MannKind Corp (MNKD) 2016 Q2 法說會逐字稿

Ladies and gentlemen, thank you for standing by. Welcome to the MannKind Corporation 2016 second quarter conference call. My name is Sherri and I'll be your operator for today's call. At this time, all participants are in a listen only mode. Later, we will conduct a question and answer session. 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 of 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 securities laws. It is possible that the actual results could differ from these stated expectations. For factors, which would 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, August 6 (sic - 8), 2016. We undertake no obligation to revise or update any statements to reflect events or circumstances after the date of this call.

I am now pleased to introduce Matthew Pfeffer, CEO of MannKind. Matt?

Good afternoon. In January of 2016, I announced an audacious plan, to pivot MannKind in a dramatic way, transforming the Company from one who's primary purpose was manufacturing into a fully developed commercial enterprise. This plan involved several critical elements. First, by the end of Q1, we had to put into place the organizations and systems necessary to support a commercial product in the marketplace. It included transitioning ongoing clinical programs back to MannKind, setting up medical information request system, developing a pharmacovigilance program, transitioning the safety database, and setting up an adverse event reporting and tracking system, transferring all of the NDA paperwork and other documentation, and so forth. Tremendous undertaking.

At the same time, we are negotiating a transition agreement with Sanofi to ensure that Afrezza would continue to be available until we had built the capability to manufacture and distribute the product ourselves. All this was completed in time to transition the product back to us on April 5 of this year as planned.

Next, we had to build from scratch our commercial infrastructure, including hiring a commercial management team, developing a marketing organization, hiring nurse diabetes educators, medical science liaisons, a payer management organization, and of course hiring and training a field sales force. While again at the same time, we had to convert our manufacturing organization to supply our own MannKind branded product, including new product configurations and to arrange for commercial distribution through a wholesale distribution network.

All of this was completed in record time and as announced last week, MannKind branded Afrezza is available now throughout the United States. Finally, we needed to ensure that we have the necessary financial resources to give us the time to change the commercial trajectory of Afrezza. Accordingly, we executed a financing in May, which provides us sufficient runway to get us into the first quarter of next year. At the same time, we continue to weigh the value proposition of every expenditure the company makes to make our existing and anticipated cash last us for as far into 2017 as possible.

Should we need to raise additional funds, we want to allow as much time as possible to demonstrate the sustained commercial growth. This will ensure that if we need to finance, we will do so under the best possible circumstances. So 2016 to date is a story of a successful pivot to the organization, transforming it into a new entity with the tools to execute on that audacious plan I mentioned earlier.

The second half of 2016 will be about taking those tools and increasing sales of Afrezza. As part of mapping out our strategy for rebuilding the company and relaunching Afrezza, we identified a number of issues that could slow or prevent the sales growth we sought. We then developed a plan for addressing each of them. These issues included, amongst others, pricing, access, reimbursement, titration, spirometry, product positioning and targeting, and potential label changes. Many of these plans have already been put into place. Others are still to come. Mike and Ray will be talking about many of them later in this call.

Bottom line, we built a strategy to get Afrezza into the hands of our target market and maximize its chances of success. But the MannKind story will not stop with Afrezza. We still have a lot of very exciting product opportunities in our pipeline. We have intentionally slowed development of some of the earlier Technosphere programs to preserve cash, but our lead program, (Epi), continues to move forward on the timeline announced at the start of the year. Ray will be providing an update on the development pipeline overall, as well as some important plans to broaden and strengthen the Afrezza label.

In summary, I believe we've successfully transformed our Company with all the pieces necessary now in place to execute on our aggressive sales plans and show sustained growth in Afrezza prescribing. We've also obtained the cash needed to finance these efforts, keep our burn rate flat by using savings in other areas to fund our commercial operations.

And finally, we continue to advance our pipeline judiciously, keeping our lead development program on track. With that short introduction, I'd now like to turn the call over to Rose to go over our financial results just announced, after which both Mike and Ray will provide some important updates. Rose?

Thank you, Matt. Turning to the financials, the net loss applicable to common stockholders for the second quarter of 2016 increased to $30 million, or $0.07 per share, compared to the net loss applicable to common stockholders of $28.9 million, or $0.07 per share, for the same quarter last year.

Research and development expenses decreased 44% for the second quarter of 2016 compared to the second quarter in 2015, largely due to the restructuring measures taken in 2015 following the completion of Afrezza registration trials. We anticipate our overall R&D expenses will decrease compared to last year as we continue to focus our efforts on the commercialization of Afrezza for the remainder of this year with minimal incremental costs associated with advancing our development pipeline and the initiation of certain clinical studies, balancing these equally critical efforts with our current financial runway.

General and administrative expenses increased 5% for the second quarter of 2016 compared to the same quarter last year, primarily due to sales and marketing expense. We estimate our continuing commercial efforts of Afrezza for the second half of this year will be between $16 million to $18 million. To date, we have spent approximately $4 million related to our sales and marketing efforts. We expect other G&A expenses for the remainder of 2016 to remain relatively flat compared to the prior year.

Manufacturing of commercial product resumed in the second quarter of 2016 in preparation for the relaunch of Afrezza, resulting in the recognition of product manufacturing costs of $3.7 million for the second quarter of 2016. We expect product manufacturing costs to remain relatively flat as compared to last year as we continue to manufacture commercial product.

In the second quarter of 2016, we earned $0.3 million under the profit and loss sharing arrangement with Sanofi related to Afrezza , which will be applied as a prepayment against the balance under the Sanofi loan facility. As of June 30, 2016, the total amount owed to Sanofi is $70.3 million, which includes accrued interest of $4.3 million. Under the terms of this facility, it is not due for repayment until August 2024. Cash and cash equivalents were $63.7 million at June 30, 2016, compared to $27.7 million at the end of first quarter of 2016. In May 2016, we received net proceeds of $47.4 million upon the completion of the registered direct offering.

As part of this transaction, we also issued warrants. Under the accounting rules, provisions of a portion of the warrants resulted in them being reflected as a liability on our balance sheet. This liability is revalued at each quarter end and for the quarter just ended, resulted in a charge to other expense in our income statement. This is a non-cash charge and there is no reason to expect that the adjusted liability will ever be satisfied in cash. If the warrants are exercised, they will result in a net cash -- in a cash payment to the Company in exchange for shares. If they are not exercised, they will expire.

In addition to the foregoing cash inflows, we received $9.2 million from Sanofi for the sale of insulin inventory in connection with the insulin put option we exercised following termination. We expect additional receipts from Sanofi under the terms of this agreement later in the year and for some time to come.

Finally, we received $0.7 million from Connecticut as a research and development tax credit. We still have $30.1 million available to borrow under the amended loan arrangement with the Mann Group, and because there has been no use of our ATM facility since its effectiveness, $50 million still remains available.

With that, I'd like to turn the call over to our Chief Commercial Officer, Michael Castagna. Mike?

Thank you, Rose. Today, I'll give you an overview of the commercial efforts to date. I want to talk first about the market trends that favor Afrezza and most importantly is where our current prescriptions have been trending. I'm really impressed that within the first three to four weeks of our sales force being out there, we've been able to stem a nine-month decline that's been ongoing since September of 2015 and stabilizing that during the month of July.

For those you that may or may not know, new technology is giving more transparency on how to treat patients individually and optimally. And what that means is when you think about the (inaudible) (lever) system launching around the world, (FX US) as well as the Dexcom FDA hearing last week, which looks like it will have a positive outcome, the ability for patients to see their highs and lows on a daily basis every five to ten minutes is now becoming a reality. That will now allow patients to bridge to our next bullet here, to measure their time in range for tighter control.

Patients often struggle with highs and lows of their diabetes on a daily basis and we often don't know what an average is as you look throughout the day. But the new technologies that we've seen advance over the last one and two years, the patient's ability to now try to manage their glucose levels in a tighter range is becoming a reality and we are seeing clinical trials continuing to enroll patients with these types of objectives in mind. A product like Afrezza that starts to work in 10 to 15 minutes allows you to see that activity pretty quickly when you're using this technology.

The third thing that we see is patient engagement in their health is shifting. As continued out of pocket costs grow and deductible plans continue to become the predominant ways for some employers, patients are taking a more active role in their health, trying to manage their blood glucose as well as multiple copays and out of pocket costs that they have. So we're seeing continued expansion as this is the number one cost driver for insurers as they're continuing to launch more, and different, and new programs to help these patients manage their glucose and manage their daily lifestyle behaviors.

Now, I want to bridge into a question that we often get, which is around our target market and how are we going to go about the segmentation with our current field program. Our focus is on the 6.5 million patients with diabetes who are on basal plus or minus insulin. The majority of whom these patients are not at goal. So if you look on the left side of this chart, type 1 diabetes are approximately $1.25 million. Type 2 basal who are not on bolus is roughly $2.75 million and type 2 basal bolus patients who are on basal bolus regimens is almost 3 million.

This is how you get to the 6.5 million patients with diabetes. Of these, you would see a monthly prescription trend of approximately 7 million prescriptions in a given month targeting this population. Our current field footprint is about 1.4 million of those prescriptions so we're targeting about 75% of the insulin market with our current sales structure.

The next question I often get that I think is important for everyone is around our price point and the cost of Afrezza. Afrezza infusion now is reimbursed across all payer segments from commercial to Medicare, but the rapid acting analog price increases over the last three years has really started to create challenges in the marketplace. You see in the box below, the WAC price of rapid acting analog has increased 80% since July 2013. So today, when you look at the price of Afrezza since we got approved, the price of Afrezza is probably one of the actual cheaper insulins, as we now know the average price of insulin per day is approximately $19. And if you look at the recent launch of our titration pack, we priced it at $3 a unit -- a cartridge. And so when you look at $3 a cartridge with patients who take three cartridges a day, you can be looking at a price point of $9 a day. If they were take six cartridges either because they need additional dosing or follow-up dosing, you'd be looking at a price point of $18 a day.

So the current WAC price of Afrezza is not the challenge. The challenge is payers are trying to control their cost and so they're being more restrictive on formularies and that's often why we're seeing patients may need to switch between a Humalog and Novolog as they're trying to manage the cost trends, especially in this category.

Going to the next slide, we were able to transition our inventory during the week of July 25. MannKind will now book 100% of Afrezza revenue pretty much starting in the month of August once the rest of the remaining supplies at the pharmacy shelves will be going out of stock. We know the majority of the wholesalers are no longer stocking Sanofi products, so we're relatively confident that every product shipping out of wholesalers from this day forward will be branded MannKind.

You see here the four NDC that now match the Sanofi, old NDC, and the MannKind new NDC. These were important to keep consistent as well as the price point to minimize any distractions in the marketplace. We did launch a new product with the titration pack, which I'll talk about further and that's the new NDC.

As you may or may not be aware, during these transitions there's multiple computer systems that feed into each other across the supply chain that has to update. Some of them update Monday, some of them update over three to seven days. So we have -- we know there were stock outs last week in a couple geographic markets for wholesalers. The majority of those issues should be resolved and our wholesalers today have done a central distribution, which means within one day, a pharmacy should be able to order and stock Afrezza. They will have to order it in some cases. In other cases, they'll stock it when a patient actually fills their first prescription. They'll continue to keep it in stock. Those are the initiatives that we're currently working on to make sure they minimize any patient disruption at the local level.

The next question we get is around our branding campaign. It's important to know that MannKind was able to develop and launch a new brand campaign and move away from the Sanofi (inaudible) insulin. What I'm proud to announce is that our focus is not on the inhalation aspects of Afrezza, but it's much more on the insulin and outsulin component. And so you see here just a brief snapshot of what that would look like and how we talk about insulin is how quickly it acts, and we talk about outsulin as how quickly it disappears. And we really want to spark a dialogue in the marketplace around the insulin and outsulin components of insulin, and how Afrezza plays a new role within that treatment of these patients, highlighting the PK profile as we see it today. There's obviously a lot more behind the campaign but I want you to rest assured the feedback from patients and physicians has been extremely positive.

Next, I want to talk about some of the new initiatives, which I believe are critical as we look at how we relaunch this product. First and most important is MannKind Cares. This is a patient reimbursement hub that is administered at the physician office and because we know Afrezza will require prior authorization in certain cases or most cases, this is meant to streamline that process so the offices can be a prior authorization approval within one to three days. Upon approval, the patients will be enrolled in an adherence programs and one of the things we did learn is a lot of patients were struggling with getting access to Afrezza at the pharmacy and/or titrating in the early weeks of treatment. This program is designed to ensure patients are titrating appropriately, reaching their goals, and getting products filled as quickly as possible.

There are numerous details behind the program on the highlight here, but for the simplicity of our shareholders, you should rest assured that we want to make sure that patient reimbursement and prior authorization within our target audience is something that we minimize. This is the program we've talked to many of our key customers about. They're excited to use it and we believe this will streamline the prior authorization process and getting approval for patients quickly.

The next program, which I'll share with you, which is our earliest indicator of our weekly prescriptions, is our Afrezza copay card program. This is administered by McKesson and we moved it and launched it the last week of July to now $15 copay per month. And what we're hoping is we know Tresiba (inaudible) and a couple other basals are about $15 per month, and we're hopeful that doctors will take a patient, simplify their life to a basal one shot a day along with Afrezza for $30 a month on the commercial side of the patients -- commercially insured patients.

We really tried to streamline this to make it easy, $15 a month consistently. So there's not a lot of confusion between the different types of programs out there. The other thing you'll hear us launch, which is just a short-term pilot, is the voucher program. This voucher program will be good for one month's sample of the titration pack and this is meant to drive demand pull through, through the wholesale channel to ensure the local pharmacy are stocking it, as well as a supplement for our current sample program. Our current sample program as we've stated previously was four unit sample packs, which we know are sub-optimal for the majority of patients to reach their goals in the first seven days of treatment. The titration pack will allow patients to have enough drug to get through the titration phase while we deal with reinsurance as well as long-term new sample program in late September, early October.

The final one we've talked about is the titration pack and this one is really meant to solve several problems, as we know patients couldn't always get the right number of boxes at a box configuration at the pharmacy. The pharmacist couldn't always figure out exactly which box to take when the doctor prescribed it, and the doctor wasn't sure which box to prescribe based on how many units the patient was using. And so there's a lot of confusion when we look back at the data and the market research.

And this new titration box literally will simplify the process for the doctor, the patient, and the pharmacy by allowing them to have a 30-day supply of titration of 180 cartridges, which will provide them enough units to combine to get the 4, 8, 12, or 24 units in a dose to ensure they have an optimal experience and don't run short within a given month.

Another question we get is around our direct to consumer and raising consumer awareness, and I want you to know we're not ignoring the feedback from our shareholders, but it is important to understand the difference between direct to consumer, which is a mass, broad advertising campaign to people who may not be your target audience versus a direct to patient effort, who are in that 6.5 million number I highlighted earlier. So we have several initiatives on track to launch starting in September, which will be our first consumer print ad you'll start to see out there in mid to late September pop up in some journals. We are updating our consumer website to reflect the new marketing campaign and once that's updates, we will kick off our new digital campaign with a few partners and you'll start to see that pop up again in mid-September at the latest.

And then we have identified several direct mail opportunities that we can pilot and see targeting patients directly in the mail, as we know the average age of a type 2 or type 1 patient could be in the 45 to 55 range, and sometimes direct mail is a better way to go as opposed to digital for a younger audience. Either way, we will have lots of data coming out of Q3 that we continue to fine tune our direct to patient efforts. And then finally, we're looking at community events and patient conferences. We know there's many conferences happening in Q4 and Q3. We plan to be present at those events. We were already present at several physician conferences over the last few weeks, as well as some upcoming ones in Florida and Texas. So we're going after the patients directly as well as trying to be present where there are local and regional physician conferences.

I will note on the consumer side, we will see well over the ability to reach in the hundreds of thousands of consumers. So if you're asking me to quantify how many patients are we looking at with our efforts, it's in that vicinity. So the next question, which I think is important to all of us is what are the early indicators and what can you tell us how we're doing to date. And I want to preface this by saying these are as early as you could possibly want. It's difficult to make projections off of literally weeks and days of data. However, I think it's important to be transparent with the market around what we're seeing and why we are optimistic around our changing curve, and what we see in the future.

So number one is samples. So we know that samples were really not out there in the channel over the last six months in a meaningful way. We were out there. We just launched our sample program two weeks ago and in the first two weeks, we had well over 300 sample requests amongst our targets. Those just shipped literally late last week or early this week, people will be receiving them and so all the prescription trends that we've seen over the last few weeks have been without samples in the marketplace for a large majority of our customers.

Now, that they have samples we know several doctors have said I want samples and copays in my office. Once I have them I'll start to prescribe Afrezza again. So those products are -- both of those are starting to hit doctors' offices this week and next week as well as last week.

The next two early indicators are the number of patients who enroll in our copay card program, which is currently only done via web. The physical cards will be dropped in the offices starting this week and then the next one is once they register on the web, how many of them are redeemed. And I'll share that data with you in a moment because those are the earliest indicators that we get on a daily basis that I think are important for you to see.

The next two aspects that we look at are new Rx trends, which we will try to be transparent and post those in some form or fashion as we fine tune this. But we know we've gone roughly from 84 to 116 new Rxs in the first few weeks and that trend should continue, and that's despite some of the stock outs that I described earlier around the inventory transition.

And the next metric that we look at is around new writers and trialists. And that number, we've seen almost 300 new prescribers in Q2 alone who now (inaudible) Afrezza in 2016 -- (inaudible) Afrezza for the first time. So we are seeing broad trialist happen and we know we'll continue to cultivate that as we go into Q3 going forward.

And on the flip side, these are the measurable indicators. We have qualitative indicators. And what I mean by that is things where we're out there talking to doctors, the feedback anecdotally from the field, the speaker program and interactions we've had and those are very strong as well. So when you think about speaker training and programs, we just kicked off our speaker program literally this week will be it will be launching. But we had our speaker training last week and we had a significant number of attendees show up last minute. We didn't have anyone not show up and the feedback and the questions are really important to have the dialogue and they left trained and ready to go and excited, and I think that gives us some momentum as well as we go into Q3 and Q4.

And then the next two around field sales, nurse educators are out there, as well as the manager feedback who are out there doing field rides and engaging in the thought leaders around the local markets. And all of that feedback is also been consistently positive and welcoming. People are generally happy to see MannKind come out and show up and know that the product will still be available. And as you could imagine, there's a lot of resistance where a lot of our customers literally thought the product was coming off the market and was no longer going to be supplied.

So when you look at the decline in prescriptions from January through June, a lot of that was the result of people not believing we were going to be around in July and they thought once the Sanofi inventory ran out, that was it, the product would no longer be available.

So as a result of that, they stopped initiating new patients back in Q1 and Q2. Now that we've been out there for almost a month creating our second and third visits, doctors are remaining confident, they're starting to see our samples and copays. We expect this trend to change quickly around the feedback and availability of Afrezza amongst our top prescribers. And then finally, the social media coverage as well as press coverage from ADA has continued to be positive and Ray will speak to that in a moment.

I just want to share with you a quick snapshot that I think is important and that looks at the claims and the enrollment. So this is what we see on a daily basis. This is for the week ending 8-5, which would have been last week. And you see here that a relatively stable number in the green line on the claims that were happening, which just basically means we weren't really promoting our copay program. We didn't have any means to promote it, besides putting on our website.

The bottom line is enrollments and that's really our reps out there highlighting that it's available on the web as well as raising some awareness on the social media around this. And you saw following the week of July 22, July 29 and 8-5, we continued to see an increase in enrollments week over week and doubling really over the last four weeks. That's the earliest indicator you could have because we know there's about a one to two week lag from the time a patient gets enrollment to the time they get their prescription filled and approved.

And you can see that in the top line when you look from 57 to 69 to 80, the prescription trends are moving in the right direction. And again, this will be the earliest indicator that we look at in addition to the new Rx and trialist that happen on a weekly basis. So we are excited. We are seeing the support amongst the physicians. The reps are getting out there. They're making the calls and we are being welcomed. Obviously, it's sometimes longer in some territories than others depending on academics versus private practice. But so far, early indicators are very positive from the customers.

With that said, I'll now turn it over to Ray.

Thank you, Mike. So with Afrezza, our overarching objective is to establish Afrezza as a safe and effective physiologic mealtime insulin that motivates healthcare providers and patients to achieve their treatment goals.

To achieve this, first, we're actively pursuing a pathway to establish Afrezza as a safe and effective medication in the pediatric population. This includes regulatory filings in the US and possibly other jurisdictions. To help us successfully achieve this goal, we have entered into a collaboration agreement with the JDRF.

Second, we are also addressing the short and long term safety questions, so patients and healthcare providers can make informed risk/benefit decisions regarding the use of Afrezza as part of their treatment paradigm.

Finally, as Mike noted in his discussion on market trends, new technologies allow tighter control and individualized care. Utilizing these advantages, we are driving efforts to optimize initial dosing and aggressive titration of Afrezza. Effectively we are introducing a new paradigm in the way HCPs will approach patients with diabetes.

To build on Afrezza's scientific platform, several abstracts were presented at the 2016 ADA conference. These data clearly demonstrate a pharmacokinetic and pharmacodynamic difference such as earlier onset and shorter duration when compared to rapid-acting analogs. This topic was covered by Mike and he's been integrated into our marketing and commercial plans as he alluded to.

The data from these studies, for example, the population PK/PD model, provides information, which we will use in subsequent studies such as our dose optimization trials. Additionally, we'll be using these data as well as data we generated during Afrezza's development program to submit a label change to the FDA in the September and October timeframe. We believe that this new label will better instruct physicians on how to optimally dose and titrate Afrezza and give us more of a competitive advantage within the marketplace.

In addition to the ADA abstracts I just alluded to, recent publications also support much of this activity, including an in-silico modeling study that was used to optimize dosing. This study was recently published in Diabetes Technology & Therapeutics. In addition to this manuscript, a review article on the PK/PD properties of Afrezza has also been published.

So finally, I'd like to mention our product portfolio. Matt had mentioned our epi program and I just wanted to mention that the innovative oral inhalation technologies used for Afrezza can also be used to improve the efficacy, safety, and tolerability of other available agents, our three lead candidates, which includes our epinephrine program for anaphylaxis with an IND submission targeted for early first quarter of 2017. Additionally, we have treprostinil for pulmonary arterial hypertension and palonosetron for chemo-induced nausea and vomiting. As Matt alluded to, these programs have been slow slightly, but we are progressing to have the INDs and filings stay on target.

With that, let me hand it back to Matt.

Thank you, Ray. So just to wrap up, clearly relaunching Afrezza is one of the most significant milestones in our Company's history. I'm really proud of what we've achieved so far, transforming the Company into a commercial enterprise in record time, putting new programs in place to change the sales trajectory of Afrezza.

We're encouraged by the results we've seen already and by the positive feedback our sales forces received as they've met with physicians and patients nationwide as Mike described. We're confident we can continue to report improved prescription data and sales trends for Afrezza going forward, given the initiatives that Mike and his team have deployed to promote access, adoption, and adherence for Afrezza.

I've challenged the organization to continue to work on other important developments, including our product pipeline, but also things like our pediatric program and Afrezza label enhancement, while still being extremely cognizant of the importance of preserving our financial resources.

So that wraps it for me. I'd like to now turn it back to the operator for questions. Operator?

(Operator Instructions) We have a question from Steven Weil of Oppenheimer.

In previous conferences, you described other applications of Technosphere and it would be good to hear more about it.

Ray, I think -? I know that was a slide in your presentation already, do you want to recap that just a little bit?

Certainly.

No, there was something about migraine, headaches and some other things.

So what I have presented today was simply our three top candidates. As you can see from the PK/PD profile that we'd see from Afrezza, we would mostly likely see this with other agents as well. So we targeted drugs ? and put into our portfolio where this type of very rapid blood levels would be effective such as migraine, which I think you're going to mention.

So parathyroid hormones, the tryptophan, some antibiotics for local treatment of lung disorders, just to name a few, some pay-medications also being considered, so this is just a small part of our portfolio, but these are the three lead candidates. So we are looking at the other ones. You maybe referring to the JP Morgan conference where I did sort of provide a little bit more of a larger list.

I plead guilty to being responsible for some of this, necessarily poor Ray has been starved of resources and dollars to some extent because we need to concentrate on Afrezza first. We try to keep at least the lead program on track and not delaying the timelines. The rest of them are still there. We went through a lot of trouble to identify the best candidates and prioritize them. But bottom line it has to be laser focused on Afrezza and everything else will follow on.

At this time, I would like to turn the call back to Mr. Pfeffer for closing remarks.

First, thanks again for joining us today. I have to say my last meeting with Al Mann before his unfortunate passing earlier in the year, I promised him we would turn things around Afrezza and I just want to repeat again that I have every intention of keeping that promise. I think he'd be very pleased with the progress we've made so far and I'm looking forward to demonstrating continued progress in the months to come both to him and to you. So, thank you once again.

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