MannKind Corp (MNKD) 2022 Q1 法說會逐字稿

Good afternoon, and welcome to the MannKind Corporation First Quarter 2022 Earnings Call. As a reminder, this call is being recorded on May 5, 2022, and will be available for playback on the MannKind Corporation website shortly after the conclusion of this call until May 19, 2022.

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 the 10-K report filed with the Securities and Exchange Commission this afternoon, the earnings release and the slides prepared for this presentation.

Joining us today from MannKind are Chief Executive Officer, Michael Castagna; and Chief Financial Officer, Steven Binder.

I would now like to turn the conference over to Mr. Castagna. Please go ahead, sir.

Thank you, and thank you, everyone, for dialing in to our current earnings call today. We're in unprecedented times as we look at the volatility in the stock market as well as our biotech sector having lots of, unfortunately, mishaps these days in terms of companies in floating on a daily basis, which from a MannKind perspective, we're expanding and hiring. So we're able to find great talent. But from an industry perspective, we see lots of change ahead.

When I think about Q1, we had some great opportunities to continue to advance our transformation in Afrezza, which I'll talk about today, as well as advance our pipeline progress with clofazimine. And we'll give an update we note today on Tyvaso. So those will be the 3 focuses of our conversation.

I personally just got back from our ATTD Diabetes Conference in Europe, and I was able to meet about 10, 15 of the top regional thought leaders in those countries that are represented in the European Union to really talk about Afrezza, the potential of Afrezza as well as the pediatric trial and the studies that we're doing. And I walked back invigorated on opportunities on how we can continue to expand with clients within diabetes.

We've also had several FDA interactions on Afrezza in the pipeline as we think about -- trying to think about the label change as well as preparing to go to advance clofazimine into Phase II. And we also had an advisory board with roughly 10 of the top thought leaders in nontubercule mycobacterium for the first time where we could really assess how we think about NTM, how we're positioning clofazimine and to confirm our strategic direction relative to where we're going in our clinical trial before we go to the FDA.

So within the UT collaboration here on the slide, our PDUFA date is May of 2022. We eagerly await for the FDA to give us a notification or -- actually UT. We are focused on preparing to support the expected commercial launch of UT in June. On the pipeline, our SAD trial is almost complete. I'll describe that in a second. We expect full results from the MAD section in Q3. On MNKD-201 and 501, both of these are progressing nicely. We're in doing animal inhalation studies and really looking at the levels as well as the bleomycin-induced lung models here in Q2 and Q3.

On the Afrezza side, we had $9.8 million of revenue for the quarter, 21% growth year-over-year. Our Afrezza pediatric trial site certification continue to increase each month, and we're on track for our patient goals for 2022. We also kicked off the Afrezza basal combination study, which I'll show you some progress on that very shortly and finished the quarter with $233 million in cash.

On the Tyvaso DPI update, we are deferring to UniTher on any questions related to indications, FDA approval time lines, any questions on the label, that will all go through UniTher, they're handling the day-to-day communications with the FDA. We do eagerly await the decision, and we are excited to continue to focus on what we can control, which is manufacturing commercial products for launch in Q2, as well as building out the plant expansion to support the additional readouts that UT expects for COPD and IPF.

On MannKind-101, which is our clofazimine product, we have completed Part A yesterday, thank god, and so we have done cohorts A1, A2 and A3. We've now dosed patients up to 90 milligrams, which is the highest dose we thought we should go. And we've so far seen great tolerability with no safety signals. We will now wait for the full data set to be analyzed along with PK and PD and assess the proper doses here for Part B. We'll know on the low end, we'll go to 30 milligrams, which we think is more than enough to overcome any MICs. And we are debating whether to go to 90 or 60 based on the data coming out of Part A. We think we can go to 90, and it would probably make sense to go to 90 just to have the max tolerated dose. Top lines are expected here in Q3 from the MAD part. Obviously, in Part A, we know the safety and tolerability of clofazimine looks very strong in the nebulized formulation.

I'm now going to bridge a little bit over to Afrezza because we haven't spent a lot of time on Afrezza the last few earnings calls, but I thought we should share with you some of the activities we're doing and what's changed over the last few months. Starting in February, we had a refocused effort, and that effort is starting to show early signs of impact on driving NRx ultra-acting share. So on the left side, you can see here, this is our patient funnel when we look at all patients coming into AfrezzaAssist, which is our reimbursement hub, as well as our cash program as well as our free goods program, which takes out a lot of the costs that used to exist in our old program. And you can see on average, we're at about 187 patients a week now involved in 1 of these 3 programs, up from 122. So these are patients that don't necessarily show up in Symphony if they're free goods or cash pay, but this is activity that's showing continued growth and momentum of the diabetes franchise.

When we look on the right side, we started refocusing our efforts on ultra-acting share, which is defined as Fiasp, Lyumjev and Afrezza. And we've had a multiyear decline in share. And this year, we changed our field incentive comp as well as our target list to really focus on moving market share back in the right direction. We had our first sales meeting in person in the last 3 years due to COVID. And that meeting happened, and you can see the early signs here on NRxs, which is where you'll see that progress, we've gained almost 1% market share through April since January with this new focus. We'll continue to watch this closely. This is one of our key metrics for 2022, and we're excited about what that can bring.

On INHALE-1, this is our pediatric trial, we now have 18 sites confirmed. These are high-quality U.S. investigators from leading academic centers as well as some of the top private practice doctors. We met with our colleagues in Europe, and there was a lot -- there was some interest in a couple of countries such as Germany, Israel and Italy, to add a pediatric site in those countries to get experience for those investigators who have a strong desire to learn more about inhaled insulin as we think about filing in Europe some time down the road.

What you can see here on the U.S. only focus so far is we are meeting and exceeding our target enrollment, and we are -- the randomization, there's a delay of a couple of weeks between time we get enrolled and the time they actually randomize. So it's not that we've lost 16 or 17 patients in these numbers, there's just a delay from the time they actually enter the trial to the time they actually randomize. I think only 1 randomization failure has happened so far. Otherwise, this track is on -- this trial is on track to continue to hit our goals for this year.

The next trial I want to talk about, which again, we haven't given much focus on, we referred to this previously as the pump-switch trial. If you look up on clinicaltrials.gov, it's called the Afrezza With Basal Combination study. And one of the things we've realized about Afrezza is a lot of people enjoy their insulin pumps that have type 1 diabetes. And a lot of them, when we get questions about our script refill trends, it turns out of a good proportion of type 1s, use Afrezza for special occasions or their meal time on top of their pump. And so we have no clinical data in showing what Afrezza plus an AID pump looks like in greater than 1 dose where some of the trials were done years ago.

We also have 0 data on switching a patient off an insulin pump so we can show people safely how to switch from their insulin pump to Afrezza Tresiba and show that they can have, hopefully, equal or better glucose control and quality of life. This is the first time in history that we can see that there's a pump switch from the pump over to Afrezza.

Then we also decided to maintain a control group so we can see what happens if we take people on a pump and continue them on the pump for the duration of the 12 weeks. So we'll really be able to compare in this pilot study, staying on your pump, adding Afrezza to your pump only for your meal time, using the pump just for your basal and they're switching off to, calling it detached lifestyle over to Afrezza plus Tresiba.

And the reason this is important is we do see an opportunity in the future where we see once weekly basals coming, that's a very compelling proposition for patients, as well as oral basal potentially watching what oral med will do later this year with the readout in type 2s. So we want to understand how best these are present in different combinations. This trial's primary output is no difference in A1c between the 3 treatment options.

The good news is pretty much by the end of this month, this trial will be fully enrolled, and we should have the results here in late Q3, early Q4. We've -- I think when you look at clinical trials, the excitement around enrollment tells you the excitement around the trial. And the fact is this trial enrolled literally in 60 days these 25 patients. So we're very excited about it. It's 2 sites, very focused effort here, and we'll await these results very shortly in the next quarter or 2.

Now I'm going to turn it over to our CFO, Steve Binder.

Thanks, Mike, and good afternoon. I'm pleased to review select first quarter financial results. Please supplement this call by reading the condensed consolidated financial statements and MD&A contained in our 10-Q, which is being filed with the SEC this afternoon.

Let's start by looking at revenues for the first quarter of '22. Afrezza net revenue was $9.8 million versus $8.1 million in 2021, a growth rate of 21%. The increase was driven by wholesaler inventory ordering patterns during the first quarter of 2021, which were adversely impacted as wholesalers decreased inventory levels plus price, including a more favorable gross to net deduction of 38.7% and underlying TRx growth.

Moving to collaboration services. Revenue for the first quarter was $2.2 million versus $9.3 million for 2021. The revenue in the first quarter was mainly associated with United Therapeutics, specifically the next-gen R&D efforts; clinical supplies for patients in the BREEZE study extension; and some pass-through expenses. We did not have and did not expect to have revenue from our commercial supply agreement with United Therapeutics in the first quarter. We expect to start recognizing revenue associated with the UT commercial supply agreement in the second quarter.

Revenue associated with the manufacturing activity in the first quarter of 2022 was deferred on the balance sheet in the amount of $7.4 million, which I will discuss in greater detail in a few minutes. From a cash standpoint, we were able to invoice and collect from United Therapeutics for these manufacturing activities.

The graph on our next slide shows the quarterly Afrezza gross margin trend from the first quarter of '21 through the first quarter of 2022. Our gross margin for the first quarter of 2022 was a record 77%, which reflects increasing Afrezza net revenue and lower cost of goods, mainly related to the absorption of indirect and overhead costs at our factory where we now produce 2 products. We expect the gross margin for Afrezza to be at least 70% for the full year 2022, but it can fluctuate quarter-to-quarter based on manufacturing activity and spend across both products.

The next slide is similar to one that I showed last quarter in that we have been deferring the revenue associated with our Tyvaso DPI manufacturing activities since the second quarter of 2021 and will not be able to recognize this revenue until we sell product to UT, which we expect in the second quarter of 2022. For the first quarter of '22, we had $7.4 million in manufacturing expenses recognized in our P&L without a corresponding revenue offset. Since the second quarter of '21, the amount of manufacturing expenses recognized in our P&L without a corresponding revenue offset totaled $21 million, which sits on our balance sheet as of March 31, 2022. Deferred revenue will be recognized over the manufacturing services agreement life, which currently runs to 2031. United Therapeutics is funding this cost as we've been invoicing and collecting from UT.

Now that we have looked at Afrezza and collaboration services separately, let's look at the gross profit and gross margin for both side by side. Please note that collaboration services is mostly associated with our agreements with UT. Afrezza gross margin increased from 47% in the first quarter of '21 to 77% in the first quarter of '22, as discussed earlier, and the gross profit associated with Afrezza increased almost 100% to a record $7.5 million. The collaboration services closing loss for the first quarter of '22 was mainly due to the revenue deferral I just spoke about. We expect this to turn positive once revenue is allowed to be recognized when we start selling product to UT.

Let me conclude with some final comments. Having done our convertible debt and sale-leaseback financings in 2021 before the capital market downturn this year, we are in a strong financial position to fund our growth with a cash and investments balance of $233 million as of March 31. In addition, with rising interest rates, which are likely to continue for some time, we are well positioned with minimized interest rate risk. The vast majority of our debt, which includes the convertible Mann debts are at a fixed rate of 2.5%.

Also anticipating a rising interest rate environment, we negotiated an interest rate ceiling for our floating rate debt with MidCap about a year ago with a maximum exposure of only 1% over the current rate. Operationally, we are showing continued progress in turning Afrezza into a moneymaking brand, and we are preparing to support the expected commercial launch of Tyvaso DPI as the FDA action date approaches.

Thank you. Now I'll turn it back over to Mike for some additional comments.

You saying a moneymaking brand was a great comment, Steve.

All right.

Thank you, everyone. So talking about the pipeline here. So we remain very excited about the pipeline. We talked about Afrezza and Tyvaso DPI and clofazimine. The next couple of things we'll start to hear about over the coming quarters will be nintedanib going forward and the outcome of the bleomycin model as well as DNase alfa and Thirona. These programs take a little more time in the beginning and then once we get them through and get the teams working, these programs can progress quite rapidly in the coming years.

Additionally, on the cannabinoid side, Receptor Life Sciences received an IND for the FDA to progress their development, and we continue to keep in touch with Fosun around their small molecule inhibitor and how that's progressing in development. We continue to look for more collaborations on our technology platform as we continue to move forward post the next FDA action date with Tyvaso.

When we look at our milestones for 2022, we clearly lay this out every year, and you can see so far, we're on track to meet most of these milestones or exceed them. We obviously did not hit the first one, which we think was very important on the Tyvaso DPI PDUFA date. That's been extended to May and we remain optimistic about that date and our ability to hopefully get Tyvaso to patients here in Q2.

So one, I think, important thing when we come to you on our next earnings call there'll be 2 additional sources of revenue as we laid this out back in Q4 earnings call on Tyvaso manufacturing and Tyvaso royalties. The bars of revenue growth for MannKind continue to grow, and we look very -- look out very forward about the exciting opportunities we have to exponential the revenue over the coming years between Afrezza collaboration services, business development as well as manufacturing and royalties.

I think we're going to stop there and open it up for questions.

(Operator Instructions) Your first question comes from the line of Brandon Folkes from Cantor Fitzgerald.

Congratulations on another good quarter. Granted, you obviously sound quite confident on the Tyvaso DPI approval, but how should we think about OpEx spending just in the case where Tyvaso DPI does not get approved this month, perhaps pushed out a little bit? Just any color in terms of how we should think about maybe some levers in your current OpEx spend that may come down.

And then secondly, maybe just on Afrezza. Can you just elaborate -- and I apologize if I missed this, but where was wholesale inventory at the end of this quarter?

Okay. I think -- the first one, I think maybe we could say -- and Steve, correct me, OpEx on Tyvaso, even there was a delay. That's mostly picked -- this is all picked up by UT and it's why you see some of the deferred revenue on our P&L. So that doesn't impact our particular cash burn or anything around MannKind.

On the wholesale inventory, Steve, I'll...

Yes, inventory remains constant between December of '21 and March of '22. So it wasn't much of a wholesaler inventory channel change.

Great. And one more, if I may. Obviously, just with that very strong cash balance you have, how do you think about maybe bringing and licensing a few more pipeline products? Obviously, you've bought a pretty robust pipeline. But I guess, do you have the capacity maybe, asked a different way, to bring in additional products just given valuations for -- and licensing maybe coming down?

Yes, Brandon, I think M&A is going to be something we continue to evaluate as a company. We've had a lot of inbound interest on looking at different opportunities so far in 2022. Obviously, a lot of companies, I think there's about 170 companies trading for less than cash value. So there's opportunities in that space.

There's also opportunities for companies continuing to streamline the products that they're going to focus on. And then there's plenty of pipeline opportunities to go. But I think on the pipeline, we feel pretty good about the shop on goal that we have in progressing those.

On the ability to find additional cash-generating assets I think is where our focus is because we think we can continue to harmonize the G&A expense and the P&L that we have as well as the infrastructure we've built up. So I think we'll continue to watch out for those as valuations have become more normal. In the last couple of years, things were just ridiculous, but I do think things are finally coming -- and it's in a good range that we're sitting in a good spot as a company to continue to look at these things.

Congrats again.

Your next question comes from the line of Gregory Renza from RBC Capital Markets.

Michael and Steve, congratulations on the progress. Maybe just building on the previous question, with respect to Tyvaso DPI decision coming up, and maybe just around scenario planning. I think you answered the question just around OpEx. I'm just curious how the various scenarios playing out whether, of course, if approval, but as mentioned, delay or otherwise, how you think about the potential permutations of your strategy, the earlier mention of business development. Are there accelerants that we would see or other things to contemplate with respect to that decision coming, with Tyvaso coming up?

Greg, I don't want to comment too much. I think we're literally within weeks of the FDA decision. I think we just got to wait for that to come through, and I think that will bring a lot of clarity around the anxiety I hear from our shareholders of what does this mean from an indication, what does this mean from the platform, what does this mean for MannKind. And like I said, I think our focus is making sure we have product supply available upon launch and approval. And I think that's what we want to make sure we're ready for with UT.

But I want to really defer a lot of Tyvaso-related questions. For us, we have enough cash. We sure have the balance sheet last year. Even if there was another delay, it doesn't fundamentally change how MannKind's operating. We look at this as all upside to the current operating trend that we have. And that's some of the decisions we made last year around the sale leaseback and the convertible debt was so that we can fund our pipeline and fund our growth and not be fully dependent on the UniTher decisions and the FDA, some of the interaction there.

But obviously we want this. We think it's important to get to patients. We're excited to partner with UT. They've been an incredible partner, and we want to get this to patients as soon as possible. We want to make sure we can supply and be there. And so hopefully, that gives you some clarity, but I think if things are delayed, it doesn't shift anything we do that much. We still want to build up inventory. We still want to be ready day 1 of launch, and we're focused on our pipeline and our platform equally as much right now.

Your next question comes from the line of Thomas Smith from SVB Securities.

Congrats on the progress. Just one, Tyvaso DPI. I understand UT is handling all the FDA communications directly. But I was wondering if you could comment on whether there's been any other requests where you had to provide data to the agency since the last submission. I think it was back in February that led to the major amendments.

I would -- Thomas, I don't want to speak on behalf of UT as everyone's having face-to-face request. I -- from my knowledge and perspective, I don't think there's been anything major that's come in since that initial request. But I'd have to defer to UT to answer that properly. There's nothing else that's part of MannKind, I can tell you that.

Okay. That's helpful. And then just on the Tyvaso DPI commercial manufacturing preparations. Could you just give us an update on where you are in terms of scale-up activities? Has there been any changes to your plans or your forecast on manufacturing here over the last couple of months as we get closer to the anticipated launch later this year?

No. I think the only thing we continue to try to do is we've re-purposed a lot of equipment over the years that we had, and we want to make sure that equipment is operating optimally, how do we increase yield, how do we increase -- product loss in the process. So I think we're just trying to continue and improve everything that this team has set out to do. And honestly, a lot of it's been operator training. And so the more proficient, the more -- they make a lot of clinical batches. They made some practice runs. They've obviously got the validation.

So I think that's helping all the new employees gain a lot of experience with our process and our equipment. And that's probably the biggest thing we can do is just continue to build proficiency, because this operation is going to be running 24/7 for the foreseeable future. So I think that's number one is making sure we're keeping our talent, we're training our talent and we're getting them proficient in how to operate the -- it's a very multiple step process with different teams involved. So I think just getting each of those teams on a 24/7 basis, operating and running equipment properly is really important.

Okay. Got it. And then just one last one, maybe on the Afrezza pediatric study. Can you just remind us how many sites you're ultimately targeting? And then as you think about expanding your sites here into Europe, how are you thinking about the balance, the regional enrollment between the U.S. versus ex-U.S. sites?

Yes. I think on the sites, we've gone back and forth, but somewhere between 25 and 40 is -- we think 45 is the max you would go to. We've got a couple of investigators who have 7 patients, 8 patients and growing. So I think it's a matter of if we have 25 sites each getting 10 patients, we'd be done in the next 9 months -- excuse me, in terms of enrollment. So I just think it's how are we enrolling, how are we tracking. And it's taken -- it takes time to get a lot of these academic centers up and running from a contractual basis. So several great sites like [Charlestown] in Boston, Stanford. These guys are just coming on board right now. So we haven't even really started a lot of the academic centers. So I think -- let's see how they're progressing.

I think in Europe, we don't have a target number. I think it was more nice to hear some thought leaders that are really podium-type presenters want to be involved in the trial. And so we're looking to see -- we weren't trying to go to Europe, but it doesn't hurt us to have a few sites in Europe collect some patients there.

And I think in that market, Medtronic 780G was all the hype at ATTD. And thinking about an alternative opportunity for those patients who aren't on pumps is a real market opportunity in Europe that we have to look at. And I think some of these countries have decent reimbursement and many of them don't have decent reimbursement. So I think it's just trying to understand what is the value proposition of Afrezza. For example, can you justify the cost of an insulin pump or avoidance of a pump and that cost is equal to Afrezza versus an MDI injection.

So I think really understanding our pump-switch trial that we're doing, how that's going to show outcomes and efficacy as well as the efficacy we get in fees will start to drive some of the strategy for ex-U.S. But ultimately, just getting fees done and getting good results will be important. And -- but we think probably 25 to 35 sites is going to get us there.

Your next question comes from the line of Bert Hazlett from BTIG.

Yes. Congrats on all the progress. And my apologies if some of this has been touched upon, but -- I came on late. But just with regard to Afrezza and the focus on the ultra-acting share, nice to hear everybody has been able to get back together with sales force meetings. Is there any contemplation of potential sales force expansion should this gain traction down the road? Or is that something that's maybe really not under contemplation? You're really trying to find out more about what strategies are working or what could work at this point.

I think, Bert, like we will always find -- if we see ways to grow the company faster, we now have the capital to deploy. So if Alejandro and Ben and our team leading efforts over there can start to show some consistent week-over-week and month-over-month growth trends and marketing programs are starting to work, I think we have a good plan for ADA, ENDO, AACE. So we have some good conferences this year, some good podium presentations.

So again, if the noise is positive, we're seeing the momentum, we're happy to fuel that fire to make it grow faster. We're not looking to spend more than we are in a meaningful way until we start to see some additional progress. But we are willing to in the event we do see that continue.

Okay. Great. And then just with regard to Tyvaso DPI, maybe you touched on it, my apologies if you have. Have you talked about expectations for the label of this? And then could you just comment on potential competitive landscape as you think about DPI rolling out? Again, obviously, you're with a great partner, but love to hear your thoughts on competitive positioning of the molecule -- or of the program.

Yes. I think, Bert, I'm not going to comment on the label. I think UT had their earnings call yesterday, they were pretty silent about that, so I'm going to defer to them on any comments on that question. And I think on the competitive landscape, again, I know there's some patent wars between UT and Liquidia. I'm going to defer ultimately to the experts over there on those questions. So I don't want to too much comment only because we're so close to the PDUFA date, let's get that date across the finish line and then happy to talk further around those things.

Your next question comes from the line of Steven Lichtman from Oppenheimer.

This is David on for Steve. Just one for me regarding what's your latest outlook on sort of the macro landscape. Are you seeing any supply disruptions or inflationary pressures? And if so, how does that impact your gross margin outlook for the rest of the year?

Yes. I think overall as a company, we had to give slightly higher raises than historical. We know some of our suppliers are going up a little bit, but I'll let Steve comment. But obviously, inflation is impacting everybody. But fortunately, a lot of our operations are fixed cost and a little bit of variable. But Steve I'll...

Yes. And a lot of our large supply agreements we had locked in for a period of time, some of them will expire during the year, and we'll have to renegotiate them. So I don't expect right now a huge increase, but there is definitely a slight increase over the previous year, but we're pretty well locked in for a period of time.

And if you think about on the flip side, the euro to dollar is going in our favor, and we have this large insulin supply commitment. So that's actually coming down from a cost perspective nicely. So fortunately, probably balances each other out. But we're not seeing any major supply disruptions with both safety stock where we could see risk, and there's things here and there that pop up, but we want to make sure a $2 pump or hose doesn't cause us to have a delay.

So the biggest impact, honestly, has been our BluHale device that we've been working on. The chips are going out of stock and there's remanufacturing. We've got to redo the motherboards. That's been probably the biggest headache. But again, that's not impacting Afrezza or Tyvaso. These are launch opportunities, enhancements to accelerate growth, but they're not on the critical time line yet, but those are probably little things that annoy us.

And there are no other question at this time. Let me turn the call back to Mr. Michael Castagna, CEO, for closing remarks.

I just want to say thank you to everyone for listening today. I know it's a turbulent time, and we're under a tremendous amount of stress to continue to perform. And fortunately, we're coming out of COVID, but we're entering into an inflationary period with a volatile stock market. MannKind's in a really good position to weather the storm, we've weathered worst over the last 5 years, and we feel very optimistic about the position we're in as well as the opportunity to continue to grow the company on behalf of shareholders and health patients. So I just want to say thank you to everyone for all the work, and really looking forward to executing the rest of this year, and hopefully, having a great 2022.

Thanks again, and we look forward to -- I think we have a couple of investor conferences coming up in the month of May. So you'll be hearing about those very shortly.

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