Teva Pharmaceutical Industries Limited (TEVA) Q2 2015 Earnings Report, Transcript and Summary

Kevin C. Mannix - Vice President, Head of Global Investor Relations Erez Vigodman - President, Chief Executive Officer & Director Eyal Desheh - Chief Financial Officer Michael R. Hayden - President-Global Research & Development Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group Robert Koremans - President & CEO-Global Specialty Medicines

Liav Abraham - Citigroup Global Markets, Inc. (Broker) Randall S. Stanicky - RBC Capital Markets LLC Jason M. Gerberry - Leerink Partners LLC Elliot Wilbur - Raymond James & Associates, Inc. Manoj K. Garg - ABR Investment Strategy LLC Sumant S. Kulkarni - Merrill Lynch, Pierce, Fenner & Smith, Inc. Umer Raffat - Evercore ISI Andrew J. Finkelstein - Susquehanna Financial Group LLLP Ronny Gal - Sanford C. Bernstein & Co. LLC David R. Risinger - Morgan Stanley & Co. LLC David W. Maris - BMO Capital Markets (United States) Gregory D. Fraser - Deutsche Bank Securities, Inc. Marc Goodman - UBS Securities LLC Douglas D. Tsao - Barclays Capital, Inc.

Thank you for standing by, and welcome to Teva's conference call. This conference is being recorded today, Thursday, July 30, 2015. I'd now like to turn this conference over to your first speaker today, Mr. Kevin Mannix, Senior Vice President and Head of Teva (sic) [Head of Global Investor Relations] (00:24). Please go ahead.

Thank you, Tracy. Good morning, everyone. Thank you for joining us today to discuss Teva's second quarter 2015 financial results. Our President and CEO, Erez Vigodman, will deliver some brief remarks and then our CFO, Eyal Desheh, will review the results with the slides that can be found on our website. The team will then open it up for question-and-answer. Accompanying the slides as well as this morning's release can be found on our website under the Investor Relations section as well as on the Teva Investor Relations app. Discussions during the call will also include certain financial measures that were not prepared in accordance with Generally Accepted Accounting Principles. Reconciliations of those non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in this morning's press release. Our presentation contains forward-looking information which is based on our current beliefs and expectations and involve a number of assumptions, known and unknown risks, and uncertainties that change over time and could cause future results, performance or achievements to differ materially from the results, performance or achievements expressed or implied by such forward-looking statements. We would ask that you take a moment to read the forward-looking statement legend at the beginning of the presentation as it contains important information. With that, I'll now turn the call over to Erez Vigodman. Erez? Erez Vigodman - President, Chief Executive Officer & Director: Thank you, Kevin. Good morning, and good afternoon. Thank you for joining us today. We have already been receiving great feedback from our investors and our (1:54) there in our enthusiasm for the Allergan Generics transaction we announced. The conjunction of moves we have conducted during the last 18 months, including this transaction, positions Teva for future growth which is very powerful cylinder that will fire for us in years to come. We have been shaping the leader in the growing generics industry, including in I&N and branded generics with an overall product pipeline and product portfolio that leads the industry in terms of differentiation and durability. We have been developing an emerging late-stage specialty pipeline that will generate an exceptional portfolio of specialty products and solutions. Our net financial profile will enable us to bolster our specialty pipeline and product portfolio in an accelerated manner. We are well positioned to capture untapped opportunities for greater integration and innovation between generics and specialty with a single powerful and differentiated offering. We believe we can deliver even greater value to our patients and shareholders as well as to the healthcare system around the world. We will obtain our financing commitments during the next few days and before August ends and we expect to close the transaction in the first quarter of 2016. To get into the details of our second quarter results, I'm turning now the call to Eyal Desheh.

Thank you, Erez. Good morning, good afternoon, everyone. Thank you for joining us. As you know, we've already previewed this excellent quarter, so let's take a deeper dive into the results. Compared to last year revenues were slightly down in nominal terms but they were 6% up in real terms, driving 16% year-over-year growth in operating income, 15% growth in net income, and 14% growth in earnings-per-share. This was also accompanied by strong cash flow generation. Foreign exchange continued to impact our top line significantly reducing sales by $341 million compared to last year but our natural hedge resulted in minimal impact on our operating income only $4 million. Cash flow: cash flow continues to demonstrate year-over-year improvement creating adequate resources to support inorganic moves such as the Auspex and Allergan transactions. This quarter we delivered 41% increase in cash flow from operation and 51% increase in free cash flow compared to Q2 last year. When we look at our revenue breakdown by markets, the U.S. market is increasing in prominence reflecting our strong focus on U.S. Generics business and a record quarter for Copaxone sales in the United States. In addition, foreign exchange had a significant negative impact on our other markets resulting in our business in the U.S. comprising of 59% of total sales. Segment revenue breakdown was fairly similar to Q2 last year, though Copaxone increased slightly as percentage of sales. When we look at the bridge of our quarterly revenue, strong results of our Generics driven by the successful launch of aripiprazole, Abilify this quarter and esomeprazole, Nexium, which was launched in Q1 increased sales significantly. The same goes for the sales of Copaxone in the U.S. this quarter. Exchange rates had a significant adverse impact on sales, but not on profit. Talking about Copaxone: Copaxone sales in the U.S. were high and in line with expectation despite the launch of the generic in June. According to IMS data, demand is holding for Copaxone family as you can see in the yellow line here on this slide, and we continue to monitor trends in the market very carefully. The result of all this is a strong trend of improvement in operating margin for Teva over the past 18 months of almost 500 basis points in operating profit. And this was built upon the impressive improvement in the profitability of our Generic business as you can see, stepped up for around 20%, 21% a year ago to between 39.5% to 30% in the first half of 2015. Quarterly operating income: operating income flow, the trends you've seen, with the increasing profits of Generics and the MS segment. Our other Specialty products have shown lower profitability this quarter, resulting from foreign exchange impact as well as a one-time provision of $26 million resulting from the situation in Greece. We anticipate a much stronger second half for this part of our business. So we've ended the quarter with a robust 16% increase in operating income overall compared to the second quarter last year. And for the full half, Q2 was a clear continuation of the momentum of Q1, resulting in a very strong first half for the year. While foreign exchange rates impacted sales, operating income was up 14% for the first half, and earning per share increased by 13%. Free cash flow was up an impressive 64% from the first half of last year. So we looked at our numbers and at the rest of the year and based on the strong first half, we are raising guidance, bringing earning per share for the year to the range of $5.15 to $5.40. And a word on dividend; I will also declare a dividend, a quarterly dividend, of $0.34 per share, as in last quarter. This concludes our prepared remarks, and I would now like to open the call for your questions. Thank you.

Thank you. Your first question comes from Liav Abraham. Please ask your question.

Good morning. First question for Erez, can you comment on whether Paul Bisaro will be joining the board of Teva following the announcement of the acquisition of Allergan Generics earlier this week? And then just a second question for Michael, perhaps on SD-809. I understand that the Phase Ib trial in Tourette's was scheduled to complete in the middle of the year. Can you confirm that that's been completed, and any commentary on the data? We haven't seen a press release. Thanks very much. Erez Vigodman - President, Chief Executive Officer & Director: Good morning, Liav. Not at this stage, and as you know, before we close the deal, we'll not provide any more comments on that. Michael R. Hayden - President-Global Research & Development: Hi, Liav. Thank you for your question. Yes, just to state of course, the Tourette's trial has finished as planned, and as indicated to the Street in June. And – just similar to large pharma, we don't usually report on Phase Ib data, but this should not be taken as if the results weren't exactly in line with what's expected, and we're looking forward to sharing more of this precise data with the Street in the near future at a function where the scientific data can be presented. But we're totally on track, and the results were as we hoped for and expected.

Next question.

Thank you. Your next question comes from the line of Randall Stanicky. Please ask your question.

Hey. Great. Thanks, guys. Just a couple. Erez, one of the things we've talked about over the last couple of days is the fact that you guys can do more Specialty deals, really between now and the end of next year, throughout this process. Can you talk about what the landscape looks like? How many more opportunities similar to an Auspex or a Labrys do you see? And maybe any color that you can provide would be great. And I have one quick follow up for Siggi. Erez Vigodman - President, Chief Executive Officer & Director: So we modeled the capacity that is required in order to execute during the 2015, 2016 Auspex-like deals.

Are you seeing a lot of opportunities out there? Erez Vigodman - President, Chief Executive Officer & Director: Yeah, there are opportunities. Same as the list of targets and opportunities, and you know there are overtures (11:55) in a number of cases, but it's too early to provide more comment on that.

Okay. Fair enough. Siggi, I wanted to ask you, we've seen a pick-up in generic approvals out of OGD over the last couple of months. That could coincide perhaps with GDUFA II negotiations. I guess you guys are now set to again have the biggest generic pipeline out there, beginning next year when you close the deal. How are you guys thinking about the approvals as we move throughout the GDUFA process? Are you expecting a continued increase, and can you maybe provide some color on what you guys are modeling? Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group: Yeah, so, Randall, I think on the approval, it's great to see the last few months things are picking up because, earlier in the year, we didn't see so much improvement. I think also I look at it like you indicated in your question. We're coming up to the time when we need to negotiate GDUFA again, and I expect it to improve. We also have good news from the FDA, especially on two or three fronts. First of all, they have indicated that they have resource better OGD so they are ready to take on more volume and more reviews. But also it's not only the volume; they are reviewing more challenging products as EpiPen so they have been increasing their expertise on the amount of reviews. Secondly, we're getting more communication from the FDA. I think that for us has been a step forward. Of course we would like to hear even more here today, but we feel very strongly that they want to communicate better with the industry. They're stepping up to that and that, to us, is very, very helpful, especially when we are preparing for launches. So I think the indicators are right, Randall, and I'm optimistic that going forward this will improve even further.

That's great. Thanks, guys.

Thank you. Your next question comes from the line of Jason Gerberry. Please ask your question.

Hi, good morning. Thanks for taking my question. Just have two. First, just can you guys give us an update – your Advair 505(b)(2) program, I think we're expecting data later this year so this program seems like it would be a good hedge if companies in the space fail to meet the requirements for substitutability. So, just kind of curious where you're at with that program, if we should get data later this year and would a go-to-market timing be around the expiry of the Advair patent August of next year? And then second, just on the formulary status in the Copaxone market, I think the expectation was that all the 40-mg patients would be grandfathered under their previous insurance policy coverage but that the new Rxs would take a hit. We're seeing new Rxs for Copaxone 40 mg kind of down as a percent of total Copaxone new Rxs, so just kind of curious how you're seeing the formulary status for Copaxone 40 mg shaping up? Thanks. Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group: So maybe on Advair 505(b)(2), Michael, you probably are in the best position to talk about that. Michael R. Hayden - President-Global Research & Development: Yeah. Thanks, Siggi. So, on the 505(b)(2) just to say that our recipe Generics program, which reflects the strengths both in our Generic as well as our Specialty portfolio are working together wonderfully. Progress is great. There's of course more than one product, but at this stage I'm not going to release any data on precise timing. But I think that we can say is that we're going to be very competitive in the space and the group is making outstanding progress built on the strengths of both organizations, the Generic and the Specialty, where there's tremendous strength in both that adds to this particular development. Erez Vigodman - President, Chief Executive Officer & Director: Thank you, Michael. Rob, please.

Thank you. Robert Koremans - President & CEO-Global Specialty Medicines: Jason on the 40 milligrams, actually we've seen a little bit of fluctuation in the, in Rx, like you said. With the health plans, in answer to your question, remain very supportive of the 40 milligrams, three times a week. They see it as a really good value both in terms of the real benefit that it delivers to patients and we have not seen any change in access for patients there, being very high at 95% of patients having access to this product through payers. So, we continue to monitor it obviously but so far really see no reaction from the payers from the health plans.

Great. Thank you. Erez Vigodman - President, Chief Executive Officer & Director: Thank you. And maybe, Rob, something on the TRx trend basically during the last two weeks? Robert Koremans - President & CEO-Global Specialty Medicines: Yeah, with pleasure, Erez. Certainly. What we've seen is really actually ever since the Glatopa made it to market a slight increase in both Copaxone 20 and 40, Copaxone 40 being at an all-time high for 18 months with close to 63,000 TRx in the U.S. and we're really cautiously optimistic on everything we're seeing. It's early days, what you've seen from the Generic entry but all the earliest indicators are actually making us cautiously optimistic and what we see both from patients, from physicians, from health plans is a very strong acceptance to Copaxone 40 and this is reflected by the TRx which is very, very nice news.

Great. Thank you.

Next question, Tracy?

Your next question comes from David Risinger. Please ask the question.

David?

David Risinger, please ask your question.

Next question, Tracy.

Your next question comes from the line of Elliot Wilder (sic) [Wilbur] (18:16). Please ask your question. Elliot Wilbur - Raymond James & Associates, Inc.: No relation to Gene Wilder. Elliot Wilbur from Raymond James. Thanks. Just a couple questions on the MS segment, specifically looking at ex-U.S. sales. They've undergone a noticeable dip in the last couple of quarters, down about 35% from the average over the past two years. Maybe you could just talk about the dynamics there, what's happened, how much of that's currency versus other factors, and whether or not we should be anticipating a rebound to more normalized levels, or at least sort of above the run rate of the last two quarters. And then just a question on profitability of the MS segment overall. It's something that's kind of been in decline for several quarters now, but this period experienced a very strong rebound and I think it's maybe the highest rate that you reported in three years or so. And it looks like, specifically, there's been a dramatic reduction in selling and marketing expense in the segment. I'm just wondering how much of that is just kind of a short-term phenomenon, or whether this is really more now kind of a tactical decision to really scale back on direct promotions, sort of given new competitive dynamics in the space. Thanks.

All right, and thank you for your question. This is Eyal. First of all the ex-U.S. Copaxone was strongly influenced by exchange rates. We sell in Russia, we sell in Europe, our ruble and euro were – are down year-over-year significantly against the dollar, so that has the biggest impact. In Russia, we have to remember also, there are tenders, and that this quarter there was no tender so basically we have a bump each time. We have a tender in Russia. It comes between once to twice a year. We expect one in second half of this year. Regarding the profitability of the MS segment, and we've talked about this in the past. Gross margin for Copaxone is just under 90%, pretty high and stable, and then we have a few hundreds of million of sales and marketing expenses supporting our sales effort in the U.S. and in the international markets, which of course are a judgment call based on launches, effort, and driving sales in the geographies. Erez Vigodman - President, Chief Executive Officer & Director: Rob, maybe if you'll just say something about Europe – one Europe, and second the roll-up of the Copaxone 40-milligram in Europe. Robert Koremans - President & CEO-Global Specialty Medicines: Yeah, happy to do so. So Elliot, we've been launching now in seven countries in Europe Copaxone 40 mg, three times a week with very good results. We're up to 15% conversion in those seven countries which is well ahead of our plan, actually. What we've seen as well in countries like France and Germany was a fairly strong impact initially in beginning of the year, end of last year, from the orals, Aubagio relatively strong in France, and Tecfidera being relatively strong in Germany and France. But it's flattening out now so going forward, we expect to really see benefits from our three times-weekly Copaxone launch, as we have seen in the U.S. and like Eyal said, the majority of the impact you've seen in revenues is really FX related. So for us, Copaxone remains a beautiful opportunity, and notably also in Europe where the position of the authorities versus generics is really different, and we believe we have a very strong franchise going forward, specifically with Copaxone 40 mg, three times a week being available in many countries already and coming to more in the near future. Erez Vigodman - President, Chief Executive Officer & Director: And my last comment here is just 2014, we saw the efforts to drive up the sales of Copaxone 40-milligram after the successful launch of course, and we basically are reducing the costs that were associated with the launch during 2015.

Next question.

Thank you. The next question comes from Manoj Garg. Please ask your question. Manoj, please ask your question.

Manoj?

Oh, hey, thanks for taking the question. Sorry. Didn't realize she was referring to me. A couple of questions. One on Copaxone. Appreciate your color on the 95% axis, but as you're having discussions for 2016, are you seeing any changes in tiering status within that axis number? Erez Vigodman - President, Chief Executive Officer & Director: So, no payer has indicated any change in market access for 40-milligram or 20-milligram.

Okay. Great. And then for Michael, maybe you can review two products for us. One is just timings of the Phase III for CGRP, and then two, the bendamustine RTU product. Michael R. Hayden - President-Global Research & Development: Okay. Well, on the CGRP, as you know, we had outstanding results. We are the only company that has results for both chronic and episodic migraine, and we decided to go to the FDA with both results, so this is a meeting that's pending, will happen in the near future. We have plans for these particular trials, extremely well-developed as part of our submission, and once we have the meeting with the FDA, we'll be able to continue and develop these as we've planned. But we're looking forward to input from the FDA. The data, as you well know, was really outstanding, also outstanding, not only in terms of the endpoints but also outstanding in terms of the improvements in quality of life of patients. We had a significant (24:40), if you look at just the one assessment of that which is the MIDAS questionnaire which measures the days with disability over three months, outpatients in episodic migraine had a score of 45. They missed days of work, 45 days, and the only other company you could compare to that's used this in the episodic migraine is Amgen. Our improvement was very large, 24 days reduction in disability. Amgen was actually only eight. So we know that we have a very competitive product, and once we've had our FDA meetings, we'll be informing the Street exact timing, but at this point we're really awaiting FDA input as to both acceptability of our trial design and our plans for aggressively going forward.

Great. And then on the bendamustine partnership? Michael R. Hayden - President-Global Research & Development: Rob, did you want to comment on the Eagle partnerships? Robert Koremans - President & CEO-Global Specialty Medicines: With pleasure. So you know that our rapid infusion bendamustine product has been submitted, and we actually expect registration still this year, which we're really waiting for and would be very good news for us indeed.

Okay. Great. And thank you for taking my questions.

Thank you. Next question, Tracy?

Thank you. Your next question comes from the line of David Amsellem. Please ask your question.

Hey guys, this is Michael (26:07) on for David. Just a few quick follow-ups on the bendamustine, actually. So first of all, how are you thinking about the rapid infusion form of Treanda that you licensed from Eagle, and specifically, do you plan a hard switch to that product once it becomes available? And then, regarding Treanda currently, what's the extent to which you're still supplying the lyophilized product to customers, given the FDA warning that you got on the liquid product earlier this year? Thanks. Erez Vigodman - President, Chief Executive Officer & Director: Rob, maybe you'll take the first one. Robert Koremans - President & CEO-Global Specialty Medicines: Yeah, with pleasure. Michael (26:35), the rapid infusion bendamustine is going to be a very important product for both the physicians and doctors. It will take down the infusion time, which helps in the administration, good for patients and good for the hospitals where they do it. We're not going to commit or comment on any – whether we do a hard switch or not at the moment. And maybe the second part of the question is yes, we still have the lyophilized products in the market. We've seen that the liquid form has not been well adapted to certain devices that are used for applications, or so-called closed system applicators. And for those hospitals where these closed systems are being used, we continue to supply the lyophilized product to the market today.

All right. Thanks, guys.

Next question.

Thank you. Your next question comes from the line of Sumant Kulkarni. Please ask your question. Sumant S. Kulkarni - Merrill Lynch, Pierce, Fenner & Smith, Inc.: Thanks for taking my questions. I have a couple. So now that Teva is back firmly in the lead on patent challenges in the U.S., will we also see a return to the more aggressive stance on at-risk launches, or has Protonix litigation somehow changed that thinking forever? And second, could you quantify for us a new EPS flow? It seems like adding Allergan Generics should probably give you an elevator there. Thanks. Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group: Yeah, so Sumant, it's Siggi here. I think we're not yet there. We need to close the transaction before we go in the lead again, but we have a extremely strong IP group. I think we look at each and every product on their own merit. Don't forget that Teva was the leader in this; Teva was the company that's built in a way as (28:25) the first to file. There was a little (28:34). Now we're back in the game with the transaction with Allergan Generics. So we have, I think, on both sides, both in Teva and Allergan, we have the best IP team there is, because there's an expertise, both on the brand business and the generics business, and we're excited to take it on and get the value out of the transaction. Erez Vigodman - President, Chief Executive Officer & Director: On the EPS flow, we provided the relevant information by the end of 2014. It pertained to 2015, 2016. We said that we'll start to grow top line and bottom line 2017 and further (29:15) momentum going forward. We are basically outpacing the targets in 2015 and by the end of 2015, we'll be able to integrate the Allergan Generic business with Teva's business, and to provide more insights that pertain to that. I believe that we'll provide information that meets your expectations. Sumant S. Kulkarni - Merrill Lynch, Pierce, Fenner & Smith, Inc.: Thank you.

Next question.

Thank you. Your next question comes from Umer Raffat. Please ask your question.

Sure. Thanks for taking my question. I have two. First one may be relatively simple. Has your house view of CGRP market size changed post the PCSK9 pricing we saw last week? And secondly, on EBITDA, so right now my understanding is, Teva EBITDA is about $6 billion. Allergan Generics got you about $4.1 billion, so that makes it $10.1 billion. The slides on Monday mentioned $11.6 billion as being the EBITDA in 2018 meaning, between now and 2018, EBITDA goes up something like $2 billion. So I just wanted to understand how you think about the key drivers of $2 billion in EBITDA increase between now and 2018. Thank you. Erez Vigodman - President, Chief Executive Officer & Director: So maybe the first one, Umer, we are okay with $10 billion market at this stage, although we believe that the commercial opportunity is even bigger. I don't think that there are good enough tools today to approximate the commercial opportunity here, so I believe that over time, we'll realize that it goes beyond that $10 billion bar (31:04). And that's something which is good enough, given also the way we see our position, and even leading position, in that space. Michael, you would like to add something? Michael R. Hayden - President-Global Research & Development: I think the one way just to look about this is to think about the number of people with migraine in the United States, for example, let's just start here: 70 million globally, a big, by the way, population in Japan as well, very frequent. And in the U.S., around 40 million, of whom 5 million have chronic migraine. So the important thing in looking at the market size is firstly, thinking about the population that suffers from this and secondly, the competitive landscape. And certainly, besides CGRP, a lot of the medications are being poorly taken up, not really providing efficacy, and also with some significant side effects. So we believe that this whole field will revolutionize the field of migraine, just like statins revolutionized the treatment of high cholesterol, and we believe, in just looking at the numbers and also, at the present time, the safety of these drugs. Early days, but still this has been very safe, particularly for the anti-ligand. There's always concerns with the receptor about hepatotoxicity. The market has the potential to be significantly higher than what's stated. But I think we will – obviously lots of studies going on to understand the acceptability, the needs in the patients and – not only in the U.S. but this is huge in Europe and also Japan. Erez Vigodman - President, Chief Executive Officer & Director: And Umer, on the second one, $0.7 billion from synergies, and the rest is coming from the growth of top line and bottom line of the legacy Teva's and Allergan businesses.

Tracy, next question?

Thank you. Your next question comes from Andrew Finkelstein. Please ask your question.

Thanks very much. First of all for Copaxone, as a family, if you think about glatiramer, you can even include the generic, but what are you seeing in terms of how that's doing in share of the MS market as we've seen some changes in growth dynamics for some of the other products? And then, as there's now the three times a week on the market and a less expense alternative for the 20, does that extend the share the glatiramer takes of the overall MS market? And then secondly, in the Generics business, if you look around the world, you noted some strong trends in the U.S. and Latin America. You did note some continued weakness in Japan. If you could just give us an update on where things stand there. Thanks. Erez Vigodman - President, Chief Executive Officer & Director: Okay. So, Mike, maybe you take the first one?

Thank you. Your next question comes from the line of...

Tracy. Erez Vigodman - President, Chief Executive Officer & Director: No, no, no. Tracy.

Tracy, please let him answer the question.

Okay. Thank you. Erez Vigodman - President, Chief Executive Officer & Director: Mike, Mike. Yeah. Okay. Michael R. Hayden - President-Global Research & Development: I'll take it, Erez. So on Copaxone, what we've seen is that the current market share globally for Copaxone is 24% and that really is all of the brand. At the moment in the U.S., the overall market share for the generic is 1.5% in MS and it's under 5% for the overall Copaxone. And what we've seen over the last three years is actually only a relatively small decline of Copaxone, about four market share percentage points in the last three years. Going forward also next year we believe that for the family of, say the glatiramerites (35:06), this going to remain relatively stable. The orals have made their inroad mostly as cost of indifferent there. But also the markets per se have grown. So going forward in terms of the glatiramerites (35:20), we think that there's not going to be major, major change in the next 18 months or so. And Copaxone, we've discussed it already before there, we have a very good position, doctors and patients and also payers seem to continue to support it but it's very early days to make very firm statements here, we're cautiously optimistic. Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group: Maybe on the generic competition, where we see it, obviously one player in the U.S. there. There is a generics in Latin America. In some of the markets in Latin America not nearly all of them, they're getting some markets here. It's locally packed product. In Europe, as we mentioned before, we haven't seen approval for generic Copaxone. Russia, there's a pending approval but no approval as of yet of generic Copaxone. And in Japan, the brand hasn't even launched so I don't expect generic competition in Japan for some time. So we are following the landscape well on Copaxone but so far it's a little bit Latin America and then in the U.S. where we see generic Copaxone competition.

Thanks. If I could just follow up, the question on Japan was actually for your Generics business separate from Copaxone. Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group: All right. So, for my Generic business in LatAm, we're doing well. We have been affected by FX a little bit in the markets. We have a leading position in Chile and Peru; we're doing well in Argentina. In Brazil it's mainly Copaxone business so that's how I can link the two together. And overall, the LatAm business is good. It's a branded generic business. We have been investing in pipeline for the LatAm market over the last few years, so I'm very pleased there. In Japan my profitability is still low, our profitability is still low. We are roughly at around approximately 10% operating profit and you see that when the overall generic business is at 29% in this quarter. It's very important to turn that around. The team is focusing on it, we have the much better launches in June from the Japanese team and we have our goals in place. But we're still under an operating profit in Japan where we want to be going forward. Erez Vigodman - President, Chief Executive Officer & Director: So basically Glaxo (37:51) in Japan and entering into a number of key growth markets is high on our priority list. It is also in line with the five buckets of BD priorities that we shared with the Street by the end of 2014 and we'll execute against it in the course of the next 24 months.

Thanks very much.

Next question.

Your next question comes from Ronny Gal. Please ask your question. Ronny Gal - Sanford C. Bernstein & Co. LLC: Good morning and thank you for taking my question. I got two: first one on bendamustine. Rob, can you remind us of the criteria to getting your own J-code for this product and do you guys believe this one, that you'll be in a good position to obtain a J-code separated from the infusion – from the product property which is going to go generic? The second one is around human growth hormone. You've had this product in this market for a while. You've started Phase III, but you're not mentioning it a lot. Can you give us a quick update on this? And if I can throw in a third one, the CGRP, any chance for a submission based on the Phase II results in the severe patients? Erez Vigodman - President, Chief Executive Officer & Director: Rob, please? The first one. Robert Koremans - President & CEO-Global Specialty Medicines: Yeah, Ronny, I can take your first one. So on the bendamustine rapid infusion, we do expect that we have a good chance to get a separate J-code but it will be not at time of launch, right. It will come a little bit later. Gives us a beautiful opportunity to differentiate it if that happens which we would consider to be a nice upside to the products. Michael R. Hayden - President-Global Research & Development: I'll just comment on the Albutropin growth hormone deficiency. Of course this product is doing well. We're in Phase III for adults and also Phase II for children. We're seeing the appropriate response that we expected in terms improvement of the growth trajectory, also measured by other factors like the ability – IGF-1 levels and both of these studies are proceeding. Recruitment is good and we're on track. The exact plan for commercialization of these products is still under deep discussion at Teva but I would say the enrollment and the conduct of the studies is going according to plan with us already seeing significant impact on some of the endpoints just by seeing the growth trajectory of patients. So this is a study that's going very well. Of course it's a long-acting growth hormone so it's going to change. It does have significant benefits for patients, but I think we have to wait the results of these particular studies. On CGRP, again this is obviously going to be discussion with the FDA. The results in chronic migraine for such a disabling condition amongst – compared to quadriplegia and dementia and above blindness and paraplegia. So this is very significant and the results were profound and of course part of the discussion will be, how quickly can we get this to patients? But at this point I don't think anybody can predict and certainly it's most likely that the FDA will require a Phase III study that continues to confirm benefit. Importantly as part of this study we do have the dosage, so for us it's, compared to the competitors, our dosage is sorted out; single injection, at the moment, monthly, 275 milligrams and that's also helpful to have a minimum dose that really is already established and at the moment given monthly. Ronny Gal - Sanford C. Bernstein & Co. LLC: Thank you.

Next question.

Thank you. Your next question comes from the line of David Risinger. Please ask your question. David R. Risinger - Morgan Stanley & Co. LLC: Thanks very much. Sorry my cell cut out before. I have three questions. First, with respect to your CGRP, it seems like this is a product that should get breakthrough therapy status and once you file it, priority review. But Michael, I was hoping that you could comment on those possibilities. And then second, when do you plan to provide a comprehensive R&D update? And then finally, with respect to Synthon it may be launching soon in Europe. Can you just update us on the timing of when Synthon can launch and then separately, what your expectation is in terms of Synthon launch timing? Thank you. Erez Vigodman - President, Chief Executive Officer & Director: So, David, I'll start. R&D update will be held before the end of the year. Michael, CGRP? Michael R. Hayden - President-Global Research & Development: Yeah, so on CGRP, I think we're very hopeful for a priority review but we don't know that yet. On breakthrough therapy, whilst this product does have all the criteria that would meet it, generally the FDA's also acting for an active comparator as part of this which we did not have, so we did not expect to get and we recognize that, without that comparator this becomes a very difficult discussion. So we expect priority review. We will not get breakthrough status. And with regard to Synthon, of course we've been talking a lot about our own product to regulatory authorities all over Europe, and there's been tremendous reception. Synthon and Copaxone are quite different in terms of their impact, for example, on various pathways, and also in terms of the protocol-defined endpoints. These were not fully adhered to. And so I think it's – I'm not going to make predictions about when Synthon and where it might be approved in Europe, but I would say that certainly the regulatory authorities are very interested in learning about the scientific issues around Synthon and its comparison to Copaxone, and these discussions have been undertaken. Erez Vigodman - President, Chief Executive Officer & Director: Thank you. Rob, you'd like to add something here? Robert Koremans - President & CEO-Global Specialty Medicines: No, I think Michael said it well. So it's – it would be purely speculative. What we know is Synthon doesn't have a registration as of yet and seeing their data doesn't surprise us. And then we are really convinced that in Europe we have a very strong position with 40 mg, three times a week, and our 20 mg. In none (44:43) of our models, Synthon would play a major, major role going forward, but speculation on the timing I don't think we should do. Erez Vigodman - President, Chief Executive Officer & Director: Next one.

Tracy?

Thank you. Your next question comes from David Maris. Please ask your question.

Morning. Just a couple questions. First, Erez, you had said in your earlier comments that you've been meeting with investors lately and they're – been widely supportive, and that seems to be evident with the stock. But maybe, has there been any consistent misperception or any pushback, and what is your answer to that then? Secondly, the other night at the analyst Q&A, someone had asked about the price. I think you gave a very detailed answer on how this deal is actually cheaper than the Mylan deal. Maybe if you could run through that again. And then lastly, for Siggi or Erez, it seems like you've eliminated the biggest risk to any major M&A with this transaction, in that you know what you're buying, given Siggi's long tenure there just a year ago. What do you think if – what's the next biggest risk factor, if we're looking back on this in a couple years of, if things didn't work out or – what are the biggest challenges to a successful integration, eliminating that other risk? Thank you. Erez Vigodman - President, Chief Executive Officer & Director: Okay. Thank you, David. On – let's start with the price. First, it's a fair price. And then, given the nature of the process, I believe that it's win-win to both parties, as was reflected by the stock performance on day one. But to dive into – more into details here, $2.7 billion is the EBITDA of Allergan Generics in 2016, and we provided a number which basically implies less than 15 times EBITDA multiple for the acquisition. The $82 per share for Mylan implied 15 times EBITDA before (46:58) the price. So that's one. Number two, look at the economics that are emanating from the transaction, so year two, more than 20% EPS accretion, year three, more than 20% EPS accretion. Look also at ROIC, and when you look at all the parameters, basically it tells us a very convincing and compelling story about how fair is the price that was paid there. And when you compare it also to comparable transactions in the space, I believe that you'll find out that also here, that's a fair price. On our reflections from investors, there is no pushback. The converse is true. People ask us about time to completion, people ask us about the process with the drug authorities. People try to understand how fast we can integrate the business. People ask us about how fast we can expect the benefits there from, from the business. People ask us about what is our strategy in Generics, an important discussion, by the way, why we believe we can basically develop here a company that is able to lead and transform the generic space. But these are questions are coming from investors; there is no pushback. The converse is true. Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group: So David, maybe on the integration, yes it's true, I think we're in a special situation of knowing both companies very well. So first of all, on the Allergan side, it's a good team, known them for a long time. They've done great building up the company. But also keep in mind, Teva has an outstanding team. If you think about the Generic team at Teva, they have improved the profitability of the Teva Generic business by approximately 1,100 basis points in two years. So I want to say that we have amazing teams, two of the best teams in the industry, of both sides. But I think this is also the biggest risk in the integration, because we need to retain the best talent. I think we're offering here amazing opportunity. This will be the fastest-growing Generic company in the industry. We are changing a little bit the dynamics of the Generic industry with this new company, so I think we're offering a great challenge. But to me, for this to be a successful company, we need to have the best teams. We need to have the winning teams, both from Teva and from Allergan Generics, because, yes, we are buying tablet presses and files and things like that, but at the end of the day, the success of this acquisition and of this integration is the human capital. We're taking this very seriously. We have already kicked off on both sides, because we need to focus also on the Teva side, but the Allergan side is very important. We have kicked off this part of the preparation for the integration already this week, same day we signed the deal, and each before. And this will be a key focus, because people are the essence of the company going forward.

Okay. Thank you very much.

Thank you.

Next question.

Your next question comes from the line of Greg Fraser. Please ask your question.

Morning. Thanks for taking the questions. This is Greg Fraser on for Gregg Gilbert. My first question is on laquinimod. Given the possibility that laquinimod could be an ideal add-on therapy to current MS drugs, do you plan to start combo studies at some point? And if so, what other drugs would you include in such studies? And then, on your NTE pipeline, the last time you discussed projections for the pipeline, you predicted risk-adjusted sales of $1 billion to $1.5 billion in 2018 and $3 billion in 2020. The question is, are those goals still intact? Thank you. Michael R. Hayden - President-Global Research & Development: Thank you, Greg. Let me just comment on laquinimod. So laquinimod is a really remarkable drug, neuromodulatory, so it's not an immunosuppressive, but it restores all the disturbed features of inflammation, and particularly immune regulation, that are disturbed, for example, in diseases like MS. Restores them to normal without immunosuppression, so these studies are ongoing. The relapsing remitting study we've said is completed enrollment Phase III, and we expect to have a full readout in about the second quarter, before the end of the second quarter in 2017. Also to say, we are – laquinimod in certainly, even though the animals' models are not great, but certainly – in the best animal models they are, and also recent publications in the marmoset, which just is out about a week ago. Laquinimod also – and these are forms of more progressive MS – laquinimod has had very significant effects, and we're also looking, and have an ongoing trial Phase II of laquinimod in progressive MS, which should read out around the same time as relapsing remitting. Now with this – with this major impact on – and the major impact of laquinimod is on disability, quality of life and disability progression. It does have impact on inflammatory processes too with regard to relapse, but the major impact, and certainly in our study on Phase III, this is – the FDA has changed the rules of the game, first time, putting disability and disability progression as one of the endpoints of this study through a special protocol agreement with the FDA. So this is playing to laquinimod's strengths. Of course with this process and this model in place, there is still room for combinations with another drug that would have impact more on relapses, and be stronger on relapse without having some of the big effects on brain atrophy and disability that laquinimod has. So we of course are looking at different combinations, and of course there they say laquinimod (53:16-53:18) to oral therapy. And when we've made that decision, hopefully be – this will really something we will tell the Street. But you can imagine, we're looking at oral therapies. Obvious targets are various agents or something like them that have impact on various targets. They already have shown to decrease relapse in this particular disease. Now I've forgotten the second part of the question. Robert Koremans - President & CEO-Global Specialty Medicines: I think the other question was on the NTE, on our projection for that. I think what we can say is we don't have any update at this point in time, but if we have we obviously would come to the Street with that. Michael R. Hayden - President-Global Research & Development: But let me just give you that the – the NTEs are a big part of our pipeline. We really prefer to think about innovation using existing molecules but the innovation takes multiple forms. It takes, of course, reformulations, different fixed combinations as well as even approaches to packaging. Important to note that for example, we have 11 NTEs by the end of this year. We have 11 NTEs in Phase I from period of starting date, this particular program in 2013. Of these, six are going to go straight to submission because we just need bioequivalence studies. Of these 11, five are going straight to Phase III, so no Phase II studies needed, and these are all going to be submitted on the 505(b)(2) pathway. And this particular program is very much intact and important to note that with the acquisition of Allergan Generics, we will have a bigger pipeline and a bigger number of molecules from which to think about novel combinations, novel ways to deliver to create value for patients. So this program is very much part of our early pipeline and will continue to be enhanced as we look at other innovations in the space between both the Generic and the Specialty side as we can build and focus on creating value for patients and the healthcare systems that we serve.

Next question.

Thank you. Your next question comes from the line of Marc Goodman. Please ask your question.

Morning. First, Siggi, I know you're specifically giving up a lot of top line in Europe to improve profitability. So first is, can you give us a sense just for the full-year, how much revenue do you think you're going to be giving up? And after this year, will we be done with that and you'll be kind of stabilized and back to more growth in Europe? And how has the profitability improved? You said the press release it's improved. Can you just give us a sense? And second question is, there was an earlier comment about Copaxone and not expecting much competition on the branded side anymore. So I guess I was a little curious about your thoughts on the Roche product which had data that came out recently. And then lastly if you could just talk about Canada. You specifically mentioned Canada was weak. Thanks. Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group: So let me start on Europe. So, first of all Europe, the only decline in revenue in Europe was FX. They in fact increased in revenue in second quarter, so we are casting (56:42) to a stable environment. We declined a little bit in first quarter, but our estimation is we are increasing slightly in revenue in Europe. Obviously it's difficult to say what the FX will do for the second half of the year, but we don't see any further casting (56:59) of the pipeline. I think we have the right mixture. Europe is ahead of schedule in improving their business. Their operating profit alone in Europe has improved over 1,000 basis points so proportionately in the overall Generic business in Teva, the European business has outperformed. There are three markets that are real stars in Europe for me this quarter. Germany again – I mentioned Germany also in first quarter – but Germany again has done extremely well. Very pleased with the business. Our Italian business has improved enormously and is one of the leading businesses in Europe now. And again UK has been doing very, very well in our business in Western Europe so Europe is really getting to the point and this is what we're saying. This is why the combination with Allergan is so interesting, that we see a growth on the top line, because basically we are ready with our own business to integrate with the Allergan business to start to see a growth in the top line because I think we really are at the right profit level. If I also take the Canada question, I think there was a dip in our Canada results in second quarter. Part of that was a one-off item. We changed a little bit our return policy so we had to accrue more for return simply due to what was in the pipeline, so part of it was a return. The second part of the one-off was a settlement with one of our customers where we had to take a write-off. This was something we had on our books and we closed the settlement. The underlying business was a tiny bit weaker due to weaker sales. We saw de-stocking in the major companies in Canada. McKesson lowered their inventory in Canada in second quarter. But overall, the business itself, the launches are doing well and for the second half of the year we assume to be back in business in Canada. We saw this more as a one-off for our Canadian business and they're doing very well. Erez Vigodman - President, Chief Executive Officer & Director: Yeah, on the MS, Michael, you would like to comment? Michael R. Hayden - President-Global Research & Development: Well, I would just say the Roche study Phase III very interesting, an excellent response and this is due to focusing on another mechanism in multiple sclerosis, B-cell depletion, so it's acting on this particular target. And I would say this is great for patients, it's another approach to looking at ways to modulate the course of the illness. And of course at Teva we're very interested in exploring in development other approaches to moderate and modulate the course of the illness but I would say the Roche results are great for patients, great for systems in that they do have some impact and explore the totally different mechanism which is B-cell depletion. And of course we're exploring other mechanisms as new data on MS and the pathogenesis and the pathways involved in MS play a role. So we're very deeply in this place, but we see this as a validation of another target in MS, B-cell depletion.

Next question.

Thank you. Your next question comes from Doug Tsao. Please ask your question.

Hi. Good morning. Thanks for taking the questions. Siggi, on the Generics business, the operating margin improvement has been quite dramatic for the U.S. business. Just curious, if we normalize for the launches of Nexium and Abilify, how much improvement have we actually seen? Or how much did that weakness, of excess rent in this quarter because I think in my math, you're up like 800 basis points on a year-on-year basis. But where are we sort of on a current run rate if we think about those launches? Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group: Yeah, Doug, so we quickly looked at what we have to be careful of, Nexium and our approvals all are really not one-off and especially when you look forward when we have a combined pipelines of 110 first-to-files and 320 NDA's, new launches will not be one-off. They will be our business and the main part of the business model. But to answer your question directly, we probably will be around 26% plus operating profit. This is why we are very comfortable with our goal of 27% for the year. We're not raising that. We obviously need to focus on the business. But we are really, Doug, we're getting the Generic business where want it to be; improvement of about 1,000 to 1,100 basis points over two years. But the run rate without these two products is probably around the 26%-plus operating profit without them.

Okay. Great. Thanks. And then just, in terms of Japan, one of your major competitors has taken a little bit of a different model in terms of a partnership with a large brand company. I know there are a lot of unique dynamics in that market. I mean have you ever thought about dramatically changing your go-to-market strategy there? Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group: Yeah, we think about all the options we have. We obviously are doing this alone. There's a challenge in Japan. First of all, the Japanese market, you have to keep in mind that the operating profit of our competitors is not in the $30 millions. The operating profit of a good generic company in Japan is around $20 million, in the low $20 millions. So we are about halfway there. We need to do better. But we are very open-minded how we can improve our business. Japan is a very important market to us. We think Japan – utilization of generics is growing faster in Japan than any other market around the world. Teva has invested significantly in the pipeline. We are launching on average about ten products per year, so we have all the indicators to do a good business and we are very committed to turn this around.

Okay. Great. Thank you very much.

Thank you. I'd now like to turn the conference back over to Erez Vigodman for final comments. Erez Vigodman - President, Chief Executive Officer & Director: So thank you, everyone, for joining us today and I look forward to continuing the engagement with you as we make progress with the transaction. Have a good day.

Thank you. That does conclude the conference for today. Thank you all for participating. You may all disconnect.