3, we made significant changes to our infrastructure to drive our focus to profitability. Number one, we decreased our T&E. We changed our salesforce bonus structure. We actually are in the process of moving our marketing team from California to Danbury, and we merged two salesforces into one that impacted over 30% of all territories.

The new team is now in place. We've put some incentives here in Q4 to close the year strong, but this impact has nothing to do with GLPs and has everything to do with internal change to set us up for 2024. The next slide you can see here is our first nine months, year-over-year, comparing the first nine months of each year since we launched the product as MannKind in 2017.

I'm really excited to see that we've doubled our growth over last year when you look at 2021-2022 versus 2022-2023. Significant growth driven by our Medicare Part D $35 insulin program that was part of the IRA with the government. As we've refocused back on INHALE-1, this is our pediatric trial, where we met the sample size we originally projected.

One outcome could it be we needed more patients, and that would have dragged on the length of this trial. We now expect completion to happen, and this is very positive as we can wrap up this trial next year and start to prepare for launch.

As you may or may not realize, most type 1 diabetes innovation has happened in kids, whether it's been Omnipod with the Podders, Dexcom with CGM, or insulin pumps that our founder, Alfred E. Mann, built.

As I bridge over to INHALE-3, here we are, who would thought, 20 years later, running one of the largest switch trials in type 1 diabetes away from the standard of care, which is including the AID automated insulin pumps, where half the patients in this trial are on an AID system and switching in record time. We're using the latest CGM technology with G7, and we're also including 20% of people whose A1C is less than seven.

This is gonna show you whether you are at goal or above goal, how can you best use Afrezza in a once-a-week, sorry, in a daily Tresiba, to show how you can maintain control or improve control, hopefully, with less hypoglycemia. These are top-tier sites, and we are well ahead of schedule and looking forward to releasing this data in Q1 and Q2 of next year.

Flipping the card over here to V-Go, the decline in V-Go has been abated after a two-year decline. We are focused on improving the margin for 2024. As you will hear from Steve, our gross-to-nets went from 49%-58%, mainly because of rebates. We've now started the process of changing these contracts and improving them, and we'll provide guidance on our next call, as we're in the middle of negotiation.

However, we've had some early wins with Kaiser and some of the DME suppliers and are now working on the PBMs. So we'll continue to watch this closely, but V-Go, we believe we can continue to drive demand and improve the margins as we go forward. Now, I'd like to turn it over to Steve. Thank you.

Steven Binder (CFO)

Thanks, Mike, and good afternoon. I'm pleased to review select third quarter 2023 financial results. Please supplement this call by reading the condensed consolidated financial statements, and MD&A contains our 10-Q, which was filed with the SEC this afternoon. Let's start by looking at the total revenues at the bottom of the table.

Our total revenues grew 56% versus third quarter 2022, and 121% for the nine months ended versus the same period in 2022, which highlights the second quarter 2022 launch and the subsequent revenue growth associated with Tyvaso DPI, and to a lesser extent, our endocrine business, which included the results of the V-Go product acquisition from May 31, 2022. Focusing on revenues from our collaboration with UT.

Revenues totaled $33 million in the third quarter of 2023, which consists of royalties of $20 million and collaboration services revenues of $13 million. Royalties earned in the net sales of Tyvaso DPI of $20 million was a result of continued strong patient demand for an innovative product. We recorded $13 million of collaboration and services revenue, which is primarily related to revenue associated with manufacturing Tyvaso DPI.

This revenue grew 27% over the prior year as we sold more product at a higher price to United Therapeutics. For the September 2023 year-to-date period, total revenues from our collaboration with UT were $87 million, as compared to $25 million for the first nine months of 2022, representing strong patient demand for Tyvaso DPI.

Additionally, the 2022 nine-month period included the start of commercial manufacturing of Tyvaso by MannKind midway through the second quarter and the commercial launch of the product by UT toward the end of the second quarter. Moving down the table to our endocrine business. Total endocrine revenues were $18 million.

Afrezza net revenue of $13 million compares to $11 million in 2022, a growth rate of 24%, which is fairly consistent with our first and second quarter 2023 growth rates. The growth was mainly driven by a higher patient demand, with underlying paid TRx growth of 12% year-over-year, a lower gross-to-net deduction and price.

For the nine-month period ending September 30th, 2023, the 26% increase was mainly related to increased volume from higher patient demand, with underlying paid TRx growth of 18% price and a more favorable gross-to-net adjustment. Net revenue from V-Go was $4 million for the third quarter of 2023. Revenues were 18% lower versus 2022, primarily due to a lower level of patient demand.

However, we have stopped the downward trend as TRx has been about the same amount for each of the first three quarters of 2023. For the nine-month period ending September 30th, the 92% increase is primarily related to the purchase of V-Go on May 31st, 2022, so the increase over 2022 is mainly from a four-month versus nine-month comparative.

The next slide shows our revenue growth by source on a quarter-by-quarter basis from the first quarter of 2022 through the third quarter of 2023. We'd like to show this graph because it highlights how dramatically our business has changed in the last two years and how we are executing against expectations. As Mike pointed out earlier, the royalties from Tyvaso DPI have been growing steadily since launch and the fastest-growing revenue source in our portfolio.

United Therapeutics management stated during their second quarter earnings call that approximately $30 million of Tyvaso DPI sales in the second quarter related to specialty pharmacies purchasing product to enable them to get through their contractual inventory levels. Then the third quarter call, held last week, UT stated that the Tyvaso DPI revenues for the third quarter generally reflected patient demand.

We have denoted the royalty associated with the specialty pharmacy inventory stocking on the chart in the second quarter 2023 bar, which allows for a clearer demonstration of the royalty-related demand growth by quarter.

Based on our third quarter revenues, we have a current run rate of over $200 million, of which approximately 40% represents royalties, which do not have any offsetting expenses, therefore falling straight to the bottom line with the associated cash flow used to fund our pipeline and reduce debt.

Below the graph, I have plotted the earnings or loss per share for each quarter, and you can see the impact from the increasing revenues. In the third quarter, we recognized earnings per share of $0.01. This is not a typo. We have hit a significant financial milestone.

We have now entered a period where we expect to bounce back and forth between earnings and loss per share. I'll call it a break-even period, and then we expect to grow earnings per share, assuming Tyvaso DPI continues its upward trajectory and the endocrine business unit increases its positive contribution.

The following GAAP to not-GAAP presentation was started in the second quarter of this year to better highlight the non-cash impacts of certain items to our P&L. In the third quarter of 2023, we reached the milestone of positive GAAP net income of $2 million, while a year ago, looking at the right column, we had a GAAP net loss of $14 million.

When we adjust the 2023 third quarter GAAP net income for non-cash items of stock compensation and a gain on foreign currency, we had net non-GAAP net income of $4 million for the third quarter 2023. As highlighted earlier, we expect to be ± GAAP break even for a number of quarters before we expect to see net income growing on a continuous basis.

I will conclude with some additional comments. In the third quarter, we started to pay down our senior secured debt based on our contractual obligation to pay the loan over 24 months, beginning in September, and we expect to be able to pay off this debt over the next two years out of operating cash flow.

We continue to tightly manage our cash flows and had a reduction in cash and investments of only $2 million in the third quarter, as we expect to progress towards achieving positive operating cash flow in the near future. Thank you, and now I'll turn it back over to Mike.

Michael Castagna (CEO)

Thank you, Steve. There's never been a better time for MannKind employees, shareholders, and partners. We're in the strongest position we've been, and we're well diversified as we look out, whether it's our in-line brand opportunities, our pipeline opportunities, or Tyvaso DPI growth, in addition to any other business development things that come our way.

We're super excited at the orphan lung business as we look at IPF and specifically the nintedanib and the TGF-beta programs. These are programs that have moved up in the priority list in terms of treatments coming down the pipeline in IPF, as we've had so many failures, which is not good for patients, but unfortunately good for MannKind, as we are now closer than ever to help more people in IPF.

We feel very strongly that MannKind 201 can provide a differentiated product for those people on a drug that's already approved on the market, but lowering the dose and deliver it directly into the lung, we think will provide a huge benefit around the GI side effects and hopefully efficacy as people can dose higher.

There's been over $400 million in the last year just in funding an ALK-5 inhibitor, as well as other, inhaled therapeutics around the nintedanib or pirfenidone. As we look at the next three quarters, I wanted to share with you the endocrine updates here, as well as orphan lung. Our 2024 milestones will be shared on the next call, but for now, today, as we look out this year, we've completed everything we've said we are, and we're on track to wrap up the year strong.

Andy is on track to file our the regulatory submission there for India, which will be an approval, if all goes well, in 2024. INHALE-1 will be fully randomized and hopefully reading out sometime next year, and INHALE-3 will be read out hopefully by March, April timeframe. On the orphan lung, 101 is on track for submission, and we expect to initiate that trial in Q2, and 201 IND submission is on track, and we'll be doing that study in phase I healthy volunteers early next year. We've been near death, and we take seriously our fiduciary responsibility to shareholders.

As we think about our future expense management, capital allocation is the number one most critical thing we have to do, which is really about deleveraging the company, investing in our growth drivers, and improving shareholder value. There are many shots on goal to think about as we close up today's call and get ready for Q&A.

Number one, MNKD-101, and the NTM is a real unmet need. Just to put some context here, for every 1,000 patients we get, it's approximately $100 million in revenue. MNKD-201 has huge upside. Until we get this through Phase I, I don't want to guess how big this could be, but it could be a nice, huge inflection for our company and our patients.

Tyvaso DPI, we can't always guess where that will be, but as you know, UT has a goal for 25,000 patients in 25, and shareholders can guess is that 10,000, 20,000, what that means for Tyvaso. What it does mean is $250 million-$300 million in revenue for every 10,000 covered patients.

We're super excited and anxiously await the UT Teton study readouts for IPF, and as we get really excited now about our pediatric INHALE-1, continued V-Go stabilization and hopefully growth, and our pump sparing trial and INHALE-3, as well as an opportunity to bring Afrezza to patients around the world. Thank you again for your patience.

It's been a long quarter, and apologize about our stock price, not anything we can see what caused the decline in the last day or so, but we'll continue to progress on everything we can to make this a great company and a great investment for shareholders. Thank you. We'll now take Q&A.

Moderator (participant)

Thank you. As a reminder to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. One moment for our first question. Our first question comes from Gregory Renza of RBC Capital Markets.

Gregory Renza (Director and Senior Analyst, Biotechnology Equity Research)

Great. Good evening, Michael, congrats on the progress to date, and thanks for taking my question. As you certainly have that commitment to the manufacturing on DPI and kind of get that in the right place, I just wanted to ask a little bit on Afrezza, and while you're guiding to sort of the inhale series of trials.

Just curious if you can articulate just a little bit about how you see that actually shaping the trajectory of Afrezza, and depending on the outcomes of one and three, how will that kind of shape your commitment to the endocrine business and to Afrezza itself?

Michael Castagna (CEO)

Hey, Greg-Gregory, great questions. I think the data is going to drive some of these decisions, right? The good news of MannKind, we have the capital to place bets if we see opportunities to grow faster. We are our goal is to run the business to profitability, but if we can see a way to cause a major inflection into that growth curve after all this time.

I think we'd be more than excited to place that bet, to show shareholders what can really happen with Afrezza. The INHALE-3 trial is a groundbreaking trial in our mind. It's one of the largest switch trials done, and it's got the new dosing regimen.

I didn't talk about that, but one of the things we got the FDA to agree to is we could basically double the dose upfront, and we're testing the first dose in the office to ensure patient safety and comfort. We're hopefully able to see, and we've already run those presentations, that we are crushing the first two hours of postprandial control.

Now, if that carries out through a trial over 12-14 weeks or six months, that should provide opportunity for improved time in range, lower hypoglycemia, as well as, hopefully better overall efficacy and tolerability and sustainability on the product. So the trial results are going to drive a big part of that outcome, but we've done everything we can after all these years.

These are the pivotal trials I would have loved to do years ago, but it's a stepwise way to work with the FDA to get the dosing right, to get the thought leaders right. These are U.S. trials. When you think about it, we have 60 trials, top centers in the U.S., many academic centers. These people have never had real exposure with inhaled insulin, so it's a real opportunity to change our future, and I think we need the good data to support that.

But I think we've done everything we can to make sure the data is the best, best outcome we could possibly hope for and we'll be ready to call that inflection if we get good supporting data behind it.

Gregory Renza (Director and Senior Analyst, Biotechnology Equity Research)

Got it. No, that makes sense. Maybe just one more, maybe even for Steve, perhaps, but just remind us on the economics on DPI, just for our own modeling purposes, so we kind of get that right and to what extent are the royalties fixed, dynamic, and just how that flows through? Thanks again, guys, and congrats on the progress.

Michael Castagna (CEO)

Thank you, Greg. I'll turn it over to Steve.

Steven Binder (CFO)

Thanks, Greg. We have two pieces to our contract with United Therapeutics that show up in our PNL. The first under collaboration services revenue is the revenue associated with the manufacturing of the Tyvaso DPI product. That is on a cost plus basis. If you look in the PNL, you'll see revenues and the costs associated, and you'll see a margin a little over 20% for collaboration services this quarter.

That fluctuates up and down, depending upon our revenue recognition with United Therapeutics and some other areas outside of the actual manufacturing of the product. The other is royalties. Our royalty rate is 10% on net sales, and that's the net sales for United Therapeutics of Tyvaso DPI to their customers.

Michael Castagna (CEO)

Does not vary by sales threshold.

Gregory Renza (Director and Senior Analyst, Biotechnology Equity Research)

That's great. Thanks again, guys.

Steven Binder (CFO)

Thanks, Greg.

Michael Castagna (CEO)

Thank you, Greg.

Moderator (participant)

Thank you. One moment for our next question. Our next question comes from Ron Feiner of Oppenheimer.

Ron Feiner (Equity Research Associate)

Hi, guys. This is Ron on for Steve. Congrats on the quarter. Just wanted to ask about gross margin. It was really strong again this quarter. If you guys can give us a little bit about your outlook for margins, sequentially and into 2024? Thanks.

Michael Castagna (CEO)

Thanks, Ron. The margin this quarter for our commercial products is 78%. It was up sequentially from previous quarters, mainly around two things happening. One is we're getting a better handle on our margin for the V-Go product.

The second is we're getting increased efficiencies in Afrezza as the factory is producing both Afrezza and Tyvaso DPI. So we don't give forward-looking statements, but I think that the 78% feels in the right territory for right now. So I think it's a, it's a good number, if you're thinking about modeling going forward.

Ron Feiner (Equity Research Associate)

Thanks. Then maybe one more. Are you guys modeling in any impact from GLP-1s on your diabetes business and, you know, now and for the future, are you seeing any impact? Maybe on any of the products in the pipeline, are you thinking about something like that? Thanks.

Michael Castagna (CEO)

So when you look at Afrezza, about 55% of our business is Type two, and 45% is Type one. That fluctuates from time to time, but in general, our focus since last year has been growing the Type one market, and our clinical trials around Type one. The reason that's important is GLPs are not going to change a Type one's patient need for insulin in a meaningful way.

So as you think about the Type two market, eventually, most patients are still going to need mealtime control. So even if they go on GLPs, we already knew there was a 7-10 year delay from the time somebody needs mealtime control to when they get it and my guess is GLPs are just going to push that off a year or two.

But as you can see, the insulin market and the diabetes market is continuing to grow. It's a pandemic in this country, and I don't see a need for insulin going away. Will the growth slow because of GLPs? Absolutely. But will that impact Afrezza? Absolutely not. I don't see that as a major impact, given that we have less than 1% of the share where we target doctors and 0.2% in the whole country.

So we've been able to increase our market share significantly where we put reps versus when we don't. But the GLPs are used much earlier, and our population is much sicker. So we just have a very different segmentation of where Afrezza plays, and we don't expect much impact there.

Ron Feiner (Equity Research Associate)

Great. That's very helpful. Thank you, guys.

Michael Castagna (CEO)

Thank you.

Moderator (participant)

Thank you. One moment for our next question. Our next question comes from Oren Livnat of HC Wainwright.

Oren Livnat (Managing Director, Senior Equity Research Analyst)

Thanks, guys. I have a few questions. It's an exciting time indeed for someone who's covered the name through the tough times. First, just to clarify, quickly on the discussion around the transitional period, this breakeven period you talked about sort of fluctuating back and forth. Is that for non-GAAP as well, or is that just a GAAP number and is that just a function of R&D investment timing, or is potentially even just gross profit going to be lumpy around here into 2022?

Michael Castagna (CEO)

Yeah. So, Oren, without getting really specific, it's probably going to be for GAAP and non-GAAP because you can see there's not a tremendous amount of amounts that go between the two, and we've got this foreign exchange gain or loss, depending upon the U.S. dollar-euro exchange rate, because our purchase commitment for insulin is done in euros, so that can swing in one direction or another over a quarter by $2 million, $3 million, or $4 million.

So I think if you just over the next few quarters, we're going to jump back and forth. We're going to be spending a little bit more on R&D, as you would expect, based on what Mike presented on the pipeline. But we're going to have revenues that are growing at the same time, in particular, or expect revenues to grow at the same time, for Tyvaso DPI royalties in particular, as well as our endocrine business.

Oren Livnat (Managing Director, Senior Equity Research Analyst)

Got it.

Michael Castagna (CEO)

I think some of the timing of the FDA feedback and when those R&D expenses kick in, some of that'll be a GAAP issue, some will be a cash flow issue, but in general, we got enough cash to fund those things. But until we get some of the FDA clarity and the INDs filed and approved, that's just going to give us a little bit of fluctuation.

Oren Livnat (Managing Director, Senior Equity Research Analyst)

Got you. Got you. Talking about Inhale, I guess the pump switch study in particular. I think we talked about this last quarter, but can you remind me, you know, what do you think is the biggest--assuming the data is compelling and what you hope to see, what do you think the biggest immediate impact from that is?

Is it the education and awareness, hopefully dramatically increasing among physicians and type one patients as a result or is perhaps the bigger lever here, the pharmacoeconomic argument you may be able to make with payers, or hopefully, would be able to make with payers with regards to relative costs of expensive pumps and whether that might get you a significantly better access over time? nd I do have one more follow-up. Thanks.

Michael Castagna (CEO)

Yeah. I think there's a couple of things, Oren, you hit on a couple of them. The first is lung safety. So getting into kids and showing expected lung outcomes that we would expect in Afrezza. Some of our latest data on FEV1 changes has shown that the control arm is worse than the Afrezza arm.

So I think really showing new lung data and the reversibility of that is going to be really important, and we feel like we've now measured this in a certain way to make it consistent in each trial and timing that reversibility. So that's going to be an important endpoint, combined with having a good pediatric outcome for FDA review and approval.

Those couple of things will give us a huge halo effect after you know, next year will be 10 years since FDA approval of Afrezza, and that will give us hopefully the length of time on the market, the lack of any safety and surveillance, plus these new trial readouts. I think are all going to be really critical.

Then there's two other things I would add, or three other things. Number one is education. We have now really world-renowned thought leaders and academic centers running these trials, who can now be on podiums, who can now be on publications, who can now do CME that we just didn't have before and I think that's gonna be critical in conjunction with marketing and sales training.

We're really putting a lot of investment in our sales force right now on training, skill sets, clinical knowledge, and really teaching them how a patient lives with type one, understanding the insulin pumps and what that's gonna mean to a patient and how they position Afrezza in that market.

Then as we think about Europe, I do think the INHALE-3 trial will be really important to think about the pharmacoeconomics, because in Europe, they do care about the total cost of care being hypoglycemia, medical, as well as pharmacy and I do think if we can show, you know, pretty good outcomes with a pump or without a pump, that it doesn't have to be better, it just has to be as good as.

There's a significant cost to consumers as well as society for these insulin pumps and pods, and that's gonna be something important as we look at Germany, Italy, U.K. They're paying more and more for diabetes technology, and we think now is the time to bring new innovation to Europe as well.

But having this data set and the pediatric data set will be important for the global market, not just the U.S. market, but it'll help us in the U.S. I can tell you, I just talked to some of the payers this past week, and we expect continued Medicare coverage. In fact, we got Medicare to update their website last week around inhaled insulin being covered for 2024 because of the IRA impact. We know that the price of insulin is coming down. We don't expect any negative formulary positions against us.

I think as we go into 2025, we'll look at how to use V-Go and Afrezza to open up access together. 2024 is gonna be a transition year for everybody, given the IRA impact on society and drug companies and discounts and PBMs. A lot of confusion happening for 2024, getting ready for 2025. So, that dust will settle. But we expect Afrezza to continue to have a good formulary coverage as well as V-Go as we go forward.

Oren Livnat (Managing Director, Senior Equity Research Analyst)

Okay, you anticipated my next question. Just regarding IRA, it sounds like for the endocrine business, you know, it's a little bit uncertain, pushes and pulls there. But, for Tyvaso DPI, I know that's years through its launch, but is your understanding that that is only a tailwind as far as to whatever extent it has any impact in 2024?

Michael Castagna (CEO)

Yeah, I don't—I mean, I think I'll let UT comment, obviously, for their future Tyvaso, but what I would say is the Medicare Part D, which is, you know, Tyvaso was a Part B for nebulized, and the Part D is what the inhaled version is covered for DPI and so those patients right now have a huge out-of-pocket cost, which does prevent some of them from switching over.

So as you think about Tyvaso going in the next year and the following year, that out-of-pocket cost should be capped at roughly around $3,000 next year and $2,000 the following year, if I recall and hopefully, that will help continue to provide incremental demand beyond our current trends for Tyvaso DPI. So that's something we anticipate as we go forward, that should be a net benefit to patients as you cap those costs, as well.

Oren Livnat (Managing Director, Senior Equity Research Analyst)

All right, thanks. Appreciate it.

Michael Castagna (CEO)

Thank you.

Moderator (participant)

Thank you. As a reminder to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. One moment for our next question. Our next, our next question comes from Andreas Argirides of Wedbush Securities.

Andreas Argyrides (Equity Research Analyst)

Yeah, good afternoon, and thanks for taking my questions here. Congrats on all the progress. Just two questions from us. The company's transformation to an orphan lung story is certainly exciting. Can you provide us with the next steps for submitting INDs for 101 and NTM and 201 and IPF, and then also how you guys are thinking about the Phase II, III trial design, endpoint, treatment duration, et cetera? Thank you.

Michael Castagna (CEO)

I wanna make sure I heard your questions. A little fuzzy on my side. So INDs and Phase II, III design. So on the INDs, we are, the number one long pole in the tent is the manufacturing stability, so everything else is pretty much on track to be ready in terms of study reports or filing for the IND and I remember we were trying to get that filed for Q4, so we were pretty well on our way for that. So at this point, it's really can we bridge some of the clinical supplies from Germany to the U.S. for the dating and for the inventory for the clinical trial?

So that's for 101, and that that's on track for an early Q1, mid-Q1, I'll say, filing, but if we can find a way to get there faster based on our FDA meeting we have coming up, that's we will do that. On the 201, it's just making the clinical supplies, which are in the process right now, and getting those up on stability, in terms of getting the three-month data we need to file that IND.

But both of those are on track. It's mainly around just making sure the manufacturing is up and running. Unfortunately, the team that's making 201 had to make 101 on top of everything else, and so, you know, they're stacked on top of each other, but they're working hard to get them both ready for IND filing.

So those are the main things, that are the last steps here. All the talks and everything else pretty much is ready to go. The Phase II, III design, we actually have an upcoming FDA meeting where I'll provide more clarity after that, because we're going to the FDA to try to change a few things we have previously, we're focused on looking at the new ARIC case data that just came out with their quality of life, as well as some of the dosing.

We think there's a way to continue to streamline these trials. As you may or may not know, we hired a new head of R&D, Dr. Burkhard, and he joined us back in May. So we've taken a fresh look at all the programs, the trials, the FDA feedback, and there's a few things we thought could be a little bit clearer and ensure the trials go as smoothly as possible, as fast as possible. So we'll get that feedback in the next month, and we'll share those updates, hopefully, J.P. Morgan, on the official trial design that we're comfortable with.

Andreas Argyrides (Equity Research Analyst)

Okay, great. Appreciate the color, and congrats on all the progress. Thanks.

Michael Castagna (CEO)

Thank you.

Moderator (participant)

Thank you. I'm showing no further questions at this time. I would like to turn it back to Michael Castagna, CEO, for closing remarks.

Michael Castagna (CEO)

Just thank you, everyone. I think you can see we've made a lot of progress. We continue to grow our revenue, we continue to help more patients, and we continue to move the pipeline forward and really, our goal to improve our mission, to give people control of their health and the freedom to live their life.

As you look at each of our targets, these people are really suffering, and in some cases, they have three to five years to live. So every day counts to get these patients our treatments as soon as possible, safely and effectively in the clinical trials to hopefully get them to the market. Thank you, everyone, for everything. We look forward to closing out the year strong, and we'll provide continued updates as news comes in. Thank you again.

Moderator (participant)

This concludes today's conference call. Thank you for participating, and you may now disconnect.