MannKind Corp

NASDAQ:MNKD

Earnings Call Analysis

MannKind Sees Record Revenue Growth and Promising Pipeline

In Q2 2024, MannKind achieved a record $72 million in revenue, marking a 49% increase from the previous year. While the company reported a GAAP net loss of $2 million, the non-GAAP net income stood at $14 million. Key growth drivers included revenues from Tyvaso DPI royalties and Afrezza. MannKind also paid down significant debt, strengthening its balance sheet. The company is optimistic about the future, expecting continued revenue growth and successful readouts from key clinical trials in the coming year.

Record Revenues and Growth

MannKind Corporation achieved significant financial milestones in Q2 2024, reporting total revenues of $72 million, a striking 49% increase from the same quarter in 2023. This growth marks the ninth consecutive quarter of sequential revenue growth, with total revenues for the first half of 2024 reaching $139 million, up 55% compared to the previous year. The increase is largely attributed to strong performances from Tyvaso DPI and Afrezza, highlighting the robust demand for these products.

Diverse Revenue Streams

Tyvaso DPI was a key driver, contributing $26 million in revenue for Q2 2024, a 34% increase year-over-year. Additionally, collaboration and services revenue soared by 132% to $26 million, due to increased manufacturing activity. Afrezza, however, saw a more modest growth of 20%, totaling $16 million in the quarter, attributed to a lower gross-to-net percentage and a price adjustment.

Strategic Focus on Pipeline Development

MannKind is not just focused on its current offerings; it is actively expanding its pipeline. The FDA has granted Fast Track Designation for clofazimine inhalation suspension. With sites activated and ready for patient enrollment, MannKind sees significant potential in targeting the refractory population. Furthermore, nintedanib DPI is progressing, with results expected in Q4 2024, highlighting the company's commitment to innovation and growth in new therapeutic areas.

Cash Position and Financial Stability

After recent repayments of convertible and senior secured notes, MannKind boasts a solid balance sheet with cash and investments totaling $262 million. The company has successfully reduced its debt load, positioning itself favorably to invest in both commercial products and new clinical programs. The management emphasizes this strong financial status as a foundation for future growth.

Positive Outlook on Afrezza

Despite a small quarterly loss of $2 million primarily due to debt repayment expenses, MannKind remains optimistic about the future of Afrezza. Following successful presentations at the ADA conference, the company anticipates increased prescribing in 2025, further supported by pediatric data expected to be released in Q4 2024. This step is crucial, as it may drive high double-digit growth through the pediatric launch slated for late 2025 to early 2026.

Guidance and Expectations

Looking forward, MannKind's management has set ambitious targets. The overall revenue run rate suggests an annual revenue exceeding $275 million, indicating continued optimism for growth. The next 12 months are poised for critical milestones, as the company targets regulatory advancements and additional data readouts in its pipeline development. Investors can expect significant updates as these developments unfold, retaining a watchful eye on the commercial trajectory of Afrezza and the potential impact of new product launches.

Conclusion

MannKind's Q2 2024 earnings call reveals a company in a strong position, with record revenue growth, a solid pipeline of innovative products, and a stable financial outlook. The commitment to reducing debt while investing in future growth avenues is commendable, positioning MannKind favorably in the competitive landscape. As we look to the future, both existing and potential investors should keep a close watch on the company's performance in the upcoming quarters and the anticipated positive impact of its clinical programs.

Earnings Call Transcript 2024-Q2

[Operator]

Good morning, and welcome to the MannKind Corporation Second Quarter 2024 Financial Results Earnings Call. As a reminder, this call is being recorded, August 7, 2024, and will be available for playback on the MannKind 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, which could cause actual risks to differ materially from these stated expectations.

For further information on the company's risk factors, please see the 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, Chris Prentiss. I'd like to turn the conference over to Mr. Castagna. Please go ahead, sir.

[Michael Castagna, executive]

Thank you, operator. Good morning, everyone. Excited to be here calling in from Danbury, Connecticut today. And joining me is Chris Prentiss, our Chief Financial Officer. Today, we'll grow our traditional operational and pipeline highlights, quick financial review by Chris with some closing remarks on myself and we'll move to Q&A.

Let me begin by talking about some of the second quarter 2024 highlights. First, we had record revenue on Tyvaso DPI between manufacturing and royalty revenue coming in. Second, clofazimine inhalation suspension is well on its way with Fast Track Designation by the FDA as well as several sites now activated and ready for patient enrollment. And thirdly, nintedanib DPI is well under its way with results expected here in Q4 along with chronic tox. We're now on our third cohort of single-dose patients, anxiously waiting to move to the MAD section of the study shortly.

In our endocrine business, we had second quarter revenue of $20.8 million, driven by Afrezza. I'll talk about that shortly. INHALE-1 top line results for pediatrics is expected here in Q4, and we're excited for this pivotal moment in our history to these results. And then the third part of endocrine is INHALE-3. We met its primary endpoint, 17-week data were presented at ADA and were very well received. We're coming up on our 30-week data readout here in the second half and implementing our ADA post success plan.

For financial results, record revenue for the company of $72 million, up 49%, with a GAAP net loss of $2 million and non-GAAP $14 million that Chris will talk about shortly. We ended the quarter with a strong balance sheet, and we continue to delever the company and reducing dilution to shareholders by paying down the Mann convertible debt in cash and stock as opposed to stock only.

Now let me talk about clofazimine inhalation suspension. We look at NTM as an opportunity with 2 players over the coming years. [indiscernible] had great data readout in early stage and they continue to penetrate the markets in Japan and the U.S. As we look at the refractory population being about 15%, 20% of this market, we see this as a very large opportunity to bring a new entrant that could be more convenient with really good lung coverage here in the U.S. as well as Japan.

Let me talk to you for a second about our Phase III design. The key attributes of this product are: one, 28 days on treatment with 56 days off treatment. What that means is the patient will have 1 co-pay for the 28 days, followed by 2 months off because the drug has a long half life. We believe it's really important to get deep lung penetration in this disease as the macrophages are deep in the lungs and they'll take the clofazimine in. And because of the half life, it will take about 2 months for it to return back to baseline.

We see that same thing with month 4 coming on the treatment and month 5 and 6 off treatment. The primary endpoint of the study will be 6 months, and we're looking at a dose of 80 milligrams of clofazimine in a 2:1 randomization. We will have an interim analysis after the first 100 people enrolled, and that will decide whether the trial should be larger to make sure we hit our endpoints or it's sufficiently staffed to reach the primary endpoint.

The co-primary endpoint in the U.S. is sputum culture conversion and patient reported outcomes and the primary endpoint for Japan has been aligned and that is sputum conversion only. We also have orphan and QID designation along with other IP given us a minimum of 12 years of exclusivity. Japan and FDA have aligned to a single trial, and we're also considering creating an expanded access program. We'll keep you posted on that.

On 201, as you see, this market, while it is crowded in terms of development, there are very few options on the market for patients. We're excited at what we see from United Therapeutics and TETON 1 and 2 reading out next year for Tyvaso. But more importantly, this is on the backbone of Ofev as the market brand leader in IPF. And we believe, while it's a phenomenal drug and it's helped thousands of people live longer, we also believe there's an opportunity to enhance the quality of life that people experience when going on Ofev, and that's really our main focus here.

As we look at this opportunity, how do we bring potentially improved tolerability relative to GI side effects, specifically that occur with Ofev, where 50% of the people traditionally dropout treatment because the GI side effects alone. We also believe that we can dose hopefully a little bit higher directly into the lungs and get higher lung concentrations. And this is really our focus here on this product is can we dose appropriately and tolerable and does that show an improved in GI tolerability?

The Phase I data readout in chronic tox are expected to both come in here in Q4, and we will then file a meeting with the FDA to move this to a Phase II/III design in 2025. Now moving on to our endocrine business. Year-to-date revenue of $39.5 million, predominantly driven by Afrezza, I'll talk about in a second. V-Go was deprioritized in Q1, as you may recall, and we restructured the field team so that we've had a different business model coming into the year, and you'll see some of that result here as I talk about our growth. Afrezza Q2 sales alone over the prior year grew 20% to $16.3 million.

Moving into prescriptions. You can see Q1 versus Q2, 8% NRx growth, leading to 5% TRx growth quarter-over-quarter. The NRxs are the leading indicator what to expect 3 to 6 months later. It's nice to see that the NRx change is paying off in TRx, and we hope to continue to see that type of growth as we go into Q3 and Q4 this year. As you may not have read or readout on the ADA with INHALE-3, this was presented at an oral presentation by 7 World thought leaders. The sub-analysis found several key attributes of this trial.

Number one, inhaled insulin achieved a target A1C less than 7 in 30% of participants versus 17. Additionally, 24% of Afrezza almost 1 in 4 patients versus 13% usual care met timing range greater than 70% with no increased hypoglycemia. Over 50% of the subjects who got the end of the trial said they'd like to continue on taking Afrezza. And the reason that's such an important number is 50% of the people in this trial were coming off the best technologies of AID systems, OmniPod, and we're generally satisfied with the treatment and to see that even when people switch and to maintain control, they'd like to continue to have the freedom that Afrezza brings to them.

We've met our 17-week primary endpoint, and our full 30-week data is expected to read out later this year and we'll likely give that information to shareholders here in Q4. When you look at the meal challenges here on the right, the RIA is the red line, clearly shows the post-prandial glucose excursions relative to the initial dose of both groups, you can see a distinct difference in the first 2 hours. And at the end of the study, when people were titrated to Afrezza, we did a second meal challenge and you can see greater improvement in mealtime control as people learned how to use the product.

And what this gives us is hope that one properly dosed Afrezza can really impact post-prandial control significantly over the current standard of care. This data was just published in Diabetes Care last couple of weeks ago. As we look out, we see INHALE-3 as pivotal to transform in the adult population, but also laying the groundwork for pediatrics, where insulin pumps is the predominant competitor of choice when it comes to choosing inhaled injected or an alternative delivery mechanism.

And we believe the SWITCH study in INHALE-3 showing consistent results of efficacy in the overall population as well as subpopulations will be important as the INHALE-1 trial was only in MDI patients, and that was by design to really show and control the one difference in the trial. The INHALE-1 day will read out shortly and we'll intend to file that next year for approval, hopefully, in the future years for launch.

When we look at Afrezza since I've gotten here, we've continued to grow year-over-year in a really good way. As we look out over the next 10, 15-plus years, we see nothing slowing down, Afrezza growing year-over-year. Finally, we will have proper data readouts, proper label updates. And now we have the capital and talent to continue to scale this business. We will wait for the data readouts. We are conducting some independent market research, so we can update you in the coming quarters on what our plans are and what to do with the data readouts as well as the additional indication on what that will mean for shareholders.

But we have grown consistently, and we will continue to grow this brand for years to come. I now would like to turn it over to Chris.

[Christopher Prentiss, executive]

Thanks, Mike, and good morning, everyone. I am pleased to review select second quarter 2024 financial results. Please refer to our press release issued earlier today for a summary of our financial results for the second quarter of 2024 as well as our 10-Q, which was filed with the SEC this morning. The second quarter with total revenues of $72 million marked our ninth consecutive period of quarter-on-quarter revenue growth and a 49% increase compared to the second quarter of 2023. For the 6-month period, we recorded total revenues of $139 million, a 55% increase over the prior year period.

Let's now discuss the details. Tyvaso DPI royalties contributed $26 million in second quarter revenue, an increase of 34% over the second quarter of 2023 and $48 million or 57% for the 6-month period. As we heard on UT's earnings call last week, they continue to experience strong patient demand and are encouraged by the record referrals and new patient starts during the quarter for both PAH and PH-ILD patients.

Collaboration and services revenue was $26 million, an increase of 132% versus second quarter 2023. The 6-month period was $51 million or 125% compared to the same period of 2023. The increase over the prior year periods resulted from a substantially higher level of production activity, which was sold through to UT. Afrezza net revenue of $16 million, grew 20% versus second quarter 2023, which was primarily driven by volume growth, a lower gross to net percentage of 37% versus 39% in the prior year and a price increase.

Similarly, in the 6-month period, Afrezza net revenue grew 18% to $31 million, primarily driven by a reduction in gross to net percentage and price. The lower gross to net percentage was mainly the result of a change in estimate for Afrezza product returns. V-Go declined 7% to $4 million in the second quarter of 2024 and 11% to $9 million for the 6 months comparable period. The decline reflects lower demand as we have focused our attention on Afrezza.

The next slide shows our revenue growth by source and basic EPS on a quarter-by-quarter basis over a rolling 8-quarter period from the third quarter of 2022 through the second quarter of 2024. For the second quarter of 2024, total revenues of $72 million, increased 9% sequentially versus the first quarter of 2024. After 3 quarters of positive earnings per share from Q3 2023 through the first quarter of 2024, we had a net loss in the current quarter of $2 million or $0.01 per share. This was the result of our early repayment of the Mann Group convertible notes and MidCap senior secured notes, which we completed in April and resulted in an accounting charge of $7 million recorded as a loss on extinguishment of debt.

Now to our GAAP to non-GAAP reconciliation. We had a GAAP net loss for the quarter of $2 million, which when adjusted for non-GAAP items, results in non-GAAP net income of $14 million. This compares to a non-GAAP loss of approximately $400,000 in the prior year quarter. For the 6-month period, we reported net income of $9 million and non-GAAP net income of $29 million. For the 6-month period in 2023, we reported a net loss of $15 million and a non-GAAP net loss of $6 million.

The second quarter represents our fourth consecutive quarter of positive non-GAAP earnings, which we expect to continue as we execute on our current business plan. As we reflect on our progress on the first half of the year, total revenues grew by 55% for the 6-month period compared to the prior year, driven by growth in both our Tyvaso DPI-related revenue and Afrezza growth. At $139 million, this gives us an annual run rate of over $275 million in revenues.

Net income for the first half of the year was $9 million and non-GAAP income was $29 million. This demonstrates the significant progress we have made as our revenues are supporting our pipeline development efforts. Cash and investments were $262 million at the end of the quarter. This is after the repayment of both the Mann Group and MidCap notes in April, leaving only the $230 million senior convertible notes due in March 2026.

This cash position, combined with our delevered balance sheet, puts us in a strong position to continue to invest in our commercial products and our exciting pipeline. With that, I will turn it back over to Mike.

[Michael Castagna, executive]

Thank you, Chris. As we look out over the next 12 months, here are some of the milestones we're going to talk about. I want to say thank you to the hard work the team has achieved in the first half, starting with our IND submissions here in Q1, which led to a kickoff of a bunch of work that we'll be looking forward to as investors and employees and patients and providers over the coming quarters and years.

Tyvaso DPI continues to progress nicely as you think about what we've been doing in Danbury between making product today to supply the market demands while preparing for hopefully positive readouts on TETON 1 and 2 and global expansion there with United Therapeutics.

Our high-speed fill/finish line is now operational and certified on most of the strengths for Tyvaso, DPI. The fill/finish -- the spray drying capacity will be completed here in the third quarter. It's been installed and now we're just running through the PPQ. What you'll see is in the first half that will require some stability time and then filing with the FDA for approval. We expect that to be fully operational in the first half of '25, well in advance of TETON 1 and 2 reading out.

As you look at INHALE-1 and INHALE-3, these are 2 pivotal trials we invested in over the last several years that are critical to the transformation we expect to bring to Afrezza over the coming quarters and years ahead. These data readouts will happen here in the second half, and they will set the stage for continued data publication and data releases for years to come at the various diabetes conferences around the world. We are just getting started on what this can mean for ourselves as employees, as patients and our shareholders.

And we're looking forward to continuing to give you more information as it comes in, in the coming quarters ahead. I think about the key value drivers that lay in front of us. Number one, the pipeline is not reflected in the value of our company. We continue to believe we're undervalued when we look at the value of the Tyvaso DPI royalties and manufacturing revenue relative to the other assets we have ongoing in the company. Just alone looking at 101 that we now look to be the only Phase III trial in the future, bringing this novel innovation to an unmet need population in NTM, where there's over 100,000 patients in the U.S. and roughly 15,000 that are refractory alone.

And for every 1,000 patients, this is $100 million in net revenue to MannKind. When I think about Ofev, the potential for this opportunity to help people live with IPF have a more tolerable option light alone if we can see better efficacy, that would be amazing. This is a $4 billion market and growing with lots of novel innovation coming, where we see Ofev as a continued backbone of treatment, where hopefully our inhaled version will make a pivotal moment for patients living with IPF.

And then we upgraded our Boston R&D footprint recently. As you may know, we have a site in Marlboro that the lease will be ending in early 2016, and we now have moved into a new facility here in Bedford, Massachusetts where we have brand new R&D and space, expanded our DPI technology platform, and we'll be consolidating our employees between the 2 sites over the coming 12 months. We're excited for that in terms of recruiting talent and continue to have more capacity to do more research programs as we go forward.

When it comes to Tyvaso DPI, this has been a great opportunity not only for us but for patients in United Therapeutics. It's transformed our company and has enabled us to execute our long-term growth strategy of funding our pipeline and continue to be a self-sustaining company. And as you can see here, for every 10,000 patients reimbursed, this is between $300 million and $350 million in total revenue to MannKind between royalties and manufacturing revenue. We will anxiously await the TETON 1 and 2, and we also will be starting to pay closer attention to the TETON PPS study as that comes forward and we see these readouts starting in the second half of 2025.

And when it comes to endocrine, we've always known when you look at innovation in diabetes, especially type 1, it starts with kids. The parents will fight for the children, the doctors are more cutting edge, and we believe that payers will find an opportunity to cover Afrezza in a more reasonable way and give patients the opportunity to need to control their sugars. The pediatrics is what we look at when you think about drugs that have been on the market for a long time and transforms, whether that's the insulin pumps that built, OmniPod or CGM [indiscernible] that all type 1s use now standard of care.

All these innovations started with kids. And we look at even GLPs today. These have been on the market nearly 20 years before we saw the inflection we've seen over the last several years in the weight loss category and wide adoption of GLPs. I know it's frustrating for all of us to think about what we sit on with diabetes and endocrine, but we are just now at the pivotal moment of new data coming out along with hopefully the ability to transform our future.

I'm going to stop there, and we'll answer any questions. And just to everyone knows, we have several upcoming scientific and investor conferences where you'll get lots of new information or updated questions and oral presentations here in the coming months. Thank you.

[Operator]

[Operator Instructions] Our first question comes from the line of Olivia Brayer with Cantor.

[Olivia Brayer, analyst]

How are you thinking about IP and just revenue run rate for your 2 pipeline candidates? And can you just remind us how well protected your Technosphere technology is? And then on the 201 update that we'll get in the fourth quarter, can you give any more color on how many patients' worth of data you expect to have? And just how you're thinking about next steps once you do have those healthy volunteer data in hand?

[Michael Castagna, executive]

I heard the IP question, and then there's a second one, and then there was the data in hand with IPF, although, as said, I missed the second part.

[Olivia Brayer, analyst]

Yes. Why don't we start with IP, Mike, and then I can follow up with 201.

[Michael Castagna, executive]

Sure. So on the IP landscape with -- I think it was Technosphere probably your second question. So Technosphere out into the 2030s IP on Tyvaso with pending, plus what we have is probably in the 2040-ish time frame, 2043. And then the clofazimine, will have QIDP and orphan designation as well as additional IP filed, so that looks to be 2039, 2040. And then same thing with IPF and nintedanib we look to have into the late 2030s. So we feel pretty good about the overall IP of the company going into the next decade and half or so.

And that's assuming we don't do any innovation, right? And so I think there is definitely things we're going to work on now to continue to innovate and make our products easier for patients to take. So we feel pretty good about the next 7, 8, 10 years as far as we can look out in terms of no major IP risk.

[Olivia Brayer, analyst]

Okay. Understood. And then yes, just second question was around 201 and the data that we'll get in 4Q. Just any color on how many patients worth of data that you guys will have? And then, obviously, just thoughts around next steps for that program going into 2025?

[Michael Castagna, executive]

Yes. So we have completed the first 3 dosing cohorts, which was single dose escalation up to a max dose we're looking for. Having report no major findings so far. They're still going through the safety, but no -- nothing appears to be getting in our way to go into the multiple ascending dose, which will be the next phase, and that will happen over the next month, and then they'll take some time to analyze those results.

So we expect that in Q4. What we'll be looking for is obviously cost, tolerability, bronchospasm, anything around that lung administration. GI toxicity or tolerability that we see any GI side effects in those patients, especially in the multiple ascending dose. And then for those results, we plan to go to the FDA with a Phase II/III design, which we're still finalizing. It's why I've not shown any details, and we'll hopefully see the FDA agree that type of a study design.

We've seen in some of the other competing programs there in IPF, but that's our intent. And hopefully, that would get us to market right around when Ofev patent would expire. And so that's what we're kind of looking -- trying to work backwards to make sure we're on time that we can be.

[Olivia Brayer, analyst]

Okay. Great. And congrats again on all the progress.

[Michael Castagna, executive]

Thank you.

[Operator]

Our next question comes from the line of Thomas Smith with Leerink Partners.

[Thomas Smith, analyst]

Just with respect to the ICoN-1 Phase III design, I was wondering if you could comment on the powering assumptions for the 6-month primary endpoint. And then for the interim analysis, it sounds like this is mostly a sample size reestimation. But can you comment on whether there's any early stopping criteria built into this interim either for futility or superiority?

[Michael Castagna, executive]

Sure. I missed your question on the assumption of 6 months, sorry.

[Thomas Smith, analyst]

Yes. Just asking about the powering assumptions on the 6-month endpoint what you've assumed in terms of placebo response and treatment effect?

[Michael Castagna, executive]

Yes. So what I'd say is when we -- in the design of ICoN-1, we benchmarked as best we could in refractory population for a delta of what we saw in the ARIKAYCE refractory population. So if it comes out better than that or placebo is not as good, that all will benefit us. It is a dual primary endpoint in the U.S., meaning our co-primary endpoint, I'll say, in terms of quality of life plus sputum. The rest of the world will be sputum only. So it will be the same trial used with 2 different statistical plans.

And the interim analysis is on 100 patients that will have a futility assessment, but not a superiority assessment in terms of shutdown from my knowledge. I know we have different numbers we need to treat if we feel like we're not powered appropriately, we can increase the powering of the study by increasing the patient numbers. So those are the key attributes we've tried to do depending on what endpoint is looking, how they're looking in terms of quality life versus sputum. So that's all predefined in the statistical plan. And I think it's 90% power, but I need to double check that and confirm with you and get back to you. I'm not pretty sure it's 90% power.

[Thomas Smith, analyst]

Got it. That makes sense. And then just one on Afrezza. I was wondering if you could just comment on some of the feedback you've been hearing coming out of ADA with the INHALE-3 results, I guess, reception to the data set and how you're thinking about translating these data in the INHALE-1 data to sales growth? Are these data sets you think could potentially impact 2025 prescribing? Or is that more of a longer-term dynamic?

[Michael Castagna, executive]

Yes. I think so far, the feedback has been very positive of those that attended ADA and listened to our data and watched our data. The data is being prepared for publication. The first dose just got published in Diabetes Care. So I'd say overall receptivity has been very positive. The team had a small at ADA just to get initial reactions, again, continue to demonstrate increased confidence. And we just got back [indiscernible] research last week, which I couldn't get in time for the earnings call, unfortunately.

But that also signals that amongst our highest writers and that we -- our highest target values that they are positively receiving the data as well. So, so far, all looks really good in terms of ability to impact future growth of Afrezza. Will that happen in a dramatic way this year? Probably a little bit in Q4 as things roll out in Q3 and the data gets published. But realistically, it will be 2025. And what I'd say about Afrezza is it's a direct reflection of our investment, meaning we've run the brand for profitability last year.

And that's been able to -- well, we wait for the data readouts and then make the decision to scale up and invest more. So if we want to grow it faster, it's going to probably take more investment. And just how much faster will that grow relative to the investment we make. And those are some of the work we're doing before we scale by any investments so we can communicate appropriately to shareholders what we want to do.

But I think right now, the data is good enough to continue to drive increased growth quarters as we go out. And then in pediatric, obviously, in Q4, and that will be the more important in terms of really inflection trends, I'll call it, meaning we can grow 20% versus 24%. That's not going to get anybody excited. But if we think we can grow high double digits through PEDS launch, that's going to be what's important at the end.

And having that data in Q4 with a filing, hopefully, early next year, that will set us up for a late '25, early '26 time frame for PEDS inflection. So I think that's what you'll probably see is my guess. But again, we're conducting additional research and insights to have some confidence before we make any big decisions here.

[Thomas Smith, analyst]

Got it. That's helpful. And congrats again on the progress.

[Michael Castagna, executive]

thank you. Look forward to working with you.

[Operator]

Our next question will come from the line of Gregory Renza with RBC Capital Markets.

[Gregory Renza, analyst]

Mike and Chris, congrats on the quarter. Mike, maybe just keeping with 101 and clofazimine inhalation. Just curious, as you and the team activate sites and stand up the trial, if you had any feedback and maybe touch on how sort of the activation and the entrenchment of the site is shaping your confidence in the program and the value proposition that you see with 101?

[Michael Castagna, executive]

Yes. I think it's true, like Greg and the team has been to about 10 sites, August will slow down a little bit for site activation just due to vacations and holidays. But we expect that to pick up a lot here in September. We already know they're prescreening patients. A couple are already scheduled for August. So I think it's only 1 month in. I wouldn't try to read too much positive or negative into it. I'd say, so far, the feedback has been generally positive as we all suspect how big is this refractory population? How quickly can we get to naive patients? How quickly can we move the dry powder along? These are the things we're working on as we know that's the much bigger population to go after.

But I think in terms of enrolling the trial in the U.S. and Asia Pacific area, there are enough patients to get that moving and enough patients to get hopefully ready for a good launch. But the real opportunity is obviously the larger NTM population, but getting this trial moving is the first step into [indiscernible]. But we continue to watch ARIKAYCE to well. That makes us feel very good about the bets here. And the market clearly that has no options. I mean so this is really exciting for patients, is exciting for the treaters, is exciting for the FDA as well as our employees who worked really hard to get here.

And from a manufacturing standpoint, we'll be really. And the trial, I think, is going -- got a lot of interest in the top investigators. So we feel pretty good about the sites that we're getting in and the patient will be recruiting very shortly.

[Gregory Renza, analyst]

Got it. And I think at the top of the call, Mike, you mentioned expanded access and maybe more to come. Can you just touch a little bit about that, maybe some of the timing and some of the inputs there?

[Michael Castagna, executive]

Yes. So I've asked the team to look to see if there is a way to get the EAP with the FDA sooner than later. And maybe that EAP would be for patients who don't qualify for the trial and would the FDA allow us to provide access, given there's only 1 treatment option out there. We don't have clarity on that yet. We've not approached the FDA yet, but that's really the key part of that comment is if we could find a way to help more people sooner that don't qualify for the trial, we would be interested in that.

Obviously, we don't want to have an EAP enrollment for the trial. It delay our ability to help get that trial recruited. So that will be some of the focus here is can we find a way to help those patients that will be a collaboration with the FDA. May want a certain amount of patients for us to see where they land.

[Operator]

Our next question will come from the line of Brandon Folkes with Rodman & Renshaw.

[Brandon Folkes, analyst]

Congratulations on another very good quarter. Maybe just two for me. Mike, I know you said you can't talk too much about the potential Phase II/III trial in 201. But would you be able to just talk about maybe if you're considering multiple dose levels there? And just elaborate on what is first prize for you in this program? Is it something that's comparable in efficacy with better GI side effects? Or would you prioritize perhaps sort of a potentially more efficacious drug here?

And then secondly, just maybe on Tyvaso DPI. Can you just talk about the manufacturing capacity where you're at today? What needs to be done if TETON is successful and just sort of how much investment does that take?

[Michael Castagna, executive]

Sure. I'll take the second one first because that's easy. So from a DPI manufacturing capacity, we've been able to build up a substantial amount of inventory for United Therapeutics this year. We should be well on our way ahead of any TETON results in terms of scale and capacity. We don't see any limitations as far as we can see with that approval. The investment in the plant has already been invested in by United Therapeutics, all the equipment has been installed and purchased. So there's no additional investment that's a major. I'm sure there'll be small things here and there, but nothing that significant for shareholders or for United Therapeutics at this point.

That doesn't account for what UT may do independently. MannKind, i.e., building their own plant. That's a separate decision on their part. But as far as we're concerned, we'll be able to supply a substantial amount of DPI as we go forward. In terms of what does a win look like, it's a great question, and we've had this internal debate ourselves in that do we really want to demonstrate the safety side of this around the severe GI tolerability issues that happen? Is it important to try to go after increased efficacy? Or is it a balance of both of those by getting to the market as quickly as we can?

And I think that triangle in terms of efficacy, speed and tolerability is something we're continuing to talk about. And there's various ways you can design a Phase II/III trial to kind of build those attributes. And the question is how fast can you get to market and help those patients? And what do you need to demonstrate?

For example, if we were to demonstrate equal efficacy somehow, but you took existing patients on nintedanib, you do not see the GI benefit as much. Maybe you'll see people take less Imodium or feel quality life better, but you could also study naive patients where you'll see hopefully a large benefit in tolerability, which could be a huge benefit to outcomes and efficacy. Or you can go after higher dosing, which could generate potential better efficacy, but how much more we don't know. And that's all the questions we have for ourselves as much as anything.

And so because we are going into a Phase II/III design that does limit some of our forecast ability on efficacy, for example. But we see the first readout here in this Phase I, make sure patients can tolerate our target doses, and then we will finalize that trial design. We're also meeting some thought leaders here in the coming weeks and months to triangulate this exact question. But we have an idea of what we're going to do, and we want to bounce that off with some investigators before we come out and talk about it publicly.

And then [indiscernible] do we want to go after dosing in multiple doses? And there's a strategy that could be 2 different doses and study them or it could be a titrate up dose effect, like you see in treprostinil type design where you try titrate to the highest tolerable dose. So those are the things we are looking at, and they all have pros and cons So no magic answer here, but other than we want to get this drug to patients as quickly as possible.

And I think once we go on market, then we can innovate even from there in terms of demonstrating additional trial outcomes, et cetera. So we'll get there. But let's get through the first step here, I think that's the most important and then met with the FDA.

[Operator]

That concludes today's question-and-answer session. I'd like to turn the call back to Michael Castagna for closing remarks.

[Michael Castagna, executive]

Just want to say thank you to everyone. It's been a fantastic year, volatile year for all of us, but the company is in a great spot. We're looking to close out the year strong and really get ready for '25 and '26 as we look at multiple data readouts on the clinical side across our entire platform and programs as well as just upside into the in-line revenue that we're driving with the diabetes business.

So we feel very good about the future. Hopeful have some news on international expansion as we go forward for Afrezza and continue to drive growth and help more patients. I just want to say thank you to all of our employees for all the hard work and all the shareholders for all your support. Have a great day.

[Operator]

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