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Viatris Inc. (VTRS)

Q3 2015 Earnings Call· Fri, Oct 30, 2015

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Transcript

Operator

Operator

Good day, ladies and gentlemen, and welcome to the Mylan Third Quarter 2015 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. As a reminder, this conference is being recorded. I will now turn the call over to your host, Kris King. Please go ahead.

Kris King - Vice President-Global Investor Relations

Management

Thank you, Stephanie. Good morning, everyone. Welcome to Mylan's conference call to discuss our third quarter 2015 earnings and our offer to acquire Perrigo Company. Joining me for today's call are Mylan's Executive Chairman, Robert Coury; Chief Executive, Heather Bresch; President, Rajiv Malik; and Executive Vice President and CFO, John Sheehan. During today's call, we will be making forward-looking statements. Such forward-looking statements may include, without limitation, statements about the proposed acquisition of Perrigo by Mylan, which I will refer to as the Perrigo proposal, Mylan's acquisition, which I will refer to as the EPD transaction of Mylan Inc. and Abbott Laboratories' non-U.S. developed end markets specialty and branded generics business, which I will refer to as the 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, Perrigo, or the combined company's future operations, anticipated business levels, future earnings, planned activities, anticipated growth, market opportunities, strategies, competition, Mylan having sufficient supply of EpiPen Auto-Injector to meet anticipated demand due to Sanofi's voluntary recall 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 the EPD transaction and the Perrigo proposal, changes in relevant tax and other laws, the integration of Perrigo and EPD business being more difficult, time consuming or costly than expected, operating costs, customer loss and business disruption being greater than expected following the Perrigo proposal and the EPD transaction,…

Robert J. Coury - Executive Chairman

Management

Thank you, Kris. Good morning, everyone, and thank you for joining us today. I would like to welcome our employees around the world to the call and thank them for their unwavering dedication, hard work and focus, which is what makes our consistently strong results possible. I would also like to welcome any Perrigo and Omega employees listening in today. We certainly look forward to welcoming all of you to the Mylan family soon, as we have never been more confident in completing what we believe will be a very successful tender offer. In addition, I would like to say a special hello to the Perrigo employees in Israel today. We are very excited to have now received approval to dual-list on the Tel Aviv Exchange and to finally have the opportunity to acquaint ourselves more closely with Israel, Israeli investors and Perrigo Israeli employees. Before I turn the call over to Heather, Rajiv and John, who have a lot to cover today, I would like to make a couple of points regarding our offer for Perrigo and to clear out some of the possible misinformation. First, the notion conveyed by Perrigo that the Mylan offer is a bad deal for Perrigo shareholders is simply preposterous and disingenuous. We will show once again today with math using Perrigo's own updated numbers that this is a substantial and compelling offer to Perrigo's shareholders. Let me also simply highlight that Perrigo themselves have left their own shareholders no other options except to rely on non-strategic measures, such as cost cuts as well as the hope that they will trade at a very high PE multiple at a time when multiples have been completely reset throughout the industry, in order to generate their stand-alone long-term shareholder value. This strategy is flawed and simply…

Operator

Operator

Thank you. Our first question comes from Marc Goodman with UBS. Your line is open.

Marc Goodman - UBS Securities LLC

Analyst · UBS. Your line is open

Morning. Heather, on EpiPen, can you talk about the pricing commentary in the press release and put in context what it means relative to the troubles we learned about yesterday with Auvi-Q and with the Teva delays? And can you also comment on have there been any changes in channel inventory levels maybe in anticipation of the Teva generic coming? And then third question is, it seems with the recent changes here with EpiPen that you should be able to do over $5 a share of earnings next year and I was curious if you would make a comment on that. Thank you. Heather M. Bresch - Chief Executive Officer & Executive Director: Sure. Thank you, Marc. I'll start with your last point. I can't disagree with your math. As far as EpiPen, I guess a couple of things. As far as inventories are concerned, we have not – and I think I had mentioned actually on last quarter as well, we have not seen any irregular things happening or our customers selling beyond because they were anticipating a Teva launch. I think that there had not been any commentary about Teva coming into the market and, obviously, they've now clarified yesterday that it won't be at least till the second half of 2016. So our inventory levels were running due course. There were no issues there, as I mentioned. There was a little softness in the overall epinephrine market in the third quarter. But as you know, we continue to see double-digit growth year-over-year and so the comparable had been very high. With that being said, we've still seen EpiPen grow in volume year-to-date. And as far as all of the recent events, I would say that our dynamic with the payers will stay just that, I think very dynamic. As I've noted throughout this year, we have been very proactive and competitive to maintain our market share. Obviously, in light of some of the recent developments, I think that we'll continue to have opportunities to improve that situation because it's not as competitive as it was. So as happens in this space, the competition landscapes can change very rapidly and I think our ability to first and most importantly be there for the patient and the safety issue. And we have been very closely monitoring and assisting to make sure patients can get the scripts of EpiPen so they're not going without product. So I would say all-in-all, as I mentioned in my commentary, the runway looks very bright and I think the future of the EpiPen franchise is just going to be one that's got a lot of brand equity and a lot of sustainability, too.

Robert J. Coury - Executive Chairman

Management

The only thing I would like to add to Heather's comments and because you asked a question, Marc, and obviously under Irish Takeover Rules we're not allowed to give forward-looking projections, but since you did the math on your own, not only do I support Heather's answer to you about your own math, but this opportunity with EpiPen really could not have come at a more opportune time because it only fuels the trajectory of our growth that we've been delivering for our shareholders over the last several years. Especially when you think about what Rajiv said about our generic Advair application being filed by the end of this year, we have the real possibility to get on the fast track. If that occurs, then if you take a look at what we see ahead of us in 2016 and then jump right over to 2017 with the potential launch of significant catalyst, you can see that the whole EpiPen situation could have not come in a more opportune time. Next question?

Operator

Operator

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

Gregg Gilbert - Deutsche Bank Securities, Inc.

Analyst · Deutsche Bank. Your line is open

Yes, hi. Good morning. I have three questions. First, John, can you talk a little more about gross margin and whether it's sustainable at these levels and some of the pushes and pulls? My second question is for Heather. When you describe Perrigo, I can't help but think it sounds like you're pitching a stock to short. Can you talk about your philosophy of why you're talking about your target in a way that suggests that you can do a far better job with it? You're about to part with a lot of precious capital of your shareholders, yet you seem to be focused on the negatives of the business more than the positives, yet you haven't lowered your price. And lastly for Robert, what are these corporate governance changes you're committed to making? I think it's appropriate to be more specific in this case so that your shareholders believe it's more than just lip service to get a deal done. Thanks.

Robert J. Coury - Executive Chairman

Management

Yes, so, first, Gregg, let me before I turn it over to Heather for her commentary. The Mylan shareholders have already spoken in terms of the Perrigo transaction and the opportunity. We've spent an exorbitant amount of time with the Mylan shareholder describing to them why this asset in our hands is the right next opportunity to bolt-on to our existing platform with our existing assets. And we convinced them when they supported us in the August 28 vote, we convinced them because we pointed to other assets that we've acquired that we said very consistently on a stand-alone basis if you look at what we paid for the other assets, this is almost déjà vu. There are many assets that we've bolted on to our platform that we do not really like on a stand-alone basis. But then bolted on to our platform, as you can see through the demonstration of our continued, very strong execution and performance, we were able to deliver continual double-digit growth to our shareholders. So I think that Perrigo is going to be no different and I'm going to have her explain that in more detail. In terms of the corporate governance, I've been very, very open, very, very direct and very transparent about, one, saying that the entire whole corporate governance discussion over this transaction has been nothing but a red herring. With that said, I do listen to shareholders, and Perrigo shareholders, in particularly. That's why I extended my offer to Joe Papa and their Board of Directors to sit down and have a dialogue. If this is really something that's all that's left out there, then let's sit down and talk about for the combination of the Mylan Perrigo combination, for that new structure, that new company profile, the new size…

Operator

Operator

Our next question comes from Sumant Kulkarni with Bank of America. Your line is open.

Sumant S. Kulkarni - Bank of America Merrill Lynch

Analyst · Bank of America. Your line is open

Good morning. Thanks for taking my questions. I have three. First, outside of over-the-counter, what are some of the specific business development priorities for Mylan, given that competition on the generic side may start to appear more formidable with the Teva Allergan transaction? Second, if the Perrigo stand-alone business appears so challenged in some fashion, what can Mylan specifically do to kick-start that business and how long would it take to turn it around, excluding any revenue synergies? And third, sorry if I missed it, but could you give us an update on the Antitrust review of this transaction in the U.S.?

Robert J. Coury - Executive Chairman

Management

So, regarding Antitrust, we should be hearing really any day, quite frankly. Heather? Heather M. Bresch - Chief Executive Officer & Executive Director: Yeah, Sumant. As I was explaining about Perrigo, their challenge is sustainable growth on a stand-alone basis. So we've continued to say they have a good solid business. It's just when put with the Mylan and brought together with the Mylan entity, our ability of how we approach customers, of how we leverage the platform in Europe, how we can then broaden and go to other geographies with the assets we've put together is what we continue to show, not to mention the at least $800 million of synergies that we think we'll be able to get out of the combined platform. So it's really just bringing the scale together and being able to leverage these complementary platforms that 1 plus 1 equals more than 3 or 4. And that's what, as we've said, our history and our track record has shown that we've continued to be able to do that with those transactions. I'd say as far as business development opportunities, yes, we've said we'll focus on the OTC channel in continuing to go about and enhance that platform. Obviously, Perrigo accelerates that. But we're interested in building and we believe there's great product opportunities in other assets out there that would let us continue to build the OTC, both in the U.S. as well as Rest of World. And as we've said before, we continue to believe there's dosage forms, therapeutic categories that we still don't have critical mass in. As we added the injectable platform as an important bolus and opportunity for us to gain critical mass in that area, we believe that we've got other areas, such as ophthalmics, that we can continue to bolt-on and really leverage our global commercial platform. John D. Sheehan - Executive VP, Chief Financial & Accounting Officer: And then the only other thing I would add is a sustainable cash flow business versus a business that is struggling to grow, I do believe that what we bring to Perrigo is an immediate protection of the downside that we can forecast that we see in their stand-alone business. You cannot ask shareholders to rely on delusional high P/E multiples in order to deliver growth. You must rely on your own capability of producing earnings growth and leave it up to the Street to decide ultimately what P/E multiple and, in particular, platform or profile it deserves.

Operator

Operator

Our next question comes from Andrew Finkelstein with Susquehanna. Your line is open.

Andrew Finkelstein - Susquehanna Financial Group LLLP

Analyst · Susquehanna. Your line is open

Thanks very much for taking the question. I was hoping you could comment more on a couple things. Number one, you mentioned better margins on some of your existing products in North America. And could you comment how much of that is related to pricing? Number two, Perrigo announced plans to spin off its BMS business. How do you think about a business like that in terms of where you can compete successfully in OTC? And then finally, you mentioned ophthalmics, if you could comment anymore on the capabilities you do have there, including with products like generic RESTASIS. Thanks very much. Heather M. Bresch - Chief Executive Officer & Executive Director: I'll start on the North American Perrigo question. Look, I would say as far as price increases, we've had a very consistent approach. We have absolutely had opportunities around generic pricing, but I would tell you is, as we noted I believe in our commentary, that we've seen our volumes up more than our increases. So when you look our broad portfolio and hundreds of products, it's not dependent on any one product or any massive price increases across the board. So I would say what we continue to see is because of the shortages and some of the issues with the FDA, that our ability to have that reliable supply has really been a differentiator for Mylan and has allowed us to continue to do more and optimize the assets we have. As far as the Perrigo businesses and commentary on their price cuts or businesses they're selling, look, I think it would be premature for us to comment on those assets or their assessment. I think that's why, as Rajiv talked about, our first 60 days it's really getting in there and assessing both the people and the businesses and before making any kind of quick rush decisions about what may or may not make sense going forward. Rajiv? Rajiv Malik - President & Executive Director: And regarding our product mix, in our global portfolio, we have a bunch of ophthalmics products, including a pending ANDA with RESTASIS, which we are waiting to hear from the FDA. We have filed this ANDA a couple of years back and are waiting to hear from the FDA. John D. Sheehan - Executive VP, Chief Financial & Accounting Officer: And I would just close by saying that similar to the last question regarding margin, that the North America increase in margin is the combination of both, as I said, a positive pricing environment, but just as importantly, the cost reductions that our global operating platform has been able to achieve.

Operator

Operator

Our next question comes from Ronny Gal with Bernstein. Your line is open. Ronny Gal - Sanford C. Bernstein & Co. LLC: Good morning and thank you for taking my questions. I have three. First, Rajiv, about the insulin product, there are two formulations (66:35) out there. There's a vial formulation and a prefilled syringe formulation. And I know you're working on the prefilled syringe formulations. Others have been struggling with the vial formulation. Can you just confirm to us that you were able to get the vial formulation right? Is this one of the formulations that will be submitted in 2016? Second, on R&D. You seem to have a lot of trials going into Phase III, both on the branded side and biosimilars. Should we expect an increase in R&D in 2016 above the current percentage of revenue, even with the nice EpiPen number? Can you just give us an idea about what is the step function in R&D to cover those? And last, to come back to you guys on this issue of governance, I understand that you want to talk to the board of Perrigo in this issue. But for your own shareholders I think the question is, are you willing to undo the stichting requirements to keep Mylan independent? Are you willing to change the board election to allow shareholders to propose new members, for your own shareholders, looking long term? Is this in the plans? Would you commit to that? Or is this something that you think is like bedrock the way Mylan should operate long term?

Robert J. Coury - Executive Chairman

Management

Thanks for the question, Ronny. Rajiv, let me take that first and then you can take the other two. Look, Ronny, I don't want to be discussing corporate governance in a vacuum. I think it's appropriate when you look at this new combined entity, its profile, its size and scale, what this new profile will be on a going-forward basis. I think it's very important rather than do this in a vacuum or on our own, I think it's very important that two boards come together and discuss this matter openly. I think it should be discussed with shareholders. Certainly, I would speak to Mylan shareholders. Let me remind you that this corporate governance has been voted in by the Mylan shareholders. And I will always be open. With that said, this is really about the Perrigo transaction right now, but I will always be open with both the Mylan and Perrigo shareholders on an ongoing basis. And all the type of governance changes that you've outlined, I will absolutely be open to all of those things with a good discussion. I believe, first, we need to deal with the Perrigo and the Perrigo potential transaction because I think, again, Ronny, a lot of this is a big red herring. I truly believe it's much more of an excuse that's being used right now than the realities. We are a public company. A company that's a public company is for sale every single day. That's what a public company is. We, as a board, we've made our position abundantly clear that we would not hold this company back. There has been several types of transactions I have mentioned that we would be open for, both in value and in structure, and especially transactions that would accelerate the mission and strategy…

Operator

Operator

Our next question comes from Umer Raffat with Evercore ISI. Your line is open. Umer Raffat - International Strategy & Investment Group LLC: Hi. Thanks for taking my question. I have a few, if I may. First, Robert, when you say corporate governance changes, are you referring specifically to stichting or are there other considerations you're evaluating as well? Just wanted to understand that better. And then, Heather, the slides mentioned that for Abbott Established Products business, the year-over-year constant currency growth is 5%. Can you give us what it is without FX adjustment for Abbott Established Products? And finally, John, so what exactly does the purchase accounting amortization entail? I just want to understand like specifically what exactly does it include in that? And what's the $41 million financing-related cost that was non-GAAPed out? Thank you.

Robert J. Coury - Executive Chairman

Management

In terms of the corporate governance, again, I don't think there should be any limitations when you have an open dialogue with your shareholders, or, in this case, with Perrigo and Perrigo's board. I don't think there should be any limitations if you really are open to have a discussion about corporate governance as a whole. John D. Sheehan - Executive VP, Chief Financial & Accounting Officer: Yeah, so on the question of the EPD revenues without being on a constant currency basis, you certainly know that the euro has weakened substantially against the U.S. dollar over the last year. And you also know we didn't own the EPD business last year, so that it wasn't included in our revenue. So I would just say that the EPD business revenues on an actual value as expressed in U.S. dollars are down year-over-year. But, again, it wasn't in our numbers, so it's not necessarily a relevant point. I guess I'll just also hit, Heather, the purchase accounting amortization. When we make an acquisition, U.S. GAAP requires the allocation of the purchase price to the value of the tangible and intangible assets acquired and the intangible assets are then amortized. That's a non-cash amortization charge which had been a consistent adjustment that we've made associated with our adjustments from GAAP to adjusted earnings. And lastly, the financing charges, those represent the costs associated with the refinancing of our capital, our balance sheet, including the committed bridge loan that we have in place associated with our Perrigo tender offer. Heather M. Bresch - Chief Executive Officer & Executive Director: And I guess just as a practical note I would add on the EPD business, as we stated when we acquired that business, Abbott themselves had forecasted it to be a declining business. And we had believed that, in our hands, we would be able to focus on investment to make that flat to slightly growing. And I think what we've seen and reported today is just that we continued to exceed those expectations. That business has done very well integrated into the Mylan legacy European platform. So we're proud to say that we're ahead of schedule and continue to see a lot of, not only great cash flows associated with the business, but they're really complementary in nature to the retail pharmacy channel that we already had our legacy business in.

Operator

Operator

Our final question comes from Jason Gerberry with Leerink Partners. Your line is open.

Unknown Speaker

Analyst · Leerink Partners. Your line is open

Hi. Good morning. This is Derek on for Jason. I just had one question. I was wondering if you could talk about the $17 million one-time customer incentive in the EU and whether that was related at all to Perrigo's distributors not taking any Omega products during the quarter? Thanks. John D. Sheehan - Executive VP, Chief Financial & Accounting Officer: No, I can confirm to you that it was not. It had nothing to do with that. It relates to the integration of our EPD business in Europe and was, as I indicated, a one-time payment associated with the bringing of the EPD business into Mylan. So, with that, I'd just like to close the call by saying thank you to all the participants. I think that the slides that we reviewed with you today will be available on the Mylan website. We think they produce a clear and compelling case for the value proposition that we're making to the Perrigo shareholders. And we would be pleased to continue to engage with you on the subject. Thanks very much, operator. And you can close the call.