Bausch + Lomb Corporation (BLCO) Q4 2024 Earnings Report, Transcript and Summary

Greetings. Welcome to the Bausch + Lomb Fourth Quarter 2024 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 your host, George Gadkowski, Vice President of Investor Relations. You may begin.

Thank you. Good morning, everyone, and welcome to our fourth quarter 2024 financial results conference call. Participating on today's call are Chairman and Chief Executive Officer, Mr. Brent Saunders; and Chief Financial Officer, Mr. Sam Eldessouky. 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, I would 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 legend at the beginning of our presentation as it contains important information. This presentation contains non-GAAP financial measures and ratios. For more information about these measures and ratios, please refer to Slide 1 of the presentation. Non-GAAP reconciliations can be found in the appendix to the presentation posted on our website. 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 unless required by law and not to update or affirm guidance other than through broadly disseminated public disclosure. With that, it's my pleasure to turn the call over to Brent.

Thank you, George, and thank you, everyone, for joining us today. I'm going to show progress against our strategy through the lens of our fourth quarter and full year results, and Sam will go deeper on our performance and provide 2025 guidance. I'll close by highlighting the products and technology that will advance our strategy in 2025 and beyond. We've booked our fifth straight quarter of double-digit constant currency revenue growth, contributing to 17% constant currency revenue growth for the year. While top line growth isn't the only metric that matters, our trajectory is clear. We're capturing market share in an industry with significant growth potential and carving out leadership positions in areas of unmet need. There is no secret sauce behind that growth. In fact, the formula is simple. We continue to introduce new products across businesses and geographies at a steady clip while optimizing our manufacturing process, which includes deploying AI. Technology is also a key component of an ongoing investment in our sales force. Our reps are leveraging digital tools to establish new relationships and deepen existing ties. The easier we make their jobs, the better they perform. Again, it's a simple formula. Underpinning our recent success is a commitment to long-term growth. We are once again an innovation company, something I couldn't say when I rejoined Bausch + Lomb two years ago. Our R&D organization has been completely overhauled and infused with top talent. Our refocused pipeline is now filled with promise and potential to significantly enhance the standard of care in eye health. This section of our road map to accelerate growth, which we highlight every quarter, focuses on Phase 2, innovate and execute. I can't think of a more appropriate way to describe our current state. Innovation is driving our decision-making process and positioning the Company for long-term sustainable growth, and our relentless focus on execution is clearly reflected in our results. Words on a road map are hollow without concrete examples. So, consider the following when it comes to execution. Our organic revenue CAGR over the past two years is approximately 10%. The success of recent product launches is well documented, particularly in dry eye space, where a comprehensive portfolio is approaching $1 billion in annual revenue. Proof of our commitment to innovation deserves its own slide. These are the pipeline products we're most excited about with representation from all businesses. Our in-house engineers are developing a first-of-its-kind biomimetic contact lens that would optimize oxygen permeability and critically can be produced on existing lines, which means minimizing future capital expenditures. We're also developing a myopia control solution for children and young adolescence. Our consumer pipeline is all about building on the success of category-leading brands with new formulations. We're once again working with the National Eye Institute to develop an AREDS3 offering, which we believe would expand the market for a high-performance PreserVision franchise, and address a significant growth opportunity in dry AMD. LUMIFY Lux is currently under development and would represent the next chapter of premium redness relief. The recent addition of Elios procedure to our surgical portfolio unlocks new opportunities to treat glaucoma in conjunction with cataract surgery, and we hope to secure an FDA approval later this year. Meanwhile, we continue to roll out premium IOL offerings in a staged approach with an expected 2026 U.S. launch for enVista Beyond and an adjustable IOL in early stages of development. Finally, we've transformed our pharma pipeline to potentially introduce several novel treatments. These include a first dual-action therapeutic to address both evaporative and inflammatory dry eye disease, the first product to treat chronic ocular surface pain and the first glaucoma product to lower intraocular pressure and approve visual acuity. Our revamped pipeline positions us to significantly enhance the standard of care for patients across the spectrum of eye health needs. That's where our focus will continue to be. I referenced our holistic strength every quarter. So, it's no surprise that I'll do the same when providing a full year review. The key takeaway is there continuous to be no lager. All three reporting segments delivered double-digit constant currency revenue growth for the year, thanks to a focus on execution, in particular, when bringing new products to market. Of note, absent Xiidra revenue, Pharmaceuticals saw approximately 15% organic revenue growth for the year. The franchises we highlight speak to that holistic strength. We updated our 2024 projections for Miebo in November and still outperformed expectations with $172 million of revenue. Xiidra hit the high end of our projections with $364 million in full year 2024 revenue and a 14% year-over-year growth for Artelac, it's a reminder that our holistic strength extends to performance across geographies. Daily SiHy lens’ uptake continues to leap off the page with over 70% reported revenue growth for the year. Three things are driving that growth: a superior product offering, sales excellence and a thoughtful approach to how we introduce multifocal and toric options in new markets around the world. I referenced our premium IOL pipeline earlier, but it's important to recognize that we're carving out a significant presence in the category with existing offerings. Revenue from premium lenses was up 35% in 2024, despite several launches taking place later in the year. I'll now turn it over to Sam for a closer look at the financials.

Thank you, Brent, and good morning, everyone. Before we begin, please note that all my comments today will be focused on growth expressed on a constant currency basis, unless specifically indicated otherwise. Turning now to our financial results on Slides 8 and 9. We saw yet another quarter of solid performance with revenue growth across our segments, geographies and product franchises. The broad-based momentum in our business continued during the quarter, driven by our sustained focus on execution. Total company revenue of $1.28 billion for the quarter reflects growth of 11% and 10% on an organic basis. For the full year, total company revenue of $4.791 billion reflects growth of 17% and 10% on an organic basis. As we have said before, 2024 was one of the most active product launch years in our history. Our steady stream of product launches continues to drive growth, and we are excited about the opportunity ahead of us in 2025 and beyond. For the fourth quarter, translational currency was a headwind of $17 million to revenue and $4 million to adjusted EBITDA. For the full year, it was a headwind of $69 million to revenue and $11 million to adjusted EBITDA. Now let's discuss the results in each of our segments. Vision Care fourth quarter revenue of $723 million increased by 11%, driven by growth in both the consumer and contact lens businesses. For the full year, Vision Care revenue was $2.739 billion and increased by 10%. The consumer business grew by 10% in Q4. Let me go over a few highlights on the consumer business. In the quarter, LUMIFY grew by 24% and continue to expand its market-leading position. Our consumer dry eye portfolio delivered $103 million in revenue, representing 20% growth in the quarter. Our two key franchises, Artelac and Blink, were once again big contributors to the strong performance. Artelac grew by 18% and Blink grew by 12% in the quarter. The dry eye portfolio has continued its outstanding performance with growth of approximately 27% on average over the past four quarters. Eye vitamins grew by 7% in Q4 as we continue to see solid consumption trends. And lens care grew by 2% for the full year, led by our Biotrue MPS franchise. Contact lens revenue growth was 13% with strong performance across modalities, key brands and geographies. For the full year, contact lens revenue growth was 11%. We are continuing to see very strong momentum with Daily SiHy, which grew 75% in the quarter. We also saw growth across other key franchises, including Biotrue, which was up 3% in the quarter, and ULTRA, which was up 10%. Contact lens revenue growth was broad-based across markets, with the U.S. up 17% in the quarter and international up 11%. For the full year, the U.S. was up 12% and international was up 11%. Outside the U.S., we saw solid performance across all of the regions, with growth in China at 12% in the quarter and 18% for the full year. While we are still in the early innings, we are seeing our investments in Opal in the U.S. and direct-to-consumer in China payoff. We believe the future of our lens business is highly promising, our execution continues to be strong and we have a robust pipeline of innovation. Moving now to the Surgical segment. Fourth quarter revenue was $231 million, an increase of 15%. For the full year, revenue was $843 million, representing growth of 11%. In Q4, we once again saw growth in each of our three surgical product categories, and we also saw growth across all regions. Consumables, our largest product category, grew in the quarter by 10%. Revenue from equipment was up 21%. Implantables grew by 19% in the quarter with our standard IOLs up 4% and our premium IOLs up 67%. Our enVista IOL platform is continuing to perform well with the enVista Aspire lens and enVista Envy showing strong early results. We are very excited about the Surgical business. We are delivering growth faster than the overall market, and our strategy remains the same. We will continue to focus on the top line growth and drive margin expansion with our premium products. Lastly, revenue in the Pharma segment was $326 million for the quarter, which represents growth of 7%. For the full year, revenue in the Pharma segment was $1.209 billion, which represents growth of 45%. Touching on our pharma dry eye portfolio. Miebo has continued its exceptional launch performance and delivered $53 million in revenue in the quarter. For the full year, Miebo delivered $172 million, exceeding our latest guidance. I will once again highlight our commitment to making investments to drive Miebo's strong growth, including investments in our direct-to-consumer campaign. Xiidra delivered $104 million in revenue in the fourth quarter. This represents 6% growth when excluding the onetime $8 million rebate benefit, we saw in Q4 of last year, which was driven by the acquisition from Novartis. For the full year, Xiidra delivered $364 million in revenue, coming in at the high end of our guidance range. As we look to 2025, our strategy remains unchanged. We will continue our efforts to maximize access to all Xiidra patients. Our team delivered strong Xiidra TRx growth in Q4 and we expect TRx growth to continue in 2025. As I have previously stated, we also expect a onetime impact from the Inflation Reduction Act to be about $25 million in 2025. Looking at our broader Pharma portfolio. We are seeing solid performance. For the full year, U.S. Generics grew by 10% and International Pharma grew by 8%. Now, let me walk through some of the key non-GAAP line items on Slides 10 and 11. Adjusted gross margin for the fourth quarter was 62.5%. For the full year, adjusted gross margin was 62.6%, which was up 160 basis points compared to last year. The increase in adjusted gross margin was mainly driven by product mix as we continue to execute our strategy to transition to higher-margin products. In the fourth quarter, we invested $93 million in adjusted R&D and $342 million for the full year, which is about 7% of revenue. Fourth quarter adjusted EBITDA, excluding IPR&D, was $259 million, which represents 14% growth versus Q4 of '23. For the full year, adjusted EBITDA, excluding IPR&D, was $878 million, up 20% versus 2023. Net interest expense for the quarter was $93 million and $384 million for the full year. Adjusted EPS, excluding IPR&D, was $0.25 for the quarter and $0.63 for the full year. Over the course of 2024, we have discussed our targeted efforts to drive cash flow. These efforts are paying off. Adjusted cash flow from operations was $263 million for the full year compared to $56 million in 2023. We are pleased with this performance and we will remain focused on this front in 2025. Turning now to our 2025 guidance on Slide 15. We expect full year revenue to be in the range of $4.95 billion to $5.05 billion. This reflects constant currency growth of approximately 5.5% to 7.5%. The fundamentals of our business and the eye care market remains strong and we expect each of our segments to deliver growth in 2025. Shifting to adjusted EBITDA. We are setting our adjusted EBITDA guidance in the range of $900 million to $950 million. Consistent with our guidance in 2024, our current guidance excludes any potential onetime IPR&D charges that we may have in 2025. As we exit 2024, we saw a swift strength of the U.S. dollar. Based on current exchange rates, for the full year 2025, we estimate currency headwinds of approximately $100 million to revenue and $20 million to adjusted EBITDA. We expect 2025 phasing to follow the natural seasonality of our business, with the first quarter being the lowest and the fourth quarter being the highest. I do, however, want to highlight a couple of factors that will impact our typical phasing. First, given the success we're seeing in the Miebo direct-to-consumer campaign, we plan to continue the investment through the early part of this year. Second, we also expect to increase our investment in R&D in the first part of the year as we continue to drive our innovation pipeline. Based on these factors, in Q1 2025, we expect to achieve roughly 17% of the full year adjusted EBITDA guidance, and we expect to build on that as we progress throughout the year. While these factors are expected to have a short-term impact on phasing, they represent a strategic opportunity that we believe will generate significant growth and sustainable margin expansion over many years. In terms of the other key assumptions underlying our guidance, we expect adjusted gross margin to be approximately 62.5%. Keep in mind that we are absorbing an estimated $25 million impact from the Inflation Reduction Act in adjusted gross margin. For the full year, we expect investments in R&D to be about 7.5% of revenue. As we continue to monitor Fed actions, we expect interest expense to be approximately $375 million for the full year, which reflects a moderate decrease relative to 2024. We expect our adjusted tax rate to be roughly 15% to 17% and full year CapEx is expected to be approximately $280 million. Now on Slide 16. Let me provide some additional color on how to think about the adjusted EBITDA guidance in 2025. The midpoint of our 2025 guidance range is $925 million. It absorbs currency headwinds of approximately $20 million. It also absorbs an estimated impact of approximately $20 million related to our recent acquisition of Elios as we prepare for the approval and the launch in the U.S. We are excited about bringing Elios to the U.S. market and believe it will be an important and profitable contributor to the surgical business for years to come. Excluding the impact of the currency headwinds and the Elios acquisition, at the midpoint of our guidance range, the adjusted EBITDA margin is 18.9% in 2025. This reflects a 60 basis point EBITDA margin expansion in our base business relative to 2024. To sum up, we are continuing to see solid execution and strong performance across all segments. Our strategy is paying off. There is a clear momentum to further drive revenue growth and sustainable margin expansion. And now, I'll turn the call back to Brent.

Thanks, Sam. Let's highlight the categories and products that will help fuel our growth in 2025. Earlier, I mentioned that we're nearing $1 billion in annual revenue for our dry eye portfolio, which is impressive on its own, but how we got there is noteworthy. Organic revenue growth increased nearly 50% year-over-year. Miebo and Xiidra volumes played a prominent role in that growth as weekly TRx trend lines illustrate. Both have benefited from effective direct-to-consumer campaigns and a full core press when it comes to educating prescribers on the distinct advantages of each medication. But I'll once again point out that our dry eye portfolio is all encompassing. In addition to our flagship pharmaceutical products, we have OTC solutions that address all needs. One prominent example is our Blink franchise, which reported 12% revenue growth on a constant currency basis in the fourth quarter. We've become a one-stop shop for dry eye sufferers. And that's not only true for the approximately 150 million U.S. adults that experience occasional or frequent symptoms of dry eye or roughly the $38 million living with dry eye disease. We offer relief on a global scale. Two OTC products with recognizable names are poised to have an impact in 2025. LUMIFY preservative-free eye drops received FDA approval last year and make a wildly popular brand even more attainable. The product was developed in response to feedback from consumers and eye care professionals. In fact, earlier this year, I had an ophthalmologist tell me she was compounding LUMIFY for a patient in need of a preservative-free option. The drops are now available on Amazon and should be on shelves at most major U.S. retailers by June. Another example being responsive to the needs of consumers and eye care professionals was last year's launch of Blink NutriTears, a clinically proven OTC supplement for dry eyes. Some dry eye sufferers have an aversion to eye drops or simply prefer adding another pill to their daily regimen. And we've heard countless times from doctors the importance of having a once-a-day nutraceutical that they can recommend to patients. The opportunity for both products is significant. In January, we launched a new 30-second ad for Blink NutriTears that will run throughout the year across linear and connected TV. It's early days, but there are promising signs. Since the ad went live, we've seen a 4x increase in sales at major retailers. Unlike NutriTears, LUMIFY preservative-free doesn't have to cultivate a nascent category. Instead, it can ride the coattails of a brand that saw a 24% reported revenue growth in the fourth quarter. Our contact lens growth is outpacing the market, which may surprise some in the industry, not us. As highlighted earlier, Daily SiHy lens are driving that growth and having the full family of offerings makes it much easier to convert eye care professionals, most of whom don't prefer to mix and match. While we typically lead with Daily SiHy performance, it's important to remember that other products are contributing to our success. ULTRA monthly contacts are a good example with 6% revenue growth in 2024. How we offer contact lenses to patients is increasingly important, which is why we're encouraged by the initial interest in Opal, our e-commerce platform launched in October. As more practices adopt this complementary service, product distribution will become increasingly automated and easier with an expected boost in patient loyalty as well. On another note, on distribution, putting the issues in Lynchburg behind us last year had an obvious impact on our performance. It's no coincidence that the long quarter of single-digit constant currency revenue growth for our lens business was at the tail end of our remediation process. Our steady drumbeat of premium IOL launches continues with an anticipated first quarter launch of LuxLife in Europe. The lens offers a continuous range of vision and adds to the buzz around our aggressive push into the category. I've mentioned this before, but it's worth repeating, given the surgical business is relationship driven. Ophthalmic surgeons are excited about our products and anxious for what's next. I hear it at industry meetings around the world and in conversations, not only with our biggest customers, but our newest customers as well. That excitement is certainly reflected in our premium IOL revenue growth and supports our pipeline strategy. I'll close with a reminder that cutting-edge technology is foundational to how we source, make and sell. I covered Opal earlier, let me highlight some other important platforms and partnerships. We're leveraging collaborations, pharmaceutical data curation and machine learning expertise to identify new drug candidates. Eyetelligence software simplifies the complex and time-consuming surgical planning process and enables device integration. Our collaboration with Character Bio will focus on developing innovative AMD treatments through the Company's patient data platform and AI-powered analytical engine. We've partnered with Arena AI to help drive yield and outlook gains at our contact lens manufacturing sites by utilizing predictive analytics. And finally, Glimpse is our proprietary digital sales platform that uses AI and machine learning to provide tailor-made guidance for engaging eye care professionals. As made clear by our investments, technology will continue to be a driving force behind our ongoing evolution. Before we take questions, I'd like to thank my colleagues around the world for everything we accomplished in 2024. It's remarkable what we fit into 12 months, and not just talking about the more visible achievements, we made significant strides in every area of our company, thanks to their hard work and buy-in. Operator, let's take questions.

Thank you. At this time, we will be conducting a question-and-answer session. [Operator Instructions] The first question today is coming from Patrick Wood from Morgan Stanley. Patrick, your line is open.

Perfect. I'll keep it to one just so everybody gets a chance. But Brent, you touched on it at the end about sort of customer side of things. And we can see the pipeline and the innovation that's coming through in the Company. But I'd love to hear a little bit more about, I know you spend a lot of time on the ground with reps and things, what you're seeing at the customer level. So, is a lot of the growth also coming from, I don't know, on the consumer side, more shelf space, more gondola ends? What are you seeing in terms of the rates are bringing new surgeons in who previously wouldn't have had the discussion? I'm trying to pull out the execution component of the scorecard relative to the innovation. I know that links, but I'm just interested to hear more about that.

Yes. Great question, Patrick. Look, as we sit here today, it kind of marks my two-year anniversary with Bausch + Lomb or my return to Bausch + Lomb. And I think you hit the nail on the head. When I joined two years ago, I think we were struggling with customer service on multiple fronts, right? It started with operational issues of being able to supply products. Some of it due to the COVID supply chain disruption, some to our own self-forced errors in Lynchburg and the like. And I think we spent a lot of time focused on operational excellence because it's really hard to have selling excellence if you can't supply your products. And Al Waterhouse and our team in supply to manufacturing have done a really great job over the last two years stabilizing. And you don't hear us talking about any more in earnings report supply issues or recalls. The quality metrics in our plants are trending all in the high levels. Our back orders are at all-time lows and so we're really delivering great operational excellence over the last two years. We then focused on selling excellence, and great proof point is since I joined the last two years, our revenue growth CAGR for the last two years is 10% on an organic basis. So, growing much faster than our industry, and taking market share. And I think that that was broad based. If you look at over the two years, you see, or in ‘24, you see consumer up 9% on constant currency. Contact lens all time high at 11%, surgical at 11%, and pharma at a 15% organic constant currency. So, really broad-based growth by geographies would be a very similar story. And so that's not a one pick trick pony, it's a really holistic commitment to selling excellence. And then the third component of my road map plan was innovation. And you're right, we see that playing out in the depth of the pipeline and the new product launches. But as we think about the next two years, it's really about driving continued growth, and now couple that with margin expansion and profitability improvement. And it's not like we ignored it. If you look at '24 P&L leverage, right, margin expansion was about 50 bps. If you exclude some of the one-off items that Sam mentioned in the prepared remarks, '25 is about another 60 bps improvement. But really, I start to get excited when I look at '26 and '27 of the opportunity we have to continue that journey and margin expansion, all while investing in the new products and the pipeline. So, as I sit here today, I give the team a really good report card on the last two years of accomplishing and frankly, doing what we said we would do and I look at the opportunity over the next two years, and I'm probably even more excited. So, all in all, it's good, I think, more specifically. And then I'll conclude, when I go out and talk to customers, I'll be in China next week and meeting with customers and the team, I'll be at the AECOS meeting in -- out West this weekend. So, I'm out of quite a bit. There is just renewed excitement about what they call the new B&L. I don't know if I'd call it the new B&L, but they do. And surgeons, in particular, that really didn't consider B&L in the past are looking at products like Envy, enVista Envy, and the chatter there, early days, but about 10,000 lenses now implanted, about 900 surgeons doing Envies, more in the queue that want to do Envy are really getting great patient outcomes. They are noticing the difference, and that's what drives customers to want to be with Bausch + Lomb, innovation and great execution.

The next question will be coming from Joanne Wuensch from Citibank. Joanne, your line is open.

I want to spend just a minute talking about contact lenses. We saw another quarter of very strong double-digit growth, both in the United States and outside the United States. And I was curious how you thought about the continuous nature of that continuality, whatever the right word is. And in particular, what you can tell us about the biomimetic lens and myopia control.

Great, Joanne. And I should have mentioned, Yehia Hashad is with us for Q&A. He's our Head of R&D and Chief Medical Officer, so I'll ask him to weigh in here as well on the pipeline. But look, I couldn't be more proud of our contact lens performance and the team, 11% for the year, 13% on a constant currency basis for the quarter. We're hitting numbers that really, we haven't hit in terms of growth at Bausch + Lomb in probably 20, 30 years, right? And really, I dare to say, we don't have all the numbers from competitors, but really probably sales leadership for the year and for the quarter based on what we believe will happen in the industry. And well, contact lens is a great business, right? It's a great market. It's got strong growth. I think we're slightly more optimistic about market growth in '25 than even '24, which was a very solid year. And our performance, I think, is quite broad-based. I look at what we're doing in the U.S. with the full family of INFUSE now. And Opal, a big investment we made last year is really making a difference. I look at a big market like China, where I'll be next week, and our direct-to-consumer capabilities that we invested in at the end of '23 and into '24 really are making a difference in terms of how we interact with customers and deliver contact lenses. But our product pipeline is probably what makes me even more excited, not just the biomimetic lines, which Yehia can contact -- touch on, but also our myopia control programs and quite a few other programs there. So, I look at the next couple of years executing on the current pipeline is sustainable growth and leadership, and then the future in probably '27 and beyond gets super exciting with the new products that are coming. But Yehia, you want to touch on that biomimetic?

Yes, sure. So actually, as you always mentioned, Brent, there hasn't been a lot of innovations in the material side of the contact lenses in so many years. And in fact, Bausch + Lomb, one of its strengths is the capabilities we have in research and development for the contact lenses. And one of the areas that we focused on is, what is next in terms of the material? And can we create really a new material segment for the future? And this is actually what came up about -- we started the project about 1.5 years ago. It's a lens done from a biomaterial substance that is designed to mimic the natural environment inside the eye from a chemistry and the biology perspective. Added to this also, we are revamping completely also the packaging solution for the contact lenses to add also to the comfort that can -- the consumer can feel. And also considering the global sustainability piece that also allow us to be expanding globally. So, we have done massive strides in terms of the development. We have done -- conducted over eight internal clinical studies, and the study is showing pretty promising results. We are going for the first external big study during mid this year. And actually, we hope that what we have put from a target product profile that we will be able to see from this clinical study. So that's it.

Yes. And I think -- and Yehia won't say this, but outside of the great work his team has done in developing this biomimetic material, the one requirement I gave the R&D team was they had to design for purpose on existing equipment to really essentially minimize or really not have any significant capital expenditure that generally comes with new material development, and they did just that. So not only as a breakthrough innovation, it's going to be high-margin lens at the get-go and not require big cash capital expenditures to get up in scale. So, we're super excited about it. Obviously, the clinical trial data is critical to the success of the lens, but we're really excited about it. Next question, operator.

And the next question is coming from Craig Bijou from Bank of America. Craig, your line is live.

I just wanted to start with the dry eye franchise on -- at least on the prescription side. And obviously, Miebo has seen a significant ramp since it launched and through '24. Xiidra looks like it's rebounded. So would just love to understand the expectations that we should be thinking about for both of those in '25. So, for Miebo, can you grow sales sequentially like you have been? And then for Xiidra, is the mid-single digits revenue growth that you've talked about in the past, is that still the right way to think about growth for that franchise?

Yes. So let me start, and then I'll ask Sam to chime in as well. So great question, Craig. Thank you. Look, I think both of those products are really the workhorses of our U.S. Pharmaceutical business. Miebo is the -- I think it is the most successful launch in ocular surface history, and we're really proud of what we've done there. We do have very high expectations for Miebo to continue to drive growth in '25 and for the long term. And look, it's one data point. You guys get the weekly report card and IQVIA data. But January looked quite strong. The momentum from Q4 has carried into January. And I think that's more impressive when you think about the seasonality of this category, dry eye category tends to see the first quarter, and in particular, January be the weakest month of the year because of the way the co-pays work and deductibles work. And so, I think that's good. Xiidra, Sam can provide some more commentary. Our goal is TRx growth. We have this asset for the next several years. And we're making an investment in managed care coverage in '25, which we talked about quite a bit, I think at every quarter last year about the investment we needed to make to maintain coverage. But clearly, we see a real opportunity to continue momentum in TRx growth and believe this is going to be a growth driver for us for the long term. But Sam, do you want to touch on any financial metrics?

Sure. And I'll start with Miebo. And Craig, I think when you reflect back on Q4 for Miebo, we had sales of roughly about $53 million. That's a pretty good baseline for us to think about as you think about run rate for -- and growth into 2025. Just keep in mind the sequential element that you asked about, we pointed out it's very important to understand the seasonality. Q1 is always the lowest, Q4 is the highest. So, if you look at Q4 to Q1, you just have to keep that in mind as you think about the Q1 and you start phasing the growth for Miebo. In terms of Xiidra, our strategy in Xiidra has been working very nice, and you've seen that in the TRxs, especially in the second half of 2024, and we ended the year with average TRx of 23,000 plus that Brent highlighted. This is a very important factor because the team is executing very well. And as you think about 2025, that momentum in terms of driving the volume will continue with us, and we expect to see that in 2025. The two things that we've been highlighting throughout 2024 is, first, is the IRA, the Inflation Reduction Act, which we quantified roughly about '25, that would be a onetime headwind for us as we think about '25 versus '24 in Xiidra. The other part is the level of confidence that we have developed as we start seeing the execution and the TRxs, we always highlighted that we have to invest also in making sure that we have the right access. And that's something we will be doing. We highlighted in '24 that we'll make sure that, that's taking place in '25, that also will be a onetime sort of investment. I refer to it as it's a short-term investment in '25. It does pay a lot of dividends. Beyond '25, as you go and you start driving those volume up, I refer to it as a simple ROI, a no-brainer in terms of the kind of an investment with the TRxs that we're seeing so far.

Next question.

Go ahead, Craig.

No, Brent. I was just going to ask one quick follow-up, if I may. So, on the market contact lens performance. Just wanted to get your comments on market share versus maybe transitioning your existing customers to -- or I guess, a mix benefit from transitioning some of your existing customers to the daily disposables?

Yes. I mean I think there's a combination here of obviously transitioning some of our existing customers and us also focusing on new fits or new starts. And I think there's a real nice balance being accomplished throughout the execution in the field. And you see that we saw ULTRA monthly up 6% for the year. So, when you look at this, it's not all just coming from the new products. It's maintaining growth in the older products while we use the new products to accelerate. And so, it's not a leaky bucket. It's filling the bucket higher and higher.

The next question will be from Larry Biegelsen from Wells Fargo. Larry, your line is open.

Congrats on a strong finish to the year here. Brent and Sam, you talked about 10% organic growth in the last two years, Brent, and in Q4. So clearly, a lot of momentum here. But you're guiding to about 6.5% at the midpoint in 2025. Why is that the right starting point? Which businesses slow relative to '24? And Sam, I did hear you talk about revenue seasonality.

Yes. Thanks, Larry. And maybe I'll take a part here. And when I reflect on sort of all businesses, we don't see any business that's slow. Actually, maybe take a step back and look at the overall market dynamics, right? The market dynamics are solid, and we've seen the market is growing roughly around mid-single digits. And as you pointed, our guidance bracket is roughly about anywhere between 5.5% to 7.5% with the midpoint of 6.5% in terms of revenue top line growth. Really, the framework that we've been following, and we've seen that work very nicely in 2024, is driving our performance to be growing above market. And that's really what our guidance, adjusted growth in terms of what we're seeing in terms of growing faster than the market and continuing to gain share. One of the elements that you have to keep in mind is, we're also absorbing some of the elements of the IRA that I mentioned earlier in terms of the growth on a year-to-year basis and also the market access element of that, that's absorbed on a year-to-year basis. But overall, still growing faster than the market. So given the fact we're -- this is the first time we're setting our guidance for 2025, we think it's a reasonable place to start with the guidance range, and we factor in all the different elements of our business, and we think it's pretty well-balanced guidance at the start of the year.

And then seasonality, Sam?

Seasonality, it follows the natural seasonality that we've seen in 2024 on the revenue side. EBITDA was really the two factors that were unusual or unique for us in '25, that's why I called them out being the investments that we're continuing in Miebo DTC, which will continue into Q1 that didn't happen in Q1 last year, as well as the Elios acquisition and registration, which we expect to be taking place in the first half of '24. So that's why I called out the EBITDA seasonality. Other than that, seasonality should follow '24 seasonality.

Next question, operator.

The next question will be from Doug Miehm from RBC Capital. Doug, your line is live.

Yes. My question has to do with Miebo. I'm really curious if you could update us on how managed care and your contracting has gone over the last year. I know that you've been hoping for one mid-year of last year, but that got delayed at the beginning of this year. I'm wondering if you could update us there. And then finally, when you think about the profitability of the product and the fact that you've extended that DTC campaign, do you expect that product, as it leads this year 2025, to be profitable? Or we're really looking at '26, '27 to see that profitability come through? And I'll leave it there.

Yes. So, thanks, Doug. Yes, so Miebo coverage is quite strong. We're just starting the second year of launch here, right? This is the sixth quarter since launch, and we're at 74% commercial coverage and 64% Medicare. So, nearing full coverage, I usually say when both numbers are in the 70s, you are at full coverage. So, we're just a hair away. And so that's why you invest in the DTC because you have that coverage. We have the reps, the doctors are experiencing it, the patients are happy. And so, all that comes together for strong execution. Clearly, what we see with Miebo, which we have for approximately another decade, is a path to driving real profitability starting next year. And so as most pharmaceutical launches, the first two years are investment years and then you see the profitability improve. I think we'll follow that very customary path. But the good news is our numbers just keep improving and improving, like we did last year, we kept taking guidance up. We kept overachieving. I do think that Miebo has the potential to just continue to outperform the category as it's an incredibly well-tolerated and effective medicine for patients that suffer from dry eye disease. So, I think we're strongly positioned, Doug.

The next question will be from Matt Miksic from Barclays. Matt, your line is live.

So maybe just a clarification on the comments you made about organic growth and the guidance for this year. It sounds like if we were to think about the difference, that double digits and then and then the slightly lower '25 growth, it's the IRA impact and then it's sort of maybe setting your goal to grow above market, but not really gunning for double-digit growth each year. That just maybe one quick clarification. And then on Surgical, if I could, maybe it'd be great to hear, you had some success with Envy, you've got a pipeline of new lenses coming to the market. Where do you think you still have key kind of gaps that you're aiming to close that you think could significantly step up the competitive and share trends within that market? Or are there any? And what are those in addition to the products that you rolled out?

Yes. So let me answer the Surgical one, and I'll pass it over to Sam for the guidance question, Matt. Look, on Surgical, our strategy was to, starting two years ago, is to really drive into the premium category. And that really just kicked off in the fourth quarter with the launch of Envy. So, we're just a few months into it. And obviously, we have Envy launching and really getting early quick adoption. We're very pleased with that. Early days, but great reported outcomes from surgeons and patients. And now in Europe, we're launching LuxLife right now. The enVista platform will launch in the back half of the year in Europe as well. Yehia and his team are -- got the EDOF lens, enVista Beyond in clinical trials with a launch towards the end of '26. And so, the IOL portfolio is -- the table is set, right? We have a -- we have to add one more piece to it, but that's in clinical studies. And I feel like we have arguably the most comprehensive. We actually do have the most comprehensive IOL portfolio once we have beyond in place. I think on the equipment side, we have Synova, our upgrade to our phaco machine. Elios, which we expect an FDA approval for in later this year is. I think really a game changer in minimally invasive glaucoma surgery. And so, I think all the pieces are coming together. I had mentioned in the prepared remarks, we have adjustable IOL in very early development. We continue to look at technologies in both accommodation and adjustability in IOLs. And so, I think -- I don't think we have any significant gaps. We have work to do. But I don't see any real significant gaps in the near term, at least over the next couple of years. Sam, do you want to touch guidance?

Yes. And Matt, when you think about the revenue, I think given the fact that, again, you're starting setting up the guidance in the beginning of the year for 12 months out. You start by anchoring into where the market is and the market growth is. And the market growth, as I said, is about mid-single digits. Our framework is to continue to grow faster than our market. That's why we positioned ourselves between the 5.5% to 7.5% in terms of growth. That you point the IRA, that's definitely a headwind for us in 2025. Also, I did mention the access, as I was talking about Xiidra, that will also be a headwind for us in 2025. But putting those two points in terms of aside, there's always going to be puts and takes with our sort of guidance range. And I think there's definitely areas where we can have the opportunity to be able to outperform, but we will have to be able to work our way through as we see those areas, how they play out throughout the year. And that's our guidance, factor in multiple scenarios as we think about it.

The next question will be from Robbie Marcus from JPMorgan. Robbie, your line is live.

Two for me. Sam, I'll just ask them together. One, maybe I missed it. How do we think about free cash flow in 2025? It was negative in '24. Can that turn positive and how positive? And second, my rough math, based on the guidance, gets me to something like $0.02 to $0.04 of EPS growth. Is that the right ballpark? And how do you think about taking this good top line growth you're seeing in driving EPS and free cash flow in the future?

Thanks, Robbie. Let me take them in parts here. So let me start with the cash flow. We are very pleased with what we've seen in '24 with the cash generation. And we've seen that really come to fruition for us in the second half, starting with Q3 and then full year as well. Our cash -- adjusted cash flow, as we reported morning, $263 million. As we think about '25 here, Robbie, I would say that the momentum that we had with the adjusted cash from operations, that would continue pretty much where not sort of taking any steps back from all the actions we've put in place to continue to drive that cash flow. So, I expect the level of conversion to continue with potential -- continue to improve as we go into '25. In terms of CapEx, we are guiding to roughly about $280 million. There's always going to be a little bit of a timing around the spend of those CapEx and the timing of projects, launches and the spend when it takes place. I do expect that we would be in a positive free cash flow in '25 based on what we see today, in terms of our actions we've taken in place for the cash generation as well as we're thinking about the CapEx, but that's something we'll continue to update on as we go throughout the year. In terms of the other part of your question on EPS. So, I would -- there's a couple of things when you think about EPS. We're going to see EPS growth on a year-to-year basis. We ended the year right now at $0.63. We expect to be growth on a year-to-year basis. The two things I'll probably highlight for you to keep in mind as you think through it is our tax rate, we're guiding to a 15% to 17% tax rate in 2025. So that will be a little bit of a headwind as we think about the EPS growth as well as the currency, which I highlighted on the EBITDA is about $20 million. I would see that flow of that currency as it goes through the EPS.

And just to clarify, is free cash flow positive in '25 or just improving towards positive?

We're expected to be positive.

The last question today will be from Gary Nachman from Raymond James. Gary, your line is open.

This is Denis Reznik on for Gary Nachman. Congrats on the quarter. Just with the dry eye franchise, are there any metrics or color that you can share as to patient compliance with the dosing? And then any color on the refill rates? And then in the third quarter, you previously mentioned about how you've begun sampling the 1.6 mL from Miebo. Can you just talk about the conversion efforts there and if you were able to activate any new prescribers?

Sure. So, one of the -- I think one of the important differentiating characteristics of Miebo versus the other drugs, including Xiidra in the inflammatory category, is higher refill rates. I don't have the exact number in front of me. I can have George send it to you. But its refill rate is significantly higher than that of the other in the category, which goes to the, I think, strong clinical profile and safety profile of the medicine. I think people just feel better on it, to be fair, and that drives a lot of refills. So, in essence, Miebo is potentially a harder working prescription because it's a stickier prescription versus the other drugs that tend to take a little longer to work and require a little bit more persistence from the patient to get relief. And so that's why that investment in Miebo and the long-term outlook for Miebo is particularly exciting for us.

Okay. Yes. So, operator, maybe just a quick few closing remarks. First and foremost, I really do want to thank my colleagues at Bausch + Lomb for delivering such a strong year and quarter, and I look forward to working with them in '25 to continue to deliver on our expectations. And then also a quick thank you to all of our customers and patients who rely on Bausch + Lomb to provide great products and continue to drive innovation. We look forward to keeping you updated and talk to you next quarter. Thank you.

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