Earnings Labs

Teva Pharmaceutical Industries Limited (TEVA)

Q1 2013 Earnings Call· Thu, May 2, 2013

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Transcript

Operator

Operator

Welcome to the Teva Pharmaceutical Industries Limited first quarter 2013 earnings conference call. My name is Sandra, and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Please note that this conference is being recorded. I will now turn the call over to Mr. Kevin Mannix, Vice President, Head of Global Investor Relations. Mr. Mannix, you may begin.

Kevin Mannix

Management

Thank you, Sandra. Good morning and good afternoon, everyone. Thank you for joining us today to review Teva's first quarter 2013 earnings results. I am joined today by our President and CEO, Dr. Jeremy Levin, our CFO, Eyal Desheh, Richard Egosi, Executive Vice President and Chief Legal Officer, Dr. Michael Hayden, President, Global R&D and Chief Scientific Officer, Allan Oberman, President and CEO of Teva Americas Generics, Carlo de Notaristefani, President, CEO, Global Operations, Dr. Rob Koremans, President and CEO of Global Specialty Medicines, Teva Europe and Jon Congleton, Senior Vice President, Global Medicines. Jeremy will begin by providing an overview of the highlights from the quarter and year, followed by Eyal who will then provide additional details on our consolidated financial results. We will then open the call for question-and-answer period, which will run until approximately 9:00 a.m. Eastern Time. Before we start, I’d like to remind you that our discussions during the conference call will include forward-looking statements. Actual results could differ materially from those projected in the forward-looking statements as a result of foreign currency translation effects, macroeconomic trends, interruptions in our supply chain and other factors that could cause actual results to differ as discussed in Teva’s report on Form 20-F and Form 6-K. Also, we are presenting non-GAAP data which excludes the amortization of purchased intangible assets, costs related to certain regulatory actions, inventory step-up, legal settlements and reserves and impairment and related tax effects. These are amounts we cannot predict at this point. As mentioned in the past, we present these non-GAAP figures to show you how, we the management team and our Board of Directors, look at our financial data. With that, I’ll now turn the call over to Jeremy. Jeremy, if you would, please?

Jeremy Levin

Management

Thank you, Kevin. Good morning, everyone and thank you for joining the call today to discuss Teva’s first quarter 2013 results. During my remarks this morning, I will briefly recap the first quarter and more recent highlights and we'll exercise the key milestones related to the implementation of our overall plan and strategy for the company. I joined the company as CEO nearly exactly a year ago, May 2012. Since that time, we developed and articulated our global strategy. Most recently in [December], the strategy is based upon six pillars to accelerate growth platforms, extend our global presence, executive on strategic business development, protect and expand our core franchises, reduce our operating cost and develop, retain and recruit world-class employees. We are executing vigorously on our strategic plan and are well advanced in many of the efforts to reach our goals. As a result, I firmly believe that Teva is poised to seize today's opportunities and successfully meet our industry's changing dynamics tomorrow. In regard to our product portfolio, our focus is on high value and sustainable products. We'll continue to expand our business in high value generics, including branded generics, industrialized new therapeutic entities or NTEs, which are the high barriers to entry, focus on specialty brand which include Copaxone, Treanda and Azilect. We will develop new branded products for areas of high medical in CNS and respiratory disease and expand our efforts in OTC through our joint venture with Procter & Gamble. Most recently, as part of the strategic plan, we announced the formation of our Global Specialty Medicines Group, known as GSM, with Rob Koremans as President and CEO of this group. Our goal is to create a structure that work seamlessly with our regional generics team to establish a single, differentiated Teva presence in the market.…

Eyal Desheh

Management

Thank you, Jeremy and good morning everyone. 2013 is going to be a pivotal year for Teva. We are diligently working on transforming our company and reshaping many aspects of its business and operations in accordance with the first of the new strategy we laid out late last year and we see good progress made on many fronts. We are streamlining our line of business and starting to increase operational efficiency. We continued to amend our business model towards a sustainable and profitable organic growth and adjust our global market products accordingly. At the same time, we continue to solidify and focus our R&D efforts, protect our core franchises while managing the lifecycle of our key assets and pursue select business development opportunities. Today, we are pleased to share with you our financial results for the first quarter of 2013. Generally speaking, we had a good quarter. We saw tough year-over-year comparison to the first quarter of 2012 for reason I am going to discuss in a minute. Many of our businesses performed well this quarter, in particular our generic business in Europe that delivered strong growth of Global Specialty Medicines business that maintain similar year-over-year sales level despite a lot of exclusivity on an important product like Provigil and finally our OTC business that delivered a very strong growth rates compared to last year building on strong fundamentals. During this first quarter, we also generated significant cash flow from operation and reduced our financial leverage. Before I dive into the numbers, I would like to touch on two matters. The adjustments we perform to our GAAP results and the exchange rate differences affecting our results. This quarter we made adjustments totaling $330 million after tax to our GAAP results. The biggest adjustments were $279 million for amortization or purchase…

Operator

Operator

(Operator Instructions) The first question is from Jason Gerberry from Leerink Swann. Please go ahead.

Unidentified Analyst

Analyst

Hi, guys. This is actually (inaudible) Gerberry. Thanks for taking the question. Quick one on OTC. How should we be thinking about that run rate going forward? Is this quarter representative of all quarters?

Jeremy Levin

Management

Jason, this is Jeremy. Thank you very much for your question on OTC. I had a little difficulty hearing you but I think what you are asking for, I will just repeat the question. Was, looking at the OTC, how do we look at this a run rate going forward? Is that correct?

Unidentified Analyst

Analyst

That’s correct.

Jeremy Levin

Management

Okay. Eyal, would you take that question please?

Eyal Desheh

Management

Yes, sure. First of all, the numbers are nice. We see the improvement for one quarter to the other. We have to remember that Q1 is a winter quarter and has a seasonal impact and depending on flu season because these are the type of medicines of some of the OTC that we sell. We do expect our OTC business to continue to grow double digit year-over-year.

Unidentified Analyst

Analyst

Great, thank you. Actually, if I could just slip in one on Lovaza. That would seem to be some major upside to your U.S. numbers if you get a favorable (inaudible) ruling. If you guys could just quickly address the readiness to launching that product.

Jeremy Levin

Management

I think what we would like to do there, Jason, is get back to you on that, if you don’t mind. We do think there's upside to that but we need to be cautious about what we say about that. So that’s what we got (inaudible).

Operator

Operator

Thank you. The next question is from Randall Stanicky from Canaccord Genuity. Please go ahead.

Randall Stanicky - Canaccord Genuity

Analyst

Hi, guys. Thanks. Just two questions. One for Eyal and one for Jeremy. Eyal, just relative to spending, it was down sequentially. We expected it to be flat both on the R&D and SG&A side. Can you just talk about that? And then how do we think about the trend going forward? Is the Q1 spend number the right run rate? Then I have one follow-up for Jeremy.

Eyal Desheh

Management

Okay, what we see is increase in R&D spend throughout the year. We started the year a little slower. We will most likely catch up on the expenses. Some increase, very modest in sales and marketing and probably flat on G&A this is the G&A run rate that we will see throughout the year.

Randall Stanicky - Canaccord Genuity

Analyst

But the major cost cuts that we should be thinking about relative to your targeted savings, that's not really going to hit in the back half. Should we be thinking early 14 or can we see some of those start to fall through earlier.

Eyal Desheh

Management

Regarding our cost savings as part of their reshape programs will start to unfold in 2014 and 2015. We have very small amount of that in our plan was 2013, mostly the second half as we are moving forward in preparation for all that.

Randall Stanicky - Canaccord Genuity

Analyst

Okay. Jeremy, on the NTE program, there's obviously a lot of focus on the revenue side of the business and the opportunity there 505(b)(2) is to bring some opportunities in earlier. Can you just talk to us about what should we think about for timing. We don't have a lot of visibility into the pipeline there, so how quickly can you bring some of those to market. Then as we think keep sales potential, are these products in the range of $200 million to $400 million, or potentially more? Is there some color that you could help us with there? Thank you.

Jeremy Levin

Management

Hi. Randall. It's a couple of things about NTE. Michael Hayden will talk a little bit more on it, so we view this overall as a multibillion dollar opportunity. There are examples of this in the past, where individual products which are, look, will be just described today as an NTE to be highly successful and so we are very keen on this. With regard to timing, remember what we are doing here is we are really handling on two fronts. One internal development, which is in the hands of Michael, and he will talk to you about that. And then secondly, in terms of business development and at this stage Randall, you should know that we are getting an absolute flood of tremendous opportunities in this area some of which could be launched as early as this year, some of which could be launched later, but frankly the opportunities are coming out and our showing us our extremely attractive waiting through then picking them very, very, very. carefully and perhaps, Michael you would make a couple of comments on this.

Michael Hayden

Analyst

Well, thank you, Randall. We are making great progress in our NTE portfolio. You got to regard these as some kinds of late-stage Phase III products. In other words, the likely development time for them is up to three-year, some of them do not have to go through clinical trials at all. Just need to show bioequivalence. And, so between 10 and 13, we think around 13 approve for development this year. That's having 13 new Phase III products in your pipeline. We expect some of these to actually go to the market within the next year few years and will continue to grow year-by-year. There's 13 new products in your pipeline line every single year going forward.

Randall Stanicky - Canaccord Genuity

Analyst

Great. Thanks, guys.

Operator

Operator

Thank you. The next question is from Jami Rubin from Goldman Sachs. Please go ahead. Jami Rubin – Goldman Sachs: Thank you. Just a couple of questions. First, Eyal, if you could address what's happening in the U.S. generics business that came in below our expectations and that of consensus. Obviously, maybe there are seasonality issues that affect comparisons, but if you could talk about that business, how we should think about it going forward? What are the key drivers that you have in the NDA pipeline that we could be looking towards? Then secondly, not sure can address, but just curious to know your confidence level in the FDA's ability to approve EpiPen, an AB-rated EpiPen in 2015.

Jeremy Levin

Management

Jami. Hi, it's Jeremy here. We've got Allen on the line, so he can address the question on the North American generic, so why don't I hand over to him. Then, we'll come back.

Allan Oberman

Analyst

Super. Thank you, Jami for the question. When we think about the U.S. generics business in Q1, it was actually in line with our expectations of where we thought it would come out in spite of the fact clearly as Eyal said that it was challenging. Our year-over-year comparison was a challenging comparison. Last year, we had our agreement with Ranbaxy on the generic equivalent of Lipitor atorvastatin that benefited us. We had exclusivity on Lexapro or escitalopram, which benefited us last year and this year we saw some price erosion on Zyprexa, olanzapine and Adderall XR mixed amphetamine salts, so it was a very tough year-over-year comparison all of which was factored in to what our expectations were for the quarter. As we look at subsequent quarters going forward we see a continued improvement quarter-over-quarter and the continued strengthening of the generics business here in the U.S. I would point out a couple of things. One, as Eyal mentioned in his prepared comments, the uncertainty relative to the court's ultimate decision on Pulmicort and the budesonide on one hand. On the other hand, as I think I said in the last quarterly call, in 2012 we launched 23 products representing a brand value of about $27 billion. We forecast a similar number of new launches in 2013. We launched three of them in Q1, brand value of a little over $400 million. So you can see we have new product upside as the year continues to unfold. We have also seen steady improvements in our service levels that we provide to our customers. I can say that our customers certainly are recognizing us in our ability to supply them, which is resulting in additional customer awards coming our way, and finally recognized, through a recent award we received from Walmart, as the Walmart Pharmacy Partner of the Year because of our partnership agreement with them and our ability to supply. So I think that gives you a good framework of where Q1 was relative to U.S. generics and where the rest of the year looks like it may unfold.

Jeremy Levin

Management

So, just to your second on question on EpiPen, I will let you know we had a settlement with Mylan and we have an entry date in 2015. The trial Is progressing well.

Operator

Operator

Thank you. The next question is from David Risinger from Morgan Stanley. Please go ahead.

David Risinger - Morgan Stanley

Analyst

Yes, thank you very much. I have a couple of questions. First, and I will actually make it three, if that’s okay. Pulmicort, could you just frame for us the U.S. revenue and EPS contribution so that we know the swing factor, if you do end up with greater competition? Second, could you speak to the growth outlook for rest of world? It was weaker than expected this quarter. Just wondering how to think about growth prospects going forward and rest of world? Then third. For the three times a week Copaxone, have you filed that and can you provide a filing update? Thank you.

Jeremy Levin

Management

Hi, David. There is a lot of people in line. So we will try and keep the answers short and crisp. The first two, Pulmicort. I think what we will do is, Allan, why don’t you handle that and growth outlook for the rest of the world, Eyal will handle that and then we will hand it over to, if we got time, depending on how (inaudible), we will hand over to Jon Congleton or Michael here can talk about the three times a week. Let me start with Allan.

Allan Oberman

Analyst

Thank you, David. With regards to your question on Pulmicort, we don’t specifically breakout individual products within our portfolio but we have said that Pulmicort or generic budesonide is the largest product with within our portfolio and depending on which way it goes, we continue to have no competition factored into the forecast. Although, again, I would reiterate that the guidance that we have given on the U.S. generics business of $4.3 billion to $4.7 billion for the year incorporates budesonide or Pulmicort. If it remains semiexclusive with us clearly we would be in the mid to high end of that range. If we find ourselves with additional competitors, we will be at the low end are slightly below the low end of that range and that’s the way you should envision what Pulmicort, the impact it has on the U.S. Generics business.

Eyal Desheh

Management

All right, David. Hi, it's Eyal. With regard to the rest of the world, just without any too many details, the two factors that impacted rest of the world business this quarter which need to be understood. The first is [chambers] especially in Japan, Japanese yen about 22.3% compared to where it was also a quarter call, and some currencies in Latin America and on sale, because in our generic business it actually grew and basically the impact of exchange rate if they remain where they are, we'll continue to see this next quarter as global currencies we are generated growth in all of these markets. The specialty part actually suffering from the lack of Copaxone tender reversal, which we had in last year and that is of course in the comparison we expect to have sales later on this year, but it depends on the timing of the tender, so these were the two major factors. Exchange rate was the main one.

David Risinger - Morgan Stanley

Analyst

Then with regard to Copaxone, I know Michael you are here. Why don't you deal with that.

Michael Hayden

Analyst

Thank you, David. Our sNDA was submitted on time as planned to the FDA, March 29 we are hopeful that first product will be approved and ready for commercialization early 2014. And in addition, we are assuming approval Copaxone in Europe and we expect to submit that for approval this quarter.

Operator

Operator

Thank you. The next question is from David Maris from BMO. Please go ahead.

David Maris - BMO

Analyst

Morning. Two questions. First, Michael on XEN402, congrats on the orphan drug status. What other indications you think this drug could be the applicable for and how are you pursuing them? And then separately, more broadly for Eyal and Jeremy, I know you are both frustrated as a number of people are with the stock price and you can't manage the stock price, but in your discussions with investors what do you think, what's most misunderstood?

Michael Hayden

Analyst

Thank you, David. Nice to have you on the line. For XEN402, we see both very focused open indication as well as quite broad indications. So, for the open indication of course, erythromelalgia that is actually not such a small market, because (Inaudible) involves [multi] neuropathy and thus it is quite significant. Important thing that XEN402 is the [topical], you get great absorption through the stems and we also for example say to the jointed cash flow and we will also initiating trials this year and in various forms of arthritis, particularly affect the lower lugs and this market is profoundly huge. So, we see both, a focused market in terms of open indications and also expansion from there and then inflammatory indications for osteoarthritis for example. So, Dave, I think just quickly and good to chat with you on the forum. A couple of things, we've spoken to a lot of investors. Some have expressed deep support and obviously they are having significant use in some of the purchases of the stock and an overall change in the portfolio of the types of people who are holding and today all of this is a reflection of some changes going on. A couple of things I think that underpins what we are describing. Number one, this is a sophisticated company that's undergoing significant change, the company with great potential, the company that's got a real future and it's very difficult for people to look back and understand more away from a essentially a top line driven strategy, driven by acquisitions coupled with essentially Paragraph IV exclusivity, which no longer play a major role in our overall strength. It's difficult for them to understand how the sophisticated strategy. But now I have laid in place which is a growth strategy with significant pillars related to the one that describes and an integrated business plan coupled now with a clear organizational structure and top line people who are now running that. Difficult for them to look at that and I think that quite rightly investors are looking for milestones evidence that we are absolutely executing, and there's little doubt in my mind for those in the company [external] as well that we are absolutely executing. So, I look forward this year very much as we did start rolling out aggressively. You will see the execution that people expect and quite rightly so.

Operator

Operator

Thank you. the next question is from Chris Schott from JPMorgan. Please go ahead.

Jessica Fye - JPMorgan

Analyst

Hi, thanks. Its actually Jessica Fye, on for Chris. Looks like Copaxone had a very strong quarter in the U.S. but can you just talk a little bit about the volume trends you have been seeing since launch of BG12 and also just any national feedback you are heading in the market on that lunch..

Jeremy Levin

Management

Hi, Jess, it's Jeremy here. I think what I will do is, we will start with Jon on that, if that’s okay. Jon, as you know, is now running our entire MS franchise and thus working with Rob on the new global specialty medicines organization. So Jon, why don’t you take that. Jon has also got a history of having dealt with Copaxone for many, many years.

Jon Congleton

Analyst

Yes, good. This is Jon. Thank you for the question. As you heard Jeremy talk about the quarterly figures, like very strong unit. Global AR up on Copaxone, quarter relative to prior years. So we are very pleased with what continues there. As far as the volume trends relative to fumarate, it is still really early to tell. We have three weeks worth of data. What we are hearing in the marketplace is continued support for Copaxone and the profile that it provides. Really the unsurpassed efficacy, safety and tolerability that has been seen over 17 years experienced with this product is what's still resonating in the marketplace. You tend to see, and not only with Copaxone, but even in (inaudible), we still continue to have business but there is a lot of stability when patients and physicians are buying the medication that works for them, they tend to stay with that. So it will be interesting to see and it will take several months what kind of disposition is occurring with fumarate and some of the other orals but I don’t think anything is surprising as of this point and we are not seeing any significant changes in volume in the short-term weeklies.

Operator

Operator

Thank you. The next question is from Mark - I am sorry. Please go ahead.

Michael Hayden

Analyst

So I just want to add to that. It is Michael here just to provide some greater perspective on that. Of course, Teva remains a supporter of the need to treat and manage MS. We welcome new therapy and of course with any new therapy like fumarate there is a level of interest that’s mitigated by the uncertainty. In the case of fumarate, the issue, of course, that’s on many people's mind is the very minimal long-term exposure and all of that in trial setting and I think now with the April (inaudible) data are out on the New England Journal on PML, this has raised concern about this particular product and its relationship to long-term side-effect. It is important to note, enough though the manuscript in New England Journal has different forms of fumarate leading to PML, it is important to note that with the DMF, as dimethyl fumarate, essentially all of these compounds have the same active compound. There is nothing else in it and the same with this. So I think that we have to see. Of course long term clinical experience is needed and so we await that data as it comes out.

Operator

Operator

Thank you. The next question is from Marc Goodman from UBS. Please go ahead. Mark, your line is now open for your question. If your phone is on mute, please unmute it. We will move on to the next question. The next question is from Gregg Gilbert from Bank of America. Please go ahead.

Gregg Gilbert - Bank of America

Analyst

Hi, two. My first one, Jeremy, other than executing on the strategies that are laid out on investor day, clearly you have some work to do there and some time. Are you and the board assessing other options to enhance shareholder value? Is everything pretty much on the table at this point? Then my second question, maybe for Eyal. Is the potential liability on Protonix something that needs to play out before you and the team and the board makes significant decisions on cash deployment such as the potential for another dividend increase or additional share buyback? Thanks.

Jeremy Levin

Management

Hi, Greg. I think you are right on that. We are looking to enhance shareholder value at all stages. The board is actively engaged in this. Capital allocation being part of this. How we think this through. How we utilize our capital. How we use all our elements within the company to increase shareholder value. So, you should understand that the strategy laid out in December is a strategy which is fundamental to the operations of the company and are things that will play out over both, the short, mid and the long-term. That includes increasing our attention to how we increase shareholder value.

Michael Hayden

Analyst

Yes. Regarding (Inaudible). First, already for the quarter [we] on that made on Q3 last year significant revision of $670 million on our books, we do also have an insurance policy that include covers any possible damages, so we will wait for the court, the legal process, which will most likely go to appeal on any sights. Regarding our buyback and dividend, first we discuss it then our board reviews a dividend every quarter as opposed to every in the past. We have continued to buyback shares this quarter. We will continue with the buyback program. The three-year buyback program the board will review frequently just as indication our dividend payment is increasing due to the, it is in shekel, so due to the dollar and shekel relationship. Basically dividend in Q1 this year was 23% higher than dividend in Q1 last year in dollar terms.

Operator

Operator

Thank you. The next question is from Douglas Tsao from Barclays. Please go ahead. Douglas, your line is now open. If your phone is on mute, please un-mute it. We will move onto the next question. The next question is from Ronny Gal from Bernstein. Please go ahead.

Ronny Gal - Bernstein

Analyst

Good morning. Thank you for taking my question. First question is around the generic business. If I kind of look at your numbers suggesting that 21% of the profits come from the generic business and subtract the CapEx, which presumably is primarily related to the generics. You come to a number which is pretty close to breakeven, taking out pulmicort, it looks like generic business is pretty close to breakeven. Jeremy, you've not only discussed a lot of strategy around the generic business, primarily in the U.S. and Western Europe, and I was wondering if you can give us a few more words are there significant plans to change how this business operates or is this business simply on a existing trajectory and we should expect it would stay that way. Second question is, around the pipeline. Two quick ones actually. First, should we expect to see the [data for]. Second, is it far to say that Treanda is a nitrogen mustard has enough side effects from being stored the liquid formulation should be expected to be safer and more [facetious] than the existing part of formulation.

Jeremy Levin

Management

Hi, Ronny. Look, I think, we are taking some very aggressive steps on our businesses on both, the E.U. and the U.S., and I think we should give you some color and. We've been doing that along the way, but let me give over to the guys who have been running this. First of all in Europe, Rob, why don't you give a quick response to this? And then, secondly, Allen, why don't you take a quick look run the U.S. I want to get to a good picture. Michael, will touch the two questions that you have on the two products [and] Treanda.

Michael Hayden

Analyst

Yes. Happy to do it Jeremy. On Europe in generics what we see is actually a very nice growth both, in sales and profitability and I can assure you that really it is a profitable business. We are executing on our strategy of going for the right business which is sustainable profitable and we continue to be and have every intent to stay market leader in this in Europe and we have over performed in markets, but it is very much a profitable business in Europe which is probably one of the more price-sensitive markets, per se, right? So, and opportunities for generics continue to be there. It's compared to the U.S., the generic market penetration is still low. There are good opportunities. We see good growth in Italy and in France, but we still can improve more, so we are well positioned as well to capture some of the future growth there, so I am actually quite optimistic for generics being in a difficult market like Europe, but we are delivering what is needed and we are increasing profitability.

Jeremy Levin

Management

Allan why don't you handle U.S. please?

Allan Oberman

Analyst

Ronny, it's Allan. Thanks for the question. Let's start with the U.S. market certainly is a highly competitive market. What we have been trying to do here is a multifaceted strategy that we try to layout on December 11. But let us dig a little bit deeper into it perhaps today. Certainly as Jeremy has said, the historical number, frequency and size of Paragraph IV opportunities have diminished with the addition of shared exclusivities. However, we are still pursuing a strategy where we look to develop first and reap 181 days of exclusivity on a number of products as we look to the future. Number two, Jeremy called some high-value adds. They are kind of known as complex generics here in the U.S. We marry a medicine and device and you put it together and you would anticipate significantly higher development costs, fewer competitors and over the longer term, a higher margin structure associated with that. Third, I talked about pricing. We have continued to aggressively take pricing looking to lead the industry forward on products that are low margin products to try and return a decent value to our company, to our shareholders. Then there is a tail of products that we are working our way through in multiple dimensions. First to mention is reformulating older products with lower cost processes and APIs in order to lower our cost and increase our margin over time. Secondly, consistent with the announcement of Sellersville moving our manufacturing East from higher cost of manufacturing locations to lower-cost manufacturing locations will enhance value. Then finally looking at the tail of products where we, after doing all of that, may not be able to enhance value long enough, finding other ways with other partners to create unique value add. So there is a whole host of activities we are doing to continue to progress the business forward, grow the top line and enhance the profitability.

Operator

Operator

Thank you. The next question is from Ken Cacciatore from Cowen and Company. Please go ahead.

Eyal Desheh

Management

Just hold on. I just want to answer Ronny, the other two questions that he had, quickly. So we are continuing to be encouraged by the unique immunomodulatory profile of laquinimod. We will be presenting that in June or July as an oral presentation and clearly have chosen that as an oral presentation. It is obvious the community, once we hear that data. With regard to Treanda we, of course, have developed an oral liquid formation and eliminated the (inaudible) process in manufacturing and this is also providing an unique and enhanced safety profile cutting down potential of human error. The FDA has accepted sNDA and there will be a review of the new liquid formulation of Treanda. This is all part of really trying to make better management for patients and Treanda has gone below that.

Operator

Operator

Thank you. The next question is from Ken Cacciatore from Cowen and Company. Please go ahead.

Anant Padmanabhan - Cowen and Company

Analyst

Thanks, this is Ananta for Ken, actually. Just had a quick clarification question. So Eyal, I just wanted to clarify your comments on generic Pulmicort. So I apologize if you have covered this before. So assuming it Apotex and Actavis enter the market, are you reiterating your guidance, if they are entering the market, assuming it’s a fairly low margin product. Then I have another question on Copaxone after that.

Eyal Desheh

Management

The answer is yes. We are reiterating the guidance range even if we will see another second competitor all with the generic Pulmicort in the market. You have to remember that once our arrangement on royalties with AstraZeneca is that the royalty level goes down if there is a second competitor. So the hit to profit would be reduce by that mechanism.

Anant Padmanabhan - Cowen and Company

Analyst

Okay, thank you. Then now that you have filed the tree times weekly, could you talk about your expectations for this product in the long-term? Do you think you might be able to transition a majority of the Copaxone, the existing Copaxone formulation to the three times weekly? Thanks.

Jeremy Levin

Management

Why don’t we get Jon to answer that and then I will also ask Michael to comment a little bit about some of the things about Copaxone as well. So Jon why don’t you start and hand over to Michael please?

Jon Congleton

Analyst

Yes, Anant. Thanks for the question. We have stated back in December during the strategy day that we are modeling right now about 30% to 35% of the patients currently on a daily Copaxone will find that three times a week, preference some of the market research that we have been doing in preparation of that and reduction show that that could go as high as 50%, but we continue to model right now about a third of the population are going to find interest in that, so certainly excited about bringing that forward. There is a strong interest in it, but there's also a strong interest in the ones a day as well. Michael do you want to?

Michael Hayden

Analyst

Thank you, Jon, and also we are excited about brining that to patients and we also, the recent data that we published and expert opinion and therapeutic targets showing how the mechanism of action of Copaxone providing a lot more clarity and we compare that to portfolio of generics and to our surprise even though this is a generic comp rate of activation of these generics compared to Copaxone, a market leader and with the potential for also the changes with potential changes in inflammatory pathway, so what goes with Copaxone goes down and as this kind of significant implication, so the bottom line for us is that we strongly believe that any generic will need clinical trial really improve that. It is a very complex molecule, so difficult to produce and I think we are seeing now more and more evidence around that in terms of the operator activated that it had to be remarkably different between Copaxone and portfolio generics.

Operator

Operator

Thank you. The next question is from David Buck from Buckingham Research. Please go ahead. David, your line is opened your question. If your phone is on mute, please un-mute it. We will move onto the next question. The next question is a follow-up question from David Maris from BMO. Please go ahead.

David Maris - BMO

Analyst

Well, thank you for taking the follow-up. Two, first on Treanda. What can you tell us about the this, the lifecycle formulation and what it's value proposition is? Then secondly, there was a lot of news this past quarter on biosimilars. Some from your own partner. What can you tell us about your current activities and any change or expectations adjustment to what you think the market opportunity is and the timing of the market evolving?

Michael Hayden

Analyst

Yes. So, to say that we are continuing to look at novel ways to extend the lifecycle of Treanda, looking at new formulations, including novel ways to delivery it and I don't want to get into too much detail on that, but I think the liquid formulation it just one example, but there are numerous others that I will be able to expand the lifecycle of Treanda in ways that are going to be significant for patients. So, there are many opportunities to deliver this product in improved formulations are likely extend the lifecycle. Jeremy?

Jeremy Levin

Management

Yes. Maybe just a sort of a brief comment on that, I know there has been a lot of news in this area by a number of different organizations, a lot of discussion around the opportunities and otherwise. The potential to develop in manufacture market, affordable, efficacious and safe biosimilars is in my opinion and our opinion an area of significant opportunity. One has to really be shake the opportunity, pick the opportunity and be very clear about what you are doing there. We both, Teva and Lonza both as partners and individual companies as you know our focus in refining the best roots to realize the benefits that safe biosimilars will bring to the community this large, but in the U.S. abroad and in the emerging market. But as we know, in some of these areas, there is significant regulatory uncertainty in the biosimilars area from that perspective, while the partnership continues to explore the field both companies are taking very measured approach. Michael [is] very hard from the pipeline prospective and choosing really to evaluate fully both, the prevailing regulatory and commercial circumstance before sort of taking any and decisions of long-term investment, but it is an area that we both regard and certainly Teva regardless, speak to Teva's perspective of great retention and we will continue to look at it very carefully and selectively.

David Maris - BMO

Analyst

Thank you.

Operator

Operator

At this time, I will turn the call over to Dr. Jeremy Levin for closing remarks.

Jeremy Levin

Management

Well, thank you everybody for spending the time with us this morning. I am sure there will be other calls later on and we look forward to those discussions and I greatly appreciate your time taken. This is the end of my, I can no longer say I am new in this job. It has been one year. I really greatly appreciate this opportunity that I have had with many of you over the last year to hear your opinion and to help shape our thinking as to how we bring value to everybody including, specifically, our shareholders. Thank you. Bye bye.

Operator

Operator

Thank you, ladies and gentlemen. This conference will be available for replay starting today at 10:30 AM Eastern Time until May 9 of 2013 until 11:59 PM Eastern Time. The replay phone numbers are 888-849-7419. For international, 1630-652-3042. The passcode number is 34657214, followed by the hash key. This concludes today's conference. Thank you for participating. You may now disconnect.