Genzyme 4th Quarter 2005 Earnings Conference Call (GENZ)
February 15, 2006
Henri A. Termeer, President, Chairman and CEO
Mara Aspinall, President, Genetics
David Meeker, President, Lysosomal Storage Disorder Therapeutics
John Butler, President, Genzyme Renal
Ann Merrifield, President, Genzyme Biosurgery
Mark Bamforth, Senior Vice President, Corporate Operations and Pharmaceuticals
Michael Wyzga, Executive Vice President, Finance; Chief Financial and Accounting Officer
Ian Somaya, Thomas Weisel
Phil Nadeau, SG Coven Securities Corp.
Mark Schoenebaum, Bear Stearns
Mark Augustin, Credit Suisse First Boston
Geraldine O’Keefe, Fortis Bank
Meg Malloy, Goldman Sachs
William Tanner, Leerink Swann & Co.
Craig Parker, Lehman Brothers
Ray Bauer, Citigroup
Jeff Meecham, JP Morgan
Adam Walsh, Jeffries & Company
Chia Kapoor, Montgomery and Company
Thank you and welcome to the Genzyme year end 2005 earnings conference call. I would like to remind everybody that the earnings released on this call are available on the investor page of our website at genzyme.com. Today we will discuss Genzyme’s business outlook on the call. Forward looking statements include 2006 guidance, expectations for Myazyme, progress of several clinical trials and drivers of our future growth. These statements are subject to number or risks and uncertainties and actual results may differ materially. Please refer to our September 10Q on file with the SEC for more information. If during the call we use any non-GAAP financial measure, you will find on our website at Genzyme.com a reconciliation to the most directly comparable GAAP financial measure. I’d like to take the opportunity to remind everyone that our first quarter 2006 earnings conference call will take place on April 19th at 11am eastern time. You may access the live web case on our website and there is also additional information for the dial in on our web site. Lastly, please limit yourself to one question per turn during the question and answer interval in order to allow others to participate.
Thank you and I’d like to turn the call over to Mr. Henri Termeer.
Henri A. Termeer, President, Chairman and CEO.
Thank you everyone for participating today. Of course, 2005 seems a long time ago at this time. We are still very, very pleased indeed to report a very strong, very robust year. Actually a year with a tremendous of activities. We integrated three transactions during the year, ILEX was closed late in 2004 and in 2005 we began the oncology field as a result of that transaction. We integrated the scan marketing and sales organization of which we took over in January and learned during the year how to deal with that very, very interesting new field.
In July, we acquired Bone Care and as a result we also acquired a product called Hectorol, which materially changes the whole franchise that we have built around Renagel. We also dedicated 2 new very significant sized manufacturing operations in Europe. One in Belgium a salt culture facility for monocal antibodies that’s now also being expanded for fusion capacity for proteins like Cerazyme and Myazyme. In Waterford, Ireland we dedicated a new facility for biological products that I think will enhance our future ability to produce the products that we have in the pipeline and the products that we currently have in production. We also increased the capacity of Alston, here in Boston, by 50%. And started to operate the plant at a much larger scale late in the year. But most materially, during the year we started a number of late stage billable trials. And, we find ourselves during 2006 with what is probably the largest number of programs in this late stage. And this is extremely gratifying because that will further enable us to grow into the future.
Of course 2005 also had a very strong financial performance. We came in for the year at $2.28 on a non-GAAP basis, which is a few pennies, three pennies above the high end of the range that we had guided you to. And that, of course, is despite all the efforts that I spoke about in terms of integrating these new operations; that’s extremely gratifying by itself.
2006 is a year that has tremendous promise now. Because, we have now the experience of the new operations that we put into place last year that clearly diversify the company in a very material sense. As an example, Cerazyme during 2006 represented about 30% of revenue, so we are clearly growing our way beyond that dependency on one single product. But we also, during this year, have a very important introduction of yet another product right in the middle of our . Myazyme, which we’ve spoken about now for many years and I have spoken about as the product that I’m personally extremely excited about, now is in the very late stage of regulatory review. We did get a positive recommendation for a broad label in Europe, recently. We hope that will get confirmed by the commission in the 2nd quarter so that we can launch a product during that quarter. Of course, we will be dependent somewhat on the pricing decision by the different markets in Europe in the rollout, but it is a very, very important development right in an area where we have such an historical commitment and such historical success.
We also have … we would expect on the FDA for Myazyme a response by the 28th of April. It’s very difficult to comment precisely on what the label will be in the United States. At this time, we are operating with the FDA on all the new data that we are collecting. In the field throughout the world over 200 patients are currently on treatment. We will have to wait until that date to precisely know what is going to be the final label in the United States.
We have started late last year a very significant additional trial in Myazyme on late stage patients, that’s now almost fully-accrued; it will be fully-accrued this quarter. So whatever happens, we are going to get a very solid experience with Myazyme in late stage patients during the year. The outcome of that trial will be the early part of next year.
We will make further investments this year to get the other late stage trials completed or started. The most material one that I would point to now that we have passed the point with Myazyme which really was a big focus of myself, I’m enormously interested in two things that are happening that really could be quite transforming in the fields that they’re in. one of the them is Tolevamar for C. Difficile Colitis. C. Difficile Colitis is increasingly a very troubled problem in those with diarrhea that is increasingly becoming a very big healthcare hazard in hospitals. One talks about antibiotics being part of the cause for this development. It’s not clear what is really the cause for this increase in C. Difficile Colitis throughout the world. But with Tolevamar and non-antibiotic or non-absorbed polymer, also similar to Renagel, we hope to have a very significant clinical solution for a very significant clinical problem. The degree of the problem is quite remarkable. In Québec, 100 patients in the last 18 months died of this condition just at one hospital. 400 patients died in New Jersey over the last year. This particular problem is becoming increasingly more difficult to control. So this is very, very exciting. It puts us into the hospital field more directly. We are looking at that in an infrastructural sense. We clearly want to make sure that we have the ability to reach these hospitals directly through our own organization in as efficient a way as possible. We are also preparing ourselves for manufacturing of this program so that we can roll it our quite quickly, as we would expect it to be of tremendous interest to take this product on. The accruals in the clinical trials are going very rapid, actually more rapid than we had expected. This is a very expensive trial. There are actually two trials, each of over 500 patients. They’re done in Europe, the US and Canada and Australia. So we don’t think we will have results of these trials this year, but will go into the early part of next year. And that I think will be quite a pivotal moment for the company to bring it to market, if we are successful. And it’s a very important care product.
The other one that I have an enormous excitement about but much work needs to be done, is Campath for MS. We showed during the year very, very exciting first on velux rate against and 75% treatment. During this year, 2006, the third quarter timeframe, we will see two year results of this trial and we will then start to get a real good sense for the affect of this therapy on progression. This is a treatment that is completely different from currently available treatments in this space. It is still very, very troubled disease situation despite the fact that there are now more products available for this area. We did see some severe adverse events in the trial, the phase 2 trial. We did file recently with the FDA program to make sure that we manage the risk associated with this very active product so that patients safely can use the therapy. Very, very exciting indeed and it clearly will change the whole space around MS.
And the most exciting thing is that we have currently a set of products in a very diversified set of markets, in the market worldwide, that have an incredible amount of space left. The only mature product here is Cerazyme which has been very solid, is clearly the standard of care and is in no particular danger to change its position, at least not in the near term. But all the other products are still in a very strong growth phase. So that we, even in the press release that you saw today and earlier analyst meetings, have been able to say that based on the current pipeline of products that are in the business, in the market, and Myazyme together, when we project out five years, we will see business that will exceed $500 billion in that timeframe. And of course when you do that, you provide tremendous leverage, allowing us to make very significant investments during this timeframe in the UB search and programs that we have ongoing and those that we can take on.
So for next year for this current year, then we’re expecting a continuation of good growth on the topline revenues between $3.1 and $3.3 billion. And we’re also expecting very growth on the EPS line on a non-GAAP basis of $2.65 to $2.75 per share. Myazyme will be a participant in that toward the end of the year but still quite modestly. We would expect by then to be really much more important contributor in 2007.
So an active year is ahead of us. Very, very exciting year. We are in an investment phase at the current time with all the clinical trials ongoing and with the Myazyme launch preparations in the spring, and the start of both the new manufacturing operations. We would expect very strong performance during the year and by the end of the year with some of the outcome of the late stage clinical trials becoming clear or maybe already being known, giving us a picture to further expand our diversified business model.
So at this time, let me ask Mike Wyzga, our Chief Financial Officer to make some comments on the financial detail then we’ll go to Q&A and we have pretty much all divisions represented in this room so we can respond to all of your questions in quite direct detail.
Michael Wyzga, Executive Vice President, Finance; Chief Financial and Accounting Officer
Thank you Henri. As Henri discussed in summary, 2005 does seem like a long time ago. But 2005 was a very strong year for Genzyme yet again. Our financial performance was primarily due to our product diversification. And you’re also seeing a good deal of leverage in our operations. Full year revenue increased in 2005 to $2.7 billion and that represents a 24% year over year increase. Q4 revenue increased to $729 million as most product lines continued to contribute to the topline as well as the bottom line. That revenue growth in our manufacturing leverage really drove the quarter and the full year bottom line. Our cash generation remains strong for both the quarter and the year. As you can see from our attached earnings per share cross walk, our GAAP earnings we $107 million or $.39 per share on a fully diluted basis. The GAAP earnings include two categories of events and I’ll walk through those if I could the first is acquisition related expenses of about $15 million. This is for write-off of expiring Colar inventory and the turnover of expected value of Hectorol acquisition. These expenses impacted our cost of goods sold line. We also incurred inprocess R&D write off of approximately $7 million. And this is associated with the acquisition of intellectual property from Avergen during the fourth quarter.
As most of you are aware and I think Henri mentioned, during the year we dramatically increased the productivity in the production capacity and that was fairly dramatic. In the fourth quarter we had some low level contamination and some scale up issues that lead to some unsuccessful Cerezyme production runs. The result was a write-off of approximately $17 million. These events have been fully investigated and we’ve put in improved systems and procedures to correct these issues going forward. Product supply to the patient was unaffected, I should mention to you.
Amortization for the quarter was $49 million.
On non-GAAP net income excluding the impact of these items in immunization was $163 million or $.60 per diluted share on a basis of 276 million shares outstanding. Our Q4 EPS includes the impact of the 9.7 million shares associated with our contingent convertible debt.
For the full year on non-GAAP income, again net of one time items in amortization, was $603 million of $2.28 per diluted share. Now I should point out that the full year EPS equals the additive impact of each of the four quarters. Also you’ll have to keep in mind that the 9.7 million shares for the contingent convert impacts the last quarter or the fourth quarter only. It doesn’t affect Q1, Q2 or Q3.
With that as an overview, let me summarize some of the key business drives in 2005 and then turn our attention to the specific guidance for 2006.
As I mentioned, we had a 24% year to year revenue increase. This revenue increase is really driven by 2 factors, acquisitionally related growth and base business increases.
Of the 24 percentage point increase on a year to year basis, six percentage points came from the acquisition of Syndics marketing reps in the United States, as well as Hectorol from Bone Care international, which was acquired in July of last year.
The majority of the revenue increase really was directly related to the diversity of our continued growth of our base product set. Renagel increased to $110 million in the fourth quarter and $417 for the year. This increase of 15% on the year to year basis was due to increased market penetration on a worldwide basis.
Fabrazyme increased and $305 for the full year. That represents a 46% year on year increase. That’s reflective of new patient accruals and continued market expansion, again worldwide.
Therazyme increased by 11% year to year and that was driven largely by additional international patients.
Sarogene increased to $21 million for the quarter and $78 million for the year.
Thymo and lymphoglobulin inceased by 14% for the quarter and 17% for the year.
Now in the 4th quarter, we also recognized about $9 million associated with milestone payments under the RDP58 license agreement. This revenue was captured in the transplant area.
Gross margin in the 4th quarter and for the full year, again excluding the impact of any of the write-offs, increased 4 percentage points on a year on year basis to 78%. This increase was due to the purchase of the Synovisc marketing rights in the United States as well as increased margins associated with volumes of Renagel.
With our operating expense, our Q4 R&D expense before the impact of BIN46 and IP R&D was $133 million or 18% of revenue. This quarter’s R&D expense reflects the impact of a milestone payment that we made to DIEX of approximately $3 million. This is due to the initiation of the phase 3 trial.
For the year, our R&D expenses were $480 million. Increase over prior year predominantly the incorporation of the ILEX pipeline, the acquisition of Bone Care as well as the ramp up as Henri mentioned of Tevelomar and late onset Myozam trials toward the end of 2005.
SG&A expenses, again before the impact of BIN46 and one timers was $207 million for the quarter and $787 million for the full year. Again, this represents the incremental expenses associated with the bone Care product line and expenses resulting from the acquisition of Synovisc marketing rights here in the US.
Our tax rate, before one timers and amortization, was 31%.
Our share count increased by about 37 million shares over last year. There’s a number of factors in this share count increase. The first is the ILEX acquisition. The second is the increases associated with the employee option exercise in stock purchases during the course of the year. We also had more in the money options as the stock price rose pretty rapidly in the 4th quarter.
As I mentioned earlier, the share count increased by 9.7 million shares, associated with the contingent convertible debt in the 4th quarter.
Cash from operation and proceeds in the 4th quarter was about $250 million. A little under $200 million generated from operations exclusively.
For the year, our cash generated from operational proceeds was about $1 billion. We used predominantly all this cash for Bone Care acquisition, the Synovisc marketing rights in the US and we did do some debt repayment and we also used it for capital expenditures. Our capital expenditures in the fourth quarter were $57 million and $190 million for the year.
We ended 2005 with $1.1 billion in cash and marketable securities.
With that, as a precursor to 2006, now let me talk about the 2006 guidance.
You probably noticed we’ve revised our 2006 guidance format slightly to focus on the key product and product growth areas. We’ll continue to provide the same level of detail that we’ve always provided historically for any of our retrospective numbers.
With that said, we expect our worldwide revenue to increase approximately to $3.1-$3.3 billion during 2006. This represents an increase of about $500 million over 2005. The largest components of the topline are Renagel, which continues to be one of the key elements of our revenue growth. With Décor and the impact of Part D, we’re expecting the increase in the topline range to come in between $495-$505 million.
Fabrazyme is expected to increase to a range of $370-$390 million, due to continued penetration worldwide.
We expect Cerezyme to show more modest single digit growth in 2006, increasing to a range of $970-$980 million. This still represents an increase of about $40-$50 million in the course of the year.
Within biosurgery, we expect Synovisc sales to increase to $255-$265 million due to market expansion.
Diagnostics products and diagnostic service revenue is expected to increase to approximately $365-$370 million. The key drive in this area is increasing testing volume and that’s predominantly focused on prenatal as well as in the oncology area.
Our overall gross margin is expected to remain consistent with 2005 at 78%.
SG&A will also remain relatively flat at about 29% of revenue. The SG&A expenses will be somewhat impacted by the costs associated with the launch activities of Almyozen and the increase Synovisc sales effort during 2006.
R&D spending is expected to increase to about $560 million in 2006 and as Henri mentioned, we have a number of programs entering the late stage trials, particularly in the 1st half of the year, so those will be costly.
Our tax rate prior to amortization is expected to remain relatively flat again with 2005, at 31%.
Our weighted average shares outstanding excluding the impact of the contingent convert is expected to come in at about 275 million shares outstanding.
Our GAAP EPS is expected to come in at $1.78-$1.88.
The amortization estimate is expected to come in somewhere around $.46 per share. The impact of the contingent convert is expected to come in approximately $.06 per share. And the impact of the stock option expense is expected to be approximately $.35 per share, due to the full adoption of FAZ-B123R.
Our non-GAAP EPS, excluding these items, is expected to increase as Henri mentioned in the range of $2.65-$2.75.
Now with the investment in the launch of Myazyme and the acceleration of some of the pivotal trials in the first half of the year, we expect our second half will reflect a more rapid EPS growth.
Our capital expenditures will be in the range of $250-$300 million as we build out additional R&D and manufacturing capacity.
Before I turn it over to Henri, I’d like to remind you that you can find the line item detail for both revenue and expense, attached to the press release or on our web site. Now with that, let me open it up to questions and turn it back to Henri.
Thank you very much Mike. Operator now we can turn to questions.
At this time I would like to remind everyone, if you would like to ask a question, please press * and the number 1 on your telephone keypad. We’ll pause for just a moment to compile the Q&A roster.
The first question comes from Ian Somaya with Thomas Weisel.
Thank you for taking my question. Just wanted to gain a little bit more insight on the underlying assumptions for the Renagel revenue guidance. Maybe if you could provide a little more contribution is from Part D, Décor data and what if any benefit does having Hectorol provide?
It’s a very good question of course they both are beneficial. John if you can give them some comments on that.
John Butler here, the President of the Renal Division. It’s very difficult to split out what’s having the effect. If you look, we saw January prescriptions from IMS this morning. They were very positive. Our highest total prescription number ever. Our highest new prescription numbers since towards the end of 2001 from a growth perspective. So we’re really confident that a lot of that growth is having to do with Part D, since Décor is not yet published. But when you look at the revenue growth, what we attribute to each piece is harder to break out. But in total, we think we have 2 extremely valuable drivers that will allow us to reaccelerate the growth of Renagel in ’06.
And the Hectorol inference?
Right. Certainly part of the strategic rationale for purchasing Bone Care was to add Hectorol to our bag in the US. Now we’re able to talk to dialysis chains and physicians about overall bone and mineral metabolism management. Not just about phosphate control. So you’re bringing more than one solution. It’s also allowed us to increase our sales organization so that we’re getting better penetration down our customer call list and seeing the most important customers more frequently. So between the three, that’s clearly going to allow us to achieve the guidance.
Is bundling an option?
No, no, no. the Hectorol IV is sold directly to the dialysis chains whereas Renagel is sold…now both are sold through wholesalers from us, but Renagel as an oral product is written by the physician and filled at the retail pharmacy. So you’re not purchasing at the same call point. But when you’re talking to a physician who makes the prescription decision, you’re talking about total management of PTH, phosphorous and calcium and you have the answers to both. So you’re really getting kind of more than a double bang for your buck when you have a rep sitting in front of a physician.
The next question comes from David Paler.
Thank you. A couple of years ago you bought back the tracking stocks and one of them was your oncology division’s, or former oncology division before Ilex. Can you discuss what’s happened to the technology of that division since its reacquisition or consolidation with the parent?
Yeah, that’s kind of a generalist question, not specifically related to the purpose of this call but we may be able to make a few comments in that regards. The president of the oncology division, Mark Bamforth is here.
The strategy following the consolidation of the tracking stocks was to accelerate or expand the oncology business into the commercial space and we were able to accomplish that with the ILEX acquisition and the addition to the portfolio of both Campath and Clolar. And parallel with that the strategy was to continue to invest in our internal R&D and many of the programs that were part of that portfolio continue to this day both in terms of focusing on anti-angiogenesis and antibody approaches to that, the development of antibodies to transforming growth factor beta, which is the program that we expect to move into the clinic during the first half of 2006. And, the small molecule program directed toward hepatacellular carcinoma, which is in phase 1-2 trial. So a continued investment in that portfolio. We also had a significant effort around vaccine, which we have de-emphasized as we’ve moved forward with oncology.
The next question comes from Craig Parker of Lehman Brothers.
Good morning. A question about Synovisc and potential competition, there was a study just published of another product, Uflexa compared to Synovisc and I wonder if you think that publication is going to have any impact on the potential of Synovisc?
The Uflexa study is a non-inferiority study versus Synovisc and shows non-inferiority at three months of efficacy and says nothing at 6 months, which is our claim. There are other studies around Uflexa that show less efficacy in subsequent months. So we are watchful and always watch the competition, but not overly concerned. Uflexa also requires refrigeration which, from a doctor’s ease of use perspective is a big barrier to use. So we aren’t overly concerned but we’re watching it carefully.
The next question comes from Adam Walsh of Jeffries and Company.
Hi it’s actually Sylvane Kotchnover. I was just wondering when we might see the published findings form the Décor study.
John, I don’t know if we can pinpoint it precisely. These reviews always take a little time. They have been submitted.
Dr. Suki is working with the Journal now and the process is ongoing. Again, it’s under the journal’s control at this point in time.
The next question is from Chia Kapoor of Montgomery and Company
I have a question about Renamed and the Renabio replacement therapy. You announced elaboration with Renamed last year in September. In November, the company announced really positive phase 2 results, really impressive results with acute renal failure. I have a couple of questions on this. What is the opportunity for this product for Genzyme and what catalysts do you expect to provide further insight into the progression of this program?
Yeah, we’ll ask John to give more details to it, but this is typical kind of program that we love. This is a very unusual program that deals with mortality. And it tries to create a step function for patients who currently die. And the phase 2A results were encouraging and currently we are starting the enrollment of phase 2B. Phase 2B really will tell us whether we have something here. We expect the results of that to be done by the end of the year and that then moves us into phase 3, a solid phase 3. So the program still has some ways to go but it is extremely exciting because indeed it does provide a way for patients to survive acute renal failure. It will be a tremendous contribution and the nature of the product is the kind of unusual nature of the product is we have had within the Genzyme picture for quite a while. So having said that, John, anything to add?
Henri I don’t think there’s anything to add at this point.
I have to say I’m very excited. It’s what we’re all about. To figure out a way to really make a tremendous clinical difference.
Henri, we’ve already seen mortality benefit in the phase 2A program, so what is the risk going forward?
The 2A was not a blinded trial and so the 2B will be a blinded trial. And when you deal with something as important as mortality, you have to be absolutely sure that you stand on strong ground. So we decided with renavent that the 2B was highly appropriate and the 2B we’ll say, we have a very manageable risk going into the phase 3. But I’m with you too; I look at 2A and say the glass is half full and therefore we invest in 2B to make sure that we are there and we have something that can be labeled and can be standardized, which of course phase 3 really allows you to confirm. This is exciting stuff.
Your next question comes from William Tanner of Leerink Swann.
I had a question on a comment that you made John about thinking that part D has already had a positive impact on Renagel usage. If that’s what you guys are thinking, kind of where did you come up with that? And then just secondly, so if we’re thinking about maybe 17-ish percent year over year growth, if somebody could remind me about the pricing history for Renagel in ’05 relative to ’04.
Sure. Bill, again we just got January prescriptions this morning so it certainly is early to know what kind of an impact part D is having but. New prescription growth is kind of a key metric there and we saw 11.5% growth vs. December, which was a strong month for us. And again, we haven’t had that month on month growth since October of 2001. So, you know, it’s very early but it’s a good leading indicator I think that this is happening. And that this is what we expected. We expect that it will come in a gradual fashion but to see that in January was helpful. We were somewhat concerned that with the issues around starting up the program that some patients might get lost, particularly the dual eligibles moving over. Where the government has guaranteed that patients shouldn’t walk out of a pharmacy without a prescription filled. We think that’s been very, very helpful. Again our formulary position is excellent. We look at the dual eligibles in our top 20 states. 85% formulary access. We’re very pleased with that. So, the first indicator that we’ve had this monthly data is consistent with the weekly scrips we’ve been seeing for the last 5-6 weeks of this year. So all those point to positive momentum.
And then just the pricing history in ’05?
Right. So in ’05, in February we did a 4.5% price increase and then at the end of the year, we did a 9.5% price increase.
The next question comes from Phil Nadeau of SG Cowan.
Good morning. Thanks for taking my question. Henri my question is actually for you, you have on this call and you have in the past expressed a lot of enthusiasm about Myazyme. Could you provide a little bit more detail on which patients you think will use Myazyme in its first year or two after launch and what plans you have or what strategy you’ll use ultimately to get the adult onset patients onto the drug and how important they are to its ultimate success. Thank you.
We believe that the ultimate success of Myazyme, the ultimately clinical usefulness of Myazyme patients. Of course it will, it is absolute total therapy, given the clinical trial that we did announce mid last year about the classical infantile patients who normally die by about 12 months of life. And in our trial, all patients were alive at 12 months. But, clearly, all patients that also relates to patients that start to slowly deteriorate over time, we expect will be helped by having Myazyme available to them. But to answer this question from both a clinical perspective and global marketing perspective more directly, let me ask Dr. David Meeker who is the President of the division to talk about it a little more.
Dr. David Meeker.
Thanks Henri. I’ll echo what you said. The infantile population today we are seeking to serve that patient population completely. It’s quite clear from the data that we have the earlier you can intervene with this group, the better they do. And, we’re committed to trying to make that possible. I think the late onset population; this is not so different from the other diseases that we’ve launched. If you think about Gauché, there are … the Gauché population of course has a range of severities. Not all patients that have the genetic defect will be symptomatic and require therapy. And I think we’ll learn with the base population is that again there’s a range of severity and that over time people become symptomatic. So to Henri’s point, we would believe today that at the earliest sign of weakness you are certainly eligible for therapy. There will be as there has been with the other diseases, discussion around that as thought leaders begin to get more experience. But, this is a life threatening disease and it’s no different for the adults than it is for the infants other than the course; the timeframe over which that happens. But they do progress to wheelchairs and to ventilators. We’ll work closely with the thought leaders on the data that will continue to drive this and we’ll also, in terms of increasing awareness – which is a fundamental problem for all of these diseases, and we’ve developed quite a bit of experience with that and we’ll be working actively on that side of the problem. Maybe to amplify that, the questions around the blood technology and our ability to facilitate diagnosis is up and running and available at several sites around the world and will be available within Genzyme genetics at the time of launch and we believe that will further facilitate that whole process.
Your next question comes from Jeff Meecham of JP Morgan
I have a question for you as it relates to the risk management program for Campath and MS. What have you guys done so far there? Any further thoughts on the phase 3 design as it relates to ITP?
Okay to answer that question I will ask Mark Bamforth to make some comments. Mark?
Thank you. We filed the plan with both the FDA and the EMEA at the end of January. The expectation is that it will go through in normal review process, with some reviewing comments back from the agency. And our hope is that we will come off from the clinical hold or partial clinical hold and be able to resume dosing sometime either late this quarter or early in the 2nd quarter. In parallel with that, we are planning to move forward with a phase 3 study. That of course has a number of design elements to it and we are spending a fair amount of time with our internal and external experts, developing that protocol that will be coordinated with additional meetings with the regulatory authorities. And our hope is again to initiate the phase 3 in the 2nd half of this year.
Your next question comes from Chris Raymond of Robert W. Baird.
Thanks. A two part question. Can you give some detail in terms of where you stand with working on …I think you mentioned before in the last couple of conference calls Hectorol had some inventory to be worked through. Where do things stand with working through that inventory? And can you give us some indication as to whether that inventory came, essentially out of the acquisition within distributors or with the physician offices?
I will ask John Butler to answer that question. John?
Sure Henri. Yeah, Chris. The inventory was in, was at the wholesaler as well as at the dialysis facilities, the dialysis clinics, not so much at physicians’ offices. It is generally used at the clinical level. We have worked that inventory down. We have put IMAs in place with virtually all; certainly the vast majority are top wholesalers. More than 85%, at this point probably more than 90% are covered by an IMA, which keeps them within a 3-4 week range at the wholesaler, at the distributor level, which we think will ensure service levels don’t slip. And when you look at Renagel, we put similar ranges in all of our IMAs in 2002 and we’ve been able to manage those inventory levels within a half week, three quarters of week consistently. So we think that we’ve put an effective control in place there.
And really quickly, can you tell us where things stand with your European filing for Hectorol?
Sure. We’ve…look at the package that was sent to the FDA. We’ve determined that we do need to do a clinical trial for Hectorol in Europe. We’re planning that protocol now. We did expect that we would need to do that when we did the acquisition. But we were hoping we could put together the US package. But we’re designing that protocol. We think it will be relatively easy, a relatively easy study. Once that’s done we can give more feedback on that.
Your next question comes from Mark Schoenebaum of Bear Stearns.
Thank a lot. Two quick questions. Number one, will Myazyme ultimately grow margin structure for the company and why or why not? Any detail you’re able to provide to help us out since we’re now forced with the challenge of modeling that product. And number two, the $5 billion in revenue that Henry threw out, I think he said it’s five years out. We’re looking at a slide that says it was in ’09. Can you clarify $5 billion in ’09 or 2010? Thank very much.
2010 is the answer. That was the number, the timing also that we indicated earlier at the JP Morgan meeting. And in terms of the margins, it’s a bit early to make very long comments about this because we won’t price this product or discuss price around this product until we know the final labels. We’ve always done that in that fashion.
Can you assume you’d price those such that we don’t have to worry about gross margins?
I did say that before on a call of this nature and I would repeat that here. So the, clearly in the early stages o a new product it is pretty expensive, but we are very confident that we have the capacity, we have the efficiency to produce a product that will not impact the average margins of the company in a negative way by the time that we are, that this program is really running it will be sometime during 2007. Clearly, 2006 is an implementation year and that’s a more expensive year from every point of view and that’s just the investment that we need to make. But, for 2006, we have given the corporate margin knowing that Myazyme is coming and we’re expecting that to be 78%, approximately the same level as it was last year. Of course, revenues from Myazyme will be very modest during this year and will become more important during the coming years. During the coming years we don’t expect it to negatively influence the margins of the corporation.
Your next question comes from Meg Malloy of Goldman Sachs.
Thanks very much. Very quickly, could you remind us of the timelines for Cervelomar chloride and separately if I can, elaborate on the new product initiatives for Syndics and comment if you can on pricing?
…I think Meg you were thinking about Cervelomar Carbonate.
I’m sorry, I was.
Cervelomar Carbonate development is ongoing. We have bio equivalents trial which is the basis for our regulatory filling for our current label, basically that it takes on the same label as Cervelomar Hydrochloride that’s a trial that’s fully enrolled, was fully enrolled at the end of the year and is ongoing now. We’ve started a trial in chronic kidney disease patients not yet on dialysis that has begun accruing patients. We’ve also started a trial for powder formulation as well, with Cervelomar Carbonate to expand the brand further. And, our expectation is that we’ll be filing toward the end of the year and approval a year later.
Ann, could you comment on Meg’s question with regard to Syndics?
Yes. The first question I believe was about the Synvisc pipeline. We have three significant clinical trials ongoing. The first is to expand the label for Syndics in the US to include the hip and if all goes well, with the results of that trial we would hope to launch that first half of next year. The hip is not as large as the knee, but still a very, very substantial piece of the osteoarthritis market, both in the US and globally. The second two trials are for second generation products; both aimed to reduce the number of injections used in the product – we hope to one – although we’re testing some other alternatives to that. And again, Syndics 2, which uses and avian formulation, Avian HA, if successful we would launch in Europe the first half of ’07 and in the US back half of ’07. Hilastin, which is the second of those new programs uses fermented HA, bacterially reduced HA. And again, if successful would be launched the first half of ’08 in Europe and the back half of ’08 in the US. Those are the…
Thank you I just want to clarify on Cervelomar Carbonate, the filling toward the end of the year, is that both for CKD or is that for dialysis only?
It might be two separate files, but both will be filed around the end of the year.
Your next question comes from Ray Bauer of Citigroup.
Hi thank you. A lot of my questions have been answered and the one remaining I know you can’t answer directly. But, maybe you can qualitatively about your acquisition strategy going forward.
I should know we have done transactions in the past. We did three transactions as I mentioned and then smaller transactions last year. And we’ve done them really over the last 20 years in a way that’s absorbable. The company is, this whole field, is characterized by numerous smaller companies, smaller programs. And of course we now have infrastructure on a global basis, both manufacturing and marketing and sales and regulatory that makes us a very attractive company to consider. We’re not a big pharma company. We are a company that has a certain reputation that allows us to be successful in the highly specific market situations. We are prepared to engage in innovative programs like the combination of the diagnostic component with the therapeutic component is something that we believe over the next 1o years will be a very important new field. And so we’ve made over the year a number of acquisitions and transactions that allowed us to build up a very significant program within the US with over 1,500 in terms of genetic diagnostics. We expect to continue to build there and do smaller transactions that will continue to build our portfolio that we can offer through that organization. So those are the kinds of things we will continue to do. The field is, I think, as exciting in this sense as it has ever been. And the realization that what it takes to bring products successfully to market and with sustainable results, the difficulty to do that, is also more broadly recognized. So, a company that can offer a way to achieve that, for a smaller company it is an attractive company. And we’re spending a material amount of effort to understand what the opportunities are on the outside.
Your next question comes from Mark Augustine of Credit Suisse.
My question for you, just to make another comment if you would about the current state in the US of testing newborns for genetic disease and where that may be headed? Thank you.
It’s not just the US, but a global area the way that we think about it. Specifically, we are working, have been working for now quite a number of years on newborn screening for Lysosomal storage diseases. And we really needed to go there because of the seriousness of the disease, where we need to get patients on treatment within the first six months of life, as early as possible. So we were working on these technologies. We have a number of beta sites around the world trying out technologies we’ve introduced. We get very good reactions on the therapeutic that have been available for these diseases and are becoming available like for the disease in the future. It is a process that will take a little while to do, because of this…it’s a small political process often. It isn’t a pure medical process to introduce newborn screening. We think that the nature of the diseases that we treat now in Lysosomal storage disease are not too dissimilar from the nature of the diseases for which currently these kinds of tests are available. And if I were to make a prediction, I would think over the next 2, 3, 4 years, we’ll see some real change in this regard. But let me ask David Meeker who is more directly involved to make a comment as well. David?
The only thing I would add is that it is, as Henri Said, both political and scientific and we’re working closely the political side of the equation. I think the scientific side is driven by what you do with that information. So if you have a newborn screen where the diagnosis of a patient will allow you to act immediately, of course that’s going to drive this process much more than one where there’s the luxury of waiting several years to make the diagnosis, in terms of the ultimate outcome. So, with the LST world, Pompei clearly and PS1 also I think all the MPS disease where earlier diagnosis is going to be important and there are some diseases outside the LST world. So we’re very much in this and we’re going to contribute constructively within the LST but also across some of these other diseases.
Mara, do you want to make a comment? Mara Aspinall is the president of Genzyme genetics, as well and her organization will play a big role into the implementation.
I think the only thing that I would add is that for all the diseases Dave mentioned and others, early diagnosis is critical not only to the quality of life but also to reducing the overall cost of care for those individual patients. So from an overall healthcare system, while there’s some additional cost in this initial screening, indeed we believe it will be cost effective on an individual basis but also a systemic basis.
I have one question actually, the experience that you’ve had with Fabrazyme, for example. Are you able to quantify in any way whether you’re picking up diagnoses earlier in the year 2006 than in ’02, ’03 by age?
Fabra is a different disease in that it presents later, but…one quick data point that might be useful. We did a market survey in the US and the average age of diagnosis was 29 years old. And that speaks again to the problem of many of these diseases where the symptoms are there much earlier, but the awareness level of the doctor is low. And the diagnosis is delayed. In that survey, the average age of diagnosis was 29 and those patients had seen on average 9 physicians before diagnosis was made. So to your point, I don’t have good data to confirm that we’re doing better than that, but I’m quite sure we’re doing better than that and there’s still a ways to go.
Alright, thanks very much.
The next question comes from Geraldine O’Keefe of Fortis Bank.
Thanks for taking my question. I’d like to go back to your comment the thought that you had about spending and revenue for 2010 for your currently marketed products and you suggested that allowing you to spend more. Do you foresee that spending in any particular area, is it renal products, cancer or any direction in particular that you see yourself focusing on in the coming years?
It’s a great question. I just have to think over the next 5 years where we see our R&D investments. in Oncology as we are making significant investments in the 2nd generation of Syndics, 3rd generation, going to a different level of convenience for patients. We really think those are very exciting and relatively predictable opportunity. We’re making material investments that will last a number of years in acute renal failure. If the 2d trial is successful. And quite a number of trials that are now in phase 1-2 that if they work out, these will amount to significant investments. The range from Parkinson’s disease to diabetes type 2, diabetes type 1. But those are early trials and who knows if they work. If they do work, we’ll have the very difficult task to try to prioritize all the things. The problem is that we have an embarrassment of riches that we find ourselves in, in terms of late phase trials. It is extremely exciting but we need to prioritize and make sure that we can afford and analyze the financials in a way that everybody understands and that meets everybody’s expectations. I would not say that there’s one specific area that we’re putting most of our increased R&D expenditures. It’s really across the board.
A follow up. Will most of your spending be on internal programs rather than growing through large acquisitions? Is that your current thinking?
Large acquisitions we’ve really never done. We’ve done smaller acquisitions. Like the ones we mentioned for last year. I think it will be very similar in the future as it has been in the past. We will have a mix of things that we see as opportunities come from the outside come to use and we’ll carry through what we have ourselves.
Once again I would like to remind everyone, if you wish to ask a question please press * and the number 1 on your telephone keypad. We do have a follow-up question from Ian Somaya
Can you reconcile the SG&A guidance that Mike provided? 29% of sales and the of $95 million. Your revenue range is $3.2 billion. I’m just wondering … the number turns out to be higher than $930 or $940. I’m just wondering which number we should use. Base it off of the product revenues or should we just stick with the numbers you provided on the guidance sheet?
I think you should use the number that’s on the sheet.
At this time there are no further questions. Sir would you have any closing remarks?
Thank you everybody for participating. We look forward to reporting on the products and our programs for 2006. Until then we will close this call.
Thank you, this concludes today’s teleconference. You may all disconnect.