Good afternoon, and welcome to the MannKind Corporation Q2 2022 earnings call. As a reminder, this call is being recorded on 9 August 2022 and will be available for playback on the MannKind Corporation website shortly after the conclusion of this call until 23 August 2022. This call will contain forward-looking statements. Such forward-looking statements are subject to risks and uncertainties, which would cause actual results to differ materially from the stated expectations. For further information on the company's risk factors, please see their 10-Q report filed with 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.
Good afternoon, everyone, and thank you for listening in. Today I'll give a quick update on our performance for the quarter. Steve will go through the financials, and then I'll close on the pipeline and company updates. Next slide. As you can see, this is the quarter we've all been waiting for. We're super excited about MannKind and the growth story that it's becoming. Overall, we have 58% quarter-over-quarter growth, and we have several new sources of revenue. As you all know, we closed V-Go in May. We booked sales starting in June. That product is off to a great start. I'll give a little bit more details on that. We also were able to book a portion of the DPI commercial manufacturing revenue, which Steve will go into more, at $4.7 million.
Royalties, which will not be broken out as a percentage, but more as a dollar value as we go forward, of roughly $300,000. Then you can see collaboration and services, other, at $1.2 million. You may recall previous years and quarters, a lot of that was the amortization of the payments that we received from UT over the time period of that contract. I think it's good to look quarter to quarter now as we look at the way the revenues look and given that that contract ended last October. Total revenues for the quarter were up 58% from Q1, and we think that as you continue to look out, we'll see more royalties, more manufacturing, more Afrezza, more V-Go.
We really feel this is the foundation of the growth story that we've been working towards over the past several years. Next slide. A couple highlights here on the orphan lung side. As you all know by now, the FDA approved our Tyvaso DPI for PAH and ILD. Then we began manufacturing and commercial product sales with UT in June, with royalties recognized. You will notice as Steve talks that some of that inventory that was built in June is hung up in the balance sheet and will carry over into the next quarter. On the pipeline, clofazimine completed the SAD and MAD trials, single ascending dose and multiple ascending dose, and we'll have those top line results here shortly, and we'll release those publicly at the appropriate time.
The other two pipeline assets are starting to move forward is nintedanib, MNKD-201, as well as MNKD-501, TGF-β 501. That development's progressing. I'll give a few updates on these at the end of the call today. On the endocrine side, we saw 7% growth in Afrezza from 2021. We saw TRx grow 12% from Q1 to Q2. Unfortunately, we did do a primary care product for the last 6 to 9 months, and that did not produce the results we expected relative to the expense, and so we terminated that at the end of June. That expense will not be going forward much further than July. That's some of what we'll see as we go forward in terms of expense reduction on the PCP product.
On the INHALE-1 pediatric trial, that's going as expected. We added a few new sites in the last quarter, as well as we're up to about 80 patients now and on track to hit our goals between now and the end of the year. We also have the Afrezza basal combination study, ABC, and that's the one looking at, you know, maintaining a pump, adding Afrezza to a pump, or switching off a pump to Tresiba Afrezza. That's on track to give us results in early Q4. It's a small study, but I think will be very important results to give us clear opportunities for 2023 and beyond.
On V-Go, we'll give a little more detail there, but we had booked net revenue of $2.1 million just for the month, and V-Go will book the revenue for April and May. From a liquidity perspective, as we look out over the future, you can see four sources of revenue. Additionally, MannKind Group converted $10 million in debt in Q2, so now we have $10 million less in debt, and we're well capitalized as we go forward. That debt does include some accrued interest that will be taken off the principal. Afrezza DPI, you can see here the final packaging, the FedEx truck leaving our Danbury facility. We are at 24/7 manufacturing. We continue to look for ways to drive more efficiency in the manufacturing process to get more cartridges per hour as we can.
We also broke ground on the expansion. As you all may or may not know, UT is pursuing two studies called the TETON and the PERFECT Study, which are much larger patient populations than PAH and ILD. We had built the original plant a couple years ago. That was to handle the first two indications at launch, so we always knew we'd have to expand. As UT starts to ramp up those trials over the next year or two, and get those results, we need to get far ahead of that in terms of ordering equipment, building out the facility, in order to be ready for that approval, when and if it should occur. That broke ground here this quarter in Danbury.
One of the big shifts we made for MannKind and Afrezza in the Q1 , specifically February, was really starting to look at market share, in particular new prescription market share relative to the ultra-acting class. The reason is that class consists of Lyumjev, Fiasp, and Afrezza, has been growing and more and more doctors continue to adopt ultra-acting insulins. While I don't necessarily believe Lyumjev and Fiasp will qualify, the reason doctors are writing those is because they believe they're faster, and I think their clinical data would say otherwise. The fact is Afrezza is competing indirectly or directly against those two launches. We felt it was good to start measuring our market share and incentivizing our corporate executive management team, all of our employees, as well as the frontline sales reps.
You can see that had a direct impact on our market share growth over the last 4 or 5 months here as we closed out the quarter. We did hit a low of 12%, and we continued to grow through March all the way to June. Additionally, on the right side here, you can also see these are prescriptions that don't show up in Symphony. We have a free goods program, a cash pay program, and Afrezza Assist, which are referrals coming in, which ultimately become the funnel for new patients. You could see on an average quarterly basis and weekly basis that those have gone up from 122 to 223 over the last couple quarters here.
That's also exciting because that kind of gives us the goals of what's to come as we go forward. When you look at new prescriptions, we delivered, you know, 14% sequential NRX growth, which will lead you to the 12% TRX growth. We need our NRXs to grow faster than TRXs in order to feel good about the next quarter as we look out. We also amplified our clinical message with healthcare providers. We had a major presence at ADA, ACE, and ENDO. I was pretty impressed when I attended ADA. Typically, you'd walk in and AstraZeneca and Novo Nordisk and Lilly had the biggest booths. You couldn't get in without walking through them. This year, MannKind was right up front and in one of the bigger booths.
The large people who've generally been committed to diabetes were some of the smaller or no booths. You know, it was really a technology conference, and that's what ADA is focused on. I think the team really tried to showcase MannKind here because this is the first conference that people are getting back to live back in June with ADA. We'll continue to see focus on the remaining impact from the conferences and the investments that the marketing team made there. I wanna talk a little bit about V-Go because we haven't had the chance since we closed that deal to have a deep dialogue on it. We really want to strengthen our commitment to mealtime solutions when it comes to running our endocrine business.
We have about 60 sales reps, and when they go in, if the doctor doesn't wanna write Afrezza, of which, you know, we see a large majority of our customers after 6 years still not writing an Afrezza prescription, it's not efficient. V-Go is a device we've watched many years, and they were doing at one time almost 2,500 prescriptions a week. You know, that was a lot more prescriptions than Afrezza at that time. When we look at it now, it's been on a decline, but they had a lot of utilization and a lot of prescribers that love the product, and those aren't necessarily prescribers who've prescribed Afrezza or tried Afrezza.
We thought, you know, being able to build more efficiency in our sales force, being able to make MannKind more committed to mealtime solutions is really something that can differentiate us as a company. There really is no diabetes company today focused on mealtime solutions. They're all focused on prandial control or devices and trying to get insulin on the go. We felt this was a very nice synergy with our portfolio. When you look at the purchase price below, $15 million, that included all the IP, $11 million in inventory, and $3 million of equipment. If you add up those two lines, we basically got V-Go for a net $1 million. This was a good investment of shareholder money.
We will get our return on that investment and hopefully grow and provide more solutions to the diabetes space than we ever had. We expect first year net revenue to be $18 to 22 million and accretive in 2023. That's a 12-month year, not necessarily the rest of this year. Commercial infrastructure, we've hired an additional 15 sales force as well as a leader to lead the V-Go business and a medical person in addition to the manufacturing people. This did increase our head count, but all of that is in our expectations. Overall, we have the former Zealand employees who joined us up in Boston, right outside Boston, Marlborough, who are continuing to run the supply chain and manufacturing network. We're very excited about V-Go.
I think you can see in the Q1 it looks very good. When you look at the next slide here, the big thing was about stabilization. This has been on a 15-month decline, mainly because they stopped promoting it back in March 2021. Prior to that, it was through a bankruptcy, and so it's just had a tough history. We were very happy to be able to get some people on board and start to stabilize that decline in Q2. Hopefully, as we look in Q3, we can start to turn that from negative to a positive growth. I would say the leading indicator NRxs and the NRx ratio over TRxs is indicating that we are starting to make impact.
We know the prescribers are excited to have V-Go and MannKind and really can't wait to get it in the hand of the rest of our sales force. Right now, we're only promoting it through those 15 reps, and those are the top reps in the top centers that probably cover 50% of the units. To my earlier comment on prescriptions and coverage, you can see now in a given month we have almost 9,000 patients filling a prescription for a MannKind product, and that gives us about 2% market share of all rapid-acting scripts. That's not just ultra-acting, that's all rapid acting, including NovoLog and Humalog. That gives us a reason to show up to the doctor's offices, and we expect to continue to grow that share over the coming years.
Also reach nurse practitioners and PAs who are heavier users of V-Go and also heavy prescribers of insulin. We feel like this is a really good opportunity to increase our share of voice, increase our commitment to diabetes and the endocrine business, and give our sales force another tool to help provide solutions to patients who aren't in control, for the most part. I'm gonna stop there and turn it over to Steve. Thank you for listening.
Thanks, Mike, and good afternoon. I'm pleased to review select Q2 and June year-to-date financial results. Please supplement this call by reading the condensed consolidated financial statements in MD&A contained in our 10-Q, which was filed with the SEC this afternoon. As Mike pointed out, this is the Q1 for three new sources of revenue for MannKind. With the approval of Tyvaso DPI in May and the subsequent launch by United Therapeutics, we have begun to recognize manufacturing revenue and royalties in our Q2 P&L. In addition, with the purchase of V-Go effective May 31, we have recorded net revenue for the month of June. This slide shows revenue for the Q2 in the left table and June year-to-date revenues in the right table.
Looking at revenues for the Q2 of 2022, Afrezza net revenue was $10.6 million versus $10 million in 2021, a growth rate of 7%. The increase was mainly driven by price, including a more favorable gross to net percentage. Growth in underlying paid TRx demand of +8% was substantially offset by a decrease in channel inventory. Year-to-date Afrezza growth came in at +13%, which was mainly due to favorable price, including a more favorable gross to net percentage, higher underlying patient demand, and favorable cartridge mix. Next is our net revenue for V-Go, the newly acquired wearable insulin delivery device, where we had $2.1 million in net revenue for the month of June. We expect V-Go net revenue for the 12 months post-acquisition to be in the range of $18 to 22 million.
Moving to collaboration and services, revenue for the Q2 was $5.9 million versus $13.3 million for 2021. The Q2 includes the sale of Tyvaso DPI commercial product to UT. The decrease in revenue from the Q2 of 2021 was mainly due to the recognition in the prior year of amortization of United Therapeutics milestone payments. I will dive more deeply into the UT manufacturing revenue and deferred revenue on our next slide. The June year-to-date revenue of $8 million is mainly lower because of the prior year UT milestone amortization as well. Also new for MannKind, we recognized $300,000 of royalties associated with the sale of Tyvaso DPI by United Therapeutics in the Q2 based on a low double-digit royalty.
We had previously communicated that we would provide the exact royalty rate upon approval of Tyvaso DPI, but we have agreed with United Therapeutics to keep the royalty rate confidential for competitive reasons. The next slide breaks down the collaboration services revenue that was discussed on the prior slide, but we also added the associated deferred revenue which sits on the balance sheet. The UT associated revenue includes manufacturing services and additionally next gen R&D services which are mostly pass-through costs.
For the Q2 , we recorded collaboration services revenue associated with UT of $5.4 million, including manufacturing services revenue of $4.7 million, and we deferred $4.1 million of revenue to the balance sheet in the Q2 , of which approximately half is associated with inventory that sits on our balance sheet and is expected to be sold to UT in the Q3 when we will recognize the associated deferred revenue to income. Beginning in the Q2 , we have started to recognize prior period deferred revenue for manufacturing services and expect to do so throughout the life of the manufacturing contract with UT, which runs through 2031. There was a total of $29.8 million of deferred revenue associated with UT on our balance sheet as of 30 June 2022.
Now let's look at the profitability of Afrezza and V-Go. Afrezza gross margin increased from 56% in the Q2 of 2021 to 68% in the Q2 of 2022, and the gross profit associated with Afrezza increased 31% to $7.3 million. The increase in the Q2 gross margin versus 2021 was due to an increase in Afrezza sales, coupled with a decrease in cost of goods sold, mainly due to a $2 million fee incurred from the amendment of our supply insulin supply agreement in the Q2 of 2021. When looking at the profitability for the H1 of 2022, Afrezza had a gross margin of 72% and gross profit of $14.8 million, driven by higher sales and lower cost of goods sold.
There will always be some variability in Afrezza gross margin between quarters due to the timing of manufacturing spend and activity, as we are not at maximum production capacity for the product. The far-right table shows V-Go gross margin of 40%, which is about where we expected the margin for this medical device to be based on a review of the seller's financial information. Prospectively, we will focus on improving the margin for this product. Let me conclude with some final comments about liquidity and performance. We continue to transform the balance sheet. In the Q2 , there was a reduction of $10 million of debt that was converted to equity by the Mann Group, resulting in reduced debt and interest expense.
We spent $15 million to purchase V-Go, including inventory and equipment valued at approximately $14 million, which infers that we got a bargain purchase price. With rising interest rates, we are well-positioned with very little interest rate risk due to the low fixed rate for most of our debt. For our one floating rate loan with MidCap, we anticipated rising interest rates and negotiated an interest rate cap with a maximum exposure of less than 1% above the current rate. Also associated with the MidCap loan, we did not exercise our right to borrow up to $60 million under Tranche three, which was accessible to us once Tyvaso DPI was approved by the FDA and was available until June thirtieth. Operationally, we are showing continued progress in generating sales growth and gross profit for Afrezza, which should turn Afrezza into a money-making brand.
We have added V-Go to the endocrine business unit, which will expand our footprint with insulin prescribing physicians, as well as help synergize our cost base and infrastructure. Our collaboration with UT is strong and has a ton of potential.
We are producing Tyvaso DPI on a 24 by 7 basis and are seeing increased efficiency in our manufacturing output while recognizing manufacturing revenue and royalties for the first time during the Q2 . We are excited about our future as we now have four growing sources of revenue in addition to an early stage but established product pipeline. Thank you, and I'll turn it back over to Mike for additional comments.
Thank you, Steve, and more importantly, thank you for keeping track of all the complexities we've established over the last few years here. I'm super excited about the pipeline. This is something that, you know, these are decisions we've made years ago and every year they take a little bit of time, and they get closer and closer to fruition. Just like Tyvaso, we made that decision in 2017. We did the partnership with UT in 2018 and expected an approval almost three years later. Took a little longer, but still got approved. Now that's gonna be a major growth driver for MannKind as we go forward in value creator. I'm not gonna go through the top half. That's Afrezza, and I'll talk about some of the Afrezza stuff in a second.
I want to focus really on the bottom half, which is really around MNKD-101. That wraps up, and that's gonna quickly go into phase 2/3 after meeting with FDA. Then the nintedanib is early, but that'll move very quickly too once we get through the FDA. You start to see an emerging pipeline that can drive value for years to come. This is not something that we currently see a lot of value on when we talk to investors because the first milestone for a lot of people who've invested in our stock over the last 2 years has been getting Tyvaso DPI across the finish line.
As we continue to grow Afrezza, we continue to grow V-Go, we continue to see Tyvaso contribute to MannKind, I think you're gonna see a lot more activity around the pipeline and readouts around the pipeline on safety and some of the animal models we're doing. That's gonna be a very exciting emerging story from this point forward. Then finally, we've got these two other programs, the cannabidiol and the small molecule from Fosun. The cannabidiol dosed their first patients, I think, last quarter. That's another exciting one that's now progressing there at Perceptive Life Sciences, which after many years took a long time to get there, but now they're finally on track to move forward in the FDA with the FDA's support. On the pipeline side, I've already talked about the pediatric and Afrezza basal. Those are both in line.
We will have that basal combo study results here probably early Q4, is my guess. On the pipeline, clofazimine completed this. We expect that data readout. The nintedanib, we have completed the animal PK/PD. I don't know if we'll put a release out on that, but obviously, we feel good about what we saw, and then this program will continue to progress here in Q3 and beyond. The last one, which is a sleeper program, TGF-β is a known pathway that works. This class of drugs has had multiple toxicities over 20 years, but we believe this molecule is unique in that it has a short half-life, and we're able to dose it through our inhaled platform at roughly one-tenth the dose, that was previously dosed with when I was at Pfizer.
That animal PK we got in Q2, we're doing pharmacodynamic work here in Q3, and we'll continue to progress the TGF-β program. Then the tox plays, those will be really important at some point in the near future. Overall, this is an early emerging pipeline, but most companies our size do not have the breadth of revenue streams coming in as well as the robust pipeline that we are continuing to develop and hire for around our teams. When you look at the milestones we laid out back in Q1, we continue to hit all those milestones that we've put out at the beginning of the year. Some were anticipated like the V-Go acquisition. In Q2, we also completed enrollment in ABC study so that we can see the study will be completed in Q4.
Here in Q3, we'll have the phase 1 readout next month and the animal PK/PD completed. Q3 is, you know, relatively on track. By the end of the year, we have a lot of FDA activity happening, and the teams are working really, really hard to hit all those milestones. There's a lot coming all at once. Overall, the company is in great shape. You can see as we go forward, I think the real question, you know, at the end of the day is are we on the path to profitability? By the fact that, as Steve stated, we did not take the $60 million tranche loan because we don't see a need for additional capital. We can manage our expense base. We can see Tyvaso growing.
We can see how the pipeline's gonna come in and when those expenses build. We also see where expenses are coming down, such as the PCP pilot or the pediatric study, you know, finishing up in the near future. Overall, we feel very good about where the company is from a cash maintenance perspective. When you look over these milestones on the left side, what's investing, what's income generating, and then you look at the next five-year plan from 25 to 30, you can see a company that really does have multiple revenue streams growing at significant rates for the next eight years. That doesn't mean we die in 2030, but there's other things we'll be doing right now to keep us going beyond 2030.
At this point, you can see a nice bright future, multiple levers, pipeline coming together, and a very, very exciting future where we're pretty much near 400 employees now and growing. That just creates a whole new company, a whole new culture, and also a new shareholder base. We continue to see new shareholders come in. Our institutional investors continue to increase. We continue to take new tours at Danbury to introduce people to the company. Overall, company's in great shape, and I just wanna say thank you to everyone's support. We're super excited to finally get Tyvaso across the finish line, and that really enables the rest of the company to continue to function at an optimal way.
Thank you to UT, who's been an incredible partner throughout this journey and huge supporter of MannKind and all of our shareholders who've been with us for some time. I'm gonna stop there and open up to questions.
Thank you so much. Ladies and gentlemen, to ask a question, you will need to press star one one on your telephone keypad. Please stand by while we compile the Q&A roster. Our first question comes from the line of Gregory Renza from RBC Capital Markets. Please go ahead.
On for Greg. Congrats on the quarter, and thanks for taking our questions. Maybe just a couple on Tyvaso DPI. Could you provide some clarity regarding the agreement with UT regarding the manufacturing margin? Understanding you have to keep the royalty rate confidential, but just wondering about the manufacturing margin there. Secondly, just wondering, you know, how has the macro environment regarding inflation, labor, and supply shortages may have impacted your manufacturing capabilities? Thank you.
I think the first one on UT manufacturing margins, we're not gonna provide that clarity yet. I think let's get full manufacturing for a full quarter or two, and we'll continue to discuss internally whether or not we provide that particular markup on those manufacturing revenues that are coming in. It was too early in Q2 because it wasn't a full quarter and it was a partial quarter of production, so we didn't wanna create any confusion. That's why you won't see much there. The second question, Steve, I think I didn't capture it, but I think it's around inflation or impact.
Sure. Yeah. Let me touch on that. This year we are seeing a mix of some rising costs in particular around energy. But we're also seeing some savings as we increase our volumes of purchases of certain supplies that go into making our products that drive the cost per unit down. This year we don't see a significant increase in costs. I think next year you probably will see a little bit of an increase, but so far nothing significant or material to our balance sheet or our P&L at this point in time.
Great. Thank you very much.
Closing on that, I think the only area where we continue to see is the people side. We've been very fortunate to not have a lot of turnover at company, a lot of excitement among our employees. They're all shareholders, so they're all committed to our journey and what we're doing. I think that's probably the area that you know we see a lot of inflation across society, but we've kind of tried to manage that through efficiencies and delayed hiring and things like that to make sure we're not incurring additional expenses unanticipated this year.
All right. Thank you so much.
Next question.
Your next question comes from Brandon Folkes from Scotiabank. Please go ahead.
Hi. Thanks for taking my questions and congratulations on all the progress. Maybe two just from me. Maybe just, Steve, just any commentary on channel and inventory in the channel for Afrezza. Where does that sit now relatively? Is it at a normalized level at the end of the Q2 ? And then secondly, how should we think about product priorities going forward, just in terms of Afrezza versus V-Go and kind of maybe where you can move revenue quite quickly? Just any commentary in terms of those two products in the reps' bags going forward. Thank you.
Sure. Let me
Sure.
Mike, I'll take the channel and then I'll drop it off to you for the revenue. Yeah, the channel inventory moves around as much as half a million dollars quarter to quarter. It's not up to us. The wholesalers are the ones who are managing their own inventory levels. We see it. It happens some quarters, not every quarter. Is it normalized now? It's in the right ballpark. I don't see material changes happening. Yeah, we had an offset this quarter that offset our growth in patient TRxs increase. It was unfortunate, but we did have 8% growth in the prior year in paid TRxs. I don't think, again, it's gonna be material quarter to quarter, but it will fluctuate.
Another thing I'll add, Steve, is we did see a 13% decrease in days on hand, so they did drop a few days of inventory. That did, you know, impact Q2 a little bit. That's if you normalize for inventory, there'd be slightly higher sales on Afrezza. I think your second question, Brandon, was how do we think about V-Go versus Afrezza as we think about the future? Is that what I heard?
Correct. Yes.
Yeah. You know, there's a very big difference in margin to the company as well as how many scripts it takes to break even on one versus the other product. We knew that when we purchased it. I think when you combine, you know, it's really about trying to get doctors to try something different because we know 80% of people on mealtime insulin are not at goal, and yet they're just not progressing these patients to better solutions. That's really our focus is how do we start to at least let the reps close those doctors. If they're not gonna write Afrezza, they can write V-Go. If they're not gonna write V-Go, they can write Afrezza. We really need to do something different, number one, and more importantly, offer patient choice.
I think after six years of us promoting this, we're just finishing up research right now, and what we're hearing is, you know, the patients are asking for Afrezza, the doctors aren't offering it. I think we gotta really shift that mindset going into next year about patient choice and giving the patients some right around that. I think that'll be really important as we go forward when it comes to Afrezza and V-Go for that matter, is that let the patient pick, especially type twos, you know, there's so many of them, what do they want best to manage their lifestyle and their mealtime control. So, we will continue to watch. We don't expect to cannibalize one product for the other. That's why I wanna remind you guys, Steve, we don't have 98% of patients on a MannKind product.
That's really the focus of how do we bring more of those patients into our portfolio and our family. With V-Go now, for example, we can add a nurse trainer in certain markets because there's enough volume to support, you know, a nurse trainer keeps them busy enough. That's not always been the case when you add just Afrezza. I think as we go into the end of this year, going into 2023, we're just starting to talk about how do we best maximize that impact? How do we best support the sales force so they can maximize their effect? I think we'll see always a dedicated V-Go sales force, cause these are the top accounts, top reps, top experience with V-Go. I think the question is on the Afrezza side, when and how do we integrate?
What does that look like? Do we have overlapping accounts or separate accounts? All that work's just starting. I wouldn't give you much guidance until we probably get to the next quarter, and we'll have it locked down.
Great. Thanks very much, and congratulations again.
Thank you.
Thank you so much. Your next question comes from the line of Thomas Smith from SVB Securities. Please go ahead and ask your question.
Hey, guys. Good afternoon. Thanks for taking the questions and congrats on the progress. Just on Tyvaso DPI, can you comment on kind of the early days, supply chain as you guys manufactured the drug product? Any challenges you see on the supply chain side of things here as UT gets out there and launches DPI into the market?
Not right now. Fortunately, we had some time to build up some inventory while they were launching, right? They I don't know how much you know about the pulmonary market, but basically it takes two to four weeks usually to start a patient between, you know, getting them started, getting insurance done, getting the forms in, getting the patient trained properly. You know, they have, you know, these are lifelong treatments usually. That process, you know, is on UT's side. And so, you know, they could see every week the referrals coming in. I think they said on their earnings call, the initial launch was really about conversion. Those people on 48, 64 micrograms, converting over one to one.
The next part was the titration pack, which launched in July, and that's going after the naive patient population. How do you start to see a naive bucket come in next? Later in the fall will be the next packaging. UT has a multi-year view of the world of how they're launching this and what they're doing. We don't expect any supply constraints as everything's passed validation, everything's on track. We don't see issues there. We have enough inventory built that there shouldn't be any stockouts no matter how fast it goes. We should be in a good spot.
The second part which you may not realize is we're actually the distributor, so we also ship it to the pharmacies every week when those orders come in. That process has gone smoothly as well. That's another area we worry about hiccups, as it's the first time we were doing something like that. Everything's built. We got a big, large storage refrigerator and trucks come every week and, you know, we're very excited about it.
Okay, great. Just a couple on V-Go. You know, I appreciate all the color on the acquisition and the strategy. Can you just help us understand how you're thinking about the longer term revenue potential here? Then can you also help us understand how you're thinking about the cost structure a little bit? Are you planning to make additional investments here on manufacturing or marketing? I guess help us think a little bit about the longer term gross and operating margin profile and how that compares versus Afrezza.
Yeah, a sale on the V-Go device, you know, they've lost half their volume roughly over the last two years, and that's obviously hurt the margins of that product. I think that that's one of the things we'll be looking at is as volume starts increasing, how do those margins improve and to what extent? Is there anything we can do to improve them even further? At this point, we don't have plans to add any additional cost. There's enough production there to handle a lot more volume. Now, if we decide to move production or make it more efficient or automated, that's a different story. We just got the product less than 60 days ago, roughly.
I think there's still a lot to learn. The team there is doing a great job at managing the supply chain of V-Go. You know, think about they're making almost 3 million V-Gos a year. That may be more than that by now. There's a lot of device production, you know, that happens with V-Go into the marketplace, and there's pretty complex supply chain. I think it's one we'll manage. We'll continue to look at it. We want to be comfortable that it's at least stable in the short term, and then we'll look at ways that maybe volume drives it, maybe automation drives it. We have a good team at MannKind, as well as a former Valeritas team that really understand device manufacturing, device scale up.
I think that's something we'll look at as we get into the H2 of this year. On the long-term expense base overall or revenue, you know, I do think V-Go will show some growth in the near term. I think there's a lot of pent-up demand. There's a lot of people who thought that it was going away. I think you'll see that come back a little bit faster than one would expect. We'll see in the coming months how that looks, but the noise on the street at least is very positive. On the expense base, we expect to pretty much manage our expense base tightly. We're not looking to increase our cash burn as it comes to Afrezza and V-Go combined. We're looking to build efficiencies as we go.
If we see ways to grow faster, we are welcoming those opportunities from the marketing and sales team to do that. We, as you know, we've tried so many different things over the years. We really wanna see productivity out of the existing investments we're making before we add more. That's how we're thinking about it. If we see something that's growing or an area that's growing and we can replicate that nationally, we'll do it in a heartbeat. At this point, we're running the brands to cash flow breakeven and ultimately cash flow positivity as we look at 2023 and beyond.
Okay, got it. That makes sense. Great. Thanks, guys.
Thank you so much. Our last question comes from the line of Steven Lichtman from Oppenheimer & Co. Please go ahead and ask your question.
Hey, guys. Congrats on the quarter. This is Ameeran for Steve.
I just had a question around the pump switch trial. Just to be clear, were you guys expecting to get the data in the H2 of this year? Then can you remind, and as a follow-up to that, can you just remind us what your goals are once you have the data on hand? Thank you.
Yeah. Yes, we always expect it. It's a 12-week trial. It's only 28 patients that are randomized. We actually went a couple above just to make sure we hit our endpoint of 25 patients. You know, that randomized, you know, I think the surprise for us was how quickly that enrolled. Usually, these things take a little longer, but it's a small trial, very manageable, 2 sites. Those two sites did an incredible job. In about 45 to 60 days, they completed enrollment. Therefore, we'll get those results much faster than we expected because the enrollment went so quickly. Now that everyone's enrolled, just multiply by 3 months, and we should be able to get those results roughly in September-October timeframe.
We have not yet, I mean, should we get the results, and then do they come out in a late breaker somewhere? Do they come out at ATTD or ADA next year? We'll decide at the appropriate time do we put out information on those results when they come. If you know this market, the entire market is all about insulin pumps and type ones, and no one's really looking to run a switch strategy away from insulin pumps or adding a Afrezza in a multitude of ways on top of insulin pumps. This is a pretty groundbreaking study, albeit small. It's gonna give us some really, really important insights to think about as we go into 2023 and beyond.
That would really help shape our strategy to the previous question, what do you do from investments? You know, if we get a superior result, then that's one thing. If we get an equal result, that's a different strategy. If you get a suboptimal result, that's another strategy. Our overall goal is change in A1C, and the working assumption is no difference between the control arm and the two other arms. If we see an improvement in hypo, improvement in time and range, or improvement in A1C, then that would be the upside scenarios that we're looking for. If we can demonstrate that people can maintain A1C control and safety by switching off a pump, I think the market does not believe that's possible. That's something we'll be looking at very closely.
Thank you.
Thank you so much.
We have one more. Oh, okay.
Yes, we don't have any questions for now.
Oren, I see a couple other analysts, so okay. Well, we'll have one-on-ones that people need any questions or comments to reach out to us. Otherwise, thank you for your time today. Look forward to really getting through here in Q3 and sharing with you further results and growth as we go forward. Thank you everyone for your time. Have a great week.
Thank you, presenters. This concludes today's conference call. Thank you for participating, and you may now disconnect. Have a good day.