Q3 2023 Bausch Health Companies Inc Earnings Call

November 2, 2023

To be a seller. [music].

[music].

Operator 1: Good morning, ladies and gentlemen, and thank you for your patience. This morning's conference call will begin momentarily. Thank you once again for standing by. This morning's conference call will begin shortly. Thank you once again for your patience. Ladies and gentlemen, thank you once again for standing by. I do apologize about the delay. There has been a technical issue this morning that we are resolving at this time. Once again, thank you for your patience. This morning's call will begin momentarily. Thank you for holding.

Unknown: Good morning ladies and gentlemen, and thank you for your patience. This morning's conference call will begin momentarily. Thank you once again for standing by. This morning's conference call will begin shortly. Thank you once again for your patience.

[music].

Ladies and gentlemen, thank you once again for standing by. I do apologize about the delay. There has been a tactical issue this morning that we are resolving at this time. Once again, thank you for your patience. This morning's call will begin momentarily. Thank you for holding.

[music]

[music]. Okay. [music]. Uh huh. [music].

Okay. [music]. Uh huh. [music].

[music]. Uh huh. [music].

Uh huh. [music].

[music].

Operator 2: Greetings. Welcome to the Bausch Health Q3 2023 Earnings Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. Please note this conference is being recorded. I will now like to turn the conference over to your host, Lisa Wilson. You may begin.

Operator: Greetings. Welcome to the Bausch Health Q3 2023 Earnings Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. Please note this conference is being recorded. I will now like to turn the conference over to your host, Lisa Wilson. You may begin.

Operator: Greetings. Welcome to the Bausch Health third quarter 2023 earnings call. At this time, all participants are in a listen-only mode.

At this time all participants are in a listen only mode.

A question and answer session will follow the formal presentation. Please note this conference is being recorded. I would now like to turn the conference over to your host, Lisa Wilson. You may begin.

Lisa Wilson: Good morning, and welcome to Bausch Health's Q3 2023 Earnings Conference Call. This is Lisa Wilson, investor relations for Bausch Health. Participating in today's call are Thomas Appio, Chief Executive Officer of Bausch Health, and John Barresi, Interim Chief Financial Officer. Before we begin, I'd 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 slides 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 filings with the Canadian Securities Administrators for a list of some of the factors that could cause our actual results to differ materially from our expectations.

Lisa Wilson: Good morning, and welcome to Bausch Health's third quarter 2023 earnings conference call. This is Lisa Wilson, Investor Relations for Bausch Health.

Participating in today's call are Thomas Appio, Chief Executive Officer of Bausch Health and John Barresi, interim Chief Financial Officer.

Before we begin, I'd 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 slides 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 filings with the Canadian Securities Administrators for a list of some of the factors that could cause our actual results to differ materially from our expectations.

Lisa Wilson: We use non-GAAP financial measures to help investors understand our ongoing business 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 to our non-GAAP measures in the appendix of the slides 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 will focus on Bausch Health, excluding Bausch + Lomb. However, we will briefly comment on Bausch + Lomb's results announced yesterday. We will refer to year-over-year comparisons with the same period last year, unless otherwise noted.

We use non-GAAP financial measures to help investors understand our ongoing business 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 to our non-GAAP measures in the appendix of the slides that accompany this presentation, which are available on Bausch Health's Investor Relations website.

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 to our non-GAAP measures in the appendix of the slot.

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 will focus on Bausch Health, excluding Bausch and Lomb. However, we will briefly comment on Bausch and Lomb's results announced yesterday. We will refer to year-over-year comparisons with the same period last year, unless otherwise noted. For the benefit of those who maybe listening to the

Lisa Wilson: For the benefit of those who may be listening to the replay or archive webcast, this call was held and recorded on 2 November 2023. With that, it is my pleasure to turn the call over to our CEO, Thomas Appio. Tom?

For the benefit of those who maybe listening to the replay or archived webcast, this call was held and recorded on November 2nd, 2023.

replay or archived webcast, this call was held and recorded on November 2nd, 2023. With that, it's my pleasure to turn the call over to our CEO, Thomas Appio. Tom?

replay or archived webcast, this call was held and recorded on November 2nd, 2023.

With that, it's my pleasure to turn the call over to our CEO, Thomas Appio. Tom?

Thomas Appio: Thank you, Lisa, and welcome to those of you joining the call this morning. At Bausch Health, our team is focused on enriching lives through our relentless drive to create better health outcomes for our patients and the physicians who treat them. The BHC team is tirelessly dedicated to business performance, driving results, and progressing our key strategic objectives. We continue to demonstrate this commitment in Q3. Let me share some highlights. Turning to slide 6. From a performance standpoint, we had another solid quarter with revenues for Bausch Health, excluding B&L, of $1.23 billion, up $127 million or 12% on a reported basis and 10% on an organic basis. I am pleased to share that each of our four segments posted revenue growth in the quarter, which we will discuss in more detail later.

Thomas J. Appio: Thank you Lisa and welcome to those of you joining the call this morning. At Bausch Health, our team is focused on enriching lives through our relentless drive to create better health outcomes for our patients and the physicians who treat them.

The BHC team is tirelessly dedicated to business performance, driving results, and progressing our key strategic objectives. We continue to demonstrate this commitment in the third quarter. Let me share some highlights. Turning to slide six, from a performance standpoint, we had another solid quarter

Turning to slide six, from a performance standpoint, we had another solid quarter with revenues for Bausch Health, excluding P&L of 1.23 billion, up $127 million or 12% on a reported basis and 10% on an organic basis.

with revenues for Bausch Health, excluding P&L of 1.23 billion, up $127 million or 12% on a reported basis and 10% on an organic basis.

I am pleased to share that each of our four segments posted revenue growth in the quarter, which we will discuss in more detail later. We continue to progress our R&D pipeline. On October 20, we received FDA approval for IDP-126, now branded as CABTREO.

I am pleased to share that each of our four segments posted revenue growth in the quarter, which we will discuss in more detail later.

Thomas Appio: We continue to progress our R&D pipeline. On 20 October 2023, we received FDA approval for IDP-126, now branded as Cabtreo. We continue to defend our intellectual property rights for Xifaxan. The consolidated appeals of the Delaware Court's ruling are ongoing at the Court of Appeals for the Federal Circuit. Briefing is now complete, and we are awaiting a date for oral argument. We expect a decision by the end of Q1 2024 and remain confident in our position. With regard to Norwich's lawsuit against the FDA in the DC District Court, where Norwich was seeking immediate approval of their ANDA, oral argument was held on 6 October 2023. On 1 November 2023, the court denied Norwich's motion and granted summary judgment in favor of the FDA and Salix.

We continue to progress our R&D pipeline. On October 20, we received FDA approval for IDP-126, now branded as CABTREO.

We continue to defend our intellectual property rights for XIFAXAN. The consolidated appeals of the Delaware Court's ruling are ongoing at the Court of Appeals for the Federal District Circuit. Briefing is now complete and we are awaiting a date for oral argument. We expect a decision by the end of Q1 2024 and remain confident in our position.

With regard to Norwich's lawsuit against the FDA in the DC District Court, where Norwich was seeking immediate approval of [inaudible]. Oral argument was held on October 6th, 2023. On November 1st, the court denied Norwich's motion and granted summary judgment in favor of the FDA and Salix.

Denied <unk> motion and granted summary judgment in favor of the FDA and Salix.

Thomas Appio: We are fully committed to vigorously defend our intellectual property and providing healthcare providers and patients with safe and effective treatment options. We also continue to evaluate strategies regarding the potential full separation of Bausch + Lomb, which I will discuss later. In the meantime, we remain focused on managing our balance sheet. We reduced our debt net of cash by approximately $150 million in the quarter. Lastly, now that we are three-quarters of the way through 2023, we are updating our guidance for BHC, excluding B&L, to a narrower band within our previously disclosed ranges. Let me now start by sharing some of our business performance highlights, as shown on slide 7. This quarter, all of our Bausch Health segments delivered revenue growth year over year, with Salix, International, and Solta Medical growing by double digits on a reported basis.

We are fully committed to vigorously defend our intellectual property and providing health care providers and patients with safe and effective treatment options.

We also continue to evaluate strategies regarding the potential full separation of Bausch Lomb, which I will discuss later. And in the meantime, we remain focused on managing our balance sheet. We reduced our debt net of cash by approximately $150 million in the quarter. And lastly, now that we are

And lastly, now that we are three quarters of the way through 2023, we are updating our guidance for BHC excluding B&L to a narrower band within our previously disclosed ranges. Let me now start by sharing some of our business performance highlights as shown on slide 7.

three quarters of the way through 2023, we are updating our guidance for BHC excluding B&L to a narrower band within our previously disclosed ranges. Let me now start by sharing some of our business performance highlights as shown on slide 7. This quarter, all of our Bausch Health segments delivered revenue growth year-over-year with SALIX, international, consultant medical growing by double-digits on a reported basis. Let us take each segment in turn. SALIX - Q3 net sales for SALIX grew 13% on both a reported and organic basis. While about half of the growth in the quarter was a result of wholesalers stocking patterns, we are encouraged by continued underlying growth in this segment, including for [inaudible] and [inaudible]. And building on the plan we laid out last year, we are continuing to focus our commercial investments on sales and marketing to spread awareness of the underlying medical conditions and the options that are available to treat these conditions. You may have seen our recent press release announcing our partnership with [inaudible] Young who is speaking out to help educate patients, families, and caregivers impacted by [inaudible] also known as EG. These efforts reflect our commitment

This quarter, all of our Bausch Health segments delivered revenue growth year-over-year with SALIX, international, consultant medical growing by double-digits on a reported basis. Let us take each segment in turn.

SALIX - Q3 net sales for SALIX grew 13% on both a reported and organic basis. While about half of the growth in the quarter was a result of wholesalers stocking patterns, we are encouraged by continued underlying growth in this segment, including for [inaudible] and [inaudible]. And building on the plan we laid out last year, we are continuing to focus our commercial investments on sales and marketing to spread awareness of the underlying medical conditions and the options that are available to treat these conditions.

You may have seen our recent press release announcing our partnership with [inaudible] Young who is speaking out to help educate patients, families, and caregivers impacted by [inaudible] also known as EG. These efforts reflect our commitment to driving long term profitable growth in this important franchise.

Thomas Appio: Let us take each segment in turn. Salix. Q3 net sales for Salix grew 13% on both a reported and organic basis. While about half of the growth in the quarter was a result of wholesaler stocking patterns, we are encouraged by continued underlying growth in this segment, including for TRULANCE and RELISTOR. Building on the plan we laid out last year, we are continuing to focus our commercial investments in sales and marketing to spread awareness of the underlying medical conditions and the options that are available to treat these conditions. You may have seen our recent press release announcing our partnership with Bellamy Young, who is speaking out to help educate patients, families, and caregivers impacted by hepatic encephalopathy, also known as HE. These efforts reflect our commitment to driving long-term profitable growth in this important franchise. Turning to international.

to driving long term profitable growth in this important franchise.

Turning to international, revenues grew by 10% on a reported basis in the third quarter and 4% on an organic basis led by strong performances in Latin America and Poland.

Thomas Appio: Revenues grew by 10% on a reported basis in Q3 and 4% on an organic basis, led by strong performances in Latin America and Poland. In Solta Medical, revenues increased by 15% on a reported basis and 17% on an organic basis, reflecting strong growth in the Asia Pacific region, including China, and low single-digit growth in the US market. Notably, more than 70% of Solta revenues are generated from consumable sales, representing an attractive and very durable business profile where we see significant opportunity for long-term growth. Efforts are underway to accelerate growth in our largest markets, expand our sales teams in the US and Europe, and advance our pipeline of new market authorizations and next-generation products. Our Solta team is focused on continuing to build a world-class aesthetics business. Turning to Diversified.

In Solta Medical, revenues increased by 15% on a reported basis and 17% on an organic basis, reflecting strong growth in the Asia Pacific region, including China, and low single-digit growth in the US market.

Reflecting strong growth in the Asia Pacific region, including China, and low single digit growth in the U S market.

Notably, more than 70% of Solta revenues are generated from consumable sales, representing an attractive and very durable business profile where we see significant opportunity for long term growth.

Efforts are underway to accelerate growth in our largest markets, expand our sales teams in the US and Europe and advance our pipeline of new market authorization and next generation products. Our Solta team is focused on continuing to build a world-class aesthetics business.

Turning to diversified, revenues increased by 9% on both a reported and organic basis in the quarter. Our neurology and generic units reported growth in Q3 as both businesses benefited from their ability to address short term supply disruptions that arose in the market.

Thomas Appio: Revenues increased by 9% on both a reported and organic basis in the quarter. Our neurology and generics units reported growth in Q3 as both businesses benefited from their ability to address short-term supply disruptions that arose in the market. While we are obviously pleased with this performance, the continuation of these tailwinds is uncertain. In particular, the neurology and dermatology businesses continue to face long-term challenges. Nonetheless, these businesses are highly profitable and cash generative, and we continue to look for opportunities to make targeted investments where appropriate. In neurology, we are excited about our recently launched marketing campaign for APLENZIN, focused on seasonal affective disorder, also known as SAD. In dermatology, we continue to focus on building consumer awareness for JUBLIA. As I mentioned earlier, on 20 October, we received FDA approval of CABTREO.

While we are obviously pleased with this performance, the continuation of these tailwinds is uncertain. In particular, the neurology and dermatology businesses continue to face long term challenges. Nonetheless, these businesses are highly profitable and cash generative and we continue to look for opportunities to make targeted investments where appropriate.

To <unk> to make targeted investments where appropriate.

In neurology, we are excited about our recently launched marketing campaign for [inaudible] focused on seasonal affective disorder also known as SAD. In dermatology, we continue to focus on building consumer awareness for [inaudible] and as I mentioned earlier on October 20th, we received FDA approval of CABTREO. We are looking forward to providing patients with this innovative product beginning in 2024.

In neurology, we are excited about our recently launched marketing campaign for [inaudible] focused on seasonal affective disorder also known as SAD.

In dermatology, we continue to focus on building consumer awareness for [inaudible] and as I mentioned earlier on October 20th, we received FDA approval of CABTREO. We are looking forward to providing patients with this innovative product beginning in 2024.

F D. A approval of cab trio, we are looking forward to providing patients with this innovative product beginning in 2024.

Thomas Appio: We are looking forward to providing patients with this innovative product beginning in 2024. In Q3, dentistry revenues declined slightly, ending down 4% year-over-year after posting solid growth in the first two quarters of the year. We expect dentistry to return to growth as we begin to benefit from the investments we have made, increasing consumer awareness efforts for ARESTIN, including our Cover Your Bases campaign in collaboration with Alex Rodriguez to raise awareness about the prevalence and the impact of gum disease. We have also strategically deployed our sales team with greater focus on each of the two customer segments, the dental support organizations and private practice dentists. We are pleased with the strong performance of our business in Q3. We have also continued to focus on the other areas of strategic importance since our last call.

In the third quarter, dentistry revenues declined slightly ending down 4% year-over-year after posting solid growth in the first two quarters of the year. We expect dentistry to return to growth as we begin to benefit from the investments we have made, increasing consumer awareness efforts for [inaudible] including our Cover Your Basis campaign in collaboration with Alex Rodriguez to raise awareness about the prevalence and the impact of gum disease. We have also strategically deployed our sales team with greater focus on each of the two customer segments, the dental support organizations and private practice dentists.

our Cover Your Basis campaign in collaboration with Alex Rodriguez to raise awareness about the prevalence and the impact of gum disease. We have also strategically deployed our sales team with greater focus on each of the two customer segments, the dental support organizations and private practice dentists.

<unk>.

We are pleased with the strong performance of our business in the third quarter. We have also continued to focus on the other areas of strategic importance since our last call.

Thomas Appio: You will recall that in January of this year, we had reached a tentative settlement with the IRS to resolve the Granite Trust matter. We expect the settlement to be finalized in the coming months. As we have previously said, the anticipated outcome of the settlement does not have a material impact on the company's results or cash flows. We continue to believe that the separation of B&L makes strategic sense. Any decision regarding if and when a distribution occurs or its structure will be based on and subject to any assessment of all the relevant factors and circumstances. Any potential distribution will also be subject to shareholder and other applicable approvals. In the meantime, we continue our focus on managing our balance sheet and growing our business for the long term. To that end, we finished the quarter with more than $1 billion of liquidity.

You will recall that in January of this year, we had reached a tentative settlement with the IRS to resolve the Grantor Trust matter, we expect the settlement to be finalized in the coming months. As we have previously said, the anticipated outcome of the settlement does not have a material impact on the company's result or cash flows. We continue to believe that the separation of B&L makes strategic sense.

Continue to believe that the separation of Biennale makes strategic sense.

We continue to believe that the separation of B&L makes strategic sense. Any decision regarding if and when a distribution occurs or its structure will be based on and subject to any assessment of all the relevant factors and circumstances. Any potential distribution will also be subject to shareholder and other applicable approvals.

Any decision regarding if and when a distribution occurs or its structure will be based on and subject to any assessment of all the relevant factors and circumstances. Any potential distribution will also be subject to shareholder and other applicable approvals.

In the meantime, we continue our focus on managing our balance sheet and growing our business for the long term. To that end, we finished the quarter with more than 1 billion of liquidity.

Thomas Appio: Let me now briefly cover the recent progress we have made advancing our pipeline, as shown on slide eight. Starting with our Salix pipeline, our RED-C program for rifaximin for reduction of early decompensation in cirrhosis continues to advance. This global program is focused on developing novel formulations and assessing the efficacy of rifaximin SSD formulation versus placebo to delay the occurrence of HE-related hospitalizations. We expect a complete enrollment of two global Phase 3 trials with approximately 1,000 patients across the major markets of North America, Europe, and Asia Pacific in Q1 2024. Amiselimod, a new oral selective S1P receptor modulator that targets the treatment of mild to moderate ulcerative colitis. The Phase 2 study completed enrollment in July of this year.

Let me now briefly cover the recent progress we have made advancing our pipeline as shown on slide eight.

Starting with our SALIX pipeline, our Red C program for RIFAXIMIN for reduction of early decompensation in Psoriasis continues to advance. This global program is focused on developing novel formulations and assessing the efficacy of RIFAXIMIN SSD formulation versus placebo to delay the occurrence of AG related hospitalizations. We expect a complete enrollment of two global phase III trials with approximately 1,000 patients across the major markets of North America, Europe, and Asia Pacific in the first quarter of 2024.

Placebo to delay the occurrence of hte related hospitalizations, we expect a complete enrollment of two global phase III trials with approximately 1000 patients across the major markets of North America, Europe, and Asia Pacific in the first quarter of 2024.

[inaudible] a new oral selected S1P receptor modulator that targets the treatment of mild to moderate ulcerative colitis, the phase two study completed enrollment in July of this year. This is a large phase two study with over 300 patients in 19 countries and the induction phase of this study is expected to be completed in the fourth quarter.

Ah new oral selected S. <unk> receptor modulator that targets the treatment of mild to moderate all sorts of colitis. The phase two study completed enrollment in July of this year. This is a large phase two study with over 300 patients in 19 countries and the induction phase of this study is expected to be completed in the fourth quarter.

Thomas Appio: This is a large Phase 2 study with over 300 patients in 19 countries, and the induction phase of this study is expected to be completed in Q4. In dermatology, we are pleased that the FDA approved CABTREO, the brand name for IDP-126, indicated for the treatment of acne vulgaris in patients 12 years of age and older. CABTREO is the first and only FDA-approved fixed-dose triple combination topical medication for acne. We are excited to bring this product to the millions of patients who suffer from acne each year. CABTREO has the potential not only to simplify dosing with a once-daily topical regimen, but also to improve patient outcomes. CABTREO utilizes three mechanisms of action to treat acne, combining an antibiotic, antibacterial, and retinoid to provide a novel, effective, and tolerable treatment that addresses three of the four pathogenic factors that cause acne.

This is a large phase two study with over 300 patients in 19 countries and the induction phase of this study is expected to be completed in the fourth quarter.

In dermatology, we are pleased that the FDA approved CABTREO, the brand name for IDP-126 indicated for the treatment of acne vulgaris and patients 12 years of age and older. CABTREO is the first and only FDA approved fixed dose triple combination topical medication for acne. We are excited to bring this product to the millions of patients who suffer from acne each year. CABTREO has the potential, not only to simplify dosing with a once-daily topical regime, but also to improve patient outcomes.

topical medication for acne. We are excited to bring this product to the millions of patients who suffer from acne each year. CABTREO has the potential, not only to simplify dosing with a once-daily topical regime, but also to improve patient outcomes. CABTREO utilizes

CABTREO utilizes three mechanisms of action to treat acne, combining an antibiotic, antibacterial, and retinoid to provide a novel, effective and tolerable treatment that address is three of the four pathogenic factors that cause acne. We expect to launch CABTREO in the United States in the first quarter of 2024.

three mechanisms of action to treat acne, combining an antibiotic, antibacterial, and retinoid to provide a novel, effective and tolerable treatment that address is three of the four pathogenic factors that cause acne. We expect to launch CABTREO in the United States in the first quarter of 2024.

Thomas Appio: We expect to launch Qatrio in the United States in Q1 2024. We have also submitted Qatrio for approval with Health Canada and expect to be poised for launch of Qatrio in Canada in H2 2024. Our Solta pipeline is very active as well. Our FDA submission for our next-generation Fraxel, a fractionated laser device for skin resurfacing, is planned for Q1 2024, with approval expected sometime in H1 2025. Our program for Clear + Brilliant Touch, a fractionated laser device for skin rejuvenation, is also advancing, with regulatory submissions planned in 2024 for Europe, Canada, and Asia Pacific markets. As a leadership team, we remain committed to driving growth through commercial excellence, intensifying our focus on business development, and expanding and progressing our pipeline, all with a patient-centered mentality.

first quarter of 2024.

We have also submitted CABTREO for approval with Health Canada and expect to be poised for launch of CABTREO in Canada in the second half of 2024. Our Solta pipeline is very active as well. Our

We have also submitted CABTREO for approval with Health Canada and expect to be poised for launch of CABTREO in Canada in the second half of 2024.

Are sold the pipeline is very active as well or.

Our Solta pipeline is very active as well. Our FDA submission for our next generation Fraxel, a fractionated laser device for skin resurfacing is planned for the first quarter of 2024 with approval expected some time in the first half of next year. Our program for A Clearer and Brilliant Touch, a fractionated laser device for skin rejuvenation is also advancing with regulatory submissions planned in 2024 for Europe, Canada, and Asia Pacific markets.

FDA submission for our next generation Fraxel, a fractionated laser device for skin resurfacing is planned for the first quarter of 2024 with approval expected some time in the first half of next year. Our program for A Clearer and Brilliant Touch, a fractionated laser device for skin rejuvenation is also advancing with regulatory submissions planned in 2024 for Europe, Canada, and Asia Pacific markets.

<unk> rejuvenation is also advancing with regulatory submissions planned in 2024 for Europe, Canada, and Asia Pacific markets.

As a leadership team, we remain committed to driving growth through commercial excellence, intensifying our focus on business development and expanding and progressing our pipeline, all with a patient centered mentality.

Thomas Appio: With that, I would like to turn the call over to John Barresi, who will provide further details on our Q3 performance. John?

With that, I would like to turn the call over to John Barresi, who will provide further details on our third quarter performance. John?

John Barresi: Thanks, Tom. Hello, everyone, and thanks for joining us. We closed Q3 with consolidated revenues for Bausch Health of $2.2 billion, up 9% on both a reported and organic basis over the same quarter last year. Q3 revenues for Bausch Health, excluding B&L, were $1.23 billion, up 12% on a reported basis and up 10% on an organic basis year-over-year, with growth in all of our segments. Let's dive into the revenue performance for each segment in more detail, starting on slide 11 with Salix. Q3 Salix revenues increased 13% on both an organic and reported basis to $614 million, driven by growth in our core products, including Xifaxan 550, RELISTOR, and TRULANCE.

John Barresi: Thanks, Tom. Hello, everyone and thanks for joining us.

We closed the third quarter with consolidated revenues for Bausch Health of $2.2 billion, up 9% on both a reported and organic basis over the same quarter last year.

Third quarter revenues for Bausch Health, excluding B&L were $1.23 billion, up 12% on a reported basis and up 10% on an organic basis year-over-year with growth in all of our segments.

Let's dive into the revenue performance for each segment in more detail starting on slide 11 with SALIX.

Third quarter SALIX revenues increased 13% on both an organic and reported basis to $614 million, driven by growth in our core products, including XIFAXAN 550, RELISTOR and TRULANCE.

By growth in our core products, including Xifaxan, 550, Relistor and Trulance year.

John Barresi: Year-over-year growth in Salix was led by Xifaxan, which grew 13% in Q3 compared to the same quarter last year. Revenue growth benefited from a year-over-year increase in wholesale channel inventory. We are continuing to observe a shift in demand from the retail to the non-retail channel, particularly in hospital and clinic-generated demand, which is not necessarily fully captured in the TRX data. Extended unit demand growth was approximately 1% year-over-year, while retail prescriptions were flat. We are also pleased with the Q3 sales performance of RELISTOR and TRULANCE, which posted year-over-year increases of 28% and 10%, with total script growth of 10% and 15% respectively.

Year-over-year growth in SALIX was led by XIFAXAN which grew 13% in the third quarter compared to the same quarter last year. Revenue growth benefited from a year-over-year increase in wholesale channel inventory. We are continuing to observe a shift in demand from the retail to the non-retail channel, particularly in hospital and clinic generated demand, which is not necessarily fully captured in the TRS data.

necessarily fully captured in the TRS data.

Extended unit demand growth was approximately 1% year-over-year, while retail prescriptions were flat.

We are also pleased with the third quarter sales performance of RELISTOR and TRULANCE which posted year-over-year increases of 28% and 10% with total square growth of 10% and 15% respectively.

John Barresi: International revenues were $275 million during the quarter, an increase of 10% on a reported basis and 4% on an organic basis compared to the prior year period, led by strong performances in Latin America and Poland. Solta Medical revenues were $83 million during Q3, an increase of 15% on a reported basis and 17% on an organic basis over the prior year period. Revenue growth was driven by strong demand in the Asia Pacific region, including China, as well as modest growth in the US, where we are investing in marketing and in expanding our sales force. With more than 70% of the revenue for this business coming from consumables, and with the focus on the pipeline that Tom discussed earlier, we believe Solta Medical is primed for continued near- and long-term growth globally.

International revenues were $275 million during the quarter, an increase of 10% on a reported basis and 4% on an organic basis compared to the prior year period led by strong performances in Latin America and Poland.

Solta Medical revenues were $83 million during the third quarter, an increase of 15% on a reported basis and 17% on an organic basis over the prior year period.

Revenue growth was driven by strong demand in the Asia Pacific region, including China, as well as modest growth in the US where we are investing in marketing and expanding our sales force.

With more than 70% of the revenue for this business coming from consumables and with the focus on the pipeline that Tom discussed earlier, we believe Solta Medical is primed for continued near and long term growth globally.

John Barresi: Diversified revenues were $259 million, an increase of 9% on both a reported and organic basis in Q3. Both neurology and generics delivered year-over-year growth as they benefited from what we believe to be product availability constraints among competing products in the quarter. Dentistry experienced low single-digit declines. For dentistry, this decline came after two quarters of solid growth, and we continue to invest in this business for the long term. The neurology and dermatology businesses continue to operate in challenging environments, facing long-term headwinds with roughly 70% of the diversified segment's revenues coming from products that are past their LOE dates. In neurology, we continue to see volume erosion for Wellbutrin and are moderating our expectations for Aplenzin in a difficult commercial coverage environment.

Diversified revenues were $259 million, an increase of 9% on both a reported and organic basis in the third quarter. Both neurology engineer delivered year-over-year growth as they benefited from what we believe to be product availability constraints among competing products in the quarter.

Dentistry experienced low single digit declines. For dentistry, this decline came after two quarters of solid growth and we continue to invest in this business for the long term.

The neurology and dermatology businesses continue to operate in challenging environments, facing long term headwinds with roughly 70% of the diversified segment's revenues coming from products that are past their LOE dates. In neurology, we continued to see volume erosion for WELLBUTRIN and are moderating our expectations for [inaudible] in a difficult commercial

In neurology, we continued to see volume erosion for WELLBUTRIN and are moderating our expectations for [inaudible] in a difficult commercial coverage environment.

coverage environment.

John Barresi: In dermatology, we expect positive demand growth for JUBLIA to continue to be offset by net pricing pressure as well as continued pressure on our non-promoted products. Based on these factors, in Q3, we revised our long-term outlook for these businesses and recorded goodwill impairments of approximately $250 million for neurology and $150 million for dermatology. We are managing the portfolio of products for these businesses, which remain highly profitable and cash generative, to balance the revenue trajectory and overall profitability. As shown on slide 12, Bausch + Lomb revenues were $1 billion during Q3, up 7% on a reported basis and organic basis compared to the prior year, with growth across all B&L segments. Turning to the Q3 P&L on slide 15.

In dermatology, we expect positive demand growth for [inaudible] to continue to be offset by net pricing pressure as well as continued pressure on our non-promoted products. Based on these factors in the third quarter, we revised our long term outlook for these businesses and recorded goodwill impairments of approximately $250 million for neurology and $150 million for dermatology. We are managing the portfolio products for these businesses, which remain highly profitable and cash generative to balance the revenue trajectory and overall profitability.

Based on these factors in the third quarter, we revised our long term outlook for these businesses and recorded goodwill impairments of approximately $250 million for neurology and $150 million for dermatology, we are managing the portfolio products for these businesses, which remain highly profitable and cash generative to balance the revenue trajectory and overall.

profitability.

As shown on slide 12, Bausch & Lomb revenues were $1 billion during the third quarter, up 7% on a reported basis and organic basis compared to the prior year with growth across all B&L segments.

Turning to the third quarter P&L on slide 15. Third quarter consolidated adjusted gross margin was 72.3%, 80 basis points higher compared with the prior year.

John Barresi: Q3 consolidated adjusted gross margin was 72.3%, 80 basis points higher compared with the prior year. For Bausch Health, excluding B&L, adjusted gross margin for Q3 was 81.3%, an increase of 50 basis points from last year. At B&L, adjusted gross margin was 80 basis points higher compared with Q3 of 2022. Consolidated adjusted operating expenses for Q3 were $833 million, an increase of $75 million, or 9% on a constant currency basis, driven by higher SG&A expenses, reflecting investments in sales and marketing, and higher R&D. For Bausch Health, excluding B&L, adjusted operating expenses increased by approximately $36 million, while B&L reported an increase of $39 million in operating expenses.

Third quarter consolidated adjusted gross margin was 72.3% 80 basis points higher compared with the prior year.

For Bausch Health, excluding B&L, adjusted gross margin for the third quarter was 81.3%, an increase of 50 basis points from last year.

At B&L, adjusted gross margin was 80 basis points higher compared with Q3 of 2022.

Consolidated adjusted operating expenses for the third quarter were $833 million, an increase of $75 million or 9% on a constant currency basis, driven by higher SG&A expenses, reflecting investments in sales and marketing and higher R&D.

For Bausch Health, excluding B&L, adjusted operating expenses increased by approximately $36 million, while B&L reported an increase of $39 million in operating expenses.

John Barresi: The increase in operating expenses for Bausch Health, excluding B&L, was driven by selling and marketing expenses as well as R&D investment. Selling and A&P increased largely due to the investments we are making in the Salix sales force, including our go-to-market channels and advertising and promotional activity. Adjusted G&A for Bausch Health, excluding B&L, was slightly favorable compared to the prior year. Consolidated R&D expense for the quarter was $153 million, an increase of 15% compared to the prior year, and represented 6.9% of product sales compared with 6.6% for the prior year period. For Bausch Health, excluding B&L, R&D expenses of $71 million increased by approximately $15 million, due primarily to the focus on our clinical programs and regulatory activities to support our mid- and late-stage product development in the Salix segment.

The increase in operating expenses for Bausch Health, excluding B&L was driven by selling and marketing expenses as well as R&D investments.

Selling in A&P increased largely due to the investments we are making in the sale of salesforce, including our go- to-market channels and advertising and promotional activity.

Adjusted G&A for Bausch Health, excluding B&L was slightly favorable compared to the prior year.

Consolidated R&D expense for the quarter was $153 million, an increase of 15% compared to the prior year and represented 6.9% of product sales compared to 6.6% for the prior year period.

For Bausch Health, excluding B&L, R&D expenses of $71 million increased by approximately $15 million due primarily to the focus on our clinical programs and regulatory activities to support our mid and late stage product development in the SALIX segment.

John Barresi: Q3 consolidated adjusted EBITDA was $830 million, an increase of $64 million or 8% on a reported basis and 10% on a constant currency basis. For Bausch Health, excluding B&L, adjusted EBITDA was $664 million, an increase of approximately 10% from last year, reflecting the factors previously described. On a consolidated basis, Q3 adjusted EBITDA margin was 37%, which was flat compared to last year. Adjusted EBITDA margin for Bausch Health, excluding B&L, was 53.9%, and for Bausch + Lomb was 18.6%. Turning to cash flow. On a consolidated basis, Bausch Health generated $642 million in operating cash flow in the first nine months.

Third quarter consolidated adjusted EBITDA was $830 million, an increase of $64 million or 80% on a reported basis and 10% on a constant currency basis.

For Bausch Health, excluding B&L, adjusted EBITDA was $664 million, an increase of approximately 10% from last year, reflecting the factors previously described.

On a consolidated basis, third quarter adjusted EBITDA margin was 37%, which was flat compared to last year.

Adjusted EBITDA margin for Bausch Health, excluding B&L was 53.9% and for Bausch alone was 18.6%.

Turning to cash flow. On a consolidated basis, Bausch Health generated $642 million on operating cash flow in the first nine months. As with recent quarters, we have also reclassified a portion of our cash interest payments to financing cash flows as a result of the accounting treatment for the bonds issued as part of our 2022 debt exchange.

On a consolidated basis vouch health generated $642 million operating cash flow in the first nine months.

John Barresi: As with recent quarters, we have also reclassified a portion of our cash interest payments to financing cash flows as a result of the accounting treatment for the bonds issued as part of our 2022 debt exchange. Adjusted cash flow from operations on a consolidated basis in the first nine months was $458 million. For Bausch Health, excluding B&L, year-to-date adjusted cash flow from operations was $430 million, which was in line with our expectations. Adjusted cash flow includes adjustments for the payment of separation costs, business transformation costs, and insurance settlement proceeds, and also includes payment of the full contractual interest. Now let's turn to our balance sheet on slide 16. We continue to prioritize liquidity management and the delevering of our balance sheet.

As with recent quarters, we have also reclassified a portion of our cash interest payments to financing cash flows as a result of the accounting treatment for the bonds issued as part of our 2022 that exchange.

Adjusted cash flow from operations on a consolidated basis in the first nine months was $458 million. For Bausch Health, excluding B&L, year-to-date adjusted cash flow from operations was $430 million, which was in line with our expectations.

For Bausch Health, excluding B&L, year-to-date adjusted cash flow from operations was $430 million, which was in line with our expectations.

Adjusted cash flow includes adjustments for the payment of separation costs, business transformation costs, and insurance settlement proceeds and also includes payment of the full contractual interest.

Now, let's turn to our balance sheet on slide 16.

We continue to prioritize liquidity management and the delevering of our balance sheet and in the third quarter of 2023, we reduced our debt net of cash for Bausch Health, excluding B&L by approximately $150 million, including fully repaying our revolver and considering our borrowings under the AR facility that we closed in the second quarter.

John Barresi: In Q3 2023, we reduced our debt net of cash for Bausch Health, excluding B&L, by approximately $150 million, including fully repaying our revolver and considering our borrowings under the AR facility that we closed in Q2. At the end of Q3, we had $350 million outstanding under the accounts receivable facility and had no outstanding borrowings and approximately $950 million of availability under our revolving credit facility.

At the end of the third quarter, we have $350 million outstanding under the accounts receivable facility and had no outstanding borrowings and approximately $950 million of availability under our revolving credit facility.

John Barresi: As shown on slide 17 and 18, total debt for Bausch Health, excluding Bausch + Lomb, at the end of the quarter was $16.4 billion, which consisted of $15.1 billion of restricted debt issued by Bausch Health, excluding BNL, and $1.3 billion of unrestricted debt, which includes the $1 billion of senior secured notes issued by the unrestricted subsidiary created in the third quarter of last year, and the $350 million drawn under our AR facility. Excluding BNL debt, approximately 85% of our debt is fixed and approximately 70% of the company's debt on a consolidated basis is fixed. Net debt for Bausch Health, excluding BNL, is down approximately $420 million in the 9 months since the beginning of this fiscal year.

As shown on slides 17 and 18, total debt for Bausch Health, excluding Bausch & Lomb at the end of the quarter was $16.4 billion, which consisted of $15.1 billion of restricted debt issued by Bausch Health excluding B&L and $1.3 billion of unrestricted debt, which includes the $1 billion of senior secured notes issued by the unrestricted subsidiary created in the third quarter of last year, and the $350 million drawn under our AR our facility.

by the unrestricted subsidiary created in the third quarter of last year, and the $350 million drawn under our AR our facility.

Excluding B&L debt, approximately 85% of our debt is fixed and approximately 70% of the companies that on a consolidated basis is fixed.

Net debt for Bausch Health, excluding B&L was down approximately $420 million in the nine months since the beginning of this fiscal year.

John Barresi: With 3 quarters of the year behind us, we have updated our 2023 guidance within our previously disclosed ranges for Bausch Health, excluding B&L, which can be viewed on slide 21. For Bausch Health, excluding B&L, we expect revenues in the range of $4.55 to 4.625 billion, in line with our previous outlook, although with one quarter to go, we have narrowed the range. We are raising our organic growth guidance to 4% to 6%, up from 2% to 5%. Our revenue and organic growth guidance reflects the business performance trends we have discussed, and for reported revenue reflects the impact of FX, which has been a headwind since our last guidance update in August.

With three quarters of the year behind us, we have updated our 2023 guidance within our previously disclosed ranges for Bausch Health, excluding B&L, which can be viewed on slide 21.

For Bausch Health, excluding B&L, we expect revenues in the range of 4.55 to 4.625 billion in line with our previous outlook, although with one quarter to go we have narrowed the range. We are raising our organic growth guidance to 4% to 6%, up from 2% to 5%. Our revenue and organic growth guidance

Our revenue and organic growth guidance reflects the business performance trends we have discussed and for reported revenue reflects the impact of FX, which has been a headwind since our last guidance update in August.

reflects the business performance trends we have discussed and for reported revenue reflects the impact of FX, which has been a headwind since our last guidance update in August.

John Barresi: For Salix, we typically see a seasonal step-up in sales in H2, particularly in Xifaxan, primarily due to wholesaler inventory dynamics, a part of which we saw late in Q3 of this year, as well as patient-level patterns related to insurance deductible activity. As we continue to realize benefits from our commercial investments, we expect full-year growth for Salix in the mid to high single digit range and in line with our expectations going into the year. For International, we expect overall full-year growth to be in line with the first three quarters of the year. We have a balanced portfolio from both a product and geography perspective, which helps this segment deliver consistent performance. For Solta, we anticipate continued strong reported and organic growth for the full year.

For SALIX, we typically see a seasonal step up in sales in the second half, particularly in XIFAXAN, primarily due to wholesaler inventory dynamics, part of which we saw late in the third quarter of this year, as well as patient level patterns related to insurance deductible activity.

As we continue to realize benefits from our commercial investments, we expect full year growth for SALIX in the mid to high single digit range and in line with our expectations going into the year.

For international, we expect overall full year growth to be in line with the first three quarters of the year. We have a balanced portfolio from both the product and geography perspective, which helps this segment deliver consistent performance.

For Solta, we anticipate continued strong reported and organic growth for the full year.

John Barresi: For Diversified, we expect full-year sales to decline in line with the segment's year-to-date performance, due largely to the pressures I referred to earlier on the neurology and dermatology businesses. We continue to expect gross margin to be in the 80% range in line with prior guidance. We also continue to expect our full-year adjusted EBITDA to be in line with our previous guidance, but with one quarter to go, are also narrowing the range here with adjusted EBITDA for Bausch Health, excluding B&L, expected to be in the range of $2.30 to $2.35 billion within the range we had previously provided.

For diversified, we expect full year sales to decline in line with the segment's year-to-date performance due largely to the pressures I referred to earlier on the neurology and dermatology businesses.

We continue to expect gross margin to be in the 80% range in line with prior guidance.

We also continue to expect our full year adjusted EBITDA to be in line with our previous guidance, but with one quarter to go are also narrowing the range here with adjusted EBITDA for Bausch Health, excluding B&L expected to be in the range of $2.30 billion to $2.35 billion within the range we had previously provided.

John Barresi: As we've discussed in prior quarters, our adjusted EBITDA guidance reflects the acceleration of approximately $50 million in R&D spend from 2024 for critical programs, which is higher R&D investment in 2023 than contemplated when we initially provided guidance for the year. Adjusted EBITDA guidance also includes the impact of charges for the MRAD recall that primarily occurred in Q2. On the expense side, we will continue to invest in sales and marketing activities to drive growth in our key brands in our Salix, international, and Solta Medical segments. These expenditures include sales force expansion, DTC advertising, and investments in sales force tools. As Tom mentioned, we expect to see the effects from these initiatives on revenues continue through the remainder of this year.

As we've discussed in prior quarters, our adjusted EBITDA guidance reflects the acceleration of approximately $50 million in R&D spend from 2024 for critical programs, which is higher R&D investment in 2023 and contemplated when we initially provided guidance for the year. Adjusted EBITDA guidance also includes the impact of charges for the Emirate recall that primarily occurred in Q2.

primarily occurred in Q2.

On the expense side, we will continue to invest in sales and marketing activities to drive growth in our key brands and our SALIX, international, and Solta Medical segments. These expenditures include salesforce expansion, DTC advertising and investments in salesforce tools.

Advertising and investments and Salesforce tools.

As Tom mentioned, we expect to see the effects from these initiatives on revenues continue through the remainder of this year.

John Barresi: Moving below adjusted EBITDA, we are reaffirming our full-year effective non-GAAP tax rate of approximately 15%, as well as holding our expected contractual interest costs unchanged at approximately $1.3 billion. Lastly, we are reaffirming our guidance for adjusted operating cash flow for Bausch Health, excluding B&L, of approximately $625 million. As I said earlier, adjusted cash flow includes adjustments for the payment of separation costs, the payment of the full contractual interest, and the estimated impact of cash tax payments, inclusive of the tentative Granite Trust settlement, which we expect to be finalized with the IRS in the coming months. I'll now hand the call back to Tom.

Moving below adjusted EBITDA, we are reaffirming our full year effective non-GAAP tax rate of approximately 15% as well as holding our expected contractual interest costs unchanged at approximately $1.3 billion.

Lastly, we are reaffirming our guidance for adjusted operating cash flow for Bausch Health, excluding be B&L of approximately $625 million.

As I said earlier, adjusted cash flow includes adjustments for the payment of separation costs, the payment of the full contractual interest and also includes the estimated impact of cash tax payments inclusive of the tentative Grantor Trust settlement, which we expect to be finalized with the IRS in the coming months.

I'll now hand the call back to Tom.

Thomas Appio: Thank you, John. In summary, as you have heard today, we continue to make solid progress against the strategic priorities we set out at the beginning of the year. We recognize that there is more to do and that some of our businesses face challenges. With one quarter to go in 2023, we are focused on closing the year strong and carrying that momentum into 2024. I want to reinforce our entire team's commitment to driving business performance and delivering against our strategic priorities, which remain intact and are outlined on slide 23. We have a clear purpose of enriching lives through our relentless drive to create better health outcomes for patients and healthcare providers who treat them. We have made key focused investments in our sales teams, marketing programs, and R&D pipeline to drive performance for the long term.

Thomas J. Appio: Thank you John. In summary, as you have heard today, we continue to make solid progress against the strategic priorities we set out at the beginning of the year. We recognize that there is more to do and that some of our businesses face challenges. With one quarter to go in 2023, we are focused on closing the year strong and carrying that momentum into 2024.

In summary, as you have heard today, we continue to make solid progress against the strategic priorities, we set out at the beginning of the year. We recognize that there is more to do and that some of our businesses face challenges with one quarter to go in 2023, we are focused on closing the year strong. <unk> and carrying that momentum into 2024.

<unk> and carrying that momentum into 2024.

I want to reinforce our entire team's commitment to driving business performance and delivering against our strategic priorities, which remain intact and outlined on slide 23. We have a clear purpose of enriching lives through our relentless drive to create better health outcomes for patients and healthcare providers who treat them. We have made key focused investments in our sales teams, marketing programs, and R&D pipeline to drive performance for the long term.

We have a clear purpose of enriching lives through a relentless drive to create better health outcomes for patients and healthcare providers, who treat them. We have made key focused investments in our sales teams marketing programs and R&D pipeline to draw.

<unk> performance for the long term.

Thomas Appio: Finally, and importantly, we have an all-in team that is principled, creative, are problem solvers, and results-focused. On behalf of our entire Bausch Health team, I thank you for your interest in and support of our company. With that, we will now take questions. Operator, please open the line for Q&A.

Finally, and importantly, we have an all-in team that is principled, creative, are problem solvers, and results focused. On behalf of our entire Bausch Health team, I thank you for your interest in and support of our company. With that, we will now take questions. Operator, please open the lines for Q&A.

On behalf of our entire Bausch health team I. Thank you for your interest in and support of our company with that we will now take questions. Operator, Please open the lines for Q&A.

Operator 2: Certainly. At this time, we will be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Your first question for today is coming from Jason Gerberry with Bank of America Securities.

Operator: Certainly. At this time, we will be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Your first question for today is coming from Jason Gerberry with Bank of America Securities.

Operator: Certainly. At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Like to ask a question please press. One. Phone keypad. Indicate your line is in the question queue. You May press start. Question from the queue. Participants using speaker equipment. To pick up your handset before pressing keys.

One. Phone keypad. Indicate your line is in the question queue. You May press start. Question from the queue. Participants using speaker equipment. To pick up your handset before pressing keys.

Phone keypad. Indicate your line is in the question queue. You May press start. Question from the queue. Participants using speaker equipment. To pick up your handset before pressing keys.

Indicate your line is in the question queue. You May press start. Question from the queue. Participants using speaker equipment. To pick up your handset before pressing keys.

You May press start. Question from the queue. Participants using speaker equipment. To pick up your handset before pressing keys.

Question from the queue. Participants using speaker equipment. To pick up your handset before pressing keys.

Participants using speaker equipment. To pick up your handset before pressing keys.

To pick up your handset before pressing keys.

One moment please while we poll for questions.

Operator: Your first question for today is coming from Jason Gerberry with Bank of America Securities.

With Bank of America Securities.

Jason Gerberry: Oh, hey, guys. Thanks for taking my questions. I guess firstly, I was wondering where you are with the status of the new CFO hire. I didn't see that listed on the priority list, but if you can have any commentary there. On the prior quarter update, you talked about exploring different strategic options for separation. Are there any kind of specific options that are emerging there? As you talk about different factors, is Canadian approval or and/or a solvency opinion options that are gonna be factors in the separation? Thanks.

Jason Matthew Gerberry: Hey, guys. Thanks for taking my questions. I guess firstly, I was wondering where you are with the status of the new CFO hire. I didn't see that listed on the priority list, but if you can have any commentary there. And then on the prior quarter update, you talked about exploring different strategic options for separation, are there any specific options that are emerging there? And as you talk about different factors, is Canadian approval and/or a solvency opinion options that are gonna be factors in separation? Thanks.

Guess firstly. I was wondering where you are with the status of the. CFO higher I didn't see that listed on the priority list, but if you can have any commentary there. And then on the prior quarter update you talked about exploring different strategic options for separation are there any specific options that are emerging there and as you talk about different factors. Is Canadian approval <unk> solvency opinion options that are gonna be factors in separation. Thanks.

I was wondering where you are with the status of the. CFO higher I didn't see that listed on the priority list, but if you can have any commentary there. And then on the prior quarter update you talked about exploring different strategic options for separation are there any specific options that are emerging there and as you talk about different factors. Is Canadian approval <unk> solvency opinion options that are gonna be factors in separation. Thanks.

CFO higher I didn't see that listed on the priority list, but if you can have any commentary there. And then on the prior quarter update you talked about exploring different strategic options for separation are there any specific options that are emerging there and as you talk about different factors. Is Canadian approval <unk> solvency opinion options that are gonna be factors in separation. Thanks.

And then on the prior quarter update you talked about exploring different strategic options for separation are there any specific options that are emerging there and as you talk about different factors. Is Canadian approval <unk> solvency opinion options that are gonna be factors in separation. Thanks.

Is Canadian approval <unk> solvency opinion options that are gonna be factors in separation. Thanks.

Thomas Appio: Thanks, Jason. Yeah, Jason, I'll take the first question. Regarding the CFO hire. Yes, as you know, Tom Vadaketh left, and John has taken over as the interim head. A search is underway. And what I would say is, you know, in the meantime, we have a really strong finance team, you know, focused on maintaining the momentum, you know, within our business. We're in good shape there, and, you know, really working to, you know, continue to drive performance in the Q4. With regard to the changes, yeah, that we've talked about in the Q2, you know, nothing has changed there in terms of, you know, what we wanna do.

Thomas J. Appio: Thanks Jason. Yes, Jason I'll take the first question regarding the CFO hire. As you know, Tom Vadaketh left and John has taken over as the interim head. A search is underway. What I would say is in the meantime, we have a really strong finance team focused on maintaining the momentum within our business, so we're in good shape there and really working to continue to drive performance in the fourth quarter. With regard to the changes that we've talked about in the second quarter, nothing has changed there in terms of what we want to do. We had time in the second quarter to consider going to a reduction of capital. We believe that completing any eventual distribution by way of return on capital basically simplifies the process and helps to manage through some of the risks that have been identified. We believe also it creates additional strategic flexibility for both companies.

Jason I'll take the first question. Regarding the CFO higher yes as. As you know Tom Abadaka left and John has taken over as the interim head search is underway. What I would say is in the meantime, we have a really strong finance team <unk>. Focus on maintaining the momentum. Within our business. So we're in good shape there. Really working to. Continued to drive performance in the fourth quarter. With regard to the changes that we've talked about in the second quarter. Nothing has changed there in terms of what we want to do. We had time in the second quarter to consider. Consider going to a reduction of capital we believe that completing.

Regarding the CFO higher yes as. As you know Tom Abadaka left and John has taken over as the interim head search is underway. What I would say is in the meantime, we have a really strong finance team <unk>. Focus on maintaining the momentum. Within our business. So we're in good shape there. Really working to. Continued to drive performance in the fourth quarter. With regard to the changes that we've talked about in the second quarter. Nothing has changed there in terms of what we want to do. We had time in the second quarter to consider. Consider going to a reduction of capital we believe that completing.

As you know Tom Abadaka left and John has taken over as the interim head search is underway. What I would say is in the meantime, we have a really strong finance team <unk>. Focus on maintaining the momentum. Within our business. So we're in good shape there. Really working to. Continued to drive performance in the fourth quarter. With regard to the changes that we've talked about in the second quarter. Nothing has changed there in terms of what we want to do. We had time in the second quarter to consider. Consider going to a reduction of capital we believe that completing.

What I would say is in the meantime, we have a really strong finance team <unk>. Focus on maintaining the momentum. Within our business. So we're in good shape there. Really working to. Continued to drive performance in the fourth quarter. With regard to the changes that we've talked about in the second quarter. Nothing has changed there in terms of what we want to do. We had time in the second quarter to consider. Consider going to a reduction of capital we believe that completing.

Focus on maintaining the momentum. Within our business. So we're in good shape there. Really working to. Continued to drive performance in the fourth quarter. With regard to the changes that we've talked about in the second quarter. Nothing has changed there in terms of what we want to do. We had time in the second quarter to consider. Consider going to a reduction of capital we believe that completing.

Within our business. So we're in good shape there. Really working to. Continued to drive performance in the fourth quarter. With regard to the changes that we've talked about in the second quarter. Nothing has changed there in terms of what we want to do. We had time in the second quarter to consider. Consider going to a reduction of capital we believe that completing.

Really working to. Continued to drive performance in the fourth quarter. With regard to the changes that we've talked about in the second quarter. Nothing has changed there in terms of what we want to do. We had time in the second quarter to consider. Consider going to a reduction of capital we believe that completing.

Continued to drive performance in the fourth quarter. With regard to the changes that we've talked about in the second quarter. Nothing has changed there in terms of what we want to do. We had time in the second quarter to consider. Consider going to a reduction of capital we believe that completing.

With regard to the changes that we've talked about in the second quarter. Nothing has changed there in terms of what we want to do. We had time in the second quarter to consider. Consider going to a reduction of capital we believe that completing.

Nothing has changed there in terms of what we want to do. We had time in the second quarter to consider. Consider going to a reduction of capital we believe that completing.

Thomas Appio: You know, we had time, you know, in Q2 to consider going through a reduction of capital. We believe that completing, you know, any eventual distribution by way of return of capital basically simplifies, you know, the process and, you know, helps to manage through some of the risks that have been identified. You know, we believe also it creates additional strategic flexibility for both companies. You know, when we look at it, you know, in terms of solvency, you know, there's many factors that go into that. John, maybe you wanna take that.

We had time in the second quarter to consider. Consider going to a reduction of capital we believe that completing.

Consider going to a reduction of capital we believe that completing.

any eventual distribution by way of return on capital basically simplifies the process and helps to manage through some of the risks that have been identified. We believe also it creates additional strategic flexibility for both companies.

Also it creates additional strategic flexibility for both companies.

And when we look at it in terms of solvency, there are many factors that go into that. John, maybe you want to take that? Yeah, I don't think anything has fundamentally changed in terms of how we're thinking about the steps to get to or how we're thinking about solvency beyond what was previously disclosed. The solvency requirements haven't changed and we continue to evaluate them.

And when we look at it in terms of solvency, there are many factors that go into that. John, maybe you want to take that?

And when we look at it. In terms of solvency.

In terms of solvency.

Many factors that go into that John maybe you want to take that yeah. I don't I don't think anything has fundamentally changed in terms of how we're thinking about the steps to get to. Or how we're thinking about solvency beyond what was previously disclosed the solvency requirements haven't changed and we continue to evaluate them.

John Barresi: Yeah. You know, I don't think anything has fundamentally changed in terms of how we're thinking about the steps to get or how we're thinking about solvency beyond what we previously disclosed. The solvency requirements haven't changed, and we continue to evaluate them.

John Barresi: Yeah, I don't think anything has fundamentally changed in terms of how we're thinking about the steps to get to or how we're thinking about solvency beyond what was previously disclosed. The solvency requirements haven't changed and we continue to evaluate them.

Or how we're thinking about solvency beyond what was previously disclosed the solvency requirements haven't changed and we continue to evaluate them.

Thomas Appio: Operator, next question.

Thomas J. Appio: Operator, next question.

John Barresi: So-

Thomas Appio: Oh, go ahead, Jason. You have a follow-up?

Go ahead Jason, you have a follow up?

Jason Gerberry: Well, yeah. I guess I'm just not totally clear. I think in the past it was framed as sort of something that, you know, a self-imposed consideration, but that perhaps under the reduction of capital it may not, it wouldn't be needed, 'cause could the Canadian approval dynamics change? I guess, is that how you'd frame it, as sort of it's still a self-imposed option and you're not saying whether you will or won't do it?

Jason Matthew Gerberry: Yeah, I guess I'm just not totally clear. I think in the past it was framed as sort of something that you have a self imposed consideration but that perhaps under the reduction of capital it wouldn't be needed because the Canadian approval dynamics changed, so I guess how you would frame it is sort of it's still a self imposed option and you are not saying whether you will or won't do it?

Something that you are self imposed <unk>. Consideration. But that perhaps under the reduction of capital it may not it wouldn't be needed. Because the Canadian approval dynamics changed so I guess does that. How you would frame it is sort of it's still self imposed option and you are not saying, whether you will or won't do it.

Consideration. But that perhaps under the reduction of capital it may not it wouldn't be needed. Because the Canadian approval dynamics changed so I guess does that. How you would frame it is sort of it's still self imposed option and you are not saying, whether you will or won't do it.

But that perhaps under the reduction of capital it may not it wouldn't be needed. Because the Canadian approval dynamics changed so I guess does that. How you would frame it is sort of it's still self imposed option and you are not saying, whether you will or won't do it.

Because the Canadian approval dynamics changed so I guess does that. How you would frame it is sort of it's still self imposed option and you are not saying, whether you will or won't do it.

How you would frame it is sort of it's still self imposed option and you are not saying, whether you will or won't do it.

John Barresi: I think fundamentally, Jason, we need to ensure that if and when we do a distribution, we have two appropriately capitalized companies that we're leaving behind, right? You know, the specific, you know, legal procedural steps to solvency I don't think are something that's necessarily germane to that discussion. We have to have two companies that are appropriately capitalized.

Thomas J. Appio: So I think fundamentally Jason, we need to ensure that if and when we do a distribution we have to appropriately capitalize companies that we're leaving behind right. And so the specific legal procedural steps to solvency I don't think are something that's necessarily germane to that discussion. We have to have two companies that are appropriately capitalized.

If and when we do a distribution we have to appropriately capitalized companies that were leaving behind right and so the specific. Legal procedural steps to solvency I don't think or something that's necessarily germane to that discussion we have to have two companies that are appropriately capitalized.

Legal procedural steps to solvency I don't think or something that's necessarily germane to that discussion we have to have two companies that are appropriately capitalized.

Jason Gerberry: Got it. Thanks.

Jason Matthew Gerberry: Got it, thanks.

Thomas Appio: Operator, next question.

Thomas J. Appio: Operator, our next question.

Operator 2: Your next question is coming from Umer Rafiq with Evercore.

Operator: Your next question is coming from Umer Rafiq with Evercore.

Operator: Your next question is coming from Umar Raffat with Evercore.

With Evercore.

Umer Rafiq: Hi, guys. Thanks for taking my questions. I have three today, if I may. First, Tom, on this point on appropriately capitalizing both companies, is that feedback you're getting from a regulator, perhaps Canada or somewhere in US? Secondly, on Xifaxan, I know there's two broad issues. There's the patent issue, which is being appealed from the district court, and then there's this issue around how the district court prevented FDA approval till 2029. Can you clarify if both these issues will be part of the appeals court ruling in H1? Finally, have you guys taken any blinded look at cardiac safety in the Amiselimod's ongoing trial? Thank you very much.

Umer Raffat: Hi, guys. Thanks for taking my questions. I have three today, if I may. First, Tom, on this point on appropriately capitalizing both companies, is that feedback you're getting from a regulator, perhaps Canada or somewhere in US? Secondly, on Xifaxan, I know there's two broad issues. There's the patent issue, which is being appealed from the district court, and then there's this issue around how the district court prevented FDA approval till 2029. Can you clarify if both these issues will be part of the appeals court ruling in H1? Finally, have you guys taken any blinded look at cardiac safety in the Amiselimod's ongoing trial? Thank you very much.

Umer Raffat: Hi, guys. Thanks for taking my questions. I have three today, if I may. First Tom, on this point on appropriately capitalizing both companies, is that feedback you are getting from a regulator, perhaps Canada or somewhere in US?

Secondly on XIFAXAN, I know there are two broad issues. There is the patent issue, which is being appealed from the District Court and then there's this issue around how the District Court prevented FDA approval until 2029, can you clarify if both these issues will be part of the Appeals Court ruling in first half? And finally, have you guys taken any blinded look at cardiac safety in the MSL [inaudible] ongoing trial? Thank you very much.

Which is being appealed from the district Court and then there's this issue around how the district court prevented FDA approval until 2029th can you clarify if both these issues will be part of the Appeals court ruling in first half and finally have you guys taken any blinded look at cardiac safety in the MSL months' ongoing trial. Thank you very much.

And finally, have you guys taken any blinded look at cardiac safety in the MSL [inaudible] ongoing trial? Thank you very much.

Thomas Appio: Well, I'll take the first one, Umer. You know, in terms of appropriately capitalized, no. The answer is, you know, have that. When we talk about it, that's what we look at as two appropriately capitalized companies. Regarding the second question you had on the appeal of the district court, what I would say is, you know, again, yesterday's decision was the district court denied Norwich's motion and granted summary judgment in favor of the FDA and the company. We are really happy with this outcome. This is a separate, you know, of course, a separate matter to our appeal, which is ongoing.

Thomas J. Appio: Yeah, so I'll take the first one Umar. In terms of appropriately capitalized, no. The answer is when we talk about it that's when we look at the spend that's what we looked at as two appropriately capitalized companies.

What I'll take the first one. In terms of appropriately capitalized no the answer is. That we just when we talk about it that's when we look at the spin that's what we looked at as to appropriately capitalized companies.

In terms of appropriately capitalized no the answer is.

That we just when we talk about it that's when we look at the spin that's what we looked at as to appropriately capitalized companies.

Regarding the second question you had on the appeal of the District Court, what I would say is again, yesterday's decision was the District Court denied Norwich's motion and granted summary judgment in favor of the FDA and the company. We are really happy with this outcome. This is of course a separate matter to our appeal, which is ongoing. And of course we're waiting for an outcome in the first quarter of next year. On the the last one, on [inaudible], yes, we did take a look at the cardio safety of [inaudible] and a large study was run.

Was the district Court denied Norwich is motion and granted summary judgment in favor of the FDA and the company.

We are really happy with this outcome.

This is a separate of course a separate matter. Two hour appeal. Which is ongoing. And of course waiting we're waiting for an outcome in the first quarter of next year. On the the last one on Amazon Lamott, Yes, we did run a we did take a look at the cardio safety of <unk> and. And a study a large study was run.

Two hour appeal. Which is ongoing. And of course waiting we're waiting for an outcome in the first quarter of next year. On the the last one on Amazon Lamott, Yes, we did run a we did take a look at the cardio safety of <unk> and. And a study a large study was run.

Thomas Appio: Of course, you know, we're waiting for an outcome in Q1 next year. On the last one on Amiselimod, yes, we did take a look at the cardio safety of Amiselimod, and a large study was run. Operator, next question.

Which is ongoing.

And of course waiting we're waiting for an outcome in the first quarter of next year. On the the last one on Amazon Lamott, Yes, we did run a we did take a look at the cardio safety of <unk> and. And a study a large study was run.

On the the last one on Amazon Lamott, Yes, we did run a we did take a look at the cardio safety of <unk> and. And a study a large study was run.

On the the last one, on [inaudible], yes, we did take a look at the cardio safety of [inaudible] and a large study was run.

And a study a large study was run.

Operator, next question.

Operator 2: Your next question for today is coming from David Amsellem with Piper Sandler.

Operator: Your next question for today is coming from David Amsellem with Piper Sandler.

With Piper Sandler.

[Analyst] (Piper Sandler): Hi. Thanks. This is Skylar on for David. First, what are your overarching thoughts on solvency in the context of the 2027 and 2028 maturities? Do you have any long-term plans you can speak to attain a more secure capital structure? How are you thinking about the divestiture as a means of addressing the debt burden? Thanks.

Unknown: Hi, thanks. This is [inaudible] on for David. First, what are over arching thoughts on solvency in the context of the 2027 and 2028 maturity? Do you have any long term plans you can speak to you to attain a more secure capital structure? And then also how are you thinking about the divestitures as a means of addressing the debt burden? Thanks.

John Barresi: Yeah. I'll take the first part of that, and then Tom can talk about the divestiture side of it. You know, we're not gonna share long-term projections. You know, you'll see our 2024 guidance when we get to February. What I will say is a couple of things as we think through. Obviously, debt reduction continues to be a priority for us. We have businesses that generate significant cash flow. You saw earlier we're guiding to $625 million for this year. As the business grows on the top line, that should flow pretty well down to cash and bottom line going forward as well. We continue to focus on our pipeline as Tom spoke about, right? Because that's important when we do get to places where we need to refinance.

John Barresi: Yeah, I'll take the first part of that and then Tom can talk about the divestiture side of it. We're not going to share long term projections. We will see our 2024 guidance when we get to February. What I will say is a couple of things as we think through. Obviously, debt reduction continues to be a priority for us. We have businesses that generate significant cash flow. You saw earlier we're guiding to $625 million for this year. As the business grows on the top line, that should flow pretty well down to cash in bottom line going forward as well and we continue to focus on our pipeline as Tom spoke about because that's important when we do get to places where we need to refinance obviously the forward-looking leverage is going to be critical there. So continuing to grow the business we have, generate cash, and focus on developing our pipeline are the keys there.

We're not going to share long term projections. We will see our 2024 guidance when we when we get to February. What I will say is a couple of things as we think through obviously.

We will see our 2024 guidance when we when we get to February. What I will say is a couple of things as we think through obviously.

What I will say is a couple of things as we think through obviously.

That reduction continues to be a priority for us we have businesses that generate significant cash flow you saw earlier were guiding to $625 million for this year as the business grows on the top line that should flow pretty well down to cash in bottom line going forward as well and we continue to focus on our pipeline is Tom spoke about right because of that <unk>.

important when we do get to places where we need to refinance obviously the forward-looking leverage is going to be critical there. So continuing to grow the business we have, generate cash, and focus on developing our pipeline are the keys there. Yeah, I'll take the second part of that question. Of course divestitures as a publicly

John Barresi: Obviously, the forward-looking leverage is gonna be critical there. Continuing to grow the business we have, generate cash, and focus on developing our pipeline are the keys there.

Thomas Appio: Yeah. I'll take the second point of that question. Of course, divestitures. You know, as a publicly held company, you know, we're always considering all options. We have a lot of great assets in this company. So if someone comes forward and is interested in looking at our assets, we'll always entertain that. You know, clearly the assets we have today, as we saw, in terms of the results of Q3, you know, we're performing well. However, you know, clearly, if there is any interest, we would entertain it. Operator, next question.

Thomas J. Appio: Yeah, I'll take the second part of that question. Of course divestitures as a publicly

held company, we're always considering all options. We have a lot of great assets in this company. So if someone comes forward and is interested in looking at our assets, we're always entertaining that. Clearly, the assets we have today as we saw in terms of the results of the third quarter, we're performing well. However, clearly, if there is any interest we would entertain it.

Always considering all options, we have a lot of great assets and this company. So if someone comes forward. And is interested in looking at our assets were always entertain that. Clearly the assets we have today as we saw. In terms of the results of the third quarter. We're performing well however. Clearly. If there is any interest we would entertainment.

So if someone comes forward. And is interested in looking at our assets were always entertain that. Clearly the assets we have today as we saw. In terms of the results of the third quarter. We're performing well however. Clearly. If there is any interest we would entertainment.

And is interested in looking at our assets were always entertain that. Clearly the assets we have today as we saw. In terms of the results of the third quarter. We're performing well however. Clearly. If there is any interest we would entertainment.

Clearly the assets we have today as we saw. In terms of the results of the third quarter. We're performing well however. Clearly. If there is any interest we would entertainment.

In terms of the results of the third quarter. We're performing well however. Clearly. If there is any interest we would entertainment.

We're performing well however. Clearly. If there is any interest we would entertainment.

Clearly. If there is any interest we would entertainment.

If there is any interest we would entertainment.

Operator, next question.

Operator 2: The next question is coming from Douglas Miehm with RBC Capital Markets.

Thomas Appio: The next question is coming from Douglas Miehm with RBC Capital Markets.

Operator: The next question is coming from Douglas Miehm with RBC Capital Markets.

C capital markets.

Douglas Miem: Yeah. Good morning. Just a couple questions on Xifaxan. Number one, with respect to the growth at around 13% relative to the flat in prescription. Is it fair to say then, you know, a small part, price increase and the bulk of it was stocking? And maybe you could actually delineate what that number was. The second question has to do with the Aplenzin and Wellbutrin. We saw strong, actually, you know, fairly strong growth relative to the weakness in prescriptions. Can you walk us through what's going on there as well? I know that you indicated that into Q4 things are gonna reverse themselves, but just curious as to what happened there.

Thomas Appio: Yeah. Good morning. Just a couple questions on Xifaxan. Number one, with respect to the growth at around 13% relative to the flat in prescription. Is it fair to say then, you know, a small part, price increase and the bulk of it was stocking? And maybe you could actually delineate what that number was. The second question has to do with the Aplenzin and Wellbutrin. We saw strong, actually, you know, fairly strong growth relative to the weakness in prescriptions. Can you walk us through what's going on there as well? I know that you indicated that into Q4 things are gonna reverse themselves, but just curious as to what happened there.

Douglas Miehm: Yeah, good morning. Just a couple of questions on XIFAXAN. Number one, with respect to the growth of around 13% relative to the flat prescription, so is it fair to say then a small part price increase and the bulk of it was stocking? And maybe you could actually delineate what that number was.

As I fax and number one with respect to the groceries around 13% relative to the flat prescription. So is it fair to say then you know small part price increase and the bulk of it was stocking and maybe you could actually delineate what that number wise.

And then the second question has to do with [inaudible] actually fairly strong growth relative to the weakness in prescriptions. Can you walk us through what's going on there as well? I know that you indicated that into Q4 things are going to reverse themselves, but just curious as to what happened there.

Can you. Walk us through what's going on there as well I know that you indicated that into Q4 things are going to reverse themselves, but just.

Walk us through what's going on there as well I know that you indicated that into Q4 things are going to reverse themselves, but just.

Just curious as to what happened there.

Thomas Appio: Yeah, Doug, I'll take some of those questions, and then John might add a few things. You know, when we take a look at Xifaxan and, you know, clearly in the quarter, it was a good quarter. I did mention in my prepared remarks, there were some changes on inventory, and, you know, our pricing, we did have a good opportunity to get some price with a higher net price, got $17 million. Overall, when we take a look at the extended units, they were up, you know, 0.5% in Q3. You know, the non-retail extended units grew by 4%.

Thomas J. Appio: Doug, I'll take some of those questions and then John might add a few things. When we take a look at XIFAXAN, clearly in the quarter it was a good quarter. I did mention in my prepared remarks, there was some changes on inventory and our pricing, we did have a good opportunity to get some pricing with a higher net price at 17 million. Overall, when we take a look at the extended units, they were up 0.5% in the third quarter. The non-retail extended units grew by 4%. When we take a look from an outpatient perspective, there are things happening and shifting of patients and especially on the AG side.

Clearly in the quarter. It was a good quarter I did mentioned in my prepared remarks, there was some. Changes on inventory. And. Pricing, we did have a good opportunity. 82 to get some price with a higher net price got a 17 million overall when we take a look at the extended units they were up. 5% in the third quarter.

Changes on inventory. And. Pricing, we did have a good opportunity. 82 to get some price with a higher net price got a 17 million overall when we take a look at the extended units they were up. 5% in the third quarter.

And. Pricing, we did have a good opportunity. 82 to get some price with a higher net price got a 17 million overall when we take a look at the extended units they were up. 5% in the third quarter.

Pricing, we did have a good opportunity. 82 to get some price with a higher net price got a 17 million overall when we take a look at the extended units they were up. 5% in the third quarter.

82 to get some price with a higher net price got a 17 million overall when we take a look at the extended units they were up. 5% in the third quarter.

5% in the third quarter.

The non retail extended units grew by 4%. When we when we take a look from an outpatient perspective, there are things happening and shifting of patients. And especially on the side.

Thomas Appio: When we take a look from an outpatient perspective, there are things happening and shifting of patients, you know, and especially on the HE side. As we look at it, if I take a look at the TRX growth, you know, it was for IBS-D, you know, 0.5% in line with the trend. When I looked at HE, on the HE side, it did decline slightly from a total TRX standpoint, but the NRX trend is good, you know. One of the things we're gonna be focusing on is refill rates as we into Q4.

When we when we take a look from an outpatient perspective, there are things happening and shifting of patients. And especially on the side.

And especially on the side.

As we look at it, if I take a look at the TRX growth, for IVSD it was 0.5% in line with the trend. When I look on the AG side it did decline slightly from a total TRX standpoint, but the NRX trend is good. So one of the things we're going to be focusing on is refill rates as we are into the fourth quarter. As you know also, I've talked about in previous calls our AI project that now has been rolled out to our large field force both on the primary care side and the specialty side. And that as we look at what our messaging is, what our targets are is going to help improve the volume performance going forward.

It was <unk> it was 0.5% in line with in line with the trend when. When I look at <unk> on the side it did declined slightly. Total Trs standpoint, but. The <unk> trend is good so one of the things we're going to be focusing on his refill rates as we are into the fourth quarter. As you know also I've talked about in previous calls you are AI project. That now has been rolled out to our large fuel force both on the primary care side in the specialty side. And that as we look at what our messaging is what our targets are is. Is going to help improve.

When I look at <unk> on the side it did declined slightly. Total Trs standpoint, but. The <unk> trend is good so one of the things we're going to be focusing on his refill rates as we are into the fourth quarter. As you know also I've talked about in previous calls you are AI project. That now has been rolled out to our large fuel force both on the primary care side in the specialty side. And that as we look at what our messaging is what our targets are is. Is going to help improve.

Total Trs standpoint, but. The <unk> trend is good so one of the things we're going to be focusing on his refill rates as we are into the fourth quarter. As you know also I've talked about in previous calls you are AI project. That now has been rolled out to our large fuel force both on the primary care side in the specialty side. And that as we look at what our messaging is what our targets are is. Is going to help improve.

The <unk> trend is good so one of the things we're going to be focusing on his refill rates as we are into the fourth quarter. As you know also I've talked about in previous calls you are AI project. That now has been rolled out to our large fuel force both on the primary care side in the specialty side. And that as we look at what our messaging is what our targets are is. Is going to help improve.

Thomas Appio: As you know, also, I've talked about in previous calls our AI project that now has been rolled out to our large field force, both on the primary care side and the specialty side. That, as we look at what our messaging is, what our targets are, is going to, you know, help improve the volume performance going forward. When I take a look at the volume and also then what the wholesalers bought, the data that they're looking at and the trends that they see, but there's a lot of things that we're doing there from a direct-to-consumer advertising. I mentioned the Bellamy Young opportunity about speaking about the need to address HE.

That now has been rolled out to our large fuel force both on the primary care side in the specialty side. And that as we look at what our messaging is what our targets are is. Is going to help improve.

And that as we look at what our messaging is what our targets are is. Is going to help improve.

Is going to help improve.

When I take a look at the volume, the volume and also then what the wholesalers bought, the data that they are looking at and the trends that they see but there's a lot of things that we're doing there from a direct-to-consumer advertising I mentioned the [inaudible] Young opportunity about speaking about the need to address AG.

I take a look at the volume. <unk> and also then what the wholesaler spot. The data that they are looking at in the trends that they see but there's a lot of things that we're doing there from a direct to consumer advertising I mentioned development young opportunity about speaking about the need to address.

<unk> and also then what the wholesaler spot. The data that they are looking at in the trends that they see but there's a lot of things that we're doing there from a direct to consumer advertising I mentioned development young opportunity about speaking about the need to address.

The data that they are looking at in the trends that they see but there's a lot of things that we're doing there from a direct to consumer advertising I mentioned development young opportunity about speaking about the need to address.

Thomas Appio: There's a lot of things happening there that will, you know, help our Salix business going forward. When we take a look at APLENZIN and WELLBUTRIN, you know, clearly, in the quarter, we had opportunities there, from, you know, looking at what our other competitors had in terms of inventory movements. We did launch the APLENZIN SAD campaign, which we're really excited about. That is, you know, the only product approved for SAD, and we think that we have a really good opportunity, you know, to drive growth, not only in Q4, but good momentum going into next year. Operator, next question.

There's a lot of things happening there that will help our SALIX business going forward. When we take a look at [inaudible] and WELLBUTRIN, clearly in the quarter, we had opportunities there from looking at what the other competitors had in terms of inventory movements. We did launch the [inaudible] SAD campaign, which we're really excited about. That is the only product approved for SAD and we think that we have a really good opportunity to drive growth, not only in the fourth quarter, but good momentum going into next year.

Clearly in the quarter, we had opportunities there from looking at what the other. Other competitors had in terms of inventory movements, we did launch the plans and sad campaign, which we're really excited about that. That is the only product approved for sad and we think that we have a really good opportunity to. To drive growth not only in the fourth quarter, but good momentum going into next year.

Other competitors had in terms of inventory movements, we did launch the plans and sad campaign, which we're really excited about that. That is the only product approved for sad and we think that we have a really good opportunity to. To drive growth not only in the fourth quarter, but good momentum going into next year.

That is the only product approved for sad and we think that we have a really good opportunity to. To drive growth not only in the fourth quarter, but good momentum going into next year.

To drive growth not only in the fourth quarter, but good momentum going into next year.

Operator, next question.

Operator 2: Your next question is coming from Les Salewski with Truist Securities.

Operator: Your next question is coming from Les Salewski with Truist Securities.

Operator: Your next question is coming from [inaudible] with [inaudible] Securities.

With Chili Securities.

Les Sulewski: Good morning. Thank you for taking my questions. First on the EBITDA guidance for BHC, excluding Bausch + Lomb. Can you just talk about some of the puts and takes on the narrowing down of the guidance there? Then second, on the RED-C program, how is this enrollment trending and any agency feedbacks from specifically Asia Pacific region? Thank you.

Unknown: Good morning. Thank you for taking my questions. So first on the EBITDA guidance for BHC excluding Bausch & Lomb, can you just talk about some of the puts and takes on the narrowing down of the guidance there? And then second, on the Red Sea program how is this enrollment trending and any agency feedbacks from the Asia Pacific region? Thank you.

From Asia Pacific region. Thank you.

Thomas Appio: Yeah. Why don't I take the first question on the RED-C, and then, John will take the question on guidance. Really excited about the RED-C program. Again, this is a global program. As you know, today we only have approval for, you know, to market Xifaxan and, you know, in the United States, this would be an opportunity globally. The enrollment of 2 global, you know, phase 3 trials is on track. One of the reasons why, you know, you see the increase in spend in R&D, we put more, you know, investment behind this program to accelerate the program, so we have an approval, you know, an earlier approval.

Thomas J. Appio: Yeah, so why don't I take the first question on the Red Sea and then John will take the question on guidance. Really excited about the Red Sea program. Again, this is a global program as today, we only have approval for [inaudible] and XIFAXAN in the United States. This would be an opportunity globally. The enrollment of two global phase III trials is on track. One of the reasons why you see the increase in spend in R&D, we put more investments behind this program to accelerate the program, so we have an earlier approval. So we expect these three phase III trials to be completed in 2025 and to file in 2026 and to launch a commercial product in the first half of 2027.

The Red Sea and then John will take the question the question on guidance. Really excited about the Red Sea program again this is a global program.

Really excited about the Red Sea program again this is a global program.

Today, we only have approval for to Mark his xifaxan in the United States. This would be an opportunity globally. The enrollment of two global Phase III trials is on track one of the reasons why.

The enrollment of two global Phase III trials is on track one of the reasons why.

You see the increase in spending R&D.

We put more.

Investment behind this program to accelerate. Program, So we have an approval. Earlier approval. So we expect these three phase III trials to be completed in 2025 to. To file in 2026 and to launch a commercial product in the first half of 2027.

Program, So we have an approval.

Thomas Appio: You know, we expect these three phase 3 trials to be completed in 2025, to file in 2026, and to launch a commercial product in H1 2027. You know, when I look at the opportunity here, of course, you know, we need the data, but we look at the opportunity for RED-C globally, it's really a great opportunity for our company. R&D team has been doing a real good job on the recruitment, and you know had many investigator meetings both in Europe and also in Asia Pacific.

Earlier approval. So we expect these three phase III trials to be completed in 2025 to.

To file in 2026 and to launch a commercial product in the first half of 2027.

When I look at the opportunity here, of course, we need the data but we look at the opportunity for Red Sea globally, it's a really great opportunity for our company and the R&D team has been doing a real good job on the recruitment and have had many investigator meetings both in Europe and also in Asia Pacific and trying to get as many sites up and running as possible and making sure that even looking at our opportunities to run a trial in China, which would be again an area of focus for us.

Of course, we need the data. But we look at the opportunity for Red Sea globally, it's a really great opportunity for our company and R&D team has been doing a real good job on the recruitment and have had many investigator meetings both in Europe and also in Asia.

But we look at the opportunity for Red Sea globally, it's a really great opportunity for our company and R&D team has been doing a real good job on the recruitment and have had many investigator meetings both in Europe and also in Asia.

Thomas Appio: you know, trying to get as many sites up and running as possible, and making sure that even looking at our opportunities to run a trial in China, which would be again an area of focus for us. John Barresi, do you wanna take the other question on guidance?

and trying to get as many sites up and running as possible and making sure that even looking at our opportunities to run a trial in China, which would be again an area of focus for us. John, you want to take the other question on guidance? Sure. In terms of the puts and takes

and trying to get as many sites up and running as possible and making sure that even looking at our opportunities to run a trial in China, which would be again an area of focus for us.

And trying to get as many sites up and running as possible and making sure that even looking at our opportunities to run a trial in China, which would be of again an area of focus for US John you want to take the other question on guidance sure in terms of the put some <unk>.

John, you want to take the other question on guidance?

John Barresi: Sure. In terms of the puts and takes on guidance, Les, yeah, I think there are a few things in there. One, you know, you start with the top line. We're gonna talk about adjusted EBITDA, but it starts with top line, right? As you can see, we've

John Barresi: Sure. In terms of the puts and takes on guidance I think there are a few things in there. One, we're going to talk about adjusted EBITDA, but it starts with top line right and as you can see we've increased our organic growth guidance a point on the top end, two points on the bottom end. But FX has really shifted since the last time we provided guidance in August and has become much more of a headwind, which carries through down to the bottom line to a degree. And then when we look at some of the other factors, we talked about the R&D spend that we've accelerated into 2023. The [inaudible] recall that happened and Q2 and trails for a little bit into Q3. We've continued to try to be really thoughtful about cost and expense, but when we look at how all of that rolls together, I think we thought it was prudent to to narrow our range to the 2.3 to 2.5 range. So hopefully that helps to answer your question.

on guidance I think there are a few things in there. One, we're going to talk about adjusted EBITDA, but it starts with top line right and as you can see we've increased our organic growth guidance a point on the top end, two points on the bottom end. But FX has really shifted since the last time we provided guidance in August and has become much more of a headwind, which carries through down to the bottom line to a degree. And then when we look at some of the other factors, we talked about the R&D spend that we've accelerated into 2023.

We're going to talk about adjusted EBITDA, but it starts with top line right and as you can see we've we've increased our organic growth guidance a point on the top and two points on the bottom end. But FX has really shifted since the last time, we provided guidance in August and has become. Much more of a headwind, which carries through down to down to the bottom line to a degree. And then when we look at some of the other factors, we talked about the R&D spend. That we've accelerated into 2023.

John Barresi: We've increased our organic growth guidance, a point on the top end, two points on the bottom end. FX has really shifted since the last time we provided guidance in August, and has become much more of a headwind, which carries through down to the bottom line to a degree. When we look at some of the other factors, we talked about the R&D spend that we've accelerated into 2023, the Emerade recall that happened in Q2 and trailed over a little bit into Q3. We've continued to try to be really thoughtful about cost and expense, but when we look at how all of that rolls together, I think we thought it was prudent to narrow our range to the 2.3 to 2.35 range.

But FX has really shifted since the last time, we provided guidance in August and has become. Much more of a headwind, which carries through down to down to the bottom line to a degree. And then when we look at some of the other factors, we talked about the R&D spend. That we've accelerated into 2023.

Much more of a headwind, which carries through down to down to the bottom line to a degree. And then when we look at some of the other factors, we talked about the R&D spend. That we've accelerated into 2023.

And then when we look at some of the other factors, we talked about the R&D spend. That we've accelerated into 2023.

That we've accelerated into 2023.

The [inaudible] recall that happened and Q2 and trails for a little bit into Q3. We've continued to try to be really thoughtful about cost and expense, but when we look at how all of that rolls together, I think we thought it was prudent to to narrow our range to the 2.3 to 2.5 range. So hopefully that helps to answer your question.

We've continued to try to be really thoughtful about cost and expense, but when we look at how all of that rolls together I think we thought it was prudent to to narrow our range to to the to three to 235 range.

John Barresi: Hopefully that helps answer your question.

So hopefully that helps answer your question.

Les Sulewski: That's helpful. If I may squeeze one more on the recent approval of Qatrio, what's the market opportunity here? Just talk about sales forecasts for one Q launch, pricing, reimbursement strategy, and then, essentially, a duration, the compliance rates that you'd expect from the product. Thank you.

Unknown: That's helpful. And if I may squeeze one more on the recent approval of CABTREO, what's the market opportunity here? Just talk about sales for ads, for 1Q launch, pricing reimbursement strategy and then essentially the duration of the compliance rates that you would expect for the product. Thank you.

And then essentially had duration the compliance rates that you would expect for the product. Thank you.

Thomas Appio: Yeah. What I would say, CABTREO, we're really, of course, excited that we gained FDA approval. The team, the R&D team, the regulatory team have worked really hard to bring this product to fruition. What I would say is, you know, the, you know, acne is clearly a focus for us, and we see it as a good opportunity. Of course, as you know, the medical derm space, in terms of the payer perspective, is a challenge. Therefore, we're looking at what our pricing will be, looking at various ways to maximize, you know, the molecule, in whether it be from a payer perspective, but also from a cash pay perspective.

Thomas J. Appio: What I would say CABTREO, we're really of course excited that we gained FDA approval. The R&D team, the regulatory team have worked really hard to bring this product to fruition. What I would say is acne is clearly a focus for us and we see it as a good opportunity. Of course, as you know, the medical space in terms of the payer perspective is a challenge and therefore, we're looking at what our pricing will be, looking at various ways to maximize the molecule whether it be of course from a payer perspective, but also from a cash paid perspective. We think that this product is the best-in-class for for the treatment of acne. So the team is still working on finalizing the launch plans as we go to launch this in the first quarter of 2024. But clearly, we're excited about it, we think it's a good opportunity to put this product in the bag to drive growth and stabilization of our medical derm business.

We're really of course excited that we gained FDA approval the team the R&D team. The regulatory team have worked really hard to get bring this product to. To fruition, what I would say is is. Acne is clearly a focus for us. And we see it is is a good. Good opportunity of course, as you know the medical space in terms of the payer perspective is a challenge.

To fruition, what I would say is is. Acne is clearly a focus for us. And we see it is is a good. Good opportunity of course, as you know the medical space in terms of the payer perspective is a challenge.

Acne is clearly a focus for us. And we see it is is a good. Good opportunity of course, as you know the medical space in terms of the payer perspective is a challenge.

And we see it is is a good. Good opportunity of course, as you know the medical space in terms of the payer perspective is a challenge.

Good opportunity of course, as you know the medical space in terms of the payer perspective is a challenge.

and therefore, we're looking at what our pricing will be, looking at various ways to maximize the molecule whether it be of course from a payer perspective, but also from a cash paid perspective. We think that this product is the best-in-class for for the treatment of acne. So the team is still working on finalizing the launch plans as we go to launch this in the first quarter of 2024. But clearly, we're excited about it, we think it's a good opportunity to put this product in the bag to drive growth and stabilization of our medical derm business.

The molecule. Whether it be from a pair. Of course from a payer perspective, but also from a cash. <unk> perspective, we think that this product is the best in class. For for the treatment of acne. So the team is still working on finalizing. The launch plans as we as we work as we gonna launches in the first quarter of 2024. But clearly we're excited about it we think it's a good opportunity to put this product in the bag to drive growth. And stabilization of our medical during business.

Whether it be from a pair. Of course from a payer perspective, but also from a cash. <unk> perspective, we think that this product is the best in class. For for the treatment of acne. So the team is still working on finalizing. The launch plans as we as we work as we gonna launches in the first quarter of 2024. But clearly we're excited about it we think it's a good opportunity to put this product in the bag to drive growth. And stabilization of our medical during business.

Of course from a payer perspective, but also from a cash. <unk> perspective, we think that this product is the best in class. For for the treatment of acne. So the team is still working on finalizing. The launch plans as we as we work as we gonna launches in the first quarter of 2024. But clearly we're excited about it we think it's a good opportunity to put this product in the bag to drive growth. And stabilization of our medical during business.

Thomas Appio: We think that this product is the best in class for, you know, for the treatment of acne. The team is still working on finalizing the launch plans as we're gonna launch this in Q1 2024. But clearly, we're excited about it. We think it's a good opportunity to put this product in the bag to drive growth and stabilization of our medical derm business. Operator, next question.

<unk> perspective, we think that this product is the best in class. For for the treatment of acne. So the team is still working on finalizing. The launch plans as we as we work as we gonna launches in the first quarter of 2024. But clearly we're excited about it we think it's a good opportunity to put this product in the bag to drive growth. And stabilization of our medical during business.

For for the treatment of acne. So the team is still working on finalizing. The launch plans as we as we work as we gonna launches in the first quarter of 2024. But clearly we're excited about it we think it's a good opportunity to put this product in the bag to drive growth. And stabilization of our medical during business.

The launch plans as we as we work as we gonna launches in the first quarter of 2024. But clearly we're excited about it we think it's a good opportunity to put this product in the bag to drive growth. And stabilization of our medical during business.

But clearly we're excited about it we think it's a good opportunity to put this product in the bag to drive growth. And stabilization of our medical during business.

And stabilization of our medical during business.

Operator, next question.

Operator 2: We have reached the end of the question-and-answer session, and I will now turn the call over to Tom Appio for closing remarks.

Operator: We have reached the end of the question-and-answer session, and I will now turn the call over to Tom Appio for closing remarks.

Operator: We have reached the end of the question and answer session and I will now turn the call over to Tom Appio for closing remarks.

Thomas Appio: Since there are no further questions, I would just say thank you for joining today. In summary, we had a solid Q3 and made good progress on our strategic objectives. We look forward to finishing the year strong with a focus on profitable growth, driving performance, advancing the R&D that we discussed on this call, and also advancing business development as well, and building on our overall momentum from Q3 into Q4, and then continuing that on in 2024. I would really like to thank everybody for joining our call today.

Thomas J. Appio: Since there are no further questions, I would just say thank you for joining today. In summary, we had a solid Q3 and made good progress on our strategic objectives. We look forward to finishing the year strong with a focus on profitable growth, driving performance, advancing the R&D that we discussed on this call and also advancing business development as well and building on our overall momentum from the third quarter into the fourth and then continuing that on in 2024. I would really like to thank everybody for joining our call today.

We look forward to finishing the your strong with a focus on profitable growth driving performance advancing the R&D that we discussed on this call and also advancing business development as well and building on our overall momentum.

Third quarter of from the third quarter into the fourth and then continuing that on in 2024, I would really like to thank everybody for joining our call today.

Operator 2: This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.

Operator: This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.

Operator: This concludes today's conference and you may disconnect your lines at this time. Thank you for your participation.

Connect your lines at this time, thank you for your participation. Mmm.

Mmm.

Q3 2023 Bausch Health Companies Inc Earnings Call

Request a DemoDemo

BHC

Bausch Health Companies

Earnings