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Transcript
EX
Executives
Management
Kevin C. Mannix - Senior Vice President-Investor Relations Erez Vigodman - President, Chief Executive Officer & Director Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group Eyal Desheh - Chief Financial Officer & Group Executive VP Michael R. Hayden - President of Global R&D and Chief Scientific Officer Robert Koremans - President & CEO-Global Specialty Medicines
AN
Analysts
Management
David R. Risinger - Morgan Stanley & Co. LLC Timothy Chiang - BTIG LLC Jami Rubin - Goldman Sachs & Co. Louise Chen - Guggenheim Securities LLC Ronny Gal - Sanford C. Bernstein & Co. LLC David A. Amsellem - Piper Jaffray & Co. (Broker) Ken Cacciatore - Cowen & Co. LLC Christopher Schott - JPMorgan Securities LLC Gregg Gilbert - Deutsche Bank Securities, Inc. Liav Abraham - Citigroup Global Markets, Inc. (Broker) Elliot Wilbur - Raymond James & Associates, Inc. Umer Raffat - Evercore ISI Jason M. Gerberry - Leerink Partners LLC Marc Goodman - UBS Securities LLC David Maris - Wells Fargo Securities LLC Sumant S. Kulkarni - Merrill Lynch, Pierce, Fenner & Smith, Inc.
OP
Operator
Operator
Ladies and gentlemen, thank you for standing by and welcome to Teva reports first quarter 2016 financial results conference call. I would now like to turn the conference over to the head of Investor Relations, Kevin Mannix. Please go ahead.
KR
Kevin C. Mannix - Senior Vice President-Investor Relations
Management
Thank you, operator. Good morning and good afternoon, everyone. Thank you for joining us today to discuss Teva's first quarter 2016 financial results. On the call with me today are: Erez Vigodman, Chief Executive Officer; Eyal Desheh, Chief Financial Officer; Siggi Olafsson, President and CEO, Global Generic Medicines; Dr. Rob Koremans, President and CEO, Global Specialty Medicines; Dr. Michael Hayden, Head of R&D, Chief Scientific Officer; Dr. Carlo de Notaristefani, President and CEO, Global Operations; and David Stark, Senior Vice President and Deputy General Counsel. We will start the call with presentations from Erez, Siggi, and Eyal before opening the call up for questions and answers. A copy of the slides as well as this morning's earnings press release can be found on our website, tevapharm.com, under the Investor Relations section as well as on the Teva Investor Relations app. During this call we will be making forward-looking statements, which are predictions, projections, or other statements about future events. These estimates reflect management's current expectations for Teva's performance. Actual results may vary, whether as a result of exchange rate differences, market conditions, or other factors. In addition, the non-GAAP figures exclude the amortization of purchased intangible assets, costs related to certain regulatory actions, inventory step-up, legal settlements and reserves, impairments, and related tax effects. The non-GAAP data presented by Teva are the results used by Teva's management and Board of Directors to evaluate the operational performance of the company to compare against the company's work plans and budgets and ultimately to evaluate the performance of management. Teva provides such non-GAAP data to investors as supplemental data and not in substitution or replacement for GAAP results because management believes such data provides useful information to investors. And with that, I will now turn the call over to our CEO, Erez Vigodman.…
KR
Kevin C. Mannix - Senior Vice President-Investor Relations
Management
Operator?
OP
Operator
Operator
Thank you Your first question comes from David Risinger. Please go ahead.
David R. Risinger - Morgan Stanley & Co. LLC: Thank you for all of the detailed prepared remarks, including Siggi's commentary on the pricing outlook. I have a couple questions. I guess first of all, Siggi, could you please comment on your expectations for longer-term pricing? Obviously, you just reiterated that you expect mid-single-digit U.S. price declines in 2016, but I was hoping that you could comment potentially longer term. And then second, you mentioned $1.1 billion in net global revenue to be divested, which is above expectations. Could you discuss the impact of that on the expected accretion from the Allergan Generics acquisition longer term? Thank you very much.
Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group: Thanks, David. First of all, on long-term pricing, it's difficult to comment on the long-term pricing, but maybe we can think about what are the factors that play into pricing. So obviously it has to do with competition in the market. We know if you look at the U.S. market, there are 230 generic companies that are competing, so the competition is fierce. Secondly, it's impacted by the new approvals by the FDA, and the FDA has been approving more products. And it's impacted obviously by consolidation of the customers. I think overall the consolidation of customers hasn't changed that much in the last 24 months, as I said in my prepared remarks. And the change in the competition hasn't been that much. So at this point in time, I don't foresee any big changes in the pricing environment in the U.S. or globally. There's nothing on the horizon that changes my mind. Over the last 10 years, I've been operating our U.S. generics business for 10 years in a row. The cycle has been from approximately minus 1% deflation to maybe minus 7%. It goes a little bit back and forth. It's a cycle, it's a process. But we are approximately mid-single-digit price erosion, and there's nothing that we see now that changes that at least in the medium term, but it's very difficult to talk about the long-term view on pricing. With regards to the $1.1 billion divestiture, you have to keep in mind this is the global revenue impact. Where we were above expectations, just so we are clear, was in the UK. We highlighted that. There was a lot divestiture in the UK than we expected. But as we highlighted also, we are committing fully to our net synergy number of $1.4 billion in cost and tax synergies as before. So there is no impact on the accretion of the deal due to the divestiture we are talking about. And the timing of the synergies is as before. We estimate that we get most of the synergies in the first 36 months after closing.
David R. Risinger - Morgan Stanley & Co. LLC: Thank you.
KR
Kevin C. Mannix - Senior Vice President-Investor Relations
Management
Next question?
OP
Operator
Operator
Our next question comes from Tim Chiang. Please go ahead.
TL
Timothy Chiang - BTIG LLC
Analyst
Hi. Thanks. Erez, Siggi, there's certainly been a lot that's happened in the generic space over the last nine to 12 months, and certainly one thing that has happened is a resetting of valuations. I know that you guys announced this deal back in July of last year. What can you comment about in terms of the price you're putting on the table for Allergan? Do think that's still a fair price in today's environment?
Erez Vigodman - President, Chief Executive Officer & Director: Hi, Tim. The answer is absolutely yes. The strategic value of the deal is at least the one that it was when we announced the deal. The opportunities in the U.S. generic market and in the global generic space are huge. And we strongly believe that with everything that we are witnessing now, the opportunities for Teva are even bigger compared to basically we were when we announced the deal. So for us, what we are creating here is a very unique platform with at least the same strategic value that we alluded to when we announced the deal. And at the end of the day, it's also about economics. And from all the messages that we are conveying in here, we strongly believe that we will be able to generate the economics that we promised.
KR
Kevin C. Mannix - Senior Vice President-Investor Relations
Management
Next question?
OP
Operator
Operator
Your next question comes from Jami Rubin. Please go ahead. Jami Rubin - Goldman Sachs & Co.: Thank you. I just have a couple questions. Siggi, again, I appreciated your explanation, but I think part of the confusion too is that we're hearing about worsening generic drug price inflation not just from other generic drug makers like Endo and Perrigo, but also from some of the distributors. And in fact, AmerisourceBergen [ABC] said last week that they were citing a worsening deflationary market worse than they had expected, and they expected it to grow to high single digits by the end of 2016 and stay there in that range for the entire 2017. So if you could, just explain the interrelationship between the manufacturers and the distributors? Why are the distributors citing something different and citing something worse? What needs to happen out there for your guidance of minus 4% or so, price deflation go to minus 6%, minus 7%, minus 8%? Give us some confidence that we're not going down this slippery slope. And then, Erez, to you, clearly you are doubling down on a sector that has faced major headwinds or clearly has been reset in terms of valuation. Can you remind us all? What is the investment thesis? What is the attractive investment thesis for being the largest generic drug company in the world? And then just lastly, you have cited your interest in continuing to do specialty pharma deals once the Allergan deal is done. But given where your valuation is and given where your stock is sitting and your confidence in the generic drug business, how do you balance the desire to do deals with a significant stock buyback program that I think investors would really appreciate in this environment? Thanks very much. Sigurdur Oli…
KR
Kevin C. Mannix - Senior Vice President-Investor Relations
Management
Next question?
OP
Operator
Operator
The next question comes from Louise Chen. Please go ahead.
LL
Louise Chen - Guggenheim Securities LLC
Analyst
Hi. Thanks for taking my questions. The first question I had here was on your CGRP program. I was wondering if you could give us an update on how enrollment for this trial is progressing. And when is the earliest we could see data here? And can you remind us also, your $11.6 billion – I know this is an older number – on EBITDA in 2018, does that include CGRP or not? And the second thing here is just on your guidance post-close of the [Actavis] Generics deal. I'm just curious. In the past you've talked about potential upside to your synergy guidance from sourcing. Is that still on the table? Thanks.
Michael R. Hayden - President of Global R&D and Chief Scientific Officer: Thank you, Louise, for that question on CGRP. I'm pleased to say that both the chronic and episodic migraine trials have begun. We're primarily recruiting in the U.S. Recruitment is going exceedingly well. And of course, this talks to the tremendous need for novel therapies in this particular space. We're looking forward to getting top line results by the end of 2017, with full exposure to results in 2018 and launching by early 2019. But we will keep obviously the Street informed. We're delighted our recruitment is ahead of schedule, and we're making terrific progress associated with this. Also just to mention and reiterate is that we will be starting our trial in cluster headache in the second half of this year, a very important unmet need, the suicidal headache for which CGRP may offer significant hope and benefit.
Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group: Louise, maybe quickly on the synergies, as we said, we reconfirmed the $1.4 billion number, taking into account the new number in terms of the divestiture of $1.1 billion. That is our statement now, but we obviously will give a full guidance on the combined company in August.
Eyal Desheh - Chief Financial Officer & Group Executive VP: Louise, on your question about 2018 EBITDA and does it include CGRP, the answer is probably nothing, as the product, even if launched sometime in 2018, is not expected to generate any profit during the first year of launch.
LL
Louise Chen - Guggenheim Securities LLC
Analyst
Thanks.
OP
Operator
Operator
The next question comes from the line of Ronny Gal. Please ask your question. Ronny Gal - Sanford C. Bernstein & Co. LLC: Good morning, everybody, and thank you for taking the questions. First, Siggi, would you be able to help us understand the Paragraph IV launches during the year? It seems that you're now sitting at a point where there are very few Paragraph IV revenue-generating or high-margin products right now in your portfolio. Can you take us through how this will change during the year? And could you also comment on your cost position, core conversion costs overall now that you are looking at your combined business with Actavis? Where would you be in terms of cost structure? And last, and this is more for the branded side, the ProAir conversion to the second generation seems to be going a bit sluggishly. Can you help us at all to think about this franchise going forward? How much do you think we can keep or Teva can keep at the time of generic entry, and is there any way you can accelerate this conversion? Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group: So let me start, Ronny. First of all, we have been very clear on that in the guidance for 2016. In the Teva portfolio, there's no significant Paragraph IV that we have pointed out. There are quite a few smaller launches that we have in 2016, none of those that we have been talking about in the public domain. But obviously for the combined company, the picture looks better for sure. Just to highlight, and I'm not here to talk about the Actavis Generics business. I think they will have their results tomorrow. But the highlight for them is as far as last week, they…
OP
Operator
Operator
The next question comes from the line of David Amsellem. Please ask your question.
David A. Amsellem - Piper Jaffray & Co. (Broker): Thanks. Joined late, so I apologize if I missed this. But on Bendeka, so assuming that there are generics on the lyophilized product, I guess with the product not having a J-code, can you talk about how it's viable if you do go to multi-source? And talk about your latest thoughts on where your share would go in that kind of scenario, assuming that the case doesn't go anywhere. Thanks.
Erez Vigodman - President, Chief Executive Officer & Director: Hi, David. I'll start. Rob might reinforce that. So I think the next important milestone and the inflection point is basically a decision on the ANDA case. So that's what we need to expect and that's an inflection point and a tipping point in the market. And I think all of us need to wait and see basically what we've got coming out in the course of the next few weeks and just then commence on potential ramifications. And, Rob, you would like to add to it something?
Robert Koremans - President & CEO-Global Specialty Medicines: Yes, Erez, I think you are fully right. And then also on the J-codes, there's a preliminary decision by the CMS. There still is – and Eagle will with our support definitely also fight that and try to address this in a public hearing later this month, and the final decision is out in November of this year. So even if the initial decision wasn't positive, the fight on the J-code itself is also not over. Clearly, and I think we need to really wait for these results. If the J-code would not comment (50:02), there would be generics for the lyophilized products, then we really are facing a difficult situation where we believe that Bendeka will become a relatively small product going forward. But we still have many options to try and intervene and prevent this.
David A. Amsellem - Piper Jaffray & Co. (Broker): Thank you.
OP
Operator
Operator
The next question comes from the line of Ken Cacciatore. Please ask your question.
Ken Cacciatore - Cowen & Co. LLC: Hi, good morning. I was just wondering, on that $1.1 billion of revenue, just could you give us a sense maybe in advance of the value that you're going to be capturing as you assign that? And then maybe discuss how that value may have some impact on your ability to either increase the size of your business development that you're looking at. And then in terms of business development, can you talk about the environment? Asset values have come down to a certain extent. But can you discuss maybe the other side of the fence, the folks you may be negotiating with, their reasonability in terms of where valuations are now? Thank you.
Erez Vigodman - President, Chief Executive Officer & Director: Hi, Ken. First, I think that's an opportunity again just to underscore the notion that the $1.1 billion, implication of $1.1 billion are embedded into the $1.4 billion of net synergies. That's something – I think that message is a very important message. And so when we say that we are committed to generate $1.4 billion of net synergies, it means that it includes the basically higher divestiture versus the initial expectation. And that's basically a clear, important message that we are conveying here. So that's number one. Number two, yes, we'll get higher value. It might increase the optionality on potential business deals (51:51) during 2016, but we prefer to discuss details when we close the deal.
OP
Operator
Operator
The next question comes from the line of Chris Schott. Please ask your question.
CL
Christopher Schott - JPMorgan Securities LLC
Analyst
Great. Thanks very much for the questions. Just going back to the competitive landscape on the generics side, it clearly seems like some of your competitors are having some challenges here. I guess two-part question here. A), what do you see happening to these smaller players given these challenging market dynamics? And B), are you concerned that these companies become increasingly less rational competitors as they try to defend their business and that could have spillover effect into Teva's business? The second question I had is on that $1.1 billion divestiture, what was the expectation? So how much more are you offsetting with the synergies in the business to keep that net number the same? And then finally on generic gross margins, some very healthy trends year over year. How much more opportunity is there to improve margins on the current standalone business as we think about the next year or so before Allergan gets into the mix? Thanks so much. Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group: Thanks, Chris. First of all, on the competitive environment and ANDA (53:06), you're right. The smaller companies are probably having a tougher time, and it goes back to what I mentioned as the first reasoning for why they're seeing a total price erosion is there was I think a market where it wasn't good for the business to be in niche environment where you had one or two products where you could take a price increases and that allowed your overall market to grow. I think in the current environment, maybe there isn't the same opportunity for that. You basically benefit from having a much larger portfolio where some of the portfolio is clearly under threat, but other parts of the portfolio you can grow with new product launches.…
OP
Operator
Operator
The next question comes from the line of Gregg Gilbert. Please ask your question.
GI
Gregg Gilbert - Deutsche Bank Securities, Inc.
Analyst
Yes, hi. Good morning, good afternoon. Sorry if you covered this, I don't think you did. But is the EBITDA contribution from Allergan in 2016 the same that you already projected other than the change in the closing timing? And, Siggi, what type of info are you getting from Allergan and how frequently do you get it? And then my follow-up is on SD-809. Perhaps you could talk about commercial readiness and how your interactions with the FDA are going so far. Thanks. Eyal Desheh - Chief Financial Officer & Group Executive VP: Maybe I'll start with the EBITDA coming from the Allergan generic piece. They're moving pieces. In the original model, we assume the full year. Now it's becoming a half a year. Of course, synergies are not linear. In six months you can achieve less. But as you heard from Siggi, our three years from closing targets remain very well on target and in place. So proportionately, it could be a little less. But keep in mind, it is a six-month period and not a full-year period. So look at 2016 as a transition year, and really the year to measure would be 2017. That's why we will provide some outlook earlier than what we normally do. Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group: And, Gregg, around the information we get from Allergan, first of all, we are competitors in the market. We have to be very careful. We cannot exchange any information. We are competing very fully in the market until closing. So for example, we have no access to financial information that we have in the quarter that they haven't reported. But the information that we have is what's in the public domain. We know how many first-to-files they have had. We know…
OP
Operator
Operator
The next question comes from the line of Liav Abraham. Please ask your question.
LI
Liav Abraham - Citigroup Global Markets, Inc.
Analyst
Good morning. Siggi, you spoke about 10% volume growth from the combined product pipeline over the next few years. What visibility do you have for this growth, and what makes you confident that you can maintain this volume growth over a period of time beyond the next couple of years? And then secondly, can you comment on the increased pace of ANDA approvals by the FDA? One could argue that this will increase the competitive environment for generic companies, including the combined Teva-Allergan Generics business. I'd be interested in your thoughts on these dynamics and the potential net impact on Teva, if any. Thank you. Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group: Thanks, Liav. So in terms of the formula I talked about for the 10% growth, we are talking about obviously value growth, revenue and profit growth. It doesn't mean necessarily that this is the volume growth because usually the new product launches have a smaller volume than the old portfolio. But we have an amazing network. Obviously, we have – in the combined network we have plenty of capacity for complex generics that we will be introducing. But overall, we are very confident that with our current network, we still have plenty of opportunity to grow going forward. In terms of how long we can maintain this, I feel we have that for the long run. What I know now is what is pending at the FDA. In the combined pipeline of Actavis Generics and Teva, I see that I'm very confident over the next two to three years because that has already been filed. So that gives me – that's the beauty of the generic business, the risk around approval is much less than otherwise. And the second reason why I think it's long…
LI
Liav Abraham - Citigroup Global Markets, Inc.
Analyst
Great, thank you.
OP
Operator
Operator
Your next question comes from the line of Elliot Wilbur. Please ask your question. Elliot Wilbur - Raymond James & Associates, Inc.: Thank you, good morning. I also wanted to touch on the subject of pricing. But actually my question is directed at Rob with respect to the specialty business. Specifically, in the press release, you talk about Copaxone having a net positive impact in terms of year-over-year growth, driven by positive pricing dynamics. I'm just curious how you're seeing that play out or how you expect that to play out over the balance of the year. Obviously, it seems like there's a lot of payer pressure on specialty products. And I think the expectation was that pricing dynamics could be neutral to negative for Copaxone, but obviously not the case in the first quarter. And then maybe just extend that question to some of – the rest of the specialty portfolio, specifically in the U.S. Maybe just generally comment on price/volume dynamics there. Then the follow-up question for Eyal given the expected immediacy of the close of the Allergan Generics business. Can you maybe just talk to us a little bit about your expectations around the debt side of the balance sheet in terms of the current bridge loan, how much of that needs to be refinanced, what you're thinking about in terms of the term structure there, and the associated interest rate with the final debt package? Robert Koremans - President & CEO-Global Specialty Medicines: Elliot, I'm happy to take those. So first, Copaxone is really doing well. And like you said, we see a lot of the impact also from the net price increase of 7.9% that we did for both strengths in the beginning of the year. But it's actually really a result of a fantastic…
OP
Operator
Operator
The next question comes from the line of Umer Raffat. Please ask your question.
UI
Umer Raffat - Evercore ISI
Analyst
Hi. Thanks for taking my question. Erez, maybe one for you. How do you intend to approach SD-809 pricing, considering your initial approval as being Huntington's but the bigger population will be tardive dyskinesia, where your competitor might come in materially lower than (1:08:28) pricing? Michael, just wanted to clarify two things with you. First, you said CGRP Phase 3 timing is late 2017, and I suspect that might put you six to 12 months behind competition. I just wanted to make sure I clarified that. And the other thing you said was on SD-809, Michael, you said FDA had raised some final questions in the review process, so I wanted to confirm, are we still on track for late May PDUFA? And finally for Siggi, Siggi, just wanted to ask, what's your updated EBITDA number for Allergan Generics standalone in 2017 given the divestitures? Thank you. Michael R. Hayden - President of Global R&D and Chief Scientific Officer: Okay, thank you, Umer. Just to answer just on CGRP, of course at the present time, yes, we've always calculated for chronic migraine that we'd be in all likelihood first to market, for episodic second. But I would say that we're making great progress. And we'll just have to see how these trials run out, all about timing of recruitment and also the strength of the results. But we believe that this particular product has a differentiated profile thus far and the recruitment is going ahead of schedule. So at the moment, we are talking about the end of 2017. But again, as recruitment continues, we'll be able to update that during the course of the trial and to be able to give you latest information on that. With regard to the FDA, at this point we don't really comment and…
UI
Umer Raffat - Evercore ISI
Analyst
Got it. But, Erez, just to be clear, would you reprice it once tardive is approved, or would you just go with one pricing for both, or is it something TBD?
Erez Vigodman - President, Chief Executive Officer & Director: TBD.
UI
Umer Raffat - Evercore ISI
Analyst
Got it.
OP
Operator
Operator
The next question comes from the line of Jason Gerberry. Please ask your question.
JL
Jason M. Gerberry - Leerink Partners LLC
Analyst
Hi. Thank you for taking my question. It's a question for Siggi. Can you comment at all, for the pro forma entity as you look at it maybe for the last three to five years going backwards, what was the average annual new product sales contribution for the generics business? I'm just trying to get a sense. Teva used to provide this disclosure three, four years ago. And I think it's important because as we look forward to your math, it implies something like $600 million to $700 million in annual new generic product contribution. So I just wanted to have a sense of where we've been coming from to how we get to that number.
Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group: Jason, thanks for that. I think on the Actavis side, obviously I have the benefit of knowing that internally. That was achieved every year because there was a significant – that was the key to the Actavis Generic business model. I can confirm that in the Teva, at least for last year, because I know the numbers very well for 2015, we achieved more than 10% (1:13:13) in new product revenues from new product launches last year. So it can be achieved with the investment in the pipeline we are talking about for sure.
JL
Jason M. Gerberry - Leerink Partners LLC
Analyst
Great. And if I could just get my follow-up in, so there's a little bit of discussion on the CGR landscape around some of the IP that Labrys had. I'm just curious if there's any plan to try to enforce that IP, if that might create freedom to operate issues for any of the other CGRP players in the market. Thanks.
Erez Vigodman - President, Chief Executive Officer & Director: We don't want to discuss it at this stage.
JL
Jason M. Gerberry - Leerink Partners LLC
Analyst
Okay. Thank you.
OP
Operator
Operator
Your next question comes from the line of Marc Goodman. Please ask your question.
ML
Marc Goodman - UBS Securities LLC
Analyst
Good morning. A few things. So first, I just want to confirm. So previously, we had divestitures that were supposed to be below $1 billion. Now they're going to be a little bit above $1 billion. We had a cost-cutting plan before of a certain amount, and now that cost-cutting is going to be bigger such that the net number which is the accretion to earnings from the deal will basically be about the same as you thought before. That's question number one. I just want to confirm that. Second, the specialty products, if you just look across the board, the ones you disclosed, Azilect, ProAir, QVAR, they all seem to be much above what everybody was expecting. So just curious why was there inventory build. And then maybe, Siggi, you could just give us some color on some of the key countries outside of the United States what's going on, a little more color than what was in the press release. Thanks. Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group: So maybe I take one and three. So you're correct on the first question. We are little bit about (1:14:49) $1 billion, but we are very confident to achieve the same net synergy number as before. So your assumption is fully correct. With regards to the international market, we have a good performance in the international. We were under a little bit of pressure. There's increased pricing pressure in the UK. We have seen that and the same in France. But we also have a good performance; we saw better performance than we expected in Italy, Germany, and in Spain, where the environment has changed as the new guidance in terms of discounts and things like that. So we are sitting at the same table as the…
OP
Operator
Operator
Your next question comes from David Maris. Please ask your question.
DL
David Maris - Wells Fargo Securities LLC
Analyst
Good morning, Erez and Siggi. Today you mentioned biosimilars that you're looking to expand the pipeline with some further biosimilar exposure. So given that Teva rarely says that they're looking to do something and then doesn't do it, so maybe you could describe what you're looking for, and then just remind us what the state of the current Teva biosimilar pipeline is. Thank you.
Erez Vigodman - President, Chief Executive Officer & Director: So maybe I'll start. We promised that during 2016, we'll basically be able to address a wave two and clear direction for wave three in pursuing potential collaborations and partnerships with players in a way that might bolster our biosimilar pipeline. Basically we have every intention and we plan to deliver on that promise during 2016.
Michael R. Hayden - President of Global R&D and Chief Scientific Officer: David, where we are currently is that we have one product in late-stage development we have a biosimilar, so fumarate (1:20:36) is in the public domain. And then we have three wave three biosimilars in development, in relatively early development. But we have the infrastructure basically to develop our own biosimilars. We have an outstanding biologic group around the world. We have the regulatory affairs and the IP knowledge to do this. And really the reason why we are looking for a partnership here, especially around wave two, because we have a gap in our pipeline around wave two and maybe some of the early wave three products where we simply don't have the time to catch up. In terms of where we are in the market today, we have a revenue of the wave one biosimilars of approximately $300 million to $400 million on a yearly basis. These are the old versions, of course, EPO, filgrastim, pegylated filgrastim, et cetera, doing well. But we also have the infrastructure to sell these products. And I think maybe as the last point here is we recognize that to sell biosimilars today and going forward, you need to be both a specialty company and a generic company because that's the key to be able to market these products going forward. I think we have the ideal partner in this way. But as Erez mentioned, focus on the partnership is on wave two and maybe early wave three, but looking for ourselves for development of other wave three products.
DL
David Maris - Wells Fargo Securities LLC
Analyst
Just as a follow up, though, based on your commentary, should we expect or is it your goal to have something or a start of that augmentation policy or strategy put in place by the end of this year?
Erez Vigodman - President, Chief Executive Officer & Director: The answer is yes.
DL
David Maris - Wells Fargo Securities LLC
Analyst
Great, thank you very much.
KR
Kevin C. Mannix - Senior Vice President-Investor Relations
Management
Operator?
OP
Operator
Operator
The next question comes from the line of Sumant Kulkarni. Please ask your question.
Sumant S. Kulkarni - Merrill Lynch, Pierce, Fenner & Smith, Inc.: Hi, thanks for taking my questions; Siggi, actually both for you. On generic pricing erosion, we've heard a lot. But specifically on alternate dosage forms like topicals, are those as attractive products as they used to be, given everything that's going on in the marketplace? And second, what are your latest thoughts on your potential to get an AB rating for your generic EpiPen?
Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group: Thanks, Sumant. I'm pleased we didn't have a call without an EpiPen question. I think first on pricing on different dosage forms, it depends a little bit of the situation in the market. You probably remember, Sumant, that in the year 2009, nobody wanted to be in injectables. Then we obviously had the quality issue in the injectables space. And then two years later, everyone wanted to be in injectables. So on topicals now, I think there is some pricing pressure. You have seen that maybe in the companies that are more exposed to topicals like Perrigo and Sandoz to some extent. They have been talking about more pricing pressure than we have been talking about or Mylan or Allergan, so that could be a reason. Overall in topicals, the competition is a little bit less. We are talking about usually maybe three to five competitors in the market, where we have on commodities maybe 18 – 19, up to 18 – 19 competitors. But currently, we are not that exposed to topicals ourselves. We have some products, but we also have a very interesting pipeline on topicals going forward where when we combine with Actavis Generics, we will have first-to-file opportunities on topicals. But regarding the EpiPen, as we mentioned before, we got a Complete Response Letter from the FDA. We were seeking advice from the FDA. The FDA offered us to get further advice on the letter; we are getting but now. We are building a strategy. We are still fully committed to this development. There will be a delay obviously due to the Complete Response Letter. We have not finalized our strategy. We are working with our partner Antares on the final strategy for this product. But I want to reemphasize, we are still fully committed to this product, but we don't know how much the delay will be until we can introduce an AB-rated EpiPen.
Sumant S. Kulkarni - Merrill Lynch, Pierce, Fenner & Smith, Inc.: Thank you.
OP
Operator
Operator
That concludes the question-and-answer session. I will now hand the call back to Erez Vigodman, President and CEO, for final comments.
Erez Vigodman - President, Chief Executive Officer & Director: So thank you, everyone, for participating this morning at the outset of a new week and have a great week.
OP
Operator
Operator
That does conclude the conference call today. Thank you for participating and you may all disconnect.