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TEVA Pharmaceutical Industries Ltd. (NYSE:TEVA)

Q1 2007 Earnings Call

May 2, 2007 8:30 am ET

Executives:

Kevin Mannix - North American Director of IR

Shlomo Yanai - President and CEO

Dan S. Suesskind – CFO

George S. Barrett - President and CEO of TEVA North America

Bill Marth - President and CEO of TEVA USA

Moshe Manor - Group Vice President, Global Innovative Resources

Analysts:

Tim Chang - FTN Midwest Securities

Robert Bonte – Citigroup

Randall Stanicky - Goldman Sachs

Richard Silver - Lehman Brothers

Greg Gilbert - Merrill Lynch

Ricky Goldwasser – UBS

Corey Davis - Natexis Bleichroeder

David Buck - Buckingham Research Group

Marc Goodman - Credit Suisse

Michael Tong - Wachovia Securities

Ron Miguel – Bernstein

Ken Cacciatore – Cowen & Company

Louise Chen - Morgan Stanley

Will Sawyer - Leerink Swann

Elliot Wilbur - CIBC World Markets

Presentation

Operator

Hello and welcome to the TEVA Pharmaceutical Industries Limited first quarter 2007 results conference call. At this time all participants are in a listening only mode. A brief Question and Answer period will follow the formal presentation. If anyone should require operator assistance during the conference please press star zero on your telephone key pad. As a reminder this conference is being recorded. It is now my pleasure to introduce your host Mr. Kevin Mannix of TEVA Pharmaceuticals Industries Limited. Thank you. Mr. Mannix you may begin.

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Kevin Mannix

Thank you Diego and good morning and good afternoon everyone. Welcome to TEVA's first quarter 2007 earning conference call. We hope that you've all 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 webcast of this call which is also available on the website.

Today we are joined by Shlomo Yanai, President and Chief Executive Officer, Dan Suesskind, Chief Financial Officer, George Barrett, Executive Vice President of Global Pharmaceutical Markets and President and CEO of TEVA North America, Bill Marth, President and CEO of TEVA USA, and Moshe Manor, Group Vice President of Global Innovative Resources.

Shlomo, George, and Dan will begin by providing an overview of our results. We will then open up the call for our Question and Answer period. I would also like to remind all of you that we will host a special quarter end luncheon today in New York. For those of you who haven't received (inaudible), or have not yet RSVP, please call us at 215- 591- 3056. And if you're unable to join us we'll be conducting a live webcast of the event which will also be available on TEVA's website.

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 webcast. I would like to turn this call over to TEVA’ss president and Chief Executive Officer, Shlomo Yanai. Shlomo?

Shlomo Yanai

Thank you Kevin. Good morning everyone and thank you for joining us. I am delighted to welcome you all the TEVA's quarterly conference call and to my first call to you as President and CEO of TEVA because this is my first opportunity to speak directly to all of you. I hope you will indulge me if I depart somewhat from usual format of these calls. Today I will give you just a brief summary of the quarter. George and Dan will provide you with more color and details and then I would like to share with you some of the basic premises that underline my approach to leading TEVA.

Let me begin with the quarter. I am very pleased to record that we have had an excellent start to the year with first quarter results that were stronger than we anticipated, something that makes us feel quite positive about the remainder of 2007. Our sales in the first quarter reached $2.08 billion with operating profits of $446 million, net profit of $342 million, and EPS of $0.42.

Now before I describe what specifically drove these results I would like to take advantage of my unique situation this quarter as the CEO, who on one hand now has full accountability for this company but who on the other can claim no credit for its success in the first quarter. Indeed these results belong to our superb management team. What I'm able to see quite clearly from this perspective is how perfectly TEVA's first quarter results demonstrate the uniqueness of this company and what market leadership really means to TEVA. After the company's major leap in growth in 2006, it was clear that 2007 would be a challenge by comparison. And yet in the first quarter, sales actually grew by 24% over the first quarter of 2006 and continued to show significant market leadership.

Ultimately the quarter ended with strong performances across all our geographies in North America, in Europe, and in the other markets that comprise our international business. In the US we benefited from high demand for our generic products. Despite no major launches in quarter one, we continued to see strong signs of leadership. In fact, new prescriptions grew by 10% over the previous quarter. We enjoyed especially robust sales of Oxycodone. Furthermore, demand for the products in our respirator franchise continued to grow with our ProAir inhaler retaining an even higher share of the markets than we have anticipated.

In Europe, sales were strong in quarter one with especially solid performances in the UK and France. And in Germany, the number one health care market in Europe, we saw the beginning of a very encouraging shift towards generic substitution. For the first time, health insurance providers began to take action to reduce cost shifting the decision from physicians to payers by politicizing tenders on certain products. We are encouraged by awards from this tender, even though our participation in this first bid was relatively minor and we are even more encouraged by what the health insurers moves seems to signal that ever increasing pressures on payers is leading to changing dynamics in the European heath care markets in ways that we believe are especially favorable for TEVA as a generic company that is both integrated and has a strong market presence.

Quarter one was a strong quarter for our international business with especially strong performances in Latin America and Israel. As I mentioned earlier, it was an excellent quarter for our respiratory products with our ProAir inhaler retaining a higher share of the US market than we expected. Demand for our respiratory products across all our markets continued to increase as the shift from CFC to HFA based inhalers continued to accelerate. Our respiratory business remains one of our important growth risers and we expect to see continued growth in this segment.

And last but not least, it was a strong quarter for our innovative business. (Inaudible) grew by 22% globally crossing the quarterly $400 million mark in sales for the first time. Azilect, our second innovative product for the treatment of Parkinson's disease, has been off to a good start particularly with the movement disorder special. Look forward during this year to increasing our presence the community of neurology.

Now that we have reviewed the highlights of the quarter I would like to give you some sense of my underlying principles as well as my initial observation of TEVA. To begin with, after two months in office, I can say with great confidence that I have entered an outstanding management team who's driven and determined team embodies TEVA's leadership values. I am very fortunate to have not only their knowledge, experience, and talent, but their support and cooperation in leading this company into what I believe will be an even more prosperous future.

During my conditional period, I have the opportunity to take part in management discussions and assessments of the business environment. Having participated in this process and as a believer of continuity, I am committed to all of those decisions and I take full responsibility for fulfilling them.

My number one responsibility of course is generating value for our shareholders and I am keenly aware of this responsibility to all the investors who have placed their trust in TEVA. As a CEO who believes strongly in growth as a key measure, I've started a process to explore how we might enhance the TEVA strategy in order to do so. The purpose of this process is by no means to reinvent our strategic will, rather as the new CEO, my goal is to consider how best to focus our efforts to seize opportunities we will face in the coming years and to seize them even more quickly and completely, especially as I foresee great opportunities for growth in generics. I see generics as the backbone of TEVA's business. And when I'm saying generics, I mean in their many forms around the globe. I believe that the opportunities in the generics industries are huge and that as a generic industry leader, TEVA is in a unique position both to capture and to maximize these opportunities, a truly exciting position to be in as business rises beyond generics.

And indeed, we have seen in our first quarter results, the significant contribution this part of our business can make. We are committed to continuing to develop this business and in fact, just yesterday we announced promising results from our Phase II Oral Laquinimod trial.

Over the last month, I had the great pleasure of meeting with some of you. During this meeting, I was very pleased to find that many of you share our vision of TEVA as a growth company. I also heard that you would like us to be more transparent, and I will do my utmost to provide you with as much information as we can publicly without harming our commercial interests. I very value your integral feedback and I look forward to getting to know more of you, and to hear more of your insights and ideas as we chart a TEVA course into what I believe is a very exciting and promising future.

And as for the near future, in recent months, we have been able to gain increased visibility on some of our key near term rivals. Given this and given my great confidence in TEVA’s capabilities, I’m optimistic about the remainder of 2007, and thus I am pleased to announce that we are raising our full year’s guidance from $207 million to $219 million, with a new range from $220-230 million.

Thank you all very much, and now I would like to turn the call over to George, for as you, is now part of the CEO and assumes responsibility as Executive Vice President of Global Pharmaceutical Markets in addition to serving as President and CEO of TEVA North America. George will provide us additional details on TEVA Global Businesses. George?

George S. Barrett

Thank Shlomo and good morning to everyone. Shlomo reported some of the key drivers for the Q1 results, and I’d like to take just a few moments to provide a bit more color. TEVA USA, our US generic business, had a very strong quarter. Although the big exclusive launches of 2006 are now fullly competitive, the beginning of 2007 was robust. TEVA USA has captured 25% of all of the generic prescription growth which occurred in Q4 of 2006 and Q1 of this year. Furthermore, we have been able to retain significant market share from some key products including Pravastatin, Simvastatin, and Sertraline.

Regarding pricing on our base business, we are encouraged that the lower rate of erosion that we’d seen in the back half of 2006 has continued into the first part of the year with erosion rates tracking below 10%. During this quarter, we gained increased visibility on the Oxycodone market. As a reminder, we launched Oxycodone ER in March of 2004, after a lower court finding that the patent was unenforceable. That decision was reserved at the federal circuit and remanded to the lower court. As we have previously announced, we entered into an agreement that required that we exit the market in exchange for full release. However, the time of that exit was tied to various events. We now have better quality on these events and as we discussed in the March press release, we now expect to remain in the market for at least the balance of 2007.

In addition, we did benefit in Q1 from the exit of two players from the market. Furthermore, we now expect we’ll be in the sole generic position for some period between June 14th and the end of the year, although we will be somewhat dependent on the amount of raw material that is allocated to our private DEA. Our pipeline continues to be full with 150 NDA’s waiting for approval at FDA, representing $90 billion in brand value. (Inaudible) to a product for which we believe that we hold the right to exclusivity, representing $35 billion in brand sales.

Our European business is becoming more robust and balanced and we saw this at work in the first quarter as solid growth in the UK, France, and Germany, and other markets more than offset the impact of a price (inaudible) back instituted by the Hungarian government.

Shlomo noted an important change in the German market. I would only add that a relatively small number of compounds were included in the initial fitting process, to which (inaudible) was quite significant, covering approximately a third of all German citizens. It’s reasonable to assume that the program will expand and we are well positioned to utilize our portfolio, our project ability, and our existing infrastructure in Germany to participate in this opportunity.

Our international group also performed well with the largest contribution coming from our Latin American businesses. Argentina led the way for us in terms of growth in Q1 with other countries providing strong support. It is worth noting here, that while in Europe, we see strong regional forces, the markets of Latin America still move very independently of one another. Having said this, we predict strong regional capabilities including a local manufacturing network which will allow us to compete effectively.

Moving to our business count generic, I’d like to highlight just a few things. Copaxone is off to a great start for the year. Our market shares increased and our program to support our MS franchise is progressing. Just this past week, data was published recording several of our initiatives. Our Phase II study on a 40mg dose, a daily dose of Copaxone, showed a 38% greater reduction in inflammatory disease activity as measured by an MRI of the brain.

In addition, patients taking a 40 mg dose of Copaxone experienced a reduced mean on trial relapse rate of 77% compared to annual relapse rate of 62% with the 20mg. This week at the American Academy of Neurology, data was presented which explored the benefits of combination therapy with Copaxone and other existing drugs, a treatment approach that holds great promise for the MS community.

Finally, Laquinimod, our oral drug for MS that showed good Phase II results provided Relapsing-Remitting MS patients treated with an oral dose of Laquinimod a significantly reduced MRI disease activity by 38%. We expect to initiate a Phase III program in the second half of this year.

Azilect, our treatment for Parkinson’s disease, has entered an important second phase. We’ve done very well with movement disorder specialists who are now working to broaden our message to the community neurologists and a marketing program is in place to drive this initiative forward.

Finally a few quick comments about our respiratory business. Of course, the conversion of Albuterol products from CFC’s to HFA propellants in the US has been a major story. We have positioned our brand to capture this opportunity. The conversion process continues to move at a brisk pace, and we work hard to prepare the commercial strategy and the capacity for the response that this needs. Today, 55% of total Rx’s are filled with HFA products and we retain a 55% share of that segment.

Of course, the competitive dynamics are changing somewhat as this process unfolds so we do expect to retain a significant share as the conversion continues. Our TEVA specialty pharmaceuticals business, PSP as we call it, has also done well with our inhaled cortocosteroids QVAR positioning the drug for those cases where small particle size will allow proper deposition into the small airways of the lung.

We now hold approximately 12% of the inhaled corticosteroid market. As it relates to a breath actuated product which remains in an approvable status at FDA, we’ve been asked by the agency to complete some in-vitro studies and to conduct a labor comprehension study to demonstrate that patients can effectively use this technology based on the labeling. Given the timelines associated with doing this study, we would hope to have final approval in 2008.

Of course our respiratory business is a global one. In Europe, we’re beginning to roll out our respiratory business from our historically strong market in the UK, France, and Netherlands. In addition, we expect to participate in the CFC/HFA conversion in Europe, but this time in (inaudible) rather than Albuterol, and on a smaller scale. Our breath actuated product using our Easi-Breathe technology are well received in Europe which bodes well first for continued European growth as well as full opportunities ahead of us in the US. That concludes my remarks and I’ll pass the call back over to Dan.

Dan S. Suesskind

Thank you very much George and good day to all of our friends around the world. We are here today to report the results of Q1 ’07, the first quarter to follow the best year in TEVA’s history. After TEVA’s huge leap in growth last year, many wondered what would follow and some believed that all severance would mark the end of TEVA’s growth story.

But as you have already heard and seen, our results in Q1 are better than even we anticipated and significantly higher than the comparable quarter last year. EPS of $0.42 compared to $0.37 last year. As Shlomo described it, Q1 is an excellent start to a very promising year, and I believe it is also a perfect demonstration of whatever scale along with our balanced business model allows us to achieve. ’07 is a different sort of year than ’06. In ’06 our success was based, basically, on the (inaudible) on a few very major quarter. In ’07, our results will be driven by contributions from many different elements of our business.

Before I describe the results of the quarter in detail, I would like to point out that my comparisons to '06 will be based on the as-adjusted figures of '06. In other words, our '06 results after taking out the (inaudible)-related drugs. We strongly believe that these adjusted results, which are the results used by our management and our board, provide the best indications of TEVA's operations. In addition, the quarter-to-quarter comparison is not a fully an apples-to-apples comparison because it was consolidated for only two months in Q1 of '06.

Let me now begin by pointing out the financial highlights of the first quarter, as compared to the first quarter of '06. Sales were up 94% to $2.1 billion, adjusted operating income was up 21% to $446 million, adjusted net income was up 20% to $342 million, and adjusted EPS were up 14% to $0.42.

We again generated very significant cash-flow from operations, amounting to $499 million for the quarter, with free cash flow amounting to $278 million.

And with that overview, let's start the line-by-line analysis starting with the sales. As I mentioned, sales reached $2.1 billion, an increase of $407 million year-over-year. Total sales this quarter include a benefit of approximately 3% derived from currency effects. But currencies had almost no effect on our earnings.

Sertraline no longer carry the exclusivity pricing, Oxycodone and Wellbutrin XL were the important drivers in our results in this quarter. In addition, we launched three generic products in the US during the quarter.

Pharmaceutical sales in Western Europe, including Hungary, which represented 25% of global sales, grew 37% to $521 million with currency effects contributing about 13% to the total sales. TEVA's most significant market in Western Europe continues to be Hungary, UK, and the Netherlands. The most significantly increased sales this quarter came from the UK and France, both in absolute and percentage terms. France is now TEVA’s fourth largest market in Western Europe.

Growth in sales in Germany was also significant in percentage terms, but in absolute terms, German sales are still not that material. These positive trends in Europe were partially offset by the negative impact of new pricing regulations in Hungary and in Italy.

In our international pharmaceutical sales business, by which we mean sales outside North America and Western Europe, we grew from $262 million in Q1 of '06 to $314 million in this quarter, an increase of 30%. Sales in Latin America grew more than 50% over Q1 of '06, and this region did not benefit from any currency effects.

Sales in the CE, Central and Eastern Europe, grew 39% and included an 11% of positive currency effect. Sales in Israel, which is a relatively stable market, grew 15% with positive currency effect contributing 9% to Israeli sales.

Our global market sales of Copaxone amounted to $401 million. This is a 22% increase over the comparable quarter. Sales in the US, a much more mature market, decreased 18% to $260 million, and non-US sales, mainly in Europe and in Canada, increased at the much higher pace of 31% to $141 million.

Non-US sales of Copaxone now account for 35% of growth in global market sales. In the US, much of the Copaxone sales both reflected the prices increases in August '06 and January of '07. But the gross also included a volume increase of approximately 5%.

Our global respiratory business really stood out this quarter, with sales exceeding $190 million. This represents more than doubling our sales from the corresponding quarter of '06. The increase was mainly fueled almost entirely by a substantial increase in sales in the US caused by TEVA's leadership, which enabled it to increase its market share in the faster-than-anticipated conversion to non-CFC-based inhaler products.

In fact, sales in our US respiratory business quadrupled as compared to Q1 of ’06. As far as TEVA API business, third party business, this quarter third party sales of API mounted to $148 million reflecting essentially no change from the comparable quarter of ’06. In addition, the API division sold $189 million worth of raw material internally to TEVA Pharmaceutical operations.

In the first quarter of last year, heads of our API divisions reflected larger volumes of material at higher prices mainly to TEVA’s own corporation, but also to third parties in support of the (inaudible) in the subsequent quarters. In fact, quantity wise, TEVA’s API sold in Q1 of ’07 16% more than in Q1 of ’06 and 10% more sequentially.

Stepping down one line in the P&L to gross profit; gross profit margin reached 49.9% this quarter compared to 47.1% in the comparable quarter. So, in these two quarters, you effectively have the high and low ends of the bend of 47-50% as indicated last year at TEVA’s normative gross margin going forward.

The high level of gross margin this quarter reflects a change in the mix, resulting primarily from increased sales from the respiratory product and sales, from what we called our international sector, where many of the products are sold as branded products, which correspondingly higher margins, but also reflect improved margins in our other business mainly in Europe.

And from gross margin to R&D, net R&D increased by 31% to $135 million. This record number reflects the importance that TEVA places in its R&D activities. More than half of this amount went to generic R&D. SG&A, which reached $456 million this quarter, represents 21.9% of sales which are significantly higher than the level of the first quarter of ’06, and on a percentage basis, slightly higher than Q4 of ’06. The absolute amount of SG&A in the first quarter of this year was lower than the $478 million recorded in the fourth quarter of ’06.

This level of SG&A expenditures principally reflects the higher rates among our total sales of branded market and branded quarter. And of such, some of the higher gross margins achieved in these markets. SG&A also includes profit sharing with some our partners in the US as part of settlement agreements on a few quarters which was substantially higher than in the comparable quarter of ’06. In addition, TEVA’s successful production of Azilect in the US and non-US market, generated higher sales and marketing costs.

On to operating profit. In this quarter, it amounted to $446 million, 21.4% of sales and up 21% from Q1 of ’06. This reflects a higher gross margin on the one hand, and a higher R&D and SG&A on the percentage of sales on the other hand. Financial expectance for this quarter is at $28 million, whereabouts two times the expense of the comparable quarter, but in line with the average quarter in financial expenses in ’06. Q1 of ’06 included only 2 months of expenses related to the (inaudible) acquisitions compared to a full quarter in ’07. In addition, as you know, the swings in this line item principally reflect hedging activities, which are partially offset in other line items and in some instances are more than fully offsetting in these line items.

Our division for taxes amounted to $75 million, so 18% of pre-tax income is our best estimate at this early time of the year of the expected annual tax rate that we will face. This is in line with the 19% percent rate in the comparable quarter for ’06, a substantially higher than the 15% rate provided for fiscal ’06. The (inaudible) of our earnings in particular, increased share coming from the US as well as some of our other factories with a high tech slate is the main reason for this high in ’08 leading to $342 million, or a net margin of 16.4%. EPS was $ 0.02 compared to the $0.37 in ‘06.

Cash flow in corporations amounted this quarter to $499 million. Our free cash flow and dividends amounted to $278 million. Part of this free cash flow was used for our share re-purchase program. You may recall that the $600 million share purchase plan was approved last November. In June, the first quarter of ’07, we spent $152 million on share buybacks so that as of today, a total of $386 million was spent to purchase 11.7 million shares, for an average price of $32.90 per share. Our working capital decreased sequentially from December by approximately $190 million and at the end of the quarter amounted to $3.4 billion dollars.

And from here to some working capital items. First, day sales outstanding in receivables: These decreased from 58 days in December to 54 days in March of ’07. We have calculated these after netting out from the receivables the sales reserves and allowances to the so-called SR&A.

As you know we record receivables on a gross basis and record the SR&A on the current liabilities. But in order to facilitate a more meaningful comparison with some of our peers who record receivables net of these reserves, we have used the net figure.

Total SR&A as of March 31, ’07 amounted to over $1.6 billion, an increase of $98 million from December. Over 92% of the total reserves are from the US, up $94 million from December of ’06.

Inventories increased sequentially by 11% to $2.1 billion, with day sales in inventory increasing to 173 days, reflecting increased inventories in the US market, both used to several anticipated product launches in the reports to enhance customer service levels.

For the convenience for our audience, I would again like to mention three figures relating to our share count so that we are all on the same page. For the first quarter of ’07 our average share count for the purpose of calculating fully diluted EPS was 827 million shares.

Our share count for calculating fully diluted earnings per share going forward as of March 31, ’07 is approximately the same 827 million shares as to buy back, a fact that was upset by the higher share price. And the count for calculating our market share is approximately 764 million shares.

Just one word of clarification regarding the guidance that Shlomo gave: As always, the guidance given by us does not include any major acquisitions or business development affairs.

Last item is dividends. Yesterday the board approved the first quarter dividends amounting to the total of approximately $79 million. On a per share basis, our dividend was maintained in Israeli shekel terms, which demonstrate that the current rate had been changed to $0.10.

This reflects an increase in US dollar terms from the last dividend payment, due to the declining value of the dollar since the date of our last dividends. Thank you all for your time and attention today. Now we will be glad to take your questions.

Question-and-Answer Session

Operator

Ladies and Gentlemen, at this time we will be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your call is in the question queue. You may press star two if you would like to remove your question from the queue.

For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. Our first question comes from Tim Chang, with FTN Midwest Securities. Please give your question.

Tim Chang - FTN Midwest Securities

I have a question about Pro-Air and (inaudible) products. Do you expect pricing to continue to increase for both products this year? Also can you comment about the share, certainly you’ve got enormous share in the Pro-Air market. I would assume you would have a dominant position there. How does the DEA quota sort of fit with (inaudible) as well?

George S. Barrett

Good morning, Tim, it’s George. Let me try to take those. First on the DEA quota, we’re in relatively good shape right now. As you probably know, this is a drug that is very tightly regulated and the DEA is basically on a no expansion of product into the system approach, a zero sum gain. They want to make sure that what comes from one player goes to the other but no more.

So right now I’m in a relatively good position, they’re depending on exactly how the demand plays out. We may have need for more material, we’ll obviously petition the DEA for that material and hopefully we’ll have an update to get that allocation.

As it relates to pricing, our price did go up late last year, which really began to affect us this year. Because that price has to roll out through the trade, you may see some aggressive move, but that’s probably just the price increase rolling through the system.

As it relates to Pro Air pricing, right now it’s relatively stable. We’re not modeling in a price increase at this moment. Obviously it’s an unusual dynamic at work with the conversion occurring. So at this point, we’re not modeling any particular increase on that.

You had another question about Pro-Air that was not pricing?

Tim Chang - FTN Midwest Securities

Again, can you basically apply even more share in this market? I guess you’re at two thirds of the market on the FHA side?

George S. Barrett

Right now that’s a pretty hefty share. And at the current rate of penetration of the HFA, surprised yet pretty tight for us, we have ramped up production several times. We have another increase that will probably start to benefit us later in the year.

I think there’s some likelihood that share will moderate a little bit. That’s a very high share. We’ll see some movement as other players ramp up their capacity, and I think we should assume some moderation of share.

Tim Chang - FTN Midwest Securities

OK great, thanks a lot.

George S. Barrett

You’re welcome.

Operator

Our next question comes from Robert Bonte, from Citigroup. Please state your question.

Robert Bonte – Citigroup

Thank you. Just wondering if you could give us a bit more detail perhaps, Dan, on the SG&A. Were there any one offs in SG&A spending in this quarter?

Dan S. Suesskind

There were no one offs. Although, there is splitting on earnings on those products where we have partners, is not the same every quarter. One other affect which increased the percentage of SG&A is much of SG&A obviously are fixed costs and since we had 10% lower sales compared with the last quarter obviously decreases the percentages.

Robert Bonte – Citigroup

A follow-up question on Top Line, in the quarter, I think your non-US operations were very, very strong. The US operations were strong, but still significantly lower than fourth quarter.

Are there anything there we should worry about, because it seems a little bit to contradict what George was saying about US market share gains and strong pricing?

George S. Barrett

Actually, we simply had the expiration of exclusivity that moved from Q4 to Q1. So actually, we feel very good about what’s going on in our US generic business.

Dan S. Suesskind

Expiration of exclusivity expired early February.

Robert Bonte – Citigroup

Where there any notable charge backs in the quarter at all affecting reported sales?

Dan S. Suesskind

Nothing worth noting.

George S. Barrett

Just a reminder (inaudible) exclusivity late in Q4 and in Q1?

Robert Bonte – Citigroup

Was there any notable health? Adjustment in the quarter?

Dan S. Suesskind

No.

Robert Bonte – Citigroup

Thank you.

Operator

The next question comes from Randall Stanicky from Goldman Sachs. Please state your question.

Randall Stanicky - Goldman Sachs

Great. I just have two, to follow up on the last question. George, can you just comment on what we’ve been hearing from your supply chain on an actual increase in pricing following an initial crash after exclusivity and how that’s impacting your view of your 47-50% margin ban for the year?

George S. Barrett

I’m not exactly sure what your question is. I’m probably going to turn to Bill, to discuss the market situation. But could you rephrase the question, so we make sure we’re clear.

Randall Stanicky - Goldman Sachs

Some of your supply chains of our pricing, which is actually then taped off following the removal of some of the smaller competitors after a short period of time….

Randall Stanicky - Goldman Sachs

And you're referring to...?

George S. Barrett

Some of the larger products, in terms of Sertraline.

Shlomo Yanai

Let's just describe as best we can how we see the situation out there on these products. Maybe that will help. Yeah, I would say, Randall, that there wasn't really anything unanticipated in a “crash” in pricing. Any product like Sertaline with 14 different competitors, or any product, with 10+ competitors, we experience a significant decline in pricing. And that occurred as competitors came in, and many people are finding themselves leaving the markets. They sell their original validation badges, and then they leave.

I think the important point, and we're sure to talk about it more at the luncheon today, is really, who ends up with the share and who holds the share? And I think we're going to talk a bit about that more, moving forward.

George S. Barrett

Randall, were you suggesting that you're hearing the price is going up?

Randall Stanicky - Goldman Sachs

Yeah, I guess the question is, are you surprised at, now that you say it was close to 40% plus or minus a share on some of these big products? Are you surprised by the level of pricing you're at right now relative to where you initially expected it to fall out?

Shlomo Yanai

No. I would say no, Randall, I think we're where we are expected to be at price, and we are very pleased with our share, and I think it's very reflective of our market position, and how our customers feel about our ability to supply very large molecules.

Randall Stanicky - Goldman Sachs

OK. Just let me ask one more question on the raising guidance. If we just take pay, if my math is right, for the remainder of the year, and apply approximately 61% of (inaudible) per quarter, can you give us some color on quarterly variation and some of the push-pulls that we should be thinking about in terms of distribution of EPS for the remainder of the year?

Dan S. Suesskind

We initially said last quarter that it's more back-end loaded. I think we see that a little more flattening then we said earlier in the year.

Randall Stanicky - Goldman Sachs

In terms of Q2 being somewhat similar to the third and fourth quarter? OK, that's helpful. Thanks a lot.

Operator

Our next question comes from Richard Silver with Lehman Brothers. Please state your question.

Richard Silver - Lehman Brothers

Good morning. Dan, do you think you could also help us out a little bit on what really is, or are the drivers of this raised guidance? Is it Oxycodone, is it Pro-Air, is it the gross margin? Just a sense of top line gross margin and perhaps the components of what would account for that kind of increase in guidance?

Dan S. Suesskind

Look, I think first of all that it's not a single item. It is more a combination of a few factors, and in the recent months we gave more clarity of how the year may evolve, and we saw some interesting developments as we described, and partially I described, both in the US in specific products, which came in and we were not sure exactly when they would come in, developments in Europe, so that it's a combination of things. But after the '06 year, we really felt that we needed some more clarity, and this came in, and we are already now four months into the year, and we feel stronger based on these developments as we felt when we gave first guidance in February.

Richard Silver - Lehman Brothers

And at least quantitatively, can you at least tell us on some of the operating expenses what ranges we can expect, either in absolute dollars or percentage of revenues, and maybe even some sort of revenue guidance, if you can't pinpoint anything qualitatively that's driving this?

Dan S. Suesskind

I'm sorry, can you repeat this please?

Richard Silver - Lehman Brothers

If you can't pinpoint anything qualitatively that would account for this raised guidance, maybe you can give us some parameters on quantitative parameters, such as SG&A as a percentage of revenues, R&D, or maybe even top line and gross margin. Just some sense there.

Dan S. Suesskind

OK, first of all, I think much of our increased guidance is actually based on margins. Our margins this quarter were higher than we initially expected, and we see them strong also going forward. It is more a margin issue than a volume or a top line issue. I would say that our R&D margin or percentage of sales, of course that's a little higher this quarter than it will be in the rest of the year. I generally hope that SG&A as a percentage of sales will be slightly lower during the rest of the year, depending obviously also on our profit sharing, which is sort of an extraordinary item, if you want to call it within the SG&A. And these are things that will be the main drivers, qualitatively.

Richard Silver - Lehman Brothers

And so you're also not making any new assumptions on products that haven't been introduced, where the probability may have increased?

Dan S. Suesskind

At least we already have clarity on what we have done already in this quarter. There is no question regarding that. And this gave us a few cents above what we initially expected. So this we have already now in our pocket.

Richard Silver - Lehman Brothers

OK, and just one more on respiratory. You mentioned the conversion from CFC to HFA, and our understanding is that that has been taking place for some time. You make it sound like it's something that's more in the future. Can you elaborate, and perhaps anyway you can give us some since of the $193 million, how much of that is US versus Europe? That would certainly be helpful.

Dan S. Suesskind

The majority is US. It used to be that a year ago it was the other way around, but by far this quarter, and actually already in the previous quarter, it's by far more in the US than outside the US.

Shlomo Yanai

And Richard, your point is exactly correct. This process has been underway, and really just reminding us that this is an opportunity that we continue to try to pursue.

Richard Silver - Lehman Brothers

And just once more. Since margin is so important, Dan, are you saying that you've been talking about this range of 47-50%, so can we assume that certainly the higher end of that is sustainable, and you're not going to see this quarter being somewhat aberrant, and then we're back down to kind of the middle of that range. Because you've made it pretty clear that that's really the driver of the better-than-expected outlook.

Dan S. Suesskind

Look, we gave a range because we feel that we have a normative range, and it's very difficult on a quarterly basis to shoot at an exact number. But I assume that throughout the year it will be better than the low end of the range, and the first quarter already has a rate causing that.

Richard Silver - Lehman Brothers

OK. Thanks very much.

Dan S. Suesskind

Thank you.

Operator

Our next question comes from Greg Gilbert with Merrill Lynch. Please state your question.

Greg Gilbert - Merrill Lynch

I just have a couple. First, Dan, couldn't you find $1 million more in cash flow?

(laughter)

Dan S. Suesskind

Ah, I knew this question was coming, and I apologize that I didn't prepare an answer for that.

Greg Gilbert - Merrill Lynch

But Shlomo, seriously, now that you've had some time to meet with some key stakeholders, what's your sense of how TEVA should be prioritizing the use of the cash flow, in terms of share approaches to dividends and acquisitions? And within acquisitions, how would you describe your current acquisitions criteria and priorities at this point? Thanks a lot.

Shlomo Yanai

I would say that any given acquisition TEVA properly (inaudible) in our side is analyzing all the opportunities in this regard, is basically following two major considerations. One, what is the strategic fit for the proposed acquisition, i.e. whether it comes along with our general gross strategy? And then, of course, what is the value proposition that this acquisition offers? And again, at the end of the day it's about creating value and about the value proposition that we offer to our shareholders.

So these are the two major issues or major considerations that we assess in any proposed acquisition. And that's again without referring to any rumors, or market rumors, or any news regarding any potential acquisitions.

Greg Gilbert - Merrill Lynch

OK, I have a couple questions regarding the handicap near term legislation on bio-similars, AGs, and settlements, and any other ones I should have been asking you about?

George S. Barrett

Well, I’ll start, and I’ll let Bill…both of us have been active here and I’ll let Bill comment today, but as you know, the day is going to be very busy in Washington, today and during the course of the week as PDUFA is discussed. I think the likelihood that we’ll have some kind of generic bio-tech legislation still remains quite high, whether or not it’s going to find its way in PDUFA I would say is changing and probably with a lower probability today than it was a week ago.

As you know, this is a fast moving subject. And you also probably are well aware that PDUFA is one of those bills that have such strong support on a broad basis that we’ll see all kinds of things attached to it. But let’s sort of back up. I’d say in a general sense, the likelihood of a bio, generic bio-tech bill during the course of this year remains quite high.

As it relates to settlements, I think this remains an issue that attracts attention, and I think it’s certainly possible that we’ll see some kind of attempt at some legislative ticks related to the nature of settlements, but again, from what we’re seeing, it remains quite more reasonable than it was perhaps a month ago. There’s certainly some activity there. Bill, do you want to just jump in on any of these things?

Bill Marth

Of all the things that are out there, bio-generics, I’d say the prospects are still increasing and that’s good. Patent settlements, as George said, are very likely that something will happen and it’ll be much more reasoned. And finally, patent reform is moving, but we think that will be very reasoned. And the authorized generic piece is probably in my, at least in our view, the least likely to occur at this point in time.

Those are all the major issues that are moving at the moment. Of course we are looking for more guidance that will be issued in July, although not, this is not actually what’s happening on the hill, but we’ll be coming out of CNS on the amp. The final guidance should be issued from CNS by July 1st.

Greg Gilbert - Merrill Lynch

That’ll be interesting. And lastly, can either of you comment on any movement in the marketplace on Lovenox? There’s been some speculation of late, so I wanted to know if you were hearing anything in the trade and/or if there’s anything to update regarding your program.

George S Barrett

You’ve heard the rumors that have been re-circulated and have no fact. Nothing, we have no facts that provide any color on that.

Greg Gilbert - Merrill Lynch

Thank you very much.

Dan S Suesskind

This is Dan, and we’re running late so I really urge you to limit your questions to one per person. Choose the most pressing one and ask us and we will try to be as short as we can in our responses because we want to cater as many people that want to ask us questions. Thank you very much.

Operator

Our next question comes from Ricky Goldwasser from UBS.

Ricky Goldwasser – UBS

Hi, yes, good morning. My questions are actually four questions, so first of all, just a clarification, is the market share moderation that you’re expecting in the factor off capacity or are you seeing any changes in the market place associated with changes on prior and such as this united and given its (inaudible), I’ll just put another question there for the pricing environment. What are you seeing is the pricing environment for the older generic stuff and the new generic coming out of the 180 day market, but for the older products in your basket. Thank you.

George S Bassett

Yeah, hi Ricky, it’s George. As it relates, I think the assumption of a moderating share relates to the fact that we got a very early move on this market. Other players are and have been ramping up some capacity, and I think it’s natural that there will be some jostling for position, number one, and number two. As I mentioned, the rate of penetration of the HFA has been quite rapid, and we’re keep up right now from a capacity standpoint to attain this share.

Obviously there comes a point where we’re pressed up against our capacity constraints, but I think there are a couple forces at work here, and it’s really not…there’s no formal way to describe exactly what will occur, except that it is reasonable to assume that there would be some moderation of share. It’s a combination of the behavior of the marketplace and some tightness on capacity as a ramp-up occurs. Obviously, we’ll be thrilled if we can contain to retain this share, but we’ve assumed a slight moderation.

And on the pricing, I think I might have covered that in my remarks on the older products, that we’re seeing a rate of erosion on the base that is better than we have seen in the early part of ’06 and certainly better than we had seen in ’05 and running just short of 10% on erosion of the base products.

Operator

Our next question comes from Corey Davis with Natexis Bleichroeder. Please state your question.

Corey Davis - Natexis Bleichroeder

Thanks, just one. Do you think the recent Supreme Court decision on obviousness could have an immediate effect on on-going litigations?

George S. Barrett

That’s a good question. Corey, it’s very new. We’re still really analyzing the Supreme Court’s decision. Certainly on the surface, it does look like it’s very favorable to us. It seems to argue that the federal circuit had applied too rigid a standard to the idea of obviousness, but we’re willing to digest it and we’ll have a better read on whether or not it has a direct impact on any of our cases.

Corey Davis - Natexis Bleichroeder

That’s all I had. Thanks.

Operator

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

David Buck - Buckingham Research Group

Yes, thanks. One quick one for George. Can you give us a sense of your view of generic Azilect prior to the May 15th decision that we’re expecting, and Shlomo, can you comment a little bit about the guidance that was put out by your predecessor for 2008 and 2009, the 215 plus for example for 2008, in terms of EPS? Thanks.

George S. Barrett

David, unfortunately my answer will be very efficient on the Azilect. It’s really not something I can provide any more insight at, at this point.

David Buck - Buckingham Research Group

Is that actually in the guidance at all for this year?

George S. Barrett

As you know, our new product program is potentially risk adjusted in various ways through our planning process. And obviously I can’t give you the individual breakdown by product but we contemplate all products and we look at how to adjust the rift on each of them.

Shlomo Yanai

It’s Shlomo now. I believe in continuity and unless we are giving any notice for change, everything is in tact, including what my predecessor said to you in previous occasions.

David Buck - Buckingham Research Group

OK. Thank you.

Operator

Our next question comes from Marc Goodman with Credit Suisse. Please state your question.

Marc Goodman - Credit Suisse

Yeah, North America, if you look at the (inaudible) from the total sales, it looks like API was pretty weak, could you talk about why so weak in the quarter and it’s just been weak the past couple of quarters and what your expectations are there for the year? And Dan, could you repeat the comment you made about the settlement agreements and the SG&A comments please?

George S. Barrett

Yeah, hi Marc, it’s George. On the API side, I don’t think there’s anything particularly noteworthy to describe here. Our business externally and internally is very much tied to the flow of product, usually with some lead time in effect, sort of a lag in time. Also, right now, internally, our PAPI as we call it, has been doing incredibly well in getting us product and products ready for launch in terms of raw material and I think they’ve, from everything we can see, are doing very well in market with their customers so, I think it’s more just a nature of the flow of products than anything else I can point to.

Marc Goodman - Credit Suisse

But it looks like it’s going to be down from last year pretty substantially. Is that the case we should be thinking about for the full year?

Dan S. Suesskind

First quarter is unchanged. And the first quarter last year was a very good quarter, so I don’t think it should be done, and not to third parties.

George S. Barrett

And your second question was about the SG&A?

Marc?

Dan S. Suesskind

He’s gone, we lost him.

Operator

Our next question comes from Michael Tong with Wachovia, please state your question.

Michael Tong - Wachovia Securities

Hi, thanks for taking the question. Actually, it’s a follow up to a previous question for Dan. You talked about the margin being better than you had previously expected and hence the revised guidance. Can you give me a little more color as to whether that’s a US phenomenon or an international phenomenon and whether that’s coming from better pricing, few competitors, or better allocation of the overhead.

Dan S. Suesskind

First of all, it is not concentrated in one area. But certainly in the US, as we have seen both Oxycodone and (inaudible) came in this quarter and they are relatively higher margins, but it is not really one single phenomena.

Operator

Our next question comes from Ron Miguel with Bernstein. Please state your question.

Ron Miguel – Bernstein

Two quick ones. First, the sales have dropped sequentially over the fourth quarter from $361 million to $340 million. Is this seasonality issue or there’s something else going on there, given the strength of the growth in that area?

And second, are we still (inaudible) in the first half?

Moshe Manor

I don’t know that again, we’ve provided complete detail on our submission plans for Europe. I will say that the bio-generic activity is moving much more swiftly right now in Europe, and certainly I think that’s an area where we should start to see some activity during the course of this year.

And the first question I think was directed at you.

Shlomo Yanai

I will say that there is nothing significant in this change between the two quarters. It’s composed of so many markers that it’s almost coincidental.

Ron Miguel – Bernstein

OK, thank you.

Operator

Our next question comes from Ken Cacciatore with Cowen & Company. Please state your question.

Ken Cacciatore – Cowen & Company

My question is for Shlomo, just that you were commenting about there’s some rumors out there, so I’ll ask you directly, have you bid on Merck KGA, and if you have bid on Merck KGA, what is the timeline in which we will know whether you were successful in your bid?

Shlomo Yanai

Obviously we cannot comment on any given opportunity or market rumors, and you will excuse me if I cannot elaborate more in this regard.

Ken Cacciatore – Cowen & Company

Thank you.

Operator

Our next question comes from Louise Chen with Morgan Stanley. Please state your question.

Louise Chen - Morgan Stanley

Hi, just two quick questions. First, in terms of the paragraph four, are there any important products that we should be looking for this year? And then secondly, what is the interest and common interest expense for the quarter, thank you.

Dan S. Suesskind

There are a number of cases that are ongoing, and again, I think things to watch for, there’s certainly (inaudible) as was mentioned earlier. There are a number of cases, but nothing that is a critical single activity to watch for. But certainly there are some cases out there in the public domain.

The second part of your question, again?

Louise Chen - Morgan Stanley

The interest income and the interest incurred for the quarter?

Shlomo Yanai

As I mentioned in my opening remarks, the main swing in financial charges is usually, and including in this quarter, are our hedging activities, which stick out in a small line item, a relatively small line item like financial expenses, while they are offset, more or less offset in other line items.

So in terms of interest expense we had practically the same interest expense as we have seen in the last quarters. Obviously we had lower interest charges because we had only two months of the business, but besides that there is nothing significant in our financial income or expenses, save the fluctuation in the hedging activities and the result of that.

Operator

Our next question comes from Will Sawyer with Leerink Swann Please state your question.

Will Sawyer - Leerink Swann

Good morning, thanks for taking my question. A couple for George. George, first on the HSA conversion process, I mean, what’s your outlook on the conversion from here. In the last couple weeks it seems like it’s stalled out a little bit.

And also, what role does the fact that physicians are writing prescriptions more generically for Albuteral and also that prices have increased quite a bit. How do you see that playing a role in the conversion?

George S. Barrett

Let me try the first part of your question, really related to the slowing in the last week or two. I think we may see intermittently from time to time some slow, probably small CFC growth into the market. There is one case that had some supplies of CFC and so that will at various moments slow the progression.

But I think generally speaking the process is in full motion. But I think we’ll see some occasional slowing based on some flow of material into the market. So it is a market that has some unusual characteristics, but as you know, our product is a brand, it was approved as a brand, it launched as a brand, and it is commercialized as a brand.

The last part of your question I think was about pricing, and I’m not sure I have anything more to add to what I mentioned earlier about price, which is that we’re not at this point anticipating any increase. It is possible there’ll be some price competition but that always occurs largely through the managed care end.

But right now things are relatively stable.

Shlomo Yanai

I don’t know how long the line is of people who still want to ask questions, but we have to limit it to one more question, and apologies to any more who are waiting in line. But we are obviously available to questions even beyond this Q&A period.

Will Sawyer - Leerink Swann

Thank you.

Operator

Our final question comes from Elliot Wilbur with CIBC World Markets. Please state your question.

Elliot Wilbur - CIBC World Markets

Thank you. I just have to ask a halfway intelligent question now. With respect to Copaxone franchise, twelve months ago a lot of us were worried about the deceleration there, but the product has held up very well.

But we’re also starting to get a lot more visibility now on pipeline products that maybe don’t have that potential but they definitely have less onerous dosing profile. And it seems like in terms of the growth of your MS franchise going forward, you’ve definitely placed your bets on an oral product, first Copaxone and Laquinimod.

But I’m wondering, are you also exploring other franchise extension avenues for Copaxone in terms of just improving the dosing profile, that maybe you haven’t talked about? I know there was some speculation a while back that you might be looking into it, but I’m wondering if you’re not also exploring some longer-acting injectible technologies as well.

Shlomo Yanai

Moshe, will you take this one?

Moshe Manor

We are looking at this opportunity as well. As you know we have the 40mg as a daily Copaxone as our main initiative and we are continuing to look at opportunities for Copaxone in different forms, a different regimen, but apparently we cannot report significant progress other than the 40mg, and that’s really most of our MS franchise.

Operator

Thank you.

At this time, there are no further questions. I will now turn the conference back over to management for any closing comments.

Kevin Mannix

OK, hi, this is Kevin, on behalf of the TEVA team I’d like to thank everybody for joining us today. As always, if you have questions we’re happy to take them offline. We have our luncheon today here in New York so please join us in person, or participate via the web chat.

Thank you very much.

Operator

To access a replay of this conference, please dial 877-660-6853. Any international callers can dial 201-612-7415. The account number is 3055 and the conference ID number is 238370. Thank you.

This concludes today’s conference. Thank you all for your participation.

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Source: TEVA Pharmaceutical Q1 2007 Earnings Call Transcript
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