Note: This is an earnings call transcript. Content may contain errors.

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DATE

Wednesday, Oct. 29, 2025, at 5 p.m. ET

CALL PARTICIPANTS

  • Chief Executive Officer — Thomas J. Appio
  • Chief Financial Officer — Jean-Jacques Charhon
  • Vice President, Investor Relations — Garen Sarafian

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RISKS

  • CFO Jean-Jacques Charhon indicated, "while the impact obviously on XIFAXAN is significant, 30% of our volume goes through Medicare Part D," highlighting direct exposure to CMS-negotiated pricing.
  • International segment revenues declined 2% on a reported basis and 4% on an organic basis, with management citing "continued market softness in Mexico," and declines in Canada and Latin America offsetting EMEA growth.
  • The diversified products segment experienced a 4% decline in reported revenue, and a 6% decline in organic revenue, attributed to the non-recurrence of 2024 temporary stockouts, and softness in certain neurology and generic products.
  • CFO Jean-Jacques Charhon identified that SG&A spend was "unusually low" due to "changes to accruals that we processed in the quarter that are non-recurring," suggesting underlying cost normalization ahead.

TAKEAWAYS

  • Revenue -- $2.681 billion consolidated non-GAAP revenue, increasing 7% reported and 5% organic, reflecting broad-based growth.
  • Adjusted EBITDA -- $986 million consolidated, up 8%; $773 million excluding Bausch + Lomb (BLCO 2.13%), up 7%, including an $81 million IPR&D charge linked to the Durect Corp. acquisition.
  • Adjusted operating cash flow -- $508 million consolidated adjusted operating cash flow (non-GAAP).
  • Guidance raised -- Full-year 2025 revenue now $5.0 billion-$5.1 billion, adjusted EBITDA (non-GAAP) $2.7 billion-$2.75 billion, and adjusted operating cash flow (non-GAAP) $975 million-$1.025 billion, with corresponding midpoint increases of $25 million, $50 million, and $150 million, respectively.
  • Salix segment -- Revenue of $716 million, up 12% reported and 11% organic, driven by XIFAXAN and one-time Medicaid/340B net pricing favorability.
  • XIFAXAN -- Revenue up 16%, with total prescription (TRx) volume up 9%, and 71,000 new patients started on XIFAXAN, an increase of 14% over the prior year.
  • Solta Medical -- $140 million in revenue, up 25% reported and 24% organic, led by South Korea's 96% growth, and double-digit gains in the U.S., Canada, and EMEA.
  • International segment -- $286 million revenue, decreasing 2% reported and 4% organic; EMEA grew 12%, while Canada and LatAm fell 8% and 17%, respectively, on a reported basis.
  • Diversified products -- $258 million in revenue, down 4% reported and 6% organic; neurology impacted by prior-year generic supply anomalies; dermatology benefitted from 186% Captur, and 11% JUBIA revenue growth.
  • Cabtrio topical acne product -- Reached number one in new branded patient starts for topical acne, with 69% year-to-date growth over the prior year, and over 105,000 new patients year to date.
  • Fraxel F launch -- U.S. rollout of skin rejuvenation device began in April, contributing incremental presence in aesthetics.
  • Direct acquisition -- Closed Sept. 11, 2025; $81 million IPR&D charge; Larsucosterol, Durect's lead asset, possesses FDA Breakthrough Therapy Designation for alcohol-associated hepatitis, with Phase III program initiation targeted for early 2026.
  • Red Sea clinical program -- Two global Phase III studies fully enrolled; initial data readouts expected by early 2026, targeting prevention of overt hepatic encephalopathy.
  • 340B and Medicaid program exit -- U.S. withdrawal as of Oct. 1, 2025, replaced by enhanced patient assistance program providing zero-cost, ninety-day supplies to eligible patients.
  • Capital structure optimization -- $7.9 billion refinancing transaction completed earlier this year; high-cost accounts receivable facility retired in October; further leverage reduction strategies under review, including asset sales.

SUMMARY

Bausch Health's (BHC +12.03%) management confirmed that the impact of Medicare Part D pricing negotiations for XIFAXAN will be mitigated across the portfolio, stating 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." This refers to adjusted EBITDA guidance for fiscal 2025 as provided by management. Debt reduction and enhanced free cash flow conversion fueled increases in full-year guidance for all key financial metrics for fiscal 2025. Strategic actions included the successful integration of Durect and advancement of Phase III programs for high-priority pipeline assets. Executives highlighted the ability to maintain capital deployment priorities -- primarily deleveraging -- while supporting targeted reinvestment in innovation and growth platforms.

  • CEO Appio said, "We remain optimistic about Solta Medical's premium positioning as a driver of future growth," signaling confidence in global aesthetics demand despite normalization in China.
  • CFO Charhon confirmed, the average EBITDA (non-GAAP) over the next two years (2026 and 2027) will not be materially different than what we're providing in the outlook and the revised guidance for 2025. To clarify, if you take EBITDA in 2026 and 2027 and average those two numbers, you shouldn't have a materially different number than what we have for the outlook of 2025, addressing market concerns regarding government pricing headwinds.
  • "Cabtrio became the No. 1 prescribed topical branded acne product in new brand patient starts" since launch, management said, demonstrating rapid product adoption in U.S. dermatology.
  • Management stated that further deleveraging would prioritize free cash flow allocation, with asset sales of Bausch + Lomb equity the "most probable outcome" if additional capital is required.

INDUSTRY GLOSSARY

  • Salix: Bausch Health's U.S. gastroenterology segment focused on branded prescription products, led by XIFAXAN.
  • Solta Medical: The company's global medical aesthetics business, best known for technologies such as Thermage and Fraxel.
  • XIFAXAN: A prescription drug for hepatic encephalopathy and irritable bowel syndrome with diarrhea (IBS-D), contributing significant U.S. revenues.
  • LOE: Loss of exclusivity, referring to patent protection expiry enabling generic competition.
  • IPR&D: In-process research and development costs, typically related to new product acquisitions or projects prior to commercialization.
  • 340B Program: A U.S. federal program providing discounted pharmaceuticals to eligible health care organizations; exiting can change net pricing dynamics.
  • Medicaid drug rebate program: U.S. federal-state program requiring manufacturers to pay rebates on outpatient prescription drugs for Medicaid beneficiaries.
  • OHE (Overt Hepatic Encephalopathy): A serious complication of liver disease, for which XIFAXAN is an approved treatment.
  • TRx: Industry shorthand for total prescription count, used to measure prescription drug utilization metrics.

Full Conference Call Transcript

Operator: Greetings, and welcome to the Bausch Health Companies Inc. Third Quarter 2025 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. Now my pleasure to turn the call over to your host, Garen Sarafian, Vice President, Investor Relations. Garen, please go ahead.

Garen Sarafian: Good afternoon and welcome to Bausch Health Companies Inc.'s third quarter 2025 earnings conference call. Participating in today's call are Thomas J. Appio, Chief Executive Officer of Bausch Health Companies Inc., and Jean-Jacques 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 Companies Inc.'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 Companies Inc.'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 Companies Inc. 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, Thomas J. Appio.

Thomas J. Appio: Thank you, Garen, and welcome to everyone joining our earnings call today. In the third quarter, Bausch Health Companies Inc. excluding Bausch + Lomb delivered our tenth 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 Companies Inc. 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 Companies Inc. excluding Bausch + Lomb.

Excluding this charge, our adjusted EBITDA grew 8%. 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 Companies Inc. excluding Bausch + Lomb. I am pleased with how our teams have navigated through a dynamic macro backdrop, embodying the culture of accountability and urgency that defines Bausch Health Companies Inc. Across our global platform, we saw traction in many areas.

Consolidated Bausch Health Companies Inc., as well as Bausch Health Companies Inc. 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 Companies Inc. excluding Bausch + Lomb, 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 Cabtrio and Rialtris, 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 Bausch Health Companies Inc.'s progress against our key strategic priorities.

Jean-Jacques Charhon: 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 Companies Inc. 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 Companies Inc. excluding Bausch + Lomb achieved its tenth 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 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 2024 due to timing in working capital. Moving now to our third quarter performance by segments, 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's strong performance in Q3 was primarily driven by two factors. First, our continued XIFAXAN volume growth. And second, some one-time net pricing favorability associated with our Medicaid and 340B channel exits. More specifically, XIFAXAN revenue grew 16% in the third quarter with volume up 9%.

The AI-driven customer insight 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 that has been on the market for its OHE indication for the last fifteen years. Separately, TRULANCE volume grew 5% in Q3, which was more than offset by unfavorable net pricing headwinds in the quarter. Finally, Rely's store 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 a reported basis. Canada and LatAm, on the other hand, were respectively down 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 2024 from the non-recurrence of Wellbutrin orders due to generic stockouts. 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 Solta 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.

Solta's performance was primarily driven by the Asia Pacific region, which continues to contribute approximately 80% of global Solta 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 segment's 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 year orders from temporary generic supplier shortages for Caudazim in Q3 of last year. Separately, the performance of our Dermatology segment was driven by Captur 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 full year is now as follows. Revenue is now expected to be between $5 billion and $5.1 billion. 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 $2.7 billion and $2.75 billion, excluding the impact of acquired IPR&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 billion, bringing up the midpoint of the 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 Bausch Health Companies Inc.'s 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 Bausch Health Companies Inc. 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 optionality for maximizing the value of our Bausch Health Companies Inc. 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 retired over $600 million in senior unsecured notes and have eliminated in October our high-cost accounts receivables 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 closing out 2025 on a strong note as evidenced by our improved full-year guidance. I will now hand it back to Tom.

Thomas J. Appio: 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. 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 (OHE), had an 8.2% increase in total prescription volume in Q3 over prior years. IBS-D increased 15.4% over the 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 XIFAXAN 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 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 been prescribed XIFAXAN. 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 Cabtrio, the first and only triple combination in one topical application for acne. The launch has progressed well. Earlier this year, Cabtrio became the number one prescribed topical branded acne product in new brand patient starts. 10,000 HCPs have prescribed Cabtrio from launch to date, with 105,000 new patients. Cabtrio year to date is 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, Solta 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 twenty 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 installed base 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, F, 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's 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 11, 2025. The addition of Direct complements our existing portfolio, enhances our R&D pipeline, and is consistent with Bausch Health Companies Inc.'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 Health Companies Inc. team. Our portfolio now includes Direct's lead asset, Larsucosterol, a novel epigenetic modulator with FDA Breakthrough Therapy Designation for the treatment of alcohol-associated hepatitis (AH) in Bausch Health Companies Inc.'s hepatology pipeline.

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 ninety days of hospitalization. A registrational Phase III program is currently planned to evaluate the safety and efficacy of Larsucosterol 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 II. Our team is working diligently to finalize the Phase III protocol with a goal to initiate the study by early 2026.

We are excited about the addition of Larsucosterol 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 Companies Inc.'s existing efforts and expertise in the 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 Health Companies Inc. has a history of 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 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.

Operator: Certainly. We'll now be conducting a question and answer session. Our first question today is coming from Les Sulewski from Truist Securities. Your line is now live.

Les Sulewski: Good afternoon. Thank you for taking my questions. First one, it appears the revenue growth for XIFAXAN is outpacing the script growth. 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 lifecycle management for the asset? And then I have a follow-up.

Jean-Jacques Charhon: Hi, Les, this is JJ. I'm going to take up, first of all, your pricing question. As I indicated in my prepared remarks, XIFAXAN 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 and 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 XIFAXAN year-over-year is in the mid-single 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.

Thomas J. Appio: 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 were 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, it's 14%. So there is 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?

Les Sulewski: Yes, thank you. 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 lands and then the script trends were tied to Medicare Part D. And any sort of commentary that you could provide, how receptive has CMS been to your challenges, specifically given OHE is an orphan indication and the LOE component to the asset? Thank you.

Thomas J. Appio: Yes, Les. So what I'll say is this, the negotiations, as I've said on previous calls, were ongoing. The discussions have been fruitful and a 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 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.

Jean-Jacques Charhon: Yes. So as we mentioned during our previous call, the CMS impact was combined with a number of mitigations 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, 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 2026, 2027, you take the average of those two numbers, you shouldn't have a materially different number than what we have for the outlook of 2025.

Operator: Next question.

Operator: Our next question today is coming from Umer Raffat from Evercore ISI. Your line is now live.

Umer Raffat: Hello, guys. 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?

Thomas J. Appio: 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.

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

Operator: Do you have any question?

Operator: Thank you. Next question today is coming from Jason Gerberry from Bank of America. Your line is now live.

Jason Gerberry: Hey, this is Chi on for Jason. Thanks for taking our questions. I have a couple. Maybe the first one is on the revised guidance. So you saw strength across multiple pharma segments, this top-line guidance by 1% and 50 bps at the midpoint. Can you just talk about that? Are you seeing one-timers 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 one-time on Alisware? What about Jubilea and some of the other legacy brands in neuro and dermatology? And I have a couple of follow-ups after that.

Jean-Jacques Charhon: 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 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 increasing guidance is greater for EBITDA and cash flow, which reflects really a change of assumptions on how we're thinking about our free cash flow conversion.

Jason Gerberry: And my second question is on the P&L. The SG&A spend this quarter is below the average run rate for the last for the past five quarters. Is there any seasonality with the SG&A spend this quarter? How do 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 rates?

Jean-Jacques Charhon: Yes, 3Q is unusually low. There's been some changes to accruals that we processed in the quarter that are non-recurring. So I would certainly look at the first couple of quarters as a better indicator of our SG&A spending.

Jason Gerberry: And then just another one from me on the pipeline. You mentioned you're going to have Phase III results for RET C early next year. Are you planning a concurrent readout for both Phase III in 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 III top line that we 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 regulators for potential filing should the studies be positive?

Thomas J. Appio: Yes, Chi, I can answer those for you. So as you know, we have two global Phase III studies. They're fully enrolled. We decided to have the readout of both trials together as these were 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 clearly, this will be our final readout of this very important program.

Jason Gerberry: 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?

Thomas J. Appio: When I look at Red Sea, it's a prevention trial, as I've said on previous calls. There is 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, U.S. adults with cirrhosis who have never had OHE is large. So the opportunity for us could be very large, and as we wait for the data, we will see what it looks like.

Jason Gerberry: Okay, great. Thank you.

Operator: Next question.

Operator: Thank you. Next question today is coming from Dennis Ng from Jefferies. Your line is now live.

Dennis Ng: Hi. Thanks for taking the question and congrats on the quarter. May I follow-up with that, what would you think about the dynamics for the commercial spillover? And by the way, I'm Liwen Wen for Dennis Ng. Thank you.

Thomas J. Appio: Just could you be more specific about what your question is?

Dennis Ng: I am saying XIFAXAN, like, the commercial spillover.

Thomas J. Appio: Yeah. The only thing I would say, Dennis, 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 growth going to CMS for the Medicare Part D program.

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

Thomas J. Appio: Okay. 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.

Operator: Next question.

Operator: Thank you. Next question today is coming from Mike Nedelcovych from TD Cowen. Your line is now live.

Mike Nedelcovych: Hi, thanks for the questions. I have a couple. Actually, first are 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?

Jean-Jacques Charhon: No. What I said is that if you combine 2026 and 2027 together, the average of those two years would be similar to 2025.

Mike Nedelcovych: Okay. And that's across the business. That's not specific to the IRA impact.

Jean-Jacques Charhon: Correct.

Mike Nedelcovych: Got it. Okay. Thank you very much. And then my next question is on XIFAXAN and its follow-on. Do you know what, or maybe you 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 rifaximin SSD if Red Sea is successful and that product is launched for AG prevention?

Thomas J. Appio: Yeah, Mike. I don't have the specific split. We look at it 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 Sea. We call it SSD. If you just take a look at just the patient 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.

Mike Nedelcovych: Got it. Thank you. And 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?

Thomas J. Appio: 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 once we get the data, providing it in totality both from primary and secondary.

Operator: Next question.

Operator: Our next question today is coming from Doug Miehm from RBC Capital Markets. Your line is now live.

Doug Miehm: Yes, thanks very much. 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 as a guideline for SG&A, but how did they specifically arise?

Jean-Jacques Charhon: It's just estimates of liability that we were thinking of incurring associated with prior fiscal that we had to adjust in the third quarter. They kind of 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.

Doug Miehm: 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 EBITDA 26%, 27%, the average versus this year, etcetera, etcetera. 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.

Jean-Jacques Charhon: 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 of 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 to 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 obviously the focus is on number one and number two.

Operator: Next question.

Operator: Thank you. Next question today is coming from Michael Freeman from Raymond James. Your line is now live.

Michael Freeman: Hey, Hi, JJ. I wonder if you could take us through the thought process that led Bausch Health Companies Inc.'s decision to cease participation in the 340B program and the Medicaid drug rebate program?

Thomas J. Appio: Yeah, Mike. I can take that question. So as we looked at it, we're continually evaluating ways to optimize our sales channel, 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 in 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 Companies Inc. medicines at no cost, consistent with the program terms. The patient benefit, when we look at it compared to Medicaid, it's an enhanced program with zero out-of-pocket cost, and then the patient also is able to get ninety days treatment where if you're in Medicaid, it would only be thirty 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.

Michael Freeman: And just following up on that, I wonder if you described the patient benefits well, I wonder if you could describe benefits to the company and any benefits beyond that sort of one-time release saw with accruals?

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

Michael Freeman: I wonder maybe a question for JJ now. 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 to delever?

Jean-Jacques Charhon: 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 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 three sources: either new equity raise, 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 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 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 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.

Operator: Thank you. We 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, Thomas J. Appio, for closing remarks.

Thomas J. Appio: 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.

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.