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Transcript
OP
Operator
Operator
Good day, ladies and gentlemen, and welcome to the Mylan N.V. First Quarter 2016 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we'll conduct a question-and-answer session and instructions will be given at that time. As a reminder, this conference call is being recorded. I would now like to introduce your host for today's conference, Kris King, Customer Relations. Please go ahead.
KR
Kris King - Vice President-Global Investor Relations
Management
Thank you, Ashley. Good morning, everyone. Welcome to Mylan's conference call discussing our first quarter 2016 earnings, 2016 guidance, and the proposed acquisition of Meda AB, which I will refer to as the Meda transaction. Joining me for today's call are Mylan's Chief Executive Officer, Heather Bresch; President, Rajiv Malik; Chief Commercial Officer, Tony Mauro; Paul Campbell, Chief Accounting Officer; and Colleen Ostrowski, Treasurer. During today's call, we will be making forward-looking statements. Such forward-looking statements may include, without limitation, statements about the Meda transaction; Mylan's related public offer to the shareholders of Meda to acquire all of the outstanding shares of Meda, which I'll refer to as the offer; Mylan's acquisition, which I will refer to as the EPD transaction of Mylan Inc.; and Abbott Laboratories' non-U.S. developed market specialty and branded generics business, which I will refer to as the EPD business; the benefits and synergies of the Meda transaction and the EPD transaction; future opportunities for Mylan, Meda for the combined company and products; and any other statements regarding Mylan's, Meda'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 uncertainty, 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 Meda transaction and offer and the consummation thereof; the ability to meet expectations regarding the accounting and tax treatments of the EPD transaction and the Meda transaction; changes in relevant tax and other laws; the integration of Meda and the EPD business being more difficult, time-consuming, or costly than expected; operating costs, customer loss, and business disruption…
AO
Anthony Mauro - Chief Commercial Officer
Management
Thank you, Rajiv. As you heard, our commercial platform continued to deliver for us in each of our key regions demonstrated by the continued strength and resilience of the Mylan business around the world, as well as our ability to continue to [thrive]. Because there's been much talk about the pricing environment throughout our industry across both the Generic and Specialty segments, especially here in the U.S., I would like to address this right up front. As Heather noted, not all generic companies are created equally. For our part, we expect to continue to benefit from the scale and diversity of our business and portfolio, our reach across customer channels and our unmatched operating platform and supply chain infrastructure, which gives us greater scale and control of our cost of goods sold and our time to market. We have created this highly differentiated model from focus execution against our strategic plan over the last 10 years and investment in scale and diversification which will become even more important going forward. Therefore, I'd like to make clear that consistent with the guidance we laid out for 2016, we continue to see nothing out of the ordinary to change our generic pricing assumptions of low to mid-single digit erosion for the full year. Our performance this quarter, both in the U.S. and globally, was right in line with these expectations. With regard to EpiPen, we continue to maintain our strong leadership position in the marketplace through the first quarter. We are very pleased with the strong volume growth in this product and see continued growth throughout the year. We also see significant opportunities to continue to expand this market to tap into more than 20 million patients at risk. Looking ahead, we believe Mylan continues to be uniquely positioned to compete within…
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Operator
Operator
Thank you. Our first question comes from Sumant Kulkarni of Bank of America. Your line is open.
SL
Sumant S. Kulkarni - Bank of America Merrill Lynch
Analyst · Bank of America. Your line is open
Good morning. Thanks for taking my questions. First one, actually both for Rajiv. So, first, could you say how much of an opportunity still exists in expanding margins within the Mylan base business, given that you've done a notable job there after you acquired Merck KGaA? And second, you called out dermatology in your remarks. What are some of the specific ways in which the company could become a stronger player in that therapeutic area?
Rajiv Malik - President & Executive Director: So, let me start with the first one. I think we have not lost our focus after integrating Merck. And we have not lost our focus on continued ways and means to optimize the parts, leverage our assets in the best possible way and not lose our sight on the cross-margin and the cost of goods line. So we continue to see opportunity as we bring more and more complex products, as we bring more and more strategic product internally to vertically integrate. We see more opportunities. Now, from – on the dermatology, other than having many organic R&D-incubated opportunities which we already seen coming to life, we continue to look out for enhancing and strengthening this portfolio in a strategic way. So, we're looking for a group of portfolio, product portfolio of families around dermatology to further strengthen this line of the business and are out there to look for more and more opportunities in this space.
SL
Sumant S. Kulkarni - Bank of America Merrill Lynch
Analyst · Bank of America. Your line is open
Thanks.
OP
Operator
Operator
Thank you. Our next question comes from Jami Rubin of Goldman Sachs. Your line is open. Jami Rubin - Goldman Sachs & Co.: Thank you. I have two questions. Heather, for you first, on Meda, we all did see the numbers this morning and they did look pretty weak. You did mention that they were in line with your expectations. But I guess if you can just give us a little bit of comfort that – we saw Perrigo lower their earnings expectation in part due to Omega. Omega's business is not that much different from Meda. So, why are you so confident that Meda to Mylan is not Omega to Perrigo? If you can give us a little bit more color around your thoughts as to why you can turn that business around. And then secondly back on the U.S. pricing dynamics, why is the environment different from you than it is for some of the niche players such as companies focused mostly on dermatology or narcotics? It seems that that's where the pressure is coming from, but maybe you could comment on that further. Thanks. Heather M. Bresch - Chief Executive Officer & Executive Director: Sure Jami. Thank you. So, first let me address your Meda question. As we stated, their results were very much in line with our expectations. I think one of the disconnects is that the Street, or here in the United States, had not followed Meda's business all that closely and then certainly, post our announcement of acquiring them, I think there's been no following of the business. So I think there was just a real disconnect with consensus as to what Meda was expected to do. As far as the businesses, I would differ that Meda and Omega don't look alike really at…
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Operator
Operator
Thank you. Our next question comes from Elliot Wilbur of Raymond James. Your line is open. Elliot Wilbur - Raymond James & Associates, Inc.: Thanks. Good morning. Maybe just following up on your commentary around targets, Heather, and going back to full year guidance, you had talked about, I think, essentially 20% top line growth in the entire Generics segment. And then thinking about, based on what you guys put up today and what that implies for the remaining three quarters of the year, certainly implies a pretty significant acceleration in terms of year-over-year growth. Essentially a doubling of the rate in the first quarter. And I guess one of the key dynamics there, or the largest factor in terms of bridging revenue growth was new product launches. Maybe you could just talk a little bit about where you are versus original expectations on the new product cycle at the beginning of the year. And just remind us for the balance of the year, what are some of the key known new product drivers? Heather M. Bresch - Chief Executive Officer & Executive Director: Thank you for that question. I will tell you that we remain completely on track with the guidance we gave. As you remember, historically, if you look back over the last couple of years, the phasing of our quarters have been very similar. From Q4 to Q1, we then step up to Q2, Q3 and Q4. Q3 typically, obviously with the EpiPen contribution, is seasonally our highest quarter. But look, we have a significant amount of new product launches, new business and volume growth. I mean, we continue to see volume growth as well as taking, as we've talked about, the price erosion that we had put in our guidance from the beginning. So, from our…
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Operator
Operator
Thank you. Our next question comes from Chris Schott of JPMorgan. Your line is open.
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Dana C. Flanders - JPMorgan Securities LLC
Analyst · JPMorgan. Your line is open
Hi. Thanks. This is Dana Flanders on for Chris. Can you just comment the Treasury regulations that came out last month and how you see the proposals impacting the industry and Mylan more specifically as it relates to M&A? And then is there any impact to Mylan's longer-term tax rate with some of the proposed rules around earning stripping?
Heather M. Bresch - Chief Executive Officer & Executive Director: Yeah, no. Thank you. We see no effect, obviously, on Mylan or our inversion from the Treasury rules that came out. I think we've also been vocal about that we don't think a Band-Aid fix to the tax code is the right thing for the industry from a global competitive perspective. So I would continue to hope that the next administration takes a much more holistic view at the tax code and makes the United States a competitive place to do business, not a place to handcuff you to stay here. So that would be our comment on inversion. And as far as we'll continue, nothing changes about the guidance that we've currently given on our tax rate or any of the other ranges that we've given. And going forward, if there's any impact, we'll be sure to communicate that.
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Operator
Operator
Thank you. Our next question comes from Randall Stanicky of RBC Capital Markets. Your line is open.
RL
Randall S. Stanicky - RBC Capital Markets LLC
Analyst · RBC Capital Markets. Your line is open
Great. Thanks. Heather, just a bigger-picture question for you. The U.S. generics sector remains fragmented. Obviously, you are one of the market leaders. As we see approvals come through over the next couple of years, I guess a question. Understanding that you are positioned differently and you guys see a stable outlook for profitability, do you think that the sector profitability could come under pressure? And then two, do you think that's going to drive consolidation amongst some of the middle-tier players? And do you guys plan to continue to participate in that consolidation? Thanks.
Heather M. Bresch - Chief Executive Officer & Executive Director: Yeah. Thank you, Randall. We absolutely believe consolidation will continue, I think not only just from a U.S. perspective, but from a global perspective. I think as you step back and look at the dynamics of this industry today, I mean they are just significantly different than they were just a few years ago. Everything from our customer base that continues to consolidate and have a global footprint, there needs to have a global partners that can truly marry up an effective and efficient supply chain, cost of goods, the breadth of portfolio while not losing sight of investing in the complex products like a generic Advair, bringing to the market. So, I believe that there will be a continued consolidation around the globe. And we absolutely plan to continue to participate. What we've said is that given the platform, both operational and commercial platform that we've built today, that it's easy to now complement it with bolt-ons that allow us to continue to grow critical mass, just like we're doing with over-the-counter business. As we bring in the Meda and now have a billion-dollar franchise, we'll be able to continue to think about the best ways to continue to grow that channel throughout the globe. So, yeah, I think there's going to be much more consolidation and I think that the global players with global scale, which is why we do really believe we've differentiated ourselves. And it took 10 years; it's not a flip of a switch. Companies may want to change their business models, but to change business model, you've got to be willing to take the time and the investment needed to truly change your business model.
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Operator
Operator
Thank you. Our next question comes from Ronny Gal of Bernstein. Your line is open.
Ronny Gal - Sanford C. Bernstein & Co. LLC: Hi. Good morning and thanks for taking my question. I have two of them, first for Tony. Tony, when I can look at your progress through the year on the public demand, I see Nuvigil, Kaletra, Benicar, Benicar HCT, Copaxone and Estrace as potential launches during the year of material size. Anyone else you'd like to highlight just so we have the right launches in place? And second, for Rajiv. Rajiv, I think Biocon mentioned on their call, they're going to file insulin glargine soon as part of your partnership. Can you just confirm to us you have both the vial and the pen as product? Obviously, there's a different IP situation on both, so it's kind of important to tell if you got both.
AO
Anthony Mauro - Chief Commercial Officer
Management
Yeah. Thanks, Ronny. As it relates to 2016 launches, I think we have a very robust launch plan phasing throughout 2016, and we look forward to those opportunities to bring new products to customers across all of our markets.
Ronny Gal - Sanford C. Bernstein & Co. LLC: Any other ones you care to highlight as important launches?
AO
Anthony Mauro - Chief Commercial Officer
Management
Not specifically.
Heather M. Bresch - Chief Executive Officer & Executive Director: Ronny, I think as we've said, we are well beyond being about any one product or launch. I mean, we're launching hundreds of products around the globe. And so I think again, as you look at more of the channels we're operating in from hospital with our injectable business to the retail business, on to our specialty, Rx business, I mean it's truly a holistic One Mylan that's allowing us to manage and absorb the volatility within the marketplace.
Rajiv Malik - President & Executive Director: And, Ronny, on insulin, we remain on track to bring forth as well as the file very soon both in Europe as well as the U.S. And also I would like to highlight that Japan approving insulin of that is the same .
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Operator
Operator
Thank you. Our next question comes from Umer Raffat of Evercore ISI. Your line is open.
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Umer Raffat - Evercore ISI
Analyst · Evercore ISI. Your line is open
Hi. Thank you for taking my question. Maybe first one for Rajiv. Rajiv on your generic Advair trial that's posted on ClinicalTrials.gov, it seemed like the enrollment was done only in 18-plus-year-old patients. Just wanted to understand, I mean FDA guidance seems to imply 12-plus, and I wasn't sure if that was just semantics on the ClinTrials website or if you have an additional bridging study beyond for the 12 to 18 year olds, number one. And then a couple of follow-ups. One was just in general, on the reclassification of Brazilian operation into North America. Just wanted to understand that and then also the cash flow conversion this quarter. Thank you.
Rajiv Malik - President & Executive Director: So, I will only – I don't know what specifically you're talking about but our study is very much in line with the guidance issued by the FDA and there is no separate bridging study just from that point of view.
Heather M. Bresch - Chief Executive Officer & Executive Director: Yeah, no, and Umer, as far as Brazil goes, if we're down to talking about things that represent 1% of our revenue, I think we're doing pretty good. So, there is no, obviously, significant impact whatsoever from the reclassing of the Brazil operation. And as far as cash flow, I think it's all expected. We had some timing issues around inventory build and some of the product launches, but certainly nothing out of the ordinary, whatsoever.
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Operator
Operator
Thank you. Our next question comes from Douglas Tsao of Barclays. Your line is open.
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Douglas Tsao - Barclays Capital, Inc.
Analyst · Barclays. Your line is open
Hi, good morning. Thanks for taking the questions. Just maybe, Rajiv, as a starting point, just could you provide some perspective in terms of timing for the filings for glargine, pegfilgrastim and trastuzumab in the U.S. in particular?
Rajiv Malik - President & Executive Director: I would say all, pegfilgrastim, trastuzumab and glargine are very much on track and we'll be filing in the next few months.
DI
Douglas Tsao - Barclays Capital, Inc.
Analyst · Barclays. Your line is open
Okay. Great. Thank you very much.
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Operator
Operator
Thank you. Our next question comes from Andrew Finkelstein of Susquehanna. Your line is open.
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Andrew Finkelstein - Susquehanna Financial Group LLLP
Analyst · Susquehanna. Your line is open
Hi, and thanks for taking the question. I was hoping that you could speak a little more specifically about the dynamics with generics in the U.S. As we look at the gross margin, there's obviously a lot moving parts depending on the timing of launches. But is the price erosion you're seeing or product mix a bigger factor in the gross margin development, particularly as we look on a year-on-year basis? And then in this environment where the customer picture has changed, how do you feel about the visibility on results for the rest of the year given we are seeing an increase in and approvals out of FDA which could mean new competition on some of your existing products over the course of the year? How much does that affect your planning assumptions for what the base portfolio is going to provide? Heather M. Bresch - Chief Executive Officer & Executive Director: No. Thank you. Look, I think there's been significant confusion both with the investment community and Washington when it comes between generics and specialty products. I think that as we look at some of the hearings that have taken place, at some of the dynamics and some of the discussions have all been around specialty products or one-player products. So, when you step back and look at the generics portfolio, the generic industry today represents 88% of the volume of all drugs dispensed in the United States. We've saved over $1.5 trillion over the last 10 years for the U.S. healthcare system and we today represent 28% of the pharmaceutical spend which is only 10% of our healthcare spend. So, when you really drill down to, generics have continued to be the backbone of this system. We have continued to have products that continue to face competition…
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Operator
Operator
Thank you. Our next question comes from Jason Gerberry of Leerink Partners. Your line is open.
JL
Jason M. Gerberry - Leerink Partners LLC
Analyst · Leerink Partners. Your line is open
Hi. Good morning, and thanks for taking my questions. Two for me. Just first maybe for Rajiv. On Advair, do you believe that you'd be entitled to six months of regulatory exclusivity if, in fact, you get an approval on your action date which is a little bit ahead of the competitor's action date? And then I apologize, but on my second question, I might have missed this, but can you just explain the Rest of the World Generics line, the sequential weakness of about 26% Q-over-Q. I know that the 1Q tends to be a little softer than the 4Q. But that was a bit further down than we expected for the quarter. Thanks.
Rajiv Malik - President & Executive Director: Okay. Let me – on Advair, I think we have a head start from filing an acceptance but we don't have a head start from the six-month exclusivity from – because it's not a Paragraph IV certification. But we might have a market exclusivity just because of that head start and where we are with the fine. The second one was both...
Heather M. Bresch - Chief Executive Officer & Executive Director: The emerging, Rest of World.
Rajiv Malik - President & Executive Director: The emerging markets. It's a timing issue. It's nothing but a timing issue. It's some delay in the launch of tenders where we already have the contracts, but there's a delay in the launch of some of the tenders in our HIV business in those emerging markets. So, it's nothing more than that. Our commercial business in India and other emerging markets are going pretty well. You saw our HIV business where we saw some delay in the launch of those tenders.
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Operator
Operator
Thank you. Our next question comes from Marc Goodman of UBS. Your line is open.
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Ami Fadia - UBS Securities LLC
Analyst · UBS. Your line is open
Hi. This is Ami Fadia on behalf of Marc. Two questions. Firstly on EpiPen, where are we on inventory levels and the changes impact to the quarter? And secondly, could you give us some color on some of the key markets in Europe such as France, Italy, UK, et cetera? Thank you.
Heather M. Bresch - Chief Executive Officer & Executive Director: Sure. As far as EpiPen goes, there's no issue with inventory. We never did have any issue with inventory. I think there was, again, a bit of a disconnect and some of the models had gotten it wrong. And I think that most of those have been corrected, at least as far as we can see. But our EpiPen inventory levels are very, very much in line with our normal business as they always have been. As far as Europe goes, Rajiv, do you want to?
Rajiv Malik - President & Executive Director: Yeah. On France, we saw some pretty strong growth from our existing products and the volume and the market share perspective. We saw very strong growth in UK whereas our Italy was pretty stable and in line with the market growth.
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Operator
Operator
Thank you. Our final question comes from Tim Chiang of BTIG. Your line is open.
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Tim Chiang - BTIG LLC
Analyst · BTIG. Your line is open
Hi. Thanks. Heather, in the past, you've talked about vertical integration being a very important aspect to Mylan. How does vertical integration sort of play into this acquisition with Meda? I mean, would you be able to bring in some of the manufacturing that Meda has in-house?
Heather M. Bresch - Chief Executive Officer & Executive Director: Yeah. No. Thank you. Very much so. I think that it, both from a vertical integration as well as just our manufacturing operating platform. So there's two aspects of that. Vertical integration means that we're producing our own API that goes into the finished dosage form and then manufacturing our finished dosage form, or we're acquiring API from a third party but still manufacturing our finished dosage form. And the multitude of finished dosage forms that we now are capable of span by the dozen, so from oral solid to injectables, to extended release, to topicals. So we've continued to really invest and build out that capability. And so what we see, again as being this differentiator, controlling our own destiny through being able to manufacture, perhaps vertically integrate as well our global supply chain is what really gives that – gives us that head start or that advantage from a cost of goods perspective and the efficiency around it. So, just like we did with the Merck business, we were able to look at products that we could either consolidate that buying, we could bring alternate manufacturing in-house and be able to really leverage again our platform. Today, even more so than eight years ago because our manufacturing footprint has expanded dramatically, ten-fold since we did the Merck acquisition. So, our ability to bring the Meda's line which they do very, very little manufacturing. Most of their products are in-license. Again, that's just another added benefit of Mylan and Meda joining forces to really be able to optimize the operational and commercial platform that we've put in place.
Heather M. Bresch - Chief Executive Officer & Executive Director: Thank you very much for joining us. We'll look forward to seeing you soon. Thank you.
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Operator
Operator
Ladies and gentlemen, thank you participating in today's conference. This concludes today's program. You may all disconnect. Everyone have a wonderful day.