Alcon Inc. (ALC) Q1 2025 Earnings Report, Transcript and Summary

Greetings, and welcome to the Alcon First Quarter 2025 Earnings Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Dan Cravens, VP of Investor Relations. Thank you. You may begin.

Welcome to Alcon's first quarter 2025 earnings conference call. Yesterday, we issued a press release, interim financial report and presentation. You can find all these documents on our website at investor.alcon.com. Please note that starting this quarter, in order to streamline our reporting, the interim financial report and other filings will be limited to information required by regulations. Non-IFRS results, including constant currency growth and core items, will only be presented in the press release and presentation. 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. 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 for IFRS. Please see a reconciliation between our non-IFRS measures with directly comparable measures presented in accordance with IFRS in our press release. For discussion purposes, our comments on growth are expressed in constant currency. In a moment, David will begin by recapping highlights from the first quarter. After his remarks, Tim will discuss our performance and outlook for 2025. Then, David will wrap up, and we will open the call for Q&A. With that, I'll now turn the call over to our CEO, David Endicott.

Thanks, Dan, and thanks everybody for joining us today. As we sit here in mid-May, it is remarkable to reflect on how dynamic this year has been so far. First, we've begun a cascade of product launches that will grow our business for years to come, punctuated by the launch of Unity VCS in both Japan and the U.S. Second, we acquired a majority position in a great long-term asset in Aurion Biotech with the potential to change the standard of care in corneal transplantation. And third, there's been an obvious disruption in the global trade environment. And yet, at Alcon, I remain encouraged by the strength and resilience of our underlying business performance. So, while the current tariff structure introduces new headwinds, our global network of 17 manufacturing sites and decades of operational experience position us well to implement mitigating strategies. In most cases, we make products in region for region and have the ability to transfer production across sites. However, our existing manufacturing footprint is optimized for a predominantly free trade environment. Shifting production across sites requires stable trade policy, along with time and capital. We'll adapt to whatever final policy decisions are made, but in the meantime, we continue to work with AdvaMed, MedTech Europe and our local Chinese affiliate to advocate for a medtech exemption or a zero-for-zero tariff regime. We remain deeply committed to access to eye care. The zero-for-zero tariff structure supports uninterrupted care by ensuring patients and providers can receive the products they need when they need them. In a few minutes, Tim will walk you through our thinking on the current tariff environment. Now, I'll shift to discussing the first quarter. We delivered sales of $2.5 billion and sales growth of 3%. We also delivered a core operating margin of 20.8% and core diluted earnings of $0.73 per share. Despite another soft quarter in the US surgical market, these results are a testament to the breadth of our geographic footprint and product portfolio, as well as the commitment of our talented teams across the globe. I'm pleased to report that at the recent American Society of Cataract and Refractive Surgery Conference, we officially launched Unity VCS and PanOptix Pro. The Unity launch is the culmination of more than 10 years of work by our R&D and engineering teams, informed by invaluable input by key opinion leaders around the world. I'd like to take the opportunity to thank all of our teams who've been involved in this transformational change in ophthalmic surgery. Unity VCS is a combined console for both vitreoretinal and cataract surgery, while Unity CS is a standalone cataract system that will be available toward the end of the year. The platform is designed to deliver superior efficiency for both types of procedures, while continuing to deliver exceptional outcomes and safety. The system features many first-to-market technologies designed to deliver transformative surgical innovation. For example, 4D Phaco delivers twice as fast lens removal with 41% lower energy delivered to the eye. Additionally, HYPERVIT 30K is the world's fastest vitrector and is 1.5 times faster than the existing best-in-class. Lastly, Unity Intelligent Fluidics creates greater stability and control at each procedural step. Unity VCS has received CE mark and regulatory approvals in Australia, Japan and the US, and we will begin delivering new units later this month. Now, I'll turn to implantables, where we recently launched PanOptix Pro. We believe this next-generation technology builds on our market-leading position and keeps us on the forefront of innovation. This lens builds upon the success of the world's most implanted trifocal PCIOL by reducing the amount of light scatter by 50%. Our surgeon research suggests that light scatter is a key driver of dysphotopsias such as halos and glare, which is why we're so excited about PanOptix Pro. This lens is now available in the U.S. and initial surgeon and patient feedback has been excellent. We look forward to bringing it to select international markets later this year. Now, shifting to vision care, starting with contact lenses. I've been extremely pleased by the performance of all of our innovative lenses built upon our water gradient technology. Our major recent innovations, including PRECISION1 family, the TOTAL30 family, and DAILIES TOTAL1 for astigmatism grew double digits in the first quarter. We launched PRECISION7 at the start of this year, and it's gaining traction with both doctors and patients. Wearers benefit from 16 hours of outstanding comfort even on day seven, due in part to our ACTIV-FLO system, which keeps lenses moist by leveraging a moisturizing agent in the lens with a replenishing agent. Additionally, wearers appreciate the intuitive seven-day replacement schedule, which enhances patient compliance and satisfaction, offering a great choice if a daily disposable SiHy lens is not an option. For eye care professionals, this lens allows them to meet diverse patient needs with a lens that balances innovation, comfort and cost effectiveness. As a reminder, PRECISION7 targets a reusable lens category, which we estimate is worth approximately $3.8 billion and where Alcon is under-indexed. Now I'll turn to ocular health, where I'll start with Systane Pro. Systane Pro is the only triple-action, multi-dose, preservative-free formulation for all types of dry eye. The unique formulation includes hyaluronate and offers patients up to 12 hours of relief. Additionally, the moisture technology helps reduce friction on the eye surface, providing both comfort and protection while blinking. This can be a meaningful improvement for patients who experience irritation or discomfort with their current drops. Systane Pro has been available in the U.S. since February, and we're continuing to expand its rollout to major retailers nationwide. Next, I'll comment on Acoltremon, our dry eye pharmaceutical candidate. We continue to expect an FDA response to our filing at the end of May, in line with the PDUFA date that we received last year. Our team has been working hard ahead of the launch. We've expanded our eye drop sales force in the U.S. We now have a group dedicated to glaucoma and a separate group dedicated to dry eye. Additionally, we continue to engage with payers where appropriate. Now, turning to BD&L activity, we have two recent exciting developments. First, I'm pleased to report that we acquired the majority interest in Aurion Biotech. Aurion is at the forefront of regenerative medicine. The company's flagship therapeutic candidate, AURN001, has received Breakthrough Therapy and Regenerative Medicine Advanced Therapy designations from the FDA. It could represent a paradigm shift in the treatment of corneal endothelial dysfunction, which is a condition leading to corneal edema, vision loss and potential blindness. 001 is an allogeneic cell therapy comprised of corneal endothelial cells derived from healthy donors and a rho kinase inhibitor that enhances cell survival and integration. 001 is administered as a single intracameral injection following a surgical intervention on the corneal endothelium. This therapy offers a minimally invasive alternative to traditional corneal transplants, which are limited by donor availability and surgeon complexity. 001 is currently approved in Japan under the trade name Vyznova. In the U.S., we plan to launch Phase 3 clinical trial activities late this year, and we aim to bring the product to market in mid to late 2028. Given the scale of the unmet need, we expect peak sales of $0.5 billion or greater. Now, we also entered into a definitive merger agreement to acquire LENSAR. The acquisition includes the ALLY Robotic Cataract Laser Treatment System. We intend for this next-generation technology to ultimately succeed LenSx as our femtosecond laser-assisted cataract surgery platform. We're excited for the opportunity to bring LENSAR's unique next-generation technologies into our innovative equipment portfolio. The transaction is anticipated to close in mid to late-2025, subject to customary closing conditions, including regulatory approval. Finally, I'll briefly discuss market dynamics for the first quarter. In cataract, we estimate that global procedures grew low-single-digits. Additionally, global ATIOL penetration was up approximately 200 basis points year-over-year. In both cases, the main growth driver was international markets. In contact lens, the retail market remained solid in the first quarter. We estimate that it grew approximately mid-single-digits, in line with historical trends. Now with that, I'll pass it to Tim, who'll take you through our financial results and discuss our outlook.

Thanks, David. Our first quarter sales of $2.5 billion were up 3% versus prior year. This growth is slightly lower than recent trends and reflects approximately 1 point of headwind from our divestiture and out-licensing of eye drops to OcuMension in China in the fourth quarter of 2024. In our surgical franchise, revenue was up 2% year-over-year to $1.3 billion. Implantables sales were $420 million in the quarter, in line with the prior period. We saw another quarter of strong growth in advanced technology IOLs in China and other international markets. This was offset by soft market conditions in the U.S. that David mentioned earlier, as well as competitive pressures. In consumables, our first quarter sales were up 6% to $712 million, driven by vitret and cataract consumables, particularly in international markets, and price increases. In equipment, sales of $199 million were down 6% year-over-year. Following the recent launch of Unity VCS, we continue to expect equipment sales to meaningfully accelerate through the second half of the year. Turning to vision care, first quarter sales of $1.1 billion were up 3%. Contact lens sales were up 4% to $688 million in the quarter, primarily due to product innovation as well as price increases. As David mentioned, we continue to see strong growth across the PRECISION1 and TOTAL30 families, as well as DAILIES TOTAL1 for astigmatism. This growth was partially offset by declines in legacy products, where we have limited our promotional efforts. We also faced a strong prior-year quarter, mainly driven by the timing of price increases. In ocular health, first quarter sales of $432 million were up 2% year-over-year. Growth was primarily driven by the sustained family of artificial tears as well as price. There was also approximately 3 points of pressure resulting from the divestment of certain eye drops to OcuMension in China that I mentioned previously. Now, moving down the income statement. First quarter core gross margin was 63.2%, broadly in line with the prior year. Core operating margin was 20.8%, down 40 basis points, primarily due to increased investment in R&D. First quarter interest expense was $49 million, broadly in line with last year. Other financial income and expense was a net benefit of $9 million, also broadly in line with last year. The first quarter average core tax rate was 21% compared to 23.2% in the prior-year period, as last year included a net expense from discrete items. Core diluted earnings were $0.73 per share in the quarter, in line with last year on a constant currency basis. Turning to cash, we generated $278 million of free cash flow in the first quarter compared to $229 million in 2024 due to higher cash from operations. Before turning to the outlook, I want to take a few moments to address tariffs. As we think about the tariff impact, we're providing our best estimate based on a set of assumptions and an evolving environment. As David mentioned, our global manufacturing footprint was built and optimized for a free trade environment. In most, but not all, markets, we're fortunate to manufacture in region for region. However, while we're able to relocate manufacturing, shifting production intelligently requires a stable trade environment. We've completed a thorough assessment of the current tariffs and mitigation strategies available to us. These strategies include supplier diversification, optimizing our manufacturing network, managing discretionary spend, and implementing selective price actions. As of today, we estimate that the gross impact from these tariffs will pressure cost of sales by approximately $80 million for the full year versus our outlook in February. As the cost of tariffs are capitalized in the inventory and then flow into the income statement as goods are sold, we expect to see nearly all of the gross impact in the second half of the year. We expect to fully offset the tariff pressure through operational actions and currency tailwinds. Importantly, these estimates do not reflect any potential impact related to future tariffs and trade policy changes. Now, moving to our outlook for the remainder of the year. Our current guidance assumes that the aggregate global eye care market grows approximately 4%, that exchange rates as of mid-May hold through year-end, and that the tariff rates and exemptions announced as of May 12 persist through the end of the year. Now, starting with sales, we are updating our full year revenue guidance to $10.4 billion to $10.5 billion, which reflects the favorable foreign exchange environment. Additionally, given the soft U.S. surgical market, we are updating our sales growth rate guidance to between 6% and 7% in constant currency. In terms of phasing, we continue to expect sales growth to meaningfully accelerate in the second half of the year, given the timing of the new product launches. Moving to operating expenses, we expect incremental R&D expense following our recent BD&L activity. However, we expect to remain within our range of 8% to 10% of sales. Additionally, we expect SG&A to step up in the remainder of the year. We expect the highest spend in the second quarter due to normal seasonality and the timing of new launches. Turning to profitability, we now expect full year core operating margin to be between 20% and 21%. This updated range reflects approximately 80 basis points of pressure from recent BD&L activity versus our February outlook. Moving down the income statement, following the consolidation of Aurion, we now expect non-operating income and expense to be between $185 million and $205 million. Turning to tax, we continue to expect our full year core average tax rate to be approximately 20%. Based on all these factors, we now expect our core diluted earnings guidance range to be between $3.05 to $3.15 per share. This updated range reflects a $0.10 of impact from recent BD&L activity. This range corresponds to year-over-year growth of between 2% and 5% in constant currency. Before I wrap up, I'm pleased to announce that at our Annual General Meeting last week, shareholders approved a dividend of CHF0.28 per share, in line with our payout policy of 10% of the previous year's core net income. I want to thank our shareholders for their continued support. And finally, I want to take a moment to thank our associates across all levels of the organization. Your dedication and focus continue to drive our performance and position us for long-term success.

So, to conclude, we remain confident in the long-term fundamentals of the eye care market and our business. 2025 is a watershed year for us. We're bringing a wave of groundbreaking products to market, each designed to help improve sight and set new standards of care. These launches reflect the strength of our pipeline, our deep understanding of customer needs, and our commitment to shaping the future of eye care. Our continued investment in research and development, along with strategic acquisitions, further fuels our innovation engine and expands our capabilities. And we're excited about what's ahead and confident in our ability to drive long-term growth through purposeful market-leading innovation. We appreciate your continued support and look forward to updating you on our progress next quarter. So with that, let's open the line for Q&A.

Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] The first question is from Veronika Dubajova from Citi. Please go ahead.

Hi, guys. Good afternoon, and thank you for taking my questions. I have two, please. The first one is just on the shape of the organic growth rate through the remainder of the year. Tim, I can push you a little bit more on sort of how do we get from the 3% to the 6% to 7%. Could you give us a bit of flavor on where you expect the second quarter to land, and just how much faster the growth in the back half of the year is going to be and kind of what is the biggest moving part or two related to that growth acceleration and your degree of confidence in those? And then, if I can squeeze in a follow-up here...

Yeah.

Go ahead, Tim. Actually, I'll do my follow-up afterwards. Go for it.

Yeah. Well, first of all, welcome back, Veronika.

Thank you.

Yeah. So again, this plan has always been based on growth acceleration in the back half of the year, driven by the cadence and the timing of the product launches. So, I'm not going to give Q2 guidance, but what we do feel very comfortable with is this, we will see, call it, high-single-digit revenue growth in the back half of the year. And what's going to drive that, Unity VCS, we're very excited about PanOptix Pro, you look at PRECISION7, Systane Pro. So, as we've talked about in the past, a lot of these launches are coming out in the back half of the year, and we expect that to take us to the 6% to 7% revenue growth for the total year.

Got it. That's helpful. And then, my follow-up, probably more for David, but one of the sort of growing investor concerns out there that we hear a lot in our conversation is just the U.S. cataract market continuing to be so subdued. And are you confident this is just a market issue or is this also a competition issue? So, I'd love to get your thoughts, David, why are we not seeing a better growth rate here? And sort of how comfortable are you with the assumption that you can maintain your sort of competitive advantage, in particular, in the premium lens space? Thanks.

Yeah. Well, thanks, Veronika. And again, welcome back. Listen, I think the share thing, I think we feel pretty good about. We're pretty much on where we had expected to be. The market is a little surprisingly soft, I think, in the first quarter to us. I think we have seen that really in the third and fourth quarters, as we've mentioned. So, to see it again in the first, we had hoped not to. Obviously, we've adjusted our market to about a 4% growth for the year as a consequence. Look, I think as we wrap around last year, we're going to see a much better growth rate to begin with. But at the core of it, this is a surge in productivity issue, because there's tons of cataracts that are not being done. We know that wait lines, for example, wait lists are getting longer. We know that the surgeons that -- some of the busiest surgeons in the country have generally been the target of private equity acquisitions. And when they do that, they're generally retiring or taking a step back. And it takes a little while for the younger guys to come along and fill up the volumes and the skill set that they're losing. So, we've heard kind of consistently that while we're improving efficiency per surgeon, it's not yet where it was. And I do think the beauty of that for us is we're launching Unity VCS right into that circumstance where we're going to be telling people, look, if you do this and use this properly, you can do more surgeries in a day, whether that's vitret or whether that's cataract. But, I do think that the cataract market normalizes over time. I feel like we've seen over the years pretty consistently in the U.S. a 3% growth. I expect that to return to normal in the rest of this year.

Excellent. Thanks, guys.

The next question is from Jack Reynolds-Clark from RBC Capital Markets. Please go ahead.

Hi there. Thanks for taking the questions. The first one I had was on contact lenses. I was wondering if you could break down the impact of the kind of the timing differences on pricing versus kind of legacy product declines in the quarter, and then what that means for the exit rate coming out of Q1, and what you've seen so far in Q2.

Yeah, well, I probably won't comment too much on Q2, but let me just talk about where we are with the quarter on contact lenses. Look, the audited data around the world looks like it was a very healthy market. And I think that should be encouraging to people because the consumer looks healthy. In U.S., there was unit growth, there was mixed trade up, there was price in the market and the market grew in the U.S. about 7%. So, we're still seeing that kind of mid-single-digit growth globally, and then we expect that to continue for the year. Now, for our number, we were wrapping around 11% growth last year. We're doing a sequential growth from fourth quarter to first quarter at -- we finished 11%, so we do a 4%. If you look at that on average accommodating pricing -- volume movements that accommodate price increases, last year, we pulled a little in last year -- last quarter, we pulled a little in. So, it just moves around a little bit across the quarter. I would think about this as normalizing -- continue to normalizing above market growth, and we expect market growth to be in the kind of mid-single-digits range.

That's great. Super clear. Thank you. And then, I had a couple on Aurion. So, the new guidance implies a fairly substantial EBIT loss from Aurion. I was wondering if you could give a breakdown of what is comprised within that cost, i.e., kind of the breakdown of clinical trials versus R&D versus kind of more standard OpEx. And then what your expectations are for clinical trial costs in 2026 through to 2028 when the product launches?

Yeah, I think you've got the numbers right. It's about 80 bps this year. And again, we -- it's almost all R&D, so I would think about it really as R&D in progress. We generally don't break apart our clinical activity or our R&D -- core R&D stuff. So, I would probably avoid doing that today on this particular topic. I would say that we're excited about this program that we will take it into clinic late this year, and we're excited about the response we've gotten recently from the FDA on the trial progress. So, I think we have good alignment with FDA at this point, and I think excellent folks running this program. So, we're excited about the team and the program, because this really is one of the things that helps patients a lot. It's a big deal. I mean, this is corneal transplant folks that can't really get to that around the world unless this product kind of succeeds. So, we're excited about the program and the folks.

And then, Jack, maybe to help you out for 2025, I would just -- if you're looking at your models, I would model that into your R&D and I would just phase it evenly between 2Q, 3Q, and 4Q.

Okay, understood. And should we expect an uplift next year?

We'll give you guidance next year on it. It'll be part of a blended R&D program. We won't break out the program specifically. We generally don't do that.

Understood. Thanks very much.

The next question is from Graham Doyle from UBS. Please go ahead.

Good morning. Thanks, guys. Thanks for taking my questions. Just kind of follow-up on Veronika's question. I know you don't love to do a quarterly guidance, but I think it's not unfair to ask it, given we've had a downgrade on revenue guidance of Q3 and we've had it now on the back of a Capital Markets Day and a recent guidance. Just trying to understand the things that give you confidence on this acceleration, right? Presumably, we're looking at a 5% or something in Q2 and then a 7%, 8% or something as we go through the rest of the year. So, is it that you've got a really strong order book already for Unity? Are you seeing great traction with PanOptix Pro? Just to give us some, like, concrete pieces that underpin your assumptions would be super helpful, please.

Well, let me start with the market. I mean, the reason for the narrowing of the range, and again, I think we're comfortable with what we said, it was the first quarter. I mean, at the core of it, the U.S. market was soft in the fourth quarter. When you do the math on that, you take it forward, it's going to be unrealistic, I think, to get the acceleration we need to get to an 8%. On the other hand, we feel really good about 6% to 7%, and we feel like maybe we do better than that, but that's really -- there's still a lot of variance in the new product flow. So, starting with the basics on this, the second quarter we think is a normal quarter. I think it should be roughly around market, a little bit better than market growth. And then, as you kind of work your way into the back half of the year, I think Tim just said it, we're going to see steady, significant acceleration through the third quarter and into the fourth quarter, because remember, we haven't shipped any PanOptix Pro till this month. We haven't shipped any Unity VCS until the end of this month. We haven't shipped a whole bunch of the PanOptix Pro to the retailers until really getting through the end of first quarter. So, you really haven't seen any new product flow other than P7 hitting right now and maybe Systane Pro a little bit. But I think as you get through all of that, really, the massive -- kind of the substantial change in trajectory occurs on the back of a very strong reception to Unity VCS, a very strong reception to Voyager, a very strong ASCRS output on PanOptix Pro. We got pre-orders in Japan on Unity VCS we feel good about. So, yes, we have a lot of pre-orders. We need to fill those, and we'll do that over time. The only gating factor I feel like on Unity VCS will be our ability to kind of install it, make sure we ship it on time, make sure everybody uses it correctly, make sure we take the time that's required to get the most out of that machine, because it is genuinely a phenomenal piece of equipment, and we've consistently heard that. There's a lot more to it than that. So, we're launching seven new products, maybe more than that, actually, when you get into the specifics of the smaller. So, there's just a lot going on, Graham, and I think it just doesn't play out in the front half.

I think the other way we've been describing this in prior calls is we think there are about 30,000 units out there. It's a 10-year lifespan. So, we've kind of said, hey, look, feathered in 3,000 a year, front half -- the first couple of years are probably a little bit more than that. Back half would be a little bit less than that. So, if you do that kind of math and then you layer that into the back half of the year, that's going to give you a nice revenue look. So that's just if you want to try to do it numerically, I would try to do that kind of math, and you'll see that we get some pretty nice revenue growth or we expect some pretty nice revenue growth.

Okay, that's really helpful. Just a quick cheeky one, which is just do you guys have visibility on that, like, those pre-orders and how that's flowing through, and early indications, does that give you the comfort on Q3, Q4? Is that kind of where that's coming from rather than just it's a great product and we -- the market should take it? Is there a good indication of interest to a reasonable level that gives you that comfort?

Yes.

Super clear. All right, thanks a lot. I'll jump back in the queue.

That was a cheeky answer to a cheeky question.

Yeah. Thanks, Graham.

Thanks, guys.

The next question is from Ryan Zimmerman from BTIG. Please go ahead.

Good morning or good afternoon. Thanks for taking our questions. When we think about the components of guidance, the market obviously is down 50 basis points from your prior assumptions. But embedded within that 6% or 7% is about 250 basis points from innovation new products. And within those 250 basis points, I assume is some price impact. So, I'm wondering, David, if you can kind of parse out in terms of how you think about price versus new product contributions within that incremental 250 basis points for the year. And then, I have a follow-up.

Well, I mean I would think about the year in total as getting the typical price we get. I would think about it as we're getting typically a couple points of price every year. If we can keep up with inflation, we're pleased with that. And I think that's typically where we're trying to get to. So, I mean, I would think about that versus the rest of the unit growth and trade up. And I would think about new products as the gap fill. And there is a lot of enthusiasm around the products right now. I think I just came off of two major meetings, the JOS in Japan and Tokyo. And then, also in Los Angeles, we had the largest surgeon meeting in the world for the U.S. That was -- I mean, the enthusiasm around the product flow that we have right now is very significant, and I think we need to execute, and we've got a lot to do, but I would just say I feel really good about where we are for the remainder of the year.

Okay. And then, Tim, I think you called out SG&A being highest in 2Q, but sales are arguably going to be higher in the back half of the year. I'm just curious kind of why we wouldn't see a higher SG&A rate in second half given kind of the pacing and again the top-line kind of cadence, if you will.

Yeah. There are really three factors in that Q2 comment. I mean, first of all, if you just look at seasonality, we do -- we have a lot of advertising and promos, particularly around the DTC area. So, if you were to go back to, say, '22, '23 and '24, the average incremental spend Q1 to Q2 is roughly $40 million. So, again, that's typical seasonality. I would expect that to hit again in Q2 of this year. And then, there are really two other things. The one is that we did have some phasing from Q1 to Q2. We had some favorability in Q1 that we weren't anticipating. Those costs will come through in Q2. I'd call that maybe $15 million or so. And then, lastly, we have the investments behind the product launches. So, we talked a lot last year about how much we're investing in the products and we want to make sure that we invest appropriately to drive that revenue growth. So, you're going to see that starting to hit in Q2. And then, as you get to Q3, Q4, kind of back out that DTC piece, whatever you put in there for that, and then it will start to normalize.

Okay. Thank you.

The next question is from David Saxon from Needham & Company. Please go ahead.

Great. Good morning. Thanks for taking my questions. Maybe two product related questions. The first one is just on PanOptix Pro and how you're thinking about that launch relative to the -- your competitor's recall and now relaunch? Has that created any meaningful opportunities? And then, also just against the backdrop of a weaker U.S. market...

We're starting to lose you.

Hey, David, you got kind of garbled there a little bit.

[Technical Difficulty]

No.

No. Not really.

All right. Well, here let's try it...

There it is. We got you now.

Okay. yeah. Just on PanOptix Pro...

Now, we lost you. So, let me do PanOptix Pro and then if you come back on we can take another one.

Hey, why don't we move on to the next one...

Let me take the Pro part of it, because I can handle that. So, look, David, on PanOptix Pro, we are obviously excited about that. One of the things I said in the opening remarks was, the big thing in ATIOL, particularly trifocals, has been halos and glare. It's something that we have been working on for a while. PanOptix Pro has 50% less scatter, which is really the source of halos and glare. So, we expect to see a really important uptake as a function of using more light in the lens, and I think that's been a really exciting thing. It's been well received. Certainly, it was well received in Los Angeles, and I think we expect surgeons are going to try it. Relative to [B+L] (ph) recall, I really wouldn't comment on that. I think they are back in business. They are going to be a fierce competitor no matter what and we are obviously excited about what we have got.

Okay, great. Thanks for that. And then, the second one is just on the PDUFA date coming up in a couple of weeks now. I guess, once you hear on that or get the response, what is left to do before the launch? Can you get that out in late second quarter here in a limited fashion at least, or would that fall into third quarter? And then, I mean, I'm assuming all that investment is baked into guidance, but anything to call out other than, Tim, what you just said around SG&A for the second half? Thanks so much for taking my questions.

Yeah, of course. And you are right about the incremental investment. It's mostly -- and when we commented on the sales force addition that's obviously a big part of the investment. We will have back-loaded investment as well for 512, which will support that launch. We do think the launch will happen probably in the third quarter, but late in the third quarter. We have to manufacture it, we got to get the PIs and the labels all put together. So obviously, we don't get to do that until we get the final word and agreement with FDA on what those labeling will look like. So, look for that late third quarter. And so, there will be a limited effect this year.

Great. Thanks so much.

The next question is from Larry Biegelsen from Wells Fargo. Please go ahead.

Good morning. Thanks for taking the question. Guys, this is the latest in the call that a tariff question I think has come up in Q1 earnings. So, here's the tariff question, Tim. The quarterly cadence, I assume it ramps through '25. So, will Q4 be the highest impact and lowest gross margin in the year? And how should we think about the annual impact for 2025? Can you still grow margins year-over-year given the tariff impact? And I had one follow-up.

Yeah. As I said in the prepared remarks, the gross impact of the tariffs will be primarily in Q3 and Q4. And that's because when you incur the tariff, you put it in, you basically amortize it, so it takes time to work its way through the P&L. So, we've obviously -- we said that we will offset that in 2025. So, we do expect margins to be pretty close to what we guided at the beginning of the year. And then, as we get into 2026, we'll give you more color then. There will probably -- if these were to stick for the full year, you would have an annualized impact. So, you'd have more gross pressure, but at the same time, you'd also have probably more mitigation efforts, whether it's pricing, whether it's manufacturing movements or things of that nature which we would obviously prepare for. But we're sort of looking for a stable environment before -- you need a stable environment before you start making a lot of those moves.

All right. And, Tim, you gave some long-term goals at the Capital Markets Day a few months ago. How does the change in the macro environment, including the tariffs, affect the outlook especially the 12% to 15% ex FX core diluted EPS growth? Thanks for taking the question.

Yeah. Listen, we still feel good about our long-term goals. Those goals are five year goals. So, obviously, there has been -- we have a very dynamic environment as we speak here today, which is very different than it was last quarter, which may be different next quarter. So, I would say, long-term, we feel very good about the fundamentals of the business. We're going to continue to invest in innovation and we feel that if we do that, we will grow faster than the markets whatever that market rate is. We obviously have demonstrated in the past that we have a very good handle on our cost envelope. We'll continue to manage that responsibly. And when you grow faster than the market and manage your cost responsibly, you'll get margin expansion, that drops down to free cash flow. So, we feel very good about all that.

All right. Thanks so much.

The next question is from Patrick Wood from Morgan Stanley. Please go ahead.

Beautiful. Thanks, guys. I'll keep it at one. Love the commentary on the contact side around what you're seeing on the consumer. I'd love to sort of dig in a little bit between cataract and contact and the different regions. What you're seeing, whether it's that mix of new fittings? You mentioned the data on the U.S. side, which we get, but how is that looking in EMEA, for example? And then, when we think of the IOL side, how we're think about the marginal mix there? Like, are we seeing people shift to like mono plus a femto, or is that not a thing? I'm just -- anything on the consumer and the marginal kind of volume mix super interested there. Thanks.

Yeah. Let me just say that the international markets have been very solid. Really all of last year and through the first quarter, certainly solid pretty much everywhere. We have seen a few -- the contact lens in Japan is soft in the market. I think it's been pretty low-single-digits. But on the other hand, we have seen some real growth areas in the United States and a few other markets that have done well. I think the expectation -- I mean the surprising thing maybe to some and I think we have said this historically is that the consumer is relatively well positioned at this point. And I would make two points on that. One is, our contact lens mix on units was up and our unit volumes were up. So, there wasn't -- in the first quarter at least there was a pretty healthy U.S. consumer and international consumer. So, all around the world that seemed to be pretty okay. I think that tells you a little bit more about just this business, which is people who wear contacts get used to wearing them and they stay in them. And so, I think that's just the nature of the resiliency of these markets. The second one is just on the ATIOLs, and I do think again there's always been some question or commentary about, well, what do we see in the ATIOL penetration? And around the world, we saw 200 basis points of movement up in ATIOL in the first quarter. So, these are people who are choosing not to get monofocal lenses and to pay out of pocket for ATIOLs, which again is healthy. As you know, we have two-thirds of the U.S. PCIOLs and we have more than half of the total IOLs. So, when the market moves to ATIOLs, that's a good thing. And in the U.S., it was up 100-and-some-odd basis points. Internationally, it was up more than that. China, obviously, is helping the international market a lot, but really kind of across the board Europe and a number of other markets were really solid on that point. So, I would tell you that kind of the regional mix with the exception of the productivity issue we observe in the market in the U.S., we feel pretty good about the fundamentals in the market. And this thing in the U.S., we are just going to have to wade through. I think there is a turnover of surgeons that are going to require the younger surgeons to pick up their game a little bit and I look forward to helping them. I think we have got some really great assets to move them forward and I think if you look at what Voyager does for productivity, if you look at what Unity VCS does for productivity, when you look at what Pro can do for conversion, these are things that help productivity in the office and I think that's where we are headed.

Thanks. Love the color.

The next question is from Anthony Petrone from Mizuho Group. Please go ahead.

Thanks. Maybe two product questions here. Just a little bit on P7, we're doing optometrist checks and they're actually coming back quite positive on P7. So, maybe just where that product is tracking in terms of expectations for 2025? And then, the second product question would be on AR-15512 just in terms of dry eye. Maybe just a recap on, David, how that product is differentiated versus competition? And when you look at that overall TAM opportunity in the United States, couple of years out, what do you think a reasonable share expectation could be for that product in U.S. dry eye? Thanks.

Yeah. Thanks, Anthony. And I am glad you are doing the channel checks. We do too. And I think it really does give you the kind of positive vibe that I think you are getting. We talked to a lot of folks on P7. We did a lot of work ahead of this. You will remember that we had this product approved for about a year before we launched it. We had to convince ourselves there was real market out there. I think we are seeing just that. I think it's a more intuitive thing for docs to say, "Hey look, put this thing on Monday, it's going to feel great all week. You can then replace it on the following Monday." And that's just way more intuitive. They feel better about getting patients out of a two-week lens where they may or may not remember what they were going to do with it, when to take it out, how long they wore it, and it's just a lot more comfortable and it's at a price point that works. And so look, if you can't get somebody into a dailies lens, which is really the game, right? Most people want to get into it -- get them into a SiHy daily lens, but that's not for everybody, not everybody can afford it. And you know what, this is priced correctly, it does a lot for the patient, and I think we are seeing very nice responses. It's really important to remember that even though 60% of the value in -- or maybe 65% of the value is in the dailies lenses in dollars, probably 55% of the patients are still in reusables and that matters. So, we -- and we are under-indexed there. So, I think that's a real opportunity for us. We see it progressing nicely so far. On 512, look, this is a very unique product. I mean, this is different than pretty much everything else out there that's been out there or that's out there now, because it's not an anti-inflammatory and it's not a supplement. This is a product that is an agonist for natural tear production. And so, very quickly when this product hits the eye, it is creating natural tears, and we are excited about that, and we think that's a very different proposition that goes to the core of the problem. And so, if you can solve the problem, you don't need to worry about the anti-inflammatories because you don't need them. If you can solve the problem, you don't need a supplement because you don't have a tear deficiency of any kind. So, what's exciting about the data we're creating is, I think we're creating enough data around us to get very convinced that this is an exciting opportunity. And look, I mean the market as you know is quite large in the United States and we were excited to see some of the competition that our branded products do well, because I think that tells us that there is a reimbursable market out there for us. So, again, I wouldn't change our outlook on this. I think we are still in that kind of [250 to 400] (ph) is what we have been saying. I will stay there, but I am probably on the higher end of that one now. That's what we like, and we will see as it hits the market where it goes from there and I can update you as we get through that.

Thank you.

The next question is from Tom Stephan from Stifel. Please go ahead.

Great. Hey, guys. First question on contact lenses. David, you sound confident in the end markets holding solid. The legacy lenses seem to be, I think, one of the incremental headwinds in the quarter. Can you just help us with how we should think about that part of your portfolio rest of the year? And for contact lenses more broadly, are there any factors besides P7 that can help drive a reacceleration? And I have a follow-up.

Yeah. Look, I mean, I think I wouldn't read too much into the first quarter contact lens number, I really wouldn't. I think you have got some comp issues in there and you have got some price overlaps that have really caused a different number than what was really happening I think in the market. What you are asking is a really good question, because we are seeing tremendous leverage in our new product flows. We are getting great share motion on daily SiHy sphere, daily SiHy toric, reusable we are getting share movement, and it's causing the hemo market, which is of course our DACP and to a lesser extent our AIR OPTIX brands, our legacy brands to decline, and that is an offset. I think we have been doing that now for -- I think ever since we started, we have been saying look we are going to move through a phase where the legacy brands go away and the new brands take over. One of the things you should observe is that the legacy brands and the reusables in particular are -- sorry, the new brands and the reusables in particular drive the margin. So, if you've looked at the segment margin, you will see us moving up nicely in the gross margin area. That's a beautiful thing. That's because we are moving people from old products where the volumes are declining and the costs are going up to new brands where the costs are coming down and the volumes are going up. So, we continue to try and change over our line, if you will. We are doing that pretty efficiently right now. But again, I think it will always be a little bit of a drag until those legacy brands kind of retire. And in this business that generally takes a long, long time. So, we will see a little bit of drag there, but generally we are going to outperform the market on a consistent basis going forward, read the market as mid-single-digits.

Got it. Super helpful. And then, pivoting to U.S. IOLs, David, I'll stick with you by. I think you alluded to maybe not seeing much that was from a share standpoint outside your expectations. Just a little surprised to hear that given Odyssey momentum, Bausch's premium portfolio performing well, [indiscernible] still growing nicely. So, David, can you just dig a little deeper into why you still feel good about U.S. share today? And if you are able to provide maybe any sort of quantification that would be great. Thanks.

Well, I mean, I think I said it on the market, we're two-thirds of the U.S. PCIOL market today. And that's after the last 18 months or 24 months of competition from just about everybody in the world. So, I think what you'd observe I think, is that things like PanOptix and Vivity are very durable, very competitive products in a market where most of the competitors are $100 to $200 cheaper. And so, there's a market -- there's always going to be a market for less expensive. I think what you're seeing right now is a movement, people trying lenses and people -- some people staying with them because they're good lens. There's nothing wrong with them, but they aren't as good as what we think we can deliver. And I think that's the -- I think that's where people get real comfortable. When you've seen millions of lenses implanted and great results consistently and then you improve that with Pro, I think that's why people stay with us. And obviously, we have a very large footprint in the surgical market. And so, when you go into an OR, you see a lot of our equipment. You see a lot of our reps. You see a lot of our energy in there. And I think there's a real loyalty to what it is that we do here. And I think that's part of why we hang on to share a little bit better than most. Now look, I mean, have we lost share, of course, but we were sitting at, I think, 85% at one point. I mean, it was -- we were always going to lose share, and that was just a question of how much and at what pace. So, none of that's really surprising. And maybe the one surprise that people just kind of undercall is the amount of growth we've created internationally. I mean, I think our share growth in international in a number of spots, but particularly China, has been really, really strong. I mean overall, our share is relatively flat. We've just basically traded share internationally for share in the U.S. And of course, that price trade is not positive. So that's -- I mean, you're kind of coming up in one market and you're coming down the other one because one started all on its own, and the other one was already in a competitive set when they started. So just -- I guess that's the color around this, why we think it's kind of as expected.

Thanks again.

The next question is from Brett Fishbin from KeyBanc Capital Markets. Please go ahead.

Hey, guys. Thanks for taking the questions. I think most of mine have been asked, so I'll ask a little bit of a nitty-gritty question here. Just noticed that in the guidance revision, the 80-basis-point headwind was attributed to both business development activities and licensing. So, it sounds like the Aurion development costs is a good portion of that. Just curious if there was like another element on the licensing side or anything else that was going into that like broader headwind. Thank you very much.

Yeah, it's mostly Aurion. I think the vast majority is Aurion, but there was -- we acquired an asset called Cylite during the quarter as well. You can find that in the notes. And again, we had a little bit of licensing work in there as well.

The next question is from Young Li from Jefferies. Please go ahead.

Great. Thanks for taking our question. I guess maybe one more just on U.S. ATIOL. Just on the competitive trialing dynamics, how much are you still seeing currently? How long do you expect that to persist in '25? And then, are you going to be trialing PanOptix Pro as well to support the launch?

So, yeah, we're continuing to see sampling. I mean it comes in waves, right? When the new products come, it'll take three to six months to get people who want to try it through that process. I think you see kind of successive product after successive product coming into the U.S. market. So, there are probably four or five now that have been in and each one of them will bring samples with them. So, we've been -- we expect that to continue. I mean, I think there'll be another J&J launch next year. We'll see some more trialing going on later this year, I'm sure. And so, again, I think that's probably a factor in some of this, but I think a diminishing factor kind of for the next probably 12 months or so.

All right. Great. Very helpful. And then, I guess our Voyager [checks] (ph) at ASCRS were really positive, solid demo and the efficiency really jumps out for both the doc and the staffing. I think you're scaling manufacturer for it now, but what's your thoughts on the pathway to making it the standard of care?

Great question. Look, I think SLTs stand-alone, I think, is the standard of care. I think the challenge is how do we get it to actually be -- occur at the same rate people believe it should occur. And so that's the magic, I think, of Voyager as we get it kind of out and going. There is an emerging consensus around SLT as the first thing to do, because it keeps people off drops, it's easier, it's a good place to start. And so, for the patient and for the doctor, that seems to be a growing consensus that we see. And I think what you're going to find is that as we get this product out and as more people get the chance to use and experience it. And as they get a confidence that it's really driving pressures down, and it does, then I think that is going to really help drive that standard through. I do think there's a new publication, I think, coming shortly on this product, and that will also help. Again, I think it demonstrates a similar kind of response to core SLT, which is what we've been looking at only this is a lot more efficient, obviously, for the surgeon, so -- or for the glaucomatologists or general ophthalmologists. So, we expect a lot of positive coming on this one. We are manufacturing it right now in Israel, and we are moving that manufacturing to the U.S. as well. So, we'll have dual locations for that product. So, we're excited about getting all that moving.

All right. Thank you.

The next question is from Jeff Johnson from Baird. Please go ahead.

Thank you. Good morning, guys. I guess, Tim, one question for you just on the implantables business. Can you remind us where we are in the phasing of the VVP tailwinds that you've been getting? I know they've been very helpful the last couple of quarters. When do those start to moderate versus the PanOptix Pro tailwind starting to kick in? Do you feel like the 0% implantable number we saw in the first quarter, are we at the trough? Should we see some sequential improvement in those year-over-year growth rates over the next few quarters? And then, I have one follow-up. Thanks.

Well, I mean, I read the implant number as a function of the U.S. market largely being very suppressed. And I think that has had more of an impact than anything else. I would read going forward that the VVP will have a tailwind through probably the end of next year -- sorry, end of -- mid part of next year and then probably that turns over -- assuming they do it on time. And again, there's been some second runs at these China VVPs where the national VVP doesn't come on time. So, we'll see -- I think the scheduled time is for the middle of the year, we'll see what happens actually there.

But I think, Jeff, if your question was like this quarter and a phasing perspective on a VVP, if you'll recall, Q2 of last year, is when we started stocking the distributors. So, I think from -- when you're looking at a year-over-year in '25 versus '24, I think it starts to normalize in Q2.

Yeah, that's kind of how I headed to my model, and that's my -- I guess, my concern is, do we think implantables could dip even from here, this level before we start back on a recovery as PanOptix Pro build throughout this year? Or are we kind of near a trough at this point?

I'd have to look at that in some specificity. I think directionally, we continue to grow share in kind of year on prior year. So, the actual consumption would be a tailwind for sure, I think, year-over-year. The question is as you wrap around on the loading of inventory, there may be a temporary number that we have to worry about, probably mostly in the Q2 frame.

Okay. And David, just as you think about PanOptix Pro building, I think you've talked about potentially been taking PanOptix, keeping that active as well and maybe pricing that down to be a little more competitive with some of the discounting we've seen from other PCIOL players. I mean, how do you think conceptually about PanOptix being such a good product on its own? How many docs might want to take the discounted version, if you will, of PanOptix versus pay the full rate for the PanOptix Pro with the less scattering there?

Well, I'm going to dodge your question just because I don't want to give our friends from the competition exactly what we're going to do on this one. I think in truth, you do -- you're 100% right, we have some flexibility here. We like both of these products. The other way to play that one would be to make sure Pro was premium. And I think we'll see how this plays out in the market. But I think it does give us a lot of flexibility. Let me leave it at that.

Fair enough. Thanks.

The last question is from David Adlington from JPMorgan. Please go ahead.

Hi, guys. Thanks for the question. And I'm sorry, but we're going to return to tariffs, please. Just on the $80 million tariff, I just wondered, geographically where that was derived from, is that U.S. to China, U.S. into Europe, just to help us think about where that might go? And then, just a clarity that $80 million gross headwind, is that rate as of now? If we return to prescribed rates following the 90-day suspension, what would that impact be for this year and then potentially annualized into 2026?

Yeah. Great question. So, the $80 million is a split between China -- it's primarily China and then let's call it and exports to China. So, our levels of imports from China is relatively small. So, the way I would think about it, we picked 10%. We held them flat from that was announced through the rest of the year. And the reason we did that is, I'm just not quite sure what the rate is going to be in August 15, depending on what you read, as you indicated, some folks think it's going to go back to $125 million. There are other trade associations say that a vast majority of the tariffs that were announced after Liberation Day had been canceled. So then therefore, it would go back to 34%. So, we chose not to try to speculate as to what's going to happen, and we basically treated it like we treat FX. We snapped 1 point in time, and that's what we've assumed going forward. So, to answer your question directly, if it is $125 million, and it does go back to August 15, it would have a material impact on four months' worth of COGS in China. Now, keep in mind, now a lot of that gets hung up on the balance sheet because it takes time to roll through the P&L, but we'll also probably have a significant impact in 2026. Now, what you need to be careful of is if this thing were long term and that was to happen, then obviously, we would take some different strategic moves from a mitigation perspective, again, similar to what we talked about earlier, we look heavily at pricing strategy. We look heavily at tax strategy at manufacturing footprint. So, I don't really want to speculate on what would happen in 2026, but that's sort of how we -- I don't want to dodge the question, but that's sort of how we thought about it.

Perfect. And then maybe just one follow-up. Are you potentially seeing any tailwinds from some of your competition potentially more exposed to tariffs, particularly on the equipment side?

No. Look, I think we're all kind of in the same spot. I think a lot of folks have a nice business in China. We have a big business in China and in Japan, both of which are countries that we mostly import from the U.S. So, that's something to think about. And obviously, most of our competition do the same thing. However, I think we look very carefully in market to see what the pricing potential is for us. And whether or not we can take advantage of our circumstance or somebody else's. And so, we'll look market to market in the -- if we get into this kind of how do we mitigate things a little more carefully. But right now, our hope in particular, is that cool minds will prevail here, and we will see kind of a zero-for-zero view on this. As I said earlier, there is not -- the AdvaMed folks will tell you -- as well the Chinese, that there is not a trade imbalance between China and the United States on medtech products. And so, there isn't a logic for it other than its part and getting caught up in a lot of this negotiation. So, our point of view right now on the whole of our business is let's ride this out. Let's be smart about it. Let's be -- we can make the moves we need to at the right times, but let's hold our investments in R&D, let's hold behind the new product flow. And let's let the new products really carry us through the end of the year. I think this is where we started the year. It's exactly where we're going to end the year. We need to get our growth going again, and that's exactly what we're having a good time doing right now.

That's very clear. Thank you.

This concludes the question-and-answer session. I'd like to turn the floor back over to Dan Cravens for closing comments.

All right, everybody, thanks for your time this morning and afternoon. If you have any other follow-up questions, certainly feel free, for media, reach out to our corporate communications team, and investors, feel free to reach out to either Allen Trang or myself. Thanks again.

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