Good day ladies and gentlemen and welcome to the BioMarin Pharmaceutical fourth quarter 2008 financial results conference call. My name is Wayne and I’ll be your operator for today. At this time all participants are in listen-only mode. We will conduct a question-and-answer session towards the end of this conference. (Operator Instructions) I would now like to turn this call over to your speaker for today’s conference, Ms. Eugenia Shen, Senior Manager of IR. You may proceed ma’am.

Thank you. On the call today is J.J. Bienaime, BioMarin’s Chief Executive Officer; Jeff Cooper, Chief Financial Officer; Emil Kakkis, Chief Medical Officer and Steve Aselage, Senior Vice President of Global Commercial Development. This non-confidential presentation contains forward-looking statements about the business prospects of BioMarin Pharmaceutical, including expectations regarding BioMarin’s financial performance, commercial products and 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 developments 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 turn the call over to J.J., BioMarin’s CEO.

Thank you, Eugenia and good afternoon and thank you for joining us on today’s call. So, I have a few introductory comments before Jeff reviews the financial details of the fourth quarter and full year 2008. Steve will then provide more detail on commercial activities, and Emil will provide an update on our ongoing R&D programs before we open the call for questions. So first, 2008 was a significant year for BioMarin. As we achieved our first fully profitable year and we ended the year with total revenue of nearly $300 million, three growing commercial products on the market, a robust pipeline and $560 million in cash and investment, which keeps us well-positioned for continued long-term growth. We are pleased to report fourth quarter and full year 2008 results with an increase in total BioMarin revenue of 121% and 144%, as compared to the fourth quarter and full year of 2007 respectively. Naglazyme continues to perform well, with an increase in net sales of 43% and 54% as compared to the fourth quarter and full year 2007 respectively. We continue to make tremendous progress in international markets such as Brazil, in which we recently secured regulatory approval from the National Health Surveillance Agency. We remain confident that Naglazyme represents a $300 million best market opportunity for BioMarin and it will continue to contribute significantly to top line growth in the coming years. Next, net third party sales of Aldurazyme by Genzyme increased 22% for the full year of 2008 as compared to 2007. Five years after launch, Aldurazyme is still growing at healthy double digit levels with good prospects for continued market expansion, similar to other therapeutics addressing orphan genetic diseases. Finally, Kuvan net revenue of $15.1 million in the fourth quarter and $46.7 million for full year 2008 were…

Thanks, J. J. I’ll start by reviewing product revenues of Naglazyme, Aldurazyme and Kuvan for the fourth quarter and year ended December 31, 2008 and follow with collaborative agreement revenue for the same period. I will then review our bottom line for the quarter and year ended December 31, 2008 and follow with a more in-depth look at our financial results before reviewing our expectations for 2009. Beginning with Naglazyme, net product revenue for the fourth quarter of 2008 was $36.5 million, an increase of 43.1% over net product revenue of $25.5 million in the fourth quarter of 2007. Naglazyme net product revenue for the year ended December 31, 2008 was $132.7 million, compared to net product revenue of $86.2 million for the year ended December 31, 2007. Naglazyme net product revenue growth is attributable to geographic expansion internationally, the initiation of therapy by previously identified or newly diagnosed patients and weight gain as patients grow. Net sales of Aldurazyme by Genzyme were $37.6 million for the fourth quarter of 2008, representing an increase of 6.2% over net sales of $35.4 million for the fourth quarter of 2007. Additionally, fourth quarter net sales of Aldurazyme by Genzyme of $37.6 million were slightly lower than Q3 2008 sales of $38.2 million. The reduction in sequential sales is entirely due to the negative impact of foreign currency exchange rates, which had an approximate $3 million impact on Aldurazyme sales by Genzyme in the fourth quarter of 2008, as compared to the third quarter of 2008. Net third party sales of Aldurazyme by Genzyme for the year ended December 31, 2008 were $151.3 million, compared to net sales of $123.7 million for the year ended December 31, 2007. Net product revenue of BioMarin related to Aldurazyme was $14.4 million for the fourth quarter…

Thanks, Jeff. Starting with Naglazyme, we continue to find significant numbers of new patients, particularly in regions such as Latin America, the Middle East and Turkey. We received marketing approval from Brazil’s regulatory authority on Visa a few weeks ago, which will allow us to more aggressively market the product there. Brazil is already our largest market and we are aware of many additional untreated patients who could benefit from therapy. It is probably worth noting that, Latin America transactions, including Brazil are currently done in U.S. dollars, so currency fluctuations do not impact revenues from this region. Please also keep in mind that as international becomes a larger portion of our revenue, the greater percentage of orders come from government entities that tend to buy in larger quantities, but less frequently. This situation is likely to cause some quarterly fluctuations going forward as we experienced in 2008. From our assessment of the market, we believe there remains significant untapped potential, particularly in the international region, which is the largest contributor to Naglazyme growth. In addition to Brazil, some areas where we see significant near-term growth opportunities include Turkey, Eastern Europe, Russia, and several countries in Spanish speaking Latin America. We are confident with our peak sales estimate of Naglazyme of around $300 million, which is double our expectation at the time of launch. Turning to Kuvan, we are encouraged by the progress we’ve made over the last year in this very complex market. As announced in January the rate of patient referrals accelerated in October and continued throughout the end of the year. We believe this was primarily the result of the free drug program, which was very well received by both patients and physicians. We have decided to continue this program through 2009, which will now offer patients…

Thanks, Steve. Starting with the BH4 cardiovascular program, we recently reported that results from the Phase II peripheral arterial disease study was not statistically significant. In the first quarter of 2009, we expect to have more data from the mechanistic study of BH4 plus Vitamin C in patients with endothelial dysfunction and an investigator sponsored study in pulmonary arterial hypertension. Early in the second quarter, we expect results from the investigator sponsored study to reduce proteinuria in patients with chronic kidney disease. Along with the results from the positive Phase IIa sickle cell studies, the collective results will help determine the future of the 6R-BH4 cardiovascular program. Moving on to PEG-PAL, we are now in the fifth cohort of the Phase I study, which will assess the safety and PK of single injections of PEG-PAL in 35 PKU patients of up to seven escalating dose cohorts and is expected to conclude by the second quarter. We expect to initiate a Phase II also in the second quarter of 2009. Pending discussions with the FDA, we may start the lower doses in the Phase II study before the completion of the Phase I study. The Phase II study will evaluate the safety and efficacy of weekly injections for eight weeks, followed by dose optimization in an extension period. This will be the true proof of concept study for the drugs considers the efficacy of repeat dosing in the presence of any immune response, that is the key question to answer. Beyond PEG-PAL our GALNS program for Morquio MPS4a is on track to enter the clinic by the end of March or early in the second quarter of 2009. Syndication fits well with our core development regulatory and commercial competencies and we hope to leverage our strengths to provide the first treatment option for this unmet medical need. There’s a large number of identified Morquio patients in clinics worldwide and many are eager to be treated. In terms of our other preclinical programs, as announced in July of 2008, BioMarin and Summit signed a development agreement for the clinical development of SMT 1100, a small molecule inducer of utrophin, a protein that can potentially replace the defective dystrophin protein in patients with Duchenne Muscular Dystrophy. Based on some early preclinical work, some reformulation work was needed as well as additional toxicology studies, which has pushed out the start of the clinical program. We have not yet set a time for the clinical study, but once the formulation and preclinical plan are resolved, we will be providing a more precise timeline for moving ahead to a clinical program. Turning to our product BMN-103 for Pompe disease, we continue to evaluate several partnering options for this program, although we have not excluded the possibility of developing this product ourselves. We’ll keep you updated on our progress on this and other programs as they advance. With that operator, we would now like to turn the call over for questions.

(Operator Instructions) Your first question comes from the line of Chris Raymond from Robert Baird & Company. You may proceed sir. Chris Raymond - Robert Baird & Co.: Thanks for taking the question. Guys, I’m a little surprised by, I guess, it seems perhaps it’s the SG&A guidance that’s driving your long range earnings, a huge differential obviously. I’m sure you’re aware to where consensus expectations are and if you do the math on SG&A for 2009, it looks like you’re about $20 million to $30 million higher than anybody thought. Can you maybe walk through the logic there? Is this is all Kuvan promotion related or is there some other thing that we’re missing on some missing lack of leverage in the model that we didn’t see?

Sure, I’ll be happy to address that just from a financial perspective. We’ve provided a range of guidance for SG&A, but we’re certainly trying to target our spending towards the lower to middle end of that range. The increase in the SG&A as compared to 2008 is due to several factors. First of all, we are increasing our spend on Kuvan for a number of the commercial programs that Steve has previously alluded to. So, the spending for Kuvan, as we continue to grow sales has increased. In the case of Naglazyme, we are spending additional funds to grow the product internationally, both in existing markets such as Brazil, but also in some of the newer markets that we’re targeting and hoping to enter. The other things that are impacting the total spends are the non-cash stock compensation, which is purely driven by the number of options in pricing the accounting rules. That spend is going to be about $5 million higher in SG&A than it was in 2008. Then finally, there’s just some other corporate costs, including depreciation from the facilities that we’re completing and facility related costs that are increasing the overall spend. Also, we’ve implemented ERP program that went live the beginning of this year. So, the costs associated with that program, which were capitalized last year, are now being incurred this year, so certainly a number of different factors that are driving it. Chris Raymond - Robert Baird & Co.: So all that wraps up to about $20 million to $30 million higher in SG&A. So what’s the delta then in 2010 and 2011? What’s driving essentially the having of expected non-GAAP earnings?

Well, I think this is really a number of factors. As you look at 2009 compared to 2008 first of all, remember that we’re not recognizing any of the collaborative agreement revenue, which totaled over $35 million in 2008 and drops right down to the bottom line. So, we won’t see much of that if any, other than a little bit of reimbursement revenue beyond 2008. Also, as you look at 2009, we’ll have the ripened expenditures of one time charge there that we hadn’t seen previously. As far as the other spending is concerned, again it’s driven by increases in R&D spend as we assumed progression of our programs into later stage activities and growth of our revenues that are being supported by our programs. So, it’s really a combination of items. The other thing I should mention, which has an important impact on the bottom line is the interest income. You may recall that back in 2007, we’re earning well over $25 million a year on our investment portfolio, which at that time was earning well over 5%. The rates that we’re seeing now are closer to 1%. So, we’re seeing a huge drop in the investment earnings that we’ve seen before and compared to 2008 we’ll see another drop of or it could be as much as $10 million or more. So, that’s another factor that drops right down to the bottom line in terms of the total picture. Chris Raymond - Robert Baird & Co.: Not to keep harping on this, but you mentioned one of your line items as Riquent; are you insinuating there’s 2010 and 2011 in Riquent?

No, I was just talking about 2009. That 2009 expenses reflect the Riquent, but clearly there wouldn’t be any Riquent expenditures in 2010 or 2011. Chris Raymond - Robert Baird & Co.: And all this adds up by 2011 to essentially a $100 million delta between where expectations are and where you’re guiding?

Well, I think the way I’d look at it is from our perspective we’re looking at the total bottom line on a non-GAAP basis by 2011, in the $100 million range, which is a pretty sizable growth as to where we’re at right now. It’s obviously different what expectations may be, but it certainly shows continuing growth as compared to where we’re at right now. Chris Raymond - Robert Baird & Co.: Okay and one final question. What kind of tax rate is assumed for 2010 and 2011?

The taxes, this year we had for 2008 about $2.5 million of tax expense. That was driven by some changes in the California NOL rules that resulted in some additional taxes in 2008 and into 2009, as well as some foreign expenses. So, I would expect to see something in that range over the next year or two, but that will all obviously be dependent upon where the tax rules go. Chris Raymond - Robert W. Baird & Company: Good, thanks.

You might want to talk about the NOL a little bit

Yes, the other point I probably should make is that in terms of taxes paid, in terms of the significant impact of growing profitability is that we have substantial NOLs, both state and Federal NOLs, as well as R&D tax credits that should shelter any significant taxes that we would have to pay for some time to come.

Our next question comes from the line of Michael Aberman from Credit Suisse. You may proceed sir.

The first question I guess, again just a clarification, the R&D expense guided at 110 to 120 includes the $15 million?

It does not include the $15 million.

You had a couple of months of the free drug, can you give us an idea of January Kuvan? What kind of traction are you getting from conversion from that free drug program to January of the new commercial patient starts in January?

We aren’t going to go into the specific numbers of commercial starts, but we did see a significant number of patients that went on to the starter program, roll over to commercial for paying drug in January. January was a good month in terms of new commercial starts.

And could you give us a sense of that in reference to your guidance for the year for Kuvan, and that do you anticipate some of that to slowdown?

We anticipate that both referrals and commercial starts are going to fluctuate from month-to-month and quarter-to-quarter this year. So, we anticipate that it is going to be a steadily increasing overall trend and that’s why we feel that the guidance of $70 million to $80 million worth to Kuvan this year is appropriate.

Okay and I guess your comments about looking for late stage assets for growth, and maybe you can make a comment on if there’s any lessons from the Riquent Deal and how that might affect your strategy moving forward as you look at later stage assets, both on the positive and the negative. Then I’ll get back in the queue.

Well, Riquent was a very unique situation and because there are not that many productivity in Phase III in determining interim analysis and this is why we could structure the deal the way we structured it. So I’m not sure there is that much we can unfortunately learn from it, except that it’s a confirmation that whatever the science, the analysis that you do, clinical development is very humbling and you have to be ready for any kind of outcome. However, this was potentially a very exciting opportunity for us, because it was a big orphan drug with a potentially high price and with a high unmet medical need. So currently we cannot give you specifics as to the opportunities that we are looking at, because many of these companies are public companies. We are continuing to look at generally Phase III or late Phase II products with orphan drug population larger than Aldurazyme and Naglazyme and I’m not talking about Naglazyme diseases, but T-orphan drugs and that basically would allow us to leverage our abilities to get these kinds of products approved, marketed and reimbursed around the world.

And our next question comes from the line of Salveen Kochnover from Collins Stewart. You may proceed sir.

Thanks for taking my questions. Maybe if you could just elaborate a little bit more on out your guidance for 2010 and 2011 versus 2009. I’m just trying to figure out kind of the delta versus the street, but if you look at top line revenue growth, you said 20% to 25% in 2010 and then 15% to 20% in 2011 are certain revenue line items much higher than your projections or Kuvan out your numbers too high? Then when you look at the other expectations, it seems like would SG&A be expected to continue to go much higher versus the increase in ‘09? Are you expecting to be fully taxed by 2010 or 2009 and maybe just give us some kind of information on your assumptions for interest income as well, just going out in the out years.

I’ll try to answer your questions. On the revenue side, we haven’t broken down the revenue between Kuvan and Naglazyme and Aldurazyme. So we wanted to try to provide a broad based overall growth in product revenues to at least provide some direction. So I probably won’t have much more information on that to provide to you. In terms of operating expenses and R&D, for SG&A, I think our spending will increase at a moderate pace. I don’t think it will be a substantial pace, but a moderate pace. Our R&D spending will be dependent upon the success of our programs. If we are successful moving PEG-PAL and GALNS for Morquio disease, for example, further along into the clinics, those programs could increase, as well as our early stage R&D programs, which we still have a goal of one IND a year. So, it’s possible that we could continue to see moderate growth of R&D, but I wouldn’t necessarily call it substantial or unreasonable, but beyond that, I don’t think I can quantify it for you. In terms of the interest income, we assumed an increase in the rate. We believe that they’re not going to stay at 1% forever, but we assumed a relatively modest increase over time, perhaps by 2% in a year or two, maybe a little bit higher after that, but obviously it’s difficult to predict which way interest rates would go. We certainly didn’t expect them to be in the range that they’re at right now, but we have assumed some very modest increase in the interest rates over a two to three year period.

And when do you expect to be fully taxed?

It’s still going to be several years. In terms of the taxes that we have to pay, our NOLs are fairly substantial, both our federal NOLs and our state NOLs. We have over $300 million of federal NOLs and $145 million of state and then we also have over $90 million of federal R&D credits and $23 million of state R&D credits. So, those will certainly shield us from paying any significant taxes for some time to come. There are still some taxes that we will pay this year and next year related to our foreign operations and some other modest taxes, but nothing too significant above and beyond what we’re paying in 2008.

Okay and just one last question. In terms of the I guess assume 7,400 in-clinic PKU patients, I mean just given that you’ve marketed the product for awhile now, are there actually 7,400 in-clinic patients? Do you believe that some have been lost to follow-up here, where physicians may have said we touch base with these patients, but they actually haven’t been into the clinics for a while? If you can just elaborate maybe, are there any steps to go out and find patients that are lost to the clinics?

Yes, good questions. The 7,400 in-clinic came from the survey we did ourselves that got feedback directly from the dietitians and physicians in the clinics. Of those 7,400, there are some that are certainly very active, being seen on a routine basis and there is some percentage that is harder to get to come in, and is less routine in their contact with the physicians. So exactly what you call an active or an inactive patient, it’s a little bit of a gray area in terms of where to draw that line, but out of those 7,400, there are certainly some percentage that are harder to get into clinic for follow-up than others. In terms of reaching out to get more of those patients in, we are running several programs with some of the centers that have really done a great job with Kuvan so far in getting their existing patients in and tested. We are reaching out to patients who have been lost to follow-up in a variety of ways, and are having some success in getting additional patients into the clinic.

Thank you.

And our next question comes from the line of Joseph Schwartz from Leerink Swann. You may proceed sir.

Alright, thanks. I can’t help but notice but ever since you’ve restructured the agreement for Aldurazyme with Genzyme, that product has decelerated, but you must have some confidence that it can continue to grow or reaccelerate, because of the guidance that you provided for ‘09, ‘10 and ‘11. So, can you share with us some of that visibility? How penetrated is the MPS I market and how many patients are left that you or Genzyme have identified but aren’t on drug?

Let me try to handle that. That’s really a question you will have to ask Genzyme. I mean, we don’t track the MPS I patients and we don’t have visibility into what percentage of known MPS patients are currently on therapy. We do believe that there are roughly three times as many MPS I patients as there are MPS VI patients. We’ve seen Genzyme consistently grow the Aldurazyme market year-over-year, including over 20%. In this I believe it is fifth year on the market, which continues to be I think a fairly robust growth acceleration. We’ve seen other enzyme replacements that have been out much longer; continued double-digit growth rates for extended periods beyond five years and we anticipate Genzyme, with the expertise they have in this market, will continue to do that with Aldurazyme.

Right, specifically the international market opportunity is still somewhat (Inaudible) for Aldurazyme similar to Naglazyme, so there is clearly room for expansion there and I think again, that Q4 here is being impacted, as Jeff said $3 million was impacted by foreign exchange, because Genzyme does not, as far as we know hedge. We do, but they don’t. I’m talking about the year when the euro goes down, they get full impact or the dollar goes up, probably at any other currency there is impacted directly, but what we know based on our discussions with Genzyme is that actually the number of patients, it keeps increasing and that’s why we believe there are positive market dynamics here that will continue in 2010 and ‘11.

It’s great that you guys are profitable this year and expect that to happen again in ‘10 and ‘11. I believe this was already asked slightly differently, but why aren’t you going to be profitable in 2009; is that primarily this Riquent charge that will hit the P&L in the first quarter?

Jeff tried to explain that already earlier, but let me try it my way. I mean, there are several impacts; one is, there is a $15 million Riquent charge that’s a one time charge. There is the fact we don’t get $7 million from Merck Serono, which was linked to the approval in Europe. So, you have those two at $45 million. Then there are $5 million we got from Merck Serono this year in ‘08, which was the amortization of the $25 million upfront payment. We’ve got away back when we signed the deal with them. So you have this, you have $50 million here, negative impact and then the final negative impact is the fact that in ‘08, when the cost of goods for Kuvan was lower or pretty low because we were basically using the inventory that was previously expensed at R&D, we exhausted that. So in a sense, you have over $50 million of just negative accounting mechanics, many of them don’t recur and that have nothing to do with the health of the business, but if we added these to our current guidance, then it would be at $35 million to $50 million.

The other thing, there’s two other things they add to that. As I mentioned earlier, the fee interest income that we expect to receive in 2009, could be as much as $10 million less than 2008 because of the lower interest rate, so that drops right to the bottom line. Then the stock compensation expense, which is a non-cash expense, just because of the accounting mathematics, that could be $7 million to $10 million higher in 2009 also. So when you add all those factors including the ones that J. J. mentioned, that’s really driving where we’re at right now.

That’s why, I think those numbers are masking the growth of our real business, which is selling products and our product revenues. Natural revenues are growing substantially despite the negative impacts we talked about. So the last thing, I forgot, actually there’s also another negative impact which is the fact that in ‘08, we had an initial inventory transfer of Aldurazyme product which we’re not going to get this year, which was due to the restructuring of the JV in January ‘08.

Yes, we received about $12.8 million in 2008 this year. A lot will depend upon time, but somewhere in the $3 million to $5 million range. That’s $7 million or more of revenue that we won’t receive in 2009 that we recognized in 2008.

So all of this makes ‘09 kind of an unusual year and this is why we believe that it will be a return to healthy profitability in 2010 and ‘11.

Very helpful. Thank you.

And our next question comes from the line of Phil Nadeau from Cowen and Company. You may proceed sir. Phil Nadeau - Cowen & Co.: Good afternoon, thanks for taking my questions. My first question is on Naglazyme. Could you tell us what the impact of foreign exchange was on your reported revenue in Q4, and what assumed foreign exchange is in your guidance for 2009?

Sure. So, looking at fourth quarter 2008 versus fourth quarter of 2007, there was a small net impact of about $300,000 due to the negative impact in currency and that’s basically our hedge position offset by any currencies that we don’t hedge. For example, we don’t hedge the British pound since that’s mostly nationally hedged by expenses, but on a revenue basis, it was a small, about $300,000 quarter-on-quarter. What was your second question? Phil Nadeau - Cowen & Co.: In 2009, what FX levels are assumed in your guidance?

Well, our policy is to hedge 70% of our projected bottom line P&L. That essentially translates into about a 55% revenue hedge, since some of our Euros and British pounds are naturally hedged. We have hedged that probably average in the lower 140 range for 2009 into the fourth quarter of 2009, but for the un-hedged positions, as you can see the Euro is currently trading in the mid-120, so that would have a negative impact. We’re estimating right now that if the exchange rates averaged in the low 1.30 range, that we could see a $6 million to $8 million negative exchange rate impact in 2009 after factoring in our hedge position, but if the dollar weakens again, obviously we would receive the benefit of that, but all of our guidance for Naglazyme reflects our hedge positions and any exposure that we budgeted for. Phil Nadeau - Cowen & Co.: Okay so just I’m clear, the $6 million to $8 million that could impact your P&L from the current FX levels, is that assumed in your guidance or would that be below where you’re currently guiding to?

The $6 million to $8 million is basically the revenue impact and that is factored into our revenue guidance. Since the bottom line P&L impact will be somewhat less because we do have some natural euro expenses that offset that. So when I talk of $6 million to $8 million, I’m talking about the euro based currency, which represents about 50% of our sales. The other currency that has a smaller impact is the British pound. We currently do not hedge our revenues with the British pound, because they’re basically 100% offset by offsetting expenses. So it’s possible that if the British pound continued to deteriorate, we could see some additional foreign exchange impact from the top line for the British pound, but it shouldn’t impact us on the bottom line for the British pound.

But again, our revenue guidance does include expectations that the euro will continue to deteriorate as compared to the dollar. Phil Nadeau - Cowen & Co.: Okay. My second question is on Kuvan. It looks like from the slides that you’ve put up at JP Morgan, that you have somewhere around 650 continuing commercial therapy patients today and based on that price per patient that you’ve suggested, that would be somewhere between $50 million and $60 million in revenue from those patients in 2009, is that fair, am I doing the math right there? Then, what I’m really trying to get at it is, are you assuming somewhere in the order of $20 million to $30 million from new patient starts during the year?

I think your math is pretty good. Phil Nadeau - Cowen & Co.: Okay, great. That’s helpful and then just two more questions; one, is housekeeping. 2009 stock comp, could you break that down between R&D and SG&A, so we have a better idea of how to model the non-GAAP numbers?

For 2009? Phil Nadeau - Cowen & Co.: Yes, that’s right.

We haven’t broken it down by 2009, but I think the best thing to do is take a look at the fourth quarter 2008 and about 60% of that is SG&A, less than 10% is cost of sales and the rest being R&D. So I think if you use the fourth quarter numbers as a percentage of the total, you should get in the ballpark. Phil Nadeau - Cowen & Co.: Okay, great and one last question on PEG-PAL for me. It seems like hypersensitivity and allergic reactions are the major concern here. Can you give us any update on what you’ve seen in the Phase I trial and what you plan to do to prophylactics against hypersensitivity reactions in the Phase II?

Well, we haven’t given any further update in the Phase I studies. I said we’re in the fifth cohort and it’s not clear what we’d see there would really inform us in what’s going to happen when we start doing repeat dose and I think you really have to wait until you see it. In the Phase II study, we will pre-medicate patients with Benadryl or an antihistamine to help reduce any reaction. It wouldn’t prevent a reaction, but it could help reduce, which is what we do in our enzyme replacement therapy studies by the way, as well. Certainly, if we were seeing some allergic reaction, depending on what they are, we will have a management plan for managing them and that would help continue injections for those patients whose reactions are manageable. We don’t really know what we’re going to see and so we’re just providing a plan that would be flexible enough to manage those situations as they came up. Phil Nadeau - Cowen & Co.: Okay, great. Thanks, that’s very helpful.

And our next question comes from the line of Brian Abrahams from Oppenheimer and Company. You may proceed sir. Brian Abrahams - Oppenheimer & Co.: Thanks very much for taking my questions. I was wondering if you could tell me the average number or the average time it takes for patients to establish reimbursements on Kuvan.

Well, it varies quite a bit and I would like to avoid giving you an average, because it can be a little bit misleading. We group our Kuvan patients into two major buckets; patients who come into BPPS and who do not require a prior authorization or any type of assistance from NORD with a co-pay, they generally go through in two to three weeks. Patients who have a prior auth requirement or patients who have a need to apply for financial assistance, it’s much more variable; it certainly takes longer and that’s a process that is largely patient and insurance company dependent. Many of them are in the 30 to 45-day range and a few stretch beyond 45 days. Brian Abrahams - Oppenheimer & Co.: I guess I’m just wondering about the patients who fall into the latter category, given that you’re now reducing the length of the free drug program to 30 days. What happens to those patients who haven’t secured reimbursement by the end of the 30 days?

We will send them an additional bridge shipment of anywhere from two to four weeks, to give them time to finish their insurance clearance. We would not allow a patient to fall off therapy because insurance is going slow. Brian Abrahams - Oppenheimer & Co.: Okay and then shifting gears just on the in-licensing front. Just wondering how involved we were in discussions with other companies about potential in-licensing or collaborations, in parallel with your discussions with La Jolla; would you say you’re now, I guess, at late-stage discussions at this point or are you sort of just revisiting potential opportunities that you may have explored?

Despite the Riquent deal, we continue to look at other opportunities, assuming we have the same speed as before the Riquent deal. So there is one opportunity where we are pretty advanced, but there are never any guarantees that it will come to fruition and we have multiple opportunities that are in review right now. So again, we did not slow down our business development efforts after the Riquent deal, not only because we thought there was a risk and it proved to be indeed unfortunately correct, but also because it’s always good to continue to look at good opportunities and we see that significant cash balances and so we can afford to acquire other assets. Brian Abrahams - Oppenheimer & Co.: And if that advanced opportunity does potentially come to fruition, is that something we should look at as a potential first half of 2009 announcement or something that might end up coming into the back half of the year?

Probably mid year, if it happens. Brian Abrahams - Oppenheimer & Co.: Okay and then just one last question, any developments potentially announcing Emil’s successor?

We are in very advanced stage of identifying candidates; actually, we are honing in on a couple of finalists and I’m somewhat confident we’ll have someone onboard or finalized by the end of this quarter as we anticipated. Brian Abrahams - Oppenheimer & Co.: Terrific. Well, thanks very much. That’s very helpful.

And our next question comes from the line of Carol Werther from Summer Street Research. You may proceed ma’am.

Thank you. I was wondering if you could characterize the dynamics of the centers that are high prescribers of Kuvan versus the ones that haven’t gotten up quite to speed, like what the differences are with the gating factors?

There can be a variety of difference. Probably the easiest thing to understand is just staffing. Centers that are fully staffed have multiple metabolic dietitians, ideally a nurse practitioner and a genetic counselor that are involved and they tend to have capabilities beyond what some of the other centers have. Then secondly, you have to have a committed prescriber and a committed dietitian, who both feel that the therapy is worthwhile and are willing to commit the additional time it takes to get patients started dosing and diet-hydrated, so that the patient has a successful entry onto therapy. So lining up all the moving parts in some centers it’s very easy; in other centers it’s substantially more difficult.

So how many centers do you have prescribing now?

It’s been a while since I looked. The last time I looked there were 93 or 94 out of the top 100. So, the vast majority of centers have at least a patient or two on Kuvan.

Do you think that most doctors and dietitians think this is an important therapy?

I think most feel it is an important therapy. I think there is substantial variation though, in terms of how they view the therapy as best applied; what patient subgroups are most appropriate to treat. It is not a uniform monolithic approach that’s being taken by the genetics community. Each center tends to have its own ideas about the best way to use the product and have not been substantially influenced by thought leaders in the genetics community. They tend to do their own thinking, draw their own conclusions and move at their own pace.

Okay, thank you.

And our next question comes from Andrew Vaino from Roth. You may proceed. Andrew Vaino – Roth: Thanks for taking my call. I had a quick question. In your call in October about the Kuvan results and sickle cell, you mentioned that you’re going to meet with the FDA the following month. Did that meeting happen and are you able to comment on it?

Yes, we did meet with the FDA and we talked about what type of things would be required for an approval path and I don’t think anything is definitively defined there, because we’re still in Phase II. I think they agreed that we’d need to do a Phase II dosing study and establish our plan, but they would expect a clinical derived end point for approval, not endothelial dysfunction. So that point was made clear, but because we’re not really at end of Phase II, they can’t make any definitive agreement with the FDA regarding what the development plan would be, but we did get good feedback and we’re looking at how to take their feedback and device a plan that might make sense and ultimately when we look at all the cardiovascular data, we try to pull those possibilities together and decide what’s the best path forward.

Yes, What we said is that also in addition to speaking with the FDA, is that we would wait until we have completed all the data of all the ongoing trials that, like PDH product in the disease and we’ve got to get all these data up by the end of April and once we have all this data, we’re going to decide what do we do next, if anything. So we wanted to have all the data before deciding.

Great, excellent. Thank you.

And our next question comes from the line of Liana Moussatos from Pacific Growth. You may proceed ma’am

Thank you. When do you think you can release data from the repeat dose study of PEG-PAL, do you think? It could happen by year end or will it slip into 2010; and then could you repeat the average patient wait on Kuvan and also the federal R&D credit amount?

So, let’s take them one by one.

The PEG-PAL time line, we’re hoping to start in Q2 and the exact timing of that is somewhat variable. There’s an eight week in live period and an eight week specking period of 16 weeks, plus the enrollment period is going to take you out to six months or so. So it’s possible toward the end of the year we’d have some of the data. Of course, if there was an opportunity for an earlier disclosure of how things are going, I think we’d probably want to do it, because you’re not the first one to ask something about when we’re going to hear and so we’re looking at what we might do, but toward the end of the year, we’d expect to have some information.

The average weight of a Kuvan patient is about 50 kilograms.

The R&D credits for federal credit is $93 million.

Thank you very much.

And our next and final question comes from the line of Eun Yang from Jefferies and Company. You may proceed sir. Eun Yang - Jefferies & Co.: Thanks very much. On PEG-PAL, assuming the drug is approved then on the market, do you have to pay a 11% royalty on PEG-PAL sales to Daiichi Suntory?

No, no, we developed the product ourselves and we don’t have a royalty to them.

Yes, it’s totally different from BH4 Kuvan. The agreement with Daiichi is only on BH4 and now we have worldwide rights. Eun Yang - Jefferies & Co.: Okay, how about Merck Serono? Are they involved in the clinical development for this product?

Not at this time. They are following what we are doing. We are providing them with information and so they can decide to obtain at any time and if they obtain before the first patient is enrolled in Phase III, they share the cost of development going forward with us, 50% and if they opt in after the first patient that’s enrolled in Phase III, they pay 100% of that cost. So they are informed. They are monitoring what we are doing. They have not decided to opt in yet at this time. Eun Yang - Jefferies & Co.: Okay, thanks very much.

And at this time, we have no additional questions. We’ll be turning the call back over to J.J. Bienaime. You may proceed sir.

Well, thank you. So, in summary, we are growing revenues that were generated from our three commercial products that have been driving our first full profitable year, which is a notable milestone for BioMarin. The remaining international opportunity for Naglazyme is significant and we believe the total market opportunity is over $300 million, which is double the size we anticipated at the time of the launch. So we have made good progress in the first year of the Kuvan launch in a very complex and challenging market. We remain confident about the total market opportunity and we remain dedicated to the successful execution of the Kuvan program. We have also a growing pipeline of products in development, including PEG-PAL and the BMN110 for MPS IVA, which is a very exciting opportunity. If it makes it to the market, will likely be the largest licensed and most (Inaudible) product that we have at BioMarin and we believe most of those will advance in the clinic in 2009. We are making sound investments in our R&D program to ensure continued double digit revenue growth in the coming years, with the goal of filing about one IND per year. We are committed to the expansion of our pipeline and we continue to pursue other attractive in-licensing or acquisition opportunities very actively. Looking beyond 2009, as Jeff outlined we expect our top line product revenue will grow approximately 20% to 25% in 2010 and approximately 15% to 20% in 2011. So these revenue estimates we figure only from existing commercial products, so they do not include potential sales from additional new products, like PEG-PAL. We expect the operating income in the range of $35 million to $40 million in 2010 and $60 million to $65 million in 2011. Excluding stock option expenses, non-GAAP net income is projected to increase very substantially to $70 million to $80 million in 2010 and $95 million to $105 million in 2011. This assumes of course, that we have not done any significant business deal which would affect those projections. Please note that we are providing a more detailed financial guidance as well as financial trading information, now that our product revenues are the lion’s share of our total revenues and are somewhat more predictable and we do this to ensure better consistency between the close to 20 financial analysts that are following the company in their model. So we are committed to providing this level of detail on an ongoing basis. So we look forward to keeping you up-to-date on our progress and we thank you for your continued support. Thank you for joining us on the call today.

And ladies and gentlemen, this concludes today’s presentation. You may now disconnect. Thank you for joining. Have a good day.