Mylan NV Q2 2016 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Chris Schott - JPMorgan - Analyst : Thank you very much. Two questions for you guys. First, on the US generic environment, and thanks for all the color on the call, is there any concern on your part that some of the weakness that your smaller competitors are experiencing results in more aggressive and less rational behavior from those companies, and that could, ultimately, impact your franchise if the market gets a little bit destabilized by that dynamic? The second question is, between the very strong EpiPen trends you're seeing right now and the earlier expected Meda close, it seems like there could be upside to the guidance range. Is there any offsets we should thinking about or are you just being either cautious and conservative now in terms of the range? Thanks very much.

Question: Ronny Gal - Bernstein - Analyst : Congratulations on the quarter. Two questions, if I can. The first one is this issue of the EpiPen cost shift to the patient that you've mentioned. Could you describe a little bit more about that? How does that get reflected in your earnings and what are you currently doing in terms of your business operations to try to help the patients along? That is, some confidence that that issue will not begin to impact your earnings into the next few quarters. And then, second to Rajiv, on Advair, I remember at the GPHA, that the people presenting from FDA mentioned that only 12% of NDA application gets approved first round. I know Advair is very important to you, but you can just give us a feel for what makes you confident that you can get such a complex product approved first round, given the rate of approval at the FDA at first round.

Question: Jami Rubin - Goldman Sachs - Analyst : Thank you. Just a couple of questions. First, Heather, I think we've talked about this before. I think you have $1 billion or so authorized for share buyback, and when you announced the Meda deal earlier this year, you had to suspend the buyback because of the pending deal. Now that the deal is closed, and, if you still believe in your $6 number next year, the stock does look pretty cheap. What is -- should we expect that you implement that buyback? And, secondly, just a question around the IPR process, which we'll hear about in the next couple of weeks. You guys still don't have Copaxone 20 on the market. Just wondering if you can share with us your expectations for what the market opportunity might look like for you for Copaxone 40, when you plan to launch. And without Copaxone 20 on the market, what does that say about your confidence level with Copaxone 40?

Question: Sumant Kulkarni - BofA Merrill Lynch - Analyst : Thanks for taking my questions. First one, could you comment on the price versus volume component of your specialty banded segment? And second, given the exceptional performance that you've had in that specialty brand segment that has helped your gross margins, could you comment on the trends within the generic gross margins and how sustainable those might be going forward?

Question: Elliot Wilbur - Needham & Company - Analyst : Thanks, good afternoon. Heather, just going back to the Meda transaction real quickly, you had earlier suggested that, in fact, that you're still on track or for $6.18 and can pull that forward in 2017. But specifically, I think you guys had talked about $0.35 to $0.40 EPS accretion in 2017. And obviously, given the earlier-than-expected close, assuming that you're still comfortable with that metric, but just want to confirm that.

Question: Douglas Tsao - Barclays Capital - Analyst : Hi, thanks for taking the questions. Maybe if you could start with the generics business and rest of world was below what I was looking for in my model. I was just wondering if you could provide some perspective in terms of what might have happened during the quarter. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 09, 2016 / 8:30PM, VTRS.OQ - Q2 2016 Mylan NV Earnings Call And then just on EpiPen, if you could provide some detail in terms of what your sense is in terms of inventory in the channel right now. Because that number looked very strong, or do you think that reflected true end demand for the quarter? Thank you.

Question: Randall Stanicky - RBC Capital Markets - Analyst : Heather, going back to your -- the sector rebasing that you highlighted, is that over or are we entering a cyclical patch that could last several quarters? And then to flip a prior question around, if that is the case, does that create opportunity for you as you look to consolidate the broader space? The second question is, what is your guys' strategy to break into the US OTC market?

Question: Andrew Finkelstein - Susquehanna Financial Group / SIG - Analyst : Thanks for taking the question. Could you talk a bit more about the guidance for the year? Can you quantify to any extent what the contribution is from Meda and Renaissance? Or to the extent, aside from timing, anything in Meda that's changed? And then as you look across some of the geographies ex-US, is there anything you can highlight maybe as a preview of the Investor Day of areas that are first on the to-do list to begin driving those synergies from Meda, whether it's in countries like Italy? Or is it bringing products across geographies? Any hints you can give there would be appreciated.

Question: David Risinger - Morgan Stanley - Analyst : Yes, thanks very much. I have a couple of questions, please. First, with respect to Meda, I'm hoping that you could paint a picture for how you're restructuring the business and what changes you're making to Meda after acquiring it, how you're integrating it, et cetera. And also how you have to change the accounting from IFRS accounting and accounting changes that are going to result there. And then, second, with respect to the second-quarter GAAP to non-GAAP, could you just provide some detail on the $174 million in restructuring and special items? I know that you completed Renaissance, and that obviously resulted in additional restructuring charges in the June quarter. But if you could provide some details on the $174 million, that would be great. Thank you.

Question: Greg Fraser - Deutsche Bank - Analyst : Thank you, this is Greg Fraser on for Gregg Gilbert. Had a quick follow-up on the very robust specialty sales. You commented on the strong demand growth and the price growth and the inventories were normal. I just wanted to confirm that there weren't any one-time-type items to help sales in Q2. And maybe you could comment on how you're generally thinking about market penetration and growth potential for EpiPen over the longer term?

Question: Umer Raffat - Evercore ISI - Analyst : Hi, thank you for taking my question. Heather, what was the year-over-year organic growth for the Abbott EPD business? And then what was the organic growth for the generics business, excluding Abbott and excluding any tuck-ins year over year, one? And then perhaps one for Tony as well. Tony, so on generic Advair, Glaxo, on their transcript, recently said they've absorbed a vast chunk of generitization effect through price reduction already on generic Advair. And they think that generics no longer have a straightforward proposition, quote, unquote. How do you think about that market going into first quarter next year and your PDUFA?

Question: Unidentified Participant - - Analyst : Hi, there, this is Eric on for Jason. Just a couple of questions. First, could you provide the contribution from the Renaissance transaction in 2Q and then just give some color on the growth profile of that business. And then second, on biosimilars, you guys have made some regulatory progress there. What would it take t get you take a larger stance in that market and maybe own 100% of the economics? Thanks.