Good day, ladies and gentlemen, and welcome to the Mylan Fourth Quarter and Full-Year 2017 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. As a reminder, today's conference may be recorded. I'd now like to introduce your host for today's conference, Ms. Melissa Trombetta, Head of Investor Relations. Ma'am, please go ahead.

Thank you, Liz. Good evening, everyone. Welcome to Mylan's fourth quarter 2017 earnings conference call. Joining me for today's call are Mylan's Chief Executive Officer, Heather Bresch; President, Rajiv Malik; Chief Commercial Officer, Tony Mauro; and Chief Financial Officer, Ken Parks. During today's call, we will be making forward-looking statements on a number of matters, including our financial guidance for 2018. These forward-looking statements are subject to risks and uncertainties that could cause future results or events to differ materially from today's projections. Please refer to the earnings release we furnished to the SEC on Form 8-K earlier this evening, as well as our supplemental earnings slides, all of which are posted on our website at investor.mylan.com for a fuller explanation of those risks and uncertainties, and the limits applicable to forward-looking statements. Mylan routinely post information that may be important to investors on this website, and we use this website address as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's regulation fair disclosure. In addition, we will be referring to certain actual and projected financial metrics of Mylan on an adjusted basis, which are non-GAAP financial measures. We will refer to these measures as adjusted and present them in order to supplement your understanding and assessment of our financial performance. Non-GAAP measures should not be considered a substitute for or superior to financial measures calculated in accordance with GAAP. The most directly comparable GAAP measures as well as reconciliations of the non-GAAP measures to those GAAP measures are available in our fourth quarter earnings release and supplemental earnings slides. Let me also remind you that the information discussed during this call, with the exception of the participants' questions, is the property of Mylan and cannot be recorded or rebroadcast without Mylan's express written permission. An archived copy of today's call will be available on our website and will remain available for a limited time. With that, I'd like to turn the call over to Heather.

Thanks, Melissa, and good afternoon, everyone, and thank you for joining our call. I recognize that a reoccurring theme on many of these calls hosted by pharmaceutical companies in recent quarters relates to the ongoing challenges affecting our industry and the entire healthcare sector in the U.S. I know that's created a lot of uncertainty about what the future holds for our industry. But the fact is, tremendous opportunity awaits the company that's both willing and able to break down the barriers to access to affordable medicine around the world, invest in capacity, and launch new products. Mylan is that company. Having built a one-of-a-kind platform whose strength, diversification and resilience positions us like no other company to provide the kind of leadership needed to truly deliver Better Health for a Better World. We continue to lead the charge to remove barriers to access globally. A couple of great examples to illustrate this. One is our generic RESTASIS, which we look forward to launching in the United States. This product may not become a significant financial driver for us as it will open the market for all, but it is a great example of our ability and willingness to fight the good fight to make an important ophthalmic product available to many more Americans. Similarly in Europe, we overcame numerous IP barriers to secure approval to market the first generic of the 40 milligram strength of Glatiramer Acetate, which we since launched in Netherlands, Germany, the U.K. and Norway. This development builds upon approvals received in 2016 for the 20 milligram strength, which already is available in several European markets. We're happy for the many additional MS patients these products will help. In various emerging markets, we've partnered with other companies to break down barriers as well. Our launches during…

Thank you, Heather, and good afternoon, everyone. I would first like to thank our employees for their unwavering dedication as we close out another strong year and successfully executed on many fronts, both commercially and operationally. I echo Heather's excitement for our Investor Day in April and look forward to highlighting the strength of our platform and our industry-leading differentiated pipeline. I will now walk you through the key drivers of our 2018 outlook. We see 5% top-line growth while targeting EPS growth of 18% at the midpoint of our guidance range. During 2018, we will focus the execution of our significant launches, like generic Advair and many more, to further strengthen our durable portfolio. At the same time, we'll continue to focus on Mylan integration while leveraging our cost of goods structure, our globally vertically integrated platform as well as our optimize G&A footprint. At the same time, we'll be strategically reinvesting in our business, especially in the area such as sales and marketing and lifecycle management of several global key banks. All of these efforts will further ensure that Mylan is Built to Last. From a segment perspective, in North America, specifically in USA, we have several exciting opportunities such as the launches of generic Advair and pegfilgrastim, our first planned biosimilar launch in the U.S. We also will continue to build upon the momentum from our Q4 2017 launches of Glatiramer Acetate and generic ESTRACE Cream. Another important effort will be around further strengthening our ARV franchise in U.S., as we will be very shortly launching our novel ARV combination of (11:05) in addition to recently launched first generic of Efavirenz. Our U.S. portfolio is now and will increasingly be more durable and diversified as a result of our meaningful investments in recent years in injectables, OTC,…

Thank you, Rajiv, and good afternoon. Like Heather and Rajiv, I am pleased with the overall performance of our business in 2017 and remain very optimistic about Mylan's future. From a commercial standpoint, our ability to continue leveraging ONE Mylan around the globe to drive solid top-line growth in 2017 in what's proved to be a dynamic and challenging environment, once again underscores the strength, diversification, and resilience of our commercial platform. We continue to believe that this platform positions Mylan uniquely within the industry and with our customers as we work to deliver better health for patients. Before providing you with an overview of our segment performance, let me first highlight a few key product updates. Over the past year, we continued to deliver on our commitments to bring complex products to market. A few prime examples include our introduction of a generic ESTRACE, a generic version of COPAXONE 20-milligram and the launch of the first generic for COPAXONE 40-milligram in the U.S. and in Netherlands during the fourth quarter. In the U.S., we continue to be encouraged with the uptake on our 40-milligram strength. For the week ending February 16, our share of new prescriptions was 18% and total prescriptions stood at 14%. And we continue to bring on new customers every day. In addition, we have seen an increase in the utilization of a comprehensive support services provided by our MS Advocate Program. This program provides a suite of services truly focused on the patient. These include access to an encore registered nurse for product questions, help to enroll into our co-pay assistance program, in-home injection training with our WhisperJECT Autoinjector and support to help patients understand their coverage and reimbursement options. We continue to view Glatiramer as a very attractive and durable opportunity. We fully believe…

Thanks, Tony, and good afternoon, everyone. Turning to our financial results. Rajiv and Tony have already taken you through the details of our consolidated and segment revenues, which were in line with our expectations. I'll cover the remainder of our financial results. Adjusted SG&A increased 3% in the quarter versus the prior year to $602 million. For the full-year, adjusted SG&A increased slightly to $2.4 billion and declined 40 basis points as a percentage of total revenues. The dollar increase is due primarily to the full-year impact of the acquisitions of Meda and Renaissance. It's important to note that both the quarter and the full-year benefited from our ongoing integration activities, which partially mitigated this impact as we continue to optimize our cost structure. Adjusted R&D was approximately 5% of total revenues for the quarter, which was in line with the prior year. For the full-year, adjusted R&D was down 80 basis points to 5.5% of total revenue versus the prior year, mostly due to the reprioritization of global programs. Our adjusted effective tax rate for both the quarter and the full-year 2017 was 18% and was in line with the low end of our revised guidance. Moving on to segment profitability. As a result of the declines in third-party net sales, including EpiPen, segment profitability in North America declined 12% in the quarter to $687 million. Partially offsetting this decline, segment profitability expanded in Europe and the Rest of World segments by 76% and 6%, respectively, reflecting new product sales contributions. Europe also benefited from higher volumes in our base business, along with favorable pricing and integration activities. For the full-year, combined regional segment profitability grew 5% versus the prior year, Europe grew 62% and Rest of World grew 54%, both benefiting from the full-year impact of acquisitions and…

Our first question comes from the line of Jami Rubin with Goldman Sachs. Your line is now open. Jami Rubin - Goldman Sachs & Co. LLC: Thank you. Just wondering if you could give us a little bit more color on your biosimilar BOTOX program with Revance. If you can talk about some of the technical hurdles in achieving these timelines, et cetera. And was wondering if you would consider bringing other aesthetic products, like fillers, to be in a position to have a more complete aesthetics offering to compete with Allergan? Thanks.

Hi, Jami, thanks for your question. Actually, we will be looking forward to give you more details about the program, the timing and where we are, what we have evaluated from our partners strength point of view. When we talk to you or meet you in our April Investor Day. And also about the line extension and the other aesthetic products that, that subject will also be addressed at the same time.

Yes. And I would just add to that, Jami. Obviously, as we talked about diversification, we're looking obviously across the whole product line, about things that have a, no reimbursement or cash pay, which, again, we think would complement our existing U.S. business. Thanks.

Our next question comes from the line of Ronny Gal with Bernstein. Your line is now open. Aharon Gal - Sanford C. Bernstein & Co. LLC: Hi. Good evening, and thank you for taking my question. One brief one to Ken. What do you expect would be the adjustment to the cash flow in 2018? Are we expecting this to be a large number or small? And then more specifically in biosimilar, HUMIRA; Rajiv, do you expect to getting the market to open in October 2018, essentially as your program move forward, so now, you now expect to be ready then or is it more that they expect market opening to be later and thus, your product will get there on time?

Thanks, Ronny. On the question on cash flow. As you know, in 2017, we have larger adjustments to cash flow as we pay the settlement of $465 million under the CMS, DOJ arrangement. As we move into 2018, the adjusted cash flow is not anticipating similar type adjustments. So I would tell you that right now, we're anticipating those to be smaller.

And Ronny, regarding your question on biosimilar to HUMIRA, we are very much looking forward to potentially launch this product in October of 2018 as market formation takes place.

Our next question comes from the line of Elliot Wilbur with Raymond James. Your line is now open. Elliot Wilbur - Raymond James & Associates, Inc.: Thanks. Good afternoon. Just a question for the team on expected new products approval pace or pipeline yield in the U.S. in 2018. I guess, outside of the complex generic products, which FDA seems to always make more complex than they should be, but there also seem to be a fairly significant slowdown in the rate of approvals, at least over the past couple of months. I just want to get your thoughts or perspective on that and whether or not you've built in additional cushion in terms of probably early adjusting the new product outlook based on the possibility of much slower review times than we've seen in the past couple of years? Thanks.

Sure, I'll start and then certainly, Rajiv, if you want to add anything. What I would say, Elliot, is I don't think 2017 has been different than the last couple of years in the sense of seasonality with approvals coming in from the FDA Q4 and especially, December have always been their largest month of approval. So as you look from December and trend that to January, February, I wouldn't necessarily call that a down tick in approvals from an annualized basis. And on your timing question, what I would say, we continue to be – see improvement in meeting these timelines, especially as we're in the post GDUFA filings and especially now coming into GDUFA II, that, one, the lines of communication, the back and forth, the more transparency around these files, especially around the complex products. We continue to see enhancement then. So we look forward to that continuing under Dr. Gottlieb's leadership. And look, that's why we're excited about this year, our approvals, and look forward to some of these various important launches.

Our next question comes from the line of Gregg Gilbert with Deutsche Bank. Your line is now open.

Thanks you. Ken, I was hoping if you could talk about how any future capital deployment factors into the EPS ranges for the year. And on generic Advair and biosimilar Neulasta, can you help us at least directionally with gross margin; is it higher, lower, or similar than corporate average? I think that, any color on that and biosimilars in general would be appreciated by all? Thanks.

Thanks, Gregg. So I think some of a – couple of the key points is, as you know and as we said and have released earlier, one of the bigger capital deployment, things that we've done and just finished up in the first quarter, was the completion of the $1 billion share buyback program. And obviously, that's going to complement EPS in 2018 and the growth year-over-year. But I would also tell you that we have consistently said over the last 12 to 18 months that once Meda was completed, we're not looking at large transformational assets and businesses to bring into the portfolio. But we do have this large, healthy and growing cash flow stream and cash flow bucket that we'll continue to look at product additions in certain gaps as we look at growing our OTC space, as we look at growing our Derm space, things like that. So, they will have some contribution. But the reality is, is we look at one of the primary areas for capital redeployment this year is, as I stated, which is in paying down debt, following the share repurchase program to reduce our leverage ratio below 3.5 times while we get to the end of 2018 and remain committed to that investment grade balance sheet.

Our next question comes from the line of Liav Abraham with Citi. Your line is now open.

Good afternoon. Just another question on generic Advair, can you just give us a little bit more flavor on the information request that you've received from FDA? Apart from these, are there any outstanding issues? And where do you stand on the manufacturing front? And then as it relates to guidance, can you confirm that you can make your guidance without any of these big launches such as Advair or Neulasta that you're anticipating this year? Thank you.

Thanks, Liav. In fact, we are very happy with the pace at which FDA has reviewed this ANDA after we have submitted the response to the CRL in August of 2017. And we have been getting – especially over the last eight weeks, we have got continuous feedback from FDA in terms of several information requests, some of those requests have already been responded to and some of them are being responded. We don't see any red flags. We don't see any big hurdles. Yes, there is a lot of clarification which we need to provide, but that's what we are left with. And as well as the manufacturing is concerned, we don't see any constraints for manufacturing the requisite quantities for the launch and what we have built in our plan.

And as far as your question around guidance, I would say this year is no different than in year's past. I believe that we've always taken a very practical approach to how we probability weight our launches to, and that's why we give a range around our – around what we're expecting. And as I've often said, all good things don't happen at one time. All bad things don't happen at one time. It's really about managing this global business across all of our segments, as well as this year, really executing on these launches. So as always, as the year goes through, as we see changes or to change those ranges, we will. But we feel good about the range we've given and the way that we've modeled our business to manage to hitting our target.

Our next question comes from the line of Chris Schott with JPMorgan. Your line is now open.

Hi. Great. Thanks very much for the question. Just two quick ones here. First, prior commentary, I think, had been for earnings of at least $5.40 in 2018. Your formal guidance here is $5.20 to $5.60. I know it's not a huge change. But can you maybe just help us bridge a little bit in terms of what changed in terms of underlying outlook here? Is this just more pressure on that U.S.-based business that we're seeing across the space? Or is it something with new launches and pipeline? And then the second one was just an update on generic RESTASIS and the opportunity here. Is that something you're thinking about for 2018? Just any more color on approval timelines. Thank you.

Hi, Chris. Thanks. As far as our – I guess, what I would say, Chris, is I think $5.60 is more than $5.40. And so we've said at least $5.40 our target. The mid-point is $5.40. As you know, there's a lot of moving pieces and parts that go into us giving that range. So really, nothing has changed. I think, again, there's a lot of moving pieces and parts, as I said earlier. And I think our track record of showing our ability to manage those has been very good, and I'm excited about this year. I'm excited about the opportunities. And as I said, as things roll in, we'll continue to hone in on that and so that's what I would say on the guidance.

On RESTASIS, Chris, we have a target action date of July 2018. We don't have any significant or any scientific issues which need to be resolved. And now we are waiting to hear from FDA. And we look forward to bring this product to the market in 2018.

Our next question comes from the line of Douglas Tsao with Barclays. Your line is now open.

Hi. Good afternoon. Thanks for taking my questions. Just, Rajiv, maybe a little bit of an update on the pegfilgrastim product. And one question I had was why was it that with trastuzumab, you simply had the PDUFA date delayed by a few months and yet you had got a Complete Response Letter even though it seems like with both, it was more of manufacturing issues rather than clinical?

So let me give you the status of pegfilgrastim and that – we have responded to the deficiencies, which we received in the last quarter. We have heard from FDA on several of those issues already. And we are already received certain information request. We feel very confident on the science part, on the execution of everything which was asked. And I think we have responded and we have a pretty good place on that. I think the only place where we're waiting now this – between that the tune action date, and this is (52:39) FDA may like to have another look into the manufacturing facility, although they have already approved or given us an approval on Herceptin, but that's up to FDA. We continue to work with the FDA very closely to respond to everything, which has been asked thus far. We don't see any hurdles. And I cannot comment about what assumptions or why they did, what they did in Herceptin in extending the product by three months. But in this case, they have given us now a target action date of early June, which we are very optimistic that by this time, all these issues will be resolved. And we look forward to launch this product in the second half of this year.

Our next question comes from the line of Marc Goodman with UBS. Your line is now open.

Hi. This is Owais (53:29) for Marc. You provided some – you indicated some countries, where you saw – overseas where you saw some good growth such as Italy and Australia. Just wondering like what other countries – if you can provide a little more details in countries that you've seen may not seen as robust of a growth in BOCs (53:53)?

Maybe I'll take a shot at this. Yes, we've seen some really great growth outside of the U.S. in markets like Italy, France, U.K, Germany, in particular last year. There's tremendous opportunity in the U.K. and Germany specifically to continue to grow our opportunity in those markets as well as many of the emerging markets, we've seen great growth in Australia, like I said, 17% year-over-year. And we think we're going to have a great year in 2018 as well. So we have great confidence in where our business has been in 2017 outside the U.S. and where is going here in 2018.

Tony, just to add, we've been very excited with our opportunities and growth we are seeing in Brazil, China, Russia, although it's a small base, but there are many opportunity, many opportunities, which have been incubated and are being now realized in the next – in 2018, as well as 2019 as we go along.

Our next question comes from the line of Irina Koffler with Mizuho. Your line is now open.

Hi. Thanks for taking my question. You mentioned that you wanted to make investments in sales and marketing. And I was just wondering if you could expand on that? And whether this investment would be completed in this year, or is it more of a head count expansion that will carry cost into the next year?

Thank you for the question. I think it will be twofold. Quite frankly, I think there will be certain investments that we see providing immediate value from a marketing perspective in key markets that from an OTC and established brand perspective. Additionally, from building an infrastructure in countries like China and Russia where we're adding sales force to ensure that we can cover broader and wider array of products that will carry on pass this year as well.

And Irina, I would just add to that that where you'll see in the charts that we provided you, that you see that we're continuing to reap benefits from our G&A initiatives. Meaning, where Mylan ONE integration initiatives. And as we move through the year, we look at how do we take that money and invest it to grow the top-line and bottom-line. And there's, obviously, more to be done in that area. We continue to have Mylan integration activities under in process.

And our next question comes from the line of Umer Raffat with Evercore. Your line is now open.

Hi, it's Akash on for Umer. Just a couple of questions. Number one, you guided to flat year-over-year in North American sales. Can you talk about what contribution from launches you're baking into have flat growth in a base case? And then also, Rest of World's profitability has been pretty choppy for you guys since Q4. Can you talk about how you expect profitability to kind of evolve going forward? And then what the contribution was to segment profit in Q4 specifically? Thanks.

I think on the segment profit piece for Rest of World, in the charts you'll be able to see both the fourth quarter and the full-year that profitability has expanded in not-only Rest of World, but Europe, as we move through the year. Now you will see that the fourth quarter had a little bit less profit expansion than what we had for the year overall. But that market can be a little bit choppy based upon tenders. But what we like is the fact that it continues to grow, it continues to follow the top-line. And as Tony just talked about, we've only begun to scratch the surface in many of the markets that we can enter into. So I wouldn't be too concerned about a quarter. And again, I would say that it's a good, healthy quarter. But what I would do is continue to watch what we're doing and how we're diversifying broadly across that Rest of World market.

And I guess, just to add to your question about the U.S. in North America, it's just – here's what I would say as you think about the generic industry as a whole, the real drivers to the success of this business as new product launches and high-volumes and offsetting erosion and other products as they can offer or have other competition enter the market. So as you look at our business now, the size of our business and the scale across the diversified portfolio we have, it's taken all that into consideration. We're not – we long ago stopped giving any kind of product by product basis. And what I would say is, again I'll just reiterate, I think our track record speaks for itself, is that giving working a lot of probability, waiting in practicality into the numbers that we come forward with as it results to all segments and rolling up to the EPS guidance that we've given.

And that concludes today's question-and-answer session. I'd like to turn the call back to Ms. Trombetta for any closing remarks.

I just want to thank, everyone, for joining our call today. We look forward to seeing you at our Investor Day on April 11th. This concludes our call. Have a great night.

Ladies and gentlemen, thank you for your participation in today's conference. This concludes the program, and you may now disconnect. Everyone, have a great day.