Welcome to the Genzyme Corporation’s second quarter financial results conference call. (Operator Instructions). I would now like to turn the call over to Mr. Patrick Flanagan, Senior Director of Investor Relations.

Welcome everyone to Genzyme Corporation’s second quarter earnings conference call. On this call, we will be making forward-looking statements, including our estimate of the financial impact of the temporary shutdown of our Allston facility, our estimated timelines of resuming production at the facility, and for supply of Cerezyme and Fabrazyme, our ability to finish and release Cerezyme work in progress, our product development and regulatory plans and timetables, including for Lumizyme in the US, and expected drivers of revenue growth going forward. These forward-looking statements are subject to a number of risks and uncertainties and our actual results may differ materially. Please refer to the Risk Factors section of our March 31st 10-Q for more information on those risks. If during this call we use any non-GAAP financial measures, you will find on our website reconciliations to the most directly comparable GAAP financial measure. I would now like to turn the call over to Genzyme’s Chairman and CEO, Henri Termeer.

I have with me as usual a group that can respond to Q&A. Comments will be before Q&A by Mike Wyzga, our Chief Financial Officer. David Meeker will specifically comment on the Allston manufacturing status, and Geoff McDonough will comment on the business impact for Cerezyme, Fabrazyme, and Myozyme off the interruption that we’re experiencing in Allston. The second quarter was a strong quarter, and outside of the manufacturing interruptions that we’ve experienced, business was very strong despite the very touch economy and despite a very difficult comparison. Last year in the second quarter, the FX translation was the most beneficial that we’ve ever experienced in the past, and of course that comparison was not helpful in this quarter. Despite that, we had a record quarter with $1.2 billion in revenues—nicely up from the first quarter, driven by businesses that are already in their market introduction and in their business development. Myozyme re-acceleration in Europe was extremely pleasing to see. Synvisc-One launch in the US was excellent. Actually it surpassed our expectations. Quite surprisingly four months after the launch in the US, 50% of revenues are from Synvisc-One, and total Synvisc franchise increased about 16% from last year, and this is a very interesting market place that we’ve already talked about, and the first few months of experience is very encouraging. Mozobil continues to be strong, and we’re reconfirming the range that we have for the year. The oncology franchise is much expanded now. We had one month of benefit of the Bayer transaction, and of course it’s comparison year to year is up 100%, and therefore we can have expectations of significant future growth as a result of Clolar in AML and the profits that have come to us. Thymoglobulin had an excellent quarter. It was up 19% from…

I am going to try to break down some of the key areas financially impacting us in Q2 as well as the rest of 2009. First we have the impact of the Allston shutdown, and while there was some impact this quarter with regard to the facility expense and some loss of revenue and margin, the major impact is obviously in the second half of the year. The second focus area is the acquisition of the oncology production of Campatho from Bayer. There is a related adoption of a new accounting rule called FAS-141R. It’s new and a bit complex for all of us, so what we’ve done is we’ve placed on the website a primer going through the new standard, and this will be the subject of our focus for the next investor roundtable which is next Thursday. And then lastly, I’ll go through the quarterly earnings. The overall business, as Henri mentioned, is very healthy, and Q2 really reflects the health of that business, so let me walk through the financial impact of the Allston plant interruption. The impact can really be placed into three categories. First is the cost associated with the sanitation of the facility as well as the idle capacity and overhead while the plant is being shutdown. Secondarily the cost associated with the impairment of the assets in the plant and the write-off of some of the material, and then finally there is a impact of the lost revenue and lost margin due to supply shortage. Now as reflected in our guidance, Cerezyme revenue is now in the range of $750 to $1 billion, and as Henri mentioned, this reflects the range of work in process material that may or may not be used. Fabrazyme revised guidance is now $510 to $520, and Myozyme…

I’d like to provide brief updates on four areas related to the Allston remediation, first investigation around the viral contamination itself, and update on the plant sanitation and where we are on the restart. As Henri indicated, we will be dedicating the Allston plant completely to the production of Cerezyme and Fabrazyme, so I’ll stick to the bioreactors. I’ll briefly update you on our risk mitigation strategy and finally the disposition of the work in process material. With regard to the investigation, as we told you on our original conference call, the identified virus is Vesivirus 2117 which is a member of the Calicivirus family. This is a strain which infects CHO cells but is not known to infect humans. The Cerezyme process is also known to or has been shown to remove 12 to 14 logs of a model non-enveloped RNA virus which would be the model virus for the Vesivirus, and we will be testing for clearance of Vesivirus specifically once we have test virus available to do that. In short, the current situation we do not believe poses a risk to patients, and therefore our focus has been on completing the sanitation of the plan and optimizing our ability to make appropriate risk assessment with regard to the handling of the work in process material within the plant, recognizing the significant patient need. So these decisions are being made in close collaborations with the regulatory agencies. With regard to the investigation, the viral contamination was noted at two different sites, and this pattern of involvement pointed us to a common raw material source although there is no specific lot that is common to each of the three bioreactors which have been affected. We have now developed a more sensitive PCR, quantitative PCR assay, which allows us to…

Here is Geoff McDonough now on the business impact.

As you said earlier, the second quarter was a very strong quarter across the portfolio with volume driven growth for Fabrazyme, Myozyme, and Aldurazyme, and the volume-driven growth in Cerezyme was actually quite good, especially if you adjust for the revenue impact that Mike referred to earlier of $13 million. That provides a platform for understanding the strength of the underlying business, a platform upon which we will resume building as we contain this overall situation at the end of 2009. I would like to step through the portfolio and make some comments on each of Fabrazyme, Cerezyme, and Myozyme, and before I do that, I’d like to just remind you of some general principles which have guided our translation of the financial and supply situation to the consequences for patients and families and for their treating physicians. The principles which have adopted in managing this situation have been roughly fourfold. They are as follows: First, we treated this as a situation of global equity. We are not giving preference or any difference in treatment across different countries in their contribution to managing this situation. Second, we’re not differentiating between charitable or commercial programs, and they are being considered equally in the same way. Third, we’ve been working with stakeholders on a broad based including treating physicians, regulators, as well as patient organizations to think about how to define those patients most vulnerable to an interruption in supply and to endeavor to protect them by asking “less” vulnerable patients to lower their consumption over a longer period in order to minimize or eliminate shortages for these vulnerable patients. To that end, we have convened a series of stakeholder working group meetings based in North America and in Europe for both Cerezyme and Fabrazyme which have been published in a variety…

Now we can turn to Q&A.

(Operator instructions) Our first question is from Michael Yee – RBC Capital Markets. Michael Yee – RBC Capital Markets: I have a question on the viral decontamination. What is your confidence that the FDA would not have to revisit/reinspect the facility after the decontamination, and what are the gating steps to get the written confirmation on the 483?

As far as getting the facility back up and running, we’ve been in close communication with the FDA every stop along the way, so they’re very familiar with what we’re doing. We do not anticipate that they need to come out and re-inspect before we actually get that plant up and running, but obviously we do anticipate given the routine nature of how they conduct GNP audit, we certainly would anticipate that they would probably want to come out and visit, but it is not a negating step in getting the facility back up and running. You mentioned the 483, with regard to that and the warning letter status, I think we had already communicated that the FDA had indeed been out and confirmed that we had addressed all of the outstanding items in the warning letter, and at this point, we believe that that’s been communicated, or we had anticipated that’s been communicated within the FDA, and we do not anticipate that that would be a rate limiting step for the Lumizyme approval either at this point. Michael Yee – RBC Capital Markets: So there’s a scenario where you could actually get approval for Lumizyme without the written confirmation?

What I anticipate happening is that there are separate pieces here. One is that they had confirmed that we’ve complied with all of the warning letter items, and how I anticipate how that will happen is that we may not necessarily get notified from the FDA, but certainly the district office who did that inspection and check against the warning letter will communicate with the compliance group at FDA who will also then communicate with the review division, and we’ve not had any indication at this point in our ongoing discussions with the review division that this is a rate-limiting step for the approval.

Your next question comes from the line of Brian Abrahams – Oppenheimer and Company. Brian Abrahams – Oppenheimer and Company: I have a question for David. How long it might take this viral extrapolation to be made in order to determine whether the additional WIP Cerezyme material is indeed going to be releasable, and does the low end of your Cerezyme guidance incorporate any potential for altered practice patterns like physicians keeping patients on lower doses of Cerezyme even once the supply is restored.

Maybe I’ll just take the latter part first. The guidance is a financial guidance which means that that is all the available material that we would have to sell, and that lower end of the guidance assumes that we would not be able to release any additional WIP at all, so that’s the most conservative view. As Geoff was saying, how patients handle this and how the patient community participates with regard to managing their own dosing might limit, that’s a way of managing the amount of time that patients might be out sequentially for doses by reducing their dose, so there is no point at which people stock out and it allows to preserve material for the most severely affected patients. With regard to the question around the timing to improve our understanding of the release of the WIP, we’re in weekly conversations with the FDA and exchanging information as soon as it becomes available. As I said, the guidance is based on our best available understanding to date of those viral kinetics, and again until we get the next set of data or the next set of experiments and have a chance to discuss that with the FDA, I’m not sure the extent to which that will be refined, but I would anticipate that by the end of August, there’s some parts of this which will need to be wrapped by the end of August, so we should have a much better handle on the availability of WIP.

Your next question comes from the line of Jim Birchenough – Barclays Capital. Jim Birchenough – Barclays Capital: I just want to understand a little bit better the timelines here. To begin with on the supply constraint, do you still have inventory available until August? I think you previously said the supply constraint for Cerezyme would begin in August; I just want to confirm that, and then trying to understand what extends the time from production beginning to release of product. Why does that take so long at your end?

The question you’re asking about the inventories is relatively easy to answer. The first half of the inventories that has been released is sufficient to take us into August, and we would always have anticipated the period of shortage to Cerezyme to begin in the early to mid August timeframe. With respect to the time of the release or the delay, obviously we are asking patients to reduce their consumption in advance of the shortage in order to attenuate consumption throughout the period so that no one is non-electively asked to miss or to lower a dose. The delay that we have before a new product comes into production is just related to the cycle time from the initial inoculation of the commercial scale reactor that David referred to and working its way through the production process to a finished and released vial.

Your next question comes from the line of Geoffrey Meacham – J.P. Morgan. Geoffrey Meacham – J.P. Morgan: I have a question on the 4000 L. Can you walk us through the approval steps from an FDA perspective for Myozyme? Do you need the 2000 L approval? Does that even matter if you have already run comparability with the 160 material? Then, the second part of the question is, since you are now expanding MTAP to include patients on the Belgium facility, will you now put patients who haven’t had access before to Myozyme, will you give them now access with an expanded MTAP?

As far as the approval process for the 4000 L, we have been in close communication with the FDA, and they have seen a lot of the information around the 4000 L, and at this point, we anticipate filing the 4000 L biochemical comparability data, if you like, to the Lumizyme, the 2000 L BLA. Now, in order to do that, we want to allow the FDA to proceed with straightforward Lumizyme BLA approval that they are currently working on so that we would anticipate to allow them to finish, give us approval of the Lumizyme BLA, which the PDUFA date is November. On obtaining approval of that BLA, we would immediately file a supplement containing the 4000 L information, and then that is the CMC supplement, so we anticipate the PDUFA being 4 months from there. With regards to the MTAP question before Geoff answers, just to comment, again in discussions with FDA and in order to transition those patients on MTAP to the 4000 L, of course, we will also be officially filing the 4000 L information to the IND in order to accomplish that.

I think with respect to MTAP, what you are seeing there, Jeff, is us trying to accomplish two goals. The first is to ensure continuous access to Myozyme for patients who have been in MTAP who are now going on almost 2-1/2 years, during the course of this transition from a regulatory perspective from 2 K to 4 K material. The second goal is to allow ourselves to maximally use and make available 2000 L inventories. It may be possible for us to offer access to naïve or new patients based on our 2000 L inventories and based on the timing and status of our discussions around the 4000 L approval with the FDA at the time of the initial Lumizyme approval, but we are not today expanding MTAP beyond its current population. Geoffrey Meacham – J.P. Morgan: A quick followup if I could, I thought you guys had previously talked about the 4000 L showing better comparability with 160 versus the 2000?

Yes, I think we had certainly talked about the fact that the 4000 L, we had targeted it so that some of the glycosylation was much more similar to the 160 than the 2000 L, and obviously we have been in close communication with the FDA. I think the important piece to remember here is that of course we have 2 patient populations here now, the infants with the 160 and the late onset with 2000 of the Lumizyme approval. I think given that we don’t have clinical data on the 4000 L, I think that from a risk-benefit perspective, it probably makes more sense at this point for the FDA to be able to approve the 4000 L for that older less severe patient population.

The sensitivity of the new assay that you have, it doesn’t sound like you really understand where the viral contamination came from, so I am trying to understand how do we get comfortable that this contamination won’t pop up again, and how sensitive is your new assay because it sounds like FDA is holding obviously some of the release pending confirmation as to how sensitive the second assay is? I am just trying to get an understanding of how do we get comfortable and you get comfortable that this won’t happen again.

I think those are 2 questions. So, how do we get comfortable that it won’t happen again? That goes to first and foremost the sanitization around the plant, so the goal there is to ensure that any potential ongoing contamination in parts of the plant are eliminated, and therefore, when we start up again, we are not at increased risk. I think with regard to the sensitivity of the assay, this assay has pretty good sensitivity. I think the things that we will be working on to potentially improve the sensitivity of the overall process is how we process the sample itself that goes into the assay, so there are still some things to do which may give us some additional insight or improve sensitivity, if you will. That said, we will then be working in this just the way I described, which is to say extrapolating from points of known contamination down to a point which will be below the level of detection of the assay but to allow us to determine to the best our ability what is the point at which we believe there was essentially no virus in the plant, and the point I made when I was providing my initial comments was we are using a PCR assay, so we are measuring viral copies which are not infectious particles. As a rule, the number of viral copies to the number of infections particles may be 1, 2, or 3 logs higher. So, there are number of factors which would say this kind of analysis hopefully will get us through a fairly conservative view of what would be unreasonable to continue to process through the plant. One last thing to the prior point, this isn’t an all or none phenomenon. We are in continual discussions as I said with the FDA, and it may well be that we are able to release part of this as opposed to all of this as we get additional information and determine jointly of what the risk/benefit is of moving forward.

Dave, do you want to make a general comment, maybe not for your own but for the audience about the appearance of viral infections in these kinds of manufacturing operations?

As I said, it is not uncommon. They tend not to be publicized, and so this event is not uncommon. We currently screen for 9 viruses which is part of the compendium, so these are standard testing which are done by our vendors, so the world has its own risk mitigation strategy in which we will be adding to now with the identification of this virus, but there is always going to be some uncertainty in the world that we live in. There are, of course, innumerable number of viruses out there that are currently not being tested for, and that is why each one of these processes has a downstream viral removal step which allows you to get to a risk-benefit position where it is safe to release these products.

In our case, it is a 12 to 14-log reduction?

There is a 12 to 14-log reduction.

In regard to the 4000 L scale material being comparable to 2000 L, initially, there were plans to file as comparable to the 160. Just to go back to that question that was asked earlier, was that plan rejected by the FDA? Are they now pointing you towards 2000 L?

As I mentioned in an answer to a previous question, I think the key thing is in the discussion where we have been moving towards is that from a risk-benefit perspective in the patient population with a late onset versus the infant that it is easier for FDA to get comfortable with a filing at this point to the 2000 L, but we have not ruled out filing for the 160 at this point. It is an ongoing discussion, but my sense af this point is it’s more likely to be for the 2000 L Lumizyme BLA

Your next question comes from the line of Davis [Wu] – Goldman Sachs. Davis [Wu] – Goldman Sachs: With regard to the Cerezyme inventory and use, on the demand side, I was wondering if you had any sense of how physicians or patients to date has been adjusting their use, and how much of a decrease have you seen, and secondly, if I do my math right, it looked like you had anywhere from 6 to 10 weeks of inventory at the time of the plant shutdown, but now extending this out to November-December, it looks like you would need well over 50% dose reduction on average to stretch that supply that. I was wondering if you can comment on that math and how the supply meets the dose reduction by physicians and patients.

First with respect to the physicians and patients, we are seeing on a global basis quite a good compliance or cooperation if you will with this treatment guidance overall, and we see that reflected in our order pattern and in the overall actuals since this began. We’re not quite yet on a global basis to the anticipated 50% level, but we are well on our way, and one of the things we are working with the stakeholder working group as well as with other members of the community is to figure out how to further increase the awareness and the adoption of this treatment guidance, and just to put that in perspective, we have some experience of course with managing a situation like this as we did for Myozyme earlier this year and biweekly infusion setting. We are right at the point where we would expect to be in a process that is global and understandably has a different rate of uptake and adoption in different countries, so I think we’re roughly where we would like to be. With respect to your question around the backend of this situation, in other words, what contains the period of constrained supply, and I think it’s two fold. First is the degree to which that the channel inventories can contribute to the period of shortage. They will be over this period expected to draw down to close to zero in almost every geography which contributes to our ability to limit the duration. Secondly is contribution of the work in process that David mentioned. As it goes through the process of being processed and released, it creates ongoing supply throughout the period of this shortfall, so there is not a simple mathematical relationship between the resumption of new supply and the time at which this period constraint is concluded.

The next question comes from the line of Ian Somaiya with Thomas Weisel Partners. Ian Somaiya – Thomas Weisel Partners: I fully understand the decision to move the 2000 K facility to the manufacturing of Cerezyme and Fabrazyme. Just curious why pin the relaunch of Myozyme on the 4000 L facility, because I think at some point next year, you would be comfortable with the supply you have on hand for Cerezyme and Fabrazyme, and if the Lumizyme plant is approved, why wouldn’t you manufacturing that drug there?

It’s a reasonable question, but we will need the Allston plan throughout next year, and the recovery is not that quick. We need full production. It may have lost a little bit the influence of channels here. We clearly need safety inventories into the system throughout the world. This has clearly shown that we were out of material safety inventory throughout the world. It’s not a good situation, so we must dedicate this plant. It’s only after we get the approval or the Framingham plant which will add very material step function to the production capacity that we have again the flexibility to utilize part of the capacity in Allston for production such as Myozyme. The other point is that Myozyme and Lumizyme is the same product, and now because we are only going to produce in the 4000 liter, the Belgian plant is a very good facility, and it was approved earlier this year in record time for European use by the EMEA, and all European patients have been on 4000 liters since that time, and we have a good experience there, and it is a very efficient operation, and of course that’s a concentration with an additional reactor going in there at this critical moment and an experience level that is very helpful, but of course over time, we don’t want to be dependent on the single plant. We will take actions over time at also Allston again once we have the capacity available through Framingham can also produce Myozyme, so that’s the approach we have taken. These things can’t be moved in a very quick way, and I think it is by far the clearest way and also allows the Allston plant to dedicate all of its focus on just two products rather than three. Ian Somaiya – Thomas Weisel Partners: When do you think you will be at more normal comfortable inventory levels for these three drugs?

For Myozyme, we are at a comfortable inventory level at the current time, and I think we will stay at a comfortable inventory level provided that we do produce with the 4000 liter. For Cerezyme and Fabrazyme, we will be tight, I think, throughout the next year as we rebuild the inventory because we do not set a criteria to have more channel inventory available. Personally, I don’t feel comfortable until that additional plant capacity is available which would be 2011.

The next question comes from the line of Geoff Porges with Bernstein. Geoff Porges – Bernstein: Henri, just to get out the weeds a little, you’ve got long-term guidance out there of $5.84, I think, in 2011. It looks like you are going to take them all again on this year, and last year obviously the restatement reflected all the investments you made. Are you prepared at this point to commit that 2010 EPS is going to be on the growth trajectory that would take you from 2007, which was more or less the last clean year, towards that $5.84 number? Do you have that visibility and confidence at this point?

I think this is early. We are as I said earlier very confident that 2010 is going to be a very good year and certainly a good year compared to a year with these interruptions that we are currently experiencing. We feel very good about the new products that we have been talking about that were at risk in the past, but now are really showing the kind of progress that were hoping for, like Synvisc-One and Mozobil. We also have a program starting up in Europe, so we feel good about that. We are somewhat ahead of our expectations in things like genetic diagnostics, but for 2010, the appropriate moment here is to let us work through this stuff through the remainder of the year and to get together to talk about the guidance for 2010 at the time that we usually do which would be February of next year, early in the year, and topline guidance maybe in San Francisco in January. That’s generally what we have done, and there is no reason for us to change our goals into our future, but this may be not the best moment to talk about these goals. At the moment, we want to get our manufacturing plant back on stream. We want to see the Myozyme approved in United States so that it becomes a positive contributor. Most of these things by themselves will make a dramatic difference into our progress in the future.

The next question comes from the line of Chris Raymond with Robert Baird & Co. Chris Raymond – Robert Baird & Co: I’m still struggling with the timelines that you guys talked about with regard to releasing the Cerezyme inventory. Can you maybe walk us through some of the steps? I mean 4 to 5 months is kind of the math I guess that you derived here from start of production to release. What are the extra steps perhaps that that you are adding in this instance that may be didn’t exist before this contamination issue?

No extra steps. The cycle time remains absolutely the same. It is roughly 110 to 120 days for the Cerezyme and Fabrazyme cycles. The additional steps which are from a viral risk mitigation step, we will be looking at points in this process where we would introduce testing, specifically for the Vesivirus since we know we have been at risk for that, but there is no anticipation that that will slow down the cycle time, so those discrete events, risk mitigation events but not prolongation of the timeline. Then maybe the other point of confusion was just around the WIP again which is independent of the cycle times for the release of the new material. That is an ongoing investigation where over the next couple of months we will through our investigations and discussions with the FDA get to a better understanding of how much of that WIP will be available for release.

The next question comes from the line of Phil Nadeau with Cowen & Co. Phil Nadeau – Cowen & Co.: I’m not looking for guidance but maybe more qualitative understanding of the impact of this situation on 2010. Maybe you can get us there by doing just a few things, like first could you quantify what every quarter of additional MTAP program in 2010 would do to revenue and EPS? Second, more qualitatively, if the plant is up and running as you suggest it will be but your inventory is tight, what does that mean for supplying the market for Fabrazyme and Cerezyme next year? Is the market fully supplied and it just takes a long time to build inventory or is there still some people who have to push out doses?

I certainly can’t give you, Phil, what you are looking for in the quantitation of the quarterly piece, but certainly with respect to our expectations around supply, it is the former case that we would expect to able to supply the market but to take our time in rebuilding the channel inventories as Henri mentioned earlier. One thing to recall is that capacity to supply both Cerezyme and Fabrazyme in 2010 is materially higher for having pulled Myozyme out of the Allston facility, so we have confidence as we work through this situation in ’09 that we set ourselves up well to supply in 2010. Phil Nadeau – Cowen & Co.: On the quantitation, did you say that you could do that or you could not?

The MTAP program is about 170 or so patients that we have been supplying free of charge now for a few years, and to the extent that that is what we are doing, it is an expensive program, and we haven’t quantified the specifics here other than that the cost per year is about $400,000. The revenue loss per year would be about $400,000 per patient.

We’ve quantified the cost in past quarters, of course, the running cost of the program over time has shifted slightly, so if that’s of interest, we can certainly include that in further updates as we go forward, but we would expect that program to wind its way down to the extent that there are patients who have not transitioned by the time of Lumizyme approval, they would move over to commercial therapy, and those who are on 4K at the time of approval would remain in the program until such time as 4K was approved. In that sense, you can imagine those curves will move at different rates depending on the timing of approval and the number of patients who have shifted over.

The next question comes from the line of Eun Yang with Jefferies. Eun Yang – Jefferies: In previous calls, you mentioned that you’re expecting Lumizyme approval well before the PDUFA date in November, but now you sound like you are expecting around PDUFA date, so the question to you is what has changed, and is there something that FDA requires or wants to see prior to approving Lumizyme at this point?

I think as far as the PDUFA date, we continue to work closely with the FDA around the Lumizyme delay, and that has continued as I have mentioned in the past. I think that we are still hopeful that we can get approval before the PDUFA date, but I think that it is more appropriate at this time for us to reset expectations with that date as the goal in mind, and I’m sorry I missed the second part of your question. Eun Yang – Jefferies: Is there something that FDA requires or wants to see prior to approving Lumizyme such as seeing start of production and release of Cerezyme and Fabrazyme at the plant?

No. As I said, discussions have continued with FDA, and I think at this point a big part of what we continue to discuss is the REMS, and I think many of you probably know from reading many information that it’s well known that looking through the FDA around the REMS and with Safety and Epidemiology Group at FDA as well as the Review Division, that’s an ongoing discussion that is a vital piece obviously for approval, but nothing else has changed.

The next question comes from the line of Bill Tanner with Lazard. Bill Tanner – Lazard: The question I had goes back to the Cerezyme revenue range, and maybe it’s for David. I’m assuming that the ultimate sales could fall somewhere in between. It’s not going to necessarily be bracketed one side or the other. I guess I’m struggling a little bit trying to understand, if I go back to the June 16th call, my understanding and I think Alison alluded to perhaps some column chromatography to decontaminate the finished products, so I’m wondering what’s the difference with the WIP that cannot be decontaminated or in fact if the finished product that was released actually was not decontaminated, and so what’s the reason for perhaps your being less confident that you could get that drug out the door?

I’ll take your second part of question first in terms of our confidence in being able to use the WIP, and that risk assessment is around what is the risk of putting material that may potentially be contaminated through the downstream processing. It’s not that we think as I have said all along that there is a risk to the patients around this specific virus or as you said once it has gone through a full downstream purification, that you would have significant clearance of any potential residual virus that might be in it, so it’s really a goal of minimizing the risk to the plant, and that’s what we will be working through, and the guidance that we have given you as I said is to determine to the best of our ability in conjunction with the FDA what material is reasonable to put through additional processing in the plant after we have gone through the work of sanitizing the plant, so it’s really that straightforward. Handicapping that at this point is hard, and as I said, the range which is most conservative says that we wouldn’t put any material from this point forward down back to the plant to this other end of the range which says we will use the data from the testing which will allow us to draw some assumptions as to the probability of having any virus in a sample that we then wanted to process downstream, and that’s the frame that we will be working into the next month or so. Bill Tanner – Lazard: So this then truly could be bracketed on either side by none and 50% and then somewhere between.

Yes. It could be bracketed on either side. Again as we get a little more data, that could be higher or lower. We could be either side of the upper end as well if we do find that we can begin to process some of this material through or we could end up at that absolutely low end where we can’t process anything. Bill Tanner – Lazard: Then would there be contemplation of a revised guidance as to when you get decision on that?

Yes. We will update you obviously when this range shrinks and the impact that has on the guidance, and I think you quite rightly focused on that. It is of course a very short-term impact. It will impact this quarter and next quarter, but we will clearly be able to communicate to you. We didn’t think there was any way for us to not give you the full range because the full range is the range in discussion, but if it changes and the range narrows, we will give you an update at that point.

The next question comes from the line of Mark Schoenebaum with Deutsche Bank. Mark Schoenebaum – Deutsche Bank: David, how can you help us, the analysts and investors, this time around get comfortable that the FDA is going to deem the 4000 liter material is bioequivalent to 160 and that additional clinical trials won’t be required? Is there any way you could possibly walk us through some of the PKPD data so those of us that want to stay in the weeds can try to get some comfort around this? The second part was if you could tell what the capacity in dollars is of the 4000 liter facility with and without the new reactor.

I think with regard to the filing strategy, we basically in our discussions with the FDA made it clear that we are looking for the absolutely most rapid route to approval of this product and that we are open to either of the scenarios, whether we reference the 2000 liter or the 160 liter. Now that said, when you just look at this biochemically as Alison highlighted, the 4000 liter was developed with an eye to having it as close as possible to the 160. Some of the discussions I know I have had previously in investor conferences had been trying to explain how we got into this situation. We had the 2000 and the 160 liter approved essentially at the same time in different regulatory jurisdictions, so in essence we are locked in as final product, whereas normally when you scale up a product, you have the opportunity of continuing to work your next scale to make the adjustments to make it as close as possible to the scale you’re starting out from, and in this case, the 4000 liter, we had that opportunity. Without going through the specifics of the changes there as Alison said related to glycosylation, the glycosylation of the 4000 liter, if you looked at it, is closer to 160 than 2000, but in the overall evaluation, working with the FDA, it may be perfectly reasonable as is currently the plan to file this as a 2000 and get us a more rapid route to approval. Mark Schoenebaum – Deutsche Bank: The capacity question?

Right now, the capacity in Belgium is on the order of 2000 patients. Adding an additional bioreactor will take that to a 3000-patient capacity, and as Henri said, we are continuing to move to create additional opportunities for additional capacity. Mark Schoenebaum – Deutsche Bank: How many patients on drug now?

A little over 1000.

The next question comes from the line of Sapna Srivastava with Morgan Stanley. Sapna Srivastava – Morgan Stanley: One on the Cerezyme franchise, ould you help us understand how do you view the potential accelerated approval for competitors as well, and what impact that could potentially have on Cerezyme, and secondly I guess I’m still a little confused about the 4000 liter facility approval. You said it’s similar to 160, but it’s contingent still on 2000, and I know you have given a lot of color, but maybe just a little bit more color as to why the letter remains hinged on the 2000 L facility approval.

I think the way to think about it is and maybe we are getting a little bit hung upon it, it is between the 2000 and the 160. Since it sits between, it’s a little closer to 160 than the 2000, but it’s between the two, so you clearly have the option as you are looking at this to reference either product.

At a certain level, the FDA and others are looking for the widest possible array of choices to support the patient community during the duration of this constrained supply. As Henri said, we anticipate this duration to be quite short in a big picture setting. I think in the same way, the FDA has asked other companies to provide a TIND, they similarly have asked us to do so for the small molecule, so I think the net impact in the end will just be to provide a broader set of experiences with these experimental therapies earlier than would otherwise have been available. I think the consequences for approval timelines and resulting uptake for competing drugs and also for the small molecule are to be determined because these treatment INDs are neither easy nor quick, and they are not generally speaking high capacity kinds of programs, so at this point I think we are looking to stay focused on providing choice and access for patients in the near term, and then we will be looking for a better sense how 2010 will evolve as we get closer to it. Sapna Srivastava – Morgan Stanley: How many patients do you expect will go on the new treatment INDs?

Actually, I have no way to answer the question because today the characteristics of eligible patients have not yet been determined. That’s part of the process of working through this with the FDA.

If I could just add a comment, one thing I would like to emphasize, it’s really important, obviously is the enrollment of the patients in the studies that we have up and started. That’s really the focus, and that’s obviously also very important for the FDA as well. In opening up the treatment IND, we want to make sure that we are not jeopardizing not being able to enroll patients into those clinical studies in order to get the product ultimately approved which is our goal of course as well.

Generally to visualize this, patients that are on chronic long-term therapy, they don’t tend to change very casually. It’s quite a process for a patient to make the decision and a physician to make the decision to go through a change, so this short-term interruption, we don’t think will guide people to make very long-term changes. Of course, long-term shortages will guide people to make those changes, but for us it is very important that we show that we are back on line and that the supply will lighten up within a reasonable period of time, and I think will most importantly determine how many patients would choose alternative therapies as enzyme replacement therapies or our small molecule.

The next question comes from the line of Maged Shenouda – UBS. Maged Shenouda – UBS : If you don’t get the 4000 liter scale Myozyme approved in March in the US, how long would it take you to scale up in the US, in the Allston facility, with the 2000 liter production process?

As we said, we have made the firm decision to dedicate the Allston plant to Cerezyme or Fabrazyme. We need all the reactors in Allston for the production of Cerezyme and Fabrazyme, so it’s not a choice that is available in this case, and we have been very clear with the FDA to this point. It’s not a threatening point at all, and the FDA has been very constructive among others encouraging us to change the MTAP patients, and we will start next month to change MTAP patients to 4000 liter material, so we are quite confident that we will be able to supply patients globally. To the earlier question by Mark, we can supply at least 2000 patients through the currently available 4000 liter reactors in Belgium, and another 1000 patients will be added by the next 4000 liter reactor. It’s about 250 per 1000 L capacity, so that will get us to 3000 patients. We are treating about 1100 patients right now, so we can significantly expand over the next few years, but all of it may not be sufficient, so once we have the capacity in place in Framingham, that will for the first time again open up the 2000 liter capacity which will for sure have depth in terms of process to be the same as the 4000 liter, so we don’t have any confusion around the 2000 liter material being different from the 4000 liter material. Also I think we have communicated to all of you that as part of the approval of the 4000 liter capacity in Europe, we did make the commitment to the EMEA to no longer supply at least European patients with 2000 material as of the end of the first quarter next year, so all of this fits quite nicely. I think it is very clarifying indeed. Maged Shenouda – UBS : You wouldn’t reconsider this if the FDA required an additional clinical trial with the 4000 liter material?

We would not, and it is extremely unlikely that such an event were to occur.

The next question comes from the line of Aaron Reames with Wells Fargo Securities. Aaron Reames – Wells Fargo Securities: I just wanted to may be better understand the competitive dynamics that taking all things into consideration in terms of being able to maintain patients on Cerezyme, so I think last year there were roughly about 5800 patients that were on Cerezyme. Are you expecting to have about 5800 patients either on Cerezyme or 638 in the 2010 timeframe being able to maintain most of those patients on Genzyme drugs?

From a capacity point of view, certainly. We will be able to maintain all patients. Everything is designed, not just those patients that we are currently treating but also new patients in addition. We would fully expect, and that’s part of our planning. As we said earlier, there will be competition. We’ve always known there will be competition. The enzyme replacement therapy competition has been developing in terms of clinical trials over many years now, and we don’t think that the treatment INDs will make a significant short-term difference in this regard, but competition will enter this field. We think the competition will particularly be around new patients, and it will be a clinically driven competition where patients that are being chronically treated and feel very well treated, and physicians make clinical decisions rather than just because there is a short-term alternative situation available. That has been the experience with many other similar kinds of disease situations, and I think it will be like that here as well.

The next question comes from the line of Shiv Kapoor with Morgan Joseph. Shiv Kapoor – Morgan Joseph: Given the strategic implications of the possible extended delay for Cerezyme manufacturing, especially in light of upcoming competition, what steps apart from fixing manufacturing are you taking now that will strengthen your position in the Gaucher market in the next 3 to 5 years? Are you thinking about increasing the size of the phase III study with 638 for instance or perhaps looking at a combination 638 with lower Cerezyme dosage? That could effectively help you compete with treatment INDs.

It’s a fair question. Of course, talking about competitive strategies, this is a call. Given that it is a competitive world, it is sometimes not so comfortable. Geoff, if you could make some comments about the 638 molecule and what we are thinking of there.

So I’ll just maybe go back to a couple of the comments perhaps quickly in my introductory remarks around 638. We’ve been developing that drug for many years and are exiting a period of our phase II trial where we were quite pleased to learn that in moderately severe patients with Gaucher, over a 12-month observation period, we are seeing results that are in the range of results that we have seen historically in similar patients with Cerezyme, and we saw our first evidence in the bone compartment that we are in fact having an impact in that most critical compartment of the disease with this orally available twice daily dose product, so our view of the eligible population and the impact that this 112638 molecule can have is getting brighter and brighter, and we are very hopeful that if the product continues on its current trajectory, it will have a revolutionary impact on the care landscape for Gaucher. Recall that the majority of patients who have been on chronic therapy over years have been on an infused therapy, and the unmet need in this group is for therapy that’s safe, effective, able to impact the bone, but that does not involve infusions, and so I think that describes the trajectory of development which is unchanged in terms of its impact ultimately. I think what we are seeing in this circumstance is that we will see not only more rapid enrollment and development of our pivotal trials which are about to begin enrollment next month, as I’ve said, but also acceleration of our already planned wider development for the drug which will explore additional applications within Gaucher, so I think you’re right to focus on the role of this product in a more complex landscape, but it’s a more complex landscape we have been planning for many years.

The next question comes from the line of Josh Schimmer with Leerink Swann. Josh Schimmer – Leerink Swann: How should we think about Synvisc and Synvisc-One revenue line going forward? If you frontloaded from individual patient revenue into Q2 by giving them the Synvisc instead of getting subsequent Synvisc injections into Q3, should we expect a drop off in that line at some point or a steady growth or some other dynamic that I’m not appreciating?

Let me just speak very briefly to the whole Synvisc situation. As Henri said very bullishly in his upfront comments, Synvisc-One has been a remarkable story out of the gate here. The 16% year over year growth hides a bit the fact that by far the largest contributor to the overall Synvisc franchise is the US market, and US market year over year has grown 21% and we’re ramping as you would expect with a launch. If you look at the last two months, June and then going into July, and again a very small timeframe, but we’re 30% plus up year over year in terms of those months, and it’s been driven both from a physician side. A large percent of our existing Synvisc accounts again have switched to Synvisc-One. As Henri said, this represents more than about 50% of our current Synvisc portfolio at this point. On the patient interest side, patients are responding well to website activities and the like, very high level of activity there. When patients go to the site, they spend 6 minutes on the site on average, which again is a very long time for that kind of interaction, and then when they see their physicians, they are asking for Synvisc-One specifically. So, we’re in a very good place. With regard to guidance, of course, we’re not prepared to do that, and we have a lot to learn as we go forward, but we would leave you with the message that this is a pretty exciting place to be in a franchise that’s already $500 plus million. Josh Schimmer – Leerink Swann: What is the market share or proportion of Synvisc that is now Synvisc-One?

The proportion of the Synvisc franchise that is Synvisc-One is approximately 50%, and in terms of total share, I haven’t seen number for the last few months on this one, but we are in the high 30 percent share of the total viscosupplementaion market.

About half of that is Synvisc-One, so that would be around 20%

Your next question comes from the line of Jon Stephenson - Summer Street Research.

On the Cerezyme and Fabrazyme side, you will be able to supply all the market plus sales for replenishing the inventories, so that would actually imply revenues could exceed end-market demand whereas on Lumizyme and Myozyme, the end of 2009 or early 2010 will be negatively impacted as you don’t produce for the market out of the 2000 L facility. Is that the way to think about it?

No. We have no limitations for Myozyme at this time. You saw nice growth in the second quarter compared to the first quarter. In the first quarter, we did have limitations. We have, for Myozyme, sufficient capacity. We expect to need more capacity. That’s why we’ve put in the 4000 L which will be operational by mid 2011. We also don’t expect that once we have approval in the US that we will have a capacity limitation during 2010, but over time of course we have decided to expand the capacity which will then become available in 2011.

But until the 4000 L approval comes through in the US, you would not be able to ship to those MTAP patients until say March or April, right?

No. We are shipping to them. We are changing them over to 4000 liters.

Right, but from a commercial standpoint, from revenue generated.

MTAP patients have never been commercial. They have always been free of charge.

I think the question is are we constrained in the ability to have a broader launch in the US until the 4K approval? What we have been saying for the last year or so is that 4K approval is essential to full commercial supply in the US.

So it is right to think though you don’t get to accelerate US revenues until the 4000 liters which is now 2010, whereas before you would have been able to ship the 2000 Lumizyme product, so you would have gotten a US bump at the end of this year?

I think that’s the right way to look at it.

In terms of this Fabrazyme-Cerezyme question, should we assume that you’ll actually ship revenues above and beyond what the end market demand is as you build up the stock? Is that the other implication?

Yes. To the extent that we have more supply that’s being consumed, we have a completely empty pipeline out there, that will be a place where the some of the production will go for certain.

Thank you.

I think this was the last question. There were probably many more questions, and I would encourage everybody to continue to make sure to connect with Patrick so we hear those questions and can respond to those questions. There’s a roundtable I think next week that Patrick will communicate on. We want to make sure that everybody does have a full understanding of this particular moment. We look forward to continue to report to you the progress that we are making. This will clearly be a very event-driven few months as we get the plant back online, and we start to get experience of producing again, and I think all of us will feel a lot better once we are more in the routine again of normal production as the many questions today indicated. It is something that all of us are very focused on. We feel encouraged by the progress that we have made and that the progress has stayed on schedule in terms of getting the plant sanitized and restarted before the end of July. We’ll talk to you all very soon.