MannKind Corp (MNKD) 2012 Q4 法說會逐字稿

Ladies and gentlemen, thank you for standing by. Welcome to the MannKind Corporation fourth quarter and year end 2012 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, February 11, 2013. Joining us today from MannKind are Chairman and CEO, Alfred Mann; President and COO, 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 afternoon and thank you for participating in today's call. I'll be summarizing our financial results for 2012 as reported earlier today. Hakan will then discuss our current operations and Al will conclude with a brief overview before we open up the call to your questions.

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 and is accurate only as of the date of this live broadcast, February 11, 2013. We undertake no obligation to revise or update any statements that reflect events or circumstances after the date of this call.

Turning to the financials. For the fourth quarter of 2012, total operating expenses were $33.5 million, compared to $30.6 million for the fourth quarter of 2011 and $35.5 million for the third quarter of 2012. R&D expenses were $25.3 million for the fourth quarter of 2012, compared to $20.2 million for the fourth quarter of 2011 and $25.5 million for the third quarter of 2012. The increase in R&D expenses for the fourth quarter of 2012 compared to the same quarter in 2011 was primarily due to an increase in clinical trial related activities as trials 171 and 175 were initiated in the fourth quarter of 2011, partially offset by the absence of insulin purchases in the fourth quarter of 2012, related to the termination of our insulin supply agreement in 2011. There was a slight decrease in R&D expenses this quarter from last quarter, due to clinical trial-related activities.

General and administrative expenses were $8.2 million for the fourth quarter of 2012, compared to $10.3 million for the fourth quarter of 2011, and $10.1 million for the third quarter of 2012. General and administrative expenses were higher in previous comparative quarters, primarily due to a litigation settlement accrual related to the securities and derivative actions. Other expense of $13.3 million for the fourth quarter of 2012 was primarily due to a non-cash, non-recurring adjustment in the fair value of a forward purchase contract with a related party which was settled in December of 2012. Net loss applicable to common stockholders for the fourth quarter of 2012 was $51.8 million, or $0.23 per share, based on 229.2 million weighted average shares outstanding, compared with a net loss applicable to common shareholders of $36.4 million, or $0.30 per share, on 122.4 million weighted average shares outstanding for the fourth quarter of 2011.

For the full year ended December 31, 2012, total operating expenses were $147 million, compared with $140.6 million for 2011. R&D expenses were $101.5 million in 2012, compared to $100 million in 2011. While clinical trial-related expenses increased $24.9 million in 2012, this increase was offset by the non-recurrence of $16 million in expenses recorded during 2011 in connection with the settlement of the terminated insulin supply agreement and decreased salary related expenses and results in the reduction of force in February 2011. General and administrative expenses increased $4.9 million to $45.5 million for 2012 as compared to 2011, primarily due to non-cash litigation settlement expenses during 2012, offset by lower salaries and benefits costs from the 2011 reduction in force. The net loss applicable to common stockholders for 2012 was $169.4 million, or $0.94 per share, based on 180.9 million weighted average shares outstanding, compared with a net loss applicable to common stockholders of $160.8 million, or $1.32 per share, based on 121.8 million weighted average shares outstanding for 2011.

Our cash and cash equivalents at the end of the year totaled $61.8 million, which compared to $2.7 million at December 31, 2011. Our cash burn during 2012 fluctuated from $33.3 million spent in Q1, $24.7 million in Q2, $30 million in Q3 and $25.9 million spent in Q4. We expect to accelerate our spending in 2013 as we complete the trials, prepare for resubmission of regulatory approval of AFREZZA.

With that, I'd like to you now turn the call over to Hakan.

Thank you, Matt. Good afternoon. Since our last call in early November, we have completed the recruitment phase of both trials in the Affinity program. Achieving this major milestone, the clinical and medical teams together with our contract research organizations have been intensely focused on execution of our trials. The monitoring of patients, the clinical side, was all in accordance with [product] protocols, MannKind's operating procedures and good clinical practice.

As a reminder, we are running two key Phase III studies, the first of these studies, study 171, is an open label study in patients with type 1 diabetes. The study includes a run-in period during which all patients are optimized on their basal insulin. A total of 518 patients were randomized to one of the three treatment groups for the meal-time insulin. A control group in which patients utilized injected rapid-acting insulin analogs, the AFREZZA using the MedTone inhaler or AFREZZA using the generation two inhaler. After initial 12 week meal time [insulation] optimization period, there is a subsequent 12 week stable insulin dosing period. The primary objectives are to establish non-inferiority of the rapid acting analogs and generation two treatment groups, and also compare the safety profile of the AFREZZA treatment groups with the two devices.

The other Phase III study, the 175, assesses the addition of AFREZZA using the generation two inhaler to patients with type 2 diabetes disease is inadequately controlled on metformin with or without a second or third oral medication. Again, after a running period during which the patient stabilized their oral medication, a total of 354 patients were randomized to additional treatment with AFREZZA or to a placebo group using only the Technosphere inhalation powder. This study also includes a titration period followed by a 12 week evaluation period to assess the hA1c levels, other secondary parameters and safety. Randomization was complete for both trials in November of last year, so the individual patient visits for the remainder of the trial are now visible and can be tracked and managed in real-time by both the clinical site and the MannKind monitors. Our teams are now managing patients through the trial patient by patient, and the last patient left continues to be on track to May and June respectively of 2013. The operational plan for rapid database log and the production of final tables, figures and lists is in place, and we expect to share the key trial results with you sometime in mid-August.

We have also submitted a meeting request this month to inform the FDA of our intention to submit a Class 2 resubmission in 2013. The purpose of this resubmission meeting is to seek concurrence with the agency on the content of the form of the resubmission. The FDA has already informed us that it will provide a written response to our briefing package in March. We are targeting to resubmit the AFREZZA NDA between late September and early October and we expect a six month review. All other activities that support the resubmission are well under way and progressing according to plan. We remind you that the amount of data and supporting information including tables, graphs and listings for the resubmission is extensive. A detailed operational plan outlining all of the activities required for the resubmission is in execution and we remain fully committed to meet the 2013 time line.

And with that, I will now hand the call over to Al. Al, please.

Thank you, Hakan and good afternoon, ladies and gentlemen. During the last conference call we reported we completed recruitments for the two key clinical trials, MKC171 in type 1 diabetes, now known as you Affinity 1 and MKC175 an insulin (inaudible) type 2 diabetes, now known as Affinity 2. Those two recruiting milestones were critical because they have set the timeline for completion of those trials that would be the primary basis of our NDA resubmission to the FDA.

Hakan described some of the details and progress of those two trials. I'm going to provide a little more detail so that we can focus more on some of the details and results that we expect. The study protocols were generated in close collaboration with the FDA. After a run-in period of four weeks for Affinity 1 and six for Affinity 2, there are 12 weeks of titration, 12 weeks of treatment and four week follow-up after completion of the therapy. Affinity 1 will thus complete in late May and Affinity 2 in mid-June. Analog and preparation of resubmission will take at least about three months so as Hakan noted, the filing is anticipated in late September or early October. We should be able to release Affinity trial results in August.

We had reported that for these trials, the FDA wanted to include patients with A1cs averaging between 8% and 8.5%. Such a high average A1c required that some patients have baseline A1cs of 10% or more. Those high initial A1cs will enable AFREZZA to show truly substantial lowering but at the premier centers conducting these trials, there are not many such poorly controlled patients. To satisfy that baseline and ensure that we have more than 399 and 246 completers respectively for the two studies, we screened 1,402 patients for Affinity 1 and 1,381 for Affinity 2. That was a major challenge and took more time but was successfully achieved. One of our concerns had been potential patient dropouts because of the substantial demands on the patients in those trials. We therefore over-enrolled to better ensure we have adequate statistical power. We are pleased to report that both studies are tracking well. At this point, we are quite confident that trials will be completed as scheduled with more than enough patients.

As of last week, 297 patients already completed the treatment phase for Affinity 1, that's about -- almost 75% of the total, and 167 for Affinity 2, or approximately two-thirds, a little over two-thirds of the target. For almost all the major earlier trials, the primary target was non-inferiority for A1c versus rapid acting analog primary insulins. The end points of those trials were successfully met and showed AFREZZA to be comparable to the best of the current prandial insulins in A1c. Additionally, those studies showed clear advantages of AFREZZA in other measures of efficacy, and also a much lower incidence of hypoglycemia. Even though the kinetic dynamic profile of AFREZZA is so much more physiologic, our earlier trials were not yet able to clearly validate superiority of AFREZZA for A1c. That can be explained.

Since A1c effectively reflects the average blood sugar over about two to three months, substantial lowering A1cs can only be realized by reducing fasting level as well as lowering prandial rises. However, since the excessive late persistence of current prandial insulin is the primary cause of hypoglycemia, out of concern for such risk in clinical practice today, physicians typically resist increasing basal insulins to lower fasting levels. As a consequence, they are managing their diabetes patients at very high fasting glucose levels that result in higher A1cs with increased risk of long-term diabetic complications. Since there is no such excessive persistence with AFREZZA, fasting glucose can be much more safely lowered. At a fasting level over 100 milligrams per deciliter is really hard to imagine how the kinetic dynamic profile of AFREZZA could lead even to a mild hypoglycemic incident. Much lower A1cs should thus be achievable and that would reduce the risk of long-term complications of diabetes.

Since our earlier trials, basal insulins were not actually titrated, the fasting glucose for the AFREZZA patients were thus excessive. What is different in this trial is the protocol very clearly defines a proper titration of the basal insulin. As a result, the AFREZZA patients end up with much lower fasting levels, so far less change would likely be possible with the current prandial insulins because of their excessive persistence. The caveat to this is that non-physiologic inter-patient variability is [purging] the basal insulin used in Affinity 1 which can also cause spikes, which is really the primary cause of hypoglycemia. Probably some residual hypos to insulin, even in the AFREZZA cohort. Past experience suggests that there should not be many of those exceptions so we're confident of good outcomes in this trial.

Expectations for the Affinity 2 trial in insulin naive type 2s are also very positive. Approvals for such patients requires only modest comparative advantages for A1c in this study for the patients on AFREZZA versus those on a placebo. Prior trials have shown that AFREZZA itself lowers fasting glucose levels according to opinion leaders, because it reduces insulin resistance. That effect, coupled with adequate dosing to reduce prandial rises, should enable much lower A1cs for the AFREZZA cohort with virtually no risk of hypoglycemia. Enrollment in this trial also includes some patients with very high fasting glucose levels and A1cs. Where those type 2 patients with more advanced disease, they will surely benefit from the substantial lowering of those measures with AFREZZA but they should be using basal insulins in addition to AFREZZA. In any case, the trial ought to further validate AFREZZA as a very effective and very safe anti-glycemic agent in insulin-naive type 2 diabetics.

Ultimately, we anticipate the use of AFREZZA throughout the entire spectrum of diabetes, not only for type 1 but also for gestational diabetes and almost the entire range of type 2, at least after metformin. That would seem to offer an enormous opportunity for AFREZZA although our factory, even with additional equipment, will be able to serve only about 2 million people. I anticipate that we will surely soon need to plan additional manufacturing facilities. As I have communicated before, I believe AFREZZA will become a major weapon in the battle against the global diabetes pandemic. AFREZZA is so very significant because it addresses the prandial glycemic problem in the most natural and most effective way. AFREZZA delivers the very same regular insulin as supplied from a healthy human pancreas. Importantly, AFREZZA's kinetic dynamic profile in the blood quite closely mimics the natural insulin physiology of a non-diabetic in response to a typical meal. AFREZZA should thus enable much improved glycemic control without the serious problems, risks, limitations of current anti-glycemic products.

And I mean not just today's insulins but also the alternative anti-glycemic drug. The value of the alternative anti-glycemics is really due to the lack of any physiologic insulins today. Indeed, in spite of the deficiencies today's [anti-glycemics] products, the limited benefits, the side effects, the potential safety risks of the alternative anti-glycemics are fostering a growing movement towards early use of insulin in type 2. A more physiologic insulin should surely accelerate that movement. The American Diabetes Association is one of the organizations urging ever earlier use of insulin.

In the January 28, 2013 issue of the Wall Street journal, there was a frightening article entitled quote, Grim New Diabetes Milestone, unquote, expressing serious concern about the explosion of type 2 diabetes in children. Metformin, now the only oral anti-glycemic approved for use by children, is apparently much less effective in pediatric patients, more even than in adults. What appears to be evolving for these young patients is far greater early use of insulin soon after diagnosis. The ultra fast kinetic dynamic profile of AFREZZA should certainly be even more important for children. Moreover, the simple, discrete and convenient inhalation of AFREZZA should be an important contributor to compliance, especially in the very young.

However, AFREZZA will not soon be available for pediatric patients. The clinical trials to date were all in adults and the initial label upon approval will be limited to use by people over the age of 18. Last year the FDA requested we submit a protocol for a Phase IV study in pediatric patients. They directed us to conduct that clinical trial in children down to age four. The protocol is almost final but as the Phase IV trial it will not be initiated until after approval for AFREZZA for adults. Key opinion leaders are becoming increasingly positive and enthusiastic about the potential of AFREZZA. Some are suggesting that by reducing pancreatic stress, AFREZZA may slow and perhaps stop and even reverse progression of type 2 disease. Moreover, delivery of AFREZZA by inhalation with a tiny whistle size inhaler is so simple, so convenient, and will be so very cost-effective. I truly believe many patients will prefer this therapy modality.

As I have consistently said in previous calls, I am absolutely convinced that AFREZZA will become widely recognized by patients and clinicians alike as a better, safer and more effective therapy throughout almost the entire diabetes spectrum. Quite a few years into the future, I assert that AFREZZA plus a basal insulin patch pump ought to be the optimum basal post therapy for type 1 and late type 2 diabetes patients. Since the first launch of early type 2 is prandial control, not fasting control, at least after metformin, an ideal therapy for most of these patients should be AFREZZA alone or along with metformin. As you can see, I remain absolutely confident of the clinical significance and the enormous opportunity with AFREZZA.

Now, let me open -- let us open up the call to your questions. Operator?

Thank you. We will now begin the question-and-answer session.

(Operator Instructions)

Ian Somaiya, Piper Jaffray.

Good afternoon. This is Matthew on for Ian. Thanks for taking the questions.

So first -- the one that always seems to come up, and that's, I was hoping you could give us the latest color, the latest take on where you guys are in terms of partnership status and how diligence is progressing with potential partners. And then I have just a couple more after that. Thanks.

Yes. This is Hakan.

And which we have indicated before is that we are in discussions and also in diligence sessions with a number of interested parties. Again, since we've indicated earlier with the addition of the Type 2 market and the significantly increased opportunity that attracted additional potential partnerships. So those discussions and due diligence sessions are under way as we speak.

Okay. And Matt, one for you.

Could you give us your sense as to expectations for operating expense run rate in 2013 and beyond, particularly once the trial's complete?

I'll try. So, you'll remember that I've been saying we are going to burn somewhere in the $10 million to $12 million a month range for a long time. We consistently seem to underspend that. I'm getting a little reluctant. That is still where our projections are showing.

I do still think it's going to pick up into that range as we hit the crescendo period of the clinical trials in the first couple quarters here, after which we should start winding down. There will be a slight offset as we gear up a little bit towards commercialization. I think post filing we should see some of the -- certainly the clinical trial expenses which have been the major driver for the increases on that side, start coming down a little bit in the latter part of the year. Beyond that, I can't be too terribly much more specific.

Sort of related, Al actually mentioned the manufacturing facilities in his remarks; and I was just hoping you guys might be able to comment on that in terms of expectations. Is that something that -- in terms of timing -- and also, is that something you think you guys would handle yourselves? Or is it ultimately the expectation that the partner would take care of that?

Well, initially we certainly will handle it ourselves, based on the Denver facility, as Al mentioned, has the capacity on a commercial basis to service up to 2 million patients. Beyond that, that certainly will be a discussion with potential partners, whether they would have an infrastructure to help build out that, and the structure for doing so is still open-ended. But it would certainly, I would say, have probably a couple of years of opportunity once we have a deal in place to determine which is the most efficient way of doing so.

Just to make sure we're all on the same page -- when we talk about a 2 million patient capacity at the Denver facility, and that's in its fully built out state, we expect to launch with about quarter capacity. We have the footprint in place for that, uses the full amount of the 2 million capacity but we haven't put all the equipment in, because obviously we didn't want to spend all the money before we had to. It has a 12 [multiple finish] line capacity; we expect to launch with three. It's about a quarter capacity roughly; and then we can build it out as we need it. Remember, the 2 million capacity while we're talking about it, is not very much, equates to somewhere in the $4 billion of sales range. We're looking forward to starting to worry about outstripping that facility.

Thank you. Steve Byrne, Bank of America.

Well, I welcome your thoughts on the merits of FDA's decision to require degludec to have a cardiovascular outcome study. More importantly, what data do you have that either shows the lack of or the strength of your view of a lack of cardiovascular signal with AFREZZA?

Well, our cardiovascular signal showed a 1.01 cardiovascular effect, which was negligible; and the FDA has not pursued this any further. The degludec numbers were enormously higher. That's why they have to -- that's why they got the CRL.

Okay. With respect to the enrollment in the 175 trial, you had 167 have now completed. I think you said 360 or so were randomized. Can you at this point estimate how many you think will complete at this point?

We only need 246, but -- Bob?

Hello, Al. This is Bob Baughman in Danbury.

We have 124 subjects who have completed the trial in its entirety and we still have about 173 subjects in the study. So that gives us up to 297 subjects to complete 246. And as you know, we are well on our way for this study, so we will have more than enough subjects to be able to complete the trial.

And Bob, based on the discontinuation rate, can you estimate how many out of that 173 will complete?

Of that total, I would say we'll only lose maybe 15% of them. As you know, most of the drops in all of our trials occur early on, when patients are still getting used to the inhaler. Relatively few drop out at the end of the trial. That's essentially where we are. So I do not expect to even see the 15% rate in the 175 study.

Okay. And one last one from me.

Matt, can you talk about the adequacy of the $62 million of cash right now to take you through at least the results in August.

$62 million by itself will get us right to about the time of results. We still have a large line of credit available from Al, across the table from me here. Not only the stuff that was available previous to the last financing, but also some monies that were reinstated. That should be enough to bridge the gap if we decide to use it. We have been trying to make that line go away. We might be looking at other alternatives from that in the meantime.

What really we need to bridge to is the data, which is in August as we said. So that should take us right to about that point. Remember also, we have in late October the expectation of a large in-flow of money on a semiautomatic basis from the launch we issued with the last finance control, otherwise it [retire] late in October. With any kind of data at all -- we obviously expect very positive data from these studies -- we would expect those warrants to be in the money and that should bring in almost $90 million additionally. I think we're going to be generally in pretty good shape financially this year.

Thank you.

Jason Butler, JMP Securities.

Thanks for taking the questions.

Just first on the trials -- you incorporated some new titration requirements in these trials, and FDA gave you the power to enforce them. Can you give us an idea of whether -- of what you're seeing in the clinic in terms of adherence to these protocols? And how your new measures are working as well as hoped or not?

Bob should answer that. We're really blinded to the data, Jason. Bob?

This is Bob Baughman again. We have not commented on the data because we remain blinded. We have an independent titration management committee that makes those recommendations to the investigators. But we are blinded to that, and the outcome of that we will only see when we evaluate the data.

Okay. Great. And then a question for -- sorry.

My comment was only going to be, is that we get the comment back from the committee that the investigators are being attentive to the recommendations.

Okay. Great. That's helpful.

We have to win big.

Right. For Matt -- just a question on the warrants following on from Steve's question. Could you talk about the cash and cashless provisions for those warrants? And then I think there were also warrants issued to Mr. Mann at the same time. Are those warrants exercisable in the time frame? And are they cash or cash-less?

There's just the usual cashless provisions if we don't have a valid listing and so forth. For all intents and purposes, you should think of them as only being cash-exercised warrants in the normal course. The same would be true of Al's, although that doesn't preclude him from using his debt or debt cancellation to exercise those warrants. They do, otherwise, have the same terms. The warrants have the same terms for everybody.

Except I had to pay a lot more for them.

Al paid more for his because he has his in his hands today, so the same term of the warrants.

I still think they're cheap, though.

Great. Thank you.

Corey Kasimov, JPMorgan.

It's actually Matt Lowe in for Corey today. Just to quickly come back to the partnership talks ongoing -- just wondering, is there a certain type of deal that you are seeking? What matters most to you with the deal? Are you looking for a company that's already in diabetes care? Or a company with a primary care sales force? And then regarding Europe, are you looking to file yourselves there or to wait for a potential European partner to do this?

Well, in terms of the type of company -- yes, if they do have a primary care sales force that certainly is an advantage and opportunity. We've seen in our market research that if the primary care physicians can retain their patients over a longer period of time, not have them say, go to specialists, that is for them certainly a continuing care and revenue opportunity. They do not necessarily have to be, say, in insulin or in diabetes, even though some of the people we're talking to certainly are in diabetes care.

In regards to the European submission, we have conducted the US trials and even the ones that we are under way right now. So they will very easily fit into the requirements that we would expect out of the European application. Probably the timing of a potential partnership deal will determine whether we go alone in Europe in terms of submission, say, subsequent to acceptance of our filing in the US by the FDA, or whether we will utilize a European partner for doing so. So I would say that's a decision that's pending until the appropriate time.

Okay. Thank you.

(Operator Instructions)

Simos Simeonidis, Cowen & Company.

Thanks for taking the question. A question for Bob.

I know you're blinded on the data, but your data monitoring committee -- have they seen any concerns of hypoglycemias up to this point?

I can say that the data is being reviewed and we have not been alerted to any concern with hypos in the studies.

Okay. Great. Final question for Matt.

Matt, how much is available under the line of credit from Al?

Approximately $120 million.

As of the start of the quarter, right? Or, the end of the quarter, I should say.

Obviously, we haven't drawn anything from that since the financing, so the full amount remains available. Remember, when Al bought the stock he reinstated that portion of the debt back into the line should we need it. Obviously, we hope we won't.

Thank you for taking the questions.

Keith Markey, Griffin Securities.

Thank you for taking my question.

I was just wondering some people have brought to my attention that there are blogs posted by different patients ostensibly who participated in one trial or the other, and I was wondering if you had any kind of thoughts about the results that these patients have posted saying that they've never had such great control? And I was wondering if these patients are eligible for use of AFREZZA on a compassionate use basis?

First, let me say that we get lots of those inputs. People send us information. I've gotten letters from patients; I've gotten e-mails from patients -- all talking about how their experience has gone, how successful it's been, how pleased they are.

I had one physician who was involved in 171 who called me and wanted -- pleaded with us to get all of his patients to remain on AFREZZA on a compassionate care basis simply because he had never seen results that had been so significant. And I said, tell that to the FDA, don't tell that to us.

A few weeks ago I ran into a physician involved in the Affinity 2 trial in Type 2, and his remark was that he has never seen such incredible results and without any hypos and he intends to put all of his patients, his Type 2 patients, on AFREZZA. Now, those are just anecdotal stories. So you can't really draw any conclusions from it.

We will get the data sometime in July, probably, and we'll be analyzing it. And once we get all of that data, then we'll be able to make a definitive statement. Until then, we have to treat these only as anecdotal stories. I think perhaps the most significant fact is that I personally heard dozens of very positive comments and opinions about AFREZZA and I've yet to hear one that was negative. So that to me is significant.

Thank you very much.

There are compassionate use applications with the FDA from physicians trying to address their patients. We do know that. Again, it's on a patient-by-patient basis.

Thank you, Keith.

Thank you.

Michael Tong, Wells Fargo Securities.

This is David on for Michael. Just a quick question.

Can you just repeat for us the number of patients who completed the MKC171 and 175 studies, please?

Well, the 171 was 297 patients, which turns out to be 74.4% of the total completers that are required. And in Affinity 2 was 167, or 67.9% of the total. So we're roughly two-thirds -- three-quarters and two-thirds done as of last week.

Okay. And then in terms of the Q4 G&A, should we expect that to be the run rate as we go into 2013?

Yes.

Okay.

Absent other non-recurring item, other income we talked about. G&A, yes, should be more or less the same.

Okay. Thank you.

If there are no other questions, let me thank you all for joining us today. Our next quarterly call will be in mid-August and by then we hope also to have been able to release our top line results from our current trials. And as I've said before, I'm very confident we will be announcing very significant results and we look forward to that call.

Thank you all for joining us today.

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