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Executives

Patrick Flanigan -- Senior Director, IR

Henri Termeer -- Chairman, President and CEO

Michael Wyzga -- EVP Finance and CFO

David Meeker – EVP, Therapeutics, Biosurgery & Corporate Operations

Geoff McDonough -- SVP, GM, LSD Therapeutics

John Butler -- SVP, President, Cardiometabolic & Renal

Alison Lawton -- SVP, Global Market Access

Mark Enyedy -- SVP, President, Oncology & Multiple Sclerosis

Analysts

Michael Yee -- RBC Capital Markets

Geoff Porges -- Sanford Bernstein

Jim Birchenough -- Barclays Capital

Davis Bu -- Goldman Sachs

Michael Aberman -- Credit Suisse

Geoff Meacham -- JPMC

Chris Raymond -- Robert Baird Co.

Yaron Werber -- Citi

Salveen Kochnover -- Collins Stewart

Mark Schoenebaum -- Deutsche Bank

Rachel McMinn – Bank of America-Merrill Lynch

Eun Yang -- Jefferies & Co.

Steve Harr -- Morgan Stanley

Phil Nadeau -- Cowen

Brian Abrahams -- Oppenheimer

Bill Tanner -- Lazard Capital Markets

Jon Stephenson -- Summer Street Research

Josh Schimmer -- Leerink Swann

Maged Shenouda -- UBS

Aaron Reames -- Wells Fargo Securities

Shiv Kapoor -- Morgan Joseph

Biren Amin -- FTN Equity

Genzyme Corporation (GENZ) Q3 2009 Earnings Call Transcript October 21, 2009 11:00 AM ET

Operator

Welcome to the Genzyme Corporation third quarter financial results conference call. All participants 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.

Patrick Flanigan

Thanks and welcome everyone to Genzyme Corporation's Third Quarter's Earnings Conference Call. On this call we will be making forward-looking statements including EPS guidance, our manufacturing plans and timetables, the timing of shipments of newly produced Cerezyme and Fabrazyme out of our Allston Plant and when we will be able to meet demand for those products.

Our plans and expectations for Myozyme and Lumizyme and our development plans and regulatory timetables for our product candidates including the advanced phosphate finder, mipomersen, alemtuzumab for MS, Genz-112638 and Ataluren.

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 June 30th 10-Q 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.

Now I will turn the call over to Genzyme's Chairman and CEO, Henri Termeer.

Henri Termeer

Patrick, thank you very much, and thank you everybody participating this morning. I have with me as usual, Michael Wyzga, our Chief Financial Officer and David Meeker, who will speak extensively about our remediation of Allston and the restart of production of Cerezyme and Fabrazyme and also Geoff McDonough who will talk extensively about the marketing side of the issues related to the Allston interaction. Additionally, we have other people on the call who will participate in the Q&A.

It's very clear that the Q3 results were dominated by the impact is really the first quarter where that comes visible, the impact of the interruption in Allston and of course we can expect a similar kind of impact again next quarter. But we are getting through the difficulties that this interruption has caused and we will spend some time with you to talk you through this.

The other businesses of the Company were actually quite strong. In Oncology, we started up the product programs that were a part of the Bayer transaction and in this early start we're dealing with customer level inventories and we have to work our way through that, but we are encouraged about how that business is coming together and we will work hard through the fourth quarter to have a very good starting point going into next year around our expanded hematology oncology business.

Synvisc-One is on a very strong start. The franchise is up 30% versus last year, about 50% of the revenues now come from Synvisc-One, that's about six months after introduction, and it has tremendous opportunity in a marketplace that is still substantially underserved. It's doing well and is tracking well against the guidance of 40 million to 50 million we've set earlier. We started introduction into Europe early in the quarter. We had double-digit growth of Thymoglobulin, Seprafilm, genetic diagnostics and Myozyme and late stage programs progressed nicely as well.

Geoff McDonough will make comments on the small molecule program for Gaucher disease. We are very excited about this. This is a program that showed very, very encouraging results in Phase II and we obviously because of the shortage currently are very anxious to make sure that we accrue into the Phase III program as many patients as we can as fast as possible.

The alemtuzumab for campus MS program is making good progress. We reported on four year results now on the Phase II trial, but we also announced the Phase III trial that are now both fully enrolled, they were fully enrolled actually well ahead of schedule which is encouraging in terms of the enthusiasm in the field for this program.

For Mipomersen, we fully enrolled in a second Phase III clinical trial for the (inaudible) patients and we expect results in the first half of next year. For Ataluren, the collaborative program with PTC in Duquesne muscular dystrophy, we have fully enrolled the 2B program, the pivotal program there or PTC has and we expect results in the first half of next year. The advanced phosphate binder and pivotal trial is fully enrolled again in record time and we expect results in the first half of next year. So a bunch of very interesting important late stage programs are making good progress.

But the dominant factors clearly are the Allston production and restart of the plant and supply of Cerezyme, Fabrazyme and Myozyme or Lumizyme for that matter approval in the United States. And here, I'm encouraged that finally, we are getting a sense that we are getting to recovery mode and we have worked our way substantially through the trough that this shortage has created.

Allston is working again; they will talk more about that. We have Cerezyme in vials and we would expect the first releases to come next month and Fabrazyme we would expect them to come in December. We would expect that we will substantially be able to get all patients back to full dose during the first quarter. We would expect the first shipments of Cerezyme will start in late November and the first shipments of Fabrazyme will start in December.

For 2010, we will be very focused on recovering our position in this marketplace. This is a marketplace that we have created that we feel very close to. It is very, very important to us. We have served these patients in depths over many years and we want to make sure that they can rely on us in the future again and we will put into place the redundant capabilities, particularly redundant capacity in inventories to avoid ever having this kind of an interruption again.

In Myozyme, for the United States, the Lumizyme, as it is called, nothing has changed here. The PDUFA date is November 14, a few weeks, three weeks from now, next month, the FDA is currently in the plant for obvious reasons, we will not make any further comments about that because that's an inspection that's ongoing, but I wanted you to know that they are there, because it was an engaging item that you've often commented on.

We are still planning, if we do get approval by the PDUFA date in November 14 to file the 4000 liter in an SBLA shortly after the approval late November. Then if the clock runs in the way that we talked to you before should lead to an approval of the 4000 liter product by the end of the first quarter in March of 2010. The FDA has given us permission to change the MTAP program or the temporary access program for Myozyme patients (inaudible) patients in the United States to the 4,000 liter. And we're currently in the process of planning these changeovers. And I think that's a good sign that we're able to continue without interruption the treatment of patients in the United States.

2010, as we look forward to it, is a year for us, back to basics, we will concentrate our investments of time and capital in those areas where we can strengthen the infrastructure and strengthen our ability to deal with the current businesses, particularly, in the anti-replacement area, but also in the new businesses that are still in a much earlier stage of development. We are very positive about what the outcome that will be because the new businesses are showing some very strong underlying growth in a difficult economic environment.

So with that let me change over to Michael Wyzga, who will go through the financial details. Mike?

Michael Wyzga

Thank you very much, Henri. During the second quarter call we estimated the temporary supply interruption to be most impactful in the second half of the year, and as Henri mentioned that's exactly what we saw in Q3 and we expect to see that in Q4. The financial impact includes both the decreased revenue as well as the expense associated with this supply interruption.

What's really interesting is in this quarter the businesses that were unaffected by the supply interruption are pretty solid and we'll go through some of those. Our top line revenue decreased by 9% over last year to approximately $1.06 billion. The genetic disease area of revenue decreased by $207 million on a year-to-year basis and most of that was the Cerezyme. Cerezyme supply constraints resulted in the decline of $216 million versus last year.

Fabrazyme also decreased by about $10 million and that was impacted by the implementation of a dose reduction. This program is intended to extend our product supply until newly produced units are available.

Myozyme revenue increased by $9 million, mostly in Europe following the approval of the 4000 liter material. In the cardio metabolic and renal area, we increased by about 7% to $261 million, both Renagel and Renvella increased with greater unit volume as well as pricing. Cerezyme also included some very, very strong revenue performance coming in at about 9% growth year-to-year.

As Henri mentioned the biosurgery area in total we increased by about 18% or up to $146 million and that was mostly driven by the Synvisc revenue which increased 30%, that was driven by the strong launch of Synvisc-One here in the United States.

In the hematologic and oncology area we increased by about $88 million. This year-to-year increase follows the closing of the deal with Bayer in June. While our revenue expectations do remain strong for the products we acquired we're working our way through the management of inventory in the field in the short-term. Mostly, it will continue to be a strong driver in this area as well.

Now just rounding out the top line our genetics business increased by 12% on a year-to-year basis. And lastly transplant revenue increased by 16% year-to-year and that is mostly due to market expansion. We're slightly impacted by foreign exchange fluctuation on the year-to-year basis, it is relatively small, it reduced our top line revenue by about $20 million.

Our non-GAAP gross margin for the second quarter came in at $723 million, of about 68% of revenue. Our gross margin captures the impact of the Allston remediation costs of $24 million, which were incurred this quarter. These costs include both the idle facility costs as well as some of the clean-up expenses.

This quarter's margin was also affected by the product mix. With constrained supply that we saw we should bless of the high margin products and that overall reduced our gross margin as a percentage of revenue. In the short-term our gross margin will be impacted by both mix as well as the more expensive initial start-up production runs.

As you will recall with little or no inventory all the expenses start-up costs and variances will impact our P&L almost immediately. And going forward we're making fairly significant investments in the manufacturing redundancies with our facilities in Belgium as well as in Framingham.

In addition we're investing in best-in-class processes and compliance improvements, that's on a worldwide basis. And while these will impact our gross margin in the short-term, they will pay a long-term benefit with the lowering our supply risk going forward.

Our operating expenses were well managed in the third quarter. Our non-GAAP R&D expenses were $205 million versus $291 million last year. Last year as you recall we included $100 million licensing fee to PTC. We set aside this R&D expenses increased only $14 million on a year-to-year basis, but about half of that increase going from the purchase of our assets from targeted to net interest to $7 million this quarter.

Our non-GAAP SG&A expenses were $343 million for the quarter and that should be compared against $307 million last year. Two major impacts here. One was the regional expansion in product launches for the base business. In addition it includes the first full quarter of the sales and marketing personnel following the transaction with Bayer. Amortization increased by $60 million on a year-to-year basis and that's largely due to the Bayer transaction.

Our interest income was lower than last year with decreasing interest rates and lower cash balances. Our non-GAAP tax rate was 23%. That was impacted by a couple of things. Our lower quarterly profits during the year were more made the fixed tax benefits that we got from orphan-drug, R&D credits and state and foreign tax credits more impactful. That somewhat was offset by the lower foreign manufacturing tax benefits. Now the tax credits impacted again in the fourth quarter will be fairly impactful on our lowering our tax rate relatively speaking. As a product supply begins to stabilize the tax rate will begin to normalize around 129%.

Our third quarter GAAP earnings per share was $0.06, and as we discussed in our Analyst Day, our revised financial presentation will exclude only the impact of stock options in acquisition-related expenses. The pre-tax numbers associated with our stock options were $46 million and the acquisition of costs related to the Bayer deal were in two actual buckets. The first was contingent consideration of $28 million and then the second was the purchase inventory step of $18 million and again both of those on a pre-tax basis.

As I stated in the second quarter call, the accounting around the Bayer transaction is pretty complex, so what we did is we revised and updated the PowerPoint presentation and posted that on our Web site.

During the quarter on the pre-tax basis we also absorbed two discrete items, the first was the Allston remediation as I mentioned of $24 million and the second is the expense associated with the purchase technology of $7 million. Both of these amounts were included in both our GAAP and our non-GAAP earnings.

Our non-GAAP EPS was $0.31 on the basis of 274 million diluted shares outstanding. I should point out that during the third quarter we took the opportunity to repurchase 5.5 million shares of our stock and we repurchased those for $307 million. That brings our total stock purchase to 13 million shares since the Board authorized the stock repurchase in 2007.

Our cash generation was solid. Cash generated from operations was $363 million. Our CapEx were $164 million for the quarter and those were focused on our manufacturing facilities as well as in Waterford, and again we used some of the cash to repurchase $307 million of our Genzyme shares. We exited the quarter with about a billion dollars on our balance sheet which again continues to give us the flexibility to do other things.

Now before I turn you back to Henri, I'd like to remind you all that you can find a line item detail of both revenue and expenses attached to the press release on our Web site. With that let me turn it back to Henri.

Henri Termeer

Thank you, Mike. David, give us an update on the Allston environment.

David Meeker

Thank you, Henri. So what I thought I do is provide an update on three specific areas, one is a production update, built a little bit on what Henri explained and take you through where we're now in our viral risk mitigation program and finally a few comments on capacity.

So with regard to production we've completed the first two Fabrazyme runs and we've initiated the third bioreactor run since the plant came down. The new material which is working its way through purification from the Fabrazyme run is scheduled to be filled at the end of October with planned release in December. The fourth Cerezyme bioreactors more than 50% of the way through their runs with the first material coming off of that out of those runs has been filled and again scheduled to be released as we mentioned at the end of November. And we are on track to work our way back into full supply by first quarter of 2010.

Now with regard to the viral risk mitigation status as we highlighted on the previous call, there is basically three levels. We are actively testing all raw materials that come into the plant specifically for (inaudible) virus but we also just to reinforce there is an extensive panel of viruses which all this material goes through for testing as well.

Second, we have the ability to monitor on a continuous basis the metabolic parameters of the bioreactors and that of course was in place before, but our understanding of those metabolic parameters and how they related to the bioinfection has increased with the review of the three events that happened over the past year so that has now become a more sensitive way of looking at those bioreactor runs.

And finally we've implemented in-process biotesting so that it allows us at points during the overall process to test specifically for virus, again looking for an earlier signal than we might have had previously.

We've mentioned the fact that when we bought the plant back up that there were some structural modifications and changes to personnel flow which again all were designed to lower our overall risk. We have a very focused program ongoing to evaluate the use of radiated serum and the use of UV light to treat the medium. Both of those programs, the goal is to have them implemented by late 2010.

And of note, the first viral contamination that we had was in the Halle, Belgium plant which occurred last Fall, last September, and we are now one year out and having run those bioreactors eight consecutive times, again with no evidence of contamination so, further support that this may have been an incidental event and we'll continue obviously to follow that closely.

So finally with regard to our capacity situation, we plan as noted to have expanded our overall capacity from the 8,000 liters which were what we had with the original Allston facility to 32,000 liters once all of the expansion projects come on line in 2012, specifically with regard to investments, we are investing over $200 million currently in the Allston plant both around an expansion project as well as very specific projects designed to increase the redundancy within the plant and again give us greater flexibility to deal with any potential event in the future.

Second, the Framingham facility is near completion, near mechanical completion with Fabrazyme engineering runs set to begin in the second quarter of 2010. The third, 4000 liter Myozyme bioreactor is that project is under way in Belgium, again with expected approval in mid 2011 and we are actively looking at pursuing other opportunities to expand capacity in the medium to ensure as Henri said that we never again in a position of compromise.

One last point which is that with the approval of the Fabrazyme bioreactors in the Framingham plant that will again give us a significant increase in flexibility and allow us to expand our production of Cerezyme in the current Allston plant as well as combining that with the additional capacity in the new Framingham facility. Henri?

Henri Termeer

Thank you, David. Geoff?

Geoff McDonough

Thank you, Henri. This past quarter we've been focused on continuing to communicate clearly and consistently with our stakeholders and managing through this period of shortage, while at the same time serving the ongoing growth of Myozyme and Aldurazyme.

As Mike mentioned, the genetics for these portfolio revenues decreased overall in Q3 compared to Q3 of 2008 by about 37% overall with Cerezyme down 70% and Fabrazyme 8%. However, Myozyme showed continued growth at 12% outside the U.S. and Aldurazyme at 5%; both Myozyme and Aldurazyme growth figures were impacted by an unfavorable Euro rate year-on-year and underlying volume growth with that 20% and 12% respectively.

I'll make a few comments in each of our product areas and then a few comments about the quarter ahead of us. First in Gaucher, as David mentioned we're making consistent progress in moving towards resupply of this community and having filled the first vials we continue to expect these to be available for shipment at the end of November.

With these vials and additional releases in December we plan to meet the goal of supplying patients with at least one infusion by the end of '09 and more importantly we expect as we come back into supply that all patients will be able to reach full dosing in the first quarter of 2010.

In addition to our progress on supply we also pass the key milestone in the development of 112638, our oral development candidate for Gaucher disease with enrollment of our first patients in the engage study, one of two Phase III trials for this program.

We expect to buy expanding sites and opening enrollment on a competitive basis that this program will accelerate in the coming months. And we plan for these measures to offset the increased duration of this trial which was increased to 12 months to support a more robust data set for submission.

In addition, the 18-month data from the Phase II trial is being presented at (inaudible) this week, which shows continued improvement in the visceral and hematologic parameters and increasingly positive data in the bone. We're passing the two-year data point for these patients and expect to report on this data set and an upcoming medical meeting in the first half of 2010.

On the Fabry side, the community has adjusted dosing to meet the 30% allocation for the fourth quarter. We're seeing a majority of centers working within this allocation by reducing dose supported by the fact that the European label contains the results of our dose maintenance trial, a post-marketing commitment which was published in genetics and medicine in 2009.

We have seen a limited number of switches as some patients are consolidating their Fabrazyme to administer the full dose of 1 milligram per kilogram to their most severe patients.

Again, most importantly, we're on track to have vials for new production available to begin shipping at the end of 2009 and expect the dosing can resume at normal levels early in the first quarter of 2010. We will provide further updates to the community on supply for both Cerezyme and Fabrazyme as we get closer to product release dates later this quarter.

For Myozyme we're resuming the growth trajectory outside the U.S. as markets continue to rapidly transition into the 4000 liter product introduced and produced in our Halle, Belgium facility, and as awareness grows around the degree to which this disease is underdiagnosed in the neuromuscular community. This growing integration of (inaudible) diagnostics to clinical practice and the inclusion of the lost data later this quarter to the European label will both be drivers of continued growth in 2010 and beyond.

As we stated in the release, the PDUFA date for Lumazyme is coming up and should allow us to submit an SBLA soon thereafter to support transition to the 4000 liter product in the U.S. anticipated as Henri said at the end of the first quarter in 2010. As we've said previously approval in the U.S. as the Spar [ph] scan manufacturing process is required to allow full commercial launch and widespread access for U.S. patients.

For the coming quarter we're focused on an individualized restart plan for each Gaucher and Fabry patient worldwide to allow these communities to resume therapy and to making the investments we need to support our ability to regain momentum in this core area for Genzyme. We recognize that this location requires increased attention and focus from us and we're eager to reenter this competitive space with expanded capabilities in 2010.

Finally a brief update on Ataluren, the oral development candidate for nonsense mutation genetic diseases that we are developing in concert with PTC Therapeutics. The pivotal Phase III (inaudible) trial is on track to be completed this quarter with last patient out in December and we expect to have top line data in the first half of 2010 to make launch in early 2011 possible.

We're currently investing in pre-launch activities outside the U.S. and are looking forward to this first step in an expanded portfolio in the genetic disease area going forward. Also, this quarter PTC has initiated and begun enrollment in two additional trials with Ataluren, a pivotal trial in nonsense mutation cystic fibrosis and a Phase II A trial looking at nonsense mutation hemophilia, which begins to develop the unique potential of this molecule across a wide range of indications.

With that I'll turn it back to you, Henri.

Henri Termeer

Okay, thank you very much, Geoff. Operator, we can now move to Q&A.

Question-and-Answer Session

Operator

Thank you. (Operator instructions) Our first question today comes from Michael Yee with RBC Capital Markets.

Michael Yee -- RBC Capital Markets

Hey, thanks. Quick question, just in you're thinking about building up inventory for Cerezyme and Fabrazyme. I know you commented you'll have enough to start treating patients in Q1, but can you talk about how long it would take to build up reasonable levels of inventory such that you wouldn't be running on low levels? Is that something that can be done by mid-2010 or?

Henri Termeer

Yes, to really have the complete redundant inventory available in the system, for that we need the Framingham plant to be approved, and as commented by David, we will start engineering runs in the second quarter I believe of next year, in that plant for Fabrazyme, and then validation runs later in the year, early in 2011. The validation runs will become relevant because they will start then to become the background inventory in the system and we want to build it up to minimally six months to nine months so that we can bridge any kind of interruption of the kind that we've just experienced. So to build for that we need to get Framingham correctly.

And in the meantime during this year, all the products that we will produce in our plant in Allston will go to the global marketplace almost immediately. We will through that effort get some level of inventory in the marketplace, but we don't quite get the background inventory that we insist now on developing the six months to nine months in our own hands to avoid this from this kind of an interruption of creating the kind of difficulty that we had again this year.

Michael Yee -- RBC Capital Markets

Okay, perfect.

Operator

Our next question comes from Geoff Porges with Bernstein.

Geoff Porges - Sanford Bernstein

Thanks very much. I'd like to clarify something, Henri, on your statement in the press release. You expect to fully meet anticipated demand in Q1 for Cerezyme and Fabrazyme. Could you be more specific do you mean for the full quarter or for half of the quarter or by the end of the quarter? And secondly, when you say anticipated demand, is that the demand that you experienced in Q4 '08 or is it demand that is increased or is it demand that's reduced because patients are taking competitors products under treatment INDs? Thanks.

Henri Termeer

Yes, the second half of your question is almost impossible to answer. It's very clear that this disruption has created actions on many patients part. Of course, we stayed in touch with the whole marketplace throughout this marketplace is hundred countries, so you can't instantaneously reestablish inventories, reestablish infusion cycles for all patients in hundred countries. So we would expect during the quarter that we can get patients back to their dose and it's a rough estimate of what we would expect that marketplace to be. It does not include a lot of growth because for growth there is no basis really.

We're not trying currently to grow the market. Of course, we know our patients that may become patients that need treatment in the future and but that's such a small fraction of what we talk about here. So essentially, you can assume that we will try to get and we feel some confidence in getting patients back to the dose that they were on before this interruption happened.

Geoff Porges - Sanford Bernstein

Okay, thanks very much. I'll get back in the queue.

Operator

Our next question comes from Jim Birchenough with Barclays Capital.

Jim Birchenough -- Barclays Capital

Yes, hi, guys. Related question. Do you have a sense right now of what percent of patients on Cerezyme have taken a drug holiday, what percent have had dose reduction? And when you think about the trough levels where at right now for Cerezyme use just following up on Geoff's question, are you suggesting you can supply that trough use in the first quarter or some higher use? It's still unclear to me.

Henri Termeer

Okay, Geoff, could you handle that question?

Geoff McDonough

Yes, (inaudible), thanks for the question. No, we would expect today that the global use is at a 20% level compared to the baseline demand that we were meeting prior to the cessation and production at the Allston landing facility. So when we talk about resuming full dosing in the first quarter we're talking about getting back to as Henri said an unknowable approximation of that baseline demand, meaning, it's in some range within a certain percentage of where we were prior to the disruption. So that's what we mean when we say getting back to full dosing, not to meeting the 20% that we're at today.

Jim Birchenough -- Barclays Capital

And just as a follow-up to that, do you have a sense of what percent of patients will go back on to drug from a drug holiday and what percent will go back to full dose from a half dose?

Geoff McDonough

We don't know, I must say, I'm not aware of any patient who's on a holiday or on a treatment interruption today who is not intending to return to therapy. Of course, what I can't tell you is how the market will sort of sell-through once we're back into supply in the first quarter.

Henri Termeer

But over the years of experience it's unlikely that patients don't go back to therapy. David, do you want to --?

David Meeker

Exactly, so as Geoff was highlighting, the ones off therapy when the disease is very well understood so patients will need to go back on to therapy maybe a matter of a month either way I suppose, but they will go back on therapy. The issue of dose is interesting because this population which again has been very well served over the past 14 years and there has been a high level of attention to getting people to "optimal doses" so I think it's likely that patients will go back to the dose they were on before, there's certainly instances where patients having experimented with a lower dose may find out that they're okay.

I think there's also a likelihood that patients who experimented a lower dose, get rechecked more closely by their physician, and the conclusion is you know what, we were suboptimally treating you previously and maybe come back a little higher, so I think the expectation is that the world more or less may go back to where it was prior to this event.

Jim Birchenough -- Barclays Capital

Great. Thanks, guys.

Operator

Our next question comes from Davis Bu with Goldman Sachs.

Davis Bu -- Goldman Sachs

Thanks for taking the call. I guess my question is on 638. So first I wanted to make sure I heard you correctly that the enrollment that began in the Engage study and not in the Encore study. And the second is how do you think about the Encore study in light of the Cerezyme shortage, I guess the entry criteria requires that they're on Cerezyme for three years that they reaches therapeutic goal. Does the supply disruption create risk for that study? Thank you.

David Meeker

Yes, thanks for the question and thanks for the catch. So you heard me correctly, but I misspoke. It is the Encore trial, the Switch trial that has begun enrollment engages open, sites are open, and patients are in screening, but have not yet begun, that's the placebo controlled naive trial. So it is the Switch trial that has begun enrollment and exactly to your point, the requirement for a relatively brief interruption to enroll in the trial is something that we're very sensitive to and investigators and sites around the world are working as quickly as they can to optimize their candidates, so that that interruption is not a factor. We are in the process of amending the protocol to allow a slight increase in that duration which we will allow us to see a greater number of patients eligible for the trial as we go forward. Thanks for the question.

Operator

Our next question comes from Michael Aberman with Credit Suisse.

Michael Aberman -- Credit Suisse

Hey, guys. Thanks for taking the question. I wanted to ask again about the testing of the material. Remind me again, all the tests that you're doing on incoming material has been tested on historical material that didn't catch a virus; is that correct or do you have new testing that did actually find out, find the material in the source material? And then the radiation in the UV treatment, can you expand on that? Is there any other process you can do to try to kill virus prior to starting, putting the raw material in with the actual sell line and is that kind of process going to be available for Framingham?

Geoff McDonough

Yes. Thanks. So your first part of that question was around the testing of the original loss, part of the investigation of the viral contamination. So we have gone back and tested all of the serum lots. We are partway through that were involved in those three incidents and we are partway through testing all of the different media lots and there was a fair number of lots that were involved there and so there's still a number of lots that are in the Q, and what we've prioritized as we've gone forward, of course, is testing material that's go into the current bioreactors and so we're working our way to catch up on the investigation.

But the answer to your question is as of today we have not identified any one of those lots as being the culprit. With regard to the UV light and the irradiated serum question, there's one other technology which is current in the industry, high temperature short-term. We've looked at that. I think the conclusion at this point is that we would pursue the irradiation of the serum and again, we're doing the testing to make sure that, of course, that doesn't affect the product in any way and we're well advanced in those evaluations and then UV light at this point looks like that may be a preferable outcome, but we continue to evaluate all possible options as to how we can mitigate our risk.

Michael Aberman -- Credit Suisse

And you expect it to be available --?

Geoff McDonough

Everything will be applied across the system, so Halle plants, Framingham plants, Allston plants.

Michael Aberman -- Credit Suisse

So is it fair to assume until you get those in place the risk those processes will lower the risk of a recontamination?

Geoff McDonough

No, they will lower it beyond where we are today, absolutely, and again we're lower than we were going into this through our ability to test and screen more effectively.

David Meeker

(inaudible) the plant was out any viral probably for 20 years.

Michael Aberman -- Credit Suisse

Yes, I got it. Thanks.

Operator

Our next question comes from Geoff Meacham with JPMC.

Geoff Meacham -- JPMC

Great, thanks. Related question to Michael. So when you think about the restart of the bioreactors for Cerezyme and Fabrazyme, and you guys have introduced a lot of new tests and methodologies, what do you think the risk is that the FDA comes back and request more data to validate those changes in the process that could somehow impact the release of material by the end of the year?

Michael Wyzga

Geoff, we don't expect that as a risk. The FDA is very interested and very involved in everything we do and it is extremely transparent to them what we do, but we don't think about that as a risk.

Geoff Meacham -- JPMC

Got you. And then second part of a Cerezyme Fabrazyme question, when you guys resupply the market in the first quarter, you obviously have two competitors with free drug available through treatment protocols. Are there any thoughts that you have on pricing when you resupply the market given that the odds of going on treatment protocol for whatever reason if it's 5% or 10% of the patients in the market, it still could potentially put pricing pressure on?

Henri Termeer

Geoff, this, as you noted this has become a very competitive field now for some time and it's more complex to discuss competitive approaches that we may engage in. I think that treatment protocols have their own characteristics and there are limitations by themselves as well. We are really focused on resupplying the patients as an extremely long experience between these products and these therapies and these patients and we want to make sure that that's where we focus and that's where we find the best possible therapy rather than engage in the competitive posturing situation at this time.

Eventually that may occur when products are approved and more broadly available. We have such a situation in Europe around Fabrazyme and Renagel, we compete in a natural way there and that may well happen eventually in the United States too, but that is not going to happen here until products are approved and available in a broad sense.

Geoff Meacham -- JPMC

Got you, okay, thanks.

Operator

Our next question comes from May-Kin Ho. Your line is open with Goldman Sachs. May-Kin, your line is open.

Henri Termeer

Next question?

Operator

Thank you. Our next question comes from Chris Raymond with Robert Baird Company.

Chris Raymond -- Robert Baird Company

Yes, thanks. I just had a question relative to maybe the renal business if we could focus on that for a second. It seems like you guys have backed off a little bit on the deadline for the Renagel, Renvella. Could you maybe talk a little bit about if there's a new plan there or any new timeline there and also maybe give an update as to what's going on with the regulatory pathway for gaining a label for all of the phosphate binders in the broader CKD population? Thanks.

Henri Termeer

John Butler?

John Butler

Thanks, Henri. Thanks for the question, Chris. So we really haven't changed our strategy around Renagel Renvella. We still are moving towards Renvella, and that switch in the U.S. certainly is occurring. I think currently, total scripts on a weekly basis are something like 41%, 42% are now Renvella. What's important is we don't want to take a risk that patients will move off Sevelamer. So we're allowing physicians and patients to make that choice as they see fit.

Our promotion is focused on Renvella and we're seeing that market move in a way that's very natural and we can supply either product and have no issues with supplying either product for some time, so we're quite pleased with the way that's moving in the U.S. We've just launched Renvella in Europe, again in Europe with a label for chronic kidney disease. It's very, very early days, we're in still a small number of markets, but the anecdotal response has been very, very good.

So we're pleased with the way that's going. And on the broader CKD label for the U.S. there's really no further updates. We have obviously backed off of guiding towards a date since it's been such an unusual process and we are working internally, we're not really working with the multiple companies anymore. Genzyme now is engaging the FDA. We're really thinking about what the best strategy is moving forward to secure that label and we still are confident that we can move in that direction.

Chris Raymond -- Robert Baird Company

And if I could ask a follow-up on that, are you getting any feedback specifically from physicians as to what they may or may not do with respect to this sort of left hook I guess that we got from CMS with the bundling rule, that is with having phosphate binders included?

John Butler

Sure. So the bundling issue is a significant one for us and it's kind of going in two parts. First, the way we're addressing the proposed rule from CMS. We are obviously opposed to adding phosphate binders to the bundle and this very importantly we're not alone. The entire kidney care community is against it, the providers, patient groups, the physician groups etc., All are opposed to it. It's bad policy. You put something in a bundle if there's a financial incentive to use product in a certain way, what they're doing is the opposite here.

There's no financial incentive to use a particular product, physician writes what he thinks is clinically best for a patient, you put it in a bundle and now there is a financial incentive so no one is in favor of this. There's an open door forum that CMS is running tomorrow, a number of people including Genzyme will give testimony feedback on that proposed rule, so we're going to continue to fight against having these added into the final rule.

That being said, it's certainly possible that CMS will decide that this is the way they want to go and we can survive very nicely in that environment as well. Then it becomes about access, and it comes out being on formulary with the providers. And the providers recognize that they need to continue to provide the best care to patients. And Sevelamer, Renagel, Renvella is used by 50% or more of their dialysis patients they need to gain access.

We're very experienced in negotiating directly with providers for access. We do that on Hecterol today and have done that very successfully. And in that environment where you have now have access and physicians can make the choices they want to make, you step away from the environment we have today where patients are covered by Part D, but many patients live with this doughnut hole, and we get very few of those patients on Renagel today, because they run into that doughnut hole so early in the year if they are on Renagel, Renvella, and (inaudible) and they don't come out.

We run our own Part D program, we run a support program through the American Kidney Fund and yet it's not utilized significantly. So now all of these patients would have access to the product in an environment with bundling. So we don't want bundling to end up in the final rule, but if it does our business plan changes a bit, but it's one we're comfortable working in.

Chris Raymond -- Robert Baird Company

Great. Thank you.

Operator

Our next question comes from Yaron Werber with Citi.

Yaron Werber -- Citi

Yes, hi. Thanks for taking my question. It's for Henri and the Myozyme team there. Two questions on Myozyme. Can you give us a little bit of a sense the FDA inspection is obviously ongoing, it's not clear to us when it actually started, but how long do you think it's going to take and how confident are you that FDA can still meet that November 14 PDUFA deadline. That's the first question. And then secondly, just the 4,000 new plants, one of the things we're getting a lot of questions on and a lot of confusion on is why would FDA approve the 4000 liter plant without any clinical data at all? Maybe you could help us understand especially given how complicated it's been to approve the 2000 liter plant. Thanks.

Henri Termeer

Yes, Alison, do you want to make a comment on these two things?

Alison Lawton

Yes. So, on the first item as Henri said the FDA is at Allston and I don't think we want to add any further comment around that, obviously at this point, they're at Allston. I think that your comment about the PDUFA deadline is a good one with three weeks away, and again, three weeks is sufficient time for them to finish the inspection and we would hope that in time for an action date of November 14, but again, we have to wait and see what happens on that PDUFA date.

I think with regard to the 4000 liter approval, obviously, FDA has reviewed all of the information that we submitted on the 4000 liter to the IND and have looked at that and accepted the benefit and decided it is appropriate to allow patients to go on to the 4000 liter under the MTAP program, so we're encouraged by that. However of course, supplements of the BLA is different and they will be looking at that in more detail, but currently we plan to submit the CMC and animal data comparability data that we submitted for the MTAP and at the moment we don't anticipate needing clinical data prior to approval.

Operator

Our next question comes from Salveen Kochnover with Collins Stewart.

Salveen Kochnover -- Collins Stewart

Thanks for taking my question. I'm not sure if you've disclosed this previously, but have you released the second part of the Cerezyme whip that was going through internal check?

Henri Termeer

We have not released it and the dating on this material is somewhere in 2010 and it's about $2 million I believe as part of the 10-Q, and it is, I've commented before as the production is restarting and as we started to be able to supply the full market this material becomes less and less attractive in the context of utilizing it in the future, but there's no particular push on that given that it does have a date that extends into 2010. I wanted to clarify too, there was a question asked earlier in terms of creating the back-up supply and the inventories for Cerezyme and Fabrazyme.

I commented that we needed in order to create six month to nine months of inventory actually inventory above current sales we needed the extra capacity of Framingham and quite obviously that's a very significant amount of additional material to put into inventory where there is zero today. We are confident that we can supply the market next year and we can supply both Cerezyme and Fabrazyme markets next year and that goes back to the comment that we have in the first quarter we say we will be able to substantially go back to full dose for the patients that are on therapy, but to create that extra half year of additional inventory we need more capacity, and that's the capacity that comes on line through Framingham. Next question?

Operator

Our next question comes from Mark Schoenebaum with Deutsche Bank.

Mark Schoenebaum -- Deutsche Bank

Thanks a lot for taking the question. I appreciate it. Maybe you said this and I just missed it but can you let me know, I heard some commentary I think from Geoff about some Fabrazyme switchers. Can you just clarify how many patients have switched off of Fabrazyme or Cerezyme to some kind of other competing drug either approved or through treatment IND since the SE virus infection and then correlate it that is how many patients have you added to Myozyme since the Europeans approved the 4K liter plant, please?

Henri Termeer

Geoff?

Geoff McDonough

Thank you, Henri. Mark, thanks for the question. Maybe I'll answer that in three different parts. So I'll bracket it all by saying we don't have total transparency in the case of the Gaucher and the Fabry markets to the degree or the pace of switching, but we have some impressions which I'll be happy to share with you. First of all, the material for Gaucher either from Shire or (inaudible) is not universally available and as Henri said there are 100 countries where the need today is quite large, so there's a capacity issue number one, and secondly, the territories in which those candidates for approval are available are limited to some of the more mature markets in Europe and to the U.S.

So where we will finally land I think we will discover with much greater certainty when we're back into supply in the first quarter, I'm not aware of more than about 100 patients worldwide who have switched today in the Gaucher space, but I don't offer that as either reassurance or as an item of worry since it's very hard to see it today and we'll have more information as we go forward.

On the Fabry side, the degree to which switches are occurring or happening in a very small number of centers where they've made the decision to consolidate their existing Fabrazyme inventory to administer it at full dose and we're aware of quite a small number of patients who have been switched to Replagal to make up the difference in that situation, fewer than 20 to my knowledge today, but again, that's not intended as a prediction, we'll learn much more as we come back into the marketplace.

On the Myozyme side, I'm not in a position to release the patient numbers, but I can tell you that particularly in Europe as supply has ceased to be a constraint and it was certainly a constraint in the first quarter so we absolutely had a dip in our rate of growth and patient accrual in the first quarter that we are back to the rate of patient accrual that we had going into the latter half of 2008 which as you recall was in the first 18 months of launch, so we really resumed our pace of growth over the last six months.

Henri Termeer

On that last part, it's about 100 patients have been added to Europe since we restarted to develop the market in the second quarter.

Mark Schoenebaum -- Deutsche Bank

Okay, thank you very much. I appreciate that.

Henri Termeer

Sure.

Operator

Our next question comes from Rachel McMinn with Banc of America-Merrill Lynch.

Rachel McMinn -- Banc of America-Merrill Lynch

Yes, thanks very much. Couple of questions. Just on the reinfection risk, at what point, in the current production cycle, can you say definitively that there is no drop-off in the really like high yield part of the process you're not seeing the cell death that you can really definitively say that this isn't going to be an issue for 2010. And then also wanted to ask you about margins with the new processes you're talking about if we should think about your historical gross margin of 75% as really sustainable? And then finally can you just reaffirm your product sales for the year? I don't think you've given specific numbers for any of your products.

Henri Termeer

Yes, on the last point we are not intending to go to that level of guidance, so I am afraid that we can't give that, there's one quarter left, that's pretty predictable overall picture. So we won't be able to go there, but in terms of the viral risk, David can you make some comments?

David Meeker

Yes, I heard two things, so let me just make sure I got it right. So with regard to an individual process so a bioreactor run with material then going downstream, I mean we, as I highlighted in my introductory comments have a much better ability today to screen certainly for this (inaudible) virus which we weren't screening for at all and probably the most sensitive test that we have going into this is where the raw materials are applied to an early cell culture and that cell culture which we know would amplify the virus or the virus was there and started to grow and then we test that material and that all happens before we go into the major bioreactor, so we have a much better ability to test this early on the process itself.

And then the second part of your question which is the risk for 2010 and I think I'd just remind you of what Henri had highlighted earlier which is this is a rare event. It happened to happen three times in relatively close connection here for these three events, but over the past 14 years, it's been a rare event. I mean this has been our first viral infection and we have now the Halle experience where we have one year post-infection of not having had a recurrence so I think the farther out we go, the risk begins to drop even further.

Henri Termeer

Thank you, David. Operator, I understand there are still 15 questions in the queue. I'd like to take those 15 questions, but not add more to it, because we are a little bit over time already. Go ahead.

Operator

Thank you. Eun Yang with Jefferies & Co., your line is open..

Eun Yang -- Jefferies & Co.

Thanks very much. You have mentioned that our SBLA to the 4000 liter process for Myozyme and Lumizyme, you're filing SBLA shortly after 2000 liter approval but has that been communicated by the FDA? Did the FDA tell you that's how they expect the process to go?

Henri Termeer

Alison?

Alison Lawton

Yes, so at the moment obviously we have been in communications with the FDA and at the moment our plan is to file the supplement for the 4000 to the Lumizyme BLA, but I will say that we continue to communicate with FDA and the moment that we file, we will then to decide what the most expeditious move is to file that supplement.

Henri Termeer

But we have had conversations with them and this is --

Alison Lawton

This is the current plan.

Henri Termeer

What they also expect us to do.

Alison Lawton

Absolutely.

Eun Yang -- Jefferies & Co.

Okay. Can I just follow-up on Myozyme side, you said that you are looking into acquiring more capacity for Myozyme. Does that imply a product or is that only applied to the manufacturing capacity?

Henri Termeer

No. Just the manufacturing capacity. We have with the additional 4000 liter that's currently being put into the Belgium facility, we have about a capacity around 3000 patients, and each 4000 liter reactor is about 1000 patients. We currently treating about 1100 to 1200 patients so we have significant growth that we can achieve with the current capacity to go through the 4000, but our expectation is that we will need more capacity than the 12,000 liters that we currently have allocated to this and therefore David was saying that we are continuing to look for a way to expand the capacity for Myozyme. This is not needed over the next two years to three years but it's essentially that what we needed beyond 2012 and we want to put it in place in a timely manner.

Eun Yang -- Jefferies & Co.

Thank you.

Operator

Our next question comes from Steve Harr with Morgan Stanley.

Steve Harr -- Morgan Stanley

Just a quick question on APB and Renagel. So at APB what are you looking for the next set of data that would lead to a go/no go decision? And on Renagel, if you could just kind of walk through the timelines are pretty tight here. What are the patent extensions available to you post-September 2014 when the patent continues exclusivity?

Geoff McDonough

Steve, thanks for the question. So on APB as we said in the past we're really looking at from 1.5 to 2X the potency of Sevelamer carbonate. Now again, at the Sevelamer trial, low, medium, high dose Sevelamer carbonate, low, medium, high dose of APB, and then a placebo control as well and looking across that we think we'll get a very good read on the differential potency between the products and that really is, we'll know the data when we see it, but that's the bar that we set to make a meaningful difference in the marketplace.

Henri Termeer

And you will see that data when?

Geoff McDonough

The first quarter of next year. And September 2014 really is the timeline that we're working on for our patent expiry and based on the development plan we have now we think we still will have time to bring APB into the marketplace and switch over significant number of patients.

Operator

Our next question comes from Philip Nadeau with Cowen.

Philip Nadeau – Cowen

Good morning. Thanks for taking my question. Shire announced this morning that it plans to file a BLA for Repligen in the U.S. by the end of the year and presumably the only way they can get through your orphan-drug exclusivity is if the FDAs revoked it because of your capacity issues in Framingham. Can you talk about whether you've gotten that communication from the FDA? Do you still have orphan-drug exclusivity as far as you're aware and what hurdles do you expect there to be to Shire's approval of Repligen?

Henri Termeer

Yes, really the orphan-drug exclusivity period is pretty much over. In April of next year, it's expiring, so it doesn't apply. They will file and the FDA will review and the orphan-drug will expire in the time frame of the review period, so I don't think it applies in this case. So it's not part, we cannot judge what they will file. They will have to pull together the data that they have and they will have pulled that together. The FDA, of course, is thinking about this in light of the shortage and it's very important that in this time frame we get the market back to full supply so that's not the issue that they are trying to manage in that review process, but other than that there's not much we can comment.

Phil Nadeau – Cowen

Well, maybe just a follow-up question. It's my impression from conversations with you in the past and also some of your other potential competitors that the FDA is really looking for data on interstitial capillary GL3 as the approvable end point. Is that still the case? Do you still expect that that is a hurdle that Shire will have to get over in order to get Repligen approved?

Henri Termeer

David?

David Meeker

Well, I think just to go back to orphan-drugs in general and how endpoints so when surrogate endpoints are that reasonably likely to predict clinical benefit part of the equation, so clearance of the Endothelium was a primary end point for our trial that was a very robust end point. We showed very robustly that we had cleared the endothelium. It was intensely discussed, for those of you who remember at the advisory committee in terms of the meaningfulness of that so to the extent that it is used as a surrogate we would expect that they would keep the bar equally high in terms of the kind of clearance that would be required, but we're also now much further along. We're seven years or eight years into the market and there is additional clinical information both on the efficacy side and the impact of antibodies, for example, which should inform that review.

Philip Nadeau – Cowen

Great. Thank you.

Operator

Our next question comes from Brian Abrahams with Oppenheimer.

Brian Abrahams – Oppenheimer

Hi, thanks for taking my question. Question on the EMEA's recent inspection of the Allston facility. I'm just wondering if the EMEA has provided a response to you regarding the action plan that you gave to the inspector and just remind us what are the next steps if you could?

Henri Termeer

Dave?

David Meeker

Yes, so, we've responded to them as you indicated. They have not responded back, but we're in the middle of that process.

Brian Abrahams – Oppenheimer

Okay.

Henri Termeer

When do you expect that?

David Meeker

No, they've identified the issues, we're working on those issues developing plans for those specific items.

Brian Abrahams – Oppenheimer

Okay, thanks.

Operator

Our next question comes from Bill Tanner with Lazard Capital Markets.

Bill Tanner -- Lazard Capital Markets

Thanks for taking the question. Henri, one for you. I know it's customary for the Company to give guidance for the upcoming year in early January when the top line results for the fourth quarter are provided, I'm just thinking forward the feasibility of that as we look into 2010. You've got obviously the 4000 liter approval is going to need to happen to switch people off from the MTAP for them to be paying patients and obviously there's still going to be a fairly dynamic situation as it relates to the Gaucher and Fabry market so just wondering if you could comment as to that? And then for either Mike or Geoff, the percentage of either Fabry sales or Fabrazyme treated patients US versus ex-US? Thanks.

Henri Termeer

Okay, I am still, Bill, working my way to being able at the January meeting to talk about top line and in the February guidance call to talk about the details. And of course, we will know a lot more at that time because we will then have started the process of supplying to marketplace, we will have gone through the PDUFA date of November 14 and I think the Myozyme situation will be very significantly clarified at that time, ahead of that time, will be clarified by the PDUFA date I'm sure. So I think we will have a reasonably clear picture and we will try and communicate as clear as we can both in January and February for the earnings. Geoff?

Geoff McDonough

Yes, to answer to your question about the share, so a little bit over 60% of total revenue comes outside the US for Fabrazyme.

Bill Tanner -- Lazard Capital Markets

Okay, thanks very much.

Geoff McDonough

Sure.

Operator

Our next question comes from Jon Stephenson with Summer Street Research. Mr. Stephenson, your line is open.

Jon Stephenson -- Summer Street Research

It's my understanding that typically when the FDA does an inspection it takes them a couple months to actually come back with a written confirmation that everything has been resolved so I was wondering if you had any kind of assurance from the agency that they're going to expedite that process to get it in before the PDUFA.

Henri Termeer

Alison?

Alison Lawton

Yes, you're correct, the process obviously after inspection and assuming as most inspections end up in some observations and then the Company submits the plan to those observations and that's part of the assessment then that the FDA takes into account as far as our assessment of the current status of GMP, so that all indeed has to happen. At this point in time, we have not had any conversation with the FDA about them expediting that process, obviously everybody is very much aware that this is a gating factor in the Myozyme, sorry, the Lumizyme PDUFA action date in November, but I can't give you any other comment than that.

David Meeker

Maybe just to build on that for a moment from the business side, so obviously the approval is crucial for us to move forward with the application for the 4000 liter material but it's really the approval of the 4000 liter material for us that allows us to get to a supply of the broadest possible population in the U.S. So we would expect the PDUFA date would be a key gateway in the regulatory process but the thing that is most relevant commercially for us and obviously for patients is the 4000 liter approval ultimately.

Jon Stephenson -- Summer Street Research

Absolutely and then just wanted one other thing. I don't know, I might have missed it but I don't think you answered the question on another call regarding gross margins and whether or not they ultimately will return to normalized levels and why did all of this capacity come on line?

Henri Termeer

No. It's too early. Clearly during the guidance call in February, we will be able to talk about that and there's more detail and more granularity if you like. At this time, the middle of this we're going to be back online at least for some time but the time be it that we have that call in February and I think that may be the appropriate moment for us to discuss it.

Jon Stephenson -- Summer Street Research

Okay, thank you.

Operator

Our next question comes from Josh Schimmer with Leerink Swann.

Josh Schimmer -- Leerink Swann

Can you please help quantify the Bayer oncology business effects, to what extent does inventory come off again and do you remain confident in your original projections for these products? Thanks very much.

Henri Termeer

Mark Enyedy, who is in London, or in Italy, I think, can you respond to this?

Mark Enyedy

I sure can. So recall, we announced the transaction, we said that the deal would advance two of our strategic platforms, multiple sclerosis and Oncology and as Henri mentioned in the initial comments to the call the MS program is in fact ahead of schedule so we're very pleased with that result and as we look at the oncology side of the deal we saw these assets as an opportunity to increase our global commercial presence in oncology and complement our existing portfolio with three products targeting the hematology, oncology space with significant incremental revenue. As well as infrastructure to accelerate some of our newer products such as Mozobil and Clolar, and as we look at the Q3 results what we can see is we're beginning to realize on those benefits with our overall revenue more than doubling.

As Henri mentioned as well, as with any transaction the path to integration is not always smooth and the revenue here has come up short from our expectations and that is due in part to the amount of inventory that was in the channel when we closed the transaction and we're looking to manage that situation down to more appropriate levels consistent with how we like to run our business and also as we look to initiate or expand Genzyme's operations in multiple new markets, that is taking some time to affect, we do see some pressure from generics in some markets. So we expect through the course of this year to work through those issues and start next year on a growth trajectory over the current revenue.

We do see some encouraging signs. We're particularly intrigued with Lukine where the revenue has more than doubled more than the third quarter of 2008. So there's a lot of work in process here but we see some encouraging signs to support the business. I think we're not in a position today to extend guidance with respect to these products but are working through that situation and with the rest of the Corporation after the first of the year we'll provide guidance for the entire business.

Josh Schimmer -- Leerink Swann

Okay, can you quantify the inventory that's in the channel and when do you expect that to be worked through?

Mark Enyedy

So I think we are not providing specific guidance with respect to the amount of inventory that we found. I think we do expect to work through that inventory by the end of the year.

Josh Schimmer -- Leerink Swann

Okay, thank you.

Operator

Our next question comes from Maged Shenouda with UBS. Your line is open.

Maged Shenouda – UBS

Sure, hi. Just with regard to the competitive treatment INDs, do you expect the FDA to pull these once you're fully serving the market with Cerezyme and Fabrazyme?

Henri Termeer

I don't think so. You may want to ask the FDA that question. We have no particular insight into what the process would be.

Maged Shenouda – UBS

Okay, thank you.

Operator

Our next question comes from Aaron Reames with Wells Fargo Securities.

Aaron Reames -- Wells Fargo Securities

Thanks for taking my question. I just wanted to know if you could help us understand how much Lumezyme inventory there is from the 2000 liter bioreactor. I know that patients in Europe have to get switched over to 4000 liter material by the end of Q1 2010 and so as patients in the US switch over to that material as well, how much additional inventory would be left to bring commercial patients on to drug in the US?

Henri Termeer

Geoff?

Geoff McDonough

Thanks for the question. So obviously we're dealing with a fixed level of 2000 liter inventory worldwide as we've decided no longer and can no longer manufacture that in Allston, so we have sufficient inventories to meet our targets for transitioning markets around the world to the 4000 liter material, and that transition is proceeding very nicely, in fact, we're ahead of the schedule that we had set for ourselves for the end of this year, and all new market launches and applications going forward are being made on the basis of the 4000 liter material. Today, we do not anticipate having a substantial 2000 liter inventory left to support commercial launch with the US approval of the 2000 liter material which is why we've been emphasizing the need for approval of the 4000 liter material in the US to provide wider spread access.

Aaron Reames -- Wells Fargo Securities

Thank you. And then in terms of the orphan designation, there wasn't really any comment around orphan designation for Myozyme and Lumizyme. I was wondering if you could provide us with just a little bit of insight around that topic?

Henri Termeer

Alison, do you want to make a comment?

Alison Lawton

Yes, unfortunately I can't remember what the orphan exclusivity date is for Myozyme. It's some years out.

Henri Termeer

Is it 2014?

Alison Lawton

Yes. But so there is obviously nothing has changed with regard to that at this point in time.

Henri Termeer

I guess what you're picking up is that we don't consider that particularly driving an issue at this time.

David Meeker

There's also no one specifically there who would be challenging orphan-drug exclusivity at this point.

Aaron Reames -- Wells Fargo Securities

But wouldn't it have tax implications though if it was eliminated to a certain degree?

Henri Termeer

No. The tax implications are early on. During the clinical trial development, the special tax rate for the expense associated with the expenses of the clinical trials and that you recognize at the time that you have it and provided as a benefit at that time, currently, we have no further benefits of that, Aaron. And on the orphan exclusivity, just to come back to that a minute, the IP position that we have for Myozyme is through 2023 and I guess that's why maybe nobody is very focused on that here as a negating item.

Aaron Reames -- Wells Fargo Securities

Okay, thank you.

Operator

Our next question comes from Shiv Kapoor with Morgan Joseph.

Shiv Kapoor -- Morgan Joseph

Thanks for taking my question. A couple of queries on Genz-112638, can you enroll patients in the Encore trial at an adequate pace now given the shortage of Cerezyme? And second one have you engaged the FDA about the possible treatment protocol for this drug, Genz-112638? Thanks.

Geoff McDonough

Thanks for the question, Shiv. So as I said earlier that the pace of enrollment for 112638 is an enormous area of focus for us. We have a small amount of Cerezyme reserved to allow for that trial to enroll based on our expectations for the coming month and a half, and the biggest source of pressure here is allowing patients eligibility for the trial based on treatment interruptions, so we're currently comfortable that we'll meet our enrollment targets in the coming quarter but those are the pressures that we're facing in meeting our goals.

With respect to treatment IND, we did engage with the FDA about the possibility of a treatment IND and I think understandably the FDA was very focused on us pushing forward with the Phase III program as our most important priority and given that we do have a substantial number of sites in the U.S. where patients can enroll and can access the small molecule we agreed with that decision so we do not have a treatment IND in place for a small molecule in the U.S. at this time.

Shiv Kapoor -- Morgan Joseph

Okay, thanks.

Geoff McDonough

Sure.

Operator

Our final question today comes from Biren Amin with FTN Equity.

Biren Amin -- FTN Equity

Thanks for taking my question. The timelines for shipment of Fabrazyme seemed to have slightly changed to late December from mid December. Could you just tell us the reason for this change?

Henri Termeer

No reason. There's no change in terms of timelines of Fabrazyme.

Biren Amin -- FTN Equity

Okay. Because I thought --?

Henri Termeer

Yes, I think you're probably right that we talked about it a bit, there's sometimes a misunderstanding between when is it least and when is it dominant and the truck being shipped, but second half of December is a way to think about that, and more likely towards the end of December and actual shipment while the release maybe mid-December.

Biren Amin -- FTN Equity

Great. Thank you.

Henri Termeer

All right, thank you very much everybody for participating. I have a sense that despite the many questions that we did, we weren't able to deal with in the last hour and 25 minutes there are probably still questions left. And I would invite you to make sure that we get your questions through Patrick from Investor Relations office so we can respond to you. We look very much forward to continuing to record our many events now in relatively short-term and important event that is much focused on today is November 14, and we look forward to communicating with you at that time as well.

That will clarify the Myozyme and Lumizyme situation in the U.S. materially and then of course the early moments when products from the new runs of Cerezyme and Fabrazyme are becoming available for shipment I think most of us are looking forward to that as well. And then in early January, we will talk at the JPMorgan Conference about where we stand, generally with our projections for the year 2010, and on the earnings side we will talk about that in February. I don't know when the date is, the 17th of February. We are very much looking forward to this because this has been a very challenging time for us. The basics of the business continue to be very robust, are very strong, but we have clearly to reset the position around Gaucher disease and Fabry disease and that will be our focus throughout next year. Thank you all very much for participating this morning and we'll talk to you soon.

Operator

Thank you for joining today's conference. That does conclude the call at this time. You may disconnect.

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Source: Genzyme Corporation Q3 2009 Earnings Call Transcript
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