Matthew Pfeffer - Chief Executive Officer Michael Castagna - Chief Commercial Officer Raymond Urbanski - Chief Medical Officer Rose Alinaya - Principal Accounting Officer.

Stephen Weil - Oppenheimer.

Ladies and gentlemen, thank you for standing by. Welcome to the MannKind Corporation 2016 Third Quarter Conference Call. As a reminder, this call is recorded November 9, 2016.

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’ll now turn the call over to Ms. Rose Alinaya, Principal Accounting Officer of MannKind Corporation. Please go ahead..

Thank you. Good afternoon. And thank you for joining us to discuss MannKind’s third quarter 2016 performance. Our third quarter results were released this afternoon and are available on the SEC’s Edgar system and on our corporate website.

Before we proceed, I’d like to remind everyone that comments made on this call will include forward-looking statements within the meaning of federal securities laws, which are based upon current expectations that involve risks, changes and circumstances, assumptions and uncertainties.

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.

The information we provide on this call is provided only as of today, November 9, 2016, and we undertake no obligation to update or revise publicly any forward-looking statements to reflect events or circumstances after the date of this call except is required by law. I will now turn the call over to our CEO, Matt Pfeffer.

Matt?.

Thank you, Rose, and good afternoon to our investors, analysts, members of the diabetes community and Afrezza users. Thank you for joining us on today’s call. I am excited about accomplishments of our leadership team, we have been able to execute on over the last several months.

The intense focus to transform the company has resulted in our ability to extend our cash runway out to Q3 of 2017 without causing shareholder dilution, while simultaneously creating financial flexibility for us to take some calculated bets on Afrezza.

By now you have seen our earnings release, one of the highlights of which is $126.5 million net income. This release included many new elements, including our first quarter of commercial sales, an income statement recognition of items related to the Sanofi collaboration that previous have been deferred.

What is not included our two new agreements, being announced with this call, which I would like to discuss now. Next slide please. First, I am very pleased to announce that we have reached an agreement with Sanofi that contains several key elements.

First, Sanofi will forgive the entire amount of our loan from them of $71.6 million and terminate the associated note and security agreement. MannKind’s also release from its obligation to pay a $0.5 million in previously uncharged costs related to the collaboration.

Next, Sanofi will purchase $10.2 million worth of insulin from MannKind in early December. Note that this insulin is considered surplus to our current needs and its carried on our books at zero value.

Finally, Sanofi will pay an additional $30.6 million in cash to MannKind in early January, cancelling and settling our Insulin Put agreement with them without or having to deliver any further insulin.

In addition, it should be noted, that the termination of the promissory note and security agreement allows MannKind to pursue the sale of its Valencia, California facility, an adjoining property, which is now on the market for roughly $25 million, without are being required to use the proceeds to reduce the balance of the loan.

So this is another source of non-dilutive liquidity for MannKind. Collectively, as result of this agreement, we have improved our financial position by over a $130 million. This will go long way towards meeting our near-term financial needs.

We have also taken steps to reduce our cash requirements to amplify this effect, which brings me to the second agreement we are announcing today. Next slide, as many of you may know, one of our largest financial commitments results from the long-term Insulin Put agreement with Amphastar.

I am pleased to announce that collaboratively with Amphastar, we have successfully updated our commitments under the contract and reduced projected spend by over $65 million for the period 2016 through 2018. This will allow us to invest our resources to drive the success of Afrezza.

We have also deferred our next purchase of insulin to the fourth quarter of next year. And finally, as described in our 10-Q filing, we enacted the reorganization in September of this year, reducing our headcount by approximately 20%.

This step was taken as part of our continuing efforts to reduce overhead and offset increase spend in the commercialization of Afrezza. As a result of these steps, we now have the financial resources to embark on important initiatives, will be discussed in detail by Mike and by Ray.

Now that we have launched Afrezza and established our infrastructure, we expect to increase our investment to grow Afrezza sales faster. Based on everything we have planned, we expect our current financial resources to last into Q3 of 2017. I will provide further updates including revenue guidance for 2017 during our Q4 earnings call.

With that, I would like to turn the call back over to Rose to run through our financial results reported earlier today, after Rose Michael say a few words about our commercial activities then Ray will discuss planned development activities, as well as our label change for Afrezza.

After that I have a few additional comments before opening up for questions.

Rose?.

Thank you, Matt. Turning now to the financials, the third quarter of 2016 was a significant reporting period for MannKind. Our financials reflect the recognition of several previously deferred amounts related to the Afrezza collaboration, as well as the first quarter of MannKind branded Afrezza product sales.

In the third quarter of 2016, we recognized total net revenue of $162.4 million, of which $161.8 million resulted from our ability to satisfy the accounting requirements for revenue recognition this quarter, following the termination of the Sanofi license agreement.

The total amount recognized relates to activities from prior periods, which were previously deferred, including the upfront payment of $150 million and milestone payments of $50 million net of $64.8 million of net loss share amounts related to Sanofi, as well as $17.4 million in sales of Afrezza and $9.2 million in sale of raw insulin, both to Sanofi.

Additionally, we recognized $22.7 million of previously deferred costs from the collaboration, which consisted of $13.5 million in Afrezza, manufacturing cost for products sold to Sanofi in 2015 and $9.2 million for a change in estimate in our recognized loss on purchase commitments as a result of the sale of raw insulin to Sanofi.

We began distributing MannKind branded Afrezza products to major wholesalers during the week of July 25th. This being our first quarter of commercial product sales, we do not have enough sales history to reliably estimate expected product returns at the time of shipment into the distribution channel.

As a result, we are currently only recognizing Afrezza revenue at the point prescription units are dispensed to patients based on reported prescription data. This model necessarily recognizes a relatively small percentage of sales into the wholesale and retail channel, and will change as a longer history of product return patterns is established.

In the third quarter of 2016, we recognized net revenue related to sales of Afrezza to patients of $600,000.

As of September 30, 2016, we had recorded $2 million in the deferred revenue, of which $1.6 million net of estimated gross to net adjustments represents product shipped to our third-party logistics provider and wholesale distributors, but not identified as having been dispensed to patients as of that date.

Estimated gross-to-net adjustments for the third quarter of 2016 were approximately 32%, which includes estimates of wholesaler distribution and logistics fees, prompt pay discounts, estimated government rebates and patient discount programs.

Deferred revenue also includes $0.4 million we received in advance for the sale of surplus raw materials to a third-party, where delivery was not completed as of September 30, 2016.

Cost of goods sold in the third quarter of 2016 includes $0.1 million of manufacturing cost of Afrezza product sold to patients and corresponds to this quarters’ recognized commercial product sales.

The remaining portion of cost of goods sold of approximately $4.2 million for the third quarter of 2016 relates to unabsorbed overhead and other costs, a decrease of 48% from the third quarter of 2015.

This decrease is primarily due to reduced depreciation as a result of the fixed asset impairment write-down in 2015 and decreased salaries resulting from the reduction in force in 2015, partially offset by a decrease in production costs in 2016.

Cost of goods sold or product manufacturing costs were $15.6 million for the nine months ended September 30, 2016, and included under absorbed labor and overhead costs, and a foreign currency exchange loss on purchase commitments for insulin offset by a change in estimates that resulted in a gain on purchase commitments for other material.

Corresponding product manufacturing costs for the same period in 2015 were primarily under absorbed labor and overhead costs.

Research and development expenses were $3.9 million for the third quarter of 2016, a decrease of 38% from the third quarter of 2015, primarily due to a reduction in force in 2015 along with curtailing certain research and development projects.

Research and development expenses were $13.4 million for the nine months ended September 30, 2016, a decrease of 43% compared to the same period in 2015, primarily due to the 2015 RIF along with the reduction in research and development projects, and facility spending offset by lower reimbursable third-party development expense and tax credits.

Selling, general and administrative expenses were approximately $13.1 million for the third quarter of 2016, an increase of 14% from the third quarter last year, mainly due to increased costs for the support of sales and marketing of Afrezza.

SG&A for the nine months ended September 30, 2016 were $31.6 million, a decrease of 3% from the same period last year. Again primarily due to the 2015 RIF lower telecommunication costs in facility and insurance costs and a lower non-cash stock-based compensation expense, offset by increased sales and marketing costs for Afrezza.

Included in the results for the three and nine months ended September 30, 2016 is a non-cash effect of a $13.2 million and a $7.9 million fair value adjustment of the warrant liability related to the registered public offering completed in May 2016.

Net income applicable to common stockholders for the third quarter of 2016 increased to $126.5 million, or basic net income of $0.26 per share, compared with a net loss applicable to common stockholders of $31.9 million, or basic net loss of $0.08 per share for the same quarter in 2015.

Cash and cash equivalents at September 30, 2016 were $35.5 million, compared to $59.1 million at December 31, 2015. Currently, $30.1 million remains available for borrowing under the amended loan arrangement with The Mann Group along with $50 million still available under the ATM facility.

I would now like to turn the call to Mike, our Chief Commercial Officer..

Thank you, Rose. Today was an important milestone for the company in order to transform us from a development and manufacturing company into a fully commercialization company. With that said, we have learned a lot about Afrezza since not only taking it back from Sanofi, but also from our own real world experience.

Couple things I will share with you before I go into details is, we have learned that patients dropped off Afrezza for two reasons, one was because of cost and two was because of efficacy. And there are other reasons they dropped out, but the two predominant reasons are based on this two factors.

One thing I’ll share with you as we continue to improve formulary access, we will see best drop out to the cost, but the efficacy part is important one that you will hear from why we are talking about today.

We need to continue to reinforce appropriate titration early on in treatment and as we solve that we’ll continue to see increase in retention of our patients. Since we have launched we believe that continues to get better than it has been in the history.

The second part we have learned is almost one out of two patients receive Afrezza as a direct result from asking their doctor to prescribe it and the other half get it because their doctor recommended it.

Obviously, with our average out there over the last three months, we want to continue to shift that imbalance that doctors voluntarily want to prescribe it and feel it is a great option for their patients.

However, at the same time, we need to continue to increase our focus on driving patients in to ask our product by raising awareness and opportunity. Now let me bridge into why we believe we are position for long-term success. There’s been a couple things happening as we look out in the near-term and the long-term.

Number one, CGM technology continues to improve and increase penetration. We all saw the FDA meeting in July for Dexcom, which should continue to enhance that coverage within Medicare at some point in the future.

The other thing we saw recently was avidly our system getting approved for the professional addition, which also allows continue glucose monitoring and we see that technology being adopted in the type 2 patients, as well as in the type 1 segment.

As people continue to get clarity on what their sugars are doing very single day in real time, we believe they are going to look for additional options to help drive tighter control of their diabetes. The second thing that we look out on is, new innovation continues to reduce injections, as well as fingersticks, while providing real-time feedback.

This goes into CGM, but this also goes into some of the new technology we are seeing implantables that continue to reinforce patients on two things, they want to get control their disease for the work they are putting in and they don’t want to remind that they are -- they have a disease they have to leave with everyday.

So the more we can continue to drive that seamless integration and help people achieve their outcomes and life that they desire, but in appearance of cunning hearts and leaving life with a disease as oppose to just leaving their life. So we see these two opportunities really transforming diabetes care over the coming years.

The third part is, as Afrezza continues to grow and gain momentum, it is a worldwide epidemic, so we will expect to grow with the natural market not only in the U.S. but the rest of the world.

Patient awareness and experience with Afrezza is extremely low and I am thankful for that, because if a lot of people had negative experiences we’ll have a lot higher road to overcome.

Today, we know that when patient is aware their desire to start Afrezza is extremely high, we have seen this first hand in the numerous community events we have been doing in the last few months. Next, I just want to highlight some key commercial activities that occurred.

For those of you who never launch the drug, it usually takes three months to six months for rep to start to make impact. Not to mention, all the activities that takes to actually run and build a pharmaceutical company.

I am really proud the team and all the hard work and late nights and weekend that everybody have done in order to establish a commercial infrastructure. This is no easy task and it’s not even easy to do on the budgets that we had or the timeframe that we had.

But I am proud that throughout Q3 we continue to get Afrezza off the ground, we continue to work out the Kingston our supply chain, as well as get the feel before they need to do their job.

So some of those things are around samples, you think it easy to get a sample at the door, there is a lot of complexity from trying to get the packaging ready, to get them all street, to get the programs adopted and implement it through the salesforce. Then you are contracting with the vendors, as well as payors and reimbursement of third parties.

Not to mention, speaker programs, [ph] unchanged acting (18:48) compliance are important parameters to running a real pharmaceutical company.

The other two parts, I am really proud that we have been able to achieve in Q3 was continue to engage top four leaders to get their feedback on where we have been, where we are and where we need to go, that feedback has been absolutely critical to the insights we have learned, as well as the direction we are going to take Afrezza and the company as we go forward.

And then, finally, we have launched a new brand campaign, usually takes six months to 12 months to launch a new campaign, we know the one we had, previously, it didn’t really make the impact we expected.

I can tell you the new one continue to grab attention and there is a lot of flexibility we have to continue to make Afrezza standout in the marketplace. The second big part of our commercial launch was really around the reimbursement and access team.

As you know, reimbursement and access these deals are challenging, there is a lot of noise in the marketplace and the paradigm how drugs are delivered in the pricing environment has completed shifted in the last 90 days. However, we have got a great team.

We have been having great discussions with the payors and I will share some data with you in a second. Before I do that, you may have heard that we had a hiccup in Medicare Part D and Medicaid during the month of August.

This was just unfortunately an oversight during the transition that typically takes about 18 months to register with CMS and we discovered ways. We got the product input our supply chain out there. Initially were told we can’t get this resolve until January of 2018.

However, our team was able to figure this out and fix it within a week and really minimize that lapsing coverage effected to from late August to early September. And I am proud today to tell you we are officially registered with CMS, we do get reimbursed in the Medicare Part D segment and also Medicaid.

The second part of that is you should know we are covered on Medicaid in almost every single state 100% for Afrezza and Medicare, while we don’t preferred coverage we do get patients covered through the pilot registration process.

I am also proud to announce that Express Scripts we are now officially on the national formulary and covered, as well as addition of the Part D starting October 1st going into 2017. There also is no prioritization required for patients in these two formularies.

And then, finally, we did launch a reimbursement support center in late August and that continue to get good positive feedback from customers who have experienced it and we just continued to see great success and reimbursement opportunities there.

Additionally, it really was helpful in the managing the Medicare gap that we had in August, because we were able to help patients cover that time through working with MannKind Cares. So this reimbursement support center is continued to become a critical part of our re-launch.

And finally, accelerated patient outreach, so this is one that we -- we did around delicately. We really want to test out a few new concepts as we went to TCOYD, Take Control of Your Diabetes Conference in San Diego and we’ll also be at one next weekend in Florida.

We have participating in the JDRF and ADA books and continue to expect to be at Type 1 Summit, as well as ADX dose going into 2017. We have seen tremendous activity in our business. We have seen amazing interest from patients and we had headlines non-stop throughout these events when we are there.

The second part of the accelerated patient outreach is continue to expansion of journal advertizing, you will see us in the for Diabetes Awareness Month in USA Today online and print editions coming out shortly.

And we continue to enhance our public relations activities as you may have seen Fox News segment few weeks ago, we have several more opportunities we are trying to work with third parties to get these at the door.

And then, finally, one of the big things we heard from patients is, hey, I want to start Afrezza, but where do I go, my doctor may not want to prescribe it and so we did update afrezza.com with the new branding, try to make the layout better and make the website more mobile friendly.

As we see probably 70%, 80% of all the website traffic continues to come from tablets, as well as iPhones. And the other part of the website that you will see that we recently added his promissory testing is available on site at doctor’s office, as well as valid data referrals payable.

Just try the doctor website, will continue to be updated and the data in is only as good as it reps that put the data in their CRM system. So while we have about 1,200 doctors listed today, as we continue to expand the salesforce and add these data parameters, we expect to continue to see increases to find the doctor.

Since launch Afrezza had almost 4,000 prescribers prescribe the drug. We continue to see repeat prescribing and we will continue to see that effect compound over time as we go out there. Just since July we had over 200 prescribers to-date.

The next thing I wanted to shed some light on is our established -- is that we established our wholesale and distribution network, and what you may not have realized is just because we started booking sales, for the large part of the quarter, those sales were not MannKind, the MannKind sales that we booked are large percent of prescriptions dispensed at the pharmacy and capture through this -- through the Symphony, as well as IMS, where Sanofi prescription that was remained in the drug distribution channel.

So what you can see in July, August and September the percent of prescriptions filled with MannKind branded product went from 10% in July to almost 80% in September, and sitting here today we see about 90% of all prescription dispensed, start pretty much MannKind branded material in November going forward.

We fully expect to remaining Sanofi inventory to create no later than December 31, 2016, 100% guarantee on that because the product that’s in the channel from Sanofi expires at that time point.

The other part that we continue to see is weekly TRx average increasing from 268 up to 274 and while that may not seem significant, I will share with you for a second on the new Rx trend which I think really what we need to focus on partially because of the continued decline in the most place where we don’t have coverage.

And then the final comment I will make here is this next comment is around penetration in terms of retention of patients. We have seen the average cartridges per prescription rise from 169 three months ago to 180 and its stayed about 180 right now. And what we think that means is people retaining the drug.

They are continue to titrate it more effectively and these prescriptions are not just for 30-day supply many of them are 45-day average or 90-day supply either due to mail or prescription coverage. So we do see patients ranging in doses from 90 above up to 180 and some patients use this are not consistent with just three meals a day.

Next slide, so the first question we had when we got the product back from Sanofi is, is this product really promotionally sensitive and so before we burn to a lot of cash and hiring about bunch of people and really trying to understand, there is a tool work that we have created, the messaging resonating with customers.

We wanted to really first understand the question, is the product promotion responsive and I am really proud to say that within the first 30 days of launch we saw an immediate trend reversal from an eight-month to 12-month into a growth trajectory for NRx’s.

There has been a lot of confusion on how many sales reps we have out, I want to clarify for you this data right here is speak from 42 sales reps, approximately one-tenth of the effort that Sanofi had out there from salesforce reach, frequency and coverage.

We expect this NRx trend to achieve roughly by the end of Q4 where Sanofi ended the year in Q4 2015. So while we have done this with minimal resources, we are excited that we could see that impact in such short amount of time is, I can tell you, having a many salesforces over the years.

It sometimes takes three months to six months for a new rep to make an impact in any geography. The two lines on the bottom I put here for transparency purposes.

It is important to understand we have had about a 20% vacancy rate and that’s due to either medical [ph] lease is absent or because we just didn’t find the right person to hire and we don’t want them to settle.

So you can see in the purple space, we did have a few reps, we saw nice small uptick, but again we put those territories in a vacant position and you see there is no impact in place even though we want to put somebody we didn’t and then we have the wide space, so we never had tension of putting rep at this point.

We will continue reevaluate the wide space as we go into January of 2017, but you can see the drag on TRx is coming from the fact that our NRx is continue to decline as well, TRx is in the wide space, as well as vacant territory.

But where we have put reps this compound effect same prescription grow week over week, we will continue to be what we see driving TRx and the way hanging there from the wide space as well as vacant territories will continue decline as you can see here they are probably less than 25 scripts to 40 scripts a week.

The next thing I want share with you is some early indicators we see which is sample. So we see in the early parts we launch the sample program, there is a huge demand to get samples in office mainly because they were vacant for so long between the transition of Sanofi to us.

That then got supplied, doctor saw those patients and start to use that supply throughout the month of September and October we have seen our sampling request continue to increase.

I won’t say this is 100% due to patients, doctor will start more and more patients, I would also tell you we know in the fall a lot of patients had Part D, don’t know how, and they often use some samples to cover that gap.

However, Afrezza in four unit sample though a sample today is only 30 count and it’s not sufficient enough to cover that gap for most patients, where insulin pens and basal pens they really are sufficient for coverage so that done a whole. However, we continue to see good progress with our sampling, as well as other early indicators.

Next, I want to share with you payor coverage, so we have a lot of request and people suggest me just lower the price of Afrezza. Fortunately/unfortunately depending on the environment you want to look at there has been a significant price increase in rapid acting insulin over the last 24 months since Afrezza was approved.

We have not taken a price increase since launch. That doesn’t mean we never will take a price increase of Afrezza, but it does mean the price gap between meal time insulin and injectables and Afrezza has now been narrowed. So when we do talk the payors the discussion around being overpriced is no longer the primary issue.

The discussion really centers around formulary position, can we become Tier 2 or Tier 3, do we have that prior authorization, and what I show you here is since launch seven out of 10 patients who complete the prior authorization absolutely regardless of our formulary position are approved for Afrezza.

So we are not going to look to just go out and give discounts in an environment where we are getting seven out of 10 patients approved through our MannKind Cares support.

Where you can also see about certain patients are not fulfilled, but we do -- once those patients don’t approved via prior authorization, we do work try to help the doctors and the insurance company and the patient achieve coverage through a secondary prior authorization and/or appeal.

So a lot of time these patients just goes and are fulfill today doesn’t mean they eventually fall in to an approved category. Next, I want show you that our national reimbursement closely mimic to rapid acting market. So almost two-third of our business is commercial, one-third is government and small percentage is cash.

In that government, you probably won’t understand, Medicare is roughly 20% any given week and Medicaid is around 5% to 10% any given week. So we do see about a third of our business continuing to come from government programs, as well as two-thirds commercial.

So our reimbursement and access activities are fully focused on these two segments and making sure we continue to remove barriers to access, we continue to help doctors achieve patients outcomes that they are looking for and we continue to simplify the out of pocket costs that patient experience giving the cost sharing design and help them to continue to grow each year.

And I want to touch on what do we expect as we close our Q4 going into 2017, there is roughly 40 selling days left if not fewer depending on holidays between now and the end of the year.

So while we do have some vacancies, I am not sure it makes sense to fill them and I expect very little impact in a very part of the year by the time these sales reps would get out in the field. So we probably continue to source and recruit talent for January 1 hire date and really set ourselves up for nice trajectory as we go into the New Year.

We continue to have momentum going into Q4. One thing I didn’t say, in last few weeks I am sure you saw some new Rx declines. What’s important to understand in this new Rx declines is we saw double-digit declines in all along the East Coast partially due to Hurricane Matthew especially due to the holidays that occurred in those segments.

We saw declines in the single digits for entire rapid acting insulin class in that same time period. The final thing I’ll tell you about that is we had -- we heard from many of our top customers that they were very nervous to continue to start new Afrezza patients given all the negative noise surrounding MannKind.

Hopefully after today and people realize we continue to expect to be here for the long-term. We will expect doctors continue to reaccelerate that growth and new prescriptions and stabilize what we have seen over the last couple of weeks. So now to think about what the world will look like starting in January.

We expect to expand our salesforce coverage. We will not share numbers exactly at this movement. But the other thing you may not realize is our reps and our nurse educators were hired through a partner called Touchpoint. They are not full time MannKind employees. They are contracted employees through a third-party but they are 100% dedicated to us.

We expect to bring people on this full employment as MannKind employees, which will be critical as you bring on new talent, because we have many cases where we are able to recruit high caliber talent from competition. But they weren’t willing to join us through a contracted organization.

I fully respect their decisions and I am excited to go back out and really get some new talent on the board as we continue to grow and expand our salesforce. The second part people have been asking is when you are going to do commercials.

Well, first, we have to understand exactly what was going on with the titration, was our re-launch going to be successful and are doctors going to adopt it.

Now that we continue to see and have those conversations, the tools to start patients appropriately such as samples and new titration packs at the door, we expect to kickoff commercials in the first half of 2017. We will share with you additional detail on this on our Q4 earnings call if not sooner.

The second part people probably don’t realize is our sample packaging especially for type 2 patients which is the largest market was only four unit samples and inhalers were not included in that, effective today we are only shipping new 60 count samples of four unit and eight unit combination packs and shortly probably as early as December we will launch eight unit and 12 unit combination packs, which will make the patient experience that the type 2 patient significantly better.

I can’t tell you how many times I have talked to doctors who started the patient that it was no longer working and in U.S. and you put why and you see those patients were taking four packs of the dose to get the 60 units and they were taking five packs to get the 20 units, that is not a good patient experience.

We really want to try to simplify and maintain tight control with these new inhalations if possible. So that’s an important dynamic as we go out there. We want resolve before we go ahead and increase our consumer efforts. Next part we are going to be talk about is flex pack which was formerly referred to as the titration pack in [inaudible].

The flex pack has 60 count of four units, 60 count of eight units and 60 count of 12 units. We expect that packaging to hit the supply chain in January of 2017. A lot of doctor are very excited to know that this coming. They believe this will simplify their on-boarding of starting new patients on Afrezza.

And then, finally, now that we have our infrastructure build and our distribution channels at the door and salesforce continue to build the coverage footprint, we are seeking complementary opportunities that will continue to leverage infrastructure, as we know one product sell bags are not always the easiest thing to maintain from an overhead.

However, we do think we can be profitable in the long run with given the model we have, but as of now we can accelerate MannKind growth trajectory by finding opportunities to co-promote and/or collaborate with other products. So with that said, I will turn this over to Ray..

Thank you, Mike. It’s important to remember that insulins are characterized and use clinical based on their pharmacokinetic profile. In this regard, Afrezza is unique among all the currently available insulins. The slow absorption of insulin from the subcutaneous tissue remains to be a limiting factor when they are used.

This is true also for the current rapid acting analogs where their slow absorption does not make normal physiologic insulin accretion. Afrezza does not have these limitations. Next slide, Afrezza has characteristics of an ultra rapid acting physiomatic insulin.

These unique characteristic afforded a key place in a physician [ph] on atrium to treat diabetes. Our recently completed pharmacokinetic and pharmacodynamic study clearly demonstrated Afrezza’s ultra rapid action. Based primarily on these results we have submitted a label change with the FDA.

This label revision will clearly differentiate Afrezza from other existing classes of insulin. Discussions with the FDA are ongoing and we are currently expecting a Q4 2017 approval for the label.

Next slide, now looking at our clinical development program for Afrezza, we recently met with several of our pediatric starring committee members and are working through some potential protocol changes for the PK portion of this program.

In addition, we have identified key partners, which we have announced previous for our pediatric program and they are going to replace and already supporting our activities.

Next slide, the subsequent pediatric Phase 3 trial, which with we will file for pediatric indication, we will incorporate evidence not only from the PK study that we have conducted previously, but as well as data from recent publications.

These publications as you can see on this slide include dosing simulation work and the Afrezza used with the artificial pancreas. The use of Afrezza with the artificial pancreas is impressive and promising, and an area that we are actively investigating.

When you take all of this data around the dosing and titration of Afrezza, it helps to inform us as after the proposed pediatric protocol changes that we will need in the Phase 3 trial, which we believe will substantially improve study recruitment and retention, and thereby, expediting our filing dates.

We are planning for study execution to begin in the first quarter of 2017. Next slide, in addition our post-marketing requirement was the long-term safety study. A long-term safety study is still progressing and we are on pace to begin recruitment in the second half of 2017.

Currently, we remain in discussions with the FDA on some key protocol elements, including the patient pollution to be enrolled. In addition, we have been able to reduce the operational cost of this study significantly and expect this to be a manageable spend once we finalize the protocol and initiate site selection.

Next slide, in addition to our post-marketing requirements, we are also planning on conducting other clinical studies with Afrezza. This is to better define the dosing and titration with the drug especially in new patients.

We recently conducted an advisory board, meeting to identify ways to enhance and simplify the initiation of Afrezza in clinical practice. At the ad board they resoundingly felt that Afrezza’s differentiated pharmacokinetic profile made it an invaluable option for the treatment of diabetes.

Afrezza clearly offers advantage to keep patients within a tight glucose target range, potentially leaning to less hypo and hyperglycemic episodes. To accomplish this, however, the proper dosing and titration of Afrezza is a paramount importance, because this is one of the areas that we have seen where healthcare providers struggle.

To address these issues we are planning a 12-week to 16-week time and range dose optimization study in type 1 diabetics using CGM with Dexcom or the new Abbott Libre system.

This study will be conducted in three to five of the most well-respected institutions in the country, an incredibility to the data and providing an immediate impact on clinical practice. We expect study start up to begin in the first quarter of 2017, where we will results sometimes in the fourth quarter.

Additionally, we are planning a short pilot study for patients with type 2 diabetes that will allow us to simplify dosing initiation and titration. This will help patients get to the optimal dose quickly and effectively.

Next slide, while we have been focusing a great deal of our activities on the near-term goals related to Afrezza, we have not lost sight of what is needed for the mid and long-term success of this company. Our currently candidate is our inhaled epinephrine for the treatment of type 1 hypersensitivity reactions.

We believe that by utilizing MannKind’s innovative inhalation technology, we cannot only deliver effective plasma concentrations, but the addition of the direct effect on the pulmonary system will lead to improve clinical outcomes, an inhaled epinephrine in this setting offer several other advantages over the currently available epinephrine oral injectors.

This will also provide patients and healthcare providers with another option that offers benefits related to convenience, ease of use and costs. We have a pre-IND meeting scheduled with the FDA in early December and our briefing book for this meeting has already been submitted.

I will provide further updates on out type 1 and type 2 study concepts that I just articulated, as well as our epi program on our fourth quarter earnings call. With that, I’d like to turn the call back over to Matt..

Thank you, Ray. So, in summary, for the third quarter we began reporting commercial sales and significantly cleaned up our balance sheet, recognizing many items that have previously been deferred, while creating the ability for us to extend our launch runway.

Subsequent to quarter end do not reflected in these results, we announced today an important agreement with Sanofi providing near-term cash and improving our overall financial position by over $130 million.

We also announced today the completion of our revision to our largest supply agreement, pushing out our next purchase commitments to the fourth quarter of 2017 and reducing our contractual cash burn under that arrangement by $65 million for the period of 2016 through 2018 compared to the prior contract.

As a result of these items and steps taken previously, we have extended our financial resources comfortably into the third quarter of 2017. [Ph] Continuing the (43:11) matters of the finish line today took significant work and extraordinary efforts.

And I want to thank all those involved in finalizing these two agreements during the course of the last several hours. Additionally, we’ve reported progress on the commercial side, as Michael said, we have learned a lot since we re-launched Afrezza.

We confirmed the Afrezza is promotionally sensitive and planned to expand our sales efforts to grow sales more quickly, where we believe we will have an impact. We also plan to expand our targeted direct-to-consumer advertising to now include television.

We continue to have success in our partnerships with payors such as our contract with Express Scripts, which covers approximately 50 million lives on commercial and Medicare Part D, and now being covered with no further prior authorizations required.

Next slide, on the development side, we have filed in our discussions with FDA regarding an improvement to the Afrezza label and we will keep you informed as this develops.

At the same time, we are investing in our future clinically not only by starting our pediatric clinical studies in Q1, but also additional studies to better demonstrate the advantages of Afrezza, Afrezza’s PK and PD profile by focusing our near-term investment in the starting and titrating the product quickly and effectively with CGM and/or standardized dose titration schedules.

We are also making progress with our inhaled epinephrine program. As Ray mentioned, we will be meeting with the FDA next month to agree on the path forward to approval, we will have a lot more news once that has been accomplished. We think time is right for simple and affordable alternatives in the FB market.

We also continue to make progress in our receptor life sciences collaboration and we’ll achieve certain predetermined tactical objectives later this month. MannKind remains committed to assuring Afrezza’s place as a leading meal time insulin for people with diabetes.

We know Afrezza disrupts the status quo but as doctors continue to start patients and see them return with success, their own confidence to prescribe will continue to increase. So, with that, I’d like now open the call for questions.

Operator?.

Thank you. [Operator Instructions].

We are having a technical challenge. So I am asking everybody for bear us, we seem to be having some technical issues getting our question queue organized and pop me in and out, so bear with us for a moment and we will be right there. Okay….

And our first question, sorry, our first question comes from Stephen Weil from Oppenheimer. Please go ahead..

Yes. Hi. This is Steven Weil. MannKind Corporation has many patents for various products [inaudible]. Can you give us any information on things other than Afrezza and the epinephrine..

Yeah. We’ve done that multiple times before, I can ask, Ray, if he wants to talk them. We actually, I am laughing a little bit to myself, because Ray, actually had a section answering that very question, which we removed, because we thought the presentation was running little long and we had some other things to talk about.

So, Ray, do you want to say couple words on that topic?.

Yes. Certainly, so we have a range of compounds in development, slightly more than 10 on the list, some include NCEs related to sort of pain management, others are B2 type of drugs, which we’ll be looking at, some are related to diabetes such as Symlin, for example, others are related to other disorders like parathyroid hormone, for example.

So we have -- we do have a fairly extensive portfolio that we are still looking at to leverage, our innovative oral inhalation technology and the pharmacokinetic profile that will provide. We believe we’ll have several compounds in development in 2017..

Thank you..

[Operator Instructions].

Once again I’ll ask everybody to bear with us a little bit. Our typical practice is always been to, we have so many retail investors, it’s impossible to take all the retail investor calls, and so we’ve tried to limit calls to analysts and 5% or more stockholders, and such as that.

Today we’ve seem to be getting varied and private investor calls, so we are having little troubles weeding out the other ones. We are getting some questions coming through online now, so while we try to work this out, I guess, since Michael is good enough to hand a couple of it to me right now, I can try to address them.

One of the most frequently asked questions they are coming through on the online we ask has to do with delisting. I am not sure what exactly to say about that. I am not terribly concerned about delisting, I think, the news today we’re long way to solving that problem.

It’s not going to be an issue till sometime in like the second quarter of next year by which point we have -- we expect to have a lot of this accomplish that will make this whole issue go away. But I can tell you that a reverse split or such as that has not currently on the table. Doesn’t mean we never consider if we came to that.

But, currently, we have no plans to do it. And I am hoping our dramatically improved financial position will help resolve some of this issue.

I also have question comes through related to some confusion about our cash position and what cash is actually available, so I’ll try to answer that one, because I have actually seen that misrepresenting a bunch of times, because many talk about a requirement under the Deerfield debt agreement that we maintain $25 million worth of cash, and I say, we will take it down to as we work into the quarter, $35 million, that means you really only have $10 million available.

That’s not actually true. The way that debt agreement was structured is that included not only cash, but also available burrowing. So as long as we have $25 million or more available from the Mann Group, for example, we don’t have to maintain a minimum cash balance under that agreement. So were we able to work out our other issues. No.

It looks like we are done. So, well, with that, I want to thank you all very much for joining our third quarter call.

Before I do close, I wanted to acknowledged World Diabetes Day on Monday, November 14th and encourage people associated with MannKind to join me in supporting the diabetes community by making a donation at the ADA or JDRF, participating in a local walk for diabetes or simply by supporting a friend or family member with diabetes.

Together we can change lives. So thank you again for your support..

Thank you ladies and gentlemen, this concludes today’s conference. Thank you for participation and you may now disconnect..