MannKind Corp (MNKD) 2013 Q3 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the MannKind Corporation Third Quarter 2013 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, November 4, 2013.

Joining us today from MannKind are Chairman and CEO, Alfred Mann, President and COO, Hakan Edstrom, and Chief Financial Officer Advisor, Matthew Pfeffer. I would now like to turn the call over to Matthew Pfeffer, Chief Financial Officer, of MannKind Corporation. Please go ahead, sir.

Good afternoon, and thank you for participating in today's call. I will discuss very briefly our financial results for the third quarter of 2013, as reported this morning, and then turn the call over to Hakan.

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 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, November 4, 2013. We undertake no obligation to revise or update any statements to reflect events or circumstances after the date of this call.

Turning now to the financials. The net loss applicable to common stockholders for the third quarter of 2013 was $50.8 million, or $0.17 per share, compared with the net loss applicable to common stockholders of $42.8 million, or $0.22 per share for the third quarter of 2012. Primary factors resulting in this change were an increase in research and development expense, to an increase in non stock cash compensation expense. Partly offset by a decrease in clinical trial related costs, resulting from the completion of Affinity studies.

Also affecting this outcome was an increase in general and administrative expenses due primarily to increased stock compensation expense and professional legal fees in 2013. Partially offset by the non recurrence of a litigation accrual made in the prior year.

Cash, and cash equivalents were $93.8 million, at September 30, 2013. Subsequent to quarter end, we received $45 million in proceeds from warrants exercised prior to their expiration on October 29, which represented substantially all of the remaining outstanding October warrants.

Additionally, last week, Al early exercised his December warrants resulting in the issuance of $30 million restricted common shares in exchange for the cancellation of $78 million of outstanding principal under the loan agreement with The Mann Group. Leaving a principal balance outstanding of $41.6 million as of October 31. Further, Al agreed to extend the maturity date of the loan agreement with The Mann Group to 2019 and increase our previous $350 million borrowing capacity to $370 million.

This, along with the Deerfield Financing Facility and the ATM, which we have yet to trigger, provides us the ability to repay our convertible debt obligation on December 15, and fund our operations into 2014, toward FDA approval and partnership.

With that brief summary, I will now turn the call over to Hakan. Hakan?

Thank you, Matt. Good afternoon.

Well, as you all probably already heard, we did this past week get the acknowledgment from the FDA regarding our NDA resubmission. In which the agency has signed a PDUFA date of April 15, 2014. Based on some question that we have received, there seems to be some confusion over the FDA procedures regarding the submission process and their acceptance of the resubmission. So let me try to bring some clarity to this matter.

The reason communications from the FDA informed us of their target action date, the next checkpoint in the FDA review process is the internal filing meeting, where they will make a determination on the filing the resubmission and any significant review issue based on their early evaluation of the NDA. We expect additional FDA feedback on our application shortly after the filing meeting or as part of the day 74 letter. Thus, everything is on track and proceeding according to the usual regulatory time line. Should the 74-day letter significantly change any of the planning assumptions for the rest of the mission, we will, of course, share such material information with you.

A partnership process is under way and we are pleased with the way Green Hill is managing our interactions with potential partners. And at this time, I cannot say anything more specific than that.

In preparation for a portrait discussion and eventually the market launch of AFREZZA, we have recently updated our pricing research in the US market, meeting with payers representing managed care organizations, pharmacy benefits managers and distribution companies. In general, AFREZZA's clinical date and product avenues will reviewed very favorably.

Payers told us that they believe the elimination of injections would be an important compliance advantage. And due to the chronic nature of diabetes, they would welcome a product of increased compliance within the diabetic population.

Another method from the pay, is if that they see RAA pen as the value and price comparison for AFREZZA, based on the current safety and efficacy profile, as well as their perceived advantages of convenience and even increased compliance associated with our mode of delivery. This is important because pens already carry a price premium due to their convenience and compliance benefit, compared to needle injections. And based on this research, we have a clear understanding of how we can drive the placement of AFREZZA on tier two formulary status, which is important to drive volume and revenue.

And of course, the most important value of AFREZZA, if the pharmacokinetic profile, leading to improved medical care, and better outcomes. Since completing studies 171 and 175, we have also updated our market research into sufficient interest of prescribing AFREZZA, which could be the first rapid acting insulin in the market.

In September, we commissioned a market research company to reach out to a large sample of endocrinologists and primary care physicians to better understand the type of patient for whom AFREZZA would likely be prescribed.

After showing physicians a full product description, reflecting our recent clinical results and safety profile, physicians identified three likely patient populations. The first one being type two insulin naive patients, who are not adequately controlled on oral agents or a GLP-1 analog. The second group was type two patients on a long acting analog would need to intensify their insulin regiment to achieve glycemic control. And the third group, type one and type two patients, using brands of insulin, who have a high risk of hyperglycemic events.

The vast majority of physicians that participated in this research, 86% to be specific, indicated that they were very likely to use AFREZZA in their practice. Physicians reported that there are many reasons why they would prescribe AFREZZA, including the ability to achieve glycemic control without the use of injections and the convenience of using the product. And most importantly the faster onset of actions compared to other brands of insulin.

The patient types identified by prescribers represent very large segments of the diabetes population, and confirms our belief that AFREZZA can meet the needs of so many patients with diabetes. Well, with that overview, let me hand the call over to Al. Al?

Thank you, Hakan. And good afternoon, ladies and gentlemen.

As we reported, the NDA for AFREZZA was submitted to the FDA three weeks ago. The agency's review of this resubmission is now in process with the PDUFA date of April 15. The FDA's two-week action, to set the PDUFA date is the agency's regular positive response at this point in today's regulatory process.

Moreover, we believe that the NDA submission incorporates all of the requirements to make the application complete. That then initiates the agency's six-month review, but does not at this point assess the prove ability.

The filings of the resubmission was an enormous effort, and I am so very proud of our team, that 16 months earlier, in June of last year, had set the goal for filing in mid October this year. The NDA package of almost 800,000 pages was actually electronically filed on October 13. That performance was incredible. After all, the Affinity trials were only actually just completed on June 17.

In only five months, the evaluation of about 240,000 pages of new data was completed and results were incorporated in the approximately 2,000 pages of the five-summary regulatory documents. Although only the FDA can establish approveability, MannKind and our regulatory advisors are satisfied that the Affinity trials met their targeted primary end points. And concur that the resubmission addressed all questions raised by the FDA in the two complete response letters.

As an earlier trial, involving patients with type one diabetes, and Affinity 1, that is MKC-171, AFREZZA showed a substantially reduced incidence of sever hyperglycemia, less weight gain, and much better prandial excursions, while also achieving the primary end point of non inferiority in lowered HbA1c, as compared to the rapid acting analog which provides today's best prandial insulin therapy.

There were no related safety signals in any of the AFREZZA patients. We had reported similar findings in past, though those prior trials had been conducted with the med tone device. The findings in this trial were with the dream boat inhaler and they also showed pulmonary equivalency of the HbA1c result with both devices. So that this study generated a bridge of the dream boat to the enormous amount of all the pulmonary safety data the earlier trials.

In Affinity 2, or MKC-175, we observed that the addition of AFREZZA to a regimen of oral medication produced an average drop in HbA1c of more than 0.008%, demonstrating superiority compared to the orals only group,. And with a P value that is a statistical equivalent of a home run. These results indicate that AFREZZA is an effective first insulin for patients with type two diabetes who are insufficiently controlled with oral anti-diabetic agents.

Just to put the size of that segment of the diabetes market in perspective, there are currently more than 15 million insulin naive type two diabetes patients just in the United States. About another half million of such patients each year convert from alternative drugs to insulin. So we think such patients and their doctors will surely be very interested in the results of study 175, probably leading to use even much earlier in type two diabetes therapy.

Indeed, far sooner than these progression, many earlier stage type two's ought to be better off with insulin than with alternative antiglycemic drugs. After all, those other drugs are primarily utilized today, because of the problems and disadvantages of current insulin products.

I would like to take a little time to talk about some fascinating new clinical results involving AFREZZA that reinforces the significance of AFREZZA's greatly-improved PKPD. This study, not previously mentioned, is in the program funded by the juvenile diabetes research foundation. The Samson clinic in collaboration with the University of California Santa Barbara is conducting this study of a closed loop quote artificial pancreas, unquote, in which the patients inhale a dose of AFREZZA at the start of each meal. A sensor controlled closed loop insulin pump then adjusts the residual glucose level 24/7, largely eliminating excessive excursions.

Initial results of this studies have been exceptional. Glucose control was far better for those patients taking the meal time AFREZZA dose. The resulting glucose pattern was actually very close to that for a healthy physiology. This study is continuing and we expect very positive results to be published in a few months.

Indeed, the obstacle with earlier efforts, the closed loop glucose controls, has been these deficient PKPD of current preglandular insulin. AFREZZA offers a potential solution to that problem for bolus control and a pump clearly offers the best solution for Basal control. This Samson USDC, JDRF study, should therefore demonstrate that in the foreseeable future, the best glucose control in type one will surely be the combination of AFREZZA plus closed loop control of the overall residual glucose levels.

However, complexity and especially the high cost of pumps and sensors will likely continue to be a deterrent to their widespread use, other than a portion of a specially committed type one patients. However, the combination of AFREZZA, even with a simple low cost fixed rate Basal delivery system, would offer a valuable compromise that should provide quite excellent glucose control for most type one and late type two patients.

We are considering such a Basal advice for use with AFREZZA for the substantial portion of diabetics that should really be on Basal Bolus insulin therapy. Of course, many early stage type two's could do very well with just adding AFREZZA much earlier in disease progression.

As we await completion of the FDA review of our NDA resubmission, we are planning a few marketing trials designed to better illustrate very important additional advantages of AFREZZA for prandial glucose control with even less hyperglycemia and throughout the entire spectrum of diabetes. Although the delay of over three years due to the January 2011 CRL has been very costly, we are now seeing light at the end of the tunnel. The Company will now be concentrating mostly on supporting the FDA's review of the AFREZZA NDA, preparing for a pre-approval inspection, and planning for commercial launch.

As Hakan noted, the process for selecting the sales and marketing partner is well under way and is being coordinated by Green Hill, our partnership advisor. But we are not yet prepared to suggest a date for completion.

The clinical trial program has been extremely extensive and has already shown important better benefits with AFREZZA. Let me then take a few moments now to summarize some interesting characteristics and advantages about AFREZZA that have been demonstrated so far.

One, the delivery device is tiny, easy to use, and discrete. Two, the powder is inhaled and there is no need for any prandial injections. Three, dosing is linear and not as critical as in current practice.

Four, delivery is far more efficient than with any other effort in the inhalation of insulin. Five, the reduction in HbA1c levels have already been proven, along with a reduced risk of hyperglycemia and less weight gain than with rapid-acting analog prandial insulins. Six, the clinical results in insulin naive type two's create a potentially huge market opportunity for AFREZZA. Study 175 showed that the addition of AFREZZA offers superior HbA1c control in early type two patients failing on oral antiglycemics.

Seven, the only real side effect seen with AFREZZA inhalation in some patients is just a single nonproductive cough in reaction to the tickling sensation when first inhaling some powder. For those affected patients, this minor problem is usually just a single cough, does not often continue for more than a few doses. In the trial, only about 2% to 3% of patients discontinued AFREZZA due to cough.

Eight, the powder quickly passes into arterial blood, peaking 12 minutes to 15 minutes, with very little remaining in the lungs after 2.5 hours to 3 hours. And no accumulation has been seen. This PKPD of AFREZZA much more closely mimics normal pancreatic physiology than does any insulin in the market today or to our knowledge in development and that by the way is the most significant of all features.

Nine, in extensive studies for as long as two years, and for some patients for as long as five years, we have seen no increased cardiovascular, or cancer risk, and only a tiny insignificant reduction of lung function. That tiny difference in PFT is reversible on sensation, and is probably just reaction to the powder before the test, rather than due to any real tissue impact.

In the extensive clinical program, there has been nothing to raise any substantive question whatsoever about safety. Based on that, AFREZZA should be viewed as a safe and superior antiglycemic for use in early stage type two and as a critical best and safest prandial insulin in type one and later type two.

Moreover our patients have been so very enthusiastic about AFREZZA. In study 171, we asked patients to respond to a quality of life survey. AFREZZA patients reported a substantial improvement in their self reported health status. To a significantly greater extent than that reported by the insulin ASVART group.

Interestingly, I expect patients will widely help to promote enthusiastic and rapid widespread commercial acceptance of AFREZZA. Of course, only time will prove this to be so. But I have and I am continuing to put my money in favor of the science and the excitement that we see with our patients and their commissions.

As Matt reported, I have just exercised my warrants to purchase 30 million shares of MannKind common stock, and have also extended my loans to the company. With all of that then, let us open the call to your questions. Operator?

(Operator Instructions)

We have several questions here. The first one is from Cory Kasimov, please go ahead, Cory.

Thanks. Good afternoon. Thanks for taking the questions. First of all, has the FDA given you any indication at this point whether or not they may want to host a panel?

No, there has been no indication at this point in time. The earliest time we would expect to see that, if again, against our belief right now, would happen, would probably be in conjunction with the 74-day letter.

And I understand you don't want to get into specifics about a partnership, but are you at this point able to say whether you would expect this to happen before or after approval?

No, I would not make a commentary on that one, and then I'm speculating.

All right. I can appreciate that. But then maybe let me ask this a different way. If you don't have a partner pre approval, would you launch yourself without a partner?

Most likely not. We would -- we have authority for that situation, so we would look to which -- not necessarily involve a self launch which certainly would require significant funding availability.

Okay. And then lastly, a quick modeling question for Matt, can you just give us your current fully diluted share count?

As of today?

Yes, just with the different warrants and things like that have been exercised with all of the financial stuff you talked about, if you can give us the fully diluted share count as of today, that would be helpful.

Yes, because it is changing very rapidly, so I understand your confusion. We did finish the quarter with roughly 310 million shares but we did have some 17 million warrants exercised post that, and then the 30 million shares to Al, so if you add all of those up, it comes to about 357 million. Technically, I think the shares to Al while he has exercised his warrants have not actually been issued to him, but it will be at any moment now, so I would count those.

All right, so 357 million. Great, thank you very much.

Our next question here is from Steve Byrne. Please go ahead sir.

Just continuing with those financial questions, what are the remaining warrants that are still outstanding?

Well, just the warrants from the February issue that we did last year, so I don't know the exact number.

20-some million?

We had -- it is in that range. We have said -- some of those exercises well, although not a dramatic number of them, and essentially all of the warrants for October were exercised. There were maybe a couple thousand I think that people just lost track of them somehow. But no material amounts went unexercised.

Okay. And the $80 million of Deerfield Loan, where is that on your balance sheet?

You will see it more obvious in the Q, but in the summary balance sheet, it is a little hard to spot because it is broken up into pieces. The accounting for the Deerfield transaction is quite complex, so it is in various pieces. You will see a little bit of it in the other liabilities number, because of the way it is being treated, and our need to bifurcate the loan into a couple of pieces relating to the milestones and the body of the loan. The rest of it is all sitting in current liabilities at this point. We don't really think of it as current, but technically, that is the way it is being treated.

Okay. That helps. Do you expect to have any of the 171 and 175 data presented at a medical conference prior to your PDUFA date?

I don't know whether the ACE may be a meeting prior to PDUFA date, because the ADA and the ADSD is of course following the PDUFA date, so there may be a couple of medical meetings, but I don't have the timing of those meetings in my head at this point in time.

And then just lastly, the status of your idled manufacturing lines in Danbury?

We don't have any idle lines. We do have two packaging lines that are basically have been delivered or about to be installed as we move forward here, getting ready for commercial readiness, but the lines that we have in right now is certainly operating as -- certainly supporting all of the clinical trials, so we don't have any idle capacity as such.

I'm referring to the other two. So you could have all three online by, what, end of 2014?

Oh, absolutely. I would say by mid 2014. Our plan is to certainly be commercially ready within six months of approval.

Okay. Thank you.

We have a question here from Keith Markey. Please go ahead, sir.

Yes, thank you for taking my question. Just wondering if you could add a little bit of information to the new clinical trial that you're running that compares or adds AFREZZA on to the closed loop insulin pump, for instance, how many patients are involved, what the length of that trial is, and whether those pumps or closed loop systems are already commercial on the market?

We're not really that familiar with that trial, Keith. It is being done by Sansum clinic under control of the JDRF, but we do have some of the early data. All we know is that we are supplying AFREZZA for meal time boluses and it is making a huge difference in the results of the patients.

That's to be expected, I guess.

We -- the details of what the trial are.

Can you tell us approximately when the data from that study will be available?

Well, I thought it would be available in just a few months, but one of the key managers at Sansum is changing his position and leaving the clinic, so I don't know what the impact is going to be.

Okay. Thanks. And then could you just tell us whether or not the risk management plan that you had in place and at least some of the negotiations that you have done already with the FDA previously regarding the labeling of your drug are going to be able to be carried forward into the discussion presently?

That is our expectation. We certainly went into the clinical trial program with what we believe a clear understanding of what the FDA were looking for, and that has certainly been accommodated in the execution of the trial and in the submission documents. So at this point in time, I have no indication that would kind of point in any different direction.

Okay. Great. And then one last question, in your discussions with the insurers, obviously benefit managers and such, I gather that they are at least receptive to a premium price relative to many of the other insulins on the market. I was wondering, how do you envision the price of AFREZZA comparing with say NovoLog?

As indicated, if you look at the RAA pens that are out there today, they I would say on average have about a 20% price premium over say injectable insulins, and based again on the safety profile and the efficacy profile, and the convenience that is perceived in conjunction with AFREZZA, plus the fact that you don't -- you avoid the cost of needles, that for planning purposes, our assumption right now that we will be in the same say range as RAA pen which is at a significant premium to say injectable insulins.

Very good. Thank you.

And next, we have Jason Butler on line with a question. Please go ahead.

Thanks. My questions have been asked.

Thank you very much. Here, we have right now Simos Simeonidis. Please go ahead.

Hi, guys. Thank you for taking the questions. If approved, how quickly do you believe you could launch AFREZZA and how quickly could manufacturing be ready and assuming you have a partner, what is the fastest you could be on the market?

Well, manufacturing will be ready at a moderate rate almost by around the time we are approved, but it will probably be a few months before we actually undertake a major marketing effort.

And that would depend I guess on how quickly you get a partner?

Certainly, that will have a major impact. The launch will certainly be a partnership with whoever it is that is going to be our commercial marketer in the United States.

Okay. And Al, Hakan mentioned earlier that in the -- in the situation where you haven't secured yet a partner, you have a potential fall-back scenario, what exactly are you referring to?

I think you need to ask him that. I don't know what he is referring to.

No, that is what I was trying to ask.

We have a number of people very interested in our product. A lot of regional partners that we have been putting off, frankly, waiting until we establish a plan for the United States.

That is basically what I was referring to. I mean compared to one global partner, there are other opportunities that we could utilize if we wanted to get out into the market without having to commit our own resources and utilize the time to be of the internal infrastructure to be able to afford and take on the capacity for a MannKind-sponsored launch. So that was the idea between the -- the continue the plans that we would have.

We have several, very, very aggressive potential partners and a number, quite a large number of others that have inquired but we haven't really followed up with them.

And Al and Hakan, you are referring to regional partner discussions versus the global partnership, which is your first preference?

That's correct.

Okay. And finally, a question for Matt. Matt, what is the remaining under Al's line of credit -- I saw that in the 8-K this morning it was increased from 350 to 370 but what is the amount remaining under the LOC?

I don't have the exact number in front of me but I think it is a little over $30 million, which is why we added some extra head room in there. Al generously expanded the line a little bit.

So it is $30 million plus the $20 million that was expanded today.

That would include the $20 million. So we added the $20 million to give us a little more room just in case. Not that we expect we will need it but you never know. At the very minimum, we would expect to continue to capitalize interest that would otherwise be payable under the loan into the principal so we wanted to leave ourselves some working room in there. And Al was generous enough to let us do that.

Okay, great. And final question for you, Matt. How should we think about spending for next year, now that the trials are done? Can you talk about that at all?

Yes, I can. I have been fairly consistent in this. I mean I felt like a broken record because I have been saying $10 million to $12 million a month for as long as I can remember and it is still remaining true. Sure the clinical spending has decreased. And we saw that in this quarter as well, but to a great extent it's being offset by increases in spending in other areas, largely in preparing for commercialization and launch of the products. I have had a lot of people call me about the large number of open head count we have that we are recruiting in Danbury and they think that is a bullish sign, which I suppose it is. We do think we are going to be successful and we need to be prepared when we get there.

So our cash burn in this quarter, we had a fair amount of non cash expenses but it still remains right squarely in the middle of that range about $11 million a month, and we've earned about $33 million in the third quarter of 2013 of actual cash. And I think it is going to be more or less constant at that level for the time being. We will have some ups and downs. We talked about the equipment that we are putting in to Danbury. To a great extent that has already been paid for but there are still some bills coming due. So we need to get ready to launch this product and make it the success it can be it and that requires some cash. So I am going to project that it is going to stay more or less flat with a few blips here and there.

What would MannKind's responsibility be, let's assume you have a global partner, what would your responsibility be in terms of spending on the commercialization part?

Well, that remains to be seen under the terms of the agreement. So I am not taking that into consideration by the way, in my projection. I guess I should have made that clear. That could obviously change our cash burn pretty substantially. And frankly, we expect it would, but I think it would be premature to speculate on the terms of that kind of a partnership.

Okay. Great. Thank you for taking the questions.

And here online, we have Mr. Graig Suvannavejh. Please go ahead, sir.

Great. Thank you very much. Thank you for taking my questions. I've got four if I could. First, if you could remind us what are the next triggers to release the balance of the Deerfield financing?

Sure. So the next one is not really a trigger per se but just the passage of time. It will trigger just prior to the due date for the 2013 convertible instrument. So we did that on purpose to allow us to have a little extra cash to the extent we wanted to pay that off at that time. So that will come due in mid December. The fourth and final tranche under the Deerfield financing does have a specific trigger. That would be approval of the product. So that was a time to handle potential launch expenses and so forth. So they were all done with a specific reason in mind. And those are the remaining two.

Okay. Great. Thank you so much. My second question just has to do, if you can just remind us of the scope and maybe the specific cost, if you have them, of the additional marketing studies that you were planning to initiate to support I guess the competitive profile or the marketing aspects of AFREZZA?

Those trials are not really designed yet. They're just in process.

Okay. Great. And just as it relates to the 74-day letter, is that something you think you would announce in terms of a press release, in terms of the contents of what might be in that letter to the public in terms of a press release?

Well, as I said, normally the expectation would be that it is just a confirmation of kind of what has been forthcoming already from the FDA. If there is a certain material event, if for instance, would be a request of an advisory board meeting, we would certainly make that information public because that is material information. And I would say if the content is what we expect it to be, not necessarily a press release, we might certainly mention it maybe in an investor conference, or anything like that, but again, if there is material information, we certainly would share it with the shareholders.

Okay. Great. Thank you. And then my last question just has to do with some of the market research that you had conducted over the past couple of months, and it was impressive that you had 86% of physicians said that they had indicated that they were likely to prescribe it. I was wondering if you had any details around the 14% that did not have the same answer and what the reasons might have been for that.

No, I do not. I have to say this was provided to me by my staff on the commercialization side. So I couldn't tell you what the 14%, if it does represent a nonuse or maybe -- I mean the positive party that a great majority, and these were -- I mean several hundred primary care physicians and in excess of 100 endocrinologists. So it was a good size sample. But I do not have the specificity with me on the 14% for you.

Okay. Great. Well thank you so much for taking my questions. And good luck to you.

Thanks.

And we have a final question here from Keith Markey. Please go ahead, sir.

Okay, thanks. Just a follow-up question on the responses that you had from the partners that you have been talking with. Not about the partnering per se but just simply can you tell us a little bit about the information, or feedback that you have been getting from them, in terms of what they like about the drug, or how they may potentially position it in terms of how, for instance, whether they like it -- especially focused on the convenience or the increased -- potential for increased compliance.

Well, certainly the convenience we do not emphasize that part of it. We emphasize the PKPD profile and the dedicated quality of care that is coming from that. If anything the convenience is really translated into a compliance benefit with the product. But then because of the type of partner, whether they are involved in, say, an insulin product or in diabetes, the questions vary all over the board. The only thing we can say is that certainly in general, they do understand why the product is different, how it is different, and how it could benefit diabetes patients going forward.

Okay. Thank you.

And at this time, I am showing no further questions. Mr. Edstrom, did you have any final remarks?

Yes, and with that, what I would like to do on behalf of the management and all of the people on the phone, wish Al a happy birthday. He is currently with us from Hawaii, so he is there on a well deserved vacation and retreat. So happy birthday, Al.

Thank you very much.

Thank you for the call.

Thank you all.

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