Novartis AG (NVS) Q2 2012 Earnings Report, Transcript and Summary

Good morning and good afternoon, and welcome to the Novartis Q2 Half Year 2012 Results Conference Call and Live Webcast. [Operator Instructions] The conference is being recorded. [Operator Instructions] With that, I would like to hand over to Mr. Joe Jimenez, CEO of Novartis. Please go ahead, sir.

Thank you. I'd like to welcome everyone to our second quarter and first half conference call. With me today on the Novartis end are Jon Symonds, the CFO; David Epstein, Head of Pharma; we have all of the division heads; and we have Tim Wright, who is the Head of Pharma Development, with us. So before we begin, I'd like to ask Susanne Schaffert to read the Safe Harbor statement.

The information presented in this conference call contains forward-looking statements that involve known and unknown risks, uncertainties and other factors. These may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Please refer to the company's Form 20-F on file with the Securities and Exchange Commission for a description of some of these factors.

Thanks. Okay. Starting on Slide #5. As you saw in the press release, our sales increased 1% in constant currencies versus year ago with our new product growth more than offsetting the loss from the Diovan patent expiration in Europe. Our core operating income was down 3% in constant currency with good operating leverage coming from the Pharma and the Alcon business, offset by Sandoz and Consumer Health. The news really, though, in the quarter was innovation. This quarter, we achieved 8 significant regulatory milestones, further proving that our R&D group is delivering. And I'm going to talk more about the specifics of it later, but I think it's important because it strengthens our future growth prospects. On Slide 5, you can see an overview of the financials for the quarter and down at the bottom, core EPS of $1.38. So we are continuing to execute well against our 3 priorities of extending our lead in innovation, accelerating growth and driving productivity. And I want to just touch on each of those in terms of the quarterly performance. So starting on Slide #7 with innovation. Of the 8 regulatory milestones, 5 were in Pharmaceuticals in the second quarter and include 3 new molecules. But I think one of the most exciting was Afinitor for hormone-sensitive breast cancer. The positive CHMP opinion means that we will -- we are ramping up to get ready for the launch of Afinitor in breast cancer, also, Jakavi for myelofibrosis. Seebri Breezhaler is important from a respiratory standpoint, which is our once-daily long-acting muscarinic for COPD. Alcon, on the next slide, you can see also had a good quarter from an innovation standpoint. Toric multifocal advanced intraocular lenses received EU approval. And Dailies Total 1, which is our best-in-class silicone hydrogel daily disposable lens, received…

Thank you, Joe, and good afternoon or good morning, everyone. So another quarter passes, and by and large, it's gone pretty well. In 4 more quarters, you'll begin to see what the true potential of this business is in the second half of next year. So you can see here on Slide 17 the numbers for the quarter in constant currency. Sales grew by 1% for the quarter and were flat for the 6 months. Core operating income declined by 3% in the quarter and by 5% for the 6 months. You'll notice that core EPS declined by the same amount as core operating income in the quarter now that we have passed the anniversary of the Alcon's merger and the issues of shares that followed that. And free cash flow for the quarter was $2.3 billion and $4.4 billion for the 6 months. Slide 18 gives you the detailed reconciliation between the core results and the reported results. For the quarter, you see that there was really very little distortion from exceptional items as there was very little difference between the exceptional income of $191 million and the exceptional charges of 230 -- $203 million. It was a different picture last year when we had both higher exceptional income from divestments, as well as higher exceptional charges from both impairments and from legal settlements. I won't go into any more detail on this slide as I hope for you the table is clear. If it is not, you can ask later. While talking about the business as a whole, I want to, over the next 2 slides, look at currency. As you can see from Slide 19, the last year has been very volatile, especially if you look at quarter 2 last year where it was 8% positive on…

Thank you, Jon. I believe our quarter 2 results in Pharma show that our strategy to focus on driving our launches is working as we offset generic competition with new patent-protected growth drivers. As you can see on Slide 30, net sales in constant currency were up 4% with good leverage again this quarter, with core operating income up 6%. Turning now to Slide 31. We see that recently launched products provided 9 points of growth, offset by 1 point of price erosion and 4 points of lost sales growth to generics for that net 4% increase in the top line. Of note, recently launched products grew 28% and now account for 34% of our sales. On Slide 32, we see that in addition, valsartan family sales, while they're eroding in Europe, they are continuing to grow in our emerging growth markets. And as a result, we can reaffirm our expectation that valsartan family sales should exceed $2 billion for the full year of 2014. On Slide 33, you see that while we are launching multiple new products, we are focusing very hard in Pharma on driving efficiency, both in terms of better positioning our products, better targeting our activities against the right customers, optimizing sourcing, as well as benefiting from the portfolio shift to specialty care. So as a result, M&S spend as a percent of sales has continued to come down steadily since 2009 with another good showing in Q2 of 2012. On Page 34, I'm showing you a slide that you have already seen before but now updated for the Q2 numbers. We're very proud of this slide and believe that this group of products, this family of products that gives us an unparalleled launch platform and it's a set of products that I continue to believe,…

Okay. So to close, we made solid progress on our 3 strategic priorities in the second quarter, and our full year performance is on track. So our outlook for 2012 remains unchanged, and that's group sales are expected to be in line with 2011 in constant currency. And we expect core operating income margin for the group to be slightly below 2011 on a constant currency basis. Now I'd like to open the session for questions.

[Operator Instructions] We will now take our first question from Tim Anderson of Sanford Bernstein. Tim Anderson - Sanford C. Bernstein & Co., LLC., Research Division: I think one of the investor concerns with Novartis has been whether 2012 is a trough year or whether 2013 is going to be a trough year. And you talk about 2013 being a story of 2 halves, but I'm not sure what it looks like when you put those 2 halves together. So I'm hoping you can give us a simple directional answer here and say whether 2013 earnings would likely be higher, lower or the same as 2012. And then on emerging markets and the growth rate of 6%, that was about in line with last quarter which was 5%. And I think if you were to exclude China, that could even be a negative growth rate or substantially lower than the 6%. And I'm wondering why is it so low x China? And do you think that double-digit growth rates in emerging markets are sustainable like a lot of industry observers seem to think?

Okay, I'll start. Tim, this is Joe. Just in terms of the '12 versus '13 being a trough year, as we get closer to '13, we'll be able to give more definitive guidance. But if you look at between now and the end of the year, obviously, we're going to be making choices around what we invest in and what we don't invest in, but it would be premature to say it today. We're right now working up our budgets for 2013, and we're not finished yet. But if you look at the charts that Jon showed, you can see that it is a year of 2 different halves where the first half is going to be impacted by Diovan in the U.S.; and then in the second half, once we get the Diovan expiration in the base, we have a different growth trajectory that will carry us through '14 and '15. And so I would just say, as a policy, we have said we're not going to give guidance beyond the year that we're in, and that's partly because as we are working up our budgets, we're making choices. In terms of EGM, if you take China out and you look at what's happening in some of those countries, they're highly influenced by the timing of -- well, a couple of things. Number one is that you've got some pretty significant price pressure in a couple of them such as Turkey, where there has been significant price cuts. And I don't think anybody's growing very fast in this industry in Turkey today. But if you -- and you also have to look at the timing of some of the tenders in some of these emerging markets that can provide significant swing. So again, while we provide this number as an EGM, which is everything essentially except the developed countries, you really have to be granular around where we're placing our bets. And one of those bets is in China, where we have a good business and a big business. And I do believe that double-digit growth for us in China is sustainable well into the future just based on the current momentum that we have and the new approvals that we're getting over the past -- I would say, even just in the past 6 months. Tim Anderson - Sanford C. Bernstein & Co., LLC., Research Division: If I can just follow up, my question was really double-digit growth across the entire emerging market bucket. Do you think double-digit growth is achievable across all of those markets, not just China?

I would say that because of the size of that, I would say no because remember that we changed the definition of emerging markets to be more consistent with our peers. It's about 25% of our total. And to do that, you put in a number of markets that we're not placing bets in. So I would say of the ones we are placing bets in, yes, we will be able to sustain double-digit growth. But as a reported segment, I would say no.

Our next question comes from Alistair Campbell of Berenberg Bank.

A couple of questions, please. Just first of all, on Consumer Health, obviously, it sounds like Q4 you're probably still won't be fully up and running. So wondering if you could talk about how should you actually think about when you think you might be back to sort of closer to full capabilities coming out of Lincoln. Is that something we should think about for Q1 next year, Q2 next year? Just to get some line of sight into how the business can recover going into next year. And secondly, as it takes clearly, perhaps, more time than you might have thought to get these lines fully up and running, do you still remain confident that you'll actually regain the share you've lost or regain the position of these brands as you go further out?

Okay, Brian?

So as we communicated, we're starting up Lincoln line by line, product by product. And we started with Sentinel and Excedrin, 2 of our biggest and most important brands. And importantly, we're going to communicate to customers today in the U.S. that we're going to launch, relaunch and start shipping Excedrin migraine and Lamisil in October of this year. As we go line by line, product by product, as we qualitate and validate, we'll move to the next ones, and that's our plan going forward. I think we can give much better guidance in 2013 as we get later in the year.

I think the other thing to remember is that we are bringing on a stream of contract manufacturers for these brands also to supplement that. So it is going to be a slow build. It's going to be slower than what we expected because it took longer to get the thing up and to start to build inventory. But now that we've got some momentum, we'll be able to create -- we'll be able to provide greater clarity as we get closer to '13.

On your second question, we are confident we can regain share. On our big brands, we have a very high loyal consumer base. They want our brands back, and we're going to support them heavily to regain that share when we launch.

Our next question comes from Alexandra Hauber of JPMorgan. Alexandra Hauber - JP Morgan Chase & Co, Research Division: Firstly, just on these additional $300 million spend, could I just clarify that this is really truly $300 million incremental spend rather than a sort of a mix of less profits made in consumer and, therefore, it's just some extra stuff that's just penalizing the margin? And if it's $300 million incremental spend, I do understand that, that just needs to be updated, but could you just be a little bit more specific what has actually changed? Secondly, on your target on the valsartan group sales just to exceed $2 billion by 2014, I think when it was originally made, I wasn't aware that Exforge was included in that number. Now Exforge is now -- the x U.S. Exforge is at a run rate of $1 billion. So based on that, I think that $2 billion is not -- looks -- it doesn't look particularly challenging. But could you just give us an idea how much of the x U.S. Exforge sales are actually at risk given that the European market exclusivity should really survive that 2014 timeline? The third question is on the Alcon Dailies. The market share gains you have shown early on in the presentation are quite impressive. Could you also tell us what has happened to the market? So what is the patient share of daily users in the total contact lens market in those markets?

Okay, this is Joe, Alexandra. I'll start with the first one. Remember, I said we would spend up to an additional $300 million. And essentially, what has changed is, when you look at the approvals and you have guys like David Epstein who are challenging his group to come up with ways to really drive new growth based on these launches, there are a number of ideas that I want to fund, and because I do believe that we can maximize the growth opportunities if we take some early spend and apply it to these launches and then set it out. So for example, more spending on the Afinitor launch on breast cancer just from a marketing and sales standpoint. But it's to give it a little bit of a push so that we can get these -- the growth trajectory for the company to a place where we want to get it that will maximize these launches. I just feel like it would be a mistake not to take advantage of what we have in front of us. Not everybody in this industry has this level of innovation. So I would leave it at that. David, do you have anything to add to that on top of the valsartan question that was asked?

No, just maybe I'll go right to the valsartan question. So Alexandra, since I've come into the role, I've been talking about valsartan family. And you may be right. Before that, it may have been described in another way. Just a couple of thoughts. The $2 billion number is not ambitious, okay? So it will be substantially exceeded. We just -- I just want to reassure people that given that we're going into the U.S. laws of patent now that it wouldn't be worse than that. So that's really the only intent there. And more specifically into your question, Exforge, x U.S., yes, that business should be sustainable for quite some time. You see, it's a growing business. It's an important product. It includes ExforgeHCT as well. So I think we're in good shape there, and this will be an important overall franchise for the company for the foreseeable future.

Kevin, on Alcon Dailies? Oh, sorry, go ahead. Alexandra Hauber - JP Morgan Chase & Co, Research Division: So just to make sure that, that number doesn't exclude some very big Canadian proportion or Brazilian proportion, which all of a sudden you may lose, and we're not aware of that, that Exforge x U.S.

The $2 billion valsartan family includes all forms of valsartan, including Exforge. There's no hidden message or anything here. We think Exforge is in good shape, particularly outside the U.S., in terms of lots of growth opportunity. And as I said, the only goal was to put a real floor on things so that people wouldn't panic essentially as we lost the U.S. patent on Diovan.

Kevin?

On Dailies, it's an interesting question, and it's obviously early in the launch of Dailies Total 1. But to give you a sense in terms of the product performance and specifically the excitement of the fitter, we're seeing sourcing of patients coming from a number of sources. Obviously, the first and probably the largest segment is from the Dailies HEMA segment, which is moving to silicone hydrogel, which is an easy move considering the same wearing modality. But we're also seeing movement in sourcing of patients because of the performance and the convenience of the lens. Weekly and monthly wear regimen, we're also seeing conversion to Dailies Total 1. And probably the most exciting part is that we are seeing fits on virgin, new patients to contact lenses being put in Dailies Total 1. So we're seeing sourcing across all of those segments. And right now, we're going to continue to focus on the markets that we launched in, in Europe. And then as Joe highlighted, we're going to look at the approvals going into '13.

We will now take our next question from Matthew Weston of Crédit Suisse. Matthew Weston - Crédit Suisse AG, Research Division: There are a number of quick-fire ones and then pretty one a little bit longer. You mentioned the change in your expectation for Pharma generic impact going from $2.6 billion this year to $2.2 billion. Can you just set out which products where you are seeing the benefits of a shortage of generic entrants? Also, with respect to consumer, can you set out how much of the $1 billion of revenue lost with respect to Lincoln would be made up from the Excedrin family, Lamisil and Sentinel combined? Looking forward in terms of clinical data drivers, relaxin and Afinitor, the overall survival data, I just wonder if you could give us a guidance as to when we should expect those data, either in the second half of this year or into early 2013. And then finally, I guess just a bit more longer term, vaccines R&D, I know you rarely get vaccines questions, but it runs at $0.5 billion a year. I mean, the basic question is what do you actually spend this on? And I suppose more importantly, Menveo and Men B, how much of that $0.5 billion spend is spent on those 2 products? And when should we expect the R&D programs on those 2 products to come to an end?

Okay, let's start with David. I want you to take the 2 Pharma questions on the change in Pharma generic assumption, as well as the clinical data.

Yes. So the first question is why do we see a little bit less generic erosion this year in Pharma. It's mostly around some of the smaller brands that were going generic, where the competition either didn't get approval or launched late or had product shortages. One example for it is Lescol XL in the U.S. market. In terms of the survival data, I think you asked about relaxin and Afinitor, if I heard correctly. We will have our relaxin data at the end of this year. You will likely see some results there. And one of the endpoints, of course, is survival in that study. And with Afinitor, we will probably see some interim mention of survival in the EU label. And then definitive data will come sometime next year, early next year.

And Brian, for the first set of brands that are coming out of Lincoln.

Yes. Excedrin, Lamisil and Sentinel represent approximately 30% of the overall sales coming out of Lincoln. But as we relaunch, we are linking -- we are launching with a limited SKU lineup.

And Andrin, can you talk a little bit about R&D?

Yes. So the $0.5 billion, Matt, that you are referring to, of course, also includes diagnostics because we also take some of the R&D spend from our partner, T-Pro [ph]. So taking that out, and I think it's more closer to the $400 million. Now of that amount, roughly, I would say 1/3 is for meningitis portfolio, 1/3 for our flu portfolio, and then 1/3 for the rest of the pipeline. I would expect that the meningitis spend will slowly go down in the years to come. Not that much, however, because we are also investing in life cycle management. I think we are not done yet even if we launch Bexsero. We want to make a combination product, an ABCWY. And we are also working on other life cycle activities to make sure that, that portfolio would become a long-standing very attractive business for us. And then, of course, we also expect in the future that some of our earlier products will come through. And we will definitely, once we would free up with meningitis, wants to invest in our next opportunities. First one to look at there would be our Group 2 streptococcus vaccine, which now has completed Phase II, and we believe that, that would also become a very promising Phase III program in the not-so-distant future.

We will now take our next question of Naresh Chouhan of Liberum Capital.

On the Sandoz margin, you talked about the quality remediation issues having a meaningful impact on the margin contraction we saw in Sandoz. How much of that was because of the quality remediation? How long should we expect that to last? Or is that now a permanent feature for Sandoz business? And should we expect something similar in terms of read across the consumer? And then secondly, on the buyback, we've seen $200 million for the first half. Should we just play rough [ph] to that for the full year or is there likely to be an acceleration in the second half?

Okay, Jeff, on Sandoz margin?

So we don't break out sources of the margin decline, but I can say, as it's been mentioned, that it's driven by the enox competition and lower pricing and share on that product in the U.S., which drove the U.S. sales down significantly, and the quality investments and related manufacturing variances at our North American sites, as well as a third factor, which is the biosimilar R&D. To comment on the warning letter remediation, we're making good progress in our remediation efforts. As Joe mentioned, all of our warning letter commitments to FDA and Health Canada are on track. And with our remediation efforts in the first half of the year, we did slow down production output, but we've seen month-over-month output in service levels continue to improve at each of our 3 North American sites. And looking forward, we would expect to see continued service level improvements but at a higher, more sustainable compliance level. It's also worth noting that last year's first half core return on sales of 22% was exceptionally high and was at the top of the generics industry. So we're coming off a pretty high base driven by enox. I think the last comment that I'll make is that while some of the costs will be reflected on an ongoing basis due to the increased quality and compliance investments we've made, a lot of the costs are also onetime and will fall out of the cost base moving forward.

Yes, I would say the similar thing for consumer in terms of the read-through that most of this is onetime. I don't think it's going to materially affect the margin going forward. Jon, on buyback.

Yes, now, as we said at the beginning of the year that we would conduct share buybacks under 2 circumstances: one, some were opportunistic; and the other, to negate the impact of shares issued under employee program, which is really what we did. And in the quarter, you saw a very weak share price at the beginning, which we somewhat took advantage of. And I think we will -- we've made no -- we've got no commitments for the second half, and we will continue to look at it in the -- under those two circumstances.

Our next question comes from Michael Leuchten of Barclays.

A couple, please. Firstly, on the Alcon gross margin, that was quite strong in the second quarter. How do I interpret that? Is there a structural change in terms of fixed cost within that margin, so product placement versus disposables? Can we assume it's going to continue with this improving trend, or is Q2 just an outlier? Secondly, I know you just said you don't want to give numbers on Sandoz, what drives the margin. But can -- from a group level, can you tell us what the overall cost in Q2 was for the remediation efforts across all divisions? Thirdly, just going back to the $300 million investments in the launches, is that budgeted for this year or is that an ongoing program that we should take into the model? And then lastly, for David, on Lucentis, it's a little hard to model that product outside the U.S. given that it's really just one line in a product breakdown. Can you give me a feel as a feel for what is driving that growth in terms of launches in markets, new indications, anything from a reimbursement side? Any color for that would be very helpful.

Okay, Kevin, on Alcon.

Michael, I think I would guide you a couple of ways. While we have programs in terms of trying to year-over-year improve our cost of goods, I think when you look at the quarter, I would look at 2 things. One is product mix. And because of the weakness in the allergy season and the impact on Patanol, which is a high-royalty product, obviously, that had a benefit. Also, I would guide you to look at the geography and look at where the growth came from. Heavier growth in the U.S. with our pricing position is going to yield better pricing as compared to a weaker European result. So I would look at it primarily as geographic and product mix.

Yes, on the next couple of questions, Michael. On quality, we haven't broken it out because, actually, if you think about it, it's not as straightforward. I mean, there are some direct costs. We've got consultants. We've got additional employees to sort the problem out. We've got lower production, and we've got some lost sales. And I think if you take all of those pieces together, if we put a number together, we would have to go through an extraordinary amount of explanation to put it into the right context. So I think the way to look at it is to track what happens to margin on a quarterly basis and follow the story that Jeff and -- that Jeff will go through on Sandoz. On the investment program, I mean, Joe described it as up to $300 million, and it was going to be in relation to specific products or projects. I think it's sensible for you to plan it into your expectations for the year, but I think we'll give you a bit of an update each quarter as it progresses, and some of it may fall into next year. But don't think about this as a one-off increase in the cost base. This is really directed to very specific programs.

And David, on Lucentis?

Yes, I'll try to give you a little bit of background. Essentially, think of it this way. First of all, in terms of numbers of patients treated, that continues to grow by double digit. In fact, the DME prevalence is about 650,000 patients; RVO incidence is about 225,000. So when you add that together, that's between 2/3 to 100% of the wet AMD opportunity, and we've only captured 15 -- about 15% to 20% of the current Lucentis businesses from the new indications. Offsetting the volume growth is some single-digit price decline on the brand, in part as European governments roll back prices generally. And also, as we've negotiated market entry for DME and RVO, we've given a little bit on price. The other thing to remember is we've recently launched in Japan. We're having good success there. We have a long way to go in terms of capturing, fully capturing that opportunity. And we've just gotten approval in China. And while you don't see any sales from China yet, that will start to grow in -- basically, starting next year, you'll start to see some numbers coming in from the Chinese market. I happen to believe that the market for VEGF inhibitors is still underdeveloped. There's a lot of growth. And the key for your model, frankly, is to figure out when the other branded VEGF inhibitor will launch and what share they will take from us, and then you can put a model together. But we're bullish on this product.

Our next question comes from Andrew Weiss of Bank Vontobel.

Just very quickly to the $300 million of additional investments, so this is an additional cost buildup. This is not just a investment in infrastructure and, therefore, does not create cost, but this is getting more people in or more infrastructure and then will then be able to leverage -- can be leveraged by new sales, that's the first. Number two, on Sandoz, one of the segments, the Asia, Africa and Australasia revenue growth is minus 4%, but you break it down as Asia is 24%, Eastern Europe is 14%, Africa -- is that where it's happening, that there is Middle Eastern, and Africa is falling off the cliff? And thirdly, David, I have difficulties reconciling on the Afinitor overall survival expectation data. The next interim analysis is 275 patients. The last one was 200. That happened in January. Why are only you expecting that event to happen in the first half or January of next year?

Jon, on investments?

Andrew, I think this is a targeted investment program with specific outcomes. I mean, as Joe said, the beginning of the year, we had to put a plan together based on what we saw was a realistic set of opportunities unfolding. I mean, we have seen this quarter and what we expect this year to be a much stronger package of opportunities than we'd anticipated. So I think it makes sense that we allow some acceleration of investment. We put money by specific -- behind specific projects so that we have the opportunities to drive the business more strongly. It is not a general increase in the cost base. It is very targeted.

So not infrastructure cost, project by project. Jeff, on Sandoz growth.

Yes. So Asia growth, excluding Australia, is up 20%. That includes Japan, which was up 14%, its 18th consecutive quarter of double-digit growth. China was up 35%, and Southeast Asia was up 26%. Australia was down, mid single digit negative, and it's a bigger base so that affected the overall number. Also, the Middle East and Africa was slightly negative due to some supply issues in South Africa and North Africa. Central and Eastern Europe, you mentioned. That's separate, so that's reported in the European numbers. Their business was up 14% versus prior year in constant currency on the back of double-digit growth: over 20% in Russia, over 30% in Poland, and over 35% in Turkey.

David, on Afinitor?

Yes. So just to go back to the regulatory process, the regulators looked at survival data trends for Afinitor as part of their review. And as I mentioned, you will likely see something in the European label which will give you a sense of what they have seen so far. So that label should be out in the next couple of months. And then in terms of when we will be public with more survival data, I expect that to be early next year. So I'm not telling you necessarily when we're going to see it. I'm talking about when you will likely see something.

Okay. And the additional overall survival data to be included in the EU label is over and above what we saw at ASCO?

You have to remind me what you saw in ASCO.

We saw the 18-month cut with -- basically from the 15th of January.

I'm going to have to go -- we're going to have to go back and double check. I don't want to give you the wrong information, so we'll follow up after this call.

Our next question comes from Seamus Fernandez of Leerink Swann .

So just a couple of quick questions on Afinitor and how we should be thinking about the pacing of the growth of the breast cancer indication and approvals in European markets. David, maybe if you can just give us a little bit of color on that. And also when you say substantially above $1 billion, we can get to some pretty big numbers just in the BOLERO-2 patient population. As you think about that, that incremental greater than $1 billion, is that just for the BOLERO-2 patient population? And then the second question is, can you just update us on the overall growth of the o U.S. market and how you're seeing it, how the market share is breaking down between Avastin, Eylea and Lucentis?

David?

I'll start with the Avastin, Eylea and Lucentis. So in Europe, there is no Eylea yet, although there are various rumors from time to time that they might be launching towards the end of this year. We do better in the U.S. -- I'm sorry, in outside the U.S. with Lucentis versus Avastin that is done in the U.S. market. We have about -- it's hard to get an exact number, but we have about -- say, 2/3 of the market is Lucentis, and the rest is Avastin outside the U.S. Regarding Afinitor, yes, this could be a fairly long story, but I'm going to try to keep it relatively brief. What I've been talking about -- when I'm talking about the much greater than $1 billion, I've been talking about -- certainly, I've been talking about breast cancer overall. Clearly, even the HER2- opportunity would be greater than $1 billion, in my opinion. We will see the HER2+ breast cancer data. Basically, the final analysis for that data will be in 2013. Of course, it's possible that there be some interim analyses before that, which could impact the brand, hopefully, in a positive way. We would expect, given the physician reaction to the data that we have shown them, plus what we expect the label to be in Europe, that takeoff should be relatively quick for the product. Obviously, we have to get through pricing and reimbursement discussions with some countries. And then there are other markets where the fact that Afinitor is already on the market for renal cancer, and TSC. We can begin to sell right away. But the really big driver for Afinitor in breast will be the U.S. approval, where you would expect the fastest uptake in the world, and we would hope to have that approval in the near term.

Our next question comes from Florent Cespedes of Exane.

Florent Cespedes, Exane BNP Paribas. Three quick questions, 2 for David and one for Kevin. First, and this one for David, could you give us the pricing impact for Pharma in Europe, U.S. and Japan and a quick comment on how you see the trend there? Second question for David, on the respiratory, when we see your competitor which filed LABA plus an ICS in the U.S., could you decide to change your plans and to file your own product in this country following this submission? And the last one for Kevin on Alcon, the new fixed combo on glaucoma that you submitted recently seems quite important for you. Could you give us some color why is it important? And could it be the product that could cushion the TRAVATAN generics in the U.S.?

Okay, David?

So starting with pricing. Basically, the toughest part of the world for pricing right now is Europe. We've been consistently down in terms of price between 5% and 6%. We're more or less been running at that rate for some time now, and that's very much in line with what we were forecasting at the beginning of the year. In addition, in Japan, this is a every-other-year effect, so this is a price-cut year. So we're starting to see now in the second quarter the negative Japanese price coming through. In the U.S., there is still some price increases. So overall, we are down more or less minus 1%, and this is, as I said, really very much what we projected. In terms of respiratory, a couple of things. We were very pleased with the NVA once-a-day COPD CHMP recommendation in Europe. That brand is now called Seebri. We have -- we will be and we're starting to enroll patients in the NVA and QVA remaining pivotal trials so that we can meet the U.S. regulatory requirements. Those enrollments will start in the back half of this year. We will also be in a position to file QVA in Europe before the end of this year, and we believe this will be a very, very important growth driver for the company. And then the QVA filing, as you know, will come later in the U.S. market. Now I think your question was specifically about the combination of basically Onbrez with a steroid, given that our competitor has just filed their new combination LABA steroid in the U.S. only in COPD. They chose not to file in asthma, which I think is a change in strategy. We are now re-looking at our product, QMF, which is that LABA-steroid combination, to see whether it would make sense to develop more of the U.S. market for COPD. But we have not made any such decision as of yet.

And Kevin, on [indiscernible].

The combination glaucoma product is an extension of our continuing strategy. If you look at our combination products, DuoTrav and Azarga, you see very dynamic growth on both of those products primarily or exclusively outside of the U.S. So when you think about combination products in the treatment of glaucoma, the challenge is, obviously, compliance which is addressed by putting 2 drugs together. Secondly, it's the ongoing reduction of intraocular pressure. Today, almost all of the combination products, with the exception of one, contain timolol. And obviously, timolol, as you probably know, is a nonselective beta blocker that has systemics effects outside of the control of intraocular pressure that are normally not wanted. In this case, it would be a combination product where you do not have timolol in the combination. And it brought very encouraging IOP reduction. And as a result, as you also probably know, because we don't have combination products per se at the same degree in the U.S. as in the international markets, we are looking at the IOP reduction and the ability to file in the U.S. So we are encouraged by this new product opportunity.

Our next question comes from Andrew Baum of Citi.

Three very quick ones. First, to David, could you outline the timing of initiation of Tasigna discontinuation trials and when you first expect 6 months data? Second, could you outline your expectations for timing of generic entry for generic Glivec in both the U.S. and outside the U.S. and some comments on legal strategy here? And then the final one is in relation to the incremental $300 million spend. Doesn't it simply reflect the fact that you start facing generic versions of Afinitor in 2018? I'll stop there.

David?

Lots of questions, Andy. So let me start. Tasigna discontinuation, so for background for people on the phone, we believe we have pretty good evidence now that Tasigna drives a much more complete molecular response than Glivec. And as a result, it will be possible to design clinical trials which will allow patients that are treated on Tasigna for a period of time, for some of those patients to actually discontinue their therapy, which would be great for patients and would also be a big economic benefit for payers, making Tasigna potentially the most attractive viscer-able [ph] therapy in the category. We are currently discussing study design with regulatory authorities and others. So as a result, I am not going to comment on those plans yet, but I'm sure Hervé Hoppenot who runs our oncology business, once we have the plan, we'll share them extensively with you. Now the second question is around timing for Glivec generic. Also, not the easiest story to tell, unfortunately, but we will see some patents begin to expire as early as next year, and that's in places like Russia and Brazil. But the big markets, of course, are coming much later: the U.S. market, with the expiration in the back end of 2015; and in Europe in the back end of 2016. But what I have to point out to you, that's an expiration of just one of several patents. And as there are additional patents around various crystalline forms of the product, and we do not yet know how that may play into the eventual launch of generic, so you'll have to do some -- make some assumptions around that in order to fine-tune your model. Obviously, we're going to protect any intellectual property that we may have. In terms of Afinitor, we have just been granted a pediatric exclusivity for the product, and so that will push out the U.S. generic date into early 2020. And I am actually trying to look up the European number for you because I don't remember it off the top of my head. And maybe what we'll do, Andy, is we'll just get -- Andrew, we'll get back to you after the call and give you the specific EU dates, if that's okay with you.

That sounds fine. I think it was 2018, but we can follow up.

Our next question comes from Jami Rubin of Goldman Sachs. [Technical Difficulty]

We can't hear you.

Our next question comes from Peter Verdult of Morgan Stanley.

Three questions for David, Jon and Joe. David, on the ALK inhibitor, big excitement at ASCO this year. I was wondering if it's too early to ask for some more detail on the trial design, and whether you're considering further studies in other counter-indications. And there was at ASCO some discussion about whether you would consider lowering the dose range in Phase III to try and maintain the efficacy but sort of get the total breezy [ph] profile up. So wondering if you can make any comments there. Secondly, it's been touched upon -- but Joe, it's been touched upon by some other people, but in terms of your European pricing, I think everyone knows it's tough out there. But I just wanted to get a sense how concerned you are about market access and reimbursement issues, facing new drugs that are getting approved there. And then lastly, for Jon. Could you just remind us, Jon, as we currently stand, with all the restructuring programs you've announced, on a greater level, what sort of state -- where are we now in terms of the savings you've achieved and the restructuring cost expense? And should we assume as a reinvestment rate around 50%?

Okay, David?

You faded out when you mentioned the name of the drug. Can you tell me which one you're referring to?

378, the ALK inhibitor.

The ALK inhibitor. Yes, so as I said, we'll start the pivotal trial at the back end of this year. We're very excited about the opportunity there. I think in terms of giving you more color, I would rather wait for a future IR event once we've started the pivotal trial to go into what the full development plan is for that product. But I think you are right to be excited about this product. This could make a really big difference for patients.

Jon, on the savings.

Yes, on the restructuring programs, you notice that we give you an update each quarter in the press release of what we see as some of the most important developments. And this quarter, we highlighted the impact of the U.S. restructuring. I mean, there are many different ways of showing this, and I think what we -- what I think we are now most comfortable with, rather than say that there's a productivity and there's a reinvestment rate, is to look at the total amount of resources that we've been generating because, of course, there are many other things going on in the business. I mean, if you think about procurement, much of what procurement is seeking to do is to offset some of the impacts that we're seeing on gross margin, for example. We've got the mix effects. So I don't think it's actually very helpful to sort of give you a line by line of where the money is and where it's gone. But just think about what the 3 big moving pieces in our business are in terms of margin: it's one, generics; two, the increasing impact of the contribution that's coming from the new product portfolio; and three, productivity, and sort of take it all in the mix rather than think about one element of coming from here and going into another opportunity.

And then, Peter, in terms of the market access and reimbursement, it is a tough environment obviously everywhere, particularly in Europe. But what we're finding on our new product launches is if you think about the Novartis philosophy from a research and development standpoint of going after areas of high unmet medical need and really differentiating the product, we're not seeing an inhibition of the ability to get reimbursement and to get pricing that allows us to recover the cost of that R&D and a good profit margin. So despite the tough environment, we're not seeing a huge inhibition in our ability to get pricing and reimbursement. But I think it's because of the fact that you've got products like Afinitor, like Lucentis, like Jakavi, which will be quite differentiated. I also think if you look at Novartis, our diversified portfolio puts us in a little bit of a different place than some of our pure-play pharma peers in that less than 60% of our total sales are reimbursed by some kind of a public agency. And that's because we have over-the-counter drugs, we have Animal Health, we have other products that are self-pay. So we're a little bit insulated from what's going on right now as a company, and I don't think that's fully understood.

We will take our next question from Florian Gaiser of BZ Bank.

It's quite about free cash flow. You used to have that nice $1 billion a month free cash flow. Now at the half year, you're at $4.5 billion. It's obviously below that run rate. Can you talk a bit about the seasonalities of your free cash flow, the one-offs and what you might see in H2? And the second question is about the slight decrease in margin. You talked about a little bit more than 100 basis points. Is that constant currency or nominal?

Jon?

Yes, the second part, it's constant currency. And then on free cash flow, I think if you look at our cycle of cash flow, annual cycle, we are generally slightly higher in the second half than we are in the first half. We have some seasonal business impacting Sandoz in the Consumer Health business. So generally, we're a bit more than 50% of cash flow in the second half. In terms of the overall cash flow for the year, I think the only 2 things that I'm signaling to you that will affect it vis-à-vis last year or maybe 3 year -- 3 things, I mean, obviously, profits [indiscernible] obviously generates less cash. Then there's an increase in the CapEx program, and we have payments out of some of the provisions, some of which we made this year and some of which we made last year, which has a slight impact on the total overall free cash flow. But generally, the first half is a little softer than what we see in the second half.

Okay, just to close, I'd like to say that it is a difficult environment out there, but you're listening to a quite optimistic management team about the future of Novartis. And I think part of it is driven by what we have coming out of our pipeline and the launches that we have across the division. So it's not just Pharmaceuticals but also launches in Alcon, launches in all of the divisions around driving continued growth. So we look forward to updating you at Q3, and thank you for joining today.

Ladies and gentlemen, this will conclude today's conference call. Thank you for your participation. You may now disconnect.