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Viatris Inc. (VTRS)

Q2 2015 Earnings Call· Thu, Aug 6, 2015

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Transcript

Operator

Operator

Good day, ladies and gentlemen. Thank you for standing by. And welcome to the Mylan Second Quarter 2015 Earnings Call. At this time, all lines are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. As a reminder, this call is being recorded. I'd now like to turn the call to our host, Ms. Kris King. Ma'am, you may begin.

Kris King - Vice President-Global Investor Relations

Management

Thank you, Eric. Good morning, everyone. Welcome to Mylan's conference call discussing our second quarter 2015 earnings and our offers to acquire Perrigo Company. Joining me for today's call are: Mylan's Chief Executive Officer, Heather Bresch; President, Rajiv Malik; Executive Vice President and Chief Financial Officer, John Sheehan. During today's call, we will be making forward-looking statements pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include, without limitation, statements about the proposed acquisition which I will refer to as the Perrigo proposal of Perrigo Company, which I will refer to as Perrigo by Mylan, Mylan's acquisition, which I will refer to as the EPD Transaction of Mylan and Abbott Laboratories' non-U.S. developed markets specialty and branded generics business, which I will refer to as the EPD Business; the benefits and synergies of the Perrigo proposal or EPD Transaction; future opportunities for Mylan, Perrigo, or the combined company and products; and any other statements regarding Mylan's, Perrigo's, or the combined company's future operations, anticipated business levels, future earnings, planned activities, anticipated growth, market opportunities, strategies, competition, and other expectations and targets for future periods. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: uncertainties related to the Perrigo Proposal, and the consummation thereof; the ability to meet expectations regarding the accounting and tax treatments of a transaction relating to the Perrigo Proposal and the EPD Transaction; changes in relevant tax and other laws; the integration of Perrigo and the EPD Business being more difficult, time-consuming or costlier than expected, operating cost, consumer loss and business disruption being greater than expected following…

Operator

Operator

And our first question comes from Sumant Kulkarni from Bank of America Merrill Lynch. Please go ahead.

Sumant S. Kulkarni - Bank of America Merrill Lynch

Analyst · Bank of America Merrill Lynch. Please go ahead

Good morning. Thanks for taking my questions. I have a quick couple. Would you comment on your alternatives just in case of the Perrigo transaction does not go through? And on your lower threshold, would you find an impact in our credit rating there, just in case that comes to fruition from a lower threshold point of view? And second on Copaxone, is your pushing out of the product out of 2015 based on a specific target action date receipt? Thanks. Heather M. Bresch - Chief Executive Officer & Executive Director: Hi, there. Good morning and thank you. So, as far as alternatives to Perrigo, I think that we have continued, ever since closing our Abbott transaction, to say that it was going to be the first of a series. Obviously, we believe Perrigo is the right next transaction for Mylan based on the strategic initiatives that we laid out. But as we said before, we like Perrigo, but we don't have to have Perrigo. There's lots of assets available out there that we believe very much would complement our platform that we would be able to leverage the infrastructure, both commercial and operational excellence that we have in place today. So, we've been actively looking at many targets out there. And as I said in my opening remarks, we believe that there's many different ways to get to the scale and size needed for us to continue to be a leading consolidator in this industry. As far as Copaxone, and then I'll let John take your other question on investment grade, look, we just did what we believe to be the financial responsible thing to do, given where we are in the year, given the momentum of our business, of our core business; and as we said, the ability…

Operator

Operator

Our next question comes from Gregg Gilbert of Deutsche Bank. Please go ahead.

Gregg Gilbert - Deutsche Bank Securities, Inc.

Analyst · Deutsche Bank. Please go ahead

Okay. Thanks. Can you hear me okay? Heather M. Bresch - Chief Executive Officer & Executive Director: Yeah. John D. Sheehan - Executive VP, Chief Financial & Accounting Officer: Yeah.

Gregg Gilbert - Deutsche Bank Securities, Inc.

Analyst · Deutsche Bank. Please go ahead

So, a couple for you, John. First, can you discuss those new customer agreements that led to the new payment terms? Is that for all major customers in the U.S. or the big buyer groups, and were there price concessions involved? And in exchange, you get any enhanced visibility, or is it the classic case of the big buyers sort of get what they want? Secondly, can you comment, John, on trade inventory levels at the end of the quarter versus the last quarter or the end of the year, whatever you can provide? And then, lastly, for Heather, I appreciate your comments about there being other targets out there. I was going to ask if the Perrigo vote fails or if something else comes along for Perrigo and pays a bigger price, how quickly can you mobilize your financial resources and move on other transactions? Thanks. Heather M. Bresch - Chief Executive Officer & Executive Director: Maybe I'll start and then I'll let John come back on some of the technical aspects. Look, I think, Gregg, you know us pretty well, I think we've shown our ability to move pretty swiftly and quickly. So, I think you should expect nothing less than that, that we will continue to be pursuing a lot of different pathways and be able to strike very quickly, just like we did Abbott and then on to Perrigo. So, there's nothing changed on that front, or certainly nothing changed about our personality or appetite for acquisitions. And I'll just, maybe more comments on the customer in a macro level, and then I'll let John speak to the agreements. But, Gregg, what we have said and what we continue to see is with the consolidation of our customers, especially from a global perspective, our ability to…

Operator

Operator

Our next question comes from Ronny Gal from Bernstein. Please go ahead. Ronny Gal - Sanford C. Bernstein & Co. LLC: Good morning, guys, and thank you for taking my question. Can you just give us a feel how you're modeling Nexium contribution? Is this kind of like a month or three months or until the end of the year trajectory? When are you assuming additional players come in, just so we can understand the contribution here to the model? And second, can you discuss, are there any complexities associated with reducing the share of Perrigo, in case, there are some Perrigo's shareholders listening, when you reduce their acceptance rate from 80% to 50%, if the result is in that range, 50% to 80%, how is that adds complexity or not to your ability to close the deal versus the result will be above 80%? Heather M. Bresch - Chief Executive Officer & Executive Director: Okay. So, Ronny, I'll start with your Nexium. Ronny, I would hope that especially demonstrating this quarter and us raising our guidance under – showing that underscoring the strength of our core business, not relying on any one product or any one territory. So Nexium, obviously, great product and right now, there don't seem to be any other final approvals and there was no one else really tied to the August 3 date because we were the only generic company that hadn't settled. So, I won't speak or have a crystal ball on anybody else's approvals coming, but I can tell you that, as always, we're managing a whole basket of risk and opportunities around the globe. And so, we wouldn't be speaking to modeling of any one particular opportunity, except that it just continues to show the strength in our core business, as well as our ability to continue to receive approvals. As far as the complexity, really, the way that the Irish Takeover Rules work and as we stated back on our – when we got the 2.5, giving us the ability to go directly to Perrigo's shareholders, we put in there that we had optionality to go down to the 50 plus 1%, and really the other – I would not say there's any operational complexity. There is a time period of perhaps one to two months of taking over the board. And then, so once that happens, you've got full operational control of the company. So, it really allows you to be running the company with 50 plus 1% of the vote in a very short period of time. So anything that there would be, it would be a very small temporary blunt of time that we weren't in control.

Operator

Operator

Our next question comes from Elliot Wilbur of Raymond James. Please go ahead. Elliot Wilbur - Raymond James & Associates, Inc.: Thanks. Good morning. Just a quick question, I guess relative to sort of external expectations around the Perrigo deal. Obviously, when you first announced it, there was a very strong initial brace of the industry logic that you guys had outlined around the transaction, and obviously you've been out and about meeting with a lot of investors since that time. And I'm just wondering if things like confidence is sort of weighing in the transactions just sort of judging by Mylan's stock price. I'm just kind of wondering sort of based on your read of investment community, do you think it's a function on the fact that people were overly fixated on the type of transaction, maybe not paying enough attention to the standalone merits of the Mylan/Perrigo combination, or do you think it's just a function more of unique considerations around the transaction that have sort of led to now a rather pronounced slippage, I guess, in terms of Mylan's equity value versus at the time when the transaction was first announced? Thanks. Heather M. Bresch - Chief Executive Officer & Executive Director: Yeah. Thanks, Elliot. Look, I think we started in the right place, which was people's reaction in April, and that's instinctive both – I think instinctive, but the fact that it was strategic and compelling and the right natural fit. I think everybody got right off the bat. I think a lot of shares traded that day and settled out with us at that $68 range, and we felt that was the right range, and we continue to maintain that. What then subsequently happened, I absolutely believe Wall Street became very fixated on a near-term…

Operator

Operator

Our next question comes from Umer Raffat from Evercore ISI. Please go ahead.

Umer Raffat - Evercore ISI

Analyst · Evercore ISI. Please go ahead

Hi, guys. Thanks for taking my question. Heather, would you consider buying back stock if it stays at current levels and do you have the flexibility to do that, while Perrigo is ongoing? And then, John, what's the year-on-year organic growth rate on revenues adjusted for FX and what drove the $500 million move in accounts receivable? Thank you. Heather M. Bresch - Chief Executive Officer & Executive Director: Hi, Umer. Thank you. Yes, we absolutely have the flexibility to buy back our stock. And I would say, it's a great buy right now. So, it's a great inflection point for people to get back in, in this moment of, as the chaos that holds itself out, and like I said, I think as we've returned to the levels that we expect to be given, given our results and our performance. But I will tell you, we're committed to investment grade. So, while we have a ton of flexibility and optionality, we obviously stay very committed to our investment grade.

Umer Raffat - Evercore ISI

Analyst · Evercore ISI. Please go ahead

Got it. John D. Sheehan - Executive VP, Chief Financial & Accounting Officer: And, Umer, with respect to accounts receivable, the increase year-over-year in the accounts receivable is the combination of the acquisition of the EPD Business, that's the majority of it, plus the change in customer payment terms that I referred to during my remarks. And as it relates to organic growth in the business, our business actually grew organically ex-FX, without FX, by – at the top line by 36% year-over-year and with the EPD acquisition representing 22% of that. So, our Mylan legacy business, as I believe Rajiv had in his remarks, grew double-digits.

Operator

Operator

Our next question comes from Andrew Finkelstein from Susquehanna. Please go ahead.

Andrew J. Finkelstein - Susquehanna Financial Group LLLP

Analyst · Susquehanna. Please go ahead

Thanks very much. I was hoping you could talk a bit more about the outlook with EpiPen, in particular, while you still anticipate the possibility of a generic in 4Q in the guidance. Was that part of the contribution to the increase in the range of guidance for the year? And then as you look into formulary coverage and pricing for next year, as some of the exclusion lists come out and where your contracting has been, if there is no generic, where would you expect share and net pricing trends to come out for next year? Heather M. Bresch - Chief Executive Officer & Executive Director: Thanks, Andrew. So, look, our outlook for EpiPen remains unchanged. I think we stay very positive on EpiPen. It's been a great product. We continue to see growth, obviously, as I said double-digits so far this year. And it is not due to our raising the guidance. As we noted, we've continued to maintain EpiPen generic coming in the second half of the year. So, if anything, it's an opportunity. And with that being said, I've maintained that I think there's a very high bar to get AB-rated approval. And so, look, we're already on a multi-epinephrine market, to your point. We're competing and we're very proactively competing for market share with our payers and formularies. And we'll continue to do so. And if an AB-rated does not come out, my thought would be next year will look very similar to this year, as far as the competitiveness of us maintaining, one our market share and our positions with formularies. So, EpiPen continues to do great. And like I said, but we've done a financially responsible thing as factoring it in. And so, we'll just have to see how the year plays out.

Operator

Operator

Our next question comes from Jami Rubin of Goldman Sachs. Please go ahead. Jami Rubin - Goldman Sachs & Co.: Thank you. Just a couple of questions. Heather, what do you mean in your press release in your prepared remarks by saying that you expect potential opportunities on the horizon. I mean, don't most companies expect potential opportunities on the horizon? Can you just clarify that a bit more? And then maybe, Rajiv, if you could talk about the upcoming IPR decision related to Copaxone 40. What we should anticipate? How you expect the legal roadmap to look like there? Thanks very much. Heather M. Bresch - Chief Executive Officer & Executive Director: Sure. Well, Jami, and I think, as I alluded to you earlier, obviously, as you know, we're under Irish Takeover Rules which prohibit really quantifying much from a forecast perspective. But I think given what we were trying to indicate is, given the strength and momentum in our business for the first half of the year, we see just a lot of opportunities in the second half of the year. And as we've said, we'll certainly update that as appropriate. But it was really just to signal, one, the strength of our business, and two, the opportunities we continue to see over the near and medium-term. Jami Rubin - Goldman Sachs & Co.: So, that's not related to a specific M&A opportunity? Heather M. Bresch - Chief Executive Officer & Executive Director: Not related to anything specific, it's just opportunities, in general. Rajiv Malik - President & Executive Director: And Jami, on Copaxone IPR, I think based on the legal arguments we see, and how it's going, we have been very confident on this IPR litigation or on IPR case and we are looking forward to the decision around end of August.

Operator

Operator

Our next question comes from Marc Goodman of UBS. Please go ahead.

Marc Goodman - UBS Securities LLC

Analyst · UBS. Please go ahead

Good morning. So, Rajiv, you had talked about Copaxone. I just want to make sure I understand. You said that you got feedback from the FDA and in those comments, there were not any concerns around the sameness of your products. So, there obviously were some other issues. Can you tell us what they were, whether just minor, procedural things that you quickly gave responses to and you feel really comfortable that the FDA has now gotten everything that they need? Were the things that they asked, were they surprising? I'm just trying to understand. I mean, I think we can understand why you would take it out of this year's numbers to be conservative, but it doesn't seem to make sense that you would be taking it out completely, given the commentary there. And then second, Heather, maybe you can just talk about some of the key markets in Europe and the performance there, France and Italy. You mentioned the volumes and stuff. How is the pricing environment, what's going on with market shares? And mention the UK as well. Thank you. Rajiv Malik - President & Executive Director: On Copaxone. Let me say, Copaxone has a – we all knew it's a complex product and if everything is not black and white, then there's a little bit of gray. So, the citizen petition response and Momenta's approval gave us a lot of confidence that, fundamentally, we are on the same page. The last bit of questions, the clarifying questions are around fine-tuning – I will not call exactly the fine-tuning, but there are some different methodologies which we have used, and we are trying to give them more information about some of the abstracts where they want to see more clarity. We just received that question. We're in…

Operator

Operator

Our next question comes from Douglas Tsao from Barclays. Please go ahead.

Douglas D. Tsao - Barclays Capital, Inc.

Analyst · Barclays. Please go ahead

Hi. Good morning. Thanks for the question. So, first, Rajiv, maybe if you could provide a little bit more detail on the status of the Advair program. I mean, I think you indicated you'd be able to file the ANDA by the end of the year. And just maybe when you would be able to – or showing your plan to – if you plan to show the Phase III clinical trial results from that program. And then, John, if you could provide just an update on the pricing environment in just the base generics business right now. Thank you. Rajiv Malik - President & Executive Director: Doug, on generic Advair, there are a number of studies which are currently underway. There are several PK, pharmacokinetic studies which are underway. We are expecting within the next few weeks or a couple of weeks, in fact, of the clinical endpoint data. We have a device robustness study which is coming around. So, everything is aligned and progressing very well. Our commercial and manufacturing installation is not only installed, but now undergoing their qualification. So, we remain very confident about filing this ANDA towards the end of this year. John D. Sheehan - Executive VP, Chief Financial & Accounting Officer: And, Doug, with respect to the pricing environment, the way I would characterize it is extremely stable. For the year-over-year, the pricing environment, the price globally is really equal or zero, with positive pricing in the North America, mid-single-digit price declines in Europe which our volume more than offsets, and low-single-digit price in the rest of world. So, we're very pleased with the development of pricing around the globe.

Operator

Operator

Our next question comes from Louise Chen of Guggenheim Securities. Please go ahead.

Louise Chen - Guggenheim Securities LLC

Analyst · Guggenheim Securities. Please go ahead

Hi. Thanks for taking my questions. First question I had was just on Mylan as a stand-alone. Curious what your strategic priorities are for this year and beyond this year. Maybe if you could refresh us on that one. And then secondly, you had mentioned that you don't have to have Perrigo. So, if it's not Perrigo, what other areas are you interested in? Is it still generics? Is it brand, U.S., O-U.S.? Any color would be greatly appreciated. Thank you. Heather M. Bresch - Chief Executive Officer & Executive Director: Sure. So, Louise, I would say our priorities right now is getting the Perrigo deal done. But as I said that if that does not happen, we obviously are actively looking at a lot of assets, and I think you should just expect there's obviously things for sale all over the globe. Starting with here in the United States, we see assets that would increase dosage form or therapeutic categories. We see interesting bolt-on opportunities that will continue to enhance the infrastructure we have in place. We see assets in Europe that could, again, given now our commercial infrastructure with Abbott, EPD and our legacy business that would complement that. We continue to see other OTC opportunities that would allow us to continue to be able to fill out that OX (52:35) channel. So, I would say that, like I said, we've been very clear about our priorities. But with that being said, we believe there's a lot of – from priorities and the dosage form and the channels which we want to reach critical mass, I mean the most to our customers and to the consumers, and we believe there's a lot of different assets that can get us there. It's just that the Perrigo kind of accelerates that for us and as well as for them. They talk about their base plus, plus, plus business, we get them to base plus overnight. So, we think that that synergy and complementary nature is why again it's the right next company for Mylan.

Operator

Operator

Our next question comes from Jason Gerberry from Leerink Partners. Please go ahead.

Jason M. Gerberry - Leerink Partners LLC

Analyst · Leerink Partners. Please go ahead

Hi. Good morning. Thanks for taking my question. First question for Rajiv, just on the Advair competitive landscape, any visibility into other companies that were recruiting patients to run these equivalent studies? You guys are the most open and visible about your development updates. So, just curious if you have any intelligence in terms of any other companies that might be on a similar timeline with you guys. And then second question for Heather, just as you think about the evolution of the generics industry with the Teva/Allergan combination, just kind of curious how you think that competitively impacts your business, if you think there's any risk to that deal closing. I know you guys raised some anti-trust issues with the Teva/Mylan combination and given Allergan's book of businesses, pretty comparable in size, just kind of curious how you think about that issue? Thanks. Rajiv Malik - President & Executive Director: So, Jason, I believe that our intelligence is not going to be far more than what you have. We have heard Sandoz-Oriel, sometime back we have heard Actavis having a program. We have also heard about 505(b)(2) between the Teva or some other programs. But, we are not actively or heard and seen that recruitment in the clinical, so we can't see anything more than that, but we believe that we are significantly ahead of others and we continue to maintain that momentum. Heather M. Bresch - Chief Executive Officer & Executive Director: And Jason, as far as the generic landscape goes, what's interesting is the FTC issues we've raised that obviously, there was the normal overlap consideration that the FTC should be looking at. But additionally, we said there is much more macro issues that they needed to take into consideration. And in fact, I actually used the example that if you look at the four top players in our industry, three of them are predominantly in the brand. That leaves only Mylan as the true global generic company. And therefore, if one of the other three consolidated, which has now happened, you take Teva and Actavis, that we thought they brought to the marketplace would be much less significant than it's taking the only generic advocate out of the industry would be. So, as I mentioned in my opening remarks, not only do I see it as different, I see it as a huge opportunity for Mylan. I mean, if we look historically at these large consolidations that take in place, we've been able to disproportionately gain market share as other use it as they divest and sell off assets. So, we see it as a great opportunity to build up our markets around the world.

Operator

Operator

Our next question comes from David Risinger from Morgan Stanley. Please go ahead. Emil Chen - Morgan Stanley & Co. LLC: Hi. This is actually Emil Chen on for Dave Risinger. Thanks for taking my question. John, earlier you mentioned that the pricing environment globally is relatively stable and apologies that I missed it, but can you just comment again specifically on the U.S. generic pricing environment? And then secondly, on EpiPen, what are the prospects for any potential future price increases? Thank you. John D. Sheehan - Executive VP, Chief Financial & Accounting Officer: So, I indicated that in my remarks that with the overall global environment for pricing being stable, that the North American pricing environment was positive. Heather M. Bresch - Chief Executive Officer & Executive Director: And as far as EpiPen goes, look as I've said, we are being very proactive and competitive in the multi-epinephrine marketplace; and therefore as we said here today, we continue to take – look at EpiPen in a holistic manner and take opportunities as you would for a brand. So, you should foresee that just continuing as we continue to maximize the EpiPen franchise. Emil Chen - Morgan Stanley & Co. LLC: Great. Thank you.

Operator

Operator

This concludes our Q&A session. I will now turn it back to Kris King for closing remarks.

Kris King - Vice President-Global Investor Relations

Management

Thank you, everyone for joining us this morning. Hope you all have a good day, and we'll be speaking to you soon. Bye-bye.

Operator

Operator

Ladies and gentlemen that concludes today's conference. Thank you for your attendance. You may now disconnect. Everyone, have a great day.