Bausch Health Companies Inc

TSX:BHC

Earnings Call Transcript 2022-Q4

[Operator]

Good morning, and welcome to Bausch Health's Fourth Quarter 2022 Earnings Conference Call. At this time, all participants have been placed on a listen-only mode. And we will open the floor for your questions and comments after the presentation. [Operator Instructions]

It is now my pleasure to turn the floor over to Judy DiClemente [ph]. Judy, the floor is yours.

[Unidentified Company Representative]

Thank you, Tom. Good morning, and welcome to Bausch Health's fourth quarter 2022 earnings conference call. This is Judy DiClemente, Investor Relations for Bausch Health. Participating in today's call are Thomas Appio, Chief Executive Officer of Bausch Health; and Tom Vadaketh, Chief Financial Officer.

Before we begin, I'd like to remind you that our presentation today contains forward-looking information. We would ask you to take a moment to read the forward-looking statements at the beginning of this presentation. 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.

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 this presentation which is 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 P& L. However, we will briefly comment on Bausch + Lomb 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 may be listening to the replay or archived webcast, this call was held and recorded on February 23rd, 2023.

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

[Thomas Appio, Chief Executive Officer]

Thank you, Judy. And welcome to those of you joining the call today. Nine months after our new management team took over Bausch Health, I am proud to report the progress we have made. First, we met guidance for the full year 2022, delivering the revenue of $4.36 billion and EBITDA of $2.32 billion for Bausch Health, excluding B&L. However, revenue and EBITDA declined during 2022. And as I have said in prior calls, my team and I are committed to delivering revenue and EBITDA growth as we go forward.

I am pleased with the momentum we saw in the fourth quarter with revenue for Bausch Health, excluding B&L, up 2% on an organic basis, driven by growth in our Salix, Solta and International businesses. We believe this encouraging top line performance provides a solid foundation for 2023.

Second, we continue to make progress on our strategic alternatives, improving our balance sheet. Debt principal, net of unrestricted cash for Bausch Health, excluding B&L, has now been reduced by $3.2 billion since the IPO of Bausch + Lomb in May of 2022. We have also continued to work to resolve several legacy matters and will continuously vigorously defend our intellectual property. Third, given our momentum, we are providing a solid 2023 outlook, which we are confident will create long term value for stakeholders.

Let me now take you through some specifics. Starting on Slide 7. I am pleased to report that we're making progress in the performance of our business segments. One, the Salix business had organic revenue growth of 4% in the fourth quarter, with encouraging XIFAXAN script growth in all channels, other than the long-term care channel, which Tom Vadaketh will touch on later in this call.

Our targeted commercial strategies and initiatives to improve diagnosis and treatment of GI and liver disease continue to drive results. The Salix business has shown momentum after declining 2% organically in the first half of the year. It grew 4% in the second half of the year, resulting in a 1% growth for the full year. Other key promoted brands also saw increased scripts, led by double-digit growth for RELISTOR and PLENVU and mid-single-digit growth for TRULANCE.

For International, we continue to grow key markets such as Poland, Mexico and Canada, with existing brands and new products. The International business posted 2% organic growth in the quarter, resulting in a healthy 5% increase for the year on an organic basis.

In Solta Medical, sales grew organically by 20% in the quarter, resulting in 2% organic growth for the full year. Our Asia Pacific business outside of China has been strong, with consistent growth throughout the year. Our business in China continued to recover after the COVID lockdowns in the second quarter and posted strong growth in the fourth quarter.

In Diversified. Sales for the segment declined by 6% on an organic basis in the quarter and by 13% for the full year. While EBITDA margins for the year remained stable relative to last year, the business has been impacted by generic competition, and we are focused on stabilizing the business within the Diversified segment. Both our Dermatology and Dentistry business units showed strong organic growth for the quarter, JUBLIA script growth increased by 23% for the quarter.

Turning to Slide 8. Let me make a few comments about the progress we have made along the strategic alternative pathway that we started back in 2020. As you know, we completed the IPO of Bausch + Lomb in May of 2022. Since then, we have made progress in delevering our balance sheet.

During the fourth quarter, we executed an additional open market repurchase which, with previous open market repurchases we made throughout the year and with the successful debt exchange we closed in Q3, enabled us to reduce our net debt by $3.2 billion.

We have also further reduced our debt maturities in 2025 and 2026. This has strengthened the company's financial position, created stakeholder value and increased our flexibility to capitalize on opportunities as we move forward.

We continue to evaluate potential options to maximize stakeholder value. The significant reduction in debt since the B + L IPO has enabled us to achieve the financial matrix required under our debt documents to unrestrict Bausch + Lomb, which we did in the fourth quarter.

Furthermore, as it relates to Bausch + Lomb separation, our effective efforts to implement transactions to further strengthen our balance sheet have resulted in us achieving our own 6.5x to 6.7x net leverage targets, excluding the $1 billion of non-recourse debt held by the unrestricted subsidiary, which is collateralized by a portion of B&L shares.

We continue to believe the separation of Bausch + Lomb, makes strategic sense. We remain committed to creating two strong companies and, therefore, to ensuring the financial stability of both companies on a standalone basis.

In addition, as previously discussed, there remain a number of steps that need to be completed to achieve full separation, including the receipt of shareholder and other necessary approvals. So we continually to thoughtfully evaluate all relevant factors related to the B + L separation. In the meantime, we remain focused on commercial performance and improving our operating results reinforcing a solid foundation for the future.

Lastly, we continue to make progress on several other matters. With regard to the Granite Trust, we are pleased to have had a productive engagement with the IRS. We applied for fast track mediation in January of this year. We reached a tentative settlement with the IRS to resolve the matter.

Through the settlement - although the settlement is subject to further review and approvals before it is finalized, we do not expect the outcome will have a material impact on the company's full year results or cash flows. Our cash flow guidance for 2023 reflects the potential impact of this matter.

Let me make a few comments with respect to the XIFAXAN litigation. As we have previously disclosed on August 10th, 2022, the court issued a decision in our dispute with Norwich finding certain XIFAXAN -550 hepatic encephalopathy HE patents valid and infringed and certain XIFAXAN composition and IBS-D patent invalid. As we have stated, we disagree with certain portions of the court's decision and have filed an appeal.

However, I would like to point out that the court's current decision prevents Norwich ANDA and from receiving final FDA approval until October of 2029. Since the court's decision was issued, Norwich has advised the court that has sought to remove the HE indication from its ANDA and has filed a motion to modify the final judgment to permit the FDA to approve the ANDA before 2029. We have opposed this motion and await a decision from the court.

Separately, the FDA issued an update to the XIFAXAN product-specific guidance to remove the opportunity for generics to receive biowaivers and now requires In Vivo bioequivalent studies for Rifaximin-550 generics.

On January 31, the US Patent and Trademark Office issued an additional US patent that protects XIFAXAN-550 product for the treatment of IBS-D and expires in February 2029. The patent is now Orange Book listed for the XIFAXAN-550 product and further supports our XIFAXAN patent portfolio. We remain confident in the strength of the XIFAXAN patents. This is all we are prepared to say about the XIFAXAN litigation at this time.

Before I turn the call over to Tom Vadaketh to discuss our fourth quarter 2022 results and 2023 guidance, I'd like to share on a high level, some of the key growth drivers we see for 2023 across our business segments.

On Slide 9, starting with Salix, we are pleased with the momentum in the second half of 2022, and we believe there is significant opportunity to accelerate the growth of XIFAXAN over the next few years.

The addressable market for both HE and IBS-D is large and XIFAXAN has been endorsed by guidelines and recommended as standard-of-care for both indications. There are still a large number of patients across HE and IBS-D who are not receiving the treatment. We are significantly increasing our investment in direct-to-consumer advertising to activate consumers for both IBS-D and HE.

We are investing in new sales force capabilities to enhance effectiveness, leveraging artificial intelligence and machine learning. We are expanding our sales force footprint in the institutional space to engage with new integrated delivery networks. We are executing a variety of new point-of-sale pharmacy initiatives to improve both the provider and patient access experience. We will continue to work with payers to solidify XIFAXAN strong value proposition.

We also continue to invest in Rifaximin. We have several programs underway in our pipeline, including a global development program for RED-C for the prevention of the first episode of HE, a complication associated with cirrhosis.

We have the global rights for this program, which address unmet needs in the global patient population that is much larger than XIFAXAN's current patient population for overt HE, which we only market in the US today.

Enrollment in our Phase 3 clinical trials for RED-C program is on track. We are pleased also to receive orphan drug designation for Rifaximin sickle cell disease program and enrollments for the Phase 2 clinical trial for this formulation are on go. Finally, in our Salix pipeline, we are progressing with our large Phase 2 study for amiselimod for patients suffering with ulcerative colitis UC.

Turning to our international business. In Canada, we are focusing our efforts in 2023 on profitable growth in dermatology for acne, atopic dermatitis, psoriasis and onychomycosis using direct promotion, digital engagement, as well as direct-to-consumer programs.

We are leveraging our data management systems to enable more rapid insight generation and enhanced understanding of HCP preferences in turn generating an expanded customized digital offering to our customers. In Europe, we aim to continue to drive strong growth through HCP education, enhanced digital engagement as well as continuous training of our marketing and sales teams.

We have several new product launches across the International business, including RYALTRIS for moderate to severe seasonal allergic rhinitis, UCERIS, an aerosol foam for distal ulcerative colitis in Canada. In Latin America, we are launching line extensions for Bedoyecta and Benedorm - in Mexico, and we were driving our expansion into Central America with the launching of existing brands.

In Solta Medical, this is a strong, durable business operating in very attractive markets with more than 70% of the revenue coming from consumables. We believe that, this business has significant growth potential.

We will continue to invest in expanding our presence in key markets, including through broadening the reach of our direct-to-consumer campaigns in the US. The geo expansion of Thermage FLX and the strengthening of our sales forces in Europe. We are encouraged by the listing of the COVID lockdowns in China, and we are cautiously optimistic about the recovery in the volume of treatment procedures to pre-COVID levels.

For Diversified. In our dermatology business, the FDA has accepted our new drug application for IDP-126, the first triple combination product for the treatment of acne vulgaris. We presented findings for IDP-126 at the innovations in dermatology conference in Las Vegas last November and received positive feedback. We are finalizing our plans for the launch of this product as soon as we receive FDA approval.

In our Neurology business, we will be investing in antidepressant APLENZIN, including for patients diagnosed with seasonal affected disorder, or SAD. And more broadly, we are looking to manage our portfolio of non-promoted products in this business in a more effective and efficient manner.

Finally, in Dentistry, we reinforced our commercial efforts on our core product, ARESTIN. ARESTIN is an antibiotic use in the treatment of periodontitis, a condition suffered by large patient population. We saw the benefit of this strategy in 2022 with an acceleration in growth in the second half and expect to see this continue in 2023.

As you can see, we have a number of exciting and encouraging programs underway. We are proud of the momentum that this team has built to date, and we continue to make strategic investments to drive revenue growth and build out our R&D pipeline to ultimately bring products to market that serve patient needs.

With that, I will turn the call over to Tom Vadaketh, who will provide further details on our fourth quarter performance and an outlook for the remainder of the year. Tom?

[Tom Vadaketh, Chief Financial Officer]

Thanks, Tom. Hello, everyone, and thanks for joining us. My comments today will refer to organic growth and adjusted results. Let's start with Slide 11. We closed the quarter with consolidated fourth quarter revenues for Bosch Health of $2.2 billion, up 4% on an organic basis over the same quarter last year and up 2% for the full year. Fourth quarter revenues for Bausch Health, excluding B&L, were $1.2 billion and up 2% on an organic basis, with growth in our Salix, Solta and International businesses.

Let me discuss each segment in greater detail as shown on Slides 13 through 16. Fourth quarter Salix revenues increased 4% to $581 million, resulting in a 1% increase for the year, a solid improvement from the 2% decline in the first half of the year.

Let me provide some more color on Salix. For the full year, we saw a 5% increase in price, including the benefit of favorable gross to net deductions. This was partially offset by a 4% decline in volume, driven by a year-over-year decrease in wholesale and retail channel inventory. Underlying demand for the year was up across all promoted products. XIFAXAN revenue grew 6% in the quarter and overall demand increased 3%, including an increase in non-retail demand at institutions, including hospitals and outpatient clinics.

We have continued to see TRx volume in the long-term care channel decline for the third year with no sign of improvement thus far. There appears to have been a shift in the HE patient journey post-COVID, with patients going directly home from the hospital, rather than to a long-term care or a step-down facility. We think such patients probably continue to receive their refill prescriptions from the institutional location.

We are proud of the positive impact that XIFAXAN can have on patient health. And as Tom touched upon earlier, we're excited about the opportunity to make it available to many more patients who need it and to adapt to the evolving patient journey. We increased investments in Salix during 2022 and are planning significant investments in 2023.

We're also pleased with the sales performance of TRULANCE, RELISTOR and PLENVU, increased 17%, 6% and 60%, respectively, in Q4 2022 versus Q4 of 2021. International revenues were $261 million, an increase of 2% on an organic basis during the fourth quarter and an increase of 5% for the full year.

For the full year, we saw growth in all three regions, EMEA, Canada and Latin America, driven by a combination of price and volume increases. We also saw double-digit growth in a number of key brands.

Solta Medical revenues of $99 million increased 20% on an organic basis in the fourth quarter, and revenues for the full year were up 2%. Revenue growth for the full year was significantly impacted by the COVID lockdown in China earlier this year. We saw a rebound in the second half, with revenues growing 14%, compared to an 11% decline in the first half, mainly driven by Asia Pacific, excluding China. The lifting of COVID lockdowns in China appears to have had a positive impact on demand in other countries within the Asia Pacific region.

Diversified revenues were $256 million, down 6% on an organic basis in the fourth quarter and down 13% for the full year. Lower sales from neurology and generics were partially offset by strong sales performance from our Dermatology and Dentistry businesses for the quarter, as ARESTIN and JUBLIA continue to perform well, with sales growth in the quarter and for the full year. Segment margins have remained stable despite the decrease in revenue.

You will note that in the quarter, we recorded an impairment of goodwill for our Neurology business of $622 million. As you know, we have seen neurology revenues decline in 2022, continuing a trend we have seen in the last few years. In addition, we have analyzed the impact of current market conditions, including the potential impact of recent legislative changes on our long-term pricing strategies for key products in the neurology portfolio.

We expect pressure from new market entrants in this business, as well as from generic launches across the neurology, dermatology and generics businesses and have adjusted our long-term view of the current portfolio.

Lastly, on Slide 17. Bausch + Lomb revenues were $996 million, up 5% on an organic basis this quarter and up 5% for the full year, driven by organic growth across all B + L segments.

Turning to the P&L for the quarter on slide 21. I will first refer to results on a consolidated basis and also provide some additional color for the performance of Bausch Health, excluding B + L.

Fourth quarter consolidated adjusted gross margin was 70.3%, 120 basis points lower than in Q4 of 2021, driven by continued pressure from inflation, along with, for the B + L businesses, pockets of limited supply availability that drove up costs and incremental production costs related to its daily SiHy lenses. These headwinds were partially offset by long-term supply agreements and cost controls. We expect these inflationary pressures to continue next year. Full year adjusted gross margin was 70.9%, or 70 basis points lower than the prior year.

At Bosch Health, excluding B + L, adjusted gross margin for the fourth quarter was approximately 80.5%, 80 basis points lower versus Q4 of 2021, due to FX headwinds, which offset underlying gross margin expansion.

Full year adjusted gross margin was also 80.6%, a 50 basis point improvement versus the prior year. Our long-term contractual agreements provided some cost stability this year despite increases in energy and distribution costs.

Consolidated adjusted operating expenses for the fourth quarter were $770 million, an increase of $33 million or 4%, with higher R&D and G&A expenses. B + L reported an increase of $8 million in operating expenses.

Consolidated R&D expense increased 21% and represented 6% of net sales compared with 5% in the fourth quarter of last year. We continue to progress our clinical programs and regulatory activities to support our late-stage product development activities, which Tom discussed earlier.

The increase in consolidated adjusted G&A costs reflects the impact of the separation and the costs to stand up two public companies. We are in the process of separating B + L's IT infrastructure from the rest of the company and have made significant progress reducing our transition service agreements this year.

Fourth quarter consolidated adjusted EBITDA attributable to Bausch Health was $823 million, a decrease of 9% and a decrease of 1% on a constant currency basis versus last year. For Bausch Health, excluding B + L, segment profit was $713 million, a decrease of 4% versus last year, driven by the decline in revenue, which includes $24 million from the impact of foreign exchange.

On a consolidated basis, fourth quarter adjusted EBITDA margin was 37.5%, down 390 basis points compared with 41.4% last year. As a reminder, adjusted EBITDA margin for Bausch Health, excluding B + L approximates in the mid-50s range and for Bosch + Lomb approximates in the high teens range.

The accounting required for the debt exchange, significantly impacted our GAAP interest expense, lowering it by $74 million this quarter. As you may recall, a substantial portion of the interest on the newly issued debt has been recorded on the balance sheet as a premium, which will be reduced as interest payments are made.

Contractual interest costs for the quarter based on principal balances was approximately $365 million on a consolidated basis and $320 million for Bausch Health, excluding B + L, compared with approximately $340 million on a consolidated basis last year. As you'll recall, B + L did not have any stand-alone debt last year.

A few words about cash flow. Excluding separation costs, adjusted cash flow from operations on a consolidated basis in the fourth quarter was $507 million versus $279 million last year, which in large part reflects the favorable working capital impact of timing of certain payments, including interest in 2022 compared to 2021. Full year adjusted cash flow from operations on a consolidated basis was $1.02 billion.

As Tom said earlier, we are pleased that revenues, EBITDA and cash flow for 2022 for Bausch Health, excluding B + L, came in around the mid-point or higher of the guidance that we provided in our call in August 2022. Revenues for 2022 were $4.36 billion, and adjusted EBITDA was $2.32 billion, a margin of 53.2%. Adjusted cash flow from operations was $637 million.

You'll note that our GAAP operating cash flow reflects the release of just over $1.5 billion from restricted cash as certain settlements of legacy legal matters for which we had placed funds in escrow became final and un-appealable.

Now let's turn to our balance sheet on Slide 22. As Tom mentioned, we continue to make significant strides in deleveraging our balance sheet this quarter. We completed an open market repurchase program of our debt, which retired $446 million of our debt at a significant discount using $250 million of cash. When compared - when combined with our Q2 open market repurchase program, we retired in aggregate $927 million of debt using $550 million of cash.

Our full year debt reduction was approximately $3.8 billion of principal balances on a consolidated basis for the full year and $3.2 billion since the B + L IPO. Furthermore, on a consolidated basis, our debt maturing prior to 2027 has been reduced by $7.5 billion compared to the start of 2022.

As you can see on Slide 24, total debt for Bausch Health, excluding Bausch + Lomb at year-end was $16.6 billion, which consisted of $15.6 billion of restricted debt issued by Bausch Health, excluding B + L, and $1 billion of senior secured notes issued by the unrestricted subsidiary created in the third quarter. Excluding B + L debt, approximately 85% of our debt is fixed and 70% on a consolidated basis.

I'll now discuss our guidance for 2023, which you can find on Slides 26 and 27. I'm going to only comment on our expectations for Bausch Health, excluding B + L, since you would have already heard on B + L's earnings call yesterday that they have not provided guidance for the full year. Therefore, we will not be providing consolidated guidance.

In 2023, we expect revenues of $4.45 billion to $4.6 billion, growth of 2% to 5% on an organic basis, reflecting the momentum we started to see in the back half of 2022. For 2023, we now expect foreign exchange impact to be a slight tailwind and we expect base business performance growth of approximately $185 million. Full year adjusted EBITDA for Bausch Health, excluding B + L, is expected to be $2.3 billion to $2.4 billion.

Let me spend a few minutes diving further into our margin expectations for Bausch Health, excluding B + L. From a gross margin perspective, we continue to mitigate the impact of inflation on our cost of goods sold and we expect our gross margin to remain comparable to last year at approximately 80%.

Our EBITDA expectations also reflect increased investments in sales and marketing, as well as a full year of the dis-synergies from the separation from B + L. First, investments we continue to invest in sales and marketing activities to drive growth in our key brands in our Salix, International and Solta Medical segments, which Tom addressed earlier. These investments include expanding our sales - our Salix sales force, the first DTC marketing campaign for HE and exciting campaigns as we launch products like RYALTRIS and UCERIS in Canada. These investments will increase our sales and marketing spend as a percentage of sales by 1% to 1.5% of sales. We expect to see the benefit of this spend in 2023 and into 2024.

Second, dis-synergies. As a result of the separation process, we estimate that a full year of stand-up costs in 2023 has a $30 million incremental impact compared to 2022. We're working hard to remain disciplined with G&A increases.

We also expect FX to be a minor tailwind to the bottom line. At the midpoint of our guidance, we expect base business performance to drive improvements of approximately 4% in adjusted EBITDA versus 2022.

A couple of points I want to make on quarterly phasing. The first quarter of the year has typically been seasonally weaker than the subsequent three quarters in this business due to the impact of resetting health insurance deductibles in the United States which impacts the patient out-of-pocket costs.

Additionally, while we don't give guidance by quarter, we do expect to have slower growth in Q1 and stronger growth in quarters two through four and when we anticipate the benefits from our sales and marketing investments will start to materialize.

Moving below EBITDA, our full year effective non-GAAP tax rate is expected to be 18%, and interest expense reported in the P&L is expected to be approximately $1 billion, including the impact of the accounting treatment I covered last quarter, resulting from our September debt exchange.

We expect our contractual interest cost to be approximately $1.3 billion, a reduction over the approximately $1.4 billion we paid in 2022, with lower debt balances offsetting the impact of rising interest rates.

Lastly, we expect Bausch Health, excluding B + L to generate approximately $625 million in adjusted operating cash flow.

I'll now hand the call back to Tom.

[Thomas Appio, Chief Executive Officer]

Thank you, Tom. In summary, this new team has made progress this quarter, and we remain laser-focused on continuing to improve our financial performance and drive operational improvements. We are committed to working with urgency and accountability, building a healthy foundation for growth. Our team has full ownership of our priorities that I outlined last year when I became the CEO. We must deliver on these priorities to create stakeholder value.

One, drive sales and EBITDA growth. Two, developing a high performance results oriented culture. Three, ensuring a keen focus and operating rigor behind R&D and business development; and fourth, creating value through strategic alternatives.

We are encouraged by the momentum in the back half of 2022, and we remain committed to investing in substantial growth drivers to position us for long-term growth of both sales and EBITDA. This includes continuing to drive top line growth of Salix, International and Solta and key brands in the Diversified Rx businesses, all while investing in R&D to expand our pipeline and open new regulatory paths.

As we execute against these goals, we are focused on broadening patient outreach, launching new products, driving awareness of existing products to targeted DTC campaigns and expanding existing products into new markets. At the same time, we aim to continue improving our balance sheet and to progress our clinical programs to bring high quality new therapeutics to patients around the world.

As we stand up the new Bausch Health, our focus continues to be on improving outcomes through innovation. We have a well established product portfolio within our core businesses, as well as a pipeline that brings new solutions into the market.

I'd like to thank the team at Bausch Health for all their hard work, focus and dedication in driving performance and building a results-oriented culture. I look forward to what 2023 will bring.

With that, we will now take questions. Operator, please open the line for Q&A.

[Operator]

Thank you. The floor is now open for questions. [Operator Instructions] And the first question this morning is coming from Georgi Yordanov from Cowen and Company. Georgi, your line is live. Please go ahead.

[Georgi Yordanov, Cowen and Company]

Hi. Thanks so much for taking our question. Congratulations on the progress. So maybe just on XIFAXAN, a couple from our end. If you can remind us about the timing of the appeal process?

And then secondly, as you discussed on the call, the updated guidance from the FDA does put up a few more regulatory hurdles. But maybe can you just put those into context in terms of specifically the new cities that are required? Is that just a PK study that could be kind of like easily performed or is it a little more involved?

And the final question on XIFAXAN specifically. Can you remind us if there are any tentative approvals for the 550-milligram dose outside of obviously?

[Thomas Appio, Chief Executive Officer]

Okay. Georgi, thanks for the question. I'll take these one at a time. In terms of your first question on the appeal process, it takes between 12 months and 18 months. Again, what I said in my prepared remarks that would be 18 to - 12 months to 18 months post the current motion decision that we're waiting for. So that's the first answer to your question.

When it comes to the FDA issued in terms of the new guidance, the FDA issued an update to the XIFAXAN product-specific guidelines to remove the opportunity for generics to receive biowaivers. It now requires In Vivo biowave equivalence studies for generics.

So what that entails, again, I can't comment on that right now. But clearly, that's another hurdle for the generics to have to get over, all right?

And then the last thing is the tentative approval for 550s - tentative approval for 550 before - again, there's one tentative approval before the new product-specific guidelines. Next question?

[Operator]

Thank you. The next question is coming from Douglas Miehm from RBC Capital Markets. Douglas, your line is live. Please go ahead.

[Douglas Miehm, RBC Capital Markets]

Thank you. Two questions. First one, just also has to do with XIFAXAN in relation to what you might be expecting as part of your guidance in terms of prescription growth? And then what type of price increases would you hope to increase on a net basis for the drug as well this year?

[Tom Vadaketh, Chief Financial Officer]

Yeah. Hi, Doug, it's Tom Vadaketh. Look, we – as you know, we do not provide guidance at that level for the products and certainly don't attempt to provide guidance split between pricing and volume. You got a sense of what we realized last year on price. I'd say from my experience, anyway, that was a little bit on the high side.

But yeah, we're going to continue - we do expect to see growth. We're making significant investments and betting on - betting a lot on the success of this business on the Salix business. And so we expect to see growth, and that's a big component and a driver of the overall company growth next year. But yeah, I'm afraid I can't give you the specific details you were looking for.

[Douglas Miehm, RBC Capital Markets]

No, that's fine.

[Thomas Appio, Chief Executive Officer]

Yeah, Doug, what I'd say to that, also in my prepared remarks, I talked about the substantial investment we're making in artificial intelligence. This is clearly a big program for us and a real focus in 2023. And then, of course, our direct-to-consumer campaigns, both on the IBS-D side and on the HE side. So we're really excited about the increased investment. And in 2022, we made additional investments that I saw when I came in as the CEO that we could make early – early on what we could do. And a lot of those investments since coming on Board in May, we made those decisions quite quickly, which put those in place.

So we're going to see a lot of that to come to fruition of the investments we made in 2022, in 2023. And then we've made a substantial increased investment in 2023. So we're really excited about the programs that we have to drive this business, XIFAXAN, these two indications, as I said in my prepared remarks, have a lot of room for growth.

[Douglas Miehm, RBC Capital Markets]

Okay. And then, my follow-up question, Tom, just really has to do with - maybe you could walk us through the puts and takes with respect to adjusted EBITDA to your operating cash flow number. So, for example, we know that you have your cash interest expense to be paid. You have your - I know you have your tax rate of 18%. But really, I'm thinking about the cash tax that will be going out the door. And then anything else that could impact the number to get to the 625. Can you walk us through that?

[Thomas Appio, Chief Executive Officer]

Yeah. I'll give back to Tom Vadaketh to walk you through that.

[Tom Vadaketh, Chief Financial Officer]

Yeah. Just at a high level for last year, I can take a crack for 2022. So we did about $2.3 billion of EBITDA. Of that, we paid $1.3-ish billion of interest cost, that's the contractual interest cost as opposed to what's in the P&L - on the face of the P&L.

And then the rest of it is, just changes in basically working capital partially and then certain other payments that we had to make, so about $400 million or so. Those would be the big chunks. And it's fairly clean, and this is adjusted operating cash flow, so it does not include, for example, the $1.5 billion, $1.6 billion of separate – of litigation costs that we settled out of restricted cash and so forth.

[Douglas Miehm, RBC Capital Markets]

Tom, I was asking about 2023 to get to the 625?

[Tom Vadaketh, Chief Financial Officer]

Yeah. So, again, the - it would be similar math, Doug. We expect interest cost to be $100 million or so lower, as I said in my prepared remarks. And then, it's going to be a case of what working capital movements we expect. We had a pretty good Q4 in 2022, with some favorable working capital movements, and that will work slightly against us as we go into 2023.

[Douglas Miehm, RBC Capital Markets]

And the settlement with the IRS?

[Tom Vadaketh, Chief Financial Officer]

Yeah. That's all baked in. As Tom said in his prepared remarks, that's baked into that 625 number. If - it is a tentative settlement. I'll just remind you, so it's not - and it remains to be approved at various levels within the IRS. So once that's done, we do not expect it to have really a material impact on the company's results, whether it's the P&L or the cash flow.

[Douglas Miehm, RBC Capital Markets]

Thank you.

[Operator]

Thank you. Your next question is coming from Glen Santangelo from Jefferies. Glen, your line is live. Please go ahead.

[Glen Santangelo, Jefferies]

Yeah. Thanks for taking my question and all the detail. Hey, Tom, in your sort of prepared remarks, you sort of made the statement that to complete the spin, you need shareholder approval and some other necessary steps. And I was wondering, if you could elaborate on what those other necessary steps are?

And to that point, there were two things in particular that I was hoping you could comment on. It's - number one, it's our understanding that in order to get the tax-free ruling designation, you need a solvency opinion on RemainCo. And I was wondering, is that technically possible given the XIFAXAN litigation fully appreciating your point of view on the patent portfolio strength?

And then secondly, I was wondering if you can give us an update on the investor litigation in New Jersey and how that could potentially impact the timing of the spin, because based on our understanding, the judge said that he's going to hear the case, but he will - that the spin was not imminent and so the timing was postponed. I was wondering if you could just give us more details on all of that. Thanks.

[Thomas Appio, Chief Executive Officer]

Okay, Glen. That's - there's a lot of questions to unpack there.

[Glen Santangelo, Jefferies]

You know, you can more of, sorry about that.

[Thomas Appio, Chief Executive Officer]

No, it's okay. Let me take a shot at all these questions you had. Firstly, we remain committed to creating two strong companies, and therefore, you know, to ensuring the financial stability of both companies on a stand-alone basis, that's the goal. That's what we are focused on.

I cannot, and I'm not going to comment on specifics. High level, we – again, we need to create two strong companies here. As we move forward, there are still steps to be taken to spin now. We've made great progress this year on those. And we remain fully committed, and we believe it's in the best interest of stakeholders to continue on with our strategic alternatives of what we've laid out.

Tom, if you want to make any further comments?

[Tom Vadaketh, Chief Financial Officer]

No, I don't.

[Thomas Appio, Chief Executive Officer]

Okay. So what I would say is from the fraudulent conveyance, you know, in terms of the status, we have filed a motion to dismiss the plaintiff's claims. We anticipate a decision in the first half of 2023. In December, the court denied the plaintiffs motion for a preliminary injunction. That's all I can – information I can give you at this time. Operator, next question.

[Operator]

Certainly. Your next question is coming from David Amsellem from Piper Sandler. David, your line is live. Please go ahead.

[David Amsellem, Piper Sandler]

Hey, thanks. So just had a couple, on the underlying Bausch Health business, the pharma business. First, I've asked this in the past, but I think it bears asking again. How do you think about the various pieces of the business? And are there any segments that would make sense to divest? That's number one.

Number two, as you think about strategic alternatives, and adding on assets and particularly in the context of the limited bandwidth, what areas make sense for further investment, be it derm or GI or something else?

And then lastly, longer term on the neurology diversified segment. I mean, should we just think about that as essentially a melting ice cube even beyond the pressure you cited for 2023? Or do you think that's a business that you think potentially could stabilize down the road? Thank you.

[Thomas Appio, Chief Executive Officer]

Okay, David. I can - let me start at the top. So when I look at our business, and I think we have really - some really great assets here. As I - when I look at the business globally, in terms of what we have, the assets to grow. Of course, I've already talked about in my prepared remarks and previous - answers to previous questions.

Salix is clearly a focus and a growth driver. And clearly, if you look at these two indications that can drive growth, IBS-D and HE. And when we look at what an HE patient in terms of what - how that drug works and then in terms of in totality, what it means for our business of an HE patient, there's a lot there to continue to grow and what that is worth.

When I look at our International business, as I talked about, we have great product portfolio, branded generics, steady growth, high single digits. We're doing business development there of tuck-in acquisitions. Solta Medical, I love this business. I think this business is - it's durable. We have really a great opportunity to geo expand this business, especially in Europe and in Latin America. We have a really large franchise - Solta Medical's franchise in Asia Pacific is large. Even when we look at the business, excluding China, okay, 45% of the business is in Asia Pacific ex-China.

So we have two real strong pillars there, both on the Asia Pacific side, excluding China, and of course, the business in China. So with the business momentum we have there and along with what we have in being able to do in Europe and Latin America and some of the things I talked about in my prepared remarks of direct-to-consumer in the U.S. on the Solta business, I'm really excited about it.

When I take a look at the Diversified portfolio, there's - you talked about what that business looks like. There is opportunities. We are being very selective from a - as we look at BD and what we can do there. So we have to be very selective given our capital constraints, but there is opportunities to bring products in there. We do have IDP 126 that we're working on, on the derm space. You saw the growth of JUBLIA. It did very well. We refocused the effort there. Our Dentistry business, we have, again, the growth there and what we see of being able to do with that business.

And then Neurology, that's a business that we're managing for cash. We're looking at opportunities. There are some interesting opportunities in Neurology. I think neurology is a very interesting space to be in. but we are being very selective. We have screened a lot of candidates there. But again, we need - we're very selective.

If I take a look overall, is anything we're willing to divest, we're always open to looking at divestitures, but it's got to be at the right price because these are really valuable assets to us and we believe that we can continue to grow them. So if there is an opportunity to divest, it would have to be at a multiple that really is premium. Next question?

[Operator]

Certainly. The next question is coming from Jason Gerberry from Bank of America. Jason, your line is live. Please go ahead.

[Jason Gerberry, Bank of America]

Hey, guys. Thanks for taking the questions. First one for me, just looking at your last 10-Q, it looked like Bausch had about $12 billion in restricted payment basket. So after you do this DLCO distribution, you should have like more than $6 billion of RP residual there. So against whatever remains of your $3 billion market cap.

So just wondering, kind of post that spin, what are the impediments, if any, to revisiting additional corporate spin-offs, that would obviously be in the best interest of your equity holders, such as Solta?

And then just on the XIFAXAN IP situation, just wondering like what - who has the next move? Is it the judge to lift the injunction for the motion of Norwich or is it the FDA making movement on the application of Norwich? Just wanted to get clarity on your understanding of who moves next year or progress [ph] next?

[Tom Vadaketh, Chief Financial Officer]

Yes. I'll start off. It's Tom Vadaketh here. On the RP basket, et cetera, I'm not going to go into that on this call. Our documents are out there. They're open. They're available. And certainly, what we are looking at doing as part of a strategic pathway, Tom has said everything we want to say on this call with the various things. I think we have a busy enough work plan right there. So going beyond that is not something for all. But I'll hand it over to Tom to talk about the XIFAXAN part of your question.

[Thomas Appio, Chief Executive Officer]

Yes, Jason, I'll take the second part of your question. So right now, we're waiting for the judge on the motion. I know as I said and I detailed out in my prepared remarks that Norwich cannot come on until 2029. So of course, we're waiting for this motion from the judge.

Also, what I'd like to add is Norwich does not have approval that we're aware of. So those are two points that I would like to make. Okay. Operator, I think we have time for one last question.

[Operator]

Certainly. And the final question today will come from Gary Nachman from BMO. Gary, your line is live. Please go ahead.

[Gary Nachman, BMO]

Okay. Great. Thanks, good morning. So could you just review the leverage targets that you talked about achieving the 6.5 to 6.7 times ex B + L. Just some more color on how you get there and how durable you think that is?

And also, how you think about the balance of having the right spending levels behind the key growth assets versus accelerating the EBITDA growth to lower the leverage further considering some of the uncertainties still with the Saxon [ph]

And then as you build out those effects and sales efforts, are there any other ways that you could potentially leverage that across the portfolio, maybe just give us a sense of is that specific to XIFAXAN or can you leverage that more broadly? Thank you.

[Thomas Appio, Chief Executive Officer]

Okay, Gary. What I'll do is let me take your questions in terms of from a XIFAXAN perspective and investment perspective, and then I'll hand it over to Tom. Okay. So firstly, as I've stated, we are investing heavily behind XIFAXAN as we think - again, it's a wonderful drug. And as I spoke about in my prepared remarks, it's guideline treatment. So both from an IBS-D perspective and an HE perspective. We - as I've also said, we strongly believe in our patents and our intellectual property. And we, as I've said also, that Norwich cannot come on until 2029 at the present time.

So the investments we're making here clearly will drive growth. We are being laser focused on our spending. I've talked about operational efficiencies throughout the organization. So a lot of the - some of the funding of these programs have come from savings in other areas. So that is what's driving that. Again, we're really staying real focused here of how we're looking at these investments.

And then to your - the second part of your question is how we're going to leverage those in other areas. And clearly, when we look at artificial intelligence, the toolbox that we're putting together, we can begin to use that in other areas and certainly in the Salix portfolio.

What I would say also is that when we look at the opportunities to invest in our business, again, we have a narrow swim lane. That's why we, again, stay laser focused. We get a lot of opportunities to look at products that we could bring in. But clearly, they have to be - have to come in here at a good valuation. And so therefore, that's what we're always looking at from that perspective.

And then it's - if you look at overall, clearly, we have opportunities to leverage the portfolio in many different ways in Salix. So I'll hand the question over to Tom on the 6.7% that you had.

[Tom Vadaketh, Chief Financial Officer]

Yes. I'll just - I won't go into the actual calculation, but just to reiterate what Tom said in his prepared remarks. The - we achieved that target. It was our own internal target that we set for ourselves a 6.5 to 6.7. So we're in - we achieved that target, if we exclude the $1 billion of debt at the unrestricted sublevel.

We have not disclosed in the past and not disclosed today, how we're calculating that. It's an internal management measure. The intent behind it, as Tom said, is that we want to create two strong companies to financially viable companies and you talked about durability, there's your answer. We want to make sure that when this is all said and done, we have that.

[Thomas Appio, Chief Executive Officer]

So Gary, let me just add one thing because you talked about the spending balance in terms of - if you look at our current R&D portfolio, RED-C is clearly going to be - we're very, very excited about this program. And therefore, as we invest behind XIFAXAN again, treating what we talked about reduction of cirrhosis. This is - the investments we're making today are - as we lead it to RED-C – into RED-C, it's creating a good foundation. So okay. So I think we actually will have time for one more question, so we'll take that, and then we'll wrap up the Q&A. Operator, next question.

[Operator]

Certainly. Next question is coming from Umer Raffat from Evercore ISI. Umer, your line is live. Please go ahead.

[Umer Raffat, Evercore ISI]

Hi, guys. Thanks for squeezing me last minute. I want to focus just on the very basics of the setup here. Your cash from operations at there's about 625, and I realize it way down a little bit because normalized could be a little higher with the separation cost. But then we also know XIFAXAN by itself produces about $600 million to $800 million, which is effectively the equivalent of entire BHC's cash flow.

So in a scenario where XIFAXAN retained and fall through early '28, that's about $4 billion to $4.5 billion of free cash flow versus about $16 billion in debt you guys have. I guess, how are you thinking about the solvency in a realistic way in the absence of a big pipeline hit? And also, even if the BLCO spend happens, would have secured that be able to pierce the corporate over to the BLCO debt?

[Tom Vadaketh, Chief Financial Officer]

Well, that's a lot for this very last question. The - let me - you talked - I can't even track your numbers, unfortunately, Umer. So maybe we'll take this off-line, but $4.5 billion of free cash flow. Okay. Yes. Look, again, you're - that is the strategic pathway. The issues that we are working through all the factors that we're considering are summed up in your question, and that's what Tom said.

So as we consider all these things, that's when we'll decide whether we - when and how we will spin off B&L. So I can't go into the specifics of how I'm thinking about solvency against those metrics. But we expect the business to grow cash flow should grow as we go forward. But really, that's all I would say. And then the question about BLCO, I can't remember. Why don't I call you back.

[Umer Raffat, Evercore ISI]

Okay, no problem. Thank you so much, guys.

[Thomas Appio, Chief Executive Officer]

Okay. That wraps up our conference call today. I really appreciate everyone joining us. As you heard on the call, there's a lot of momentum here that we're working on, and the team is really focused to promising and delivering. So thank you for joining us this morning.

[Operator]

Thank you, everyone. This does conclude today's conference call. You may disconnect your phone lines at this time, and have a wonderful day. Thank you for your participation.