Earnings Labs

Teva Pharmaceutical Industries Limited (TEVA)

Q2 2010 Earnings Call· Tue, Jul 27, 2010

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Transcript

Operator

Operator

Greetings and welcome to the Teva Pharmaceutical Industries Ltd. Second Quarter 2010 Results Conference Call. (Operator instructions) It is now my pleasure to introduce your host, Ms. Elana Holzman, Senior Director of Investor Relations. Thank you, Ms. Holzman, you may begin.

Elana Holzman

Management

Thank you, Diego. Good morning and good afternoon everyone. Welcome to Teva's second quarter 2010 earnings conference call. We hope you had a chance to review our press release, which we issued earlier this morning. A copy of the press release is available on our website at www.tevapharm.com. Additionally, we are conducting a live web cast of this call that is also available on our website. Today, we are joined by Shlomo Yanai, President and CEO; Eyal Desheh, Chief Financial Officer; Bill Marth, President and CEO of Teva North America Pharmaceutical; Moshe Manor, Group Vice President, Global Branded Products; and Dr. Gerard Van Odijk, President and CEO of Teva Europe and Dr. Ben-Zion Weiner, Teva's Chief R&D Officer. Shlomo and Eyal will begin by providing an overview of our results. Please note that Shlomo will be referring in his prepared comments to non-GAAP gross margins, operating profit, net income and EPS. Eyal will provide additional detail on the items excluded from our non-GAAP results. We will then open the call for question-and-answer period. Before we proceed to the call, I would like to remind everyone that the Safe Harbor language contained in today's press release also pertains to this conference call and web cast. Shlomo?

Shlomo Yanai

President and CEO

Thank you, Elana. Welcome everyone, and thank you for joining us today as we review Teva's results for the second quarter of 2010. This was an outstanding quarter for Teva. Indeed, it was our strongest quarter ever in (inaudible) of any growth. Net sales reached $3.8 billion breaking all previous records in local currency clearance with record gross margins of 59%. Quarterly operating profit reached a record $1.2 billion, a 22% increase over the second quarter of 2009. Net income in the quarter reached $981 million, 32% increase of the Q2 '09 and for the first time EPS cross the $1 mark to reach $1.08. Our free cash flow reached $700 million, an increase of 86% of the Q2 '09. Teva's better than anticipated results in the second quarter were driven by superb performances across our many geographies and lines of business including especially strong sales in North America. We got a great quarter for Teva in North America with record breaking results. Record sales of generics and record number of new product launches. Total sales in North America reached $2.5 billion in Q2, up 17% over the second quarter of 2009. We have sales of $1.5 million in US generics, up 14% over the second quarter of 2009, and strong sales of our branded products. It was also an exceptionally busy quarter with nine new launches representing a brand value of over $7.5 billion. This intensive pace has continued into the beginning of Q3 with our launch of (inaudible) ER, generic version of Fexo XO (ph). Thanks to the efforts of our outstanding global team, within 24 hours of launching over 25,000 pharmacies in the U.S. were supplied with the products, ready to dispense to the patients. This was also an excellent quarter for our European business, which despite…

Eyal Desheh

Chief Financial Officer

Thank you, Shlomo, and good day to everyone. I hope you have had an opportunity to review the press release we issued earlier today. As you can see, we reported an outstanding second quarter with record sales in local currencies, as well as record gross profit, operating profit, net income and earnings per share or in a GAAP and non-GAAP basis, completing a very strong first half and heading to an excellent 2010. We also reported cash flow from cash flow from operations of almost $1 billion and free cash flow of $700 million, both representing substantial gross compared to Q2 last year. Before we delve into the numbers, I would like to touch in two technical topics. First, I would like to remind everyone that we are presenting GAAP and non-GAAP results. In our non-GAAP presentation, we have excluded the following items this quarter; amortization of purchase in tangible assets amounting to $130 million of which $122 million are included in cost of goods sold and the remaining $8 million is (inaudible) in marketing expenses; finance expenses, $123 million, which reflect $147 million in expenses resulting from hedging activities in connection with the acquisition of Ratiopharm; net of finance income of $24 million resulting from sales of security; construction (ph) cost of $11 million resulting mostly from closing and manufacturing facility in Ireland; $5 million purchased R&D in process; impairment of assets of $3 million and these expenses were offset by income of $23 million in connection with legal settlement and addition, the related tax benefit of $65 million. You should note that the item excluded in arriving to our non-GAAP results for the second quarter of 2009 are not identical to those in the current quarter. Most notably, Q2 2009 included an inventory step up in connection with…

Operator

Operator

Thank you. I will now conduct the question and answer session. (Operator instructions) Our first question comes from Randall Stanicky with Goldman Sachs. Please state your question.

Randall Stanicky

Analyst · Goldman Sachs. Please state your question

Great. Thanks for the questions. Just for (inaudible), it's verification. The updated guidance had remained, has the standalone and did not yet reflect Ratiopharm is that correct?

Eyal Desheh

Chief Financial Officer

Yes, absolutely. As the exact date of the closing is still not known, we did not account for Ratiopharm results in this guidance and this is apples to apples with what you know on 2010, in general. We, of course, will provide an update, but will take it a little while to study the exact data of the company as right now our plans are based on due diligence information and as always take a little bit of time. We do expect this to have a positive impact on sales, of course, as to our earnings per share will probably be a couple or three cents below but not more than that in the first period and of course, it will have a contribution in 2011 as we mentioned when we announced the deal.

Randall Stanicky

Analyst · Goldman Sachs. Please state your question

Okay, great. And then for Gerard, with respect to what you reported the 10% constant currency growth in Europe, can you just give us a sense of how much of the known pricing cuts reflected in that second quarter reported number at this point?

Gerard Van Odijk

Analyst · Goldman Sachs. Please state your question

Thank you, Randall, for the question. I think it's a complex question you're asking there because it's almost different through each market to answer. But I think I should start with saying, repeating what Shlomo said, if you take it across the board, Shlomo has been able to demonstrate that our setup in Europe makes us less vulnerable to some of the price dynamics in Europe. We know how to handle the complexity and detail and just that are coming from the clear price pressure that we see in Europe. I also think that we've learned in tougher pricing environment like the U.S. to handle this. If you look at that, there is – people who stay with us like the price pressure, but has been with us for a long time, it will stay with us. we've seen prices going down in markets, but it's been overcompensated by volume growth and very clear that it has to do with our portfolio, which is quite well spread between OTC, with hospitals, with retail, with many other products and also our geographies. We are not overweighed in one place or the other. We have a very nice well-spread portfolio and products and geography. On top of that, of course, we have launches that give us the tools to respond to all of these challenges. On top of that, we believe that the environment is helping us. There's volume growth in many, many places, which is very strong and that's why I believe that it's for that that we can explain that our growth in this quarter was as good as it was. I'm sure that it will require every quarter, a lot of hard work from us and very specific (inaudible) may answer (ph) to the different challenges and opportunities we see in the different geographies in Europe and it's very clear that we're up to it. I'm happy to give you a few examples, but perhaps we can talk about that later in line with other questions.

Randall Stanicky

Analyst · Goldman Sachs. Please state your question

Are there a couple main regions or major countries that you can highlight or points to that pricing pressure have been fully reflected of the known pricing (inaudible) at this point?

Gerard Van Odijk

Analyst · Goldman Sachs. Please state your question

Well, in some places, thought it and in some places its most thought. I'll take the much (inaudible) open about example in Spain, for instance in retail where we all know about the announced 35% price decrease on the gross prices but also with limitation on discounts in the trade as part of that whole package.

Randall Stanicky

Analyst · Goldman Sachs. Please state your question

Yes.

Gerard Van Odijk

Analyst · Goldman Sachs. Please state your question

As Shlomo reported, we had – or I think (inaudible) was we had excellent growth and we've been growing nearly 20% in our retail in Spain in a period of that, all of these matches were kicking in Spain, so it's been absorbed and despite that we have been able to grow our business very strongly in a place like Spain. And in other places, like in Italy, it will take a bit more time, it's just been announced the 12.5% again on gross price. In Germany, you see that some of the (inaudible) vendors are currently kicking in and where some companies have been gaining senders (ph) last year and they see now some of the results in that we know that we've once intended in this first half of this year, which will be kicking-in in terms of market share and volume growth next (inaudible) and the rest of this year or next year and the pricing pack will be related to that. It's a very diverse picture across Europe. If I talk about Germany, I talk about the Panda (ph) business, but as you know large chunk of the German market is not expose to Panda's (ph), so it's a segment in Germany that's under price pressure or the segments that are feeling the pressure of price, but as I said that's a sort of price pressure that we see coming in every year.

Randall Stanicky

Analyst · Goldman Sachs. Please state your question

And France is reflective?

Gerard Van Odijk

Analyst · Goldman Sachs. Please state your question

And France, in France, we know that the government is going after some extra savings and it haven't yet specifically announced although that the indication is that they're going to go for a few specific therapeutic areas and that hasn't yet kicked in and we expect the specific price decrease on some specific therapeutic areas like they did last year.

Randall Stanicky

Analyst · Goldman Sachs. Please state your question

Okay, great. Thanks very much for the color.

Operator

Operator

Our next question comes from Rich Silver with Barclays Capital. Please state your question.

Richard Silver

Analyst · Barclays Capital. Please state your question

In respiratory business in the quarter seems stronger than we would have expected can you provide a little bit more detail on what's happening both in the U.S. and overseas and what we can expect going forward? I have a second question, thanks.

Shlomo Yanai

President and CEO

Okay. So, Bill will you take the U.S. piece and then Moshe will follow by the international (ph) or countries with the international part?

Bill Marth

Analyst · Barclays Capital. Please state your question

Sure. Good morning, Rich and thanks for the question. With respect to respiratory, obviously, as you've seen ProAir has been holding around 50%, so that's been very well. And then we've got some seasonally adjusted advantage because there's this particularly good season for us, and really the strength of QVAR has been really exceptional. It's almost 20% of that category now and Teva's done very, very well and continues to grow. So, I would say the ProAir really holds steady and moves with the market, with the season, and QVAR is really showing it, just great strength for us.

Richard Silver

Analyst · Barclays Capital. Please state your question

So, with the seasonal strength that you cited, does that mean that in the coming quarter, we should not expect the same level of sales that we saw in this quarter?

Bill Marth

Analyst · Barclays Capital. Please state your question

Well, it's hard to say what's going to happen in the Q3. It all depends on the weather and the season. So, right now, the quarter seems to be pretty good, but we'll see how it ends up.

Richard Silver

Analyst · Barclays Capital. Please state your question

Okay.

Shlomo Yanai

President and CEO

Wait, Rich, for Teva, there is only one season in a year.

Richard Silver

Analyst · Barclays Capital. Please state your question

Okay. And then the gross margins that maybe Eyal had comment, I didn't hear that range in 59 to 60% is that still the case for the full year guidance?

Eyal Desheh

Chief Financial Officer

Yes, I believe so, Rich. I think that has 59% (inaudible) refer to this quarter or earned this quarter, the second half of the year was then the (inaudible) coming in. So you could see some improvement there and I think what we have guided at the beginning of the year, so it's pretty valid.

Richard Silver

Analyst · Barclays Capital. Please state your question

Okay and then lastly, I know you haven't provided 2011 guidance yet, but specific to (Inaudible) are you assuming additional competition in January?

Shlomo Yanai

President and CEO

Bill? I think it's too early to answer this question, unless Billy would like to add something here.

Bill Marth

Analyst · Barclays Capital. Please state your question

Well, I would just add that it's too early to answer that question. So, I concur.

Richard Silver

Analyst · Barclays Capital. Please state your question

Okay.

Shlomo Yanai

President and CEO

That's way to each, we will get there.

Operator

Operator

Our next question comes from Chris Schott with JP Morgan Chase & Company. Please state your question.

Chris Schott

Analyst · JP Morgan Chase & Company. Please state your question

Great. Thanks. The first question was just the follow-up on Europe, I think you average about 5% constant currency growth for the first half of this year, when we consider the mix of further price cuts as well as potential new (inaudible) and volume growth, is that 5% type of growth rate we've seen so far this year, a decent proxy of what you're anticipating for the second half? I mean (inaudible) fall off after that.

Shlomo Yanai

President and CEO

Eyal? (ph)

Eyal Desheh

Chief Financial Officer

I think the second half last year, was a very good second half and although we are anticipating continued price pressure as we spoke about earlier. I would assume that we would be able to sustain the same sort of growth range as we have been doing so far.

Chris Schott

Analyst · JP Morgan Chase & Company. Please state your question

Great. And then (inaudible) guidance, can you talk a little bit about the earnings progression as we think about 3Q and 4Q given the generic effects or launch this quarter and number of potential opportunities, we think about 4Q. Should we think about 3Q and 4Q as roughly equal quarters or are you anticipating one that's going to be meaningfully above the other? Thanks.

Shlomo Yanai

President and CEO

Yes. You're living me very little choice but to return to our old type of describing a market, as a market with many moving parts and that is true also this second half. I mean generally we could see the rest of the earning per share for the second half exclude more or less even between the quarters, but it could definitely, we could definitely see a couple of cents moving from one quarter to another depending on timing of launches, demand in the market, how we've allocated over the period and of course, this does not include the Ratiopharm impact. So, I would calculate this more or less even perhaps minus two cents that could move.

Operator

Operator

Thank you. Our next question comes from Ken Cacciatore with Cowen & Co. Please state your question.

Ken Cacciatore

Analyst · Cowen & Co. Please state your question

Great. Thanks. I was wondering if you all could give us a little bit a sense of what the (inaudible) did since petition taught you about your own Lovenox filings. Is there anything that you saw and how you can go back and address or are you in the direction with the agency. And as well, Shlomo, you're commentary about some of the teachings in the Lovenox citizens petition, this are the Copaxone. How do you think the FDA is going to address some of these potential deficiencies? Do you think that they'll have to solicit kind of expert commentary or open up to the public to help address maybe the mechanisms and assays (ph) that should be utilized on Copaxone? Thank you.

Shlomo Yanai

President and CEO

Okay. So, Bill, you take this one and then Ben, you will follow to complete the answer to this question.

Bill Marth

Analyst · Cowen & Co. Please state your question

Good morning, Ken and thanks for the question. With respect to our Lovenox file, we are continuing to dialogue with the agency. I would say to you that we feel that we're on track. We're progressing ahead. We did file slightly later, about a month later than Momenta on the response the immunogenicity, which is very likely why we haven't received our notification yet. But as we review the five criteria, we find that our product falls clearly within the range that we believe is approvable. Now, of course, we have to let the FDA – they're going to have to give it their opinion as well. But the fact of the matter is as we read through it, we think that we did all the criteria very, very well and it's just the timing issue.

Shlomo Yanai

President and CEO

Ben-Zion, would you like to add on?

Ben-Zion Weiner

Analyst · Cowen & Co. Please state your question

Yes. In relevance to the correlation between Lovenox and Copaxone, I don't think that there is a direct correlation between approval of Lovenox and future generic approval of Copaxone. The FDA had issued five criteria by which Lovenox has to follow and then get approval, three of those have to do with the external (ph) material, physiochemical aspects for the fragment, et cetera. I won't go into details unless you want me and the two criteria that have to do with biological access and test and human exposure and I think Copaxone is very different from Lovenox in the first part, in the three criteria that have to do with the actual product, and primarily with the two biological ones. The first three, Lovenox is the parent compound is obviously heparin, known chemical, a known product for 90 years, structure is known, activity is known and Copaxone is obviously a very different molecule based on random polymerization of four (ph) amino acid, structure is not very clear. There is no specific epitope through which the activity can be explained, and I won't go into details about the series of polypeptides and the number of repeating units in the Lovenox. What is very important to note here is that Lovenox, the essays through which FDA approved Lovenox is based on very simple straightforward acceptable test that everybody can do, which are directly related to the target organ, which is the blood. Copaxone target organ is the brain and there is no direct correlation between the mechanism of action of Copaxone, which has to do with influencing immune cells and the target activity in the brain. So, in my mind and other people mind, there is no direct substitution to a proper clinical trial conducted on MS patients with clinical end points. In my mind, there is no good way to demonstrate safety and efficacy unless such as clinical trial is being performed. No PK, no PD and no biological essays can substitute this notion.

Ken Cacciatore

Analyst · Cowen & Co. Please state your question

Great. Thanks, very helpful. And Bill, just to finalize, can you talk about the Irvine facility, any update there?

Bill Marth

Analyst · Cowen & Co. Please state your question

Yes. The Irvine facility, we continue to work with the agency. We have released 12 products to date in cooperation with the FDA, and we are continuing to work with them on a daily basis to bring that facility up. I would remind that any of the big launches that people are concerned about Onaxiperine (ph) is not tied to the Irvine facility or Gemcitabine for that matter is also a product that can be manufactured elsewhere.

Ken Cacciatore

Analyst · Cowen & Co. Please state your question

Great. Thank you.

Bill Marth

Analyst · Cowen & Co. Please state your question

We have our final approval. Thanks.

Operator

Operator

Our next question comes from Ronny Gal with Sanford Bernstein. Please state your question.

Ronny Gal

Analyst · Sanford Bernstein. Please state your question

Good morning and thank you for taking my question. (Inaudible) one around the filing of the Lovenox (ph), do you happen to have any update on whether the product will be entitled for a three (inaudible) and second, a little bit of – if you can how you think about the risk in – that you currently have Plutonic (ph) and the chances of exclusitivity on (inaudible).

Shlomo Yanai

President and CEO

Bill, can you take the second one and then you will take, Moshe, the first one.

Moshe Manor

Analyst · Sanford Bernstein. Please state your question

You're welcome.

Bill Marth

Analyst · Sanford Bernstein. Please state your question

Moshe, you want to go first?

Moshe Manor

Analyst · Sanford Bernstein. Please state your question

Yes. As you probably know, we have submitted the file or the 0.5 ml (ph) and the file were accepted by the FDA and with the action date as when both mentioned in the January 1st, 2011. Of course, I think it's too early to comment that you ask about exclusivity, well, definitely we have a good data there that show that the 0.5 ml is associated with less local size reaction and same local pain and that's something that we are going to discuss the FDA and with relation to the potential ore-exclusivity to the low volume product.

Ronny Gal

Analyst · Sanford Bernstein. Please state your question

But you would not know the answer to that until January 1st or would you know the answer before that?

Moshe Manor

Analyst · Sanford Bernstein. Please state your question

I don't think that we know the answer. I don't believe that we know the answer before January 1st for this question.

Shlomo Yanai

President and CEO

Unless the FDA will give us the answer earlier. Bill, can you answer the second on the Clopanics (ph).

Bill Marth

Analyst · Sanford Bernstein. Please state your question

Yes. Let's talk about the last two questions, Ronny. The Plutonic and the Denapazil (ph), on Plutonic's, let's just – we go back to that and say, I think it's a little early to talk about damages on Plutonic because we still believe we have a very long way to go here. Although, obviously, we don't agree with the judge and at the appropriate time, we will appeal that decision. We still have two defenses that remain alive out there, the patent (ph) meds used in the (inaudible) hands. So, we will still pursue those with full vigor and we'll be looking for discovery in those particular areas. So, I think we're a long way away from that on Plutonics (ph). On the Denapazil (ph), I can recount to you where we're at, as you know that we have actually two files. But our first file, we have a final approval on that file, we believe, we are first to follow on the compound patent. We believe we are entitled to exclusivity, we maintain that position. Of course, Ranbaxy challenges that position but we beg differ to that view and so we're just proceeding.

Ronny Gal

Analyst · Sanford Bernstein. Please state your question

(Inaudible), I mean once the station needs to take place in the FDA end, is on the court, what does that stand, what is the timeline to approve in this, to resolve without a question?

Bill Marth

Analyst · Sanford Bernstein. Please state your question

Well, we don't what's going to happen at this point in time. Obviously, we think the decision will be in the hands of the FDA. There's no issue with the court so.

Operator

Operator

Thank you. Our next question comes from David Amsilumer (ph) with Hyper Jafford (ph). Please state your question.

David Amsilumer

Analyst

Thanks. Just a couple. First on Copaxone, do you think you're getting to a point in the U.S. at least, where you won't be able to be as aggressive in raising prices and just talk about what you think the long-term outlook on price increases for Copaxone and how you're thinking about the pricing (ph) in the U.S.

Shlomo Yanai

President and CEO

Bill, would you like to take this one?

Bill Marth

Analyst · Barclays Capital. Please state your question

Yes. Yes. Thanks, for the question, David. You bring up an excellent Copaxone and the pricing. We did take another price increase this quarter and as we move forward, we begin to wonder about where this price increases will lead us to. But for frankly, you've see the competition raised their price as well, so price in this particular area seems to go up. I would tend to agree with you that I would not be as aggressive in the future on my pricing, but we'll have to see. My concern is always been, Teva is generally speaking not a price leader, we're a price follower and what I can't tolerate is the situation where what I believe is the standard of care in this particular therapy and the leading product in the U.S. and the global market to be disadvantage on price. So, we'll continue to watch that as we move forward and just follow the market.

David Amsilumer

Analyst

Okay. And then just the second question about competition from the oral and specifically, Gilenia, I mean what's your market research telling you regarding the willingness of doctors to potentially use Gilenia in earlier stage patients or do you expect that Gilenia, largely, at least initially we'll see usage and treatment failures and potentially switches from TYSABRI. I guess talking about what your research has been telling you though.

Ben-Zion Weiner

Analyst · Cowen & Co. Please state your question

Well, based on our research and discussion, extensively discussion actually with the premier (ph) leader, we believe the oral and specifically, Gilenia will enjoy flow will still uptake and the reason, I believe, is the first of all, most of the patient in Copaxone are stable, they are doing well and we don't see (inaudible) or twitching phase and that they are doing well to a product that is really relative new with unknown long-term safety concern. And actually if you talk about safety, we have to look at the own safety as the issues that already were published and more that I think, we have to pay attention to the long-term, potential long-term safety and based on the experience we all had in the market and physicians and patients with TYSABRI, we know there is a question of issues of safety and the emergence of safety issues on the long-term. So, therefore, I believe that physicians will and definitely patient will follow, will prescribe the oral mainly as a third line therapy and in some cases in the second line therapy after patient have failed on one or two therapies. I think it's fair to say that the oral might have the chance or the opportunity to extend the market as those patients that really (inaudible), early (inaudible) no treatment or (inaudible) neither for their patient that's an opportunity that all can offer to the market, that will not – on the extent on the existing (inaudible) and definitely not the extent of Copaxone. So, now, (inaudible), if you look at the oral and we look at Copaxone, Copaxone can deliver. We are confident that Copaxone will maintain its leadership and actually we will grow Copaxone (inaudible) in 2011.

David Amsilumer

Analyst

Yes, that's helpful. Thank you.

Operator

Operator

Our next question comes from Gilbert Gregg with Bank of America. Please state your question.

Gregg Gilbert

Analyst · Bank of America. Please state your question

Thanks. Good morning, and I think this one is for Bill on the 0.5 ml filing, regardless of whether you will get exclusitivity or not, do you expect the product to have its own orange book entry and separately, is there any intellectual property pending that is specific to that formulation?

Bill Marth

Analyst · Bank of America. Please state your question

Gregg, good morning. Should I call you Gregg or Gilbert?

Gregg Gilbert

Analyst · Bank of America. Please state your question

Your call.

Bill Marth

Analyst · Bank of America. Please state your question

I was kidding. But in any case, it's impossible for us to say at this point in time really whether we'll get the exclusitivity on the SNGA (ph) and Molevon (ph). I would like to believe that we should get that, but the fact of the matter is right now, we will have to wait to see what the FDA's opinion is on this.

Gregg Gilbert

Analyst · Bank of America. Please state your question

Okay. So, whether or not it has its own orange book listing and exclusivity archive to each other, you don't know based on the type of application whether you would get an orange listing that is separate or not? To make sure I'm clear.

Bill Marth

Analyst · Bank of America. Please state your question

Yes, it all depends on the label. So, at this point in time, we're just not sure.

Gregg Gilbert

Analyst · Bank of America. Please state your question

Okay, fair enough. And then the other sort of bigger picture, North America question, I have for you, Bill, is your latest take on the implementation of AMP and the implications for your business and the industry? Last time we check in with you, I think it was still unclear to you what the final deadlines would be and what the effects might be.

Bill Marth

Analyst · Bank of America. Please state your question

Well, we know that the effect actually is – the bill was signed in March 23rd and then it actually goes into effect at the first of next year and it will go back and reference pricing from the fourth quarter of 2010, that's our estimates right now. The actual, what the effective AMP will be in the U.S. is really a very interesting question. We just don't have a good sense for that. One has to speculate that if you're talking about AMP being a weighted average of pricing that's sold using a particular formulation with some exclusions and exclusion (ph), essentially those largest purchasers that are not mail order, being the large chains in the U.S. are likely to be those individuals that drive the AMP. So, those largest chains prices will be largely what make up the weighted average AMP because if you aggregate maybe CBS and a Walgreens, and a Wal-Mart and a Rite Aid together, you got to have what's largely the retail market in the U.S. So, if you think about that you have to wonder about the new dynamics and why does this – why do these large chains want to drive down price, where they did prior. Prior, they always wanted to get advantage over the other chain. Now, when if you drive down price at one particular location, whether it be, whatever city you're located, whichever chain drive down price, there is effect against everyone, so you don't get to capture that benefit. So, it's really a perverse incentive (ph) and this was something when this whole theory of AMP was talked about in Washington, we fought against it because we didn't think it was proper, the proper incentive, but we'll see what happens. It's very much an open question and anyone's guess is this probably valid at this point.

Gregg Gilbert

Analyst · Bank of America. Please state your question

Thanks, Bill. And then lastly on (inaudible), have there been any color to offer on regulatory or legal issues with your G-CSF filing and are you doing anything with EPO in the U.S. Thanks.

Bill Marth

Analyst · Bank of America. Please state your question

Our file so far on the G-CSF is progressing. I don't think we will have anything to add on EPO just yet, but we may have something to talk about a little later, but nothing to talk about right now, and we are proceeding down the path as a VLA at this point in time and not with this ABLA route. Again, why would you take the ABLA route, which is very uncertain as to how to go down that path now and if you look at some of the legal characteristics of how the (inaudible) work, why would I reveal my whole process to the innovators so that they can decide what to sue me on. It just makes a whole lot of sense for us. It's just much simpler for us to go down the path of VLA.

Gregg Gilbert

Analyst · Bank of America. Please state your question

Thanks a lot.

Operator

Operator

Our next question comes from David Buck with Buckingham Research. Please state your question.

David Buck

Analyst · Buckingham Research. Please state your question

Yes. Thanks. Just a couple of quick ones, first, Eyal, can you give a sense of Ratiopharm, how you think they're reacting in terms of performance to the European price cut environment and what the run rate of sales would be from Ratiopharm in 2010. Secondly, for Moshe, can you talk a little bit about, you mentioned clinical trials as your view that you think it's a gold standard for a (inaudible) or equivalent form of Copaxone, how do you expect at this point to get your message across to the FDA. Obviously, the (inaudible) route has been tried and what sort of the next step we should be exciting and dialogue with the agency and finally, can you just talk about what the statuses of Laquinimod and what the filing target (inaudible) into that next.

Eyal Desheh

Chief Financial Officer

Regarding Ratiopharm, I think this is way too early (inaudible) provided educated answer. We will open the boxes once we complete the acquisition. We'll learn and we'll come back to you guys, well-informed and educated. I don't anticipate any material changes, it seems that the business has been running well, but numbers will be provided on a timely basis. It's a private company as you know much less information then we you acquire a public traded company still viewed and (inaudible) foreclosing as the potential competitor. So, the level of detailed information (ph) provided to us was natural limited and we will study and report, but as I said, we don't anticipate surprises. I think they've been dealing – from all we know they've been dealing well with the environment and Germany and the rest of Europe for our (inaudible).

Moshe Manor

Analyst · Buckingham Research. Please state your question

David, as far as Copaxone based on – wants to be (inaudible) and they're now understanding the Copaxone and the (inaudible), we believe that we will continue our interaction and we plan to do to reach the FDA and actually demonstrate to them and convince, we believe that we convinced the FDA that they in age of Copaxone, it's unavoidable that any generic competitor will need to embark on clinical study and even on clear clinical activities as well. As far as Laquinimod, as we reported we have completed the (inaudible) quarterly quote (ph) med and the first study, we've seen the result of the first study in the first quarter of 2010, 2011 (ph) and followed by the result of the second study by the mid of 2011and everything goes as we plan. We immediately plan to submit the file as we have fast track anything in the U.S. We are planning to launch the product by May of 2010 (inaudible).

David Buck

Analyst · Buckingham Research. Please state your question

Just one follow-up, would you anticipate any type of public forms such as an advisory committee on the Copaxone, on the issues that you raised?

Moshe Manor

Analyst · Buckingham Research. Please state your question

That could be one of the scenarios where that can take place. I think that the dialogue with the FDA is ongoing and we believe that based on the recent or publication that on the Copaxone and the mode of fraction (ph), this is the case that the FDA will require clinical challenge from any colon Copaxone.

David Buck

Analyst · Buckingham Research. Please state your question

Thank you.

Operator

Operator

Our next question comes from John Boris with Citi. Please state your question.

John Boris

Analyst · Citi. Please state your question

Thanks for taking the questions. First couple for Eyal and then I have a couple of follow-ups for Bill. First off on the cost to goods, can you just help us understand what the intent of foreign exchange was on COGS within the quarter, then you do provide us with your ATI sales, can you provide us with your global generic and branded sales within the quarter?

Eyal Desheh

Chief Financial Officer

I'm sorry, first of all, on COGS, it was a major (inaudible). In fact, they're going to get improvement in cost that we've seen mostly a matter of called, product mix that we've seen the – what was the second question?

John Boris

Analyst · Citi. Please state your question

You gave us API sales, can you –

Eyal Desheh

Chief Financial Officer

Yes.

John Boris

Analyst · Citi. Please state your question

Can you possibly provide percent –

Eyal Desheh

Chief Financial Officer

Yes.

John Boris

Analyst · Citi. Please state your question

Generic and percent branded sales.

Eyal Desheh

Chief Financial Officer

Yes. The breakout I don't have under my hand. Regarding, API sales, we had a very strong and good quarter on sales of API activity with growth of (inaudible) 23% year-over-year and as you know we stop publishing this individually as a business, say (ph) unity. But around $163 million for the quarter and 23% growth.

John Boris

Analyst · Citi. Please state your question

For Bill, can you just comment on whether you have large quantities available on Lovenox and your capability of being able to supply the market, some (inaudible) checks with – and indicate the mental (ph) might be, somewhat capacity constraint and then second question, just has to do with the office of generic drugs. It seems as though between some patch formulation getting approve, some high profile has sustained the least preparations and then Lovenox approval – are we seeing a pickup at OGD or this just an anomaly? Thanks.

Bill Marth

Analyst · Citi. Please state your question

Thanks for the question, John. As far as launch quantities with respect to an Oxyperone (ph) the answer is yes, we're in good shape. So, we just will need the approval and of course, we comment on that earlier. The second question, your second question was about the OGD and its activity now and the leadership there. I think on that particular question, I do see them getting bolder and making some very interesting calls and I think that this is really a step in the right direction. There's interim leadership right now in the department and we take our hats off to them for proving an Oxyperone (ph) and in proving that they can stand some tough (inaudible). So, we think that's a really a positive thing at this point in time.

Operator

Operator

Thank you. Our next question comes from Mark Goodman with UBS. Please state your question.

Mark Goodman

Analyst · UBS. Please state your question

Yes. First, you keep talking about the U.S. base business being strong. Can you just give us an indication of is this stronger than last quarter is, last quarter stronger than fourth quarter? Is this getting better or is this just continues to be stable and so you can put some color on that and then also Canada. Obviously, we've seen what Canada is going to do to pricing, give us a flavor for how that's going to impact you're business, the business you're about to get from Ratiopharm. Should we be assuming that the Canadian sales are going to be down in 2011 versus 2010?

Shlomo Yanai

President and CEO

Bill?

Bill Marth

Analyst · UBS. Please state your question

Yes, Mark. A couple of points here. The base is strong (ph). We've done a lot of things to improve our base over the last couple of years, whether it's pruning, where we take out some of the less profitable products and sell more of the profitable products. We've seen more impacts around pricing increases, just is lots and lots of different things. Some of the products that have launched, they launched it a little better with pricing than it had historically. Some of these can be retraced to the quality concerns and lots of proactive things going on our base business. So, I think by and large our base business has been strong for the last few quarters and continues to be strong, and really there's not much more to say about it the next. Whether you say there's – is that changing from quarter to quarter. Remember, the way we track our base business, its products that have been in the market for two years, so every quarter an old launched product becomes a base product and of course, that changes your numbers somewhat, but it's been a very strong business. As far as Canada goes, the Canadian business, we continue to believe it's going to be strong out. Obviously, the effects in the various provinces of the changed (inaudible) with respect to Ontario, that's going to have an effect. The idea though, the big change is what happens with the chain or the pharmacy itself. In that particular system where they're lowering the reference price, it's not indifferent by the way to what's happening in other markets. Whether you see the U.S. change in AMP or you see the change in Spain, it's really the government trying to take something out of the channel and what they're doing is lowering price and then you're limiting your backend to the pharmacy themselves. So, net for us is not as huge of a change as one might expect. We certainly believe we'll get some pressure from the chain, in order to give more on the backend. But at this point in time, we don't see a huge change. It may actually be a net positive for the business as it becomes more difficult for some of the smaller companies to manage.

Mark Goodman

Analyst · UBS. Please state your question

So, we should be assuming Canadian sales in 2011 will be up from '10? I mean obviously –

Bill Marth

Analyst · UBS. Please state your question

Obviously, with the addition of the Ratio –

Mark Goodman

Analyst · UBS. Please state your question

Excluding the Ratio pharmacies –

Bill Marth

Analyst · UBS. Please state your question

And again, I can't really comment on that until I actually get my hands on the Ratio business and I'm able to look at –

Mark Goodman

Analyst · UBS. Please state your question

But just on your own base business in Canada, are you expected to be up next year?

Bill Marth

Analyst · UBS. Please state your question

Yes. Our business has been growing and we'll continue to grow.

Mark Goodman

Analyst · UBS. Please state your question

Okay.

Shlomo Yanai

President and CEO

Let me take this opportunity to follow on because I see that the pricing pressure is the time for comment dominator question all over the globe. I think that the results in Europe, 10% growth is actually the best answer to prove the statement that Teva knows how to operate in a price-pressure environment and this is not just a statement for stating the obvious from our point of view, just to say that we know how to leverage our market leadership, how to leverage our scale and how to leverage our largest ever portfolio and our different lines of business, and if you add to that the deep understanding and the know how in different models of businesses, countries and healthcare systems, that's actually give you in a nutshell the answer how we are managing to continue a (inaudible) journey in a pressurized environment, exactly as we did it for many years in the United States. So, we believe that this is one of our unique advantages that make us different from part of our peers that we know how to operate and how to make money and even how, of course, to grow the business, handle different business or market environment.

Operator

Operator

Thank you. Your next question comes from Corey Davis with Jefferies & Company. Please state your question.

Corey Davis

Analyst · Jefferies & Company. Please state your question

Let me just follow on then for just last comment you just made. So, if you're continuing to grow in the face of pricing pressure, I guess the only way to do that would be to gain share and so, (a) do you agree that and (b) since you're the first of the big public companies to report, when the others report are we going to see that perhaps less robust results. I'm not asking you to comment specifically on their results, but if you're gaining share in volume terms, you have to be gaining it from other players. So, is that the right way to think of how you're being so successful when you're up in the face of such pricing pressure?

Shlomo Yanai

President and CEO

First of all, it's a general statement. I would agree with you that market leadership is about getting the market share and we have said it many times in the past that our strategy is to gain more market share. There is only one caveat to your way of reposing the question, I do believe that in certain markets, definitely Europe is a good geography for that we can also see larger pride or actually see more market or potential market, as the European markets, at least some of them, the level of generic penetration is relatively low compared to a market like U.S. or less quality (ph) generic developed countries in Europe. So, there is still more room to grow generics and therefore, we are so optimist on the business in Europe, not only by taking the market share for our competitors, but also by growing the overall market for generics in Europe and some other countries in the world as well.

Corey Davis

Analyst · Jefferies & Company. Please state your question

Okay, great. And for Eyal, did I hear you say that the goal is to take your tax rate down to 12% in 2012?

Eyal Desheh

Chief Financial Officer

No, no. We didn't. I don't recall saying anything of that kind. I said that –

Corey Davis

Analyst · Jefferies & Company. Please state your question

Okay. I'm going to finish (inaudible) –

Eyal Desheh

Chief Financial Officer

In my opening comments, I said that our GAAP tax rate for this year is estimated at 12%, at 15% in a non-GAAP basis and we don't see that just declining in 24 (ph).

Corey Davis

Analyst · Jefferies & Company. Please state your question

Okay.

Eyal Desheh

Chief Financial Officer

Yes.

Corey Davis

Analyst · Jefferies & Company. Please state your question

For Bill, I think I got the message, but I (inaudible) fairly extreme optimism on your own generic Lovenox and can you elaborate even more on maybe that you're interactions with the FDA discussion, is it really nothing more than checking all the boxes that they put out in and their response to the CT (ph) and just finishing up their review of your immunogenicity data that you mentioned?

Bill Marth

Analyst · Jefferies & Company. Please state your question

Yes, Corey. It's hard for me to say much more. We have dialogue with the agency. We believe – first of all, we've looked at the citizen's petition and we believe that we meet all the criteria on the citizen's petition. Our dialogue with the agency says that our review is going nicely and we're just waiting for a couple – we're just waiting for an answer. So, we feel that we're in a good position, but again it's up to the FDA to decide, not me.

Corey Davis

Analyst · Jefferies & Company. Please state your question

Last one, Eyal, can you just run down the list of countries in Europe or (inaudible) when the royalty rates flip from the rough 50% on Copaxone down to the 6% as we go through 2012.

Eyal Desheh

Chief Financial Officer

Well, we could take your thought offline and I don't think that we – if you want to be precise, you should have the list and (inaudible). Let's take this offline.

Corey Davis

Analyst · Jefferies & Company. Please state your question

Fair enough, thanks.

Shlomo Yanai

President and CEO

Just one more.

Eyal Desheh

Chief Financial Officer

Last one.

Shlomo Yanai

President and CEO

Just before the next question, just one more follow-on on the Copaxone as it become the major subject in this conference call. To add-on comments, to add to what we all of the answer in this respect, one is just to remind you that about third of our Copaxone sales is in a non-U.S. market, which the whole discussion that we are involving is less relevant for this 1 billion growing business. The second comment is regarding the oral therapies as kind of a food for thought, I would like to take the subway (ph) case study for you and you can look in the retrospective, which it reminds a little bit the next oral therapies and you see the chronic market share and the currency (ph) developing the last six years, it can give you the time of a good hands on where we see this all is going to be into coming in all the coming years.

Operator

Operator

Thank you. Our final question comes from Milan Parati (ph) with Credit Agricole. Please state your question.

David Maris

Analyst

Hi. It's David Maris. On Copaxone, can you just update us again on the timing of the trial and the decision and walk us through your timing assumptions. You mentioned it earlier.

Shlomo Yanai

President and CEO

(Inaudible)?

Eyal Desheh

Chief Financial Officer

The GALA (ph). Are you referring to GALA (ph) sign?

Shlomo Yanai

President and CEO

No, no.

David Maris

Analyst

The legal trial.

Eyal Desheh

Chief Financial Officer

The legal (inaudible).

Bill Marth

Analyst · Barclays Capital. Please state your question

I'll take that one.

Shlomo Yanai

President and CEO

Bill?

Bill Marth

Analyst · Barclays Capital. Please state your question

Yes. Right now, David, as you know we're waiting for our claims construction, there's no trial date set. So, whether the claims construction, whether the mile in that go date (ph) that gets rolled into that claims construction, it's very difficult to say at this point in time. Judge Jones is a fairly busy judge and so, we'll have to wait and see. We just don't know the timing of the claims construction. Once we get that of course, then we can get on to scheduling the trial and so on and so forth.

David Maris

Analyst

Hey, but, Bill based on your best guesstimate, would you assume that it starts in the fall or early winter to get the result sometime mid-year next year?

Bill Marth

Analyst · Barclays Capital. Please state your question

No, I think that that's very optimistic. I'd say much farther out than that.

David Maris

Analyst

Great. Thank you very much.

Shlomo Yanai

President and CEO

Thank you all very much for joining us today. As you have heard we had a great quarter and we are very enthusiastic about the rest of 2010. So, thank you again and you have a good day.

Operator

Operator

Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you all for your participation.