BioMarin Pharmaceutical Inc (BMRN) 2005 Q3 法說會逐字稿

Good day, ladies and gentlemen. Welcome to the BioMarin Pharmaceutical, Inc. third-quarter 2005 earnings conference call. My name is Anne Marie, and I will be your coordinator for today. At this time, all participants are in 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 Mr. Joshua Grass, Director of Business Development and Finance. You may proceed, please.

Good morning. On the call today is Jean-Jacques Bienaime, CEO of BioMarin; Jeff Cooper, Chief Financial Officer; Steve Aselage, Senior Vice President of Global Commercial Operations; Emil Kakkis, Senior Vice President of Business Operations.

Before we get started, I'd like to remind everybody that this non-confidential presentation will contain forward-looking statements about the business prospects of BioMarin, Inc., including potential future products in different areas of therapeutic research and development. Results may differ materially depending on the progress of BioMarin's product programs, actions of regulatory authorities, availability of capital, future actions in the pharmaceutical market and development by competitors and those factors detailed in BioMarin's filings with the Securities and Exchange Commission, such as 10-Q, 10-K and 8-K reports.

Now, I'd like to hand the call over to JJ Bienaime, BioMarin's CEO.

Thank you, Josh. Good morning to everyone. Before getting into the financial results, I would like to touch upon some important accomplishments and upcoming milestones for BioMarin.

First, Jeff Cooper has now assumed the role of Chief Financial Officer at BioMarin. Jeff was most recently acting CFO and Vice President and Controller for BioMarin, and so this has been a seamless transition for us. So Jeff will cover the financial results for the third quarter in a couple of minutes.

So as we head into the final stretch of the year, I want to highlight the progress we have made on a number of programs. First, the U.S. Naglazyme launch is well underway. And following the positive opinion from European authorities, we expect to launch in Europe early in 2006 assuming final approval.

Aldurazyme continues to grow. Yesterday, we raised our Aldurazyme sales guidance for this year to a range of 74 to $77 million, up from our previous guidance of 70 to $75 million. Enrollment of the Phenoptin Phase III study in PKU is proceeding as planned, and we are on track to announce topline results from the double-blind, placebo-controlled portion of this study in late March of 2006.

We have greatly reduced the spending related to Orapred through a major sales force reduction, and we have filed the Orapred oral-dissolving tablets NDA with the FDA, which was recently accepted for review by the FDA. We hope to receive marketing approval for Orapred ODT June 2006, and we are evaluating all strategic options with Orapred so as to maximize the value of this asset.

And finally, we are well into the planning phase for our program to evaluate BH4 in cardiovascular indications, an area in which we continue to see new data published, supporting the importance of BH4 in a wide range of diseases involving endothelial dysfunction.

And now, Jeff will cover the financial results for the quarter.

Thanks, JJ. Starting with net sales from Naglazyme during the third quarter, BioMarin recorded 2.3 million, bringing sales for the 9 months ended September 30, 2005 to 2.4 million. As a reminder, Naglazyme was launched June 20, 2005.

Sales of Aldurazyme reported by the BioMarin/Genzyme joint venture were 20.1 million, an increase of 95% over sales of 10.3 million in the third quarter of 2004. Aldurazyme sales for the 9 months ended September 30, 2005 were 55.2 million compared to 27 million for the same period last year. BioMarin's share of the profits in the joint venture in the third quarter of 2005 was 3.4 million compared to a loss of 0.5 million in the third quarter of 2004. For the 9 months ended September 30, 2005, BioMarin's share of the profits from the JV was 8.8 million compared to a loss of 4 million in the same period last year.

Net sales of Orapred, including the branded and authorized generic product, for the third quarter of 2005 were 200,000, which were equal to net sales of the third quarter of the previous year. Demand for Orapred is generally correlated with the flu season when exasperation of asthma in children is more common. So we expect the demand to be substantially lower in the second and third quarters relative to the fourth and first quarters of the calendar year. Net sales of Orapred for the 9 months ended September 30, 2005 were 6.5 million compared to 4.7 million for the same period in 2004.

The Company incurred a net loss of 15.5 million or $0.21 per share in the third quarter of 2005 compared to a loss of 29.5 million or $0.46 per share in the third quarter of 2004. Research and development expenses increased by 2.1 million to 13.9 million in the third quarter of 2005 from 11.8 million in the third quarter of 2004. The increase is primarily attributable to a 3.4 million increase in Phenoptin clinical and manufacturing activities and offset somewhat by a 2.3 million decrease in Naglazyme research and development costs.

Sales and general and administrative expenses decreased by 3 million to 9.8 million in the third quarter of 2005 from 12.8 million in the third quarter of 2004. This was largely due to the reduction of the Orapred sales force, which occurred in July of this year.

Cash, cash equivalents, short-term investments and cash balances related to long-term debt totaled 83.9 million as of September 30, 2005. We are updating the financial guidance for net product sales as well as for projected net loss and end of year cash balance for the fiscal year ending December 31, 2005. This guidance was last provided in a Company press release issued August 1, 2005.

With regard to 2005 product revenue guidance, we are increasing Aldurazyme sales guidance to a range of 74 to 77 million, up from our previous guidance of 70 to 75 million. This is the second time we've raised guidance for Aldurazyme this year. The original guidance was 60 to 66 million.

Naglazyme sales guidance for the year remains unchanged at 4 to 6 million. And we are lowering our Orapred sales guidance to a range of 7 to 8 million, down from 8 to 10 million. This reduction is primarily a result of continuing generic competition for the liquid formulation.

As for 2005 financial guidance, we are lowering our projected GAAP 2005 net loss to be in the range of approximately 73 to 78 million, down from our initial projection of 75 to 80 million. This includes Orapred deover-related (ph) expenses of approximately 6.7 million. We are also updating our guidance for the cash balance at year end, increasing it to a range of approximately 59 to 64 million, up from our initial projections of 55 to 60 million.

That concludes my prepared discussion and analysis of Q3 2005 financial results. Now, we would like the operator to open up the call for questions.

(OPERATOR INSTRUCTIONS). Phil Nadeau, SG Cowen.

(technical difficulty) sales in Europe under I guess you call a "compassionate use basis." Could you--?

Phil, could you start over the question? We could not hear the beginning of your question; there was a technical problem.

The first question is on Naglazyme. I understand it is only approved in the U.S., but it does sound like you can recognize some revenue from Europe based on sales on I guess what you would call a "compassionate use basis." How much of this quarter's revenue that was recorded on the topline came from the U.S. versus how much came from territories outside the U.S.?

The majority came from the U.S.; a few hundred thousand came from European sales.

My second question is actually on Orapred. In the past, you said that you were going to run this franchise as a breakeven or slightly profitable entity. Is the franchise currently breakeven or profitable? And if not, what do you plan to do with the franchise in the future?

Well currently, the franchise is slightly less than breakeven due to the lowering in sales that occurred over the past number of months. However, with the reduction in spending and our potential launch of the ODT business, we absolutely expect the franchise to be very profitable.

(multiple speakers) I tell you just to throw in on that; we've done some recently implemented some marketing research on Orapred ODT to better understand the potential of this product, and that market research was very encouraging as to the reception aproris (ph) of the paid prescription community for ODT.

And so we really are looking at all the options to maximize the potential revenues of this product, whether they are within BioMarin or through a partner. So we believe there is some business to be gained there and that that will be the franchise once we launch ODT -- will be profitable.

Are you considering ramping your sales and marketing spend behind the Orapred franchise?

Yes, we're looking at different options. If we decide to launch the product ourselves and again that is only one option, it's unlikely that we would build a sales force inside BioMarin. To do it and deploy it, we use a contract sales organization to do it. So there would be yes marketing expenses to that. But we're not planning on building fixed sales expenses.

Steve Aselage is on the phone. I don't know; Steve, do you want to add to that?

No, I think you hit it right on the head. There is an opportunity with ODT we want to take advantage of, but it is not an opportunity that we want to build a significant internal commercial structure to support for the long-term. We can take it to market with a contract sales organization, hopefully minimize our costs but still get some significant value from the franchise.

My last question is actually on both Aldurazyme and Naglazyme. In the past, you have shared with us your own estimates for the number of patients out there that have been diagnosed and identified by BioMarin. What are your latest estimates for the number of patients worldwide would be appropriate for Naglazyme and for Aldurazyme?

You mean the whole market?

That's right. Well, the ones that you have yourself identified and maybe how that compares to the whole market?

Then I will tell you what, I think at the last call when we reported Q2, we said that now that Naglazyme was on the market, we would stop reporting the number of patients identified. I think before that time, it was about slightly less than 300 patients for Naglazyme. But that would be the last time we would be reporting this information; that does not mean that our efforts to continue to identify patients have been terminated, not at all. We are still continuing through that first. But now that the product is on the market, the importance is to get patients treated and reporting revenues through that.

I think Genzyme looks at about twice a year or so -- reports the number of patients that are treated, not identified, but treated. And we might do that ourselves starting with Q4 of this year.

Now in terms of our estimates of the worldwide patient population, it hasn't changed recently. Based on epidemiologic study, we believe in the developed world it's about 1,000 patients for MPS VI for Naglazyme and about 3,000 patients for MPS I, which is served by Aldurazyme. Emil, do you want to add anything to that?

No, I don't think we have any more. I think that's information we still have. I think we said we had 300 MPS VI patients, approx 294 identified at the last call, and that represents a significant fraction of 1,000. Finding these patients is a challenge because they are scattered about; they know certain diagnoses as well. But it's certainly an effort we are continuing. It's important to both franchises in their developments.

Alan Leong (ph), Biosoft Research (ph).

Congratulations on the approval in Brazil in August. There is an interesting cluster of MPS I patients here in Brazil, since Aldurazyme was just approved in August for them. Are the bulk of Brazilian MPS I sufferers just now obtaining the drug, or were they already receiving it before this current quarter?

In Brazil, we have some studies ongoing that relate to both marketing commitments, so there are some patients getting drug as part of study. Commercially, the other is a significant process that Genzyme is working through to get reimbursement in Brazil. I don't have any specific numbers for you on patients on commercial -- of paid therapy yet in Brazil.

I can't give you any specific numbers either, but Genzyme is working actively to roll patients off the study on to commercial. I believe they had some patients receiving commercial product even prior to the approval through an in-patient basis program.

JJ, you got me excited on the use of Phenoptin with vascular problems. Hopefully, I did not miss something, but are we still looking at a possible Phase II for next year?

I mean I have thought on this; I will let Emil elaborate. But yes, actually we -- and I will get back to that again on the call -- we're having an R&D Day in New York in early December, where we will be outlining our strategic staple plan for BH4 in cardiovascular. And right now, our intent is indeed to initiate some (technical difficulty). We're opening some Phase IIA studies in one or several cardiovascular indications by the middle of 2006 and so that hopefully we can get some results in earlier studies. But Emil, do you want to--?

Yes, we are on track to do that at this point; that is starting some exploratory Phase IIA-type studies in the middle of next year. We want to do it in a very careful, methodical fashion. We're not going to go into very large (technical difficulty) incurring the expenses. We have assembled a group of cardiovascular advisers, the top people in the field, which we will talk about at our R&D Day, who are gathering to help us guide us through the process of looking at these indications. But I think the group is a very solid group, and I think you'll get more information at our December 6th R&D Day.

But we are very excited about it. It's a key focus of what I do and the team and the program management's -- and others of the Company now. So expect more information on December 6th. But we are on track for our Phase IIA in next year.

Joseph Schwartz, Leerink Swann.

A couple questions on Naglazyme. The gross margin in the quarter was extremely robust. I was wondering if you could share some commentary on that, if that's sustainable or maybe perhaps just an anomaly for this quarter. As well, some fundamental commentary would be helpful regarding how useful the Aldurazyme experience may be for extrapolating the continued rollout of Naglazyme now that you have a quarter of experience with that drug under your belt. Thank you.

With regard to your question on the gross margin, the costs get sold for Naglazyme is minimal because we're still selling previously-expensed inventory that we built prior to approval. However, we expect Naglazyme to have gross margins in the 70 to 80% range once we are producing larger volumes similar to other biologics and work our way through the pre-expensed inventory.

But regarding next end of the commercial experience of Aldurazyme on Naglazyme, I will let Steve Aselage answer that.

I think it has actually been very helpful. Clearly, Genzyme has over a decade of experience in the enzyme replacement. I think they deserve credit for having blazed a lot of trails in the area. And we have learned as much as we can from watching them both with the Aldurazyme experience and also what they've done with their other enzyme replacement therapies. That holds true in the United States, and I think the experiences they have had in rest of world as far as which countries have they been able to get reimbursement for, pricing levels in those countries, timing to approval and processes can give us at least guidepost for our own approaches in other countries. And it hopefully will save us a lot of time and a lot of effort.

Okay, that is very helpful. And then just one follow-up if I might regarding guidance for Aldurazyme. I think in the past, it's been Genzyme that released that to the street on behalf of the joint venture. Does the difference this quarter, if it is one, with you releasing that guidance, does that signal anything with regards to management of maybe BioMarin taking a greater role in guiding that franchise?

No, no. Actually, no. We have communicated with Genzyme prior to this call to make sure that we were in agreement with the guidance. And for BioMarin, this is an important product relatively to our revenues as compared to Genzyme, and I think this is the reason why we are giving guidance more than anything else. But Genzyme is still fully responsible for the commercialization of this product on a worldwide basis in collaboration with us, but they have primary responsibility for it.

Navdeep Jaikaria, Rodman & Renshaw.

This is Vernon Bernardino calling in for Navdeep. Congratulations on an excellent quarter, especially the Aldurazyme sales were very impressive. I just wonder if you could answer a few questions. And that is, just wondered if you could talk a little bit about the current Aldurazyme penetration rate. And also could you characterize how MPS I patients are captured for Naglazyme at this point in the launch? And then also, if we could get an update on Phenylase as well as just a little more color on the vascular dysfunction program with BH4.

We have lots of questions here. In Aldurazyme, I think we have talked about during the call and in Q&A about Aldurazyme penetration. Again, the whole worldwide market is about 3,000 patients. And I think we are far from having sweet payem (ph) in Genzyme with us; it is far from having penetrated this whole market. This market take years to develop and penetrate. If you look at PrFabrazyme as an example; that was the first enzyme replacement therapy. After I don't know 15 years or so on the market, now it is still growing. So again, we're still at the beginning of the lifecycle of Aldurazyme.

So I think you had questions on Phenylase and BH4 cardiovascular. I will let Emil answer that as to where we stand with Phenylase and again reiterate what we just did on BH4 cardiovascular.

The Phenylase program is our preclinical stage program to treat the more severe heart portion of the PKU population, BH4 being the drug we are developing with Phenoptin for the milder half. And the Phenylase program is continuing in developing the molecule. It's an enzyme substitution therapy, and we expect it to be a subcutaneous self-administered injection.

But we are still in preclinical experiments trying to optimize and fine tune the molecules, so we go into the clinic with something we feel has all the right properties. We will expect at some time by the middle of next year, we will have a better understanding when we finalize what the molecule is and would be able to give better guidance on the future of that program at that point in time. We do think it's an important product for PKU patients, particularly those that don't respond to Phenoptin.

The question you had was on the cardiovascular program; I think we have talked a lot about it. And what we have said in our presentations previously is that there is increasing evidence that endothelial dysfunction, which is the inability of your blood vessels to make nitrous oxide and dilate properly, is in many cases due to a secondary BH4 deficiency. That BH4 deficiency appears to derive from a number of different problems that can occur in the vasculature. In the case of diabetics, it appears that glucose suppresses the biosynthesis of BH4 until it becomes deficient.

Smokers, the smoke actually destroys the BH4. In all cases, secondary BH4 deficiency occurs, and this makes the blood vessels unable to make NO.

So we believe that BH4 as a treatment for vascular disease is really a replacement therapy for a secondary deficiency that occurs in a number of different disorders. And we can -- there's substantial literature out there. And if you would like to check it, you simply look up tetrahydrobiopterin on MEDLINE, and you will see a wide array of literature on the topic of secondary BH4 deficiency and its relationship to endothelial dysfunction.

So because of this core importance in how the body makes NO, we believe that BH replacement, BH4 deficiency is a potential treatment for cardiovascular disease. But our plan is because of the wide array of indications that are possible, we can very carefully and thoughtfully explore through small Phase II studies a series of possible indications and from that engage the best direction to take the molecule forward. We expect to start that assessment in the middle of next year.

Will there be any BH4 studies related to cardiovascular disease presented at AHA this year?

No, not that we have conducted ourselves. There have been over the last few years (technical difficulty) that people have presented relating to BH4. So the scientific sessions that you are talking about in mid-November are very broad and include a wide array of both animal and other studies. There may be BH4 studies being presented but not ones that BioMarin has sponsored. But the literature is extensive, so I would not be surprised if there were not some BH4-related topics.

And then lastly, maybe I missed the answer -- at this point in the launch, how are the MPS patients captured for Naglazyme?

I don't know, Steve, if you want to talk about that?

Steve, do you want to talk about it?

Yes, I think if by captured, you are talking about rolled into a therapy with Naglazyme, those patients are being worked up and followed in the genetic centers and then treated by the geneticist. If you are talking about how they're found out of the general population and then moved into the referral system and to the geneticist, there's a variety of different ways in which that happens -- ranging from a primary care pediatrician noticing a cluster of symptoms that leads them to feel that genetic testing is appropriate to a variety of subspecialists that are referred to when specific disease manifestations are noticed and a specialist is asked to take a look at the patient. It might be an endocrinologist, a pediatric endocrinologist. Due to short stature, it might be a radiologist or an orthopod due to joint problems or a variety of other subspecialists of it all -- ophthalmologists; ear, nose and throat physicians.

So part of our goal is to create awareness within both general pediatrics population and within the subspecialties if there is a treatment available. And if there is a suspicion of an underlying genetic disease, that early testing and referral is important for the well-being of the patient. And we're putting substantial efforts into helping those patients be referred to a physician, who is in a position to give them the help that they deserve.

Maneesh Jain, Thomas Weisel Partners.

I was hoping to actually drill down to Naglazyme a little bit as well. You kind of mentioned the translation of your experience with Aldurazyme, but I was actually hoping to learn more about the translatable experience in the U.S. for Naglazyme into Europe, specifically some of the programs that you just mentioned, perhaps your experience with securing reimbursement across different countries.

When do you think you'll be building out the sales force? And how many people you think you'll need in order to build out an effective sales force in Europe?

I will just say a few words, and then I will let Steve Aselage add to it further.

But as we see as it is right now in Europe, we are hiring people as we speak. And we have hired already several people, and so we are very actively putting together a commercial infrastructure in Europe. And just a few more words before I will let Steve talk -- but regarding reimbursement, we're also already actively prepared for reimbursement in different countries. If you knew this done (ph), we are already selling the product on our name/patient basis in several countries, which bodes well for future reimbursement for the product in different European countries. But Steve, please pick up from there.

Yes, I would say that the reimbursement situation in the States is substantially different from that in the EU. Obviously, it is a state system in major EU countries. And what we are doing is preparing value dossiers that we will take into each country. We have gotten some outside expertise in that area to provide us some assistance, making sure that that is done right and done on time.

We are, as JJ mentioned, currently pulling a commercial group together. We feel very fortunate that we can adequately cover Europe with a very small commercial structure. We will have a European branch office in London, which will provide some medical regulatory marketing support. And we will have a very small group of country managers. We anticipate that we will be able to cover the major European markets with five country managers. Three of those positions have offers out and accepted already. And as JJ mentioned, I am in London today interviewing for the other open positions. We anticipate being in a position to launch the product by early Q1 of 2006.

Dr. Anthony Pfaffle, Black Diamond Research.

Three questions in terms of pricing for BH4 for Phenoptin both in the PKU setting and also in potentially in the vascular setting. And then if there would be any difference between pricing for Phenoptin versus Phenylase? And how we might look to model that in the future?

That is a good question. We are still -- we had filed for PKU in -- starting right now in early '07. So we still have a little time to figure out -- or finalize our pricing strategy. But the use of medical formula today for these patients when they are on diet is around $10,000 a year. And it's very impossible and very difficult to follow up. And we believe that we are providing an unmet medical need here, which should command some premium over the $10,000; that is all I can say right now. So we have not established a price.

So for cardiovascular, we also have even more time to figure it out. The brand name, Midudifioneagan (ph), is going to be the same; active ingredient is going to be 6R-BH4, but it will be a different brand name. And by the time the product -- if everything goes well -- by the time we get into cardiovascular, it will have been on the market for several years hopefully for PKU and we will have time to modulate the price accordingly and according to what the doses will be required in two different indications. So we anticipate it is quite manageable.

And finally, for Phenylase, in this Phenylase, it will be an enzyme substitution therapy, not oral therapy. So it will be a subcutaneous injection, which will be able to address the entire PKU population, not only the mild-to-moderate patients. And consequently, it's likely to command a premium over Phenoptin; I will agree with that.

As much of a premium -- it is hard to tell today until we continue to develop the product and see what kind of clinical profile Phenylase has as compared to Phenoptin. So it's all we can say at this time. Anything you want to add, Emil?

I would add one other thing on the dosing issue. In PKU, we are using pharmacologic doses to treat the mutant protein, which can be -- which may be who are they intending for kilo (ph), but it could be anywhere for them 10 to 20 perhaps mixed with kilo.

In the replacement setting, the doses are likely to be potentially lower so that even if the same product were being used, which I think is just your question, it's likely that the PKU pricing would not substantially be altered by what would be needed in the diabetic population, assuming a dose difference of let's say five-fold lower dose than diabetics for example.

We haven't set though -- we have done studies to know what the dose is but absolutely. And so, there are certainly uncertainties, but we are aware of that potential issue. They're also other possible combination formulations for BH4, which are also under consideration that might optimize treatment with sample diabetics or other populations. So those are also other ways in which we might distinguish the two forms of products.

And one last follow-up, is it too simplistic to assume that because PKU is screened for on a mandatory basis on a state level that the patients will be identified and almost delivered to BioMarin as opposed to the roundabout way of finding patients that have MPS I or MPS VI?

Yes that's also a good question. Carry -- all newborns are screened at birth, so the parents know right away if their child has PKU. So in this respect, there should be less of a need for patient identification programs. However, my experience in the biosecond (ph) pharma entries shows that patients are never delivered to you on a platter. You always have to go out and get them and educate the medical community on the value of the treatment, so the marketing efforts will be needed. But finding the patients should be less of an issue that it has been for MPS I and MPS VI.

So there is certainly some concentration of the patients in the genetic centers. And the market research that we have done to date is actually very encouraging. It is a substantial majority of the patients are being followed in one of the genetic centers.

There are some patients, particularly as they reach adulthood, that fall out of the system and are lost to follow-up, and that will be one of the challenges and opportunities for us -- is to make the awareness that there is a therapy available now that can really help these patients and to get them back in the system. But it is a much more concentrated patient population than certainly the MPS.

Well, gentlemen, thank you, and congratulations on the continued progress on the resurrection of BioMarin.

(OPERATOR INSTRUCTIONS). Craig Yesim (ph), Arthos (ph) Capital.

Can you just help us understand a little bit about how the collaborative agreement revenue line is put together? Obviously, it is the amortization of the upfront Serono payment. How can we think about the additional component of that? And what did it consist of this quarter?

Yes, the collaboration revenue consists of two components. One is the amortization of the $25 million upfront payment from Serono related to Phenoptin that occurred earlier this year. The second component is the reimbursement of 50% of the ongoing Phenoptin development costs from Serono, which totaled about $2.8 million this quarter.

And is that level supposed to be relatively consist quarter to quarter?

It's really a function of the spending. As spending increases, then that reimbursement would increase also.

There are no further questions at this time. I would like to turn the conference back to Mr. Bienaime for any closing comments.

Thank you. So in closing, I think BioMarin is a unique position as a Company. There are very few small cap biotech companies I can think of with a profile like BioMarin, which is indeed why I accepted the job as CEO earlier this year. And we have three products on the market; two of which are protected by both orphan status and patents that will likely grow for many years into the future and for which there is currently no significant competitive threat. These two products alone, Aldurazyme and Naglazyme, will likely generate more than $100 million in combined sales in 2006.

We have a third product, Phenoptin for PKU, which is a more common genetic disease, which we believe represents a very favorable risk profile for investors, as we are only testing patients in our Phase III trials that have demonstrated positive response to the drug. This product could be launched in 2007, late 2007, and it has orphan designation in both the U.S. and Europe.

BioMarin has two top-tier corporate partners, Genzyme for Aldurazyme and Serono for Phenoptin and Phenylase, ex-U.S. and ex-Japan. And while Orapred has been a challenging business for BioMarin, given where we stand today, there could be substantial upsides in the ODT formulation. Beyond that, we're working on Phenylase for PKU patients that do not respond to Phenoptin and BH4 in other indications that represent large market opportunities and that could significantly alter the valuation of the Company.

In closing, I would like to remind you that we're presenting at two conferences in the next few weeks -- at the Rodman & Renshaw Conference in New York on November 7th and the SG Cowen conference in Barcelona on November 10th. And this invitation will be webcast, and you can access them through our website at www.biomarin.com if you are unable to attend. We are also hosting an R&D Day in New York on the morning of Tuesday, Decembers 6, and we hope you can attend.

So for an invitation to the events or if you have additional questions, please contact BioMarin's Investor Relations department at IR@biomarin.com. Thank you and good-bye.

Ladies and gentlemen, this call will be available for replay purposes. To dial toll free, it is 888-286-8010 or internationally 617-801-6888. The access code for the replay will be 32265695.

Ladies and gentlemen, we thank you so much for your participation in today's conference. This does conclude the presentation, and you may now disconnect. Have a great day.