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Teva Pharmaceutical Industries Limited (NYSE:TEVA)

Q1 2010 Earnings Call Transcript

May 4, 2010 9:00 am ET

Executives

Elana Holzman – IR

Shlomo Yanai – President and CEO

Eyal Desheh – CFO

Bill Marth – President and CEO, Teva North America

Moshe Manor – Group VP, Global Branded Products

Gerard Van Odijk – President and CEO, Teva Europe

Analysts

Randall Stanicky – Goldman Sachs

Gregg Gilbert – Banc of America/Merrill Lynch

Richard Silver – Barclays Capital

Ken Cacciatore – Cowen & Co.

Chris Schott – JP Morgan

Ronny Gal – Bernstein

David Buck – Buckingham Research Group

Mark Goodman – UBS

John Boris – Citigroup

David Maris – CLSA

Elliot Wilbur – Needham & Co.

Operator

Greetings and welcome to the Teva Pharmaceutical Industries Ltd. first quarter 2010 results conference call. At this time all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. (Operator instructions)

It is now my pleasure to introduce your host, Ms. Elana Holzman. Thank you Ms. Holzman, you may begin.

Elana Holzman

Thank you, Diego. Good morning and good afternoon everyone. Welcome to Teva’s first quarter 2010 earnings call. We hope you’ve 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; Moshe Manor, Group Vice President, Global Branded Products; and Gerard Van Odijk, President and CEO of Teva Europe.

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 a question-and-answer period.

Before we proceed with 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

Thank you, Elana. Welcome everyone, and thank you for joining us today as we review Teva’s results for the first quarter of 2010. I'm pleased to report that the year is off to a great start for Teva.

Next sales in Q1 reached $3.7 billion with gross margins of 58.4%, and I would like to point out that this 16% growth over the first quarter of 2009 represents pure organic growth. Once again we passed the $1 billion mark in quarterly operating profit, a 21% increase over Q1 ’09.

Our quarterly cash flow from operations was $886 million with net income in the quarter reaching $830 million, a 31% increase over Q1 ‘09. And all of this ultimately brought us to EPS of $0.91.

Teva growth in the first quarter in both the top and bottom line was driven by contributions from across our diverse businesses and geographies, demonstrating once again the great value we derive from our balanced business model.

In North America, we had an excellent quarter with record sales of $2.3 billion, up 20% over the first quarter of 2009. We had record-breaking sales of more than $1.3 million in US generics, up 28% over the first quarter of 2009, and strong sales of our branded products.

We achieved these results with only one major launch during the quarter, that of generic Mirapex. We are pleased with the excellent performance of our base portfolio, which not only grew very nicely but also improved its profitability. In Canada, sales of generics grew 32% over Q1 ’09 from the strength of two first to market launches.

2010 is also off to a solid start to our European business, where sales reached $812 million, representing 10% growth over the first quarter of ’09. Despite increased competition, we have maintained or improved our market share. Sales were especially strong in Italy, in Poland, and the central and eastern European countries, where we are now enjoying the full benefit of the successful integration of Pleva into Teva.

Of course, the major event in Europe this past quarter was our agreement to acquire ratiopharm, which will make Teva the leading generic pharmaceutical company in Europe, a subject I will elaborate on a bit more later.

Q1 was a very good quarter for Teva’s international business. Sales reached $532 million, up 10% over Q1 09. We enjoyed especially strong sales in Russia, one of the fastest growing markets where we continue to strengthen our market position, as well as an Israel, Chile, and Argentina.

Teva’s innovative business continued to grow in Q1, once again achieving record breaking sales of Copaxone, the world's leading therapy for the treatment of multiple sclerosis. Copaxone global market share reached 30% in revenue terms. Global in-market sales of Copaxone grew by 28% over the first quarter of 2009 to reach $796 million.

Outside the US sales of Copaxone hit a new high of $283 million. In the US, in market sales for the first time crossed the $0.5 billion mark. And IMS reported that Copaxone TRx [ph] reached a record of 39.2% in March. This over 1 million patient-years of experience, Copaxone’s track record for safety and efficacy is unmatched, and we are continuously researching new ways to enhancing the experience of patients of Copaxone, just as we brought pre-filled syringes and the 29-guage to market, we have now developed a low-volume 25 mg injection of Copaxone at the currently approved dose.

And now I would like to share with you great news. Based on the positive results of the strong study to evaluate this new formulation, we submitted an sNDA, which was yesterday accepted for filing by the FDA.

I'm also pleased to report that patient enrolment for GALA [ph], our 40 mg reduced frequency trial begins next month. And of course, we are also very enthusiastic about laquinimod, now in phase III trials with results due in 2011.

Let us turn now to Azilect, which had an excellent first quarter. Global in market sales grew 30% for Q1 09, led by strong sales in major European markets and the US. In the US, Azilect has benefited from newly revised prescribing information, reinforcing its selectivity (inaudible) fewer food and medication restrictions, which was previously a barrier to some for prescribing.

Turning now to our global respiratory business, where we had another piece of great news. I'm pleased to report that we have successfully completed our phase III study of Beclomethasone dipropionate HFA for the treatment of seasonal allergic rhinitis, the most common allergic disease both in the US and globally. We will be initiating the remaining phase III trial for allergic rhinitis in the second quarter. We are on track to submit our NDA in early 2011, and anticipate having the product on the market in 2012.

By the way this is a $1.9 billion market.

During Q1, sales of respiratory products reached $193 million, up 4% over Q1 09. The increase was driven primarily by sales of ProAir and Qvar in the US. ProAir HFA remains the leading short-acting beta of agonist with over 50% share of the market. And Qvar continues to grow. It is now the solid number two in the inhaled steroid segment with 19% market share in NRx.

Turning to our women health business, sales during the first quarter were $79 million, down 19% over Q1 09. This is largely due to weak sales of Plan B One-Step, however, I am pleased to report that the measures we put in place at the end of 2009 to recapture our share of the emergency contraceptive market have begun to bear fruit, and we look forward to continued improvement and growth in 2010.

Turning to other women health products, we continue to experience double-digit growth in key franchises during the first quarter, led by the Seasonique franchise, which grew by 10% over Q1 09, and ParaGard, which grew by 17% over Q1 09. Seasonique continues to reach all-time highs in weekly prescriptions, and we're pleased with the Nevada’s Court ruling, which found our Seasonique patent to be valid and enforceable.

As you know, 2010 was also off to an exciting start for Teva strategically. In January, we presented our long-term strategic plan to reach revenues of $31 billion and net profit of $6.8 billion by 2015. Two months later, we took the first major step in delivering on this ambitious plan with the announcement of our agreement to acquire ratiopharm. This acquisition would enable Teva to extend our global leadership to Europe, providing us a leading presence in all key European markets. It will also provide us with significant additional capability in biosimilars, an important future growth engine for us.

Teva has a long track record of successfully integrating companies, something we (inaudible) once again in the integration of Barr, and in our ability to deliver significantly low synergies from the acquisition than we had originally anticipated. We are very much looking forward to working together with the ratiopharm team to implement the integration process as soon as the (inaudible) closes. And I am confident that the integration process will be a smooth and a successful one.

I like to take a moment to provide you with an update on pantoprazole. As you know, on April 23 following a jury trial, in the patent case, the jury upholds the pantoprazole patent as valid. However, we still strongly believe in the merit of our argument, and on May 6 we will meet with the court to discuss the post trial briefing schedule on the many issues that we believe remain for the judge to decide.

It is appropriate that these are called at-risk launches, as there is obviously always some risk involved, but we have developed highly effective tools and capability to analyze and mitigate the risk before we bring the end product to market. This is an integral part of our business model, and we will continue to launch new products based on an analysis of all relevant factors, including the strength of our patent challenge.

Before I turn the call over to Eyal, I want to reiterate our guidance for the year. Of approximately $16 billion in sales and non-GAAP EPS of $4.40 to $4.50, we had an excellent start to the year, and I would like to remind everyone that we expect the second of the year, which will be kicking off on July 3, with our exclusive launch of generic Effexor [ph] to be significantly stronger than the first half.

I would like to clarify that when we provided guidance to 2010 this past February, we had already anticipated and factored in the impact of health care legislation in the US both for our generic and branded business. So the impact, which included $20 million in the first quarter have, has no bearing on our 2010 guidance.

So looking ahead, we believe that the benefit of this complex multifaceted legislation will far outweigh cost [ph] for Teva, and we expect the legislation to have a positive impact to us. However, we have not factored this positive impact into our numbers as much of the implementation and timing of the health care plan is yet to be determined.

And one last clarification, our 2010 guidance does not include ratiopharm as we expect the closing to occur towards the end of the year. In the event that the transaction should close earlier, we will of course provide you with [ph] update guidance.

As you have heard, 2010 is off to a great start, and when I think about the strength of our generic business, continued growth in Copaxone, the good news about low-dose coupled with strong respiratory franchise, growing women's health business, and the addition of ratiopharm to our family, I believe we are uniquely positioned to achieve our 2010 goals, as well as laying the foundation for our $31 billion sales target for 2015.

And now, let us turn the call over to Eyal for a more detailed financial update. Eyal?

Eyal Desheh

Thank you very much 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 this morning a good first quarter and a strong beginning for 2010. It is important to note that we reported record GAAP results this quarter in terms of operating profit, net income and earnings per share.

As Shlomo already discussed, our strongest performance for the quarter were in the US, particularly for the US generic business, as well as in Canada, Russia, Israel and Poland.

We had record Copaxone sales with very strong sales outside the US, and record sales for Azilect.

Cash flow from operation and free cash flow delivered strong growth compared to Q1 last year. Before we delve into the numbers, I would like to touch on 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 purchased intangible assets amounting to $130 million, of which $122 million are included in COGS, and the remaining $8 million in sales and marketing expenses; legal settlements of $17 million; acquisition and restructuring expenses of $17 million related primarily to the acquisition of ratiopharm, as we now have to expense it through our P&L; $4 million purchase of R&D in process; and in addition the related tax benefits of $51 million.

You should note that the item excluded in arriving to our non-GAAP results for the first quarter of 2009 are not identical to those in the current quarter. Most notably, Q1 2009 included an inventory step up in connection with the Barr acquisition, and no amortization of purchased intangible assets. Please review our press release and related tables for the complete information.

As indicated in the past, we present non-GAAP figures to show how we, the management team and our Board, look at our financial results. Foreign currencies continue to play a significant role in our results. As you all know, the US dollar has been strengthening against other currencies, primarily the euro and the British pound, during the course of the last six months. Nevertheless, when comparing first-quarter average rates in 2010 versus 2009, the US dollar declined in value.

Therefore in the first quarter, foreign currency differences contributed approximately $98 million to sales as compared to Q1 2009. The impact on sales, resulted primarily from the decline in the value of the US dollar relative to certain other currencies, primarily the euro, the Canadian dollar, the Hungarian forint, the Russian ruble, the Polish złoty, and the British Pound. However, the continued strengthening of the US dollar from Q4 2009 to Q1 2010 had a negative impact on sales of $69 million in Q1 compared to Q4 last year. Nonetheless, the impact from operating profits was insignificant.

Teva’s diverse geographical presence continues to provide us with a good natural hedge that mitigates much of the risk involved in currency fluctuations and minimizes the impact on our bottom line.

Looking at consolidated results for Q1, sales totaled $3.7 billion, an increase of 16% compared to Q1 last year. North America, which grew 20% experienced growth in its major businesses, generic, Copaxone, Azilect and respiratory. Europe grew 10% in US dollars and 1% in local currency terms. Turning to international markets grew 10% in US dollars and 7% in local currency terms.

Non-GAAP operating income reached $1 million, up 21% compared to Q1 2009, benefiting from strong gross margins and tight expense control. Non-GAAP net income reached $830 million, up 31% compared to Q1 2009, and non-GAAP fully diluted earnings per share were $0.91, up 28% compared to Q1 of 2009. To housekeeping points related to earnings per share calculation. The rated [ph] average share count for fully diluted non-GAAP EPS was 921 million shares, and the add-back for the non-GAAP calculation was $11 million.

Now let’s discuss profit margins and operating expenses. Non-GAAP gross profit margin, which excludes amortization of our purchased intangible assets was 58.4% in the reported quarter, similar to the first quarter last year. Gross margin continued to benefit from contribution to sales of our innovative and branded franchises, contributions from new and recently launched generic products in the US market, as well as improved gross margin of US generic base business.

Non-GAAP operating margin reached 27.4%, up from 26.2% in the comparable quarter last year. Similar to previous quarters the improvement in operating margins were driven primarily from strong gross margins, lower G&A, and net R&D as a percentage of sales, partially offset by higher royalty payments, which are reflected in sales and marketing expenses.

Net R&D expenses reached $207 million or 5.7% of sales. Gross R&D before reimbursement from third parties for certain R&D expenses was $217 million or 5.9% of sales. We remain committed to our 2010 R&D plan, and the low R&D expenses in Q1 reflect timing of certain expenses. For the full year, we expect net R&D expenses to be between 6% and 6.5% of net sales as we guided last quarter.

Sales and marketing expenses, excluding amortization of purchased intangible assets totaled $744 million in the quarter or 20.4% of sales compared to 18.9% of sales in Q1 2009. These higher sales and marketing expenses are the results of two main factors, higher royalty payment in connection with new and recently launched generic products in the US, and higher payments to Sanofi-Aventis in connection with higher Copaxone sales in the US. Let me remind you that this is the last quarter in which we paid Sanofi-Aventis of in market sales in the US.

Total G&A expenses this quarter were $182 million or 5% of sales compared with 6.2% of sales in Q1 last year. The Barr acquisition synergies contributed to this decline in G&A expenses. We recorded $27 million of net financial expenses on a GAAP basis in Q1 compared to $63 million of GAAP financial expenses in the comparable quarter in 2009. The decrease in financial expenses resulted primarily from low level of debt, which consistently reduces the acquisition of Barr compared to the first quarter of 2009, as well as lower interest rates and lower cost of hedging activity.

In anticipation of closing the ratiopharm acquisition later this year, we accumulated the cash generated during this quarter, and did not apply most of it towards debt repayments. Furthermore, we began to acquire the (inaudible) required for the acquisition consideration, and entered into certain hedging contracts (inaudible) of the strengthening of the euro. This may result in greater final income or expense in the second quarter, which we will adjust in our non-GAAP results.

The tax rate provided for the first quarter was 14% of pre-tax non-GAAP income. This represents our current estimate of the annual tax rate for 2010 compared to 16% of pre-tax non-GAAP income for all of 2009. The estimated tax rate for 2010 GAAP results is 11%.

Now let’s have a look at our cash flow. Cash generated from operations totaled $886 million, up 21% compared to Q1 2009. Our free cash flow, excluding net capital expenditure of $164 million and cash dividends of $165 million amounted to $557 million in free cash flow. The strong cash flow was driven primarily by strong collection in the quarter.

On March 31st, cash and marketable securities totaled $3 billion, up approximately $550 million from December 31, 2009. Our total outstanding loans, bonds and convertible debentures stood at $5.4 billion, down from $5.6 billion as of the end of December. During the quarter, we reduced our debt by approximately $175 million by repaying some debt and through the continued conversion of senior convertible debentures. As a result, our financial leverage as of March 31, 2010, was 22% down 1% from year end and down 12% from March last year.

Moody’s raised Teva rating to A3 in January, and Standard & Poor's followed with raising our rating from BBB+ to A- on March 19, immediately following the announcement on the acquisition of ratiopharm. Moody’s also affirmed its A3 rating after the ratiopharm announcement. Moody’s upgrade had an immediate positive impact on our finance expenses as the interest rates charged on the floating rate debt assumed in the Barr acquisition was cut by 25 basis points.

Days sales outstanding, DSO, amounted to 53 days this quarter compared to 51 days in Q1 last year. We calculate the DSO after netting out from the receivables the sales reserves and allowances. Inventory days stood at 183 days down from 191 days in Q1 2009. Capital expenditures reached $164 million this quarter similar compared to $136 million in Q1 2009.

As for dividends, yesterday Teva’s Board approved a quarterly dividend amounting to approximately $175 million. On a per share basis our dividend, which is declared in Israeli shekel is 0.7 shekels per share. Based on yesterday rate of exchange of the shekel to the US dollar, this translates into approximately $0.19 per share.

I thank you all for your time and attention today, now we will be glad to take your questions.

Question-and-Answer Session

Operator

(Operator instructions) Our first question comes from Randall Stanicky with Goldman Sachs. Please state your question.

Randall Stanicky - Goldman Sachs

Great, thanks guys. I just wanted to follow-up on the strength of the US business and specifically as your comment on the improved base business possibility, can you just maybe talk about what's driving that and then are you seeing some of the delays that the Fed [ph] and your peers have pointed to?

Shlomo Yanai

Bill, will you take it.

Bill Marth

Good morning Randall, and thanks for the question. A good couple of points, as far as let us take the delays, we haven't really seen a delay on first to market products. You know, we have been saying this for a long time, unless there is something new in the labeling or some other mitigating factors. So we really haven't seen a delay with first to market, we think the FDA is doing an excellent job there. There are complex products (inaudible), but that you understand. So we’re not seeing that. With maybe the you know, 10 product, you know, the 10th or the 15th atenolol, you know, obviously those are slow.

We think the FDA has done a good job of replacing them versus (inaudible). With respect to our base business, we've got a variety of lifecycle management initiatives going on. Lifecycle management initiatives aren't only for branded products. We are doing things to lower our cost, lower our API cost, various ways that we look to sell more of the products with better margins, and we eliminate products pulling products from our portfolio, such as sertraline and a few others where you've seen some prescription loss. We saw a prescription gain you know, this quarter but not as much as we've had in the past and that was due to very purpose of pruning of our portfolio around profitability.

Randall Stanicky - Goldman Sachs

And then Bill, I think you had alluded to it, but I know we've been talking a lot about your Lovenox and the timing, and you obviously had, you guys have had some discussions with the FDA, is there anything that we should be thinking of differently in terms of that product and can we still expect that you know, to come up this year in terms of the way you're viewing it?

Bill Marth

Yes, our view hasn't changed. We are still very hopeful for something yet this year and, you know, we're prepared for it. So let's hope for the best.

Randall Stanicky - Goldman Sachs

Great, thanks guys.

Operator

Thank you. Our next question comes from Gregg Gilbert with Banc of America/Merrill Lynch. Please state your question.

Gregg Gilbert - Banc of America/Merrill Lynch

Thank you. First for Bill, should we continue -- expect continued shipments of pantoprazole as normal, and on the new Copaxone what's the action date for that. Can you provide any color on the commercial strategy there, and whether we should view that as a switch or a transition?

Bill Marth

Good morning Gregg. The pantoprazole at this point in time we're not shipping further product and in abundance of caution. The second part was -- what was --

Gregg Gilbert - Banc of America/Merrill Lynch

The action date on the new Copaxone and any commercial color you can plan, switch versus transition or anything else you could offer on that strategy. It is not so far way anymore?

Bill Marth

Well, on the new Copaxone our action date would now be out of December. So we would be looking for in market hopefully with, you know, all the right caveats for caution, we would hope to be in the market in the first quarter, early 2011.

Gregg Gilbert - Banc of America/Merrill Lynch

And can you share anything strategically whether it will replace Copaxone in its entirety?

Bill Marth

No.

Shlomo Yanai

We cannot -- we won't share.

Gregg Gilbert - Banc of America/Merrill Lynch

Okay, thank you. So question for Gerard, in conjunction with the ratiopharm deal, you indicated that the tender portion of the market in Germany is about 25%. You said it's the time you thought that would shrink rather than go and I think some other companies have been saying other things. So can you just update us on your thinking with that, and lastly for Shlomo, any update on the Irvine [ph] quality issues and are you confident that you know, that's behind you as a company. Thank you.

Gerard Van Odijk

This is Gerard. Thanks Gregg. Good morning. Well, first of all let me say that what we see in the German market is, of course still subject to what the government is currently contemplating, but what we’ve seen so far, we don't expect our views to change dramatically. First of all, as I know, the pure tender, one product wins all kind of the marketplace. It's only a quarter of the total market in terms of value, and I think it won't move far away from that.

More importantly, to the other part of the market is about 75%. It is quite a complex bit of business. You see, on one hand you see the hospital business, you see OTC products, and new generic launches that are not subject to that. They will become subject, maybe in the future but they’re not today and there are no clear plans to do so. Two, we see that a lot of the insurers don't like the one product takes all kind of business. They have portfolio agreements or they have three, four, five players who win the business, which is a totally different concept and there you see different price developments as well, and therefore that businesses is also not as dramatic as the pure tender business.

And thirdly, we see that pharmacists and doctors still have a substitution freedom. They claim it or they get it, and doctors can tick a box on the prescription by which they basically prevent any substitution to happen and on top of that you have private insurers that still have a large chunk of the business in Germany that are not tendering at all. So you see that besides the tender business of about 25%, you see 75% is the sort of a mixture of different type of policies.

And the problem there is that it won't be easy for anybody in the German market to attack that chunk of business with one match. You will have to have all sorts of different policy changes to take them one by one. So that's why we're quite confident that the marketplace in Germany will be having much more profile of the branded generics side of the market than a pure generic generics market.

Gregg Gilbert - Banc of America/Merrill Lynch

Thank you.

Shlomo Yanai

What was your last question Gregg.

Gregg Gilbert - Banc of America/Merrill Lynch

The FDA issues in the Irvine facility, have they been addressed, are you confident that those issues are behind the company?

Shlomo Yanai

First of all, let me say on a broader scope that quality for Teva is the first priority, and that we are seeing the raising the bar by the FDA is for Teva, will Teva see it as something which is good not only for patients, but also for Teva as well. Having said that we are working with the FDA to fix the problems that we have in Irvine, and I believe that we will be over with that hopefully very soon. Right now I cannot give you a specific date for that, but I can assure you that we are doing utmost effort to get it done as soon as we can and to raise the bar for quality in Teva as much as we can.

Gregg Gilbert - Banc of America/Merrill Lynch

Thank you.

Shlomo Yanai

And Bill, would you like to add.

Bill Marth

Gregg, yes. Gregg, if I could just add to that. I just want to let you know that you know, we responded to the warning letter in January as was appropriate, and the FDA right now is performing a follow up inspection of the facility. So, you know, until they close out we really can't comment any further on that, but as Shlomo said quality is an absolute concern. We are working with the agency and we support the agency completely on their effort in order to make sure that all facilities are in compliance.

Gregg Gilbert - Banc of America/Merrill Lynch

Thank you gentlemen.

Operator

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

Richard Silver - Barclays Capital

Yes, a couple. First for Gerard, well, actually Gerard and anyone else on Europe and international, for year-over-year growth in the quarter was approximately 10% for both Europe and international, and at least relative to our estimate seemed a little bit lower than we would have expected. Can you comment on how we should think about growth going forward whether this, you know, this is a reasonable run rate or whether you think that there are, you know, where things may be in the quarter that might have led to a sort of below average growth rate, and just a little bit more detail that what you provided in the prepared remarks on the drivers and the outlook aside from your commentary on Germany. And I do have a follow-up. Thank you.

Shlomo Yanai

Gerard, you take Europe, and I will follow with international.

Gerard Van Odijk

Very good. Thank you very much Richard. Good morning.

Richard Silver - Barclays Capital

Good morning.

Gerard Van Odijk

Good morning. Well, you know, Europe is not one market. It's a heterogeneous bunch of geographies. There are 400 million people with a sentiment for high quality healthcare, and therefore growth for generics, but there are months that one market is doing better than the other. Overall, one could say that the market that has been slightly less attractive over the last quarter has been the UK. We've seen that the impact on pricing and competition has been quite aggressive, and as you know we are a leader in the UK market. We are almost twice as big as number two and then you've got long time nothing and then you've got few other players.

That probably means that we focused on our leadership rather than a profitability of that. So we didn't go and bid for all sorts of deals that were not worthwhile going after, and that meant that, and that is one of the reasons by the way was that the sterling has been as it has been. Therefore, our cost of goods had been influenced a bit. So you better do it like that and continue to keep your market leadership on a profitable base.

So that's on the UK. So all in all, with that policy despite us holding back we grew our share a little bit in the UK over that period. So, yes, it's not a great number, but that explains. If you would take out the UK from our retail business, our overall growth in Europe would have been 10%. If you would look at our hospital specialty business, it would be over 20%.

So I think beyond the line currents of our business in Europe is very healthy. We did excellent business in Italy and Poland. In Central Eastern Europe we benefited also a lot from the Pleva integration and we're really reaping the benefits of that. And you know, we are also very enthusiastic about the deal that was signed in Germany, because it will give us an even more balanced business across Europe. So all in all I think the indicators are good. We had a bit of an issue in one market, but that is basically telling a story for Europe.

Shlomo Yanai

Good morning Richard.

Richard Silver - Barclays Capital

Good morning.

Shlomo Yanai

As per the international business, I would like to say first of all that no doubt that this is not the trend. The international business for Teva is a growth driver, and I believe it will be so in the coming quarters, in the coming years as well. Actually, if you take the results, which are a 10% growth on the first quarter, from pharmacist’s point of view it's 14%. The reason that is 10% is due to the weak sales of API that we are allocating it to the international or the relevant path is allocated to the international, which is mainly the weak sales of sales policies of API, and it's too early to say whether it's a trend or not regarding the API. So to make it short this is not a trend and international sales of Teva will be growing in the coming years in the third quarter as well.

Richard Silver - Barclays Capital

So just to recap both of your comments, are you saying that the growth rate we saw in Europe and the growth rate international is expected to accelerate on a year-over-year basis on the coming quarters. Can you say that?

Shlomo Yanai

I can say so for the international. As for Europe, I would like to take a more cautious approach as we first have to better understand the impact of the current economic turbulence in Europe. I don't think it would make a big difference, but just to be on the safe side, let's see during the coming quarter what is the impact there, but as Gerard well stated it, (inaudible) you have to understand that this is a great region or a great potential growth for Teva as there are 400 million inhabitants that's exactly Gerard said, that are wealthy, they are looking for healthcare and they’re suffering from a booming health-care budget. So whether it will take a few more quarters, nevertheless I'm sure that Europe is a great potential source for growth.

Richard Silver - Barclays Capital

And just one for Eyal on the R&D spending, you know, I appreciate there is a -- as you pointed out a timing issue. That said, growing from 5% of sales, which on a sales number that's supposed to be lower than the sales in the coming quarters, and then still coming out with an average of 6% to 6.5% is a pretty sharp step up. Can you provide some detail as to what it is that's going to drive that number or do you think that maybe it's actually at the lower end of that range of 66.5% if you can give us a little bit more color there? Thank you.

Eyal Desheh

Thanks Rich. I will start with D&O, no, we are not targeting the lower end of that range. We're targeting the range and it depends on a lot of R&D activity that sometimes are impacted by timing issues. I mean sense has to right for the next phases, and sometime you move into that and spend a lot of money in one quarter. So as we look at our plan and an overall budget for the year was approximately $1 billion, and we have all the plans in place to spend that money.

And we believe that we will do it in a timely manner. We also looked at and analyzed it, not just the expenses but the activities of R&D this quarter, and all our plans are in place for submissions and other R&D fruits [ph] that result from all these activities. So, yes, the number will grow up and you know that in R&D all the non-people based part, which is almost a half can be very, very quickly accelerated when the time comes.

Richard Silver - Barclays Capital

Just one last one on low volume Copaxone, even though you're not sharing your strategy, can you just I guess perhaps reiterate or add to comments before on disclosure of that date. I think before you said it would be likely or might be possible in a peer-reviewed publication as opposed to maybe a medical meaning, but I think you may be more recently said there is a possibility of the data being disclosed at a medical meeting before the end of the year. So can you give us some sense of when we might actually see that data in a public forum other than just a press release.

Shlomo Yanai

Moshe, would you like to take this one?

Moshe Manor

Yes. Thank you Rich. We are going to publish the data actually in May or June timeframe in the MS Congress. As you know, the data of this study was about looking at the low volume versus the product in the market (inaudible) looking at the pain and pain associated with the injection, and we are pleased the data and we're going to show the data and as Bill mentioned by the end of the year, we heard from the FDA and if everything goes as we planned we plan to submit that in the beginning of 2011.

Richard Silver - Barclays Capital

And what was it you said, you said MS Congress?

Moshe Manor

Yes.

Richard Silver - Barclays Capital

And when is that again.

Moshe Manor

In May -- in June. That's June. The MS Congress in June. We’re going to publish the data.

Richard Silver - Barclays Capital

Okay, thank you.

Operator

(Operator instructions) Our next question comes from Ken Cacciatore with Cowen & Co. Please state your question.

Ken Cacciatore – Cowen & Co.

Thanks. Good morning guys. You know, Bill I was wondering if you could help us and maybe if you want to speak specific to Protonix, speak a bit hypothetically about how you do manage risk at an at-risk launch in terms of maybe pricing your kind of tactics you take in terms of shipping in amounts and maybe you could speak to is the insurance on a per product basis or is this general portfolio products or do you actually go per product in terms of how you get insurance, and then I have a follow up question on Lovenox as well.

Bill Marth

Hi Ken, thanks for the question and good morning to you. Well, first of all I think it's a bit premature to be speaking about insurance, as we think that there is quite a ways for us to go yet on Protonix. As I've said earlier we're not shipping at this point in time in abundance of caution, but you know, that's where we have to leave that right now.

With respect to when we launch at-risk, I think Shlomo had said it well that you know, that Protonix although at this point is disappointing. We hope to turn that around. This isn't going to affect the way Teva acts in the marketplace. We take risks with a great deal of concern and consideration, before we launch and we will continue to do that. I don't think you'll see that practices of Teva change at all. So, with respect to Protonix I really can't say a whole lot more than that.

Ken Cacciatore – Cowen & Co.

Okay. On Lovenox and I'm going to try to link two things that are probably completely separate, but you just had a meeting, a bioequivalency meeting on what is considered probably more simple products so their deliveries are a little bit different. So Concerta was discussed and the agency has been chewing on this for about six years, but yet we're still optimistic about Lovenox, a much more complex product, understanding that there are a lot of different issues. Can you help us square these things. You’re continuing to say you’re confident in Lovenox. It's very complex. So maybe talk about the interaction with the agency and square the agency’s inability to approve what could be considered more simple product like Concerta and Adderall XR, and help us try to understand you know, why you think Lovenox could come soon or should we maybe start anticipating this is a bit of a delay?

Shlomo Yanai

Well, I think the first thing you have to think about here is those are much different issues and you know, we look at Concerta where there is absolutely no action with the FDA, between us and the FDA or between our products with the FDA on their product actually being an impact product. As opposed to you know, Lovenox or enoxaparin, where we're getting continuous dialogue as the file progresses and the questions are very specific and very narrow and they are pretty minor. The types of things we see with a normal review.

So those things lead us to believe that we're still down the right path with enoxaparin and I think it is extremely unlikely that after six years in the agency, they're going to come back to us and ask for something as elaborate as a clinical study, and I say that because that's probably your next question. We just don't believe that that's going to happen. Again you know, all the questioning we get from the FDA leads us to be fairly confident that this will come. I will remind you I've made no predictions on timing. I think others have. We're just hopeful that it comes soon as we see the questioning. It just lends us to believe that it is that we're far down the path.

Ken Cacciatore – Cowen & Co.

Okay, thank you very much.

Operator

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

Chris Schott - JP Morgan

Great. Just first question is following up on the US-based business. Can you just elaborate a little bit more in what you're assuming in terms of kind of volume and price dynamics when we see some of your competitors who are having some issues return to the market? What I am asking here is do you feel that to help your environment you're currently experiencing it sustainable longer-term, and then a second question on respiratory growth in the quarter, was it a bit lower than we've seen recently. Is it just an issue of seasonal timing or is it just something else we should be watching there? Thanks.

Bill Marth

Chris, this is Bill Marth, and I'll answer the second one first. The issue there was respiratory. It is just you know, it is seasonal. We've seen this before. It's just a seasonal issue. We are very happy with ProAir, and you know, it is over 50 share and you know, I would remind people by the way that when we launched ProAir as a brand and it is a brand that we had always guided to about a 45 and 50 share, and we had achieved higher than that, and of course we need to balance managed care payments and profitability and we're managing both our price and our volume. So we are keeping it we think in the right place, and we're very pleased of course with the growth in Qvar, which has done excellent over the last year or so. So we're pretty enthused about the respiratory business.

The first part of your question is where we see some of the competitors who may come back. I assume you allude to the (inaudible) of the world, and, you know, we wish them well and we're sure that at some point in time they would come back to the market, but as we wish them well, we also you know, we will compete, and we will compete effectively with those companies, as well as we believe our partners who we came to the rescue and helped, and did many things turning our plans around in order to supply their needs in their time of need, will return the favor to us with respect to keeping us in these markets. So we don't really think we have, I don't think there's going to be rush to switch to these companies, as soon as they come back to the market. We -- our conversations with our trading partners don't show that to be a very likely event.

Chris Schott - JP Morgan

Thanks very much.

Operator

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

Ronny Gal - Bernstein

Good morning. Thank you for taking my questions. I have two. First, just looking at the biosimilar, it essentially applies to all products, particularly either NDAs or BOA [ph], and I was wondering if either you or Sanofi for that purpose are likely to raise that issue with the FDA and ask the FDA to regulate Copaxone as a biosimilar to regular Copaxone generic, essentially a biosimilar. Second question is, can you just take us a little bit to the branded pipeline, what products apparently potentially could be approved by year-end 2012.

Shlomo Yanai

(inaudible).

Bill Marth

Yes, on the Copaxone line, your question is, you know, why are we essentially petitioning the FDA to call Copaxone or to put it in the same area as a -- in the same realm as a biosimilar, and I just really can't comment on what may or may not be part of a future citizen petition. So we really you know, don't want to say much more on that at this point in time. And second question…

Ronny Gal - Bernstein

Second question was around the branded pipeline. I know you got incremental products coming somewhere around the end of this year, product for PDUFA by the end of this year, but I was wondering what other products you think you might be able to get to the market on the branded side before you end 2012.

Shlomo Yanai

Moshe.

Moshe Manor

I think this is Moshe. I think as we mentioned other than the coinciding that of Copaxone by 2012, of course, we expect to launch BDP nasal product in the market, and definitely we expect to launch laquinimod in 2012, and beginning of 2013 in the US and later in the year in the rest of the world. So, these are the, I will say the major products that we expect in the relatively short-term to launch from the branded pipeline.

Shlomo Yanai

Ronny, I would also follow-up Moshe that there is one women's health product that we have not disclosed yet that should launch prior to 2012.

Ronny Gal - Bernstein

That includes the (inaudible)?

Shlomo Yanai

We can’t really say any more at this time.

Ronny Gal - Bernstein

Thank you very much.

Operator

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

David Buck - Buckingham Research Group

Just two quick ones, first on the generic Protonix case, can you give some level of what you think the risk might be in terms of quantification of either sales since 2007 or what do you think damages may be at this point, and one for Gerard, on your -- picking the commentary on what sales growth would have been ex the UK issue. There are still obviously currency fluctuations for the remainder of the year. So I guess, why should we be expecting the European business to get better, and can you talk a little bit about the pricing actions, and how they affect your view on Europe? Thanks.

Shlomo Yanai

David, let me first take the one on the Protonix, and the impact on our business. As I said, when I reiterated the guidance for 2010 that include all the subject issues, concerns, challenges. Another thing that we are dealing with or we believe that we will have to deal during this year, and so without getting into the Protonix specifics because we are still in court. What I can say that that answer actually gave you in an indirect way that we are a strong believer in our guidance, in our results for 2010. As I said, it is going to be a strong year for Teva, another strong year for Teva.

And the second part of your question, please again.

David Buck - Buckingham Research Group

Sure. Looking at Europe in the first quarter, growth rate just being at 1% ex-currency, why should we be expecting it to get better, and can you talk about how some of the -- how the government pricing actions might impact the outlook?

Shlomo Yanai

Gerard, please.

Gerard Van Odijk

Yes, well, first of all as I told you, the main explanation for the constant exchange rate related numbers is the slowdown in the UK market, and without that we would have been doing in the range of 10% in retail and 20% in the hospital business. So just to give you a flavor there, there is no reason for us to assume that that will change through the rest of the year. However, the UK market is continuing to be an aggressive market, and there are possible, as you are rightfully asking for, interventions of government, but there is no sign of anything concrete happening. We see a change of government in Hungary.

We see clear -- we see government in Germany making plans, but basically as I told you before not really pushing into a direction that is making us nervous at this stage. We have seen a change of policies of government in Spain, which should basically be positive for us rather than negative, not to same in top line, but definitely in profitability. We see stabilization in the French market meaning it continues to grow, but the system seems to be getting down in a good way. Italy, we had a good quarter and we are on the right track there. So if you look overall, it is going to be like every year in Europe, rollercoaster with different solutions in different markets. But the other currencies are giving us confidence that we should be able to close the year in a good spirit here.

David Buck - Buckingham Research Group

Okay. And to follow up I guess one more time on Europe, is the constant currency growth rate a good indicator of what you expect for the year in the low single digits?

Shlomo Yanai

You know, we -- I said what I said and I think the number that I mentioned should be the number going forward. And as I said, the sterling and the euro are moving northwards and Bolivar and to each other. So that is a big uncertainty on which one is (inaudible). But the underlying volume growth and value growth in local currencies without is, is still at the high end of that.

David Buck - Buckingham Research Group

Okay, thank you.

Bill Marth

David, this is Bill Marth. Let me just follow up on one point on the Protonix. Just to make sure everyone understands, on May 6 we have another meeting with the court, and we believe that Teva’s defenses on the obviousness type double patterning are we believe are questions of law for the court, and the court has reserved the legal standard for determination of these defenses. And they will decide that at a later time. So we think it is quite premature to discuss damages.

David Buck - Buckingham Research Group

Okay, thank you.

Operator

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

Mark Goodman – UBS

Bill, obviously we know about the key four launches this year with Mirapex, (inaudible) Effexor. Can you talk about some of the ones we are not so focused on, and what you have highlight as potential (inaudible) over the next not just a year, year and a half?

Bill Marth

Well, you know, I think Mark that key is for this year. We have as many as 39 launches that are potentially possible with about $20 billion worth of innovator value. And of course the ones that we do not launch in this year would flow into 2011 and maybe some even into 2012. I think the big product that everybody thinks about for 2011 and more likely 2012 of course is atorvastatin, and so that is -- and that is an absolutely huge launch, and let us see where we get there. But there is no shortage of products through the 2010, 2011 and 2012 periods.

Operator

Thank you. Our next question comes from John Boris at Citigroup. Please state your question.

John Boris - Citigroup

Thanks. Hi guys. Thanks for taking the question. First question, just has to – with Europe and in particular for Gerard in the Spanish market in particular, you have a very solid market share following the Bentley acquisition there. I think the Spanish government is indicated in that they do want to reduce its annual drug budget by a little over $2 billion with an unfair burden placed on generic companies. How do you think about what percent of that burden is going to be allocated to your Spanish affiliates business there? And then I have just one follow-up question for Shlomo.

Gerard Van Odijk

Yes, the Spanish business, as I said before on the previous question was we believe that the measurements that are being taken by the Spanish government could be beneficial, yet the gross price that will be let us say paid by the insurers and by the patients will go down. But as you also know is that in the same measurement from the Spanish government, there is a limitation in the discounts that could be given to pharmacies.

So the margin between the gross sales and the net sales will decrease in top line, but the overall discount that will be given will be limited, meaning that the pharmacies are the ones that are probably going to pay the highest chunk of that $2 billion. So for us with the way we look at that is that if you look at our net business it could be very beneficial. It helps us with our multi-branded strategy, which we have in place there is even more important to have that. So we actually will be well positioned to take advantage of the change in situation.

And after the get together with ratiopharm, it makes us even stronger, because as you know we will be by far the largest company in Spain with some very strong brands in retail and in the doctors’ offices. And this whole change of -- governmental change will play to our strength rather than to our weakness. So we're optimistic. We need to see how it lands in reality. Spain, it is announced. So we need to see how the final version will look like, but the way it is presented today should be seen as a positive news for us.

John Boris - Citigroup

Okay, thanks. And for Shlomo, I guess if we think about accumulated risk on at risk launches like a barometer, obviously this is something that your board must look at and take issue with. If we do look at it as a barometer, and based on the amount of cumulated risk Protonix and certainly other products that you have launched at risk on, is that leading at least that barometer to be at a level where you are becoming more conservative on at-risk launches, or will you continue to be fairly aggressive on the at-risk launch area based on that accumulated risk?

Shlomo Yanai

Well, I would say if I well understand the question, as you rightly said the broader question is whether we are going through a changed Teva behavior, or let us call it Teva appetite for risk, and the answer is no. We will continue to do the same thing that we have done in the previous years going forward as well. Launches at-risk is part of our business, part of our activity.

And as I said before we thoroughly analyze any launch at-risk, because we do believe that this is something that during the year we found a way how to do these things including the pantoprazole launch that was a launch at-risk, and part of it is, of course, seeing the big picture or the overall accumulated risk. So we think the risk is manageable, and we will do it in a way that will continue Teva’s future growth and the level of risk, which we are taking into account in any given launch of risk.

John Boris - Citigroup

Thank you.

Operator

Our next question comes from David Maris with CLSA. Please state your question.

David Maris – CLSA

Good morning. Sorry if I missed it, on Plan B, it seems like demand year-over-year would be the same. What caused the big swing in Plan B? The other is going back to the bioequivalency changes in the FDA, on a broader basis, what do you think the implications from that meeting are for the industry and for Teva, and then lastly on India, a lot of your peers or US peers are moving production to India as fast as they can. Would do you think -- I don't think with your tax rate in your API cost basis really matters, but what do you think the implications are for these kinds of moves?

Shlomo Yanai

Bill, take the first one. I will take this.

Bill Marth

David, good morning, this is Bill Marth. The question about Plan B actually is a great question. You know, unfortunately you know it was a timing issue. We got off to a late start. Once this product got approved, we didn't get approved as quickly and get the transition from our original Plan B to a Plan B One-Step effectively. So, we didn’t get it done in the right timing, unfortunate for us in cost of share.

That said we put together our marketing program, have done a great job and actually the volumes in the last quarter have gone up 16% in volume and grown more than 6 share points. So we're putting that -- we are putting Plan B back on track and we have committed and will have Plan B back on track. We expect to have it before the end of the year with considerable growth. So we feel pretty good about this Plan B.

The second question was more about what happened with the discussions with the FDA around bioequivalence, what are the standards. Now, I thought we were going to get something tougher out of that. I really thought we might get to an area where bioequivalence, we will have to run bios on individual strengths within the (inaudible) business and guidance like that.

We didn’t get any of that. We did get that the agency is going to be a bit tougher on bioequivalence in general tightening the ranges. We at Teva believe that good plan. We think that anything that builds the confidence of consumers in generics is absolutely a good thing. So we are very supportive of it. You know, these are things that we can do and we are happy to comply with whatever changes they want to effect.

Shlomo Yanai

As for your question about moving production to India, I would say the following, and that deserves probably a more -- a longer time to answer a full answer on that. But let me try to be short. First of all, Teva made a strategic decision after looking at that many times that we are not going to base our production on India, or we're not going to move major part of our production to India due to the cost of labor, because we think in a different way. And we prefer to concentrate our production in Israel, Europe and United States of America.

We of course had some plans in some other parts of the world, but that is mainly where we would like to see our future major part or the significant part of our production. And that is because we believe that scale, technology and expertise matters in this respect more than the cost of wage in a given country.

You ask about, what are the things to move, let me take you to one kind of different argument or consideration that sometimes people are not so tuned or following it. There is a learning curve that it takes time and a lot of resources when you are moving production from one plant to another plant regardless to what country in the world. And sometimes companies are not aware that this could be a very significant not only cost, but a risk and I believe so.

So we prefer to strengthen our hubs and our production sites based on what I said, the scale, better technology and very qualified, highly experienced people with doing that and excelling that for the last 60 years, which is a strong advantage or competitive advantage.

David Maris – CLSA

And just as a follow-up, how are you engaging with your customers about that approach and is that resonating especially with the recent disruptions?

Shlomo Yanai

Well, I can say to you that the customers first of all like it. More and more customers are more aware where you are producing your API, and I see it as one of our great competitive advantages that we are focusing and we are producing our API in those places I mentioned.

David Maris – CLSA

Thank you very much.

Operator

Our next question comes from Elliot Wilbur with Needham & Co. Please state your question.

Elliot Wilbur – Needham & Co.

Thanks. Just back on the subject of Copaxone in various pending citizen petitions, I believe that the six-month date for the second citizen petition you filed in Copaxone, was you refiling I guess of the first petition is approaching, and I am wondering, basically the question is, should we be surprised if the FDA just simply denies that as we saw the first time around. That is the first question, and then the second I guess is for Bill, you specifically highlighted the performance of Accutane in the quarter as a year-over-year growth driver. And I guess, just looking at the numbers that has gone from being a non-descript base product to being your third or fourth largest product at least according to IMS sales. I'm just wondering if you could maybe shed a little light on the dynamics there, talk about how much do you think that is sustainable given part of it is due to -- Ranbaxy’s [ph] issues that also looks like Roche here had some issues. They got the other market entirely. Thanks.

Shlomo Yanai

Bill.

Bill Marth

Thanks Elliot for the question, with respect to the citizen’s petition, I guess you are right. I believe our date is coming up in mid-May, and you know it is the FDA policy that if there is not a product that is close or pending approval that they will likely, essentially return the citizen petition to us. So, we fully hope and anticipate that they will return that to the citizens’ petition to us or in your term denial.

So that is pretty much -- I wouldn't be surprised if that happens. The second question was with respect to Clovis [ph], and I believe it was Clovis. And you know that has been a great product for us. It happens in the markets and we talked a bit about this in the beginning, when you looked at your base, where products at some point or sometimes, the prices are way below the values that one would expect for them to fall to. It is not necessarily logical, and you need to correct that, and bring value back.

And that is exactly what we did with Clovis. I think that market remains pretty well divided at this point between us and Mylan [ph]. And to my knowledge, Roche is not shipping at this point in time.

Elliot Wilbur – Needham & Co.

Thank you.

Operator

There are no further questions at this time. I will now turn the conference back over to Mr. Shlomo Yanai for closing remarks, thank you.

Shlomo Yanai

Thank you all very much for joining us today. As you have heard we had a great quarter and we are very excited about what lies ahead for us in the rest of 2010. Thank you very much and have a good day.

Operator

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

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Source: Teva Pharmaceutical Industries Limited Q1 2010 Earnings Call Transcript
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