Operator: Greetings, and welcome to the Bausch Health’s First Quarter 2026 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. It’s now my pleasure to turn the call over to Garen Sarafian, Vice President, Investor Relations. Garen, please go ahead.

Garen Sarafian: Good afternoon, and welcome to Bausch Health’s First Quarter 2026 Earnings Conference Call. My name is Garen Sarafian, Vice President of Investor Relations. Participating in today’s call are Thomas Appio, Chief Executive Officer; JJ Charhon, Chief Financial Officer; and Jonathan Sadeh, Chief Medical Officer and Head of Research and Development. Before we begin, I would like to remind you that today’s presentation contains forward-looking information. Please take a moment to review the forward-looking statements disclaimer at the beginning of the slides accompanying this presentation as it contains important information. Actual results may differ materially from those expressed or implied in these forward-looking statements, and you should not place undue reliance on them.

Please also refer to our SEC filings and our filings with the Canadian Securities Administrators for a discussion of certain risk factors that could cause actual results to differ materially from expectations. We use non-GAAP financial measures to help investors better understand our operating performance. These non-GAAP measures may not be comparable to similarly titled measures used by other companies and should be considered in addition to and not as a substitute for measures calculated in accordance with GAAP. Reconciliations to our non-GAAP measures are included in the appendix of the slides accompanying this presentation, which are also available on Bausch Health’s Investor Relations website. Finally, the financial guidance in this presentation is effective as of today only.

We do not undertake any obligation to update guidance. Our discussion today, Wednesday, April 29, will focus on Bausch Health, excluding Bausch & Lomb. However, we will briefly comment on Bausch & Lomb’s results announced this morning. We will refer to year-over-year comparisons with the same period last year, unless otherwise noted. With that, I will turn the call over to our CEO, Tom Appio. Tom?

Thomas Appio: Thank you, Garen. Thank you to everyone joining us today. We began 2026 with another strong performance. Our first quarter results extend our track record to 12 consecutive quarters of year-over-year growth in both revenue and adjusted EBITDA for Bausch Health, excluding Bausch & Lomb, reflecting strategic execution and disciplined accountability across our global organization. Our priorities remain, we are focused on execution within our core business, R&D innovation, business development and optimizing our capital structure. We delivered a strong start to the year in cash flow, supported by solid operating performance. That cash generation supports continued progress on capital structure priorities, enables investments in our businesses and preserves capital allocation flexibility.

It is also important to consider the composition of reported results this quarter. Core operating performance continues to demonstrate steady growth and is tracking well with expectations. Overall, this was a solid start to the year. Let me take a moment to share a few highlights from the quarter before handing it over to JJ for a closer look at the financials. Bausch Health, excluding Bausch & Lomb, increased revenue by 14% on a reported basis when compared to the first quarter of 2025. Results were led by Salix and Solta. Within Salix, revenue growth was driven by Xifaxan, which continues to perform well in both IBS-D and OHE. We also benefited from residual volume in certain channels that we exited starting last quarter. Underlying prescription trends remain healthy.

Solta continued its double-digit growth trajectory. Demand for systems and consumables remain robust in core markets. Adjusted EBITDA for Bausch Health, excluding Bausch & Lomb, increased by 17% on a reported basis, largely attributable to Salix and Solta performance. Salix benefited from improved margin dynamics following payer channel optimization and Solta earnings growth was particularly notable given we had a onetime acquisition-related cost. Cash flow generation in the first quarter was healthy and progressing well towards guidance expectation. This includes the remaining settlement of our U.S. opt-out litigation, which have now all concluded as well as reducing our net debt by over $100 million. Taken together, core operational performance was solid.

Turning briefly to R&D and business development. Through our acquisition of DURECT last year, we are advancing our larsucosterol Phase III program for alcohol-associated hepatitis, where there remains a significant unmet need. We believe larsucosterol has the potential to be a platform asset with applicability in multiple indications. In recent months, we have made meaningful progress narrowing our broader list of potential indications to those with the strongest scientific and clinical rationale. Beyond larsucosterol, we continue to assess multiple business development opportunities that leverage our proven commercial execution and strengthen our R&D pipeline. Our capital allocation strategy remains consistent and disciplined. We prioritize strengthening the balance sheet through ongoing delevering while we invest in our commercial engine and evaluate business development prospects.

Within that framework, we evaluate opportunities selectively across our portfolio, emphasizing assets aligned with our strategic model and our outstanding commercial capabilities. Overall, we are very pleased with our start to the year and the momentum we are carrying forward. With that, I will turn the call over to JJ to walk through the detailed financial results. JJ?

Jean-Jacques Charhon: Thank you, Tom. Let’s review first our non-GAAP financial results for the first quarter, which you will find starting on Page 9. Revenue was $2.524 billion, up 12% on a reported basis and 7% on an organic basis compared to the same period a year ago. Adjusted gross margin was 70.9%, 100 basis points higher year-over-year. Adjusted operating expenses were $1.023 billion, an increase of $29 million compared to the same period last year. Please note that this excludes, among other adjustments, the $1.4 billion goodwill impairment charge following the RED-C clinical trial outcome. Adjusted EBITDA was $837 million, an increase of $176 million or a 27% increase year-over-year. Finally, adjusted operating cash flow was $374 million.

Moving now to the performance of Bausch Health, excluding Bausch & Lomb, for the first quarter, starting on Page 11. As Tom indicated earlier, 2026 started on a very strong note. We delivered in Q1 the 12th consecutive quarter of year-over-year revenue and adjusted EBITDA growth, demonstrating once again the consistency of our operational execution. The highlights for the quarter were as follows: Revenue was $1.280 billion, up 14% on a reported basis and 9% on an organic basis when compared to the first quarter of 2025. Adjusted EBITDA was $673 million, up 17% year-over-year, demonstrating our continued commitment to driving profitable growth and leveraging our supply chain and SG&A infrastructure. Finally, adjusted operating cash flow was $319 million, nearly $200 million higher than in the first quarter of 2025, thanks to stronger business performance as well as the difference in timing of our interest payments.

Moving now to our first quarter performance by segment, starting with Salix on Page 12. Salix had another outstanding quarter. Revenues were $639 million, an increase of $97 million or 18% on a reported basis as compared to the same period last year. Salix strong performance in the first quarter was largely driven by higher-than-expected Xifaxan revenue, which grew 21% year-over-year. This was primarily attributable to continued volume growth in the channel we currently serve, net pricing and to a lesser extent, the residual volume we are still seeing throughout Medicaid at the state level. Total scripts in the commercial and Medicare channels grew 6% and new-to-brand script growth was 3%. Now moving to the International segments. Revenues for the quarter were $285 million, which was up 9% on a reported basis and was broadly flat on an organic basis compared to the first quarter of last year.

Performance by region was mixed. On an organic basis, EMEA was up 3%, LatAm was flat, while Canada contracted 7% due to its non-promoted portfolio. More specifically, here are the highlights of each geography. EMEA achieved its 13th consecutive quarter of organic revenue growth, which is remarkable. In LatAm, there was solid growth in core commercial products such as Bedoyecta. Conversely, the softness of receive orders associated with secured government tenders continues to be a headwind. In Canada, the performance of our promoted portfolio grew 18%, which was more than offset by the drop in volume in our branded generic portfolio. As a reminder, starting in the second half of 2024 and all the way through the first quarter of 2025, we benefited from higher-than-usual Wellbutrin volumes due to generic supply shortages.

Now moving to Page 14 for a review of our Solta Medical segment. Revenues were $171 million, an increase year-over-year of 51% on a reported basis and 19% on an organic basis. Separately, segment profit grew 42% on a reported basis. Solta’s revenue performance was driven by a 193% year-over-year revenue growth in China. This remarkable performance was partially attributed to higher pricing associated with the integration of our full-service distributor, Shibo, we acquired in December 2025 and to our impressive volume growth in the quarter, which stood at 52%. China has now reclaimed the #1 position as the largest geography of Solta. South Korea, our second largest revenue contributor, grew 17% in the first quarter. Outside of the APAC region, the U.S., EMEA and Canada also showed positive momentum, delivering high single to low double-digit reported revenue growth in the quarter.

Finally, please note Solta segment profit in Q1 was impacted by the residual impact of the higher inventory costs associated with the Shibo acquisition. Turning now to our diversified segments, which you will find on Page 15. Revenues were $185 million, a decrease of 10% on a reported basis compared to the same period a year ago. The Diversified segment’s performance is largely driven by our neuroscience business. The year-over-year revenue contraction this quarter was due to lower volume, partially offset by favorable pricing. Finally, Bausch & Lomb revenues were $1.244 billion, up 9% on a reported basis and 6% on an organic basis compared to the same period last year. Now turning our focus to our balance sheet. Our net debt, excluding Bausch & Lomb, decreased by approximately $150 million in the first quarter.

This is after an approximately $160 million outflow due to various legacy litigations, which included the last set of payments of our U.S. opt-out settlements. Before wrapping up with our financial priorities, let’s review our full year guidance, which you will find on Page 19. We are reaffirming our full year 2026 guidance for Bausch Health, excluding Bausch & Lomb, which remains as follows: Revenue is expected to be between $5.250 billion and $5.400 billion. The midpoint of that range would translate into a 3% increase year-over-year. Adjusted EBITDA is expected to be between $2.875 billion and $2.950 billion, representing a 4% increase year-over-year at the midpoint. The 2026 guidance for adjusted EBITDA now includes the anticipated impact of the new tariffs on pharma products expected to be effective on September 29, 2026.

Finally, we expect adjusted operating cash flow to be between $1.200 billion and $1.275 billion. The midpoint of that range would translate to a 4% increase year-over-year. Please also note that the guidance for 2026 is at current FX rates. Before I turn it over to Tom for his wrap-up, let me review our financial priorities, which remain broadly unchanged. First, increasing the value of Bausch Health. Our management team remains committed to driving profitable growth through innovation, excellence in operational execution, effective resource investments and selective business development projects. Second, evaluating all options for unlocking value for all stakeholders, including maximizing the value of the Bausch Health and Bausch & Lomb assets.

On the B&L front, we believe in Bausch & Lomb management team and their Vision 2027 plan. We fully expect the financial markets to reward B&L’s progress in the future. This will likely guide, among other considerations, the timing of our equity stake monetization. And third, optimizing our capital structure. While our current debt maturity profile allows us to take a more opportunistic approach to capital allocation decision, we will continue to look at all options to improve our liquidity and financial flexibility. In summary, we had a great first quarter and remain confident in our financial outlook given the strength of our current operational momentum. I will now hand it back to Tom.

Thomas Appio: Thank you, JJ. Looking ahead, we see continued progress building our company for growth in 2026 and beyond. Throughout our markets, we are gaining share, seeing favorable prescription trends, expanding partnerships, advancing new product launches and extending the reach of our existing products to new geographies. This progress reflects strong execution within our portfolio, the integration of new businesses and disciplined investments that strengthen our competitive position. As we have noted on prior calls, certain dynamics relating to our exit from Medicaid and 340B may impact our growth as reflected in our Salix and Diversified segments in the back half of the year. Even so, we are excited about initiatives underway across the portfolio to ensure we plant the seeds for future growth.

A few examples from different segments illustrate the breadth of that progress. Within U.S. Pharma, this quarter again proves our ability to execute with precision. By maintaining a disciplined approach to capital deployment, we are focusing our resources on high-growth opportunities that drive demand and operational efficiency. At Salix, this approach continues to translate into strong performance for Xifaxan, supported by high levels of physician engagement, improved patient access and a channel mix that reinforce both stability and scale. We are investing thoughtfully, prioritizing returns and optimizing growth that can be realized from a highly resilient, well-established franchise. Turning to Solta China. We are pleased with our integration of the Shibo distribution business, which is progressing as planned.

By deepening our vertical integration within this core market, this acquisition secures a critical segment of our value chain. It provides unfiltered visibility into end consumer behavior, enabling more precise demand forecasting and strengthening our long-term competitive advantage. In EMEA, 2026 is expected to be an active year for new product launches. Products launched in 2025 and those launching throughout this year are expected to contribute meaningfully to growth in 2026 and beyond. We currently have more than 30 products launching in 10 countries within EMEA, spanning gastroenterology, dermatology, joint health, neurology and hospital-based therapies. We are also targeting geographic expansion of existing portfolio of products, including Poland and Serbia, Montenegro.

In Latin America, we continue to extend our cardiometabolic franchise. In addition to the three products launched in Mexico during the back half of last year, two additional therapies are expected to launch in the second quarter. Within Solta, we launched Clear and Brilliant in Canada, expanding access to advanced aesthetics technologies in new markets. Within dermatology, our collaboration with the FDA has successfully streamlined patient access for Salix. Patients can now begin their journey with this specialty medication sooner as pre-prescription blood tests are no longer a requirement for starting on-site sampling. More recently, in mid-April, we also launched Biafine in the United States, first developed in France. This heritage formulation is gentle for sensitive skin is scientifically proven to fortify the skin barrier and is now available without the need of a prescription.

While these investments vary in scale, each is a strategic building block in our global portfolio. They reflect our commitment to investing with purpose, ensuring we have the right mix of products to drive consistent operational excellence across the entire organization. Beyond product innovation, we continue scaling our core capabilities. Given the frequent questions, I want to dive deeper into our AI road map and how it’s delivering our growth. We were early in recognizing the potential of AI to drive commercial performance, and that conviction has paid off. Our AI-enabled customer insights engine first developed for Xifaxan has been instrumental in the continued growth of the brand within both OHE and IBS-D indications. These insights ensure our field teams are engaging the right customers at the right frequency with the right message.

Since the 2023 launch of the customer insights engine, we have seen a 20% surge in sales productivity. More importantly, this efficiency has enabled nearly 700,000 Xifaxan new patient starts, directly advancing our mission to deliver better health outcomes for those living with OHE and IBS-D. These core capabilities are involving in a suite of digital tools that streamline the HCP experience while significantly increasing the precision and impact of our promotional efforts. Building on that foundation, we have expanded AI-driven insights in additional U.S. pharmaceutical brands at various stages of field force deployment. For Relistor, we launched an AI-enabled program in the second half of 2025. While still early, our preliminary data suggests as much as a 20-plus percent lift in new prescriptions with certain high-priority HCP cohorts.

And with the most recent launch of the customer insights engine for neurosciences late in the first quarter, all U.S. pharmaceutical business now leverage AI and advanced analytics, driving meaningful increase in field productivity and effectiveness. On the other end of the spectrum, AI is also playing an expanded role in accelerating both the efficiency and effectiveness of our R&D organization, spanning operations, clinical development, medical affairs, pharmacovigilance and project management. Three examples illustrate the tangible impact. In clinical operations, we leverage AI-enabled site selection and patient recruitment models to evaluate site expertise and patient population, expanding our qualified investigator network. Not only did the number of eligible sites increase by a substantial margin in less time, but we believe this has led to a significant increase in high-quality investigator sites expected to reduce recruitment time lines and study costs relative to traditional methods.

Pharmacovigilance is a second area of impact where AI-assisted workflows are eliminating months of manual effort and improving the speed and consistency of our safety monitoring. Finally, in indication selection, we applied AI-driven analysis to our full asset portfolio, integrating internal data with public domain sources to identify potential new indications as well as model probability of success and sharpen prioritization. While we are in the early stages of our AI transformation, our initial targeted applications have already delivered measurable impact. These early wins give us the confidence to invest in building a sustainable competitive advantage in how we develop and market life-changing medicines. Lastly, I want to highlight our continued focus on business development.

Our approach is disciplined and consistent with the financial priorities I outlined earlier. We are actively screening opportunities based on therapeutic fit with a focus on areas where we have established expertise, including GI, hepatology, neurosciences, dermatology and aesthetics and where we believe we can create the most value. We are prioritizing assets that are late stage or commercial-ready, where our existing outstanding commercial capabilities allow for efficient execution from development to commercialization across the markets. This focus helps ensure that any potential investment is aligned with how we operate the business today. We continue to screen opportunities through the lens of our capital allocation strategy by first ensuring an efficient capital structure, we can then focus on disciplined investments and business development that deliver sustainable long-term value creation.

In closing, our solid first quarter performance is a testament to our global team’s relentless commitment to operational excellence. Our performance in the first quarter gives the confidence to reaffirm our full year guidance. As we strengthen our balance sheet and execute with discipline, we remain steadfast in our mission to drive long-term value for shareholders. With that, can we open the line for Q&A. Operator?

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Operator: [Operator Instructions] Our first question today is coming from Leszek Sulewskifrom Truist.

Unknown Analyst: This is [ Jean ] on for Les. What are your expectations for Xifaxan inventory destocking in 4Q due to IRA? Do you have any color on how you expect wholesalers to act ahead of the pricing step down in 2027?

Thomas Appio: Yes. I think, J.J., you can take that.

Jean-Jacques Charhon: Yes. So in terms of volume, there’s really not that much destocking. As we indicated during our fourth quarter call is that we’re expecting a gross-to-net accrual adjustment as a result of that higher discount rate that will be effective January 1, 2027. So that will be an entry we will take. But in terms of volume, we’re not anticipating any change versus the current volume we’re seeing right now.

Thomas Appio: Operator next question.

Operator: Our next question today is coming from the line of Douglas Miehm from RBC Capital Markets.

Douglas Miehm: Very strong numbers that came out of Solta, especially out of China. And of course, part of that is a function of the Shibo acquisition and seeing a full quarter of that. But even so, you did have 22% organic growth, I believe. And I’m just wondering, that seems in contrast to a couple of other companies that we’ve heard recently, including B&L this morning, who says that’s probably the weakest market. So just wondering why you’re having so much success over there and if it’s sustainable?

Thomas Appio: I think the first thing, as you mentioned, the acquisition of Shibo was a — that was a part of what we wanted to build there to be able to get closer to the providers and the customers and the consumer. What I would say is we have an outstanding team in China. We have a team that is executing to precision. The integration is going extremely well. What we’re seeing right now is there’s high demand. As I mentioned during the last conference call, I was in China at the end of December. We had an event where we met the key customers in China and the product is viewed as the gold standard. So now having this integration, having direct access to the providers, the consumers and also to the field force and then developing the processes and enhancing the processes to have a better sales execution is what’s driving it.

The Thermage business in China, the customer in terms of their ability to pay, it’s a very — it’s a business and a customer base that is sort of a little bit insulated from the economics that are going on in the country or even globally. So we still see strong demand for the product. As you know, it’s a durable business, both with capital and consumables. So the more capital we can put in with this integration of Shibo and then driving the use of those machines going forward with our consumable base. So we see that the growth can continue, and we’re expecting a very good year in 2026. And as I said, it all begins with having an outstanding team on the ground in China.

Douglas Miehm: Okay. Great. And then just with respect to business development as a follow-up question. Given the success that you’re seeing at Solta, but also the importance of your GI franchise, capital commitment opportunities, those sorts of things, which of those two businesses would you — are you just going to be simply opportunistic? Like where would you expect to see some investment go?

Thomas Appio: Yes, Doug, another great question. When I look at it in terms of a business development standpoint, and I look at our U.S. Pharmaceutical business, along with our international pharmaceutical business, again, it starts with people. We have an outstanding global commercial team. So as we’re looking at business development opportunities, what I see for Bausch Health, our greatest asset is our people and being able to execute globally. So as we look at various opportunities throughout the therapeutic areas that we have expertise in, I see opportunities to be able to bring in some products that we can grow and we can develop. So as I said in my prepared remarks, looking at assets that are commercially already on the market or coming to market and at the same time, having the pipeline, we have an outstanding R&D team as well to be able to develop some of those pipeline assets.

So overall, I’m not specifically looking at areas in the therapeutic classes that we compete. But we have, if you look at even — if you look at Xifaxan and you look at the OHE indication, that’s really a specialty area. So we have expertise to be able to sell and market specialty drugs or extending off of that into the rare space. At the same time, also on the Solta side, we’re also looking at other opportunities as well in terms of there’s a few assets that we could look at to bring in. So overall, really robust discussions happening here to get more products into the hands of our outstanding commercial teams. Operator next question.

Operator: [Operator Instructions] Our next question is coming from Umer Raffat from Evercore ISI.

Umer Raffat: I have two here, if I may. First, your planning around separation, debt refi, et cetera. How does that change considering your current scenario January 28, how does that change if the D.C. Circuit Court reverses some of the prior findings of courts? And how does that change the level of urgency and planning? Do you have a contingency plan in place if that were to happen on Xifaxan? Number two, JJ, you mentioned you’re looking at tuck-in opportunities for assets that are either already on the market or coming to market with the pipeline. I guess my question is, do you guys have the flexibility and room to be able to raise equity to finance some of those? Because this is a strategy that’s been used very successfully by a lot of SMID biotechs. But what I didn’t know is do you have the visibility on being able to raise cash from the markets to finance those R&D and the trials in case you were to find a good asset, let’s say, a Chinese asset or the like?

Thomas Appio: Okay. Umer, I’ll take the first part of your question and hand it off to JJ for the second part. The way I’m looking at it right now, we know we will have a generic entrant 1/1/2028. But right now, today, Teva remains the first filer, has first filer status. If we look at it, as you know, recently, the one thing that has changed is that Teva has gained final approval by the FDA. So as we look at it, there’s two appeal cases that are fully braced, and we are waiting on a decision. Clearly, as I said, we remain a generic entrant of 1/1 — of like 1, the 2028. And as I look at it and we look at what our contingency planning is, of course, we are looking at contingencies and what we would do, but we continue to remain confident in our IP and planning for 1/1/28. JJ?

Jean-Jacques Charhon: Yes. Umer, let me take a step back first and probably reiterate the equation we’re dealing with. As you know, our capital structure optimization really relies on three variables. The first variable is the free cash flow we’ll be generating between now and the end of 2027, assuming, obviously, we retain exclusivity until the 1st of January 2028. The second variable is the EBITDA post FX and LOE. And then the third variable is the average selling price we hope to get by monetizing our equity stake in BLCO in completing the separation, if that’s the path we’re going to be taking. In case we lose exclusivity before the 1st of January 2028, what it does, as you know, is that basically it curtails the free cash flow generation between now and the end of 2027.

So that would translate into — in the absence of any other levers that we would put in place, the need to monetize some of our assets earlier than originally planned. But from an operational standpoint, I think Tom covered it. Obviously, it’s an event we’ve been preparing for. We’re trying to mitigate it as much as possible through looking at potential BD opportunities, but it’s not something that would be a dramatic change of plans. There are opportunities to increase our level of financial flexibility. I think I mentioned that in my prepared remarks, the ability to potentially do some other refinancing of our debt structure so that the maturities between now and the end of 2028 could be pushed back. That would be one option. And then the other options would be to do some sort of capital reallocation within our portfolio.

Equity is not something that is high on our priority list at this stage, given where the share price is. So I certainly wouldn’t consider that. It’s a possibility, but it’s probably — it’s not a probability at this stage.

Thomas Appio: Operator next question.

Operator: Our final question today will be coming from Mike Nedelcovych from TD Cowen.

Michael Nedelcovych: I have three actually, if I thought all right. My first is on larsucosterol. What are the key changes that have been made to the Phase III trial to avoid the failure that was seen in Phase IIb? Is it just a larger, better powered trial? Or have there been other changes made to trial design or inclusion criteria? That’s my first question. My second question is just a simple one. I’m just curious where the internal review for amiselimod stands. It’s been underway for some time. And I’m just wondering what factors are still being considered? And then my third question relates to your tariff exposure. I think since you last quantified your tariff exposure, there has been news from the White House. So I’m wondering if you might be able to characterize your current tariff exposure with a little bit more detail?

Thomas Appio: Yes, Michael, I’ll take the last one, and then I’ll hand it off to Jonathan for your first two. As you know, generally speaking, we have local production in many of the markets, so which naturally helps us there. And then the recently announced tariffs that probably will have an impact on Xifaxan and TRULANCE probably starting in September or the end of September of 2026. But what I would say is, as of today, that we noted in our guidance that we reaffirmed, it includes the impact of any existing tariffs or those signed to become effective in ’26. So right now, that’s the way we see it with what we know today. JJ, do you want to add anything else on tariffs?

Jean-Jacques Charhon: No, I would just say at a high level, it’s minimal impact in 2026. 2027, we’ll have to wait until what mitigants we put in place to try to minimize even more, assume, obviously, those tariffs be in place for the full year of 2027. But at this stage, I think what we have provided earlier, which is that tariffs had a minimal impact on our P&L, I think, remains the same even with those latest round of tariffs.

Thomas Appio: Jonathan, do you want to take the first two parts of that question?

Jonathan Sadeh: Yes. Okay. So first of all, [indiscernible]. Your question is what have we done to mitigate for what happened to DURECT in their Phase IIb study. So first, it’s important to remember what really happened there. Remember, it was a global study, although 80% — about 80% of the patients were in the U.S., about 20% were ex-U.S. And when we reviewed the data, it seemed like the 20% of patients who are randomized outside of the U.S. were somewhat different than the ones in the U.S. The main issues there were that those patients seem to be randomized later on. So the earlier you’re randomized after presentation to the hospital with alcohol-associated hepatitis, the sooner you’re randomized, the more likely you were to respond, which, of course, makes sense ex-U.S. There were a few sites where they really took a very long time to randomize these patients.

mainly, we believe, based on different treatment algorithms in some of these countries. They took a long time to rule out any other issues, any problems they had. And so they randomized them sometimes weeks after presentation. So the ability of the drug to actually be impactful was much lower. It also seems to be like a slightly different patient population. They are heavier drinkers than they were in the U.S. So all of those together, all those issues together, when we look at the U.S. patient population was much more homogeneous patient population, all randomized early on after presentation to the drug. And we consistently saw a very strong effect of over 50% reduction in mortality in this patient population. So we strongly believe that, that is true, and that is a real finding.

It was highly statistically significant in the U.S. population. And what we’ve done to make sure that we don’t see those same issues in the Phase III trial was, first, to focus on the U.S. population. We want to make sure that we’re taking a homogeneous patient population. So we decided to run the trial in the U.S. only. Second is we made sure that patients are randomized early on. They cannot be randomized to the drug unless they are — unless they’re randomized within 9 days of presentation, which is what we saw in the Phase IIb trial, those patients seem to have a strong response. So that was the second important adjustment. And the third, as you’re alluding to, we did power the study highly to 90% alpha, made sure that we have a very large number of patients randomized to active and placebo, and we believe that the probability of success here based on all of these is quite high.

The study is now in start mode. We’re opening up sites and are very optimistic about the probability of success here. So that’s the larsucosterol question. The second was about the review of amiselimod. And maybe I should take a broader view here and tell you what we’ve been doing is looking at our portfolio overall and looking at not just amiselimod. We have — we got the data on UC a while back and have been reviewing it. The data we thought was very good. The indication is one of interest for us and fits well with our strategy. But what we have been doing over the past few months is looking at all possible indications with all possible drugs that we have in our hands right now. So larsucosterol is one. We have — we’ve said before that, that is a platform drug that can be used for multiple indications.

So — we have been looking at possible indications to progress with that. We’ve been looking at rifaximin, which is, I think, a really effective drug, and we have multiple formulation of that, and we’ve been looking at possibilities for new indications there as well as with amiselimod. So we’ve put all those indications together, all the possibilities, and we’re right now prioritizing what is the best indication for us to progress forward based on scientific evidence, developability of drugs, regulatory path and importantly, commercial opportunity. We’re looking at all of those variables for all indications and making decisions with all drugs and all indications and making decisions on which ones we will progress with.

Operator: We reached the end of our question-and-answer session. I’d like to turn the floor back over to Tom Appio for any further or closing comments.

Thomas Appio: Thank you, operator. Thank you all for joining us today and for your questions. We had a solid first quarter performance, and I want to thank the global Bausch Health team for their relentless commitment to operational excellence and delivering results. We are committed to our mission to drive long-term value for our shareholders. Thank you for your time today and your interest in our company. Have a good evening.

Operator: Thank you. That does conclude today’s teleconference and webcast. You may disconnect your line at this time, and have a wonderful day. We thank you for your participation today.

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