Kris King - Mylan NV Heather M. Bresch - Mylan NV Rajiv Malik - Mylan NV Anthony Mauro - Mylan NV Kenneth Scott Parks - Mylan NV.

Aaron Gal - Sanford C. Bernstein & Co. LLC Jami Rubin - Goldman Sachs & Co. Elliot Wilbur - Raymond James & Associates, Inc. Irina R. Koffler - Mizuho Securities USA, Inc. Chris Schott - JPMorgan Securities LLC Umer Raffat - Evercore Group LLC Gregg Gilbert - Deutsche Bank Securities, Inc. Randall S. Stanicky - RBC Capital Markets LLC.

Good day, ladies and gentlemen, and welcome to the Mylan Third Quarter 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. I would like to introduce your host for today's conference, Ms. Kris King.

Ma'am, you may begin..

Thank you, Brea. Good afternoon, everyone. Welcome to Mylan's conference call discussing our third quarter 2016 earnings. Joining me for today's call are Mylan's Chief Executive Officer, Heather Bresch; President, Rajiv Malik; Chief Financial Officer, Ken Parks; and Chief Commercial Officer, Tony Mauro.

During today's call, we will be making forward-looking statements regarding our financial outlook and 2016 guidance, EpiPen Auto-Injector, the integration of recent acquisitions, certain targets, such as $6.00 in adjusted EPS by 2018, and leverage ratio of approximately 3.0 times by the end of 2017, and other matters related to the company and its business, including regulatory matters, product development and acquisition.

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 filed with the SEC on Form 8-K earlier this afternoon for a fuller explanation of those risks and uncertainties as well as the limits applicable to these forward-looking statements.

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.

These non-GAAP financial measures include adjusted net earnings, adjusted diluted earnings per share, adjusted total revenue, adjusted gross margin, adjusted cash provided by operating activities, constant currency third party net sales, constant currency total revenues, net-debt-to-adjusted-EBITDA leverage ratio, adjusted R&D expense, adjusted SG&A expense, and adjusted tax rate, and are presented 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 the reconciliations of the non-GAAP measures to those GAAP measures, are available in our third quarter earnings release, which is posted on our website at newsroom.mylan.com.

Let me also remind you that the information discussed on the call, with the exception of the participant questions, is the property of Mylan and cannot be recorded or rebroadcast without Mylan's expressed 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'll turn the call over to Heather..

North America, Europe, and Rest of World starting with the fourth quarter. We will now manage our global platform as one business across all products and channel types. Turning to the quarter, our performance was consistent with our revised full-year guidance.

On the top line, we generated total revenues of nearly $3.1 billion, a year-over-year increase of 13%. This result was fueled by strong performance across our Europe and Rest of World regions as well as solid performance across our North America region.

On the bottom line, we delivered adjusted net earnings of $726 million, or $1.38 per adjusted diluted share, a year-over-year decline of about 3%, which was primarily driven by the significant contribution in the prior-year period of new products.

As we look ahead to Mylan's next chapter, we believe we now have the commercial and operating scale needed to fulfill our mission. As such, our BD efforts going forward will emphasize bolt-on deals. We also remain committed to our investment grade rating.

As for our full-year financial performance, we remain on track to achieve adjusted EPS within our revised range of $4.70 to $4.90. The majority of the revision is the result of the previously announced changes related to EpiPen, and much of its impact occurred in the third quarter.

In addition, we remain committed to our $6 adjusted EPS target in 2018, with the targeted growth in the low teens in both 2017 and 2018. We are anticipating that EpiPen's contribution to be approximately 6% of total sales in 2017.

We look forward to discussing Mylan's future, including our guidance for 2017, in greater detail during our next Investor Day event, which we'll host in conjunction with fourth quarter earnings.

I'd like to take this opportunity to thank our employees around the globe for remaining focused and steadfast and executing to deliver better health for a better world. Before turning the call over to Rajiv, I'd like to conclude by stating that while the world may be filled with uncertainty and the future of the U.S.

healthcare system may be unclear, one thing is certain. The world can count on Mylan to maintain our unwavering commitment to our mission and strategy and continue operating, executing, and delivering for the benefit of all of our stakeholders. Thank you.

Rajiv?.

Thank you, Heather, and good afternoon, everyone. As Heather noted, despite the public attention paid to Mylan and our EpiPen franchise during the past several months, we remain focused on managing our global business, integrating our acquisitions and executing on the future drivers of our growth.

While our sector continues to face challenges, we are very confident in the strength of our business, our future opportunities, our pipeline, and our ability to continue to create value for customers, patients, and healthcare systems globally, while also continuing to deliver for shareholders.

The credit for this goes to our 40,000 employees around the world who continue to remain focused on our mission of providing the world's 7 billion people with accessible, high-quality medication. Thanks to each and every one of them for their commitment to our cause. Now, turning to the third quarter.

Overall, our Generics business delivered third-party net sales of approximately $2.6 billion for the quarter, an increase of 17% compared to the prior year quarter. Meda contributed $324 million of these revenues, in-line with our expectations.

In North America, our Generics business grew approximately 1% to just about $1.1 billion on a constant-currency basis. Growth came primarily from our acquisitions of both Meda and the Renaissance topicals business as well as new product introductions.

Note that we have a challenging year-over-year comparison this quarter due to significant contribution from the new products in the last year's third quarter, especially Esomeprazole, Lidocaine and Bexarotene. We also experienced increased competition with new entrants on a number of other key products.

The Generic pricing environment was again consistent with our expectations and previous guidance. Tony will elaborate on this topic shortly. In Europe, sales totaled $842 million, a year-over-year increase of approximately 39% on a constant-currency basis.

This strong result was mainly due to contributions from Meda, as well as stable pricing of our portfolio, and sales of new products. In Rest of World, sales totaled $670 million, a year-over-year increase of 20% on a constant currency basis. This strong growth was due in part to the contributions of Meda business in new expansion markets.

We also saw volumes increase across the region, specifically as our HIV tender volumes improved and returned towards our expected levels. Additionally, Japan, Australia and the rest of emerging markets showed favorable sales on existing products as well as benefits of the new product introductions.

Our Specialty division delivered revenues of $419 million in the quarter, a year-over-year decrease of 4%.

This decrease was primarily the result of the timing of wholesaler purchases of EpiPen, which resulted in lower volumes, as well as the actions taken during the quarter to improve access to EpiPen, such as the increase in our Coupon Program and Patient Assistance Program.

We are making very good progress in what we are calling Integrating Mylan, as we bring together all of our recent acquisitions; Meda, Renaissance, the EPD business, and Famy Care with legacy Mylan.

We continue to see significant opportunities to optimize our cost base as well as create value by integrating across our branded Generics and OTC platforms in all of our regions and operating as One Mylan.

As we continue to learn more about these businesses, we had even greater clarity on the opportunities to create meaningful efficiencies and truly maximize our business for the future in a differentiated way. We will provide details about this enhanced potential during our Investor Day.

That said, all of our work today provides us with greater confidence that we will not only achieve the operating synergy estimates provided upon the Meda closing but potentially exceed them. We also continue to see revenue synergy opportunities as we apply our One Mylan approach to our combined portfolio.

With that said, let me turn to some of the significant progress we have made on our key pipeline programs. Turning first to our biosimilars portfolio, yesterday, along with our partner Biocon, we announced the FDA submission of our BLA for our proposed biosimilar trastuzumab through the 351(K) pathway.

This is our first FDA biosimilar submission, and we believe it has the potential to be the first submission of a proposed biosimilar trastuzumab in the U.S. The submitted BLA includes a comprehensive package of analytical similarity, non-clinical and clinical data.

The clinical data consists of two PK studies and a HERITAGE Phase 3 confirmatory efficacy and safety trial. The results of the HERITAGE trial were presented at this year's ASCO and ESMO Congress. Our applications for trastuzumab, pegfilgrastim, and glargine have already been accepted for review by European Medicines Agency.

For pegfilgrastim, the results from our Phase 3 clinical efficacy and safety study as well as our PK and PD study that supported our EU application were also presented at ESMO. Our insulin glargine EMA filing announced last week included analytical, pre-clinical, and clinical data.

Our pre-clinical package included our PK and PD studies, demonstrating bioequivalence of our insulin glargine compared to Lantus. Finally, the EU registration relies upon an efficacy and safety clinical trial in type 1 diabetes patients, which successfully demonstrate equivalence of our insulin glargine with Lantus.

We are on track to file our applications for pegfilgrastim and glargine products with FDA. We continue to generate additional data and work with FDA to establish an interchangeable pathway for our insulin glargine program.

15% of world's pharmaceutical spend will be on diabetes medicines by 2020, and there's a significant unmet need around the world for more affordable versions of injectable insulin products. Turning to our partnership with Momenta.

We announced last week that dosing has begun in our Phase 1 study to compare the pharmacokinetics, safety and immunogenicity of M834, a proposed biosimilar of ORENCIA. This is the first product in our portfolio of six biosimilars in development with Momenta to advance to clinical trial.

We also recently signed a development and commercialization agreement with Mabion, a Polish biotechnology company for a license to rituximab in all European countries and non-European Balkan States.

Through these various collaborations, we have access to a combined portfolio of 16 biosimilar and insulin analog generic products in development, which gives Mylan one of industry's the largest and most diverse portfolio. We remain committed to robust investments in this portfolio.

It's also worth noting that we have also filed applications for trastuzumab, pegfilgrastim, and glargine in more than 30 other markets around the world combined.

It's our broad portfolio of biosimilars, insulin, niche respiratory products as well as our strong HIV basket and Hep C products that will fuel the organic growth of our expansion market platform, which has been further enhanced by addition of Meda footprint in these countries.

On the respiratory front, we announced with our partner, Theravance Biopharma, positive results from two replicate Phase 3 efficacy studies of revefenacin, an investigational LAMA and first once-daily, nebulized bronchodilator in development for the treatment of COPD.

The data confirms that revefenacin has the potential to offer meaningful benefits to patients with moderate to very severe COPD and represents another exciting milestone in Mylan's robust global respiratory pipeline.

Additionally, we look forward to the completion of an ongoing Phase 3 safety trial in 2017 with the goal of filing an NDA by the end of 2017.

We believe Mylan's strong experience with nebulized products and experienced salesforce in the respiratory segment, which has been further enhanced through our Meda transaction, will help ensure this product's success when approved.

Our generic Advair, we remain confident in our application, as we continue to be actively engaged with FDA and move towards our GDUFA goal date. We also had some good developments on generic Copaxone program this quarter. In September, we launched a generic version of – 20-milligram version of this product in Germany known as Clep (20:25).

Multiple sclerosis medicines are among the top-class drivers in Germany and we believe that the generic version can help provide meaningful cost savings for the German healthcare system. In the USA, we are very encouraged that our ANDA for our Glatiramer Acetate 20-milligram product is moving forward.

We very recently received some additional clarification and questions from agency, but based on the type of questions, we can say that we are in the final stretch, and we look forward to bringing additional competition to this marketplace. With regard to Copaxone 40-milligram, we're pleased that the U.S.

Patent and Trademark Office ruled in favor of Mylan in our IPR proceeding, finding all claims of three challenged Copaxone 40-milligram patent to be unpatentable. We believe the board's decision is highly persuasive in detaining the basis for the invalidity of these patents.

Last week, we also filed an IPR on a fourth patent covering Teva's 40-milligram Copaxone product. In USA, we were pleased to have received approval of our AB-rated generic version of Concerta, further demonstrating our ability to develop and manufacture such complex products.

The details on the launch of this product are subject to a confidential settlement. With that, I'll turn the call over to Tony for some additional perspective on the commercial landscape. Thanks..

maintaining one of the industry's broadest portfolios, consistent execution of new product launches, and being able to reliably supply significant volumes to our customers.

Because of this, our relationship with customers continue to not only remain strong but to thrive given the strength of our portfolio, our reputation for reliability, our shared excitement around our pipeline and our commitment to continuing to deliver high customer service levels.

As we have said consistently, we continue to see pricing across our very broad generics portfolio to be in line with our expectations, with year-over-year price erosion in the mid-single-digits, including in the U.S. We continue to anticipate price erosion in the mid-single-digits for the remainder of the year.

Our business model has never been premised on price increases for our growth, and this remains the case today. In fact, the generic industry is based on vigorous competition driven by supply and demand.

Occasionally, prices increase due to market conditions, but in the vast majority of periods, our business has experienced a net deflationary price environment. Looking ahead in our generics business, we recently launched with exclusivity, our generic versions of Benicar and Benicar HCT with annualized sales of almost $2 billion based on IMS.

And we expect this to be a strong launch for us. We also see the potential for several other important launches in the fourth quarter. Additionally, we have continued to see growth across the majority of our global brands and are pleased with our performance.

With respect to EpiPen, while we saw scripts increase quarter-over-quarter, volumes were down due the lack of wholesaler purchases in the quarter in anticipation of our upcoming generic launch.

We have been in extensive dialogue with our customers to ensure successful launch and at a wholesale acquisition cost of $300, we believe our authorized generic will create significant cost savings for patients and the healthcare system. The new assets we have acquired had even further strengthened our expansive portfolio offering for our customers.

Our EPD brands are already doing well as part of the One Mylan Platform, and we see significant potential to translate this success and our learnings to our recent acquisitions.

As we bring Meda and Renaissance into our commercial business, we continue to see opportunities to do more with our combined product portfolio as we optimize our salesforce, bring new products into new countries, and maximize high potential brands.

Additionally, by now having OTC products along with our strong Gx and Rx businesses, we have a broader commercial reach than ever before and greater flexibility and optionality to successfully expand in any geographic market, especially the emerging markets.

With these current assets combined with our strategic growth drivers, we have a portfolio and pipeline that we believe is second to none. Further, we are well-positioned to continue to reduce healthcare costs for payers and patients as we bring more affordable versions of key drivers of rising pharmaceutical costs to markets around the world.

With all that said, we recognize along with many stakeholders in the pharmaceutical industry the challenging dynamics at play and that we will need to evolve to reflect these dynamics.

As Heather said, we will do our part to lead this dialogue while continuing to serve as an important partner to our customers to ensure that we address these challenges in the right, balanced way in order to enhance patient access to affordable medication, preserve and reward innovation, and allow for a robust and competitive industry.

With that, I will turn the call over to Ken..

Thanks, Tony, and good afternoon, everyone. Turning to our financial results, third quarter revenues grew to $3.1 billion, that's an increase of 13% over the third quarter of last year, and as Rajiv already noted, our Generics segment grew 17%, while our Specialty segment declined 4%.

The generics pricing environment was consistent with our expectations, declining at a mid-single-digit rate overall in the quarter. The year-over-year impact of currency translation on our third quarter revenues was insignificant. Adjusted gross margins for the third quarter of 2016 were 57%.

That's down approximately 100 basis points due to significant contribution from new products in last year's third quarter. Moving on to our operating expenses on an adjusted basis, R&D investment expanded to $176 million as we continue to invest in our respiratory, insulin and biologics programs, yet it remained at approximately 6% of total revenues.

SG&A expense, also on an adjusted basis, increased to $605 million or approximately 20% of total revenues. The increase is primarily due to the impact of acquisitions. Our adjusted tax rate was 16% for the quarter, which was in line with our expectations.

Adjusted net earnings decreased by $7 million to $726 million compared to $734 million in the prior-year quarter, and adjusted diluted EPS was $1.38 compared to $1.43 in the prior-year quarter. As previously announced during the third quarter, we accrued $465 million for a settlement with the U.S.

Department of Justice and other government agencies that was related to the classification of the EpiPen Auto-Injector for purposes of the Medicaid Drug Rebate program. Mylan continues to work with the government to finalize that settlement.

In addition, during the quarter, we agreed with Strides to settle substantially all outstanding claims associated with our acquisition of Agila.

As a result of the recent settlement, we'll have access to approximately $80 million of currently restricted cash in the fourth quarter of 2016 and we recorded approximately $90 million of expense in the third quarter of 2016. For the nine months ended September 30, total revenues grew to $7.8 billion, a year-over-year increase of 13%.

Adjusted gross margins for the same period were 56%, up approximately 100 basis points from the prior year. Adjusted R&D expanded to approximately $533 million and remained at approximately 7% of total revenues, consistent with the prior year. Adjusted SG&A expense expanded to approximately $1.6 billion or approximately 22% of total revenues.

Again, the increase in SG&A was mainly due to the impact of acquisitions. Resulting adjusted earnings for the nine months ended September 30 increased by $188 million to $1.7 billion and adjusted diluted EPS increased 7% to $3.31.

Turning to our cash flow and liquidity, adjusted cash provided by operating activities was strong, $1.9 billion for the nine months ended September 30, compared to $1.6 billion for the prior-year period. The record performance in the current quarter was the result of continuing to tightly manage our business and effectively manage working capital.

We have no amounts outstanding in our accounts receivable securitization and revolving credit facilities. At the end of Q3 2016, our net-debt-to-adjusted-EBITDA leverage ratio was approximately 3.8 times, which includes Meda debt.

We are fully committed to our investment grade rating and reducing our debt and leverage during 2017 towards our target leverage ratio of approximately three times by the end of the year 2017. We have the financial flexibility to achieve this goal while still deploying capital strategically for bolt-on acquisitions.

In addition, as we continue to optimize our capital structure and align it with our more balanced geographic profile, we remain committed to the Euro bond market. Subject to prevailing market conditions, the terms and specific timing are to be determined.

We expect our diluted share count to be approximately 535 million shares for the fourth quarter, and that's including the full impact of recognizing the shares issued for the Meda transaction. We also expect our diluted share count for the full year to be approximately 520 million shares. We look forward to ending the year strong.

We're in the process and feel confident with our ability to continue to integrate Meda into Mylan, leveraging our existing outstanding global operating platform. We remain fully committed to our revised 2016 guidance, as communicated in early October, and to achieving our $6 adjusted EPS target in 2018.

With that, we'll now turn the call over for questions..

Our first question comes from the line of Ronny Gal with Bernstein. Your line is now open..

Good afternoon. Thank you for taking the question. And I'm going to try to do one housekeeping and one content.

On the housekeeping, the common question we keep getting this afternoon from investors, if you can give us some comparable number about your North America business, that is excluding the acquisition, what was the price and volume trend? And then the question I actually have is around glargine. I think you mentioned you filed in Europe.

Can you let us know where you stand in terms of filing in the United States and confirm that you're both filing – both the vial and the pen in the United States given that the vial market is still quite substantial?.

Thanks, Ronny, for your question. Let me start with glargine. Yes, we are on track to file glargine for U.S. with the FDA and it will be in a very – over the next few months in a very short period of time. And yes, we remain on track to file both pen as well as vial. And your first question was about the pricing.

We basically – we track our pricing across our global business, across our – including various markets, but even for – if I have to just take U.S., we believe – on a consolidated basis, we are still in the single-digits, in the mid-single-digits as far as the price erosion is concerned..

Next caller, please?.

Once again, ladies and gentlemen, to ensure everyone has time to ask a question, please limit yourself to one question. Our next question comes from the line of Jami Rubin with Goldman Sachs. Your line is now open..

Thank you. Let me just try to ask the question this way. I think this is what Ronny was trying to get at. Ken, can you just provide us the contribution this quarter from Meda and Renaissance? And if I just kind of back into it based on what our numbers look like, and I want you to confirm this.

It seems that the overall Generic business is about flat with last year. And I'm wondering if you could just kind of take a step back, you and Heather, and talk about what's happening in the marketplace? It does feel that pressure is building across your portfolio, along with many of your peers.

And many of your peers, as you know, this week have described a worsening pricing environment driven by consolidation of buyers, potentially a change because of the Teva/Allergan deal. So I'm just wondering if you could talk about the state of your business. Am I right that the business is about flat? Describe what's really changed.

And how do we think about this business on a go-forward basis? Thanks..

So, Jami, let me give you – thank you for the question. Let me give you – and it'll be kind of reiteration of points out of some of the prepared comments. We said that – Tony said that Generics pricing was down mid-single-digits overall, and he said the U.S. was relatively consistent with that. So that should give you kind of an indication of pricing.

Meda contribution, we're not going to break out by region, but we did indicate that Meda for the quarter contributed about $330 million of revenue. But that's across the world.

The third comment I would say is, is that, when we talked about North America, we said the third variable that you're looking for to kind of triangulate is excluding the impact of acquisitions, the business was – the volumes were relatively – the revenue was relatively flat..

And Jami, just – I'll kind of high-level and then let Tony or Rajiv fill in.

Look, I hope and tried to convey in my opening remarks our – not only excitement and the opportunity that we see ahead, given both our organic pipeline and the assets that we continue to complement now given the commercial and operational scale we have, and we believe really this diversification around geographies, around products and channel.

So our ability to really maximize and optimize how we go to market in every country, I think we've never had a better opportunity to do so. And when I think of the U.S.

space, and I, again, look at our portfolio and our mix, it's why I think we are able to talk about mid-single-digit erosion, and that has been what we have seen over the recent quarters and years. And I think it's that mix and the breadth of our portfolio, over 630 products here in the United States alone, over 2,000 globally.

But it's that mix, that portfolio, and our capacity and capability of supplying the demands that's needed out there is what's allowed us to continue to compete in a market that I would say has always been competitive.

And lastly, I would just say that, again, I think as you look at the transactions and the acquisitions that we've done, we've said it's about what we can do with those assets. And I think we have continued to execute, and as we said in our remarks, these next couple of years really give us the opportunity to leverage the economies of scale.

And so, I think the future is bright both here in the U.S. as well as around the globe..

And just maybe to add, Jami, certainly I think based on both our diversification and differentiation of those 635 products across the U.S. portfolio, I've always felt like there's been pressure in the U.S. Generic business. I don't think that's going away. But what you need is a broad portfolio. You need best-in-class service levels.

And with these assets, you can certainly keep erosion to a level that we believe is mid-single-digits, like we've commented on..

Next question, please?.

Our next question comes from the line of Elliot Wilbur with Raymond James. Your line is now open..

Thanks. Good afternoon. Same question or same line of questioning, maybe different data points. Probably maybe just best answered by Tony to start with.

But with respect to expected growth in the Generics business, at the beginning of the year when you announced year-end numbers and the Meda acquisition, the global Generic business was expected to grow 20%. Year-to-date, it's up 12% year-over-year. Obviously, you have kind of stuck with the same metrics in terms of pricing realization in the U.S.

market but it seems like something else isn't working or isn't going necessarily according to plan. So maybe you could just comment on price and volume trends in ex-U.S. markets versus expectations at the beginning of the year and also maybe a little bit further commentary on the new product cycle in the U.S.

and sort of timing of realization of pipeline assets versus original expectations? Thanks..

Hey, Elliott. Maybe I'll kick it off and then let, again, Tony, Rajiv comment. Elliott, I guess what I'd start off by saying and you've probably heard me say this a lot of times, not all good things happen at once, not all bad things happen at once in this very dynamic volatile marketplace.

And what we've said, is our continued ability to diversify and differentiate and have the operational scale that we do allows us to mitigate these headwinds and how we manage the business and execute, I hope what our actions and track record speak to, is our ability to do just that, manage this business and deliver what we have stated that we'll do.

And we get there sometimes at the beginning of the year and the end of the year. How we achieve it, obviously looks a lot different from launches that you expect happening that don't happening, market dynamics. As you know, there's many, many different levers.

But I think the overarching point is given the amount of levers that we have to manage this business, we're able to execute and deliver on our stated targets..

And I would say, let me just, Elliott, go around the wall a little bit over here. We remain very confident with our business in the Rest of the World market, Australia, New Zealand, Japan and other emerging markets. We had some initial hiccups early in the year on our HIV tenders, which have come back to normal and we see that normalcy come back.

Europe is, in fact, very stable, pricing is stable. Our EPD acquired products are doing very well from the growth perspective. And when you come to USA, it's about the diversity of this product mix, with the Mylan Institutional – with so many injectable products we have and so many other complex one.

Yes, we said that this quarter there has been some challenge on the growth because previous year, this quarter we had some huge new product launch contributions like from products of Esomeprazole, Lidocaine, Bexarotene, and that's where you see that, this volume shift. But this has been like always, so this – we're not seeing anything different..

Yeah, maybe just to add. We are certainly pleased with our European business from a volume and price stability standpoint. And just adding to the U.S. it really is about portfolio mix, dosage form mix across multiple channels in that breadth of portfolio that allows for this to happen..

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

Hi. Thanks for taking the questions. I was wondering if you could help us with the amount of destocking for EpiPen? And then just looking out into next year with the launch of the AG, do you expect to capture more patient volume? I'm just trying to understand a bit more about your remark about 6% of next year's sales being EpiPen.

Does that assume any additional volume growth? Thanks..

Maybe just to start off, certainly from an inventory perspective, it's fairly typical in the U.S. business when you're launching a generic, the wholesalers will bring down inventories to lower rates than they're normally holding, and that's what we're experiencing. And I think the second question was around....

Volume growth – for next year (43:45).

Yeah. We're very hopeful that our authorized generic converts like a traditional generic from a volume and a conversion perspective, in the high 80s, I believe, we've commented on. So that would be our aim and our goal entering 2017..

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

Great. Thanks very much. Can you help us bridge a little bit from the $4.80 midpoint of your EPS guidance range this year to that $6 target in 2018? I know a lot of questions we've been getting is with just the pressures on EpiPen next year and beyond.

How do we get comfortable that that $6 number is achievable? What assumptions go into that? And maybe just a little bit more color to help us understand how you still have confidence of hitting that type of number? Thanks so much..

Sure. Thank you, Chris. I think if we step back for a second, Chris, and I'll go back to our Investor Day when we put the $6 target out there that, at that time, obviously, perhaps for different reasons, but at that time we said that by 2018 that we assumed EpiPen would only account for about 5% of revenue.

So obviously, as I said for other reasons and for – as we looked at the competitive landscape, we didn't have that as a major driver, 2017 especially then going into 2018. So yes, has that pulled forward? A little bit. That's why we tried to quantify and say that we're estimating – anticipating that about 6% of revenue next year would be to EpiPen.

So again, I think that as you look, and as you guys know, that we're much more than any one product and much more than any one country, that all of this differentiation and our product portfolio mix again, as I said, has allowed us – this platform has allowed us to absorb these headwinds when they hit, to mitigate them and to manage them.

And I hope that in both our response to the EpiPen situation but again, managing this overall business is allowing us to deliver and giving us the confidence about that $6 target. And as we also said, we see this low, mid-teens growth, 2017 and 2018.

And we look forward to coming to you in Investor Day, in conjunction with fourth quarter, to really detail that out more. But hopefully that gives a little bit, when you think about the launches we've got coming, when you look at the business, again, across the globe and now the diversification outside of the U.S.

that you can start seeing a real clear pathway to how we're going to get there..

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

Hi, guys. Thank you for taking my question. Heather, what feedback are you seeing from PBMs on your portfolio, especially on the larger products as you head into 2017? And on that note also, I noticed gross margin this quarter was similar to 2Q even though EpiPen was bigger and Meda was in, and Meda is a higher gross margin business.

So I'm just trying to understand, what are you seeing on gross margin level? It seems like there's some pressure in 3Q..

So look, Umer, I'm going to let the guys operating and running these businesses talk about it. Maybe Tony can hit PBM and Rajiv can hit gross margins..

Okay. Yeah, thank you, Umer. Yes, we've certainly had dialogue with all our customers over the last quarter and we continue to do that. Like I said, I think both our strength of portfolio and the partnership we have from a pipeline perspective and our future outlook of growth drivers allows this dialogue to be one of a bilateral nature.

And I continue to feel that way moving forward with our EpiPen Generic launch coming here in the coming weeks and in any other new products we have as well..

And, Umer, yes, there's a little bit of drift of the gross margin, and I'll attribute that to the product mix..

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

Yes. Thank you. About the $6, how does the amount of capital you've had to deploy to get to the $6 compare to your expectations, and how does that play into management comp if you achieve the $6 but had to spend a lot more to get there? And second, some would say you've thrown the supply chain under the bus.

Others would say that you've highlighted what has long needed to be highlighted in terms of the complexity of the system. I guess my question is – and you've been a proponent of wanting to have a dialogue, what is the next step in this dialogue? Is there anything specific you have in mind, or is it just sort of take it as it comes? Thanks..

Thanks, Gregg. So I'll start, and then turn it over to Ken. Here's what I'd say.

I think that we certainly continue to look for the opportunity for the facts to catch up to the story and the headlines that have been out there, and I think with the election behind us, that opportunity for our facts to be heard in a better digestible way, we're going to continue to work on that.

As far as blaming the system, again, that is not what we said. What we did is start a discussion about the transparency that's needed and that people understand the complexity around the pricing.

And I think that, obviously not only did we, yes, start that discussion and happy to see that that discussion has continued with many other company executives talking about the gross to net and that the entire – everybody needs to come together and sit around the table and talk about a solution, that you can't do it piecemeal, you can't try to do it by legislating a certain slice of it.

So we absolutely hope and will obviously continue to drive not only that discussion but look for solutions. As I said in my opening remarks, we need to – this system needs reinvented across the healthcare, across the entire U.S. healthcare landscape.

And we look forward to those next steps being looking for solutions, not just driving certain headlines.

With that, Ken, you want to...?.

Yeah, so the $6 when we launched it back in the 2013 Investor Day, certainly included a component for acquisitions because that's part of what we've been doing with the business and a lot of the discussion you've heard today around broadening the portfolio inside the U.S. as well as across the world. So there is an acquisition component to that.

We'll update you on what that roadmap might look like when we do Investor Day to give you a little bit more specifics around it. But I'll tell you, you've heard us say since we've done the Meda acquisition the words around capital redeployment have been more around bolt-on acquisitions.

So you should anticipate that you're going to see us invest in those that create good, positive profit streams going forward, and add on to the portfolios that we have already. And at the same time, remain committed to our investment grade credit rating..

Our next question comes from the line of Randall Stanicky with RBC Capital Markets. Your line is now open..

Great. Thanks. Heather, can I just follow-up? What do you guys mean by bolt-on? Because I think at one point you called Perrigo a bolt-on deal.

So when we think about the capital deployment for opportunities that you see, is that a $2 billion opportunity or is that a $10 billion? And then the one thing that we haven't discussed is share repurchases given where your stock is. Can you talk about how that factors in as well? Thanks..

Sure. So Randall, I'm not sure who referred to Perrigo as a bolt-on deal. I certainly, I think we talked about it as a transformational acquisition of those companies coming together. So I would say what we mean by bolt-on deals is – look, product lines – we don't need to do any big acquisition.

We've got the commercial and operational scale that we need but as we look across channels, therapeutic categories, products, as we want to complement just like we did around injectables, Renaissance around the derm. So, look, and we think, look, it's a buyer's market.

I think there's great assets out there that we could complement and leverage our economies of scale. But first and foremost, our focus these next 18 to 24 months is integrating Mylan, truly leveraging our assets, optimizing them.

And like I said, I think we've never had better opportunities around the world in these countries to have a great go-to-market strategy now having scale across all the channels, OTC, Generics and brands..

And on your point around share repurchase, we have an authorization for an incremental, right now, $930 million of share repurchase. That is in our toolbox.

You hear us talking about right now, we're focused on post Meda driving down our debt, reducing our debt and reducing our leverage, and then keeping dry powder in the short term for these bolt-on acquisitions that Heather talked about..

Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program, and you may all disconnect. Everyone have a great day..