MannKind Corporation (MNKD) Q3 2019 Earnings Report, Transcript and Summary

Welcome to the MannKind Corporation Third Quarter 2019 Earnings Call. As a reminder, this call is being recorded on November 6, 2019 and will be available for playback on the MannKind Corporation website shortly after the conclusion of this call until November 20, 2019. All participants will be in a listen-only mode for the duration of this conference. [Operator Instructions]. This call will contain forward-looking statements. Such forward-looking statements are subject to risks and uncertainties, 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-Q report filed with the Securities and Exchange Commission, the earning release and the slides prepared for this presentation. Joining us today for 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.

Thank you. And thank you, everyone, for dialing in this morning for our Q3 earnings call. I look forward to sharing our results and discussing our plans for the future. Before I get started, I'd like to wish our Founder, Alfred E. Mann, happy birthday. Today would be his 94th birthday if he was with us today. His foresight was 20 years ahead of the market in terms of predicting automated insulin pumps and the challenge that we can now see with continuous glucose monitoring in regards to the delay of insulin that has on controlling sugars post mealtime. His quote here is true more than ever as we just completed 35 interviews with healthcare providers, and I don't believe one of them understood that injectable insulin subcutaneously took almost two hours to start working to bring down your post mealtime sugars. The scientifically engineered particles that we create today will not only impact people living with diabetes, but will extend to many diseases such as pulmonary hypertension, cystic fibrosis, oncology, migraine, and allergies, which impacts someone in each of our families. Despite the challenges and setbacks we have faced, our company has survived for over 20 years and our growth is just beginning. As we've talked about previously, these four pillars have fundamentally transformed our growth. As you look back, the partnerships highlighted in bold are important to our future. As you can see this year alone, UT will generate more revenue than AFREZZA. As we look forward over the next 24 months, these four pillars will be critical to our growth platform that we expect to drive shareholder returns over the coming years. For Q3 update, first I want to highlight international sales to Brazil through Biomm at $0.7 million. Second, as we announced on Monday, United Therapeutics TrepT is progressing as planned, and we received our second milestone payment of $12.5 million in November. We completed construction of our high potency manufacturing facility in Danbury, and we dosed the first patients for TrepT back in Q3. The feedback so far in the study is very positive that we've heard from United Therapeutics. We've also completed our recapitalization in August that gives us a solid financial foundation as we go forward where we drew down $40 million of the $75 million credit facility. We've met our revenue covenants as of September 30 and maintain an open dialog with our new lending partner about our sales trends and actions we're taking improve them, some of which I'll discuss in a high level detail in a few slides. I believe we have a strong relationship with MidCap, and we will successfully work together to resolve any issues that may rise throughout the term of our loan. In the third quarter, we had total revenues of $14.6 million or 225% year-over-year, and net revenue of AFREZZA of $6.4 million or 46% growth year-over-year. We continue to reduce our spending and manage our employee base as we think about departures and not backfilling people continues to bring down our cost, as well as reducing cost structure year-over-year in various functions throughout the company. We're really proud that we now increased our coverage to five analysts, with the latest being Cantor Fitzgerald that initiated coverage in October, and we advanced two molecules to the next phase of development, which are sumatriptan and to tadalafil, which is new today for many of you, and they are advanced into an animal PK study that will help us get some additional information as we think about dosing in animals and how that's going to correlate to bioavailability of the current available formulations. So, our pipeline slide here has been updated in orange to talk about the two next pipeline slides that went to non-clinical pharmacology, that will help us get better understanding of the absorption through the lungs and really help us understand the dosage form as we continue to progress these in development. We will expect this data pretty much by the end of the year, but full study outcomes in Q1. Additionally, UT has not made a decision on the undisclosed compound as they have a right to opt in for a certain period of time, and they are completing a market assessment before making any decisions. Finally, our long-awaited AFREZZA pediatric study protocol is now down to FDA for review, and we expect to have feedback by the end of the year. Now bridging to AFREZZA, in terms of TRx of the net sales growth, from the left side here, you can see year-over-year 17% growth in TRxs increasing to almost 3,000 a month or 9,094 a quarter, and net sales growth basis of 46% year-over-year, $6.4 million is our highest sales ever of AFREZZA when you include the Brazil number. The next part of the equation, as we've been thinking about the company and the history here with David Kendall joining, has been around the scientific communication and really helping adopt what does the clinical profile of AFREZZA look like and how do we get a lot of our data published so that the guidelines that are out there can start to create a new ultra-acting category, as well as communicate the scientific value of AFREZZA and why it's different from subcutaneous insulin. Here, you can see we have seven papers that we expect to be accepted and presented -- I'm sorry, eight accepted and/or presented at upcoming conferences between publications and article journals, as well as ATTD and the Diabetes Technology Meeting in Baltimore later this month. These journals help highlight everything around hypoglycemia, ultra rapid profile, better early glucose control, and really are meant to articulate the attributes of AFREZZA that people are not all aware of as we look in the marketplace. The last two you see here around BluHale and as we get ready to launch this device, we're really excited about the data coming out of the trial we ran to get some feedback on user experience and how this would help better train our AFREZZA patients out there and give our customers more confidence. This scientific platform is really going to help us continue to propel growth for AFREZZA as we go forward and as I talk about our new strategy going into 2020, and the laser focus as we get into Type 1 versus Type 2 patients. When you look at this year, we have had continued growth quarter-over-quarter with the exception that we always see in Q1, a small dip year-over-year. In Q2 to Q3, we saw sequential growth in prescriptions of 5%, and if you look at the marketplace of the competition and what's been happening, people actually have been having a decline sequentially quarter-to-quarter, and the insulin market is flat to declining depending on how you look at it. In the end, as we look at cartridges, which is another way to look at our business, we weren't happy as we looked into the summer. We made several changes in our marketing department. They identified gaps that were the highlight in our market research, and we rolled out several plans in Q4 around coverage and training and launched new reimbursement support materials. As well as our first pharmacy network in several key markets are piloting new CDE trainers, and we have an enhanced focus to move our free bridge program to paid claims as we expect to exit the free goods program and transition to a more cost-effective program during Q1 2020. So, you can see here our cartridges since we commercially re-launched the product ourselves in Q1 of '17 have almost tripled from almost $200,000 a month on a rolling basis to over $600,000 a month in October when we look at the latest data we have. This trend continues to demonstrate growth for AFREZZA, and while we weren't happy where we saw where we were because we thought we should be ahead, we do believe making the appropriate adjustments will continue to propel us into Q4. And as we continue to fine-tune this going into 2020, we'll continue to see more growth ahead. So what is that inflate that we got as we look to 2020? We did research with over 200 providers between quantitative and qualitative research in Q3 up into including last week, and we identified three areas for faster AFREZZA growth. Number one, a one-stop hub that will provide reimbursement support, pharmacy fulfillment, coordinate patient training and help address any drop-off that occur in the first 30 days. As we look at our data on drop off, I know it's a big question we get, we did hear 30 to 40% of patients may drop off AFREZZA for one reason or another. A big part of that is making sure we do the onboarding properly around cough inhalation proper technique in the first 30 days, we believe will address a lot of the issues. The second thing we heard was around Type 1. When you think about our business, 45% of the patients are living with Type 1 diabetes. Some of those patients may use AFREZZA on top of their insulin pumps. This is not something that we market, but when you think about how they're using it, they're taken one dose when they get high on the sugars post meal, which could be once a week, it could be twice a week. But those patients are not refilling every 30 days, as one would expect. So they may fill once a quarter, they may fill once a year, but those are prescriptions that we see one time and we wonder what happened on refills. I wanted to provide that insight to our customers as we go forward and our shareholders. The second part of the pillar will be an increased focus of resources on Type 1 diabetes. When you think about AFREZZA, we have roughly 6,000 patients on the product today, 3,000 Type 1 and 3,000 Type 2, and yet Type 1s only make up 5% of all people living with diabetes. However, we do see that the unique attributes of the product are disproportionately benefiting a Type 1 focus when you think about the challenges people with Type 1 live with around hypoglycemia, weight, dosing speed of action, CGM. These are all attributes that we've demonstrated AFREZZA to be equal or better than the standard of care. So as we go into next year, you'll see sales and marketing efforts targeting advocacy and future [indiscernible] generations will be more focused on Type 1 versus Type 2. We feel we're adequately prepared to continue to address the Type 2 market, and as it further grows, we will continue to go back into a larger penetration. But when you think about what we've done this year, we came into the new year with a big focus on Type 2 with a big retail presence with our bridge program, the co-pay card, along with the DTC campaign. We weren't happy with the results we saw as a result of those efforts through August of this year, and that's why we did pivot a little bit here in Q3 and continue to expect to see positive impact of those pivots in Q4. The third part of this was continued health care provider education and patient education. We did not believe that the large majority of our endocrinologists do not understand time action profile of injectable insulin versus inhaled insulin. They directionally understood that AFREZZA's faster than any other out there. However, they did not understand that subcutaneous insulin takes about two hours to start working. In fact, lot of them thought because it's subcutaneous, it starts working immediately or within 20 to 30 minutes. That's a really big difference and we have lots of data on this particular topic to go out and educate the market. The second part of AFREZZA, as I mentioned, is around weight and late hypoglycemia. David Kendall has done an incredible job at getting some of the data out there in the various publications and conferences throughout this year. And then we think about the last part of AFREZZA is the unique ability to deliver insulin through the lung really creates unique attributes when it comes to understanding monomark and exomark insulins. I want provide you more clarity on this strategy as it goes forward, but I wanted to give you a preliminary glimpse of where we're going into 2020 because the next time we'll have an earnings call will be roughly in late February, early March of next year. And finally, the last part of this that I think is important is something I mentioned earlier about BluHale. This slide -- on the left side, you can see very confident to confident was about 37% of providers when it came to training on our inhaler. When you look at post-using BluHale in five people to get comfortable, you saw that number went from 37% to 96%, an improvement of 3.4 to 4.7 on a scale of one to five. 80% of customers thought BluHale would reduce their teach time, and 91% of customers believe this would be more successful to inhaled insulin going forward. We expect to launch a BluHale Pro version, it will be called, for HCP's in Q1 of 2020, and we're very excited as this will really help demonstrate and set up the market as we get the Bluetooth-connected care hopefully in late 2021. Now I'm going to turn it over to Steve Binder.

Thanks, Mike. And good morning. I will be discussing preliminary financial results for our third quarter, which show total revenue growth of 225% for the third quarter over 2018, net AFREZZA revenue growth of 46% for the third quarter, including our first international sale of AFREZZA to our partner Biomm in Brazil, and continued improving gross margin as the year has progressed. We also announced Monday that we achieved the second milestone in our license agreement with United Therapeutics and received $12.5 million subsequent to the quarter end. Let's start out with looking at the revenues for the third quarter. Total revenues for the quarter, which is the bottom blue line, for $14.6 million versus $4.5 million for the corresponding third quarter of 2018. The 225% increase is primarily generated from the recognition of revenue related to the United Therapeutics license agreement in the amount of $7.9 million, as well as growth of 46% in AFREZZA net revenue to $6.4 million. The AFREZZA net revenue increase is favorably impacted by volume, including our sale Brazilian partner Biomm, cartridge mix, and partially offset by an increasing gross net deduction of $4.7 million. The AFREZZA gross net deductions were 43% for the third quarter of 2019, a decrease from 47% in the prior year. The third quarter 2019 growth to net percentage was favorably impacted by the sale of $0.7 million Biomm, which does not have any gross to net deductions, and accounted for approximately a 2% rate favorability, but was more than offset by unexpected increases in our product returns and rebate accruals of $0.7 million, having a negative impact on the gross to net percentage of approximately 6%. We continue to refine our gross net estimates each quarter, which can result in unexpected adjustments like these. Also please note that wholesaler inventory levels did not significantly change in the second quarter; therefore, having no significant impact on the third quarter AFREZZA revenue. Inception to date, we have recognized $29.7 million from the United Therapeutics license agreement and $9.6 million from the United Therapeutics research agreement, where our performance obligations are substantially complete. This slide shows U.S. versus international revenue mix for the third quarter. Our U.S. AFREZZA net revenue of $5.7 million grew by 31% versus the third quarter of 2018, and was impacted by the gross to net accruals just discussed. Our year-to-date growth net rate for the U.S. AFREZZA revenue was 42%, and was favorably impacted by lower rates in the first and second quarters as compared to the third quarter. Below the U.S. AFREZZA revenue line, you can see that in September we had international net AFREZZA revenue of $0.7 million for the sale to our Brazilian partner Biomm in preparation for their launch. As mentioned before, sales to Biomm did not have any gross to net deductions. On the left hand side of this slide, it shows our cartridge mix and mix favorability versus the third quarter of 2018. We grew our 12U cartridges at the fastest rate of 33%, followed by the 8U cartridges at 15%. The faster rates of growth had a positive impact on revenue growth due to our 12-unit being priced 3x the 4-unit, and our 8-unit in priced at 2x the 4-unit. The right hand side of the slide shows the same data, but in 4-unit cartridge equivalent, which is our lowest priced cartridge. The growth rates are still the same, but it shows visually how the sale of 12-unit and 8-unit cartridges are more impactful to our AFREZZA revenue growth. For example, on the left, the 12-unit cartridges had approximately 400,000 unit sales in the third quarter of 2019, and when equivalized to 4-unit cartridges on the right, it becomes approximately 1.2 million units. The top table on this slide shows AFREZZA gross profit or loss and gross margin for the third quarter. We had AFREZZA net revenue of $6.4 million, and cost of goods sold at $7.1 million. Included in the cost of goods sold is a $2.75 million one-time charge related to an amendment fee for our insulin supply agreement with Amphastar. You may recall that we amended our insulin supply agreement in August, which allowed us to move $46 million of insulin purchases out of the 2019 to 2023 period to better align our insulin supply with AFREZZA demand. Because of this one-time charge, the GAAP reported gross loss was $0.7 million. On a non-GAAP basis without including the one-time charge and cost of goods sold, the gross profit would have been $2.1 million and would have produced a non-GAAP gross margin of 32.1%. In the third quarter of 2018, we had a gross loss of $0.9 million, which reflected a lower level of sales and included inventory write-offs of $0.7 million. At the bottom of this slide is our gross margin trend for 2019, which has been increasing each quarter from 20.8% in the first quarter to 32.1% in the third quarter as we continue to increase AFREZZA revenue while holding manufacturing costs at a fairly steady level quarter-to-quarter. We expect sales increases to outpace cost of goods increases in the near term as excess capacity costs are absorbed into inventory, which is expected to produce increase in gross profit as revenues rise. One last item to note: we ended the third quarter with $50.4 million of cash, cash equivalents, restricted cash and short-term investments. This balance is prior to the United Therapeutics milestone payment that we received at $12.5 million in early November. Thank you. Now, I'll turn it back over to Mike for some additional comments.

Thank you, Steve. Go to the next slide here. You see that our TRx have continued to grow just like I just previously showed you our cartridges and this is on Symphony PHAST Data. So this is not adjusted for gross-to-net. And what you continue to see quarter-over-quarter growth in prescriptions and revenue and we expect to see this in Q4 as we go forward despite some of the challenges in sequential growth Q3 to Q2. I'll talk about some of the next near term milestones that we look out for the company. Number one is the Brazil launch. They just recently had a conference, there down there in Brazil with all the thought leaders where they showcased AFREZZA and introduction of AFREZZA into the marketplace. Number two, is initiate our Phase III clinical trial in India, which was recently approved a few weeks ago by the SEC which is the equivalent of the FDA here in the U.S. I want to remind you, this is actually a robust study where we're going to generate data in another 200 to 300 patients in the type 2 setting against oral placebo products -- placebo against the oral product standard of care. We look forward to using our new dosing protocol that we saw in Phil Levin results back in Q2 and we think we're going to demonstrate in a much larger study really clinically strong results for a market where 81 million people are living with diabetes with the large majority having an A1c of 10 and out of control. When you think back to the Phil Levin study, the average A1c was a 9. We saw a 1.16% A1c reduction in 12 weeks. So we look forward to using that protocol in our next Phase 3 trial here. We also expect the data read any day now on a Type II study where we used DexCom and switching people on insulin that were out a control on to AFREZZA. This is referred to as the QIP this trial and that data we expect to be presented early to mid-next year. I previously just talked about the blue Hill pro launch. We're in the process of manufacturing those and getting those into the market in Q1. We've had several conversations with our partner Amsel in Australia. We expect to file regulatory approval there and start to work on ways to build a pharmacoeconomic registry so that we can launch successfully in Australia at the appropriate time. International market expansion is also one of the things as we've demonstrated with the partners we have and continue to new part as we look to add AFREZZA into other markets around the world. Every time we make a decision to go international, we know it's a 12 to 24-month timeline lead time by the time you file all the way to get an approval. And so it's really important to continue to identify partners as we think about our growth plans over 2022 to 2024. Another part that's been important is around short-dated product and inventory management. On our side is that we expect approval on exploration dating, which will allow us probably another 4 to 5 months of dating on our inventory by the time it gets the wholesale channel. Fortunately, with our volumes where they are today and our manufacturing improvements we've made, we don't expect to have any inventory write-downs as we continue to go forward. FDA feedback in our pediatric Phase 3 trial will be important. We wrapped up cohort 2 and we submitted several comments at FDA to confirm that we're comfortable closing our Part 1 of the study before we begin Part 2 and Part 2 is the Phase 3 protocol which we've given FDA our draft for comments and we expect those comments back by the end of Q4. I'm really looking forward to moving the company forward as we think about 2020 and beyond. Refocusing our efforts in 2020 to drive more growth faster and the team is currently working on closing out Q4 strong and making sure we have a very successful 2020 and beyond. I want to thank everyone who worked hard for this quarter and we'll open up for questions.

Thank you. [Operator Instructions] We will take our first question from Brandon Folkes of Cantor Fitzgerald. Please go ahead, your line is open.

Hi, thanks for taking my questions and congratulations on the progress during the quarter. Firstly, can you just talk about the data you have generated that you're using to help prescribers with a better understanding of how to convert patients onto AFREZZA from the current insulin, and any feedback you've received from the prescribers since you began this effort? Thank you.

Brandon, first thank you for initiating coverage last week. I really appreciate it and thank you for also visiting our site up in Danbury. That's a great question. One of the things I will tell you about the research, I think we're really happy with this. We always feel like sometimes we're moving our scripts at a snail's pace, which is true, because this is a large market and we should be growing a lot faster. But I'm really proud that some of the insights we have gained is around the clinical profile AFREZZA. We don't need additional data to convince doctors that AFREZZA is a great product, and that’s the good news. A lot of doctors understood the profile and actually believe it's better. A lot of their objections to adoption were related to managed care and reimbursement, patient onboarding, patient dosing, and patient training. That's very different than talking about clinical data and clinical considerations. The second part I mentioned is what you just asked about was the conversion from current insulin to inhaled insulin. As some of you who've been following the company, for those doctors that we target, I was really happy to hear doctors actually understand that conversion feature a lot more because when you look at the latest data on AFREZZA, it's somewhere between a 1.5 and a 2 and you’ve really got to use each individual patient's results to make that judgment call. And that's one of the things you'll see in the [indiscernible] trial where we took people an injectable insulin and we converted them at a 1.5 to inhaled and we'll get those results shortly, and we think they'll be very compelling to reinforce this exact nature. But a lot of the doctors we talk with actually understood how to do the conversion, and our messages are resonating with customers in regards to the clinical efficacy and the dosing of the product’s appropriate dosing, which was a major issue historically. So, we feel good about that. I think the proper training around inhalation and cough probably a lot more noise on that than we've seen in the trial and I think that's really important to address, but I think it's a great question. I'm really happy that the customer feedback. Actually, I did call that out and confirm that they are starting to understand that more and more.

Great, thanks, and one follow-up. You actually just touched on my next question which is, you called out the coughing in your prepared remarks, can you just give us some color in terms of how you are going to manage that feedback and how you manage those patients to make sure that they don't drop off AFREZZA? Thank you.

I think the first thing is reminding doctors of our clinical trial data, which you know we have thousands of patients who've used the AFREZZA in trials. And then, there you saw a 3% cough discontinuation rate, so any doctor says I lost the patient for cough, it probably means if they lost 1 patient out of the 3 that they've written, there is a problem meaning they probably either didn't train them properly or the patient coughed because they weren't getting the drug, and we got to give clarity that it's okay to cough because 1 out of 4 patients will get a cough in the first 30 days. But really getting patients to that 30-day adjustment period, where very few people have a cough after 30 days. And if they do get a cough, it is interment. It's not hacking cough or a mucus-producing cough. So, I think it's really just clarifying, and a lot of doctors are writing their first script right now and they don't understand that sometimes. And so, for the experienced doctors, it is not big of an issue, the less experienced doctors is building their confidence. So, I think that's why I highlight this because it just came out of the research a little bit more than we expected, but we know from all of our clinical data that it can be addressed and controlled. The second part, I'll answer your question is we've actually put things in our [indiscernible] study as well as our Indian trial on how to address cough if it does occur. For example, take a glass of water, before and after, evaluate split dosing if it's 20 units of insulin, at a mealtime take it 2 eights and a 4, break down the inhalation. Bluehale I think will give proper inhalation technique where someone is trying to inhale too strongly, they might try to get more force than it's required. So, all those things are going to our retraining as we think about our business model next year. It will be really important that a trainer that goes out educates that patient face to face on those particular issues, and I think that's going to really reduce that dropout rate.

Great, thank you very much.

We will take our next questions from Oren Livnat of H.C. Wainwright. Please go ahead, your line is open.

Thanks. So, a few questions. You did speak to the gross-to-net this quarter and some of the pushes and pulls, and I'm just wondering going forward, especially as we head into Q1 2020 and beyond, it sounds like some changes to the free drug and that may be copay treatment program. Can you just talk about how we should model scripts translating to revenue with your best guess at this point going forward?

I wouldn't. Until we identify the new program that we're going to be launching, I wouldn't adjust your model yet. We're getting a feedback, give me one second. Okay. I wouldn't adjust your model yet because Q4, we wouldn't expect any major shifts from Q3. And I think by the time we get to the Q4 earnings call, we'll have clarity for you on how to interpret that. I can tell you one thing we are considering, we still have a program we just don't promote as much. Is the free goods program and that was managed through our reimbursement hub and that's at our COGS as opposed to retail prescription costs. So the cost dramatically dropped by two-thirds just by moving it from one platform to another. But before we do something like that, we want to make sure all the kinks are worked out and that's going to be able to launch successfully. So I wouldn't change anything yet, but know that will bring you clarity either interim before as it gets implemented or as we get to the earnings call.

We will now take our next question from Pasha Saraf of SVB Leerink. Please go ahead, your line is open.

Hi, this is Dylan pre-sitting in for Pasha. What I'm trying to get a little more clarity around Brazil with the early market looks like, what the potential ramp might look like and then walk us a little bit how you guys are recognizing revenue as part of the partnership?

On Brazil they just got the product of customs a couple of weeks ago, so I don't want to comment yet on their launch plans. I know they're finishing up pricing negotiations with the government, I think until all that happens, we're just -- we know there's a lot of excitement down there, but I think we need another month or so to get the feedback on how that flows out but otherwise product down there has gone through customs. It's in the warehouse.

And I'll take the second piece of that. Dylan so we recognized revenue when we ship the product or hand it off to our partner AUM. They take possession of it as it ships out of the United States. There is no right of return on the product so that's why we recognize it right away. And we also don't have any growth to net. There's no rebates or anything associated with it.

Okay, thank you very much.

We will now take our next question from Bert Hazlett of BTIG. Please go ahead, your line is open.

Thanks. Thank you for taking the question. Just with regard to [indiscernible] and the revenue there. I have a couple of different questions. Should we be considering the gross-to-net being exactly the same as it was this quarter or how should we think about gross-to-net with that particular component of revenue going forward?

So Bert, we tried to identify the U.S. AFREZZA on the gross-to-nets on the slide which was at 45% for the quarter. There is a little bit higher. It actually created 2% favorability for us and also we talked about this quarter having some unexpected accruals that we took into the gross-to-net. So we don't project out and we don't try to do that as a general rule. So I think you can look at the prior quarters, which on a year-to-date basis we had a 42% gross-to-net. They're going jump around a little bit. So I hope that helps.

I think it's right to say we don't expect to be as high as it was in Q3, but until we get to Q4 we can't really guess.

Okay. Then, with regard to United Therapeutics, what are the particular -- the pacing that we can -- that you're expecting from the personal [indiscernible] for your program? How long will the clinical effort take? And anything where you can provide along the trajectory of the timeline that would be helpful.

But I can say a couple of things. Everything is on track to date so there is nothing that from what we laid out a year ago to today, we've been actually ahead of schedule on certain manufacturing attributes. Products are upon stability, the plants built, we were ready at the inspection whenever that occurs. That's all very strong. The clinical trial that's ongoing with Tretti -- I don't remember if they have 7 sites or 12 sites, but they have enough sites up enrolling. Patients are enrolling. I know the preliminary feedback that we're hearing anecdotally is extremely positive. Some of the quote -- I won't get into here. But the quotes from the patients are heartbreaking at the end of the day, how this is impacting their life. So we remain very, very excited about getting this to patients because we believe being able to dose higher level to partner will be important in this trial, we actually allow people after I think a couple of weeks dosing to go to higher doses in the trial and follow-up for a while. That's the pivotal trial on the switch study. The next part will be running here in a few weeks will be the human factor study. Mankind is running that based on our history of our dream both device. Our team is fully capable of doing a study. I don't expect a lot of risk. It should be relatively easy to do. That will be happening here in LA in a few weeks with people living with pulmonary hypertension. And then after all this is done, early next year we'll run a PK study and that'll be the pivotal PK as a result of the dosing we're doing now and the preliminary data we have previously. Once that's done we'll pretty much start to wrap up any final attributes of the product and we get ready to file. So not a lot left. It's really just time consuming more than anything, but there is nothing here that's freight limiting beyond -- what we had to do first was get manufacturing batches up on stability.

So just to follow on, there is discussions on United Therapeutics call about material label expansion for Tyvaso. Are you expecting to be able to participate in that label expansion, and if so how? And if not, if you have to do additional work could you just describe the plans for that additional work as well?

I think there's a saying you may need a bigger boat. Depending on that label expansion and where they're going after we've built our plant to serve the current capacity of what we expect the market. If the label expansion dramatically improved their population penetrations such as the COPD and early treatment of PH then that will dramatically increase the potential Tretti royalties that we would expect at some point. I can walk you through just how that happens. So they will get their label update for Tyvaso and Tretti and then our labor will be a 505B to that label. If you look back on growth hormone I did this where we got approved with 2 indications. Our competition has 5 other indications because we were 505B we filed an amended application and got all 7 indications. It will be a very similar process here. The question is, does it happen before or after Tretti approval and that's going to drive the strategy meaning if the expanded label happens before our approval by default we should get that label. I'm not aware of anything that's different that wouldn't apply to us. If our approval happens and then their label approval happens after we'd have to file an amendment to our application and get the label expansion, but it would apply to Tretti is the short answer.

Okay, thank you. That's helpful. Just one more for me. Just could you give a little more granularity on the changes in marketing effort that you were referring to from Q3 to Q4? Just a little bit more granularity on what you were discussing in the prepared remarks.

I think Bert when we did research in late July, August we got the results and I think presented one slide back in September, which I'm happy to share with you offline. But it really showed that on 11 out of 13 attributes, doctors understood AFREZZA was as good or better than the standard of care. The 2 areas that came in a little weaker were around dosing and the second one was around managed care coverage. Managed care coverage is way more important than dosing because the dosing one is solved with experience. We have an update to support that one. The managed care was frustrating for us because we had launched several programs this year that we felt addressed this objection. And so when we went out and talked to some of the customers we realized while we may have the right tools, how on they were being communicated and how they were being marketed through the sales force was off a little bit. And so that's where the marketing team quickly came together with the change in marketing that we made. We have several new members in the marketing team in Q3. They came together and relaunched a set of new materials primarily focused around reimbursement support prioritization checklist, simple things like that, re-messaging around our co-pay card in the bridge program and we saw an immediate impact of that the following 3-4 weeks post-sales meeting. So in September, we actually retrained all of our sales force in 2 to 3-day meetings in separate weeks across the month of September. They have all the new materials and that they can now go to the customers and some of that was additionally around messaging around patient type on Type 1 and patient type on Type II and getting more specific of who is the appropriate patient for AFREZZA. So all that information literally rolled down in the second and third week of September. It has been implemented. We saw some nice trends as we exit September and came into October. So I hope that gives you some clarity but it's really focused on managed care and how to make sure that patients are covered. That's one of our frustrations as doctors give you this excuse. And I understand why and then we don't always have no prior authorization but when you look at our PPAs for CVS or United Healthcare Optum they're pretty much a prior off the label and given that 80% of the people on insulin aren't the goal they pretty much get approved. Then we've been talking to payers about removing those PPAs completely as we go into 2020 and we'll continue to enhance the managed care situation as we go forward. And like I said I've talked to Prime Therapeutics Optum, CVS, ESI all in the last 3 weeks. So we're continuing to look at how we enhance Medicare coverage and how we get these prior off perceptions removed or reduced. Including last week, I was at a payer board with 15 payers getting really direct feedback on our budget impact model and how we can move this forward as it's been 3 years and it's really ridiculous that some of these criteria is still out there. But we've got to remove the barriers that exist for the providers either creating a better mousetrap to get them through and help them or just give them completely removed from the marketplace. So that there is no prior offset at all. So we think that's possible. We've seen that happen in a few plans and we know 70%, 80% of scripts should go through within a couple of days upon PA submission. So we feel good about the ability so is much more around the communication.

Okay, thank you for the color.

Oren, I do apologize if you're still listening. We lost you on the queue so we can talk offline if there's any other questions. Thank you.

I would now like to turn the call back over to our speakers for any final or closing remarks.

Thank you. No other questions?

I think we're good.

Thank you. Everyone have a great afternoon and evening.

This concludes today's call. Thank you for your participation. You may now disconnect.