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EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2017 - Q1
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Executives

Elif McDonald - Valeant Pharmaceuticals International, Inc. Joseph C. Papa - Valeant Pharmaceuticals International, Inc. Paul S. Herendeen - Valeant Pharmaceuticals International, Inc. William D. Humphries - Valeant Pharmaceuticals International, Inc..

Analysts

Gregg Gilbert - Deutsche Bank Securities, Inc. Gary Nachman - BMO Capital Markets (United States) David A. Amsellem - Piper Jaffray & Co. Umer Raffat - Evercore Group LLC David Maris - Wells Fargo Securities LLC Andrew Finkelstein - Susquehanna Financial Group LLLP Annabel Samimy - Stifel, Nicolaus & Co., Inc. Tim Chiang - BTIG LLC.

Operator

Good morning. My name is Mellissa, and I will be your conference operator today. At this time, I would like to welcome everyone to the First Quarter 2017 Financial Results 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. Ms.

Elif McDonald, Director of Investor Relations, you may begin your conference..

Elif McDonald - Valeant Pharmaceuticals International, Inc.

Thank you, Mellissa. Good morning, everyone, and welcome to Valeant Pharmaceuticals first quarter 2017 financial results conference call. Participating on today's call are Chairman and Chief Executive Officer, Mr. Joe Papa; Chief Financial Officer, Mr. Paul Herendeen; and Executive Vice President, Dermatology, Mr. Bill Humphries.

In addition to this live webcast, a copy of today's slide presentation and a replay of the 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 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 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 only update or affirm guidance 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.

Thank you, Elif. Good morning, everyone, and thank you for joining us today. Let me start with the topics we'll cover this morning. I'm going to begin with a high-level overview of the progress we've made so far in 2017, particularly since our last earnings call on February 28.

I'll then turn the call over to CFO, Paul Herendeen, to review our first quarter financial results. He will also cover the update we have made to our 2017 guidance. I'll then comment on the performance and outlook for our Bausch + Lomb business, our GI business, before turning over to Bill Humphries to talk about our Dermatology business.

He'll wrap up with an update on our new product pipeline before taking your questions. So let's begin.

On slide 4, I want to start with some of the positive developments since our last earnings call, beginning with the strong performance of our two largest segments, the B+L/International segment, which represents over half of our business, and our Branded Rx segment increased adjusted EBITA by 8% and 12%, respectively, year-over-year.

Debt reduction continues to be a priority, and I'm pleased to report that to date we've reduced the principal amount of our debt by $3.6 billion since quarter one 2016.

This includes $1.3 billion of debt retired in the first quarter of 2017, with proceeds from the non-core asset sales, including the sale of three skincare franchises to L'Oreal, which closed on March 3. And with the successful debt refinancing we completed in March, we extended our maturity profile.

Paul Herendeen and Linda LaGorga and our finance team did a great job with the refinancing. In terms of execution, we're raising adjusted EBITDA guidance, which is good news that Paul will cover in more detail later. In Dermatology, we have stabilized our average selling price or ASPs.

Importantly, we saw strong growth in Asia, led by China which was up 11% in volume. Our Xifaxan primary care sales team is gaining new Rx shares since the launch of the sales team in February 2017. And cash flow from operations was great at $954 million for the quarter.

Moving onto our new product pipeline, we have many positive developments to share and I'll talk about some of these in more detail later, but briefly, in January, we reported results of a confirmatory Phase III study of IDP-118, a topical treatment for psoriasis.

We're optimistic about these results which demonstrate that the novel formulation IDP-118 could, if approved, be a promising treatment for patients who use a corticosteroid retinoid combination to treat psoriasis.

We also received two 510(k) clearances last month, the first was for Stellaris Elite vision enhancement system, a next-generation cataract platform that offers many cutting-edge innovations. The second 510(k) clearance was for Vitesse, the first and only hypersonic device for vitreous removal.

We also have filed Luminesse, our novel treatment for ocular redness with the FDA and we have received a PDUFA date of December 27, 2017. And finally, we've resubmitted Vyzulta with a PDUFA date of August 24, 2017. Turning now to some of the challenges.

Notwithstanding the progress we made at stabilizing our sales force over the last three quarters of 2016, we have been working through some recent challenges. While we recently added more than 250 sales professionals to our GI sales force, those additions were offset by the loss of a number of reps to a new market entrant.

We recently took steps to right-size the dermatology field force following a review by our new management. Moving now to products, while Xifaxan underperformed our expectations in the first quarter, recent TRx market share was up by 200 basis points and we remain on plan for the year, largely due to the addition of the primary care sales force.

Finally, we're in the process of winding down the Commonwealth business, which will further simplify our portfolio and reduce complexity. Also, we continue to make progress in resolving the company's legacy legal matters.

As you know, we settled the Salix class-action litigation last quarter, and separately, we've increased our legal reserve by $76 million this quarter. In addition, with respect to the Shower & Shower (sic) Shower-to-Shower (06:23) lawsuits, it is our belief that J&J has obligations to pay for our legal defense and to indemnify Valeant.

We have provided Johnson & Johnson with notice that the various lawsuits filed against Valeant relating to Shower & Shower (sic) Shower-to-Shower (06:37). On that note, I'll turn the call over to Paul to go through our first quarter financial results in details..

Paul S. Herendeen - Valeant Pharmaceuticals International, Inc.

one, reducing our leverage though asset sales; two, through cash generation; and three, the best way, through growth of our operating earnings.

That said, as we entered 2017, we were facing a wall of maturities in 2018, 2019 and 2020, and we're operating the financial covenants that left us with only a modest margin of error and restricted our ability to take actions to improve our prospects. So what do we do about it? Turn to slide 10.

Slide 10 shows our upcoming debt maturities after using the proceeds from the sales of the skincare assets to reduce debt and then the completion of our debt transactions back in March. We think that completing the debt transactions was a significant event that, in my opinion, was underappreciated by the markets.

By refinancing the debt, we now have a very manageable debt paydown schedule for the next several years. We shifted to about 75% fixed versus floating rate debt and, finally, we substantially improved our covenant position.

So what did we get? We gained the time and the flexibility to continue the work that started last year to put the company on a path to sustainable, profitable growth. We provided ourselves with a runway to continue our efforts to divest non-core assets, without the time pressures that could lead to sub-optimal transactions. We got peace of mind.

Now, I've heard chatter in the markets that Valeant doesn't have the ability to repay all of its debt. Let me respond. We can meet all of our financial obligations through a combination of cash generation from our business, asset sales, and importantly, refinancings. There's a permanent role for debt in our capital structure.

The goal is not to repay all of our debt and operate debt-free. The goal is to maintain a credit profile that will enable us to access the capital markets when necessary to fund our future capital requirements, including to refinance maturing debt. I've been a debt guy for the vast majority of my career.

I've been the CFO of several highly-leveraged companies. With these debt transactions in our rearview mirror, I'm comfortable with our position here.

To be clear, we still have a lot of work to do and I promise each and every one of you that the team here will focus everyday to chart and execute the steps needed to get our capital structure right-side up. I say all the time, if we take care of our debt, and we will, our equity will take care of itself. Let's turn to the cash flow in the quarter.

On slide 11, you see that we generated $954 million of cash from ops in the quarter. Looking backward over the last five quarters, a more normal level of cash generation from ops might be in the range of $500 million to $550 million. So cash flow from ops in Q1 was likely higher than you might have expected.

Roughly $200 million of that was due to the timing of cash we received under our agreement with Walgreens. We also generated a fair amount of cash from the reduction of working capital due to the sequential decline of revenue from Q4.

It's worth pointing out that compared with the end of Q1 of last year, we made substantial progress in the management of our working capital. A lot of work remains to be done, but we're focused on unlocking cash from our balance sheet for sure.

Away from operations, we realized $1.3 billion upon the closing of the sale of the skincare assets to L'Oreal and we used $1.1 billion of those proceeds to prepay debt. In the aggregate, we did reduce debt in the quarter by $1.3 billion. Onto the guidance on slides 12 and 13.

In a nutshell, we're maintaining our guidance range for revenue and raising our guidance range for adjusted EBITDA by $50 million despite the impact of the skincare assets sale. When we originally gave guidance back in February, it did not reflect anticipated asset sales.

The change from our prior guidance comes mainly from the impact of the divested skincare assets, which, as we previously disclosed, decreased our 2017 revenue expectations by $160 million and our adjusted EBITDA expectations by $70 million; and our revised estimates of the impact of the LOE products on 2017, where we increased our revenue expectations by $110 million and adjusted EBITDA by approximately the same amount.

See slide 13 for the bridge. I want to point out that our guidance does not assume the closing of the sale of Dendreon to Sanpower. We expect to close that transaction around mid-year and will adjust our guidance when the timing and impact on 2017 results are more clear.

One last quick note for modelers, we've included additional financial information that you may find helpful in the appendix at slide 24. With that, let me turn it back to Joe..

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Thank you, Paul. As I mentioned briefly in my opening remarks, 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 14 shows the progress we have made in closing the transactions.

As you can see, we have now closed eight of the 10 asset sales we announced, and we continue to expect Dendreon to close mid-year. Upon completion of the divestitures in this chart, we will generate total potential proceeds of $2.7 billion.

We reiterate our expectation to pay down $5 billion of debt from divestiture proceeds and free cash flow by February 2018, and we are well on our way to delivering on this goal. First quarter revenues for Bausch + Lomb/International segment on slide 15 were $1.15 billion, and adjusted EBITA growth was up 8% in constant currency.

Internationally, we have a solid market leadership position in contact lenses. To call out a few highlights, we have a 30% share of the contact lens market in China and a 60% market share in India, two fast-growing markets.

Asia is a significant growth driver for the business, particularly in China, where Bausch + Lomb is celebrating its 30th anniversary, and that milestone is generating opportunities to create excitement about the brand. Our consumer products business also remains strong.

To call a few highlights, PreserVision and Ocuvite are now the number one ocular vitamin brands globally. Biotrue is the number one multi-purpose solution brand with the highest loyalty metrics, and PreserVision AREDS 2 Formula 120 count is the number one selling vitamin item in the United States.

Finally, we're advancing new products through our pipeline. In addition to receiving 510(k) clearances in April 1 for Stellaris Elite and Vitesse, we have PDUFA date for Vyzulta in August 2017 and Luminesse in December 2017.

Moving on now to our GI business on slide 16, we're seeing some promising script trends as we exit first quarter that we expect to continue in the back half of the year. Apriso TRx growth was up 9% year-over-year; Relistor was up 12%.

And although Xifaxan new Rx were reasonably flat year-over-year, a new Rx as a leading indicator grew approximately 10% from January to March. In addition, Xifaxan primary care target market share has increased by 440 basis points since February and we continue to expect a ramp in the second half due to our sales force expansion.

Finally, the draft Rifaximin guidance that the FDA issued in March raises important questions about generic formulations and may impact the approval of generics. We believe the new generic requirements are a step in the right direction to confirm product effectiveness.

We continue to be confident in our legal position in the existing Xifaxan ANDA litigation. On Relistor, we're seeing new Rx writer growth of 26% since launch in September 2016, and we now have more than 80% of covered lives. The PCP sales force is benefiting from Relistor also, with TRx market share up 150 basis points from January to March.

In Dermatology, we have recruited an experienced team and we're preparing to launch new products. On slide number 17, Bill Humphries, who is here with us today, joined Valeant this past January to lead our Dermatology business. Before joining Valeant, Bill was the CEO of Merz North America from 2012 to 2016.

Before that, he was President of Stiefel, a global leader in dermatology and skin health. He also held multiple senior roles at Allergan, including Vice President of the U.S. Skincare business. I'm going to ask Bill to take us through the next slide and share his perspective on the outlook for the Dermatology business.

Bill?.

William D. Humphries - Valeant Pharmaceuticals International, Inc.

Thank you, Joe. As Joe mentioned, I joined Valeant at the beginning of the year, and I'm very excited to be here. I'd like to start by running through some of the first quarter highlights for the Dermatology business and sharing my perspective on our goals and priorities for the remainder of the year.

First and foremost, we've taken a series of actions to further stabilize the business. This includes recruiting a new and experienced team. Valeant has a long track record in the dermatology space, and we continue to attract and retain excellent talent.

In terms of our sales force, we right-sized the number of representatives in the field and organized them around roughly 150 territories. Our team is in the midst of a nine-city management tour to rebuild relationships with the doctors and other healthcare providers who prescribe and recommend our products.

This is a useful exercise for our team that is yielding important insights into our business. We've coupled these efforts with a very strong presence at first quarter dermatology and podiatry conferences to talk about the changes we are making and to rebuild relationships with those stakeholders.

As we undertake these actions, we remain focused on profitability. ASPs have stabilized, and we've adjusted copay caps. I'm most excited about our efforts to reinvigorate our portfolio and prepare for a new growth driver.

Our team is working hard to prepare for the upcoming launch of SILIQ, which was approved in February and is expected to launch mid-year. When it's launched, SILIQ will be the most competitively priced injectable biologic for the treatment of moderate-to-severe plaque psoriasis.

As an IL-17 blocker, it will be a differentiated product, and we are very excited about its efficacy profile. Finally, as Joe mentioned in his opening remarks, we also have IDP-118 in the pipeline which we believe has the potential to be a very promising topical product for the treatment of psoriasis.

So with those comments, I'll turn it back over you, Joe..

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Thank you, Bill. Moving to slide 19, new product launches, this is an area where I am particularly excited about because these new product launches are the drivers of our future growth.

Year-to-date, we have launched 20 new products, and this year we expect to launch more than 50 new products globally, which we anticipate to generate approximately $100 million of sales. Moving onto slide 20, as you can see from this list, our R&D organization is robust and productive, and we have the strength in our late stage pipeline.

A special thanks goes out to all the 1,000-plus Valeant employees who are working on our R&D organization globally for their continued progress. These innovations will be the foundation of our future growth, and we look forward to bringing new products to the market that will improve peoples' lives.

To conclude, on slide 21, our first quarter results confirm these steps we have taken to stabilize the business and deliver on our commitments are resulting in steady, measurable progress that will lead us through the turnaround phase in the 2017-2018 timeframe. As a recap, we continue to strengthen our balance sheet.

We are encouraged by the strong performance of our B+L/International and Branded Rx segments, which grew adjusted EBITA by 8% and 12%, respectively. We continue to manage our Diversified Products business for cash generation, and our business produced strong cash flow from operations of $954 million this quarter.

We remain focused on specialty-driven markets with above average growth rates, like Dermatology and GI. We're encouraged that our primary care sales team performance and the increased market share gains they've seen just – and how they've exited the quarter.

Our pipeline continues to produce innovative new products as we prepare to launch more than 50 new products globally this year, and finally, we've raised our adjusted EBITDA guidance. With that, operator, let's open up the line for questions..

Operator

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

Gregg Gilbert - Deutsche Bank Securities, Inc.

Yeah, hi. Thanks. Good morning. I'll ask one few-part question. First on Xifaxan, I think you said inventory in the channel didn't change much for the business, so there must have been a lot going on in gross to net.

So perhaps you can speak to that, as well as the latest on your dispute with Alfa Wassermann? And the third part of my question, maybe for Bill since you're on the call, maybe you can frame for us whether you're layering the new launch story in Derm on top of an eroding base, a stable base or a growing base? And help us understand the prospects for the non-new launch part of the story? Thanks..

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

All right. I'll start with the first two-part, and then I'll turn it over to Bill on the Derm question. Let me start with the Xifaxan question. Yes, as Paul pointed out, in the appendix on – I think, it's slide number 32, the GI business, it came down slightly in the first quarter versus – but basically it's flat, is the first comment.

On the question of where we are with gross to net, the gross to nets for Xifaxan are essentially flat year-over-year, in fact for the entire company year-over-year. We, during the first quarter of 2016 and then through now, really took a look at what we were doing, adjusted the incremental rebates that we needed to get to.

And since that time, I think we've tried to stay on balance relatively flat. I mean, there's a slight change of the total company, I think our gross to nets went up very slightly, but for the most part, they've been relatively stable. On the big question for us on Xifaxan was the Rxs during the quarter.

As I said, it was relatively flat versus year ago, but what we've really tried to focus on right now is the growth as we've seen it and how the growth is projecting with the TRx and new Rx share predominately because of some of the capabilities we've added in our primary care team.

As I said, there's a number of really positive indicators there for the future on where we're going. Relative to the second part of your question, the question of Alfa Wassermann, we are focusing – that question is focused on a specific drug development program. It has nothing to do with Xifaxan in total.

It is a specific Xifaxan drug development addition for a new indication. It does not impact our Xifaxan marketed product. I want to be very clear on that. And that's just a normal part of any discussion of a partnership where you try to work together as a business.

On the third part of your question, Gregg, I think we're back to Dermatology, and I think you're going to hear a lot from Bill about some of the positive steps he's taking to reinvigorate that growth, albeit we clearly said this year is a transition year for our Dermatology business, but let me turn it over to Bill..

William D. Humphries - Valeant Pharmaceuticals International, Inc.

Sure, thanks, Joe. Gregg, we're stabilizing the business, selling nine products through our sales force right now. We'll go to 10 products this month. So the ability to promote a full portfolio of dermatology and podiatry is an exciting base.

In response to your question, I would say we're stabilizing the base in volumes, and we're improving the base in terms of ASPs which was consistent with our comments earlier in the call..

Gregg Gilbert - Deutsche Bank Securities, Inc.

Thanks..

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Next question?.

Operator

Your next question comes from the line of Gary Nachman from BMO Capital Markets. Your line is open..

Gary Nachman - BMO Capital Markets (United States)

Hi. Good morning. For the B+L business, what are you doing to prepare for the new launches, Vyzulta and Luminesse? How big of an effort will you have? How big are these opportunities? And then just walk through the benefit you're seeing in International and if that's sustainable, it seemed like it really helped you in the quarter. Thanks..

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Well, thank you for your comment, Gary. You're absolutely correct. The B+L business is a really important part of our business. It represents over 50% of our business and clearly it's an area that we're very excited about for future growth. On the question of our preparations, the team is working very hard on the Vyzulta product opportunities.

I think as you may recall, we said at the last quarter we've made some significant improvements in our Tampa facility to make sure that there was no questions in the Tampa facility. Number two, we've got a number of meetings.

I was just out last week with some of the prescribers, key opinion leaders in the area of cataract and surgery, and some of the people that look at the area of glaucoma. So we're doing a lot of work with those key opinion leaders as we think about what's the future messaging and opportunity with Vyzulta.

I remind you that if you think about the entire treatment of glaucoma, approximately two-thirds of the market, a little less than two-thirds of the market is for latanoprost, or the generic of Xalatan.

So we're entering in with a great product, and we have the dual ability to have not only the latanoprost, but the bunod or nitric oxide donation portion which we think is going to make a big difference potentially for patients, so we're very excited about that. The Luminesse product, that's a product that is an over-the-counter product.

We think it's an exciting opportunity for the ocular redness. Joe Gordon and his team are doing a lot of the work right now on some of the messages that need to be developed for it, but we think it's going to continue to build on what we think is a very successful platform for our over-the-counter consumer business going forward..

Paul S. Herendeen - Valeant Pharmaceuticals International, Inc.

Yeah. And, Gary, it's Paul.

I mean, talking about the prospects on the International side, we're expecting to continue to see strength even relative to what we've originally thought through the balance of the year in the International group, but particularly in what we call EMENA, which is Eastern Europe, Africa, Middle East; APAC, we're very strong in the APAC region, and a little bit less in LATAM.

And so as we look beyond Q1, as I think I reported out in my prepared remarks, we have a little bit of momentum there in the International side and we believe that will continue..

Gary Nachman - BMO Capital Markets (United States)

Okay. Thank you..

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Operator, next question?.

Operator

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

David A. Amsellem - Piper Jaffray & Co.

Thanks. Just a question, a longer-term question on the Dermatology business.

So you talked about ASPs stabilizing, but as we head into the back half of the year, and particularly next year, and given the exposure to a lot of mature products, how should we think about ASPs, particularly as we get into next year? And then secondly, regarding SILIQ, can you talk about just the market dynamics there in terms of how you're going to attack promotion or how much – what's the extent to which we're going to see significant DTC? It's a highly promotion-sensitive market, so maybe give us a little bit of detail on how you're planning to promote that product once you start getting in the field.

Thanks..

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Sure. Let me start and then, Bill, please feel free to add to what I say. I think it's a good question because really as we think about what's happening with our Dermatology business, the model changed, and it changed and we're adjusting to that change.

It's taken some time for us to work through that from the previous management team's model, but we are changing, we are adapting to that change that's occurred in the marketplace.

Relative, though, to the story on Dermatology, what I think you're going to hear is that as we thought about the opportunity with Walgreens, we thought it was a great opportunity. We've been working closely with Walgreens and we think that they're a great partner for the future.

So I think we've made some changes to be flexible to work with the Walgreens program and I think you're starting to see that. A year ago in the first quarter, second quarter, it was a challenging time with ASPs because, as you know, many of our products were going out the door at a relatively low ASP. We've now adjusted that.

We've addressed the questions, so we've made the progress for that. As it would relate to, though, the rest of the story, I think you referred to it as the long term, the story there for us is clearly going to be about new products. The first one is the opportunity to launch SILIQ, our brodalumab product, it's psoriasis. Then, we've got the IDP-118.

If approved, that's going to be another great opportunity for long-term usage for potential topical usage in psoriasis depending on the label. Those are what we think are the exciting opportunities we see. And then there's a whole host of others behind that, I'm not going to go into great detail now, but I think that's the real key.

On the question of positioning on brodalumab and SILIQ, I think Bill may want to talk about it, but it's a big market. It's a $7 billion approximate market. The market's growing ballpark 40%, so that's what we think is a very exciting opportunity.

And if you talk to patients, and Bill's done a lot of it, and talk to the key opinion leaders, the number one problem patients have is the total clearance or the 100% clearance of the plaques. And we think we have a product that, based on the data, is going to be very beneficial to patients based on that clearance.

I do think that it's not going to be something that's going to ramp up overnight, but as patients try it, because we have a receptor blocker, we have the, to our knowledge, the only receptor blocker approved, that's a big difference.

As with any category of drugs pharmacologically, receptor blockers always tend to do better than an inhibitor of a pathway, just because the body can compensate for pathway inhibition, whereas you can't compensate for receptor blockers. That's the reason why we think it's a really exciting opportunity.

I will be clear, we don't think it's going to ramp up overnight, but we think once patients try it, they'll realize the added efficacy for the future.

Bill, anything you want to add?.

William D. Humphries - Valeant Pharmaceuticals International, Inc.

I'll just add on ASPs, we continue to look at beneficial product effects on patient assistance that support not only patients, but physicians. And then on SILIQ, completely agree with Joe, right, it's a very active and exciting market.

The focus is completely on patient outcomes and there's a desire for that not only from patients, but from physicians. On promotion, we look at this as a very efficient audience and so we're excited about having very intimate discussions with the prescribers that drive this category.

And then finally on patient activation and our ability to compete, we're going to focus on working with the KOLs, certifying those physicians, pharmacies and patients to drive demand for this product..

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Thank you.

Operator, next question?.

Operator

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

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Umer?.

Umer Raffat - Evercore Group LLC

Yeah. Thanks so much for taking my question. Sorry about that. I was shuffling between two calls.

Joe, I guess, my question is – what I'm trying to understand is, given where your share price is currently, how should we be thinking about the equity, especially as it relates to the price of stock at which the options were granted to most of your employees versus where the stock is, do you need a big option repricing event and how dilutive will that be? I guess, that's the real question.

Thank you..

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Sure. So obviously, we believe our share price is not where it should be. It should be higher, to be clear. But the fact is, that's what – where it is today.

I think what we're doing is working very hard every day, as Paul said, to reduce our debt, and we think as we reduce our debt, we think that's going to help us tremendously with the share price going forward.

On the questions of what we need to do from the – with the team, we've been able to pull together a team that is absolutely committed to what we think is the turnaround opportunity of a lifetime. And so I think the team is committed to try to make these things happen because of some of the things that we are putting in place.

I view the incentive program, though, as a long-term issue. It's something that we've put in place. We're focusing – as I think I've said in the previous calls, the long-term incentive is going to be increasingly focused on return on capital, it's going to be – for the performance share plan, it's also going to be focused on total shareholder return.

So a lot of those things are really where I think you're going to see the real returns for our team. But I think it's a long-term program. We'll continue to look at it, but I don't want to go so far as to say anything about options repricing or things like that.

We'll continue to work with the board to think about all alternatives, but I think we're looking at it as a long-term program and we've got a team that's dedicated to try to turn this business around because we do think it's the turnaround opportunity of a lifetime.

Operator, next question?.

Operator

Your next question comes from the line of Christopher Schott from JPMorgan. Your line is open..

Unknown Speaker

Thanks for taking the question. This is Chris (39:53) on for Chris.

Can you elaborate on the progress you've made rightsizing your Dermatology portfolio? And how large is the field force today relative to your prior sizing? And just given the two potential launches for SILIQ and IDP-118, how are you approaching the balance between restructuring and these upcoming launches? Thanks..

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Sure. Well, I'll start, it's Joe, and then I'll give Bill a chance if he wants to add anything further.

But relative to the activity in our Dermatology, we did a lot of work with Paul's arrival, my arrival and now Bill's arrival just looking at what were the resources we need to reach the key opinion leaders, to reach the prescribing dermatologists and podiatrists across the country.

And we looked at it and said previously we had 250 sales professionals. We think the right number for us given our portfolio, given the opportunities in front of us and given the focus on psoriasis especially with some of these new products, we said it was somewhere in the 150 sales professionals position.

So we now moved from 250 to 150 is the direct answer to that question. I think where we're going, though, is clearly to look at the opportunities for the psoriasis drugs and brodalumab and some of the things we'll focus on there.

Bill, maybe you want to just talk a little bit about some of the activities on brodalumab and then potentially, if approved, IDP-118..

William D. Humphries - Valeant Pharmaceuticals International, Inc.

Sure. So I look at us as having, again, as I mentioned, sufficient audience in the biologic space. So we have the opportunity to have a very targeted discussion with key prescribers to have discussions about SILIQ and the opportunity there.

As you think about products in the pipeline and our opportunity to have engagement with not only the top prescribers but also important healthcare providers that may work with physicians, we believe that our sales force of 150 is right now very efficient.

And we'll be able with the right amount of data analysis and the excellent operations team we have here at Valeant to really fine tune our activity and make sure that our sales force is behaving in the most efficient way to support this product portfolio..

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Yeah. It's Paul. I just want to pile on. I mean, I think this was part of the exercise for us looking at all of our business units and determining where we were under-invested in terms of annual OpEx and over-invested in OpEx intensity in the Derm space.

Based on our analysis, we were over-invested in OpEx in Derm, and with a sales force of circa 150 territories, we'd be in terrific position to be able to optimize the portfolio of assets we both have today, but those assets that we expect to come out of the pipeline as well.

The important element of that is it enabled us to redeploy some of those resources to the areas where we felt we were under-invested and that is the obvious one, it was the increase in the GI sales force in order to target the primary care segment, but also to build up the, as I called out in my prepared remarks, build out the patient access and sales ops teams that are necessary to be able to match (43:03) productivity of those very healthy investments that we make on an annual basis.

So we think we're right sized..

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Thank you.

Next question, operator?.

Operator

Your next question comes from the line of David Risinger from Morgan Stanley. Your line is open..

Unknown Speaker

Good morning. This is Anna (43:20) on the call for Dave. Thank you for taking the question. I have a two-part question regarding the new guidance.

So first regarding LOEs, could you please provide a framework for how the increasing guidance impacts the outlook for 2018? And second, regarding pending divestitures, what is the annual run rate of EBITDA yet to be excluded from guidance because the deals are pending? Thank you..

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

All right.

Paul, do you want to take this?.

Paul S. Herendeen - Valeant Pharmaceuticals International, Inc.

Yeah. I mean, a couple of things. I think you'll find in that chart that we posted on the website, you'll be able to see exactly what we think the impact is on 2017. I point out – that's slide 23 for those following along.

I want to point out, one, we're not providing guidance for 2018, but second and very importantly, these assets we believe will go generic and so whether they go later in 2017 or they even carry forward into 2018, they are kind of a melting ice cube and so you should treat that portfolio accordingly.

I think we've been, I think, quite transparent in helping you follow along by providing that slide 23 that you can see the impact. And to call it out, you'll see it's circa $110 million more revenue expected in 2017 than previously and approximately the same amount of profitability due to the changed view of timing of these date uncertain LOEs.

So regardless of when that occurs in 2017, you got to think about the knock-on effect to 2018. And when we provide 2018 guidance, we'll let you know about that.

The second question was?.

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

The question of the pending divestments and where we are with them..

Paul S. Herendeen - Valeant Pharmaceuticals International, Inc.

Oh, right, with respect to guidance. And on that question, I said we reduced our guidance. And if you see the bridge for the change to the guidance, we reduced our guidance for adjusted EBITDA – I'm sorry, with respect to the divested skincare assets by $70 million and we reduced the – our revenue expectations by $160 million.

No other potential divestitures are currently considered in our guidance..

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

I think, Paul is – I agree with everything Paul said. The only thing I'd say is that as we complete the sale of Dendreon, depending on the timing, we'll build that in, but that's not in the numbers as we sit right now.

Operator, next question?.

Operator

Your next question comes from the line of David Maris from Wells Fargo Securities. Your line is open..

David Maris - Wells Fargo Securities LLC

Good morning. A couple quick things. First, Joe on the Alfa Wassermann thing that Gregg mentioned, you mentioned that this is a drug development for a new indication. I thought this was for a new formulation and it was the follow-on for Xifaxan.

And also, if they win in arbitration, they're looking for something like $300 million and the rights to that follow-on. I just want to get a confirmation of that. Then separately, Paul, a couple of housekeeping things.

One, you mentioned that you reduced debt, but could you remind us what the leverage ratio was a year ago and what it is now? And then also on the EBITDA calculation, you mentioned that in the beginning of the first quarter of 2017 you no longer include adjustments for foreign exchange gains or losses.

What did that contribute to the first quarter EBITDA and to the full-year guidance? Thank you..

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

I'll start on the first part. David, on the Alfa Wassermann, the first comment I said is that is the result of a question and discussion between the two companies. We have made – continued to make some progress with them, but we still have not resolved it yet. We look forward to getting it resolved in the near future.

Specific to your question, though, it dealt with two issues, both a new formulation and a new indication, if I left out the indication, I'd respond to that as well. There's two portions of both the new indication and a new formulation are part of it.

The important part for Valeant is that we have a number of different opportunities including the Alfa Wassermann opportunity as well as other opportunities for formulations to take into the marketplace for a follow-on Xifaxan. So as I said before, our expectation is that this has nothing to do with the Xifaxan current business today.

This is simply for an opportunity to take it into a new – new formulation into a new indication. Paul, do you want to take the second part of the question from David relative to....

Paul S. Herendeen - Valeant Pharmaceuticals International, Inc.

Sure. Yeah, sure. Let's cover the leverage first, and I'll go off of what you could calculate. A year ago, our leverage would've been 6.3 times, and if you calc, the other way you could calc using the publicly available information, you'd see that it was like 6.98 times.

And if you were able to adjust that to pro forma for the divestiture of the skincare assets, it's approximately 6.75 times. With respect to the question around FX, it's approximately $35 million in the quarter relative to what it had been in the prior-year quarter had been a gain of about $2 million....

David Maris - Wells Fargo Securities LLC

Okay.

So of that $50 million increase for the year's guidance, something like $35 million in the quarter was contributed just from an accounting change of how you account for adjusted EBITDA with – for FX?.

Paul S. Herendeen - Valeant Pharmaceuticals International, Inc.

No.

Operator, next question, please?.

Operator

Your next question comes from the line of Andrew Finkelstein from Susquehanna Financial Group. Your line is open..

Andrew Finkelstein - Susquehanna Financial Group LLLP

Hi. Good morning, and thank you for taking the question. I was hoping you could talk a bit more about how pricing and volume is playing out.

You talked a bit about the ASPs in the Derm business, but since the third-party data aren't perfect, what are you seeing for the core segments in terms of price and volume? And how are formulary discussions shaping up for next year? Can we continue to see ASP improvement across your marketed products? And then if there was any feedback you can share on the SILIQ pricing decision and how that plays into formulary coverage, that would be helpful.

Thanks..

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Sure. So there's a lot involved in the question. If I miss any part of it, Paul, you can add to it.

But we've been working very hard in this question, I think, going back really for a year now, we've had a Patient Access and Pricing Committee set up in May of 2016 to really get to the heart of these questions and make sure that we're doing the right thing when it comes to pricing, gross to nets and all the activities there.

On the general comment of your question, though, specific to where we are this quarter versus a year ago, we have seen some brand price increase versus a year ago. There was a price positive to that, both in the Branded Rx and the Bausch + Lomb/International business. The answer to that is yes.

Bausch + Lomb/International business on a constant currency basis also had volume growth, as Paul said, it was – but there was also some negative FX. So it was really those three combinations for the Bausch + Lomb/International 1.41% or 1.5%, somewhere around there for the pricing, 1.5%, and some volume growth.

On the question, though, the gross to net as it was specifically talking about the entire company, this is mostly a – this is really a U.S.-based comment, predominantly, what we have found is we've stabilized the gross to nets relative as a percent of discount to the total business versus a year ago.

So we're about stabilized with that, which I think was an important step in the right direction. On the question of brodalumab, as we thought about where would we price branded SILIQ, we look at all the factors, we had a number of different conversations with our managed care staffs (51:35), our market access.

We've looked at the conversation with the payers, we had conversation with product profile versus how we would position it. The discussions are going well, and that we think was partially because we made a decision to make it a competitively-priced product and certainly on the affordable side of competitively-priced.

We think that's an important place to get trial. Once again, as I said before, once we get trial with this product, we do think that based on its efficacy, at least from what we've heard from many of the key opinion leaders and the clinical investigators that have used the product, it is a very good, very efficacious product.

Patients like this product, and that's where we're going to really be successful with it in the future. Thank you very much for the question.

Operator, next question?.

Operator

Your next question comes from the line of Annabel Samimy from Stifel. Your line is open..

Annabel Samimy - Stifel, Nicolaus & Co., Inc.

Hi, guys. Thanks for taking my question. You made some earlier comments about the reorganization efforts in B+L, some improved efficiency and growth. So what do you think you still need to do to improve efficiency and growth in that segment? It seems to be a franchise that's working for you.

What are your expectations of where margins and growth can go, and over what timeframe are we talking about? Thanks..

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

So that – absolutely, you picked up exactly what I said. The point really for that was a couple of points. Number one, we've had some very good success with our surgical business.

We wanted to make sure that we brought the leadership of that surgical business together so that there was an oversight of looking at not just the existing business, but also the new products, the opportunities, the development opportunities as we work with the research and development team for new product opportunities like the Vitesse, like the Stellaris Elite.

There was a good coordination going through the sales, the marketing and also obviously research and development. So, we brought together that team. We now have an international head of the surgical business as well as a U.S. head of the surgical business. Those two dramatically make it much easier than to deal with 10, 15, 20 different countries.

So, that was step one. Step two was as we're talking about the new launch, like the Vyzulta, we brought together a team, we've brought some additional people put in place there to support the new launch. And we were successful in recruiting a number of new sales reps into our Vyzulta team, and that's what we're preparing for right now.

In addition, it's somewhat related, but not exactly, we've done a lot, as Paul said, with our market access team to make sure that at least in the U.S. we've got sufficient resources so that the sales force will get the appropriate support for what we're trying to accomplish. And I think we're seeing some results.

I mean, we talked about what we saw in Asia. Asia's a great example. We're seeing great results in our contact lens business, we're seeing just good, strong market shares, et cetera. So, that's what I think we just talked about with B+L/International. Those are really the three steps we took.

So some steps in it to globalize some of the leadership; number two, to bring on some additional sales force; and then some additional market access, other people to help us to be successful with the business..

Annabel Samimy - Stifel, Nicolaus & Co., Inc.

And anything in terms of operating efficiency and margin in that business?.

Paul S. Herendeen - Valeant Pharmaceuticals International, Inc.

Well, it's Paul speaking. Yeah, there's definitely some opportunity for margin improvement.

I even called out and said, yeah, you look to see some operating efficiency – never use one quarter to project forward many years, but we're able to get some operating expense efficiency in the B+L/International segment simply by virtue of taking a look at each individual unit, as Joe said, organizing it under one leader, Tom Appio, who now runs that business globally.

There are opportunities to combine to be more efficient, to deploy resources where we have our greatest growth opportunities. So, yes, we have the opportunity to potentially increase the operating margins across that business..

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Operator, we have time for one more question, please?.

Operator

Your last question comes from the line of Tim Chiang from BTIG. Your line is open..

Tim Chiang - BTIG LLC

Hi. Thanks. Could you guys talk a little bit more about the GI franchise you guys have? I know you guys have shored up some of your sales and marketing aspects, but I looked at Relistor, for instance. You guys highlighted that the prescription trends were up, but I noticed that the net sales were down.

Could you just comment on some of the other GI products that you have, how you sort of plan on growing them throughout this year?.

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Sure. So first and foremost, on the GI franchise we said, versus a year ago, there was some challenges early in the first quarter. Those challenges that we dealt with on the noise that occurred as a result of the rumors about us selling the Salix business. We think we've corrected those questions, number one.

Number two, we added a primary care capability. We believe that primary care capability was absolutely critical for us in terms of our ability to reach the primary care physician where much of the IBS-D is prescribed, as well as clearly where a lot of the Relistor usage is.

So, with that additional capability, we're seeing some positive trends that primary care new Rx share gains are for the trailing eight weeks, from before to now that we have it, are – we gained 440 basis points from before the primary care till the eight weeks after it. When you look at Xifaxan new Rxs, we saw a 10% gain from January through March.

Apriso was up 9%. Relistor is up 12% year-over-year. So, we are seeing the gains, we think mostly because we've added the incremental sales force. And it goes back to what I think Paul mentioned in his comments.

It's really about us taking a look at where do we want to make the investments in our – utilization of our resources whether it'd be the sales force capabilities, the advertising promotion capability, but those allocations were what we needed to do and we did it and we now are starting to see some of the results..

Joseph C. Papa - Valeant Pharmaceuticals International, Inc.

Operator, that's going to conclude my comments. I thank everyone for joining us today, and very much look forward to answer any additional questions anyone has as we go forward. Thank you, everyone. Have a great day. Thanks for joining us..

Operator

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

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