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Bausch Health Companies Inc. (BHC)

Q2 2017 Earnings Call· Tue, Aug 8, 2017

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Transcript

Operator

Operator

Good morning. My name is Kim, and I'll be your conference operator today. At this time, I would like to welcome everyone to the Valeant Second Quarter 2017 Earnings Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. Thank you. Art Shannon, Senior Vice President, you may begin your conference, sir.

Arthur J. Shannon - Valeant Pharmaceuticals International, Inc.

Management

Thank you, Kim. Good morning, everyone, and welcome to Valeant Pharmaceuticals second quarter 2017 financial results conference call. Participating on today's call are Chairman and Chief Executive Officer, Mr. Joe Papa; and Chief Financial Officer, Paul Herendeen. In addition to this live webcast, a copy of today's slide presentation and a replay of this conference call will be available on our website under the Investor Relations section. Before we begin we would like to remind you that our presentation today contains forward-looking information. We also ask that you take a moment to read the forward-looking statement legend at the beginning of the presentation, as it contains important information. This presentation contains non-GAAP financial measures. For more information about these measures, please refer to Slide 2 of the presentation. Non-GAAP reconciliations can be found in the appendix to the presentation posted on our website. Finally, the financial guidance in this presentation is effective as of today only. It is our policy to generally not update guidance until the following quarter and not to update or affirm guidance other than through broadly disseminated public disclosure. With that it is my pleasure to turn the call over to Joe.

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Management

Thank you, Art. Many of you on the call know Art Shannon. Art joined us as Senior Vice President, Head of Investor Relations and Communications on June 19. Art and I worked together in the past. And we are very happy to have him as part of the Valeant team. So welcome, Art. With that let me start with the topics we'll cover on today's call. First, I'll give you a high level overview of what we've accomplished since our last earnings call. I'll then turn the call over to our CFO, Paul Herendeen, to review our Q2 financial results in detail. He will also cover our updated 2017 financial guidance. Then I'll run through some of the highlights in our business units and talk about the new product pipelines before opening the call for some questions. Starting with Slide 5. This is how we are thinking about the progress we are making towards a turnaround and transformation of our business. We have a journey ahead of us to be clear. As I've said before, it's going to be a multi-year process to transform this company. But I am very pleased with the progress that our team has made so far. We completed the stabilization phase in year one. And we are now on the early part of a two-year turnaround phase, where our focus is on strengthening our balance sheet, maintaining leadership positions in specialty-driven markets and those markets with above-average growth rates, and allocating resources efficiently. Now over to Slide 6. Let's run through some of the positive developments since our last earnings call. First, in terms of execution we continue to deliver on our commitments. Our two largest businesses are doing great and are now showing solid organic growth of 8% on a combined basis due to…

Paul S. Herendeen - Valeant Pharmaceuticals International, Inc.

Management

Thanks, Joe. Before I get started, I want to make clear that when we use the phrase organic growth related to revenue, we're adjusting reported revenue growth or decline to reflect the changes in FX rates compared with the relevant period in the prior year, what we call constant currency, and for the impact of divested assets. Next, the basket of LOE products included on the chart in the appendix to our slides continue to have a meaningful impact on our revenue and pre-tax profits compared with 2016. As a reminder, in a normal situation we'd simply call your attention to the impact of LOEs in our discussion of performance. However, the bolus of LOEs hitting the company in the 2016 and 2017 timeframe is quite large and creates a growth drag that we cannot overcome. As such, we've tried to be transparent with our expectations for these products, so that you can strip away the impact of the LOE products and see through to the performance of the balance of our business. The decline in the LOE products reduced revenue by some $110 million and pre-tax profits by roughly $100 million in the quarter compared with Q2 of 2016. I'll call out the impact of the LOE products a few times in my remarks. So I want to be clear as to why I'm doing that. Slide 10, financial results. Top-level summary, compared with the prior year quarter, revenue declined 8%. However, 220 basis points of that decline was due to changes in FX rates and another 280 basis points was due to the divestiture of assets, mainly the skincare assets in the B+L/International segment and Ruconest in Branded Rx. On an organic basis our business was down approximately 3%. If you further strip out the $110 million decline…

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Management

Thank you, Paul. As I mentioned briefly in my opening remarks, our focus on delivering on our commitments. Over the past 18 months we have made a number of non-core divestitures that have enabled us to simplify our operating model and reduce our debt. The chart on Slide 19 has been updated from last quarter to show the progress we've made in closing the previously announced transaction and announcing new divestitures. As you can now see, we have now closed 10 of the 12 asset sales we've announced. And we expect Obagi and iNova to close in the second half of 2017. We were able to execute transactions that delivered attractive returns for our shareholders. In the aggregate the average multiple received, including expected milestone payments, was greater than 10 times EBITDA. On slide 20 second quarter revenues for Bausch + Lomb/International segment were $1.241 billion. The business is growing 6% organically, driven by continued strength in China. China has delivered organic revenue growth of 9% year over year. And the Europe and Africa/Middle East were up 11% year over year in organic revenue growth. We are also excited about the launch of AQUALOX in Japan. These lenses were developed in-house by our scientists to offer maximum comfort. And they represent the first new innovation in the bi-weekly contact lens category in five years. And in terms of new product development, Luminesse is filed with a PDUFA date in December of 2017. We're proud to have developed Vitesse, the first and only hypersonic device and the first major vitreous removal innovation in 40 years. We've received FDA clearance in April 2017. And the first case was on July 18, 2017. In addition, the rollout of the Stellaris Elite cataract system has been successful. And we're receiving positive comments from surgeons…

Operator

Operator

And your first question comes from the line of David Risinger with Morgan Stanley. Your line is open.

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Management

David?

Arthur J. Shannon - Valeant Pharmaceuticals International, Inc.

Management

David, are you there?

Operator

Operator

David, if your line is on mute, please unmute. Your line is open.

Arthur J. Shannon - Valeant Pharmaceuticals International, Inc.

Management

Okay. Let's go onto the...

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Management

Let's go to the next one, operator.

Operator

Operator

Your next question comes from the line of Umer Raffat with Evercore. Your line is open.

Umer Raffat - Evercore Group LLC

Analyst · Umer Raffat with Evercore. Your line is open

Hi, thanks so much for taking my question. Perhaps first, Paul, Joe, how are you thinking about the $5 billion maturities in 2020? There's a lot of investor feedback and questions around a possible use of some sort of a combination of a convert, divestitures, and/or even perhaps an equity offering. So I just wanted to get color from you on that. Perhaps one for Scott [Hirsch, Chief Business Strategy Officer]. Scott, the SILIQ is now the lowest priced biologic on a WACC basis. Is it also so on a net basis? And if so, what type of feedback are you hearing from docs on how the REMS component is or isn't offsetting the fact that it actually is a cheaper alternative? And finally, just wanted to get a bit more specific feedback on exactly what remains un-remediated on the Florida batch facility for latanoprostene (30:58)? Thank you.

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Management

All right. Let me have – Paul, you take the first one on the – yeah, and then I'll take the SILIQ and then the Tampa.

Paul S. Herendeen - Valeant Pharmaceuticals International, Inc.

Management

Sure. I mean, Umer, as I said on the – in my prepared remarks, I think the good news is that we have a bit of runway here to deal with the maturities that are coming up in 2020 and then into 2021. Our intention is to deal with those debt stacks through a combination of cash flow generated from our business. Our goal is to generate the maximum cash flow we can and deploy it to reduce our indebtedness. Second would be to use as available senior secured leverage to address those unsecured bonds that are due in 2020 and 2021. And third would be, to the extent that we continue to sell assets, that would obviously reduce our refinancing requirements for those debt stacks. And then last, and as I said in a number of different conferences over the course of the last, call it, three months to four months, we always have to have on the table the prospect of raising equity or reissuing equity linked type securities to deal with that debt stack. Obviously it is our preference to use cash flow, senior secured leverage, and proceeds from the sale of non-core assets as a means of reducing that debt stack in 2020.

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Management

This next part of the question was relative to SILIQ and the WACC and net. Obviously we don't have all of the net charges. We just do know that number one, we priced SILIQ to be the most affordable biologic for the treatment of psoriasis. As we look at what we are doing with the different physicians that we're talking about, we are very encouraged by the response we're getting. We're still working through some of the managed care contracts and agreements. But the physician response has been very favorable to the product, predominantly because of the efficacy profile and our status as the only IL-17 blocker. I think we continue to look to generate more data, on not only the initial – the fast uptake of the SILIQ product relative to patient response, but also the opportunity to show the durability of the patient response. And we think that's what's going to be the primary reason why people will use it over time. But we're continuing to work to get additional access with managed care on the agreements. Importantly, we think this is going to be an important product for patients who have psoriasis, because of the significant efficacy associated with SILIQ. And we're working through the REMS program, which we – physicians – have already signed up physicians for the program as we sit here today. On the last part of your question was about Tampa. We are working through that. We obviously got a letter from the FDA yesterday afternoon. It is disappointing, as I mentioned in my comments. We do not believe there's any issues of safety or efficacy with Vyzulta. We believe it is specifically related to our Tampa facility. We had an inspection of our Tampa facility. We have responded to the observations from the FDA on that facility. And we've sent an additional response just recently to the FDA. Yesterday was our first feedback from the FDA. And we're going to obviously meet with the FDA and talk to them about the progress that we've made in resolving their questions. But I probably can't comment any further about the specifics of it, until we have firsthand conversation, another conversation with the FDA. But importantly, we've brought in some new capabilities in our quality team. We've hired a new individual from – previously with Lachman. And we've got a new head for the quality site in our Tampa facility that we hired from Alcon. And we've got some additional medical device experience that we've rehired into our Bausch + Lomb business. So we're taking the steps we think are required to remediate this program. Operator, I'll take the next question

Operator

Operator

Thank you. Your next question comes from the line of Gregg Gilbert with Deutsche Bank. Your line is open.

Gregg Gilbert - Deutsche Bank Securities, Inc.

Analyst · Gregg Gilbert with Deutsche Bank. Your line is open

Thanks. I have a few here. First, can you speak to non-Bausch + Lomb/International and whether that's core or non-core longer term to Valeant? Paul, on Salix can you talk a little more about what is temporary about the price effect that helped Salix? And quantify the gross-to-net benefit? And comment on whether there were any inventory changes in the quarter? Thanks, guys.

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Management

Sure. Starting, Gregg, with the non-Bausch + Lomb/International portion. That is an important part of our business. We like that business. Obviously you're seeing some very significant growth. The leader we have of that business, Tom Appio, has just got done an outstanding job in getting that team focused and delivering on the results. We're very pleased with the business. We very much run it as part of our International business, including both the Bausch + Lomb as well as the non-Bausch + Lomb sales. But we run it as one business unit in each of the countries. So it is critical to us as we think about the future of how that business, the critical mass we have in the business and how we run it. So we like it. We think Tom has done a great job with it. And we're going to continue to have it as part of our business. I think, Paul, you had the next question on the portion of the Salix price increase.

Paul S. Herendeen - Valeant Pharmaceuticals International, Inc.

Management

Sure. Yeah. Yeah, saying, which I mentioned it, and a part of it is less durable, Gregg. And what I'm talking about there is if you – to the extent that you have net pricing, and it's on Xifaxan, clearly, that is sticky and hopefully – clearly. Or it is sticky. And you'd expect that to continue on into Q3, into Q4. To the extent that we get good pricing on products that are – have a projected decline, that is less sticky. And so doesn't stick with the company here as we go ahead into Q3 and 4. But there's really good news there. I mean if you look at Salix, it was very strong growth in Salix even setting aside some of that price increase that may not continue on as strongly. I mean we had volume. We had price. Look at Xifaxan, for example, if you want to look at an impact of pipeline. Because overall, the GI space did not have a lot of pipeline change relative to Q2 of 2016. Xifaxan did a bit. I mean you have – I mentioned in my prepared remarks, people look in at Rx as up 2%. Well, extended units were up 4%. Volume in Xifaxan, fundamental volume, up circa 4% plus. We had the benefit of some modest price increases with respect to the brand. And then we did benefit in the Xifanan brand within Salix year over year from a relative pipeline expansion. Now before anybody gets excited, pipeline is well within a normal range in 2017 in Q2. It's just that in the year-ago quarter, we had a contraction of – I'll get the number close. It was about 0.4 months, versus a contraction in the Q2 of 2017 of about 0.1 months. That is a net expansion, if you will, in Q2 of about 0.3 months of Xifaxan. So that helped that 16% increase year over year in the quarter.

Gregg Gilbert - Deutsche Bank Securities, Inc.

Analyst · Gregg Gilbert with Deutsche Bank. Your line is open

And the gross-to-net benefit too lastly? Q2?

Paul S. Herendeen - Valeant Pharmaceuticals International, Inc.

Management

Yeah, the gross-to-net benefit was quite modest but also should be sticky.

Gregg Gilbert - Deutsche Bank Securities, Inc.

Analyst · Gregg Gilbert with Deutsche Bank. Your line is open

Thanks.

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Management

Operator, next question.

Operator

Operator

Thank you. Your next question comes from the line of Louise Chen with Cantor Fitzgerald. Your line is open.

Louise Chen - Cantor Fitzgerald Securities

Analyst · Louise Chen with Cantor Fitzgerald. Your line is open

Hi, thanks for taking my questions. I had two here. So first question I had was we've often gotten the feedback or pushback that even though you've been very aggressive with debt pay-down that the leverage ratio isn't coming down fast enough. And just curious how we should think about that maybe qualitatively in 2018 and beyond? And then secondly, just curious. You've done a lot to stabilize this business and turn things around. But what still keeps you up at night? What are some of the key hurdles left that you think are really important to overcome to get the company back to consistent earnings growth? Thanks.

Paul S. Herendeen - Valeant Pharmaceuticals International, Inc.

Management

Louise, it's Paul. I'll start with the leverage ratio. Obviously our goal is to reduce that leverage ratio over time. As we said many times in public forums, our company carries more debt than it should based on the assets that we presently manage. The two ways that we can address that most easily are through generation of cash flow and growth of adjusted EBITDA. Those are absolutely the best ways to do it. So as we look forward, a combination of reducing debt from cash flow, as I outlined. To the extent that we see opportunities to sell assets and improve our credit profile and the quantum of debt, yeah, we'll go ahead and do that. The best way is for us to grow our adjusted EBITDA.

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Management

Yeah. And clearly I think as we go to the key hurdles that you're talking about, number one, it's all about the execution of the business. It's taking and finding ways to grow our Bausch + Lomb business, which we did in the quarter at plus 6% organic, as well as growing the Salix business. That's clearly one of the comments that I made in the call, plus 16% organic. We know that the Derm business is not performing up to expectations. And that's the next area we have to focus. But the good news for us we think is that 73% of the business, the Bausch + Lomb/International plus the Salix, is performing on a combined basis of about 8% organically. We think that's a real important factor towards the question for the future. On the question that Paul mentioned on the debt, it is an issue. The good news is we brought it down from $32-plus-billion to it'll be somewhere in the $27 billion, after we make these additional payments. So we think that's an important part of what is critical for us for the future, as Paul very appropriately commented on. And final comment is we need to continue to resolve some of these legacy legal issues. Christina Ackermann and her legal team are just doing an outstanding job. And I think as mentioned today, we've cleared up a number of important issues that have been part of our legacy legal issues. We believe we need to continue to work towards resolving those for the future. And that really will be our focus for the next three months and the next year.

Louise Chen - Cantor Fitzgerald Securities

Analyst · Louise Chen with Cantor Fitzgerald. Your line is open

Thank you.

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Management

Operator, next question.

Operator

Operator

Thank you. Your next question comes from the line of Chris Schott with JPMorgan. Your line is open.

Unknown Speaker

Analyst · Chris Schott with JPMorgan. Your line is open

Morning. This is Chris (42:06) on for Chris. First question, can you elaborate on the progress for rightsizing the Dermatology portfolio? Between your upcoming launches for SILIQ in IDP-118, the sales force realignment, and your work to stabilize the ASPs, what's the next steps for the Derm business? And how do you think about the balance of restructuring the effort, your restructuring efforts and upcoming launches? And for a second question, can you talk through the 2018 pushes and pulls on EBITDA? Just looking to next year as a flat EBITDA possibility in 2018. And should we think about EBITDA being down with the divestitures and ongoing pressures in the Diversified business? Thank you so much.

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Management

Sure. Let me start with the – what we're doing on the Derm business. Clearly the Derm business, as I mentioned in the call, has a number of market dynamics that are changing. We're seeing some of the products, for example, some – a retinoid that has switched to over the counter. We've seen some of the changes in managed care access and rebates and the gross to net. And appropriately what we did is we took the decision early in the year to move to the right number of sales reps for our company. That meant we reduced it from 250 approximately to 151 sales reps. That was an important step to right-side the expenses relative to what we saw in the portfolio. As we think about the future though, the very clear direction we have is going to be to grow this business as a result of launching new products. These new product launches, starting with SILIQ last month, then moving to IDP-118, which is we think a very novel way to treat psoriasis, are going to very important opportunities for us to grow this business and to grow EBITDA into 2018 and beyond for the Derm business. But I think that's probably the best I can answer relative to where we're going with it. Clearly the action steps I talked about, also talked about stabilizing the average selling price, which we've done, partnering with our Walgreens and trying to continue to amend and enhance that program, looking at a new branding for the Derm business, a new management team in place. I think we've taken the steps that are going to position us for growth for the future. But it's really going to come down to new products really is the important comment.

Paul S. Herendeen - Valeant Pharmaceuticals International, Inc.

Management

Yeah, with respect to EBITDA, adjusted EBITDA for 2018, we're not going to provide guidance for 2018. But I will provide a couple things to think about. If you're solely looking at growth, aggregate growth, stating the obvious things that need to be taken into consideration are the LOES, the timing of those LOEs, and the divestitures, and the timing of those divestitures. So if you're simply laying down actual results expected for 2017 versus 2018, you need to take those into consideration. And definitionally the LOEs and the divestitures will be a earning – excuse me, a growth drag on 2018. Now interesting with respect to the LOEs, our hope would be that the LOEs would continue to get pushed out. And we'd gain more revenue and therefore, cash flow from those LOEs in 2017. And then ultimately they go – when they go generic, where they lose their exclusivity, it's a growth drag. But we would prefer as you've seen that we continue to see increased revenue expectations for that LOE basket. But those – make no mistake, those are going away in 2018. So that you need to keep that in the back of your head. The important thing is I think talking about LOEs and divestiture is you strip both of those away and look at our underlying business. Joe referenced, I referenced in our – my comments about the underlying strength of our core businesses. I mean I'd use the B+L business, B+L/International segment as an example. It's growing strongly. The Salix portion of our Branded Rx business has returned to a growth mode. It's our goal to bring – excuse me – the Dermatology business back to a growth mode. If we do all those things, then the core part of our business for sure would grow in 2018 relative to 2017.

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Management

Operator, our next question please.

Operator

Operator

Thank you. Your next question comes from the line of David Amsellem with Piper Jaffray. Your line is open. David A. Amsellem - Piper Jaffray & Co.: Thanks. I have just a couple questions on the GI business. First on Xifaxan, can you talk about the mix from growth related to – was it driven by primarily IBS or HE or both? And how much of it was just benefit from the more restrictive labeling for Viberzi? So maybe you could talk to those near term dynamics. And then just secondly, on a broader GI question. Before Salix was acquired, there was a fair amount of R&D spend on the business. That's obviously fell by the wayside. I guess the question here is this. You've talked about R&D in Ophthalmics and Dermatology. I'm not hearing a ton about R&D in the GI space. So maybe you could talk about what you're doing to try to rebuild the R&D infrastructure for the GI business? And how much of a priority that is?. Thanks.

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Management

Sure. So let's start with the first part of your question. Clearly the IBS has been an important part of the growth. But I do want to be – let you know we've got specific HE programs that are helping the hepatic encephalopathy as well, especially with patient compliance. First, to deal with the IBS question. The IBS-D opportunity for us was one that was very – we recognized it going back about six months, eight months ago. And we looked at it and said, we really need to build additional primary care capabilities. We've put together that primary care capability of over – approximately 250 sales representatives, sales professionals out there. That was important to us to reach the majority of the IBS physicians that prescribe IBS products. That work, together we got that in place on or about February. And that has really driven a majority of the incremental volume that we're seeing. But I don't want to be – I want to be clear that having the incremental sales force and growing that, as I mentioned in the call, 1,200 basis points was absolutely one of the important primary care efforts. On HE though, one of the things we've also put together for HE is additional programs to help with compliance when a patient is first diagnosed and discharged from a hospital with HE to make sure that the patients who are discharged get the appropriate product and stay on it from a compliance point of view. So we put together some nurse educator programs, some discharge planning programs to help us with the HE in making sure that the patient gets the maximum benefit of Xifaxan, so that they do not get readmitted to the hospital. So I think it was both of them. But clearly…

Operator

Operator

Thank you. Your next question comes from the line of Gary Nachman with Bank of Montreal. Your line is open.

Nicole Germino - BMO Capital Markets

Analyst · Gary Nachman with Bank of Montreal. Your line is open

Hi, this is Nicole on for Gary. I just wanted to ask a couple questions. Have you completely fixed the Walgreens partnership? Or are there still more tweaks that need to happen there?

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Management

Well, I would say that Walgreens is an important partner for us. What we've worked – and especially in the Dermatology area on a number of projects with Walgreens to improve the patient experience for patients that go in looking for filling a Dermatology prescription. So we – but we clearly do think there are additional things that we're working with Walgreens to improve in the program. So I think in general what I'd say is number one, we've fixed some of the issues we had a year ago, which was relative – we're seeing in relative average selling prices. Number one, that's been fixed. We feel we now are stabilizing our average selling prices for Dermatology. Number two, I do think there are some additional opportunities for us. And we're talking to Walgreens all the time about what are some of the next generation opportunities for us to partner with Walgreens for the future and looking at how we can modify or enhance the existing agreement. So I think there are still opportunities there that we'll spend more time working with Walgreens for in the future. Okay?

Nicole Germino - BMO Capital Markets

Analyst · Gary Nachman with Bank of Montreal. Your line is open

Okay. And how much of the Dermatology volume is going through Walgreens? And why aren't we seeing more of a benefit with those prescription trends there?

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Management

Yeah. I don't know we're going to give out the exact percentage of our Dermatology business that goes through Walgreens. I would say clearly Walgreens is an important part of the business to be clear, relative to just as a general comment. But I don't want to suggest that we're going to give out the percentages right now. But I think the important part when I step back from Walgreens, or step back from your question and say, what's going on with our programs with Walgreens? We think Walgreens is a good partner. And we're working to try to enhance the program for the future. And that's really how we're doing it. But I probably don't want to give out the exact line that goes through Walgreens.

Nicole Germino - BMO Capital Markets

Analyst · Gary Nachman with Bank of Montreal. Your line is open

Okay, great. Thanks so much.

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Management

Next question.

Operator

Operator

And your next question comes from the line of Doug Miehm with RBC Capital Markets. Your line is open.

Douglas Miehm - RBC Dominion Securities, Inc.

Analyst · Doug Miehm with RBC Capital Markets. Your line is open

Yeah, good morning. First question just has to do with the foreign exchange component there. I believe it was $38 million that you're showing in the – Page 18 on the guidance slide in terms of the bridge. I'm just wondering if that was the full amount that was impacting Q2? Or if there was an amount from Q1 that I had just overlooked right now. And then the second question just has to do with the changes in contingent consideration/milestones from $230 million to $270 million I think it is and what that relates to? Maybe SILIQ? And then finally why CapEx dropped from $250 million to $175 million? Thanks.

Paul S. Herendeen - Valeant Pharmaceuticals International, Inc.

Management

Yeah, I'll start with the FX piece. That $38 million that we call out is the one that you can quite easily find in our financial statements. It's the FX gain on intercompany debt balances that is a component of our adjusted EBITDA. And so it's kind of – that was what was recognized in the quarter. There was also a gain recognized in Q1 – help me, someone, with the...

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Management

$26 million, I think, or something like that.

Paul S. Herendeen - Valeant Pharmaceuticals International, Inc.

Management

It was $26 million in Q1. But specifically the $38 million was what impacted our adjusted EBITDA in Q2. As you're thinking about the impact of FX in its entirety on adjusted EBITDA, I did call out that it has two components. One is this transactional gain. And the other are headwinds, basically less favorable FX rates relative to the prior year period. And net-net that translated into a bit of a tailwind, not an enormous amount in adjusted EBITDA.

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Management

And the final question was on CapEx. CapEx is something, it just depends on when your – how projects progress through the year. It's really for us, one of the things that we talked about is changing how we've taken approach to globalize our business and globalize our capital expenditures. Dennis Asharin on our team has done really nice job in putting together a program and activities for how we look at CapEx. And I think we just believe we can be a little bit more efficient with CapEx this year. As for where it goes for the future, we'll talk more about that next year. But this year we think we can be a little bit more efficient. Obviously that helps on our return on capital. That's one of the metrics that we put in place for the company in terms of looking at the future and where – how we can be more efficient for the future. Operator, I think we have time for maybe one more question.

Operator

Operator

Thank you. And your final question comes from the line of Annabel Samimy with Stifel. Your line is open. Annabel Samimy - Stifel, Nicolaus & Co., Inc.: Hi. Thanks for taking my question. So you've talked about some of the volume and access pressure that you're seeing due to reimbursement and changes in the payer landscape in Dermatology. And it looks like in 2018, there's going to be some more, not just for Derm but also from Relistor. So maybe you can talk about what you might do to offset some of this? And how are some of your other contracts shaping up for 2018? What might we be expecting there? And then just to go back to the remediation efforts around the B + L plant, I know that you don't really have much detail at this point. But do you have a sense maybe of the timing? Is this a several-month delay? Is it going to be another re-filing of the NDA and six-month review? Is it going to be a technical delay? Do you have any color there you can provide? Thanks.

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Management

Sure. Maybe just a couple of comments. Number one, in terms of this, the volume and access. I mean just – I probably want to correct some. There's some noise out there in the system. There was at least one report about whether or not some of the changes in the managed care plans occurred this year or last year. To be clear, some of the changes that occurred with CVS and Caremark really occurred in 2016. So they haven't really been a 2017 event. They were rather a 2016 event. And there really is no significant impact on our business relative to volume and access for our product. Having said that though, let me go to really the heart of your question in terms of where are we going. And I'd say the most important thing that we can do with our Dermatology business is bring out these new products. I think it's always going to be about new products, new innovation. And that's why I think a product like SILIQ, where we have the most efficacious product when – at least as it relates to PASI 100 scores, certainly a very efficacious product. That we think that is going to be the reason why people are going to use our products in terms of the efficacy. We did price it though, to be clear, as the most affordable product in the area of biologic for psoriasis. So for that reason we think we will get the innovation that's going to be important for patients and allow us to work through some of the issues on the REMS program for that specific patient, physician, and pharmacist. So we're excited about innovation. I think it's the number one way we're going to work through that. Beyond that, it's always going to come down to the next product, the IDP-118, the IDP-126, all the other products that we'll launch and the innovations that those will bring to the marketplace. On the question of Tampa, I really can't say very much more than that. We just got the letter yesterday. We're going to obviously be in touch with the FDA. I know there's an outreach to the FDA even as we speak today. So that's really going to be the important thing before I make any specific comments on the next steps or timing, I'm really going to, at this point, want to work through that with FDA. I think we feel we've made significant progress at the Tampa site. We're going to continue to talk to the FDA about some of their observations. We've put together a response to their observations already. And we'll see where it goes for the timing for the future.

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Management

But thank you very much for your questions, everybody. Let me close there with saying I thank you for your participation this morning. We clearly are looking at some of what we think are exciting opportunities for the future of Valeant. First and foremost, really looking at our ability to grow the Bausch + Lomb/International business as well as the Salix business. Having 73% of our business showing the growth that we've showed of approximately, on a combined basis, 8% on an organic basis we think is a really exciting preview of our future. And importantly, bringing down the debt, giving us some additional flexibility on how we could manage the debt, and having zero maturities and debt payments between now and 2020 we think is an important milestone. And then importantly, some of the progress we're making on the legal liabilities. We think all those total into a company that we can really begin to have some significant success in our turnaround. But it's not going to happen overnight. It takes some time. But we're excited about what we see for the future. Thank you, everyone, for joining us today on the call. Have a great day.

Operator

Operator

Ladies and gentlemen, this concludes today's conference call, and you may now disconnect.