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Teva Pharmaceutical Industries Limited (TEVA)

Q1 2018 Earnings Call· Thu, May 3, 2018

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Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing by and welcome to the Teva First Quarter 2018 Financial Results. At this time, all participants are in a listen-only mode. There will be a presentation, followed by a question-and-answer session. I must also advise you the call is being recorded today, Thursday, May 3, 2018. I would now like to turn the conference over to your first speaker today, Kevin Mannix, Senior Vice President, Head of Investor Relations. Please go ahead, sir.

Kevin C. Mannix - Teva Pharmaceutical Industries Ltd.

Management

Thank you, Steve, and thank you everyone for joining us today to discuss Teva's first quarter 2018 financial results. Earlier this morning, we issued our press release detailing our results for the quarter and year. A copy of the press release, as well as a copy of the slides being presented on this call can be found on our website at www.tevapharm.com, as well as on our Teva Investor Relations app. Our discussion today includes certain non-GAAP measures as defined by the SEC. Management uses both GAAP financial measures and the disclosed non-GAAP financial measures internally to evaluate and manage the company's operations to better understand its business. Further, management believes the inclusion of non-GAAP financial measures provides meaningful supplementary information to and facilitates analysis by investors in evaluating the company's financial performance, results of operations and trends. Reconciliation of GAAP to non-GAAP measures are available in our earnings release and in today's presentation. Today, Kåre Schultz, our Chief Executive Officer, will open the call with some remarks on our results, recent events and outlook for 2018. Mike McClellan, our Chief Financial Officer, will review the first quarter financial results in more detail and discuss additional assumptions around our 2018 outlook. I'd also like to note that on the call with us and available during the Q&A is Brendan O'Grady, Teva's Head of North America Commercial. And with that, I'll now turn the call over to Kåre. Kåre, if you would, please. Kåre Schultz - Teva Pharmaceutical Industries Ltd.: Good morning or good afternoon to all of you and thanks for calling in. We had a strong start to 2018. The sales in the first quarter came out above $5 billion, $5.1 billion, and you will have seen that our earnings per share also came out strong. So, the GAAP…

Michael McClellan - Teva Pharmaceutical Industries Ltd.

Management

Thank you, Kåre. Good morning, everyone. You've received a lot of information today in our press release as well as the 8-K we furnished last week with a lot of details on our new segment reporting. Following the reorganization we announced in November of last year, we have adjusted our segment reporting to align to the new organizational structure of the company. We are now organized by three regional segments, which have full P&L accountability, as well as an other non-core activities segment, which includes third-party API business. To assist you in your analysis, we have provided historical information for select revenues by activity in each of the three regions, and for your reference, it is in slide number 26 in the backup sections of this presentation. In addition to this information, I think it's important to point out the following, which I hope will help you in adjusting your historical models. First of all, our Canadian business, which had annual revenues in 2017 of approximately $590 million, including $476 million in generics, has moved from rest of the world into the North American segment. Second, our API business, which had approximately $750 million in revenue, is no longer included in the generic figures or in the regions. It is in the separate non-core segment. For your reference, about 37% of the API sales were generated in the U.S. in 2017, 36% in the Growth Markets and 27% in Europe. API is now under other activities, which also includes our Medis business, which had revenues of $445 million in 2017. Third, we moved the payments we received in connection with our agreement to sell the NINLARO royalty stream from rest of the world to North America in the new segmentation. This includes two payments of $75 million each in quarter…

Operator

Operator

Thank you very much. The first question we have today comes from the line of Gregg Gilbert from Deutsche Bank. Please go ahead.

Gregg Gilbert - Deutsche Bank Securities, Inc.

Analyst

Good morning. Good afternoon, team. Thanks a lot for the question. Kåre, I'm trying to get a sense of urgency, or a sense of your sense of urgency to reduce debt. Obviously, you've done a good job so far with cash flow. But to the extent your turnaround continues to deliver on plan and the equity price improves, can you talk about your thoughts about using equity at some point to reduce debt, to accelerate de-levering and get back to playing some offense and being able to do some BD, et cetera? And my follow-up is for Brendan. Curious about the status of your generic XIFAXAN program. I saw the stay get extended the other day. Trying to understand what that means in terms of your belief in approvability of your current application in light of the draft guidance – or the guidance at FDA. Thanks, guys. Kåre Schultz - Teva Pharmaceutical Industries Ltd.: Thank you very much. I'll answer the first question, and then I'll hand it over to Brendan for your second question. So, with regards to using equity, I've said it before and I'm pleased to repeat it again. I have absolutely no plans of issuing new equity. Basically, no matter what the price would be, the plan we have right now is based on, you could say, an organic improvement of the balance sheet by using our cash flows to reduce debt and by a strategy of consolidation and efficiency and profitability improvements over the coming years. So, there are no plans for any kind of M&A activity or any issuance of equity whatsoever. We will simply use the operating cash flow we generate to reduce the debt over the coming years.

Gregg Gilbert - Deutsche Bank Securities, Inc.

Analyst

Thanks. That's clear. Kåre Schultz - Teva Pharmaceutical Industries Ltd.: So, with that, I hope I addressed that question, and then I'll hand it over to Brendan.

Kevin C. Mannix - Teva Pharmaceutical Industries Ltd.

Management

And Gregg, that was XIFAXAN, right?

Gregg Gilbert - Deutsche Bank Securities, Inc.

Analyst

You got it.

Kevin C. Mannix - Teva Pharmaceutical Industries Ltd.

Management

Thank you.

Brendan O'Grady - Teva Pharmaceutical Industries Ltd.

Analyst

Yeah. So, just a quick comment on XIFAXAN. Obviously, that is driven by the litigation and the approval. We had a 30-month stay that is over in August of 2018. We're responding to the FDA's revised guidance around bioequivalence. So, we've moved that out of 2018 and do not expect a launch in 2018. Kåre Schultz - Teva Pharmaceutical Industries Ltd.: Okay. I hope that addressed your question.

Gregg Gilbert - Deutsche Bank Securities, Inc.

Analyst

Thank you, Kåre. Your answer was clear. Thanks.

Kevin C. Mannix - Teva Pharmaceutical Industries Ltd.

Management

Next question?

Operator

Operator

Thank you. The next question comes from the line of Jason Gerberry from Bank of America. Please go ahead.

Jason M. Gerberry - Bank of America Merrill Lynch

Analyst

Hi. Good morning. Thanks for taking my questions. Just wanted to get a sense, your interaction with the FDA so far on the fremanezumab application and what gives you guys, I guess, confidence in approval by year-end. And have you guys had any advancement in terms of finding or securing a backup API support source? Kåre Schultz - Teva Pharmaceutical Industries Ltd.: Jason, thanks for that question. I'll handle that. So, first of all, we've had a very constructive dialogue with FDA and we continue to have that. And it's pretty evident from the clinical data we have and actually that of our competitors as well, there's not much doubt about the efficacy of this class. It's very efficacious. It's a huge improvement in the health situation for people with chronic migraine. So, we don't see any real issues on the efficacy and safety side. So, the only, you could say, issue we have had outstanding or we still have outstanding is the fact that our API source Celltrion have had warning letter based on the inspection they had last year, where they got a 483. And we have been in discussions of course with FDA on this, and based on those discussions, we are expecting to see a inspection of their plant in the coming months. And of course, we're expecting that we will be able to have our partner meet the demands from FDA. And based on that, we are expecting to see a approval and launch before the end of this year. And we do not have any backup source that we have filed with the FDA. So, we are basically assuming and expecting that Celltrion will get in good shape in terms of GMP compliance, and we have no reasons to believe otherwise.

Jason M. Gerberry - Bank of America Merrill Lynch

Analyst

And Kåre, just to follow up, what ultimately makes you confident that the broader issues in the warning letter beyond just fremanezumab are resolvable? Is that something that you've gained incremental comfort on over the course of the past few months? Kåre Schultz - Teva Pharmaceutical Industries Ltd.: You could say my assessment is based on mine and some of my colleagues and external experts' assessment of the outstanding issues mentioned in the 483 and then the activities undertaken by our partner Celltrion to remedy all these different deficiencies and make sure that they have a good state of GMP compliance.

Jason M. Gerberry - Bank of America Merrill Lynch

Analyst

Got it. Thank you.

Operator

Operator

Thank you very much. The next question today comes from the line of Elliot Wilbur from Raymond James. Please go ahead. Elliot Wilbur - Raymond James & Associates, Inc.: Thanks. Good morning. Kåre, I just wanted to get a little bit more color around your commentary on the U.S. generics business optimization, maybe a little bit more detail kind of where you are in that process. I'm just sort of wondering, based on your interaction with customers, what are some of the pushes and pulls in terms of customers being willing to accept or – being told they have to accept higher price versus risk discontinuation, how willing are they to cede on price, given what seems to be fairly large retrenchment across many manufacturers in the U.S. and the potential supply chain risk that creates versus letting you out of some of these contracts without having to be forced to pay a lot of inabilities? Second question, just want to get a little bit more color around the guidance increase in revenue, hard to get too granular on $200 million or 1% in revenue, but just curious if it's fair to say the bulk of that is COPAXONE and FX. Thanks. Kåre Schultz - Teva Pharmaceutical Industries Ltd.: So, Elliot, thanks for that. I'll give a little bit of color to the U.S. generics, and then I'll let Brendan give some more details, and then Mike will give you some answers on the guidance. But if we start with the overall situation on U.S. generics and pricing, I think it's really important to understand the basics of the dynamics that's been happening. And the way at least I've analyzed it is that we had a consolidation on the buyers side and you've had a situation where suppliers were maybe…

Brendan O'Grady - Teva Pharmaceutical Industries Ltd.

Analyst

Thanks, Kåre. And yeah, I'll give you a little bit more color there. So, we've met with all of our major customers and supplied each one of those customers with a list of products that we specifically wanted to address. And I will say that having worked through all of the issues we have, we're just about through that exercise and it's really kind of like an 80/20 rule. About 80% of the products we will get out of and they will move to other suppliers, and about 20% of the products we will see an increase in price on. So, we've been happy with the response from our customers. We've worked with them very cooperatively and responsibly. And the idea here, as Kåre mentioned, is not to create any kind of supply shortage in the market, but to do so in a very easy way for them and for us as well. So, we've been able to minimize or even eliminate any failure to supply penalties. Kåre Schultz - Teva Pharmaceutical Industries Ltd.: Thank you, Brendan. And then, we'll move on to the guidance. And before we do that, I'll just remind you all that when we sent out the guidance a quarter ago for the full-year, we had taken into account that this would happen in the U.S. So, our $4 billion expectation for U.S. generic sales was inclusive of the loss of turnover as a result of the tail cutting. And of course, the reason why we do it is that there's no sense in selling products when you have a cash loss on doing it at the margin. So, there's no real change in the guidance from what we saw a quarter ago and from what we saw now when it comes to the U.S. generics. But with that, over to you, Mike, on the $200 million up on the top line.

Michael McClellan - Teva Pharmaceutical Industries Ltd.

Management

Yeah. So, I'll tell you a little bit about why we raised the guidance both on the top line and the operating profit. So, the $200 million on the top line is coming across the different regions. Europe has had a good performance, Growth Markets as well. We've seen a strong performance in the Anda business in the U.S. COPAXONE is maintaining very well. So, we're off to a very good start. It is only 1% on the full-year, so it's not a major deviation. FX is a slight advantage there, but we did build our expectations on FX rates that are pretty close to what we've seen in Q1. So, I don't see that as a major driver. We also have included the expectation that we will have a little bit additional cost savings based on what we've seen through the Q1. When you add all of that together, you end up with about $200 million both on the top line and on the EBITDA, and that's the basis of our guidance. So, it's no one single driver. It's just strong performance across the portfolio. Kåre Schultz - Teva Pharmaceutical Industries Ltd.: Thank you, Mike.

Kevin C. Mannix - Teva Pharmaceutical Industries Ltd.

Management

Next question?

Operator

Operator

Thank you very much. The next question today comes from the line of David Risinger from Morgan Stanley. Please go ahead. Zhu Shen Ng - Morgan Stanley & Co. LLC: Good morning. Zhu Shen here for David Risinger. Thanks for taking my question. Could you please discuss the R&D and SG&A cost reduction opportunities looking forward? Yeah, that's it for me. Kåre Schultz - Teva Pharmaceutical Industries Ltd.: Okay. Thank you, Zhu Shen. I'll handle that. Yeah, you could say, in broad terms, what we've done is we have sort of resized our portfolio and our R&D to what we think is sustainable and needed for a healthy business. And in broad terms, that's sort of ongoing $1 billion in yearly spend on R&D, roughly 50/50 between generics and specialty. Of course, we have some elements, pilot scale, manufacturing upscaling, some clinical testing and whatsoever, where we have facilities that we use both for specialty and R&D. So, we're seeing some synergies there by consolidation of the two branches of R&D, which we've done. This enables us to constantly produce enough new generic filings to keep our business going long-term. And you could say the $0.5 billion in specialty R&D in my mind is enough to keep us going, and having a couple of good hits, not on a yearly basis, but over a 10-year period, we will have several good hits and we will have products like fremanezumab coming to the market and products like AUSTEDO, like COPAXONE, these types of products which will be high, high clinical benefit, relatively high price in the specialty segment. And we think we can maintain that balance nicely with the current spending. We don't have any plans of further dramatic reductions below the sort of $1 billion level. But we don't see any reason why we would take it up either. So, for the coming years, that's really the level we are expecting. And Mike, you can just give some more clarity on it.

Michael McClellan - Teva Pharmaceutical Industries Ltd.

Management

Yeah. Let me give you some color. Our spend base reduction, we are planning to get to $3 billion by the end of the restructuring plan. We promised you $1.5 billion in this year. If you look at Q1, the spend base versus Q1 of last year is actually down by a net $400 million. That is against a currency headwind of about $190 million. So, overall, we were able to reduce the real operating and cost of goods by $420 million. We had a headwind against that of FX of $190 million. But then, again, we also benefited from the divestment which reduces the spend base. It's not part of our $1.5 billion net target that we're talking about. But you'll see overall the $400 million is minus $400 million in operating, plus $200 million in FX, and then another $150 million coming back out from the divestments. Kåre Schultz - Teva Pharmaceutical Industries Ltd.: Thank you, Mike. I think that covers the question. Zhu Shen Ng - Morgan Stanley & Co. LLC: Thank you.

Kevin C. Mannix - Teva Pharmaceutical Industries Ltd.

Management

Next question?

Operator

Operator

Thank you very much. The next question comes from the line of Irina Koffler from Mizuho.

Kevin C. Mannix - Teva Pharmaceutical Industries Ltd.

Management

Irina?

Irina R. Koffler - Mizuho Securities USA LLC

Analyst

(40:31) market in terms of commercialization for AUSTEDO. And the second one is for migraine, we heard at AAN that you would be considering using some of your primary care respiratory reps to promote CGRP. Can you just comment on that briefly? Thank you. Kåre Schultz - Teva Pharmaceutical Industries Ltd.: Irina, I'm sorry, but for some technical reason, I didn't get fully the first question on AUSTEDO. Could you just repeat it, please?

Irina R. Koffler - Mizuho Securities USA LLC

Analyst

Sure. Are you planning to start promoting AUSTEDO in the psychiatry market more aggressively? Kåre Schultz - Teva Pharmaceutical Industries Ltd.: Okay. Thank you very much. I will refer both the question on AUSTEDO and the CGRP and respiratory sales force question to Brendan.

Brendan O'Grady - Teva Pharmaceutical Industries Ltd.

Analyst

Yeah. So, thank you, Irina, for the question. So, in regards to AUSTEDO, yes, we are increasing the amount of sales support around AUSTEDO to the psychiatry group, and we did so just recently. That sales force – that increase in FTEs will be out there in the first part of May. So, we're there. As far as the question about fremanezumab and how we plan to promote that, we have two sales forces that will be promoting fremanezumab. One is a neuroscience sales force, and we've kind of restructured our respiratory sales force a little bit to allow some promotion there as well.

Irina R. Koffler - Mizuho Securities USA LLC

Analyst

Thank you.

Kevin C. Mannix - Teva Pharmaceutical Industries Ltd.

Management

Next question?

Operator

Operator

Thank you very much. The next question comes from the line of Liav Abraham from Citi. Please go ahead.

Liav Abraham - Citigroup Global Markets, Inc.

Analyst

Good morning. First question is on COPAXONE. Just given your experience with one generic 40 milligram on the market and the response of both customers and patients and payers, are there any changes to how you think this market will evolve with two generics in the market? Any change to your assumptions there regarding how the revenues will progress as a second generic enters the market? And then secondly, just on the CRL that Celltrion recently received for biosimilar RITUXAN and Herceptin. I noticed yesterday that Sandoz received a CRL for its biosimilar RITUXAN. Was the Celltrion CRL only due to manufacturing or were there any other deficiencies noted in that application? And any other – any additional color you can provide there? Thank you. Kåre Schultz - Teva Pharmaceutical Industries Ltd.: Thank you for those two questions. We'll handle the COPAXONE first. I'll just give a few general comments, and then Brendan can give you some more specifics. From an overall point of view, there's no real change in how we see it. You could say the best proxy we have for it is, if you look at the 20 milligram, where you have two players beside us that each have a generic in the marketplace. And you can get some inspiration by looking at how much volume they've got by now. And then, you can look to other markets where it's kind of a similar specialty injectable product that we're talking about, similar to COPAXONE. And my thinking is that we will of course see some further pressure on our pricing by the fact that there will be two generic 40 milligrams in the marketplace and probably also marginal pressure on the volume throughout the rest of the year. And that's what we modeled into our guidance as well. But Brendan, do you have any specifics – any new thoughts on how that will play out?

Brendan O'Grady - Teva Pharmaceutical Industries Ltd.

Analyst

Yeah, just a few things to add, Kåre. So, I've been in this market a long time and I've seen this market evolve. And I will tell you that I haven't seen any surprises as the way this market is shaped since 2013, 2014, as we've seen generic competition on 20 milligram as well as 40 milligram. So, as Kåre mentioned, as we see another 40 milligram generic into the market, I think there will be some downward pressure on price, probably a little on volume as well. But today, we maintain about 85% of the overall COPAXONE market, and it is following our expectations and our plans for the year. Kåre Schultz - Teva Pharmaceutical Industries Ltd.: With regard to the biosimilars, then of course the details you will have to discuss with Celltrion. But it's so that we assess that the key issue in the CRL for both the products that we have licensed here in the U.S. from Celltrion is really the warning letter and as such, we are expecting that with a positive re-inspection in the coming months, we will be able to see Celltrion eventually lift the CRL and get approval. But our planning is such that we are planning to have these lunches next year. So, it's really not something that's affecting the financial outlook for the current year.

Liav Abraham - Citigroup Global Markets, Inc.

Analyst

Thank you.

Kevin C. Mannix - Teva Pharmaceutical Industries Ltd.

Management

Steven?

Operator

Operator

Thank you very much. The next question today comes from the line of Umer Raffat from Evercore. Please go ahead.

Umer Raffat - Evercore Group LLC

Analyst

Hi. Thank you so much for taking my questions. Actually, I wanted to focus on two of your most important highflying items. First, Regeneron said in their press release this morning that they're discontinuing the high dose of their NGF program. So, I just wanted to get some update from you on what happened, what was seen at that high dose. Was it RPOA or is it neuro-sensory changes? And what does that mean for the overall program now, because Teva – because Pfizer really haven't seen much of the RPOA events from my understanding? And secondly on CGRP, my question really is, you mentioned you expect an approval by year-end, but not in June. So, like mechanistically, how does that work? Because my understanding is, if it's a CRL in June, then you need to wait for an inspection and then re-file, which may put a new clock in. So, I just wanted to get clarity there. Thank you. Kåre Schultz - Teva Pharmaceutical Industries Ltd.: Thank you for those two questions. First, on fasinumab, so the details you would have to discuss of course with Regeneron. But as it's stated today in their release, what happened was basically that the independent data safety board that's overlooking the trials, they concluded based on an overall risk-benefit analysis that the high dose arms should be – or they recommended that the high dose arms should be discontinued, and that's happening. And FDA of course has been updated on everything, and there will now be a dialogue with FDA with regards to the program. And so far, the trials are being modified with the high dose arms being taken out of the trial for fasinumab. With regards to the question on CGRP, then we are in a positive constructive dialogue with the FDA, and based on that dialogue, we do see a possibility for us having the approval and launch this year. I can't get into more specific details on that.

Umer Raffat - Evercore Group LLC

Analyst

Thank you.

Kevin C. Mannix - Teva Pharmaceutical Industries Ltd.

Management

Next question?

Operator

Operator

Thank you very much. The next question today comes from the line of David Amsellem from Piper Jaffray. Please go ahead. David A. Amsellem - Piper Jaffray & Co.: Thanks. So, just on fremanezumab, just thinking beyond the potential approval, so your competitors among the monoclonals are formulating it in auto-injector pens, and your product has relatively high volume compared to the Amgen and Lilly products. So, I just wanted to get a sense of the extent to which you think you can formulate it over time in a pen device, and do you think that the relatively high injection volume could put you at a competitive disadvantage? Thanks. Kåre Schultz - Teva Pharmaceutical Industries Ltd.: Yeah. I'll give you the overall comment, and then Brendan can give some more details. I don't think we have any disadvantage. We don't have a significant high volume of the dosage. It's pretty complete standard like any other antibody that's given once a month and it's comparable to what competition has. And with regard to the auto-injector, then for device development reasons, which are not linked to the product as such, we don't have the approval of the auto-injector that we'll be using yet. But we are in testing and moving ahead with that according to plans. So, we expect to see that in the market. It's correct that if you get the therapy once a quarter, then of course you get a higher volume once a quarter. But it's very likely that the quarterly dosing will be taking place with a nurse or at a doctor's office with some assistance. And that in itself might be preferable for a certain segment of the market. At least in my long experience with injectables, fewer injections seems to win over more injections. That's what I've seen in diabetes over the last 30 years and it's also what I've seen in psychiatry over the last 5 to 10 years. So, I'm very optimistic there will be a significant part of the market that will prefer less injections. But Brendan, do you have any color to it?

Brendan O'Grady - Teva Pharmaceutical Industries Ltd.

Analyst

Yeah. I think there's some confusion going on regarding fremanezumab and the dosing frequency. So, as Kåre said, we will have a monthly as well as a quarterly, and the quarterly does require more injections, but it'll give the patient flexibility to have that injection either monthly at home, quarterly at home or quarterly in the doctor's office. And because it's quarterly in the doctor's office and there's more than one injection, I think people are confusing that with our lack of a pen device at launch. So, we do have a pen device in development. We hope to launch it after we obviously launched the product itself. And so, there's no issue with the pen device is related to the volume of the product. So, we think that we have a very, very competitive offering, because we will be the only ones that have the quarterly dosing, and we think that that will be both a benefit to physicians and patients. David A. Amsellem - Piper Jaffray & Co.: Okay. Any specifics on timing of the launch of the pen device? Kåre Schultz - Teva Pharmaceutical Industries Ltd.: No, no specifics. It will be following the approval and launch of the product in a prefilled syringe. But we don't have any specific date on it. David A. Amsellem - Piper Jaffray & Co.: Okay, thank you.

Operator

Operator

Thank you very much. The next question today comes from the line of Jami Rubin from Goldman Sachs. Please go ahead. Jami Rubin - Goldman Sachs & Co. LLC: Thank you. Question for you, Mike, on debt pay-down. You ended this quarter with net debt of $29.3 billion. I don't know if I saw it, but where do you expect that to be by the end of the year? And just given the results this quarter and clearly what seems to be faster debt pay-down, can you hit 4 times leverage by 2019? And is there an opportunity for further divestitures which could speed up debt reduction? Thanks very much.

Michael McClellan - Teva Pharmaceutical Industries Ltd.

Management

Yeah. So, thank you, Jami. So, so far, we've paid down $2.2 billion, which is actually a gross pay-down of $2.5 billion, but the currency has gone against us by about $300 million. We originally said we'd pay down about $3.5 billion this year. I think with the free cash flow guidance range, we will probably try to pay even more now. The currency of course will be the wild card in that. So, I could see us going down another $1.3 billion to $1.5 billion by the end of the year. And we're still on track to meet our goal of 4 times by the end of 2020. But of course, that relies on the fact of us generating enough cash to cover maturities in the next two-and-a-half years as well as seeing a stronger EBITDA as we go into 2020 and we get past the COPAXONE trough. So, we still feel confident that we're on track for it, but there are some moving parts that we will be keeping a close eye on and we will be managing over the course of the next two years. In terms of additional asset divestments, we are still looking at a couple of assets that we have – we have made public that we are no longer really looking at the Anda business. We're going to keep that and run it. We are still looking at Medis and there's a few other minor assets. But we really don't see that as the huge lever to de-lever. It's really about generating organic cash flow and raising the EBITDA over time, so that we can get our ratios down to where we want to be. Jami Rubin - Goldman Sachs & Co. LLC: Thank you.

Kevin C. Mannix - Teva Pharmaceutical Industries Ltd.

Management

Next question?

Operator

Operator

Thank you very much. The next question comes from the line of Ami Fadia from Leerink Partners. Please go ahead.

Ami Fadia - Leerink Partners LLC

Analyst

Hi, good morning. Thanks for the question. I had two questions. Firstly, just a clarification on fremanezumab. You indicated that patients will have the option to either self-inject or have the dose injected at a healthcare professional's office. Now, how would that impact how the drug is reimbursed between the prescription benefit versus something like a buy-and-bill? And secondly, just with respect to Celltrion, could you give us a little bit more color around what gives you confidence that they will be able to address FDA's questions around the warning letter in the coming months, thereby triggering another FDA inspection? Or are you really telling us that irrespective of whether or not they address their issues, based on your conversations with the FDA, you still think that they'll come back for a re-inspection for fremanezumab? Thank you very much. Kåre Schultz - Teva Pharmaceutical Industries Ltd.: Thank you very much, Ami. I'll try to explain how we see the Celltrion issue first, and then Brendan will talk about the thing about the injections and the reimbursement. So, the way we see it with Celltrion is, of course, they need to be in a good state of GMP, and we believe that they are and they have remedied the outstanding issues. But that's of course up to the FDA re-inspection to assess that. And what needs to happen is they need to have a re-inspection and there needs to be a PAI, pre-approval inspection, of fremanezumab API manufacturing. Now, on the API manufacturing, of course, we've been following that closely for the last years since it's crucial for fremanezumab. The actual 483 that Celltrion had last year in June, I believe it was, was actually on their finished pharmaceutical manufacturing. And of course, they have done everything needed to remedy those deficiencies that they had and they have of course had to inform FDA on an ongoing basis of what they were doing like any other manufacturer would have to do it. And they have to report to the FDA that they have now completed their remediation plan as they are ready to take a re-inspection. So, they have of course done that, and that is why that we say that we expect that there will be a warning letter re-inspection and a pre-approval inspection in the coming months. And of course, then any approval and launch is then on the assumption that Celltrion has done a good job and they are in a good state of compliance and that FDA will find this when they do the re-inspection and they do the pre-approval inspection. And based on that, we're saying that we expect approval and launch before the end of this year. So, I hope that clarifies it. Now, Brendan, could you explain about self-injection and injection at a clinic and reimbursement and so on in the U.S?

Brendan O'Grady - Teva Pharmaceutical Industries Ltd.

Analyst

Yeah, sure. Just let me jump in on that. So, we expect that these products being self-injectable products will go through the pharmacy reimbursement. So, we're not necessarily saying that this is a medical reimbursed product, but these are all self-injectables. But they will also likely go through specialty pharmacy distribution. So, I think what we're saying is that for patients that want a quarterly option and that may not want to inject it themselves and are likely seeing their neurologist or their physician for migraine once every quarter, that option exists and there's a way to do that through specialty pharmacy distribution or other channels. And I really don't want to say much more about our reimbursement strategy other than that.

Ami Fadia - Leerink Partners LLC

Analyst

Okay, thank you.

Operator

Operator

Thank you very much. The next question today comes from the line of Rohit Vanjani from Guggenheim Partners. Please go ahead.

Rohit Vanjani - Guggenheim Securities LLC

Analyst

Great. Thanks for taking the question. I just wanted to – I'm sorry, another question on fremanezumab. I think last time, you had said the API site where that was being produced had not been inspected. So, as part of the PAI, will this – the inspection of the API site be the first time that that's being inspected? And then secondly, you mentioned that 80% of products – 80/20 rule, 80% of products moving and 20% taking a price increase. Has that 80% of the products moved yet? And if not, is that a 2018 or a 2019 event? Kåre Schultz - Teva Pharmaceutical Industries Ltd.: Okay. Rohit, thanks for the questions. I'll address the fremanezumab API thing, and then Brendan will give you a flavor on the U.S. generics pricing. So, the pre-approval inspection of fremanezumab, the way you have a pre-approval inspection done on an API site is that you have to have your manufacturing up and running. So, you've got to make sure that you're actually producing fremanezumab when the inspectors come to the site and they have a good look at everything that's going on. And since this is a pre-approval inspection of a new product, then obviously that process has not been inspected before. But of course, you can also judge from the portfolio that Celltrion has that their API facility as such has been inspected before. So, that's really the situation on that one.

Brendan O'Grady - Teva Pharmaceutical Industries Ltd.

Analyst

Yeah. So, let me address the other question on the 80/20 rule. So, the list differs by customer. So, there is some overlap of course. But to just generally answer your question, it's probably more of a 2019 event than it is a 2018 event as we work through the list with each individual customer.

Rohit Vanjani - Guggenheim Securities LLC

Analyst

Okay, thanks. Kåre Schultz - Teva Pharmaceutical Industries Ltd.: Thank you for that, Brendan. I think we will have time now to take one last question.

Operator

Operator

Thank you very much. The last question today comes from the line of Ronny Gal from Bernstein. Please go ahead. Aharon Gal - Sanford C. Bernstein & Co. LLC: First, thank you very much for sticking me in, and since it was done before, congratulations, Kåre, on a very successful quarter. I got two. The first one I've got COPAXONE for Brendan. Brendan, you've talked about the potential additional pressure coming in from Sandoz. But speaking to payers, it does not seem like anybody is too excited about getting a product from a facility in McPherson when there is like a warning letter every year or so. So, the question is until you get additional competitors, do you really expect that Sandoz product to be a pressure or are you assuming there'll be other products coming in before the end of the year? And second, switching over to fremanezumab, I know you heard a lot about this today. Brendan, I understand you guys expect the product approved by the end of the year. But as we think about the payer cycle of adoption of anti-CGRPs, how late can you be without beginning to see an impact on your final market share? Do you have to be there for the 2020 contracting cycle in early 2019? Or if something happens and you need to be a little bit later, do you still you can get to where you need to be on that market share for this product?

Brendan O'Grady - Teva Pharmaceutical Industries Ltd.

Analyst

Yeah. So hi, Ronny, and thanks for the question. So, let me address the COPAXONE question first. So, beyond Sandoz, we don't expect any other generic competitor coming to the market of 40 milligram this year. So, we're expecting the Sandoz/Momenta product here in the first half as they've communicated and we'll see how that shapes. I think we've built that into our plan. If you look at the market share that we hold today, about 85%, we will likely cede some share and some price, but I think it'll be right according to what we've planned. In regards to the question on frem, I think that if we launch in the second half of 2018, we'll be there on time for the 2019 formulary cycle. We've – payers are aware of where we are. They've been asking questions. So, I think we'll be right in the mix with everybody else. My expectation is that payers will wait until all three products are on the market before they make their formulary decisions for 2019. And I would expect that because this is a new class of drug and this is a – these are new products that most payers will try to take a look at this and give patients and physicians the flexibility to choose what product is right for them. And so, hopefully, this is a push towards access for patients. Aharon Gal - Sanford C. Bernstein & Co. LLC: Thank you. Kåre Schultz - Teva Pharmaceutical Industries Ltd.: Thank you very much everybody for listening in. This concludes our Q&A session. And we look very much forward to talking to you again three months from now. Goodbye.

Operator

Operator

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