Arthur J. Shannon - Valeant Pharmaceuticals International, Inc. Joseph C. Papa - Valeant Pharmaceuticals International, Inc. Paul S. Herendeen - Valeant Pharmaceuticals International, Inc. Mark McKenna - Salix Pharmaceuticals.

Annabel Eva Samimy - Stifel, Nicolaus & Co., Inc. Umer Raffat - Evercore Group LLC Greg Fraser - Deutsche Bank Chris Z. Neyor - JPMorgan Securities LLC David R. Risinger - Morgan Stanley & Co. LLC Jennifer Kim - Cantor Fitzgerald Securities David A. Amsellem - Piper Jaffray & Co..

Ladies and gentlemen, thank you for standing by and welcome to Valeant first quarter 2018 earnings 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. I will now turn the call over to Mr. Art Shannon, Senior Vice President, Investor Relations.

Please go ahead..

Thank you, Crystal, and good morning, everyone. Welcome to our first quarter 2018 financial results conference call. Participating on today's call are our Chairman and Chief Executive Officer, Mr. Joe Papa; Chief Financial Officer, Mr. Paul Herendeen; Mr. Mark McKenna, Senior Vice President and General Manager of Salix Pharmaceuticals.

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'd 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. 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 on 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..

Thanks, Art; and thank you, everyone, for joining our call. For today's call, first I will cover the first quarter highlights. I'll then turn the call over to our CFO, Paul Herendeen, to review the first quarter results and update our 2018 guidance.

Finally, we'll wrap up with a review of the segment highlights and the 2018 catalyst, including an update on XIFAXAN from Mark McKenna before opening the line for questions. Beginning on slide 4, we are now well in the turnaround phase of our multiyear plan and we continue to make tangible progress towards transformation.

Over the past two years, we've taken a number of steps to strengthen our core business and to refocus on areas in need of improvement. Our goal is for 2018 to be a year of operational excellence as we focus on what we refer to as Project Core, CORE, or Cost Optimization and Revenue Enhancement.

I think our great first quarter results demonstrate that we are on track; a special thanks to the 20,000-plus dedicated employees that did a great job in turning around and transforming our company. Notably, for the first time, since the third quarter of 2015, the company delivered overall organic revenue growth that tracked above expectations.

Moving on to slide 5, keeping with the theme of operational excellence, let me give you some examples of what we have achieved as a result of the investment we have made and the steps we have taken to strengthen our core businesses.

Revenues from the Bausch + Lomb/International and Salix continue to grow nicely, up 10% organically from Q1 2017 driven by strong growth in Salix or promoted products Global Vision Care, International Prescription business and our Global Surgical.

We also saw our top 10 products, which is, are listed on the slide 32 in the appendix, grow by more than 20% in the aggregate compared to the first quarter of 2017. At the same time, we are driving growth by advancing our new product pipeline and promoted products.

The launches of RELISTOR, SILIQ, VYZULTA and LUMIFY, four of the significant seven, are currently underway. That RETIN-A MICRO 0.06% launch is tracking ahead of the company's expectations.

We are conducting clinical trials to evaluate new formulations and new indications for rifaximin and we are promoting current branded products in our portfolio like MIGRANAL and WELLBUTRIN XL, which are benefiting from this refocus. We've also made tangible progress in the debt reduction front.

As of May 8, 2018, we have reduced total debt by approximately $6.9 billion since the end of the first quarter of 2016, which includes $280 million in the first quarter of 2018. Finally, we continue to make progress in resolving legal issues. Since January 1, 2018, we resolved approximately 20 additional litigations and investigations.

Some of our recent successes, the UCERIS Cosmo arbitration was decided in our favor and the Tribunal ordered Cosmo to pay the entirety of Valeant's legal costs, equivalent to $3 million. The core in our ANDA RELISTOR injectable case granted partial summary judgment on the validity of the U.S.

patent in our favor, protecting the formulation of our product to at least April 2024.

We agreed to resolve the SOLODYN antitrust litigation, and from $1.875 million we resolved another matter relating to our terminated relationship with Philidor by reaching a settlement agreement with the California Department of Insurance with no admission or findings of facts or liability.

You'll also recall in May 2017 the New Jersey State Bureau of Securities closed its investigation on the Philidor matter, also with no admission of facts or liability by the company.

Importantly, we resolved cases that represent in the aggregate over $1 billion of alleged exposure, and our team has been able to do this for substantially less than initially claimed amount of exposure. Another item of importance is the recent 90-day extension of the XIFAXAN ANDA case with Actavis, now Teva, which was filed on April 30, 2018.

As you know, one year ago we agreed to a stay on the matter to provide Teva an opportunity to meet the revised draft guidance on rifaximin issued by the FDA. Not much has changed over the year, and Teva is still considering how to proceed.

We believe that at this time, Teva does not have an approvable ANDA, and we continue to feel confident about the strength of our intellectual patent portfolio protecting XIFAXAN. All in all, we had a great quarter of progress both on the legal front and in the businesses. On slide 7, we present a snapshot of the Q1 financial highlights.

To me, this slide says it all in terms of how we are executing on our plan. Overall, revenue, adjusted EBITDA, cash flow, and adjusted net income of the quarter were above expectations.

76% of the quarter one revenue was generated by the Bausch + Lomb/International segment and the Salix business, which grew organically by 10% during the quarter combined. Specifically, the Branded Rx business delivered 8% organic revenue growth compared to Q1 2017 and B + L/International grew modestly at 2%.

And with that, I'll turn it over to Paul to take you through the financial results in further detail..

Thank you, Joe, and good morning. Just a quick reminder, whenever I talk about organic changes compared with the prior year, that means on a constant currency basis and adjusted for the impact of divested assets. Here we go. I'll start on slide 8, and that provides a look at total company performance.

We posted a solid first quarter, with revenue just shy of $2 billion. On a reported basis, revenue declined 5% adjusting for currency, which was a tailwind relative to the prior year, when we were down 9%.

However, divestitures accounted for an 11% year-over-year decline, so on an organic basis, we were up 2% compared with Q1 of 2017; as Joe said, the first time we posted company-wide organic revenue growth since Q2 of 2015.

Our gross margin declined roughly 50 basis points, mainly due to mix driven by the declines in the high-margin LOE products in the U.S. Diversified Products segment. Total adjusted operating expenses were favorable to the prior year on an organic basis by 4%, with a reduction in corporate G&A expenses being the main driver.

Our adjusted EBITDA was $832 million, down 3% on a reported basis, down 5% on a constant currency basis, and up 4% on an organic basis, again, adjusted by divestitures.

The roughly $2.7 billion GAAP net loss in the quarter was driven in part by goodwill impairment charges of roughly $2.2 billion related to our early adoption of new rules to simplify the accounting for goodwill. Let's get into our segment results, starting on slide 9 with the B+L/International segment.

Top level and all on an organic basis, revenue in the segment was up 2%, with solid contributions coming from Global Vision Care, up 9%, and Global Surgical, up 4%. Global Consumer in our international pharma businesses were flat and the Global Ophtho Rx business declined 3%.

The organic growth in Global Vision Care in dollar terms was split evenly between the U.S., where we were up 16% versus Q1 2017, and outside the U.S., where we're up 6%. Beginning in late 2016, Joe took steps to globalize the lens business and to put in place leadership to drive this business forward.

We started to see the results of those actions beginning in the second half of 2017, and that progress continued into Q1 of 2018. The progression over the last four quarters for the Global Vision Care business, beginning in Q2 of 2017, was minus 2% versus the prior-year quarter, then plus 8%, plus 5%, and now plus 9% in the current quarter.

All of those again are on an organic basis, pretty good, right? During that period, both the international lens business under Yang Yang and the U.S. business under Joe Gordon delivered stronger results. The instauration of the U.S. Vision Care business has been particularly impressive.

Starting in Q2 2017, the business declined 2% versus the same quarter in the prior year, then grew 10%, then grew 16%, and in the current quarter grew 16%.

The improvement has been driven by an increased promotional footprint, the launch of ULTRA toric, the continued expansion of parameters on our other new products, and targeted use of price to drive meaningful increases in volume.

Outside the U.S., our Asia-Pacific region continues to be a source of attractive Vision Care growth, led by China, where our lens business was up 14% organically versus Q1 2017, as we continue to drive demand for both our newly launched and legacy products.

Global Surgical was up 4% organically, as 7% growth in markets outside the United States more than offset a 3% year-over-year decline in the U.S. Outside the U.S., we continue to have success leveraging our strength in equipment, particularly Stellaris, and the associated demand for our consumable products.

Global Consumer revenue was flat on an organic basis versus the prior quarter with the U.S. up 2% organically, but offset by a decline outside the U.S. In the U.S., we had a sizable sell-in of product in Q4 of 2017 ahead of a seasonal promotional program with a large U.S. retailer, and the timing of that program dampened our U.S.

Consumer sales in this quarter. Outside the U.S., the Consumer business in China was up 20% organically and Mexico was up 17% organically, but those gains were offset by a decline mainly in Russia, due to a very weak cough/cold season and rebalancing of channel inventories.

The international pharma business was also flat organically versus Q1 of 2017, as strong growth in our Amoun operation was offset by declines in Russia and other Eastern European countries, again, mainly due to the rebalancing of channel inventories.

The Global Ophtho Rx business was down 3% organically, as 6% growth outside the United States was more than offset by a 9% decline in the U.S. Ophtho business. The decline in the U.S. was driven by a large low margin sale of Visudyne in the prior year quarter.

Full promotional activity against VYZULTA kicked off in January and sales of VYZULTA in the quarter were nominal. Below revenue, I'll call your attention to the total operating expense line.

On an organic basis, operating expenses were up or unfavorable by 2%; mainly this is reflective of us committing additional resources in selling, advertising and promotion, for example, resources in U.S. Consumer to support the launch of LUMIFY and the expanded deployment of lens fit sets in the U.S.

Vision Care business to sustain the recent volume in share gains there. We will continue to deploy resources to this important segment to deliver growth over the long term.

Turning to slide 10 and the results for the Branded Rx segment, revenue was up 8% organically as we had a monster quarter in the largest component of this segment, Salix, plus growth in our Dentistry and Global Solta businesses that together more than offset the decline in our dermatology business.

When looking at the 40% organic growth of Salix in the quarter, I'll dust off one of my favorite lines, the growth looks great and we'll take it, but it's one quarter compared back to a quarter a year ago.

Think back to Q1 of 2017 and recall that we were in a bit of disarray while we had the rumored sale of Salix, our loss of a large number of reps to a competitor, and a significant contraction of both wholesale and retail pipeline inventories in Q1 of 2017. So attribute some of the growth this quarter to a weak Q1 2017.

Add to that, a bit of increased realized selling prices in the current quarter and a favorable impact from better management of non-retail channels, and you get that 40% year-over-year growth.

Obviously, this is above trend and expectations for the full year, but the takeaway should be that the hard work for the Salix team, led by Mark McKenna, has put Salix in a position to deliver fundamental growth across the portfolio of Rx's, of unit volumes, and of realized selling prices. The Salix business is really firing on all cylinders.

Our Ortho Dermatologic business continues in transition. We're doing our best to sustain our legacy product portfolio in a very challenging environment, while at the same time gearing up for the upcoming launches of the new innovative products that we believe will be the future of this business.

In January, we expanded the dermatology sales force by approximately 25% to increase our efforts against SILIQ and RETIN-A MICRO 0.06% and to be fully deployed against potential high volume prescribers well ahead of the expected launches of DUOBRII in the summer and ALTRENO and BRYHALI later in the year.

We now include Solta as part of the Branded Rx segment and Global Solta delivered 18% organic growth with half coming from the U.S. and half outside the U.S. This is another business that benefited from a change in how it was organized and managed, including a change of leadership.

A tip of the hat to Tom Appio, our Executive VP of International, for leading the changes that have transformed Solta into a global business with excellent future prospects. Below the revenue line, I point out that operating expenses in the Branded Rx segment on an organic basis are up or unfavorable by 4%.

Similar to my remarks about the B + L/International segment where appropriate we're making in the investments in OpEx needed to support the future growth of this segment. Turning to our Diversified segment on slide 11, just a reminder, this is where the bulk of our LOE assets reside as you can see in slide 29 in the appendix.

So it's expected to decline, but I'll point out that the rate of decline is slowing as we work our way through the massive LOE assets that are losing exclusivity over a relatively short timeframe.

I do want to point out that we manage the assets in this segment to maximize the cash flow that can be generated from the portfolio and our team led by Barb Purcell does a great job.

If you look at slide 35 in the appendix, just call your attention and notice the expansion of our sales force and promotional efforts around WELLBUTRIN and APLENZIN, which are reinvigorating those brands. I'm going to switch gears and turn to the balance sheet summary on slide 12.

We ended the quarter with just north of $900 million of cash on hand and $25.6 billion of debt. You can see the progress we made in reducing our debt and we are in the process of repaying an additional $150 million of senior notes due 2020, which is a good segue to slide 13.

A slide you've seen before, but one that is important in measuring our efforts not just to reduce debt, but to manage upcoming maturities as well. Since last November, we reduced the amount of debt due in 2020 from $4.4 billion to $2.7 billion as of February 28 to the $1.078 billion you see as of May 8.

Although 2020 and 2021 seem a long way off, we're focused on staying ahead of the future maturities and ensuring that the company maintains access to the capital markets to manage its liabilities.

I've said this before, but I think it bears repeating, our efforts in 2017 and through today have provided us with a clear pathway, including a range of options to deal with our debt load. Good progress, but plenty more work to be done for sure. On to slide 14 and the cash flow summary.

Here, I just want to point out that after we provided 2018 guidance, we indicated that the smooth average of expected cash provided by operating activities might be in the low $400 million per quarter. Q1 of 2018 was a strong cash flow quarter as we generated $438 million, despite paying $170 million of legacy legal settlements in the quarter.

Good stuff, indeed. On to the updated guidance slide on slide 15. The headlines are that we increased our revenue guidance range by $50 million and our adjusted EBITDA range by $100 million. There are, what I will call, modest changes in some of our key assumptions and those that changed are shown in red on the slide.

Turning to slide 16, the bridge from our prior guidance to our updated guidance.

But for the unfavorable movement in FX rates our expectations for revenue increased by $120 million, comprised of $25 million in our LOE portfolio, and importantly, that's coming not from a change in the expected timing of the LOEs, but from better fundamental performance; next $55 million from stronger expected performance of APRISO, UCERIS and ZEGERID; and finally $40 million in improved outlook across our other core businesses.

On the adjusted EBITDA bridge, the $10 million negative impact from FX includes the favorable $25 million FX gain on the intercompany loans included in our Q1 2018 results but that pickup was more than offset by the estimated translational impact of unfavorable movements in FX rates from February to this forecast and the FX loss on intercompany loans so far in Q2.

In my opinion, the most important takeaway from quarterly results is how those results inform your view of our future prospects. Our results in Q1 2018 provided the support to raise our guidance for the year and that's a good thing. Back to you, Joe..

Thank you, Paul. Let's start with an update on the Bausch + Lomb/International segment on slide number 17. Overall, this segment delivered organic growth of 2% versus Q1 2017, driven by strong growth in Global Vision Care and Global Surgical. The China portfolio was particularly strong with 15% organic growth compared to last year's first quarter.

The chart on the right shows the U.S. contact lens manufacturer growth as compared to a year ago. Bausch + Lomb is significantly outperforming the competitor's growth rate.

This is another great example of successful execution as the investments we made into growth capital and new products to support this business are now translating into strong growth. In addition, we continue to expand on ULTRA, and we've recently received FDA approval for an extended wear indication.

In the consumer business, we delivered industry-leading growth in consumption, up 4.3% across all products in the first quarter of 2018. This growth was led by more than 20% growth in the PreserVision and Soothe franchises, while the overall U.S. health and beauty retail category was actually down 8.8%.

Our e-commerce presence also continues to grow with Amazon sales up 44% compared to the first quarter of 2017. And we continue to advance innovative new products in this segment, including three of the significant seven new products, VYZULTA for glaucoma, LUMIFY for ocular redness, and SiHy Daily Lenses, which are expected in the fourth quarter.

Finally, we have submitted to the FDA Loteprednol Gel 0.38% for ocular inflammation during the second quarter of 2018. This new formulation has improved dissolution kinetics, improved penetration into the eye, and reduced concentration of dosing with a similar efficacy profile.

As a result, we believe this life cycle product enhancement will be preferred by patients and physicians. Going back to LUMIFY for a moment, let's move to slide number 18. LUMIFY is the first and only over-the-counter eyedrop with low-dose brimonidine for the treatment of ocular redness.

Ocular redness is a common condition that can be caused by inflammation of almost any part of the eye. When this condition is treated frequently with non-selective redness leaving eyedrop users can develop tolerance or experience a loss of effectiveness as well as rebound redness.

But the active ingredient in LUMIFY low-dose brimonidine selectively constricts the veins in the eye, which increases the availability of oxygen to surrounding tissues and reduces the potential risk of these side effects. We announced yesterday that LUMIFY is now shipping and will be in stores later this month.

In addition to the retail channel, our prescription ophtho sales force will be sampling this OTC product with doctors, as we have done successfully for with other consumer products like PreserVision. We expect that physician recommendations will translate into retail demand.

Turning now to slide 19, the headline on the Salix business that we delivered growth across the entire portfolio of promoted products in the first quarter. Revenue growth of 40% in the quarter was driven by improved operational effectiveness and an investment we made in our sales force more than a year ago.

The chart on the top right shows the success we've had in growing this business since the Salix acquisition in 2015, with net revenues tracking more than 10% annual growth since the acquisition. XIFAXAN and RELISTOR led the way in revenue growth, up 49% and 54% respectively compared to the first quarter 2017.

The chart on the bottom right shows RELISTOR's total prescriptions up 44% in the first 13 weeks of 2018 versus the prior year. APRISO and UCERIS also delivered strong revenue growth in the first quarter, up 31% and 27% respectively, compared to quarter one 2017.

On the pipeline front, we announced yesterday PLENVU, our next-generation bowel cleansing preparation for colonoscopy was approved ahead of the scheduled PDUFA date. When it came to Valeant, there were several areas that needed more focus, and candidly one of those areas was Salix.

So we bought Mark McKenna over from the Bausch + Lomb team, where he was Vice President and General Manager. Mark looked at the pieces of the Salix business and identified areas that needed improvement. For example, we had high turnover in the sales force. We had a new XIFAXAN indication for IBS-D, but we weren't calling on the primary care physicians.

With new leadership in place, we were able to address the turnover issue and build a primary care sales force. Now having made the investments we needed to make, the business is growing nicely and XIFAXAN is driving a substantial amount of that growth, including a higher refill compliance rate with hepatic encephalopathy patients.

I'm going to ask Mark, who is here with us today, to take us through the next slide for more of an update on XIFAXAN.

Mark?.

Thank you, Joe, for inviting me on the call and for your comments. The team shares your enthusiasm about XIFAXAN's potential. In XIFAXAN, we have the first and the only approved microbiome drug for IBS-D. This is a significant differentiator that offers patients a short-term treatment with long-lasting relief.

As you know, we announced on the last quarter's call that XIFAXAN had reached blockbuster status during the first quarter of 2018. It is a significant milestone that a lot of the people in this office helped achieve. And the momentum continues. Just last week XIFAXAN hit an all-time prescription high.

With that in mind, I want to dive into XIFAXAN's first quarter performance.

If you look at the chart on the right, you can see XIFAXAN prescriptions were up 7% year over year during the first 13 weeks of 2018, driven by the primary care sales force investment that you just talked about, Joe, and continued growth in our GI segment as well as proactive steps we took, including adjusting our co-pay offers to improve refill rates during the high deductible season.

During the quarter, we increased NRx market share from 77% to 81%, with the bulk of the growth coming from IBS-D. In fact, the chart on the bottom right shows that NRx market share is up 20 points in primary care as a result of the sales force expansion we implemented in February 2017. We believe we are just scratching the surface on this opportunity.

So what's next for XIFAXAN? We believe we have a durable asset and we will continue to invest in this product through the study of new indications and new formulations of rifaximin. We've initiated the enrollment of clinical sites and a 300-plus patient Phase 2 clinical study for the treatment of acute overt hepatic encephalopathy.

The data gained from this trial will allow us to study the new rifaximin formulation in a number of additional indications in gastrointestinal and liver diseases. We are planning to initiate a second study with SIBO later this year. As you may be aware, there are no approved products for small intestinal bacterial overgrowth.

To wrap up, XIFAXAN is a solid growth driver. We're taking concrete steps to build this franchise for the future. Joe, I'll turn it back to you..

Bausch + Lomb/International, Salix, Ortho Dermatologics and our Diversified Products.

I'm excited about this development, because it signals we've reached an important point in the turnaround process with the steps we have taken are yielding concrete results and we're beginning to turn the page away from legacy issues that have been headwinds over the past few years. With that, operator, let's open up the line for any questions..

Thank you. Your first question comes from the line of Annabel Samimy with Stifel..

Hi, guys. Thanks for taking my questions and congratulations on the strong quarter. So I just need to ask you about the dermatology portfolio. In a year's time you will have essentially completely refreshed this dermatology portfolio.

Outside of the expansion of the sales force are there any commercial plans for sort of bringing these products to gain or bundling these products to gain some kind of preferential positioning with payers? Or any commercial strategies at all to really expose your dominance in this medical dermatology area? And then on, SILIQ, I know that you've been in a softer launch, focusing on REMS certification.

Are we know in that stage where you're going to have a much stronger presence from a DTC effort to really broaden to a larger audience now that you also have – are going to have a bigger portfolio with that? Thanks..

So a couple of good questions. And let me say, dermatology, we are very excited about the opportunity to double the dermatology business. But candidly, we've acknowledged that. The dermatology turnaround, it's approximately 12 months behind the rest of the Valeant turnaround. What did we do? We clearly had to bring in new leadership.

That new leadership came in last January and that was clearly one of the important things that we needed to do. The second thing that we needed to do is realizing that we had some significant new product launches, what we invested in was a new sales force.

We increased the number of sales reps in our total sales organization, and importantly, reallocated them so that we now have a complete psoriasis team of sales representatives to go to market, to help us especially with SILIQ, but then also with DUOBRII and BRYHALI as the new products that are coming.

So that really is the primary way in which we believe that we will turn this business around. As I said going back to last six months, it's all going to come down to dermatology and the launch of our new products.

These – we have five new products to launch starting with SILIQ that we launched last year, moving to the RAM or RETIN-A MICRO 0.06% going to DUOBRII, ALTRENO and BRYHALI. It is those five new products that is really going to be the stimulus for the growth and going forward into the marketplace coupled with the incremental sales organization.

It's very similar to what we did with the Salix. We added sales representatives into Salix and now we're experiencing the benefit of that in 2018. In January, we added sales representatives.

I expect a year from now as we're talking about these new launches and talking about the sales organization that you'll see is really going to be what's going to drive our dermatology business under the leadership of Bill Humphries, our new leader there. So that's really the primary area in which we will compete.

We've already had some very important discussions with managed care market access about a product like DUOBRII that we think is a potential game changer.

And the reason I say that if we can help patients to avoid the need for a biologics and the cost of a biologic and delay that for six months or something like that, we think that's obviously going to save managed care and employers significant value, but still give patients what they're looking for, a topical treatment for psoriasis.

So look to us to have more to say about the DUOBRII launch in the next several months as we approach that PDUFA date, but it's going to come down to investment, and a new leadership, new sales force, and new products is really going to be the key for our dermatology business..

Operator, next question?.

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

Hi, guys. Thanks so much for taking my questions. I have a few if I may. And maybe this, Joe, for you and for Paul. I'm a little confused about the FX reported this quarter. Because for all the other companies, we look at in large cap biopharma, they all had a headwind from FX.

And the way that comparison tables are laid out, it makes it look like FX was a tailwind in your numbers. So I'm just curious why that is and maybe just to get some color there.

On Salix, I wanted to understand what the revision of contractual term implies and if you could quantify that for us, and will that continue for the balance of the year? And then, finally, I want to focus on your slide 42, which is a channel inventory. That slide implies that GI inventories are actually down from 1Q 2017 to 1Q 2018.

But as you discussed in opening remarks, inventories have actually improved. So my question is what exactly does that disclosure imply? And I ask because investors have really cared about this disclosure in the past because of some of the legacy Salix issues. Thank you..

Sure. So let's start with the headwind/tailwind on FX. And, Paul, why don't you – you can talk to that comment and then we'll to the Salix..

Sure. I'll start by speaking, when we talk about the tailwind, the tailwind is Q1 of 2017, I can't speak to the characteristics of anybody else's business. But the mix of our business with the way currencies move between here and there, it was a circa $65 million tailwind to our results.

In other words, if you take that out of the equation and go to a constant currency, if we reported 5%, it's not 5%, it's less than that on a constant currency basis.

And so, again, can't speak to how that would affect all the company's portfolio and the particular mix of revenues across currencies, but that is how it played out for us on a translational basis.

When we talk about the headwinds, the point where I talked about headwinds was, with respect to forward-looking, with respect to the guidance, you can see on the chart that shows the waterfall and the progression from last guidance in February to where we are today, since that time, there were some substantial unfavorable movements in rates that cause us to reduce our forecast for the full year 2018.

For our company – every company is different. But for us, the three currencies that make a real difference to us are the euro, the Polish zloty, and the Chinese yuan. And in those cases, if you look at – if you go and do the charts from February, when we provided our guidance to today, you see that it changed pretty dramatically.

We called it out that was a $70 million headwind at the top. And in my prepared remarks, it was less than that down below simply because through Q1 that we had actually realized in adjusted EBITDA $25 million gain. And that was offset by the headwinds that we expect through the entirety of 2018 relative to our prior guidance..

Let me take the second question. I think it was related to some of the revision of the contractual terms in trying to understand Salix. I think let me step back a bit. What happened with Salix, I think there was a number of really positive things that happened.

First, on the volume side, if you follow the weekly prescription numbers through March, the total RXs were up 6.8%. Importantly, within that, there's a couple of things that went on beyond that.

The number beyond that, we also saw increases in the refill rates mostly behind the hepatic encephalopathy patients where they're getting incremental refills that we think our compliance programs have helped us significantly there with the volume side. We did see some incremental pricing that occurred.

I remind you that the net pricing for Salix over the year, we took approximately 9% price increase over the year on the pricing side. And the final area was really it was related to our non-retail channel.

In the non-retail channel we had some contract terms that were pricing items related in non – what I'd call channel dynamics that allowed us to sell more profitable XIFAXAN into the channel in this non-retail channel. So we had some positives go on there as well.

But it really was a question of the volume increases predominantly also the effective net price of approximately 9% was the total price adjustments. Obviously, we don't realize all the pricing when we make pricing adjustment. And then this, what I've referred to as non-retail channel dynamics.

The final question, I think, was on slide 42, and you are correct in that, there's two dynamics going on. First of all, the net channel months on hand went down from March 31, 2018 to versus March 31, 2017. As you can see in March 31, for GI total was 1.48 months and then it was 1.39 months, so it decreased.

Having said that, though, you can also see that there was a difference and probably Paul could best describe that portion of the question..

Yeah, Omar. It's a great question. Because I know with the advent of AMA, it was beautiful; we've got wonderful visibility into what goes on in the wholesale channel. Over time, we have to start looking at the retailers as well. And I'd called it out in my remarks.

I will tell you that in Q1 of 2017, there was a lot of inventory apparently in the retail channel. We can get at that not with the same degree of specificity that we can for wholesale, but we can get at it by looking at the data of product going out from wholesalers, trying to match that up against end product demand.

And what we saw in Q1 of 2017 was a significant reduction of retail pipeline inventories in the year-ago quarter. I described this as it's a little bit like whack-a-mole.

We and every other pharma company got good visibility control over the inventories in wholesale, but the challenge has shifted to keeping an eye on what goes on with some of the larger retailers who tend to sometimes buy product ahead of demand..

Operator, our next question, please?.

Your next question comes from the line of Greg Fraser with Deutsche Bank..

Good morning and thanks for taking the questions. This is Greg Fraser on for Gregg Gilbert. On XIFAXAN, the recent extension of the stay in the patent case, was there any magic behind the length of the extension? Was it set by the court or was it decided by you or Teva? Just any color on that would be helpful.

And then, on the rifaximin development programs, sorry if I missed this, but the studies that you mentioned for acute over AG and SIBO, are those going to use the new formulation? Thank you..

So on the question on the XIFAXAN stay, I guess I'll just back up a little bit on the question and just reiterate. We think we have a strong intellectual property position. We have patents that run through 2029. We like our position with XIFAXAN.

As you appropriately pointed out, we had previously given originally Actavis, now known as Teva, a one-year stay on this in terms of negotiation discussions with the court. That stay expired in April. There was a request for an additional 90-day stay on this case. We obviously agreed to that and believe that nothing really has changed.

So for that reason, we feel very good about our intellectual property position. And we believe, as I said in the call, there is at this time no ANDA that's been filed that we believe is approvable based on the requirements that are required for a XIFAXAN generic equivalent.

But we'll await further conversations and see where it goes from this, but we did grant an additional 90-day or agreed to an additional 90-day stay on the case. On the question of OHE, overt hepatic encephalopathy placebo, we are running the new indications with a new formulation.

We have published the new clinical trial protocol on ClinicalTrials.gov is out there. And you'll see it as a new formulation for the treatment, starting with the OHE, and we'll have more to say about SIBO at some point in the near future.

Operator, next question, please?.

Sorry, operator. We're having a problem with the webcast at least on my end. It says that there are no participants..

No, sir, everyone is still connected..

Okay, thank you..

There was question on rifaximin development..

Yeah, I did that one – that's SIBO.

Operator, next question, please?.

Your next question comes from Chris Schott from JPMorgan..

Good morning. This is Chris Neyor on for Chris Schott.

First question, with the increase in your 2018 guidance, how should we be thinking the free cash flow trajectory for the full year? And then on DUOBRII specifically, can you elaborate on how you're thinking about the launch curve dynamics as we move ahead with this opportunity later this year? Thanks..

Hey, Paul, why don't you take that?.

Sure, I'll talk about the cash flow trajectory. Again, as I pointed out in my prepared remarks, based on our original 2018 guidance that we were talking about prospects for the cash flow for 2018, we said we felt like on a smooth average basis, we'd generate something in the low $400 million per quarter. We had a very strong first quarter.

I think that low $400 million average over the year continues to hold true. It's certainly helpful when your adjusted EBITDA increases. Obviously, that might nudge that upward. But order of magnitude, I think the low $400 million is accurate..

And then on DUOBRII, the question is, where are we and what are our expectations? I think with any new launch, you have to realize that new launches today, you have to go through the appropriate managed care market access discussions. We have had good progress with that already.

Our hope and our belief is that managed care market access physicians will recognize that DUOBRII offers patients really a game changer in the concept of now we will have a topical treatment for psoriasis, which is what people are looking for, that has the potential to be used for a longer duration than what currently high-potency corticosteroid can be used for only approximately two weeks.

We believe we have an opportunity to give patients benefits for a longer duration, and obviously, await the PDUFA date from discussions with the FDA. But we're excited about what that means over the long term.

We would say, though, that with any new product at least because of some of the new-to-market blocks ramp is somewhat slower than it used to be historically. But we think we have an important advance for patients and for physicians and a topical treatment of psoriasis..

Operator, let's take the next question..

Your next question comes from the line of David Risinger with Goldman Sachs (sic) [Morgan Stanley]..

Thanks very much. I hope I got a compensation step-up to make a move. Actually, it's Dave Risinger from Morgan Stanley..

Morgan Stanley. Hi, David..

Hello, so a couple questions. First of all, with respect to the organic revenue growth, obviously that was nice to see and compelling this quarter and boosted by XIFAXAN.

Could you talk about the prospects looking forward for organic revenue growth? Second, with respect to XIFAXAN, just so that we're level-setting appropriately, how should we think about the second quarter sequential sales prospects versus the $276 million that was reported in the first quarter? And then third, when do you expect to start to disclose new product quarterly sales? Thank you..

Okay, let me start with the first comment on organic growth. And I think one of the important comments – and thank you for noticing. One of the important comments is when you have a turnaround, the first thing you need to do is stabilize the company and then focus on turning it around and starting to show organic growth.

We did indeed show that 2% organic growth, the first time since 2015, so I feel very excited about that. But I think the other piece that I made mention of in the call that I think is an important factor is that if you take our top 10 products, obviously, our most important products, looking at those, the top 10 products grew by 20% versus last year.

So I think that that's an important indicator of this turnaround process that we have underway. There's always going to be some quarterly variations and we don't really comment specifically about quarters in terms of where things are going.

But I think the momentum we have in these top 20 products, I think, is probably the best leading indicator of what we're trying to accomplish. Once again, XIFAXAN, we don't really talk about the specifics of the quarterly sales numbers.

But obviously, as you look at the prescription levels versus where we are, I think as Mark just said in his comments, we have hit an all-time record as we have just recently released weekly results for an all-time record for XIFAXAN. We're up approximately 6.8%, I think, year-to-date 7% year-to-date.

And obviously, gives us very comfortable feelings on our growth potential versus a year ago as we approach the second quarter and beyond in terms of where we're going with business. But we can't really make any more specific comments about guidance for quarterly guidance on products.

And I think the final question when will we disclose new product sales, our new view on new product sales is that we give updates on prescriptions, but actually, we don't report on new product sales until they achieve the status being one of the top 10 products as we disclose top 10 products in each of our therapeutic segments.

The good news is that with the second quarter, we'll provide even greater clarity because we'll start reporting Bausch + Lomb/International. We'll start – we're reporting Salix, we'll be reporting the dermatology business all as separate entities as well as diversified. So you'll see even greater clarity on what's happening with our overall sales.

We hope that transparency helps you in your modeling..

Operator, next question?.

Your next question comes from the line of Louise Chen with Cantor Fitzgerald..

Hi. This is Jennifer on for Louise. Thanks for taking my question. I have a couple here. First, just going back to derm. A lot of companies in the derm space seem to continue having some difficulty getting candidates to approval.

So I'm just wondering as a larger and I guess more experienced key player, can you talk about what drives your confidence in getting your key pipeline candidates to approval? And then, related to that, I think on IDP-120, I think, originally Phase 3 was expected to initiate in the first half of 2018, and now it's second half.

And I'm just wondering, if you can give a bit more color on the reasoning behind that? And then, my second question is just on VYZULTA, I know it's very early. But do you have any color on how much – how the uptick has been or has it been driven more by market growth or like what the feedback you've been hearing from patients is so far? Thanks..

Sure. Sure. So let me start with your derm question. I think your question in terms of our ability to get approvals stems from really just one major fact. We just have a great dermatology R&D team. They've done just phenomenal relative to not only the existing portfolio of products we have, but also these new products.

They really know how to develop these products. They know how to show the benefits.

And I think as we look at what we're doing with products like DUOBRII, ALTRENO, BRYHALI, we think these are the types of products that we feel very comfortable based on our interactions with FDA that we are delivering NDAs that are showing the appropriate studies that will generate the approval.

I will say that we put a statistic in based on, I think, it was last quarter that this team, the team that previously was known as Dow, which is part of Valeant – the Ortho Dermatologics team is responsible for a significant portion of all – many of the products that have been developed not just here at Valeant, but even prior to Valeant's acquisition of this business, maybe it's dermatologics product.

So they truly are a center of excellence. On the question of IDP-120 moving from first half to second half, that's really just a slight timing variation, no big issues with the product or what we are expecting, it's just really moving through the clinical trial process, just a slight change in the timing. VYZULTA, we're excited.

We continue to see the numbers of prescriptions that are being – waiting for VYZULTA to continue to climb. So we're excited about that. As we said at the beginning of the launch, 2018 is an important year to get up and running. But we do know we need to get the Part D coverage. And that's something we're working on right now.

So that's why the end of the – this 2018 timeframe entering into 2019, we'll have an appropriate coverage across the entire spectrum of our opportunities. So excited about what it means, we're getting great feedback about this dual mechanism of action with VYZULTA, and what it means for patient in terms of patients benefits.

So we'll continue to make progress there with the belief that we'll need to do some additional contracting. Much of that is well underway already for even better 2019. Operator, I think I have time for one more question please..

Your last question comes from the line of David Amsellem with Piper Jaffray..

Thanks. And I know you're not breaking out SILIQ just yet. But maybe talk qualitatively to the payer landscape here and just going forward, how heavily contracted do you think the product's going to be.

And in terms of how it's being used, are you finding that you're seeing a significant number of patients who have already cycled through Cosentyx and Taltz? Just talk about those dynamics if you can? Thanks..

Sure. So SILIQ will continue to make progress. As I mentioned in the call, we have more than 2,500 doctors REMS certified.

Because of what we did on the pricing of SILIQ we priced it, we think very cost effectively for managed care plans in the 10%-plus reduction from existing injectable biologics, depending it can be even more than that, depending on how one quantifies it. We haven't got any good reception.

To-date we have 49% of commercially insured patients that have been covered. So we're getting good coverage so far. Obviously, that will continue to improve as we make progress with the managed care plans. I think the important issue for us is that two things on SILIQ.

Number one, we're getting a great response from those physicians that have been REMS certified. They wouldn't go through REMS certification if they did not believe there was a space in there (58:12) for the use of SILIQ. So physicians are responding well and going through REMS certification.

We have an all-time record in terms of number of new patients coming into the process. Week over week, we continue to climb on the TRx side. I think the actual number REMS certified physicians is actually now up to like 2,719 or increasing the number of calls we're making.

As a reminder, we launched this with a very limited, almost like a SWAT team of sales reps going in to get to the key opinion leaders and also the docs that were part of the clinical trial. We've now expanded it to a full team in the treatment of psoriasis team calling on those docs.

So completely new approach as of January based on the fact that we first have to get through REMS certification; we've done that. Now we're starting to see the benefits of that for the patients. And we're very excited about where that goes for the future..

Thank you, everyone, for joining us today. Thank you very much for your interest in Valeant. Have a great day, everyone..

This concludes today's conference call. You may now disconnect..