Good morning. My name is Angela, and I will be your conference operator. At this time, I would like to welcome everyone to the Valeant Pharmaceuticals Second Quarter 2015 Financial Results Conference Call. [Operator Instructions] Thank you. I would now like to turn the conference to Ms. Laurie Little, Head of Investor Relations. Please go ahead.

Thanks, Angela. Good morning, everyone, and welcome to Valeant's Investor Relations -- Investor Conference Call, where we will be discussing our second quarter 2015 financial results. Participating on today's call are J. Michael Pearson, Chairman and Chief Executive Officer; Rob Rosiello, Chief Financial Officer; Dr. Ari Kellen, Company Group Chairman; and Anne Whitaker, Company Group Chairman. In addition to a live webcast, a copy of today's slide presentation can be found on our website under the Investor Relations section. Before we begin, our presentation today contains forward-looking information. We would ask that you take a moment to read the forward-looking statement legend at the beginning of our presentation as it contains important information. In addition, this presentation contains non-GAAP financial measures. For more information about these non-GAAP financial measures, please refer to Slide 2. Non-GAAP reconciliations can be found in the press release issued earlier today and posted on our website. Finally, the financial guidance in this presentation is effective only as of today. It is our policy to update our firm guidance only through broadly disseminated public disclosure. And with that, I will turn the call over to Mike.

Thank you, Laurie. Good morning, everyone, and thank you for joining us. We are pleased to report exceptional results across all financial and operational metrics for our second quarter, driven by strong sales growth and profitability across our regions and businesses, and once again demonstrating the strength of our diversified and decentralized business model. Before we begin discussing the details of our performance, I want to provide the highlights of the quarter. We have now delivered 4 consecutive quarters of more than 15% same store organic growth. Strong performance throughout our businesses resulted in both our top and bottom line exceeding the Q2 guidance that we provided on our last call. These results were driven by the continued outperformance of our U.S. businesses and strong market results around the world, including Asia, Australia, Canada, Mexico and the Middle East and North Africa. I'm also pleased to report that Salix is off to a fast start. The productivity of Salix's R&D portfolio is demonstrated by the approval of Xifaxan for IBS-D in May, and the NDA filing for RELISTOR Oral in June, 2 significant milestones for our G.I. business. We remain focused on reducing Salix's wholesaler inventory and are on plan. Specifically, we have reduced inventory levels for Salix products to approximately 3 to 3.5 months as compared to 4 to 5 months at the April 1 close. Finally, we have already achieved $500 million in run-rate synergies and fully expect to achieve $530 million by the end of the year. Third, Dendreon continues to exceed our expectations for both revenue and profitability. We achieved $74 million of revenues for the second quarter, an increase of 18% versus the previous quarter, and gross margins of approximately 64%, an improvement of 15%, and operating margins of approximately 40% to 45%, which we…

Mike already described our exceptional Q2 results. Our revenue of $2.7 billion exceeded the midpoint of the guidance we provided during our Q1 earnings call by approximately $200 million, primarily driven by the outperformance of our U.S. businesses, including dermatology, contact lenses and dentistry. Our overall cost of goods sold improved to 23% in the second quarter, primarily due to the continued growth in dermatology as well as the acquisition of Salix, resulting in improved gross margins of 77%. SG&A remains above historical levels, but improved by 1 point from last quarter on an overall basis, despite increased costs associated with our launch initiatives. In the second quarter, we spent approximately $60 million in DTC advertising supporting Jublia, ONEXTON and Luzu. The overall improvement also demonstrates our rapid synergy capture from the Salix integration. R&D was $81 million in the quarter, an increase of approximately 45% relative to Q1, reflecting our continued investment in legacy Valeant programs and the addition of the Salix programs described earlier. As Mike mentioned, Salix contributed negative $0.04 in cash EPS for the quarter, taking into consideration the incremental interest and incremental shares related to the Salix financing. Valeant, excluding Salix, showed an even stronger sequential and year-over-year cash EPS. Legacy Valeant's topline organic growth and improved product mix more than offset increased investment in our launch brands. Turning to Slide 28, the acquisition of Salix have an even more significant impact on GAAP cash flow and adjusted cash flow. Valeant's GAAP cash flow, excluding Salix, was substantial at $714 million and there were minimal add backs to arrive at adjusted cash flow of $770 million. Salix had negative GAAP cash flow of $303 million, driven by significant cash charges related to unvested equity awards, restructuring charges, primarily severance, and the buildup of accounts receivable…

Thanks, Rob. [Operator Instructions] And with that, we will take our first question.

Our first question comes from the line of Chris Schott with JPMorgan.

Mike, can you just elaborate little bit more on the Xifaxan launch and IBS-D? Just specifically, how should we think about the rest of the year in terms of priorities for the organization? When should we think about DTC really starting to rollout? And are you comfortable at this point giving us a little bit more color in terms of peak sales opportunity for this particular indication?

Hey Chris, thank you. So we've submitted the marketing materials to the agency, and we hope to get those approved sometime in August. Unfortunately, probably late August. So our current expectation is we'll rollout our DTC program in September. We plan for a very, very heavy spend in the back half of the year. Actually, much higher than we had for Jublia last year. And as long as, again, keeps working like it has for Jublia, we continue that spend. We are not going to give a peak sales yet. We're not ready to give a peak sales yet for IBS-D. And we'll pull the whole sales force, all the sales forces in that are -- they'll be selling the IBS-D indication in late August and have a launch for these as well. We also recently decided to actually create a fifth specialty sales force covering G.I., and doctors that have the potential to prescribe Xifaxan. So we'll now have 5 sleeves rather than 4 sleeves.

Your next question is from the line of Andrew Finkelstein with Susquehanna Financial.

Perhaps you could address in a bit more detail what you're seeing in the global eye care market, particularly, where are you taking share and one of your competitors had a much more challenging quarter in that area, so maybe you can talk a bit about what differentiates your growth profile there? And then bigger picture, as you think about the spending levels, you talked about some of the incremental investments you're making. But as we look out to next year, has the level of SG&A and R&D investment you're thinking about changed from what you'd previously talked about for '16?

Sure. So we -- in eye care, it's a category that has a number of great companies competing in it. And I think we've just been a little bit lucky in having some great new products, and we've been able to introduce them to the market, so I talked about the Biotrue ONEday, which is doing extremely well. It's a great contact lens, very, very comfortable and I think it's certainly doing extremely well. ULTRA, I think it's going to be a bit of a -- it's a great lens too. So we're the beneficiaries of having some newer products. And I think we've also reorganized our business into local teams. And so through our decentralized model, I think that's really helping in terms or so. Well, we are gaining share in contact lenses, we are gaining share I think in the Rx parts. We are gaining share in surgical. But I think it's a combination of some great products and a really focused and talented team. And we are not going to give guidance on 2016 yet in terms of -- but in terms of philosophically, we have not changed our view in terms of what we think sort of R&D and sales and marketing expense be for the company.

Your next question is from the line of Louise Chen with Guggenheim securities.

It's Brandon on for Louise. We just like to get your view whether you're still interested in animal health? And if so, why and why not?

We're not going to comment on future acquisitions.

Your next question is from Annabel Samimy from Stifel.

You've pretty successfully added some very strong source of organic growth. And you have some meaningful franchises now, and it looks like your M&A activity is going a little bit back to bolt-on. Is this what we can expect in from like right now? And how do you see the pricing environment in the different regions looking, and how does that drive your M&A strategy?

Sure. I think we've always -- our M&A strategy will always be a collection of sort of the tuck-ins or bolt-ons as you referenced. And opportunistically, larger acquisitions. One can never predict the timing of a larger acquisition. So when those happen, those happen. We don't put them on our time line. But what you should continue to see at minimum is continued bolt-on acquisitions. And the segments of the deals we did, the deals this quarter, again, they're all -- none of them were competitive. They're more processes, and I think we don't -- at least the deals we're doing, we're not seeing a big change in any kind of pricing environment. So I guess that answers the question.

Your next question is from the line of David Amsellem from Piper Jaffray.

So with the recent 500% price increase on Glumetza in mind, can you talk about the extent to which you envision more pricing power, not just for other products acquired by the Salix transaction, but maybe just your assets, broadly speaking, in the U.S. How should we think about that?

So I think most pharma companies that I'm aware of is, the product gets into the last stages of their life, like Glumetza. We're going to lose Glumetza within 6 months. Often price increases are taken at the end. And so that was just consistent with what most companies do. And our view of pricing, across most of our portfolio, we do not take prices outside the U.S. There's like 0 price. I think, David, as we get more and more into segments like contact lenses and consumer products and other devices, we're not able to take price. So we're opportunistic, when it comes to price, but our base strategy is how do we grow organically through volume, which I think this quarter, we once again exhibited our ability to do so.

Your next question is from Tim Chiang with BTIG.

I think in past quarters, I've asked you about Emerade. Is there any update on Emerade? Is that a product that you're still targeting for a U.S. launch sometime like late next year, early '17?

So we can't -- yes, we are still hoping to get that product approved in the U.S. We have a meeting with the FDA coming up. And -- so why don't we update you on the next quarter on that. So hopefully, we can agree on the timing in the past, on the FDA. But before we have that meeting, I don't want to guess.

Your next question is from Gregg Gilbert with Deutsche Bank.

On the Salix increased guidance, is that all IBS, or there are some other drivers? And can you also share with us what the gross to net is for Xifaxan at this point?

So Rob why don't you answer the gross to net question, but first in terms of the revenue increase in Salix, when we modeled in the IBS-D, some of the other products are doing a little bit better than our forecast, but we wanted to be prudent in terms of raising our guidance. So the $200 million raise for IBS-D is what's included in the guidance.

And our forecast for gross to net is 30%.

Your next question is from Alex Arfaei with BMO Capital.

Can you provide more detail on the profitability of your Amoun business, probably synergies and how accretive the deal could be?

Yes. So Amoun, their operating margin today is sort of mid-30s, so 35% is probably a good proxy. So it should be actually quite accretive. We don't know the exact timing to close. Our partners, or the private equity company we purchased it from, think it will close in the third quarter, but we've built in fourth quarter close. We need to meet with the Minister of Health in Egypt, and the process is not as clear in Egypt as it is in some countries. But it should be quite accretive, and we will obviously get some synergies from this deal as well. The synergies may come more on the Valeant side than on the Amoun side, but as we consolidate our Middle East and Northern African business, and we do expect to maintain and maybe even accelerate the growth rates of that business.

Your next question is from Marc Goodman with UBS.

Mike, on Slide 13, you started to go through some of the organic growth you were seeing in different parts of the world. Could you go into a little more detail, just on Russia, China, some of these emerging markets and what you're seeing? Because clearly, the rest of the industry is struggling in these regions.

So Russia, we had a tougher first quarter, as you may recall. And part of that was everyone was buying like crazy in the fourth quarter. So Russia, we're very pleased. We have a great team over there. Very pleased to see that organic growth has now returned. We used to be growing there about 15%, but 7%, we're satisfied with for this quarter. Obviously, we'd like to get back to double digits, and well, we're very pleased to get that back. China, we just have a great team over there. It's just -- and again, you may remember an acquisition of Bescon last year, and that was on actually inorganic growth. There's probably still pro forma, but with some new colored contact lenses, but we've launched Biotrue Daily in China, and it's really taking off and they're just doing a great job. I think a lot of this is driven, in China and North Asia by the B&L business. And again, I think we have a set of products that -- newer products that are allowing us to maintain the growth and gain share. But I would really point to our people as the main reason we're doing so well.

Your next question is from Gary Nachman with Goldman Sachs.

Now that you filed VESNEO and RELISTOR oral, what are some of the commercial initiatives you're thinking about with those products? How will they be differentiated in their respective markets? And how big do you think they could be?

Yes. So we haven't done a lot of work yet on the launch product plan for RELISTOR oral. We just got it filed. We hope to get it approved next year. But what's great about this product is it's fast acting. And competitive products I think act within a couple of days. Our product will act within 3, 4 hours. And for most people, it reacts right away, 30 minutes. So since you -- if you are super constipated, fast-acting is good. Also, what we're finding is it's actually a product that helps save the healthcare system money. If you're in a hospital, you're not allowed to be discharged until you have a bowel movement. And so it's a product that I think is going to be a premium product based on helping healthcare economics. All that considered, we really haven't laid out our full sales and marketing plan, but we'll start doing that now that it's filed.

Your next question is from the line of Douglas Tsao with Barclays.

Mike, maybe on Jublia, if you could just elaborate, given the sort of transition to the 8 ml. Curious what you're seeing in terms of the gross to net on that product versus the 4 ml? And then also, are you seeing comparable coverage from managed care, or are you seeing any sort of limitations in terms of quantities and refills the patients were able to get?

I'm going to let Ari take that question. It's closer to...

Yes, the uptake on the 8 ml is being strong and it's running just under, as we said, around 29%. And the -- in terms of the gross to net, we're in ongoing discussions with managed care, and we suspect the gross to nets will be no worse than and probably better than the 4 ml.

Which is -- and then also just in terms of the limitations on refills, if any?

Well, the label, as you know, requires treatment up to 48 weeks. That is what we're promoting. And physicians understand that this product needs to be taken for a duration of therapy to achieve the desired results. And we're tracking -- refills are tracking very nicely.

Yes. So what we -- many people have multiple toes that are infected. And so we're seeing the refill rates on the 8 ml to be quite comparable to the 4 mls, if that's what you're asking.

Your next question is from David Risinger with Morgan Stanley.

I am -- I guess my first question is I'm wondering if you're trying to suggest with the background noise that you maybe on-site doing due diligence on a duck-farming [ph] business. We don't want you diversifying that much. But my real question is with respect to cash flow. Obviously, you've provided upgraded adjusted cash flow guidance of over $3.2 billion. Could you provide some more color on GAAP cash flow, and how we should think about that in the back half of the year? And then one tidbit of a question, could you just, Mike, tell us in a little bit more detail, the timing of when you're assuming Glumetza generics launch?

I think Glumetza generic is in February.

Yes.

Early February of next year. We'll get you a precise date. But that's -- so we assume we have it for the rest of this year. In terms of GAAP cash flow, Rob, you want to take that one?

Yes, and here's what I'd say, with respect to the $3.2 billion overall until this inventory situation that we are in is resolved, we're being conservative. What we described on the disaggregation was when you look at the GAAP cash flow for Valeant, excluding Salix, it was very, very strong. And as we work through, both the inventory on Salix as well as these largely onetime item that hit in Q2, you're going to see an acceleration in our overall GAAP cash flow.

Yes, in terms of GAAP cash flow, obviously, we'll converge to our adjusted cash flow over time. The big components are -- we've taken all the expenses for all the severances in this quarter for Salix. It's largely driven by Salix. And so there should be a ton, ton more charges. I think the next quarter, GAAP will still be probably a big, a significant difference, but by fourth quarter, we should be in a pretty good place. The only piece that will be lingering is there were some employee -- the severance agreement with Salix for some employees paid out over rather than a one-time payment, they were paid out over 12 months or 24 months, in some cases. So there'll be some small cash component. We did not accelerate that for obvious reasons, but we probably will offer a program where people want to get accelerated at a discount, we'll give it. But I think by fourth quarter, we should see significant convergence, and I do think this will be the most extreme -- Q2 will be the most extreme quarter.

Your next question is from the line of Corey Davis with Canaccord Genuity.

So if gross margins going to be running at close to 80% by the end of the year, without giving formal guidance for 2016 directionally, can you tell us how we should think about that going into 2016?

We certainly plan to get to 80% by next year. And we'll see if we get there by the fourth quarter or not. And then over time, we should do -- again, absent any other big deal, which could have an impact on it, I think gross margins will continue to improve.

And one quick follow-up on an earlier question on VESNEO. Are you still feeling as good on that one as you have in the past, and have you developed a commercial plan for that yet?

As Mike mentioned, we've filed VESNEO. We still feel optimistic about the product, as we've discussed in the past, and the unique mechanism of action for this monotherapy and the nitric oxide donating a piece of it. And we've had, obviously, since the last call, many more discussions with KOL, so we remain optimistic about the prospects of this product and its approval expected next year.

Your next question is from the line of Douglas Miehm with RBC Capital.

Doug? We'll go on to the next call.

Your next question is from Glenn Greenberg from Brave Warrior Advisors.

A quick question. On Salix, you've said the revenues this year would be about $1.2 billion, and it looks like they were $300 million in the last quarter and will be $300 million again in the third quarter, so does that imply that the fourth quarter revenues will be $600 million, and that we can maybe annualize that or a little better as we look into its contribution to revenues next year?

Yes. We're projecting $600 million for the fourth quarter. The $1.2 billion, in the end, may prove a little conservative, it depends. It's just hard to know all the inventory that could be out there. But the business is also accelerating, the growth continues to be very strong. And certainly, by first quarter of next year, we should be selling to full demand. So if you incorporate maybe a slight bit of inventory still in the channel in the fourth quarter, we don't know, that's what we're assuming. And then you continue to model in the growth that we're experiencing across the brands. That should give you a pretty good feel for what the setting [ph] will look like for next year.

Okay. And one further point, how did you make such improvement on the gross margin there?

In which -- you mean overall or?

Yes, in Salix as you know.

In Salix. Well, a lot of it, again, there was a lot of discounting going on in terms of inventory in the channels, so we're obviously just selling to demand.

And your next question is from the line of David Steinberg with Jefferies.

Just wanted to follow-up on the Jublia question. You mentioned the change in the gross to net, but did -- especially did the number of scripts going through the specialty pharmacy improve? I think it was about 50% last time. And secondly, given strength in some of your other Derm products in ONEXTRON and Luzu, what percent of those scripts are through your specialty pharmacy channels?

Yes, the adoption through multiple specialty pharmacies continues. I think last time, Jublia was around 50% and that trend continues. For Derm overall, it varies by product, but it's around 40%.

Your next question is from the line of Alan Ridgeway with Scotiabank.

Mike, you commented in your prepared remarks about the number of commercial lines for contact lenses, now planned to be 5 or 6. Can you maybe just comment on what you guys are seeing in the market as far as what gives you comfort that you'll be able to fill up that capacity? I'll leave it at that.

Sure. We talked about the 2 platforms that are really growing, one is Biotrue Daily, and I think they're increasing by 5 or 6, and then the second being ULTRA. And there, we're increasing by -- we're going up to 6. We only have -- currently have one installed. The size of the lines are quite different. Biotrue has much lower capacity than an ULTRA line, so that accounts for why so many more Biotrues than ULTRAs. It's probably close to 2:1, so it's probably about the same level of expansion. What gives us comfort is first, well, in the case of ULTRA, right now, we're only signed in the U.S. The other markets are clamoring for it. We may -- we're probably going to expand, in the next quarter, to a few more countries, but we have the whole rest of the world, and we can't satisfy demand in the U.S. Biotrue Daily, again, in the U.S., for example, is growing 4x the -- 4x the growth rate of the segment. And when we sort of model out what we think our final share will be and how quickly we're going, we're going to need this capacity. And I think what we have is a reenergized sales forces around the world. And maybe most important, eye care professionals, especially the contact lens area Ari, we're beginning to see it all back again [ph], and you may want to comment further.

Yes, I think that as Mike said, both the Biotrue as well as ULTRA is demonstrating the impact of the terrific technologies that B&L has been developing that we're fortunate to have received. And it really is new technology with better comfort, better oxygenation and better hydration and comfort throughout the day. And I think the expectation is in the end of the day, trying to deliver outstanding products to their patients, and we're simply enabling that. Hence, the growth share in the U.S. for both of those platforms, and again, as Mike had said earlier, tremendous growth across Asia, China, Korea, Japan and also in the world with these new technologies.

And we have no further questions. I'll turn the call back to you for closing remarks.

Great. Well, thanks, everyone, for your questions. And I guess it's time to get back to work. We'll talk to you next quarter.

This does conclude today's conference call. You may now disconnect.