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John Sheehan - CFO

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Gregg Gilbert - Bank of America Merrill Lynch

Mylan Inc (MYL) Bank of America Merrill Lynch Global Healthcare Conference September 12, 2013 8:00 AM ET

Gregg Gilbert - Bank of America Merrill Lynch

Good afternoon everyone, welcome back from lunch. This is Gregg Gilbert, I cover U.S. specialty and major pharma, thank you for attending and welcome to those of you listening in or reading in on the transcript. We are very pleased to have again this year, Mylan. John Sheehan made the trip across the pond to help get us back up to speed on Mylan. He is going to run through some slides for a portion, and then we are going to have plenty of time for Q&A.

So without further ado, I am going to turn it over to John Sheehan. John, thank you so much for making the time for us again.

John Sheehan

Thanks Gregg and I appreciate the opportunity to be with you here today. I have some slides to run through. You may be aware that in early August, we held an Investor Day in New York, and the entire presentation associated with that Investor Day is posted on our Investor Relations website. I selected some slides out of it to just provide a 15 or so minute update on the company and who we are and some of our financial targets and so forth. So I will run through those quickly, and then we will do some Q&A, but I do encourage you to take look at the full set of charts that are on our Investor Relations website.

So who is Mylan, right? We are the third largest global generic pharmaceutical company, and we are the largest headquartered out of the United States, and we are really positioned for growth, and you will see in a couple of charts, the type of growth that we have experienced over the last five years, which has been double digit top line and bottom line growth. We believe that that growth will continue into the future, really based upon the differentiated global platform that we have built. It's differentiated from a geographic perspective into different markets around the world. It's differentiated by types of products, we have a very broad product portfolio. So we are not relying on one region of the world. We are not relying on one product or a small group of products, but rather a diversified global platform.

We have also grown with mass into injectables. We are currently in the process of closing on the acquisition of an Indian injectables manufacturer, by the name of Agila. Agila has a very broad injectables product portfolio that will provide products to our global salesforces around the globe, and the injectables is definitely a high growth higher margin business that we are getting into.

We also developed -- distribute a branded product by the name of EpiPen. EpiPen is for treating severe allergic reactions. EpiPen has approximately 90% market share in the United States, and this product has been -- the market for this product has been growing by 20% on a year-over-year basis here in the summer weeks, which is the prime season for allergies in the United States, so a very strong product for us on the branded side.

Branded represents about 15% of our total revenue, so we are 85% generic, 15% branded. We are a generic company with a branded arm. And lastly, we have very strong cash flow and we have been using that free cash flow to invest into our future with acquisitions like Agila that I mentioned a few moments ago.

We believe that there are really some global trends in healthcare that are taking place, whether it be with respect to containment of costs, or the increase of demand for products. The increasing role of consumers, and also the bend towards higher quality and safety of products, all of which play to Mylan's strength and position us very well.

When you look at the healthcare costs, and just some of the things that have been happening across the globe, the U.S. Insurance Reforms and the Affordable Care Act increasing the number of Americans who have access to healthcare, that's a positive in terms of the number of patients that would be prescribing pharmaceuticals; or in the EU here, with the increasing generic utilization rate that has been increasing, we are strongest in the Southern European countries, and France is a great example where over the last year, there has been a demonstrable increase in the generic utilization rate, as they put into -- place legislations to push generics. And also in Japan, where the generic utilization rate has increased by nearly 10% over the last several years. So healthcare cost is driving governments to look for lower cost alternatives, that's where generic and companies like Mylan can really benefit.

In addition to that; this is a great case study associated with our anti-retroviral products in India. Anti-retroviral for treating the AIDS virus. You go back 10 years ago, it cost $15,000 per person to -- on an annual basis to treat the AIDS virus. Today, through the technology and the product development that Mylan has been able to pioneer, as you move from that branded product to a generic product, today that same patient can be treated for $150 per year. That is a tangible difference obviously, and has allowed Mylan to be the leading generic manufacturer for treating the AIDS virus around the world. We have almost a 40% market share in emerging markets around the world.

Increasing generic utilization rates, this is a great chart to show you what type of annual growth in the generic conversion rate that we have been seeing recently. On an overall basis, you are seeing almost double digit rates here in Europe and Japan, and the U.S. and Australia also growing nicely. And you see those are all places where Mylan has substantial market share which really endures to our benefit.

Healthcare dynamics are changing. Consumers taking more control over their bodies and what they are putting into their bodies, and looking for lower cost alternatives, Mylan has been very much looking to manage the messaging with the consumers, to let them know about the quality of our product, and why the Mylan product is better for them.

Reliability and quality of supply is important, not just with the patient but also with our customers, the pharmaceutical chains around the globe; and Mylan has one of the most -- the highest quality reputation in the industry, and that has really endured to our benefit, as other suppliers have had quality issues. Mylan's reliability of supply has really worked to our benefit with customers that know that when they contract with Mylan, that they are going to be assured of having products on the pharmacy shelf when they want it.

One of the things that we have also done is, since 2007, we have grown dramatically through the acquisition of Merck here at Germany, and Matrix of India acquisition, and in 2007, we indicated in an Investor Day that we would grow our EPS by 30% to 35% annually, that we would deliver 250 million of synergies. We would have significant tax savings, we would delever our balance sheet. Those are the things we said we would do in 2007, and when you look at the last six years and the last 24 quarters, what you will see is, we have executed on everything we said we were going to do in 2007, and that's really important; because what Mylan wants to be known with, with investors like you, is that we tell you what we are going to do and then we execute on it that when we say something, that you can rely upon it.

We had an Investor Day in February of 2012, and there we told you were going to double our manufacturing capacity, and our product portfolio, and we were going to achieve $6 per share in 2018, and over the last 18 months, we have been bringing those commitments to life.

This is a great chart. This shows you over the last five years the financial results of Mylan. And as I said, in 2007 at our Investor Day, our CEO at that time indicated that we would have 30% to 35% EPS growth over the next five to seven years, and as you can see, we have achieved a 34% CAGR in our adjusted diluted EPS over the last five years, and our topline revenue has grown by 10% and our adjusted EBITDA by 16%. This also demonstrates operating leverage that we have in our business.

Turning a little bit more shorter term; first half of the year versus second half of the year 2013. We did grow the top line by 2%. However there was a very large product launch of the generic version of Lexapro in the United States in the first half of the last year. If you exclude that, we are actually -- because there has been a lot of price reduction after the initial launch there, we were actually at 11% growth year-over-year for revenue, first half of 2012 and first half of 2013, with a 15% bottom line growth first half of the year versus second half of the year.

More importantly, when you look at the European Region, we have been reporting double digit revenue growth since fourth quarter of last year, as our business in Europe and those generic utilization rates increasing have driven a top line growth for us in the EMEA region.

For the full year of 2013, we are projecting revenue to be at the low end of our guidance range of $7 billion to $7.4 billion or about $7 billion, and adjusted diluted EPS of $2.75 to $2.95, and we really are on track to deliver the 2013 guidance that we provided in February of 2013.

We also in our Investor Day projected our growth for 2014, and on the back of the Agila acquisition that we will close and the growth of our injectables business, we see our top line for 2014 growing by 12% versus 2013, and the bottom line growing by 19%, certainly fueled by the acquisition of Agila, as well as we believe that we will be in a position to launch the generic form of Copaxone in May of 2014.

This chart shows you our strategic growth platform, and the point really here, as I said at the beginning is, we are not reliant upon any one product, any one region, we are incubating at any point in time, a number of opportunities; whether it be in injectables, or our respiratory programs for the generic form of Advair, or our infectious diseases, which includes the treatment of the AIDS virus or malaria with our Indian operations, or our biologics program, where we have a joint venture, a partnership with Biocon, an Indian manufacturer of biologics, for the bringing of biogenerics to market. And a number of other opportunities as you can see. So Mylan is not about one opportunity, but growing a whole base of opportunities on a global basis.

In our Investor Day, we laid out the path to $6 per share, not just simply at the bottom line, but also through the top line, and this chart just shows you some -- shows you each of the growth drivers that get us from revenue of $7 billion in 2013, with a CAGR Of 13% over the 2013 to 2018 period of time, and we believe that each of these assumptions actually are very reasonable and balanced and conservative. For example, with EpiPen, where as I start with generic Advair, we believe that we will bring a generic Advair to market. We have not assumed that we will be the sole supplier there, but that rather it will be another competitor there.

If we believe that we are going to be able to bring generic Advair to market, which is a drug and device, we on the other hand also assume that we would have competition on EpiPen. So that's also built into our guidance. So we believe that we have taken both sides of the equation into consideration in building this model, and that when you look at each of the individual growth drivers and the assumption that they make sense.

Each of those price drivers will drive a 16% CAGR to $6 per share in 2018, and there is a lot of detail in our Investor Day presentation to be able to provide you with how we get in each of these individual growth drivers to that growth.

Just looking at our capital structure for a few moments; as I mentioned, we are generating about $650 million of free cash flow each year. We've used that cash flow, plus our growth in EBITDA to deleverage the company. At the end of 2012, our gross debt-to-EBITDA was 2.7 to one. After the Agila transaction this year, will be at 3.3 to one. Our long term gross debt-to-EBITDA target is three to one ratio, and whenever we are above that three to one, we will delever down, within an 18 month period of time, to three to one.

We don't have any substantial debt maturities until 2015, and we have a very balanced debt maturity profile, out over the next 10 years. And we have been using our free cash flow and our balance sheet capacity to reduce our share count. We have executed on several share repurchase programs, that have substantially reduced our overall share count by about 20% over the last couple of years.

At the end of 2013, we will end with about $1.6 billion of financial flexibility, meaning cash plus borrowing capacity, maintaining our investment grade credit profile of $1.6 billion and over the 2014 to 2018 period of time, we will generate $15 billion of financial flexibility to be able to be -- to put to work for our stakeholders.

In terms of our capital allocation, we are focused on expanding our business through strategic M&A that's disciplined, maintaining our investment grade credit portfolio, and accretive transactions, through continued debt repayment as that comes due, and also through continued share repurchase program. Again, all the while, maintaining our investment grade credit profile.

So in terms of strategic M&A, what type of opportunities would be interesting to us. Our mission statement is to provide high quality affordable medicine for the world's 7 billion people. There are a number of people that are in regions that we don't have operations today. Whether that be Eastern Europe, whether that be China, we have a small commercial operation in India, that we would like to expand, or whether it be South America. So there are a number of places where you could see us from a geographic perspective, expand to be able to meet our mission statement; or into therapeutic category, dosage forms that we don't have strength, such as creams or gels, ointment, eye care, etcetera. So it's therapeutic category, dosage forms, geographic, overall expansions are all interesting to us.

And lastly, I will just close that, we have an absolute history over the last years of increasing shareholder value. A couple of benchmarks against that, if you look at our return on invested capital, which is above our weighted average cost of capital, and has been steadily increasing since 2009, or our share price, which has outperformed multiple benchmarks over the last five years.

So we are very focused on driving our business for success. We are committed to the financial -- we have achieved the financial commitments that we have made to our stakeholders, and that drives the increases in shareholder value that you see on this chart. And as I said, just to close, we have an absolute track record of execution over the last five years.

So with that Gregg, I said I would take 20 minutes, I am right on 20 minutes.

Gregg Gilbert - Bank of America Merrill Lynch

Thanks. Let's start with BD. You have described yourselves as a generic company with a branded arm. Could you have a branded arm and a branded leg? How far would you take the branded piece?

John Sheehan

Gregg is right, and I think I said it when I was presenting. We see ourselves as a generic company. We started as a generic company. We know that pays the best. However we are very proud of the branded business that we have. It focuses primarily on allergy and respiratory space, and I think we certainly -- you could certainly see us consider opportunities that would be in the -- to expand in that space.

I think that we are not looking to be a branded company with a generic arm, and so if there were branded opportunities to expand and leverage what we already have, yeah, I think you could see us do something there. But we concentrate really on just both generic and branded opportunities and look at everything.

Gregg Gilbert - Bank of America Merrill Lynch

When you had that chart with the $6 in financial -- do you still have financial flexibility factored in there, is that simply looking at share buyback in certain years at certain prices, or is there another? How do you get to that?

John Sheehan

Just from a tactical perspective, how the model is built. It first -- cash flow must first go to pay down debt to get to three to one. Once that is achieved, then the cash flow is used to buy back shares, so that we would use our free cash flow to buy back shares, and growth in EBITDA is used to make acquisitions that brings -- keeps EBITDA at a gross debt-to-EBITDA of three to one. So it's a combination Gregg of pay down debt to stay -- to get it down, because we don't close 2013 at three to one, and then it's a combination of share repurchase plus strategic M&As. And that in reality, that's actually what's going to happen, is that we will continue in the future to do a combination of share repurchase and strategic M&A. Timing of when share repurchases would occur, obviously within the purview of our Board of Directors.

Gregg Gilbert - Bank of America Merrill Lynch

Within generic M&A, you talked about different dosage forms bolstering existing markets. You talked about certain -- you'd mentioned a few different emerging markets. Are there developed markets in which you are underrepresented, in which you would do a deal that is geographically focused, even if it doesn't enhance you technologically?

John Sheehan

I think that we have a very strong presence in the United States and Western Europe. That doesn't mean that in particular in the United States, we might not look at something else. But the geographic expansion is probably more about expanding our reach to the world of 7 billion, people than necessarily more of the same.

Gregg Gilbert - Bank of America Merrill Lynch

But what about Western Europe? Are you as broad within Western Europe as you would like to be?

John Sheehan

I think that we have a very strong presence in the Southern European countries, and less so in some of the other markets. But I wouldn't say it's our number one priority.

Gregg Gilbert - Bank of America Merrill Lynch

I think when you were here two years ago, it was difficult for you to think about predicting when sales growth could go from negative to positive in Europe?

John Sheehan

That's true.

Gregg Gilbert - Bank of America Merrill Lynch

Does that sound right, two years ago, sitting here?

John Sheehan

Yes.

Gregg Gilbert - Bank of America Merrill Lynch

So can you talk about what was causing -- talk about the volume in price picture that existed in Europe at the time, and how that has changed? I know you are confident that we are at sort of the new normal level of growth in that, let's say for Europe that can be a multiyear trend?

John Sheehan

In the -- if you go back 18 months ago to the beginning of 2012 and the outlook at that time for the European market -- it was not a good situation. The European governments were struggling with austerity measures and the bailouts and all that stuff, and so as a result, there was a lot of price cutting going on. Really starting with France, but then other European countries began to spur generic utilization, and that really had two benefits.

Benefit number one is, it increased the generic utilization rate, with things like French Pharmacy convention that I mentioned a little bit earlier, during my presentation, and that caused there to be growth in the -- for everybody in the market. That growth in the market is allowed in the higher generic utilization rate. Allowed European governments to see savings versus having to pay for brand. But it also resulted in our peers, our competitors, also seeing growth, and therefore there became more rationality in the market. One of the things we definitely talked about during our earnings call, was the fact that they were irrational players in the market.

They were irrational because of the fact that there was no growth, and so therefore they needed -- in order to be able to push their top line, they were discounting to take market share away from each other. When the market is growing, there is enough growth for -- to go around for everybody. Over the last three quarters, fourth quarter of last year, first two quarters of this year, we have seen double digit growth in our European operation led by France, and we are very pleased with that, we indicated that we do see our European operations growing to the full year 2013 at double digit rates. So price pressure has normalized, waned, whatever the right word is, and that has made for a much more stable environment here in Europe, we are very pleased with that.

Gregg Gilbert - Bank of America Merrill Lynch

Do you think about it as a multiyear trend?

John Sheehan

I guess what I would say is that, we don't see a reason why it should -- why there should be a change. Obviously if we were to go back to financial crisis in Europe and austerity measures, all those things, it may cause government to take action that they otherwise wouldn't take, but generally speaking, no we do not.

Gregg Gilbert - Bank of America Merrill Lynch

But the reason to believe where the growth can be strong double digits in Western Europe for some period of time, is tied to the fact that the penetration rates are still quite low?

John Sheehan

When we acquired the Merck -- we went international, went global and acquired the Merck business, including the Western European arm, that was the long term strategic play, was the increase in generic utilization rate, and what that would mean in terms of top line growth. And we are starting to see that play out a little bit, it's a demonstration of that.

Gregg Gilbert - Bank of America Merrill Lynch

And in the U.S., we have seen pretty remarkable price stability, at least high generic standards in the past several -- over the past several quarters here. Are we moving into an environment where we could actually see a plus versus a minus? I know in certain products, there have been price increases, maybe you can talk about what Mylan has done to be a leader in terms of price in the industry too, in the U.S.?

John Sheehan

I think that Mylan, I'd say a couple of things with respect to that. So I think that, there are certainly product situation, where there may be disruption in the market, or there may be -- with older products, competitors that leave the market and therefore, when you think about product pricing, that there is adjustments that should be made. However, we also look and want to have long term complete relationships with our customers, and therefore we want to make sure that customers feel that we are being fair on the overall product portfolio, recognizing there weren't going to be situations, where we are going to -- where, as a result of market disruption or entrants leaving the market, that -- competitors leaving the market, that we would adjust price in those products.

But there are other products where there are price decreases, and the overall package is a fair set of pricing to our customer, and we believe we achieved that. Overall, the pricing in the United States over the last several years has been highly stable, and I think you are right, it's probably even, perhaps improved a bit over the last 12 to 18 months.

Gregg Gilbert - Bank of America Merrill Lynch

Do you think that potentially is a sustainable trend, a long term model? While it's not in your model, could we be using stability in our pricing assumptions for many years potentially?

John Sheehan

I talked in my presentation about the importance of quality and as regulatory authorities around the globe, but especially the FDA focus on quality. That has made the factors that go into a purchasing decision by customer, to not just simply by (inaudible) about price, but also about reliability of supply, and therefore, suppliers who have high quality, I believe are being rewarded for that through, and the customers are not fully looking at getting the last dollar of price.

Gregg Gilbert - Bank of America Merrill Lynch

That's one big picture, and I know there are some specific questions here, starting over there. The alliance, sort of Walgreens alliance -- Alliance Boots, Walgreens alliance. Large generic companies will say and have said that this is an example of wide scale matters, and this is why it was multinational etcetera. Can you offer maybe any sort of tangible implications that that deal has from Mylan, if we were to build a spreadsheet of sales going to that entity? So we just have to accept, that some typical generic company A, that they are going to be a better buyer, and that there is going to be an eventual volume offset to that, in terms of price decline with volumes. How should we think about the modeling aspect of what that kind of deal means, to a manufacturer?

John Sheehan

Gregg is right that, we have talked and one of my charts had [hit] the bottom. Scale, scale, scale, scale, scale, right? And that was the whole premise of Mylan going global into -- one of the premises of Mylan going global in 2007-2008, was that scale mattered, and we believe that we have the competitive cost structure of any supplier in the world.

With respect to Walgreens Alliance Boots, there you have a strategic alliance for making strategic choices among suppliers, and we will absolutely reward customers who provide us with additional volume, with additional price incentive to spur that volume. And therefore, I see, we see, the Walgreens Alliance Boots-Mylan relationship as a win-win. They make strategic choices of suppliers. We incent them to provide more volume to Mylan, through volume priced incentive, and that volume comes out -- that allows Walgreens Alliance Boots to realize cost savings, versus what they otherwise would have been able to achieve, and it provides Mylan with additional volume, which drops to the bottom line.

So that's it from me, it's a win-win situation. It does require, and I believe Walgreens Alliance Boots is making strategic choices of suppliers, and we want to be one of their best global suppliers.

Gregg Gilbert - Bank of America Merrill Lynch

Just may be a simple question, but just so I understand, you are getting more volume from them in Europe, but the same volume -- they are getting better pricing in the U.S. and Europe and you are getting more volume in both places, with the simple sort of --

John Sheehan

The simple way to think about it is, is that they continue to receive market pricing in the United States, and market pricing in Europe, the pricing is different, based upon the dynamics of each of those markets, and they received a global incentive to push volume into either or both of those markets.

Gregg Gilbert - Bank of America Merrill Lynch

Got you. And that's what's different about this arrangement than others that have come before the global nature?

John Sheehan

Right, we don't have any other -- there really has not been a global customer. I think maybe there will be more in the future, but we haven't really had that. It has been very much geographically separated, and this is a (inaudible) book. So we have market pricing in each of the regions, with an incentive to push volume on a global basis by each of these respective organizations.

Gregg Gilbert - Bank of America Merrill Lynch

And you need to believe, your net is at least as good as it would have, otherwise [than otherwise] you wouldn't?

John Sheehan

That's correct. This is about price per volume. It's not just price per price stake.

Question-and-Answer Session

Gregg Gilbert - Bank of America Merrill Lynch

Do you have a question?

John Sheehan

Because we already had market based pricing.

Unidentified Analyst

Hi, can you talk about the generic Advair guidelines that came out earlier this week, and where they sat relative to your expectations, and who do you think your competitor will be?

John Sheehan

Well look, we were -- if you go back to our Investor Day in early August, we laid out -- with respect to our generic Advair program, where we stood and indicated that we had been working very closely with the FDA, and therefore we believe our program was in line with what the FDA guidelines could be, when they were issued. The guidelines that came out earlier this week are right in line with what we said on August 2, and a validation that our program is on the right track for approval. And I think -- I talked about credibility and execution and I think this is -- what occurred earlier this week, the validation of what we said on August 2 in our Investor Day is just as important as the pure guidelines themselves, because what we want to be seen, is a management team that tells you it like it is, and that you can rely that when we say something, that we mean it, and we are going to execute on, as we have seen over the last five years.

So the guidelines, very positive for us. We believe that they will be achievable, and that we will have a generic form of Advair in the August 2016 timeframe when the device patent expires. And I think that it's -- other companies have talked about their programs, and including Endo, including Teva, although maybe not a generically substitutable program. So I think there are other announced programs out there, I won't speculate as to who is going to get there with us.

Unidentified Analyst

Perfect. (Inaudible) generic in August of 2015, that's what you are comfortable with?

John Sheehan

Yes ma'am.

Unidentified Analyst

And any update on Copaxone?

John Sheehan

So with respect to Copaxone, as you may be aware, we were successful in the intellectual property appeal, earlier this year back in the June timeframe, and as a result, the pathway for introducing Copaxone from a legal perspective would be available to us in May of 2014. We believe that based upon our interaction with the FDA and where we stand in the approval process for that product, that we would receive FDA approval by May of 2014, and be in a position to launch that product at that time.

Gregg Gilbert - Bank of America Merrill Lynch

Yes, Grant.

Unidentified Analyst

So a couple of follow-ons on the respiratory program. Can you remind us where your device technology actually comes from? I know there are products building from [size of it], and there is an original partner for that, and to the extent, to what you think you have to (inaudible), meet through the partners, on the look and feel, that they put into the guidelines?

John Sheehan

Right. So we have not -- the device is ours, and we haven't indicated anybody else that we are working on with respect to that, and then with respect to that device, we did indicate on August 2, that the FDA had inspected our device. We have actually said this for some time now, and that the FDA has confirmed that our device is the equivalent of the Advair device, and therefore meets the requirement of their 505J -- the guidelines that came out this week, for the 505J program, including substitutable program.

Unidentified Analyst

And I think historically you have said -- you expect to be the first to market with a fully substitutable product -- and kind of haven't really given much on guidelines, so I am wondering where your confidence in them comes from?

John Sheehan

We believe that we will be first to market from the perspective of that in August of 2016, is most likely the [first aid] that anybody is going to be there, and therefore -- I can't speculate on whether somebody else will be there, but we will be there. That's all we mean by that.

Unidentified Analyst

Then in terms of how you see this market developing, given the -- and the fact that you said a competitor as earlier -- it's one or two, let's say. Do you envisage, given the extensive additional clinical trial work, etcetera, is needed for this, this would look more like an -- I don't know, like a [car] type market, where a limited players on the market, and actually pricing is as substantially different from branded product?

John Sheehan

We do believe that the -- while the guidelines are very helpful, and that it is still a very -- that there is a lot of work to be done, we are very confident in our ability to achieve fully substitutable generic Advair, but the hurdles are still high, and therefore, there will be small number of players, that that will result in value being created for those who run the marketing in the Mylan program.

Gregg Gilbert - Bank of America Merrill Lynch

Well John thank you so much. We are going under the 40-minute slot. Thank you all for attending, and look to see you next year.

John Sheehan

Thank you for all your support and if that didn't help -- with that, don't hesitate to call.

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