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Teva Pharmaceuticals (NYSE:TEVA)

Q3 2006 Earnings Call

November 7, 2006 8:45 am ET

Executives:

Israel Makov, President and Chief Executive Officer

Moshe Manor, Group Vice President, Global Products

Dan Suesskind, CFO

William Marth, President & CEO, Teva Pharmaceuticals USA

George Barrett, Group VP, North America, President & CEO, North America

Kevin Mannix, Director Investor Relations

Analysts:

Greg Gilbert, Merrill Lynch

Rich Silver, Lehman Brothers

Robert Bonte-Friedheim, Citigroup

Ken Cacciatore, Cowen & Co

Doug Landy, CIBC World Markets

Randall Fenicki, Goldman Sachs

Marc Goodman, Credit Suisse

Ron Miguel, Sanford Bernstein

Louise Chen, Morgan Stanley

Adam Greene, JP Morgan

David Buck, Buckingham Research

William Sawyer, Leerink Swann

Corey Davis, Natexis Bleichroeder

Operator

Greetings ladies and gentlemen and welcome to the Teva Pharmaceutical Industries Ltd. Third Quarter 2006 Earnings Results Conference Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press * and 0 on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mr. Kevin Mannix, North American Director of Investor Relations for Teva Pharmaceutical Industries Ltd. Thank you, Mr. Mannix, you may begin.

Kevin Mannix, Director Investor Relations

Thank you, Dan. Good morning and good afternoon everyone, welcome to Teva’s Third Quarter 2006 Earnings Conference Call. We hope 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 our website. Today, we are joined by Israel Makov, President and CEO; Dan Suesskind, Chief Financial Officer; George Barrett, President and CEO of Teva North America; Bill Marth, President & CEO of Teva USA; and Moshe Manor, Vice President of Global Products. Israel and Dan will begin by providing an overview of our results. We will then open up the call for a question and answer period.

I’d also like to remind all of you that we will host a special quarterly luncheon today in New York. For those of you who haven’t received our invitation or have not yet RSVP’d, please call us at 215-591-3056, and if you’re unable to join us we are conducting a live webcast of the event, which will also be available on our website.

Before we proceed with the call, I’d like to remind everyone that the Safe Harbor language contained in today’s press release also pertains to this conference call and the webcast. I would now like to turn the call over to Israel Makov, our President and CEO. Israel?

Israel Makov, President and Chief Executive Officer

Thank you, Kevin, and thank you all for joining us today as we announce Teva’s results for the third quarter of 2006. Third quarter ’06 was not just another record breaking quarter for Teva. It was truly a superb quarter across the board, one with record sales and record profit and profit margins. Our quarterly sales approached $2.3 billion, and for the first time in our history our profits passed the $600 million mark representing net income margin of 26.5%, and we achieved record cash flow from operations of approximately $800 million.

These outstanding results were driven primarily by record breaking sales and operating profits in North America including the major launches of sertraline and venlafaxine, which combined with our continued exclusivity on simvastatin drove quarterly generic sales in the U.S. beyond the $1 billion mark. On a different order of magnitude, but still quite significant, our respiratory franchise in the U.S. more than that doubled its sales quarter-over-quarter. I believe our overall results in the U.S. this quarter once again illustrates Teva’s leadership, and this leadership is not confined to the U.S. but it is expressed across all our businesses and geographies.

In our international business, those geographies outside North America and Western Europe, we had record breaking results this quarter as well, and the excellent performance of our European business was driven by new launches and volume growth. We will be describing our European business in greater details in depth at our luncheon this afternoon.

This was also an exciting quarter for our innovative business. We launched our second innovative product, Azilect, for the treatment of Parkinson’s disease in the U.S. in mid-July and are extremely pleased at the reception it is already receiving in the market. We are enjoying a high rate of growth with the prescriptions, and the latest IMS weekly information shows over 1800 new prescriptions and over 3000 total prescriptions for Azilect. We estimate that 15,000 patients are now being treated with Azilect in the U.S. Sales in Europe are also growing nicely and our most recent launch in another large European country, Spain, is already quite successful. Altogether sales of Azilect in the third quarter reached $16 million.

I’m also very pleased to announce the swift progress that we are making in our Edratide, a phase three clinical trial which studies Azilect’s potential effects on modifying the progression of Parkinson’s disease. We have now completed recruitment for the study, something we had expected to complete only in the first quarter of 2007, and we expect the study’s results already in mid 2008. As you know, there is currently no other driver in the market indicated for disease modification of Parkinson’s.

Last quarter sales of our innovative product, Copaxone, totaled $354 million, an increase of 15% over the third quarter ’05. Outside the U.S., primarily in Canada and Europe, sales of Copaxone grew 26% to reach $128 million. In the U.S., Copaxone continues to lead the MS market in terms of both new and total prescriptions based on IMS data. A recent study showed Copaxone being slower than all of the generative tissue damaging that is a key aspect of MS. In addition, this long-term study suggested that Copaxone had a beneficial effect in slowing axonal loss and enhancing recovery.

This was also a strong quarter for TAPI, Teva’s Active Pharmaceutical Ingredient business. We supplied the API for a broad range of our own pharmaceutical products including some of our most important launches. Sales to third-parties were just 3% higher than in the third quarter ’05, but of course one of our largest external customers from last year, IVAX, became an internal customer this year. I believe that we will see a higher and higher proportion of internal sales of API, something we are pleased about, since of course internal sales or if you like vertical integration yields the most value.

I would now like to turn to some of our accomplishments in the IVAX integration. We set ambitious goals including an ambitious timetable for the integration, and I’m very pleased to say that in many cases we are exceeding these goals, which means that we are realizing more synergies. In many geographies around the world we’re integrating IVAX’s supply to chain into Teva’s global supply chain, something that is also allowing us to eliminate production overlaps and streamline operations.

We have already closed four plants in the U.S. and Canada this year and have announced the close of Cidra, IVAX’s largest plant located in Puerto Rico, earlier than we had originally planned.

And while we are on the subject of operations, I would like to announce that the FDA inspection of our new state-of-the-art manufacturing plant in Jerusalem is now underway. This plant in 2007 will be able to produce 4 billion tablets and in 2008 8 billion of tablets will greatly enhanced the capabilities of our global supply system to meet the growing demand for our products.

I’m delighted to report that we have completed the integration of all of IVAX’s R&D team’s generic, innovative, and API into Teva’s global R&D. By combining the talents, best practices, and development projects of the two companies, we are of course eliminating duplication and are also creating the optimal portfolio of projects. We have also fully integrated our marketing and of course our administrative teams around the world, and this allows us only to achieve one of our goals, presenting one face to our customers in most of our geographies.

As I’m sure you can appreciate, we have realized not just cost synergies but significant sales synergies. The extremely successful launches of simvastatin and sertraline were accomplished by IVAX and Teva teams working together. Neither company could have achieved these results on their own. And we are realizing sales synergies in many other products and lines as well. One of the most exciting is our respiratory line in the U.S., where as I said earlier we have already doubled our sales in the third quarter ‘05. We believe that the transition away from CST prophylaxis is beginning to accelerate, and we are very pleased that to be among the pioneers leading the conversion to HFA-based products in the U.S. market.

And all of this is having a positive impact on our results for 2006 and beyond. We are therefore raising the range of our earnings per share guidance for 2006 by $0.10 from a range of $2.15 to $2.25 to a range of $2.25 to $2.35. Of course, there is still another quarter to go this year as you all know and our guidance is based on certain assumptions, particularly about our plans for new product launches during the fourth quarter and about the effect of competition on products whose exclusivity will expire in the near future.

As of 2007, we are now in the midst of our annual process of developing our three-year work plan, this time covering the years 2007 through 2009, and we will be able to provide you with formal and detailed guidance for next year in February when we record our full year’s results for 2006. What I can say now is that our preliminary look at our trajectory for the three-year planning period is good and it is consistent with the long-term guidance that I gave you in August, and we expect 2007 to be a good year. Having said this, I need to remind you that 2006 is an extraordinary year in which we are experiencing the confluence of a number of factors, notably the concentration of very large exclusive generic launches in the U.S. These naturally will create a challenge for 2007 in terms of period-to-period comparisons when these exclusivities expire. Nevertheless, next year in 2007, we still expect to obtain a single digit growth in top line against this extremely robust year, based on the fact as we have frequently reminded you that we have multiple growth engines in our business.

In general terms, we would expect 2007’s margin to return to more typical levels, frankly making bottom line growth challenging. But, there is still a great deal of work to do in our planning process and it is therefore again really too early for us to provide any more specific indications.

Before I close I would like to say just a few words about the plans recently announced to retire from Teva in the early part of next year. I want to assure you that in every respect it has been…and that I’m fully dedicated to continuing to lead the pack until my retirement. And of course I intend to give our CEO designate, Shlomo Yanai, as much support as he needs until I retire, and after that in my capacity as an advisor to the board. I also believe that Teva’s leadership team will give Mr. Yanai the utmost support, and this in my opinion means he will have the support of the best leadership team in the industry. I’m not saying my farewells to you today. We will have an opportunity for that in the future, and in the meantime I look very much forward to seeing you all at our luncheon this afternoon. Thank you very much and I will pass the mike now to Dan.

Dan Suesskind, CFO

Thank you very much, Israel, and good day to all of our friends around the world. I hope you have had a chance to review the excellent figures we released this morning. If you have, I believe you found that they are significantly better than most expected. The comparison between the two quarters is not an apples-to-apples comparison, because the result of IVAX was not included in 2005 since we only closed the acquisition in January’06, but the comparisons between the two quarters involves any acquisition related or other similar challenges that we would typically adjust for in our presentation.

Let me give you the synopsis of our figures. Let’s compare to the third quarter of ’05, sales are up 74% to almost $2.3 billion, net income is up 127% to $606 million, and EPS is up 85% to $0.74. This quarter we once again exceeded $2 billion in our sales, gross profit of $1 billion, and for the first time exceeded $600 million in net income. Cash flow from operations and free cash flow both reached a new record level of $793 million and $658 million respectively. For the nine months sales exceeded $6.1 billion, up 59%, net adjusted income is up 87% to over $1.4 billion, and adjusted EPS has increased 55% to $1.77. These nine-month figures for ’06 have been adjusted to exclude primarily acquisitions related items arising from the acquisition of IVAX, which we have highlighted to you in previous quarters. We strongly believe that the adjusted results that are used by management provide a better indication of Teva’s operations and plans.

With that I will take you now through our quarterly results line by line beginning with sales. As I mentioned, sales increased by $969 million year-over-year with only 1% of currency effect. This is the second quarter where the most significant impact on global sales was derived from our major product launches in the U.S. These launches also impacted the breakdown of global sales by increasing the U.S. component. Outside the U.S., the acquisition of IVAX was the primary but not the only contributor to significant increases in our European sales and a dramatic increase in our international sales, which grew 2.5 folds quarter-over-quarter mainly as a result of adding new markets or expanding sales in existing markets in Latin America and Central and Eastern Europe.

Total international sales, which are all sales outside North America and Western Europe which includes Israel, amounted in the quarter to $337 million, and accounted for 15% of global sales. Sales in Western Europe which grew 37% decreased their rate in total global sales to 23%, while North America rate in global sales increased to 62% in the reported quarter.

The major launches in the U.S. not only impacted our breakdown of global sales but also had a major positive effect on the consolidated margins because as they both increased the relative rate of the higher margin U.S. sales and reduced Europe’s proportion with its lower average margins.

Global market sales of Copaxone amounted to $354 million. This is a 15% increase over the comparable quarter. Sales in the U.S., a much more mature market, increased 10% to $226 million, and non-U.S. sales, mainly Europe and Canada, increased at a much higher pace of 26% to $128 million. Non-U.S. sales account now for 36% of total global in-market sales.

As to Teva’s API business, sales to third-parties this quarter amounted to $141 million, up 3%. Remember that API sales to IVAX, which in the past were recorded as third-party sales are this year recorded as internal sales. In addition, the API business sold $180 million worth of raw material internally to Teva’s pharmaceutical operations, an increase of 42% over the 2005 comparable quarter, reflecting the supplies used to support some of Teva’s major U.S. generic launches.

Stepping down one line in the P&L to gross profit; gross profit margin reached 55% in this reported quarter compared to 47% in the comparable quarter. This is a gross margin level that is far outside Teva’s historical range of 45% to 48%. While this should not be seen as a sustainable level, this is certainly not the last quarter in which we expect to achieve gross margins above the normal range that we have indicated to you in the past. Going forward, this band should be more in the 47% to 50% level.

And from gross margin to R&D; net R&D increased by 45% to $134 million; by far a historical record. This record number represents the importance that Teva is giving to its R&D activities and demonstrates the combined R&D efforts following the IVAX integration on generic API and innovative R&D.

From here to SG&A; this reached $404 million in this quarter and represented 18% of sales. As we mentioned in previous quarters, this is a substantially higher percentage of sales compared to Teva’s standalone historical figures prior to the IVAX integration, which averaged 15.2% in fiscal ’05. To a large extent, this increase reflects the consolidation of IVAX’s significant branded products and operations in many branded generic markets, which usually is a higher gross margin but also require substantially higher selling and marketing expenses.

While substantial synergies have already been realized in the SG&A line items, going forward we expect the further realization of synergies as well as economies to scale created through the growth of Teva sales. The net effect may result still in an increase going forward of the SG&A line item as a percentage of sales with a change in the product mix and the higher proportion of branded products. In addition, Teva’s successful introduced of Azilect in the U.S. and non-U.S. markets generated higher sales and marketing costs. Option expensing which was introduced in 2006 accounted for approximately $9 million in this quarter and was mostly included in SG&A.

Operating profit this quarter reached 32% of sales compared with 25% which was our average operating margin in fiscal 2005. The quarterly interest paid on our $4.7 billion current level of long-term debt plus interest on our short-term debt amounts to around $50 million, against which we earn a yield on our cash and quasi cash balances which at quarter end has stood at about $2.1 billion. Thus, our net financial expenses for the reported quarter including income from derivatives amounted to $28 million. This compares with the third quarter of ’05 prior to the financing of the IVAX deal where we achieved financial income of $7 million.

The third quarter financial income are, however, lower sequentially as we have indicated to you already in the previous quarter. Going forward, we still expect the typical financial expenses net of currencies and hedging activities, which fluctuate from quarter to quarter, to be in the range of $30 million to $35 million a quarter.

As to the provision for income tax; in the first quarter we provided for 19% of tax on adjusted earnings, which was then our best estimate of our annual rate. We adjusted the annual rate to 17.5% in the second quarter which mainly reflects the exclusive launch of simvastatin, something which was not certain when the first quarter figures were released. This adjustment resulted in a second quarter quarterly tax rate of 16.7% including a catchup for the first quarter. Now, we adjust the annual rate again due to the changes in our product mix and better than expected launches of our exclusive products. Now, it is an annual rate of 15.5% resulting in a quarterly tax rate again including catchup of 12.5%. All that leads to our net income of $606 million, up 127% from last year. EPS based on this adjusted income to which about $7 million were added back related to the converts works out at $0.74 on the larger share base.

As we already indicated three months ago, our quarterly cash flow from operations is catching up this quarter, subsequent to the low level of cash flow generation in the previous quarter. Last quarter, it reflected the steep increase in working capital due to the huge late quarter launch of simvastatin and the upcoming launch of sertraline. Cash flow from operations amounted to a record $793 million in this quarter as compared to $212 million in the prior quarter of ’06 and $385 million in the comparable quarter of ’05.

Our working capital, receivables, and inventory net of payables decreased sequentially by approximately $60 million to approximately $2.4 billion. Free cash flow, which is calculated as cash flow from operations net of capital expenditures and dividends, increased 10 folds sequentially and amounted this quarter to $658 million.

Yesterday, the board of directors approved the buyback program of stock and converts of $600 million. We have had three prior buyback programs over the last several years, each of which was smaller than the one just announced. In the past, due to the active volume of trading in our securities, we were able to complete each of these programs in a relatively short period of time, and we would hope to be able to do so again this time.

The volume of this program represents less than 30% of our cash reserves at the end of the third quarter and less than the free cash flow that we have generated this quarter, and leaves ample funds for M&A and product acquisition opportunities as they may unfold and any other needs, be it CapEx investments or support of our extensive R&D program.

From here some working capital items; first day sales outstanding and receivables. This decreased from 59 days in June ’06 to 63 days in September ’06. We have calculated this after netting out the sales reserves and allowances, the so called SR&A, from the receivables. As you know, we record receivables on a gross basis and record the SR&A under 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 at September 30, 2006, amounted to over $1.4 billion, an increase of $159 million from June 30th. About 93% of the total reserves are from the U.S., up $145 million from June of this year. The large products launches create substantial SR&A.

Inventories increased by 5% to $1.9 billion with day sales and inventories down from 163 days to 162 days. This quarter, CapEx amounted to $96 million compared with a quarterly average of $77 million in fiscal ’05. However, net profits from sales of products net of these sales, CapEx amounted to $76 million in this quarter.

As to our debt, $4.7 billion or 86% of our total interest bearing debt at September 30th is long term, $2.6 billion in converts and $2.1 billion in straight, fixed and floating interest debt. The debt-to-equity ratio stands on this date at 0.34. Shareholders’ equity at September 30, 2006, exceeded for the first time the $10 billion mark and reached $10.6 billion.

For the convenience of our audience, I would again like to mention three figures relating to our share count before we open up for Q&A, so that we are all on the same page. For the third quarter of ’06, our average share count for the purpose of calculating fully diluted EPS was 833 million shares, while at the end of the third quarter our share count for calculating these earnings was approximately 834 million shares, and for calculating our market cap, it’s approximately 769 million shares.

Yesterday, the board approved also a third quarter dividend amounting to approximately $60 million. On a per-share basis, our dividend base on the current rate of exchange of the Shekel to the Dollar amounts to approximately $0.79 per share, slightly higher in dollar terms than the dividend in the last few quarters.

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 * and 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press * and 2 if you would like to remove your question from the queue. For participants using speaker equipment it maybe necessary to pick up your handset before pressing the * key. Our first question today is coming from Greg Gilbert of Merrill Lynch, please proceed with your question.

Greg Gilbert, Merrill Lynch

Thanks. First for Dan on some financial stuff, do you still think you can do about $8.5 billion in revenue this year and do you think you can hold margin at 50 or above even with some exclusivities coming off?

Israel Makov, President and Chief Executive Officer

This is Israel Makov. This would be the top line for this year based on the last three quarters, and it will probably closer to $8.4 billion than to $8.5 billion. And as you may know we are going to lose the exclusivity of simvastatin at the end of the quarter, and we are going to lose it certainly at the beginning of the first quarter of 2007, and you will see the margins going down but still would be very, very high.

Greg Gilbert, Merrill Lynch

Can you comment on what has done less well than you originally thought on the top line?

Israel Makov, President and Chief Executive Officer

Well, I don’t think that it rests well. If you are talking about say a difference of 1% to 2%, the resolution of our estimates is not that great and it’s not something specific that will slow. It’s just an overall 1% or 1.5% less and the difference is not that big.

Greg Gilbert, Merrill Lynch

Okay, and one quick followup for George and/or Bill, how would you characterize the level of discounting going on in the albuterol HFA stage currently, and can we still assume a nice healthy premium above the generic CFC pricing when all the dust settles? Thanks.

George Barrett, President & CEO, Teva North America

Great, I’ll take it, it’s George. Certainly the HFA market continues to trade at a pretty healthy multiple to the generic CFC market. We have not seen a significant amount of erosion. I think what we will probably see and are seeing and certainly participate in our programs to facilitate the change and programs to help patients convert from one to the other, but pricing is relatively robust in the HFA segment.

Greg Gilbert, Merrill Lynch

Thank you.

Operator

Our next question is coming from Rich Silver of Lehman Brothers, please proceed with your question.

Rich Silver, Lehman Brothers

A couple questions, first of all on some of the operating expenses. Dan, maybe I missed it but what was your commentary on R&D going forward either in absolute dollars or as a percentage of sales?

Dan Suesskind, CFO

You didn’t miss because I didn’t mention, but we are talking about net R&D of approximately 6% to 7% going forward, and that’s our indication.

Rich Silver, Lehman Brothers

Okay, and on a specific product, ProAir Breath Actuated inhaler, can you give us some sense of when we should expect a response from the FDA?

George Barrett, President & CEO, Teva North America

Rich, it’s George. We submitted data to the agency in late spring, end of June, and it’s our hope that we’ll hear something back from them late this year or early next year. Again, whether or not that is a final approval or some additional requests, we’ll know then, but sometime late in the year or early next year.

Rich Silver, Lehman Brothers

Can you provide some commentary on the international and European businesses in the quarter looking forward?

Israel Makov, President and Chief Executive Officer

As I said Rich, we had a record quarter for our international business, both on the top line and on the bottom line. We expect this section of our business to grow at relatively a fast rate, and this quarter we had very good results. It was close to the all time record in Europe, a very strong result, again both top and bottom line.

Rich Silver, Lehman Brothers

And one last one on the U.S. business, can you comment on the base business and what you saw in the quarter relative to the previous quarter, stability, any kind of deterioration, just something to give us a sense of how that base excluding the major new introductions is doing.

George Barrett, President & CEO, Teva North America

Rich, the base actually looks very good. Pricing was I would say pretty comparable to prior periods, so very comparable to what we gave you in the second quarter. And on a volume basis actually if you eliminate our large exclusive, actually our year-over-year growth is a rolling 12 months on our base was actually very robust at about 16%. So, from a volume standpoint we see some strong signs and pricing is relatively stable comparable to the last period.

Rich Silver, Lehman Brothers

Okay, I’ll jump out, thank you.

Operator

Our next question is coming from Robert Bonte-Friedheim of Citigroup; please proceed with your question.

Robert Bonte-Friedheim, Citigroup

Hi, I promise to ask just as many questions as Greg. I just wanted to double check, could you give us an outlook on the margins Dan? I’m just running through the numbers here and if I take out all the big exclusivities, I get to even Teva alone a gross margin underlying that is actually at the top end of your historic range by itself before the big exclusivities, again obviously you’re not going to 55%, but I guess to 49% or 50%, could you comment on that, is that reasonable that excluding the exclusivities we need to kind of be upping our range in the medium term for Teva?

Dan Suesskind, CFO

As I said, we are increasing the band that we have indicated in the past from 45% to 48% to 47% to 50%, which is certainly higher than we indicated in the past.

Robert Bonte-Friedheim, Citigroup

Okay, I have you right, and on this quarter it feels like you are basically 50% down, Teva is at 50% and IVAX at 47%, so together you’re at 49.5% already?

Dan Suesskind, CFO

So isn’t 49.5% somewhere between 47% and 50%.

Robert Bonte-Friedheim, Citigroup

Okay, that’s correct. Now, were there any one-offs in the numbers if I may followup, any sort of stock adjustment or wholesaler inventories moving around either way?

Dan Suesskind, CFO

Nothing out of the ordinary.

Robert Bonte-Friedheim, Citigroup

Okay, could you break down for us the Azilect sales U.S. versus non-U.S.?

Dan Suesskind, CFO

No, we said $16 million, I don’t think that’s a small number that we have to break up into two elements.

Robert Bonte-Friedheim, Citigroup

And in the U.S. Copaxone sales how much of the increase year-over-year is price increase and how much is volume?

Dan Suesskind, CFO

Most is price increase.

Robert Bonte-Friedheim, Citigroup

Okay and the last question, just trying to get to Greg’s number here. Just double checking on generic pricing as the outlook, as we’ve seen sort of people were very worried towards last year on generic pricing pressures, and now it seems there are a lot of headlines about it, but actually I can’t find examples of a lot of pricing pressure in corporate numbers, are you seeing a lot of pricing pressure increasing right now?

George Barrett, President & CEO, Teva North America

Again Robert, it is George. Again, from the U.S. standpoint we are at a range that’s very comparable to what we reported in the last quarter and actually the quarter before that. So, having said that, you know the nature of this market, it’s always competitive, but it seems to be relatively stable period over period. Outside of the U.S. as you know it varies tremendously by market, so markets are actually very stable and some more governments take actions and those happen episodically.

Robert Bonte-Friedheim, Citigroup

Okay, and then if could do a last followup, outside the U.S. was there any one big one off in any major market either way plus or minus?

Dan Suesskind, CFO

There were no special one offs.

Robert Bonte-Friedheim, Citigroup

Okay, thank you very much.

Operator

Our next question is coming from Ken Cacciatore of Cowen and Company; please proceed with your question.

Ken Cacciatore, Cowen & Co

Hi, thanks. This is a question for Israel. Israel, you drive the point here with Teva becoming a very large company. It’s obviously good news but you’re going to have difficulty growing it in the future. You have industry specific issues, you have Wal-Mart, KMart, and TDS, so you have consolidation of the customer base, and from India and China and probably fewer generic opportunities going forward. My question is why would Teva look outside of the company and outside of the generic industry to add a CEO when you have what you would think you would need kind of industry specific expertise?

Israel Makov, President and Chief Executive Officer

Well, I think that they are industry specific and not so negative as you described them. I think the consolidation on the customer’s side is actually good news for us, because the larger the customer they like to work with a larger provider. And as I told all of you in August that I believe Teva will be able to enjoy a growth rate of mid-teens in the next few years. I also have to remind all of you that we always in the long run grew at a faster rate than we stated. If you look at the last five years, we grew in the top line over 30% and the bottom line over 40%. This is number one. Now, you know that change of captains occurs and I think it should be done when the times are good and not when the times are challenging, and I think that Teva is now enjoying fantastic prosperity, we have a fantastic year, we see a very bright future, and probably this is the time. You don’t want me to hand over the driver’s seat when we meet all of our challenges, and this is probably going to take another 100 years, and I’m not going to stay that long.

Ken Cacciatore, Cowen & Co

George, if I could ask a specific question on Pravachol, what you learning from Pravachol as you look towards Zocor, anything surprising you in the pricing of the level or lack of competition or level of competition?

George Barrett, President & CEO, Teva North America

Why don’t I let Bill address that, Ken?

William Marth, President & CEO, Teva Pharmaceuticals USA

Yeah, Ken. The Pravachol actually seems to have gone very well, the transition from exclusivity. As you know, there weren’t quite as many players as one had expected. Although price is lower, we’re very pleased with the share that we kept with a very orderly transition.

Ken Cacciatore, Cowen & Co

Great, thanks guys.

Operator

Our next question is coming from Elliot Wilbur of CIBC World Markets.

Doug Landy, CIBC World Markets

Hi, good morning everyone this is Doug Landy speaking for Elliot Wilbur. Thank you for the R&D guidance. I was wondering if we might be able to get some for SG&A as well. And also a question on Azilect, noticing IMS, the prescriptions were around 8000, which at an ASP of 175 assumes about $70 million for the year, is that a good number to think about going forward? Thank you.

George Barrett, President & CEO, Teva North America

Why don’t we get to the second first and we’ll come back to the first. Doug, we’ve not provided guidance specifically on Azilect for the year. You know that we’ve given some very broad stroke guidance as it relates to what we think peak sales could be. What we can say is it’s off to a really good start. You may notice by the way for those of you followed IMS, a little dip in the last week or two and that really relates to a methodology change when you get to a certain size and they start working the product individually rather than aggregate it with the category. It’s off to a really good start, but in terms of specific numbers for the year that’s not something we have or provided.

Moshe Manor, Group Vice President, Global Products

One thing I would add if you look at the results so far, and actually it’s only three months, looking back at the PD market it definitely looks as one of the best launches in the PD market if you look at the market share. So, this is very positive for us.

Doug Landy, CIBC World Markets

Okay, thank you.

Operator

Our next question is coming from Randall Fenicki of Goldman Sachs; please proceed with your question.

Randall Fenicki, Goldman Sachs

Great, thanks guys. Can you just run through the ’07 detail that you gave again and clarify the single digit top line growth on the $8.4 billion to $8.5 billion number, then the band, 47% to 50% of the gross margin, and from a tax rate perspective is the 15.5% the way to be thinking about that? Secondly, as you think about the three-year plan, is the Copaxone take back a part of that and is there any further detail you can update us on that? Thanks.

Dan Suesskind, CFO

I don’t understand what we have to repeat, but relating to the tax rate, the tax is something which is very difficult to estimate in advance for Teva, but I would say it should be higher than 15.5% next year. Our historical levels were in the upper-teens and it will be somewhere there. Relating to Copaxone, the impact of the take back of Copaxone as we have indicated to you will initially only have an impact on the top line, it won’t have an impact on the bottom line.

Randall Fenicki, Goldman Sachs

But, is that a royalty base?

Dan Suesskind, CFO

We didn’t specify in the past what it is but we said that it will have an immediate impact as of March or April of ’08 on the top line and after a relatively short period will also have the full benefit of the bottom line. In between, it is not expected to have an impact on the bottom line.

Randall Fenicki, Goldman Sachs

Okay, thank you.

Operator

Our next question is coming from Marc Goodman of Credit Suisse; please proceed with your question.

Marc Goodman, Credit Suisse

Yeah, the question had to do with the pharma sales in the rest of the world, it jumped to a new level and I was wondering if you could tell us what happened in the quarter that was so special, were there new product launches, did Latin America just take off, and this is a new sustainable level?

Israel Makov, President and Chief Executive Officer

I would say that international comprised of tens and tens of markets, and since we have done well in most of these markets the increase is just an accumulation. If you compare it to last year of course, last year we didn’t have the IVAX market in our results, but this year we have so many markets, and those markets are not huge markets, but each of them is not a huge market. Some of them are larger, some of them are smaller, but we have done very well in most of these markets and the result is an accumulative result.

Marc Goodman, Credit Suisse

What if we just compare this to the last quarter or the first quarter when you had IVAX?

Israel Makov, President and Chief Executive Officer

It’s better than that.

Marc Goodman, Credit Suisse

I was just wondering if you could comment why.

Israel Makov, President and Chief Executive Officer

Just look, we are integrating the two companies in many of these markets. Integration is going very, very well. We are doing better than each one alone. In many of these markets you have to remember the emerging markets for generic, so the markets are growing and in some of these markets we are still in a trend of a very high year growth rate. So, this is why we increased the sales and we are going to increase it in the next year and the year after. It’s one of the growth engines that we have, but we cannot tell you that there is one product or one market which makes a huge difference. Remember CEE is a high growth region, Central Eastern Europe, and Latin America is a high growth market. As we have shown in other places, I think that Teva specializes in current opportunities and realizing the fully potential of these opportunities and this is exactly what we are doing now.

Marc Goodman, Credit Suisse

Thanks.

Operator

Our next question is coming from Ron Miguel of Sanford Bernstein; please proceed with your question.

Ron Miguel, Sanford Bernstein

Good morning and thank you for taking my question. Three quick ones; the first one, George, about the HFA, can you tell us a little bit more on the capacity situation in the industry, are we looking here at a situation where the transition will be on capacity constraint or is there enough sufficient capacity across three or four manufacturers to fill the market needs pretty comfortably?

George Barrett, President & CEO, Teva North America

Hey Ronnie, I think we’re sort of in that transition phase. As you probably know, one of the major…as far as we announced earlier this summer that we would discontinue sales of CFC having visibly run out of gas literally, and now one of the major CFC players has also announced. I think capacity in a sense is relatively well matched to demand right now, but it’s a little bit lumpy, I guess the way I describe it. So, it’s not completely clear. I don’t think there’s a huge excess capacity around the industry to deal with it today. Everybody is adjusting. We have of course ramped up our capacity which will be building over the course of ’07, so again I think it’s perhaps a little tight at the moment, but that’s the general direction.

Ron Miguel, Sanford Bernstein

And a couple of quick follow-ons from there; one of them is, now that you probably have your ’07 managed care agreements already signed, how do you see pricing in ’07 comparing to ’06? And last on this issue, you have a relatively smaller sales force in the PCP area comparing to some chief competitors, you’re probably ahead in the HFA market but can you maintain that lead in terms of market share?

George Barrett, President & CEO, Teva North America

I’ll deal with the second one first and then I’ll come back to the first. Yeah, we have a pretty good share, and we’ll talk a little bit about that at lunch today on the HFA market. We certainly hope to retain it. Obviously now the world will be a little bit different. There will be some sensitivity just to supply and capacity. Companies may reposition a little bit to try to take advantage of those opportunities. I think we’ve got the tools to do that. We built a small sales force but this is going to be a unique kind of situation which in a way involves the physician but also in a way involves the pay orders and the resell chains, and we are going to work with all of our tools across both our branded and our generic enterprise here to see if we can supply to that market.

Ron Miguel, Sanford Bernstein

Right. And last one on bio-generics, your CapEx plans already include to build $1 billion cell culture facility?

Israel Makov, President and Chief Executive Officer

We have plans to build up facilities to do whatever is needed in order to make sure that our bio-generics will reach the market in the best possible way. Some of it by the way is produced by third-parties, not just our own, and I guess that one day we’ll give you more color into this business. But the one thing we surely are not going to do is build one of these $1 billion monsters for production of bio-tech products.

Ron Miguel, Sanford Bernstein

Okay, thank you.

Operator

Our next question is coming from Louise Chen of Morgan Stanley; please proceed with your question.

Louise Chen, Morgan Stanley

Hi, just followup on the HFA question. I was wondering in terms of the market size and the opportunities if you could talk a little bit more about. And then the IVAX respiratory franchise, what are the growth drivers for that as we look into 2007?

George Barrett, President & CEO, Teva North America

Again, it’s George, I’ll take the HFA. I can talk a little bit about respiratory here in the U.S. and then one of the others will touch base outside. I’m sorry the HFA question was?

Louise Chen, Morgan Stanley

The market size and the opportunities.

George Barrett, President & CEO, Teva North America

Again, this s a little bit tricky to answer because it does depend a little bit on the price point. The market may be in the $1 billion range. I think it is a little bit difficult to zero in on that because this is a bit of a unique situation. We’ve got a conversion from one kind of market to another, so I’m a little reluctant to give you firm data. I don’t think anyone of us actually has that at this point. I think we should also expect that each player in the HFA market – I know for sure Teva and I guess should speak for everyone else – but we are certainly aware of how to make sure that we could help patients transition and working with managed care and payers to do that. So, from a general sense I can give you that. From the U.S. perspective, there have been really two drivers, and the factory Israel mentioned, while this is a small business in the U.S. we have doubled over the year. And surprising it’s not really just HFA. It’s really the repositioning of ProAir which is our inhaled corticosteroid, which is a very interesting product and very interesting in light of more recent IAH protocols for asthma. So, we’re able to take advantage of its positioning and small particle size. This product is Qvar we’re referring to. So, Qvar has done very well, very strong growth this year. We expect it to continue to grow next year. The HFA conversion will take place increasingly as Israel mentioned, and then as we look to the Breath Actuated product we’re hoping that sometime in ’07 we’re able to launch that product. Again outside, we’ve been doing very, very well with both short-acting beta agonists and the inhaled corticosteroids in other markets, particularly in the U.K., so we still have got good positioning here.

Louise Chen, Morgan Stanley

Thank you.

Operator

Your next question is coming from Adam Greene of JP Morgan; please proceed with your question.

Adam Greene, JP Morgan

Thanks, good morning. First on the API business, I realize that buybacks was third-party customer last year, but this year we’ve seen a sequential decline for the last two quarters. I’m just wondering if you could explain what exactly is going on there, where do you expect that to stabilize, is this kind of the third quarter number more of a base level than what we’ve seen in the past?

Israel Makov, President and Chief Executive Officer

As I said, a proportion of internal sales are just going to grow. Remember that we get greater revenue from internal sales and not from external sales. Now, the external sales to customers are product related, and if we participate in the customer’s launches then of course the demand increases. And if their sales are declining, the demand for our API is declining. So, what I can tell you is that we haven’t lost customers except for the one that became from external to internal. On the contrary, we are adding customers and of course it takes time to turn a customer to a major supplier. Normally we start with a customer at a time that he is developing the product, not when he’s manufacturing it. And there is one thing I can tell you, we are adding customers around the world for API. But, having said that, of course we have a major, major emphasis on internal sales, which is vertical integration, which of course provides us with huge, huge revenues.

Adam Greene, JP Morgan

Thanks.

Operator

Our next question is coming from David Buck of Buckingham Research; please proceed with your question.

David Buck, Buckingham Research

Yes, thanks for taking the question. If we look at the Jerusalem plant, Dan or Israel, what should we be thinking about that as a driver for gross margin tax free and what’s the time frame there? And this is one for Israel. Can you talk about your view of the global supply of generics, there was a comment one of your large wholesale customers that there’s an over supply of capacity, and how do you see that affecting Teva globally? Thanks.

Israel Makov, President and Chief Executive Officer

Let me start with the Jerusalem plant. The Jerusalem plant as we always said is a state-of-the-art pharmaceutical plant. We haven’t seen a plant as modern as this anywhere. There might be but we haven’t seen. And the plant is going to increase our capacity. Remember that our demand for our products in terms of tablets and units is increasing continuously and we are now at a very, very high level, and we expect this demand to increase. Therefore, we need this plant to support our supply chain. Moreover, in this plant we can be sure that we are going to supply at the highest possible quality and the lowest possible cost, and this is exactly what a generic company needs. I don’t think that there is oversupply in the world and not over capacity in the world. We see competitors coming from…look in India the India suppliers want to get out of India because the local conditions in India are not very favorable to them because of the new patent law. So, you see their attempt to do more in Europe and in the U.S., and there are other small companies that are trying to grow, and what you see is the consolidation process. During the consolidation process you will see a lot of disturbances, but the process is very, very strong and we don’t think that there is over supply. People are trying to survive in this highly competitive environment and therefore you have the consolidation process, and you can see how many transactions are being done over the last 12 months.

David Buck, Buckingham Research

Just to follow up on that point, do you see any change in behavior from the U.S. customers, particularly using some of the smaller suppliers to play against yourselves or the other large suppliers?

Israel Makov, President and Chief Executive Officer

I don’t think so. I think it’s the other way around. I think that what we can offer to the larger customers is much more than a product. It’s not just a product and a price, and by the way we meet the prices, so this is not an issue. It’s all about service and saving cost to our customers, and doing business with us is much more cost effective than doing business with a small customer.

George Barrett, President & CEO, Teva North America

Yes, I would just add. Israel makes an important point about how not only to deal particularly with this market but most markets where there is consolidation on the customer side. You know this is all a two-way proposition and that we invest a lot in creating value for our customers and fully expect our partners who seek to draw value from us to working ways that create value for us. Again, it’s important to remind everybody, this is a two-way proposition and we create value in both directions, and I think that’s how it works.

Dan Suesskind, CFO

You asked something about tax savings. As you know, production of this plant will be tax free almost to the end of the next decade, and as such it will obviously have a positive bearing on our tax rate, although you have to remember that there are so many moving parts and it doesn’t necessarily mean that it will decrease our tax rate.

David Buck, Buckingham Research

Thank you.

Dan Suesskind, CFO

We will have two more questions.

Operator

Our next question is coming from William Sawyer of Leerink Swann.

William Sawyer, Leerink Swann

Good morning, thanks for taking the questions. Two big picture questions; first, does the board’s decision to repurchase shares imply that there is a relative lack or dearth of attractive proprietary R&D and licensing opportunities, and also was this an easy decision for the board to reach? Second, a question for George, the impact of the elections on the generic industry, many believe that significant changes will be pro-generic, but there have been significant accomplishments over the last few years, I just want to hear your views on the elections, George.

Israel Makov, President and Chief Executive Officer

Regarding the buyback, it’s not that we lack opportunities for investments, and by the way we have chosen probably the best investments in our opinion. So, it’s not necessarily because of lack of opportunities. I think that what we are doing and because of the very successful acquisition and integration with IVAX, we are generating a huge amount of cash. To generate free cash flow of $650 million in one quarter is really fantastic. And what we are doing is, and you have to remember that in the future we will probably additional companies and you will use both the cash currency and the stock currency. And now that we have an opportunity to reduce the cost base at what we consider is a low cost, it will give us the leverage in our next acquisition.

Dan Suesskind, CFO

You referred specifically to the R&D. I think that I can guarantee you, and I don’t do that often as the CFO of the company, that cash will not be the limiting factor for future R&D projects that come to our table. In our R&D we have to take into account the right proportion of expense of R&D and our total expense and income structure, but cash will not be the limiting factor in any case.

George Barrett, President & CEO, Teva North America

Well, regarding your question regarding the elections. Clearly we’ve enjoyed excellent relationships with the Democrats over the years and our issues seem to resonate with them. But having said that, our issues tend to cross party lines, because any outcome of the election is likely to be a thin majority one way or the other, and the import legislation is likely to need bipartisan support. So, we are fortunate to be in a position where I think the issues of affordable access seem to go across party lines.

Operator

Our next question is coming from Corey Davis of Natexis Bleichroeder; please proceed with your question.

Corey Davis, Natexis Bleichroeder

Thanks and I’ll maybe kind of follow on that George. I know it is touch to quantify, but can you give your latest thoughts on how much of a one-time bumpy thing you’ll get in 2006 as a result of Medicare Part D? You mentioned a 16% volume growth overall on the base business, any idea how much of that came from Part D and does that make for materially tougher comps in ’07?

George Barrett, President & CEO, Teva North America

I’m sitting next to Bill Marth and every day we chart out for ourselves how exactly to quantify this. What we see in the data is growth. We have seen it basically accelerating over the year, of course with also these enormous statin launches throughout the system and essentially which SKU the day, Corey it’s very difficult to discern what’s exactly attributable to Medicare and what’s attributable to other forces in the industry, particularly the launch of some major sort of standard of care products generically. We think it’s pretty clear that there is a growth particularly in generics coming from Medicare as people in the private system adapt and attempt to bring the cost down of medicine.

William Marth, President & CEO, Teva Pharmaceuticals USA

And I would just add, Corey, I don’t think I would look at these things as one-time bumps. As we proceed into 2007 and of course we did refer to the elections before, there are likely to be changes in Med D, and as there are changes in Med D they’re looking for solutions to close the gap in the development hole, and generics is one of the ways to do that. So, we think that the programs for 2007 – we’ve already got a glimpse of them – will be even more efficient, be more cost effective, and will probably include more generics.

Corey Davis, Natexis Bleichroeder

Great, thank you very much.

Kevin Mannix, Director Investor Relations

Thank you everybody. We’d like to thank you for joining us today. As always, we’ll be happy to take additional questions offline if you have any. We also hope you will join us in person today at the luncheon or listen into the webcast. And Dan if you could please provide the replay information, I’d greatly appreciate it. Thank you very much.

Operator

If you would like to hear a replay of this conference, domestic parties may dial 877-660-6853. International parties may dial 201-612-7415. The account number is 3055 and the conference ID number is 217756. This concludes today’s teleconference, thank you for your participation.

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Source: Teva Pharmaceuticals Q3 2006 Earnings Call Transcript
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