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Transcript
OP
Operator
Operator
Good day, ladies and gentlemen, and welcome to the Mylan Third Quarter Earnings Conference Call. As a reminder, this conference call may be recorded. I would now like to introduce your host for today's conference, Ms. Melissa Trombetta, Head of Investor Relations. Please go ahead.
MN
Melissa Trombetta - Mylan NV
Management
Thank you, Crystal. Good morning, everyone. Welcome to Mylan's Third Quarter 2017 Earnings Conference Call. Joining me for today's call are Mylan's Chief Executive Officer, Heather Bresch; President, Rajiv Malik; Chief Commercial Officer, Tony Mauro; and Chief Financial Officer, Ken Parks. During today's call, we will be making forward-looking statements on a number of matters, including our financial outlook and 2017 guidance. These forward-looking statements are subject to risks and uncertainties that could cause future results or events to differ materially from today's projections. Please refer to the earnings release we furnished to the SEC on Form 8-K earlier this morning, as well as our supplemental Q3 earnings slides and our investor presentations titled Built to Last, all of which are posted on our website at investor.mylan.com for a fuller explanation of those risks and uncertainties and the limits applicable to forward-looking statements. Mylan routinely post information that may be important to investors on this website, and we may use this website address as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's regulation fair disclosure. In addition, we will be referring to certain actual and projected financial metrics of Mylan on an adjusted basis, which are non-GAAP financial measures. We will refer to these measures as adjusted and present them in order to supplement your understanding and assessment of our financial performance. Non-GAAP measures should not be considered a substitute for or superior to financial measures calculated in accordance with GAAP. The most directly comparable GAAP measures as well as reconciliations of the non-GAAP measures to those GAAP measures are available in our third quarter earnings release, supplemental earnings slides and investor presentation. Let me also remind you that the information discussed during this call, with the exception of the participants' questions, is the property of Mylan and cannot be recorded or rebroadcast without Mylan's express written permission. An archived copy of today's call will be available on our website and will remain available for a limited time. With that, I'd like to turn the call over to Heather.
HN
Heather M. Bresch - Mylan NV
Management
Thanks, Melissa, and good morning, everyone, and thank you for joining our call. Before we get started, I'd like to send a special message to our employees in Texas, Florida and Puerto Rico, and thank them for their perseverance following the devastating hurricanes that struck there during the quarter. We're extremely grateful that all of them are safely accounted for and are proud of how we all came together to support one another and people and surrounding communities in the storm's aftermath. Though we recognize that the journey to rebuild will be a long one, especially in Puerto Rico, which was affected most severely. We're glad to report that our plant there is operational, and we have not experienced any shortages of the drugs we manufacture at the facility. Turning now to our business. I'm personally very grateful to say that after years of hopeful anticipation, it finally happened. Early last month, we received FDA approval of our Glatiramer Acetate product for both the 20-milligram and 40-milligram strengths and immediately launched them into the U.S. marketplace. Being first-to-market with the 40-milligram strength as well as offering the 20-milligram is a milestone in many regards. First and foremost, it underscores our scientific and regulatory capabilities to develop, secure approval of, manufacture and bring to market an extremely complex product, despite an arduous multiyear process. Second, and equally as important, is our ability to continue to deliver on our mission of providing access to more affordable products to patients, and that's where our new Mylan MS Advocate Program comes in. It's designed to help patients get started and stay on track with their physician's treatment plan for either dosage strength. It should be noted that this program also paves the way for the many other products in our pipeline that have special…
RN
Rajiv Malik - Mylan NV
Management
Thank you, Heather, and good morning, everyone. Before I begin, I would like to thank our employees around the world for their hard work and unwavering focus on our mission, especially those who were affected recently by natural disasters. We are very proud of our employees who, despite personally going through this ordeal, were able to ensure that there was no significant disruption and drug shortages from our facilities. Let me briefly turn to our third quarter results. I will provide an overview of our top line performance, and Ken will cover segment profitability. Overall, we delivered nearly $3 billion in total revenues for the quarter, a decrease of 2% compared to the prior year. We saw strong performance in our Europe and Rest of World regions, which again, represent more than half of our revenue. This helped to partially mitigate the expected decline in North America. All regions benefited from contributions from our acquisition of Meda businesses, which continue to perform well and meet our expectations. Mylan integration is going strong, and we're excited to see the integrated platform come to life with no business disruption, while we brought various assets from Meda and Renaissance together. Now, we are continuing to optimize the assets we have acquired, and identify additional cost-savings, as well as revenue opportunities, beyond what we have previously stated and are expected to generate additional annual saving of more than $200 million. In North America, our robust portfolio, rich pipeline, commercial infrastructure and our long-standing relationships we have fostered with our customers give us the unique ability to face the turbulence of this market. We expect to see sustainable cash flows from our hard-to-make, complex product portfolio, which generally have a high regulatory hurdle to climb, and oftentimes, require clinical trials and, thus, give relatively better…
AN
Anthony Mauro - Mylan NV
Management
Thank you, Rajiv, and good morning. As Heather and Rajiv commented, the strong global diversified business we have built over the past decade gives us more confidence than ever about our future and our ability to be a key supplier to customers and patients around the world. Our unique commercial platform is fit to withstand change in our industry and continues to distinguish Mylan as a partner of choice during a time of further customer consolidation and globalization. One of the most important drivers behind our confidence is the daily effort made by our commercial team of nearly 7,000 people around the world. Without them, our products wouldn't reach the patients and providers who need the most. We are beginning to reap the rewards of a long-term and significant investments in science and innovation that Rajiv outlined in his remarks with the much anticipated U.S. launch of the first generic for Copaxone 40-milligram as well as a generic version of Copaxone 20-milligram. We are particularly pleased with our prescription uptake to date for the 40-milligram strength. For the week ending October 27, our share of new prescriptions was 16.2%, and total prescriptions was approximately 8%. We also are encouraged by the number of patients who are utilizing our comprehensive support services through our MS Advocate Program. Some of these services include in-home injection training with an experienced MS nurse, educational resources and a 24/7 patient support center. We view this launch as a critical opportunity to provide an affordable alternative for patients and payers, while still optimizing conversion and delivering value for Mylan. We look forward to successfully commercializing both strengths of this product in other key markets around the world as we receive appropriate regulatory approvals. In addition to generic Copaxone in the U.S., we are pleased with the…
KN
Kenneth Scott Parks - Mylan NV
Management
Thanks, Tony, and good morning, everyone. Turning to our financial results for the third quarter, total revenues in the quarter declined slightly year-over-year to approximately $3 billion. Rajiv and Tony have already taken you through our top line results for Mylan, in total and our segments; I'll now take you through the rest of our financial performance, which was in line with our expectations. In the third quarter, our adjusted gross margins were approximately 53% compared to approximately 57% from the same period last year. The decline is the result of lower gross profit from the sales of existing products in North America, primarily EpiPen, partially mitigated by new product introductions and contributions from last year's acquisitions. Moving on to our operating expenses, on an adjusted basis, R&D was approximately 6% of total revenues, which was in line with our expectations and down slightly from the prior year period due to the timing of clinical activities related primarily to our respiratory programs. SG&A expense, also on an adjusted basis, declined 3% to $586 million, or approximately 20% of total revenues and also in line with our expectations. In the quarter, the benefits from our ongoing Mylan integration activities more than offset the incremental SG&A from our Meda acquisition. Our adjusted tax rate was 17.5% for the quarter, bringing our year-to-date tax rate to 18%. We continue to expect our adjusted tax rate for the year to be in the range of 18% to 18.5%. Moving on to segment profitability, as a result of the declines in third-party sales, including EpiPen, segment profitability in North America declined 27% in the quarter to $576 million. Partially offsetting this decline, segment profitability expanded in the Europe and Rest of World segments, reflecting contributions from the Meda acquisition as well as new products sales.…
OP
Operator
Operator
Thank you. Our first question comes from Elliot Wilbur from Raymond James. Your line is open.
Elliot Wilbur - Raymond James & Associates, Inc.: (42:45). Thanks. Good morning. A question for Heather and the team, I guess, as you head into the year-end and you think about the budgeting, planning and, obviously, forecasting process, certain things like uncertainty and variability in the U.S. generic market is going to remain high elevated for the foreseeable future...
HN
Heather M. Bresch - Mylan NV
Management
Elliot, I'm sorry. Operator, if you could – we're not being able to hear you, Elliot at all on your questions.
OP
Operator
Operator
Elliot Wilbur - Raymond James & Associates, Inc.: Could you hear me now?
HN
Heather M. Bresch - Mylan NV
Management
Much better.
OP
Operator
Operator
You may proceed with your question sir, your line is still open.
Elliot Wilbur - Raymond James & Associates, Inc.: Okay. Thank you. Sorry about that. A question for Heather and the rest of the team, I guess, as we head into year-end budgeting, planning, forecasting process, obviously, uncertainty around where generic market is going to likely remain high for the foreseeable future. So just wondering, what you're thinking about in terms of or how you would characterize what you think are the greatest risks or the greatest unknowns at this point, whether it's continued uncertainty around FDA approval timelines for pending pipeline products, the impact of additional competitive entrants on portfolio products or sort of ongoing or evolving consortium purchasing dynamics. Just maybe sort of comment or kind of rank order, where you think the greatest risk among those factors lie with respect to the base business? Thanks.
HN
Heather M. Bresch - Mylan NV
Management
Sure. Thanks, Elliot. Look, Elliot, what I would say and hopefully, this call continues to underscore the global nature of our business. I think all the weaknesses you just laid out are all primarily U.S. driven. And as we continue to show, both from our European as well as our Rest of World segments, our ability to continue to grow at double-digit in the case of Europe and high single-digit in Rest of World, that as we continue to leverage our assets, our products in these areas and continue to bring complex Generics as we'll be launching Copaxone throughout Europe. I think those are very important to telling the story of how we're continuing to be able to absorb the volatility in this U.S. Generics market, and which is why I made the commentary that just to remind everyone that we moved out of the neighborhood of just U.S. Generics and Specialty and into this global community, that's helping us absorb that, and the Mylan that we built today is able to continue to deliver and on our growth profile as we continue to bring these products to market. As far as the U.S. Generics, we continue to see those headwinds are going to continue for the foreseeable future, but I think again, the dynamics of our portfolio of the products we're launching, Rajiv spoke of the multiple injectable products we've launched and the 70 that are in our pipeline. So the durability again of what we are launching from complex to injectables as well as continuing to deliver on our outside of the U.S. platform is what's able to give us the confidence to say that at least $5.40 next year. Given all those things you just mentioned, taking into consideration. So what I would say is just again the message of the durability of our platform and our ability to absorb the volatility, which we believe really distinguishes us from our peers.
OP
Operator
Operator
Thank you. Our next question comes from Jami Rubin from Goldman Sachs. Your line is open.
Jami Rubin - Goldman Sachs & Co. LLC: Great. Thank you. Heather, maybe if you could just take a step back and would love your thoughts on what you're seeing industry-wide, obviously the industry has been decimated with all the factors we've already talked about. But that's leading to in some cases, consolidation, other companies like Novartis, Mallinckrodt, maybe others are talking about selling their generic businesses. Where do you see Mylan fitting in with all this change? Are you in a financial position to be able to take advantage of some of these assets coming to the market, presumably at lower prices? And, I guess, Ken, to that question, I'm just wondering if – you've talked about your goal of getting your debt-to-EBITDA to three times or better. How flexible would you be on that if the right deal were to come up? Thanks very much.
HN
Heather M. Bresch - Mylan NV
Management
Hi, Jami, so thank you. We have been pretty staunch since the Meda acquisition that we really had the assets that we needed to leverage this global commercial platform and have that infrastructure in place. With that being said, we've continued to say as we see bolt-on opportunities that we can now use this commercial platform that we've built to be able to continue to feed this platform, we'll do so. And I think to your point, it truly is a buyers' market, because there's lots of great assets out there for sale and we think at reasonable prices. So I can assure you that the financial flexibility that we still have today and are maintaining because of our – the generation of our cash flows, that we're going to continue to be balanced as far as, yes, paying down debt and staying committed to investment grade, but also have the flexibility to be able to bring the right products or dosage forms into our mix, both whether it's U.S., Europe or Rest of World, and I think you're going to continue to see us execute on that. And the last thing I'd say, because I think your point about the decimation of the industry, I think one thing I would just ask, and I've said this before, but I think it's continuing to play out is the continuity of our management team and the tenure of it. We've been together a decade, as we've continued to not only manage at the peaks, but in the valleys. And I think that's where you see a management team that has – had a strategy out there, we've executed to it. We've continued to navigate the waters, I think, better than anybody else out there. So hopefully, that differentiation is what continues to put investors at ease with not only the credibility we've now hopefully amassed on the scientific side, but also just being able to continue to maximize this global platform and absorb what the industry is going through here in the U.S.
KN
Kenneth Scott Parks - Mylan NV
Management
Listen (49:29), Jami, I would just add on that on the financial discipline side and flexibility, you've seen us last year even with the Meda acquisition and a leverage ratio covenant extended to 4.25 times that we really never reached more than 3.8 times, and we remain committed to bringing that down as you've seen last quarter and this quarter down to 3.6 times under our credit agreement calculations. We did say, and I did say in this call that we've asked and obtained an extension from our banks at 4.25 times for the balance of 2017 and 2018, and that doesn't mean we're not committed to continuing to de-lever. But it actually speaks to the strength of our cash flows, and we talked about that a lot during the call today, as well as the fact that, as Heather said, in this environment, there are assets out in the marketplace that we just are going to continue to take a look at for potential bolt-on opportunities. And the banking group supports us, and that's why we have continued to de-lever, but have asked for that extension at 4.25 times. So there is a little bit of flexibility in our financial decision there, but obviously, with the discipline that over the long-term, we target a 3.0 times EBITDA leverage ratio number.
OP
Operator
Operator
Thank You. Our next question comes from Marc Goodman from UBS. Your line is open.
ML
Marc Goodman - UBS Securities LLC
Analyst · UBS. Your line is open
Yes. Just in the U.S., Tony, can you talk about the Econdisc and WBAD, the latest consortium to get together. I'm just wondering if you're starting to see any impact from that in this quarter. When do you expect we'll know what type of impact to expect there? And then, just in Europe, I mean, it was a pretty big number, and I was wondering if you could just give us a sense of was there any major launches? I mean, was Copaxone a big number in the quarter? Or biosimilars? Just give us a sense of was there anything unusual, because it was pretty good. Thanks.
AN
Anthony Mauro - Mylan NV
Management
Thanks, Marc. Around the global customers we're speaking of, in particular WBAD and Econdisc, we continue to work very closely with them and all of our customers to ensure that we're identifying not just risk, but opportunities. We feel like the markets we're in globally gives us a very good advantage in terms of how we overlay our portfolio with those particular opportunities. And as Econdisc joins WBAD, we feel like we reviewed it and looked at it and feel confident that we have the opportunity to grow in the future as these customers get larger with more scale across multiple markets, so.
RN
Rajiv Malik - Mylan NV
Management
And for Europe – Marc, this is Rajiv. I think we see a slew of launches; not of big launches, but the multiple countries and multiple launches. But more importantly, the portfolio expansion and the focus and attention these brands are getting, not only to sustain, but continue to grow, that's driving it basically. That's driving the growth in Europe.
KN
Kenneth Scott Parks - Mylan NV
Management
And one other – as you think about how the numbers come together, remember that we closed the Meda acquisition in early August of last year. So the year-over-year results do have an incremental month of Meda in them, especially in Europe.
OP
Operator
Operator
Thank you. Our next question comes from Ronny Gal from Bernstein. Your line is open.
Aharon Gal - Sanford C. Bernstein & Co. LLC: Hi, everybody. Good morning, congratulations on the result (52:56). Two, if I can sneak one in. One, you've got a corporate contingency in your cash flow statements of $275 million. Can you just let us know what that is? And second on Advair, do you have a target action date? And do you expect one?
KN
Kenneth Scott Parks - Mylan NV
Management
So on the first question, Ronny, I think what you're seeing is that in the reconciliation in the back of the press release, there's an add-back of $275 million to get from GAAP operating cash flows to adjusted operating cash flows. As we called out, we paid for about half of the DOJ settlement in the third quarter. The other half has already been paid in the fourth, but that's essentially what makes up the $275 million.
RN
Rajiv Malik - Mylan NV
Management
And Ronny, for Advair, yes, we have a target action date of June, middle of June. But at the same time, given this GDUFA I and GDUFA II, the bridging goal date, this being a high-priority product to the FDA, we continue to work with FDA very closely on this to better (54:03) that date.
HN
Heather M. Bresch - Mylan NV
Management
And I would just say, to add to that, that with the new Commissioner Gottlieb, his emphasis on complex Generics and being very mindful of bringing products to new market formation, we continue to know that generic Advair stays a priority review. And to Rajiv's point, we're hopeful as all the science behind us that we will continue to stay very close and work with this administration on what they've stated as real priority for them as well. So we find that very encouraging.
OP
Operator
Operator
Thank you. Our next question comes from Umer Raffat from Evercore. Your line is open.
UI
Umer Raffat - Evercore ISI
Analyst · Evercore. Your line is open
Hi, guys. Thanks so much for taking my question. I have two, if I may. First, maybe for Heather. Heather, is there an EPS number between $5.40 and $6 for 2018, which could serve as a threshold for additional compensation for senior leadership? Is there a $5.70 EPS, for example? Just wanted to understand that. And then, secondly, Rajiv, could you just give us some more color on RESTASIS, specifically, what you meant? The bridging date is end of December 2018. So does that put your potential target action date in second half of 2018? I just wanted to make sure we fully understood that. Thank you.
HN
Heather M. Bresch - Mylan NV
Management
Hey, Umer, so thank you. So first, Umer, what I would say is that our target of at least $5.40 is just that: our target. And when we come out in Q4, we'll certainly give detailed guidance and, at that time, provide ranges and everything, as appropriate. And I think any of the other disclosures are certainly out there that you can go check on our website, but I would just say that's why we feel very confident in our at least $5.40.
RN
Rajiv Malik - Mylan NV
Management
Yeah. And on RESTASIS, actually, if you have tracked, we had a target action date, Umer, on September, and that's when we received a IR (56:00) based on that new guidance change, which was immediately addressed and submitted. And this bridging goal date is now, basically, the December end is a bridging goal date, and there is no – we believe we have addressed every aspect of science (56:13), and we can be technically looking us getting over the threshold and getting approval of this very important product by this date.
HN
Heather M. Bresch - Mylan NV
Management
And I think, Umer, that just underscores what we had said earlier, what – our mission of continuing to fight for and bring affordable Generics to the marketplace, globally, is what drives us, and I think this is a great example of persevering through what I would call pretty desperate legal maneuvers to try to maintain a monopoly that should have been gone a couple of years ago, and our ability continue to fight not only in the courts, but with the science and have a clear pathway to approvals. So we're looking forward to bringing this important product to the market.
OP
Operator
Operator
Thank you. Our next question comes from Gregg Gilbert from Deutsche Bank. Your line is open.
GI
Gregg Gilbert - Deutsche Bank Securities, Inc.
Analyst · Deutsche Bank. Your line is open
Hi. Good morning. Another two-parter. I was hoping, Tony, I know you're not emphasizing the U.S. part of the generic neighborhood today. But on the generic price in the U.S. excluding the effect of your launches or the semi-exclusive products, was the erosion on your base of products, let's say, that they have been on the market more than a year, the same as it's been in recent quarters, or did it get better? Did it get worse? And separately for Heather and Ken, you both commented on dissatisfaction about your valuation. Would your acknowledge that part of the valuation disconnect can be accounted for by investor perception around shareholder friendliness and corporate governance. And if so, what are you doing tangibly to address those? Thanks.
AN
Anthony Mauro - Mylan NV
Management
Thanks, Gregg. On the U.S. Generics portion of the business, certainly, we've been discussing and talking about a full year number of mid-single digits, and I would say for Q3, we talked to you last quarter about it being a little bit choppy as well as Q4 just due to specifically around some significant first-to-file products in the previous year for the quarter that we're measuring against. So, I would say it was exactly where we thought we would be. And, at the same time, looking from a full year perspective, we feel high single digits is the accurate estimate that we have for 2017.
HN
Heather M. Bresch - Mylan NV
Management
Yes, Gregg. And as far as our discontent with the valuation, I think, as I said, I'm personally committed to get out there and educate and sit down with our shareholders to really talk about the business we have today, because I think that what you'll find in the presentation that we provided, Built to Last, is that when you look at Mylan in the portfolio, we have in each of these segments and you look at peers within, especially Europe and Rest of World and some of the valuations that are happening around their businesses where we have as good, if not, better businesses within those geographical regions, I think that's where a multiple expansion is certainly warranted when you now put our whole global product mix together. And I don't believe that's rooted or grounded in governance, I think that as we continue to have shareholder meetings and certainly stay open-minded and have these discussions, again, what I can say is, we look at companies out there around the globe with a whole host of governance issues from family-owned to a whole wide array of how they're on the public markets. We really believe it's the fundamentals that should drive that valuation, and we believe that the shareholder outreach program is going to go a long way to help rebase and have honestly us get credit of the company we've built over the last decade. And believe that we've got a real strong lead ahead of anybody else out there and have a real opportunity to really be the bellwether of this industry.
KN
Kenneth Scott Parks - Mylan NV
Management
Couldn't agree with Heather more, and I would just say, look, from a finance perspective, the presentation just went out there this morning. I would ask you to just really take time and take that presentation apart, because what you'll see is that under kind of any kind of measures, you would look at the performance, you would look at the global footprint, you look at the stable, durable cash flows of this business, and it is truly, truly undervalued. And the message that we're all trying to get across today and over the coming months, because we'll be out there talking to you more as we put this together, and we think the solidification of the business transformation has effectively been completed is we'll talk about that opportunity. But what I would challenge you to do is look at the numbers, look at the math, look at the compares and any case, the stock price, the company is not fully valued yet.
OP
Operator
Operator
Thank you. Our next question comes from Douglas Tsao from Barclays. Your line is open.
DI
Douglas Tsao - Barclays Capital, Inc.
Analyst · Barclays. Your line is open
Hi. Good morning. Thanks for the questions. Just a question on the Copaxone launch. If we look at the scripts according to IMS, the traction in the 40-milligram seems to be going very nicely, not necessarily being reflected in terms of the 20-milligram. Just curious if we should expect that to upturn? Or do you see most of the opportunity lying in the 40-milligram? Thank you.
AN
Anthony Mauro - Mylan NV
Management
What I would say Doug certainly, we knew from launch on onset that the 40-milligram made up almost 85% of the market. However, the 20-milligram is still very important to us as well, and we're very encouraged the 40-milligram script trend is (1:01:29), specifically new prescription trends over 16% after three weeks of launch, we feel like this is a tremendous opportunity, as well as an opportunity to look at market expansion, with 17 brands in MS space and only a one generic with the 40-milligram, we think there's an opportunity to expand on that product and expand the market at the same time. So yes, the 20-milligram is equally important to us, although the 40-milligram is the larger opportunity.
OP
Operator
Operator
Thank you. And that does conclude our question-and-answer session for today's conference. Thank you for participating in today's call. This will conclude the program. You may all disconnect. Everyone, have a wonderful day.