Kris King - Vice President, Global Investor Relations Heather M. Bresch - Chief Executive Officer Rajiv Malik - President John D. Sheehan - Chief Financial Officer.

Ronny Gal - Sanford C. Bernstein & Co. LLC Gregg Gilbert - Deutsche Bank Securities, Inc. Jami Rubin - Goldman Sachs & Co. Umer Raffat - Evercore ISI Douglas D. Tsao - Barclays Capital, Inc. Louise A. Chen - Guggenheim Securities LLC David R. Risinger - Morgan Stanley & Co.

LLC Christopher Thomas Schott - JPMorgan Securities LLC Marc Goodman - UBS Securities LLC Sumant S. Kulkarni - Bank of America Merrill Lynch.

Good day, ladies and gentlemen, and welcome to Mylan Incorporated Fourth Quarter and Year-End 2014 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 be given at that time. And as a reminder, this conference call is being recorded.

I'd now like to hand the conference over to Ms. Kris King, Vice President of Investor Relations. Ma'am, you may begin..

Thank you, Saeed. Good afternoon, everyone. Welcome to Mylan's fourth quarter and year-end 2014 earnings call. Joining me for today's call are Mylan's Chief Executive Officer, Heather Bresch; President, Rajiv Malik; and Executive Vice President and Chief Financial Officer, John Sheehan.

During today's call, we will be making forward-looking statements pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements relate to, among other matters, the acquisition of by Mylan N.V. of both Mylan, Inc. and Abbott Laboratories' non-U.S.

developed markets specialty and branded generics business, which I'll refer to as the Abbott business.

Our and Mylan N.V.'s expected or targeted future financial and operating performance; results, metrics, and plans and expectations related thereto; the inability to obtain regulatory approvals and planned launches of and anticipated exclusivity periods for new products.

Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such statements.

Factors that could cause or contribute to such differences include, but are not limited to, the ability to meet expectations regarding the accounting and tax treatments of the transactions with Abbott, changes in relevant tax and other laws, the integration of the Abbott business by Mylan being more difficult, time consuming, or costly than expected, operating costs, customer loss and business disruptions being greater than expected following the transaction with Abbott.

The impact of competition; situations where we or Mylan N.V.

manufacture market and/or sell products notwithstanding unresolved allegations of patent infringement; any regulatory, legal or other impediments to our or Mylan N.V.'s ability to bring new products to market; those set forth under Forward-Looking Statements in today's earnings release, and the risk factors set forth on our Form 10-K for the period ended December 31, 2013 as updated by our Form 8-K filed on August 6, 2014, our quarterly report on Form 10-Q for the period ended June 30, 2014, our quarterly report on Form 10-Q for the period ended September 30, 2014 as well as our other filings with the SEC.

These risks as well as other risks associated with Mylan, Mylan N.V., the Abbott business, and the transaction with Abbott are also more fully discussed in our proxy statement filed with the SEC on December 24, 2014. We undertake no obligation to update any statements made today whether as a result of new information, future events or otherwise.

Today's call should be listened to and considered in its entirety and understood to speak only as of today's date. 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 measures are presented in order to supplement your understanding and assessment of our financial performance. Please refer to today's press release, which is available on our website, as well as the SEC website, as it contains detailed reconciliations of these non-GAAP financial measures to the most directly comparable GAAP measures.

Before I turn the call over to Heather, let me also remind you that the material in 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 later today and will remain available for a limited time. With that I'll now turn the call over to Heather..

Thank you, Kris, and good afternoon, everyone, and thank you for joining us today. Mylan is off to a phenomenal start this year. Our announcement this past Friday is a great example, having successfully completed our acquisition of Abbott's non-U.S.

developed markets specialty and branded generics business, we now are beginning our next exciting chapter of growth.

As we've been stating all along, this is absolutely the next right strategic transaction for Mylan and nearly doubles our size in our top 10 markets outside the United States, further expands and diversifies our product portfolio and customer base, and gives us significant financial flexibility to aggressively pursue opportunities that make strategic and financial sense for the company.

We expect the transaction to be approximately $0.20 accretive to EPS in 2015, $0.25 in the first full year, and to increase thereafter through 2018. We also expect to maintain double-digit revenue and EBITDA growth rates through 2018.

In addition, we see our tax rate declining to approximately 20% to 21% during the first full year and then following into the high teens thereafter.

Anticipating all of these benefits, we began planning with Abbott leadership as soon as we announced the deal back in July so as to lay the ground work for what we believe will be a very smooth integration now that the transaction has closed.

I'd like to take this opportunity on behalf of Mylan's board of directors and senior leaders to welcome Abbott's EPD employees to the Mylan family. We very much look forward to the contributions they'll make as they take up our cause of delivering better health for a better world.

As we take a moment and look back at 2014, we again delivered strong financial performance by leveraging the diversity and breadth of our global platform, maintaining our relentless focus on disciplined execution and seizing opportunities whenever and wherever they arose.

Sales for the year totaled $7.7 billion, a constant currency increase of 13% compared to 2013. Adjusted diluted EPS totaled $3.56, an increase of 23% compared to our prior year performance.

Every one of our business segments contributed to this growth with our North America and Rest of World generics regions and our Specialty segment delivering double-digit revenue increases. In addition, EpiPen became our first product to generate $1 billion in annual sales. Our employees around the world deserve the credit for these great results.

On behalf of our board and senior leaders, I'd like to thank them for their hard work and unwavering dedication to our cause. Their commitment will serve us well in 2015, which we believe will be yet another very strong year for the company. Specifically, we anticipate revenue growth of 33% and EPS growth of 21% both on a constant currency basis.

In addition, we continue to see opportunities to accelerate our 2018 target of at least $6 on adjusted EPS. As I mentioned in 2014, EpiPen became our first product to reach $1 billion in annual sales.

We're proud to have reached this milestone and note that we achieved it by growing the franchise at a compound annual clip of nearly 30% since 2008, a reflection of the product's tremendous brand equity.

As I've often reiterated, we have continued to expand the epinephrine market in unconventional ways, specifically by focusing on education, awareness and access. Our EpiPen for schools program is a great example as is our advocacy on the regulatory front with 48 states now allowing undesignated epinephrine auto injectors in schools.

Our assumptions around EpiPen for 2015 incorporate that we already participate in a highly competitive, multi-player EpiPen marketplace and that we are operating in a very aggressive payer environment.

And while we continue to believe that the regulatory barrier-to-entry for an AB-rated generic EpiPen remains high, we also are factoring the impact of an AB-rated competition into our guidance in the second half of the year. That said, we continue to invest in product innovation and geographic expansion as well as new formulations.

We also continue to pursue our unconventional approach to growing this franchise. It focuses on shaping legislation to continue to expand assets for consumers and other public entities, generating awareness about severe allergies, providing education to help those at risk take control and continually looking for ways to enhance consumer's experience.

With that, I'll now turn the call over to Rajiv..

Thank you, Heather, and good afternoon, everyone. As you have heard 2014 was another very strong year for Mylan strategically, operationally, and financially.

We saw double-digit growth in our business including 21% growth in Specialties, 18% in Rest of World, 12% in North America, as well as 3% growth in Europe, which includes absorbing 4% to 5% of price erosion.

Our strong performance in North America was particularly noteworthy as it comes despite us not being able to get certain key approvals due to continued regulatory delays at FDA. We believe that FDA has made some good progress implementing GDUFA since the program went into effect in October of 2012.

The agency has increased its inspections of domestic and foreign manufacturers although the median review time for ANDAs is standing at about 42 months. Nevertheless, we remain confident that over the long run, a properly resourced and transformed FDA will yield substantial benefits in the U.S.

and beyond in the form of improved safety access and transparency. I'd also note that Mylan received more FDA approvals in 2014 than any other company including six first to files all, of which have fueled our strong financial performance during the year. In addition, we have more ANDAs pending approval than anyone in our industry.

283 to be specific including 44 pending first to files opportunities. As you know at Mylan, we are never standing still and we have started off 2015 with an announcement of several additional complementary transactions that will further enhance our existing platform.

Last month, we announced an agreement to acquire certain female healthcare businesses from Famy Care, which is the world's largest producer of generic oral contraceptive products. This acquisition will provide Mylan with an enhanced and now vertically integrated platform to accelerate our growth in the global women's healthcare space.

Famy Care will bring us four high quality manufacturing facilities in India, two of which have been approved by FDA and the European health authorities.

They have one of the lowest costs and largest manufacturing footprints dedicated to oral contraceptive products and will bring Mylan strong capabilities in OCP cycles, injectables, IUDs and tubal rings.

On the commercial front, this acquisition will build on Mylan's existing partnerships with Famy Care in North America, Europe, and Australia, and will also make Mylan a hormonal contraceptive leader in high-growth emerging markets around the world.

This transaction also complements the business acquired from Abbott, which includes a women's healthcare portfolio and sales and marketing capabilities. The purchase price represents a mid-teen EBITDA multiple on a forward basis for a high growth and profitable business.

Looking ahead, we are anticipating annual EBITDA growth in excess of 25% over the next several years. That acquisition is expected to be immediately accretive to Mylan's adjusted diluted EPS upon closing, which is expected to occur in the second half of 2015, subject to regulatory approval and certain closing conditions.

We also recently announced a partnership with Theravance Biopharma on the development and commercialization of TD-4208, a novel investigational, once-daily, nebulized, long-acting muscarinic antagonist for COPD and other respiratory diseases.

TD-4208 has shown positive top-line results in COPD patients in multiple Phase II studies and FDA recently agreed to the design of the Phase III program, which is anticipated to begin this year.

We believe TD-4208 has the potential to be the only FDA-approved once-daily, single-agent nebulized product for COPD and it may offer longer-term opportunities for combination with other nebulized products. In addition, the patent portfolio for TD-4208 is currently expected to provide exclusivity in the U.S.

until at least 2025, which doesn't include any potential patent term extensions. In addition to the geographic and portfolio expansion, we continue to make significant progress across all of our other key growth drivers.

Continuing with respiratory, we are further developing our presence in this space both through external activities such as Theravance and internal development programs. Our Phase III clinical trials for generic Advair are progressing well and we anticipate filing our application with FDA at the end of this year.

We continue to believe that Mylan will be the first to bring to market an AB-rated substitutable generic form of Advair in the U.S. We're in the process of giving final shape to our manufacturing in order to be positioned to handle the appropriate capacity upon launch.

We also anticipate two European respiratory launches in 2015, generic Seretide MDI and generic Flixotide MDI. With regards to complex products, we continue to advance our insulin analog program; we commenced two Phase III trials for Glargine, which are progressing well.

We continue to pursue the opportunity to have one of the first interchangeable insulin analogs to Lantus. We also have made significant progress in terms of manufacturing readiness.

On the Copaxone front, as we told you last quarter, we have responded to all FDA requests to date in terms of our ANDA and we remain confident that we're well positioned to receive approval for our application and be in a position to launch at market formation. On the legal front, the U.S.

Supreme Court's decision did not address the invalidity of the last remaining patent and we believe that the prior invalidity ruling will be confirmed by the Federal Circuit. We are pleased with the Federal Circuit's accelerated briefing schedule.

From a guidance perspective, we are taking a conservative approach and assuming launch in the second half of 2015. We also continue to advance our biosimilars program. We strategically selected our portfolio with a primary focus on monoclonal antibodies.

We are aggressively executing on the development of this global pipeline, which currently includes six products. We expect three of these programs to be in Phase III in 2015. As we have noted before, we expect to launch these products initially in the Europe and Rest of the World markets.

As you know, we launched in the world first trastuzumab biosimilar in India in 2014 and we have now submitted this product in 15 more countries. We also continue to expand our injectable business and today we offer a global portfolio of more than 230 injectable products in a broad range of dosage forms.

We continue to take steps to integrate the Agila business and ensure its position as a high quality reliable source of injectables for the long-term. Hence, we are taking all steps necessary to ensure that Mylan's one quality standard is deeply embedded across the Agila's manufacturing sites.

While we may continue to have some issues as we implement our remediation efforts, we are confident that a deliberate, thorough approach to ensure a sustainable culture of compliance is the right way to capitalize on our Agila investment.

Turning to our infectious disease growth driver, during the fourth quarter, two of the three largest buyers of antiretrovirals in the world, The Global Fund and the Government of South Africa completed three year tenders and Mylan won a leading share in both cases.

Today, we supply more than 40% of ARV volume in developing markets and provide access to high quality ARV treatments to more than five million patients each year. In addition, we continue to expand our infectious disease business beyond ARVs, signing several agreements with Gilead for the distribution of Hepatitis C treatments.

We were recently appointed as exclusive partner for the launch of Sovaldi and Harvoni brands in India and we expanded our non-exclusive rights through Sovaldi and Harvoni in 91 developing countries. Let me now turn the call over to John, who will walk you through our financial performance in greater detail. Thanks..

Thank you, Rajiv, and good afternoon, everyone. I'm going to be referring to financial metrics that have been prepared on an adjusted basis. These are non-GAAP financial measures and I refer you back to Kris' comments at the beginning of today's call regarding our use of adjusted measures. Starting on slide 16.

As you can see our total revenues for the fourth quarter and full year 2014 experienced double-digit constant currency growth. We are very proud of the commercial performances of each of our businesses and regions in 2014.

Looking at our operating profitability measures, adjusted gross margin for the fourth quarter of 2014 was a very strong 54%, up nearly 300 basis points from the same prior-year period. Our adjusted gross margin for the full year was 52%, up approximately 200 basis points from the prior year.

Our strong gross margins are primarily the result of new product introductions in North America as well as a positive pricing environment, and the growth in sales of EpiPen Auto-Injector.

Importantly, 2014 represented the sixth consecutive year of gross margin growth that has resulted in our gross margin increasing from the mid-40% range to well over 50%.

During 2014, our gross debt outstanding decreased slightly from the prior year and with the purchase of Abbott completed on a debt-free basis, we have ample financial flexibility going into 2015. We continue to benefit from low short-term interest rates as the average rate on all of our outstanding borrowings was below 4% in 2014.

Additionally, to further enhance our capital structure, during the fourth quarter, we redeemed our 2018 high-yield senior notes by issuing a term loan at substantially lower interest rate and extended our revolving credit facility on enhanced terms. Turning to slide 17, 2014 continued a six-year period of exceptional growth in our business.

As we look forward to 2015, we are very pleased with our consistent double-digit growth in revenues, adjusted EBITDA, and adjusted diluted EPS, all of which demonstrate our unwavering commitment to achieving our target and enhancing shareholder value. With that, I'd like to now discuss our expectations for 2015, which are laid out on slide 18.

At the bottom line, we are projecting an increase in our constant currency adjusted diluted EPS guidance of 21% based upon the midpoint of our 2015 guidance range. Our EPS guidance is after absorbing $0.15 per share of FX headwinds on the combined business.

This EPS guidance range is based upon the following income statement line item guidance metrics, all of which are on an adjusted basis with the exception of total revenues. Total revenues are projected to be between $9.6 billion and $10.1 billion, the midpoint of which on a constant currency basis is an increase of 33% from the 2014 total revenues.

Our generics business is expected to generate revenue growth of approximately 40% in 2015, which includes revenues from acquisitions of approximately $1.5 billion to $1.8 billion. Specialty revenue is expected to be flat as we've assumed generic competition for EpiPen in the second half of 2015.

With the recently completed Abbott transaction and the pending Famy Care acquisition, we continue to diversify our business, both in terms of our portfolio and geographically.

Following completion of these transactions, slightly more than 50% of our revenues will come from North America, about a third will come from Europe, and the balance will come from rest of world. I'll speak further in a few minutes on the drivers of our year-over-year revenue growth.

Gross margins will increase again to be between 53% and 55%, the midpoint of which is approximately 200 basis points higher than 2014. Drivers of the increase include new product revenues and the strength of our North American generics business as we continue to benefit from an improved product mix.

Our gross margins are being further enhanced by the Abbott assets acquired combined with the efficiencies of our global platform.

SG&A will be between 19% and 21% of total revenue, a slight increase from the prior year due to the inclusion of the business acquired from Abbott and R&D will be between 6.5% and 7.5% of total revenue as we continue to invest in our future. With these guidance metrics, we project adjusted EBITDA of between $2.9 billion and $3.3 billion.

Also, we expect our adjusted effective tax rate to be in the range of 19% to 21%. The midpoint of which is a 500 basis point decline from our adjusted effective tax rate in 2014 of 25%, which is attributable to our enhanced global tax structure and improved competitive positioning from the closing of the Abbott transaction.

Based upon 2015 guidance metrics, for operating cash flow of $1.6 billion to $1.8 billion and capital expenditures between $400 million and $500 million, we are projecting adjusted free cash flow in the range of $1.2 billion to $1.3 billion, with a midpoint of $1.25 billion, a 41% increase from the prior year.

Finally, we are projecting an average diluted share count of between 495 million and 500 million shares utilizing an assumed average full year share price of approximately $60, which includes the impact of the shares issued in conjunction with the Abbott transaction.

As a reminder, under our cash convertible notes, we have approximately 43 million warrants outstanding with the majority of the warrants having a strike price of $30. We have assumed dilution from these warrants to be approximately 20 million to 22 million shares for 2015.

Turning to slide 19, you will see a reminder of some of the key assumptions utilized in the 2015 guidance. Specifically, we've factored in the strength of the U.S. dollar and the expected foreign currency impact for 2015. Included in our earnings release is a table of assumed foreign exchange rates used in developing our 2015 financial guidance.

The 2015 guidance includes the contribution from the Abbott EPD business from the date of close as well as the inclusion of Famy Care beginning in the second half of 2015. Slide 20 provides further details regarding our revenue growth in 2015.

We expect the legacy Mylan business to contribute approximately $700 million to $900 million of incremental revenue in 2015. Revenue from new product launches as well as volume growth in our base business will serve to offset single-digit price erosion on our existing products.

In terms of base pricing assumptions in the generic segment, as we traditionally have, we've assumed low single-digit price erosion in North America. Further, we have assumed mid-single-digit price erosion in rest of world and mid-to-high single-digit price erosion in Europe.

We expect revenue from acquisition, principally the established products business we acquired from Abbott to contribute approximately $1.5 billion to $1.8 billion of incremental revenue in 2015.

The year-over-year negative impact of foreign currency translation including the impact from the acquired businesses is expected to be approximately $300 million to $400 million due to the strengthening of the U.S. dollar.

Slide 21 shows a projected bridge between our actual 2014 adjusted diluted EPS of $3.56 and the midpoint of our 2015 guidance range of $4.15, an increase of 17%. New product launches and revenue from acquisitions will drive our earnings growth in 2015.

We expect our Q1 EPS to be in line with the prior year with each of the following three quarters' EPS being higher than the prior year. We expect the third quarter EPS to, once again, be the strongest quarter in terms of earnings.

Our second quarter EPS is expected to be slightly lower than the fourth quarter due to the anticipated timing of new product launches. Turning to slide 22. At the end of 2014, our debt-to-EBITDA leverage ratio was approximately 2.8:1, down considerably from our leverage ratio of 3.5:1 at the end of 2013.

With the closing of the Abbott transaction, our balance sheet becomes even stronger as our debt-to-EBITDA leverage ratio now stands at approximately 2.3:1. We now benefit from a competitive global tax structure that strengthens our financial position and will help to accelerate future growth.

We remain committed to our stated M&A parameters and our long-term gross leverage targets at investment grade levels. To summarize, our fourth quarter provided a very strong finish to 2014 and is a testament to the strength and diversity of Mylan. We look forward to doing more of the same in 2015 and beyond.

That concludes my remarks and I'll turn the call over to the operator for Q&A.

Operator?.

Thank you, sir. Our first question comes from Ronny Gal from Bernstein. Your line is open. Please go ahead..

Good afternoon. Thank you for taking my questions. A couple of them. The first one is on EpiPen. Can you just go into the assumption – a bit more granularity, are you assuming next generation product coming from you guys in 2015? And what kind of a share and price are you willing to share with us, you're assuming on attrition.

Second question about your European plan, now that you had a little bit more time to look at the Abbott asset, can you just drive a little bit into that business with a bit more granularity? What are the few things you have to execute on in 2015? What products will drive the growth? What countries will drive the growth? How much cost synergy are we looking for? Is there some synergy assumption in there? Just a bit more granularity about how this business will go forward? And frankly, how are you going to report it? That is, how can we, from the outside, track your progress over the next couple of years with this business?.

Hi Ronny. Well, thank you. So I'll start with EpiPen. As I have stated now for quite a while as expectations around our product innovation and lifecycle, I've tried to maintain and reiterate the fact that we've grown the market in a very unconventional way, around, I think, first the underlying fundamental strength of the brand equity.

But what became obvious to us is that there was the lack of awareness and education, and, quite frankly, just the ability to have access to EpiPen was quite low.

So as we did EpiPen4Schools, for instance, to allow undesignated EpiPens in school, and we now are continuing to take that into other public entities, that I've said while it has grown in unconventional ways, we wouldn't be looking at your traditional lifecycle management brand product switches, that we believe that the EpiPen has not only brand equity but as well as the comfort and the ease of use after over 25 years of being on the market.

So as I mentioned in my opening remarks, we are absolutely continuing to look at product innovation and geographic expansion as well as new formulations. And you will continue to see us come out with some of those things, those features.

But as it relates to a brand new product or new device, our EpiPen and the brand equity around it is what will remain our mainstay in the U.S. market.

As far as our assumptions, Ronny, also as we've reiterated, as we continue to diversify ourselves and have many levers to pull on to manage this business, it makes each individual lever that less material.

So I think what you should know and take comfort in, especially given our track record, that we've said that we've incorporated the multi-player environment, the competitiveness of that, the reimbursement, the payer reimbursement and how we're seeing that; those dynamics continue to play out as well as an AB-rated in the second half of the year.

So I think we've taken a very balanced conservative approach around our assumptions with EpiPen. I think we think it will continue to be a great product for us into the future, kind of regardless of these near-term dynamics. So that would be on EpiPen.

As far as Abbott, obviously, we had said a couple of things, that from a strategic and complementary perspective it doubled the size of our top 10 markets outside of the U.S. and many of those – most of those being in Europe.

So to be able to take that business now and really leverage both the physician channel as well as the pharmacy channel, we believe, is why in our hands with the enhanced focus and investment behind it, we can do more.

And I think as you look at the portfolios and the complementary nature of where we could enhance from a physician call point and that branded generic model as well as enhance the scale and our breadth of product portfolio to the pharmacy, we are going to be able to continue to leverage that franchise.

And as we get into more granularity just as far as those product opportunities, I would say, again, it's not about a product, it's much more about the therapeutic and the therapeutic areas and the franchise and the breadth of that.

If you look across cardiovascular and GI, some of the places that Abbott EPD, their strength has lied, it marries up very well now with the breadth that we can bring on that. So, look, I think in these coming months, after integration, we'll continue to keep you guys updated as we are successfully integrating the businesses.

And as far as the reporting perspective, it will be absorbed in our generic segment throughout our divisions between North America, Europe, and rest of world..

Thank you. Our next question comes from Gregg Gilbert, Deutsche Bank. Your line is open. Please go ahead..

Hi. My first one is on generic Advair; I'm sorry if I missed it.

But are you still confident that you can receive approval and launch by the end of next year on generic Advair in the U.S.? And then on business development, Heather, how likely do you think is it that a deal in the near to medium term would actually be able to leverage the infrastructure you got from Abbott as opposed to being unrelated to that? Thanks..

Regarding generic Advair, Gregg; as I mentioned, that we remain on track to file this ANDA by the end of this year and in the new GDUFA environment, I think, given that time, we expect to launch it after about maybe 12 months to 15 months period of time. That's what's the expectation is..

And, Gregg, as far as BD; obviously, we've been pretty vocal that Abbott certainly was the right next transaction, not only from a strategic perspective, but because of the significant financial flexibility that would afford us.

So I hope you've heard in my voice and will continue that we are actively pursuing very aggressively on opportunities and absolutely anticipate that we could announce another material transaction before the end of the year..

Thank you. Our next question comes from Jami Rubin from Goldman Sachs. Your line is open. Please go ahead..

Thank you. Heather, maybe you can elaborate a little bit on what sort of acquisition that might be, what specific areas.

I mean, what do you think – where are there holes in your portfolio? What – should we be surprised if you guys try to buy a company like a Salix or are you more looking at opportunities to expand geographically? And then, secondly, if I could ask just about – trying to understand your strategy in respiratory.

I mean, obviously, respiratory is a very competitive category. We've seen your competitor Actavis get out of the respiratory business, while you're – it looks like you're doubling down on respiratory.

Can you talk about where you see that in terms of the importance of that business? And is the COPD drug that you licensed from Theravance, is that going to require a large sales force or is that something you can bundle with generic Advair? Just trying to understand how it all fits together. Thanks..

Okay. Sure, Jami, thank you. Look, I'd say as far as targets goes, the good news is given now our scale across the globe there are many, many opportunities to complement it.

And what I mean by that, that everything from whether it's enhancing on the specialty side, enhancing on the generic side through geographic expansion as well as other categories or dosage forms we're not in, we've said many times that we're at 12%, 13% market share here in the United States. There is still therapeutic categories.

Just as we recently bolstered our injectable to really put us in – the ability to have a leadership position in injectable. So I think as you think about these different categories, we have an opportunity to add. And so with that being said, it allows us to kind of be smart and patient as we find that right next transaction for Mylan.

So I don't want to hone in on any one area. I want to tell you that we're looking at everything. Actively pursuing, as I said, as you can imagine standing still is not in our DNA, and especially given the environment that we're in today, which is I consider still to be kind of a hyper consolidation activity going on in our sector.

So we are truly looking that we could add, we believe, significantly both from a strategic perspective as well as the financial perspective, here in the near term. As far as respiratory, I'll touch on that and then I'll let Rajiv add to it.

But, obviously, we've continued to look at very – if you think of this in kind of a couple of buckets from a niche perspective, really our enhancement around COPD, our experience, our infrastructure, our relationships in that market, we believe continue to put us, as you know, a great partner in that space.

And I think that's something that we will continue to build leadership on.

When you think about whether it's our generic Advair and some of the other opportunities, the franchise, when we acquired it from Pfizer, really gave us the opportunity to take some of these more complex, very difficult-to-manufacture products that have, we believe a high barrier-to-entry to let us participate in those marketplaces.

And as far as our go-to-market strategy, I think that, that continues to evolve. I think from the marketplace here in the U.S. throughout Europe that that continues to evolve. And the good news is given now our scale whether across physician, hospital or retail, we're really going to be able to maximize those products at the time they come to market..

In fact I think I can build upon. I think, Jami, you should take it in two buckets for us, one is the COPD, the nebulized space where we have some pretty decent share with the performance and this will complement very well that space, the nebulized space and we will continue to look to further expand this space.

Second is the generic Advair or other slew of products like Seretide, Flixotide, Flovent and we can go on where we continue to add more and more portfolio internally as well as externally like our – some relationship with ProSonic (40:31) because we believe this is the high barrier, difficult to make, needs considerable investments, not just from the science perspective but also from the manufacturing perspective.

And we also believe that with Abbott now, we have sales infrastructure so whether it's a generic or we need to have a hybrid approach or needed approach the physician, we are well positioned across geographies to take this portfolio of respiratory products very successfully..

So I guess just in conclusion on that point, as you talked about how it all fits together, I think that, hopefully, what you're continuing to see us execute on is continuing to diversify our businesses across both therapeutic categories, dosage forms and geographies into these channels that continue to let us have multiple levers on managing this business and that scale and our product portfolio and really our investment and not only R&D to some of these are complex products as well as commodity products that really truly I think set us apart to have a portfolio as deep and wide as ours goes.

And lastly, our continuing investment in our global supply chain. So, controlling our own destiny, we believe in the environment that we're living in today from a regulatory perspective continues to differentiate us as we are now manufacturing about 80% of what we sell around the globe. Thanks..

Thank you. Our next question comes from Umer Raffat from Evercore. Your line is open. Please go ahead..

Thanks for taking my question. I wanted to focus today on one of your key growth opportunities going forward perhaps in the Hepatitis C partnership with Gilead. And so we understand the prevalence pool is very large in these developing markets, maybe 100 million patients or so. And we also understand you had a very good partnership with Gilead in HIV.

So I guess the question is what types of market share have you had in reference to the other companies that had Gilead's HIV licenses, market share versus other guys.

And then also what type of cumulative treatment rates have you seen in developing markets with your big antiretroviral sales base?.

So I'll kick off here and then again I'll let Rajiv, who is obviously very close to this. What I will speak to is our relationship with Gilead is that as you mentioned has been very good through the years.

And I think that we've continued to distinguish ourselves as the partner-of-choice as you probably saw them giving us the exclusivity in the India commercial space.

So I think that speaks to not only the partnership as you look across all of the markets that we're exporting into with them but their selection of us on an exclusive basis, especially around this Hep C product, both of them..

And again, you know, it's a future – you're asking me question of future, but I can give you a data point from the past that there were several such agreements Gilead had with eight or 10 generic companies on Truvada and Atripla.

And Mylan has the one, which has capitalized it to the maximum that we today around those products have a large market share to the tune of 60%, 70%.

And that's all our partnership with the Gilead is just beyond signing an agreement, having rights to the market, but working with them to bring the next level of science and the efficiencies into this so that we can provide access to millions of the patients out there.

So we are at the end of process focusing on filing this product into all those 91 countries and also continue to assess those market space to be able to give you the answers that you are seeking for..

Thank you. Our next call is from Douglas Tsao from Barclays. Your line is open. Please go ahead..

Hi, two questions. First, just in terms of the SG&A percent, obviously, you're going to be taking out some of the infrastructure with the Abbott business.

But how should we think about that? And I know it's not necessarily a perfect way to think about it, but just as a percentage of sales, do you think that in-time, as you enjoyed that business that we should see some greater leverage there? And then also if you could provide just a little color in terms of how you're seeing your insulin program develop and how you see that marketplace playing out over the next couple of years?.

Okay. Thanks, Doug. I'll take your first one. Look, I think that when you look at our SG&A right now for 2015, we were primarily focused on business continuity as we're integrating the Abbott businesses.

So I absolutely think there is opportunity as we look out into the future, as we look at the combined businesses and what makes the most sense from an infrastructure perspective. And, look, we're also continuing, as I said, investing in everything from EpiPen and some of the other the brand products that we have.

So I think you can continue to see us be responsible like I said first and foremost, it was about business continuity this year.

And as far as the insulin program?.

Yeah. On insulin, I think as an update our Phase III on glargine, two Phase III studies of glargine continue to progress very well. We have also invested heavily with our partner Biocon in Malaysia in preparedness for – manufacturing preparedness for glargine.

At the same time, I think, we are continuing to focus on interchangeable, bringing the interchangeable product ahead of every other player in USA and we see this as a very exciting opportunity..

Thank you. Our next question comes from Louise Chen from Guggenheim. Your line is open. Please go ahead..

Hi. Thanks for taking my questions. So my first question is on Copaxone. Just curious what gives you confidence in the approval in 2015 and what type of share you expect to take from both regular Copaxone and the 3TW.

And then secondly, on Famy Care, just curious if you could give us more color behind some of the metrics that you've mentioned earlier, maybe sales growth would be helpful and also some of the gross margin, operating margin. Thank you..

Okay. Thank, Louise. So I'll start with Copaxone. Look, I would say, our confidence level is around again are our continued, our interaction with the FDA, us believing that there is nothing left for us to do on our end.

We've submitted and answered all the open questions that we have with the FDA and feel that that therein lies our confidence with action, regulatory action to be taken this year. And as far as, I guess I'll comment kind of collectively on share, whether it's Copaxone or Famy Care.

You know, look, given the size of our businesses now, we again aren't getting down into product individual opportunities or the kind of market share.

Obviously, our guidance is significant and we give that range to as we continue to look at the risks and opportunities and the volatility around this business across the geographies and everything that we take into consideration.

And I think our track record in really trying to guide appropriately that we've taken those things into consideration and don't break out product-by-product or any of these bolt-on type of acquisitions that we've made to enhance our product portfolio..

Thank you. Our next question comes from David Risinger from Morgan Stanley. Your line is open. Please go ahead..

Thanks very much. So I have a couple of questions. I guess first, with respect to your assumption for EpiPen, obviously, Mylan has a lot of experience in launching AB-rated generics. Maybe you could just talk about what the typical impact is on the brand in terms of price and volume when an AB-rated generic launches. That's my first question.

Second, with respect to ex-U.S. pricing, obviously, there is – continues to be price pressure ex-U.S., could you just talk about the outlook for pricing in Europe and Rest of World in 2015? And then finally, two product opportunities, on Lidoderm, I didn't quite catch exactly what your expectation is there in terms of launch timing.

And then on glargine, could you just walk through the Phase III conclusion timing, the estimate of concluding Phase III for glargine? Thank you..

Wow, at least somebody didn't disappoint us in getting four questions or five questions into the queue. So I'll, David, try to hit you, hit each one of them. So EpiPen, we have stated, I don't – I think that EpiPen is a very atypical product.

And I believe a couple of things, not only just from a brand equity perspective, but as we've mentioned, the comfort and the familiarity of the use of that product in a life – potentially in a life-threatening situation. And we believe that that's what puts a very high barrier bar to an AB-rated in the first place.

But if an AB-rated were to get approved, we also believe you would not see the typical conversion that you do around an oral solid product.

And with that being said, we've even seen oral solid products as you may know, whether it's a levothyroxine or a Dilantin, there are some products out there that people feel very secure about the product that they're on and resist changing them for – whether it's neurotherapeutic.

So as you can imagine, none of those fall into the category of having seconds count when you could be in a potentially life-threatening situation. So we believe patient's familiarity, use and comfort with the product now that's been in the market for over 25 years, that there would not be a typical generic curve.

But like I said, with that being said, we have taken the conservative approach and modeled AV competition in, but like I said, I think EpiPen will be a very important brand for us for many years to come. As far as ex-U.S.

pricing goes, especially around in Europe, this year, this past year, we continued to see volume be able to overcome the price erosion that we did see, which is as we still saw growth in that region despite the price erosion. And we have factored in middle single-digit erosion going forward.

So with that being said, we're still seeing – anticipating double-digit growth across all of our generic business segments next year. As far as Lidoderm is concerned, look, I put my crystal ball away last year because I would have said we absolutely were in a ready position to have that approval.

As you know there has been a lot with GDUFA and the FDA's restructuring and there has been some very important first product, market formation products that haven't been approved yet. And we consider Lidoderm to be one that's important. We certainly believe that, hope to get an approval here soon.

But with that being said it's really kind of immaterial to any particular contribution because we've again anticipated and absorbed all of that in the range that we've given for 2015. And I think on Lantus – I'm sorry, I forget the last one on Lantus.

David if you could repeat? Yeah, do you have that?.

Yeah, it was both I think the completion of the Lantus study. And David, we have two studies going on, one on the type 1 which is a 52-week treatment and second on the type 2 which is 24-week treatment. And these studies will be finishing, the top line data will be available by the second half of 2016..

Thank you. Our next question comes from Chris Schott from JPMorgan. Your line is open. Please go ahead..

Great. Thanks very much, had a couple here.

Maybe first, just looking out, if we look out, let's say, three years to five years for Mylan, is the company a much more brand-focused organization than it is today, looking longer term, or do you see relatively equal opportunities to grow and acquire in the generic franchise relative to brands? And then second question was just thoughts on Pfizer's acquisition of Hospira and how that factors into your view of the injectable markets and how that market evolves for Mylan as we look out the next few years? Thanks very much..

Sure. Thank you, Chris. Look, Chris, I wouldn't try to put us in a box of brand, generic. What I would say is that we continue to expand and diversify ourselves to be a healthcare provider. And I think that spans across everything from the physician, the retail, the hospital.

And when I think about our ability to take a very broad portfolio and whether it's, as we're interfacing with a much more consolidated customer base on, from a global perspective, the GPOs, I think that it's this breadth across our portfolio that really is continuing to put us in a differentiated category.

So as we look at opportunities, I'm not saying we're more branded focused, we're more generic focused, we're more OTC focused. What I can say is that we continue to look at ways that we can mean the most to our customer, that gives us that diversification across geographies as well as across products.

And like I said, just allows us to continue to deliver on our mission of wanting to reach 7 billion people. So I think just to underscore that there is many, many assets out there available that will let us accomplish this in many different ways. As far as Pfizer and Hospira goes, look, I think that consolidation always lends itself to opportunity.

And I think going back to when, whether from Bioniche and then when we added Agila, we said that we believe that put us in an opportunity to really leapfrog to a leadership position in the injectable space. And I think we continue to have a great opportunity to do so..

Our next question comes from Marc Goodman from UBS. Your line is open. Please go ahead..

Heather, can you give us a flavor for some of the key countries in Europe and how you did? And then can you also talk about the breakdown in Asia, just kind of the key franchises and how you did in the quarter and for the year? Thanks..

Sure. So, look, I think obviously as you know, as France goes, goes Europe for us in the Mylan legacy world. And so I think we have maintained a leadership position. I think we have been quite – we're operating obviously in a highly competitive marketplace over there. But we have continued to see actually regaining of some market share.

We've been doing some direct advertising as well as building that Mylan brand and that Mylan equity. And I think we've seen great growth when I look at Italy and some of the other substitution countries. What I think now married up with Abbott, what this provides us is to take their strength.

And about eight of these top markets in Europe, whether it's Germany, UK, some of the Central Eastern Europe, and really allow us to now bring this critical math across all of Europe.

So while, like I said I'm excited with our growth in Europe last year on a legacy basis, I'm more excited about what I think the Abbott and Mylan business can now do together and the kind of growth that we're going to see in Europe.

As far as the rest of Asia, Asia grew double digits in 2014 led again by India and our emerging markets, our HIV franchise, the ARVs continues to grow at an accelerated double-digit rate. And lastly Australia and Japan continue to be very well and meet our expectations..

Thank you. And our last question will come from Sumant Kulkarni from Bank of America Merrill Lynch. Your line is open. Please go ahead..

Good evening. Thanks for taking my questions. The first one is a clarification. If AB-rated competition on EpiPen does not appear, will the upper end of the range still hold all else equal? And secondly on Biologics and the HIV and HCV franchises, there could be potentially lots of patients ex-U.S., and it could be a growing market.

But could you give us any quantitative or qualitative color on how profitable those business businesses could be?.

Okay. So let me first start, as I said earlier we gave a range for a reason. There is a lot of – there is many moving pieces and parts to this business globally as far as all the range is considered. So, look, I can't answer a hypothetical as an AB doesn't come, but 16 other things do. A lot of things factor into that range that we've given.

So I can't take one individual aspect of that with EpiPen and give you an answer. What I can say is that again I think we've been responsible in guiding you to the midpoint of our range and what we think that the opportunities or challenges that lie ahead.

And as far as given you any further breakout around these franchises, we've really don't get into like I said product profitability or margins around these products. I think you've got a look at the overall health of our franchise and the results we just reported and the guidance we've given you now going forward as an overall indicator.

And, obviously, we've shown tremendous growth on those segments and gross margins..

Thank you..

With that operator and everybody, we appreciate your support and interest. And you can close out the call..

Ladies and gentlemen, thank you for participating in today's conference. This concludes our program. You may all disconnect and have a wonderful day..