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spk07: Good morning and welcome to the Bosch Health 4th Quarter 2021 Earnings Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by 0. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then 1 on your telephone keypad. To withdraw your question, please press star then 2. Please note this event is being recorded. I would now like to turn the conference over to Art Shannon Senior Vice President, Head of Investment Relations and Communications. Please go ahead.
spk06: Thank you, Anthony. Good morning, everyone, and welcome to our fourth quarter and full year 2021 Financial Results Conference Call. Participating on today's call are Chairman and Chief Executive Officer, Mr. Joe Papa, and Chief Financial Officer, Mr. Sam Eldersuke. In addition, Tom Appio and Scott Hirsch will be joining Joe and Sam for the Q&A portion of today's call. In addition to this live webcast, a copy of today's slide presentation and a replay of this conference call will be available on our website under the investor relations section. Before we begin, we'd like to remind you that our presentation today contains forward-looking information. We would ask that you take a moment to read the forward-looking statement legend at the beginning of our presentation as it contains important information. This presentation contains non-GAAP financial measures. For more information about these measures, please refer to slide two of the presentation. Non-GAAP reconciliations can be found in the appendix to the presentation posted on our website. Finally, the financial guidance in this presentation is effective as of today only. It is our policy to generally not update guidance until the following quarter and not to update or affirm guidance other than through broadly disseminated public disclosure. With that, it is my pleasure to turn the call over to Joe.
spk10: Thank you, Art, and thank you, everyone, for joining us today. We have a lot to cover, so I'll begin with an update on the Bausch Health strategic alternatives process and discuss the 2021 full-year highlights. Sam Eldosuke, our CFO, will then review the fourth quarter and full-year financial results in detail and discuss our 2022 Bausch Health guidance. Finally, I'll conclude by reviewing the business results before opening the line for questions. As you can see on slide five, we continue to make great progress in our efforts to unlock value across the company. The most recent milestones were we raised new debt to refinance certain existing Bausch Health debt and announced a refinancing of our existing credit facilities, each subject to the B&L IPO to facilitate the B&L IPO in full separation. And we publicly filed the registration statements for the proposed IPOs of Bausch & Lomb and Solta Medical. Our planning and preparations to launch the IPOs of Bausch & Lomb and Solta Medical are substantially complete, and we are prepared to move forward subject to market conditions and other approvals and factors. After the IPOs are complete, we plan to distribute the remaining Bausch & Lomb shares to existing Bausch Health shareholders following the expiry of customary lockups, achievement of target net leverage ratios, and subject to regulatory approvals. Turning to slide six, as we have said previously, we are targeting net leverage for Bausch and Lomb of less than 2.5 times and a range of 6.5 to 6.7 for the Bausch Pharma business at the time of the spin. We intend to achieve these target leverage ratios by paying down debt with cash generated from the immune divestiture that occurred in 2021, the IPO of Bausch and Lomb, a Bausch & Lomb debt raise, and the IPO of the Solta Medical business. We also expect to use the remaining value of Solta Medical to de-lever, as well as cash generated from operations and improved working capital efficiency. I also want to note that beginning with the first quarter of 2022 earnings, we will be reporting our financial results in three segments, Bausch Pharma, Bausch & Lomb, and sold to medical. Slide 33 in the appendix shows how the new segment structures line up against our current segments. Turning now to slide eight, we finished the year with total company organic revenue growth of 6% and reported revenue growth of 5% versus 2020. Importantly, strong adjusted cash flows from operations of more than $1.6 billion and cash proceeds from the immune divestiture helped us to exceed our goal of paying down more than $1 billion of debt in 2021. Our leading brands saw strong performance and recovery in 21, including Zyfaxan, with a reported revenue growth of 11% versus 2020, and Trulance, which reported more than $100 million of revenue for the very first time in 2021. The international RX segment reported organic revenue growth of 7% versus last year. And finally, we are delivering on near-term R&D catalyst with four new product launches in 2021, in addition to the Zypyr launch this quarter. And the advancement of our late-stage clinical trials with statistically significant top-line results for both Novo 3 and our IDP 126. Thanks to a great Vouch Health team effort, we achieved our goals in 2021 and entered 2022 well-positioned for continued growth. The full year and fourth quarter results demonstrate that we are successfully growing market share of key products and capitalizing on key growth drivers and catalysts while taking steps to unlock shareholder value and create three great companies. With that, I'll turn it over to Sam to cover the financial results in more detail.
spk01: Thank you, Joe. Just a reminder, before I discuss our fourth quarter results, when we talk about organic revenue growth, we mean on a constant currency basis and adjusted to remove the impact of investors and discontinuations. Now, turning to our results on slide nine. Our fourth quarter results build on our strong performance throughout 2021 and confirm the continuation of our recovery from COVID, demonstrating the results of our businesses. In the quarter, we posted 3% organic revenue growth, For the full year, we posted 6% organic revenue growth, with our B&L business up 9%, our Salix business up 9%, International RX up 7%, Orsoderm up 1%, and Diversify down 11%. Now, let me provide more details on each of our segments, starting with the B&L segment. Fourth quarter revenue of $1 billion was up 7% organically. Three of the four businesses within B&L posted organic growth, Starting with the global vision care business, fourth quarter revenue of $227 million was up 9% organically, led by 21% growth in the U.S., which was driven by strength in our buy-through-one-day lenses and continued growth in market share of our daily sight-high lens and fuse. International vision care was up 3% organically, driven by our key promoting brands, including buy-through-one-day, ultra, and soft lens. We continue to see strong performance in our global vision care business, with a full year growth of 17% organically as compared to last year. Moving on to our global surgical business. Fourth quarter revenue of $198 million was up 10% organically, with the U.S. up 4% and international up 13%. The growth in our surgical business reflects continued recovery in the number of surgical procedures in all our major markets. For the full year, the global surgical business grew 22% organically as compared to 2020, with strong growth in the US, Europe, and Asia. Turning to the global consumer business, fourth quarter revenue of $399 million was up 9% organically, with the US consumer business up 7%. Lumify led the growth in the US with 33% growth in the quarter. With this strong performance, Lumify exceeded $100 million in annual revenue. Our iVitamin brands, OctoVitamin Preservation, and our LensCare brands, Buy True and Renew Multipurpose Solutions, also gained share in the quarter. The international consumer business was up 11% organically, mainly driven by gaining market share and strength in Artelac, and then our LensCare brands, Renew and Buy True Multipurpose Solutions. For the full year, the global consumer business grew 6% organically versus 2020. Finally, the global opt-RX business' fourth-core revenue of $177 million was down 3% organically versus fourth-core of 2020. The decline was mainly driven by the LOEs and LORMACs and the natural erosion of the generics branded products in the U.S. business. Excluding the impact of the LOEs, the global OptoRx business was up 4% organically in the fourth quarter. In the U.S., our promoted brands benefited from expanded patient access. In the current quarter, Vizulta saw 40% TRX growth versus Q4 2020. International Opto was up 27% organically, driven by growth in EMEA and Asia. Now turning to Stelix. Fourth quarter revenue of $559 million was up 6% from Q4 2020. Performance was mainly driven by Zyfaxan, which was up 9% driven by higher demand and higher net price. In the fourth quarter, Zyfaxan achieved a milestone by reaching $450 million net sales, the highest revenue we've reported for the brand. Zyfaxan continues to demonstrate strong growth trends. Despite the long-term care channel not being fully recovered through pre-pandemic levels, we're seeing a steady recovery in the long-term care channel, but nursing home occupancy rates remain low. We expect the recovery to continue throughout 2022. True Alliance was up 21%, driven mainly by volume, in part due to our successful efforts to expand managed care coverage for the brand. Real estate was up 21%, mainly from volume, but also from an increase in net price. For the full year, the Stelix business grew 9% as compared to 2020. Now, turning to the international RX segment. Reminder that during the third quarter of 2021, we completed the sale of Amun, our Egyptian pharma business. The international RX segment was up 7% organically, with fourth quarter revenue of $276 million. The growth was mainly driven by strong performance in Canada, which was up 13% organically, and Poland, which was up 16% organically versus Q4 2020. For the full year, the international Rx segment was up 7% organically. Moving on to orthoderm segment, fourth quarter revenue of $146 million was down 7% organically. The medical derm business was down 19%, mainly driven by lower net realized pricing. The global SALTA business was up 2% organically with strong performance in the U.S. and Asia. For the full year, global SALTA revenues were up 18% organically. Finally, our diverse bi-segment fourth quarter revenue of $214 million declined 14% organically. Our nerve business was down 9% due to lower volumes on mycelin and adivan, which benefited from a comparative supply issue in the prior year quarter. Offset by growth in both Paul Putrin and F. Lenton. Our genetics business was down 30% organically, with the biggest factor being the natural erosion of volumes and net pricing as additional competitors enter the market and compete with our genetic products. Finally, dentistry was flat versus the prior year quarter. Turning to the quarter and full year P&L on slides 10 and 11. I just covered revenues, so let me walk you through three non-GAAP line items. starting with the adjusted gross margin, which was up 60 basis points versus Q4 2020. Mixed was a key favorable factor to the score, which more than offset manufacturing headwinds and enabled us to absorb inflation impacts that we saw in the quarter. Note that our full year adjusted gross margin is 71.6, which is slightly above our full year adjusted gross margin guidance of 71%. With operating expenses, On an adjusted basis, SG&E costs were slightly higher by $17 million versus Q4 2020, as we returned to a more normal level of promotion activity as compared with Q4 2020. Our full-year adjusted SG&E was $2.41 billion, which was favorable to our full-year 2021 guidance of $2.45 billion. R&D was down in the quarter by 2%. mainly as a result of timing of spend, for the full year, R&D was up 3% to $465 million. Adjusted EBITDA of $909 million for the quarter was down 1% on a constant currency basis compared with Q4 2020. Excluding the impact of the immune divestitures, adjusted EBITDA was up 2%. A solid fourth quarter performance enabled us to post adjusted EBITDA of $3.472 billion for the full year, which is up 3% on a constant currency basis from 2020, which was at the high end of our final guidance range for 2021. For modeling purposes, I thought it may be helpful for you to understand how our 2021 adjusted EBITDA splits between our key businesses. The 2021 adjusted EBITDA splits roughly 24.7% for BNL, 4.3% for Global Salta, and the remaining 71% is for our pharma businesses. Slides 12 and 13 were included to provide additional GAAP information in response to new disclosure requirements. Now turning to slide 14. During the quarter, we generated $24 million of cash from operations on a GAAP basis. As we disclosed during our second quarter earnings, we made a payment of $205 million for legacy legal settlements in Q4 2021. Also in the fourth quarter, we made a payment in connection with taxes related to the Amun disaster. Adjusting only for the legacy legal settlements and separation rate cost of $50 million, the adjusted cash generated from operation in Q4 2021 was $279 million, bringing the full year adjusted cash flow to $1.657 billion. We're very pleased with the strong cash generation in 2021, which brought us above our final 2021 guidance of $1.6 billion. Turning to slide 15, We'll continue to make progress on our debt pay down. During 2021, we repaid 1.3 billion of debt. Now 285 million revolver drawn in Q4 that we subsequently paid in Q1 of 2022 with cash on hand. Our focus and commitment to reducing our debt combined with our strong performance in 2021 resulted in net leverage of 6.5 times as of the end of the fourth quarter of 2021. On slide 16, we'll continue to make nice progress with our debt matures by repaying the outstanding revolver in Q1 2022 with cash on hand. As of today, we don't have any debt matures or mandatory amortization payments until 2025. Now turning to our guidance on slides 18 and 19. Our revenue guidance for 2022 is a range of $8.4 billion to $8.6 billion. and that represents organic growth of 3% to 5%. Considering the 185 million impact of the immune deflector in 2021 and the FX pressure based on current rates, which we estimate to be 95 million, the base business performance is an improvement of 405 million. As we previously communicated, the LOE impact on our business continues to moderate and is much lower than prior years. We estimate the impact to be approximately $55 million. Also, to help you in your modeling, we provide additional details on our organic revenue growth by business. We expect organic growth for the pharma business to be about 2% to 3%, for B&L to be about 4%, 5%, and 15% to 18% for Spalta. Our adjusted EBITDA guidance for 2022 is a range of $3.45 billion to $3.6 billion. Considering the impact of the immune divestiture of $65 million and the FX pressure, which we estimate to be $30 million, our adjusted EBITDA guidance suggests 4% growth at the midpoint of our range. So with that backdrop, let's go into the details of our full-year guidance on slide 19. We expect our adjusted gross margin to be roughly 72%. which is slightly favorable to our 2021 gross margin. At a macro level, we have seen gross margin pressure driven by inflation and supply chain pressure, which is consistent with what you have seen across the market. We're taking proactive steps to mitigate and overcome these challenges by taking measure, price increases, and through supply chain efficiencies. Also, product mix has an impact on the overall gross margin. We expect adjusted SG&A to be in the range of $2.44 billion, which remains relatively flat year over year as a percentage of revenue. In the last few years, we have taken steps to optimize and manage our baseline cost structure. Our guidance suggests that we will benefit from the cost optimization that we achieved in 2021 and continue to leverage our cost structure to support the top-line growth. We are guiding to roughly $500 million in R&D for 2022, which is $35 million from 2021. For interest expense, we're guiding to $1.4 billion. We expect our adjusted tax rate to be roughly 10%. And we expect fully adjusted cash flows from operations to be in the range of $1.7 billion. Finally, we provide additional guidance details that will be helpful for you as you update your model. In summary, we're very pleased with our 2021 performance. We believe that the strong underlying momentum in the business will continue in 2022. Our 2022 guidance is based on our expectation of solid organic revenue growth and adjusted EBITDA growth, improved gross margin, optimized cost structure, and strong cash flow generation. Now back to you, Joe.
spk10: Thank you, Sam. Let me make a few comments on the business results, starting with Bausch & Lomb on slide 21. Let me call out a few highlights first. Global VisionCare saw strength, both in the U.S. and internationally, and we believe that the continued rollout of our Sci-Hide daily lenses will be a kale win in 2022 as we launch the spherical and the multifocal lenses in many new markets. Our Sci-Hide daily lenses continue to accelerate sales and gain share. In the U.S., we ended the year with a 140% increase in fit set coverage. We now have over 13,000 customers. We also grew U.S. consumption sales by 70% in the second half of 2021 versus the first half. This not only exceeds our plans, but builds a strong base for our future launch of the SciHi Daily Multifocal. In global consumer, Lumify became a $100 million plus brand in 2021, and achieved approximately a 50% market share in the redness reliever category. Global Surgical rebounded from 2020 as markets reopened and saw 25% reported revenue growth compared to 2020, driven by Invista, IOLs, Dolores Elite consumables, and instruments. Geographic growth in Europe was driven by strong demand in the UK, France, and Spain. I want to spend a moment on Lumify on slide number 22, Here we have illustrated the power of our fully integrated B&L iCare platform to successfully launch, promote, and drive the performance of our products. In the case of Lumify, we began with a highly differentiated product backed by clinical results. Our team was able to drive education and awareness for the product by collaborating with iCare professionals while driving awareness among beauty enthusiasts with a strong television, public relations, and social media presence. We were then able to leverage the 400-plus-person Bausch & Lomb sales force for detailing and distribution directly to optometrists and ophthalmologists and achieve the distinction of being the number one physician-recommended product in the redness reliever category. These efforts, along with a 97% customer satisfaction rate, helped to drive patient demand, which we were able to meet through the ongoing partnership with retailers and through e-commerce channels. We believe these results speak for themselves. After launching in May of 2018, Lumify became a $100-plus million brand in 2021 with approximately a 50% market share in the readiness reliever category. Lumify's performance is one example of the benefits of a fully integrated IKEA platform, and we expect to continue to leverage this key Bausch & Lomb differentiator with future products and innovations. The charts on slide 23 illustrate the ongoing growth and progress B&L has made over the last few years. Moving now to slide 24, I'll start by calling out a few highlights for Bausch Pharma. Salix reported revenue growth by 9% compared to fiscal year 20, driven by Sifaxon, Trulance, and Relastor. We are also driving pipeline advancement for Salix with the initiation of a Phase III clinical trial of the Rifaximin SSD formulation and a Phase II trial of Amicillamide. International RX revenue grew by 7% versus last year. Orthodermalogics reported statistically significant top-line results from the second pivotal Phase III trial of IDP-126. Finally, in diversified products, Welbutrin and Implensin saw reported revenue growth of 16% versus the prior year quarter on a combined basis, driven by net realized pricing on both products and higher Implensin volume. And I'm happy to say... that Applenzen also has now crossed the $100 million product level in 2021. Dentistry saw a reported revenue increase by 38% in 2021 compared to a full year 20. As a catalyst for the business, we just launched the Aura Fit aligner yesterday. We're very excited about this opportunity. On slide 25, Sifaxon fourth quarter revenue of $450 million was the highest quarterly reported revenue on record. Newark's market share also grew to 87.2% in the fourth quarter. And while nursing home occupancy levels continue to weigh on Syphaxin's recovery, we believe this represents a potential tailwind for 2022 as nursing home occupancy returns to pre-pandemic levels. Like Syphaxin, TrueHands finished the year strong and generated the highest quarterly revenue on record in the fourth quarter of 2021. TrueHands 2021 Total prescription volume grew by 23% versus 2020 and outpaced the market growth of approximately 4%. I want to spend a minute on Trulance on slide 26. Since we acquired the product for approximately $180 million in 2019, the Bouchel team successfully implemented strategies to improve market access and physician targeting while growing geographic footprint, which resulted in more than a 120% TRX growth since acquisition. as you can see on the slide on 26. We also launched Trulance in Canada earlier this month. We're proud of the team's coordinated efforts to grow Trulance into a $100 million-plus brand and believe there's a lot more we can do here. On slide 27, we show the strong TRX and Newark share market share gains we achieved last year for Xifaxon, Trulance, and Relastore. We believe these gains are a great leading indicator of the overall strength of our gastroenterology product portfolio. Turning now to slide 28, InternationalRx. This business has a very diverse portfolio of more than 500 prescription products. In the full year and fourth quarter of 2021, this business grew organically by 7% compared to the prior period. We've shown the revenue breakdown by region on the top right and listed the three products in each region along with the evolution index, which shows the growth of these products is outpacing the market growth rate. Moving on to Solta Medical on slide 29. First, we announced the public filing of the Solta Medical registration statement on February 8th, and we are substantially complete in our preparations and planning for the Solta Medical IPO. The Solta business had a very strong 2021 compared to last year. ending the year with a 22% reported revenue growth driven by 26% consumable organic growth for the year. As we noted on the third quarter call, the comparison with 2020 is denormalized as COVID-related shutdown in 2020 shifted our selling days into the second half of 2020 and skewed the comparison. However, as a reference point, on a more apples-to-apples basis, Revenue for the fourth quarter of 2021 was 39% higher than the normalized 2019 fourth quarter, and it grew sequentially over the third quarter of 2021 by 20%. In the U.S., growth versus 2020 was impressive with a 46%. year-over-year growth. Clear and Brilliant reported revenues grew by 100% versus 2020, primarily due to the successful launch of our Clear and Brilliant Touch in the U.S. On slide 30, we have listed the key highlights for the company, showing in particular Bausch Pharma, Bausch & Lomb, and Solta Medical. For Bausch Farmer, we have a differentiated product portfolio. We have a global presence in approximately 70 countries. We have strong cash flow to support de-levering and investment. We have the advancement of the pipeline opportunities, including novel refactoring formulations. We have a global infrastructure that can be leveraged to pursue a robust business development agenda and a fit-for-purpose operating model supporting top-line acceleration and operating margin expansion. Moving now to Bausch & Lomb. We're going to build on the strong momentum with key franchises and the continued rollout of our SightHide daily lenses and new geography. We also anticipate the launch of a 3D microscope. We plan to build out our premium IOL platform, launch the next generation eye intelligence ecosystem. We continue to roll out Visalta and additional international markets. We have the U.S. launch of Zype here. an NDA filing acceptance for Novo 3, and finally a BLA filing acceptance for Lucenta Biosimilar is also planned for 2022. Next, Solta Medical, which has posted an impressive 32% revenue CAGR from 2018 to 2021, we believe proves the market opportunity for the Solta brand is sustainable and will still have substantial room to grow. Key highlights for Solta are a strong double-digit growing aesthetics market, Cross-selling programs include this full Solta product portfolio, a geographic expansion both in Europe and LATAM, and also product enhancements and next-generation launches. Lastly, of course, we have organic and inorganic growth opportunities. As you can see, each of these business segments has a variety of initiatives, products, and near-term catalysts to drive growth. To wrap up, we made great progress in our efforts to unlock value across our company. In addition to completing the preparations and launching of the IPOs of Bausch & Lama and Solta, we grew market share for our key products, we paid down debt using strong cash from operations, and we advanced our scientific innovations. Looking ahead, our focus is on significant debt pay down, separating it to three publicly traded companies, driving execution in three large, distinct, and addressable markets, and continuing to focus on innovations for the future. With that, operator, let's open up the line for questions.
spk07: We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then 2. At this time, we'll pause momentarily to assemble our roster. Our first question comes from Ken Cacciatore with Cowan & Company. You may now go ahead.
spk12: Hey, good morning, Joe and team. I was wondering if we could try to tighten down the timing. It looks like the order you've established on slide six. Can you give us a sense of timing, and is there anything in the current markets? I know we're subject to market condition, but I would assume we're not seeing anything Currently, that would kind of skew the timing, so that would be great to review. And then also, you know, one of the questions that we're constantly getting is, you know, how do we close the real or perceived operational and real valuation discount to your peers? Can you talk about from the Bausch & Lomb business when you get standalone, Joe, any first priorities as steady as we go, really what we need to accomplish here? or any kind of low-hanging fruits in terms of priorities that you want to address when you get standalone. Thanks so much.
spk10: Great questions, Ken. I'll try to make sure I get them all. If I leave any out, please remind me. On the question of our overall timing of the IPOs, I think we tried to lay out the specifics here. We are substantially complete in all the information that needs to get accomplished. To be clear, we will continue to update our financials with the SEC. As we now completed the fourth quarter, we'll submit those fourth quarter reports to the SEC on a timely basis. But we'll be ready, pending market conditions, to go with that. revised financials sometime, let's call it mid-March. We'll be ready for mid to end of March to go forward with the IPOs, both for the SOLTA and for the Bausch & Lomb IPOs. We are substantially complete on both of those. Obviously, we will make sure we manage that in a prudent way to maximize shareholder value as we think about the overall market conditions that we face for these two IPOs. But we're excited. We've done all the work that needs to get done in terms of looking at the opportunity. Obviously, we've got to make sure the markets are correct. We wanted to do this with urgency, to be clear, but we also want to make sure we maximize the value for our shareholders. On the question of the B&L and some of the valuation discount to peers, our expectation is that as these companies are separated to three independent pure play eye health company, a Solta medical aesthetics company, and the Bausch Pharma global company. We believe that the market will have a better way to evaluate the total of these companies as well as the amount of debt pay down that we will realize through the IPOs and through the BNL debt we put on BNL. By reducing that overall quantum of debt, we think that will help in terms of valuation. The second thing is, as we certainly execute on these IPOs, we believe that that also will help the market look at the pure play Bausch & Lomb, for example, versus the pure company. So I think all those things are going to help the marketplace as they assess the overall valuations of the BNL PurePlay iHealth company, the Solta Medical Aesthetics Company as it compares with the likes of the other medical aesthetics company, and overall the Bausch Pharma business. On the question of, I think the last one was the priorities for BNL, once we're standalone, obviously we will continue to focus on the execution of the business. We think that's an important part of it. We talked about some of these new products, the SideHide daily lens as an example, and the launch of that product across the globe, as well as launching the multifocal product. So all those things are going to be the absolute focus on how we will move forward. We do believe, though, that as Bausch & Lomb goes out as a pure play eye health company with an improved balance sheet, it will give us more flexibility to look at additional inorganic growth as well as the organic growth that I mentioned. So I think it's those types of things that we'll look at from a priority point of view as we have a little bit more flexibility with the overall Bausch and Lomb balance sheet as we think about the future. So clearly look at B&L as a balance of both growth organically and look at potential bolt-on opportunities for inorganic. I think I got them all, Ken. Let me go to the next question, please.
spk07: Our next question comes from Chris Schott with JP Morgan. You may now go ahead.
spk05: Great. Thanks so much for the questions. Just two for me. I guess first, can you talk a little bit more about Solta Dynamics in the quarter? You're obviously still seeing healthy kind of two-year growth, but it did look like growth slowed a bit as we went through 2021, if we kind of look at that. kind of two-year CAGR against a 2019, maybe more normalized number. So just elaborate a bit more what's happening there and maybe just help bridge out to that 15% to 18% growth in 2022 in light of that trend. And then my second question is just on maybe another timing question. I guess if for whatever reason the SOLTA or B&L IPOs don't allow you to raise as much capital as you're expecting, how does that affect the broader separation plans? I guess, Does that just, you know, if we're in a situation like that, does that mean we just have to wait for the company to organically de-lever a bit before you can fully, you know, spin off B&L? Or is there any maybe shorter-term flexibility on some of those leverage targets that you laid out? Thanks so much.
spk10: Okay, thank you for the questions, Chris. Scott's on the line. I'm going to ask Scott to address that CILTA dynamics in the quarter. We obviously are very pleased with the overall growth for the full year, notwithstanding some of the dynamics. But Scott... Do you want to talk about SOLTA, and then I'll take the comment about the IPO timing?
spk02: Sure. Sure, I think so. And good morning, Chris. So for SOLTA, just to reiterate some of the metrics, 2021, we saw 22% reported, 18% organic growth, with consumables really comprising a big piece of it, 26% of the growth year over year, and Clear and Brilliant Touch, which was launched in the U.S. in 2021, showing 100% growth year over year. So many of our performance goals are hitting right where we're aiming, despite some of the global Omicron shutdowns and the carve-out structuring demands, which, as Joe mentioned, manifested into the S-1 filing earlier this month. So overall, I'm incredibly pleased with how on-target execution is with so much going on. With respect to the comps over 2020, as Joe outlined in his remarks, right? The phasing of our 2020 numbers were impacted with COVID shutdowns in the first half, pushing our selling day substantially into the second half of 2020. That makes for an apples to oranges comparison for this cycle, which is why we point you to the annual metrics to smooth that out, and they're really strong. For our growth guide, right, there's a few underlying factors. First, obviously, is demand, and demand has been incredibly strong. In fact, in fourth quarter, our syndicate consensus had us about 10% below where we finished off. And so we really came in nicely relative to expectations. And we also finished with probably another, I would say, a little short of $10 million or $9 million of incremental back orders and demand that's really out there. And it leads to my second point, which is, as I've said before, we're a premium business line. And if we put a machine in every storefront that wants one in an aggressive form, those storefronts start competing down price against each other, which is just something we don't want. Solta has been in this business for 20 years and we're building a long-term platform in aesthetics with great clinical results and really strong economics for practitioners. I'm really proud of the global footprint that we're building out and the tax structure, which means that we have a really long-term focus of where we're placing equipment and then really driving consumables as the ratio, which is now approaching 73% of revenues, which I think is the true differentiator of the business. And that's where a lot of our strength is coming from. So lastly... I'd say there's a dynamic, as Sam mentioned, between price and supply. I think it's well known now that the supply chain for electric componentry is in high demand, and we're making sure that we have a balancing act with price as well as ensuring that we're meeting all the needs of our customers. And so net-net, all of it is a really strong economic play on what we're targeting with metrics right in the high teens to 20% levels, and I think we're on track for it.
spk10: Thank you, Scott. Chris, I'll take the second part of that question. And Sam, if you want to add anything, please do. But I think I want to start with, once again, we are substantially complete in our preparations for the IPO of both Solta and Bausch & Lomb, which we obviously think is the first very important step being complete. And obviously, we have a high degree of confidence in the value opportunities for each of those Solta IPO and the Bausch & Lomb IPO. Having said that, number two, we clearly want to make sure we move expeditiously, but we're looking to maximize the shareholder value creation opportunity in each of those businesses. So we're not going to be reckless in the timing. We want to move expeditiously but not be reckless in that timing. So we're going to look to monitor markets and work with our advisors to make the right decisions there. Third point I want to make, because I think it's an important point, comment, is that each quarter that we stay together, we will increase the amount of cash we generate, and that cash will go substantially to pay down debt, which obviously moves us forward in the process of deleveraging the company. So all those things will be part of the considerations as we think about it. But as we stated publicly, our view for Bausch and Lomb is that we will IPO something less than 20%. We believe that's the most efficient way to do Bausch and Lomb. is be very tax-efficient for us. But we can obviously look at less than 20% as well, depending on market conditions. So I think we're going to be flexible thinking through this. Our overall North Star goal is to maximize shareholder value creation, and that's the way we're going to look at this. Obviously, we want to move as quickly as we can, though, as well. Sam, anything you want to add to what I said?
spk01: Joe, I would just add that, and Chris, if you look at how we ended 2021, the fundamentals of the business are very strong, and we're carrying that momentum with us into 2022. And that's really given us sort of an excitement that as we move forward in 2022, between our performance in 21 and the guidance that we just provided in 2022, we believe that we'll be able to generate strong business prospects results as well as cash that will help us also to deliver as we go forward.
spk10: Operator, next question, please.
spk07: Next question will come from David Amselum with Piper Sandler. You may now go ahead.
spk09: Thanks. I have a few questions on the pharma business. First, I appreciate the pipeline update here, but we're all aware of the eventual LOE on Zyfaxan. So I guess with that in mind, how do you think about BizDev and M&A? Obviously, the business is going to be highly levered, but what do you think you can do there, and what kind of sense of urgency do you have in terms of, bringing in assets for the pharma business. So that's number one. Number two, on orthoderm, obviously in the past you had some high hopes for assets here. It's a smaller portion of the mix. Can you just talk generally, Joe, about the fit of orthoderm within the broader pharma business? Are those assets you would look to divest given the headwinds? And just talk generally about again, where it fits and the future of that segment within the broader pharma biz. Thanks.
spk10: Sure. I'll start, but Tom, you might want to also add. Tom Appio is with us. He can also add some comments. First of all, on the business development, I can tell you that Tom Appio and Tom Vatiketh, our new best pharmacist, CFO have been very, very active in thinking through business development and opportunities for the future in terms of some of the things they've been looking at and thinking about. Obviously, we're going to have to balance that with the ability to pay down debt. But there clearly is, you know, the sense of urgency in thinking through that as we think about the loss of exclusivity of the Zyfaxan in 2028. So that's something that they're thinking their way through. Clearly, though, I think one of the slides we included in the presentation was Trulance, a product that we acquired for approximately $180 million, and you can see it's already generating over $100 million of revenue. Things like those type of bolt-on opportunities we think are going to be the perfect type of programs. I'm going to probably ask Tom to speak specifically before we go to Orthoderm about a little bit maybe about some of the things he's been able to do in the international pharma business and some of the products that he's been able to acquire help build that segment of the business as well. So maybe talk a little bit about the international pharma business and the past success you've had and predictor of the future.
spk08: Okay. All right, Joe, thank you. Yeah, so when I look at the R&D pipeline, you know, clearly we'll have to accelerate the R&D pipeline, and as Joe pointed out, you know, clearly there'll be a balance between, you know, paying debt versus the assets that we can bring into the organization. When I look at it, you know, clearly we have a wonderful footprint in GI with our Salix business, and we've already started screening opportunities that we could take a look at there in adjacent categories as well to be able to leverage our footprint there and our scale. When we take a look at the business internationally, we have, as we said in the presentation, over 70 countries. We have scale in Eastern Europe, Latin America, and Canada. And over the last few years, we've been able to do many deals that I would call tuck-ins, deals that bring us revenue and EBITDA at reasonable rates and reasonable prices. Given the fact that with the scale that we have and being able to leverage that, we already have many deals that are sitting there that we can continue to execute on. And that's why I see an opportunity to leverage the international business with the scale that we have and the ability to grow it with no LOEs. So it's going to be a balance, of course, between the U.S. business and the international business and then paying down debt. We'll have to be extremely focused of what we bring in and making sure that we do exquisite due diligence on any deals that come in to make sure that we have success.
spk10: Tom's a little modest. He's got 45 products that he's planning for 50 different markets in the next five years that he's expecting to launch. And I think that's going to be a really important part of what he's done historically, but what he can do for the future as well. So you'll see that on page 35 of our presentation. And then the other question was on the orthoderm business. Does it fit within the pharma business? I think the answer is still yes. We will continue to look at all opportunities, though, in terms of looking at our portfolio. But as we sit here today, we've got a new product, IDP-126, that we have now completed two phase three clinical trials that have met their primary endpoints. We do expect to submit that NDA in the second half of 2022. So we're excited about what that means in terms of the opportunity in addition to what we've previously said. And I can't leave this without also commenting, David, as you know, that the plans we have for the Refaxman novel formulations and the MSL mod, as we mentioned in the call, also are a big part of that organic story that they were putting together. So thank you for the question. Operator, next question, please.
spk07: Our next question comes from Gary Nachman with BMO Capital Markets. You may now go ahead.
spk03: Hi, good morning. So, Joe, when you say actively monitoring market conditions for BNL and SALT IPOs, do you see the conditions or receptivity to those IPOs being very different? Is it more likely one will happen before the other? And if market conditions are not good, How long can this potentially be on hold beyond the March timeframe that you just outlined? And then, you know, with all the moving pieces and changing dynamics on capital generation for the spins, why are you confident you can still get to the leverage targets that you laid out a bunch of months ago? Are you starting to think any differently about those targets at all? So if you could just walk through your confidence there, that would be great as well. Thank you.
spk10: All right, I'll start with a lot of good questions there in terms of looking at the market conditions for both IPO. Once again, I want to start with we have substantially completed the preparations for both the BNL IPO and the SOLTA IPO at this time, which I think that's important. We obviously will need to update our financials, which we'll do, but essentially the mid-March, end of March timing is what we're currently contemplating. Obviously, the market conditions can, you know, change, and we're going to work with our advisors on that particular question as to when to go forward. What I will say is that we're balancing two things. Number one, the desire to move expeditiously in terms of moving forward with these IPOs to unlock what we believe is significant shareholder value. So we would like to move expeditiously. Having said that, though, The bigger commentary that goes along with that is to maximize the shareholder value-free opportunity. So we're going to balance those two things as we think about how we go forward with these IPOs. I think part of the question you're asking, is there a different market potential for each of these IPOs? Yeah, there are different IPOs. One is a pure play Bausch & Lomb eye health business. The other one is a social medical aesthetics business. There's differences in valuation in terms of overall valuations in terms of relative size. One of them is a ballpark $4 billion business in terms of revenue. The other is a $350 plus million revenue business. So depending on which one we're talking about, there's going to be a different market for each of those. But both of them we think are exciting opportunities. And once again, being a pure play eye health business or a pure plate medical aesthetics, we think there's great opportunities for both of them. How long will we wait in terms of the March timeline? I think, once again, I'm going to just simply stick with the point that we want to move expeditiously, but we're also looking to maximize our shareholder value creation across the entire Bausch Health Company. Our confidence on getting to the leveraged targets, would I change them? The answer to that is simply we are highly confident we'll get to these leveraged targets. We are not going to change them. We are looking at these leveraged targets being Bausch and Lomb at less than 2.5 times leverage, and that Bausch Pharma at that 6.5 to 6.7 times is the leveraged target that we've spoken about in the past, and we'll stay with those leveraged targets as we look at them right now. Obviously, the important thing that would change to that is when we actually do the full separation is the only question that's going to depend upon, of course, our performance and our ability to raise the capital through the IPOs of the Bausch & Lomb business, the Solta business, and the amount of incremental debt that we'll put towards the Bausch & Lomb 2.5 times leverage. I think I got all your questions, Gary. Thank you very much for the question. Yeah, thank you. Appreciate it. Jason?
spk07: Our next question comes from Jason Gerberry with Bank of America. You may now go ahead.
spk04: Hey, guys. Thanks for taking my questions. Just wanted to ask about the diffraction patent litigation situation and basically what can you offer Alvagen to try to drive a settlement? As we look at the situation, trying to offer early market entry versus the January 2028 entry data, the other generic settlements, would just pull forward the other generics, I would assume. And also looking at a settlement to launch alongside three other generics probably is not hugely valuable to Albigen. So just sort of curious what you can offer incrementally. And if you can't drive a settlement and you have to go to court, just curious, and we could get a decision by the end of the year in worst case if that goes against you, how does that impact the ability to spin off B&L? Because I know that a B&L spinoff would occur something like six months after the IPOs. Just curious, given Xifaxan is sort of really important to absorbing a lot of the debt for Romain Co. Thanks.
spk10: Sure. Very good question. Maybe I'll just review a couple of the facts and get to specific questions. There is, in fact, a planned trial with Norwich on the Xifaxan intellectual property, and that's planned for March the 21st. Let me back up now in terms of how we view this. Number one, we believe we have very strong intellectual property for the Xifaxin product. We have 26 patents. We obviously believe very strong intellectual property. Number two, as you appropriately pointed out, we have previously visited this question three times before. We settled with Teva, a very leading generic company, for 2028. Number two, we settled for Sandoz, a leading generic company, for 2028. And number three, Sun Pharmaceuticals, a leading generic company, we settled for 2028. I think there's a theme there. These are three very strong, very good generic companies. They've reviewed our intellectual property. We've had the conversations, and we've settled with them for 2028. I think my view of being around the business for over 30 years Teva, Sandoz, and Sun are very capable, very competent companies. They've looked at intellectual property and they've made the decision to settle for 2028. So we feel very good about our capabilities here in terms of our ability, whether to settle or to go to trial, we feel very strong about our position. And I think it's certainly indicated by not just my point of view, but the point of view of what Teva, Sandoz, and Sun previously decided. As to the question of how this could impact the B&L spinoff, once again, we feel very confident in our abilities to prevail in this trial. The other thing, though, that has happened since we prevailed, or since we settled, let me say that. One thing that's happened since we settled with Teva, we settled with Sandoz, and we settled with Sun for 2028, we've also seen the FDA make a decision to add to the refaximin product guidelines, product specific guidelines, and they've added an additional requirement. So we think that even strengthens our position for 2028 when the FDA put forth an in vivo bioequivalency study requirement. So feel very good about our situation. Obviously, it's up to whether we settle or whether we go forward with the trial. I'm not gonna comment specifically on that, but we like our intellectual property position And that's evidenced by decisions that Teva made, decisions that Sanders made, and decisions that Sun made.
spk04: Joe, if I could just quickly follow up. Can you just confirm in a worst-case scenario, if you lose on the patent litigation, there's nothing in the debt covenants as it pertains to the RP basket that would preclude a spinoff?
spk10: The only thing that I'll say on that is that Relative to the full spinoff, we want to make sure we hit the debt leverage ratios that I talked about previously, the 6.5 to 6.7 times for the Bausch Pharma. So we'll obviously consider that. But otherwise, we have the ability to go forward. But Sam, do you want to add to that question?
spk01: No, you covered it well, Joe. And Jason, just on the covenant, the way I look at it is we are in full compliance today with the covenants. We're watching the covenants. And as we go forward with our uh strategic alternatives and we're going to continue to be in compliance with it great thank you guys thank you operator next question our next question comes from greg frazier with truer securities you may now go ahead good morning folks thanks for taking the questions
spk11: I was wondering if you could provide some color on the growth assumptions for the Salix business and specifically the assassin that's contemplated in the revenue guidance. And then on cash flow, how much do you anticipate paying in 2022 related to the settlement of legacy litigation? I'm just trying to get a sense for how much free cash flow you'll have available to deploy towards debt reduction. Thank you.
spk10: All right, I'll take the growth assumptions for Salix and business and specifically Syfaxon. Obviously, we're very pleased with the overall growth that Syfaxon showed, specifically the record revenue that we saw in the fourth quarter. Our view of the growth for Salix business will be a balance. It will be a balance of the TRX growth that we've seen with Syfaxon and then also the ability for the Syfaxon to we've achieved certain pricing. I haven't talked about it, but we did take pricing on our prescription products and some of our consumer and vision products early in January of this year. So we do have that pricing that is part of the overall growth assumptions for Stalix. But also for the rest of our business, I probably should say. So it's gonna be a balance. It's gonna be a balance of TRX growth as well as what we expect to have as a realized pricing. I remind you that when we take a price increase for Xifaxin specifically, if we take somewhere in the 7% range, we expect that we'll realize approximately 50% of that in terms of a net pricing. It's going to vary from product to product, year to year, but a ballpark way to think about it is about half of the price we take will be a net price adjustment. On the second point, Sam?
spk01: Greg, on the cash flow, let me just remind you that we have roughly about $1.5 billion of cash sitting in our balance sheet as restricted cash, and that's really dedicated towards the litigations and legal settlements. We expect that to start going out. We've already seen disbursement out of that balance, and we'll continue to see that in 2022. The timing exactly of when it's going to happen in 2022 is not really going to be clear because it's in the hands of the judge and multiple administrative processes. From an overall cash flow, I'm just going to take the opportunity just to comment on overall cash flow because you touched on it. The $1.7 billion that we're guiding to The way you think about it, it's really running on the strength that we built in 2021 from a cash conversion. We roughly converted about 47% of our EBITDA to adjusted cash, and that's really up about 5% from where we were in 2019, which was running in the low 40s. So we're continuing to run with that high level of cash conversion, which is really a very strong thing that we're very pleased with.
spk10: Thank you, Sam. Operator, we have time maybe for one last question, please.
spk07: Our last question will come from Balaji Prasad with Barclays. You may now go ahead.
spk00: Hi, good morning, and thanks for squeezing me in. So I'll just restrict myself to one question. With regard to the guidance that you provided in Bausch & Lomb of 4% to 5% growth, can you contextualize this with broad industry trends that you're seeing and also the upside and downside risks to this guidance? If you could also maybe compare this number with the guidance provided by one of its peers, Alcon, with the 7% to 9% growth, and what do you see are the key differences between these two, that would be great. Thank you.
spk10: So I'll start, but Sam, you may want to add as well. Number one, as we think about the opportunity, we're excited about what we see in terms of the overall Bausch & Lomb opportunity. The upside for us is going to be we're seeing some very significant growth in the Bausch & Lomb on the consumer side of the business. For example, in consumer eye health area, we're seeing the market growing somewhere in that 7% range. So that's a real positive. indicator for us. Number two, we are seeing some pricing in our overall B&L business pricing opportunities in both the vision business as well as what we're seeing on the consumer side and of course we've also seen some on the pharmaceutical prescription side of our business. We think that those are things that we're continuing to monitor and we're looking at selected pricing in each of those categories that's going to help on the overall and would be probably on the upside depending on what happens to the overall portfolio. So seeing clear growth in the consumer side of the business, seeing clear growth in the vision business, especially for us, the opportunity as we're launching our SAHAI daily product, we think that's a very important driver of the 2022 opportunity as we launch both the spherical and the multifocal products. I think all those would be some of the critical parts of the B&L guidance as we're thinking about the overall question. The only other thing that – Sam, is there anything else you want to add to this question?
spk01: No, you covered it pretty well, Joe. In terms of the guidance, I will look at it that we're striking a balance between the positive business performance that we've seen in 2021 and how does that momentum – is going and carrying us into 2022. So we're very excited about that. We're also balancing it with positive trends that we're seeing in the overall market. We're in surgical and as well as in the vision care and consumer business, and we're excited about the new launches that we're gonna be seeing in 2022 for ophthalmology and going to 2023. So we're balancing all those factors with, I'll call it the macroeconomics and the different situations that emerged and making sure that it is factoring in the positives and the negatives as we went through our guidance.
spk10: The only thing I'll add to, I think the last part of your question was the Alcon Cooper comparisons and what they're seeing. I can't obviously speak for them, but when I talk about our growth, it comes down to, I think, a couple things. Number one, the new products that I talked about, the the Infuse or the Ultra one-day product clearly in the launch of that. It comes about to our Zypure new product launch opportunity and the additional new products that we expect to launch during the year in our surgical business. I know that Alcon and Cooper, when they talk about their growth, they're also talking about some of the bolt-on acquisitions they do. We're talking about our growth simply and only as the true organic growth, not including any M&A or business development. So I think that's maybe a slight differential versus what they talk about. They talk about their growth inclusive of any business development M&A activity. So maybe that's probably the only difference that I'm aware of right now as I sit here today. Obviously, as we go out as an independent organization, B&L business. We do think there's going to be opportunities for additional bolt-on opportunities for us, but at this point, we do not build it into our current 2022 guidance. Operator, thank you very much. Everyone, thank you very much for joining us. I think that's going to conclude our conversations for today, but I appreciate everyone's interest in the business. We're excited about what's in front of us. We have the simultaneous opportunity to continue to increase our EBITDA, also to launch new products, and then clearly make progress on our strategic alternatives. Thank you all for joining us today. Have a great day.
spk07: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
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