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Edited Transcript of MYL earnings conference call or presentation 1-Mar-17 6:00pm GMT

Thomson Reuters StreetEvents

Q4 2016 Mylan NV Earnings Call and Investor Day

New York Mar 2, 2017 (Thomson StreetEvents) -- Edited Transcript of Mylan NV earnings conference call or presentation Wednesday, March 1, 2017 at 6:00:00pm GMT

TEXT version of Transcript


Corporate Participants


* Kris King

Mylan N.V. - Head of IR

* Heather Bresch

Mylan N.V. - CEO

* Rajiv Malik

Mylan N.V. - President

* Ken Parks

Mylan N.V. - CFO

* Tony Mauro

Mylan N.V. - Chief Commercial Officer

* Haribabu Bodepudi

Mylan N.V. - COO

* Sanjeev Sethi

Mylan N.V. - Chief Scientific Officer

* Arnd Annweiler

Mylan N.V. - R&D

* Rakesh Bamzai

Mylan N.V. - India & Emerging Markets

* Jose Cotarelo

Mylan N.V. - Japan, Australia & New Zealand

* Matt Erick

Mylan N.V. - North America

* Jacek Glinka

Mylan N.V. - Europe

* Adele Gulfo

Mylan N.V. - Commercial Development

* Peter McCormick

Mylan N.V. - Oral Solid Dose Operations

* Andrea Miller

Mylan N.V. - Biologics Operations

* Deb O'Brien

Mylan N.V. - Corporate Brand

* Walt Owens

Mylan N.V. - Respirator & Dermatologics Operations

* Carmen Shepard

Mylan N.V. - Quality


Conference Call Participants


* Marc Goodman

UBS - Analyst

* Randall Stanicky

RBC Capital Markets - Analyst

* Elliot Wilbur

Needham & Company - Analyst

* Chris Schott

JPMorgan - Analyst

* Hima Inguva

BofA Merrill Lynch - Analyst

* Jami Rubin

Goldman Sachs - Analyst

* Liav Abraham

Citigroup - Analyst

* Sumant Kulkarni

BofA Merrill Lynch - Analyst

* Umer Raffat

Evercore ISI - Analyst

* Doug Tsao

Barclays Capital - Analyst

* Erica Kazlow

Bernstein - Analyst

* Brittany Chen

Barclays Capital - Analyst

* Tim Chiang

BTIG - Analyst

* Andrew Finkelstein

Susquehanna - Analyst




Unidentified Participant [1]


Ladies and gentlemen, please welcome Head of Investor Operations, Kris King.


Kris King, Mylan N.V. - Head of IR [2]


Hello, everyone. It is good to see everybody again. It has been a while, since August of 2013 so we are glad you could make it today on a rainy day in New York City. It is my pleasure to welcome everyone in the room as well as those that are on the webcast or dialing in via telephone.

We have a very exciting day for you today. We hope you enjoy it as much as we think you will. We have got a full lineup of our leadership team; we have several hours of prepared remarks and we will save time at the end for roughly an hour of Q&A. And with that I do have to keep my i's dotted and my t's crossed, so bear with me while I read you our forward-looking statement.

During Investor Day we will be making forward-looking statements on a number of matters including our financial outlook and 2017 guidance. These forward-looking statement are subject to risks and uncertainties that could cause future results or events to differ materially from today's projections. More information about our forward-looking statements and the limits applicable to them can be found on the slide displayed behind me now, which is also available where this presentation is posted on our webcast.

In addition, we will be referring to certain actual and projected financial metrics of Mylan on an adjusted basis which are non-GAAP Financial measures. We will refer to these measures as adjusted and present them in order to supplement your understanding and assessment of our financial performance.

Non-GAAP measures should not be considered a substitute for or a superior financial measure to calculated in accordance with GAAP. The most directly comparable GAAP measures as well as reconciliations of the adjusted non-GAAP measures to those GAAP measures are available in our fourth-quarter and fiscal year-end 2016 earnings release and the appendix to this slide.

Let me also remind you, as you have also heard, the information discussed during the presentation, with the exception of the participant questions, is the property of Mylan and cannot be recorded or rebroadcast without Mylan's express written permission. An archived copy of today's presentation will be available on our website and today's slide presentation in totality will be posted at the conclusion of today's event.

So with that it is my extreme pleasure to welcome our CEO, Heather Bresch.


Heather Bresch, Mylan N.V. - CEO [3]


Thank you, thank you, Kris. Well, good afternoon, everyone. As Kris said, it is been since August of 2013 since we held an Investor Day and not truly by design. But as many of you know, there has been a lot of activity since August of 2013 and we couldn't be more excited to share with you who we are today.

And we believe that there has been a lot of transformation since we were last together, both from our differentiated and diversified platform. And we believe there has probably never been a better time for not only as to tell our story about who we are today, but more importantly where we are headed tomorrow.

And hopefully you will enjoy today, we have got a lot of leadership here with us, many will be speaking and then all of us will be joining you for cocktails afterwards. So I look forward to all of your questions once we get through our presentations. And like I said, I truly hope that it is a great reflection of not only who we are today but where we are headed.

So I will start with just what we always say it comes -- what we are grounded in which is our mission statement. And we truly have been committed to setting new standards and providing access to high-quality medicine for the world's 7 billion people.

And I hope what you see today shows that our words -- actions speak louder than words. And it really is about serving the developed markets as well as the developing markets. And serving the HIV population and breaking down barriers to access. It is who we are and it is what motivates us.

We have been committed; we have had a long-standing [committed] to both access and innovation. And while we have the traditional innovation in R&D with 3,000 scientific affairs, over 4,200 active patents, we have spent a tremendous amount in research and development and I am excited to give you that update today as well from biologics, our generic Advair.

But we also innovate unconventional means which is breaking down barriers to access to make sure that the people who need our medicine can get it whether it is in sub-Saharan Africa or here in the United States. Our team of over 35,000 employees truly believes that this is what we get up every day to do. It is important work and we work hard to get it right.

And as we know, there is a lot of volatility in the world today, a lot of things happening around us. But what we do know is the world needs access to high-quality medicine and we believe that we are best positioned to deliver on that mission.

So just a quick look back at the last now almost decade. When you think about our commitment not only to this track record, but more importantly the assets that we have pulled together over these last 10 years, starting with the Merck/Matrix acquisition, both were very transformative, Matrix really leapfrogging us into the API space and the vertical integration, while Merck took us from being a domestic Company to a global one truly overnight.

From there obviously was a very challenging environment. The financial markets were crashing around us. And to say that we had our headwinds I think would be an understatement for those of you that have been with us since 2008.

But as many of you know, not only did we continue to execute through that time, we continued to invest. And we continue to invest in important areas that are a byproduct of the success we are enjoying today and the growth and opportunity in front of us.

So hopefully what this demonstrates and what you are going to hear a lot of today since 2013 from Agila to Abbott to Meda to Renaissance to Famy Care to launching Hertraz in India back in 2014, we have now launched that in a dozen other countries. A lot of exciting not only opportunities but these assets.

We have had a long-standing -- a long-standing commitment to it is not just about what the Fed is doing or the Company is doing on their own, it's what we have always truly believed that we could do together. That has been about how we bring the people together from these companies, how we bring the assets together and how we optimize them.

And again, you are going to hear a lot today about how we are approaching integration, what that means for Mylan, and more importantly what it means about how we are running our business going forward.

So if you look at who we are today, we believe a very unique and differentiated profile serving over 165 countries, $11 billion in revenue, 68 billion doses sold. We have $700 million spent last year in R&D, our 35,000 global workforce, 7,500 products and, as I mentioned, 4,200 active patents.

Hopefully that shows you -- I always say a picture can say 1,000 words. This picture is not just again about size, because a lot of people can have a lot of assets. It is how we leverage and optimize these assets, how our scientists, how are manufacturing, our operation excellence comes together with our commercial excellence and how that we truly leverage in every country we operate.

Because every country has got a unique profile. Every country has different needs; every country has a different way that you have got to go to market. And what we believe we now have are the assets, the products and the different channels with the right people and expertise to truly leverage the best go-to-market strategy in each and every country that we operate in.

And when you think about where we are headed as a society, the growing global demand for medicine, I mean it certainly is not -- the trend is not going the other direction. The trajectory for the population growth, the over 65, the spend and the doses that are going to be needed to take care of the population is certainly a demand that not many companies can fulfill.

When you think about the infrastructure both from an operating and a commercial perspective to deliver this kind of volume to this many patients, that infrastructure is where we believe that we have got one of the best not only platforms but the best execution to deliver on our promise and commitment.

When you look at our global presence today to meet this demand, today we stand number six worldwide. That is both Rx for prescription volume overall both brand and generics, Mylan is number six worldwide. About 2% market share and again in over 165 countries. So the volume that we have been able to not only both through organic and inorganic, but the dosage forms.

And as we said, it is not just about high volumes or a lot of assets, it is how we are leveraging complex dosage forms both from oral solids to transdermals to injectables, how we are able to deliver this medicine and most effective and cost efficient way.

When you look at some of the stats just throughout that we'll obviously be taking a deeper dive into today, but from being number two in the US to number one in France, number two in Italy, you are going to hear a lot. Our transformation in Europe has been significant.

The assets that we have pulled together have positioned us to truly, truly get our disproportionate share of growth. We see tremendous opportunity when you just think of generic utilization where we stand today in the United States with almost 90%. Most other countries are far behind that and offer a huge opportunity not only to capture the utilization to go up but our market share within these markets that we are competing.

And on our theme of just highlighting this diversification and just since we met last in 2013, if you look at by geographies, our North America our Europe our rest of world segment certainly has continued to become more balanced as well as our revenue by channel.

You look in 2013, the predominant matrix being generics and today that blend between both Gx, Rx and OTC, again, we believe it gives us a real unique opportunity in how we go to market, how we commercialize, how we mean the most to our customers around the world. And there is a lot of them. Meeting that global demand, meaning the most to the customer as well being meaningful to the patient is what we believe we have now been able to put the right infrastructure in place to do just that.

And as we talk about today's discussion, I couldn't be more excited to introduce not only our leadership team but really everything that we've pulled together and how we are driving and managing this Company, how we are managing the countries that we are operating in, how we are delivering truly on our mission of delivering to the world 7 billion people. We are going to talk about the global trends and our ability to leverage this opportunity, our unmatched operating platform, partner of choice to reach 7 billion.

We have also done a lot of strategic partnerships that have allowed us to, again, how we go to market in any individual country; we take a lot of time to think about that. Japan is a great example; you are going to hear more about Japan today.

But our partnership with Pfizer, going to market, leveraging both strengths of both companies from the Pfizer brand and their infrastructure to our operating platform, our portfolio and our pipeline and bringing those both together catapult us to a leadership position in Japan in a very short period of time. Financial performance and then, as Kris mentioned, Q&A.

So before I introduce and have the management team introduce themselves I would like to -- I know we have shown some videos in the past, and you are going to see some more today on our operational excellence and where we have come both with biologics in insulin and generic Advair. But I thought it would be good to highlight a short video that truly shows you that we are so much more than one product and in so much more than one market that it really hopefully emphasizes who we are today and how many products and people make up the Company of Mylan.

(video playing)

So again, just a little teaser. Hopefully you saw some of the Mylan store as you came in, but a lot of exciting products, a lot of exciting opportunities. And most importantly, exciting about how we are pulling it together in what we call a One Mylan strategy and really leveraging all of these assets and approaching our customers and our patients with one voice with this complement of products.

So with that I would like to highlight what we always say is our best asset, which are our people. And I think sometimes something that is overlooked or perhaps not discussed but is that truly special sauce, that what we believe is part of our differentiator, it is the continuity of our management.

I have been with Mylan 25 years, my fifth year as CEO, and truly have been able to not only grow with Mylan, this industry, evolve now into this global Company with 35,000 colleagues. And truly understand what -- the fabric of what we do every day and what it means. And when I think about just between myself, Rajiv and Tony, we have got 75 years in this industry, the majority of those, over 55 of those years at Mylan together.

And just if you look over the last decade and as our leaders introduce themselves hopefully you will get a feel that many of us have been together for a long time. We have been part of the Matrix/Merck/Mylan coming together back in 2007. And part of truly, as we say integrating Mylan, bringing together assets, not just transactions. It's not just about buying a product or a company; it is really about bringing two organizations together and getting the best out of them.

And we believe that that is what we have done and that is what we will continue to do as we now bring great assets into this infrastructure. So with that I would like to ask some of our management team representing our 35,000 to stand up in the front row and just turn around and take the opportunity to introduce themselves to you. Rajiv?


Rajiv Malik, Mylan N.V. - President [4]


Good afternoon, everybody. I'm Rajiv Malik; I serve in the role of President. I have been in this business for 35 years; it is my 35th year and 10th year with Mylan. So proud to be part of this member. I do my bit with Heather, our Chairman Robert and Board to define the strategy. But then I quickly step back to do what we do best is to execute with this wonderful team. And thanks to -- good to have you here.


Ken Parks, Mylan N.V. - CFO [5]


Good afternoon, I am Ken Parks, probably the newest member of the team. I joined Mylan in June of 2016. And I am the Chief Financial Officer. And I have the pleasure to be joining the industry. I spent about 25 years in companies -- United Technologies and Wesco, which are in the industrial space, and have great partners to move along this next phase of the path with Mylan.


Tony Mauro, Mylan N.V. - Chief Commercial Officer [6]


Good afternoon, my name is Tony Mauro and I have the great privilege of being Mylan's Chief Commercial Officer. I just started my 22nd year here with Mylan and I am very proud of where it has grown and watching it transform and diversify from one country to 165 countries around the world. So look forward to today. Thank you.


Haribabu Bodepudi, Mylan N.V. - COO [7]


Good afternoon, I am Haribabu, Chief Operating Officer. Last 11 years I have been working with Mylan. So I have a total of [35] years experience, worked in R&D quality operations. Thank you.


Sanjeev Sethi, Mylan N.V. - Chief Scientific Officer [8]


Good afternoon, I am Sanjeev Sethi; I am Chief Scientific Officer for Mylan. I have been in the industry for almost now 28 years and I came to Mylan through Matrix acquisition in 2006. A really great exciting journey of 11 years in Mylan. And I am really proud of the scientific affairs management team. We are very hands on and we diligently track every submission and every launch. And we're glad to be here today. Thank you.


Arnd Annweiler, Mylan N.V. - R&D [9]


My name is Arnd Annweiler, I am Head of R&D. I joined Mylan about 2015, and 25 years in the industry. And prior to my role here in Mylan I was head of R&D for Abbott's established pharmaceutical business. So I am probably the second newest member behind Ken here in the team. But I bring a lot of experience from the previous products. And what I've got to say, when I joined Mylan what I was really impressed with is the breadth and the depth of the science and the capabilities that my new team here really has to offer. So looking very much forward to meeting all of you today. Thank you.


Rakesh Bamzai, Mylan N.V. - India & Emerging Markets [10]


Hello, my name is Rakesh Bamzai. I have responsibility for India and emerging markets. I have around 23.5 years of experience in pharmaceutical business. And this role that I have, this responsibility I have here, I in Mylan for more than three years now. Me and my team are extremely excited and committed to see the portfolio coming together, the infrastructure coming together, enhancing access every single day, reaching those 5.5 billion people that live in my geographies. I will be happy to talk to you later during the day. Thank you for coming.


Jose Cotarelo, Mylan N.V. - Japan, Australia & New Zealand [11]


Good afternoon, everyone, I am Jose Cotarelo; I head up our commercial businesses in Japan, Australia and New Zealand. I am coming up on my eighth year at Mylan. Previous to Mylan I was with Merrill Lynch for many years. And could not be more proud of the evolution of the Company, the transformation since I have been at Mylan. And even as I met Mylan many years before me actually joining and very excited about our opportunities ahead.


Matt Erick, Mylan N.V. - North America [12]


Hi, I am Matt Erick; I have the honor of heading up our North America business. I have been at Mylan now eight years and I have been in the industry over 20 years primarily in retail, wholesaling and now manufacturing. Thanks for coming today.


Jacek Glinka, Mylan N.V. - Europe [13]


Good morning, my name is Jacek Glinka; I joined Mylan three years ago to head the European business. And I will be sharing some slides on the Europe to you later on. So this is my first Investor Day, hopefully not the last one. Thank you for coming and I hope you will enjoy.


Adele Gulfo, Mylan N.V. - Commercial Development [14]


Good afternoon, everyone, I am Adele Gulfo; I have been with Mylan just over three years. Most of the time in the role as strategy officer. But in January I've taken on a new role to head up our global commercial development. And in that role I am very excited because it is an opportunity to ensure that all of our markets are optimally prepared to successfully launch and grow our pipeline assets and you will hear a lot more about that today.


Peter McCormick, Mylan N.V. - Oral Solid Dose Operations [15]


Good afternoon, Peter McCormick. I lead Mylan's oral solid dose operations, some 24 manufacturing sites globally that underpin access to high-quality affordable medicines. I joined Mylan in 2007 with the Merck acquisition. I have some 22 years operations leadership experience having held numerous local, regional and global leadership roles working and living in Australia, Japan, Ireland and the United States. Thank you very much.


Andrea Miller, Mylan N.V. - Biologics Operations [16]


Good afternoon and welcome. I am Andrea Miller; I head our global biologics operations. I may be the old folk here; I have been with Mylan for 28 years. Most of my time and tenure at Mylan has been in R&D and regulatory affairs, focusing more actually on our brand drug research and we have involved in five of our NDAs. My past role was with our global complex products operations, but with -- as we are advancing and expanding our biologics portfolio, I have this past year focused on biologics only and look forward to giving you an update on the exciting advancements we have made.


Deb O'Brien, Mylan N.V. - Corporate Brand [17]


Hello. Good afternoon. I am Deb O'Brien and I have the great honor to be head of the Mylan corporate brand and digital operations. I have been with Mylan going on seven years and prior to that I spent most of my career with Novartis mostly in marketing and marketing capacity and finishing my career there heading up one of their growth drivers. I look forward to seeing you this afternoon and spending some time with you.


Walt Owens, Mylan N.V. - Respirator & Dermatologics Operations [18]


Good afternoon, everybody, my name is Walt Owens. I head up our respiratory and derm operations. I've had the great pleasure of being with the organization now for 24 years, served in the roles of quality, R&D and really I am proud of the way we have progressed this all forward that you are going to see today. I'll be sharing with you some information around our respiratory programs later today and look forward to chatting with you.


Carmen Shepard, Mylan N.V. - Quality [19]


Good afternoon, my name is Carmen Shepard, I am heading quality here at Mylan, this is my fifth year. Prior to coming to Mylan I was in private practice helping a variety of pharma and device companies negotiate compliance, quality and other regulatory issues with FDA and other global regulatory agencies. Thank you for joining us today.


Heather Bresch, Mylan N.V. - CEO [20]


Please help me; I would love to give a round of applause to our leaders. I would also like to thank our 35,000 around the globe because it is truly a team effort and it takes every single one of us. And there is likely some other Mylan leaders that are here as well that you will get to meet this evening.

And I guess I can't underscore enough, I didn't add up the years, but I am pretty sure somehow between us there is, what, 300 to 400 years of experience. And as you have heard, a lot of it together. And it truly is that business continuity. I think the management and really owning and being accountable for the things and the transactions and the assets that we have acquired over the last 10 years.

This wasn't about a hit and run, it has truly been about how do we get the best. And we had been able to attract talent from these acquisitions and we have been able to then truly work together to maximize and optimize them. And like I said, I look forward to all the things that you are going to get to hear and learn and get updated on today on that front.

So if I just for a second -- you heard a lot about all of these assets. And like I said, it is not just about a lot of assets, it is really how we are organizing ourselves, how we are thinking about markets, how we are looking to see still where we have gaps and voids. And we believe this is a really good demonstration of just showing that it starts with of course these great assets.

But we really have started thinking about in these therapeutic franchises. And as you are going to see, we serve a leadership role in many of them. And the breadth across these franchises, again, it is not just about products, it is we are thinking about the Rx channel, the generic channel, the OTC channel and you are going to hear a little bit about our Hx channel, healthcare solutions. So it is really about how we embrace and think about that patient in the center of healthcare.

As I have said before, including this country, a lot of us get -- it is more sick care than it is healthcare. How do we start thinking about truly the wellness and preventative and taking care of patients from cradle to grave. And as we think about that holistic not only the products and how we are packaging them together, but the solutions that we are wrapping around them to truly bring more value and education to patients and physicians and healthcare providers around the world.

So as you think about this portfolio and we look at our products through this lens, it really gives another view to show that, again, so much more than one product, so much more than one therapeutic category. When you look at out our 10 therapeutic franchises we have 6 that are $1 billion or more. And these are with hundreds and hundreds of products, these aren't with one or two. These are with many, many products that go very deep and broad from dosage form delivery as well as the therapeutic category that we are treating.

And with that being said, I know we came out in Q3 and said that we were going to be changing our segment reporting. And I know many of you have reported on this and said not quite sure what that was going to bring. Hopefully what you are going to see and what we are going to demonstrate today is it is going to bring more transparency.

Not only is it how we run and drive the business, how we are organized, but it truly is how we are thinking about our markets, thinking about these regions and how, as you are going to hear from Rajiv and Tony and Jacek, as we think about how do we bring to bear these products in the market. We are not running individual businesses in these countries. We are going to France and we are thinking about behind the counter, over-the-counter, how we are interfacing with the physician, how we are interfacing with the pharmacist and how we are interfacing with the patient.

So it is truly how we believe is the best way to not only show you what is happening around the world in these geographies, but it is how we are running and driving the businesses. And Meda truly was that turning point when you think about the OC products that we have now brought in, how we have truly transformed Europe, that this is a much better way to demonstrate our business.

And I think if you take this look, again I think this picture says 1,000 words. When you look at from North America starting there, obviously we know North America, the United States is one of the most profitable countries. And you look at our CAGR both on top line as well as our profitability and it has been steady at around 50% and we have continued to grow very nicely throughout North America and our profit has kept pace.

But the real story and what has allowed us to be the diversified and differentiated Company we are today and absorb the volatility whether it is a year like 2016 in the United States or in some other part of the world, this differentiation, really looking at our business in these three parts is what has allowed us to absorb that volatility and manage through it.

You look at Europe, while we have had great growth on the top line, 41% CAGR, 127% on the profitability. When you think about that, our vertical integration, our horizontal integration, truly bringing together these assets, I mean these numbers again I think really tell a story of how we are continuing to not only do good but do well.

We are bringing great assets together strategically and complementary and we are getting the most out of them, how we are organized, our operating platform. And like I said, I think that the -- Europe has really been -- really been not only transformed but, as Jacek said he has going to share an update on a couple of countries, about how not only where we are today but more importantly all the products we have coming in our pipeline and how we are going to be able to best maximize them through our infrastructure.

And then rest of world, again, 21% CAGR, 46% that growth in profitability. And as you know, this is where the tenders, how we approach our HIV business. I can't say that -- when you look across our sector and across many of our peers, not only are many not global and can find themselves when something -- when there is volatility in a market being very confined and defined by that volatility. But there aren't many serving the developing world as the developed.

And you look at the products and the portfolio we have and our ability to not just sell them in United States in Europe, but our ability to sell them and distribute them throughout, like I said, Africa when you think of the tenders. And the opportunity for us to take what we have done really well and grown a great business and use that as a channel to now continue to sell these other assets. And that is really our opportunity from an expansion perspective in a lot of these emerging markets.

So I am going to just quickly hit our 2016 guidance and our actuals. Ken will be talking a little more in detail about the quarter. But, look, you take 2016, there couldn't have been I would say a more noisy, volatile year for healthcare, for pharmaceuticals here in the United States and for Mylan. I mean everything from EpiPen to the pricing discussions to healthcare.

And you look at our revenues, we came right at the middle of guidance. You look at our EPS we came in at the high end of our revised range, still within the range of our original -- our initial $4.85 to $5.15 and, like I said, at the high end from our revised at $4.70 to $4.90 all while generating tremendous free cash flow, almost $2.1 billion.

So again, that ability, that strength to manage, to use the levers we have across the business to deliver both top line and bottom line. I think, like I said, not only speaks to the platform and the fact that now 50% of our business is outside of the United States to help us truly absorb that volatility and continue to show growth in many, many areas across many countries. But to be able to deliver and continue to maintain that strong balance sheet and financial flexibility.

As we look towards 2017, again, I think as you look at top line, North America greater than 5% growth, Europe greater than 30%, rest of world greater than 20%. So again, great opportunity both from the acquisitions. You are going to hear about how Meda, Abbott we have really combined. As you know, that was mostly a story around Europe.

But again has given us such great infrastructure and assets that to complement this now, as we look at products and where we still have voids and gaps, like I said just see tremendous opportunity both from a generic utilization perspective as well as market share perspective. And if you look down from, again, generating significant free cash flow, a range between $2 billion and $2.4 billion, all while we continue to invest in our business.

So -- and it doesn't stop with 2017. As we continue to reiterate our $6.00 target, when you look at this chart, and I know this has been a chart that we have been using since our first Investor Day back in 2012, and I know at the time many of you looked at that and said, geez, $6.00, how in the world are you going to get from here to there.

And what I would say is I totally understand as you look at those early years it was a very -- we were a show me story. We had acquired a Company 2.5 times our size, like I said, in a very challenging environment at the time. But we delivered and we delivered on those financial commitments.

And as you look over these last several years, not only did we continue to deliver on these financial commitments but we were continuing to invest. So while we delivered on the short-term we were building this Company for the longer term. $5 billion in R&D, over $3 billion in CapEx, generating over $11 billion in free cash flow.

I mean, so we certainly weren't running or building this Company for the short-term or the returns. But I will tell you and I truly believe a well-run Company delivers tremendous shareholder value. And I think that that is what we have been able to continue to show.

And most excitedly we are still investing. You see our R&D spend last year, $700 million. This year we aren't pulling back and not investing. That organic investment is what has allowed the exciting opportunities you are going to get updated on today from Advair to our investment in biologics.

When we came to this chart back in 2012 and then in 2013 we said biologics didn't even make up the $6.00. We weren't counting on launches or monetary return in this period of time. But we certainly have the investments in this.

So I think that, again, a differentiator is that the building for the long-term, delivering on the short-term and, like I said, with the business continuity that we have. And all of those great things, as you are going to hear today, is what's showing that growth beyond 2018.

So our investments in biologics, insulins, these exciting products, expanding into these other markets, being able to leverage now the over 7,400 products that we have in the new markets is what really is going to get that growth beyond 2018. But certainly is providing the roadmap and, like I said, you are going to hear a lot more today not only about 2017 but about 2018.

So with that I'd like to just turn for a couple of minutes to the dynamics here in the healthcare and then I am going to turn it over to the team to start walking you through the Mylan story.

So I thought this quote probably summed it up best. I think we can all agree that healthcare is complicated. And I would at least say from my perspective the first stage in trying to address a problem issue have got to try to understand it. And I think that the discussion that has happened over the last six to nine months is at least an acknowledgment that it is complicated and very complex. And I would argue too complicated and too complex. And therein lies what needs to happen and what needs to change in a transformative way.

Just to ground us, because, again, I think there has been a lot of discussion around generics. And I think sometimes what has got lost in that message is how much generics drive access and savings for the US healthcare system. When you look at the spend, the amount that is spent on pharmaceuticals and then out of that 3% being generic drugs. However, that represents 89% of the doses are coming from generics as only 11% from the brand. And from a cost perspective the 89% worth of prescriptions is 27% of our healthcare cost.

So I would argue that in the generic space we are getting it right from a competitive perspective, a supply and demand perspective. But from an overall perspective I think what we know is that this isn't working in the healthcare environment we live in today. And the patients aren't reaping the same savings as our system has reaped over the years and that is what needs to change.

When you look at our role in the US, we filled one out of every 13 prescriptions brand or generic, that is 22 billion doses last year, which is more than Pfizer, Glaxo, Sanofi, Astra, J&J, Merck and Lily combined.

People don't -- when I share that stat they are like how -- I don't know Mylan, I haven't heard of Mylan and yet you are 1 out of 13 scripts. And again, I think therein lies our opportunity. This was our launching pad to tell our story about who we are, what we have become today and, importantly, the role we play in delivering affordable healthcare. And what access means and how we fight for that access.

And when you think about our 635 products across the United States, almost 10% of the market, it is a deflationary model. We have continued to model it as a deflationary model. Our business model has been about high-volume, new product launches and delivering the most affordable effective medicine that we can into the healthcare system. That is what it has been about for over 55 years. We just continue to grow that scale and grow outside the United States. But we have not lost sight of the role we play and the need for that role in the system.

I think that when you though think about where we are today and the inflection point for patients and payers, if I go back -- and again dating myself -- 25 years when I came into this industry, we had about 35% if not 40% cash paying patients, cash paying customers.

And there was a lot of discussion about cash paying customers and the fact that Medicare didn't have a prescription drug benefit. And there was a lot of discussion about how do we reduce that burden for the cash paying patient because the system, the prescription system wasn't -- it wasn't built for this consumer activity.

So over the years, back in 2003 of course Medicare brought in Part D and a couple of years ago we were down to 1% or 2% of cash paying customers in this country. If you now look at what has happened over these last couple of years with high deductible plans, we have over 51% of Americans that are paying $1,000 or more out-of-pocket before really their insurance kicks in.

So all of a sudden, almost overnight, we are back to having over 50% of Americans look like cash paying customers again. They walk up to that pharmacy counter and they are being asked to absorb that full list price. And as you may remember, this is a chart I used on CNBC, I say it truly was an inflection point in and of itself, showing the difference between what the manufacturer captures of that list price and what happens throughout the middle.

And this isn't about pointing fingers or blaming, it is about the fact that I realize what a significant lack of knowledge people had about the supply chain or the players in it, or the fact that there were any players between the manufacturer and the patient.

So as you look at this system that is very much driven by institutions today, you see the patient at the end of the page. And it is a very linear vertical way that we get from the manufacturer to the patient and the fact that this list price is absorbing the entire supply chain.

The other dynamic is patients aren't isolated anymore. As I said, over 50% look like cash paying customers and so they are not getting the benefit or feeling the benefit of their plan. And as this is going to continue I don't think any of us would think that that is going to the other direction.

I don't think deductibles are going to come down; I think more and more there is going to be a cost shift to employees. And as that cost shift continues we are going to continue to put more people looking like cash paying customers, which is why we have got to really think about this in a transformative way.

These incremental solutions that have been discussed, the legislative solutions that have been discussed I would argue are merely not even band-aids for symptoms, they certainly aren't going to the problem and the issue, which is that we need to make consumers in the middle, this patient centric.

We shop for everything else in our economy. I would argue that the United States have the best shoppers in the world. We want the highest quality for the lowest cost and we demand that as consumers. We demand it in other parts of healthcare, over-the-counter medicine, you can walk in, you get to make a decision. Do you want the brand? Do you want the generic? What brand do you want? What are you looking for? You get to shop. And that ability to shop drives up quality and down price.

The prescription market doesn't work that way, it is not market-based in the true sense of supply and demand and consumer driven. And until we make it market-based where consumers can be informed -- we have got CEOs of households out there, moms out there that have no information, don't know how to shop, are being asked to spend significant healthcare dollars without any information.

So until we make not only greater transparency, that is one half of the equation. But the ability for market driven dynamics to really allow prescription medicine to work like every other part of our economy, we are not going to solve the issue, the problem of that patient walking up to the pharmacy counter and not benefiting from the savings that generics bring to the market nor benefit from the savings that robust, innovative, new medicines bring to the patient.

So I wanted to, like I said, share. It has been a very interesting year, a very dynamic year to say the least. I will look forward to your questions this afternoon. And until then I would love to turn it over -- my last slide, sorry, I got ahead of myself -- to just capture kind of all of this.

All of the diversity and differentiation that we have built over the last decade has really put us in a position to be a catalyst for change. And as I have said, if EpiPen was a window into a broken system and allow that to be a catalyst to change what needs to change here in the US, that Mylan's position to be that leader in many markets that we serve, how we are fighting for access for patients, how we are working with governments to decide how healthcare is delivered from emerging markets to the developed markets to growing utilization throughout Europe.

So, this platform has given us the ability to be not only that catalyst for change but a true leader in this space so that we can meet patient's needs while continuing to deliver on our financial commitments. So with that, I'm going to turn it over to Rajiv. I can't thank you guys enough. It is great to be together. Like I said, look forward to your questions and answers afterwards and the cocktail reception.


Rajiv Malik, Mylan N.V. - President [21]


Thank you, Heather, for laying the foundation of this beautiful story. And I am going to do my best, along with this team, to put some more meat on these bones. The next few minutes I'm going to share with you why we believe in this story, in what way we believe this is a differentiated asset. It is a diversified asset. More importantly how we have transformed and evolved over the last three to four years.

We met last in August of 2013. Mylan has changed a lot and I'm going to share with you in what dimensions and how many dimensions we have changed and evolved. And I am also going to share with you why we believe that we have a lot of growth ahead of us. With that I'm going to jump onto my first slide and again bring this slide which Heather shared with you. This is just to highlight that this market is -- there is still a lot in this market.

This is the [IMS] data, about 1 billion population being added over the next 12 years; age 65-plus, about 10.5 billion patients are people in that age group. Pharma spend increasing by about another 400 billion. But more importantly, the volume, the doses are about 1 trillion doses -- additional doses required by the system.

And just one more slide on this same, which is very relevant for what we're going to talk to you about, is about a difference between the developed countries and [far] emerging countries. And the stark difference which is here, and if you just enter the Rx bucket, that how much of Rx bucket is not getting to these far emerging countries, many of the big pharma is not launching their latest innovations of new products in those countries for obvious reasons.

But there is a lot of Bx, which is the branded generics, Gx and Ox. And that is where I want to draw your attention to when we talk about our growth opportunity in these markets.

Let's look into the top 20 countries based on IMS data. So I have just marked blue where Mylan has significant commercial presence and orange ones show Mylan has a margin commercial presence where we have established some commercial foot presence, where we have some foot soldiers. So take even the markets like US, Germany, Japan, we will talk to you about it is not that we -- there is no opportunity to grow there. There is a lot of opportunity for us to grow in these markets.

But just look into the China, Brazil, India, Russia, Turkey, Mexico, Poland. All these markets we have -- we'll share with you we have now I am not going to call significant commercial presence but we have made a start. We have people on the ground, we have salespeople on the ground, we have products now available to us. We have a huge pipeline and we're going to share with you why we are excited about this far emerging market growth.

Two countries we see over here, maybe one South Korea, we don't have the commercial infrastructure but we still sell some products through our export channel. And why we believe we are uniquely positioned to provide greater access. Every word on this slide I'm going to walk you through in the next hour or so of unmatched operating [perform].

We are going to share with you strong R&D pipeline, and more importantly the capabilities, the technologies, the range of technologies we have assembled, global manufacturing skill with extensive capabilities, and a true global supply chain. It is not just because we are globally presence so it is a global supply chain. We think about these products and many of these products in a global way. And second to none operating team.

At the same time on the right-hand side you will see it is very different; it is just not a generics platform, it is a diversified commercial platform with a deep and broad portfolio of more than 7,000 [partner] products. Critical mass in all channels including Gx, Rx, OTC as well as institutional. Global (technical difficulty) reach across 165 markets. Globally integrated sales and marketing team and some very strong strategic relationship with our key customers across the globe.

Before I take you to the R&D or our operating platform I would like to share with you what changed for us over the last three to four years. We made some strategic moves. And just say that (inaudible) was Agila, Abbott, Famy Care, Renaissance, how they helped us enhance already strong operational platform which we had in 2013.

I put Agila there because when we met you we had announced Agila but not closed Agila. But Agila has given us a critical mass in injectable manufacturing, a strong R&D pipeline and more importantly a platform.

Abbott expanded our European footprint manufacturing footprint, we got a very nice facility in one of our key markets, France. And other state-of-the-art facility in Japan. We got some flu vaccine capabilities.

Famy Care got us to the scale in oral contraceptive manufacturing. They're the world's largest provider of oral contraceptives which is a (technical difficulty) Mylan team. Leading R&D for hormonal contraceptive products and a global pipeline.

Renaissance, we were really missing a derma portfolio, but more importantly derma capabilities. Through Renaissance we have acquired a range of technologies around topical manufacturing, but more importantly R&D pipeline and a great team.

Meda, brought us OTC capabilities, OTC manufacturing, OTC R&D and some additional capabilities with (inaudible). But the story on the commercial [world] is more exciting because it helped us transform our business which we will share with you.

Agila gave us a little [footstep] in Brazil which we are building upon. Abbott enhanced our position beyond USA. It significantly helped us increase our presence in Japan, Canada and many of the European markets. Later on Meda basically gave us almost double the size of these markets especially I would say in Europe. You will hear from us how our position in Italy, Germany, Spain, Portugal -- we significantly enhanced our position and we got a decent scale in the Eastern European market.

How, more importantly, we acquired a strong medical sales and marketing infrastructure in these markets through Abbott and Meda. Meda brought us a very vital component which we were missing is the OTC commercial infrastructure. And Famy Care gave us a significant piece on the human healthcare franchise.

So with this I think we acquired a lot which we were missing and more importantly were looking out for. And because of the number of products which are coming already like biosimilars or respiratory products.

It is not about just what we acquire, this is where we are -- we differentiate ourselves and I am so proud of what we have done with these assets. It is just not about acquiring, it is what we do with these assets we acquire. And integration is a very big act [to follow for us]. It starts way before we acquire this asset. It starts with understanding the culture of (inaudible) organization. And more importantly what can we do with an asset.

And you start with that and you share that within your partner. We bring them on board that what we can achieve with this asset along with that team. And I think you will set the stage for a successful integration and that is what we have proved again and again.

Focus on business continuity. Many people say 1 plus 1 is going to make 4. Yes, first of all 1 plus 1 needs to make 2. So let's continue with the business, let's ensure that the business continues. Let's retain the people because without people you don't have an asset.

We have taken our time to develop integrated operating models because if we would have gone with this Rx and OTC business and Gx and just put them the way they are we would have lost not just cost synergies but value creation which opportunity we have in the front.

Harmonized best practices and processes. Meda or Abbott, gave us so many such opportunities which we have been able to retain and bring it back to our Mylan legacy processes. And rationalization, the infrastructure, optimizing the infrastructure, doing more with what we have is an ongoing process.

And every (inaudible), especially these last two buckets over here continue optimizing and do more with more. We have a focused team, dedicated time. And a commercial we are trying to follow and establish. And not on the (inaudible), we have done followed a One Mylan approach. There is a team to focus on cross pollination. How can we take these products to all the geographies.

Optimize sales and marketing infrastructure. Operationally we have got a lot now. How do we optimize this manufacturing footprint, and reduce cost in both direct and indirect spending and leverage R&D, more importantly the capabilities as well as the investments? At enterprise-level there is a lot of opportunity here and we call this function as a GIS.

There is a lot of backroom activities which can be pulled together, but it is more about the processes. It is more about that once you harmonize the processes the (inaudible) can be pulled together and that is what we are doing on an integrated way.

Leverage technology. All this hard work has to pay. And it is paying in terms of synergies. Restructuring which we have taken, which we announced sometime back. Sourcing, vertical integration, a lot of products which came in were again with the third parties and we have been able to vertically integrate those products, optimizing our manufacturing footprint, leveraging shared services and value creation.

So, as I shared with you in my approval when we last spoke on the earnings, we are well on a plan to accelerate and achieve almost double of whatever Meda synergy targets we had put for ourselves.

And more importantly, we are still perceived as a very US centric Company which is not the case. We are diversified by geography, 45% of our business is now North America, 31% Europe, 24% rest of the world. And when you think and when you guys talk about -- when we all talk about the headwinds around the generics pricing and all that, we have to take into consideration this diversification. We have to take into -- take a point of view about how Europe is performing, how rest of the world is performing.

And more importantly I think between the Rx, Gx and OTC, it is a great fit for us now. With the OTC although 8% but a great opportunity for us to grow. And our operations -- just a snapshot before I go into the -- talk further about operations. Capacity enhancement or (inaudible), $54 billion to $80 billion.

More importantly across the board on complex products we almost increased 5 times the capacity. 1,100 unique products in 2013 which we shared with you; we have 2,300 unique products today. 75 -- [7,400] market products. But more importantly the pipeline. The strength of the pipeline, the pending approval, plant submissions and we are still -- we are almost -- we were investing only $456 million -- we invested $456 million in 2013 when we last spoke. Today we are investing $750 million in the same R&D.

So let me talk about the operating platform which we all talk so proudly and are so proud of. And you have to take a closer look into this. It is not just about the numbers, it is about the capabilities and the complexity which we have pulled together and why we believe that we can deliver.

50 global manufacturing sites across the globe with 10 sites in North America, 12 in Europe, 25 sites in India, two in Japan and one in Australia across multiple dosage forms. But it is a truly global network. We know about -- we -- in a very globalized way we exactly know where we are making our key products, what we are making, why we are making, how do we control them, how do we manage them.

So we exactly -- it is a very integrated -- it is not just we have a number of sites and they are on its own we exactly know why we are doing what we are doing. Many of these sites have proximity to the key markets. 80% of our [euro] products are made at US sites. Just a small staff. France our number two site has three manufacturing sites just in the close proximity of that market. Japan our other key market has two sites.

So, yes, we have structured it in a way -- it is a very well thought out and well laid out plan and we still have some regional supplies. Because the complexity of Europe just cannot be managed by one or two sites around the world. So sites like Europe we have a regional site at (inaudible) where we bring the products in maybe it's packaging or distribution, but we do a lot over there in Europe through those 12 sites.

And when it comes to the cost optimization, vertical integration, India, Indian sites play a huge role. And we still make 80%, approximately 80% of our products internally and we control our destiny with -- more importantly from the supply chain perspective as well as from the cost of goods perspective.

And I want to walk you through this slide. 24 oral solid dosage sites, 80 billion doses. But please understand it is just -- not just tablets, it is about a range of technologies you have over there. Whether it's multilayer tablets, whether it is orally dissolving tablets, OROS tablets, hot-melt exclusion, Wurster, spheronization -- you talk about it, that is where the complexity and the differentiation lies.

You talk about injectables, it is not about just lyophilized products, it is about the bags, the prefilled syringes, the microspheres, the emulsions you talk about. And we will share with you some of those examples that -- this is what it makes different or diversified or differentiated.

Complex products, transdermal patches, topicals -- just take an example of topicals, the [forms], the ointments, the lotions, nasals, dry powder inhalers, pens and we're still investing in this platform. We still continue to invest. We are investing in the automation of these plants. We are investing to further fine-tune this network.

And also we have some dedicated sites I would like to mention on the previous one, whether it is oncology products, the hormonal products, certain cephalosporin for injectables. So you name it we have that complexity built in that.

A lot has changed in Mylan over the last 50 years. One thing that has not changed is about our philosophy to the quality. How we think about this, how do we react to what is handed over to us. It is not that we don't have our issues, it is about how we deal with those issues.

We are engaged; we are engaged with the regulators, we exactly -- we have no other option but to be engaged and stay close to this space. Because it can impact a lot when it comes to our business. And we always -- we have our share of -- you talk about those 50 sites. Last year we had more than 90 health authority inspections. Not just from FDA, US FDA or MHRA, but a number of agencies all around the world. So this should tell you what we deal on around the world every day with these sites.

Let me talk to our -- one of the best assets, R&D. Our R&D never sleeps. They work around 24 hours, integrated R&D network of two global sites at Morgantown and [Hyderabad]. But 12 technology focused on these sites with more than 3,000 scientists across the globe.

Over the last -- since we met from 2013 to 2017, we will be spending close to $3 billion cumulatively on R&D. But as we said in 2013, we will be -- this pie will be moving more from -- more towards the respiratory, biosimilar or complex products. So that is where we are investing in a big way. We are still significantly investing in our base generics [and our core] generics business.

Let's just talk about pipeline and these various aspects, R&D or oral solids. A strong team of 1,300 scientists, 601 unique products which will have about eight OROS technology products, 18 bilayer products, 405 immediate release tablets and capsules and you can go on. So it is not just a number, it is a complexity and the technology behind this number, 940 submissions pending approval and another 2,900 planned submissions over the next few years.

Talk about injectables. $44 billion [RMS] brand value, 500 scientists, 389 unique products. This business is coming to life. This franchise is coming to life -- lyophilization, prefilled syringes --. We are expecting, and Tony will share with you, why we believe we can still double this business over the next few years, because we are looking at launching more than 800 products over the next four to five years from this pipeline.

Still 654 submissions pending approval and 819 planned submissions. And some, as I mentioned dedicated sites, whether it comes to the oncology, hormones, beta lactams and cephalosporins, because all of these require dedicated assets.

OTC, you talk about the integration. We knew how sensitive and how important is for us to retain this workforce at [Monzei Ekley] when we acquired Meda. So we have been able to retain that small but smart team and they are working internally to develop some line extensions of some of the brands which are already out there in the market.

But we plan to invest a lot more in this space, because this is one of the exciting growth opportunities we have for us in the future. We have today currently about 40 unique products in pipeline, but I'm sure Sanjeev's team is now looking into it, how can we do more with this and how can we add more given our scale and size.

Topicals, I cannot be more excited for this portfolio because we acquired what we acquired with Renaissance. But I think across the globe, whether it has been Europe or rest of the world markets, we have not been able to launch any topical product because we didn't have a lot of topical assets.

But what we have acquired with Renaissance, now we have everything what we need. So we are looking forward to take this portfolio and further add to this portfolio over the next couple of years.

We are going to talk more about our respiratory programs, especially generic Advair and also revefenacin. We have been able to not only retain but grow this 140 scientist team which we acquired from Pfizer few years back at Sandwich UK. We have been able to retain and build upon that. We have today 26 unique products in pipeline, six DPIs, another six MDIs, eight nasals and nebulizers.

We are going to again talk in depth about our biosimilar portfolio. We are going to talk about -- we are very excited to share with the progress we have made over the last three to four years. Andrea is going to come up with me and talk about that. But we are going to talk about submissions we have made and a lot more which has been planned with this portfolio.

And I'm going to tell you we can't do this alone. And this is something which is a very complex area -- complex subject matter and that is why this strong partnership with the Biocon and Momenta. We have worked like in a -- as a team in a seamless way and that is key to the execution around this platform.

Let's just sum it up: about 1,219 products in pipeline, IMS value of $330 billion, with a planned submission of 6,000 -- more than 6,000 planned global submissions, more than 1,800 pending approval, 45 first-to-files pending with the US. And I've just given a breakup in how much of this is North America, how much is in Europe and how much is ROU (sic - see slide 57 - ROW). That is why we feel so excited about the opportunities which lie above. Now we have commercial infrastructure, we can do more with this platform.

So I am going to invite Andrea and Walt to come up and join me. And we're going to give you an update on our biosimilars program. Heather talked of the continuity of the team, this is what it means. Their roles in the organizations have evolved, but their goals have not evolved. They still own the same projects we stay on a few years back. That is one key to their success when you come to the execution.

Many others today in industry are having second thoughts about how much to go, how much to invest because there are still certain gray areas. We understand that. But I think we have shown our commitment and we continue to stay committed to this investment because we believe that we're going to need this. As we go along this healthcare system is going to need this. With that, Andrea, I am going to hand it over to you.


Andrea Miller, Mylan N.V. - Biologics Operations [22]


Okay, thank you, Rajiv. As Rajiv said, I am going to give you some very exciting news today, talk about our progress. But one thing that hasn't changed, and I think I may be preaching to the choir here, is that the biologics market is not a small market by any means. As the data up here shows, you all probably have even more data than I do, but it is a continually growing market.

There are over 900 biologics in development today. So there is quite a bit feeding the pipeline for biosimilars. There is going to be continually markets come in. So this is just not a small play and a small investment for a handful of products. It is literally the beginning of what I am going to call the biosimilar industry. So if you can't hear we are not a one product Company, you can hear my passion about biosimilars. So we will spend a little bit of time.

What is our opportunity? Where are we playing right now? Currently we have 16 products in our portfolio. We believe that is one of the world's largest portfolios of biosimilars. And 8 out of the 10 of those, if you look at the top 10 biologics, we have 8 of those in our portfolio.

I'm not going to spend a lot of time on how we did our selection for our products. But we had a strategic plan for how we selected our products, how we chose our portfolio. I would like to really focus on our partners and our geographies. Rajiv already mentioned our partnership. We did partner with Biocon and have half of our portfolio with them with the other half of our portfolio with Momenta. Those are key.

We are building our own internal capabilities, we have internal capabilities, but we complement each other. And so, again, 1 plus 1 equals 4 when we put together all of our strengths and come up with solutions. So they've proven to be good partners for us.

And our geographies, as we come to market, we own the rights for that key markets, we will be launching in the key markets. And we have early entry markets for the emerging markets as has been demonstrated by our success that we have had with Hertraz launching trastuzumab in now 13 countries.

Looking at the portfolio, there's a lot of people that will talk about wave one, wave two, wave three based off of what the patent expiry is. And I have just listed a selection here of different brands that will reaching patent expiration date during each of those waves.

As you see, we didn't enter the biologics game until 2009 with Biocon. So we really didn't pay attention to the human growth hormones, we were a little late to the game. So we put all of our focus on the 2014 to 2020 with Biocon and that is the focus of that portfolio.

This past year, with our signing and our collaboration with Momenta, we are now focusing on the third wave, the products in 2021 to 2025. So focusing on developing those products with them.

Now it is an exciting part for me to talk about. Last time we talked in 2013 we were busy, we were busy in development. And when we spoke we had eight products in the portfolio and those eight products are listed here. Actually there is an extra product there, so I apologize for that, filgrastim was not in here.

But we had just announced in 2013 the collaboration with Biocon on glargine, Aspart And lispro. And this was where we were in our development. We were again busy, progressing ahead, but still pretty much early development, still getting our feet wet.

Since that time the team has been very focused on execution. So in that time period out of those eight products we have had five of them now advance through their Phase 3 and into clinical trials, the confirmatory clinical trials. And three of those programs are now in submission states. So let's just take a quick look at where we have come.

Trastuzumab, you have heard a little bit about that with Hertraz. You see that at the time we talked last it had just entered its clinical trial. And now we have found an application for that product both in Europe and in US. And while we that we were a little late to the game for wave one, we believe -- we actually don't believe, we are very firm in our belief that we are the first application filed in the US for trastuzumab for BLA -- a BLA.

Pegfilgrastim we progressed from preclinical to submission and that product now is submitted in Europe, US, Canada and Australia.

The third one of our lead product is insulin glargine. As we brought that on we were again at the Phase 1 portion and now have advanced that to a submission through clinical trials, have submitted that in US and in Canada -- excuse me, misspoke -- submitted that in Europe and in Canada and actually just submitted it in Australia yesterday. So our numbers are even actually a little out of date here, we just submitted it in Australia. And we are working on our US submission to go in later this year.


Rajiv Malik, Mylan N.V. - President [23]


I have to add, one on the execution part, that is what we say we are good at it. We said something and we followed it up. And I am just going to build upon the insulin, which is highly complex when it comes to science. But we have a real good science around this program. We are constantly engaged with the FDA because we have continued to work towards [switchability] which we are pretty confident.

And we are -- we are very close to filing this product. I will call it eminent filing in the next -- over the next few weeks and months, we going to file this product. We have already filed and got a very good feedback from our European health regulators. So all these programs, I think after we talk, we have added a lot but we have executed upon what we said a few years back.


Andrea Miller, Mylan N.V. - Biologics Operations [24]


Thank you, Rajiv. And that is absolutely right. And then I mentioned we did add pegfilgrastim, which is a wave one product. But we added that as a complementary portfolio actually to -- at our sales request and in collaboration with our pegfilgrastim.

In addition, we will talk a little bit about the Momenta progress and the progress with the products we are collaborating with Momenta. As announced in January, we have signed a collaboration on six products with only one disclosed at this point is ORENCIA. And we have been busy with them since we [started] that collaboration, extremely busy. And have advanced the ORENCIA into PK/PD, the Phase 1, which should read out at the end of this year and be looking to go into clinical trials thereafter.

We are also advancing, as you see, another product is advancing fairly close and getting very close to preclinical also. And then as we have these two partnerships, as we are focusing on the bulk of our portfolio, we always look at opportunities to in license product to fill niches or to help expand our portfolio. An example of that is our deal -- our in license this year with Mabion, rituximab for Europe. And that product now is going into a confirmatory Phase 3 trial.

So we talked last time and what we talked about we have been executing, we have invested and we have executed on development. And we are continuing to do that and will continue to do that with the portfolio. But this is exciting for me because now I am talking to my commercial partners, I look at them in the front row and I am talking to my commercial partners, because now we are advancing towards commercialization.

We are actually -- and my background, as I mentioned -- I don't know if I mentioned -- is regulatory. So we are actually now into filing the applications which is an exciting time. We have now actually nine submitted applications and with five additional in developed markets.

And this coming year we are looking at filing additional applications for trastuzumab, pegfilgrastim, insulin glargine and now adding some applications for bevacizumab and adalimumab. And if you look, we also are submitting in emerging markets, again, keeping the same trastuzumab model for some of our upcoming products.

The other thing we have done in this last year is that we had over 50 -- or not this past year, in the past four years we have had over 50 interactions with health authorities, either through direct meetings or scientific advice. And that is very critical. We have been able to go in and talk to them and it just shows, as Rajiv said, we have added bench strength to our team but we also have consistency and it is getting that experience.


Rajiv Malik, Mylan N.V. - President [25]


Now, and I want to again emphasize this, the value of these interactions because every interaction, believe me, is [at the root of science]. We learn something new, we learn about their expectations, we know some other partners who are coming in and talk about certain things. So it has been a great value add these 50 meetings.


Andrea Miller, Mylan N.V. - Biologics Operations [26]


Not only have we been able to advance in our regulatory filings and our development programs, but now we've been able to get our actual data and be able to share it with the scientific community, and to be able to share the results of our development, of our research and our clinical trials.

And this past year has been a sort of red letter year for us; we have had some pretty prestigious recognition in the scientific community. The HERITAGE trial, which is our trastuzumab trial, biosimilar trial, was presented as late breaking in ASCO. And then followed up and submitted again in ESMO, which is in Europe, along with some of our data from pegfilgrastim. And then at the end of the year it was published in JAMA.

And we believe that this is the first publication, biosimilar publication, study publication [JAMA has] conducted. So again building that reputation with the scientific community on the validity of your studies and your product.

And then, while we have been investing in development, investing in submissions, the next piece we have to invest in and we are investing in is the commercial manufacturing.


Rajiv Malik, Mylan N.V. - President [27]


And this is also again a very critical aspect because R&D -- science is complex, regulatory space has been challenging, legal is still evolving and then you have to invest upfront to build these manufacturing facilities. And that is where I think us being a little bit global, we have the flexibility that these assets when we build they are not sitting idle. We are putting them to use and shipping these products to the rest of the world markets.

Andrea said we are today selling Hertraz our trastuzumab to 13 countries. So we have -- we're continuously working with our partners, [accept] big investments. For example, [insulin] we were here with you where we are. [Accept] investment close to about $300 million, which our partner and us are sharing the cost of that. And that is why some of these programs make sense that you have risk/reward approach to this and you have a partner with you because some of them otherwise can become very challenging programs.


Andrea Miller, Mylan N.V. - Biologics Operations [28]


Absolutely. And you see the diversity of some of the products with the monoclonal antibody facility for the drug substance, the micro facility and the insulins. But we will talk a little bit more about the insulins as he brought it up.

With our collaboration partner, Biocon, we have developed probably one of the largest and most integrated facilities, campuses if I actually should say that, that there is for the insulin analogues where we have campus on the drug substance, the drug product and the assembly. So everything is contained within this campus. We actually have opportunities to expand more as we continue to develop into lispro and aspart and yet also balance that and still be able to manufacture in what we have.

I would like to take you all to Malaysia, it's just across from Singapore. But since I don't think I can do that what we will have is show you a brief video and take you through a tour through a brief video. What you are going to see is -- you are going to see our upstream and downstream.

It is a lot of stainless steel because it is fermentation. Walt will show you something with a lot more activity. But it is stainless steel with a lot of fermentation. But to show you the capacity, the breadth of our capacity and the broadness of the capacity, the complexity and then we will show you the filling process.


Rajiv Malik, Mylan N.V. - President [29]


It is important because people always have questions. It's one thing to file, it's one thing to go through the site, [quick] execution; it is another thing to bring the product to so many markets. And insulin specifically, the scale you need, the size and scale you need is a challenging question. And I think we and Mylan say seeing is believing so we have this small video for you.


Andrea Miller, Mylan N.V. - Biologics Operations [30]


So if we could we can go ahead and play the video of the Malaysia facility. (Video playing). Okay, with that I will turn it over to Walt.


Rajiv Malik, Mylan N.V. - President [31]


Yes. If you recall, Walt shared with you that -- I will say that was that the beginning of journey in generic Advair. And I am very excited to share with you the progress we have made over these last few years, the follow-on we have done to what we have laid out for us, the goals we have laid out for us. Walt.


Walt Owens, Mylan N.V. - Respirator & Dermatologics Operations [32]


Thank you, Rajiv, and good afternoon again, everybody. So I am going to try and confuse you and use the term Wixela Inhub for generic Advair; it is actually our proposed brand name for that product. So what you are going to see the out this particular presentation is the branding. And I'll also discuss with you some of our key updates around revefenacin that is for nebulization.

When I came to you in 2013, as Rajiv said, this was in its -- it was the beginning. And now what I want to share with you is how far we have advanced in our preparation and operational readiness for the products as we move forward.

So just a little bit of background. I think we all know the information. But we know that Advair, one of the top products in asthma and COPD, and complex drug device combination. Revefenacin is very different for us, it represents a brand product opportunity for us. It is a novel LAMA and indicated in COPD as well as gives us the opportunity for a once daily dosing regimen.


Rajiv Malik, Mylan N.V. - President [33]


And I would say last time when we spoke we talked about a product combo which was an ICS and LABA combination. We came almost maybe halfway when we evaluated that and from a commercial point of view the market has changed and that is why we left that program on the side and identified this very exciting opportunity which is a once-a-day LAMA.


Walt Owens, Mylan N.V. - Respirator & Dermatologics Operations [34]


So let's just jump right into Wixela Inhub, again the generic equivalent of Advair. And where are we today and why are we so confident? I think the one thing we should focus on is the regulatory progress. And if you all recall back in 2013, actually not long after I was on the stage in front of you guidance issued -- draft guidance had issued that laid out five key criteria that needed to be met for submission of such a product and to be considered equivalent.

This included formulation design, same componentry, same formulation design, in vitro equivalents, systemic equivalents through PK studies across all three strengths, as well as clinical equivalents conducted on the lowest strength of the product. And finally, there were device considerations, same size, shape, same operating principles and operating steps.

And what I can tell you is that we have knocked off all of these. You can check the boxes for all of these components of the draft guidance as being met. And it really forms the basis for the filing that was made at the end of 2015 and is now progressing. And I think as this group knows and is well aware of, that we have our GDUFA goal date of March 28, 2017 coming up.


Rajiv Malik, Mylan N.V. - President [35]


And we had several pre-submissions and post submissions interactions with the FDA on those three, four, five turns of the information requests. So FDA has been very engaged, there have been five preapproval inspections, whether it's a drug substance, or a device, or a clinical trial, wherever the clinical trials were conducted.

So there is nothing which has changed our confidence towards this when we talk about this -- our goal date of March 28. But just to be prudent, we are basically guiding -- we are working towards being ready but we have [studied] -- we have taken into consideration everything which is moving and we are planning for midyear launch, summer, June launch, July launch of this product. And Walt, it will be good for also you to address the Sandoz (inaudible) over here.


Walt Owens, Mylan N.V. - Respirator & Dermatologics Operations [36]


Yes, thanks for that, Rajiv, I mean it is a reasonable tee up. So one thing I will say about that particular point is guidance is guidance. These are the fundamental criteria that need to be met to bring a product through the agency and to approval. But that being said, there is an incredible amount of science and detail and understanding that goes into the background. So understanding the characteristics and all of behaviors of the innovative product.

It is also understanding how this body of data needs to fit together to demonstrate equivalence. And as Rajiv also said, what is important is that long engagement and continued engagement with the agency to share data, information and understand each other's perspectives and learn what is being required.

One point I do want to focus on because I think in 2013 we focused on our pilot manufacturing, I am going to show you a little bit more about manufacturing. But I wanted to give you more insight about the device. And the guidance itself talks about having a robust device design. Fundamentally we have met those guidance criteria. But that guidance criteria is rather general.

And I think some of you may have seen that we have commented to the agency on February 6 of 2017 providing much more detailed considerations that should be taken into account when thinking about these respiratory devices and what criteria need to be met for them to be acceptable as a generic equivalent.

In addition, when we designed our device we considered the patient experience. And, for example, the device contains a large dose counter, it is very readable. There is a consistent feedback from dose to dose across the entire life of a single device and how it operates. There is a clear indicator of when the device needs to be refilled. And last but not least, it is unique in that our device has a last dose lockout feature.

So I can sit up here and can put all this in words for you, but what I am going to do is show you a movie clip on how this device actually functions. I will narrate it for you -- don't have any cute music behind it but I will narrate it for you and walk you through each of those steps so that you can see how this actually works. So if you want to go ahead and roll the video.

So Inhub, again, is our trademark for the device. The device, simple representation here with what our proposed branding and labeling will look like. Key features, this is what the patient is going to see and feel. It has a large dose counter window, the air vents become exposed when the mouthpiece cover is dropped and there is an activation lever, it is this yellow lever that actually actuates the device and then the patient inhales through the mouthpiece.

How is the device actually actuate, how does it operate? Same steps as the Advair Diskus, open the cover, you push down the lever to actuate the dose, the patient then would inhale and then the cover will be closed, indexing the dose counter down one dose.

Now something unique in the way our device operates is that the patient feedback across that actuation process is very smooth, it is a smooth force profile, which I can show you here. As you pull the lever down you will see the force profile that the patient actually feels in their hand as they actuate that device.

And then when it returns, when we close the cover and you index the dose counter down, by the same token you get a very smooth operation across the life of the device. And again, you will see this force profile coming back to you. And that will become important here in a moment.

Prescription refill reminder, something that is very important in this patient population. So when the device reaches 10 doses remaining and it is actuated and used it will index down to nine but what you will see is that it indexes down to nine, there is a red indication in that window that stays with it through the end of the device.

Our device also contains a lock out. When you actuate the device at zero you try and pull this lever down you are going to meet substantial force, you can't actually push it down the full stroke, so that you know you have no doses left in the device. And as you can see, the force profile changes dramatically as that patient interfaces with that device at that point of lock out.

So again, some of the unique features that have been built into our device. And hopefully that gives you a feeling for how it operates, and gives you some sense of what that product is.

So now I want to move on to manufacturing and actually what I call operationalizing the science. When I was in front of you in 2013 we showed you a video of our pilot plant operations which actually made the submission of this particular product a reality. But now what I want to talk to you about is the actual commercial capability that we have now built in our Dublin facilities.

We have built a state-of-the-art facility, it is end-to-end drug formulation, filling and device assembly. The facility itself was initiated in 2014 and then completed in November 2015. We have a workforce there now of about 220 folks on staff. And another important component of this overall product is to ensure that you have the device componentry on hand. We actually have a dedicated device component partner as well for the Wixela Inhub product.

What I am going to show you is Andrea took you to Malaysia, I'm going to take you to Ireland as we continue our world tour here. And what you are going to see in this upcoming video is the actual commercial equipment that we now have validated and on hand in Dublin operating, making product. You are going to see the filling of the discs, the drug containing discs that are used in the device. You are going to see how the device is actually assembled and you are going to see how the product is packaged.

I am not going to narrate this one for you, there are cubes as to each one of those processes in the video. What you are also going to see in this video is a complex process with a high degree of automation and a high degree of technology. So with that we will let this video roll and I hope you enjoy this.

(video playing)

So exciting stuff there for us and certainly kudos to our team in Ireland that is working on this and keeping this moving.

So moving on to revefenacin. Revefenacin, again as we said in the beginning, nebulized therapy for COPD, once daily dosing LAMA. Why revefenacin? It is an unmet medical need. If you look at the gold guidelines for COPD, LAMAs are actually a cornerstone of that therapy for moderate to severe COPD. And there is no nebulized LAMAs currently available as we stand here today.

Patient population is real. Greater than 100 million patient treatment days on nebulized [COPT] in general, as well as patients in this particular space are not naive to nebulization therapy. It is either being used as ongoing maintenance therapy or even on occasional bronchodilator therapy.

Where do we stand today? Very pleased with the outcome that we have seen from the replicated Phase 3 studies where we had a very robust and sustained improvement in FEV1. More importantly I think is the positive data that we saw with this being used as monotherapy, but also positive results associated with revefenacin being used as an add on therapy to standard treatment with LABA or LABA ICS combinations.

The drug is extremely well-tolerated. And where this puts us standing here today is that we plan on filing this particular product later this year. That is pending the results of our 12-month safety study that we are working through with our very experienced partner in Theravance Bio Pharma, that is expected to complete here in mid 2017.


Rajiv Malik, Mylan N.V. - President [37]


Thank you, Walt and Andrea. I am going to share with you certain brand names and I know you in your roles you want a lot of transparency about which product at what time and how much you have modeled. And we have all limitations, [computative] limitations, certain regulatory limitations, or legal limitations. And we can't share with you everything and we understand that.

But I am going to say that for a Company with having all these assets and of this scale and size, you would expect us to have these brand names which are going to come up all next few years across the globe, launch these products across the globe. Exciting.

And let me just some up before I invite my partner, Tony Mauro, up here with me. Just to sum up, very proud to share with you today the unmatched operating platform, strong industry leading pipeline, whether it is respiratory or leadership in OSDs, the building and diversity finding in OTC space, again, diversifying in the topicals, exciting story of the biosimilars.

But more importantly the food chain behind the truly global supply network which we have behind that, the proximity to the key market, the control of our internal manufacturing, 80% internally controlled manufacturing. Continued investing, whether it is automation or expansion, on our upgrade of these facilities. And three things: liability, agility and cost -- our customers can count on us and quality at the core of everything we do.

With that I am going to close this chapter and invite Tony up with me to share with you it is one thing to have all this, it is what are we going to do with these assets. How we going to deploy these assets, in which markets? How exciting, not just new markets, but even the journey in our existing markets, whether it is USA or France or [Germany], what more we see in those markets. So please, Tony.


Tony Mauro, Mylan N.V. - Chief Commercial Officer [38]


Good afternoon. As Rajiv, Walt and Andrea, walking through those slides, the years of investment and time put into these products. We, me, my team, my partners in commercial around the world get the opportunity to be the face of the customer. And we get a chance to launch these products. And I can tell you we are excited and, perhaps more importantly, our customers are excited.

So if you look at our commercial platform today, it really is about who we are as an organization, operating in 165 different countries, 75 marketed products across channels of generics, OTCs and Rx with over 5,000 sales team around the world, really about ONE Mylan shipping to 60,000 customers and trying always to be the partner of choice. To mean more to our customers than anyone else in our industry. That is our goal and that is who we are and what we are about.

So when we think about what we are made of it is really a few things, it is a mixture of diversity, depth and scale. When I say diversity I mean we are not one market, one product or one country. Today we promote over 200 branded products around the world. We have six franchises over $1 billion from a therapeutic perspective.

And depth -- when I speak of depth I mean how are we executing in those local markets. In six of our top seven markets we have over 50% of our products that are ranked either number one or number two. Eight of our top 10 markets are growing faster than the market itself. So that is about performance in market.

In the last but not least is about scale. This is how we deliver to our customers. 68 billion doses sold in 2016 and over 7,000 sales and marketing employees around the world. That is how we perform and how we execute to our plans to ensure that we are the partner of choice.

So, I know there has been a lot of discussion around the generic business and certainly the generic business has been our foundation and it is very important to us in the future. And maintaining leadership is very important to that success.

So what differentiates Mylan from everyone else? Really it is just a few very important key operating pieces: a broad offering, greater than 4,000 generic products sold around the world; global scale, 45 billion doses sold annually; a robust pipeline, 450 products launched in 2016 alone with 1,100 products for generics in our pipeline.

A diverse portfolio, not just on one particular dosage or form but multiple forms, multiple channels. And best-in-class service. This leads to strategic partnerships with our customers taking it from tactical to strategic in a more holistic portfolio fashion.


Rajiv Malik, Mylan N.V. - President [39]


And many times the question comes about consolidation of our customers and what it means to us. Look into the flipside. When you have a broad offering, global scale, more importantly the exciting pipeline and such diversity it gives us an opportunity to change the dialogue with our customers and talk a little bit more long-term, long, strategic -- take a strategic direction. And not many of our peers have that sort of global scale to talk to these customers in a global way.


Tony Mauro, Mylan N.V. - Chief Commercial Officer [40]


So we believe not only has generics been a great historical piece for us, we think there is a very strong future for generics as well. If you look at our top markets, we think there is both a utilization opportunity and a share capture opportunity. From a top market perspective you can see three markets still are underneath 40% generic utilization, very important markets that (inaudible) will talk to you about later.

Additionally, we have three markets that have greater than 20% share. Most of our important markets are in single-digits, so we to believe not only is there an opportunity to increase utilization around the world, but to increase capture of market share in our most important markets.


Rajiv Malik, Mylan N.V. - President [41]


And we always talked about -- even in 2013 we talked about this growth opportunity. And (inaudible) you look at that previous slide, France, if I remember correctly, was at about 34% and has improved about 4% or 5% from the generic utilization over the last four years. But Italy has gone from 17% to 21%. So it is happening, it is not these numbers, but it is the chain that generic utilization is coming through.


Tony Mauro, Mylan N.V. - Chief Commercial Officer [42]


So with that strong history and that great future we have in front of us even the US we think is a very, very good opportunity for generics. If you look at the generics only market from an IMS perspective today it is about slightly over $60 billion. We participate in half of those products. So half of the product opportunity are in the form of BD and pipeline that we haven't even captured today.

In the 31 billion dose market that we do -- I'm sorry through $1 billion of accessible market we do participate in we have about 20% market share, about $6.4 billion in IMS value. So once again, an opportunity to add new products to our portfolio and an opportunity to add market share in our existing business.

So moving to our Rx business, a very, very important segment of our business from our acquisitions of EPD and Meda and certainly our US business. As you saw earlier, this now makes up almost 30% of our global revenue. And really it is a story about focus and a story about growth.

It is about promoting the right products in the right markets. Ensuring you are optimizing your commercial infrastructure, you are prioritizing the products appropriately. You are building efficiencies and you are doing this in a ONE Mylan fashion.

It is about dedicated focus around these key brands, ensuring that not only locally but globally you have that focus to ensure that you continue to grow these products in the markets you want.


Rajiv Malik, Mylan N.V. - President [43]


And while are into the integration phase and that is what we said, Mylan integration, we took a step back that we were not just integrating Meda or (inaudible), we said we have acquired a lot, we have changed our dimension, scope has changed in many markets, which is the right way to deploy these assets in these markets.

So we took a step back and we called it Mylan integration because if you just look into this Rx, if you don't focus on this, and we have a very small team whose job is to live this brand, their job is to just live this brand. And we have already seen we have been able to arrest -- not only arrest the decline but turn them into the growth part.

But it is about the love, tender care that these brands need some of these. These are not $1 billion brands anymore, but these are still a very exciting branch -- a bunch of the branch. And that is where what we meant from integrating looking back how to deploy this, as I said. That is also what led to our segment reporting and change in because this is how we are managing these businesses.


Tony Mauro, Mylan N.V. - Chief Commercial Officer [44]


Yes, and it is about, as Heather's video showed, we are much more than one product, actually greater than 200 products detailed around the world. And how do we continue to innovate around our existing portfolio and bring new products like revefenacin to market. And certainly there will be multiple opportunities to expand our geographic reach and build these brands in new markets as well.

So, you saw earlier a lot of discussion around OTC. Certainly a very, very vital and great opportunity for Mylan, a $75 billion global market, we currently have $1 billion in sales. We plan to double this business over the next five years. We have 200 products we currently serve the markets with from an OTC perspective, and a portfolio -- a pipeline of 293 submissions pending. Really a great opportunity to double that business including executing on Rx to OTC switches and promoting and reintegrating some of the legacy Mylan OTC products as well.


Rajiv Malik, Mylan N.V. - President [45]


You will see us not only growing our internal brand here, Yes, Rx to OTC and some internal R&D. But we will keep on adding and dropping opportunities like Cold-EEZE, a brand here, and brand there depending on the need of those markets. So you will see us doing some business development and spending some BD dollars to add on some and drop some more brands into this portfolio.


Tony Mauro, Mylan N.V. - Chief Commercial Officer [46]


OTCs are a tremendous opportunity for us to expand our retail partnerships around the world. Today we have got a very good generic and Rx business. And with OTCs it is very complementary with our customers in many markets to really enhance and expand upon that partnership.

So injectables in the same way. With Agila, with Bioniche we have seen this has been a very good business for us, $336 billion market. Today we do about $1 billion in sales. Once again, planning to double this business over the next five years.

It starts with a very broad portfolio. A portfolio of 870 products across multiple technologies, long acting injectables, bags, oncology, vials and prefilled syringes. And it is about launches, 820 new product launches over the next five years and 389 products in our pipeline awaiting submission.


Rajiv Malik, Mylan N.V. - President [47]


Actually one area which we are not satisfied with what we did with this asset so far, because these are -- only two markets have leveraged this opportunity, that is USA and France. We see a lot of organic growth outside these two markets. We are working on the European institutional strategy because that is imperative for us to get right before we bring biosimilars.

So we are working on that you put that in place and it will be a great -- actually the growth driver for the rest of the world markets, because those markets, there are not many providers for these products.


Tony Mauro, Mylan N.V. - Chief Commercial Officer [48]


And then dermatology, with our acquisition of Meda and Renaissance here in the US, a $30 billion market that is growing fast, complex manufacturing, complex development. We have got $500 million of revenue today and will double over the next five years.

It starts again with a theory broad, diverse portfolio globally of 500 complementary brand and generic products, 42 products in our pipeline and a dedicated sales force in the US and Europe and the rest of world. This is a great opportunity to take these assets and bring them to new markets to expand this reach.


Rajiv Malik, Mylan N.V. - President [49]


Renaissance has provided us this opportunity because outside US, Meda provided us this [commercial] platform but not many products. They had what they had but they didn't have a pipeline. So now Meda has provided us that pipeline and that opportunity to drop more product into these markets.

Tony talked about these three areas about injectables, OTC and its underlying theme is about focus. And this is a story about that if you focus and hone in on something you can create.

Eight years back, seven, eight years back HIV drug products, we were nowhere in the game, it was zero. That [sheet] which we take you, we were selling some APIs but no drug products. Today we are the leading provider not only in the sub Sahara but across the globe. And 45% of HIV patients are on Mylan. But it took us -- took R&D investment, the innovation, the investment in the CapEx and the capacity -- it is just not $4 billion, it is the [tons] of the API which you have to drop into this to sustain this market.

And working with our partners, partners at the policy level whether it is WHO, whether it is Global Fund, Clinton Foundation, medicine patent pool, working with partners and then working with partners like Gilead, J&J. And we have created something which we are so proud of which is now going to be the backbone of our emerging market business.

But still a lot of growth when you look into the prep, the pre-exposure prophylaxis of the TLE, new therapies, which we are -- continue to stay ahead on, and market expansion which new markets which are coming already like [Mexico], Latin America, China and many other markets where we have not launched these products.

And more importantly, extending this infrastructure to the similar category like antimalarials and [tuberculosis]. So we see a huge opportunity. And I think we are sharing with you these nuggets because this is how we're going to bring these together when we go into [separate] market-to-market discussions.


Tony Mauro, Mylan N.V. - Chief Commercial Officer [50]


Yes, and I think as Rajiv just articulated, this is a great foundational approach to building our emerging markets business, really ensuring that you build it from the ground up in a right way to ensure success.


Rajiv Malik, Mylan N.V. - President [51]


I am going to invite Adele for you to come up and just share with you -- Heather shared this picture with you, but it is about another lens we are applying and taking these -- all these assets because every market is a unique market. So there are opportunities for us now deployed -- not just showcase, but deploy these assets and in meaningful different ways. And Adele is going to share with you what we mean by this franchise value creation, please.


Adele Gulfo, Mylan N.V. - Commercial Development [52]


Thank you. So you have heard a little bit about our therapeutic area franchises at a very high level. I will attempt to bring a bit more clarity on our franchise approach and how we innull