Greetings, and welcome to the Bausch Health Third Quarter 2025 Earnings Conference Call. [Operator Instructions]. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to your host, Garen Sarafian, Vice President, Investor Relations. Garen, please go ahead.

Good afternoon, and welcome to Bausch Health's Third Quarter 2025 Earnings Conference Call. Participating in today's call are Thomas Appio, Chief Executive Officer of Bausch Health; and JJ Charhon, Chief Financial Officer. Before we begin, I would like to remind you that our presentation today contains forward-looking information. We ask you to take a moment to read the forward-looking statements disclaimer at the beginning of the pages that accompany this presentation as it contains important information. Our actual results may vary materially from those expressed or implied in our forward-looking statements, and you should not place undue reliance on any forward-looking statements. Please refer to our SEC filings and our filings with the Canadian Securities Administrators for a list of some of the risk factors that could cause our actual results to differ materially from our expectations. Those documents, including the full cautionary statements are also available on Bausch Health's Investor Relations website. We use non-GAAP financial measures to help investors understand our operating performance. Non-GAAP financial measures may not be comparable to similarly titled measures used by other companies and should be considered along with but not as an alternative to, measures calculated in accordance with GAAP. You will find reconciliations of our historic non-GAAP measures in the appendix of the pages that accompany this presentation, which are 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, October 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 would like to turn the call over to our CEO, Tom Appio. Tom?

Thank you, Garen, and welcome to everyone joining our earnings call today. In the third quarter, Bausch Health, excluding Bausch + Lomb, delivered our 10th consecutive quarter of revenue and adjusted EBITDA growth, consistent with our strong performance this year. Our teams continue to execute with discipline and focus, driving operational and financial momentum across the business. I will start by providing some highlights from our third quarter results. In the third quarter, Bausch Health, excluding Bausch + Lomb delivered year-over-year revenue growth of 7% on a reported basis and 5% on an organic basis. We achieved 7% adjusted EBITDA growth for Bausch Health, excluding Bausch + Lomb, which included an $81 million charge to acquire R&D. Excluding this charge, our adjusted EBITDA grew 18%. We reduced our debt by approximately $600 million using cash on hand and as a result of our strong performance in the first 9 months of the year, we are raising full year guidance for revenue, adjusted EBITDA and adjusted cash flow from operations for Bausch Health, excluding Bausch + Lomb. I am pleased with how our teams have navigated through a dynamic macro backdrop embodying the culture of accountability, urgency that defines Bausch Health. Across our global platform, we saw traction in many areas. Consolidated Bausch Health as well as Bausch Health, excluding Bausch + Lomb, both achieved year-over-year revenue growth of 7% on a reported basis and 5% on an organic basis during the quarter, showcasing the consistent strong performance across the enterprise. Focusing on Bausch Health, excluding Bausch + Lomb at a segment level, we saw excellent double-digit growth in our Solta and Salix businesses. Solta saw a 25% growth on a reported basis and 24% on an organic basis while Salix delivered 12% growth on a reported basis and 11% growth on an organic basis, 2 key growth areas that continue to deliver outstanding results. At the product level, we continue to see healthy performance across our diverse portfolio with notable results in our hepatology, dermatology and neurology offerings. We saw triple-digit growth for Cabtreo and Ryaltris as well as double-digit growth for Xifaxan and Thermage. Overall, we continue to demonstrate strong operational performance in the third quarter, and we are well positioned to execute on our strategic priorities as we close out this year and move forward to 2026. With that, I will pass it over to JJ to discuss our financial results in more detail before I conclude our call with BHC's progress against our key strategic priorities. JJ?

Thank you, Tom. Let's first turn to our consolidated performance, starting with our non-GAAP financial results for the third quarter, which you will find starting on Page 9. Revenue was $2.681 billion, up 7% on a reported basis and 5% on an organic basis compared to the same period a year ago. Adjusted gross margin was 72.7%, 40 basis points lower year-over-year. Adjusted operating expenses were $1.024 billion, an increase of $41 million compared to the same period last year. Adjusted EBITDA was $986 million, an increase of $77 million or 8% year-over-year. Finally, adjusted operating cash flow was $508 million. Moving now to the performance of Bausch Health, excluding Bausch + Lomb for the third quarter starting on Page 11. The third quarter marked another period of strong performance. As Tom mentioned, Bausch Health, excluding Bausch + Lomb, achieved its 10th quarter of consecutive year-over-year revenue and adjusted EBITDA growth. Revenue was $1.4 billion, up 7% on a reported basis and 5% on an organic basis when compared to the third quarter of 2024. Adjusted EBITDA was $773 million, up 7% versus the prior year and included a charge of in-process R&D of $81 million related to our acquisition of DURECT. Excluding that, our adjusted EBITDA increased operationally 18% year-over-year, which was outstanding. Finally, adjusted operating cash flow of $347 million was only 1% up versus the third quarter of 2024 due to timing in working capital. Moving now to our third quarter performance by segment, starting with Salix on Page 12. Revenues were $716 million, an increase of $74 million, up 12% on a reported basis and 11% on an organic basis compared to the same period last year. Salix strong performance in Q3 was primarily driven by 2 factors. First, our continued Xifaxan volume growth. And second,…

Thank you, JJ. We made progress in the third quarter on multiple fronts in support of our 5 strategic priorities: people, growth, efficiency, innovation and unlocking value. These remain central to our culture, lay the foundation for our strategy and guide our vision for the future. Additionally, we are growing the business with the discipline required to achieve our financial targets, taking all capital allocation priorities into account, including deleveraging. With that in mind, I'd like to take a few minutes to highlight the progress we are seeing against these priorities. Xifaxan growth continued to accelerate through 2025. In Q3, the growth was broad-based, driven by both volume and price and across all indications. Our largest indication for Xifaxan, overt hepatic encephalopathy, OHA had an 8.2% increase in total prescription volume in Q3 over prior years. IBS-D increased 15.4% over prior year. This growth was driven by innovation in marketing and operational excellence that is core within our U.S. pharmaceutical commercial engine. Starting with marketing. In Q3, we doubled our media investment in high-return addressable and connected TV launching a new I Wish I Knew campaign for OHA. Providing important educational information directly to patients and caregivers on the impact that cirrhosis can have on the brain, which is an important driver of patient action often resulting in prescription given that Xifaxan is the only product approved to reduce the recurrence of OHA and prevent rehospitalization. Direct-to-consumer advertising combined with continuous improvement and enhanced capabilities in our AI customer insight engine enabled us to directly target and activate patients, caregivers and health care professionals in Q3. Our laser focus on driving new patient starts resulted in 71,000 new patients being started on Xifaxan in Q3, an increase of 14% in Q3 over the prior year. Year-to-date, 196,000 new patients have…

[Operator Instructions]. First question today is coming from Leszek Sulewski from Truist Securities.

First one, it appears the revenue growth for Xifaxan is outpacing the script growth. So first, can you touch on the disconnect there? Is it backed by a greater focus on commercial plans and direct-to-consumer initiatives? And then second, can you talk to which channel is mostly driving the overall script growth? Is it the primary care side? And how durable is this growth profile as we kind of look out for the end of the life cycle management for the asset? And then I have a follow-up.

Les, this is JJ. I'm going to take up, first of all, your pricing question. As I indicated in my prepared remarks, Xifaxan benefit from a onetime benefit associated with the gross to net accrual that's typically whole on the balance sheet based on the inventory that is held by our distributors given our exit of 340B and Medicaid that gross to net weighted average, if you want, has changed. And so therefore, there was a benefit that really increase or inflated, if you want, what is referred to as pricing. Typically, pricing for Xifaxan year-over-year is in the mid-single digits. So that's what you should assume year-over-year. On the volume side, we have, I think, a fairly balanced growth across all channels. As you can see, the new patient starts have been -- continue to be very strong, which we're very happy about. And the AI-driven engine that allows us to optimize our call points really continues to drive benefits as we continue to develop scripts growth across the board.

Yes. Les, let me just add to that in terms of when you take a look from the channel perspective. So the TRx -- total TRx growth was 9% in the quarter. Non-retail extended units was 20%. So when we take a look at it from a total extended unit perspective, it's 11%. On the new to brand, which is the one we're really looking at a lot is 14%. So there's a lot of new to brand on Xifaxan in the third quarter and which has been historically for this year, the focus is to drive new to brand, and that's where clearly, our investments in DTC, along with the artificial intelligence engine that we're having is focusing there. You had a follow-up?

Yes. That is helpful. Okay. So as we're getting ready for CMS to disclose the final pricing from IRA price negotiations. Perhaps maybe give us a little bit of a sense of where Xifaxan land and the script trends for tied to Medicare Part D. And any sort of commentary that you could provide, how receptive has CMS been to your challenges, specifically given OHEs and orphan indication and the LOE component to the assets?

Yes, Les. So what I'll say is that the negotiations, as I've said on previous calls were ongoing. The discussions have been fruitful and good exchange of information between the company and CMS. As I said on previous calls, we did not think that we should have been on the CMS list, but we were and the team, our market access team has worked really hard working with CMS. So negotiations have concluded. We are expecting that CMS will publish their agreed pricing on November 30, 2025. In terms of the overall impact, I'll pass that to JJ.

So as you -- as we mentioned during our previous call, the CMS impact was combined with a number of mitigation strategy across all of our portfolio to reduce the impact that this would have on our financials. And while the impact obviously on Xifaxan is significant, 30% of our volume goes through Medicare Part D. The only indication I would provide at this stage is we still are assessing the final impact on our business moving forward is that when you look at our business across all segments, including the CMS impact, it's probably fair to assume that the average EBITDA over the next 2 years will not be materially different than what we're providing in the outlook and the revised guidance. And I just want to clarify what I mean by that. If you take EBITDA in '26, '27, you take the average of those 2 numbers. You shouldn't have a materially different number than what we have for the outlook of '25.

Your next question today is coming from Umer Raffat from Evercore ISI.

Congrats on the quarter. This is [ JP ] for Umer Raffat. First question, on MFN, are you guys planning or negotiating anything regarding manufacturing in the U.S.? What's your exposure there?

Yes, I can take that question. As you know, we have our footprint around the world when it comes to manufacturing is regional based. So where we produce our products is where we sell in the U.S., of course, Xifaxan comes out of Canada. Right now, the way our manufacturing footprint plays out. There is no plan at this time. However, we are open to continuing to take a look at it as new products come into the portfolio.

Let me just add a couple of elements to that for Xifaxan specifically, it's a single active ingredient product. And so therefore, country of origin is considered to be Italy. For all the other products is typically in U.S. pharma coming mostly from Canada. Both EU trade agreements currently and obviously, the EUMCA excludes former products from those tariffs. So at this point in time, there is no material tariff that are imposed on our fund flow or the flow of our products. Obviously, that could change in the future, but that's where we are right now.

Operator, any more questions?

The next question is coming from Jason Gerberry from Bank of America.

This is Chi on for Jason. I have a couple. Maybe the first one is on the revised guidance. So you saw strength across multiple pharma sets this quarter, but yet you're only taking up the lower bound of the top line guidance by 1% and 50 bps at the midpoint. Can you just talk about that? Are you seeing onetimers in 3Q that you want to expect to carry forward in 4Q. I know you've just talked about the gross to net dynamic with Xifaxan. But are you seeing onetime elsewhere? What about Jublia and some of the other legacy brands in neuro and dermatology? And I have a couple of follow-ups after that.

Yes. So just to reiterate, we got some onetimers in Q3 in the form of an adjustment of our gross-to-net rebates associated with our inventory in the channel. And we had anticipated, I would say, a good proportion of that. And the fourth quarter is roughly in line with our prior expectations. I think on the size of our business is not a material change, but still reflects, I think, the positive trend that we're seeing across the portfolio. As you can see, our increase in guidance is greater for EBITDA and cash flow, which reflects really a change in assumption is how we're thinking about our free cash flow conversion.

And my second question is on the P&L. The SG&A spend this quarter is below the [indiscernible] fun rate for the past 5 quarters. Is there any seasonality with the SG&A spend this quarter? How should we think about the SG&A run rate going forward? Should we look at 2Q balance or the 3Q balance as a better indicator for future run rate?

Yes. 3Q is unusually low. There's been some changes to accruals that we process in the quarter that are nonrecurring. So I would certainly look at the first couple of quarters and a better indicator of our SG&A spending.

And then just another one for me on the pipeline. You mentioned you're going to have Phase III results for RED-C early next year. Are you planning a concurrent readout for both Phase II and early 2026? And I think I heard the commentary framing that the data will be early initial. I just want to confirm this is the final Phase III top line that will have the final results in early 2026, and once you have the results, do you expect you need more data before you can go to regulate this potential filing should the study be positive?

Yes, Chi, I can answer those for you. So as you know, we have 2 global Phase III studies. They're fully enrolled. We decided to have the readout of both trials together. As these were -- these 2 global trials as we look at the patient populations that are in each and the geographies we thought it best to combine them and read it out in the first quarter. And clearly, this will be our final readout of this very important program.

Do you have any expectation or how would you frame what would be a successful outcome of the trial? Is it just needing the primary endpoint? Or is there more to it?

When I look at RED-C, it's a prevention trial, as I've said on previous calls, there's a lot of important information there. The primary endpoints, there's also very important secondary endpoints as well. So too early to comment there. But as I've said in the past, this program and the amount of patients or U.S. adults with cirrhosis who've never had OHA is large. So the opportunity for us is -- could be very large. And as we wait for the data, we'll see what it looks like.

Next question is coming from Dennis Ding from Jefferies.

Congrats on the quarter. The I follow up with IRA that what would you think about the dynamics for the commercial spillover, and by the way, I'm Liwen Wang for Dennis Ding.

Just could you be more specific of what your -- what the question is?

The IRA. The Xifaxan, like the commercial spillover.

Yes. The only thing I would say, Denise (sic) [ Liwen ] is that this impact really -- or this renegotiation really impacts only 2027. It really doesn't change the commercial dynamics per se just changes the discount that will be provided to the volume of drug going to CMS for the Medicare Part D program.

Got you. And can I follow up with what do you think about the erosion curve with the generic for 2028 plus?

Go ahead. What we have guided in the past is that you should assume a typical erosion curve for multiple generic entry in 2028. So nothing unusual, I would expect. But obviously, it's all speculate it at this stage.

Next question today is coming from Mike Nedelcovych from TD Cowen.

I have a couple actually. The first one just a couple of points of clarification. In response to an earlier question, did I hear correctly that you suggested 2026 and 2027 EBITDA is expected to be flattish versus 2025?

No. What I said is that if you combine '26 and '27 together, the average of those 2 years would be similar to 2025.

Okay. Okay. And that's across the business. That's not specific to the IRA impact?

Correct.

Got it. Okay. And then my next question is on Xifaxan and it's a follow-on. Do you know what -- or maybe you've told this before, but roughly what proportion of prescribers of Xifaxan that use it to treat hepatic encephalopathy or hepatologists versus gastroenterologists? And how do you think that split might change for rifaximin SSD if RED-C is successful and that product is launched for AG prevention?

Yes, Mike, I don't have the specific split. We look at in terms of gastroenterology together with hepatology. That's why we always say the franchise is gastroenterology. So I don't -- I can get you that after the call of what the actual split is. But when we take a look just -- in terms of the opportunity between -- of course, this is a different product in terms of the program we're running with RED-C. We call it SSD. If you just take a look at just the patient population and how it splits out, it's like 650,000 patients in the U.S. adults with cirrhosis with OHA and 1.9 million with cirrhosis who have never had OHA. So that's how it kind of splits out as we look at the opportunity that is in front of us.

Got it. And if I may, one more question on RED-C. When we get the initial top line data, what is the likelihood that we also see the all-cause mortality data? Would that be mature as well? Or might we at least expect an initial data cut?

Yes. When we look at the initial data, as I said on the previous question, the primary endpoint and then there's a very important secondary endpoints. So we'll be looking once we get the data, providing it in totality, both from primary and secondary.

Our next question today is coming from Doug Miehm from RBC Capital Markets.

Yes. Just with respect to those accruals, would you be able to expand on those that impacted this quarter? I know you indicated that we should use Q1 and Q2 is guideline for SG&A. But how did they specifically arise?

It's just estimates of liability that we were thinking of incurring associated to prior fiscal that we had to adjust in the third quarter. They kind of roughly offset with the IP R&D that were recorded, obviously, as a result of the DURECT acquisition. So that's why I think Q1 and Q2 is a little bit cleaner from a run rate perspective.

Okay. And then with respect to capital allocation, as you think about the next couple of years, you've given helpful guidance with respect to, I believe, that the EBITDA, '26, '27, the average versus this year, et cetera, et cetera. But can you speak to cash flow in those 2 years as well and how that cash flow is going to be apportioned or used to pay down debt? And I'll leave it there.

Yes, we'll provide some more specific guidance around cash flow associated with '26 when we report our fourth quarter results. We were trying to provide a little bit some directional view on how 2026 and 2027 taken together really is going to behave as a result of CMS and other dynamics in our portfolio. Our capital allocation remains the same, which is, first and foremost, to service our debt, including deleveraging the business. Second is reinvest in the business whenever -- obviously, it makes sense in light of our strategy. And then third and last, only if there is some excess potentially return capital to shareholders. But we obviously -- the focus is on #1 and #2.

Next question is coming from Michael Freeman from Raymond James.

JJ, I wonder if you could guess through the thought process that led to Bausch Health's decision to see participation in the 340B program in the Medicaid drug remake program.

Yes, Mike, I can take that question. So as we looked at it, we're continually evaluating ways to optimize our sales channel in all the markets we operate in, including the U.S. So when we did the evaluation, we determined that it was in the company's and the patient's best interest to exit Medicaid and the 340B channel for all products marketed in the U.S. as of October 1. What I would say is that as we looked at it, made the decision, the key was to enhance our patient assistance program to really make sure that the care was there and the patient assistance program was robust to be able to offer eligible Medicaid patients access to a broad range of Bausch Health medicines at no cost, consistent with the program terms. The patient benefit when we look at it compared to Medicaid, it's an enhanced PAP program with 0 out-of-pocket costs. And then the patient also is able to get 90 days treatment where if you're in Medicaid, it would only be 30 days for each script. So we -- as we looked at it, we thought we could really have an opportunity to enhance the patient experience and also have a good situation for the company.

And just following on that. I wonder if you describe the patient benefits. Well, I wonder if you could describe benefits of the company and any benefits beyond that sort of onetime we saw with accruals.

As I said, we're always looking at different sales channels and how to optimize them. And there are benefits as we've looked at. I'm not going to get into the specifics. It's early days since October 1 and how each of these benefits flow through and what it will look like.

All right. I wonder maybe a question for JJ now. I wonder if you can give us the lay of the land on your debt refinancing programs and further steps you envision taking in the future 2D lever?

Well, the -- we've repeatedly said that there are really 2 main sources for deleveraging the company. The first one is free cash flow generated by operations that will continue certainly at a fairly similar level than what we've incurred for the next couple of years. until we lose exclusivity on Xifaxan. And that needs to be supplemented by one of 3 sources, either new equity raise, which obviously would be very dilutive at our current share price. So very unlikely that we would do that would be certainly a last resort option. The second possibility would be to capture some of that discount. As you know, our debt has traded back up and therefore, the discount that is left is fairly minimal. So the last source of extra funding would be proceeds from asset sales, either at BHC or B+L. The B+L equity stake is the more logical candidate given that it's the only one that is not associated with some EBITDA generation for BHC. So that becomes, I would say, the most probable outcome for completing the leveraging or the deleveraging solve for us between now and sometime in the future.

We reached of our question-and-answer session and our earnings call. I'd like to turn the floor over back to our CEO, Tom Appio, for closing remarks.

Okay. Well, thank you all for joining the call today. and for your continued interest and support of the company. We remain committed to executing against our strategic priorities and focus on unlocking value. We appreciate your ongoing engagement and look forward to sharing further updates with you on the progress to close the year. Thank you, and have a good evening.

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.