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10/29/2025
Greetings, and welcome to the Bausch Health Third Quarter 2025 Earnings Conference Call. At this time, all participants are in listen-only mode. A question-and-answer session will follow the formal presentation. You may be placed into question queue at any time by pressing star 1 on your telephone keypad. If anyone should require operator assistance, please press star 0. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to your host, Garen Serafian, Vice President, Investor Relations. Karim, 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 Charron, 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 Bosch 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 29th, 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 and Long, 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 nine 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 & Long, at a segment level, we saw excellent double-digit growth in our Solta and Salix businesses. Solta saw 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. Two 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 Captrio and Rialtris, as well as double-digit growth for Xifaxin 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 nine. Revenue was $2,681,000,000, 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 $1,024,000,000, an increase of $41,000,000 compared to the same period last year. Adjusted EBITDA was $986,000,000, an increase of $77,000,000 or 8% year over year. Finally, adjusted operating cash flow was $508,000,000. 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 $1,400,000,000, 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 Direct. 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 a third quarter performance by segment, starting with Salix on page 12. Revenues were $716 million, an increase of $74 million of 12% on reported basis and 11% on an organic basis compared to the same period last year salix strong performance in q3 was primarily driven by two factors first our continued zyfax and volume growth and second some one-time net pricing favorability associated with our medicaid and 340b channel exits more specifically Zyfaxan revenue grew 16% in third quarter with volume up 9%. The AI-driven customer insights engine has been a significant contributor to the overall and new patient script growth, which were respectively 9% and 11%, a remarkable accomplishment for a drug which has been on the market for its OHE indication for the last 15 years. Separately, Truland's volume grew 5% in Q3, which was more than upset by unfavorable net pricing headwinds in the quarter. Finally, Relistore continues to face a challenging payer coverage environment, yet we remain optimistic that the brand will soon return to growth. Now moving to the international segment. Revenues were $286 million, a decrease of 2% on a reported basis, and 4% on an organic basis compared to the third quarter of last year. Performance by geography was mixed. EMEA led the segments with a 12% increase on reported basis. Canada and LATAM, on the other hand, contracted respectively 8% and 17%. In Canada, the performance of our promoted portfolio grew 21%, which was more than offset by the reduction of our LOE portfolio, which benefited in Q3 of 2024 from the non-recurrence of Wellbutrin orders due to generic stock-outs. LATAM's performance, on the other hand, was primarily due to continued market softness in Mexico. Now moving to page 14 for a review of our SALTA medical segments. Revenues were $140 million, an increase of 25% on a reported basis and 24% on an organic basis compared to the same period last year. Salter's performance was primarily driven by the Asia-Pacific region, which continues to contribute approximately 80% of global Salter revenue. Within the APAC region, South Korea again outperformed all other markets with an impressive 96% growth year-over-year. China, on the other hand, grew only 3% in Q3. This was primarily attributable to aesthetics consumers adopting a cautious behavior given the uncertainty surrounding the macroeconomic environment. Outside of Asia, on another positive note, we are encouraged by our double-digit growth in the U.S., EMEA, and Canada following our commercial investments in these geographies. Turning now to our diversified segments, which you will find on page 15. Revenues were $258 million, a decrease of 4% on a reported basis and 6% on an organic basis compared to the same period a year ago. The diversified segments performance was largely driven by our neurology business. This quarter, year-over-year growth in neurology was impacted by the expected non-recurrence of prior orders from temporary generic supplier shortages for caudism in Q3 of last year. Separately, the performance of our dermatology segment was driven by Capture and Jubia, which grew revenue respectively 186 and 11%. Finally, Bausch & Lomb revenues were $1.3 billion, up 7% on a reported basis and 6% on an organic basis compared to the same period last year. Before wrapping up with our financial priorities, let's review our full-year guidance, which you will find on page 19. Our outstanding performance for the first nine months with revenue and adjusted EBITDA excluding acquired IP R&D growing respectively 6% and 14% has put us in a position where we will raise guidance across all our three metrics, revenue, adjusted EBITDA, and adjusted operating cash flow. The new guidance for the fall year is now as follows. Revenue is now expected to be between $5 billion and $5,100,000,000. The midpoint of that range has been increased by $25 million and translates to a 4% increase year-over-year. Our adjusted EBITDA outlook is now expected to be between $2,700,000,000 and $2,750,000,000, excluding the impact of acquired IP R&D. The midpoint of that range is now increased by $50 million and represents a 7% increase versus 2024. Adjusted operating cash flow is now expected to be between $975 million and $1,025,000,000, bringing up the midpoint of that range by $150 million. Before I turn it over to Tom for his wrap-up, let me review our financial priorities, which remain unchanged. First, increasing the value of Bosch Health operational assets. Whether it is our acquisition of Direct or the operational performance during the first nine months of the year, continuing to execute our innovation and profitable growth agenda remains top of mind for all leaders of Bosch Health. Second, evaluating all options for unlocking value for all stakeholders. The $7.9 billion refinancing transaction we closed early this year has provided us with expanded optionalities for maximizing the value of our Bausch Health and Bausch & Lomb assets. We are now assessing all initiatives for driving shareholder value creation. And third, continuing to optimize our capital structure. As we indicated earlier, we retire over $600 million in senior unsecured notes and have eliminated in October our high-cost accounts receivable facility. Moving forward, we will continue to look at all options to improve our maturity profile, provided, of course, it is in the best long-term interest of the company. In short, we are proud of the progress we have made in the last nine months, and look forward to close out 2025 on a strong note as evidenced by our improved full year guidance. I will now hand it back to Tom. Thank you, JJ.
We made progress in the third quarter on multiple fronts in support of our five 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. Xifaxin growth continued to accelerate through 2025. In Q3, the growth was broad-based, driven by both volume and price and across all indication. Our largest indication for Xifaxin, overt hepatic encephalopathy, OHE, had an eight 0.2% increase in total prescription volume in Q3 over prior years. IBSD 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 OHE, 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 Xifaxin is the only product approved to reduce the recurrence of OHE and prevent rehospitalization. Direct-to-consumer advertising combined with continuous improvement enhanced capabilities in our AI customer insight engine enabled us to directly target and activate patients, caregivers, and healthcare professionals in Q3. Our laser focus on driving new patient starts resulted in 71,000 new patients being started on Zyfaxan in Q3, an increase of 14% in Q3 over the prior year. Year-to-date, 196,000 new patients have been prescribed Zyfaxan. This quarter marks the seventh consecutive quarter of top-line organic revenue growth in our Salix business, and we will continue to maximize its growth. Turning to our dermatology business, in January 2024, we launched Captrio, the first and only triple combination in one topical application for acne. The launch has progressed well. Earlier this year, Captrio became the number one prescribed topical-branded acne product in new brand patient starts. 10,000 HCPs have prescribed Captrio from launch to date, with 105,000 new patients prescribed Captrio year to date, up 69% over the prior year. Turning to our aesthetics business. Solta. We have made excellent progress driving new opportunities for growth in this business. Solta is a global leader in medical aesthetics that operates a portfolio of trusted brands with a leading presence in South Korea and China. While each market is unique, we see significant white space across the region and expect to further strengthen our reach across our footprint. During the third quarter, Solter delivered exceptional results with another quarter of double-digit growth in our leading aesthetics portfolio. Revenue grew by 25% on a reported basis across multiple regions, led by South Korea, which nearly doubled year over year. This growth was supported by robust domestic demand complemented by high levels of medical aesthetics-related tourism to the region in recent years. Beyond the strength in the Asia-Pacific region, we achieved double-digit growth in the U.S. and European markets. We remain optimistic about SOLTA's premium positioning as a driver of future growth and are encouraged by another quarter of solid growth outside the Asia-Pacific region. Building on this momentum, earlier this year, we received medical device licensing clearance for Thermage in Canada as the fourth generation of radio frequency technology. The Thermage platform has been relied upon for over 20 years by providers and patients. We also reached a key milestone. Our Thermage non-surgical treatment technology has now been used to perform more than 5 million skin tightening and smoothing treatments worldwide. Additionally, in Korea, Thermage has now surpassed the 1,000-unit install-based milestone, which is a significant achievement. These successes underscore our belief in Solta's growth potential and may position us to capitalize on the opportunities ahead. We launched Fraxel FTX this past April, beginning the rollout of our leading skin rejuvenation treatment for dermatologists, plastic surgeons, and other licensed aesthetics professionals across the United States. With global expansion plans in the pipeline, while it is still early days, we are pleased with Fraxel's momentum in the U.S., This expands our Solta portfolio and presence in key growth geographies and that we anticipate will contribute to the strength and breadth of our aesthetics business. In summary, Solta had a terrific quarter and we continue to invest in our clinical programs and R&D innovation to deliver long-term growth. Underscoring our commitment to innovation, We closed our acquisition of Direct Corporation on September 11th, 2025. The addition of Direct complements our existing portfolio, enhances our R&D pipeline, and is consistent with Bausch's efforts to focus on areas of strength for innovation to drive future growth. Since then, we have been working seamlessly integrating Direct into the Bausch team. Our portfolio now includes direct lead asset, larsucosterol, a novel epigenetic modulator with FDA breakthrough therapy designation for treatment of alcohol-associated hepatitis, or AH, in Bausch Health hepatology pipelines. Currently, there are no approved therapies indicated to treat AH and patients must rely on supportive care such as corticosteroids, which are often inadequate for long-term treatment and result in about 30% mortality within 90 days of hospitalization. A registrational phase three program is currently planned to evaluate the safety and efficacy of Lorsucosterol for the treatment of patients with severe AH. It is important to recognize that this is a global opportunity and we are initially pursuing the U.S. market to replicate the region's success in phase two. Our team is working diligently to finalize the phase three protocol with a goal to initiate the study by early 2026. We are excited about the addition of LasukaStraw to our R&D portfolio and look forward to updating you through the development and commercialization process. Direct is an important addition to our hepatology portfolio that supports our innovation and growth priorities, while also leveraging Bausch Health's existing expertise in development and commercialization of assets. Now turning to Red Sea. which we believe could be a next-generation treatment to delay and prevent the occurrence of overt hepatic encephalopathy. We remain on track with our two global Phase III studies, and we expect to see initial data readouts by early 2026. Our hope is that Red Sea may offer this patient population a therapy to slow disease progression and provide a meaningful clinical benefit, addressing a significant unmet need and bringing a novel therapy to cirrhotic patients on a global scale. Bausch has a history treating liver disease and providing patients with innovative treatment solutions. which we hope to continue and expand upon with Direct and Red Sea. In summary, we had another standout quarter. I want to thank our teams around the world for their dedication and hard work in driving these results. Our focus on disciplined execution against our strategic priorities and operational excellence will enable us to continue to deliver tangible results and long-term value for shareholders. With that, we will now turn to questions. Operator, please open the line for Q&A.
Certainly. We'll now be conducting a question and answer session. If you'd like to be placed into question queue, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to move your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing star one. One moment please while we poll for questions. Our first question today is coming from Les Zaleski from Truist Securities. Your line is now live.
Good afternoon. Thank you for taking my questions. First one, it appears the revenue growth for Xifax 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 initiative? 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 I have a follow-up.
Hi, Les. This is JJ. I'm going to... I'll take up, first of all, your pricing question. As I indicated in my prepared remarks, ZyFaxon benefits from a one-time benefit associated with the gross-to-net accrual that we typically hold on the balance sheet based on the inventory that is held by our distributors. Given our exit of 340B in Medicaid, that gross-to-net weighted average, if you want, has changed, and so therefore there was a benefit that really increased or inflated, if you want, what is referred to as pricing, typically pricing for Zafaxan year-over-year is in the mid-signal digit, 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 continued 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 script growth across the board.
Yeah, Les, let me just add to that in terms of when you take a look from the channel perspective. So the total TRX growth was 9% and a 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 Xifax 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, thank you. That is helpful. Okay, so as we're getting ready for CMS to disclose the final pricing from IRA price negotiations, you know, perhaps maybe give us a little bit of a sense of where that facts and lands and the script transfer tied to Medicare Part D and any sort of commentary that you could provide, how receptive has CMS been to your challenges? you know, specifically given OHEs and orphan indication and the LOE component to the asset. Thank you.
Yes, Les. So what I'll say is 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.
Yeah, so 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, you know, the impact obviously on Xifaxan is significant, you know, 30% of our volume goes through Medicare Part D, The only indication I would provide at this stage as 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 two 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 two numbers, you shouldn't have a materially different number than what we have for the outlook of 25.
That's very helpful. Thank you. Thank you. Our next question today is coming from Umar Rafat from Evercore ISI. Your line is now live.
Hello, guys. Congrats on the quarter. This is JP from Umar Rafat. First question, on MFN, are you guys planning or negotiating anything regarding manufacturing in the U.S.? What's your exposure there?
Yeah, I can take that question. As you know, we have our footprint around the world when it comes to manufacturing is regional based. So, you know, where we produce our products is where we sell. In the U.S., of course, ifaxing comes out of Canada. Right now, you know, the way our manufacturing footprint plays out, there is, you know, no plant at this time. 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 Zyfaxan 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. farmer coming mostly from Canada. Both EU trade agreements currently and obviously the UMCA exclude 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, they could change in the future, but that's where we are right now.
Operator, next question. Thank you. Next question today is coming from Jason Grayberry from Bank of America. Your line is now live.
Hey, this is Chi for Jason. Thanks for taking our questions. I have a couple. Maybe the first one is on the revised guidance. So you saw a strength across multiple pharma segments this quarter. yet you're only taking up the lower bound of the top-line guidance by 1% and 50 bits of the midpoint. Can you just talk about that? Are you seeing one-timers in 3Q that you wouldn't expect to carry forward in 4Q? I know you've just talked about the growth to net dynamic with Syfaxon, but are you seeing one-timer 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.
Yeah, so just to reiterate, we got some one-timers in Q3 in the form of an adjustment of our gross to net rebate associated with our inventory in the channel. And, you know, 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 $25 million on the side of our business is not 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 assumptions, 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 LFH run rate for the past five quarters. Is there any seasonality with the SG&A spend this quarter? How should we think about the SG run rate going forward? Should we look at 2Q balance or the 3Q balance as a better indicator for future run rates?
Yeah, 3Q is unusually low. There's been some changes to accruals that we process in the quarter. that are non-recurring. So I would certainly look at the first couple of quarters and a better indicator of our SG&E spending.
And then just another one from me on the pipeline. You mentioned you're going to have phase three results for RETC early next year. Are you planning a concurrent readout for both phase three and early 2026? And I think I heard the commentary framing that the data will be early initial readout. I just want to confirm this is the final phase three 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 studies be positive?
Yeah, Chi, I can answer those for you. So as you know, We have two global phase three studies. They're fully enrolled. We decided to have the readout of both trials together as these two 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, you know, clearly, you know, 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 meeting the primary endpoint or is there more to it?
You know, when I look at Red Sea, it's a prevention trial, as I've said on previous calls. There's a lot of important information there, you know, 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 who are U.S. adults with cirrhosis who've never had OHE is large. So the opportunity for us could be very large. And as we wait for the data, we'll see what it looks like.
Okay, great. Thank you.
Next question. Thank you. Next question today is coming from Dennis Ting from Jefferies. Your line is now live.
Hi, thanks for taking the question and congrats on the quarter. May I follow up with IRA, but what would you think about the dynamics for the commercial spillover? And by the way, I'm Liwen Wen for Dennisting. Thank you.
Just could you be more specific of what the question is?
The IRA, the vaccine, like the commercial spillover.
Yeah, the only thing I would say, Denise, is that this impact really or this renegotiation really impacts only 2027. It really doesn't change the commercial dynamics per se. It just changes the discount that will be provided to the volume of grub going to CMS for the Medicare Part D program.
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 speculative at this stage.
OK, thank you.
Next question. Thank you. Next question today is coming from Mike Nedeljkovic from TD Cal, and your line is now live.
Hi. Thanks for the questions. I have a couple. Actually, the first are just a couple 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 two 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. Thank you very much. And then my next question is on Zyfaxan and its follow-on. Do you know what, or maybe you've told us before, but roughly what proportion of prescribers of Xifaxan that use it to treat hepatic encephalopathy are hepatologists versus gastroenterologists. And how do you think that split might change for Rifaxan and SSD if Red Sea is successful and that product is launched for aging prevention?
Yeah, Mike, I don't have the specific split. You know, we look at in terms of gastroenterology together with hepatology. That's why we always say, you know, the franchise is gastroenterology. So I can get you that, you know, 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 Sea, 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 OHE and 1.9 million with cirrhosis who have never had OHE. So that's how it kind of splits out as we look at the opportunity that is in front of us.
Got it. Thank you. If I may, one more question on Red Sea. 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?
Yeah, when we look at the initial data, as I said on the previous question, you know, the primary endpoint and then there's very important secondary endpoints. So we'll be looking, you know, once we get the data, you know, providing it, in totality, both from primary and secondary.
Thanks so much.
Next question. Our next question today is coming from Doug Neum from RBC Capital Marketers. Your line is now live.
Yeah, thanks very much. Just with respect to those accruals, would you be able to expand on those that impacted the I know you indicated that we should use Q1 and Q2 as a 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. roughly offset with the IPR&D that were recorded, obviously, as a result of the direct 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, the the EBITDA, 26, 27, the average versus this year, et cetera, et cetera. But can you speak to cash flow in those two 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. Thanks very much.
Yeah, 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 reinvesting the business whenever obviously it makes sense in light of our strategy. And then third and last, only if there is some excess potentially returned capital to shareholders. But we obviously, the focus is on number one and number two.
Excellent. Thank you.
Next question. Thanks. Our next question today is coming from Michael Freeman from Raymond James. Your line is now live.
I wonder if you could take us through the thought process that led to Vouch Health's decision to cease participation in the 340B program and the Medicaid drug rebate program.
Yeah, 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 1st. What I would say is that as we looked at it and 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, You know, it's an enhanced PATH program with zero 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 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 up on that, I wonder if you could describe the patient benefits well. I wonder if you could describe benefits to the company and any benefits beyond that sort of one time where 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, you know, since October 1st and how each of these benefits, you know, flows through and what it will look like.
All right. I wonder, maybe a question for JJ now. I wonder if you could give us the lay of the land on your debt refinancing programs and further steps you envision taking in the future to deliver.
Well, we've repeatedly said that there are really two main sources for deleveraging the company. The first one is free cash flow generated by operations that deliver 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 Zyfaxan. And that needs to be supplemented by one of three sources, either new equity rates, which obviously would be very dilutive at our current share price, so very unlikely that we would do that. It would be certainly a last resort option. The second possibility would be to capture some debt discounts. 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 BNL. The BNL equity stake is the more logical candidate given that it's the only one that is not associated with some EBITDA generation for the BHC. So that becomes, I would say, the most probable outcome for completing the leveraging or the deleveraging solve for us between now and, you know, sometime in the future.
Thank you. We've reached the end 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 in 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.
