Vanda Pharmaceuticals Inc (VNDA) 2007 Q1 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the first quarter 2007 Vanda Pharmaceuticals earnings conference call. My name is Carissa, and I will be your coordinator for today.

At this time all participants are in a listen-only mode. We will be facilitating a question-and-answer session towards the end of today's conference. (Operator Instructions)

I would now like to turn the presentation over to your host for today's conference, Mr. Steve Shallcross, Senior Vice President and Chief Financial Officer. Please proceed, sir.

Thanks, Carissa. Good morning and thank you for joining us to discuss Vanda Pharmaceuticals first quarter 2007 performance. Our first quarter results were released this morning and are available on the SECs Edgar system or on our website at www.vandapharma.com.

In addition, we are providing live and archived versions of this conference call on our website, and a telephone replay of the call will be available through May 8th. Joining me on today's call is Dr. Mihales Polymeropoulos, our President and CEO. Following my introductory comments, Dr. Polymeropoulos will summarize our significant accomplishments for the first quarter and comment on our key milestones and plans for 2007. Then I will comment on our financial results for the quarter and provide initial financial guidance for 2007 before opening the lines for your questions.

Before we proceed, I'd like to remind everyone that various statements that we make on this call will be forward-looking statements within the meaning of federal securities laws. Words such as but not limited to "belief," "expect," "anticipate," "estimate," "intend," "plan," "target," "likely," "will," "would" and "could" and similar expressions or words will identify forward-looking statements.

Our forward-looking statements are based upon current expectations that involve changes in circumstances, assumptions and uncertainties and other risks. These risks are described in the Risk Factor section of our annual report on Form 10-K for the year ended December 31, 2006, which is available on the SEC Edgar system and on our website.

We encourage all investors to read this report and our other SEC filings. The information we provide on this call is provided only as of today, and we undertake no obligation to update any forward-looking statements we may make on this call on account of new information, future events or otherwise, except as required by law.

With that said I'd now like to turn the call over to our CEO, Mihales Polymeropoulos.

Thanks, Steve. Good morning and thank you for joining us. I am pleased to review our recent accomplishments and to talk about our future plans. As I will review in more detail, we believe that we are well positioned to continue our clinical development plans and to obtain approval for and to launch Iloperidone and to pursue potential partnerships.

Let me start with Iloperidone. Iloperidone is our normal treatment for schizophrenia and other psychiatric disorders, which together represent a $16 billion-plus global market. We believe Iloperidone offers efficacy with a differentiated safety and tolerability profile given its substantial commercial promise given in the competitive market. We have several initiatives underway to realize this commercial promise.

We remain on track to file an NDA with the FDA in the fourth quarter of this year. We reported previously that we successfully completed our pre-NDA meeting, which was largely procedural and focused on the structure and content of our NDA submission.

We believe that we are making substantial progress with our four-a-week injectable formulation of Iloperidone for which we already have early Phase II data from previously Novartis-conducted study. The success of Risperdal [answer] points to the commercial importance of improving patient compliance through long-acting injectables.

We believe that our formulation has the potential to have superior patient compliance and consequently efficacy relative to [konsa], which is injected once every two weeks, and they also offer a better tolerability profile than the other two long-acting injectable anti-psychotics in development, Zyprexa depo and [Invega depo].

We also have started substantial freelance commercial activities for the oral formulation of Iloperidone. Though we continue to evaluate partnership opportunities, both global and regional, we are also preparing to launch Iloperidone on our own in the U.S.

We continue to assemble a seasoned team to drive the strategy and to lay the groundwork for the competitive launch. In the past year, these teams have done extensive work on market research, [banding], medical community calculation, and publication planning. Over the next year, we plan to publish our results extensively in peer review journals with an emphasis on our present safety and efficacy as well as an important pharmacogenetic discoveries with respect to the compound.

In total, we expect to present all our pertinent data at major medical conferences including the American Psychiatric Association meeting next month in San Diego and several others in the coming months.

We are also continuing our pharmacogenetics work with Iloperidone. As we have explained previously, our vision is to offer physicians a simple blood test to identify the optimal Iloperidone patients and the optimal dose for those patients.

Our market research suggests that physicians will welcome using such a test to customize treatment for their patients. We believe we remain on track to realize this vision and over the coming months we will continue discussions with the FDA and with potential partners about the steps to operationalize this vision.

Let's turn our attention to VEC-162, our compound for the treatment of sleep and mood disorders. We believe the compound's normal mechanism of action has unique potential in the treatment of both sleep and mood disorders. VEC-162 is a melatonin receptor agonist that works by adjusting circadian rhythm; in other words, by resetting the body clock.

Unlike other melatonin receptor agonists, VEC-162 appears to offer both sleep onset and sleep maintenance benefits because it binds to the melatonin receptors in a balanced fashion. As it works through the natural sleep/wake cycle, VEC-162 also appears to lack the Phase II residual effects associated with hypnotics and sedatives and also should not be scheduled as a controlled substance.

In sleep disorders, VEC-162 may be able to compete effectively with approved drugs that treat primary insomnia and may also be able to treat sleep disorder patients for whom only suboptimal treatment options currently exist.

These include patients with circadian rhythm sleep disorders, or CRSD, which have difficulty sleeping due to a misalignment of the circadian rhythm over a patient's internal sleep/wake cycle does not match the desire of sleep time.

Yesterday we met with the FDA in an end-of-Phase III meeting to discuss the design of additional Phase III trials for VEC-162 in sleep disorders and to lay out potential paths to an NDA for VEC-162. Our plan is still to resume clinical status in the third quarter of this year. We are considering a few different target populations and trial designs including primary insomnia, insomnia in depressed patients, and CRSD. We will provide you with further updates in the near future.

We are pleased to have been invited to present our Phase III insomnia data at the 2007 Associated Professional Sleep Society (ADSS) meeting in Minneapolis in early June.

Let's turn our attention to our third compound, VSF-173. As you saw in our recent press release, we initiated a Phase II trial for this compound. As many of you know, the excessive sleepiness market exceeds $800 million in revenue and is essentially dominated by Cephalon with Provigil.

As you may also know, the mechanism of action for this compound is unknown, which makes it extremely difficult for other companies to develop challenges to this franchise. Our pharmacogenomics expertise allowed us to see the potential of VSF-173 for excessive sleepiness.

Our Phase II trial is a proof-of-concept trial for excessive sleepiness indication. Success in this trial will inform potential usage in a number of patient populations that suffer from excessive sleepiness, which includes sleep apnea, worker sleep disorder, and also new degenerative disorders like Parkinson's and Alzheimer's disease.

We previously reported that we should have results for this trial in early 2008. As enrollment continues, we'll be able to offer you an updated timeline.

Finally, I would like to touch on our recent financial report in the (inaudible) team. As you know, we raised over $111 million in net proceeds in our follow-on equity offering in January. The most important benefits of this is time -- time to evaluate partnership opportunities and to wait for the right deals, in time, to continue to enhance the value of our assets.

We are using this these proceeds to prepare and file the Iloperidone NDA this year, continue Iloperidone commercial activities, start an additional Phase III trial for VEC-162 in chronic sleep disorders in the second half of '07, and conduct the Phase II trials for VSF-173 in excessive sleepiness in mid-'07.

Now Steve will address our financial results for the quarter. I will then provide some concluding remarks prior to opening the call to questions. Steve?

Thanks, Mihales. Overall, our company's first quarter results reflected completion of our clinical development program for Iloperidone and a shift in focus for the preclinical commercial activities in NDA preparation for Iloperidone; for the preparation for the upcoming chronic Phase III program for VEC-162 in the second half of the year; the initiation of the Phase II trial for VSF-173 in excessive sleepiness; and the strengthening of our financial condition as a result of our successful completion of our follow-on offering in January.

Our R&D expenses for the quarter totaled $10.6 million compared to $7.9 million in the fourth quarter of 2006, and $15.5 million in the first quarter of 2006. The quarter-over-quarter increase is primarily attributable to higher costs related to the preparation of the new drug application for Iloperidone, clinical supply manufacturing costs for VEC-162, and the Phase II trial initiation expenses for VSF-173.

The decrease in R&D expenses in the first quarter of 2007 relative to the first quarter of 2006, was primarily due to lower clinical trials for the company's Iloperidone and VEC-162 Phase III trials that were completed in 2006.

General and administrative expenses were $6.2 million in the first quarter up from $4.5 million in the fourth quarter of 2006 and up from $2.9 million in the first quarter of 2006. The increase in G&A expenses in the first quarter of 2007 relative to both the fourth and first quarters of 2006 was primarily due to increased stock-based compensation charges, marketing, insurance, and facility expenses.

We recorded noncash stock-based compensation expense of approximately $4 million in the first quarter of 2007. Of this $4 million approximately $3 million was recorded as G&A expense and $1 million was attributed to R&D.

Our net loss applicable to common stockholders for the first quarter of 2007 was $15.4 million. This compares to a net loss of $11.9 million in the fourth quarter of 2006 and $18.1 million in the first quarter of 2006.

Total cash, cash equivalents, and marketable securities increased by approximately $98.1 million during the first quarter. This increase is primarily attributable to net cash proceeds of $111.3 million from the issuance of common stock in our follow-on public offering, $15.4 million in operating losses, a decrease in accrued R&D and accounts payable of $2.2 million, and approximately $0.1 million for fixed asset purchases.

These items were further offset by $4.3 million of noncash depreciation, amortization, and stock-based compensation charges and $0.2 million of other items.

Our March 31, 2007, balance sheet showed $130 million of unrestricted cash, cash equivalents, and marketable securities, up from $31.9 million at December 31, 2006, and $20.1 million in March 31, 2006.

Finally, our view or outlook for the company's financial performance for the full year of 2007 -- please note that these projections are based on our current expectations about the costs and timing of the activities I will describe.

Full year 2007 financial results are expected to show total cash use from the company's operations to be approximately $80 million to $90 million. The total cash balance at December 31, 2007, is expected to be in the range of $55 million to $65 million before proceeds from collaborations or partnerships that the company may enter into in 2007.

Vanda anticipates that its current funds will be sufficient to complete the work necessary to file an NDA for Iloperidone by the end of 2007, to continue the pre-launch commercial activities for Iloperidone, to expend funds on the extended release injectable formulation of Iloperidone, to initiate at least one additional VEC-162 Phase III trial for chronic sleep disorders in the second half of 2007, to conduct a VSF-173 Phase II trial for excessive sleepiness, and to continue additional R&D activities into mid-2008.

Net loss for the year is expected to be between $110 million and $120 million, or approximately $4.18 to $4.56 per share. Noncash charges for 2007 consisting primarily of stock-based compensation expense and depreciation and amortization expected to be approximately $20 million.

Per-share figures were computed on a weighted average basis of approximately 26.3 million shares of common stock outstanding at the end of the year.

At this time, I'll turn the call back to Mihales.

Thank you, Steve. Let me say again that I am very pleased with the progress that our team has made since our last call. I am extremely proud of the team and results they have delivered, and we look forward to our continued success in the coming months.

At this time, I would like to address any questions.

Ladies and gentlemen (Operator Instructions). Adam Greene, J.P. Morgan.

I was hoping to get an update on the posters that you plan on presenting at APA later this month, then, also, Mihales, if you could go into a little more detail in terms of what transpired at the FDA yesterday with the Phase III design for VEC-162.

Certainly. Let me address the second part of the question about the FDA yesterday, and I will ask Chip Clark to update you on the poster content.

The meeting yesterday with the FDA was the end of Phase II for VEC-162, and we concentrated to understand development fast-forward, in particular, for sleep disorders. The discussion had to do with potential alternatives, number of trials, and size of safety database. This will be a continuing discussion over the next few months, but there is a general tone of excitement from the agency and a lot of interest in developing this compound further. Chip?

Adam, just a couple of points. First is just the principle here that as we get closer to launch, we get closer to revealing the most important data, and this meeting at APA is the first time we will, for a while, be giving you new data building, really, toward ACMP at the end of the year and APA next year as the time when we're going to reveal the most recent clinical data in full detail as well as the newest and greatest pharmacogenetic stuff.

The posters at the APA this year will fall into two categories -- there are a couple of elaborations on older data such as the QT prolongation profile of Iloperidone and a couple of important new papers. The first is on akathesia. This is an emerging side effect concern that causes a lot of treatment failures and is something that is most closely associated with Risperdal, Geodon, and Abilify, and we show some head-to-head data with ourselves an Risperdal.

The second is on TKPD, showing that we understand the dose response curve of Iloperidone, which is critical both because it is not well understood for several of the approved anti-psychotics and also because there has been some question about whether or not Iloperidone's PK/PD curve is well understood.

Corey Davis, Natexis.

First is back to VEC-162, and have you thought about or have you decided the sequence of studies for CRSD primary insomnia in depression? Can you do them in parallel, or does it make more sense to do them sequentially?

Yes, absolutely, we are thinking for all these things, and just to remind everybody on the call that it is our belief that VEC-162 will have obligations not only for primary insomnia but also circadian rhythm sleep disorders, secondary insomnia, the context of depression anxiety but also as a monotherapy for major depression as well.

We are thinking now the trial designs and the sequence of these trials. It is true that some of them can be done in parallel, and clearly a few of them will be done in another lab. But I would say we will have a much better idea in the coming few months of the details of that sequence of events.

But we do maintain that we will start at least one additional Phase III clinical trial by mid-'07 in chronic sleep disorder condition.

And was the discussion with this division of the FDA about discrete indications for each of those three things that we mentioned, or is it at least for CRSD in primary insomnia that it would be one approval, one indication, with subsets to that?

That's a very interesting question. You know very well that primary insomnia and major depression are very well understood, clinical development and regulatory paths. So for that we did not discuss much with the agency yesterday. We focused on CRSD, which is actually the most uncertain clinical development forward given the fact that they have never approved an insomnia drug for CRSD, but they have approved Provigil for the worker sleep disorder for excessive sleepiness.

So we focused on the most difficult and unknown clinical development path, and what I can tell you about that -- they were very receptive in allowing any of the potential indications on the CRSD as a group of indications or as individual indications for the label. And just to remind everyone that under CRSD there are three main indications -- sleep worker sleep disorder; trans-meridian travel, jet lag; and delayed sleep phase syndrome. We had excessive discussion for these things.

And then I originally thought that the plan was to wait for a partnership before starting on these Phase IIIs just from a financing standpoint and from an input standpoint. Has something changed there or did I misread the original plan?

No, there has been no change. We all along communicated that we will start a chronic sleep du jour study most likely in a CRSD indication by mid-'07, and we have continuously said that, with a partner, additional studies can happen in parallel so speed up development towards registration multiple indications. That continues to be the plan.

Okay, and then the last question on 173 -- if, let's say that proof-of-concept study that's starting now doesn't work. Are there other options for it, like, I'm thinking ADHD, that Provigil explored and, for odd reasons, never seemed to work out.

Well, it is very early to discuss what else this compound can be used for. We do believe, however, that in our team development thinking, these trials, the proof-of-concept trial, is pivotal, and it's going to be very important.

Now, you asked about potential other indications where a compound with a Provigil-like profile could go. Excessive sleepiness, as I said, is a symptom, a symptom of different types of disorders including sleep apnea, worker sleep disorder, but also something not very well explored today -- patients with Parkinson's disease and Alzheimer's disease experience quite often excessive sleepiness during the day, and such a compound can be very useful.

Now, on the concept of attention deficit hyperactivity disorder, we understand that Provigil, with a [spinal] indication, showed an ADHD effect, and there were other reasons that this compound was not approved. So that does remain the potential for the Cephalon (inaudible) as well.

Michael Rockefeller, Morgan Stanley.

Just back on VSF-173, it seems like you're starting this trial a little earlier than at least I expected. Is there a possibility that we could see data by the end of '07 rather than '08, which I was thinking? And then, also, if you could just talk about what your commercialization strategy for this product is, assuming that you do get through the clinic?

First of all, let me address the timeline. It is true that the trial starts a little bit earlier than originally we anticipated and planned. It is a smaller trial. We do not have a good idea yet on an equivalent rate. So we are maintaining, for now, beginning of '08, but for the reasons that you pointed out, smaller starting. There is a potential for seeing results earlier.

Now, you asked for commercialization. I think it is difficult to have a very complete plan on that, but I would just point to the potential synergies with the other two compounds, both Iloperidone and VEC-162, addressing physicians with overlapping clinical interest and patients.

David Amsellem, FBR.

First, going back to Iloperidone, can any of you elaborate on your pre-launch activities that are ongoing for the drug this year? And, also, do you have a timeline on when you think you might bring on ahead of sales and marketing in terms of filling out the senior commercial team for the drug, assuming that you do keep rights?

First of all, let me address the head of commercial -- we are actually very actively interviewing people for the position. We want to bring someone on in the very near future. I will ask Chip Clark to address a little bit what the rest of the team looks like and what is the plan for pre-launch activities.

Just to continue on Mihales's point, we are interviewing people. It's our feeling that as long as we have somebody in place by the end of the year, we will be tracking -- well, and, of course, whether or not we do that depends on partnership discussions.

Now, for the other activities we are undertaking right now, first, a little bit on our team. We have a marketing director and a couple of product managers. This is a director that we hired out of Novartis with experience launching CNS compounds. And the team is undertaking a number of different things in parallel right now. Obviously, there's a lot of market research, obviously, there's a lot of value proposition work on the pharmacogenetics. We are also doing branding work. We're cultivating KOLs, we are extensively plowing resources into publications and presentations for the next 12 months or so.

Okay, that's helpful, and then quickly on the depo, can you give us an update on timeline on when you may start any studies there? And where you are in terms of your commercial scale-up?

We are still at the technology transfer stage. Remember, this is a formulation, they are developed internally by Novartis, and we have transferred it now to a commercial partner, manufacturer, to develop the formulation.

It is our intent to have (inaudible) ready for preclinical pharmacokinetics for validation of the commercial batches towards the end of the year, and soon thereafter be ready to initiate the pharmacokinetic study.

Okay, great, and then one last question, if I may. This goes back to 173, I mean, you did mention that there would be some synergies with the rest of the pipeline. Are you inclined -- it may be too early to answer this -- but would you be inclined to bring the product to market on your own, or do you believe that this is a drug that you would look for a partner?

It is possible -- well, I guess (inaudible) is several years as well as from, I would say, some commercialization, but, as you know, as we know from Provigil, the sales force that promotes Provigil is actually addressing general practitioners as well.

So I think the best decision will be made at that time where we will have a lot more clarity on our partnerships and our partners on VEC-162, which will be promoted primarily in the GP community as well as a psychiatric sales force or partnership on Iloperidone. We just need to wait a little while before we are very complete on that.

Lawrence Fleischer, Noble Financial Group.

I wanted to ask two questions -- your comments about Iloperidone, your market research suggesting physicians would welcome a pharmacogenetic test for schizophrenia. I'm hoping you can give us some more detail about that.

Secondly, comments made regarding VEC-162 where you talked about how it's differentiated from other melatonin agonists. Presumably, you're discussing Rozerem. Can you talk about what we've seen in terms of data, thus far, to suggest that there are meaningful clinical differences in the efficacy of the compounds, and whether any of the FDA enthusiasm you alluded to in the answers to the first question were reflective of the differences between VEC-162 and Rozerem. Thank you.

First of all, you asked the question on -- let me see what was that?

Your comment about --

Yes, the uptake, yes. What has been very interesting is when we presented physicians with the base case profile of Iloperidone, and that is the efficacy from the clinical trials, the safety as we know it, and we asked them to quantify how many of their next 50 patients will be placed on Iloperidone. The answer is about 15%, which is a very formidable market share.

When we laid on top of that that a genetic test that gives them some higher probability of efficacy and a genetic test looking for how to best dose these patients, we asked them again, now, with this profile, to date, what would the uptake be? It almost doubles. It went to 28%.

So that is a very big number, and I would say, on the conservative statement, we should be very encouraged that physicians are ready and welcome this type of testing.

You asked the question about the differences between VEC-162 and Rozerem, and I would say the most significant -- yes?

Particularly, also, whether the FDA enthusiasm you referred to in the end of Phase II VEC-162 meeting, you know, relates to these differences that you are about to get into?

Certainly. So the clinical differences, first of all, with Rozerem is that VEC-162 has been proven now in a Phase II and a Phase III 400-patient study to show effect of both on sleep onset, you sleep faster, and sleep maintenance -- you maintain sleep. And it was not just statistically significant but, clinically, very meaningful results.

This is in concert to Rozerem's performance in the clinic where, while it improves marginally, the onset to sleep, it does not have any statistical significant effect on sleep maintenance, and we believe that this is explained by two key factors -- the drugs address different mechanisms. VEC-162 binds both NT1 and NT2 receptors while Rozerem preferentially binds the NT1 receptor and, second, Rozerem is not a highly bioavailable drug. In fact, it is very [co-bioavailable] with less than 2% of what individuals take end up on the bloodstream. Where with VEC-162, our initial understanding, it is higher than 50% or 60% in bioavailability.

You asked me about why is the FDA interested and enthusiastic about this compound? I think it is the combination of both the unique mechanism of [axin]. Two, the very significant data, which, in fact, in our discussions yesterday, it was very clear that the FDA appreciates the magnitude of both the effect on (inaudible) sleep and wake after sleep onset.

But also it's something slightly softer. It is the commitment of the company to take this novel mechanism of action and understand how to fully use it across all types of possible indications.

Excellent, thank you, one follow-up regarding the pharmacogenomic Iloperidone answers you were giving. Would you characterize it, the physician conversations you've had, thus far, would you say that physicians have been well informed about the status of Iloperidone or have they, in general, sort of been under the impression that the drug was still gathering dust on the shelf at Novartis? I mean, have you been bringing physicians up to speed? Do you feel that might account for what the investment community seems to perceive as a lack of enthusiasm among physicians about Iloperidone, maybe it's just due to the fact that they don't yet know what you guys have done with the drug?

It is true that Iloperidone is not very well known, it is not a positive or a negative feeling. It is not very well known among practicing physicians, who are usually informed about drugs in late development by the sponsors or pre-launch. As we said, our efforts are to cultivate this understanding, and the best way that one can do that, the most credible way, is through peer reviews, scientific publications, which we have absolutely committed ourselves post our Phase III results that we'll announce in December to pursue rigorously over the next 12 to 18 months.

The other way that physicians are informed are through meetings. We had the first opportunity to present at the International Congress of Schizophrenia research late March. We are presenting, as we said, several posters at the American Psychiatric Association in San Diego this month, and we will continue to present in several meetings in this year and the coming 12 months.

(Operator Instructions) Corey Davis, Natexis.

This is just a question on the numbers, maybe for Steve. We see your guidance, $100 million to $120 million, but I guess, a, can you just help us through sequentially over the next three quarters? I'm assuming that loss will increase over each successive -- the next three quarters, and, b, I'm also assuming that the majority of that increased spending is coming from R&D, but can you help us quantify the split between R&D and SG&A?

Sure, Corey. When you look at the total guidance for the year, what I would do is assume about 70% of the total spend will be R&D-related, and then of the remainder, about 15% related to marketing activities and the remaining 15% related to general administrative costs.

Yes, the ramp will start out lower in the first half and then increase as we progress into the third and fourth quarters, and that's primarily due to how the clinical trials will progress along and, indeed, the additional costs associated with the VEC-162 trial results in a higher Q3 and Q4 burn as well.

So there will be a ramp quarter 2, a little bit more than what you saw here in the first quarter, Q3 up from that, and Q4 up from that.

Okay, that helps a lot and, actually, one I didn't think of before -- Mihales, have you picked a dose yet for 162?

We will continue to evaluate several doses. As you know, the most successful dose in the last study was the 50 mg dose, but 20 mg was successful as well. So it is quite possible that in the following trials, we will have more than one dose. And, by the way, Corey, that is usually a requirement for people in the Phase III studies by the FDA as well. It's almost like even more than one dose.

David Amsellem, FBR.

On 162, it sounds like you're leaning toward your next study being in a circadian rhythm type disorder, but can you walk through your thinking on a program in mood disorders and given that Novartis has had some success with their melatonin agonist in mood disorders, would you consider moving that forward, moving the 162 forward as well in mood disorders or is that dependent on finding a partner to run the kind of studies -- large enough studies necessary to have in a robust clinical program in that setting?

First of all, let me say that the application of melatonin agonist, again, in major depression as monotherapy is informed, as you said, by Novartis's success in the Phase III programs for major depression in Europe and now, as you may already know, there are two Phase III studies in major depression that are being run side-by-side by Novartis.

We are considering all options at this time. You said whether we're leaning towards CRSD, while this is the immediately informed study from our prior data, it is actually very prudent for us to evaluate clinical programs that will give us data in primary insomnia, data in secondary insomnia, and data in major depression.

And I would say we have not made a final decision yet. The busy season will be coming in the next month or so, and soon after that when we finalize the direction, we will be informing everyone.

There are no further questions at this time. I'd like to turn the call back over to Dr. Mihales Polymeropoulos for closing remarks.

Thank you. Let's conclude this first quarter investor call. We thank you for your interest and continued support to Vanda and we look forward to speaking to you again next quarter.