Ladies and gentlemen, thank you for standing by. Welcome to the MannKind Corporation 2016 Second Quarter Conference Call. My name is Sherry and I’ll be your operator for today’s call. [Operator Instructions] Please note that this conference is being recorded. Joining us today from MannKind are Chief Executive Officer, Matthew Pfeffer; Chief Commercial Officer, Michael Castagna; Chief Medical Officer, Raymond Urbanski; and Principal Accounting Officer, Rose Alinaya. I would 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 8, 2016. We undertake no obligation to revise or update any statements to reflect events or circumstances after the date of this call. I’m 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 whose 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. These included transitioning ongoing clinical programs back to MannKind, setting up a medical information request system, developing a pharmacovigilance program, transitioning the safety database and setting up an adverse event reporting and tracking system, transferring all the NDA paperwork and other documentation and so forth. Tremendous undertaking. At the same time, we were negotiating a transition agreement with Sanofi to ensure that Afrezza would continue to be available until we’ve built the capability to manufacture and distribute the product ourselves. All this was completed in time to transition the project back to us on April 5 of this year, as planned. Next, we had to build from scratch our commercial infrastructure, including hiring 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 supplier-owned 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 a sufficient runway to get us…

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 same quarter in 2015, largely due to the restructuring measures taken in 2015 following the completion of Afrezza registration trial. 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 cost of $3.7 million for the second quarter of 2016. We expect product manufacturing cost 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…

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 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 2015 and stabilize that during the month of July. For those who 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 [indiscernible] system launching around the world [ex-US] as well as the Dexcom FDA hearing last week, which looks like that’ll have a positive outcome, the ability for patients to see their highs and lows on a daily basis every five to 10 minutes is now becoming a reality. That will allow our patients to pursue a next fold here to measure their timing range for tighter control. Patients often struggle with highs and lows of diabetes on a daily basis and we often don’t know what an average is as you look throughout the day. But the new technology 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 activity pretty quickly when you’re using this technology. The third thing that we see is patient engagement in their health is shifting [indiscernible] and deductible plans continue to become…

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 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 Stephen 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.