MannKind Corp

NASDAQ:MNKD

Earnings Call Transcript 2023-Q1

[Operator]

Good afternoon. And welcome to the MannKind Corporation 2023 First Quarter Financial Results Earnings Call. As a reminder this call is being recorded on May 9th 2023 and will be available for playback on the MannKind Corporation website shortly after the conclusion of this call until May 23rd, 2023.

This call will contain forward-looking statements. Such forward-looking statements are subject to risk 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 for MannKind are Chief Executive Officer Michael Castagna and Chief Financial Officer Stephen Binder. I would now like to turn the conference over to Mr. Castagna. Please go ahead, sir.

[Michael Castagna, CEO]

Thank you, operator. Hope everyone is having a great afternoon. At MannKind, our mission is to give people control of their health and the freedom to live life, and what we call that is Life More Humann. We're really excited about our first quarter highlights of 2023. Number one, our UT collaboration is strong. Patient demand has driven royalty revenue growth of 29% versus Q4 of ‘22. We're currently undergoing manufacturing capacity expansion, which I'll talk later in this call. Our pipeline is quickly moving ahead with Inhaled Clofazimine going into Adaptive Phase 2/3, and we had a very successful pre-ID meeting with FDA on MannKind 201, in which we received written comments on how to proceed.

Our endocrine business underlying business is strong with Afrezza growing 26% versus 2022, and we had sequential growth over Q4 versus the traditional decline that we see in the New Year. Additionally, we are kicking off our first large phase 4 trial in a health rate called Pump Sparing, which is going to be head-to-head against the standard of care, and that should be enrolling hopefully late this quarter, early next quarter. And in V-Go, we dropped that product in our Afrezza sales bag starting in Q1, and we expect to continue growth throughout Q2 and beyond.

From a liquidity perspective, we had $167 million in cash on hand, which is only a six million decrease from the end of last year, and our net loss per share decreased by 60% versus last year as well. Can continue to see the progress we're making in our growth engine versus managing our cash balance. I've made the DPI a strong patient demand. As a result, there's several things we've put in place this quarter that should continue to drive strong uptake and support of the demand that UT is asking.

Number one, we've improved our current manufacturing process by doubling our bulk spray drying capacity. This was a rate limiting effect right now in terms of continued increased demand that we wanted to make sure we addressed before we hit any supply constraints. We expect this to be online in June. Additionally, we're increasing yield and throughput when it comes to the fill finish and the packaging as well. All of this means that we should see an improvement in our inventory ability to supply by over 200% in the second half of 2023.

Additionally, we are building out a high volume capacity expansion that we expect to be online in 2024. This is around scale up bulk spray drying capacity for the possible IPF indication, as well as additional cartridge and blister fill capacity will be done in this expansion. From a revenue expectation, we saw strong patient growth here in Q1 and Q2. We expect for every 10,000 patients, annual revenue to MannKind should be between 200 million and 240 million, which would include the collaboration of services as well as royalties.

On our endocrine business, operationally we look at Medicare as $35 copay that happened in January 1st of this year is driving favorable impact in Q1. We continue to see these patients grow and impact in our business as we look at Q2 and beyond. We had lower Afrezza growth than that, but as we continue to shift our direct purchase orders to specialty pharmacies out of the wholesale channel. And now our sales force has been cross-trained and we have about 65 reps selling both V-Go and Afrezza and about 15 reps selling V-Go only. As we previously communicated, we anticipate the endocrine business chain to be break-even by gap by the end of this year.

Additionally, we're trying to really enhance the scientific understanding of Afrezza and we have three trials that we're expecting to read out over the next 12 months. Number one, INHALE-1, we have over 35 sites and we've seen a lower patient dropout than expected. INHALE-2, which is what we're referring to as the CIPLA Phase 3 trial for India, we expect that data readout here momentarily in the next few weeks. I don't know if they will publicly announce or present the data at a future conference, but we will at least know the data as we go into a filing for the second half of 2023.

And INHALE-3, we're calling Pumps Sparing, which is Afrezza to receive a Dexcom, hence the three, versus Standard of Care. This will be the largest adult trial we've done with top tier KOLs across 20 U.S. sites. As we look at V-Go, NRx is our leading indicator, which grew for the first time in two years. We made several changes coming into 2023 that impacted our TRx. Number one, we canceled the cash pay card, such as a GoodRx, that could be administered at the pharmacy.

Number two, in April, we ended our free goods program. And number three, we upped our copay card a little bit so that patients have to share a little bit more in the cost as we go forward. All three of these things combined would have impacted Q1 TRxs. But as we look at NRx being our leading indicator, we can see continued growth from this point forward now that we've integrated into the Afrezza sales force. Therefore, we do see we're on track to meet the high end of our forecast, $18 to $22 million. As you look at Afrezza, in 2022, we really focused on accelerating NRx growth.

This was a complete shift from top to bottom in the organization, and it was a major focus of our sales force. And you could see every quarter, we continue to improve NRx growth, which is what we needed to see happen faster than TRxs in order to grow TRxs. And you can see NRx again is the leading indicator here, as you see Q3, 18% growth, NRx, 10% growth TRx, and continuing on for Q4 and Q1. So, a lot of the Q1 upside has been the Medicare $35 copay, where we're seeing over 90% approval rates through our reimbursement hub.

As we close out the first half, we see several key milestones in the first half going into the second half. We've already completed the first two, which is V-Go and the Afrezza sales force bag, and Medicare $35. Additionally, we have inhale three kickoff. We expect to have our investigator meetings here in about a month and kick those patients off, hopefully in Q2, going into Q3. In Q3, we should have our BlueHale Viz launch, which is the visualization to integrate with Dexcom CGM data with our inhaler.

And in Q4, we expect to be fully enrolled with INHALE-1 and fully enrolled with INHALE-3 as we close out the year. Now I'm going to turn it over to Steve.

[Steven Binder, CFO]

Thanks Mike. And good afternoon. Pleased to review select first quarter 2023 financial results. Please supplement this call by reading the condensed consolidated financial statements and MD&A contained in our 10-Q, which was filed with the SEC this afternoon. Our total revenues grew 239% versus first quarter 2022, which highlights the revenue growth associated with Tyvaso DPI and, to a lesser extent, our endocrine business. Revenues from our collaboration with United Therapeutics totaled $23 million in the first quarter of 2023, which is made up of royalties of $12 million and collaboration and services revenue of $11 million.

Royalties earned on the net sales of Tyvaso DPI of $12 million was a result of strong patient demand and a low double-digit royalty rate. We recorded $11 million of collaboration and services revenue in the first quarter, which was over four times the revenue of a year ago. We were not yet manufacturing commercial product for UT and deferred much of our revenue for recognition later in the manufacturing contract life.

Moving down the table to our endocrine business, total endocrine revenues were $18 million, which are made up of Afrezza net revenue of $12 million and V-Go net revenue of $5 million. Afrezza net revenue of $12 million compares to $10 million in 2022, a growth rate of 26%. The growth is mainly driven by higher patient demand with underlying paid TRx growth at 26% year-over-year and higher price, including a more favorable growth to net adjustment. Our growth to net went from 39% to 38%, reflecting a continuing shift from using full-line wholesalers using specialty pharmacies with lower fees.

Net revenue from V-Go was $5 million for the first quarter of 2023, and there was no comparison for prior year due to the product being purchased in the second quarter of 2022. Since acquisition, V-Go net revenue has totaled $18 million. It's on track to achieve the high end of our original forecast of 18 million to 22 million, with a period of 12 months post-acquisition.

The next slide shows our revenue growth by source on a quarter-by-quarter basis from the first quarter of 2022 through the first quarter of 2023. The mix and growth of revenues has significantly changed over this period as we've added Tyvaso DPI royalty revenue, revenue associated with the commercial manufacture of Tyvaso DPI, and sales from V-Go, all starting in the second quarter of 2022.

Looking across the time span, our first quarter of 2023 total revenues grew 239% versus the first quarter of 2022, reflecting not only the new sources of revenue, but also the strong growth in Tyvaso DPI-related revenues. The next slide shows the impact that cash inflows associated with Tyvaso DPI have had in our cash, cash equivalents, and investment balance. You can see the inflection point happening in mid-2022. Starting with the third quarter of 2022, our cash investments quarter-on-quarter changed, with only in a single digit, the first quarter of 2023 being reduced by only $6 million.

We continue to tightly manage our cash outflows while benefiting from the increasing revenues associated with Tyvaso DPI and our endocrine business, which move the company towards profitability and being cash flow positive. Also note that we have started to increase our investment in the development of our product pipeline, which is quickly becoming our next lever of shareholder value. We believe that our current level of cash, cash equivalents, and investments, plus anticipated operating cash inflows and outflows, will allow us to adequately invest in and grow our business without a need for any follow-on stock offerings.

And finally, we haven't spent much time on EPS in the past, but as we grow our revenues and manage our expenses, the loss per share has been significantly reduced as we progress down our path to profitability. The first quarter loss per share of $0.04 versus a loss of $0.10 per share in the first quarter of 2022. Thank you, and now I'll turn it back over to Mike.

[Michael Castagna, CEO]

Thank you, Steve. As you all can see, we have a very robust product pipeline in addition to our marketed products. We expect to be able to file in the second half and hopefully get ready to relaunch back in Brazil early next year. As we look at the pipeline, Clofazimine along its way to get into patientcare in the second half, and nintedanib is really moving forward quickly as we just received dosing data in our supportive model, as well as the [Indiscernible] is ongoing. We expect to be able to put this product in humans late this year, early next year.

DNA-1000 TGS beta continued to progress nicely, and we'll have updates on those as we progress the year. Part of the story we always get from shareholders is what's next. We don't believe we have a lot of value in our company as we look at our pipeline momentum building over the next 24 months. We have several studies on Afrezza, which is basically redoing a lot of the work that was done over a decade ago, but the new insights around dosing and how do you titrate up quickly and manage basal at the same time. These new studies are based off the small pilot studies we've done over the last five years.

And we're excited to see these results in the near future. On the organ side, we have several assets moving forward development over the next 24 months, as you can see here, going from IND to phase one, to submission to phase one, and continue to progress this very rapidly. As I look out, I wanted to bring you some perspective on how these key value drivers create shareholder value as we go forward. The first is the pipeline. MannKind 101, we expect a dose. This trial should take roughly 24 months in terms of dosing and enrollment. For every 1,000 patients, once this is approved, we would expect approximately $100 million in revenue.

This is an orphan disease that has somewhere between 60 patients and 100,000 patients alone here in the U.S. MannKind 201, we expect to be dosed by the first half of 2024 and progressing rapidly into phase 3 from there. Tyvaso DPI for every patient's royalties and collaboration and service revenue should be in the range of $200 to $240 million in revenue. And we remind you UT has a T-hub study readout for idiopathic pulmonary fibrosis that would be upside to these forecasts. And in our endocrine business, we have pediatrics. When we look at diabetes over the last 20 years, innovation continues to happen with kids.

We really do believe once we get these results, we should be able to help a lot of children and parents manage their kids' diabetes. Every 10% market share there is roughly $150 million in additional revenue on top of what it will be at that time. We're excited about the India launch upcoming and the data readout there, as well as this new pump sparing study that we're doing to really show not that pumps are good or bad, but that there's an opportunity to delay using an insulin pump and start with inhaled insulin and delay the skin damage that can occur over the next 30, 40 years.

V-Go, we've put a stabilization and growth plan in place. You're starting to see the early fruits of this labor. As we look at the type 2 market, one of the things we do see is a lot more people coming in with insulin delivery devices in type 2, and that should rise all time. So, thank you for that. And we will talk about our annual shareholder meeting. MannKind annual meeting will be May 25th at 10 a.m. This will be conducted live via the internet to reach more shareholders as we typically are seeing three, four times more shareholders dial in for this than we had in a live meeting, and hence why we wanted to go this route.

For those shareholders interested in joining us to see Danbury, at some point in the future, please reach out to our investment relations. All information of this meeting and instructions for voting can be found on your website or our proxy, and there are several proposals that need to be voted on that were endorsed by the board and ISS supporting all eight proposals.

I want to close out just letting you know over the next two, three weeks, there are several RSU grants that are scheduled events that were granted in years past. As a result, you will see multiple Form 4s being filed by executive leadership team members to reflect these vesting events, as well as to sell to cover transactions that will be conducted under 10B5 trading plans that they set up last year to cover their tax liabilities.

Rest assured that we all believe in the long-term future of MannKind, but the IRS expects to be paid in cash when RSUs vest, so we need to address that obligation. I just wanted to add some context for the various Form 4s that you'll see throughout this month. I want to thank you again, and we will open up for questions.

[Operator]

Ladies and gentlemen, if you have a question or comment at this time, please press star 11 on your telephone keypad. If your question has been answered or you wish to remove yourself from the queue, simply press the star 11 again. Again, if you have a question or comment, please press star 11 on your telephone keypad. Please stand by while we compile the Q&A roster. Our first question or comment comes from the line of Oren Livnat from HC Wainwright. Mr. Livnat, your line is open.

[Oren Livnat, HC Wainwright]

Hi. Thanks for taking the questions, and congrats on another strong quarter. So, I listened to the United Therapeutics call, and I guess I couldn't have been any more bullish about Tyvasa DPI highlighting the demands, I think even outstripped expectations, which has actually led to some surprising dynamics with inventory and demand at specialty pharmacies not being able to be satisfied.

So, can you just confirm for us your expectations that through this year as you execute on the capacity expansion initiatives you highlighted in the script? And then the bigger expansions next year, are you confident that you can meet all the demands through the rest of this year and into next year? And I have follow-ups. Thanks.

[Michael Castagna, CEO]

Thank you, Oren. So, yes, obviously we tried to give a little bit extra clarity on this call given the UT comments last week. I think as far as we can look out, we've been close with UT on a daily and weekly basis to make sure we're supplying patients every time. We made some changes here in Q2 that will be in effect and should be in full production mode by June.

Those are happening as we speak and that should make sure we have more than enough adequate supply and at the same time allow the pharmacies to build off the contracted inventory that UT has mentioned in the past. We weren't as close to some of those contracts and what that obligation was.

As we went out the door last year to launch, the launch took off very fast. I think the conversion has gone very well. The new starts have gone well. I think overall, it's meeting and meeting expectations. And we had to make sure we increased our ability to continue to supply in the second half of this year, which we're doing. And again, nothing in the short term do we see any impact. It's really getting ahead of the long term. And as that patient base builds, we should be more than comfortable to be able to supply from now all the way through the future.

[Oren Livnat, HC Wainwright]

Okay. And I guess you segued into my next question. Speaking longer term, I was surprised on their call to hear that they are in fact investing half a billion dollars to build their own UT owned plant for Tyvasa DPI to, I guess, triple or even theoretically quadruple your expanded capacity even for next year. So, I guess just, you did highlight the, 200 plus million in revenue from every 10,000 patients. And I guess if they're already investing behind that now, it must mean they're pretty confident in some pretty extreme growth potential.

So, how are you planning for the longer term with, a real possibility of a couple extra couple hundred million a year in royalties coming in the door? How are you planning for investments on your end now that, we're coming not only out of cash burn, but into a pretty big surplus, whether it be a pipeline investment M&A.

And on the flip side, have you even thought about potentially breaking up and maybe selling for some large amounts of dollars via the franchise to UT?

[Michael Castagna, CEO]

Lots of questions on that – I think we wanted to show what every 10,000 patients equal, because, whether you want to assume it's 10,000, 25,000, 75,000, you can see this as a meaningful engine growth driver for MannKind and our shareholders. I think, any company who's going to have a billion dollar plus product wants to have a reliable, consistent and backup supply.

So, we're fully supportive of UT build out of a second facility, because as you've been to Danbury. It's a wonderful facility. It's large. It can do a lot, but it's one facility. And so, I think if you really look at the future where UT is going, having a second facility come online as a backup, whether we're the backup or they're the backup, I think all that going to be years in the making. It's not going to, these things take five to seven years to build sometimes and certify.

So, I think we've got time to worry about some of those details, but at the end of the day, there's definitely things we're doing in IPF on the scale up that could increase, the capacity within Danbury to more than meet the needs over the next three to five years. So, we feel very good about Danbury meeting current demand, UT having a backup facility or a second facility as they look at increasing global supply.

It's all net-net positive for everybody and ensuring continuity of care. In terms of what MannKind will do with that excess capital coming in, I think you see we've been building a pipeline over the last four years in anticipation that Tyvasa would do well, MannKind would be able to self-fund R&D and ultimately launch it because believe me, we'd all be happier as shareholders and employees if the money coming out of the door every day to UT would go into MannKind.

And I think that's one of the things we want to make sure we can do, whether it's NTM, it's [indiscernible]. These are real assets of real value that we've been building for the last three to four years. And will now finally be starting to enter patients and launching over the next three to five years. So, we're excited about the future and the capital deployment. And that's our number one job, is to make sure we are appropriately, deploying that capital to drive the best opportunities for growth.

And you look at the company, we've done a lot when we didn't have a lot of capital. Now imagine what we could do to drive faster growth now that we do have adequate capital and that's what we're doing. We're taking a bet, for example, on INHALE-3. It's a small bet, but it's a big bet that you could show you're as good as an insulin pumper better.

We couldn't take those types of bets, but that's how you're going to really change the future trajectory for the company.

[Oren Livnat, HC Wainwright]

All right. Thanks. I appreciate it. I'll hop back in the queue.

[Michael Castagna, CEO]

Thank you.

[Operator]

Thank you. Our next question or comment comes from the line of Brandon Folkes from Cantor Fitzgerald. Mr. Folkes, your line is now open.

[Brandon Folkes, Cantor Fitzgerald]

Hi. Thanks for taking my question and congratulations on the quarter. Maybe just following on from the prior question, can you just help us think about the UT announcement versus potential future Danbury expansion? Was this always contemplated and would UT have an obligation to buy from MannKind first and then use their own facility as a backup? Thank you.

[Michael Castagna, CEO]

Brandon, I think it's too early to speculate some of the supply chain contracts. We have a 10-year supply agreement with UT. They've invested a lot of money in the plant and the people. I don't see that changing in the near term or in the midterm. As you look at the pipeline, we have a couple of assets we're moving into Danbury for manufacturing, for commercial.

So, there's going to be a lot of activity positive at Danbury regardless of UT as we look out in the future. We would expect to be able to continue to supply out of Danbury. There's some unique capabilities there that take time to duplicate. As we're a single-purpose facility and the only one of its kind in the entire world. So, there's a lot of work to get ready to do that a second time.

[Brandon Folkes, Cantor Fitzgerald]

Thank you. Thank you very much.

[Michael Castagna, CEO]

Thank you.

[Operator]

Our next question or comment comes from the line of Gregory Renza from RBC Capital Markets. Mr. Renza, your line is now open.

[Unidentified Analyst]

Hi. Can you guys hear me okay?

[Michael Castagna, CEO]

Yes.

[Unidentified Analyst]

Hi, Mike and team. It's Anish [ph] on for Greg. Congrats on the progress this quarter and thanks for taking my questions. Just a couple for me. Firstly, on the new user-owned facility to support growing demand for Tyvasa DPI and continued ramp-up of commercialization, could you remind us of any economics or incentives in place in the degree of your involvement to get this facility up and running? And I do have a second question.

[Michael Castagna, CEO]

I think we have every incentive to make sure the facility is up and running as UT gets ready for the IPF. I hope that that indication goes well. That's a huge upside to everybody and I think that's enough incentive for us to make sure we meet the timelines. We started this a long time ago. This is honestly, some of the beginning equipment that's important for the scale just arrived yesterday. So, we're installing the equipment to build us moving forward. We're super excited. The team is working night and day to make sure it's ready. And we'll be validating that equipment here in the fall and hopefully having a commercial product come off it at some point in 2024.

[Unidentified Analyst]

Great. Great. Thanks for that. And then secondly, just on the macro side, do you have a sense of how the current inflationary environment has affected OPEX in terms of relative change in capital costs over the past 12 months to 24 months just to get a sense of any potential factors from under the covers? Appreciate it and thanks again.

[Steven Binder, CFO]

It's Steve Binder here. I'll take that one. Inflation and our costs are probably up in the low single digits, nothing that's unusual in the marketplace. We don't see anything unusual coming our way on the manufacturing side or the OPEX side. So, planning purposes, I think that should be fine if you're modeling that out.

[Unidentified Analyst]

Great. Thanks.

[Operator]

Thank you. Again, ladies and gentlemen, if you have a question or comment at this time, please press star 11 on your telephone keypad. Our next question or comment comes from the line of Thomas Smith from SVB Securities. Mr. Smith, your line is open.

[Thomas Smith, SVB Securities]

Hey, guys. Thanks for taking the questions and congrats on the progress during the quarter. Two questions from us. First, can you comment on whether you're seeing any impact to Afrezza from some of the price reductions that were announced for injectable insulins earlier in the year? And then secondly, we saw the strong data for sotatercept and PAH back in March. Just wondering if you could comment on how you see potential sotatercept approval affecting Tyvasa DPI use, either positively or negatively? Thanks.

[Steven Binder, CFO]

I think, let me take the first one on sotatercept. I want to defer to UT in terms of, they're the experts in the PAH market. I think it's a great drug. Everything I've seen, it's being used in combination. There's 50,000 patients in PAH. I think there's enough room for everybody. And, for us, Tyvasa DPI is off to a very strong start. And, I think that's the best news for patients in MannKind and UT. I'm sure this probably will have a place in the market when it's approved, and I'll ultimately defer to UT on how that best looks.

[Michael Castagna, CEO]

On Afrezza, the insulin price reductions have not had any major impact or even small impact on MannKind. In fact, we're having some of our best weeks over the last month in terms of demand and outflows that we see at wholesalers. So, from our perspective, Afrezza is on track to meet our expectations. We don't see any risk as it pertains to the insulin price declines that happened by Novo, Sanofi, and Lilly.

And you have to note that they only took those prices on drugs that were exposed to Medicaid penalties in 2024 that did not reduce the price of their innovative basal insulin. They didn't do it on the non-interchangeable basal glut [ph] for example, and they didn't do it on [indiscernible]. So, all the legacy insulin, all the newer insulin that have been approved the last five to ten years have not had price reductions.

It's only the 20-year-old products that are really exposed to Medicaid best price and Medicaid penalties for the price increases they took. So, a lot of companies are going to have to deal with that in 2024. I'm sure the first couple were these three because they're the biggest in terms of what's happened over the last 20 years.

However, we've looked at our numbers, our price points. We're comfortable with it. We think our value proposition, economic support to payers is warranted. And that's another reason why we're going out to do the studies we're doing to hopefully show cost of an insulin pump plus better timing range plus A1C leads you to this total cost of care.

So, we think that's really important to payers, not just in the U.S., but globally. But we don't anticipate any fundamental changes to Afrezza. We're seeing strong growth as we close out March and April, and we expect that to continue the rest of the year.

[Thomas Smith, SVB Securities]

Got it. That makes sense. Thanks for taking the questions.

[Michael Castagna, CEO]

Thank you.

[Operator]

Thank you. Our next question or comment comes from the line of Steven Lichtman from Oppenheimer. Mr. Lichtman, your line is now open.

[Steven Lichtman, Oppenheimer]

Hi, Steven, guys. Question on V-Go. Now that it's been in the field for you guys for several quarters, are you seeing a cross-selling building with Afrezza? And do you see opportunities looking ahead for those types of synergies, particularly with V-Go stabilizing, as you mentioned, Mike?

[Michael Castagna, CEO]

Yes, Steve, thank you. And I know you've followed V-Go for a long time. We committed $18 to $22 million last May. We're hitting the high end of that $22, as we expected. I think the question is, how do we go from $22 to beyond? And I think it's really important that we just put this in the sales force. We know it takes three to five months for those reps to get launches, in-services, follow-up, nurse training. All that's been happening.

We're hearing really good progress locally on the front line. So, I think that's important. We're seeing some early indicators with the NRxs that's positive. We've got to, unfortunately, offset that with the white space where there's TRxs dropping off due to either the commercial changes we made to increase the profitability of the asset.

And that's been our main focus here, is how do we optimize V-Go given the cost structure of the manufacturing, the rebates that are paid to payers? So, for example, removing the patient hub, really focused on retail. It's a very different product than Afrezza where we're pushing patients to a reimbursement hub and not rebating. And so, there are two different models. We've kind of executed that at our sales force level. I think we are hearing that V-Go doctors who have written V-Go historically are opening the door for Afrezza.

Our reps are getting into places they would have never gotten in, which was part of our strategic move. And that integration just happened in the last 12 weeks. And I think we'll continue to see positive impact on Afrezza as a result of that integration, but also continue positive momentum on V-Go as we close out Q2 and beyond.

It's a great product. I've seen it firsthand. We've had some recent ad boards. We think if you look at Omnipod GO, in fact, some more type 2, I'll call insulin delivery devices come into market that should rise everybody up in terms of demand and type 2. We think we have a very simple to use patch pump. At the end of the day, it's an incredible product. Afrezza is an incredible product. And now we have reasons to show up to offices across 7,000 customers. And so that's really been a major focus this year is narrow our focus and go deeper with customers, position V-Go for type two and Afrezza for type 1. And that's happening consistently as we look out every week.

[Steven Lichtman, Oppenheimer]

Great. That's helpful. And then, Steve, gross margin looked firm again this quarter. I apologize if I missed it, but what was the Afrezza gross margin in particular as we disaggregate that from V-Go? And what's your outlook sequentially as we look forward here on gross margin?

[Steven Binder, CFO]

Steve, as we've combined Afrezza and V-Go into the endocrine business unit, we're going to be just disclosing endocrine product gross margin going forward. So, as you can see, it's just under 70% for combined. We disclosed this in prior quarters. You can take those gross margins from a modeling perspective, and I think that would put you in the ballpark going forward.

[Steven Lichtman, Oppenheimer]

Okay. Fair enough. Thanks, guys.

[Steven Binder, CFO]

Thank you, Steve.

[Operator]

Thank you. Our next question or comment comes from the line of Anthony Petrone from Mizuho. Mr. Petrone, your line is open.

[Anthony Petrone, Mizuho]

Thanks, and congrats on another good quarter here. Couple just on looking ahead to ADA in the next month or so here, just what we should be expecting from MannKind A. And then B, just overall when we think about the discussion on GLP-1s, Ozempic, Mounjaro, some other products out there, and just how that plays into timing for utilization of insulin in type 2 patients, just can you maybe level set us there on what we should expect into ADA, and I'll have a follow-up question.

[Steven Binder, CFO]

Sure. Anthony, great to hear from you, and thank you for joining us today. We just came out of AACE last week, which is the other diabetes conference every year, and it was really nice to hear people like Irl Hirsch, who's world-renowned, announce on stage that he personally is taking Afrezza. That gave us a lot of proud moments. We've worked really hard with him and others over the years.

And finally, C, physicians living with type 1, starting to use Afrezza after eight years on the market, kind of gives us some good excitement, and his experience was wow. I think that's what his quote was from stage. And that sparked a whole bunch of questions around how to use it, to use it on top of a pump, when do you use it.

So, I think we're starting to get in the context of conversation, which is really what's been missing for Afrezza for many, many years. As we look to ADA, we have one small presentation on the ABC trial, which was the pump switch trial. I think that'll be a poster, if I recall. We are going to be present there. We're going to have lots of dinner events, one-on-ones, customer engagements. Don't expect a large booth presence there. We've kind of redistributed that investment at the dinner events and one-on-ones. But otherwise, we'll have a presence at ADA. I'll be there, and I think it'll be quite a busy meeting. We're going to focus on the nurse practitioners, nurse educators, diabetes educators, the rest of the year.

Those are deeper focuses for us as we go forward. Your question on GLPs is a good one, which is, we do know GLPs are only delaying insulin for type 2s that much further out. We already know from the time a patient needed insulin to the time they got it. I think it was about a 7-10 year delay based on history. So, it's probably just going to make that another year or two longer, because what I'm hearing from customers is, yes, the GLPs work amazing, but they still need post-prandial control. And that's one of our main focuses, whether it's V-Go or Alfrezza. You still need better post-prandial control. You need to cut those highs down if you're going to improve time and range.

And we're the only insulin that really gets out that it works in the body. The data is showing at ADA, and the data showed at ATTD, we work 30 minutes faster than the current gold standard. We reduce those highs substantially. And so that's not going to change. We have a nice competitive, differentiated profile. How do we start to make customers understand that?

That's a big focus as we launch our INHALE-3 trial with 20 top centers in the U.S. around understanding the product, the product profile, the dosing, and ultimately what that means to a patient. So, GLPs will do great, and they're great drugs. I think there'll be a study we're looking at, maybe an investigator's trial, of how do we use a GLP plus Alfrezza? That's probably the areas we want to try to help patients who have stubborn highs to bring their meal time down.

So, I hope that helps bring some clarity.

[Anthony Petrone, Mizuho]

I just have a quick follow-up, but just beyond the BlueHale launch with Dexcom CGM, just to clarify, I'm assuming that would be with Dexcom G7, and maybe just thoughts on how that can trend starting in 3Q. And when you think about utilization with CGMs, is there a potential that we could see a collaboration also with Abbott for that product? Thanks.

[Michael Castagna, CEO]

Yeah. Look, I think when you look at where diabetes is going, it's finally getting easier. It's never going to be easy for patients, but to think about once-weekly basals, once-weekly GLPs, inhaled insulin, we're starting to get to really a differentiated place in life where someone's not sticking their fingers, they're not sticking their skin, they're not having to wear insulin pumps every day. It's really exciting when we look at it over the next 12 months.

I think in the context of BlueHale, one of the things we're excited about is we're probably going to have our own digital platform where we integrate CGM along with the dosing of Alfrezza, your inhalation effort, and start to show you what's happening real-time, and then you can download those reports and send them to your doctor.

So that's in beta testing right now. We'll kind of get through the next eight to 10 weeks, make sure it's all tight. And you're right, it's currently with Dexcom G6 or G7, and we would fully expect Abbott to allow us that Libre API at some point in the future. We're not there yet. We're in discussions with them. I expect that we will get there. It just probably won't happen at the same time from Dexcom. But we're going to be using BlueHale hopefully in the trial and collecting some of this data real-time and showing what value it can bring to patients.

[Anthony Petrone, Mizuho]

Okay. Helpful. Thank you. Congrats again.

[Michael Castagna, CEO]

Thank you, Anthony. Nice hearing from you.

[Operator]

Thank you. Our next question or comment comes from the line of Oren Livnat from HC Wainwright. Mr. Livnat, your line is now open.

[Oren Livnat, HC Wainwright]

Oh, sorry. The operator cut out. Can you hear me?

[Michael Castagna, CEO]

Yes. We hear you, Oren. Sorry, I wasn't growling. I was clearing my throat.

[Oren Livnat, HC Wainwright]

I just wanted to follow up on 101. You mentioned that's going to be a 24-month study. So, I know there's no rush on that, but I think on the last call you mentioned as we get into this year towards Q2, maybe we can get some more color on that study and design and expectations. I'm wondering if you're able now to give us just even if it's just big picture, what are you trying to accomplish in that study?

How are you trying to differentiate from existing treatments? How do you imagine if you see what you want to see 101 differentiating in the marketplace? And I guess longer term how you think market share, I don't want to get into specifics, but just where you think it differentiates from the existing market?

[Michael Castagna, CEO]

Yes, no, thank you, Oren, for asking on 101. I think we've had a lot of research coming in with doctors that we're doing in the U.S. and Japan specifically. And I think the first thing of differentiation that is turning out to be a real good competitive advantage is our 28 days of dosing. So, we're planning to dose for 28 days straight, stop for two months, and then dose again.

So a patient is only going to need two dosing cycles on a nebulizer for two months straight. We're continuing to work on the dry powder formulation. That will be a life cycle management play. But in terms of pure differentiation from the only currently available approved NTM treatment, we feel very good about that first step.

The second step is going to be around tolerability. And so, we believe, we know Clofazimine is a well-established agent out there. People love the product. It's used globally through an expanded access program from Novartis. And so, doctors know it. And they know the challenges with it around drug accumulation, QT prolongation, and accumulation skin discoloration.

We really do believe lowering the dose dramatically like we are in our formulation, we will minimize or remove those types of concerns. And that will be one of the key pivot points we want to understand in the trial. The other parts we'll be looking at will be sputum conversion as well as quality of life, because we know those are important aspects for the FDA.

Less important outside the U.S., but more important for the U.S., and we'll collect that data. The trial size is roughly 180 patients. I'm comfortable sharing that at this point. And we will study a high and low dose of Clofazimine versus the standard of care. And so we're not, we're just going to take people in general background therapy and randomize them one to one to one.

So, that's the current protocol that's going into the FDA that we've had multiple discussions with. And it's really exciting. So, anyway, from the time that IND is approved, we will be activating sites very shortly thereafter. And clinical supply will be available at that time. And the tox study is going on for one year.

We'll also be wrapping up. So, we'll be able to dose patients for a year and get chronic dosing in this trial. The primary endpoint will be six months. I think that from an overall product, we're excited. We think it's going to serve a unique need in this market. And we are going after pretty much, after you're on TBT and not responding. So, earlier line of treatment.

[Oren Livnat, HC Wainwright]

So, is there a particular type of patient you're aiming for to recruit into this study in particular? And if it works and you see what you want to see, how much of a registration package do you think this one, I guess it's a phase 2/3, do you think this study could represent? Do you have to do another pivotal after that?

[Michael Castagna, CEO]

No, because it's a 505(B) on a repurposed drug, we only need one pivotal trial. We're calling it a phase 2/3. There's really not a stopgap, I'll say, from phase 2 to phase 3. It's a continuous enrollment all the way through. So, from that perspective, it's pretty straightforward. The FDA has indicated that a single trial is appropriate. Probably the biggest part that, we're working on is how do you show the correlation of quality of life, disputed conversion, positive and negative. And there's some data generated around the world that we're trying to make sure we analyze as we finalize the statistical design, which again, doesn't have to be done until the trial database is locked.

So, we have time to get that data, generate that data, present, publish that data. That'll be really important to the package at the end of the day. But right now, we're focused on getting the trial off the ground as soon as possible. And, sites are very interested. We have inbound calls from sites asking to participate. So, we're excited.

We think there's going to be, I always feel like trials never go as planned. They always take longer. But so far we've had luck with ABC, INHALE-1, INHALE-3, we've had a lot of inbound. So, we feel pretty good that MannKind is doing good trials. We're getting more and more experience running these trials. And we're learning how to take appropriate risks to move them as fast as possible.

[Oren Livnat, HC Wainwright]

All right. Appreciate the added color.

[Michael Castagna, CEO]

Thank you.

[Operator]

Thank you. I'm showing no additional questions in the queue at this time. I'd like to turn the conference back over to Mr. Castagna for any closing remarks.

[Michael Castagna, CEO]

Thank you everyone for dialing in today. It's been a great quarter. We're only in the first quarter, which should be a phenomenal year for our employees, our shareholders and all of our stakeholders and ultimately the patients we serve. We have multiple avenues of growth. It's an exciting time to be here. We're hiring great people. We're having higher and higher quality job applicants. Jobs are filling.

People are not leaving the company. It's just a great time to be here. And we're very, very excited about the patients we're helping, the demand we're seeing on Tyvassa, the demand we're seeing on Afrezza, the early trends of V-Go and the pipeline. We're really firing all cylinders this year. It's been a long time to get to this point, but we see nothing but very positive momentum as we go into Q2 and beyond for this year, next year and years to come.

So, thank you everybody. I know it's been a long ride for our shareholders, but you should finally start to see the fruits of all the labor that we've been investing in over the years. So, thank you again and have a great week everyone.

[Operator]

Ladies and gentlemen, thank you for participating in today's conference. This concludes the program. You may now disconnect. Everyone, have a wonderful day.