Alcon Inc. (NYSE:ALC) Q3 2024 Earnings Conference Call November 13, 2024 8:00 AM ET

Company Participants

David Endicott - Chief Executive Officer
Tim Stonesifer - Chief Financial Officer
Dan Cravens - Vice President, Investor Relations

Conference Call Participants

Graham Doyle - UBS
Jack Reynolds-Clark - RBC Capital Markets
David Saxon - Needham & Co.
Larry Biegelsen - Wells Fargo
Patrick Wood - Morgan Stanley
Ryan Zimmerman - BTIG
Jeff Johnson - Baird
Anthony Petrone - Mizuho
Tom Stephan - Stifel
Brett Fishbin - Keybanc Capital Markets
David Adlington - JP Morgan
Giang Nguyen - Citi
Issie Kirby - Redburn Atlantic
Sajid Aznar - HSBC
Falco Freidrichs - Deutsche Bank

Operator

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 Cravens, Vice President, Investor Relations. Thank you sir, you may begin.

Dan Cravens

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 Stonesifer, 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 20-F, earnings press release and interim financial report, which are all on file with the Securities and 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 in 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.

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 Precision7. Precision7 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 two-week category is well established and represents a meaningful growth opportunity for us.

Precision7 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 toric 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.

Now turning to ocular health, where we have several exciting new developments, I’ll start with Systane, the world’s leading over-the-counter artificial tear. Systane had its fifth consecutive quarter of double-digit growth driven by our multi-dose preservative-free formulations. We’re going to strengthen the Systane brand with the launch of Systane Pro preservative-free, our newest and longest lasting formulation that hydrates, restores and protects dry eyes. Importantly, this formulation includes nanosized 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 OcuMension Therapeutics in China. Like Alcon, OcuMension is singularly focused on eye care. As a China-based company, OcuMension has demonstrated success in identifying, developing and commercializing ophthalmic pharmaceuticals. We believe this expertise, paired with OcuMension’s local presence and established capabilities will help maximize the value of our dry eye products and procedural eye drops, including the Systane family. Importantly, OcuMension is committed to develop and commercialize AR-15512 in China. In exchange for the divestiture of approximately $40 million in annual eye drop sales, Alcon received approximately 17% of the equity in OcuMension royalties on the existing business, as well as royalties and sales milestones on 512.

Now I’ll discuss the anticipated U.S. launch of 512, for which Phase III 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 U.S. 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 on our last earnings call, we have received our PDUFA date of May 30, 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 payors, and given the timing of a midyear 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 ACIOLs, 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 ACIOL 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 intraocular lenses, including PanOptix, Vivity, and their toric modalities to Clareon material. Our lenses are now available on the Clareon platform in most markets globally. As a reminder, Clareon 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 ACIOL offering in major markets across the globe with AutonoMe, the first and only automated preloaded delivery system. Notably, we’re finishing the inventory build for the launch of Clareon AutonoMe 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 system. I’ll start with Unity VCS, our combined phaco and vitret 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 phaco removal with 40% less energy into the eye as compared to Centurion. In vitreoretinal advancements, this new technology provides up to 1.5 times faster vitrectomy with cutting speeds of up to 30,000 cuts per minute, which is significantly faster than Constellation’s Hypervit Pro.

We 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 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.

With that, I’ll pass it to Tim, who will take you through our financial results and provide more color on our outlook.

Tim Stonesifer

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 was 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 in intraocular lenses in international markets, including a benefit in China primarily related to volume-based procurement. This was partially offset by slower market conditions in the United States.

In consumables, our third quarter sales were up 6% to $701 million, driven by vitret 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 multi-focal 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 for Systane. 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 53.2%, 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 and 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 plants’ 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 billion 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 towards 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 $3.00 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 headwind 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.

David Endicott

Thanks Tim. 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 franchises, and we look forward to solving some of the most complex challenges in eye care.

With that, let’s open the line for Q&A.

Question-and-Answer Session

Operator

Thank you. At this time, we will be conducting a question and answer session. [Operator instructions]

Our first question comes from Graham Doyle with UBS. Please proceed with your question.

Graham Doyle

Hi guys, thanks for taking my question. Just as we look into next year, and obviously the stock is weak there, I suspect, given people are slightly worried about the slower growth in Q4, so if 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 if we think about VBP and product launches, just to give us a sense as to whether a 7, 8, 9 sort of growth rate next year is doable.

Maybe just a quick one on the margins - could you contextualize again how we think about investments next year versus margin expansion? Thank you.

David Endicott

Yes Graham, thanks for the question. Look - I mean, I think when we get to next year, we’ll certainly guide next year. I think what we would start with is just saying that the slower quarter in the third in the U.S. specifically was probably a consequence of a couple of things, but certainly competitive sampling into the market will obviously dampen revenue - reported units in our audited data does that, so you see a 1.5% growth in the U.S., it’s probably dampened by whatever was going on in that sense. I think that should stabilize.

Our sense of the market, particularly in cataracts, is it’s very stable over the long term, and I think very good international growth for us - you know, the market internationally was up, I think 5%, 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, so you won’t get a full-year impact. 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 aggressive as we get products into play.

Tim Stonesifer

Then on the margin front, 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, Precision7. 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.

Graham Doyle

That’s really helpful. Thanks a lot, guys.

Operator

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

Jack Reynolds-Clark

Hi there, thanks for taking the questions. Just two for me, please.

Firstly on consumables, can you talk about what drove specifically the demand for vitret consumables here, is there something out of the ordinary going on there? Then just on Voyager, how well recognized are the potential benefits of DSLT in your customer base, and what’s the plan to roll out here from a geographic perspective and what kind of launch curve are you expecting next year? Thank you.

David Endicott

Yes Jack, thanks for the question. I think on consumables, we had a nice quarter with vitret, 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 we had 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 SLT is very well accepted as an idea, and I think if you ask glaucoma folks and really general ophthalmologists whether the data is there to believe that SLT is the right place to start, almost everyone agrees. I think what has not been agreed is how--you know, 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, which is 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.

Over time, we think this is a positive change, and I think directionally that adds to our glaucoma portfolio where we see an algorithm that is very widely accepted, I think, which will be SLT, drops [indiscernible]. Really, that is what we’re trying to create, is a new and recognized algorithm that drives real benefits to patients.

Jack Reynolds-Clark

That’s great, thank you. Just on the geographic launch, or launching geographic [indiscernible]--

David Endicott

Yes, yes - sorry Jack. 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 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.

Jack Reynolds-Clark

Great, thanks very much.

Operator

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

David Saxon

Great, good morning David and Tim. Thanks for taking my questions.

I just have two product pipeline related questions. The first is on AR512, just thoughts about the adverse events, the stinging and burning, how much did that impact opportunity, and then it sounds like you’re expecting immaterial revenue contribution next year when it launches kind of midyear. How should we think about the level of investment needed to support the second half launch, and then I’ll have one follow-up.

David Endicott

Yes, so burning and stinging is very common with eye drops, as you probably know. I think it was about 50% in the trial, but 97% of that was mild, and I don’t think anybody--maybe one patient or something got knocked out of the trial, so I think we believe it to be very, very manageable. 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 at this point, so 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 payors, good for patients. I think we’ll see some very positive response to that.

The revenue contribution, obviously we get it out midyear, by the time we get it out and start working with payors 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 be thoughtful about our promotion as we kind of move forward. We’ll put certainly more folks on the ground behind this and there will be more advertising and promotion, but we’re going to be thoughtful about the timing of all that and we’ll work our way through next year. Think about this as a full speed idea really in ’26.

David Saxon

Okay, great. That’s helpful.

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 thoughts around launching that in the U.S. while it seems that the U.S. market is kind of softer. Thanks so much for taking my questions.

David Endicott

Yes, look - I think we have a lot of market share in the U.S, 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 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 my hope is that we’ve got it out end of the first quarter, early second, something in that zone. We should be ready to go.

But 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 PanOptix has been it’s a very, very good lens. If you want a true multi-focal, this is the lens out there that provides tremendously positive near term midrange 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.

David Saxon

Okay, thank you.

Operator

The next question comes from Larry Biegelsen with Wells Fargo. Please proceed with your question.

Larry Biegelsen

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 have one follow-up.

Tim Stonesifer

Yes, 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 U.S. surgical market, probably in the June time frame. That softness continued in Q3, so that’s really what drove the adjustment to the revenue guide.

Larry Biegelsen

And that $40 million in the divestiture of the eye drop sales, Tim, where does that show up? And just for my follow-up, David, maybe just give us an update on the Unity VS 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 will probably accelerate through the year, David, as you said it’s a second quarter launch. Thank you.

Tim Stonesifer

The $40 million is an annualized number that will show up in the ocular health segment.

David Endicott

Yes, and then on the Unity VCS stuff, the soft launch has been great. We’ve really--we’ve been patient with this because we’ve got two really terrific products out there in Constellation and Centurion, and as I said in the prepared remarks, this product is doing really amazing things. 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--you know, I would just call them cosmetic or small-ish, which is exactly what we wanted to find out.

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’ve got the new thing out, a little bit more accelerated growth in the first couple of years, the last couple a little soft - you know, as you see right now, this year is going to be a little soft for us in equipment, all kind of expected as you normally cycle through equipment like this.

I do think that the growth will certainly accelerate in the back half of next year as opposed to the front half, because it will take us a while to get things moving and get everything going; but yes, equipment should pick up next year from this year, for sure.

Larry Biegelsen

Thank you.

Operator

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

Patrick Wood

Beautiful, thank you. I’d love on the OUS and ex-China ACIOL business--I mean, that’s been strong for a little while now and definitely above trend. Could you unpack that for us a little bit? I mean, Vivity 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 med tech, so what do you think is driving that strength and how sustainable is it, ex-China, OUS?

David Endicott

Well, look - if you take apart the international businesses in surgical, the ACIOL penetration is probably what’s driving the over-performance, so there’s some share movement in here positive for us, for sure. 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.

Remember too, we didn’t really get Vivity out there in every market everywhere, so we’re still--for example, we’ve got Japan AutonoMe to go with Vivity, so there’s a bit of a sequencing that goes on as we kind of put capacity out there in all of the markets. That’s part of it.

The share growth, I think internationally was very solid, but penetration 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 is 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 is going to pay for, and so I think you see kind of a--they start from a low base in the 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--you know, I think that’s mostly penetration.

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.

Patrick Wood

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

David Endicott

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. Aurion has given us a real beachhead there with our glaucoma drops, and I think as 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.

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, but not in a hurry to do it. We’ve got a great plan right now.

Patrick Wood

Love it, thanks guys.

Operator

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

Ryan Zimmerman

Good morning, thanks for taking the questions. Sorry to be a little myopic here, David and Tim, but 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 maybe a little over 3%, which based on my model is evident in equipment and ocular health, but I’m wondering if you can talk about how you see and what’s underlying your assumptions for the fourth quarter, maybe from a segment perspective.

David Endicott

Well, let me try and give you a broad sense, Ryan, and myopic is always the right word for us. We spend a lot of time on that topic.

When you look at implantables and our consumables business, it is dependent on the procedural growth, so based on what we’ve seen in the end of the second quarter, in the third quarter, we’re just being appropriate, I think, in the way we’re thinking about the fourth quarter volumes. That drives obviously those two categories. 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 the difference between 6 and 7, so I think that’s one element.

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’ve just got to chalk that one up to if we hold at stable, which has been our goal this year and we’ve done a little better than that, 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.

Then when you move to vision care, contact lens was pretty solid, actually, so I think if 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. 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 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 in the third quarter on the gross margin with the product that we had to spoil, so I think in the fourth quarter, we should be relatively stable. Those markets look fine to us and our performance has been really, even despite that, quite good in the Systane product, for example, which has been double digits.

I think segment to segment, if you cut it all there, it should be pretty close to what we’re describing. We have a pretty good read on it, so again I think it will grow faster than market. We hope the market grows well.

Ryan Zimmerman

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

David Endicott

Yes, 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 easy to use, all of those things, but not everybody can afford it, and today still about half the market goes into a reusable lens, which is usually a monthly lens, sometime a two-week lens.

As a consequence of that, what we keep asking ourselves is there something in between there, and the answer is we believe so, and it is basically 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 reuseably 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. What we believe is that putting this lens in every week gives you a fresh lens every day and at day seven.

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.

Ryan Zimmerman

Thanks for taking the questions.

Operator

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

Jeff Johnson

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, 4Q implied guidance seems to be kind of a broad range, 5% to 9% at the organic growth level. Tim, can you narrow us into the 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.

Tim Stonesifer

Yes, 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 it down; if it’s a little bit better than we thought, that would bring it up. Then again, performance - we have a lot of momentum, in particular contact lenses, to David’s point, internationally a lot of momentum there, gaining a lot of share. Ocular health, we have a favorable comp, so those would be the movers.

Jeff Johnson

All right, fair enough. David, I think I heard you say, correct me if I’m wrong, whatever the second half is, where fourth quarter shakes out with 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 normal variability by quarter. Thanks.

David Endicott

Jeff, for the second part, 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 that doesn’t really generate full speed revenue until you start getting into the back half, so I would think about 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 have all our thoughts together on the market and how these things are going to actually roll out.

Jeff Johnson

Fair enough, thanks.

Operator

Our next question comes from Anthony Petrone with Mizuho Securities. Please proceed with your question.

Anthony Petrone

Thanks. Maybe one on IOL and one on just the broader new product collection. 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, how long do you expect trialing of competitive lenses, I think in the PCIOL side, 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 in the U.S. has been, I think, a little bit soft, so is there any update on the state of the consumer.

Then if I can just sneak in the one on new products, you have three new products coming next year that are pretty substantial. When you think about contribution of new product growth, is that something that we should be thinking 200 to 300 basis points, or perhaps more as this gets going? Thanks.

David Endicott

Yes, let me take on the first one. Look - there is two dynamics, you’re right. 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. 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, but--and that could explain some it.

There’s also a lot of other views on this, which is we can see that some of our largest accounts have been a little bit less productive this year than they have been in the past, but the thing I’d tell you is there is no shortage of cataracts. There’s plenty of cataracts to go. They could do as many as they wanted to do. The limiting factor is how long they’re in the OR and how many they schedule, so really I expect all this stuff to kind of naturalize into what has historically been the global growth rate, we kind of called that 4% to 5% range globally is the right answer. We’re on the low end of that because the U.S. was a little bit soft, but international was solid, they were right in the middle of where they should be - they were 5, I think.

I think 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 just trying to figure out. How long does it last? I don’t know, 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, cataracts come back, this is a 3% growth market view, as it 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. The consumer is really not part of the cataract surgery discussion, really. I think we know there’s a lot of headroom for ACIOLs. We know there’s a line of--you know, 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 are we going to put into that, when they launch, and how to think about that. But as I said before, what I’d give you right how is back half is probably stronger than the front half.

Anthony Petrone

Thank you.

Operator

Our next question comes from Tom Stephan with Stifel. Please proceed with your question.

Tom Stephan

Great, hey guys. Thanks for taking the questions.

Two on the consumables opportunity for Unity - I’ll ask both upfront. I think it’s understood price is a potential growth driver for Unity consumables, but 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? Then second, my tack-on, 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.

David Endicott

Yes, the last one is pretty easy - there isn’t really a lag different than what you’d see on our normal sales, but you do see a--you know, when you bring a new machine in, there is a cut-over period, so you start a little bit slower and then it accelerates up, so you’re going to have put in 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 - you know, 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 world that can afford this machine and the world that is using very 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 think about India, you think about developing markets where, frankly, there would be some of our machines in there, but only in very large centers in very large metro areas. We tend to have a very low share in some of those developing markets, but those are opportunities for us, but probably opportunities for other of our products, say our legacy brands and/or our legion product.

I think that was probably what it is, but I think directionally the growth is going to be positive in consumables because, of course, we’re looking to get a premium on the packs as we get forward.

Tom Stephan

Thanks.

Operator

Our next question comes from Brett Fishbin with Keybanc Capital Markets. Please proceed with your question.

Brett Fishbin

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

David Endicott

Yes, 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 lens [indiscernible]. I think there was a slight--I think you can attribute that 1% certainly to the price that was in last quarter. Then 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 for us a third of volume coming from share, a third of trade-up, and about a third of price.

Brett Fishbin

All right, helpful, then just one more clarifying question on operating margins. 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 the biggest moving pieces there, other than a little bit less sales leverage, and then specifically the estimated FX impact versus the original guidance. Thank you very much.

Tim Stonesifer

Yes, well we had roughly 30 basis points of pressure driven by the supplier issue that we had in Q2, so if you kind of take that out, then we’re right in the middle of the range that we had guided before. From an FX pressure--let me see, I can’t see that far, roughly 40 basis points.

Operator

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

David Adlington

Hey guys, thanks for the questions. Two please, firstly on Chinese and the BDP. I just wondered if can 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?

Secondly on 512, just in your discussions with payors, just wondering how the early onset of action is resonating with payors, and is it enough to see 512 as first line therapy? Thanks.

David Endicott

On the China piece, I think we’re exactly where we’d hoped to be. Right now, we feel really good about our progress. As you know, you’ve got to get the products listed, you’ve got to get them inventoried into the hospital, and then you’ve got to convert surgeons to a new method. Many of these surgeons have never had the opportunity to use Vivity, although they’ve obviously heard about it around the world - same thing with PanOptix, so 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 the inset of inventory into--and we’re getting some pull through right now, which has been great, but I think 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 payors piece of it, I think has been pretty good. Again, we’re very early in this conversation, so I would say 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 payors, and you need to be thoughtful about that because you’re going to have to clear that hurdle. 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 is a real opportunity to save money to the system and to the patients, and obviously if you could create a substantial impact early on, that is our economic thesis right now. 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 largely driven by historically lower priced products as it is today, and we’ll be competing for what happens right after that, or how do we compete with that.

David Adlington

Sure, okay. Thank you.

Operator

Our next question comes from Giang Nguyen with Citi. Please proceed with your question.

Giang Nguyen

Hi guys, thank you for taking my questions. I have two, please.

The first thing is, could you just give us a quick update on how the penetration of ACIOLs in the U.S. trended in the quarter, and if you’re seeing anything different in the first half of Q4. 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.

David Endicott

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 as 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, 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, again, mix has been good for us, so we’re getting some good reuseable mix in here, which is good for profit. You will have seen our sector profit up, and I think directionally our contact lens business seems like it’s doing quite well, both on a share basis but also on a, call it trade-up, and our prices seem to be holding nicely.

Giang Nguyen

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

David Endicott

We take that kind of quarter by quarter. What we’re looking at is obviously our input prices first, so what does it cost us to make this product and what’s the inflation from suppliers, so we take that into account. We’re also looking at--very quickly, 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 reuseable lens into a daily lens, because we don’t want to price anybody out. Obviously we’re always sensitive to are we a reasonable value relative to competitors, so that’s what we’re trying to figure out. We’ll reserve judgment on what we’re going to do forward as we collect that information in the new year.

Giang Nguyen

Thank you.

Operator

Our next question comes from Issie Kirby with Redburn Atlantic. Please proceed with your question.

Issie Kirby

Hey guys, thanks for taking my question. I was just wondering if you could talk to some of the dynamics supporting the Systane 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.

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 mix pressure coming through from the implantable slowdown and how we should be thinking about that division into ’25. Thanks.

David Endicott

Yes, thanks for noticing the Systane growth - it has been terrific, and I think probably an underappreciated asset for us. One of the things that we had noticed obviously when we put this product out was the preservative-free multi-does format is a very attractive format for people, and 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 multi-dose version of the preservative-free product quite well. 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 Systane piece.

Now, we hope that the share gain will pick up as well next year as we launch Systane, what we’re calling Systane Pro. Systane Pro has hyaluronic acid in it, which 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 tear, and so we’ve been able to formulate Systane Complete with hyaluronic acid and some other clever ideas the folks have come up with to really give us a very durable comfort, which I think gives Systane another boost as we go forward next year on a share basis.

We’re excited about that. It comes out in the first quarter, and so I would look for steady growth in Systane through next year.

Tim Stonesifer

If you look at the surgical margins, there was a little bit of pressure on gross margin, which was primarily mix - that was a piece of it, but it was really predominantly incremental R&D.

Issie Kirby

Okay, that’s helpful, thank you. 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?

Tim Stonesifer

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

Issie Kirby

Okay, great. Thank you.

Operator

Our next question comes from Sajid Aznar [ph] with HSBC. Please proceed with your question.

Sajid Aznar

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, if there’s any pull forward effect, should we expect a normalization of that, and how will the phase-in be going into 2025? The second question is can you can give some more color about how value-based procurement has evolved for you, maybe some insight into the share gains, and whether that was any--that had any impact on the lower surgical margins that you’ve had this quarter. Thank you.

Tim Stonesifer

Yes, 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. 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 discretes than we had anticipated.

Then on the free cash flow, yes, we’re excited about the free 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, we’ve 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.

David Endicott

Yes, and on the global share, I would just say we have--our global total IOL share has been relatively flat, so we are trading international share for U.S. 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 whether or not--you know, what they are, because the data is a little bit muddy, I would just say. 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 over-read the positives we’re getting.

Sajid Aznar

Thank you very much.

Operator

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

Falco Freidrichs

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 turn--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 stay on a stable softer level that you saw in June?

Then my second question is if the root cause of the slower U.S. growth is IOL customers sampling competitive products, isn’t there a risk that some of those customers stay with the 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.

David Endicott

Well, first of all on the tempo, it was slightly slower in June and it pretty much stayed there. It kind of was stable through the third quarter, so nothing to really write home about. I would just say it was the low end of normal, is what I would typically say.

I think the question ultimately is if it’s really sampling, then people are going to 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 will be a little bit of a different story because at some level, you’ve got to be better than the lens not putting in, and we feel very confident about the performance of PanOptix and Vivity against all of the competitive lenses.

There’s going to be a market for price, there’s certainly a market for free, and I think what we believe right now is that we’ll do well when it comes time to really perform.

Falco Freidrichs

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

David Endicott

I’m sorry, what was the question again - market was closer to the recent quarters--?

Falco Freidrichs

I think you said market growth was 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%--

David Endicott

No, we’re in the middle of the quarter right now, but I’d give you the third quarter - it was 1.5% in the U.S. and it was solid overall, it was 4 globally, 5 international. Those are the numbers that you had in the third quarter. They were a little bit softer than the second quarter.

Falco Freidrichs

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

David Endicott

That’s right.

Falco Freidrichs

I guess that’s what you want to say, right? Okay.

David Endicott

Yes.

Falco Freidrichs

Thank you.

Operator

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

Dan Cravens

Great. Thanks everybody again for joining us. If you have any follow-up questions, certainly reach out to either Allen 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-date closer to the end of the year.

Thanks again, and enjoy the rest of your day.

Operator

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