Shire plc Q2 2009 Earnings Call Transcript

Aug. 5.09 | About: Shire PLC (SHPG)

Shire plc (SHPGY) Q2 2009 Earnings Call Transcript August 5, 2009 9:00 AM ET


Clea Rosenfeld -- IR

Angus Russell -- CEO

Graham Hetherington -- CFO

Sylvie Gregoire -- President, Human Genetic Therapies

Mike Cola -- President, Specialty Pharmaceuticals


Rodolphe Besserve -- Societe Generale

Dani Saurymper -- Goldman Sachs

Peter Verdult -- Citi

Martin Wales -- UBS

Corey Davis [ph]

John Simpson [ph]

Tom Russo [ph]

Ken Cacciatore -- Cowen & Co.

David Amsellem -- Piper


Welcome today to your Shire PLC Q2 results conference call. My name is Carly, and I am the event manager for your call today. During the conference, your lines will remain on listen-only. (Operator instructions). May I remind all parties this call is being recorded for replay purposes.

With that, I'm glad to hand you over to Clea Rosenfeld. Clea, go ahead.

Clea Rosenfeld

Thank you very much. Good morning and good afternoon, everyone. Thank you for joining us today for Shire's second quarter 2009 financial results. By now you should all have received the press release and should be able to view the presentation via our web site on If for some reason you have not received the press release or unable to access the web site, please call back Sue Hale in the UK Investor Relations Department on 44-1256-894-160 and she will be happy to assist you.

Our speakers today are Angus Russell, Chief Executive Officer; Graham Hetherington, Chief Financial Officer; Sylvie Gregoire, President of HGT; and Michael Cola, President of Specialty Pharma.

Before we begin, I would refer you to slide #two of our presentation and remind you that any statements made during this call which are not historical statements will be forward-looking statements and as such will be subject to risks and uncertainties, which if they materialize can materially affect our results.

Today the agenda is as follows

We begin with opening remarks of Shire's performance and highlights during the second quarter from Angus. Then Graham will continue with the financial review. Mike will follow with a review of our Specialty Pharma business performance, and Sylvie Gregoire will update you on the latest developments in our HGT business. Angus will then summarize the key points of this presentation and we will open up for your questions.

This presentation is likely to take about 45 minutes. So can I please ask that you limit yourself to two questions only so that everyone gets a chance to ask questions. Otherwise, Eric Rojas and I will be more than happy to follow-up offline with any subsequent questions. Thank you for your understanding. And now over to you, Angus.

Angus Russell

Thanks, Clea, and hello, everyone. Thanks very much for joining today's Q2 results call. Now if I can ask you to turn to the slide #5 in the body of the slide pack. I believe these results really demonstrate very clearly the strategic steps that we’ve taken in recent years to put in place a broad and diversified now portfolio of new products. In this quarter you can see that those products sales, excluding Adderall XR, were up 20% to $491 million. If we measure that on a constant exchange rate basis, the growth was actually 27%.

Our non-GAAP earnings per ADS were 0.6 or $0.60 per ADS. At the bottom of this slide, you will see that we’ve adjusted that for some anomalies in the tax rate this quarter, and I will leave Graham to highlight those in a bit more detail later in the presentation.

Cash generation was also very strong in the quarter. We delivered underlying cash flow of $192 million. Most importantly, the results of this quarter have led to us reaffirming our 2009 financial guidance framework.

If you turn to the next page, I wanted to build on the theme of the fact that Shire in this quarter I think has clearly demonstrated that it is moving into a new phase of its development. As I have just said, we're delivering very solid earnings growth through excellent execution, particularly in the new product portfolio. But we're also managing the erosion now of Adderall XR, an event that we all know we’ve been waiting for, for several months, if not years and planning for.

And part of that planning as you know was the proactive cost management in our business. And I pay tribute to Graham and Sylvie and Mike and all their colleagues for the very active way they have managed our costs through this year, continuing to invest in priority and projects in R&D, continuing to drive the sales growth of the new products, but obviously providing a good offset to the now expected erosion in the Adderall XR revenues.

We are also deriving growth through the continued globalization of our products and reducing the reliance on just the U.S. market. We now today have a presence and that's defined as employees in country in 26 different markets and that's compared to only nine countries just four years ago. At the same time, we are deriving growth as you know through these new product launches, and I'm pleased to say we’ve the prospect in the next few months of two further product launches.

INTUNIV, our new ADHD treatment. As you know, we received a full response from the FDA a week or so ago, and we continue now to finalize labeling, and Mike will just give you a few more details on the prospective launch of INTUNIV.

Velaglucerase alfa, as you know, was scheduled for launch in 2010, and again, Sylvie will take you through the most recent updates, which were included in the press release earlier this week in light of the production difficulties that Genzyme is currently experiencing.

If we turn over the page and look to key events in the second half of this year, as I said already, there is the prospect for progression in terms of product launches with INTUNIV and velaglucerase, but also further R&D progression in terms of DAYTRANA and sNDA filing their carry away programs that Mike will also talk to. Sylvie will highlight a number of aspects of her R&D pipeline and how that's progressing into later stages with the next three products on this slide and then SPD550 is the product for celiac disease which was in an early Phase II study we expect more data on that later this year. So all in all a very, very healthy set of results. The business looking in extremely good shape.

And now I will hand over to Graham who will give you some more financial detail behind the quarter.

Graham Hetherington

Thank you, Angus. Before I address the specifics of the second quarter results, I would like to highlight that during the next 10 minutes I'm going to be addressing four specific dynamics that reinforce the momentum of the business and support our guidance specifically for this fiscal year.

The first is that while Adderall XR generated $67 million of net revenues in the second quarter, we expect this is going to increase to as much as $90 million in each of the third and fourth quarters. The second is to reinforce the growth profile of our core portfolio. The third is to address the net revenue run rate for VYVANSE and how that puts us into great shape to meet market expectations in 2009. And finally, the fourth to explain how key income statement ratios will improve during the second half.

But turning first to the second quarter and chart nine in the deck, I think the headline of these results is the growth of our core portfolio, up 27% to constant currency. They reinforce the strength and momentum of our business as we enter the new phase of Shire. It's also significant that we are generating healthy earnings and cash during the quarter of the most significant erosion of Adderall XR.

As Angus indicated, the EPS result was boosted by an unusually low tax rates in the second quarter. At pro forma 24% tax rate, our EPS would have been just above market expectations at $0.47.

Let's move on to the second quarter's revenues on chart #10. If we look at net revenues in general, foreign exchange has impacted sales, particularly in our HGT business. Foreign exchange will have a smaller impact year on year in the second half if the euro and sterling remain at their current levels.

Looking specifically at royalties, the historic royalties from GSK and J&J have continued to decline and have also been impacted by foreign exchange. What you can see in the detail that's in the appendix, that despite the women's health deal we put in place at Teva earlier this year, we still recall that $14 million of royalties from Teva, which includes royalties on Teva sales to fill the wholesaler and retailer pipeline in the second quarter.

Looking forth, the third quarter we will see lower royalties from Teva, and at the beginning of the fourth quarter the royalties from impacts will replace those from Teva that will end at that time.

Moving on to chart #11, I would like to just focus for a minute on Adderall XR and look at the first big point. Adderall XR is set to deliver higher net revenues in the third quarter and fourth quarter compared to the second quarter.

XR is still operating at significantly higher price levels than VYVANSE despite the increased rebate levels. These rebates are supporting XR's current market share and create the potential for valuable ongoing cash generation. There are two key reasons why we expect net revenues to increase in the third quarter and fourth quarter. This quarter, i.e. the second quarter has seen significant destocking reflecting the rapid early falling demand for XR and destocking was $67 million in the quarter.

As you know, we are not looking at a standard erosion curve here, and with the flattening erosion of demand, we should see a slowdown in the dollar rates of destock in the third quarter and fourth quarter. And our estimate is that we are likely to see destocking at a level nearer $35 million a quarter in each of the third and fourth quarters.

We have also seen a spike in sales deductions in the quarter on XR, up to 72%. Of that, 11 percentage points reflects a catch-up from the first quarter pipeline estimates now that we’ve a better fix on the mix of the business following the initial erosion.

Ongoing sales deductions for the rest of the year are likely to be in the 55 to 65 percentage range depending on the mix of the business in the second half. Taking these two taxes into account, XR is likely to generate quarterly net revenues of as much as $90 million in each of the third and fourth quarters.

First turn to chart #12 now, which starts to focus on the Shire of the future. This chart really captures the new phase that Shire is entering and reinforces that in just 2007, while we were launching many of our new products, Shire generated just over $500 million of product sales in the second quarter.

Of which over half, in fact, 51% was from Adderall XR. This year we’ve generated 11% higher total product revenues at nearly $560 million, and nearly 90% of these revenues was generated by our core portfolio. We're definitely looking at a very different shape for Shire.

Moving on to #13, which goes and expands on our core portfolio. And I think the pie chart on the right reinforces that we now have a broad-based growth portfolio. And on the table on the left, you can see LIALDA's growth was driven by a 53% increase in U.S. prescriptions supported by price increases. You can see growth from PENTASA and FOSRENOL, both of which are benefiting from price increases that we've posted in the last year. And the HGT business continued to demonstrate its ongoing growth potential with 15% constant currency growth versus last year.

Looking specifically at VYVANSE, VYVANSE grew by 75% in the second quarter year-on-year. Specifically, sales productions have moderated in the quarter to 31%, likely to return to nearer 33% in the second half, driven by back-to-school promotional activity. Dollar inventories were unchanged in the quarter.

My third big point is that VYVANSE is well set to meet market expectations for 2009. If I put the revenue momentum of the products into context, with market expectations at $517 million, VYVANSE will have to grow its rolling 12-month average net revenues by 20% in the second half compared to 35%, which has been achieved in the first half. Mike will talk through the drivers that will make this happen.

Moving on to chart #14, you can see that we’ve continued to generate good operating cash. This has funded the payment to Supernes [ph] to buy out future royalty payments when INTUNIV launches in the fourth quarter of this year. And while we are talking about INTUNIV, it's probably worth reinforcing that Shire does not recognize revenues for launch stocks. So INTUNIV's revenues in 2009 will be limited to prescriptions made by the year-end.

With the year-to-date net cash inflow, we've ended the quarter with nearly $300 million of cash in hand. We have a $1.2 billion facility, which we haven't used, and we’ve no refinancing until 2012, which means that Shire has a strong and flexible funding position.

We could move on to now my fourth big point, which is covered in chart #15, that is that the shape of our income statement will change during the second half. We've all seen that a number of our ratios are skewed by the specific dynamics of the second quarter.

Our gross margin has temporarily dipped to 84% in the quarter. I now expect this to increase in the second half to give us a full year margin of around 86%, which is in line with the historic trends for Shire and I think is indicative of the margin levels we will likely see in the future.

The impacts of the sales of the authorized generic to Teva will reduce, and we will see a moderation in the sales productions at XR, which held back the margin in the second quarter, and that dynamic will be removed in the second half.

R&D is tracking flat in dollar terms year-on-year so far. The acceleration of velaglucerase and the impacts of in-licensing means further investment into the pipeline in the second half. And I expect full year absolute R&D dollars will be showing a low-to-mid single-digit percentage increase year-on-year.

SG&A in the first half is $40 million down compared to last year. Bringing forth the velaglucerase program is incurring additional commercial costs, and there will be less foreign exchange benefits in the second half. I still expect full year absolute SG&A dollars to be showing a low-to-mid single-digit decrease year on year.

I've highlighted that we've experienced a significantly lower tax charge in the quarter than any of us had expected. This resulted from the recent publication of detailed guidance relating to the new Massachusetts state tax rules.

By the end of the quarter, we were able to work through the impact of this on our accumulated losses and tax credits, which up until now we had not been able to recognize. We expect a higher tax rate in the second half, and I believe that 24% is still a good number for the full year.

So moving on to Chart #16 and to recap. There are four key dynamics that will deliver our expected earnings for 2009. Our core portfolio is set to continue to grow strongly. VYVANSE is in a good place to deliver. Adderall XR's run rate will increase for the balance of the year and we are set to leverage off on our cost base. This all supports our growth aspirations and our full year guidance, and I am happy to reiterate our previously stated guidance framework.

I will hand you now to Mike to talk you through the progress that's been made in Specialty.

Mike Cola

Thank you, Graham. I plan to cover five areas; VYVANSE, ADDERALL XR, INTUNIV, LIALDA and our growing pipeline. I'm on slide #18 for those of you following on the web.

Let's start with VYVANSE. VYVANSE continues to have solid performance, holding market share during the summer holidays when long-acting stimulants traditionally lose share. For those of you who have followed the market over the years, you know that share gains during this period are not a great indicator of progress in the market as it's highly seasonally dependent, particularly for PED, and you really have two distinct segments of the market, the pediatric market and the adult market, which I will walk you through in detail today.

Our share trends in May and June really reflect the seasonality related to the end of the school year and resulting drug holidays for pediatric patients who are primarily taking long acting stimulants. And I am talking VYVANSE, ADDERALL XR and CONCERTA. In the past you have seen those long acting stimulants go down in total market share by as much as a point or 2 share points during this period.

You would expect VYVANSE to be disproportionately affected because it's still predominantly a pediatric product versus the market with over 70% of our business in the PED segment. The effect of the reduced volume in the pediatric segment is really to shift our mix of business towards the adult segment during the summer holiday period. Since VYVANSE has a lower share in the adult segment due to its more recent launch, the weighted average effect dampens our overall share growth. And again, I will show you that in detail.

And 2008 was really unique for us as we were very early in the launch of VYVANSE, and we had just received the adult indication and the 13-hour data during this school summer holiday period.

Again, I will cover in detail why we feel there has been no significant impact on VYVANSE from generic XR and why we expect a strong back-to-school performance and continued steady progress in adult.

Slide #19, many of you have seen this slide for ever, and I apologize to you, but I will put it up there one more time. If you look at what we're trying to show here, we’ve script volume on the Y-axis time, on the X-axis, and you actually have a 2006 through 2008 average as far as market volume, in red, and 2009 market volumes in black.

And you can see that 2009 is following the trends from previous years as far as market volume decline during the school summer holidays. Again, these pediatric patients that are primarily on long acting stimulants take a summer holiday and take a drug break during that holiday. That goes from May all the way through the end of July, and then beginning of August with the first children going back to get their physicals to go back to school, you see the market really start to pick up, grow in volume. Generally, we see share growth during this period, and that runs right through the middle of October when the first marking period grades come out.

So you would expect VYVANSE, which is disproportionately dependent on this long-acting stimulant PEDs market to be affected greatly. In fact, we haven't seen that this year. If you move to slide #20 where we show share and volume, the dark green being the volume for PEDs, the light green being the volume for adult, you can see the volatility that we’ve that's driven by seasonal events in the pediatric market. And if you look at just April, May and June, you can see the volume beginning to decline in that pediatric market.

Again, the overall market decline as far as volume is anywhere from 25% to 30%, and the pediatric market decline is generally 30% to 35%, and we’ve seen that again this year. Again, we've held share when traditionally long-acting stimulants have lost share.

In the last week of data that we’ve ending July 24th, you have seen a nice share bump in VYVANSE. We saw a 2/10th of a share point gain. I think you will continue to see those gains as we get the back-to-school rebound in August, September and October.

Let's take a deeper look at each one of the pediatric and adult segments to understand the dynamic. If you look at slide #21 where we’ve shared just for the pediatric market, you can see that we've continued to gain share during our most difficult time of the year, which is the summer school holiday. We are at a 14.5 share and have gained that share during this slow period. Again, the overall volume's dropping anywhere from 30% to 35% from March to July. So although we've gained share, it has a lower overall effect on our total market share.

If you move on to slide #22, where we look at a similar chart related to the adult market, you can see that we've made great progress since the launch a year ago, but we are about where we were a year into the launch of the pediatric indication, and that's about an 8.5% market share, has very similar trajectory in a very rapidly growing segment of the market. But in fact, as the PED market declines in volume, our overall share becomes more dependent on that 8.5%. So even though we saw both PEDs and adults grow quite nicely through the quarter, we saw an overall flattening of our share.

If we move on to slide #23, it explains why we are so excited about the adult segment. Year-to-growth date of the ADHD category has been excellent at almost 9%. But if you look at what makes up that growth, the adult market has really dominated with almost four times the growth that the PEDs market.

We'd like to think we've had a lot to do with that with the adult of our adult indication in the middle of last year, with the approval of our adult indication in the middle of last year, and bringing on GSK in the second quarter of this year. You will continue to see us grow that market segment and penetrate it over the coming years, but again tremendous area for us to be in, in the adult segment of the market.

Let's move on to slide #24. For those of you who are still not convinced that AXR hasn't really been what's flat and share, let's take a deep dive into the launch of the generic. We have total scripts in the Y-axis on the left side. We have total share on the right hand axis, and we’ve the bars representing volume and the line represents share of the combined molecule. You can see in April based on the light blue bar that Teva had an excellent launch in April and May. They garnered a good chunk of the volume and obviously made share gains.

In June and July, you saw a different story as our managed care contracts kicked in, and we feel we've really put a floor under the XR molecule as Graham described in our going forward look at what we think XR will do for Shire the next two quarters. But overall you've seen no increase in the share of the combined molecule. This looks like traditional AD substitution and genericzation [ph] of a brand. This does not look like therapeutic substitution, this does not look like a Lipitor/Zocor type situation. We've seen no share gains from the combined molecule.

Let's take a deeper look on slide #25 at the sources of business for generic AXR. There were over 400,000 net switches to generic AXR in the quarter. 97% of those switches were from branded AXR or generic IR, about 6% of them came from IR, again, very traditional view of an AB switch so far one quarter into the launch of the generic. Less than 1% of those switches were from VYVANSE. In fact, there were more switches from CONCERTA.

Just to give you a feel for the order of magnitude, there's about 1.2 million scripts for VYVANSE in the quarter. There was a net change from VYVANSE to generic XR of only 2,500 scripts. So nearly zero impact. And if you think about VYVANSE today and what we told you two years ago, it remains true that it pulls 60% of its total switch patients from brands other than Adderall or Adderall XR. Again, we launch this product as the first drug in a new category of pro-drug stimulants. We've established it as a truly new entity. It is not a line extension of Adderall XR, and we’ve not suffered the therapeutic substitution that you would normally see in a line extension.

The other concern we've had over the two year period is really about third-party reimbursement. If you look at slide #26, we've continued to make progress with both Managed Care and Medicaid in the second quarter in the face of the launch of a generic. Since April 1st, two large Managed Care organizations and two state Medicaids have moved VYVANSE into a preferred status on their formulary, and generic XR still remains significantly more expensive on average than the cost of a prescription of VYVANSE. Again, there was fear of macking the category step edits, tear reductions, etc., etc., that we just have not seen.

So in summary, what do we expect for the second half performance for VYVANSE? Strong back-to-school volume and pediatric market share balance as we've seen in the past. We could see continued strong growth in the adult market, and our continued penetration with Study 316, which we are just rolling out with 14-hour efficacy in adult, and potential upside from the GSK co-promote. We have talked about it being really a long-term partnership and strategy, but we see it starting to bear fruit in the second half of this year.

Let's move on to Slide #28 and talk about INTUNIV. As you know from our press release, we were not able to reach a final agreement on the label in time to meet the PDUFA date, which was July 27. FDA did not identify concerns around safety or additional clinical data or additional analysis. It's purely the language of the label, which we are confident that we're going to resolve in the next four weeks to eight weeks, and we anticipate a fourth quarter 2009 launch as planned. Again, we are quite confident that this label is going to end up in a very good place for us.

Why are we excited? Slide #29. INTUNIV is a breakthrough, nonscheduled product with demonstrated efficacy in ADHD patients with oppositional and disruptive symptoms. Some of the patients with the most unmet need of some of our most difficult patients. And although VYVANSE remains the cornerstone of our ADHD franchise, INTUNIV will really complement it as it really targets a different sub-population and should expand the overall market.

Let's move on to the performance of LIALDA on slide #30. Just briefly it continues to make great progress against Asacol. We ended the month with about a 17.5 new XR share, which has been excellent performance. We have about a 33% total share of the oral Mesalamine market, and this team continues to perform.

Let's move now to what do we’ve in the pipeline, slide #31. For existing products core to our strategy, we’ve a number of line extensions that are ongoing at the moment. For LIALDA we’ve Phase III trials in diverticulitis, which we think has tremendous potential. Again, that indication area is potentially twice the size of ulcerative colitis. We think we will have that work done at the end of 2010 with a potential early 2011 launch.

VYVANSE non-ADHD, after a thorough review of all the possibilities and all the work that's been done to-date, we've picked a number of areas that we are going to look for signals in, in Phase II studies. As you know, amphetamines have been used in cognition, mood and also metabolic disease, these are the first of the indication areas that we're going to look at. You've seen this data on clinical or these studies on clinical, and we'll tell you more about them middle of next year.

Finally, we come to our early pipeline. As you know, the SP model is really focused on investing in low risk development NCEs. We redesigned no molecules to create NCEs with improved attributes or enhanced PK/PD. A great example of that is SPD535, the anagra [ph] light analog. As you know, we’ve XAGRID out there for essential thrombocythaemia. It is a platelet lowering agent. It has quite severe cardiovascular side effects.

We will initiate a Phase I study this quarter. We think we'll have a pretty clean go/no go decision based upon known biomarkers, which are platelet counts and PDE 3 levels. Our initial indication is really a niche indication. It's prevention of thrombotic complications associated with AV graft and hemodialysis. But obviously if we're successful, there is much broader utility for this anticoagulant in both DVT, stroke Afib, post-MI potentially. Those are the types of indications, again if we are successful, that we would probably partner for.

Finally, CARRIERWAVE, we continue to make progress with CARRIERWAVE. We have a number of molecules that are moving in demand in the second half of this year in both pain and ADHD, and we will have more data available in the first quarter of 2010 on these products. And now I will turn it over to Sylvie.

Sylvie Gregoire

Good morning, good afternoon, everyone. I'm going to give you a review of the highlights of the second quarter for the HGT business and then move on to tell you what important milestones we see going forward in the back half of this year and the beginning of next year.

So let's start on page #34 with our marketed products. ELAPRASE for Hunter syndrome has continued to grow in the mid-teens from a volume perspective year-over-year, and it's approved, of course, in 43 countries now. You will recall that we've talked about in the past the fact that we’ve added manufacturing capacity, cell culture manufacturing capacity for this product. This construction project is completed, and the plant is validated and dispatches for submission for approval have been made, and therefore, we anticipate the facility and the product that's been made there to be available in the first quarter or second quarter of next year.

Regarding Replagal for Fabry disease, this has also benefited from significant growth year-over-year also in the mid teens. It's now approved in Brazil in July and in 45 countries all around the world. An important advancement from our perspective, of course, is the fact that this method of manufacturing has been switched from roller bottle to bioreactor process, and this offers significant advantages, including the fact that the process does not include any serum in the manufacturing.

So it's a chemically defined media. And this process and the product therefore is approved by the EMEA in this quarter and whatever country comes after EMEA approval or derives from the EMEA approval is now supplied from a bioreactor process. It also gives us an advantage in terms of cost of manufacturing since it significantly reduces the cost of manufacturing.

Regarding FIRAZYR, in Q2, we've continued the launch of FIRAZYR in Europe with launches in France and in Portugal during the quarter. And FIRAZYR is now launched in nine countries, including four of the five largest European countries. FIRAZYR also received final price and publication in Italy during June, which will enable the launch of FIRAZYR in Italy during the third quarter, another very important market for us.

So there has been significant growth volume this quarter during the second quarter in terms of syringes sold, patients on therapy and physicians who have prescribed. And the feedback from FIRAZYR from physicians and patients continues to be very positive, and therefore, we continue to be very confident about the benefits of FIRAZYR and the potential for this product.

Now we will move to the next page #35 in the deck. And to give you an overview of the many progresses we've made with velaglucerase and advances over the last month specifically and we've announced many of those. Most recently, of course, this week we've announced the positive results of the first of our three Phase III trials for velaglucerase, and we're very pleased, of course, with these results, and they met our expectations. And they are very consistent with the Phase I/II trial for which the data is already available. The full data of this trial will be presented at a scientific meeting, and we expect that to happen before the end of the year.

Earlier in the month of July, the FDA had contacted us and asked us to help the patient community of Gaucher in facing of the supply issues with Cerezyme and asked us to file a treatment protocol that would allow pre-approval access of the product to some patients for velaglucerase. We filed the protocol, and this protocol was approved, and we’ve announced that this week. And therefore, as of this week, patients can now enroll in this treatment protocol.

Also, at the beginning in July, the FDA granted fast track designation to velaglucerase. It's a regulatory process that allows the Company to file the sections of the submission or the dossier as they are complete, allowing the agency to start reviewing these sections as they become available. And we’ve announced that we were able to file at the end of last week the preclinical and the CMC completed sections of the submission for velaglucerase, and hence the agency can start its review.

This brings us to a US filing target now or later in this quarter and by the end of the third quarter and an EU filing by the end of the fourth quarter of this year. And, of course, offers us the potential for potentially an earlier launch than planned in 2010.

The next slide is page #36, and I would like to just highlight a few products in our pipeline that are having some important milestones also in the next half of the year. HGT-1111 is our enzyme replacement therapy for Metachromatic Leukodystrophy or MLD. It will be starting its pivotal trials Phase II/III trials in this back half of the year, and this is an important continuation of our investments in enzyme replacement therapies.

Through our collaboration with Amicus, we are continuing in the development of the chaperone therapies, and as you know, AMIGAL for Fabry disease we’ve had a Phase II data available. Amicus has initiated its trial in the U.S., and we are reviewing the EMEA feedback regarding a trial program for the development of AMIGAL in Fabry disease, and we will be able to announce the outcome of our reflection by the end of the year.

PLICERA for Gaucher is also going to read out some data in the next half of the year, and we are looking forward to present to you as well as Amicus I am sure on these results in the back half of the year.

A program that's important to us, idersulfase-IT for Hunter CNS, the site has been initiated, and we are ready to start now enrolling patients at that site. It is a method of administrating the enzyme for Hunter syndrome through an intrathecal port that is implanted into a patient and allowing us to administer the drug in through the CNS. This is a model for us, a trial that we will be using for accessing a few other diseases of the central nervous system that will be going in demand next year, and that's Sanfilippo and GLD.

And so if you turn to our pipeline or review of our pipeline on page #37, I think what's important to highlight here is that we’ve a broad pipeline for rare diseases that really promises to deliver some steady growth certainly on the revenue side from REPLAGAL and ELAPRASE and FIRAZYR in the near term with new launched products such as velaglucerase and an advancing pipeline in both ERT and novel technologies.

So we expect velaglucerase, of course, to be approved in 2010, and then the products from our own research efforts led to additional ERTs, for which now we're using this novel technology I was referring to in the route of administrations and particularly for three other of these enzymes. And of course, we’ve been able to diversify the pipeline by adding novel technologies in the chaperone, the pharmacological chaperones, which offer an oral alternative to some of diseases.

Of course, our research effort continues, and we continue to expect the research effort to add to the pipeline at the rate of one preclinical product per year. And of course, we are always looking at other external opportunities on an ongoing basis that would match and fit the rare disease pipelines that we’ve.

And I'm going to turn it over now to Angus who will give us some concluding remarks.

Angus Russell

Thanks very much, Sylvie. Just turn to slide #39. Overall I think this quarter shows again another strong financial performance. And as has been highlighted I think with my colleagues and myself on this call, we all feel very strongly that Shire now shows clear evidence of moving into a new phase of its development, which will drive our growth for years to come.

I just want to rehighlight that statistic that Graham took you through. If you just look at this business in two years, quarter 2007 when we started to roll out many of these new products, sales were in total about $500 million, but ADDERALL XR was still 51% of sales. And today, sales in a period when ADDERALL XR has come down to only 12% of the portfolio this quarter, have actually grown overall by 11%. And I think that's a tremendous achievement.

Product sales now excluding ADDERALL XR are growing by 20%, and that's the core portfolio that we're driving, that we're focused on in Shire, and that will provide this platform for growth into the future. At this same time, we're mindful of continuing the management of ADDERALL XR erosion over the balance of this year and through 2010.

And in that regard, again I pay great tribute to my colleagues who've managed the business very tightly in terms of costs, and Graham told you those statistics about how we're managing R&D and SG&A throughout the balance of this year. And all of that has allowed us to reaffirm the guidance framework and the targets that we’ve had out in the market since the end of last year through a very difficult period of transition.

On top of that, I feel we’ve very strong continuing momentum in our business. We're driving the growth of all our new product portfolio, but at the same time, we've even more product to launch. So, as Mike already said, we are very hopeful now of getting a good label and finishing our discussions with the FDA, which will lead to the launch in June, which we all feel will provide a very good new treatment in ADHD and will complement VYVANSE very nicely.

And in velaglucerase, as Sylvie taken you through, we're meeting the demands from the FDA and from the patients as quickly as we can and moving that product now into the market, and we look forward to our continued dialogue with the FDA in that regard.

At the same time, I'd highlight that the growth is not only just from the product portfolio alone in the existing markets. We used to trade in, as I said earlier, we've moved up our number of markets now, and we're in three times the number of markets we were in just four years ago.

And we continue to see a lot of pipeline progression of things that some years we're very early now moving again into later stages and providing the prospect of even further launches in the period up to 2015. And that we believe we will very much underpin our aspirational targets, which you remember to return to mid-teens growth in this period from the end of this year through to 2015. So with those concluding remarks I would like to hand back to the operator for your questions.

Question-and-Answer Session


(Operator instructions). Your first question comes from Rodolphe Besserve.

Rodolphe Besserve -- Societe Generale

Good afternoon. Series of questions on velaglucerase. Do you think that there is any chance that the EMEA could propose a specific protocol which would be similar to that of the FDA? Also, on the first Phase III data that you've generated, do you have any indication at this stage that velaglucerase has a clinical benefit versus Cerezyme? I think not (inaudible) side effect profile. Any chance to differentiate on the (inaudible) sensitivity issues that have been observed with Cerezyme? And also, could you tell us any specific protocol for patients who switch from Cerezyme to vel in terms of, I don't know dose escalation and all monitoring for instance?

Angus Russell

Okay. Well, they all seem to be vel-related questions, so I will ask Sylvie to answer those.

Sylvie Gregoire:

I will take them. Yes, good afternoon. Your first question on the EMEA, prior to approval in Europe, the system is slightly different on a country per country basis. There can be the request for named patient sales, and the process is different in every national country. And so that's a possibility in Europe. We haven't anything to say really relative to that as there has not been much initiated on that point. But that is a possibility for patients going forward, and we will let you know as we get more information or as things evolve in that region as well. For Phase III data, the data that you have, we've reported the top-line data, and it's consistent with the Phase I/II data. And so there is nothing much I can add until the data is really published in the scientific meeting. But regarding safety, I think we've given you the highlights of what we can, and you can look at the Phase I/II data that was all very consistent with that. So we're pleased with the results, and there is nothing untoward that we could see on the safety side that would merit any worries.

From a protocol for a switch, you asked about the switching of Cerezyme to velaglucerase. There is, as you know, one of our trials that's ongoing and just completed actually is exactly that study is the switch of Cerezyme to velaglucerase. There is no particular protocol to follow other than just to transfer the patient from one product to the other in that particular protocol, and we will be able to see the outcome of the transfer of patients, and they transfer at the dose that they were at in this protocol. So we will soon see the results from the last two Phase II trials, and we will be able to give you the top-line of these results in the fall. I hope that answers your question.

Rodolphe Besserve -- Societe Generale

Thank you.


Thank you for your question. We do have another question. And this question comes from…

Dani Saurymper -- Goldman Sachs

Hey, good afternoon, this is Dani Saurymper from Goldman Sachs. Some REPLAGAL questions and I'm just wondering whether in your course of conversations around velaglucerase, is there a conversation brewing around REPLAGAL and potential entry into the U.S. market given the supply issues with Fabrazyme? And secondarily, on velaglucerase can you just maybe talk us through how you plan to expense the supply of that product since you are giving it for free? So where does that cost turn up?

And then maybe, Sylvie, can you remind us in terms of your ability to produce this product in terms of capacity and where you are as it is today in terms of how much product you could in theory supply to the market? And then just lastly, I will push my luck, but I just wanted to ask on the tax rate. Is your guidance for 24% the underlying tax rate for the full year, or is that a full-year target implying the second half is going to be a very high tax rate?

Graham Hetherington

Dani, why don't I just take the tax rate first so Sylvie can concentrate on vela and REPLAGAL. We're still looking at a full-year tax rate of 24%. That does mean that the second half will, in likelihood, be nearer 32%, something like that. So that is the reported rate.

Sylvie Gregoire:

Yes, so I'm going to answer your REPLAGAL questions and your two vela questions if I remember them correctly. Let me know if I don't. Your first question was whether in the course of discussions with the FDA we’ve had discussions on REPLAGAL. And indeed, during our discussions at the beginning of July on velaglucerase, the agency has asked us our intentions for filing REPLAGAL in the U.S. And as you know, Genzyme's period of exclusivity for Fabrazyme in the U.S. goes until April of 2010. And so at the present moment, we're evaluating our options regarding a potential file in the U.S., and we will announce as we go forward any new information regarding this product, our intentions and our plans in that territory.

As for velaglucerase, the expenses for the product will flow through the R&D line as this is all under clinical protocol at this stage, treatment protocol in the U.S. And as for capacity of the enzyme, we clearly have no inventory at the moment to supply any acute demand. We've made our batches for the submission, and so we’ve plenty of inventory. And so, as the demand clarifies itself, it's a little unknown how many patients will transfer on to our product. The protocol has just been opened. If there is any issue with demand, we will, of course, update you. But at the moment, we feel confident that we can supply a good portion of the market. And of course, we can continue to manufacture the product. We will remind you that velaglucerase is made in the bioreactor process using a serum free process, again it's chemically defined media, and this bioreactor process is scalable. We use a human cell line to make the product, and the product has the natural amino acid sequence. And so that's what I think how I can update you on the supply issues of the inventory of velaglucerase.

Dani Saurymper -- Goldman Sachs

Thanks, Sylvie.


Thank you very much for that question. Your next question comes from Peter Verdult.

Peter Verdult -- Citi

Good afternoon, everyone. It's Peter Verdult here from Citi. I'm going to be focusing on the same issues as the previous callers, velaglucerase, REPLAGAL and tax. Graham, if we kick off on the tax rate, I think in the past you talked about longer-term guidance around 23, 24. I realize a lot of things can change. But just in terms of the comments you're making about the second half, has anything changed which would impact that sort of guidance longer-term? I will start there and then move on to the HGT questions.

Graham Hetherington

Peter, if I back up in the 23%, 24% always talk to an annual rate, and if you look at our tax rate over the last few years, you have always had some volatility. This is extreme in the second quarter. I totally acknowledge that. But indicating that the second half will be higher is not an indication for the future. I still think the 24% is a good rate to model for the future.

Peter Verdult – Citi

Thanks for the clarification. Okay. On to velaglucerase. Sylvie, I realize that we are literally days into the program having been opened, but could you give any indication as to how many patients or any indications you have as to how many patients are enrolling into this program? And if we assume a commercial launch in the second half of next year or mid-year next year, should our base assumption be that velaglucerase is priced at a discount to Cerezyme? And if the issues at Genzyme persist, could we see a scenario emerge where that discount might narrow? And then on REPLAGAL, just to better understand the process here, correct me if I'm wrong, but I believe Fabrazyme is still protected by orphan drug exclusivity. So how would the mechanism work by which you could potentially launch in the U.S.? Would it be compassionate use until that exclusivity ends, or is there some way of getting around that?

Sylvie Gregoire

Many questions, Peter (inaudible). Your first question was regarding the protocol and if we had any indications of how many patients would be unveiling themselves or physicians of this protocol, and it's really too early. It's just been opened as of Monday, and so it's just really too early to give any indication. As time goes by, we will see if that helps us, we can give some clarity or more clarity around that again as time goes by. And then you talked about the price and that we will launch velaglucerase at and discount. And again until we really understand many things about the product regarding its product profile, the situation with Genzyme, supply at the time and then all of this is sort of evolving information that will clarify and stuff I think that will determine not just our price but our commercial strategy in general, and we will announce that at the time of the launch.

And your next question was on REPLAGAL, and as I said, regarding Fabrazyme, the exclusivity for that product runs through April 2010. And so, therefore, in order to put the products on the market in principle, that's the time by which thereafter that, that the expiry is over and a new product could come online. And as I said, we are looking at our options at the moment regarding the possibility of bringing the products into the U.S., but we haven't made a final decision. And as soon as we do, we will, of course, inform you.

Peter Verdult -- Citi



Next question comes from the line of Martin Wales from UBS.

Martin Wales -- UBS

I will leave velaglucerase for the time being are you pleased to hear? Just a couple of quick questions. Firstly, if you can remind me of who you made INTUNIV license payment to and what it was for. Secondly, could you just tell us a little bit about ADDERALL XR in Canada? When did the patent go there?

Angus Russell

Mike, question is for you. Do you want to talk to Supernes [ph]?

Mike Cola

The payment was to Supernes, who we had a royalty commitment to, and reflecting the imminent launch and our confidence in the product, we bought out that future royalty stream, and the company was called Supernes.

Angus Russell

It' is the old (inaudible) laboratories. If you remember, we sold it to a management sort of private equity buyout, and they developed the drug originally at Shire in terms of helping with some of the formulation work around INTUNIV. And when we spun it out, they had a small royalty associated with the work that they had done, and that's what we've bought out.

Martin Wales -- UBS

There's no further payments due?

Angus Russell

No. Well, there is one, nothing else for them, and the rest is kind of minor stuff. There is nothing any note of substance.

Martin Wales – UBS

Okay. And XR Canada?

Mike Cola

XR Canada I believe is middle of 2010. I don't know the exact date. And Clea will follow up with you.

Clea Rosenfeld

I will get back to you on that, Martin.

Martin Wales – UBS

Thank you very much. I will get back in the queue.


Thank you very much for that question. We do have another question and this question comes from Corey Davis [ph].

Corey Davis

Thanks very much. First, at the risk of sounding a little bit like a dope, I have to say your presentation this time was incredibly clear and very helpful, especially with regards to the ADDERALL XR pricing stuff. But first question I wanted to ask was with respect to your guidance and just to make sure that I know what you're saying. $0.60 it seems like from this quarter you are counting towards the full-year guidance, which would imply future quarters would come down relative to our models. But that's probably not a problem because the tax rate for the year is still going to be what we had assumed yesterday. Is that the right way of saying it? So that your guidance is completely unchanged

Graham Hetherington

That's it, Corey. Absolutely.

Corey Davis

Okay, easy enough. Second, on INTUNIV, I didn't think you were going to get ODD in the label, but from the comments, Mike, you made on the slide, it sounds like that's how you're going to be positioning it. A) Am I correct it's not going to be in the label, and B), if so how are you going to be able to talk about ODD?

Mike Cola

Yes, I think you are referring to Study 307. I hope we've been fairly clear about the use of the term ODD in the past because I think that is not something that the agency has been willing to entertain going in the label. It's really viewed as sort of specific indication and part of the overall disease of ADHD. The language that we will be using promotionally will be around is difficult to treat patients that have disruptive behaviors. And I think that has really been a better marketing tool than what we've been able to get back from our physicians as far as positioning the patient type we're looking for. These oppositional and disruptive behaviors. So there is no DSM-IV or ICD-9 code around ODD. The agency has been pretty clear with us about that. But I think we will be able to use Study 307 in promotion.

Corey Davis

Okay. Last question on velaglucerase, what does it say in the protocol if anything about the attributes of the drug? I'm assuming very little. So what's going to be the forum and mechanism by which you can get all the Phase III data out there so docs can at least be better informed that, yes, this product is at least as good as Cerezyme?

Clea Rosenfeld

Yes, Peter, under this protocol -- sorry, Corey, the investigators have access to an investigator brochure that helps them that's generally updated with data in order to allow them to understand the specifics of the drug. And then, of course, very shortly, the data will be presented at meetings, and they will have a good understanding of that data.

Corey Davis

And will all of that data then go into the IB?

Clea Rosenfeld

Yes, the investigator brochure is updated in time with the data that it becomes available.

Corey Davis

But it is not in there right now?

Clea Rosenfeld

Well, an investigator brochure is a living document. It's always updated to the most recent information that we’ve and so certainly safety for instance might be in there, and that many of the aspects of the treatment of Gaucher disease have to do with parameters as measured as safety. So there will be information in the investigator brochure that I think will help physicians guide themselves for the use of velaglucerase. It's a small community, many of them have participated in trials and are already familiar with the use of velaglucerase.

Corey Davis

Great. Thanks, everyone.


The next question comes from John Simpson [ph].

John Simpson

Congratulations on the quarter. In terms of velaglucerase, are you expecting expedited review for that when you do submit it?

Sylvie Gregoire

The process in the U.S., as you know, is that as we complete the submission, then the PDUFA date can be established by the FDA. And at that time also or 30 days after you completed the submission of all the applications that the FDA indicates to you whether they have granted you priority review. If they were to do that, that would provide a six months review rather than the standard 10 months review. And so as again information becomes available regarding the timeline of the review and the PDUFA date, we will make you aware of that.

John Simpson

Right. But I mean based on your interactions with the FDA, have you had any kind of feeling as to which way the FDA might be leaning in that regard?

Sylvie Gregoire

Well, it's obvious that the FDA is working on the benefit for the patient sake in trying to get a product available for them to use as early as possible and therefore, velaglucerase pre-approval. They've also granted fast track designation, which is a methodology that ensures that they can review as fast as they can with the hope obviously of bringing the product on the market and giving approval in a shorter time than the standard review time.

John Simpson

Okay. And then one other question on velaglucerase. I understand that the community has come up with recommendations for managing the potential shortages in the Gaucher market. Do you have any sense from speaking with people in the field as to how good compliance has been with those recommendations and whether or not there is any likelihood of acute shortages during the fall period?

Sylvie Gregoire

Yes, we’ve seen guidelines. They are certainly published on the EMEA web site regarding the use of Cerezyme, and so we've not heard feedback really on the compliance with those guidelines at this stage. And probably best to ask Genzyme about that.

John Simpson

If I may, just one last question for Mike Cola. In terms of CARRIERWAVE, do you see any therapeutic potential benefits for taking guaifenesin and putting it in the CARRIERWAVE technology?

Mike Cola

Short answer, yes. Yes, I mean you don't have our INTUNIV label, but look at the short-acting guaifenesin label, I think there is some areas that we can improve via CARRIERWAVE, things like food interaction. Potentially PK changes that address the somnolence and sedation. So, yes, that is something we are looking at.

John Simpson

Thanks a lot.


Your next question comes from Tom Russo [ph].

Tom Russo

Good morning. First on velaglucerase, I was just hoping, Sylvie, can you confirm that by a comparable to Phase I/II that would include the magnitude of organ reductions and lack of antibodies? And then secondly, with regard to INTUNIV, Mike, I was wondering if this would be a time where you could try to set expectations a little bit. There seems to be a disconnect between expectations for INTUNIV and maybe what we've seen in the past for other non-stimulant medications in ADHD? Thanks.

Sylvie Gregoire

Tom, yes, regarding velaglucerase, yes, when we mean that the data is consistent with the Phase I/II data, it does apply to organomegaly and the impact of the drug on the organ volume, as well as on the platelets and the hemoglobin. And so all the data is very consistent with what you've seen in the Phase I/II data, and again it will be published fairly soon. And then your second question was (inaudible).

Mike Cola

Yes, I think back to your comment, I assume you're referring to Strattera, and the fact that it garnered almost a 20% share in two years. I think we've been careful not to set that expectation, but in fact, I think that the expectations that are out there today when I look at consensus are relatively low. As we get a final label and we've always said this, when we’ve a label, we will try to address those expectations, and we hope to have that in the next four weeks to six weeks. But I think we will end up with a clean label, and I think it will be a very nice product for us. It addresses a really unmet need in the marketplace, and it could be larger, much larger than what we've seen in the general consensus today.

Tom Russo

And, Sylvie, I just missed it, but can you say anything about lack of antibodies in any of the Phase III trials so far?

Sylvie Gregoire

I'm sorry. Yes, we are collecting all the antibody data, and it's probably best to report it all at once since we're continuing to gather that aspect of the data and it's a safety parameter. And so, we will announce that. When we announce that I think the top-line results of the two other trials and we'll have all the safety information, and that will be a more reliable way of announcing our views on that particular parameter

Tom Russo

Thanks very much.


Your next question comes from Ken Cacciatore.

Ken Cacciatore -- Cowen & Co.

Sylvie, on the REPLAGAL, your comments around REPLAGAL, just wondering, it was our understanding maybe you would have to do another study before you could file in the U.S. Is the agency signaling otherwise? Can you give us a little bit of clarity? And then on ADDERALL XR, maybe, Mike, if you could talk about some of your thoughts around final penetration rates? I know we don't have impacts in the market yet, but you guys are talking about Q4 numbers in a general sense on ADDERALL XR. So maybe some of your thoughts around where that finally levels out once you have two competitors in the market? And then lastly, on VYVANSE anything different as we do go back into the back-to-school season? The ADDERALL XR did go generic at the very end of the season. So wondering as the children come back into the treatment fold, are you just going to proceed as before, or is there going to be more additional couponing? I think you signaled there might be. But is there anything different that you're going to do as you enter it this season with the generic available?

Sylvie Gregoire

So, Ken, on REPLAGAL, obviously the product has been in the market in Europe for many years, and there have been many longitudinal type surveys, including an outcome survey and some other trials that were published. So there is data that has accumulated over time. But if you're referring specifically to the letter that was issued at the time in the U.S., indeed, it indicated that another trial would be required. So again, as I said, we are sort of evaluating all of the information that we’ve, what the options are at this point, and as soon we’ve something to indicate on that matter, we will certainly let you know.

Mike Cola

On XR, I think Graham gave you kind of round numbers looking forward. But on the penetration rate as far as market share, we still have a ways to go. I don't now how closely you guys look at the data. Although we’ve stabilized, there is still a chunk of Medicaid business out there that is I assume going to go towards the AG at some point. It's not huge. It's not particularly profitable to us, but I think you will still see some more decline based on that Medicaid piece of the business. Going forward I think the big question we continue to get is the impacts launch. I don't think it has huge impact to our share going forward.

As we've always said, their model is more built around reimbursing or discounting to the pharmacy chains. I think they will compete directly with Teva in that rebating strategy for the major chains, and I think our Managed Care contracts around XR will continue to hold in place. I think there is enough room as far as price between our AXR and the rebates we are paying and where Teva is for them to come into the market without being tremendously disruptive. On the VYVANSE back-to-school, I don't think there is anything dramatically different. Graham did mention the fact and it's coupons you mentioned promotional activity. We will be out their couponing. That is seasonal for us in general. I don't think it's an unusual level of couponing for us at all. There's two campaigns that will be happening. They may be a little different than in the past, but in fact, they are more in line with what we’ve traditionally done. I think the one thing that has changed, and no one has really asked about this, is that we will really focus on VYVANSE through the back-to-school period right through the middle of October. We will give it our full attention. We will have GSK by our side in the adult segment. So I think with this very minor delay, these are important weeks that we will continue to have to push VYVANSE through the back-to-school period. Hopefully that answered your question.

Ken Cacciatore -- Cowen & Co.

Yes, does. Thanks, Mike.

Angus Russell

Okay. Operator, I think in the interest of time and some of the questions are getting a bit repetitive, maybe just take one final question.


The final question comes from David Amsellem.

David Amsellem Piper

It's David Amsellem, on INTUNIV, how should we think about pricing, and should we expect that pricing will be similar to how you've priced ADDERALL and VYVANSE historically?

Mike Cola

We typically haven't signaled pricing. But I would tell you think of this product as a premium price, right? It's a niche part of the market. It should be premium-priced. I don't want to draw the analog to Strattera because I think the general view is Strattera has not been a success in the marketplace. But, in fact, Strattera was able to garner premium price worldwide because of its unique attributes.

David Amsellem

Okay. And then just quickly on VYVANSE market expansion studies. Are you looking at psychiatric indications such as refractory depression or bipolar depression? Can you comment on the extent of off-label usage of long-acting stimulants in these settings?

Mike Cola

Yes, we do have a slide in there. I can't remember what number it is, but it actually names those studies. Again --

Angus Russell

Slide 31.

Mike Cola

No, it's actually 31. Yes, if you look at slide #31, we've adjunctive therapy in depression, cognitive impairment and depression, and negative symptoms in schizophrenia. And I think it's a good flavor for what we are doing. These agents, as you know, have been used off-label for years and years around mood cognition and metabolic disease, and those are the areas that we're going to focusing on. There will be another group of these indication areas that we will talk about probably at the end of the year.

David Amsellem Piper

Thank you.

Angus Russell

Okay. So thanks very much, everyone. We appreciate you spending time with us today and for all your questions. In summary, again, I would just say I think this quarter you've seen a clear product of the strategic steps of recent years to put this new product portfolio in place that is growing at 20% this quarter. We're managing I think the ADDERALL XR erosion extremely well, and our costs control is being maintained through this quarter, and it's our intention to continue all of that for the rest of the year to deliver the framework of guidance that we've talked to you about for a long time. So, again, thanks, and have a good day.


Thank you very much for that. Ladies and gentlemen, that concludes your call for today. You may now disconnect and thank you very much for joining.

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