Rose Alinaya - SVP & Principal Accounting Officer Matthew Pfeffer - CEO Michael Castagna - CCO Raymond Urbanski - CMO.

Analysts:.

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. At this time, all participants are in a listen-only-mode. 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 now like to turn the call over to Ms. Rose Alinaya, Senior Vice President and Principal Accounting Officer MannKind Corporation.

Please go ahead..

Good afternoon and thank you for joining us on today’s call. Before we proceed, 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. The 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 will 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 growth 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 work force, and a reduction for capitalized cost 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 in the first quarter of 2017, a decrease of $2 million of 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 start by development program 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 $8.0 million compared to the same quarter of 2016 due to our efforts in the selling and marketing of Afrezza, whereas our former partner which 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 the 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 the insulin put option, $16.7 million from the sale of a 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 cost 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 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.

In fact, if you look at our financial position versus the time last year, we have significantly more cash and less debt than we had at that time. In spite of having taking the product back, put in place all the infrastructure to support it, and then full fledge commercial infrastructure, still managing to reduce our burn rate.

So, not only -- and that does 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 and improving our financial position on a daily basis.

Now, the numbers I've talked about before did not include the changes we've made to the Deerfield debt earlier the second quarter specially in addition to that where we really $10 million of that obligation, so our current position today is even better than just spoken about.

We're continuing to make changes in that regard and having further discussions with Deerfield regarding potentially extending maturities and restructuring some of those debt instruments. We think that we're also becoming more efficient in another ways. Our inventory turnover 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 at few places on message boards that our -- the lease on our corporate headquarters here in California expired in April.

And maybe that was coming and took a hard look around looking for ways we could potentially improve our situation and finance space that would cost us less money.

And I'm happy to announce and this is reported to short time ago in our 10-Q that we recently signed a new lease on a new corporate and commercial headquarter, which will be located in West Lake Village, California closer to the Biopharma talent pool, which is great help to us and attractive and retaining talent.

But also due to the rental abatements and tenant improvement allowances and so forth, our cost to that facility will actually be a quite a bit less in 2017 and less than in 2018 as well through these critical periods. One of those areas I want to bring up that we're continuing to improve on is in our international areas.

You did ask about this a lot, but I can't announce today that we are actually on file in one new listed country and are in later stage negotiations in number of this different jurisdictions, and you'll see announcement of that in one near-term.

But as this typical with our past practices, we cannot to make these announcements still 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 a third quarter, but we estimate to get to the end of the year or probably take us another $20 million to $30 million beyond that. That said, I have no doubt and are quite confident we have no difficulty raising that money, get us to where we need to be.

We've primarily been focusing on debt instruments recently because we've not been very happy with stock price, but rest assure we will do what it takes to keep appraisal on the market and make at 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 will try to answer some of the commonly asked questions that we'll be getting.

So with that, Ray?.

Thank you, Matt. So today, I am going to cover three topics. I am going to address the Afrezza label of submission, I’ll go over the Afrezza clinical strategy and I’ll you an update on Afrezza clinical program. Hopefully, I’ll show you how they are all tie together around the key differentiating attributes of Afrezza.

So, let me talk a little bit about Afrezza label of 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 PK/PD graph from the one that currently is there. I’ll talk about this is a moment. We also requested, updated line goods that reflects the most recent data more actively.

Some of this includes for example, direct comparative data to other rapid-acting analogs. We expect the date label approval, the PDUFA date to be September 30, 2017. Now, as it's typical for the FDA, we don’t expect to hear back from them regarding any label components and so probably up to July or August timeframe.

So, this is a slide that I have shown many times before and we use it as a basis for how our clinical strategy and our clinical programs are going to be led out. These graphs are important because they demonstrate or basically show Afrezza's key differentiation from rapid-acting analogs and this particular graph is lispro.

This difference is the base for our strategy and our program, as I said previously. It's the PK profile that makes it so much different in lispro and it demonstrates clearly that it starts acting within five minutes to where lispro acts much later than that.

It is dedifferentiation where we believe that Afrezza is actually a different class of insulin outside of the RAAs. So, let me show you or articulate for you, how we are going incorporate the Afrezza attributes and it's clear differentiation from rapid-acting analogs into our clinical programs.

So first, we are going to be looking at efficacy studies, utilizing precision medicine and [Indiscernible] dosing concepts. So, here we take Afrezza's unique PK/PD profile, the one that I showed you on the graph previously and this will allow for real-time control of postprandial glucose.

This is the especially beneficial to those patients specially type I who are wearing CGM. This will allow some improved time and range therefore reducing the incidents of hypo and hyperglycemic events. We will also lead to improve the A1c levels with more patients gaining to go.

Michael will speak a little bit about the number of patients that don't need go in his commercial presentation. Other thing 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 in cancer data or evidence that currently exists.

There is a tremendous amount of missed information out there and these efforts will be directed to counteract that information. The next, we're going to look at the pediatric population. So, we are going to work with 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 Pediatric Steering Committee that consists of top tier KOLs, academic centers and organization such as the JDRF. We are putting together an Afrezza pediatric program that will include not only the regulatory required studies, but ancillary studies 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 15th. 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 been heard from me previously, we are aggressively managing the cost of this study while still driving to meet the FDA timelines. We are still on target to do so.

The next two studies I'm going to speak about are part of our overall strategy around dose optimization, timing management as I articulated previously. The dose optimization study is the Afrezza dynamic dosing study, which we're calling [AED-1] study.

This protocol is very close to finalization and we're aiming for a July/August start with the possible Q4 completion, date available sooner after. The timing range study which is a study comparing prandial insulin aspart versus Technosphere insulin, which is Afrezza in patients with Type I diabetes on multiple daily injections.

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 where we focus Afrezza today and where you see us going over the next three to five years. The Afrezza U.S. target population is large as we've indicated for over 18 million out of the 22 million 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 all why we're indicated for the large population because any time 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 due to the competitors contract and strategy and it's where drug start really serving the unmet need where the people need it most.

As doctors get experienced in this population, we expect them to move up to the yellow box over the next 12 to 18 to 36 months, and they start to use Afrezza earlier in the treatment.

We see that happened in various markets already today, but it's unrealistic to expect every doctor to start with this giving some of the payer restrictions that do exist and the lack of experience with the product. As they get experienced, as they see the patient 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 and mostly orals and combination of orals where we treat people in a successive targets, obviously [ph] treatment failure, but we continue to add one, two and three drugs, then on GLP and when nothing else works, we then go insulin.

And our strategy obviously long-term is to reserve that trend where people can use insulin early 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 overtime we will continue to demonstrate our success as we progress the clinical development program and our commercial strategy.

I don’t think it's a question even to give up as MannKind want to success and I’ll share with some of our early commercial success as an update in March 16th meeting, but more importantly we have strong improvements to remain focused.

One in five people on injected insulin regularly miss their dose, which mean they are going to achieve the personal goals or getting the A1c less than seven, because daily injection doing a fair with the daily activities as well as many patients are embarrassed of an injection embarrassment in public of injecting.

Number two, while we have had 14 new drug improved in past decade, we have made very minimal progress in advancements of the percent of population achieving in A1c less than seven.

We see in the general population of type II in general across the Board 50% of the people do get the less than seven; 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 seven that are currently take insulin.

And that’s a very disturbing statistic, 7 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 analogs insulin despite the adoption of pumps and CGMs have not made a big move in the outcome of the patients across the country, despite increasing our cost across the healthcare system.

One of the main reason of this is doctors are afraid of appropriate titration help people meet their goal, and as they very spoke about, some of the trials we're working on is going to demonstrate superior time and range and showing that people can safely dose to insulin and maintain low rates of hypoglycemia while maintaining time and range and getting the Ac1 outcomes.

In the end, patients desire insulin that may have weight neutrality and reduction in severe hypoglycemia. This is where we are focused and hoping.

Next, the Afrezza is some of the lifestyle brand today, we see people all over the internet, we see stories we get, people we know are on Afrezza whether its physician, researchers, bloggers, several famous people, someone who you see in publically.

We have a lot of support at the top end of the spectrum of people using our drugs, seeing first hand for themselves how it works and want to help others. This is exciting news for us because we continue to see insulin series 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 own on the web or letters that get emailed and mailed to us. Patients as well as caregivers write to us and post publically about how this has changed their life.

One thing I believe is taken for granted is what is like taking care of somebody and living with somebody with diabetes. The challenge is one faces not just looking at the disease, but the meals you cook when you going to have to eat and the vacation is a constantly struggle.

And we continue to see benefits from the caregivers of people and enjoying their life and this is something that will be important as we go forward. Now, I focus on Q1 commercial highlights. I don't have a lot to say here mainly because we just had call, not even eight weeks ago where we did provide an update.

So, I plan update a little bit more of the facts around the lost that hind point, but just to reinforce for those of you who did listen to the last call, we did expand our sales force in this 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 is not commercially responsive.

I think you can see now through our expansion and our regional launch that when we put sales force efforts and marketing dollars against Afrezza, we see an uptick in prescription then when we pull back, we have see a decrease in prescription.

That’s what we wanted to see when we launch last year was before we spent a lot of money, we want to make sure that this drug was the most responsive and the patients are doctors are getting benefits they're expected. Today, we sit here a year later since I joined with 100 plus people in the field, 75 nurse educators on a per doing basis.

We just had 20 people in training this week. They're going up and starting tomorrow and hit the ground running. We also have a new payer coverage. For those of you who don’t know we had PPACA [ph] on January 1 with no prior authorization. They serve a lot of government state Medicare Part D, Medicaid et cetera.

We also didn't announce but you should be aware, we had Anthem starting on April 1, 2017. We’ll be now covered with Anthem with its prior authorization to label. And so far we've seen 90% approval prior authorization coming in through our MannKind carrier hub.

And I'll remind you this follows additional wins to Express Scripts National Formulary as well as [IMA] and there is many more to come. Unfortunately, it just takes time to work through the payers and the challenges they face and they can formulary changes in the notification they must do in the due process.

This is something we continue to work closely with payers and in fact recent we just expanded our managed care team to call on more payers to drive more prior authorization removals as well as reduction in restrictions around the prior authorizations.

And I can tell you the conversions we continue to have with big payers that we uncovered yet continued to be positive and now expect to continue to announce better payer coverage as the year progresses. So thank you for bearing with us as our patients are the ones who to suffer from the controls of payers and put in place.

But everyday day it was getting easier and easier and I imagine throughout this year it will be better and better and more clarity will exist. We have launched several key programs some of which I announced previously. So in office around sound promotions, we so we have in-office waiting room wireless, we get a commercial from patient signs for that.

We have the waiting room TVs that you may see, we have in-office -- when we [Indiscernible] in the room, there is poster out there, so forth. So, we've done a lot of good work on round sound promotion. We've also done a direct mail campaign to physicians and that is educator which we had a nice response.

And as I just previously mentioned, we did expand to make fixed cost investment work through a variable cost network which now on top us provide more coverage for patients which is 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 with noise every week from people saying, the scripts are up or down or the flat. And one of the things I wish all you had, the crystal ball that I do have.

And probably it's 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 in January 1 and so those NRxs no longer showed up in 2017. Number two, you may not be aware, but sometimes patients do get two prescriptions, they will get a 90 count folding box and they will get a 90 count combo box. So that patient will get into two prescriptions.

We've have had many people now that we have launched these two new titration boxes of a 180 count cartridges start to switch over from getting two different prescriptions to one prescription, so that does cause some consolidation in our weekly scripts.

We also have free goods program call Start Out and that program is growing from roughly three scripts a week to 12 scripts a week, after 20 weeks so far in April/May time period.

So, we continue to see nice progress with patients who do not approve by the commercial insurance in the first week, we will provide Afrezza free of charge because we know the majority of prioritization will be resolved within the first month and very high percentage of time successfully.

So, sometime when that happens, it delays the patient starting NRx or TRx in that process because these prescriptions do not show up in the Symphony data and they are prescription that we do see a relief to give up some early indication.

And then finally, reauthorization insurance changes always happen in the New Year, people get, prioritization, they get insurance, that does cause some fluctuation that we have seen in the early part of this quarter. And the finally, the sample program which we did launch had 60 counts units of 8 and 12.

The sales force expansion, we've definitely seen an increase in sampling which has definitely probably hurts TRx in certain parts of the country. We have taken actions to reduce the number of samples in those particular markets, and we also will be launching a voucher program around June 1st.

That program will start to show up in NRx as well, that’s also way to show you transparently what's happening on the sample world and also make sure we accelerate the time when a patient starting a drug to a patient getting a prescription.

So, now I turn to the actual numbers that I gave little bit of the backdrop and you look back over the last nine months. And here you can see on the top line when we launched our sales force, this is weekly cartridge account. It's important to know that we book revenue on a price per cartridge.

So, we really focus on the cartridges and what happening in cartage volume. And you look back in July of last year, we launched our sales force and you saw a nice continued uptick in that purple line on top.

So, when you look down on the bottom on the green line and you look at NRx quantities, what you do see is while we had a nice lift early on, we could see pretty quickly back in back in Q4 of last year that we have to do something different because our NRxs were starting to flat now only cartridges.

And now as a big reason why we made this shift from a contract sales force to an internal MannKind sales force because we knew we had to upgrade, we have to expand and we had to have a better region frequency model in order to drive that green line faster.

And so something we didn’t realize what's happening, but we could see really on 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 sales force transition.

And again what you see is when we disrupted the sales force NRx to TRx slowdown, cartridges slowdown and now we expanded the sales force to take a backup.

And now we expect when you look at the green line on the bottom here that has surpassed refills, that is what we need to see in the market place in order to expect TRx to improve as well as TRx cartridges to improve, and we have now cross that line and we expect to see continue progress on a weekly basis as we go forward.

I personally overreact to one week up, one week down. I think we have to look at trends and that what despite show you as a fully growing average of what's happening when you smoothed out the week to week fluctuations. The next thing that people don’t realize is there is various days in months.

And so one of the thing this slide will show is when we normalize for 31 days or 28 days in a month, it gives you little bit different picture of what we have seen. So in January you could see there are about 34 TRx a day and in March you saw about 39 TRx a day. So, we grew TRx of about 14% in that timeframe.

But more importantly, the cartridges per day grew 37%, and again I remind you, we do book our revenue on prescription sold but also the number of unit sold per prescription. So today per price per cartridges, but we are evaluating whether it should be a linear price as we launched two new SKUs in the June/July timeframe.

You can expect to see a 90 count 8 unit and then 90 count 12 units packaging launching in the near future. Now just remind you, not every NRx is for new patient nor an every NRx or TRx for 30 days. So some patients use this as for their highs in their pumps, some people use that on a daily basis.

And so that refill patterns don't always be 30 day jump over 30 days, but our trends are now currently move and we're starting to see compounding.

And do get the question, are we losing patients? are we retaining patients? And I can tell you that the average cartridges expensed Rx is close 200 and that we see that the average patients getting our 30 day supply and I can tell you historically that was not always respective of that what was happening with regard to that many patients from and getting about 15 to 20 day supply, which means that we are running out refill too.

We solve that issue with our new packaging, we continue to see increase retention update like all drug, not every drug is perfect for every patients and you do -- can you tell me that, if you get a 150 NRx for the week and that we get a 150 new patients, because not every single one [Indiscernible] 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 it really looks that we see from an early view data of our as our sales forces have an impact and where we are going week to week.

This is the data that you don’t see in the prescriptions, but MannKind care referrals and our Start Our program has grown consistently since our February expansion.

You can see in Q3 of last year, we launched our MannKind's care portal, we had about 150 referrals and in Q4 we enter into a transition, we were able to get that to roughly 250 referrals and we almost doubled in Q1, and so that’s really the only sales force been for six weeks.

And so I can tell you typically, it's three to six months for any new sales force to show impact, and it's quite affect that we did keep more than two thirds of the customer sales force even though we expanded, we did this almost every territory in the country.

So even though we kept the basis sales up on our previous contract, now we need to scale up, but we did have to disrupt territories and relationship which call a short term set back. But in Q1 you can see early on, in that first six weeks of the sales force, we were able to double the referrals.

And these referrals can take one to four plus weeks to come out of MannKind care and it really depends on how quickly the doctors fills up the paper work and how quickly the insurance company responding, returns to call or etcetera.

So, we don’t see 500 people coming in March and going out next week, it's about 25% a week and then about 25% continued on beyond 20 days. So, obviously both these referrals are coming in March and we continue to see strength in the month of April as well.

Our Start Out program as you can see in Q1 also jumps 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 will share more details over the coming weeks and months.

But here I think we have an aligned partner who see the complexity of diabetes care and how do we start to counter and change, how people access care, how they get titrate on our drugs, how retain on the drug and how we answer their questions. Based on a fantastic job built on a very unique platform that provides, but not every person can achieve.

Now, we do believe we will see more than -- a lot more initiatives and we will be excited to see where this is going. I don’t want to -- the things are working on, but we are excited about this partnership as we go forward.

The social media launch campaign is happen, we saw we launched our Facebook, we will start to advertise on Facebook and we see a Tumblr feed happening very shortly and Twitter will more after.

So, apologize it doesn’t always go as fast as everybody wants, but we do have Board regulations we have to follow and it's not like I can just put out a present and not deal with our regulations. So, this is something we continue to advance some work through, but we are pretty close now at Facebook someone want to see some more campaigns around this.

We are in active preparation to film our first TV commercial. As you know we submitted this for FDA back in April, we expect any day now to get feedback from FDA and incorporate into our final edits.

We anticipate the launch in July which goes into next bullet here is the discovery partnership with Reversed and Charles Mattocks is where we'd expect the first air this commercial.

But there is other initiatives we're working on and you'll soon here about Damon Dash launching the Dash Diabetes Network, which will really be at focused targeted outreach effort with lot of online opportunity revolve other partnership launches.

And as I previously mentioned, the voucher program, we will launch around June 1st and that will be focused on helping doctors under how to start patients and get patients started quickly.

So hopefully, you would see with label change come in Q3 that stat study that Ray discussed that we expect to readout in Q4, our pediatric expansion focus [Indiscernible]. We're excited about our future.

We continue to expect to build help 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 use and continues 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..

Thanks Mike. So at this point, we want to take the opportunities to answer some of your pre-submitted questions consistent with last quarter. For the most part, we tried to incorporate the answers to these questions in the prior presentation, so we wouldn't make this an extended period, but there couple within next week fit to all.

So, I’ll try to -- want me try hit some of those now. First question relates to the recently filed change in control agreements. Change in control agreements, are quite common for senior executives in general as well as among our peer companies.

If that every single company we track and reporting our proxy as comparable peer company have such agreements in place, we also common at MannKind, I am and other tenured executives here at MannKind have agreements in place for many years. And in Q1, our Board extended these agreements to include newer numbers to the senior leadership team.

MannKind agreements are standard, double trigger arrangements, which means they're only triggered if the Company both acquired and effective losing their job as a result.

The timing of the filing was to proceed the proxy statement in which the agreements were discussed and nothing should be inferred from the adjustments or the timing of this particular action by the Board. The next question, that we often asked, has to do with the pipeline and for that I am going to turn it back over to Ray for a couple of minutes..

So as I said before, the pipeline we continue to progress the multiple tablets that we have there. We did have the -- held pretty IND meeting in December, we continue to be in with dialogs with the FDA around the appropriate regulatory pathway to lead to the indication we believe that product should have.

For Treprostinil for pulmonary arterial hypertension, we have a pre-IND meeting scheduled with the FDA on June 28th. We expect that to be relatively successful as well as this pathway a little bit clear and so such before anaphylaxis, but we are also progressing into pipeline.

Triptans for migraines, PTH and Symlin and I’ll update everyone at our next call..

Okay. Next, I think the final question relates to whether we consider a co-promotional arrangement in future, it sounds like a question that directed to Mike..

Thanks you, Matt. So, as we go forward, one of the things we look back on is there is a large type II market that fits within the primary care audience, and one of the barrier that further face that launch was fair pay restriction, that were in place at that time.

And as we continue to remove payer barrier restrictions and simply that process, it will make sense to go back out and target a larger primary care type base. And we always have to evaluate our options with pursuing that our own or pursuing that through a co-promote partner.

I think there are plenty of sales force who have capacity out there and it's doesn’t always make sense to take on in expense of 300 or 500 reps calling a primary care physicians when their capacity that exist in the market place.

So as we continue to get better payer coverage and simplify the access, I think we can see a nice upswing and adoption as we target primary care docs in type II market and increase our share voice in reaching frequency.

As of today, we will continue to focus on driving near-term performance, which only make that option much more valuable as we go forward..

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. And just as a reminder, our Annual Meeting for stockholders will be held on May 18, at our Danbury, Connecticut Facility. And I look forward to seeing you many of you there.

Operator?.

Thank you ladies and gentlemen, this concludes today's conference. Thank you for participating..