Bausch Health Companies Inc

TSX:BHC

Earnings Call Transcript 2023-Q1

[Operator]

Greetings. Welcome to Bausch Health First Quarter 2023 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] Please note, this conference is being recorded.

I will now turn the conference over to Mark Maico, Investor Relations. You may begin.

[Mark Maico, Investor Relations]

Thank you, Holly. Good morning, and welcome to Bausch Health's first quarter 2023 earnings conference call. This is Mark Maico, 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 the slides that accompany this presentation, as they contain 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.

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 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 B+L. 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. For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on May 4, 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, Mark. And welcome to those of you joining the call this morning. It has been almost a year since I took over as CEO of Bausch Health. While our business faces challenges, we have some great franchises and we are continuing to balance the constraints of a tough balance sheet with the need to continue to invest and grow the business and the pipeline. With the IPO of Bausch + Lomb in May last year, we assembled a seasoned, resilient executive leadership team with a track record of hard work, dedication and accountability. While we have had some bumps in the road, we have accomplished a lot in the last year, and we are hopeful and realistic for the future of our company, powering up the potential and creating a great healthcare company.

The team and I have been able to focus on improving the remaining Bausch Health businesses. Firstly, through operational excellence and focused investments in key businesses that have growth opportunities such as Salix, Solta, Dentistry and International business. Starting in the back half of 2022 and continuing this year, we are increasing our investments in sales, marketing and R&D to accelerate growth in Salix. I will touch more on this in a few minutes when we take a closer look at the performance of the business segments. Our International business consists of a branded generic business in the EMEA and Latin America and a branded business in Canada. Taking together, this business is a profitable and growing business. To maintain sustainable long-term growth, we have to continue to bring in new products into the portfolio, as we have done historically through business development and licensing deals, which in this space are not typically capital intensive. Our neurology, dermatology and generics business operate in a challenging space. Together, over 70% of the revenue from these businesses are from products that lost their exclusivity and are subject to generic competition, which continues to put pressure on both volumes and pricing. Our approach has been to manage these businesses for optimal profits and cash generation. We have a great platform and a talented team and we will continue to review opportunities to add to the portfolio.

Secondly, we have intensified our focus and operating rigor behind R&D and business development, which is critical to the success and health of our company. We are accelerating certain aspects of our planned R&D effort and Tom Vadaketh will discuss this shortly in his commentary on the financial performance.

Let me share several pipeline developments, which you can see on Slide 7. For amiselimod, the Phase 2 trial is progressing and is expected to be completed in the second half of this year. Amiselimod is a new oral S1P receptor modulator, which targets the treatment of mild to moderate ulcerative colitis.

Turning to rifaximin, we are focused on developing novel formulations to address unmet medical needs. We are accelerating our investments related to RED-C program, which stands for Reduction of Early Decompensation in Cirrhosis. This is a global program and the treatment is targeted at preventing the first occurrence of hepatic encephalopathy, which we call HE for patients with early decompensation cirrhosis. Two global Phase 3 studies are currently underway with clinical trial sites expected to be opened in more than 15 countries by the end of Q3 and the enrollment is on track. We have completed scientific advisory meetings with the Medicines Evaluations Board in the Netherlands, with Health Canada and with plans to meet with the authorities in Japan and China later this year.

In Solta, the next generation Fraxel, a fractionated laser device for skin resurfacing is on track for FDA submission later this year and we are excited about this device for skin rejuvenation. Clear and Brilliant Touch with Canada and -- with Europe and Canada submissions planned in 2024 and Asia Pacific in 2025. We are also working on the next generation VASERlipo system that is planned to be released in late 2024 and on future features for Thermage FLX as well as additional security measures to prevent the use of counterfeit tips.

In dermatology, adding to our established acne portfolio, the FDA has accepted our New Drug Application for IDP-126 with an October 20, 2023 PDUFA date. If approved by the FDA, IDP-126 would be a first-in-class triple combination treatment for acne vulgaris. Additionally, our submission in Canada is planned for the second quarter of this year. We are actively looking for business development opportunities for our U.S. and international businesses that will synergize with our current capabilities and also looking at new therapeutic areas. We are proud of our R&D team and the work they have done to progress our pipeline and we will continue to focus on obtaining approvals for these products.

Now let me turn to the first quarter. Turning to Slide 8. I am pleased with the first quarter of the year. We delivered a solid performance in line with our expectations. Total reported revenues declined by 2% and organic revenues were flat compared with the prior quarter for Bausch Health excluding B+L. I am pleased to share that for three out of our four business segments Salix, International and Solta, grew versus last year on both a reported and organic basis.

Let's take a closer look at the first quarter performance of our business segments as shown on Slide 9. Starting with Salix, which posted reported and organic revenue growth of 7% in the first quarter with increased demand and encouraging XIFAXAN script growth across all channels. We are very pleased with the performance of the Salix business in this quarter. XIFAXAN is a fantastic option for healthcare providers that their patients -- for their patients and we have increased our marketing investments in XIFAXAN for both of our approved indication IBS-D and HE. The increased investments in targeted consumer activation is currently being deployed across a range of media channels, such as connected and addressable TV as well as many digital and social platforms. As a result, we are seeing very encouraging signs of increased consumer engagement.

In addition, we have also expanded our institutional sales footprint by 40%. The increased sales force allows us to engage with new integrated delivery networks, their associated hospitals and clinics, and to continue to educate new healthcare providers on the importance of initiating therapy for AT patients to reduce the risk of reoccurrence and rehospitalization. We expect these efforts will help to drive future growth. We are implementing AI-enabled solutions to improve our commercial engagement. These solutions leverage artificial intelligence and machine learning to help our commercial teams optimize their interactions with physicians and direct efforts to the right opportunities at the right time. AI has the potential to significant improve how we interact with our customers and meaningful expand the number of patients getting on the right treatment. As part of our continued investment and to improve HE and IBS-D patient care, we are implementing an advanced analytical-driven medical approach. This approach leverages multichannel medical engagement, including a meaningful expansion of our specialized medical field team to prove care for thousands of HE and IBS-D patients. It will help us execute -- educate physicians to address the largest patient care gaps and track the positive impact on patient lives over time.

Turning to International. Sales grew 5% on an organic basis and 1% on a reported basis with organic growth in all three regions. Key markets such as Poland and Canada saw double-digit growth for the period. In Europe, our sales and marketing teams are driving growth through HCP education and enhanced digital engagements. And in Canada, we are driving growth of our promoted brands while focusing on the launch of RYALTRIS. Solta grew organically by 6% in the quarter with strong customer demand in Asia Pacific markets excluding China. We are cautiously optimistic for the remainder of the year for return to growth in China following the lifted of the COVID restrictions. In the U.S. we are focusing on growth drivers, which will include expanding DTC campaigns and building top and sales marketing teams. As I said before, Solta is a great business for BHC. With our global footprint and our product mix between capital equipment and consumables, more than 70% of Solta's revenues are from consumables, which gives us together a good platform for future growth.

Turning to Dentistry, which is part of our diversified segment. We delivered 4% organic growth for the quarter. We have refocused our commercial effort on our core product ARESTIN and antibiotic used in the combination with scaling and root planing procedures to treat patients with adult periodontitis. The periodontal treatment market is expected to reach $12.2 billion by 2031, up $7.6 billion in 2021. With this market, we are driving demand with the private practice dentist segment, which is the largest portion of the market and the corporate DSO dentist, which is the fastest growing segment.

In Diversified, sales for this segment decreased by 21% on an organic and reported basis in the quarter with declines in neurology, dermatology and generics. We are striving to stabilize the business in our promoted and non-promoted products within this segment. This year, we intend to make additional investments in the marketing and advertising of APLENZIN and expand our consumer awareness campaign for JUBLIA, which both saw increased scripts. Again, I am pleased with the performance in the first quarter, which was in line with our expectations. We are reiterating our guidance for Bausch Health excluding B+L for this year, and as always remain committed to delivering long term value for stakeholders.

Let me take a few minutes to talk about some key priorities. The process of delevering our balance sheet is ongoing, and in the first quarter of 2023 for Bausch Health excluding B+L, we reduced our debt by approximately $100 million, including revolver repayments. We have made significant progress in delevering our balance sheet over the past year, reducing debt since the B+L IPO by $3.3 billion and we will continue to effectively manage and enhance our capital structure.

With regard to the Granite Trust, as you know, we reached a tentative settlement with the IRS during the first quarter and we expect final resolution of this matter later this year. Regarding the XIFAXAN proceedings, as a reminder, the court's current decision prevents Norwich's ANDA from receiving final FDA approval until October 2029. Norwich advised the court that he has sought to remove the HE indication from its ANDA and has filed a motion to modify the judgment to prevent -- to permit the FDA to approve their ANDA before 2029. We have opposed this motion and await decision from the court. Lastly, we continue to believe the separation of Bausch + Lomb make strategic sense with the end goal of having two independent strong financially stable companies.

With that, I will turn the call over to Tom Vadaketh, who will provide further details on our quarter performance. 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. We closed the quarter with consolidated first quarter revenues for Bosch Health of $1.9 billion, up 4% on an organic basis over the same quarter last year. First quarter revenues for Bosch Health excluding B+L were $1 billion and flat on an organic basis, with growth in our Salix, International and Solta businesses.

Let me discuss each segment in greater detail as shown on Slide 11. First quarter, Salix revenues increased 7% to $496 million. This increase was largely due to higher demand for XIFAXAN 550, TRULANCE and RELISTOR, coupled with relatively favorable changes in channel inventory this quarter for XIFAXAN 550 and TRULANCE in comparison with the channel inventory changes in the prior year. XIFAXAN revenue grew 7% in the quarter and overall demand grew 4%. In the first quarter, we continued to see an uptick in non-retail demand at institutions, such as hospitals and outpatient clinics, increasing our market share. We also saw a slight increase in demand from long-term care facilities, but we believe the shift in the HE patient journey post-COVID with patients going directly home from the hospital rather than to a long-term care or step-down facilities ongoing, and we are keeping a close eye on this trend. As Tom said, we have increased our investments in Salix during the quarter and we plan to invest further in the remainder of 2023.

We are also pleased with the sales performance of RELISTOR and TRULANCE, which posted increases of 29% and 19%, driven by total script growth of 22% and 10% respectively in the first quarter versus the prior year. International revenues were $247 million, an increase of 5% on an organic basis during the first quarter, led by strong growth in Canada and Poland of 11% and 15% respectively. We also saw double-digit growth in a number of key brands. Solta Medical revenues of $73 million increased 6% on an organic basis in the first quarter. Our Asia Pacific business grew 7% with strong demand despite a sales decline in China due to the effects of COVID-related government restrictions in the early part of the first quarter, immediately following the opening up of the market from COVID. Excluding China, the region grew 35%. In the U.S. sales were slightly down driven by lower volumes. We are continuing the expansion of our DTC campaign in the U.S. and the expansion of sales teams in Europe.

Diversified revenues were $197 million, down 21% on an organic basis in the first quarter. For neurology, lower sales were mainly driven by lower demand for WELLBUTRIN, as well as net pricing pressure on APLENZIN, although APLENZIN script growth remained positive at 4%. In dermatology, JUBLIA sales were impacted in part by a shift in patient coverage mix, which reduced net pricing, the effect of which is higher in Q1, as patient deductibles reset at the beginning of the year. JUBLIA scripts grew 17%. These decreases were partially offset by our Dentistry product ARESTIN, which had sales growth of 5% in the quarter. We continue to expect challenging market conditions in the neurology, dermatology and generic businesses for the balance of the year, and remained focused on stabilizing this part of our portfolio.

Lastly on Slide 12, Bausch + Lomb revenues were $931 million, up 8% on an organic basis in the first quarter, with strong organic growth across all B+L segments.

Turning to the P&L for the quarter on Slide 15, I'll first refer to results on a consolidated basis and also provide some additional color for the performance of Bosch Health excluding B+L. The first quarter consolidated adjusted gross margin was 70.1%, 120 basis points lower compared with the prior year. At Bausch Health, excluding B+L, the adjusted gross margin for the first quarter was approximately 79.3%, 90 basis points lower than last year. The decrease was mainly driven by favorable net pricing adjustments in the prior year.

On the B+L side, the unfavorable change in gross margin was mainly driven by higher costs of inventory, product mix and pockets of supply challenges. Consolidated adjusted operating expenses for the first quarter were $834 million, an increase of $129 million or 18% with higher SG&A and R&D expenses. For Bosch Health excluding B+L, operating expenses increased by approximately $76 million while B+L reported an increase of $53 million in operating expenses. Selling and marketing increased for Bosch Health excluding B+L due to the investments we are making in the Salix sales force, go-to-market channels and increased advertising and promotional activity. The increase in consolidated adjusted G&A costs reflects the impact of the separation and the costs to stand up two public companies.

Adjusted G&A for Bosch Health excluding B+L increased by $29 million driven by the favorable impact in the prior year of a settlement we received relating to a contractual dispute and TSA fees received from B+L in Q1 2022. We're in the process of separating B+L's IT infrastructure from the rest of the company and continue to make significant progress reducing our reliance on transition services. Also of note, in our pharma business, we successfully migrated our U.S. and Ireland operations to a new Enterprise Resource Planning or ERP platform, meaning that all major markets are on dedicated systems. The consolidated R&D expense increased 13% and represented 7% of net sales, flat compared with the first quarter of last year.

For Bosch Health excluding B+L, R&D expenses increased by approximately $16 million, primarily for Salix, due to the focus on our clinical programs and regulatory activities to support our mid and late stage product development. First quarter consolidated adjusted EBITDA was $605 million, which includes $17 million of adjusted EBITDA attributable to the B+L minority interest. This was a decrease of 18% versus last year. For Bosch Health excluding B+L, adjusted EBITDA was $462 million, a decrease of 18% from last year, reflecting the factors previously described. On a consolidated basis, the first quarter adjusted EBITDA margin was 30.2%, compared with 38.2% last year. Adjusted EBITDA margin for Bosch Health excluding B+L was 46% and for Bosch + Lomb was 15%.

Let me briefly touch on the GAAP interest expense we are reporting in the quarter. The accounting required for the debt exchange last year 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 $381 million on a consolidated basis and $330 million for Bosch Health excluding B+L.

Turning to cash flow, adjusted cash flow from operations on a consolidated basis in the first quarter was $70 million versus $325 million last year. For Bosch Health excluding B+L, the adjusted cash flow from operations was $94 million which was in line with our expectations. Adjusted cash flow includes adjustments for the payment of separation costs, business transformation costs, and also includes payments of the full contractual interest. This quarter's cash flow was affected by the unfavorable timing of certain working capital movements, as well as higher interest payments due to the lumpiness of interest coupon payments.

Now let's turn to our balance sheet on Slide 16. As Tom mentioned earlier, the process of delevering our balance sheet is ongoing. And in the first quarter of 2023, we have reduced our debt for Bosch Health excluding B+L by $105 million including revolver repayments. As slides 17 and 18 show, total debt for Bosch Health excluding Bosch + Lomb at the end of the quarter was $16.5 billion which consisted of $15.5 billion of restricted debt issued by Bosch Health excluding B+L, and $1 billion of senior secured notes issued by the unrestricted subsidiary created in the third quarter of last year. Excluding B+L debt, approximately 85% of our debt is fixed. Approximately 70% of the company's debt on a consolidated basis is fixed.

Our 2023 guidance for Bosch Health excluding B+L is unchanged, and can be viewed on Slide 20. For Bosch Health excluding B+L, we continue to expect revenues in the range of $4.45 billion to $4.6 billion representing growth of 2% to 5% on an organic basis. Full year adjusted EBITDA for Bosch Health excluding B+L is still expected to be $2.3 billion to $2.4 billion. As a reminder, our EBITDA expectations reflect increased investments versus last year. We continue to invest in sales and marketing activities to drive growth in our key brands in our Salix, International and Solta Medical segments. These investments include expanding our Salix institutional sales force footprint, the first DTC marketing campaign for HE and exciting campaigns as we launch products like RELISTOR and UCERIS in Canada. We expect to see the benefit of this spending later in 2023 and into 2024.

As Tom mentioned earlier, we are pleased with the progress we are making on our product pipeline and our EBITDA expectations also reflect increased R&D spending to maintain this progress through the rest of the year. The performance for Bosch Health excluding B+L in the first quarter was in line with our expectations. As I mentioned in our call last quarter, the first quarter of the year is typically weaker than the subsequent three quarters, due to the annual resetting of health insurance deductibles in the United States, which impacts the patient out-of-pocket cost. While we don't provide guidance by quarter, our expectations are for stronger growth in quarters two through four, relative to the first quarter, when we also 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 approximately 15%. We expect our contractual interest cost to remain unchanged at approximately $1.3 billion.

Lastly, we continue to expect Bosch Health excluding B+L to generate approximately $625 million in adjusted operating cash flow. 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 estimated cash tax payments inclusive of a tentative Granite Trust settlement.

I'll now hand the call back to Tom.

[Thomas Appio, Chief Executive Officer]

Thank you, Tom. In summary, we are building on the momentum from the second half of 2022, as we continue to focus on our core businesses, driving growth through operational excellence and our new high performance, results-oriented culture. We will make investments in key businesses that have growth opportunities such as Salix, Solta, Dentistry and the International business. We continue to invest in our R&D pipeline, including our global development programs for RED-C as well as the continued development of amiselimod. Our mid and late stage R&D pipeline is active and exciting. And we are looking forward to sharing more details.

When I took over as CEO, I told you I wanted to create a fit-for-purpose company and we will continue on that journey, looking to simplify our business, invest wisely and grow profitably. We will also improve our capital structure and I've already made significant progresses in delevering the balance sheet. Together with this, gives us the ability to better focus and invest in our core business.

I want to thank the global Bausch Health team for all their resilience and motivation, working each day to build our special company, driving performance through hard work and accountability, powering up our potential, elevating people's lives each and every day that use our great products. On behalf of the entire BHC team, I thank you all today for your interest in and support of Bausch Health.

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

[Operator]

Certainly. [Operator Instructions]. Your first question for today is coming from Glen Santangelo at Jefferies.

[Glen Santangelo, Jefferies]

Yes. Thanks and good morning. Thanks for taking the question. Hey, Tom, I just want to follow-up on your comments regarding the separation of Bausch + Lomb. You seem to suggest it still makes sense. Could you maybe give us a sense what are the big hurdles that you need to climb over in order to be able to execute the spin? And in particular, there has been a lot of questions around the XIFAXAN litigation, if that's sort of a gating factor to ultimately get a solvency opinion, which will pave the way for the spin? So if you could just let us know like what pieces need to be in place, given that the leverage seems to already be in the acceptable range?

[Thomas Appio, Chief Executive Officer]

Sure, Glen. Thanks for the question. So as you know, we continue to evaluate potential options to maximize stakeholder value. Okay. So -- and as I said in my prepared remarks, we believe the separation of Bausch + Lomb makes strategic sense, and we remain focused on creating two strong companies. What I would say is, also we are evaluating all the relevant factors and considerations regarding the distribution as we assess the potential impacts of Norwich in terms of the XIFAXAN litigation.

So what I would say is, there is many things to look at. We are looking at each and all the alternatives that we can, as we look at some of the things that need to come together for us. But what I would say is, I'll turn it over to Tom who is just kind of talk about what some of the things that we still need to do.

[Tom Vadaketh, Chief Financial Officer]

Yes. Thanks, Tom. Yes, I think I don't know if I have much to add. We have committed to creating two financially strong, viable companies. We continue to work on the balance sheet on the BHC side. Both management teams you heard yesterday from Brent and Sam and today you heard from Tom and I, we are focused on driving these businesses, improving performance, growing revenue. And we have not given a timeframe as you know, Glen, and that remains the case. We are not going to put a forecast out there. But at the right time, we will separate both teams and both boards, believe that the right thing to do is to separate. It will allow the two management teams to focus on kind of pure play companies. And so we will move towards that goal.

[Glen Santangelo, Jefferies]

Okay. Maybe -- go ahead, Tom. Sorry.

[Thomas Appio, Chief Executive Officer]

Yes. We are continuing to carefully and thoughtfully evaluate all such strategies and we will proceed with evaluating these strategies in the best interest of all stakeholders.

[Glen Santangelo, Jefferies]

Okay. Thanks. Tom, maybe if I could just ask a quick follow-up question. A lot of focus on the 1Q EBITDA sort of coming in a little bit lower-than-expected. And in your comments, you sort of mentioned that 1Q is typically weaker, because of the reset of the deductibles. If you look the past couple of years, right, EBITDA also stepped down in the second quarter. And so in your remarks, you seem to suggest that this should be the low point of the year. But sort of given your guidance, it looks like the ramp is pretty steep in the back half of the year, as a result of that. I'm just curious if there is anything else that I'm missing? Thanks.

[Tom Vadaketh, Chief Financial Officer]

Yes. We have reiterated our guidance, Glen, as you noted, and feel pretty good about it. Q1 is typically lower on the top-line. I'll mention a couple of things. Last year, we had a number of net pricing adjustments. So basically not the pricing that we were taking in the market, but net pricing adjustments in the gross-to-net area, that perhaps sort of exaggerates the year-on-year performance delta. And then in addition to that, we are making investments, as you noted, in the first quarter that we didn't have last year as we are lapping a quarter with pretty low investments.

So we feel pretty good. We think these investments will drive the growth that we are expecting in quarters two through four. And yes, I don't want to give you specific guidance per quarter, but we obviously do expect an uplifting of performance in order to get back to revenue going up 2% to 5% and EBITDA growing 2% year-on-year.

[Thomas Appio, Chief Executive Officer]

Okay. Operator, next question.

[Operator]

Your next question for today is coming from Douglas Miehm at RBC Capital Markets.

[Douglas Miehm, RBC Capital Markets]

Thank you. Tom, what I'd like to start off with is just XIFAXAN. After last year of flat prescriptions, we are starting to see some growth. And perhaps you can tell us what's working there? And if you think there is going to be an acceleration in the year-over-year growth that you are seeing or is it 2% growth figure, the one to use on the growth?

[Thomas Appio, Chief Executive Officer]

Okay, Doug. Thanks. So clearly, we are really happy about the performance of our Salix business and XIFAXAN growth. And as I said in my prepared remarks, 7% growth in the quarter, overall demand increase of 4%, increases in non-retail demand at institutions, growing hospitals and outpatient clinics. So really all good signs encouraging XIFAXAN script growth in all the channels. So this is really something that we have been looking at and following very, very closely. What I would say is, as I said and I had lengthily in my prepared remarks, of all the things that we are doing in the Salix franchise and XIFAXAN, we are investing in our in our field force, as I talked about artificial intelligence and the machine learning, we think we can really accelerate as we launch that project. I talked about the institutional sales increase, that is going to have a nice benefit for us. And clearly, the investments we are making in our medical affairs team, we think there is a large unmet need.

XIFAXAN is a great product in two indications for IBS-D and HE and we think there is a great unmet need, and with the investments that we are making in our medical team to go out and talk to doctors and educate them on these diseases, will really provide great care to patients for the future. So we are really looking forward as we launch these programs. We started some of it in the back half of last year, and really the ramp up is that's why you see especially on the SG&A line, the investments that are going in there. So we really think that, we will have a really good opportunity to continue to grow this franchise and we are really excited about it.

[Douglas Miehm, RBC Capital Markets]

Okay. Good. And just related to that, of course, I think I'm just curious, the timing of the court's decision as it relates to the skinny label. Do you have any better information on that? I know at one point you were thinking it could be back in Q4, and that obviously changed. But is everyone still thinking it could come this quarter or do you have some revised information?

[Thomas Appio, Chief Executive Officer]

As I said in my prepared remarks, we are still waiting a court's decision on the motion. And I don't have anything, no changes or updates at this time, other than what I had in my prepared remarks.

Operator next question?

[Operator]

Your next question is coming from David Amsellem at Piper Sandler.

[David Amsellem, Piper Sandler]

Thanks. So wanted to ask about longer-term picture and solvency. And that's I guess in context of a lot of maturities in the later part of the decade. And the fact that in generic competition for XIFAXAN in '28 and beyond. So I just wondered if you could frame on how you think about solvency and ultimately how you can get the capital structure to a more stable place? Thank you.

[Tom Vadaketh, Chief Financial Officer]

Yes. David. Let me take that. Tom Vadaketh here, David. Obviously, I'm sure you don't expect us to had long-term projections here. We would not talk about any year past this year. But I would just maybe comment on it in a couple of ways. One, Tom has reiterated today that when we are thinking about separating the companies, one of our focus areas is to create two strong financially viable companies. And hopefully -- and we would not separate unless we believe that, that was the case. So hopefully that speaks for itself. You have seen us in action for about a year on both sides with both companies. We have improved operating performance. We are making investments in growth that will go towards assuring the long-term viability of the company. And we have been fairly agile, I would say, in dealing with our balance sheet. We have reduced debt since the IPO for this company by $3.3 billion. And so we are going to continue to work on all of those fronts, and keep improving the prospects of this company. I mean that's why Tom and I are here and we are excited for the future.

[David Amsellem, Piper Sandler]

If I may sneak in a follow-up, I guess maybe drilling down. I mean, how do you address debt pay when you have got $4.5 billion due in '27 and $5 billion due in '28 and your biggest selling drug is going to lose exclusivity?

[Tom Vadaketh, Chief Financial Officer]

Yes. I mean, I can't comment on details. Of course, the company is highly cash generative as we go forward. And then as you know and this applies to all companies, you don't expect to pay every single dollar of your debt down, you will at some point refinance. What we have to make sure is that our company has the right financial position at the time. And then also we look at the future prospects of the company. We look at the pipeline that we are investing heavily in and we are investing in future growth and that will all go into the mix, when the time comes to deal with those maturities.

[Thomas Appio, Chief Executive Officer]

Yes, David. Just to just add to that. That's why in my prepared remarks I went through the R&D pipeline. As I said, we are excited about it. We are looking forward to getting more data as things come through. But we have some really interesting projects ongoing in R&D that we are going to -- will help us for our long-term growth.

Okay. Operator, next question.

[Operator]

Your next question for today is coming from Jason Gerberry at Bank of America.

[Qi Yang, Bank of America]

Good morning, guys. This is Qi on for Jason. Thanks for taking our questions. So thank you for providing an update on the current litigation matters. You've discussed the Granite Trust. You have discussed the recently motions. I didn't hear anything about the recent proceedings in fraudulent transfer in New York -- in New Jersey, pardon me. Can you talk about what's the implications there in that case update? And how does that impact the timeline for company separation? And I follow-up after that. Thank you.

[Thomas Appio, Chief Executive Officer]

Okay, Qi. I'll take that question. So we are pleased that the significant portion of the claims were dismissed at this early stage. So that's firstly. Second, we remain confident in our position in this litigation with respect to the remaining allegations. Beyond this, we do not intend to comment on any ongoing litigation at this time. All right? At the end, we want to again reemphasize to two strong companies. That is our goal. You had a follow-up?

[Qi Yang, Bank of America]

Yes, thanks. So I guess the second question is, what is your understanding of whether the fiduciary duty of the Board is governed by the U.S. or Canadian law? I'm curious if it is Canada, does it mean that the duty isn't clearly to shareholders like in the case in the U.S. and how does that factors into the separation process if at all? Thanks.

[Thomas Appio, Chief Executive Officer]

Okay. Let me see, just to take a look at it, let me see. What I'd say is, in terms of that, we cannot -- we will not provide legal advice on this call. So I can't really make any comments further to that.

Okay. Operator next question.

[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, Chief Executive Officer]

Okay. Well, what I would say is, as I said, I am really pleased with the performance in the first quarter, and we are looking forward to powering up our potential and delivering long-term value for stakeholders. I would thank everybody for joining today, and we look forward to having future discussions on our company. So have a great day and we will talk to you soon. Thank you.

[Operator]

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