Alcon Inc.

Greetings and welcome to the Alcon third quarter 2024 earnings conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Dan Craven, Vice President, Investor Relations. Thank you, sir. You may begin.

Welcome to Alcon's third quarter 2024 earnings conference call. Yesterday, Alcon was alerted that our third quarter earnings press release and interim financial report were inadvertently posted early to our investor website. We immediately accelerated our disclosure process. The NYSE briefly halted trading pending the issuance of the release. Trading was resumed on the NYSE shortly after the release crossed the newswire. In addition, earlier today, we also posted a supplemental slide presentation on our website to enhance today's call. You can find all these documents in the Investor Relations section of our website at alcon.com. Joining me on today's call are David Endicott, our Chief Executive Officer, and Tim Stonecipher, our Chief Financial Officer. Our press release, presentation, and discussion will include forward-looking statements. Please note that we expressly disclaim any obligation to update forward-looking statements as a result of new information or future developments, except as required by law. Our actual results may differ materially from those expressed or implied in our forward-looking statements, and as such, you should not place undue reliance on any forward-looking statements. Important factors that could cause our actual results To differ materially from those in our forward-looking statements are included in our Form 20F, Earnings Press Release, and Interim Financial Report, which are all on file with the Securities Exchange Commission and available on their website at sec.gov. Non-IFRS financial measures used by the company may be calculated differently from and may not be comparable to similar measures used at other companies. These non-IFRS financial measures should be considered along with but not as alternatives to the operating performance measures as prescribed per IFRS. Please see a reconciliation between our non-IFRS measures with directly comparable measures presented in accordance with IFRS and our public filings. For discussion purposes, our comments on growth are expressed in constant currency. In a moment, David will begin by recapping highlights from the third quarter. After his remarks, Tim will discuss our performance and outlook for the remainder of 2024. Then David will wrap up, and we will open the call for Q&A. With that, I will now turn the call over to our CEO, David Endicott.

Thanks, Dan, and thanks, everyone, for joining today's call. I'm pleased to report another solid quarter with sales of $2.4 billion and sales growth of 6%. Core diluted earnings were $0.81 per share, which grew 25%, and core operating margin was 20.6%. Additionally, we generated $1.3 billion of free cash flow in the first nine months of this year, which is a record for this company. These results demonstrate our ability to continue to outpace our markets, driven by our broad geographic footprint, our innovative portfolio, and our category leadership. In addition to our ongoing focus on operational excellence, this quarter we continued to prepare for a series of product launches that will drive growth. We intend to discuss many of these in detail at our upcoming Capital Markets Day this March. Today I'll start with our recently announced launch of Precision 7. Precision 7 is a new one-week replacement contact lens that provides 16 hours of outstanding comfort and precise vision even on day seven. Most optometrists agree that a one-week replacement schedule is more intuitive for patients as compared with a two-week schedule. The 2E category is well established and represents a meaningful growth opportunity for us. Precision 7 offers a breakthrough in comfort by leveraging our proprietary Active Flow system. Active Flow is a unique combination of a moisturizing agent embedded in the lens and a replenishing agent that continually releases moisture to the surface over seven days. Select optometrists in the United States began fitting both the SPHERE and the TORQ modalities earlier this year, and feedback has been extremely positive. We plan to make this lens fully available in the U.S. beginning in January 2025, with markets outside the U.S. to follow later. At Tourney Docular Health, where we have several exciting developments, I'll start with Sustain, the world's leading over-the-counter artificial tier. Sustain had its fifth consecutive quarter of double-digit growth, driven by our multi-dose preservative-free formulations. Now, we're going to strengthen the Sustane brand with the launch of Sustane Pro preservative-free, our newest and longest-lasting formulation that hydrates, restores, and protects dry eyes. Importantly, this formulation includes nano-sized lipids and hyaluronic acid to both reduce tear evaporation and provide long-lasting hydration. Based on market research, we're seeing very strong interest to purchase from consumers and intend to recommend from eye care professionals. We look forward to bringing this eye drop to the U.S. in the first half of next year. Moving to pharmaceutical eye drops, I'm pleased to announce that we recently finalized our strategic arrangement with OccuMention Therapeutics in China. Like Alcon, OccuMention is singularly focused on eye care. As a China-based company, OccuMention has demonstrated success in identifying, developing, and commercializing ophthalmic pharmaceuticals. We believe this expertise paired with OccuMention's local presence and established capabilities will help maximize the value of our dry eye products and procedural eye drops, including the sustained family. Importantly, OccuMention has committed to develop and commercialize AR15512 in China. In exchange for the divestiture of approximately 40 million in annual eye drop sales, Alcon received approximately 17% of the equity in OccuMention, royalties on the existing business, as well as royalties and sales milestones on 512. Now I'll discuss the anticipated US launch of 512, for which phase three pivotal studies were presented at the American Academy of Ophthalmology. 512 is a novel prescription candidate for the treatment of dry eye, and we estimate the US prescription dry eye market is worth about $1.4 billion. 512 works by stimulating receptors on corneal sensory nerves to rapidly increase natural tear production. As we mentioned in our last earnings call, we have received our PDUFA date of May 30th, 2025, and look forward to bringing the medication to the U.S. market in the second half of next year, pending FDA clearance. We've already started developing our launch strategy and engaging with payers. Given the timing of a mid-year launch, we do not expect meaningful revenue contribution before 2026. Now I'll transition to surgical, where I'll start with implantables. I've been particularly pleased by the international uptake of our ATIOLs, where we're seeing high single-digit or double-digit growth in most regions. I expect the international market to remain our main growth driver in implantables as we've seen penetration in these markets drive ATIO growth in recent quarters. In particular, we continue to see positive momentum in China on both share and penetration as we work through VBP implementation. International penetration growth combined with consistent market share growth should enable us to continue to offset the slower market conditions in the U.S., I'm also excited to announce that we've completed the migration of all of our interocular lenses, including Panoptix, Vividi, and their toric modalities to the Clarion material. Our lenses are now available on the Clarion platform in most markets globally. As a reminder, Clarion is a unique material formulation that provides excellent visual performance and sets a new standard for IOL clarity characteristics. It has amongst the lowest levels of surface haze and subsurface nanoglistenings of any IOL material. We're also excited to announce that we are continuing to expand our ATIOL offering in major markets across the globe with Autonomy, the first and only automated preloaded delivery system. Notably, we're finishing the inventory build for the launch of Clarion Autonomy TORIC in the U.S. and rounding out our TORIC offering in Japan. Next, I'll turn to surgical equipment, where we have several exciting launches, including Unity VCS and the Voyager DSLT systems. I'll start with Unity VCS, our combined FACO and VITREP platform. This system builds on Alcon's expertise in surgical equipment with pioneering innovations to deliver breakthrough workflow efficiencies that enable excellent outcomes for the patient and the practice. For cataract surgery, Unity leverages a novel ultrasound modality to deliver up to two times faster FACO removal with 40% less energy into the eye as compared to Centurions. In vitro retinal advancements, this new technology provides up to one and a half times faster vitrectomy with cutting speeds of up to 30,000 cuts per minute, which is significantly faster than Constellation's HyperVit probe. I will continue to work with surgeons for final user experience testing ahead of the expected commercial launch in the second quarter of 2025. Additionally, we expect to receive CE mark in the first quarter of 2025. Now I'll discuss the Voyager direct laser trabeculoplasty device, formerly known as the Belkin Eagle. We demonstrated this device at the recent AAO conference in Chicago and saw strong interest from our core customer base. Voyager delivers laser energy to the trabecular meshwork using proprietary robotic eye-tracking technology for accurate, automated treatment. This eliminates the need for a gonioscope or manual aiming, which is necessary with traditional SOT. This design is friendly for both patients and physicians. Its precision and streamlined workflow position Voyager to become a first-line treatment for glaucoma. Voyager is already available in certain markets in the EU, and we plan to launch this device in the U.S. in the first quarter of 2025. Finally, I'll briefly discuss market dynamics for the third quarter. In Cataract, we estimate that the global procedures grew approximately 4%. Additionally, global ATI well penetration was up approximately 200 basis points year-over-year, primarily driven by international markets. In contact lenses, we estimate the retail market was up approximately 5%. This growth was mainly driven by pricing and lens trade-up. To wrap up, we have one of the most exciting product pipelines that we've had in years, and we're looking forward to bringing them to market over the next 12 to 24 months. And with that, I'll pass it to Tim. We'll take you through our financial results and provide more color on our outlook.

Thanks, David. We're pleased to report third quarter sales of $2.4 billion, up 6% versus prior year on both a reported and constant currency basis. This growth is primarily driven by strength in our innovative contact lens portfolio and consumables. In our surgical franchise, revenue was up 5% year over year to $1.3 billion. Implantable sales were $422 million in the quarter, up 5% year-over-year, mainly driven by our advanced technology intraocular lenses in international markets, including a benefit in China primarily related to volume-based procurement. This is partially offset by slower market conditions in the United States. In consumables, our third-quarter sales were up 6% to $701 million, driven by VITREC consumables in international markets, Cataract consumables, and price increases. In equipment, sales of $215 million were up 1% year over year, in line with our expectations. We continue to expect equipment sales growth to be broadly flat until after the planned commercial launch of Unity VCS. Turning to vision care, third quarter sales of $1.1 billion were up 7%. Contact lens sales were up 8% to $664 million in the quarter. Our innovative lenses, including toric and multifocal modalities, continue to win in the market. Additionally, we had another quarter with solid contribution from price. In ocular health, third quarter sales of $431 million were up 4% year over year. We saw strong performance in our portfolio of eye drops, including another quarter of double-digit growth was sustained. This growth was partially offset by declines in contact lens care in international markets. Now, moving down the income statement. Third quarter core gross margin was 63.2%, broadly in line with last year. Looking to the fourth quarter, similar to last year, we expect to see normal seasonal pressure in the gross margin as we perform annual preventative maintenance at many of our plants around the end of the year. Core operating margin was 20.6%, up 120 basis points year over year, driven by operating leverage in SG&A from higher sales, partially offset by investment in R&D, particularly in surgical. Third quarter interest expense was $49 million, broadly in line with last year. Other financial income and expense was a net benefit of $10 million compared to a net expense of $8 million in the third quarter of last year. This improvement was primarily driven by higher interest income and lower foreign currency losses. The third quarter average core tax rate was 12.8% compared to 17.2% in the prior year period. The decrease in tax rate was primarily driven by favorable geographic mix of profit and higher discrete tax benefits in the current year. Core diluted earnings were $0.81 per share in the quarter, up 25% from last year. Turning to cash, on a year-to-date basis, free cash flow was a record $1.3 billion, compared to $592 million in 2023. This improvement was mainly driven by higher cash from operations. As you've seen in prior years, we expect to see a meaningful step up in CapEx in the fourth quarter during our plant's annual maintenance period. Now moving to 2024 guidance. Our current outlook now assumes that markets grow in line with recent quarters and exchange rates as of the end of October hold through year end. Starting with sales, we are updating our full year revenue guidance range to $9.8 to $9.9 billion, and our constant currency sales growth rate to 6% to 7%. Moving to operating expenses, we continue to expect full year core R&D expense to be toward the high end of the range of 7% to 9% of sales. Turning to profitability, we are tightening our guidance range to 20.5% to 21% and are trending toward the low end of the range. This reflects 30 basis points of pressure from the inventory provision we recorded in the second quarter, as well as our planned investment behind new product launches. Moving down the income statement, we now expect interest and other financial expense to be between $155 million and $165 million. This improvement is primarily due to higher interest income as a result of a higher cash balance and higher interest rates. Turning to tax, given the discrete benefits we've received this year, we now expect our full-year core effective tax rate to be approximately 19%. Based on all these factors, we are tightening our core diluted earnings guidance range to $3 to $3.05 per share, which corresponds to 15% to 17% constant currency growth over 2023. Given recent movements in foreign currency, we are absorbing approximately $0.08 of FX headwinds versus the guidance we issued in February. To wrap up, I want to thank the entire Alcon team for another great quarter. And with that, I'll turn it back to David.

Thanks, Tim. And to wrap up, our investments in R&D have created one of the most productive periods since our spin. And I want to thank the teams working on innovation and manufacturing excellence for their dedication and efforts to making these projects successful. These projects will drive meaningful long-term growth across both our franchise, and we look forward to solving some of the most complex challenges in eye care. With that, let's open up the line for Q&A.

Thank you. At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. We ask that you limit your questions to one and a follow-up so that others may have an opportunity to ask questions. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys while we poll for questions. Our first question comes from Graham Doyle with UBS. Please proceed with your question.

Hi, guys. Thanks for taking my question. Just as we look into next year, and obviously the stock is weak today, I suspect, given people are slightly worried about the slower growth in Q4. So when we think about the exit rate in terms of top line for Q4, would you be comfortable talking about the incremental growth we can get next year when we think about VBP and product launches, just to give us a sense as to whether a 789 sort of growth rate next year is doable? and maybe just a quick one on the margins. Could you contextualize again how we think about investments next year versus margin expansion? Thank you.

Yeah, Graham, thanks for the question. And, look, I mean, I think, you know, when we get to next year, we'll certainly guide next year. I think what we would start with is just saying that, look, the slower quarter in the third in the U.S. specifically, you know, was probably a consequence of a couple of things, but certainly competitive sampling into the market will you know obviously dampen revenue reported units and our audited data you know does that so you see a 1.5 percent growth in the us it's probably dampened by whatever was going on in that in that sense and i think that should stabilize our sense of the market particularly cataracts is it's very stable over the long term and i think a very good international growth for us um you know the market internationally was was up i think five percent and and so I expect that over the long haul, these are very stable, very normal markets. But obviously, it was a weird one for us in the third quarter and in the U.S. in specific. But after that, I think what we would say about new product flow is we're excited about it. I do think that you need to be careful about how you cadence it because a lot of these products are coming out second, third quarter. And so you won't get a full year impact. You know, the first full year impact is going to be 26, but obviously it contributes to the back half growth of next year. So perhaps think about the front half as a little bit more in line with where we've been and the back half a little bit more, you know, aggressive as we kind of get products, you know, into play.

And then on the margin front, you know, we'd expect to continue to get operating leverage next year. I mean, if you look at the last couple of years, We've expanded margins by, call it, 150 basis points a year in constant currency. I do think next year will be a little bit less than that, given the investments we want to make. So think about 512, think about Unity VCS, Precision 7. But we're committed to making the appropriate investments to drive the long-term revenue growth. But overall, we'd expect to see nice operating leverage next year. And we continue to be comfortable with the long-term margin goals we discussed at our last Capital Markets Day.

That's really helpful. Thanks a lot guys.

Our next question comes from Jack Reynolds-Clark with RBC Capital Markets. Please proceed with your question.

Hi there. Thank you for taking the questions. Just two for me, please. So firstly on consumables, could you talk about what drove specifically the demand for direct consumables here? Is there something out of the order going on there? And then just on Voyager, how well recognised are the potential benefits of DSLP in your customer base? And what's the plan to roll out here from a kind of geographic perspective? And what kind of launch curve are you expecting next year? Thank you.

Yeah, Jack, thanks for the question. I think on consumables, we had a nice quarter with BitRet, and I think that was positive. Obviously, we had a solid quarter for the global consumables in Cataract as well. Retina, sorry, Refractive was soft, so a little bit of an offset there. But I think directionally, very good consumables number for us given where the market was. Again, growing faster than the market in consumables. On Voyager, I think, you know, SLT is very well accepted as an idea. And I think if you ask glaucoma folks and, you know, really general ophthalmologists, whether the data is there to believe that SLT is the right place to start, almost everyone agrees. I think it is really good. What has not been agreed is how it's not an easy thing to do, and a lot of people don't do it. And I think that's really what the DSLT has an opportunity to fix, which is, This is a product that fundamentally has an eye-tracking robotics that gives an accurate and automated delivery of laser light into the trabecular meshwork, whereas opposed to what you have to do now with this manually hold a gonioscope, anesthetize the eye, it's a bit of an exercise to really get it done right now. And I think what we believe is we can make this a good bit more acceptable for patients and for physicians. So over time, you know, we think this is a positive change. And I think directionally that adds to our glaucoma portfolio where, you know, we see an algorithm that is very widely accepted, I think, which will be SLT drops, you know, into hydrous. I mean, really that is what we're trying to create is a new and recognized algorithm that, you know, drives real benefits to patients.

Just on the geographic launch or launching kind of geographic.

Oh, yeah, yeah. Sorry, Jack. Yeah, indeed. We'll start with the U.S. And there is some product available in the European markets now. So it's CE marked already. But I think directionally we're going to put most of the inventory we have at the U.S. market in the beginning. And then we will, as we lift the ability and our capacity to make the product, we'll move market to market, but largely Europe after the U.S.

Great. Thank you very much.

Our next question comes from David Saxon with Needham. Please proceed with your question.

Great. Good morning, David and Tim. Thanks for seeing my questions. I just have two kind of product pipeline-related questions. The first is on AR512, just thoughts about the adverse events, the stinging and burning. How much does that impact the opportunity? And then it sounds like you're expecting immaterial revenue contribution next year when it launches kind of mid-year. How should we think about the level of investments needed to support kind of the second half launch? And then I'll have one follow-up.

Yeah. So, burning stinging is, you know, very common with eye drops, as you probably know. I think it was about 50% in the trial. So, But 97% of that was mild, and I don't think anybody, maybe one patient or something, you know, got knocked out of the trial. So I think we believe it to be very, very manageable, and obviously what really matters is how well it works. And I think what we're after is something that works much more quickly than the alternatives that are out there. That is the data that we seem to have right at this point. Instead of waiting a month to figure out or even two or three to find out whether something's working or not, I think you can find this out quite quickly, which is good for payers, good for patients. I think we'll see some very positive response to that. The revenue contribution, obviously, we get it out mid-year. By the time we get it out and start working with payers in earnest, you're really not going to see much. in the back half of next year. What we have said is we're going to, you know, be thoughtful about our promotion as we kind of move forward. We'll put certainly more folks on the ground behind this, and there'll be more, you know, advertising promotion. But we're going to be thoughtful about the timing of all that, and we'll work our way through next year. And I think think about this as a full speed idea in really in 26.

Okay, great. That's helpful. And then my second question is just on Panoptix Pro, when will we hear which of the two lenses that are currently approved will be the one you ultimately go through with commercializing and then kind of thoughts around launching that in the U.S. while it seems like the U.S. market is kind of softer. Thanks so much for taking my questions.

Yeah, look, I mean, I think we have a lot of market share in the U.S., and so we're obviously very interested in getting here first. We'll certainly take it around the world as we get approvals and CE marks for it. But in this case, you know, we should have a decision made in the first quarter. We'll certainly manufacture it as quickly as we can and get it out quickly. So, you know, my hope is that we've got it out, you know, end of the first quarter, early second, something in that zone. We should be, you know, ready to go. But, you know, we're excited about what we've got. We've got two very good ideas, and it is very difficult. I mean, I think one of the cool things about, you know, Panoptix has been it's a very, very good lens. I mean, if you want a true multifocal, you know, this is the lens out there that, you know, provides tremendously positive near-term mid-range and distance vision without a lot of visual disturbance. And that's something everybody else has got to come to. We're going to improve on it. I don't think people have gotten there yet.

Great. Thank you.

Barry Beagleson with Wells Fargo. Please proceed with your question.

Good morning. Thanks for taking the question. Maybe, Tim, could you give a little bit more color on the factors that led to the top-line guidance reduction? The reported range came down by about $150 million at the midpoint, constant currency range maybe 50 bps, just a little bit more granularity. on the guidance change, just bridge from the old to the new, and I had one follow-up.

Yeah, sure. Thanks, Larry. If you look at the beginning of the year, markets were pretty good. Our performance was very good. and that's why we increased the guide after the Q1 call. When you get into Q2, we started to see a little softness in the US surgical market, probably in the June timeframe. That softness continued in Q3, so that's really what drove the adjustment to the revenue guide.

And that 40 million in the divestiture of the eye drop sales, Tim, where does that show up? Just for my follow-up, David, maybe just give us an update on the UnityVS soft launch and feedback so far, and if we should expect above-average growth next year for your equipment and surgical businesses given that launch. Understanding that that'll probably accelerate through the year, David, as you said, it's the second quarter launch. Thank you.

The $40 million is an annualized number that'll show up in the Ocula Health segment.

And then on the Unity VCS stuff, you know, the software's been great. I mean, you know, we've been patient with this because, you know, we've got two really terrific products out there in Constellation and Centurion. And as I said in the prepared remarks, you know, this product is doing, you know, really amazing things. And I think we've had a very positive set of feedback and a lot of good input, too, on just the way it's set up in the software and how it looks to the surgeons. So we're making some small changes as we go through this, but all things that I think are, I would just call them cosmetic or smallish, which is exactly what we wanted to find out. So where we are right now is feeling very good about this launch, and I would say that you expect in a 10-year cycle to see, especially when you get the new thing out, a little bit more accelerated growth in the first couple of years, Last couple are a little soft. You know, as you see right now, this year is going to be a little soft for us on equipment. All kind of expected as you normally cycle through, you know, equipment like this. So I do think that the growth will certainly accelerate in the back half of next year as opposed to the front half because it'll take us a while to kind of get things moving and get everything going. So, but yeah, I mean, equipment should pick up next year from this year for sure.

Thank you.

Our next question comes from Patrick Wood with Morgan Stanley. Please proceed with your questions.

Beautiful. Thank you. I'd love on the OUS and ex-China ATIOL business. I mean, it's been strong for a little while now and definitely above trend. Could you unpack that for us a little bit? I mean, Vividi and Panoptix have been in the market a while. There's not been a huge change in structure. We're not really seeing that increased adoption in other areas of medtech. So what do you think is driving that strength and how sustainable is it ex-China OUS?

Well, look, I mean, you know, if you take apart the international businesses, you know, in surgical, the ATI well penetration is probably what's driving the overperformance. So there's some share movement in here, positive for us, for sure. And I would call that, you know, we start with a much lower share historically. We were later to market in Europe and in Japan and in Eastern Europe and the rest of Asia. So all those markets, I think, are still on the rise and they continue to grow nicely. And remember, too, we didn't really get Vividi out there in every market, you know, everywhere. So we're still, for example, we get Japan autonomy to go with Vividi. So we're, you know, there's a bit of a sequencing that goes on as we kind of put capacity out there in all of the markets. So that's part of it. So the share growth, I think, internationally was very solid. But penetration, you know, in Europe, for example, was up 70 basis points. It was up 30 basis points in Japan. It was up a lot in China. It's really been a positive everywhere on penetration. General APAC was up 120. That would include Korea. So I think there's a general movement from a lower base into a more aware market that is very interested in these cash-paying products that do more than what the government's going to pay for. And so I think you see kind of a – they start from a low base and they're kind of low teens. And then depending on which market you're in, they're moving up towards where the U.S. is. Obviously, the U.S. is more like 19. But I think it's – I think that's mostly penetration. And then there's a fair bit of share on our benefit because we're putting products out there and we start again from a lower starting point.

Got you. And then maybe just as a quick follow-up, like what's the holistic – uh, appetite internally around, you know, slightly more therapeutic assets. I mean, I know you've got your stake in Orion, you know, on the cell therapy side, like, is that generally a direction of travel that you want to take the business in totality? Or is it more of a sort of, um, I don't want to say side venture, but you know, how's the appetite for more pharma like assets?

I think it's appropriately sized. I think we have a desire to get back into biopharma. I think we are capable of it in quite a significant way. Ariane has given us a real beachhead there with our glaucoma drops. And I think if you kind of think through what we're doing now, we're very patient around this, but I think we are very interested in what's the front edge of what happens next. And we certainly like Things like cell therapy, we do like small molecules still, but formulation is probably where we've always had our strength. So think about drug delivery as a primary idea. Think about other kinds of ideas that we would patiently develop over time. So I would think long-term, absolutely interested and would like to build a business there, not in a hurry to do it. We've got a great plan right now. Love it. Thanks, guys.

Our next question comes from Ryan Zimmerman with BTIG. Please proceed with your question.

Good morning. Thanks for taking the questions. Sorry to be a little myopic here, David and Tim. I want to ask about the fourth quarter. If you look last year in terms of 3Q to 4Q, there's been a less pronounced step up from 3Q to 4Q, about 1.3%. This year you're pacing to maybe a little over 3%. which, based on my model, is evident in equipment and ocular health. But I'm wondering if you can kind of talk about kind of how you see and what's, you know, underlying your assumptions for the fourth quarter, maybe from a segment perspective.

Well, I mean, let me try and kind of give you a broad sense, Ryan. And myopic is always the right word for us. You We, you know, when you look at implantables and our consumables business, it is dependent on the procedural growth. And so, you know, based on what we've seen, you know, in the, you know, kind of end of the second quarter and the third quarter, you know, we're just being, you know, appropriate, I think, in the way we're thinking about the fourth quarter volumes. I mean, that drives obviously those two categories. You know, they run very close. You know, we're going to grow faster than the market, but we're, you know, we lose one point on the market and all of a sudden that affects us. It's a difference between six and seven. So, you know, I think that's one element. I think the, you know, when you get to equipment, I think there's a natural tendency right now to wait for a lot of things that we've got going on. So I think you just got to chuck that one up too. If we hold, you know, at stable, which has been our goal this year, and we've done a little better than that, you know, that's really what's going on in that market. It's not a market phenomenon. It's not really a capital thing. It is really, you know, we've got some awesome technology coming and I think people are waiting for it. And we kind of knew that was what was going to happen. It's happened in prior launches. And then when you move to vision care, you know, contact lens was pretty solid, actually. So I think, you know, we look at contact lens. We had a little less price in the third quarter, and the fourth quarter should be pretty solid. So I don't really anticipate a lot of change there. And I think ocular health has been beset a little bit by some one-offs, right? So you've got a contact lens care problem that we had, you know, with some inventory in China last year that we're wrapping around as a comp. And then we had, of course, a bit of a mistake with a vendor, you know, in the third quarter on the gross margin with the product that we had to spoil. So, you know, I think, you know, in the fourth quarter, we should be kind of relatively stable. And those markets, you know, look fine to us. And our performance has been really, even despite that, quite good in, you know, the sustained product, for example, which has been double digit. So, you know, I think Segment to segment, you know, if you cut it all there, it should be pretty close to what we're describing. You know, we have a pretty good read on it. So, you know, again, I think it's good. You know, we'll grow faster in the market. We hope the market grows well.

Okay. And then I got a lot of questions. I'm going to actually ask about P7 just because it is such a, you know, paradigm shift in contact lens adoption. And so if you could spend a minute kind of, you know, is the target to switch the two-week wares? Is the target to go, you know, the initial target? you know, on the monthlies. How are you thinking about kind of segmenting the market? I mean, in order to drive what is, you know, essentially a new category in contact lenses?

Yeah, it's an interesting question and it's a really good one. That's why we've been a little bit careful with this product. You know, we've talked about it really for maybe 18, 24 months because we had the idea some time ago, but we wanted to test it. We've had it in the market now for about six months with maybe 30 to 50 KOLs that we really think a lot of. And I think what we believe is that everybody believes that dailies should be the product people should use because it's, you know, they're healthier, they're, you know, they're easy to use and all of those things. But not everybody can afford it. And today, still, you know, about half the market goes into a reusable lens, which is usually a monthly lens, sometimes a two-week lens. As a consequence of that, you know, what we have asked ourselves is, well, is there something in between there? And the answer is we believe so. And it is basically... you know, this two-week market or the monthly market that we're thinking about because a one-week lens is certainly more intuitive. You know, every Monday, every Sunday, whatever you want to do, you take it out, you toss it, and then you use it, you know, reusably, you know, all week, and you get rid of it. But that's a much more intuitive replacement profile. It's healthier. It's a lot more comfortable than a monthly lens, especially as you get to the end of the month or you get to the end of the two weeks. You know, what we believe is that putting this lens in every week gives you a fresh lens every day and at day seven. So at the core of that is we think there's a price point and a comfort benefit, a wearability benefit that is very meaningful to the two-week wearer and the monthly wearer. So that's roughly how we see it. For everybody who can't afford dailies, this is going to be the best lens for them.

Thanks for taking the question.

Our next question comes from Jeff Johnson with Baird. Please proceed with your question.

Thank you. Good morning, guys. Wondering if I could ask maybe two clarifying on the model and then just a contact lens question. On the model itself, you know, 4Q implied guidance seems to be kind of a broad range in 5 to 9% at the organic growth level. Tim, can you, you know, kind of narrow us into that 5 to 9? What would it take to be at the bottom end of the range, at the top end of the range? Is that the right range doing the math? And I guess I'll listen there and then ask one other question. Thanks.

Yeah, I mean, as far as the ranges go, to David's point, I think he laid out sort of the sequential growth that we're expecting. I think what moves that market would be one of them. Again, we've assumed the market will be consistent with what we saw in Q3. So if that's a little bit softer than we thought, that would bring you down. If it's a little bit better than we thought, that would bring you up. Um, and then again, performance, I mean, again, we have a lot of momentum international contact lenses to David's point internationally, a lot of momentum. They're gaining a lot of share ocular health. We have a, we have a favorable comp. So, uh, those would be the movers.

All right. Fair enough. And David, I think I heard you say, correct me if I'm wrong, kind of whatever this second half is where fourth quarter shakes out and what the third quarter. you'd be somewhat comfortable with that being kind of the stepping off point for the first half of next year and then maybe some acceleration on top of that. Is that correct, number one? And number two, just on the contact lens market, the 5% growth you cited for the market this quarter seemed maybe a point softer than the first half. Anything to read into that? Our recent survey picked up maybe a point of softening as well. So just wondering if anything's changed in the market or if that's just kind of normal variability by quarter. Thanks.

Jeff, I think that for the second part, I mean, we've always said the contact lens market runs between 4% and 6%. It's right in the middle of that right now, so I would call that normal. I think the first part of your question, front half versus back half, what I was really trying to imply was we really have a lot of stuff coming in in the front half, but it doesn't really generate full-speed revenue until you start getting into the back half. So I would think about you know, the back half a little bit stronger than the front half next year. And that's really all we can guide you at this point until we get really into next year and, you know, have all our thoughts together on the market and how these things are going to actually roll out.

Fair enough. Thanks.

Our next question comes from Anthony Patron with Musa Hubrit. Please proceed with your question.

Thanks. Maybe one on IOLs and one just a broader new product question. You mentioned a couple of times, David, on competitive dynamics, but also the market's a little bit soft in the U.S. Maybe if you segment between those, you know, how long do you expect trialing of competitive lenses? I think in the PCIOL side, you know, will that bleed into the first half of next year and then does it subside? So a little bit on those dynamics and just that underlying market, you know, in the U.S. has been, I think, a little bit soft. So is there any update on the state of the consumer and just sneak in the one on new products you have three new products coming you know next year that are pretty substantial when you think about contribution of new product growth you know is that something that we should be thinking two to three hundred basis points or perhaps more as this gets going thanks yeah let me uh let me take on the first one look um

There's two dynamics, you're right. I mean, there's one that won't last that long, but certainly it's hard to know how big it is, and that is competitive sampling. I mean, sampling takes out revenue units that should depress the market, so some of that is in there for sure, because there were two relatively new products into the market with competition in the third quarter. It started kind of in the second, and that could explain some of it. There's also a lot of other views on this, which is, you know, we can see that some of our largest accounts, you know, have been a little bit less productive this year than they have been in the past. But the thing I tell you is, you know, there is no shortage of cataracts. There's plenty of cataracts to go. They can do as many as they want to do. The limiting factor is how long they're in the OR and how many they schedule. And so really, you know, I expect all this stuff to kind of naturalize into what has historically been the global growth rate. We kind of called that that four to five range globally is the right answer. So, you know, we're on the low end of that because, you know, the U S was a little bit of soft, the international was solid. They were right in the middle of where they should be. They were five, I think. So I think, you know, or, you know, we were, you know, we were pleased with, I think what happened in international continue to see strong growth out there. It's been the U S dynamic that we're, we're just trying to figure out, you know, how long does it last? I don't know. I mean, I, but I wouldn't really worry about it over the long haul. I think if you're in this for the long haul, like we are, you know, cataracts come back, You know, this is a 3% growth market in the U.S. has been for a long time. So I wouldn't expect it to be different than that over the genuine long-term horizon. On the other piece, you mentioned on the consumer, you know, I would really take the consumer out of this. You know, the consumer is, you know, really not part of the cataract surgery discussion, really. I think we know there's a lot of headroom for ATL wells. We know there's a line, you know, of Right now I think the wait times even in the U.S. have gotten to be four and five months. So there's a significant amount of wait time out there, plenty of consumers who will come and pay for their surgery. On the last bit on product growth for new products, give us a little bit of time to think that through. We need to position that a little bit better, but I think what we're trying to figure out as we get into next year will be how much we're going to put into that, when they launch, and how to think about that. But as I said before, what I give you right now is back half is probably stronger than the front half. Thank you.

Our next question comes from Tom Stefan with Steeple. Please proceed with your question.

Great. Hey, guys. Thanks for taking the questions. Two on the consumables opportunity for Unity. I'll ask both up front. You know, I think it's understood price is a potential growth driver for Unity consumables, right? You know, what about the share gain opportunity? David, can you talk about that a bit? And I guess if and how that can also drive consumables growth. And then second, my tack on, you know, is there any sort of tail or lag on the consumables revenue from Unity compared to system placements that we should be thinking about as we try to model out the impact from Unity consumables? Thanks.

Yeah, the last one's pretty easy. There isn't really a lag, you know, different than what you'd see on our normal, you know, sales. But you do see, you know, when you bring a new machine in, there is a cutover period. So you start a little bit slower and then it accelerates up. So just, you know, you're going to have to put in a, you know, a lag of growth to full speed But that's not different than what we would sell now. So I would think about it that way. We've been very fortunate the last couple of years. We've gained share in our platforms. So I think we've gained one or two share points of platform around the world, largely international, I would say, and a little bit in the U.S. But I think there is some share in the U.S. to be had. I would not say there's a lot. I would really think about it as a replacement cycle for our current machines with a premium to that replacement, both on the consumables and the consoles. Internationally, I do think there's a share opportunity. But again, you have to divide the world up into the kind of world that can afford this machine and the world that is using very kind of inexpensive, what they can afford machines where we really don't compete. And that's a significant part of the international share as you would look at it. So you'd think about India, you'd think about developing markets where, frankly, there'd be some of our machines in there, but only in very large centers, in very large metro areas. So, we tend to have a very low share in some of those developing markets. But, you know, those are opportunities for us. They're probably opportunities for others of our products. So, say, our legacy brands and our Legion product. And I think that was probably what it was. But I think direction of the growth is going to be positive in consumables because, of you know, we're looking to get a premium on the PACs as we go forward. Thanks.

Our next question comes from Brett Fishman with KeyBank Capital Markets. Please proceed with your question.

Hey, guys. Thank you very much for taking the questions. Just had a brief one on the contact lens business trend. So I think you annualized one of two pricing increases that you took last year and still grew approximately 8% constant currency in the sub-segment. So just curious how much of that performance was tied to volume and mix versus price and growth this quarter?

Yeah, I think you've got it exactly right. We had a lot more price last quarter than we did this quarter. And obviously, I think we grew 9% last quarter. Contact lenses were great this time. So, you know, I think there was a slight, you know, I think you can attribute that 1% certainly to the price that was in last quarter. And then, you know, I'm not sure we've broken down in general what the price element of the lens category was, but I would think about it as generally the category runs a third, a third, a third, which is, you know, for us, a third volume of coming from share, a third of trade up, and about a third of price.

All right, helpful. And then just one more kind of clarifying question on operating margins. So you started the year with guidance of 20.5 to 21.5 and now trending toward the lower half of that range. Was just curious if you could hit on kind of like the biggest moving pieces there other than, you know, a little bit less sales leverage and then specifically the estimated FX impact versus the original guidance. Thank you very much.

Yeah, well, we had roughly 30 basis points of pressure driven by the supplier issue that we had in Q2. So, you know, if you kind of take that out, then you're right in the middle of the range that we had guided before. And from an FX pressure, let me see, I can't see that far, roughly 40 basis points.

Our next question comes from David Adlington with JP Morgan. Please proceed with your question.

Hey guys, thanks for the questions too, please. Firstly, on Chinese and the VVP, I just wondered if you help us try to quantify what sort of tailwind you're seeing in China and how you expect that to evolve from here. Should we see a bigger tailwind developing from here? And then secondly, on 512, just in your discussion with payers, just wondering how that early onset of action is resonating with payers And is it enough to see 512 as first-line therapy?

Thanks. On the China piece, I think, you know, we're exactly where we'd hope to be right now. We feel really good about our progress. As you know, you've got to, you know, get the products listed. You've got to get them, you know, inventoried into the hospital. And then you've got to convert surgeons, you know, to, you know, a new method. Many of these surgeons have never had the opportunity to use Avivity, although they've obviously heard about it around the world. Same thing with Panoptix. So, You know, for us, this is an exciting time and we're moving nicely through our cadence of activity. And I think we're kind of, as I would say, you know, full year effect next year is probably the thing to think about. We're getting some effect on it this year, but largely it's distribution and, you know, the inset of inventory into, and we're getting some pull through right now, which has been great. But I think, you know, our share is moving nicely. But again, relatively early days for us there. Look for next year to be a bigger step forward. I think on 512, the payer's piece of it, I think, has been pretty good. You know, again, we're very early in this conversation. So I would say, you know, we have a thesis on this that we are testing. It seems to work well. I do think that first-line therapy is going to be almost always given to a generic if there's one available in many of the payers. And you need to be thoughtful about that because you're going to have to clear that hurdle. And, you know, that's not new news. I think what's exciting about this, though, is that – even in that circumstance, the economics of knowing that something works in a week versus knowing that something might work a month from now and then having to have another visit around it, I think has a real opportunity to save money to the system and to the patients. And, you know, obviously, if you can create, you know, a substantial impact early on, you know, that is our economic thesis right now. And I do think it certainly resonates. We're going to need to make sure that we can make that come alive for people as we go forward. I think first line will be you know, largely driven by historically lower-priced products as it is today, and we'll be competing for, you know, what happens right after that or how do we compete with that. Sure. Got it. Thank you.

Our next question comes from Guy Nugent with Citi. Please proceed with your question.

Hey, guys. Thank you for taking my questions. I have two, please. So the first thing is, could you just Give us a quick update on how the penetration of ATLLs in the U.S. trended in the quarter and if you're seeing anything different in the first half of Q4. And then the second question is on the contact lens business. Seeing that the organic growth has been trending down over the course of the last three quarters, aside from pricing, is there anything else that you would like to call out about this business? Thank you.

On the penetration in the U.S., it was up about 70 basis points. So I think nice movement up. I think it was in the low 19s. So, again, kind of returning back to where it was after a bit of a hiatus there. So we were pleased with the sequential growth and the year-over-year. Both of them were up. I think directionally that the contact lens organic growth trending down, I think, probably has more to do with price. than it does anything else. I think underneath that, trade-ups are pretty solid. And, you know, again, mix has been good for us. So, again, we're getting some good reusable mix in here, which is good for profit. You will have seen our sector profit up. And I think directionally, you know, our contact lens business seems like it's doing quite well, both on a share basis, but also on a, I'll call it trade-up, and our prices seem to be holding nicely.

Thank you. And if I could just quickly follow up, what is your view on pricing going forward into the new year?

You know, we take that kind of quarter by quarter. You know, what we're looking at is obviously our input prices first. So, you know, what does it cost us to make this product and what's the inflation from suppliers? So, you know, we take that into account. We're also looking at very quickly, you know, every quarter we look at what the trade up looks like. So is there any hesitation as prices moved up from consumers trading from a reusable lens into a daily lens? Because we don't want to price anybody out. And obviously, You know, we're always sensitive to, you know, are we a reasonable value relative to competitors? So, you know, that's what we're trying to figure out. So we'll reserve judgment on what we're going to do forward, you know, as we collect that information in the new year.

Thank you.

Our next question comes from Issy Kirby with Redbird Atlantic. Please proceed with your questions.

Hey guys, thanks for taking my question. I was just wondering if you could talk to some of the dynamics supporting the sustained growth. This has been very impressive growth for some time now. Just wondering if you could help us understand the extent to which this is share gains versus market transition into preservative free and the sustainability of that growth into next year. And then my follow-up is on the surgical margins, which were a little bit softer this quarter. Just if you could talk to some of the moving parts within that surgical contribution margin, if it is mixed pressure coming through from the implantable slowdown and how we should be thinking about that division into 25. Thanks.

Yeah, well, thanks for noticing the sustained growth. It has been terrific. And I think... probably an underappreciated asset for us. One of the things that we have noticed, you know, obviously when we put this product out was the preservative-free multi-dose format is a very attractive format for people. And, you know, the unit dose preservative-free products are good products. And what was surprising to us is that those have really persisted pretty well. I think some people find them convenient. But what's exciting is that most of the market, I think, has taken to the the multi-dose version of the preservative-free product quite well. And we have always thought that it would kind of approximate the international markets in its penetration ultimately. So I would say it's a little bit of share gain, but it's a lot of movement to preservative-free multi-dose on the Sustain piece. Now, you know, we hope that the share gain will pick up as well next year as we launch Sustain, what we're calling Sustain Pro. Sustain Pro has hyaluronic acid in it, which is, as most people know, it's a really popular lubricant and does a lot of really nice hydrating qualities if you include it in a tier. And so we've been able to formulate Sustain Complete with hyaluronic acid and some other kind of clever ideas that the folks have come up with to really give us a very durable comfort, which I think gives Sustain another boost as we go forward next year on a share basis. So we're excited about that. It comes out in the first quarter. And so I would look for steady growth in Sustain through next year.

And if you look at the surgical margins, there was a little bit of pressure and gross margin, which is primarily mixed. That was a piece of it, but it was really predominantly incremental R&D.

Okay, that's helpful. Thank you. And if I can just squeeze in a clarification, I think at the start you mentioned 1.5% growth in the U.S. I just wanted to confirm, was that in implants or broader surgical?

That's surgical procedures as we define them, and that's largely around implants.

Okay, great, thank you.

Our next question comes from Sajee Aznar with HSBC. Please proceed with your question.

Hi, thanks for taking my questions. One on the tax and cash flows, tax rate was lower and cash flows were much stronger than Q3. So the question is, is there any pull-forward effect? Should we expect a normalization of that, and will there be a Phase B going into 2025? And the second question is, can you give us some more color about how value-based procurement has evolved for you? insight into the shared gains and whether that had any impact on the lower surgical margins that you had this quarter. Thank you.

Yeah, on the tax front, we did settle some tax disputes, one in the U.S., I think one in Germany. So we had some discrete benefits. So that's what you're seeing in Q3. So, you know, the overall tax rate that we updated, moving it from 20% to 19%, that was really driven by the fact that we had more favorable discreets. than we had anticipated. And then on the pre-cash flow, yes, we're excited about the pre-cash flow performance. We've been talking about this step up. We actually saw that in Q3. And what you're basically seeing is now that we're done with separation, now that we're done with transformation, You know, we flowed through the higher cost inventory that we bought when inflation was a problem and supply was a problem. You're sort of seeing all that flow through right now. So we're getting to a much more normalized free cash flow, and we'd expect that to continue to grow as we improve our operating performance going forward.

Yeah, and on the global share, I would just say, you know, we have – Our global total IOL share has been relatively flat. So we are trading international share for US share. And I think as a consequence, there is some price erosion around that. Now, we're making that gross margin up in productivity inside of the manufacturing groups. So again, you don't really see a net effect in gross margin on that. But it is obviously a lower price on the European stage and on the China stage, for example. Our share gains have been meaningful in China, but it's hard to tell right now what they are because the data is a little bit muddy, I would just say. So we're very pleased with our performance. It's exactly what we'd hoped for. But I would just say I wouldn't want to overread the positives we're getting.

Thanks very much.

Our next question comes from Falco Fredericks with Deutsche Bank. Please proceed with your question.

Thank you. Two questions, please, from me. Firstly, on the U.S. market, I think you said that you noticed that it turned a little bit softer in June. Did this get worse throughout the third quarter or did it just stay on this slightly softer level in June? So essentially, did the U.S. market deteriorate further in Q3 or did it just sort of stay on a stable, softer level that you saw in June. And then my second question is, if the root cause of this lower U.S. growth is IOL customers sampling competitive products, isn't there a risk that some of those customers stay with a competitive product, in which case your implantable growth might be a little bit slower structurally heading into next year, Or asking it differently, what gives you confidence that you can keep your share in the IOL market in the U.S.? Thank you.

Well, first of all, on the tempo, it was slightly slower in June, and it pretty much stayed there. It was kind of just stable through the third quarter. So nothing to really write home about. I would just say it was a low end of normal is what I would typically say. And, you know, I think the question ultimately is if it's really sampling, then, you know, you're going to have to stop. People have to stop sampling at some point and try and make some money. So I suspect that when they have to pay for the lens, it'll be a little bit of a different story because at some level, you know, you've got to be better than the lens that I'm putting in. And, you know, we feel very confident about the performance of Panoptix and Vividi against all of the competitive lenses. So, you know, there's going to be a market for price. There's certainly a market for free. And I think, you know, what we believe right now is that, you know, we'll do well when it comes time to, you know, really perform.

Okay, thank you. And if I can squeeze in a quick follow-up, I think you said that you expect the market growth sort of to be closer to the growth over the recent quarters. Could you put a number on that for us? Is it 3%? Is it 2%?

I'm sorry, what was the question again? The market was closer to

I think you said, yeah, you said market growth is closer to what you've seen over the recent quarters rather than what you've seen historically. Can you put a number on that? Do you mean 3%?

No, we're in the middle of the quarter right now, but I give you the third quarter. It was 1.5 in the U.S., and it was solid overall. It was four globally, five international. So those are the numbers that you had in the third quarter. They were a little bit softer than the second quarter.

Okay, and that's just a little bit less than the 4% to 5% for the market you've seen historically?

Yeah, that's right.

On average. I guess that's what you want to say, right? Okay. Yes. Thank you.

There are no further questions at this time. I would now like to turn the floor back over to Dan Cravens for closing comments.

Well, great. Thanks, everybody, again, for joining us. If you have any follow-up questions, certainly reach out to either Alan Trang or myself. And also, just as a reminder, as David mentioned, we are planning our next Capital Markets Day for the end of March of 2025, and that will be at our Fort Worth campus in Fort Worth, Texas, and we'll plan on distributing the Save the Days closer to the end of the year. Thanks again, and enjoy the rest of your day.

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