Patrick Flanigan – Senior Director, IR Henri Termeer – Chairman and CEO Mike Wyzga – EVP, Finance and CFO Scott Canute – President for Manufacturing Operations, Global Pam Williamson – Head of Global Regulatory Affairs Thomas DesRosier – Chief Legal Officer Ron Branning – Head of Quality Operations, Global David Meeker – COO Mark Enyedy – SVP and President Genzyme Oncology Geoff McDonough – SVP John Butler – SVP; President, Cardiometabolic & Renal

Michael Yee – RBC Capital Markets Jim Birchenough – Barclays Capital Eun Yang – Jefferies Geoff Porges – Bernstein Salveen Kochnover – Collins Stewart Yaron Werber – Citi Ian Somaiya – Piper Jaffray Josh Schimmer – Leerink Swann Geoff Meacham – JPMorgan Ram Selvaraju – Hapoalim Securities Bill Tanner – Lazard Capital Markets Steve Harr – Morgan Stanley Shiv Kapoor – Morgan Joseph Aaron Reames – Wells Fargo Securities Jon Stephenson – Summer Street Research Rachel McMinn – Bank of America Merrill Lynch Phil Nadeau – Cowen Chris Raymond – Robert Baird

Welcome to the Genzyme Corporation’s first quarter financial results conference call. All parties will be in a listen-only mode until the question-and-answer session. (Operator Instructions). Also this call is being recorded. If you have any objections you may disconnect at this time. I would now like to turn the call over to Mr. Patrick Flanigan, Senior Director of Investor Relations. Sir, you may begin.

Welcome everyone to our first quarter earnings conference call. As a reminder, on this call, we will be making forward-looking statements including those regarding our current Cerezyme and Fabrazyme supply expectations, our plans to increase manufacturing capacity, and the to exit fill-finish operations at our Allston facility. Our expectations regarding the terms and timing of the consent decree being negotiated with the FDA, our product development plans and regulatory timetables for Lumizyme and our late-stage pipeline, and our assessment of the future of the business. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. Please refer to the Risk Factor section of our 2009 10-K on file with the SEC for more information on those risks. These statements speak only as of today's date, and we undertake no duty to update or revise them. If during this call, we use any non-GAAP financial measure, you will find on our website a reconciliation to the most directly comparable GAAP financial measure. And also just as a reminder, we are going to host an Analyst Day on May 6th, space is limited. So we do recommend that URCP as soon as possible for a seat at Analyst Day. And with that, I would like to now turn the call over to Genzyme's Chairman and CEO Henri Termeer.

Thank you, Patrick, and thank you, everybody participating this morning. I have with me, Mike Wyzga, Chief Financial Officer; he will go through the financial details. Also Scott Canute, our new President for Manufacturing Operations Globally and he will talk about where we are in the manufacturing recovery programs. David Meeker is here, our new Chief Operating Officer, whom all of you know and Ron Branning, our Head of Quality Globally and he will make some comments and respond to Q&A. Actually he will respond to Q&A, Ron. And then Pam Williamson is here, the Head of Regulatory Affairs Globally, and the usual business unit leaders that all of you are familiar with are here too to respond to Q&A. The first quarter was a very eventful quarter and a quarter where a number of things happened in our route to – our path to fully recovery and the least start of sustainable growth, that actually were constructive in some way and somewhat counterintuitive if you look at the fact that we had during the quarter, the issuance of at least the beginnings of discussions with the agency, the FDA on the consent decree and also late in the quarter, we had a manufacturing interruption that was talked about in the release. It was very clear that in the short term our most important value creating and important thing for us to be able to accomplish is to get our manufacturing operations specifically, Allston into shape, so that we can produce at the high productivity in a reliable and productive way. Our, these two key products that have been impacted now for the last 12 months, Cerezyme and Fabrazyme, and Scott will talk about that. And it is very clear that we are making progress in this regard. We are seeing it on a daily basis when you are close to it, you can see it, discuss and talk about what that progress is. But it is something that has to stay in focus for us for the remainder of the year. If this clearly the subject around the consent decree, but it’s very importantly it impacts our ability to come back to full supply for Fabrazyme and Cerezyme. And those two programs have been impacted now for a period of time. It is gratifying to see how – these are tremendous efforts, throughout the corporation, we are able to maintain connection into the marketplace that works and (at least) work well, the loyalty in the marketplace is really quite gratifying, but we clearly have to be able to get to full supply in order to maintain the right clinical impact of these therapies. We are hopeful indeed that the progress that we are making will expand itself in a much more reliable flow of product starting now. The consent decree situation is much clarified. I think we did receive the draft from the agency, we did tell you in the release what that draft shares and we are in the middle of discussing important elements of this and the most important ones are – is a schedule, and the schedule that allows us to get out of the Allston facility in terms of filling and get to Waterford, our fill-finish operation in Ireland and to our CMO, Hospira in this case as (good way), predictable way and safer way, so that we don’t interrupt supply to products, but we do meet the schedule that we reown this agency. That’s where the discussions are taking place. Thomas DesRosier, our Chief Legal Officer is here, so I am sure if you have questions, he will be happy to answer them. The business was also pretty good during this quarter. We have made very progress indeed on a number of new products that were introduced last year or recently. Myozyme was up 28% from last year, despite an impact on shipping late in the quarter that we are recovering in the second quarter. Synvisc was 26% from last year and the first quarter is really a tough quarter for – the seasonality is quality pronounced around this product, the second quarter has actually traditionally been a very, very strong quarter. We are off on a strong start in the second quarter. And Synvisc-One is now 70% of revenues in that area and it’s quite gratifying to see how that product in an important way is making contribution to the company now. Mozobil was up 75% in the first quarter versus last year and we only introduced it across by the year-ago. And Clolar was up 36%, results are quite gratifying to see and a product that has long ways to go. For this quarter, we are looking forward to June quarter, we are looking forward to June the 17th, the PDUFA date for Lumizyme. It’s an important date. We have been – it’s been a long (concluded) path to get to the point where we have again look forward to an approval of the product and start to really comfort the (inaudible) market side of (inaudible) base in the United States to free of charge programs, but also start to promote really the program in the United States which we have not yet been able to do. The other thing that happened last week at AM, the disclosures on the risk benefits of Alemtuzumab for MS contained to be extremely reassuring. We are now about 12 months away, a little more than 12 months away from seeing the results of the first Phase III clinical trial. We are learning a lot more about this marketplace. It is a very large marketplace and we are becoming increasingly encouraged about the role that Alemtuzumab can play in the treatment of MS. So it is clearly a game changer and if we are able in the Phase III clinical trials that we are enrolled in record time to reproduce these long-term results that we are now seeing on the Phase II, this truly is going to be a very, very important contribution to the treatment of these patients. Of course, the marketplace is large, it’s well over $10 billion right now. By the time we get there, it’s estimated to be about $13 billion and it’s clearly going to be very important driver in our future. So we are at an very interested juncture in our recovery and repositioning of the company and we are going to have shortly on May the 6th, where we can talk about again at the Analyst Day about some of the things we are thinking of, how we think the composition of businesses that we have, the contributions that they make to – in this diversified picture that we represent in a unique way in biotechnology and also talk about some of these big drivers, growth drivers like Alemtuzumab for MS in the future. So at this moment, let me hand over to Mike, let’s (inaudible) show the financial results and then Scott will talk about the manufacturing. Mike?

Thank you Henri. As Henri mentioned, the first quarter was a challenging quarter, we had so many moving parts. We are working our way through the manufacturing consent decree. And as we reported, we received the draft consent decree from the FDA. Now that consent decree provides with an upfront disgorgement of past profits of a $175 million as well as potential other future disgorgements. Still actively negotiating with the FDA, and we expect those to be completed in the second quarter. Non-GAAP accounting we were required to record a charge against our current income. If it’s two tier, if it’s probable that the expense has been incurred and if that expense can be estimated. So based upon the legal assessment of negotiations today, (it would determine) that the $175 million of the disgorgement of past profits meets both of those conditions. So with that, we backed up and we recorded a $175 million as an expense in our Q1 results. We tax effected that as (a corporate) right. We expect these negotiations to be complete in this quarter and we will provide an update for the full consent decree at that time. We are also working our way through the impact of healthcare reform. The impact from our estimate in 2010 will come from three major areas. The first is the Medicaid rebates which will increase from 15.1% to 23.1%. And the second is the 340V discount program, which provides outpatient drugs at reduced rate for those qualifying entities. Often drug products are exempt from the expansions of these new entities just as a backdrop. And the third is the change in the AMP discount definition. While still in estimate at this point, the total impact in the United States for revenues for Genzyme is less than $20 million in 2010, with most of the impact occurring in Q3 and Q4. If you multiply that by a Q4 run rate for those – for those items that will take you to about $30 million to $40 million in 2011. The device tax which is the last leg of this tool is most impactful in 2013. We estimate that will be about 2.3% of the device products of Genzyme and again that’s in 2013. So with that as a backdrop, let me turn my attention now to the quarter results. For Q1 of last year – from Q1 of last year, our top line revenue decreased by about 6% to approximately $1.07 billion. PGH revenue decreased to by about $157 million on a year-to-year basis. Now with all of that happening, Cerezyme decreased to – by to $179 million and that was mostly due to the supply limitations. With all that said, Cerezyme revenue increased by $74 million from Q4 to Q1, even as we started to rebuild our working inventory. Fabrazyme revenue decreased on a year-to-year basis to $53 million and again that was implemented by the implementation of dose reduction. Myozyme revenue came in at $86 million with Europe 4000 liter, making up most of the revenue. As we mentioned in our press release, we had a shipment of about $8 million that was delayed late in the quarter due to a quality hold, but with the subsequent release, the product has shipped and the revenue will be booked in the second quarter. Revenue in the renal and endocrinology area increased by about 4% to $252 million. Renagel and Renvela revenue was $165 million, with increased volumes somewhat offset by the – by the average selling price declines. The average selling price decline was due to the impact of the conversion from Renagel to Renvela as well as lower pricing in Brazil. Thyrogen continues strong performance increasing by 18% on a year-to-year basis. Within the biosurgery area, we increased by 15% overall. And the increase was predominantly Synvisc. Compared to last year worldwide Synvisc revenue increased 26% driven by Synvisc-One and increasing marketing share. From Q4 of last year, the revenue for Synvisc actually went down a little bit due to the normal seasonality that we’ve experienced with both Synvisc, our classic and now we are seeing with Synvisc-One. In the hematologic and oncology area, we increased by about 76%. Year-to-year increase files close of the – close of the deal with Bayer in June and the incremental revenues associated with Leukine, Fludara, and Campath. Mozobil impact, as Henri mentioned continues to grow. We had about 75% increase on a year-to-year basis. And Thymoglobulin, which is now part of the hema and oncology area increased to $53 million as we saw our greater sales in Asia. Rounding up the top line in our other segment, genetics business is relatively flat due to shifts within the product mix and between reproductive testing and oncology; that resulted in lower ASP. And the diagnostics products increased to about $41 million. Year-to-year the revenue was benefited by foreign exchange, that increase was about $30 million, but from Q4 of last year, the foreign exchange actually was negative and impacted our top line negatively by $18 million. Our non-GAAP gross margin for the first quarter was $745 million or 69% of revenue. Our gross margin includes the $11 million of the manufacturing related to discreet cost, most of those are associated with the Iona facility in UK. On a year-to-year basis, the gross margin was impacted by both product mix as well as product margin decreases. With regards to the product mix, with constrained supply, we have shipped high margin PGH products, which lowered the overall our gross margin as a percentage of revenue for the quarter. Secondly and going forward, we see a – we continue to invest in our manufacturing. And while we expect the facilities to increase in both productivity and capacity overtime, in the short-term, the individual margins will be somewhat impacted. Our operating expenses came in significantly under our estimates in 2010 and decreased as a comparison for the Q4 of last year. Compared to Q1, our non-GAAP R&D expenses were $206 million. Last year’s R&D included about $18 million associated with the Exact Sciences transaction. And if you look at this on an apples-to-apples basis, the R&D actually increased by about $31 million. Now most of that was focused on the small molecule programs in the Myozyme ATAP support cost. We also increased due to the impact of the Bayer transaction, which we can close off in the June timeframe. Our non-GAAP SG&A expenses were $353 million for the quarter. And as with the R&D expense, SG&A decreased on a quarter-to-quarter basis from Q4 last year. Compared to Q1 of last year, we saw an increase due to the full quarter of the oncology team, following again the transaction with Bayer. SG&A, also reflects some of the increased cost associated with the Synvisc-One. We also saw some increase in the global IT infrastructure cost. Amortization increased in the quarter to a $13 million over last year and that was again due to the Bayer transaction. Our non-GAAP tax rate was 15%. Now this reflects the benefit of the audit settlements that we saw during the quarter, which we took as a discreet item. Over the remaining quarters, we expect our tax rate to be more normalized somewhere around the 28% range of profit range. Our first quarter GAAP loss per share was $0.43 and again that’s due to the $175 million of the consent decree. In addition, we also on a GAAP to non-GAAP basis showed the pretax income – pretax expenses associated with the stock options. Those came in at $48 million. Pretax acquisition cost related to the deal with Bayer, were – contingent consideration of $62 million and purchase inventory step up of about $9 million. The contingent consideration cost increased due to the revised – we had a revision of the long range forecast, and increased revenue assumptions for both Fludara and Leukine as well as Campath for MS. Our non-GAAP earnings per diluted share was $0.37 on a basis of 272 million shares outstanding. Our cash position decreased slightly in $952 million. Net cash from operations was approximately $126 million and our capital expenditures came in at a $152 million for the quarter and that was mostly focused on our manufacturing facilities. So, let me stop there and turn it back over to Henri.

Okay, thanks Mike. Scott?

Okay. Before I talk specifically about the supply guidance for Cerezyme and Fabrazyme that we provided today, I would like to briefly provide an update on a number of important aspects of our strategy across global manufacturing here at Genzyme. The timeline for our major capacity addition for our programs are all holding firm. Our new bioreactor suite at Framingham has now gone aseptic, we have cells in the building, we are preparing for engineering around and everything still remains on track for approval at yearend of 2011. Our additional fill-finish capacity at Waterford is also on track for 2011 approval as well as our third Myozyme bioreactor at Belgium. Our projects move all of our fill-finish operations out of Allston is progressing well. We have previously transferred all of our Cerezyme 400 units filling to our Waterford plant. This represents about 80% of the volume of Cerezyme and 50% of the total volume that was previously filled at Allston. We will begin validation loss at Hospira in June of this year to transfer the remaining products out of Allston. We will be manufacturing all of our products in Q3 of this year at Hospira and the ultimate exit will depend on the regulatory pathway going forward. We continue to progress well on our plans to upgrade our facilities, systems and equipment at Allston, increasing our levels of redundancy in overall level of reliability. In addition, while we don’t know the final elements of the consent decree yet, we are preparing our organization, our resources and our processes to be able to operate effectively under conditions that would be typically of most previous consent decrees. We have initiated the new working cell bank at both Fabrazyme bioreactors and have seen approximately 30% improvement with the first bioreactor run is now complete. We have made some minor adjustments to a key process parameter that affects bioreactor productivity and we expect to see further improvement with the second bioreactor, which has recently been set and is currently running very well. I do want to be clear that while we are working with minimal inventories of Cerezyme and Fabrazyme, while we complete these capacity addition projects and we strive to improve operations at our Allston manufacturing facility. Therefore, ability to supply these drugs can be impacted by non-routine manufacturing issues until we are able to build inventory after Framingham comes on line at the end of 2011. Today as you have seen already, we have updated our supply guidance due primarily to a problem relating to a piece of equipment in our water for injection system which was further compounded by a subsequent municipal power outage that we experienced. In early March, we began to see bioburden levels in our water for injection system that were higher than normal. We took all necessary actions to maintain control of the system, ultimately resulting in the removal of a heat exchanger from that system. At that point, we were in a state of control producing high-quality water for injection for our plant operations. On March 29th, the plant suffered a significant municipal power outage. After the power outage, we again saw higher than historical levels of bioburden in our water for injection system. We immediately took the appropriate steps to remediate the problem, ultimately performing a chemical cleaning and sanitization. The system is currently in a state of control and is producing good quality of water and production is going very well. The impact of this problem really falls into two categories. The first is the loss of production time in order to take the necessary interventions to remediate the problem. Most of these interventions occurred post power outage, so it’s been relatively recent. Second impact is the potential to impact the work in process to the (way up) that was made during this period of higher than normal bioburden level. No product manufactured during this period has been released or will be released until we complete investigation report including product quality and medical assessment, that’s probably normal routine procedure. And I do want to stress that this is just a normal part of our overall operations that when we see incidents like this much like the event that we saw in Belgium around the Myozyme shipments, we take timeout, we do the proper investigations and then we make the proper disposition decisions going forward. We will provide an update on our expectations for supply of both Cerezyme and Fabrazyme in approximately one month. Henri?

Scott, thank you very much. And at this moment, operator, we can move to Q&A.

Thank you. We will now begin the question-and-answer session. (Operator Instructions). Our first question comes from Michael Yee with RBC Capital Markets. Michael Yee – RBC Capital Markets: Great, thanks guys. The team has acknowledged regulatory risk for a lot of things, so I just wanted you guys to sort of revisit your confidence level on Lumizyme 4K and you know given the things that have happened over the last few weeks and a month, walk through again your takeaways from FDA during the last month and in the context of the regulatory group for Lumizyme 4K and also any observations in Belgium, more or less what have you heard from them? Thanks.

I am directing the question to our Head of Global Regulatory Affairs, Pam.

Sure Michael, thanks for the question. I can confirm that as far as the FDA’s review of the Lumizyme application is that we are on track. We have been in discussions with the agency, responding to what I would consider the types of normal routine request. It would occur during the course of the review. And again we stand by the fact that that they have indicated that our PDUFA date is June 17th and I don’t see any reason that that would be in anyway jeopardized. Michael Yee – RBC Capital Markets: And then comments with regards to the Belgium impact.

Right. So as was mentioned by Scott, there was the need to take – time to take a look at a mechanical issue that occurred and that was discovered quite frankly during our routine maintenance in the facility. And as a precautionary measure, we suspended the shipments until the quality assurance assessment could be completed and the relevant regulatory agencies could be informed. That investigation has now been resolved and we are in midst of continuing to ship as usual. Michael Yee – RBC Capital Markets: Okay, thanks.

Next question.

Thank you. Jim Birchenough with Barclays Capital. Jim Birchenough – Barclays Capital: Yes, hi, guys. In reading the description of the consent decree, it seems that it’s really all tied to getting out of Allston. Is there anything you need to do in the intermediate term in terms of remediating Allston to avoid disgorgement of profits or is it all just related to getting out of Allston in a timely manner and what is that timeframe?

Maybe you can ask Tom DesRosier, our Chief Legal Officer, to kind of go through it, because there is two elements and one deals with Allston and the daily $15,000 number, and the other deals with fill-finish and the royalty numbers, or maybe you can just outline it for him for the group.

Right. So as Scott mentioned, we are on track to get fill-finish out of Allston. That’s the – that’s the initial primary concern that FDA has and we have as well. We – we will come up with a timetable agreed upon with FDA for that exit. We expect that to be a reasonable time period, the discussions have gone quite well, quite cooperatively, we expect that to happen sometime this year. So we don’t think there is a – there is risk in missing the deadline and missing the deadlines would result in the 18.5% royalty disgorgement. So we have a lot of incentive to move quickly out and FDA is going to work with us to get an appropriate timeline in place. The second item – Jim Birchenough – Barclays Capital: I just asked – I just want to follow up on that. Just to be clear, the 483 observations from November, there is no timeline for resolving those?

The exit from fill-finish in the timeline that we will agree upon with FDA has nothing to do with addressing the observations in the – Jim Birchenough – Barclays Capital: (You want me to) to address them?

The 483 comments that were based on the fill-finish which were most of the comments, of course, those become (inaudible) where we no longer use the fill-finish in Allston and that’s the reason – the whole intent here, it’s frankly (inaudible) 483, (that’s where are) these concerns, we share those concerns, we were in the process of moving out of Allston and this particular consent decree is actually putting some hard schedule behind that operation to move out. And they want to make sure that we are moving out and that’s why they have put this royalty obligation if we are missing the scheduled timelines.

Right. And then the second piece of the equation is over the course of the next couple of years, we will have a remediation plan that will address any of the issues that have come up over the past year at the facility other than the fill-finish portion of the facility. That plan will be again agreed upon between Genzyme and FDA to the extent we don’t miss some of the timelines, some of the deadlines in that timeline then we be required to pay $15,000 a day until we do meet those deadlines. But that – that will have nothing to do with the fill-finish facility. Jim Birchenough – Barclays Capital: Great. Thanks for taking the question.

Okay.

Eun Yang with Jefferies. Eun Yang – Jefferies: Thank you. I want to ask you a question on Hospira. You mentioned that you are getting out of – at least fill and finish out of Allston to Hospira in third quarter. And has the fill and finish process for Genzyme to product the Hospira been filed for approval? And if it’s so, the recent one letter to Hospira (with their) facility is it different for Genzyme’s product, (inaudible) that then might impact the approval process?

Scott?

Sure. Yes, we are certainly on track. And the – and Pam made comment as well. But the regulatory pathway for Hospira is reasonably clear. We have submitted comparability protocols actually back in the January timeframe, which will show comparability as we transfer products to Hospira in Kansas. And we are working through the specifics on the regulatory path approval for markets outside of the US as well. In terms of the warning letter, we really don’t see that having any impact on our ability to transfer products nor on the regulatory pathway forwards, the warning letter impacted on different plants. And keep in mind, we currently fill and finish – we have filled a number of products already at Hospira. We have a good working relationship with them and feel that this won’t have any impact in terms of our ability to expedite our exit from Austin. Eun Yang – Jefferies: Thank you.

Geoff Porges with Bernstein. Geoff Porges – Bernstein: Thanks very much and lots of questions. But perhaps on the consent decree, you addressed already about the timeline, but Quantic is involved. Have you have got any indication from the FDA about whether they are an acceptable supervisor for your remediation assets or you are going to have to significantly expand that relationship or bring in another relationship to sort of (inaudible) that. That would be helpful.

Tom?

So the standard way FDA deals with that is they define the criteria for which the company uses to choose an expert and Quantic clearly fills with that definition. They have been used in multiple consent decree situations before. We have been in communication with FDA about using Quantic and they have not raised any objection to that and Quantic continues to work with us and putting together the timelines that we will agree upon with FDA, so they are involved in the negotiation, discussions, and in the total picture. We have no expectation that that we won’t continue to use Quantic or that we would need anyone else. Geoff Porges – Bernstein: Right, thank you.

Salveen Kochnover with Collins Stewart. Salveen Kochnover – Collins Stewart: Hi, I have another question on the consent decree, but will Thyrogen fill and finish be allowed to continue at Allston during the time period?

Tom.

So we continue to operate Thyrogen as usual and we are in discussions with FDA to convince them that it is medically necessary as they have determined already for Cerezyme, Fabrazyme and Myozyme. We are hopeful that they will conclude that it is and it will be grouped with the other drugs, but we are still in discussions on that. Salveen Kochnover – Collins Stewart: Perfect, thank you.

Yaron Werber with Citi, your line is open. Yaron Werber – Citi: Great, thanks for taking my questions. So I had a question about – give us a little bit of understanding, it’s relating to Cerezyme and Fabrazyme and the Allston delay. So I mean it sounds like the – it was the question of bioburden and a question of water injection and the power outage, but we are talking now to another two to three months push-out on Cerezyme. So help us understand a little bit what needs to happen for you to be able to ship to make sure this doesn’t get pushed out again. And how – do you have any whip at all, it sounds like from the press release that there is a work in progress in Fabrazyme which might be impacted. What about Cerezyme and how – when are you going to know whether you are going to be able to use it.

Let me ask Ron Branning, our Head of Quality Operations Worldwide to talk about that.

Good morning. I have just been in discussions with the – our expert consultants and our folks in the Allston facility this morning and we have a clear path to resolve the investigation by the end of this week and begin shipments of product early next week. Yaron Werber – Citi: So why, it sounds like it’s going to be a two to three month push-out essentially or maintaining the 50% supply, so I am (inaudible) handicap why is that?

Let me ask Scott to answer that question. But as Scott said early, there were two impacts, one of whip, one on the actual productivity, because we couldn’t process everything. But Scott will go through that.

That is exactly right, Henri. And just to echo what Ron has said, there are two, in fact, impacts, we have whip that we currently that we are currently evaluating. Again, it’s a normal process, a routine operation, anytime we see if you will an excursion or change from historical performance, we will as a precautionary measure, we will put material on hold until we can complete an investigation of it and then release it appropriately and that’s what Ron was alluding to. So that’s one piece of the impact. The other piece of the impact is that we did lose some production days, because of the remediation efforts that we needed to take place to get the water systems back into a state consistent with historical performance. So these would be things like sanitizations we took, we changed some gasket materials and aligned, we did the chemical cleaning and all those types of things would impact our ability to process material on an ongoing basis. So that’s really the combination of those two impacts that have attributed and led us to the revised guidance that we did today. I do want to emphasize that the product work, the water system is fine today. The (inaudible) levels are very good and consistent if not better than we have seen historically, we are producing good quality of product. And so all of the whip of product that we are currently making and we have been making for the last – last week and a half or so, it’s currently good product and we will push it forward as we normally would. Yaron Werber – Citi: Okay, thank you.

Ian Somaiya with Piper Jaffray. Ian Somaiya – Piper Jaffray: Yes, good morning, guys. So I was hoping Mike can walk us through the accounting of the various I guess line items associated with the consent decree. I guess you touched on the $175 million. If there are future disgorgements, are they – are you going to treat them as one-time items or is that going to be an impact on the non-GAAP earnings. And then if you can talk about the cost associated with the remediating plant and where that will show up.

Sure. Well, we hope there won’t be anything to start off with, because that as we clarify the negotiation with the FDA, hopefully we will remediate our way out of it. But I will also tell you, so if you think about the remediation expenses on a percentage basis, those would be part of the manufacturing cost, we won’t carve those as one-time and we will keep those off on the discreet items, so you can see what’s occurring there. And that’s probably the way we capture it. With regard to the current expenses that are going through facility, we will obviously we have incremental cost associated with Quantic. Those expenses show up in our manufacturing costs, so those also show up in the cost of goods sold and those are in our cost of goods sold now. Ian Somaiya – Piper Jaffray: Okay, and if – just to be clear, the $15,000 per day violation or fees associated with it, it’s my understanding that there is typically a cap is placed on it, would that also apply to your situation?

Tom?

Yes, we are negotiating with FDA a cap on the liquidated damages portion which is the $15,000 per day, but we haven’t arrived at a number yet. Ian Somaiya – Piper Jaffray: Okay, thanks.

Josh Schimmer with Leerink Swann, your line is open Josh Schimmer – Leerink Swann: Okay, thanks for taking the questions. Scott, I guess you talked about the analysis of the whip to determine whether it’s something that can be released and refer to common incidents like this. Based on your experience, what’s your confidence that the whip can be released, but this is for Cerezyme specifically, what you need to demonstrate in the whip to make a go release decision or not and how soon will that decision be made?

Let me ask Ron to make answer that question.

Thanks very much. The discussions that we had ongoing in the path forward that we had is we will close the investigation this week and we will begin shipping product and we are releasing product next week. We have a very clear path for each of the individual lots that we have in place and we are confident that that they are all in a releasable state at this time based on the reviews of the individual lots data that we have so far. Josh Schimmer – Leerink Swann: So the two to three months delay is with the assumption that the whip will all be released and if it’s not released what is the delay.

The two to three months really deals with the lost production days that were mentioned by Scott. And the difference between two to three months, the range that that represents deals with this process that Ron was mentioning. Josh Schimmer – Leerink Swann: Okay, that’s – and then with Thyrogen and the determination of medical necessity. If you can’t convince the FDA that that it is a medically necessary product, does shifting the fill-finish out of Allston, for Thyrogen specifically then allow you regardless of medical need or not to return to shipping Thyrogen or to continue shipping Thyrogen?

Tom?

Yes, absolutely. We do have current plans to move that fill-finish for Thyrogen out of Allston, that will also happen this year. And so to the extent FDA does not ultimately agree with us on the medical necessity, we may even decide to prioritize the move of Thyrogen out of Allston, but your assumption is right. Once it’s out, then it’s not affected by the consent decree. Josh Schimmer – Leerink Swann: Okay, thanks very much.

Geoff Meacham with JPMorgan. Geoff Meacham – JPMorgan: Hi guys, thanks for taking the question. When you guys initially talked about the consent decree, it was restricted to Allston and I am wondering if the discussion on fill-finish in Waterford, if it’s a natural extension of resolving the issue or if it’s a new item. And the follow-up to that is when was the FDA last – when have they last inspected the Waterford facility?

Yes, Waterford is not involved in the consent decree and Waterford is a place where we will be going with filling. This is a fantastic facility that’s being expanded, so we will be filling many of our products in the future in Waterford and we will use Hospira as was mentioned earlier. And the last time that FDA was there, Pam?

It was last fall – fall of 2009. Geoff Meacham – JPMorgan: Okay. Okay, thank you.

Ram Selvaraju with Hapoalim Securities, your line is open. Ram Selvaraju – Hapoalim Securities: Yes, thanks for taking my questions. So with respect to the fill and finish moving it out and into Waterford, could you sort of go through the enzyme replacement therapies, how – what percentage of fill and finish is currently being conducted at Waterford and what percentage would be conducted at Hospira? And specific to Lumizyme, where would the fill and finish be sourced?

And Scott, do you like to take that?

Yes, I will make an attempt at it anyway. We have – Waterford capacity that’s currently on line is approximates the capacity that we have currently at Allston. And if you just look at the filling line and the (finish line) we have, obviously we are adding additional capacity at Waterford as I mentioned early, and we will be on track in 2011. Currently, Waterford does Myozyme, it does the Cerezyme 400 that I mentioned earlier, does all the Cerezyme 400 units that we have, as well as it does some Thymoglobulin formula, excuse me, cell finish as well. What’s remaining in Allston is about – they said about it’s around 50% of our volume is already moved out. Our historical volume has already moved out to the site and the remainder of that will be done at Hospira and that’s the two Fabrazyme formulations as well as the Thyrogen formulation. We will probably – not probably, we will absolutely when we have time to, we will validate Hospira for additional formulations of Cerezyme and we will validate Waterford, for additional formulations that we are doing in Hospira, so we have redundancy as we need to going forward. And so, that we have got multiple capacity. So right now, if you just look at it today, we will be to a point where about half the volume is in Waterford, half of it will be in Hospira after we exit Allston. The Myozyme currently is already done either at Hospira or is done at Waterford.

Cerezyme will be done also in Waterford.

Yes, absolutely, and the Lumizyme would be at Waterford.

That’s right. Ram Selvaraju – Hapoalim Securities: And then with respect to the Framingham and (Hale) derived drugs, where are those going to be fill and finished? Are – is of the product that is scheduled to be produced from Framingham or (Hale) going to be handled by Hospira?

Yes, Fabrazyme, it – that we will do at Framingham, will definitely be done at Hospira. One – yes definitely, at least initially. Now when we – when we get the additional capacity at Waterford and we get the cross registrations done at both sites, we will look at the whole network as a whole and we will try and optimize how we have our – are using all of our capacity on a global basis to make sure that we can enhance the reliability and ensure redundancies across the system. So we may change the actual product mix across the plants overtime. Ram Selvaraju – Hapoalim Securities: Okay, thank you.

Bill Tanner with Lazard Capital Markets. Bill Tanner – Lazard Capital Markets: Thanks for taking the questions. Maybe – question for you Scott, you mentioned that the inventories were relatively low and I don’t know if anybody can quantify that. But how serious of a production event would need to occur for that cushion to be depleted?

The inventory as a month. Bill Tanner – Lazard Capital Markets: That’s right, that’s right.

So, this is David Meeker. Just to provide some additional clarity on that. So the 50% allocation which we went to over the past two months was designed to create this two to four weeks of a buffer inventory if you will which will allow us to manage the logistics of shipping. So it wasn’t an inventory in any sense that would allow us to mitigate an event in the plant. And that’s I think the key piece going forward is that this is a kind of event if we had the usual amount of inventory, of course we would be invisible. In the world we are living in with at most two to four weeks of inventory, any kind of interruption to the manufacturing supply potentially comes visible. So that’s where we are in this situation. Bill Tanner – Lazard Capital Markets: And then just maybe a bigger picture. I guess you are never really out of the woods, but at what point in time is it like are we looking at sometime in mid – in early 2011 or mid 2011 when everything will be up and running such that any externalities could be reasonably well absorbed by the system. I mean just trying to think about when is this whole manufacturing situation pretty firmly behind us?

We need the capacity of the new plant in Framingham to start to build the inventories and that has been the case for a long time. We have always mentioned that we will be starting to produce validation runs, I think starting this year.

End of the year.

And in some grade, that does start to provide an inventory build, but obviously not releasable until the plant is approved. But that is the key factor here. Bill Tanner – Lazard Capital Markets: Okay, thanks.

Steve Harr with Morgan Stanley. Steve Harr – Morgan Stanley: I just wondered (inaudible) tax here for a second and ask you about the strategic review you guys are undergoing in your businesses. Maybe you could talk it to us a little bit about what the goals of the review is and then (how you look) in the different business lines and whether you are looking to sell assets or businesses or spin them out or simply to restructure them. And what the endgame here is likely to be?

Yes, this is an earnings call and it would be quite a diversion to go into strategic review to different businesses. And – but we will be able to talk about that with greater clarity in – during the analyst call, analyst meeting on May the 6th. But generally what you do when you go through these processes, you look at the whole packets of your portfolio of businesses and you look at the opportunities that that represents and what we want to end up is, is a company that has a diversified capability to sustain the kinds of risks inherent in this business, but it is also optimized in terms of what is in the package and that allows us to manage that in an effective way with greater synergies the different businesses. So we will look at all of these elements. We look at return on investment, we look at all the different things that anybody would look at when they do a portfolio review of businesses as we now – is starting to be engaged in a much more direct way. Next question.

Shiv Kapoor, Morgan Joseph. Shiv Kapoor – Morgan Joseph: Thanks for taking my questions. I have got a couple of questions on Alemtuzumab. You mentioned – Henri you mentioned the Phase III very briefly in your opening remarks. Now some of the patients have been on this drug in the Phase III for two and a half years and some are probably taking the third injection. I am wondering if you are witnessing any progressive increase in opportunistic infections through the patient monitoring program that you have.

Yes, we don’t have a medical person in the room to make comments there. So Mark Enyedy who actually is a lawyer, this might help him, to make comments on that. But he is very, very close to this program. But Mark, can you make any comments?

Sure, so briefly the trial design here, there are two Phase III studies. The first is the study in treatment naive patients head-to-head against Rebif. And these are two-year studies followed by an extension study where the patients are rolled over for the potential for additional therapy if needed. So if the patients manifest progression of the disease, are they eligible for additional therapy and in addition to that the patients that were on the Rebif arm are also eligible to receive Alemtuzumab in the extension study. The second Phase III study is again a head-to-head against Rebif in this case in patients who were on a license therapy, prior to study entry either one of the Inteferons or Copaxone, and have had progression with their disease, while on that therapy or the patients that are seen in this second study what we call the treatment experience study. Similar design in the sense that there is two-year follow-up for those patients and then they are eligible then to roll over into the expansion study. The – there is nothing new to report in terms of the adverse event profile of the product in the Phase III studies. And what I can describe to you however is the experience in the long-term follow-up from the Phase II studies which was that the incident of opportunistic infection declined overtime with the patients in the study, so we saw the most infections in the first year and it declined in the second year. And then the Phase II study was the three-year follow-up and the rate of infection declined in the third year as well. And the important point here is that infections seen in these studies were overwhelming mild to moderate in their severity and consistent with some of the data that we reported at AN last week. What we see here is as opposed to a drug like TYSABRI or even FTY720 where there is chronic suppression of the immune system, what we see with Alemtuzumab is the reconstitution of the immune system, following therapy which seems to confer higher degrees of protection from infection while the patient is on therapy. Shiv Kapoor – Morgan Joseph: That’s very helpful. One more question, do you have agreement with the FDA on the primary endpoints of SAD?

Mark?

So there is not a special protocol assessment in place for these studies. What we would say is that this is the first study that I am aware of with progression, sustained accumulation of disability as a primary endpoint in the study. So we think we are setting a new benchmark in terms of the efficacy endpoints for this study.

And Pam you want to make a comment on the meetings that we have with the FDA results getting ahead of the subject too far.

Yes, and in fact, we had a meeting not too long ago and in fact we do have agreement with the FDA on our protocol designs for the Phase III studies. Shiv Kapoor – Morgan Joseph: Thank you.

Okay, thank you.

Aaron Reames with Wells Fargo Securities. Aaron Reames – Wells Fargo Securities: Thanks for taking my question. I just wanted to know if the Consent Decree is going to be handled out of the main justice or the US attorney’s office in Massachusetts. And then if Thyrogen is deemed as being medically necessary, does the disgorgement increase above $175 million then?

So, the answer to the first question is the consent decree is being handled by attorneys at FDA, compliance attorneys at FDA. The discussions are going between them and us. And the second question is no. The Thyrogen being medically necessary or not won’t have anything to do with the upfront disgorgement. Aaron Reames – Wells Fargo Securities: And then just to clarify the first. You know if it’s going to get filed either there or in the – with the US attorney’s office in Massachusetts or does that have any impact on the terms of the consent decree?

It doesn’t have any impact on the terms of the consent decree, but when the ultimate consent decree is filed with the complaint, it’s likely to be in the district court of Massachusetts, the federal district court of Massachusetts. Aaron Reames – Wells Fargo Securities: All right, thank you.

Jon Stephenson with Summer Street Research. Jon Stephenson – Summer Street Research: Great. I was just wondering if you could provide any more clarity on patient losses on the Cerezyme and Fabrazyme front and then I have a separate question on the working cell bank.

Geoff?

Sure Jon, thanks for the question. And I think when we last spoke at the end of the fourth quarter, we had estimated losses on both sides to be about 300, about 300 patients each. At this time, our estimate is about 400 patients, that’s not total. So an incremental 100 patients on – on each side. Jon Stephenson – Summer Street Research: Okay, and then in terms of the working cell bank, you had mentioned that you are seeing a 30% bump in the yields with the first run, but you are hoping for an additional 30% yield bump from that point. If you are not able to get that second 30% bump, what does that do to your ability – I mean what proportion of the demand would you actually be able to provide for the market if you are not able to get that second bump?

Geoff?

Yes, Geoff here. So we estimate and I emphasize here we estimate because it’s based on our modeling of demand. But at the current level of productivity that we have attained now, we think we can meet about 85% of global demand. Jon Stephenson – Summer Street Research: Okay, great, thanks.

Yes.

Rachel McMinn with Bank of America Merrill Lynch. Rachel McMinn – Bank of America Merrill Lynch: Yes, thanks very much for the question. I wanted to ask how – there is a sentence in the press release that talks about the impact of the pending consent decree on products release timelines and maybe I missed your discussion of this in the call, but can you just help us understand that point and how whether FDA will have any ability to sort of require a certain level of inventories beyond just the four weeks that you have now in order to be able to release products?

Ron?

The intent in the negotiations with the FDA is to describe how we can go through the release process and coordinate that with the expert consultant of Quantic. So we are going from a self certification to a Quantic certification process and we want to have FDA understand what that process needs to be and to give a sufficient time to put that in lock steps so that we do not significantly impact our product release times. Rachel McMinn – Bank of America Merrill Lynch: Okay, but does the FDA have any control over how much inventory levels you keep on a go-forward basis?

No. Rachel McMinn – Bank of America Merrill Lynch: Okay, and then just separately, can you give us your thoughts on oral products in dialysis and whether you expect them to be – I guess we are expecting an update soon on from the final regulations or are they going to be included or not and will that start sort of effective January 1, 2011 or be pushed out several years with your current (inaudible)?

John Butler

Yes, thanks for the question. And it still is a question. We are waiting for the final rule to come out. And again we expect it soon, the dialysis centers need to have time to assess the final rule across the board in order to decide whether they want to opt in fully to bundling or phase in over a four-year period, so they need time to do that. CMS recognizes that, so we do expect that before the end of April or sometime in the spring. We have continued to have conservations as has the entire dialysis community around the fact that adding oral phosphate binders to the bundle isn’t the right decision for patients. We know that all of those meetings have been positive and they have certainly listened. It’s difficult to handicap what the outcome will be. But when the entire dialysis community from providers to patients to physicians to manufacturers all agree that this is something that needs consideration before you rush into it, we would like to think that that will allow for that kind of thinking and at a minimum have a delay in implementation. Rachel McMinn – Bank of America Merrill Lynch: Okay, thanks very much.

And operator, we will have two more questions, and then I would refer all those that didn’t get the questions hurry to – to make sure to get in touch this hour with Patrick in Investor Relations department. Go ahead.

Thank you. Phil Nadeau with Cowen. Phil Nadeau – Cowen: Good morning, thanks for taking my question. I apologize if I am being dense on this, but I want to better understand what led to the – the two to three month delay in being able to fully supply Cerezyme and Fabrazyme. If I understand your response to Josh’s question, it sounds like most of that delay came from a reduction in production times because of the water problems. But it sounds like the delay or the loss in production was only a few days long. So can you help me understand how a few days loss in production has led to a two to three months push-out to being able to supply the market?

Scott?

Yes, we went – and the vast majority of this happened post power outage, that’s why we keep emphasizing the power outage piece of it. But we actually went through and had three of about 20 days where we have lost all our significant portion of about 16 days of production during that time period. And the water for injection system is kind of the life blood if you will of your plant if you use it for everything. And so even though if it was a reasonably short period of time and the impact in terms of loss in production days and our ability to process whip through the plant was reasonably significant for that time period and that’s what led to the delay here.

Maybe Scott you can clarify too when we run all the reactors that we round up at a high probably typically level and it impacts at that moment we have a bigger impact.

Yes absolutely. We are running, we are running everything obviously as aggressively as we can and that just means you need for water for injection, need more water to able to capture harvest, to be able to make up immediate to feed the reactors and be able to process buffers to put everything through. So the fact that we are running as aggressively as we are as well as we are means that if you don’t have access to that water, the impact will be more significant and again that’s a good place to be running very aggressively. Phil Nadeau – Cowen: Okay and David in response to some of earlier questions, you mentioned that disruptions like this would typically be invisible, had you had an inventory buffering. So in the past, there may have been disruptions like this that we weren’t aware. So can you give us some idea of how frequently it is when the product – when that facility is up and running, everything is going smoothly just under the normal course of business, how frequently do disruptions of this magnitude is slightly less typically happen?

In the ongoing production operations, in any kind of a manufacturing operation, I mean you will see small downsides and small upsides both actually on a routine basis. It’s just part of the normal variability of running any manufacturing process. And again a downside from that standpoint would normally – would be invisible due to reasonable inventory levels that you had. So you would see those on a routine basis. Occasionally you will see interventions or you will see issues of a more major significance. And again inventory typically would protect the marketplace I mean from that and you set inventory targets based on your ability to just to supply reliably and that’s just normal supply chain management. We don’t have that luxury here obviously. Everyone is well aware of that. So you will see more of these things will impact on a real-time basis. I would say that because the water for injection system does – does touch so much of our operations that this would be a bit of an anomaly, it would not be usual to see this type of event occur on a frequent basis. So it’s – it does touch everything. And as Henri said very clearly, we are running very aggressively and so it has more of an impact in the short-term because of that, but again for good reason. Phil Nadeau – Cowen: I guess, I guess what I am driving at and what a skeptic might say is if you have disruptions like this periodically under normal conditions, then for reasonable assumption for your ability to supply the market in the future might not be a 100% between now and the end of 2011, but something more like 70% or 80% leaving room for error until the Framingham plant comes up. How would you respond to that?

Yes, I understand your question very well and it’s the one we ask ourselves continually all the time and I want to assure that we don’t – we don’t assume a perfection in terms of when we put our supplies together. We assume we are going to see some normal reasonable levels of ongoing variability in our overall production processes. But we don’t – we don’t plan for significant events. And if we see a significant event in the future, it could very easily, potentially unroll into a supply impact and as we have been trying to say as well. So I hope that’s clear. Phil Nadeau – Cowen: Yes, that’s very helpful. Thank you for the time.

Thank you. Our last question comes from Chris Raymond with Robert Baird. Chris Raymond – Robert Baird: Thanks for letting me sneaking here. If possible, just a Renagel and Renvela question. I am kind of struck up on the revenue run rate here, and I wonder if you could – I know you kind of walked through the reasons for the number being where it is, but this is the lowest I think the number you have seen quarterly since ’07. And I know much of it has to do with conversion from Renagel to Renvela. But could you maybe qualify what the – what the revenue boost you saw in ’09, what’s from the price increase you had for Renagel to try to encourage that conversion to Renvela, just so we can understand the run rate here going forward.

So we took 25% increase on Renagel versus Renvela, now that all doesn’t play through and so I – because of (inaudible) penalties on Medicaid, et cetera. So I don’t have a definitive number of what the boost was on that. What’s important to note is that the convergence accelerated significantly. So Renvela in the second quarter represented about – actually just two-thirds of our overall sevelamer sales in the US. And the Renagel sales that remain are increasingly the lower priced Medicaid sales. So the prices actually as we go through the year will be coming together as well. And as the Renagel was left is just our lowest price product. The other thing that Mike mentioned was the price change in Brazil. Remember Brazil is our second largest market in the world, now significantly smaller than the US. But we took a significant price decrease there as we were competing against a couple of similar products that were approved and we decided to be very aggressive. Still we are left with a healthy gross margin in the 67% range. But again, it was a significant drop in our ASP and that had an impact on us. Chris Raymond – Robert Baird: Okay. But that – to meet the guidance range that you guys gave for – for the Renagel Renvela franchise is 740 to 770, one would assume that we need to see a trajectory that kind of takes off from here, is that fair?

And as we said, we still are seeing volume growth. We are just introducing Renvela into most of the large European countries in the second quarter, second and third quarter, so we do expect that we will see – we will see that. I think Mike had something – something to add as well.

Yes, the only thing that I would also point out is from Q4 to Q1 we did see a significant impact of FX rate as it impacted this business, again predominantly the European, but that would be part of it as well. Chris Raymond – Robert Baird: Okay. And then if you don’t mind repeating something, Mike, you quantified the FX impact in the quarter, we didn’t catch that. Could you repeat what that was?

It was $30 million as I recall on a year-to-year basis positive. And from Q4 to Q1, it was $18 million negative. Chris Raymond – Robert Baird: Great. Thank you very much.

You’re welcome.

All right. Thank you everybody very much. I bet there are some questions that have not been answered. So I do hope that you follow up and call our Investor Relations department so that we can have a responsive moment with any of the outstanding questions. We look forward to seeing many of you at the May 6 Analyst Meeting. And hopefully at that time, we can further clarify where we are with consent decree discussion and where we are in terms of the manufacturing issues that we talked about so extensively today. Look forward to talk to you then.

Thank you for participating in today’s conference call. You may disconnect at this time.