MannKind Corp (MNKD) 2017 Q1 法說會逐字稿

Ladies and gentlemen, welcome to the Q1 2017 MannKind Earnings Conference Call. My name is Danielle, and I will be your operator for today's call. (Operator Instructions) Please note that this conference is being recorded.

Joining us today from MannKind are Chief Executive Officer, Matthew Pfeffer; Chief Commercial Officer, Michael Castagna; Chief Medical Officer, Raymond Urbanski; and Principal Accounting Officer, Rose Alinaya.

I would like to turn the call over to Ms. Rose Alinaya, Senior Vice President and Principal Accounting Officer for MannKind Corporation. Please go ahead.

Good afternoon, and thank you for joining us on today's call. Before we proceed further, please note that comments made during this call will include forward-looking statements within the meaning of federal security laws. It is possible that the actual results could differ from these stated expectations. For factors which could cause actual results to differ from expectations, please refer to the reports filed by the company with the Securities and Exchange Commission under the Securities and Exchange Act of 1934. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, May 10, 2017. We undertake no obligation to revise or update any statements to reflect events or circumstances after the date of this call.

I'll now turn to our financials. Our total net revenue for the first quarter of 2017 was $3 million, which included $1.8 million from the sale of surplus bulk insulin to a third party, and $1.2 million of recognized Afrezza product dispensed to patients after giving effect to gross to net adjustments of $0.4 million. In addition, as of March 31, 2017, we had $1.8 million of deferred revenue related to Afrezza product that has been shipped to the third-party logistics provider and wholesale distributors, but not yet dispensed to patients and recognized as revenue.

Cost of goods sold was $2.5 million in the first quarter of 2017 compared to $5.2 million in the first quarter of 2016, a decrease of approximately $2.7 million or 52% due primarily to a decrease in under-absorbed labor and overhead as a result of the reduction in workforce and a reduction for capitalized costs related to the manufacturing of Afrezza that has not yet been sold in 2017. These decreases are partially offset by $0.3 million of cost of goods sold attributed to commercial product sales of Afrezza dispensed to patients.

Research and development expenses were $3.1 million for the first quarter of 2017, a decrease of $2 million or 39% compared to the first quarter of 2016, primarily due to reduced development activities as we focused on the commercialization of Afrezza. We continue to starve our development programs, but have incurred expenses related to our clinical trials.

Selling, general and administrative expenses were $15.4 million for the first quarter of 2017, an increase of $8 million compared to the same quarter of 2016 due to our efforts in the selling and marketing of Afrezza, whereas our former partner was responsible for selling activities in the first quarter of last year.

G&A expenses increased $0.3 million for the first quarter of 2017 as compared to the same quarter of 2016, primarily due to increased spending on regulatory activities associated with Afrezza.

The net loss for the first quarter was $16.3 million or $0.17 per share compared to a net loss of $24.9 million or $0.29 per share in the first quarter of 2016. Cash and cash equivalents at March 31, 2017, were $48 million compared to $27.7 million at the end of the first quarter of 2016.

During the first quarter of 2017, we received $30.6 million from Sanofi pursuant to the settlement of an insulin put option, $16.7 million from the sale of the Valencia property, and $2.1 million from shipments of Afrezza. Currently, $30.1 million remains available to borrow under the amended loan arrangement with The Mann Group.

With certain costs containment measures, we reduced our monthly average cash burn rate from $10.3 million in the first quarter of 2016 to $7.4 million in the first quarter of 2017. We will continue to focus on these efforts as we work to extend our financial runway.

I will now turn the call over to our CEO, Matt Pfeffer. Matt?

Thank you, Rose. Well, clearly, the focus in the first quarter has been on increasing our sales, rehashing our sales efforts and putting out an enhanced and enlarged sales force and many new marketing efforts. Most of these Michael will be talking about in just a few moments. But at the same time, we continue to focus on various savings initiatives and spending reductions. As Rose noted, we've decreased our cash burn rate from roughly $10 million a month down to $7.4 million in the first quarter of 2017 in spite of having built out a fully formed commercial infrastructure over the past year.

And in fact, if you look at our financial position versus the same time last year, we have significantly more cash and less debt than we had at that time. In spite of having taken the product back, putting in place all the infrastructure to support it and a full-fledged commercial infrastructure, still managing to reduce our burn rate. So not only -- and that doesn't even include the clinical trials that Ray is going to be talking about later, which also are factored into there. But we're becoming more and more efficient in improving our financial position on a daily basis.

The numbers I talked about before did not include the changes we made to the Deerfield debt earlier, the second quarter, so that's in addition to that, where we relieved $10 million of that obligation. So our current position today is even better than just spoken about. And we are continuing to make changes in that regard and having further discussions with Deerfield regarding potentially extending maturities and restructuring some of those debt instruments.

At the same time, we're also becoming more efficient in other ways. Our inventory turnover has changed pretty dramatically since last year. We're now at a point where we have 59 days of sales in channel versus 193 days last year. And we're taking other steps as well. Many of you noticed, and I heard it reported a few places on message boards, that our lease on our corporate headquarters here in California expired in April, and we knew that was coming and took a hard look around, looking for ways we could potentially improve our situation and find nicer space that would cost us less money. And I'm happy to announce, and this was reported just a short time ago in our 10-Q, that we recently signed a new lease on a new corporate and commercial headquarters, which will be located in Westlake Village, California, closer to the biopharma talent pool, which is a great help to us in attracting and retaining talent. But also due to rent abatements and tenant improvement allowances and so forth, our cost of that facility will actually be quite a bit less in 2017 and less in 2018 as well during these critical periods.

One other area I wanted to bring up that we're continuing to improve on is in our international areas. We get asked about this a lot, but I can announce today that we are actually on file in one Middle Eastern country and are in later-stage negotiations in a number of different jurisdictions. And you'll see announcements of that in the near term. But as is typical with our past practices, we tend not to make these announcements until we actually get the approvals or sign the agreement. So stay tuned on that front as well.

So with that, clearly, our cash position is better than it has been in most quarters in the past, but don't have everything we could possibly want. The cash we have today should take us comfortably into the third quarter, but we estimate to get to the end of the year will probably take us another $20 million to $30 million beyond that. That said, I have no doubt and I'm quite confident we will have no difficulty raising that money to get us to where we need to be. We primarily have been focusing on debt instruments recently because we've not been very happy with the stock price. But rest assured, we will do what it takes to keep Afrezza on the market and make it the success we all know it can be.

So with that, I want to turn the call over to Ray to discuss progress on the clinical and regulatory front. After which, Mike will give us an update on commercial progress. And then we'll try to answer some of the commonly asked questions that we've been getting.

So with that, Ray?

Thank you, Matt. So today, I'm going to cover 3 topics. I'm going to address the Afrezza label submission, I'll go over the Afrezza clinical strategy and I'll give you an update on the Afrezza clinical program. Hopefully, I will show you how they are all tied together around the key differentiating attributes of Afrezza.

So let me talk a little bit about the Afrezza label submission. So first, it provides clarity on starting dose and dose-adjustment concepts. This is vitally important to ensure that patients use Afrezza appropriately. This will help us retain patients once they start using Afrezza. Other label components consist of changes to the PK/PD comparative statements. We have replacement of the PK/PD graph from the one that currently is there. I'll talk about this in a moment.

We also requested updated language that reflects the most recent data more accurately. Some of this includes, for example, direct comparative data to other rapid-acting analogues. We expect the date of label approval, the PDUFA date, to be the 30th of September of 2017. Now as is typical for the FDA, we don't expect to hear back from them regarding any label components until probably of the July or August time frame.

So this is the slide that I've shown many times before and that we use it as the basis for how our clinical strategy and our clinical programs are going to be laid out. These graphs are important because they demonstrate or basically show Afrezza's key differentiation from rapid-acting analogues. In this particular graph, it's Lispro. This difference is the basis for our strategy and our programs, as I stated previously. It's the PK profile that makes it so much different than Lispro, and it demonstrates clearly that it starts acting within 5 minutes, whereas Lispro acts much later than that. It is this differentiation where we believe that Afrezza is actually a different class of insulins outside of the RAAs.

So let me show you or articulate for you how we are going to incorporate the Afrezza attributes and its clear differentiation from rapid-acting analogues into our clinical programs. So first, we're going to be looking at efficacy studies, utilizing precision medicine and individualized dosing concepts. So here, we take Afrezza's unique PK/PD profile, the one that I just showed you on the graph previously, and this will allow for real-time control of postprandial glucose. This will be especially beneficial to those patients, especially type 1s, who are wearing CGMs. This will allow for an improved time and range, therefore reducing the incidence of hyper and hypoglycemic events. It will also lead to improved A1C levels with more patients getting to goal. Michael will certainly speak a little bit about the number of patients that don't reach goal in his commercial presentation.

Other things we're focused on is around the risk/benefit or the safety profile of Afrezza. We are going to increase the awareness of lung function and cancer data or evidence that currently exists. There is a tremendous amount of misinformation out there, and these efforts will be directed to counteract that information.

And next, we're going to look at the pediatric population. So here we're going to look at generating data that will demonstrate that Afrezza is safe and effective in this population. As you all know, this is a requirement to get regulatory approval to launch this drug in any jurisdiction.

So let me speak a little bit about the actual studies themselves. So we are approaching our pediatric indication as a program. So we are looking -- we have formed, I should say, a pediatrics steering committee that consists of top-tier KOLs, academic centers and organizations such as the JDRF. We are putting together an Afrezza pediatric program that will include not only the regulatory required studies, but ancillary studies as well to address patient, provider and payer needs. We anticipate the first study in this program, the PK start program, I should say, to start around June 15. We are hoping to capitalize on the summer months to recruit these pediatric patients a little bit more quickly.

Next, let me talk a little bit about the long-term safety study. The protocol has been finalized and we're putting the operational components into place. As you may have heard from me previously, we are aggressively managing the cost of the study while still driving to meet the FDA time lines. We are still on target to do so.

The next 2 studies I'm going to speak about are part of our overall strategy around dose optimization and time in range that I articulated previously. The dose optimization study is the Afrezza Dynamic Dosing Study, which we are calling the ADD-1 Study. This protocol is very close to finalization and we're aiming for a July, August start with a possible Q4 completion, data available soon thereafter.

The time-in-range study, which is a study comparing prandial insulin aspart versus Technosphere insulin, which is Afrezza, in patients with type 1 diabetes on multiple daily injection. This is an investigator-initiated real-life pilot study, which we're calling the STAT Study. This study is being conducted by well-known thought leaders such as Dr. Satish Garg. Bruce Bode and Anne Peters are leading this effort.

So with that, I am going to turn the call over to Mike so he can walk through the commercial update.

Thank you, Ray. Good afternoon, everyone. I want to first talk about our -- where we focus Afrezza today and where you see us going over the next 3 to 5 years. Afrezza's U.S. target population is large as we are indicated for over 18 million out of the 22 million people in treatment. The reason for this reduction is obviously because of our label restrictions around patients who have COPD and asthma. I'll remind you of why we're indicated for this large population, because anytime a new drug launches, you have to focus on the biggest unmet need first. And so when you look at the bottom of this pyramid upside down, the next 18 months, we're really focused on the 2.5 million people with diabetes who have an A1C greater than 7.

The reason this is important is these particular patients are already on insulin. They're used to taking insulin. The payer coverage is much easier to achieve and there's a competitor's contracting strategy. And it's where drugs start, really serving the unmet need where people need it most. As doctors get experience in this population, we expect them to move up to the yellow box over the next 12 to 18 to 36 months and to start to use Afrezza earlier in their treatment. We see that happen in various markets already today, but it's unrealistic to expect every doctor to start with this, given some of the payer restrictions that do exist and the lack of experience with the product. As they get experience, as they see their patients' success, we do expect that trend to accelerate.

And then finally, you look at the 22 million people in this big bucket. This is where we've had 40 new drugs approved in the last decade, mostly orals and combination of orals, where we treat people in a successive target -- I don't want to say treatment failure, but we continue to add 1, 2 and 3 drugs and then a basal, then a GLP. And if nothing else works, we then go to insulin. And our strategy obviously, long term, is to reverse that trend where people can use insulin earlier in the treatment as that's what they're missing in many cases.

Each of these market segments are large enough for us to compete, succeed and grow as a company. And over time, we'll continue to demonstrate our success as we progress the clinical development program and our commercial strategy.

I often get the question, are you going to give up? Is MannKind going to see success? And I'll share with you some of our early commercial successes and updates from our March 16 meeting, but more importantly, we have strong reasons to remain focused. One in 5 people on injected insulin regularly miss their dose, which means they aren't going to achieve their personal goals or getting to A1C less than 7 because daily injections do interfere with your daily activities as well as many patients are embarrassed of pen injections, embarrassment in public of injecting.

Number two, while we've had 40 new drugs approved in the past decade, we've made very minimal progress and advancements of the percent of population achieving an A1C less than 7. We see in the general population of type 2s, in general, across the board, 50% of the people do get to less than 7. However, when you zoom in and look at the percent of people who take insulin and ask yourself, over the last 20, 30 years, what percent of the people are less than 7 that currently take insulin? And that's a very disturbing statistic. Seven out of 10 people who are on insulin today are not at goal. This number has not really moved meaningfully in the last 30 years of treatment. So I think what's important is, despite the adoption of analogues influence, despite the adoption of pumps and CGMs, we've not made a big move in the outcomes of patients across this country despite increasing our costs across the health care system. One of the main reasons of this is doctors are afraid of appropriate titration to help people meet their goal. And as Ray spoke about, some of the trials we're working on is really to demonstrate superior time in range and showing that people can safely dose their insulin and maintain low rates of hypoglycemia while maintaining a time in range and getting their A1C outcomes.

In the end, patients desire an insulin that may have weight neutrality and reduction in severe hypoglycemia. This is where we're focused on helping.

Next, Afrezza is somewhat of a lifestyle brand today. We see people all over the Internet. We see stories, we get -- people in the know are on Afrezza, whether it's physicians, researchers, bloggers, several famous people, some of whom you've seen publicly. We have a lot of support at the top end of the spectrum of people using our drug, seeing firsthand for themselves how it works and wanting to help others. This is exciting news for us because we continue to see influencers get more excited about the product every single day. And in the end, I wish all of you could see the letters that we get, whether they're on the web or letters that get e-mailed or mailed to us. Patients as well as caregivers write to us and post publicly about how this has changed their life.

One of the things I've always taken for granted is what it's like taking care of somebody or living with somebody with diabetes. The challenges one faces, not just living with the disease, but the meals you cook, when you're going out to eat and your vacations is a constant daily struggle. And we continue to see benefits from the caregivers of people in enjoying their life, and this is something that will be important as we go forward.

Now I want to focus on Q1 commercial highlights. I don't have a lot to say here, mainly because we just had a call not even 8 weeks ago, where I did provide you an update. So I plan to update a little bit more of the facts around the launch since that time point. But just to reinforce, for those of you who didn't listen to our last call, we did expand our sales force in mid-February. This is not a third launch. This is something that we set out to do last July when we got the product back from Sanofi. As many recall, the news was that this product was not promotionally responsive.

I think you can see now, through our expansion and our original launch, that when we put sales force efforts and marketing dollars against Afrezza, we see an uptick in prescriptions. And when we pull back, we see a decrease in prescriptions. That's what we wanted to see when we launched last year, was before we spent a lot of money, we wanted to make sure that this drug was promotionally responsive, and that patients and doctors were getting the benefits they expected.

Today, we sit here, a year later since I joined, with 100-plus people in the field, 75 nurse educators on a per diem basis. We just had 20 people in training this week and they're going out the door starting tomorrow and hitting the ground running.

We also have enhanced payer coverage. For those of you who don't know, we had MedImpact on January 1 with no prior authorization. They serve a lot of the government, state (inaudible), Medicare Part Ds, Medicaid, et cetera. We also didn't announce, but you should be aware, we had Anthem starting on April 1, 2017, where we now have coverage with Anthem with a prior authorization to label. And so far, we've seen 90% approval prior authorizations coming in through our MannKind Cares hub.

And I'll remind you, this follows additional wins through Express Script's national formulary as well as Aetna and there's many more to come. Unfortunately, it just takes time to work through the payers and the challenges they face in making formulary changes and the notifications they must do and the review process. This is something we continue to work closely with payers and, in fact, recently, we just expanded our own managed care team to call on more payers to drive more prior authorization removals as well as reduction in the restrictions around the prior authorizations.

And I can tell you the conversations we continue to have with the big payers, where we aren't covered yet, continue to be positive, and I expect to continue to only announce better payer coverage as the year progresses. So thank you for bearing with us as our patients are the ones who suffer from the controls that payers put in place. But every day, those are getting easier and easier, and I imagine throughout this year, it will get better and better and more clarity will exist.

We have launched several key programs that -- some of which I announced previously. So in-office surround sound promotions, so we have the in-office waiting room wireless. We get a commercial for patients signed on for that. We have the waiting room TVs that you may see. We have in-office, when you're waiting for a doctor in the room, there's posters up, there's billboards up. So we've done a lot of good work on the surround sound production. We've also done a direct mail campaign to physicians and diabetes educators, which had a nice response. And as I just previously mentioned, we did expand from a fixed-cost nurse network to a variable-cost nurse network, which now does help us provide more coverage for patient [teachers] as we move forward across the country.

Next, I'm going to talk about some of the data trends I'm sure you're all interested in, as I hear the noise every week from people saying the scripts are up or they're down or they're flat. And one of the things I wish all of you had the crystal ball that I do have, and it's not always accurate, but what I can tell you, when you look at our data historically, I want you to keep a few things in mind. Number one, in 2016, we did have a voucher card program. And every week, there were 10 to 20 NRxs that were associated with that voucher card program. We shut that program down on January 1, and so those NRxs no longer showed up in 2017.

Number two, you may not be aware, but sometimes patients do get 2 prescriptions. They'll get a 90-count 4-unit box and they'll get a 90-count combo box, and so that patient was getting 2 prescriptions. We've had many people, now that we've launched these 2 new titration boxes of 180-count cartridges, start to switch over from getting 2 different prescriptions to 1 prescription. So that does cause some consolidation in our weekly scripts.

We also have a free goods program called Start Out, and that program has grown from roughly 3 scripts a week to 12 scripts a week up to 20 weeks so far in April, May time period. So we continue to see nice progress, where patients, if they're not approved by their commercial insurance in the first week, we will provide Afrezza free of charge because we know the majority of prior authorizations will be resolved within the first month, and a very high percentage of the time, successfully. So sometimes, when that happens, it delays the patients starting an NRx or TRx in that process because these prescriptions do not show up in the Symphony data and they are prescriptions that we do see every week to give us an early indicator.

And then finally, reauthorization insurance changes always happen in the new year. People get prior authorization. They get new insurance. That does call some fluctuations in the week-to-week data that we've seen in the early part of this quarter. And then finally, the sample program, which we did launch, had 60-count units of 4s and 8s or 8s and 12s. With our sales force expansion, we've definitely seen a bigger increase in sampling, which has definitely probably hurt TRxs in certain parts of the country. We've taken actions to reduce the number of samples in those particular markets and we also will be launching a voucher program in June, around June 1. That program will start to show up in NRxs as well, but it's also a way to show you transparently what's happening in the sample world and also make sure we accelerate the time from a patient starting a drug to a patient getting a prescription.

So now I turn -- sorry, Rose, go back a slide. Sorry, I just want to go back 1 slide. So now I turn to the actual numbers that I gave you, a little bit of a backdrop when you look back over the last 9 months. And here you can see on the top line, when we launched our sales force, this is weekly cartridge count. It's important to know that we book revenue on a price per cartridge. So we really focus on the cartridges and what's happening in the cartridge volume. And when you look back in July of last year, we launched our sales force and you saw a nice continued uptake in that purple line on top. But when you look down on the bottom, on the green line and you look at NRx quantity, what you do see is while we had a nice lift early on, we could see pretty quickly back in Q4 of last year that we had to do something different because our NRxs were starting to flatten out on the cartridges. And that was a big reason why we made the shift from a contract sales force to an internal MannKind sales force because we knew we had to upgrade, we had to expand and we had to have a better reach and frequency model in order to drive that green line faster.

And so some of you didn't always realize what was happening, but we could see early on that in order to continue to have that purple line growing, we had to make a shift. And we announced that back in November in the field force transition. And again, what you see is when we disrupted the sales force, NRxs, TRxs slowed down, cartridges slowed down, and now we've expanded the sales force, they go back up. And now we expect, when you look at the green line on the bottom here, that has surpassed refills. That is what you needed to see in the marketplace in order to expect TRxs to improve as well as TRx cartridges to improve. And we've now crossed that line and we expect to see continued progress on a weekly basis as we go forward.

I personally overreact to 1 week up, 1 week down. I think we have to look at trends, and that's what this slide shows you is a 4-week rolling average of what's happening when you smooth out the week-to-week fluctuations.

The next thing that people don't realize is there's various days in a month. And so one of the things that this slide will show you is when you normalize for 31 days or 28 days in a month, it gives you a little bit different picture of what we've seen. So in January, you could see there were about 34 TRxs a day. And in March, you saw about 39 TRxs a day. So we grew TRxs about 14% in that time frame. But more importantly, the cartridges per day grew 37%. And again, I'll remind you, we do book our revenue on prescriptions sold, but also the number of units sold per prescription. So today, we price per cartridge, but we are evaluating whether it should be a linear price as we launched 2 new SKUs in the June, July time frame. You can expect to see a 90-count 8-unit and a 90-count 12-unit packaging launching in the near future.

And I'll just remind you, not every NRx is for a new patient, nor is every NRx or TRx for 30 days. So some patients use this just for their highs on their pumps, some people use us on a daily basis. And so that refill pattern won't always be 30-day jump over 30 days. But our trends are now starting to move and we're starting to see compounding.

And I do get the question, are we losing patients? Are we retaining patients? And I can tell you that the average cartridges dispensed to Rxs are close to 200, and that we see that the average patient getting now, at least, 30-day supply. And I can tell you historically that was not always reflective of what was happening with Afrezza, that many patients were only getting about a 15- to 20-day supply, which means they were running out of refills too soon. We solved that issue with our new packaging. We continue to see increased retention of patients. But like all drugs, not every drug is perfect for every patient, and you do lose some people. So I'm not sitting here telling you that if we get 150 NRxs a week that we get 150 new patients because not every single one is a new patient. But we do believe that we can see early on that we are having better retention as we go forward.

This slide is probably the most important one I want to mention because this really looks at what we see from an early view data of our -- is our sales force having an impact, and where are we going week-to-week. This is data that you don't see in the prescriptions, but MannKind Cares referrals and our Start Out program have grown consistently since our February expansion. You can see in Q3 of last year when we launched our MannKind Cares portal, we had about 150 referrals, and in Q4 as we went through a transition we were able to get that to roughly 250 referrals. And we almost doubled that in Q1. And so that's really with only the sales force being out there for 6 weeks. And so I can tell you, typically, it takes 3 to 6 months for any new sales force to show impact. And despite the fact that we did keep more than 2/3 of the Touchpoint sales force, even though we expanded, we did disrupt almost every territory in the country. So even though we kept the base of sales reps from our previous contract, we know we need to scale up, but we did have to disrupt territories and relationships, which caused us a short-term setback.

But in Q1, you can see early on in that first 6 weeks with the sales force, we were able to double referrals. And these referrals can take 1- to 4-plus weeks to come out of MannKind Cares and it really depends on how quickly the doctor fills out the paperwork and how quickly the insurance company responds when the patient (inaudible) returns our calls, et cetera. So we don't see 500 people coming in, in March, going out the next week. It's about 25% a week and then about 25% continuing beyond 28 days. So I would say a bulk of these referrals are coming in, in March and we continue to see strength in the month of April as well.

Our Start Out program, as you can see here in Q1, also jumped significantly, which is an early indicator of new patients to come.

So in closing, what can you expect in Q2? You saw our announcement on One Drop initiative. And the real focus here -- we'll share more details over the coming weeks and months. But here, I think, we have an aligned partner who sees the complexity of diabetes care and how do we start to conquer and change how people access care, how they get titrated on our drug, how they're trained on our drug and how we answer their questions. They've done a fantastic job building a very unique platform that provides inroads that not every person can achieve.

Now we do believe you'll see more -- a lot more on this initiative and you'll be excited to see where this is going. I don't want to preempt the things we're working on, but we are excited about this partnership as we go forward.

The social media launch campaign is happening. We saw -- we launched our Facebook page last week. We will start to advertise on Facebook, and you'll see a Tumblr feed happening very shortly and Twitter become more active. So apologize if it doesn't always go as fast as everybody wants, but we do have rules and regulations we have to follow, and it's not like I can just put out a (inaudible) on Afrezza and not deal with FDA regulations. So this is something we continue to dance and work through. But we are pretty close, now that Facebook is up and running, to see some more campaigns around this.

We are in active preparation to film our first TV commercial. As you know, we submitted it to the FDA back in April. We expect any day now to get feedback from the FDA and incorporate that into our final edits with an anticipated launch in July. Which goes into my next bullet here, is the Discovery partnership with Reversed and Charles Mattocks is where we would expect to first air this commercial.

But there's other initiatives we're working on, and you'll soon hear about Damon Dash launching the Dash Diabetes Network, which will really be a focused, targeted outreach effort with a lot of online opportunities as well as other partnership launches. And as I previously mentioned, the voucher program will launch around June 1, and that will be focused on helping doctors understand how to start patients and get patients started quickly.

So hopefully, you see with the label change coming in Q3, the STAT study that Ray discussed that we expect to read out in Q4, our pediatric expansion focus and getting the trials to [ground], we're excited about our future. We continue to expect to build out more people and help articulate the scientific profile of this product, which will really help doctors get comfortable with how to dose, titrate and understand when you're using continuous glucose monitoring, how Afrezza can really help you succeed in your treatment goals.

With that said, I want to thank everyone and turn it over to Matt

Thank you, Mike. So at this point, we wanted to take the opportunity to answer some of your pre-submitted questions, consistent with last quarter. For the most part, we've tried to incorporate the answers to these questions in the prior presentation so we wouldn't make this an extended period, but there are a couple that didn't actually fit too well. So I'll try -- why don't I try to hit some of those now. So the first question relates to the recently filed change of control agreements. Change of control agreements are quite common for senior executives in general, as well as among our peer companies. In fact, every single company we track and report in our proxy as a comparable peer company have such agreements in place. They're also common at MannKind. I and other tenured executives here at MannKind have had such agreements in place for many years. And in Q1, our board extended these agreements to include newer members of the senior leadership team. MannKind agreements are standard double-trigger arrangements, which means they're only triggered if the company is both acquired and the affected executive loses their job as a result. The timing of the filing was to precede the proxy statement in which the agreements were discussed. And nothing should be inferred from the existence or the timing of this particular action by the board.

The next question that we are often asked has to do with the pipeline, and for that, I'm going to turn it back over to Ray for a couple of moments.

So as I've said before, the pipeline, we continue to progress the multiple candidates that we have there. We did have the [in health] epi pre-IND meeting in December. We continue to be in dialogue with the FDA around the appropriate regulatory pathway to lead to the indication we believe this product should have. For Treprostinil for pulmonary arterial hypertension, we have a pre-IND meeting scheduled with the FDA on June 28. We expect that to be relatively successful as well, as this pathway is a little bit clearer than those such as epi for anaphylaxis. We're also progressing in the pipeline triptans for migraines, PTH and SYMLIN, and I will update everyone at our next call.

Okay. Next, I think the final question relates to whether we'd consider a co-promotion arrangement in the future. It sounds like a question best directed to Mike.

Thank you, Matt. So as we go forward, one of the things we look back on is there is a large type 2 market that sits within the primary care audience. And one of the barriers Afrezza faced at launch was severe payer restrictions that were in place at that time. And as we continue to remove payer barriers and restrictions and simplify that process, it will make sense to go back out and target a larger primary care target base. And we always have to evaluate our options of pursuing that on our own or pursuing that through a co-promote partner. I think there are plenty of sales forces who have capacity out there and it doesn't always make sense to take on an expense of 300 to 500 reps calling on primary care physicians when there is capacity that exists in the marketplace. So as we continue to get better payer coverage and simplify that access, I think we can see a nice upswing in adoption as we target primary care docs in the type 2 market and increase our share of voice and reach and frequency. As of today, we're continuing to focus on driving near-term performance, which only makes that option much more valuable as we go forward.

Okay. Thank you, Mike. So with that, I think we can bring the call to a close. I want to thank you all for joining us today. Just as a reminder, our Annual Meeting of Stockholders will be held on May 18 at our Danbury, Connecticut facility, and we look forward to seeing many of you there. Operator?

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