MannKind Corporation (MNKD) Q2 2015 Earnings Report, Transcript and Summary

Ladies and gentlemen, thank you for standing by. Welcome to the MannKind Corporation Second Quarter 2015 Conference Call. At this time, all participants are in a listen-only mode. Later, instructions will be given for the question-and-answer session. [Operator Instructions] As a reminder, this call is being recorded today, August 10, 2015. Joining us today from MannKind are President and CEO, Hakan Edstrom; and Chief Financial Officer, Matthew Pfeffer. I would now like to turn the call over to Matthew Pfeffer, Chief Financial Officer of MannKind Corporation. Please go ahead.

Good morning and thank you for participating in today’s call. I’ll discuss our financial results for the second quarter of 2015 as reported this morning, elaborate on the August 15 convertible notes strategy, and then address a number of key investor relations questions I received. I’ll then turn the call over to Hakan for a review of our Afrezza business and the company’s development portfolio, as well as an exciting announcement regarding our executive team. 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 the actual results could differ from these stated expectations. For factors, which could cause actual results to differ from expectations, please refer to the reports filed by the company with the Securities and Exchange Commission under the Securities and Exchange Act of 1934. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast August 10, 2015. We undertake no obligation to revise or update any statements to reflect events or circumstances after the date of this call. Now, turning to the financials, the net loss for the second quarter of 2015 was $28.9 million or $0.07 per share, compared to a net loss of $73.4 million or $0.19 per share for the second quarter of 2014, and $30.7 million or $0.08 per share for the first quarter of 2015. Total operating expenses declined $45.7 million compared to the same quarter in 2014, reflecting the commercialization of Afrezza in 2015 and reduced non-cash stock compensation expense. The slight increase of $2.4 million in total operating expenses for the second quarter of 2015 compared to the first quarter of 2015 is primarily due to increased product manufacturing cost in the second quarter of 2015. Research and development costs were at $7.7 million for the second quarter of 2015, a decline of 79% compared to the second quarter of 2014, largely due to reduced non-cash stock compensation expense. R&D expenses decreased by $1.7 million compared to the first quarter of 2015, mainly due to decreased clinical expenditures resulting from the reduction in clinical staff. General and administrative expenses were $10.6 million for the second quarter of 2015, a decline of 67% compared to the second quarter of 2014, also primarily due to reduced non-cash stock compensation expense. G&A remained stable quarter-over-quarter in 2015. For the second quarter ended June 30, 2015, our portion of this loss sharing agreement with Sanofi relating to Afrezza was $12.8 million, which we subsequently financed by a way of an advance under the loan facility with our partner. The amount outstanding under the Sanofi loan facility is now $28.4 million. For the three and six months ended June 30, 2015, Afrezza product shipments of $5.9 million and $13 million respectively were recorded as deferred product sales from our collaboration with Sanofi. Cash and cash equivalents were $107.2 million at June 30, 2015, compared to $120.8 million in the first quarter of 2015. In addition, we have $30.1 million available to borrow under the amended loan agreement with The Mann Group. This week on August 15, the company’s $100 million senior convertible debt comes due. As announced on July 29, 2015, MannKind entered into privately negotiated exchange agreements with select holders of these 2015 notes, which resulted in us exchanging $27.7 million aggregate principal into the new 2018 [ph] notes. We also agreed to issue shares of common stock in exchange for up to $56.9 million aggregate principal amount of the 2015 notes. At this point, we are still in the midst of exchange period for these shares. Until this process is complete, I cannot predict how many of these conversions will occur. You will see that we’ve taken some steps to maximize the number of conversions that will be announced shortly. We have not been willing to compromise on share price. Whatever remains outstanding will be paid from our substantial cash reserves. I may now take a few minutes to discuss our strategy surrounding our convertible debt. First, I’ll comment on the technical nature of secondary offerings versus share dilution. Some of you will remember that I said, we were considering various alternatives to address the notes, but then secondary offering of common shares was not one of them. That statement was intended to signal to those shorting MannKind stock that they would not likely get an opportunity to unwind their position by purchasing stock in the secondary offering. I did not say that whatever solution we came up with would require no dilution, as convertible instruments by their nature are dilutive. Share issuance for the convertible debt can be deferred, but most analysts treat those shares as outstanding from the time the convert is issued. With that in mind, the stock and note exchange was structured with a couple of goals in mind. First, we wanted to minimize ultimate dilution with a goal that we would not issue materially more shares that were already underlying the convertible instrument. Second, to the extent the holder of the notes willing to extend them, we’d be willing to do so, but only if the holder was a fundamental holder that do not hedge the position. We were not willing to consider setting up a new borrow facility to support the new notes. And finally, we want to be sure that the final terms enabled the old notes to go completely away so that MannKind would be certain to get back the 9 million shares lent to the underwriter in the previous transaction. Should these shares would have to be repurchased in the open market after maturity and would be returned to us removing them from circulation, we like to think that any shares we ultimately issued as being net of these shares coming back. As such, we expected we can remove the convertible notes while issuing only a few million shares thus, net that is thus minimizing dilution. As some of you may be aware, the SEC tend to offer rules would apply in the event that we sought to approach all holders in the notes, the most of the larger holders that are already been in touch with us or bankers. So we were able to structure agreements with the holders of roughly 85% of the outstanding debt. Of that amount, approximately 27 million of the notes were rolled into new three-year notes with terms similar to the old notes, with slightly more MannKind-friendly conversion terms, including no borrow facility, so it’s not a facility short-selling. Of the remaining notes, agreements were reached with investors holding over 58 million for potential exchange into common shares. This was then to conserve cash, but that was not our only consideration. Because we’ve found ourselves so often subject to share price erosion in these circumstances, we want to make sure we would under no circumstances issue shares at a volume weighted price before discount, based on a percentage below market at the time we agreed on the ultimate deal. This was to cap our potential dilution at a very small number as subscribed above. Certainly, we are not going to exchange shares based on a price lower than approximately $4.60 at that time. Now, I would like to move on to some frequent questions I received from the investment community. As you know, we routinely take questions from the callers at the end of our quarterly presentations. Out of necessity, we limit these questions to covering analysts and major stockholders, which we defined as being 5% or great a holder. This is intended to keep the call at manageable length. While we cannot answer every question a retail stockholder might have, I want you to know that I do get all your questions. My schedule doesn’t allow me to contact each of you back individually, but I want to answer some of the more common questions here, particularly those our analysts might not cover. First, I’ve gotten a lot of inquiries regarding Sanofi’s recent investor call, focused on concerning that Sanofi did not discuss Afrezza. It is essential to understand that this was not a surprise to MannKind that Sanofi is a $35 billion plus worldwide company, and the call is intended to address their global operations. The call should no way be interpreted at any form of lack of support or a lack of belief in the product. Hakan will comment on several items that demonstrate Sanofi’s commitment to Afrezza. In addition, the joint MannKind Sanofi joint Afrezza committee recently approved a major increase in promotional spending for Afrezza over what was previously budgeted. More specific details on specific promotional spending is proprietary and will be managed by Sanofi. Second, a writer named David and I’ll spare the rest of his name, sent me a note Friday typical of many others I have received. In it, he recounted a lot of anecdotal information regarding the widely reported successes people have had using Afrezza to dramatically lower their HbA1c numbers even while eating food they could not before, yet avoiding complications and greatly improving their lives. He suggested that we use such patient testimonials on calls such as this and in Afrezza advertising. He further suggested that we e-mail every diabetic and doctor in the U.S. and suggest do their diligence to look into Afrezza which leads to these testimonials. The problem with this suggestion is that, it is not allowed by the FDA, as advertisements and public reporting of patient results may only be as a result of a controlled FDA approved study. Such anecdotal information is not allowed to be used by us to promote the product. I’m happy to suggest that everyone consider using Afrezza and to do their own diligence, including information located on afrezza.com. And if you’re amongst those using it and happy, please feel free to share your experience with your doctors and your friends. MannKind’s efforts must stop there. Third and most relevant to our stock performance, I’ve gotten in many, many calls requesting that we quote – do something about the short position on MannKind stock. Please understand that the Securities and Exchange Commission, not MannKind is the organization that manages public markets in the U.S., and currently the SEC allows holders of shares to lend them, making them available for shorting. Here’s what I can say the company has done regarding shorting of MannKind stock. Within MannKind, employees are not allowed to hold shares in an account where they can be lent, which certainly means shares must be held in a cash account, not a margin account. If any non-employee shareholders are unhappy about the fact shorting on MannKind’s share price, I strongly encourage you to make sure you’re not enabling the practice. Talk to your broker and make sure your shares are held in an account that doesn’t support lending. This is particularly important right now, as we swap stock for bonds. I believe the effects on your stock price this may cause will be worth much more to you than whatever you might get in the near-term for stock lending. On a related topic, I do get questions about possible stock manipulation be the practice of naked shorting, publishing spurious articles online and so forth. Any discussion of stock manipulation is the purview of the SEC, not MannKind. I do know for a fact that they are aware of this issue and are looking into it. MannKind remains wholeheartedly focused on seeing our flagship product Afrezza, reach the widest possible market for the improvement of diabetics health worldwide, while finding new Technosphere applications to build our product portfolio. To paraphrase our Chairman, Al Mann, we must always concentrate on taking care of the patients, and the stock price will work itself up. I hope that answers a few questions. And with that, I’ll bring the Finance and Investor Relations section to close and turn the call back over to Hakan. Hakan?

Thank you, Matt, and good morning. I will now transition to review and update on MannKind’s manufacturing operations, the Afrezza business, and MannKind’s development program plans. But let me begin with an exciting announcement regarding the MannKind’s leadership team. I’m pleased to announce Dr. Raymond Urbanski, has joined MannKind as Chief Medical Officer effective today. Ray, come to us within impressive clinical research and pharmaceutical industry expertise across oncology, cardiology, endocrinology and immunology. He’s led the development and approval of numerous new drugs and new indications across several therapeutic areas. And I’m confident, he will help accelerate our development efforts and do the same for us. Ray has held CMO roles at Mylan and Metabolix. Previously he was Vice President at Pfizer, and Vice President and CMO at Suntory Pharmaceuticals. He earned both his MD and Ph.D. in pharmacology and toxicology from the University of Medicine and Dentistry in New Jersey at New Jersey Medical School. Dr. Urbanski is a critical hire for us, as we aggressively move forward to exploit the Technosphere technology in new therapeutic areas. We are excited to welcome Ray to our team. Now, I will speak to manufacturing in our Danbury, Connecticut facility. As announced on July 31, 2015 production lines two and three have been successfully validated, increasing our production capacity and providing manufacturing redundancy to ensure supply to Sanofi. Concurrently in this effort we have completed all validation work in support of commercial manufacturing demand of the Afrezza 12 unit cartridge strength. This would allow us to cover a greater patient population, especially those who need a higher doses cartridge. And it will also minimize multiple inhalations for some patients. You will see this cartridge offering being introduced to the market by Sanofi during the next couple of months. And while I’m on the topic of cartridge strength, I can say that MannKind and Sanofi have both heard market input about a possible two unit cartridge. Currently, our joint clinical committee is validating the rationale for this size. Our Danbury manufacturing lines would support such a cartridge strength, so from a technical development viewpoint, it is very feasible. And then now, I want to talk about the status of our four post-marketing Afrezza studies required by the FDA when Afrezza was approved. As I mentioned in our last call, the draft protocol for the four studies have all been submitted to the FDA. And now, I can report significant progress on each study. First, the pediatric study protocol has been approved and will begin screening patients by September of this year, as all vendor and site contracts will be finalized this month. The second study on dose range is now fully enrolled and the trials are expected to complete in the first quarter of 2016. The third study on within-subject variability is underway and subject dosing should be completed in the fourth quarter of 2015. The protocol for the fourth and final study on the five-year pulmonary safety received comments and recommendations back on the FDA in July, which are now being reviewed by the joint Sanofi and MannKind clinical team. Discussions are expected to be held with the reviewing division of the FDA to further clarify their recommendations and provide our comments back. That study is planned to begin in early 2016. So, in summary, we are pleased to note that the strong progress has been made in meeting the FDA post-marketing study requirements for Afrezza. And we note that Sanofi continues to support the partnership by coordinating and leading all efforts in this key ongoing activity. So now, let’s turn to the sales and marketing efforts for Afrezza. During the last quarter, we have seen more patients successfully transitioned through the introductory requirements and reimbursement process to begin using Afrezza. Total and new prescriptions show consistent month-over-month growth. In addition, the patient community showed an enthusiasm for Afrezza that is so convincing that there should be a little doubt of the ultimate success of this unique brand of insulin. Users are reporting outstanding treatment result and sharing their positive Afrezza experiences with the diabetes community via social media, speeches, and media interviews. The availability of the 12-unit cartridge discussed earlier is just one of several marketing in these sales and marketing initiatives being implemented by Sanofi in the second-half of 2015 that we trust and believe will build on this momentum of patient’s endorsement and accelerate the uptake of Afrezza. Let me briefly outline some of these activities for you. First, the direct to consumer advertising campaign is now underway with featured print ads for Afrezza beginning in July in high circulation media, including the Time magazine, Diabetes Forecast, and other widely distributed media that reach our target audience and there’s plenty more on this horizon. Also, Sanofi recently expanded the number of sales people promoting Afrezza and efficient targets for the sales force, as well as launching a targeted in-office promotion. Sanofi has also launched an expanded consumer website afrezza.com, as well as afrezzapro.com website for physicians, both which have been positively received them. Sanofi has introduced the Afrezza COACH program, which house patients with their overall diabetes management, providing access to an online or in-person educational session laid by the certified diabetes educators. Sanofi has also expanded the Sanofi Patient Connection program to include prior authorization and benefits verification support. Importantly, Afrezza data is being published in peer-reviewed journals and getting in front of physicians. Both of our recent Phase 3 pivotal studies 171 and 175 have now been published electronically in diabetes care with print versions to follow. This is important, as it allows Sanofi’s medical liaison staff to more freely discuss the excellent results seen in those studies with their fellow doctors and potential prescribed Afrezza, such as improved hyperglycemia, less weight gain, better fasting glucose levels, et cetera. There is little doubt that the speed of market adoption has been significantly impacted by the introductory requirements of spirometry, the 10-day sample period, and probably most importantly the process of securing insurance coverage, including in many cases prior authorization requirements. Sanofi has made excellent moves to address the spirometry requirements and our research shows that it’s no longer a critical gating item. But insurance coverage continues to slow the process. At this point, permanent formulary placement decisions have not yet been made by most plants. These decisions are typically made 6 to 12 months following the launch. The good news is that, we are now in that period, and Sanofi’s discussions with managed care organizations are ongoing, and we expect the insurance coverage and patient access to improve. Sanofi is focused on resolving all of these issues, while continuing to build market awareness and patient access to Afrezza. These issues are typical to new product introductions, once they are addressed, I expect adoption by patients to increase rapidly. It is also important to note that the Sanofi MannKind partnership and management teams are prepared to continue investment in support of the Afrezza launch, as demonstrated by their efforts previously detailed. The important takeaway is that, once we reach the patients with Afrezza, they are very pleased with the results, show strong loyalty to the brand and are excited to share their positive outcomes. MannKind continues to expect that the medical and lifetime benefits coupled with user loyalty to Afrezza to translate into greater adoption numbers in the rapidly increasing sales over time. Now, let me turn to our development portfolio. We made progress in the two key initiatives discussed in our last call: first, the pulmonary hypertension; and second, pain management. Our program in pulmonary hypertension has entered the technical feasibility phase, during which we prepared for the dry powders and evaluated their aerodynamic properties, stability, and other characteristics. We expect these activities will take about six months or so, before we will have powders that can be evaluated in animal models. The pain management program is focused on the product that is intended to manage moderate-to-severe acute pain and is also in the technical feasibility phase. We have already prepared several prototype powders to formulate around a small number of active pharmaceutical ingredients or API, and we have evaluated some in preclinical models. The results have been actually very encouraging so far. The focus now is to select the optimal API and move to Investigational New Drug or IND-enabling studies. Behind these programs we identified a short list of additional product candidates for which development plans are being drafted and commercial business opportunities models. The hiring of Dr. Urbanski as Chief Medical Officer is the key step to manage these and all future new product development efforts and we look forward to providing more detailed update in our upcoming calls based on Dr. Urbanski’s work. Lastly, I want to call attention to MannKind being part of saving life at birth, a grand challenge for development program sponsored by the Gates Foundation. It was announced that the Mintaka Foundation for Medical Research was an award recipient for innovative solutions to prevent maternal infant deaths in hardest to reach regions of the world. The award recipients were selected from more than 750 submissions. The Mintaka grant that powers MannKind’s effort for dosage form development was based on work performed at MannKind to develop a highly heat-resistant and noninvasive formula of oxytocin to reduce maternal death due to postpartum hemorrhage. We offer congratulations to the members of our clinical team who contributed to this research. So in closing, MannKind is undergoing a very exciting period in the company’s history. We are seeing our flagship product Afrezza gain market visibility and be described as life-changing by diabetic users. We are watching our Afrezza work in Sanofi make great strides in the sales and marketing of this revolutionary product. We have exciting new product developments underway based on our patented Technosphere platform. MannKind continues to focus on innovative technologies that solve patients’ needs. And we thank you and the diabetic community for the tremendous support of our efforts. So thank you for your time today. So, operator, we are now ready to proceed to the question-and-answer session.

Thank you. We will now begin the question-and-answer session. [Operator Instructions] And our first question comes from Adnan Butt from RBC Capital Markets. Please go ahead.

Hey, good morning. Thanks for taking the question. First, Hakan, that – product shipments have increased, MannKind also announced expansion of the Afrezza supply lines. Is that something that the companies are seeing, or is that part of a pre-agreed-upon expansion? Can you expand a bit on the rationale behind expanding supply?

Well, a part of it is certainly a critical component is to be able to start the manufacturing of the 12 unit cartridge. We needed to add a line beyond what we had. So from that point-of-view in building kind of the commercial capacity for us it was important to add these two lines to the existing line that we had.

And can you – so would you be able to say anything more about the commercial efforts? Is the sampling program still ongoing and in terms of the supply, how much of the supply is going towards the sampling program?

I don’t have a specific number for you and the sampling program is certainly ongoing. And we are supplying the need from the sampling program’s point-of-view. So, yes, particularly since Sanofi decided to expand the target physician targets, so with those also to get them and get them familiar with the opportunity to try out Afrezza, yes, the sampling program is still underway, and it’s actually quite active.

Okay. Just a couple more, and then I’ll get back in line. I think in the prior calls, it was mentioned that the pulmonary function test and scheduling the appointments was a gating factor. So how has that flow improved since the last update?

Yes, let me take that one, Adnan, because I recently saw presentation on that very topic from our partner.

Okay.

So, it’s not an issue that’s completely gone away. But they track very closely the number of doctors who have this equipment, or have ready access to it, or they’ve set up some interesting programs to provide access to this kind of equipment, or this type of work quickly and easily and simply for the doctor. And based on the statistics they’re tracking now, while it’s not completely gone, the numbers were still an issue or small enough that it isn’t believe that it’s significantly impacting our sales. The sales get high enough and get pervasive enough, it may have to be readdressed, but we’re not quite there yet. So at this point, that doesn’t seem to be the issue that’s holding things up very much. It slows things down, but it’s not a blocking issue [Multiple Speakers] prescriptions.

So, Matt, in your view, sorry, in your view at this time, the bigger hurdle is permanent formulary inclusion, or is it the PFG?

It seems to be insurance coverages is a bigger factor than they switch around. I think it started off the opposite and now it has become more insurance reimbursement issues. So the good news is, we’re right in the midst of – it’s a typical process that you don’t – as Hakan mentioned, you don’t see a review of these permanent formulary placement until, at least, six months and often 12 or sometimes even longer until that you get permanent formulary placement. So we’re kind of coming into that period. Now, most of the plants have not made that determination, but they should over the coming months, and that should make things simpler. We hope – we don’t, we can’t guarantee where we’ll end up in the formularies. But the current practices were a small number of plants don’t cover at all and the majority will put it into two or three, but require significant restrictions usually in the form of prior authorization is a big pain in the neck frankly for everybody concerned, and if we can ease some of those things, that will have a significant impact.

And then lastly, when did the DTC campaign begin? And I think you mentioned it might be broadened, so what would be the scale of broadening it? Thanks.

Actually, I think what was said was, it would be – it’s going to continue. We have to be a little bit careful about what we say. It just started. It’s been in a few different publications, mostly print at this point. We have said there is money budgeted for TV production, but I won’t expect it to do at anytime real soon. It’s – we always – Sanofi was always pretty open that this was going to be a focused and stepped sort of process, and we’re kind of coming into step two with DTC and broadened sales force efforts and position targets and so forth. So we’re kind of coming into that second phase, it only started a few weeks ago. So certainly, we haven’t seen the impacts of it yet. But obviously and it could take some time yet, but we do expect to see those eventually.

Okay. Thanks.

Thank you. And our next question comes from Cory Kasimov from JPMorgan. Please go ahead.

Hey, guys. This is actually Brittany in for Cory. Thanks for taking the questions. So I understand that you said the adoption of Afrezza, obviously, take time. Just curious what your thoughts are on when we can see an inflexion point? And then just wanted to get a sense of your thoughts on your current cash runway was only $28 million left under the Sanofi agreement? Thank you.

So, well, let me address that last one, because it kind of startled me when you said. We actually have quite a lot available under the Sanofi agreement. It was intended to go up to $175 million, which we thought at the time was an outlandishly high number. But clearly, we pick that, so people wouldn’t have any concerns that we would run out of cash under that agreement. So I’m not sure, where we confused you with the numbers. We’re just talking about what was outstanding about the total amount that was available. And I’ll leave the other part of the question to Hakan?

Yes, it’s hard to give you a specific inflexion point. I mean, certainly we’re doing, say, the DTC campaign right now and the expanded target in terms of an increased sales – the number of people on sales-force promoting Afrezza and going to more doctors. So hopefully that will translate into certainly a faster uptake by the patients and also if we can address more of the reimbursement issues and getting more – better and confirmed placements, that should accelerate. But I would say that you probably still are looking in, I would say, hopefully during the, say, late September through the end of the year you would see a significant uptick in terms of the uptake.

That’s always really hard to predict. We can see the factors that we think will cause that uptick you’re talking about, but translating that is when you see it in script numbers is a little harder, because we’ve already shown that there are factors in place that slow down the actual receipt and the filling of the prescriptions in our case, including spirometer requirement, which is we don’t see it preventing the prescriptions any longer. But it does still slow it down, so all these things tend to make it harder to predict exactly when you see that uptick. It could be faster or it could be slower. We’re obviously optimistic. A lot of it will also depend on the degree to which words spreads and the fantastic results people are seeing become more widely known which could accelerate it. So there’s a lot of wildcards here, then – we’re keeping our fingers crossed and hoping it’s sooner rather than later obviously.

Yes, that’s helpful. Thank you.

Thank you. And our next question comes from Jay Olson from Goldman Sachs. Please go ahead.

Good morning, guys. Thanks for taking the questions. I had a few. Starting off with the product shipments, you had $7.1 million of Afrezza shipments in the first quarter, and $5.9 million of shipments in the second quarter. Can you just help us understand why it declined? Was there some initial stocking that took place in the first quarter? And I’m assuming that those product shipments are mostly going toward samples. Does it mean that Sanofi is giving out fewer samples?

No, I think it’s exactly what you said, Jay. Obviously, we needed to fill the channels initially, so we filled them up and including a lot of samples which were delivered, for the most part, upfront, and then it becomes more of normal course replenishment.

Okay. And then just on the refinancing, you spoke about offering certain bondholders conversion to equity. Can you talk about what percent of those bonds would – or have been today converted to equity?

No, I think it’s premature, because we’re right in the middle of it, and I don’t want to jinx the process by saying anything prematurely. Once it’s completed, we’ll be in a position to be more specific about that.

Okay. And then, thanks to Hakan for the additional color on the development work in your pipeline. It sounds like pulmonary hypertension is the lead program and you mentioned it would take six months to get into animal models. How long should we think about it taking to get into clinical studies? And when might we expect you sign a partnership for that program?

Oh, well, this gets into, say, qualified guessing. I would say and certainly this is why I certainly welcome Ray Urbanski onto our team, because he can certainly help us make a much better assessment. But I would assume that after we’ve done the initial component, I mean, I would hope that within the next, say, 12 months, so maybe about 18 months from now, we would be in some type of clinical assessment of the product. And the reason I mentioned that first, this was one of the programs that came out of the kind of major undertaking we did with a consulting company in looking at areas and came out of that one. And the API is readily available; it’s in-house. So from that point-of-view, yes, we’ve been able to pursue that aggressively and we’ll certainly continue to do so.

Yes, Jay, the only thing I would add is maybe correcting a little bit your statement, has that been the lead program, I think that’s – I’m not sure that’s a fair characterization. In some ways it perhaps is, but if you note from Hakan’s remarks, the other program in pain has actually been in animals already, so it’s a bit ahead in that regard. But that one is a little different because we have multiple APIs we’re evaluating. We haven’t selected one yet and all of us coming from that animal model preclinical, pre-human work, but that’s already underway.

Okay. Great. Thank you.

Thank you. [Operator Instructions] And our next question comes from Keith Markey from Griffin Securities. Please go ahead.

Good morning and thank you for taking the question. I was just wondering if you can tell us a little bit about your Sanofi’s plans for expanding Afrezza into international markets?

Oh, Keith, I’m actually really glad you asked that question, because we get that one a lot too. I can’t be terribly specific, but I can tell you that this is a very active area of discussion and investigation for them. They have spent a lot of time and probably a lot of money, although I haven’t seen those members, doing market research in the various countries of the world. And they’re really intending to do this as a global marketing plan as opposed to picking out an area like I get – we get a lot of questions about Europe, for example. They want to look at Europe in the context of the whole world. And so, that work is underway, it’s nearly the completion we understand, and it’s anticipated to be presented to us at our next during Afrezza committee meeting. So we’re all looking forward to that as well. But I think we get a lot of inquiries about it. I know, they’re interested in as well. So we’ll have to stay tuned. I can’t give you specifics at this point, except to make sure you it’s something we’re all looking forward to.

Thank you. And I had one other question. I was just wondering, not too long ago, some of the larger players that have already established in the diabetes space created or signed deals with some of the insurance companies regarding exclusive rights to – for their formularies. I was just wondering has that posted much of an issue for Afrezza in getting listed on the formularies so far, or do you anticipate that being a problem?

Well, Keith, I feel like I might be able to answer your questions very forthrightly. We know it clearly is an issue. I know that – I don’t want to tip our hand too much, but I know Sanofi has some strategies for dealing with that. And given that most of the larger players haven’t come to decisions, I’ll see how successful they are. But, yes, it certainly is an issue, we’re aware of it, and we have strategies to deal with it and stay tuned.

Okay. Thank you.

Thank you. And our next question comes from Shaunak Deepak from Jefferies. Please go ahead.

Hi. Thanks for taking my question. I just wanted to know a little bit more about Sanofi’s efforts to increase marketing? And if you could provide a little bit more about the decile of prescribers that they are looking to reach with their current sales force?

Yes, basically, initially, the target was endocrinologist and I mean, very, very, kind of high, say, diabetic prescribers in kind of general physician community. I think we’ve demonstrated to them and they’ve also realized that, we’ve been contacted by the number of patients that have been trying to obtain Afrezza prescriptions with their physician and their physician based on, say, the profile and their prescribing have – may not have been part of the target group. So this is a way to expand the reach out to more physicians to more kind of GP-type, again, higher prescribing physicians in reaching out. So that is ongoing right now and there’s actually also a specific plan in place by Sanofi in bringing their people together to further put emphasis around this one. So that’s as much as I can say at this point in time.

Okay. Thank you. And then just on the DTC effort right now, I was wondering if like what we’ve seen so far in terms of the print advertisements and publications you guys are reaching, if that’s something which we should consider reflective of like DTC effort for the foreseeable future before a possible ramp up into television and so forth?

Well, I’m going to try to answer that. I guess broadly, yes, but I mean, I’m not going to run the same answer over and over every time. They – I mean, they’re pretty good at the stuff and they have a lot of interesting plans, and I think it would be a mistake to talk about them in too much detail in it.

Yes. I mean, it certainly is a significant DTC effort over a number of media, whether it’s magazines, online and other approaches. So it is a significant batch of programs and activities that you will see, I would say, over the next quarter, before any type of, say, TV would be considered. The decision there by the, say, joint management team is that the investment into producing a, say, commercial would be taken right now, and then eventually they will have to sit down and make a determination of when it will be appropriate to utilize that as part of the promotional programs.

And I’m really glad Hakan mentioned the online stuff, because that’s often overlooked and maybe underemphasized, but that’s a really important area to focus in, and I know Sanofi is very active there. And I want to – if you haven’t seen already, you will start to seeing that more and more, because these days, people rely on online things to find this kind of information much more than they used to. So it’s a huge focus area. It isn’t as visible as, say, a three page spread in Time magazine; it’s easy to point you. But it’s one of the bigger areas we’re focusing on.

Right, right, great. And also as I had mentioned, it is targeted by – in some of the doctor’s office, as you sign in, you basically are entering a kind of an electronic kind of registration process. And there again, Sanofi is out right now in, say, producing, say, promotional messages as part of that one. So there is – even in the doctor’s office there is the reminder of the fact that patients, hey, there is a new approach here, that you might be able to address in terms of dealing with your diabetes. So they are, I would say, playing on many different instruments in trying to reach both physicians and patients?

All right. Well, thanks for the color.

Thank you, Shaunak.

Thank you. We have no further questions at this time. I will now turn the call over to Mr. Hakan Edstrom for closing remarks.

Right, right, well, thank you so much for listening this morning as you hopefully will hear that we are aggressively pursuing certainly both the Afrezza part of our business which is certainly very, very critical; and we are encouraged by the efforts that being put forward by Sanofi in bringing that to a really successful – not really conclusion, a successful going forward into the future; as well as the – or now much higher emphasis on the new product development components utilizing the Technosphere platform; and the hiring of Dr. Urbanski, which I see as a significant component. And we will continue into recruiting significant staffing in that level to further up the opportunity. So with that I would like to conclude today’s call and thank you for you – thank you for listening in. Goodbye.