Bausch + Lomb Corporation

Good morning and welcome to Bausch & Lomb's fourth quarter 2022 earnings call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your touchtone phone. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Mr. Art Shannon. Please go ahead. Your conference will be recorded after the tone. Apologies, just a technical issue. I am fixing something.

Thank you very much. Good morning, everyone, and welcome to our fourth quarter and full year 2022 financial results conference call. Participating on today's call are Chief Executive Officer, Mr. Joe Papa, and Chief Financial Officer, Mr. Sam Eldersuke. Additionally, incoming Chief Executive Officer and Chair of the Board of Directors, Mr. Brent Saunders, will provide remarks but will not address Q&A during the call today. 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 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 statement 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, 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, 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 Joe.

Thank you, Art, and thank you, everyone, for joining us today. Before we get into the results, I'd like to say a few words about last week's announcement that Brent Saunders will become Bausch & Laub's next CEO on March 6th. Brent has a long and esteemed track record as a healthcare industry leader, including as Chief Executive Officer of Bausch & Lomb from 2010 to 2013. I have personally known Brett for many years, and I am confident that he has the right skills and experience to lead Bausch & Lomb at this pivotal time in the company's history. Brett is here with us today, and I'd like to invite him to say a few words. It's my pleasure to introduce Brett Saunders, the incoming CEO of Bausch & Lomb.

Thank you, Joe. Let me begin by saying what an honor it is to have this opportunity and how excited I am to be here today. Bausch & Lomb was the first company I led as CEO, so in many ways, this feels like coming home. Ophthalmology and eye health are two areas that I care deeply about and have stayed close to due to Allergan's presence in the eye care space. I strongly believe that there is a great need in the marketplace for an integrated company that is solely focused on advancing eye health. and I'd like to thank the board for their trust that they have placed in me to grow this great company into the future. I would also like to thank Joe Papa and the entire team for further strengthening Bausch & Lomb's strong foundation and focusing the company's strategic priorities. I joined Bausch & Lomb because I believe in this company. I believe in its products, I believe in its people, and I believe there is a tremendous unmet need in the eye health space along with the opportunity to make a real difference through innovation. The overall eye health market is growing, driven by favorable demographic trends that are creating strong demand for eye health products around the world. As a company with great brand awareness, an amazing team, and a global footprint in approximately 100 countries, Bausch & Lomb is well-positioned to meet this demand by delivering on its mission to help people see better to live better. Bausch & Lomb has always stood at the forefront of cutting-edge scientific and technological optical advancements, and I believe continued innovation will be key to the company's success going forward. Finally, I want to recognize Joe Papa and thank him for all he has done to advance the eye health, safety, and wellness of patients around the world. I look forward to working closely with Joe in the coming weeks to ensure that we have a seamless transition. I'm grateful for the opportunity to once again lead this great company, and I'm eager to get started in just a few weeks.

Thank you, Brent. I appreciate those kind words. Let me conclude by saying that my years here with Valiant, Bausch Health, and Bausch & Lomb have been a truly memorable journey for me, and the successes we have achieved since I joined the organization in May 2016 are a credit to our outstanding colleagues around the world. Thank you for your tireless work, trust, and support in building Bausch & Lomb into a global company dedicated to protecting and enhancing the gift of sight for the millions of people around the world. Now let's cover the agenda for today's call. I will begin with an update on the separation process and a brief review of the 2022 highlights. Sam Meldesuki, our CFO, will then review the fourth quarter and full year financial results in detail and discuss our outlook. Finally, I will conclude by discussing the upcoming catalyst before opening the line for questions. Sam and I will be taking your questions today, and Brent will be available beginning on March the 6th. Beginning with slide five, as the most integrated eye care company operating today, Bausch & Lomb is uniquely positioned in the eye health market. Building on 170 years of success as a leading eye health brand, Bausch & Lomb is a company with the highest brand awareness in eye care. And as the third largest eye health company, Bausch & Lomb is a global leader in consumer eye health. Turning to slide six, we continue to see compelling opportunities for standalone Bausch & Lomb as a pure play eye health company. We believe the company is well positioned for growth in large, durable markets. We continue to see potential margin expansion over the long term, and we expect to have balance sheet flexibility to expand investment in the business. Substantial progress was made in 2022 towards the completion of the separation process. After filing a registration statement and launching the roadshow, we completed the IPO and began trading as a public company on the New York and Toronto stock exchanges on May the 6th, 2022. Importantly, Bausch and Lomb is not a guarantor of the debt of our parent Bausch Health. And on November 29th, Bausch Health made Bausch and Lomb an unrestricted under the Bausch Health debt covenant, which helps provide us with greater potential flexibility and one more obstacle to full separation. And as a final comment... We understand that Bausch Health continues to believe that the separation of Bausch & Lomb makes strategic sense and has stated that they're going to thoughtfully evaluate all the factors related to the B&L separation. On slide seven, our revenue grew organically by 5% for the full year 2022 and in the fourth quarter, making this our seventh consecutive quarter of organic growth. A few highlights to cover. First, continued momentum in key portfolios. Reported revenue of Occuvite and Prezavision grew by 10% versus 2021, and we are pleased to report that Occuvite and Prezavision U.S. market share grew by 170 and 120 basis points, respectfully, in 2022 compared to the prior year. Reported revenue of the BioTrue Solutions franchise also grew by 10%, and market share grew by 360 basis points in 2022 compared to the prior year. Next, investment in fast-growing categories. Lumify's U.S. weekly market share in the redness reliever category has reached 50%. We are seeing signs of a strong early launch in Canada, and we have recently acquired rights in an additional 18 countries for Lumify. Reported revenue for our CyHide daily lenses grew by 46% in 2022, and we are working towards multifocal and toric launches in 2023 and 2024. Finally, new product category expansion. We have completed six acquisitions or licensing transactions, albeit small transactions, since our IPO in May 2022, including the Synoculus Distribution Agreement and the AccuFocus acquisition. These transactions expanded our surgical portfolio, adding a minimally evasive surgical treatment for glaucoma and the ACE-ICA Apthera Premium intraocular lens, which I'll cover in more detail when we discuss our upcoming catalysts. In addition, we launched six new products in 2022, including Zypyr and Revive, along with our geo-expansion of Lumify and Visalta. To summarize, thanks to a great B&L team effort, we grew our organic revenue at a mid-single-digit growth rate in 2022. Our key brands have demonstrated their durability through challenging economic conditions, and we are making strategic investments in R&D and bolt-on acquisitions to expedite our future growth. Turning to slide 8, we have provided our guidance targets for 2022 along with key assumptions underlying them, and we are pleased to say that we have delivered against our latest guidance in 2022. And with that, I will turn the call over to Sam to cover the financial results in more detail.

Thank you, Joe. Before we get into the details, I'll remind listeners that when we talk about organic revenue growth, we mean on a constant currency basis. adjusted to remove the impact of acquisitions, divestitures, and discontinuations. Turning now to our financial results on slide nine. Our fourth quarter results demonstrate the continued momentum of our business and the durability of our diverse portfolio. Throughout 2022, we continue to deliver predictable and consistent organic revenue growth driven by the strength of our diversified iCare platform. Total company revenue of $996 million grew organically by 5% in the fourth quarter, marking our seventh consecutive quarter of consolidated organic growth. For the full year, total company revenue of $3.768 billion also grew organically by 5%. The business has now demonstrated solid organic growth in each of the last two years following the COVID downturn in 2020. The fourth quarter was the second consecutive quarter where we saw organic growth in each of our three segments. VisionCare up 5%, Surgical up 4%, and OptRx up 7%. This broad-based growth reflects a strong, durable portfolio we have established across our segments, which enabled us to perform despite macroeconomic headwinds on market volatility. We have continued to see volatility in foreign exchange, During the fourth quarter, FX headwinds impacted revenue by approximately $54 million. Adjusted EBITDA was negatively impacted by approximately $80 million in the quarter. We are encouraged by the COVID policy changes in China and the consumer sentiment towards a full reopening. However, the mobility restrictions in the early part of Q4 and the rising number of cases in the latter parts of the quarter have highlighted the stop-and-go nature we have seen throughout the year. Our top-line results were negatively impacted by 200 basis points in the fourth quarter and 150 basis points for the full year due to economic conditions in China as the country's COVID policies evolved. We will continue to monitor the pace of the recovery, and now we believe that the China market has a path to return to stable growth over time. Now let's discuss the Q4 and full-year results in each of our segments. Vision Care revenue was $626 million in Q4, up 5% organically, driven by strong growth in our key franchises. Total revenue for the segment in 2022 was $2.373 billion, up 6% organically year-over-year. The consumer portfolio continued its market leadership position with momentum in our strategic brands. Lumify reported revenue grew by 25% in the fourth quarter, and the brand achieved a market share of approximately 50% in the redness reliever category. We continue to execute our strategy to grow the Lumify brand. The launch in Canada is off to a strong start, and our plans for geo-expansion and line extensions are on track. Fourth quarter revenue from our iVitamins, Preservision, and Ocuvite grew by 13% on a reported basis and 16% organically. This market-leading franchise continues to demonstrate the ability to drive growth in the AMD market. We expect our recent launch of PreserVision OcuSorb and our upcoming launch of PreserVision CoQ10 to continue the momentum. While consumers have faced pressure from higher inflation and potential economic uncertainty, we have not seen broad fundamental changes in the segment. Consumers continue to prioritize trusted brands and reward innovation, We have been able to leverage our strong consumer brand equity to execute on our pricing strategy, and we expect to continue to balance the pricing and volume dynamic in the coming quarters. We also saw continued growth in our key contact lens franchises. Reported revenue from our DailySci high portfolio grew by 85% in the fourth quarter versus the prior year, and 46% on a sequential basis. Revenue re-accelerated towards the back end of Q4, following increased activities to expedite the lower than expected production output that we have recently experienced. We're continuing to see a ramp up in production, which is in line with our expectations, and we expect the output to continue to increase going forward to meet strong market demand. We are also looking forward to our multifocal launch in the U.S. to potentially accelerate momentum in 2023. Revenue from Bausch & Lomb Ultra grew by 2% in the fourth quarter on a reported basis and 9% organically. And revenue from BioTrue one day grew organically by 6% in the quarter and was flat on a reported basis. In the quarter, U.S. contact lenses grew organically by 7% and international sales organic growth was up 3%. The dynamic nature of the recovery in China continues to have a more pronounced impact on our lens portfolio, where we are more heavily indexed to the China market. Excluding China, the global lens portfolio grew organically by about 7%, both for the quarter and for the full year. Moving now to the surgical segment, fourth quarter revenue was $188 million, an increase of 4% organically. Implantables grew by 13% organically in the fourth quarter, driven by premium and standard IOLs. We continue to see momentum in our Invista IOL franchise, and we're seeing an increasing contribution from our Luxmark premium lens. The premium IOL category is a strategic priority for us, and we expect growth to continue as our premium product offering expands. We also saw the demand for our consumables continue in the quarter up 3% organically, mainly driven by an increase in cataract and retina procedures. Our equipment revenue is down approximately 5% organically in the quarter. We continue to see strong market demand, especially for our Stellaris system. However, growth was impacted by availability of supply of certain components. We are mitigating the supply constraints by spot buying certain components from secondary vendors, and we expect an improvement in the coming quarters. Overall, the surgical segment grew organically by 8% in 2022, driven by the strong growth in consumables and implantables. The markets have continued to recover throughout 2022 and work through the substantial backlog of procedures created by COVID. We expect the backlog to continue to be a tailwind for some time. as the market matches staffing constraints and procedure volume capacity. Finally, we announced the acquisition of AccuFocus in the beginning of this year, which brings breakthrough IOL technology to our surgical portfolio. This acquisition was funded with cash on hand. Approximately $31 million in cash was paid in the first quarter of 2023. The AccuFocus IOL was launched earlier this year and allows us to build our portfolio in the premium IOL category. While we do expect the revenue contribution to grow over time, we do not anticipate it will have a material impact on our financial results in 2023. Last, revenues in the OptoRx segment were 182 million, representing organic growth of 7% driven by the U.S. portfolio. Byzolta TRX has grew by 18% in the fourth quarter, and we continued our geo-expansion strategy by launching in Brazil, Turkey, and the Middle East. We are approaching the first anniversary of Zypera's commercial launch in the U.S., and we have filed Zypera in Canada. We're actively capitalizing on comparison supply issues within our U.S. generics portfolio, and we are continuing to progress towards the PDUFA date of June 28 for NOVA III. We expect to support the incremental launch activities throughout 2023, with the level of investment increasing during the third and fourth quarters to position Novo 3 for optimal future growth. Similar to other parts of the B&L business, we have also seen the COVID recovery in China create a headwind to revenue growth in our international opto portfolio. Growth in the ophthalmology segment for the full year was impacted by LOE-related headwinds in the earlier parts of 2022. We do not expect LOEs to have significant impact in our portfolio, but we expect the Prolenza LOE in late 2023, which mostly will impact 2024. Now that we have covered revenue for each of the segments, let me walk through some of the key non-gap line items on slide 11. As a reminder, given the timing of the IPO, the 2021 results were not fully burdened by all the standalone costs associated with the separation. Adjusted gross margin for the core was approximately 58%, a decrease of 190 basis points compared to Q4 2021. The change in gross margin was driven by macro headwinds, including higher cost of energy, shipping, and labor, along with pockets of limited supply availability that required spot buying from secondary vendors to meet market demand. Fourth quarter gross margin was also impacted by an incremental cost of approximately $7 million related to accelerating the output ramp-up of data-side high lenses. This amount is in addition to the $15 million we previously estimated in the third quarter. The data-side high production output improved substantially in the latter part of Q4, which led to the 46% sequential data-side high revenue growth and enabled us to be on track to reach our target production levels for 2023. As we continue to accelerate the production output, execute our planned geographic expansion, and the planned launch of the multifocal lens, we expect the DailySight High to be an important catalyst for growth in 2023 and beyond. Fourth quarter adjusted EBITDA was $181 million. The adjusted EBITDA in Q4 was mainly impacted by currency headwinds of approximately $18 million. an incremental $8 million investment in R&D to accelerate our pipeline strategy, and gross margin headwinds, including the $7 million impact related to accelerating the daily site high production. In the fourth quarter, adjusted SG&E was flat year over year. While we continue to prioritize investment in value-enhancing activities, we have also maintained a cost-discipline approach by taking steps to reduce our operating costs. Over the longer term, we maintain our strategy to drive margin expansion by expanding our portfolio of premium products, continuing to build scale, investing in our product launches, and leveraging our global infrastructure. Lastly, adjusted EPS for the quarter was 23 cents. Moving on to the cash flow and balance sheet summary on slide 15. Adjusted cash flow from operations was 167 million in the fourth quarter. bringing full-year adjusted cash flow to $383 million. This includes the impact of strategic inventory build throughout 2022 to mitigate potential supply chain disruptions. Fourth quarter CapEx was $50 million, bringing the full-year CapEx to $175 million. Our debt outstanding is $2.488 billion, which equates to a net leverage ratio of 2.93 times. As Joe mentioned, On November 29th, Bausch Health announced that BNL became an unrestricted subsidiary of BHC, which means BNL is no longer subject to the debt covenants under BHC's outstanding debt. We view this as a positive step towards the expected full separation. Total interest expense for 2022 was $146 million. Our interest expense for the fourth quarter was approximately $47 million. We expect interest expense to be approximately $215 million for the full year 2023. The increasing interest expense reflects a rising interest rate environment. As a reminder, we have an interim capital structure in place with interest expense at the variable rate of so far plus 3.25%. Upon full separation from BHC, we plan to refinance our debt and transition to a longer term capital structure. As a standalone company, we expect to have a more favorable credit profile and potentially lower cost of debt. Year-end cash and cash equivalent and restricted cash was $380 million. We had undrawn revolver of $500 million at year-end, and we have no borrowings under the revolver as of today. We are confident in our strong balance sheets and cash flow, which gives us the flexibility to pursue value-enhancing investment opportunities. Finally, our adjusted tax rate for 2022 was 2.25%, and we expect our adjusted tax rate to be roughly 6% in 2023. Turning now to slide 17. Given last week's announcement that Brent Saunders will become our new CEO on March 6th, we are planning to provide full year 2023 guidance when we report our first quarter earnings. This will give Brent the opportunity to provide input on our go-forward strategy and financial outlook once he transitions into his new role. Today, I will share some color on our expectations for the first quarter of 2023. We expect Q1 2023 organic revenue growth to be in line with the overall ICARE market growth. While we're not providing full year guidance at this time, we would note that we expect quarterly phasing to be an important consideration. We expect the first quarters to be lower than Q1 2022, mainly driven by currency headwinds, the pace of recovery in China, and macro factors leading to gross margin pressure. Based on current exchange rates, we anticipate FX headwinds to first quarter revenue of approximately $35 million. We also expect headwinds to adjust to EBITDA of approximately $10 million in Q1. The higher cost inventory we built in 2022 will increase pressure on gross margin as it flows through the P&L. mainly in the first half of 2023. We expect our first quarter adjusted gross margin to be approximately 130 basis points lower than in Q1 2022, mainly due to higher cost of inventory. Keep in mind that the comparability between 2023 and 2022 will be impacted by the timing of the BNL IPO. The 2022 first quarter financial statements were prepared prior to the BNL IPO in May 2022 and do not reflect the full run rate standalone costs. These incremental costs are approximately $15 million in the first quarter. Along the same lines, the basis of interest expense and taxes reported in the Q1 2022 financial statements also does not fully reflect the BNL operations as a standalone entity. In summary, We're pleased with our overall 2022 performance of 5% organic revenue growth, which was at the high end of our guidance range. The fundamentals in the eye care market continue to be strong, and we are excited to launch more than 15 products in 2023. We expect to support the incremental launch activities throughout 2023, with a key focus on accelerating our investment in Novo 3 during the third and fourth quarters to position it for optimal future growth. We look forward to providing our full-year guidance for 2023 when we report our first score results. Now back to you, Joe.

Thank you, Sam. I'll now comment on some of the upcoming catalysts we are anticipating. On slide 19, Lumify is a strong, established $125 million plus brand with reported revenue growth of 21% in 2022 compared to the prior year. In the U.S., Lumify is the number one physician-recommended brand. Redness Reliever in the category with approximately a 50% weekly market share. Building on the phenomenal success of this product and using the power of our BNL fully integrated iCare platform, we are planning to expand the brand geographically and through line extensions. Lumify is now launched in six countries, and we recently acquired the rights for 18 additional countries. In addition to geographic expansion into new markets, We're expanding Lumify's beauty positioning to a specialty eye care and have a number of new products planned, including a line scientifically developed for the sensitive eye area to help enhance the eye's natural beauty, which we expect to launch in the first quarter of 2023. We expect to submit our single-dose preservative-free eye drops in the second quarter of 2023 and a combination product with ketotifin for allergy symptom control in the first quarter of 2024. Turning to slide number 20 for an update on the expansion of our daily SIGCHI launch, we have launched the spherical lenses in approximately 25 countries to date and expect about five additional spherical country launches coming in 2023, including China. We also anticipate the launch of the multifocal and toric lenses in the 2023-2024 timeframe. These additional launches are expected to be key drivers of future growth. Looking back at 2022, we are pleased to report 46% reported revenue growth compared to 2021, including 85% reported revenue growth in the fourth quarter compared to the fourth quarter of 2021 due to a great work by our supply chain to increase output from our manufacturing line. Importantly, the growth we are seeing is not resulting in significant cannibalization as 70% of the spherical lens starts in the U.S. are sourced from competitive lenses. I'd like to spend a minute on the recent enhancement of our surgical portfolio through the acquisition of AccuFocus. First, on slide 21, AccuFocus ICA aperture intraocular lens is a breakthrough in small aperture IOL technology. The lens was approved by the FDA in July of 2022 as the first and only small aperture non-torque extended depth of focus IOL for certain cataract patients who have as much as 1.5 diopters of corneal astigmatism and wish to address presbyopia at the same time. This innovative premium IOL is available in select markets across Europe, as well as Australia, New Zealand, Singapore, and is now launching in the U.S. From our perspective, this acquisition is a synergistic fit for B&L. First, it fills a gap in our portfolio by providing us with our first eat-off lens in the U.S. Second, it fits strategically within our current infrastructure without requiring a lot of additional resources. And finally, It's the first IOL of its type used for aberrated corneas, which brings additional doctors and their patients to our platform. On slide 22, we show the breakthrough design of the embedded filter ring component, which delivers high optical quality light to the retina and filters out distorted low optical quality light, providing a clear, continuous range of vision. We see a substantial market opportunity for this innovative design. The global premium cataract IOL market is projected to grow at a 13% CAGR between 2022 and 2027. On slide 23, we show the ongoing geographic expansion of our IOL portfolio and the expected timing of the upcoming premium IOL launches. Our near-term focus is on launching these premium IOLs in North America and the EU, followed by the Asia-Pacific region. In addition to the U.S. launch of the IC8 up there IOL, which is ongoing, we are preparing for the anticipated 2023 launch of the Bausch & Lomb Aspire, the Invista extended-range monofocal IOL in the U.S. and Canada, followed by the EU launch expected in 2024. We are also planning for the anticipated 2024 launch of the Bausch & Lomb Envy, the Invista trifocal IOL in the United States, Canada, and the EU as we further our strategy to grow in the higher margin categories. Turning now to slide 24, as we mentioned earlier, We now have a June 2023 PDUFA date for NOVO3, a potential first-in-class treatment for dry eye disease associated with meibomian gland dysfunction. If approved by the FDA, we expect to launch NOVO3 in the second half of 2023. We also plan to file in Canada in the first quarter of 2023. Dry eye disease is one of the most common ocular surface disorders. And while it affects approximately 36 million Americans, only about half are diagnosed, and only about 1.2 million patients are treated with a prescription medication. Novo3 is expected to address the evaporative dry eye, which is an unmet need in approximately 90% of dry eye disease sufferers. This is a fast-growing market with unmet patient needs. From 2016 to 2021, The U.S. prescription dry eye market grew at a compound annual growth rate of approximately 24% and expect double-digit growth from 2021 to 2027. Given the current market for dry eye disease treatment and the results of two Phase III studies, we believe that NOVA III has the potential to be a major future growth driver for our business. On slide 25, we have outlined the opportunities we have in high-growth, high-margin categories. First, in vision care. We are adding to our well-known product lines and pursuing a geo-expansion opportunity for our key product franchises. In the OptoRx business, we are launching and expanding the launches of high-margin pharmaceutical products like Zypyr, Bisalta, and Novo3. And in surgical, we are shifting our portfolio to premium categories. And our investments in premium IOLs and technological advances are poised to grow that portfolio. All this work is supported by our M&A strategy, which we have deployed to strategically enhance our portfolio and fill gaps. Since our IPO of May 2022, we've completed six acquisitions and licensing transactions to enhance our pipeline. And thanks to the efforts of our R&D and business development teams, we expect to launch more than 15 products in 2023. Slide 26 outlines the three main areas of our strategic focus for the years ahead. Number one, continuing the momentum in our current portfolio. Number two, investing in categories that are growing faster than the overall IHOP market. And number three, expanding into brand new product categories. To highlight a few, we're expecting another year of organic revenue growth in fiscal year 23, driven by continued strong performance in key franchises, geo-expansion, and line extension opportunities and market share gains. We continue to invest in innovation and anticipate more than 15 launches in high-growth markets in the coming year. These include the continued rollout of our SightHight daily lenses and the expected launch of Novo 3. And lastly, expanding to new categories with our new Lumify products, premium IOLs, and the 3D microscope and eye intelligence platforms. To wrap up on slide number 27, our fourth quarter and full year 2022 results demonstrate that our business is continuing to deliver strong performance. Our team remains focused on continuing to generate momentum in our key products, investing in fast-growing categories, and expanding into new product categories. Looking ahead, continue to believe that Bauschalant is well-positioned for success as a standalone, pure-play eye health company. And finally, I'm grateful that I'm leaving the company in the hands of an incredible leader, and I wish Brent, the senior leadership team, and the 12,000-plus employees of Bausch & Lomb all the best in the future. With that, operator, let's open up the line for questions.

Thank you very much. We will now begin the question-and-answer session. To ask a question, you may press star, then 1 on your touch-tone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star, then two. We will be taking one question at a time to allow for everyone to have the chance to ask questions. At this time, we will pause momentarily to assemble our roster. Thank you. Your first question is coming from Craig Bijoux of Bank of America. Craig, your line is live.

Good morning, guys. Thanks for taking the questions. Let me, I guess I want to ask about EBITDA margin in 23, and obviously you had some headwinds in Q4, and you're not providing guidance for the full year. But Sam, maybe you can walk through some of the puts and takes that are going to affect the EBITDA margin, kind of looking at the headwinds, the macro headwinds that you're seeing, if they're going to get better. And then Sam, do you still have an ability to expand margin in 23 relative to where you ended at 22?

Good morning. So let me take the question in different parts here and maybe stepping back and just looking at what we have done through 22 and what we have communicated as we got B&L to stand alone after the IPO was we outlined a roadmap of how we think about our business And one of our immediate steps was to continue to drive top-line growth in a consistent and durable way. And you've seen that, and I highlighted that in my remarks this morning, that we've seen seven consecutive quarters of organic growth. Also, we've highlighted that Q4 was the second consecutive quarter that we've seen all our three segments growing. And that's an important factor here because now you're seeing that our businesses, especially the opto business, have pivoted from or moved from discussions around LOE to focus more on growth and positioning them for what is coming next in 2022, which is the pedofa of NOVA III and the launch of NOVA III. Now, there's a number of levers when you think about where we think about our margin and how margin progresses for us as we go forward. The first one was really the shift over our portfolio to more of a premium category. And that's really very pronounced in our surgical business. We've seen the steps that we've taken in 2022 to be able to introduce LensSmart in Europe. It's a premium IOL. We've also completed the acquisition of AccuFocus, which we're very excited about. It will give us the opportunity to be able to go forward with another premium IOL in the U.S. And also, we spent more in 2022 behind R&D to be able to expedite our pipeline and bring our own IOL, which we expect to come in in 2024. And also the other lever that we talked about quite a bit was the scale in our lens business and building up that scale. And we've seen the steps that we've taken through 22 with our daily site high-end Although we did have the output challenges that I spoke to last earnings call in November, we actually did put our focus and spend behind it to be able to get the output to where we want it to be. So we are seeing that nice improvement and a 46% sequential output growth that we've seen between Q3 and Q4. That's really something very encouraging. And that's meeting our end market demand. So we're seeing that step moving forward and positioning us very well for 23. as we think about building up the scale for infused and subsequently the launch of multifocal in the U.S. And then the last part is on the opto piece, which is I did already talk about sort of pivoting to the growth, but NOVO3 is a critical part of our story for the pharmaceutical business. And we're very excited to position it for a launch in the second half of 2023. We think we will invest behind that launch and we'll be able to have a successful position for NOVA III as we go forward. In terms of a couple of things between Q4 and I highlighted in Q1, we've seen, I'll call it a short-term pressure on gross margin. And part of that is we've seen inflation play a factor for us throughout 22, both on the cost of labor, cost of shipping, and utility costs. And we've seen that work its way through 22. We've built a fair amount of inventory to be able to secure against supply chain constraints. And we will have to just let that inventory work its way through, which we expect it to be in the Q1 and maybe a spillover into Q2 of 23. But that will have a short-term pressure on the gross margin as we go forward. But that's three. I just want to give you all the different pieces of how we think about the margin.

Maybe I agree with absolutely everything Sam said. The only thing maybe I'd add to it is just on that last point. The positive is that over time, the operational efficiency of our teams, like on Sci-Hi dailies, we believe will improve. A simple example, the supply chain team has installed all of our Sci-Hi capital equipment. They validated it. They're ramping it up. But we know that output and yield will get better over time. In year one of any new piece of equipment like that, you may only get a 60% yield out of it. by year two and three, it'll go 70%, 80%, and then at some point above 80%. So that will also add to the comments that Sam has in terms of the operational efficiency over time. I'm not trying to suggest right now, but over time that will also help with your question of 23 and beyond.

Just following up on that, guys. I mean, can some of those positives offset some of the negatives or the pressures in the You know, the positives in the second half offset some of the negatives in maybe the first half so that we see expansion for the full year.

Yeah, and Greg, we'll have more to say on this in the first quarter when we give guidance for the full year of 23. But the way I would think about those levers that I spoke to, it's important to keep in mind that they're not all linear in terms of how they will actually play out. So I think they will play out over time, as we said in the past. I think the other part that I would just point you to is, again, back to the NOVA III. NOVA III is an important launch. I did make comments on it in my remarks this morning that we are going to be making sure that we spend behind NOVA III in terms of the launch, and we'll see that accelerate as we go forward into 2023. Okay.

Operator, we have our next question. Thanks for all the color. Oh, thank you. Sorry, Joe. Thank you very much. Operator, next question, please.

Your next question is coming from Cecilia Furlong of Morgan Stanley. Cecilia, your line is live.

Great. Good morning, and thank you for taking the questions. I wanted to ask just your underlying assumptions for Q1 and stated expectations to go in line with the market. If you could talk just about how you're thinking about China, recovery there, surgical, any impact from some of the backlogs and cataracts. And then also, just as you're thinking about the daily CyHi growth, that we saw in 22, how you're thinking about your relative growth versus the overall side high market in 23 in the first quarter.

So let me take the first part of your question. As we think about the market growth, we always think about the market growth is roughly about mid-single digits. So that's how we think about it from our perspective. I think there's different data points that we look at and probably the same data points that everyone looks at as well. So we think the mid-single digits is probably a good way to think about it. In terms of China, we're very pleased with what we've seen in China thus far in terms of reopening. And we think it's a very positive step as you move forward. However, when you step back and you look at how sort of the process in China shifted from a complete lockdown restrictions to a full opening, you probably have to look to places like the U.S. or other parts in Europe where you see as a proxy how actually the reopening after COVID took place. And what that educated us in terms of understanding the rise in the cases, and that would result in more quarantine time, also does result in potential shortages in labor, as well as special impacts on the healthcare system within China. So we will expect that to be a short-term pressure that we will probably start to see some of that in Q4 2022. We expect that will be a spillover into 2023, at least in the early part. But we expect also a gradual improvement in China as we go forward. So overall, long-term, we think it's very positive momentum in terms of where China is heading.

I'll take the backlog portion for cataracts. You're absolutely correct. It's there. It exists. It goes back to COVID. I think many of the centers that are doing cataracts around the world have attempted to try to catch up. They've had some staffing shortages. But just order of magnitude, you know, in the United States, 4 million cataract procedures. We lost probably about 15% of the procedures. We are clearly making up for that. And we are seeing, as Sam was saying, the opportunity for a cataract surgery implantable IOL growing somewhere in that almost double-digit range, at least that's what the external sources are saying, and we're certainly looking at that opportunity in terms of what we're seeing there. So I guess that gives you kind of our view on the backlog. One of the things that, it's a related question, is we looked historically at what happens in potential times of recession, and we have not seen any real input impact on the recessionary times. So I don't know what exactly will happen with that, but certainly we think that the need for cataract surgeries will continue going forward. I think there's a second part of the question was about the psi-high growth versus the market in the first quarter of 23. As Sam said during his comments, we absolutely see psi-high growth continuing in terms of that kind of growth that not only that we saw last year, we talked about what we saw with our INFUSE, the revenue was up 46% versus the 2021. In our fourth quarter, we had about 85% growth versus the fourth quarter of 21. So we continue to see tremendous demand for CyHi dailies and especially our new INFUSE based on what we've been able to do with INFUSE by putting Osmoprotectus and electrolytes into the formulation, giving patients all-day comfort. We expect to see continued strong demand for our infused and for the entire daily market. Operator, thank you.

Thank you for taking the question.

Operator, next question, please. Thank you.

Your next question is coming from Matt Mixit of Barclays. Matt, your line is live.

Hi. Thanks so much for taking the question. I had a question on how you're thinking about Outlook this year, understanding you're only providing color on Q1 and then bit of a longer term question on on the outlook um wondering if you could give us a sense of um you know what sort of variables you see as you're thinking about the whole year guide um in terms of top line uh or or cadence of the top line that that's a that's a consideration or you know i assume that some of the headwinds and componentry and inflationary costs are part of this constructing of a new outlet for the year, but just maybe some of the bigger puts and takes on top and bottom line, then I have one follow-up.

Let me just, I'll just hit the first part about, you know, why we're going to wait until May, and then, Sam, you can take some of the variables. Obviously, I hope everyone understands that as we announced Brett Saunders joining the company, I'm last week and then obviously it started the CEO on March 6 we really wanted to get Brett a chance to really you know get into the numbers and all the things that we are putting forth in terms of our process so it gives him a chance to do that we'll have a chance to talk more in May but we clearly believe you know Brett was the right person to take on this role and And importantly, he comes both with the knowledge of working with other companies, but also we're very much beneficial is that he has a past history at V&L. So we think clearly he's the right person. But, Tim, why don't you talk a little bit more about the outlook, some of the puts and takes on that?

Sure. And good morning, Matt. And maybe I'll start with the top line and just think about it from all three different segments here. And when you think about our vision care segment, and I think a big part of our vision care segment is within our consumer business, And we've seen a really good progress in terms of what the growth rates that we've seen in both the consumer brands and the expectation of what we will do from line extensions, as well as geo-expansion in the consumer business. So you see that we've got IQVI Preservation was growing very nicely throughout 2022. We've seen also Lumify continue to demonstrate very nice growth in 2022. And you expect that momentum to carry forward with us as we go into 2023. From a lens perspective, I think probably the highlight is we talk a lot about daily side high, but we're also seeing nice growth in both Ultra and BioTrue. And they are the base brands as well. So we're seeing growth on both all three different brands or families that we have in our lens business. And we think about the side high side of it. The 46% sequential growth, I re-highlighted that because it's an important factor of how you start thinking about 2023 because you're seeing that we did have the challenge with the output and meeting the end market demand in the second half of 22. So we're able to really do a nice job with the supply chain team. They've done a fantastic job to be able to get us back to where we need to be. And right now, we're actually ramping up that demand and positioning us very well for 2023 as we go forward. On the surgical front, really, when you think about surgical, about I'll call it, 70% of the portfolio is staying between implantables and IOLs, and those two parts have been growing very nicely in 2022, and we expect with the comments that Joe made earlier regarding the backlog and the surgical procedures, that that will continue. On the equipment front, we've seen it down in 2022, but I think we are working through the number of the supply constraints that I highlighted in my remarks. I think that will continue to gradually improve as we go forward. So just on balance, you'll see between the two of them, you'll see that overall we expect the surgical business to continue to perform pretty well. And then the last one, the ophthalmology, it's really a very good story in terms of pivoting from the LOE. And again, it's going to be an investment here for ophthalmology. We launched this idea last year. We're now expanding between Zypera and Visulta on a geo-expansion, and we're focused to push forward more on expanding beyond that with the NOVA III launch in the second half of 2023.

That's super helpful. Just to follow up on Surgical and some of the launches that you talked about in premium IOLs towards the end of the year, I guess, as we... Think about the cadence of those and the impact on growth, but also importantly, margins. Two things, I guess. One is, how do you see yourself as positioning to take share in a market that you've been a little bit behind in relative to your large competitors in the US in particular? What's your You know, what's the edge of the strategy or the product differentiation to do that in particular? And then is that a, you know, mid-24, late-24, you know, where we start to see some of the margin benefit of these things coming through mix? Or, you know, what's the cadence of the margin lift that you hope to achieve through these products? Thanks.

Yeah, I'll start, and Sam can add in. I think I left out. But I think it comes down to a couple things. Number one, As we launch these premium IOLs, we clearly believe that we're coming forward with new innovation. The easy, easy example is what we just did with acquiring the AccuFocus, where it's a very specific technology that we will have and that we will be able to bring to the marketplace. And at least as we've seen so far, very early, I will caveat that, but we've seen great response from the physicians, the KOLs that have implanted the lenses. But I think that's certainly one simple example. I remind you, we've done the same thing with our Lux Smart or Lux platform. Predominantly, that's around the world, but we put that forth outside the US and to Western Europe, Central Europe, Israel, and then continue to add it to Latin America, Russia, Iran. A lot of things that we're doing there in terms of our Lux Smart portfolio. I think we're in like 20 countries or thereabouts. also clearly i think you know as part of this in terms of the margin i i think you realize that the you know we'll sell a monofocal ios for somewhere in the 100 150 per lens whereas the premium lenses are somewhere in the let's call them 750 to a thousand dollars per line and the cost of goods is not that dramatically different so that's obviously going to help that that margin opportunity for for the long term uh but to to the slide that i have in the deck um i get the exact page here but There really is a focus there on what we're thinking about in terms of doing some things starting in 2023, bolting on these additional assets like the AccuFocus, and then 24 and 25 will be the continued delivery on the platform. Our view is this integrated strategy we have at Bausch & Lomb. The reputation that Bausch & Lomb has will help us as we go forward with what we believe are quality lenses, quality IOLs for patients. And I think those relationships with doctors will really help us over the long term. Sam, other comments you want to add?

Yeah, and Matt, I just want to maybe remind you of comments I made previously is when you think about launches as well, it's important to think about how that launch translates between top line from the time of launch to the margin. And on average, depending on what product you're launching and where you're launching that product, anywhere between 18 to 24 months before you start seeing that sort of the impact of that launch start to translate to a meaningful impact on that margin because you're investing behind that launch as you prepare for and you go forward with it right super helpful thank you operator our next question please certainly your next question is coming from Vijay Kumar of Evercore ISI Vijay your line is live hey guys thanks for taking my question

I had two-parter, and I'll ask them up front. First on margins here, your Q1 gross margins, that's a pretty big sequential step up from Q4. What drives the Q1? What are you assuming for pricing and inflation? And my second, below-the-line items, when I look at interest expense, FX losses, is that something that's – expected to sustain here or any changes below the line. Thank you.

Yeah, so, Vijay, let me take the first part of your question first. When I think about the margins and we think about Q1 23, one of the things I did highlight is we're seeing a couple of things on the margin is you're seeing the inventory working its way through that was built in the second half of 22. You're seeing that working its way through the P&L And because of just the way inflation played out, we've seen inflation ramp up throughout 22. It starts to moderate towards the end, but you're seeing at a higher rate. So you're building up inventory with higher costs, and you're working that inventory through the P&L, and that will give you an impact on the margin in Q1 as you start thinking through it from that perspective. There's other elements. Obviously, you see the top line. We talked about the market growth in Q1, so we expect that. And we expect also the fact that we're ramping up the benefits of the data size with the ramp up in scale. That's going the flip side of the margin pressure and giving an opportunity as you go forward in 2023. In the second part of your question regarding below the line, the most notable item that we've seen below the line in Q4 was the $18 million of currency headwinds. That was something that it really impacted us in the later part of Q4. And what we saw in currency throughout 22 was really the volatility of the currency and hitting the peak in the second half of 22. One unique factor we saw was that all currencies were relatively moving in the same direction with the USD. But then we started to see also with the USD sort of weakening towards the end of the year, we started to see movement in currencies happening not all the same magnitude and not all in the same direction. So we've seen different currencies moving. As I reminded you in the past, we are naturally hedged in certain currencies within our P&L. So when you start seeing some movements across currencies, that does have an impact for us in the P&L that will be more pronounced in the EBITDA than on the top line. That's why it's here on the bottom line.

The only thing I'd add, Vijay, is that you asked about pricing, and I did want to just comment that similar to 2022, We did take mid-single-digit price increases in selected markets, specifically for the OptoRx business, our contact lens business, and our consumer business. Mostly we looked at those markets that were impacted most by inflation as we looked through and made decisions on our pricing. But we did take what I refer to as mid-single-digit price increases. Now, please realize that, for example, in our Opto business, if we take a mid-single-digit price increase, not all of that drops to the bottom line. Some of that, of course, does not. Usually I think about whatever price increase I take, I usually get in the opto side something about half of that that goes to the bottom line. So just to give you some sense on that part of the question of pricing. I'm ready. We have time maybe for one more question.

Okay. No problem. Your next question is coming from Joanne Wunsch of Citi. Joanne, your line is live.

Thank you very much, and good morning. Novo3 gets a lot of attention, and I appreciate the Pedeva date in June and the launch at the end of the year and the large market opportunity. But how do you think about it ramping and contributing in the early days as well as how it will launch? And I'm looking for an idea of penetration rate and salespeople that may or may not be needed, and is it just a switch that flips and sales go?

So I think when we start with the first part of your question, we are very excited about Novo3. We think that the opportunity here for Novo3 to help millions of Americans who have dry eye disease, especially now that we have some data that shows the impact on the meibomian gland dysfunction for dry eye disease, we think is very exciting. So if we get approved by the FDA, we're really excited about what that opportunity will be for us. As it would relate to the question of ramping, I think, as you know, With new product launches, there's always some type of formulary process that we will go through. We've already started that process of working with the market access and managed care teams to think through the opportunity. We do believe this myeloma and gland dysfunction is an important part of that question, simply because at this time, there's no other products that have that specific pharmaceutical application of the evaporative side of dry eye disease. where we believe somewhere about, as I said in the call today, about 90% of patients have the evaporative dry eye disease. So we do think there's a big opportunity. We will also state, though, that we will need to work through market access, managed care to gain that formulary position. But we think the data is compelling. The data says that the product works based on two phase three clinical trials, and it could start working as early as day 15. We think that's important to patients. So we're excited about that. Relative to the actual part of the question you asked was the actual number of sales reps. And we feel good about the number we have today. We will reallocate them, of course, from other products. But we do feel very good about our capabilities. And teams have been building up not just sales rep capabilities, but also working with key opinion leaders, working on this meibomian gland dysfunction in terms of a concept with the KOL. So a lot of activity. We're excited about it. It will take a while to ramp up, but long-term we see this being a very important product for us.

Thank you very much.

Everyone, that concludes our call today. Thank you very much for your interest in Bausch & Lomb. We look forward to talking to you over the next several days and weeks ahead. Have a great day, everyone.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.