5/8/2025

speaker
Conference Operator
Call Moderator

Good day, and thank you for standing by. Welcome to the Site Sciences first quarter 2025 earning results conference call. At this time, our participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 1 again. please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Hannah Jeffries, Investor Relations. Please go ahead.

speaker
Hannah Jeffries
Investor Relations

Thank you for participating in today's call. Presenting today are SightScience's co-founder and chief executive officer, Paul Badawi, and chief financial officer, Aoi Bowerly. Also in attendance is SightScience's chief commercial officer, Matt Link. Earlier today, Site Sciences released financial results for the first quarter ended March 31, 2025, and reaffirmed its revenue and reduced its adjusted operating expense guidance for full year 2025. A copy of the press release is available on our website at investors.sitesciences.com. I would like to remind everyone that comments made by management today and answers to questions will include forward-looking statements within the meaning of federal securities laws. These forward-looking statements include statements related to our 2025 revenue and adjusted operating expense guidance and the primary factors impacting our ability to achieve our guidance. The impact of tariff costs on our cost of goods sold, our plans to expand our manufacturing lines to additional manufacturing locations and the expected timelines and related costs, our ability to offset costs associated with tariffs and manufacturing expansion with adjustments to our cost structure, Our ability to achieve our current and long-term strategic objectives and value drivers. Our market opportunity and ability to compete and capture market share. The continued adoption of our products by surgeons. Our product reimbursement coverage and strategy, including our ability to achieve positive reimbursement coverage decisions for tear care. Expectations regarding commercial momentum, account utilization, and customer engagement. Our pipeline of interventional glaucoma and dry eye technologies. our clinical trial strategies and results, and our investments in market development and research and development projects. Forward-looking statements are based on estimates and assumptions as of today, are neither promises nor guarantees, and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in these statements. A description of some of these risks and uncertainties can be found in our public filings with the Securities and Exchange Commissions. including the risk factor section of its annual report on Form 10-K and quarterly report on Form 10-Q. We undertake no obligation to publicly update or revise any forward-looking statements except required by law. On this call, management refers to certain financial measures that were not prepared in accordance with generally accepted accounting principles in the United States, including adjusted operating expenses. We believe these non-GAAP financial measures are important indicators of its operating performance because they exclude items that are unrelated to and may not be indicative of its core operating results. See our earnings release for a reconciliation of these non-GAAP financial measures to the most directly comparable GAAP financial measures, as well as additional information about our reliance on non-GAAP financial measures. I will now turn the call over to Paul.

speaker
Paul Badawi
Co-founder and Chief Executive Officer

Thanks, Anna. Earlier today, we reported our financial results for the first quarter of 2025, including total revenue of $17.5 million. In a dynamic MIGS market, our solid results reflect the significance of our proven interventional technologies for our customers and patients, and the consistency and hard work of our team to effectively serve eye care providers and their patients. We remain focused on addressing the significant unmet medical needs in two of the largest markets in eye care, glaucoma and dry eye, and committed to our mission to develop transformative, interventional technologies that allow eye care providers to procedurally elevate the standards of care, empowering people to keep seeing. As we discussed on our prior call, our focus in 2025 is rooted in our key strategic initiatives, which include building commercial momentum in MIGS through our continued commitment to customer education and engagement, establishing equitable reimbursement for tier care, publishing new clinical and economic data, supporting the adoption and use of our portfolio of interventional technologies, and progressing our robust product pipeline, including a recent next generation Omni release. I would also like to address our tariff exposure, considering the material tariff increases on all goods imported from China. As most of our products are manufactured and assembled in China, We expect increases to our cost of goods sold starting in the second quarter of 2025 and throughout 2025 for as long as these tariffs remain in effect. We expect to mostly offset the incremental tariff costs with reductions in our operating expenses. Allie will cover these details and their associated financial impact in her prepared remarks shortly. As part of our routine assessment of manufacturing operations, we have been evaluating additional manufacturing locations and are in the process of establishing third-party manufacturing lines outside of China, which would lower our tariff costs over time. In nine to 12 months, we expect a new manufacturing line to be available outside of China to produce our OmniEdge product. We plan to phase in additional manufacturing capacity outside of China for our other impacted product lines over the subsequent six to nine months. Diving into our surgical glaucoma segment, The first quarter of 2025 marked the first full quarter in this new MIGS environment, in which Medicare coverage in most states for multiple MIGS procedures that are performed at the same time as cataract surgery has been restricted. In these regions, Medicare limits coverage to only one MIGS procedure performed with cataract surgery. Our better than expected results in the first quarter, despite these changes, reinforce our belief that the comprehensive procedure enabled by Omni, will continue to be a market leading treatment option in the MIGS category. We believe Omni is performing well against the competition at or slightly above the levels we expected due to Omni's clinical efficacy, surgeon preference, our focus on our long-term customer relationships, and our expanding Omni technology platform. We will continue to adapt within this new MIGS environment and are actively optimizing our commercial approach. In the first quarter of 2025, surgical glaucoma revenue was 17.1 million. We are encouraged to see only a slight decline in sequential ordering accounts considering the MIGS restrictions, and our account engagement efforts are gaining traction. We are confident that patient need and demand for glaucoma treatment will continue to grow in 2025 and beyond, and we believe we are well positioned to benefit from the shift in surgeon adoption and utilization toward an interventional mindset. We are focused on advancing multiple strategic initiatives, including demonstrating the clinical benefits of earlier interventions with the comprehensive Omni procedure, engaging accounts around reimbursement clarity, enhancing competitive counter-selling, investing in targeted commercial resources, optimizing pseudophakic standalone Omni market development strategy through refined patient targeting and selection, and expanding the use of our new product, the OmniEdge. I will now highlight our recent progress made against these initiatives. We recently attended the annual meeting of the American Society of Cataract and Refractive Surgery, or ASCRIS, a large industry event. At ASCRIS, we hosted several events and spent time highlighting the pseudophagic standalone unmet need. We are excited by the growing interest in learning about earlier interventions with OMNI, and we were pleased with the strong surgeon engagement and increased focus on interventional glaucoma. We believe that standalone intervention performed with Omni can be effectively utilized for pseudophagic standalone glaucoma patients to potentially delay or avoid the need for riskier advanced future procedures. We continue to make headway as a result of our team's engagement with surgeons and other customers on the advantages of Omni for this patient population. We believe we have trained approximately half of the mixed-train surgeons in the United States, and we continue to add Omni and Scion-trained surgeons. Our robust clinical data highlighting the efficacy and benefits of our Omni technology supports our surgeon education and account engagement efforts. Lastly, I want to briefly touch on our product pipeline. We recently launched our next generation OmniEdge, which is the latest evolution of our MIGS platform that is helping glaucoma surgeons effectively treat primary open-angle glaucoma patients. Surgeons are leveraging this technology to address the diverse needs of these patients, including combination cataract and standalone patients, as well as mild, moderate, and severe patients. In March, we commenced a controlled release of our OmniEdge devices to select key opinion leaders before our formal launch at ASCRIS two weeks ago. We are pleased with the early reception from surgeons and their clinical outcomes. OmniEdge, with TruSync technology, incorporates a proprietary motion synchronized viscoelastic delivery mechanism whereby surgeon rotation of the control wheel results in predictable and reproducible viscoelastic deployment along every treated clock hour of Schlem's Canal. OmniEdge is designed to deliver significantly more visco-dilation than prior versions of the Omni system, while maintaining the consistency and safety surgeons have come to trust in the Omni platform. The addition of OmniEdge is intended to accommodate varying physician preferences and patient needs in today's evolving MIGS marketplace. With this product, we are expanding our portfolio to supply surgeons with more options to support their patients. Now I'll turn to our dry eye business, where we continue to advance our strategic initiatives. As a reminder, our long-term strategy is to be a pioneer in the estimated $3 billion core market for patients with moderate to severe meibomian gland disease, or MGD, who are candidates for an interventional procedure. We have been intentional in executing our strategy beginning with developing best-in-class technology, followed by delivering superior long-term clinical outcomes demonstrated through randomized controlled clinical trials. We are now increasing customer advocacy and advancing our market access initiatives to establish equitable reimbursement for tier care, with coverage policies and or payment decisions still expected to begin in 2025. In the first quarter of 2025, dry eye revenue was 0.4 million. Our results for the first quarter of 2025 in our dry eye segment reflect our focus on market access and our new pricing. We believe there is a significant unmet need within the MGD patient population for an interventional treatment option, and we continue to engage in meaningful conversations with payers to seek coverage and appropriate reimbursement for care care. Our customers have been very supportive and are actively submitting claims to payers to demonstrate the unmet need, real-world utilization, and significant value of our technology. We continue to develop our clinical evidence with the progression of our three-stage Sahara RCT, a landmark trial that has demonstrated the effectiveness of tear care when compared with the leading prescription eyedropper stasis in stages one and two. We expect the results from the third and final stage, which assesses the durability of tear care treatment effect through 24 months, will be published in 2025. As we have worked to support coverage and payment for the tear care procedure, we have built a foundation with an established commercial infrastructure that has trained eye care providers at over 1,500 facilities and performed over 65,000 tear care procedures to date. We are confident this meaningful and experienced customer base is capable of quickly ramping to meet demand if and when reimbursement determinations come. We believe tear care can be a catalyst to drive growth and the robust dry eye opportunity. Our continued ability to be a leader in addressing the unmet needs served by our innovative technologies is a top priority for us. And we are pleased with our achievements through the first quarter to solidify our position as we execute our strategic initiatives. In our surgical glaucoma segment, we are building commercial momentum within the evolving MIGS market through surgeon education and engagement with our customers, as well as developing the pseudophagic standalone market. In dry eye, we have created an important foundation from which we can execute and appropriately scale following coverage and or payment decisions for Tiercare. I will now turn the call over to Allie to discuss our financial results and guidance for 2025.

speaker
Aoi Bowerly
Chief Financial Officer

Thanks, Paul. In the first quarter of 2025, total revenue was $17.5 million. This reflects a 9% decrease compared to the same period in the prior year. Surgical glaucoma revenue for the first quarter of 2025 was $17.1 million, a decrease of 6% compared to the same period in the prior year, primarily due to a decrease of 10% in account utilization. This expected decrease was the result of the impact to the mixed market associated with the new Medicare LCD. Ordering accounts were up 3% compared to the same period in the prior year, and down only 3% compared to the fourth quarter of 2024, despite the MIGS restriction, demonstrating our ability to maintain our customer base, albeit at slightly lower volumes. Our dry eye revenue for the first quarter of 2025 was 0.4 million, a decrease from 1 million in the same period in the prior year. This expected decline was primarily due to fewer SmartList sales resulting from our SmartList price increase on October 1st, 2024, which we enacted to more appropriately reflect the clinical efficacy and value of the tear care procedure. Gross margin for the first quarter was 86%, flat relative to the same period in the prior year. Notably, we did not see an impact to first quarter gross margins from the tariffs as we used inventory purchase prior to the tariffs taking effect. Total operating expenses for the first quarter were $29 million, a decrease of 7% compared to $31.2 million in the first quarter of 2024, primarily due to lower legal fees in the first quarter of 2025. Adjusted operating expenses were $24.7 million for the first quarter, a decrease of 7% compared to $26.6 million in the same period in the prior year. Our net loss for the first quarter was $14.2 million, or 28 cents per share, compared to a net loss of $16.3 million or $0.33 per share for the first quarter of 2024. We ended the quarter with $108.8 million of cash and cash equivalents and $40 million of debt, excluding unamortized discount and debt issuance costs. Cash used was $11.6 million in the first quarter and included annual bonus payments. We continue to focus on operational discipline and improving our working capital. As a reminder, we have not received any monetary damages awarded in our successful jury trial verdict in our patent infringement case against Alcon. We are awaiting the judge's final order, whether to confirm the jury's verdict, establish ongoing royalty damages, and or determine any potential enhancements. And the final ruling is subject to appeal. Moving to our revenue outlook for full year 2025, we are reaffirming our revenue guidance of approximately 70 to 75 million. This guidance range takes into account the expected impact to the MIGS market following the effectiveness of the new Medicare LCV. While we expect patient demand and need for treatment to continue to grow in 2025 and beyond, we expect total claims billed will be reduced in 2025 due to the multiple MIGS restriction. Looking closer at the second quarter of 2025, we expect surgical glaucoma revenue to be down high single digits to low double digits compared to the same period in the prior year. This revenue guidance range also assumes revenue of approximately $1 million for full year 2025 for our dry eye segment and does not contemplate achievement of reimbursement coverage and or payment decisions for tier care in 2025. While we outperformed our revenue expectations in dry eye in the first quarter of 2025, we expect revenue to be modest until these decisions are made. I also want to expand on our tariff exposure, which is applicable only to our imported products and does not impact overhead or other cost of goods sold. At the current 145% China tariff rate and based on current revenue expectations including product mix and related inventory on hand, our surgical glaucoma segment unmitigated tariff exposure would increase the segment's cost of goods sold by between approximately 3.5 million and 4.5 million for full year 2025. The impact is expected to be larger in the second half of 2025 versus the first half of 2025. We expect dry eye cost of goods sold to also be negatively impacted as new inventory is purchased. We will provide more visibility on impact to that segment if dry eye revenue becomes more significant relative to our overall revenue. As Paul mentioned, we have been working on additional third-party manufacturing locations, which likely would take 9 to 12 months to begin producing a portion of our volume, starting with our Omni Edge product line. The cost to set up new manufacturing locations are relatively small and not material to our overall cost. We expect our cost to manufacture in these new locations will be similar to the cost incurred in our current manufacturing facility, in each case after excluding the impact of tariffs. We are also announcing improved adjusted operating expenses guidance expectations for full year 2025 of 101 to 105 million, representing an increase of 0 to 4% compared to 2024, versus our prior adjusted operating expenses guidance of 105 to 107 million. The expense reductions identified are the result of our ongoing focus on fiscal discipline throughout our business, combined with additional expense controls put in place to mostly offset the cost of goods sold impact associated with tariffs on our business. The revised estimated 2025 adjusted operating expenses still include investments in pseudophagic standalone surgical glaucoma market development, tier care market access, and increased research and development projects. This guidance does not assume expansion of the commercial dry eye team in response to the achievement of positive reimbursement coverage and or payment decisions. We are proud of the progress made this quarter, both operationally and strategically, and we remain focused on further penetrating and expanding the surgical glaucoma and dry eye market as we execute and deliver on our long-term goals and build for our future. Operator, please open the line for questions.

speaker
Conference Operator
Call Moderator

Thank you. At this time, we will conduct a question and answer session. As a reminder, to ask a question, you need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while I compile the Q&A roster. Our first question comes from Tom Steffen from Stifel. Please go ahead.

speaker
Tom Steffen
Analyst (Stifel)

Great. Good afternoon, everyone. Thanks for taking the questions. I'll start with surgical glaucoma. Paul, Allie, or Matt, maybe if you can talk to kind of MIGS trends year to date and how Omni and the market are really tracking versus your expectations. And maybe to dig in there, you know, talk about share dynamics specifically, you know, that you're seeing as doctors obviously may now be forced to choose a single option and what otherwise would have been a stacked procedure. What are you seeing year-to-date specific to shared dynamics? And then I have to follow up.

speaker
Matt Link
Chief Commercial Officer

Yeah, Tom, I'll handle that first. And obviously, Paul or Ali can jump in. So as we've discussed previously, while the number of patient encounters continue to grow based on the prevalence of the disease state in glaucoma, actual utilization is declining to your question on the elimination of combo mix from five of the seven max. And so as we've discussed previously, obviously we were aware of this proposed change that went into effect in November of last year. I think our team has done an outstanding job of being in front of that communication to providers, making them aware of the pending change and really engaging them on what their needs were for these patients. And in many instances, those needs really center around the efficacy of the combined technologies and the complementary nature of stents and, say, the comprehensive procedure enabled by Omni. And so while we've seen a net reduction in the number of units of technology used in those procedures impacted by the ConvoMIG, we have seen results consistent with our expectations and guidance provided for the year. as it relates to our ability to continue to retain physician in physician practices. And I think in particular, the comprehensive efficacy provided by Omni is something that the providers are continuously turning to. And so thus far, we are pleased with our team's engagement in the market's continued reliance on Omni and the treatment of mixed patients. And we're going to continue to obviously amplify that messaging in physician moving forward to both retain and take new share. But thus far, in line with our expectations and consistent with our objectives always, we'll continue to seek to do even better moving forward.

speaker
Paul Badawi
Co-founder and Chief Executive Officer

And Tom, just to add to that, just to add to Matt's comment, I think our team has been performing well in this new environment while we believe strongly that surgeons should have all the flexibility in the world to best take care of their patients. In this one MIGS environment, you know, Omni was designed from the beginning to be multimodal, multimechanistic. It's per its indication from the FDA, it's indicated to perform two sequential procedures, if you will, in one comprehensive procedure, canaloplasty followed by trabeculotomy, which helps the surgeon comprehensively address the disease downflow pathway in the eye. So, In this one MIGS market, I think Omni has a strong competitive position and very strong product market fit.

speaker
Tom Steffen
Analyst (Stifel)

Got it. That's great. And a quick follow-up. First, are there any efforts ongoing to reverse the stacking component of the LCDs? And then my second question is just on competition. Paul, any thoughts on... the new competitors in MIGS, notably with New World's Via360 that's been out there for a little longer now. So, you know, what are you seeing on the competitive side with that product? Thanks.

speaker
Paul Badawi
Co-founder and Chief Executive Officer

Yeah, I'll start and feel free to add. In terms of data supporting multiple MIGS, we have heard of multiple efforts underway that are, you know, multiple efforts to collect clinical data on those combinations of procedures that should hopefully show that addressing multiple sources of outflow resistance is better than addressing one or two, addressing all three. Now, you can address all three with OMNI if you take advantage of all of OMNI's functionality, but some surgeons prefer to take advantage of some of that functionality and perhaps deliver a permanent implant in combination with OMNI. That's another way of addressing all three points of resistance. So hopefully those efforts are successful. We've heard about them. We're not actively participating in them, but we do support the effort. We'll see what that data looks like. I think it'll need to be compelling to support multiple MIGS procedures, as you can imagine. As it relates to competitive entrance, this is not anything new, Tom. You've been following site for a while in the MIG space for a while. It's a very dynamic environment. A number of products have been introduced recently. Over the past few years, we've seen a number of new entrants. As it relates to our specific category of, you know, canaloplasty, trabeculotomy, circumferential nonimplantable angle surgery, We've been innovating in this area for well over a decade. We are, you know, with the OmniEdge, it's yet another great addition to our portfolio. We listen to the market. I think we do a great job of engaging with our surgeons, listening to their feedback and turning around elegant technology that meets their needs and patients' needs. And so we're not sitting idle. We're staying, you know, we're staying ahead of the category, continuing to push it as far as we can take it. We've seen, again, we've seen other entrants come in. We haven't seen anything that we believe is truly disruptive in terms of the proven safety, efficacy, and usability of the Omni surgical system today and where we will continue to take it tomorrow.

speaker
Conference Operator
Call Moderator

Thank you. One moment for our next question. Our next question comes from Danielle Antalfi from UBS. Please go ahead.

speaker
Angela
Analyst (UBS, representing Danielle Antalfi)

Hi, this is Angela on for Danielle. And I have a few questions. The first one, can you talk about the reimbursement mechanics for Omni versus competitive MIGS devices like Stance? Just trying to get a sense of how that will look going forward in a one MIGS environment, and then one follow-up.

speaker
Aoi Bowerly
Chief Financial Officer

Yeah, so the reimbursement dynamics really are unchanged on a competitive front. There always has been the mass majority of procedures have been done not in a stacked procedure, but as separate MIGS procedures being performed either in combination with a cataract or on a standalone basis. for a single MIGS procedure being performed on a patient at the time. So if you recall, the market data that we estimate is that there were, before the restrictions went into effect, about 85% of the market done on a single MIGS basis and about 15% where we saw that combination procedure being done with multiple MIGS. So from that perspective, the reimbursement dynamic for the mass majority of the market is the same. Of course, now with the single MIGS restrictions, the provider must choose which MIGS procedure they believe is correct for that patient. So the provider is seeing reduced economics, where in that scenario before they were getting some reimbursement for the single MIGS procedure and then 50% of the second MIGS procedure. In terms of specific reimbursement dynamics, That varies based on what product is used in the combination. But we do feel like we are, you know, we have a proper reimbursement for the procedure and we can compete effectively against our peers based on our clinical efficacy and our overall value proposition to the market.

speaker
Angela
Analyst (UBS, representing Danielle Antalfi)

Thanks, Ali. That's helpful. And then any update on the progress of TA care reimbursement wins? I was wondering if you can give us color on maybe anything trackable like number of lives now covered or max successfully enrolled, anything like that that you're tracking.

speaker
Aoi Bowerly
Chief Financial Officer

So certainly we would love to provide any details as we have them. However, we do not have any covered lives at this point for care care. So we do have an established code. We have been having individual claims paid as we work through this process with payers, but no coverage determinations have been made by any payer. We are continuing to have great conversations with both commercial payers as well as some Medicare administrative contractors. And we still feel like we should have some either payment decisions or coverage policy decisions this year that would allow us to really start pursuing this reimbursed market for care care for this compelling interventional procedure. So we do feel like we are on track, but we do not have a win yet to discuss publicly.

speaker
Angela
Analyst (UBS, representing Danielle Antalfi)

Okay. Thank you so much. I'll go back into the queue.

speaker
Conference Operator
Call Moderator

Thank you. Our next question comes from Joanne Welsh from Citi. Please go ahead.

speaker
Anthony
Analyst (Citi, on behalf of Joanne Welsh)

Hi, team. This is actually Anthony on for Joanne. Thanks for taking our questions. Can we talk about just Scion briefly? Are you seeing any

speaker
Aoi Bowerly
Chief Financial Officer

talent for that product um just given you can't stack anymore with lcds and are you able to provide what scion revenue was as percent of your total revenue yeah so we don't break it out specifically it's within obviously our total surgical glaucoma revenue it is a modest portion of our total revenue in that business so the mass majority is omni Scion in general is a complementary product. It's meant for surgeons who are looking for a more straightforward procedure. Maybe they need less efficacy than they can get with Omni. So that's really the target market for Scion. It has seen similar trends overall to Omni in terms of as we've seen the business grow and change over time associated with these reimbursement changes. So there hasn't been a material shift in our revenue mix between Omni and Scion, but Scion is a good option for certain accounts and sometimes leads to future Omni usage as accounts get more comfortable doing MIGs.

speaker
Paul Badawi
Co-founder and Chief Executive Officer

Yeah, it's complementary. It's an important category in glaucoma surgery. There's maybe to simplify MIGs, you have three kind of mainstream mechanisms. trabeculotomy or goniotomy, that's where we have scion, canaloplasty or canaloplasty followed by trabeculotomy, where we have omni and then there's stents. And so we believe, obviously strongly, that omni offers the surgeon and patient the most comprehensive outflow procedure in terms of up to 360 degrees of canaloplasty and trabeculotomy. Scion, as Ali mentioned, it's a more straightforward procedure, preferable for some surgeons who are looking for something either more straightforward or a patient that might be more mild in disease and doesn't necessarily need the, you know, comprehensive procedure profile of Omni.

speaker
Anthony
Analyst (Citi, on behalf of Joanne Welsh)

That makes sense. And then on tariffs, I recognize it's pretty early in the year, but the three and a half to four and a half, is it appropriate for 2026 to annualize that, or how should we think about that moving forward with the mitigation strategies?

speaker
Aoi Bowerly
Chief Financial Officer

Yeah, so great question. Going into 2026, that's where our commentary on our new manufacturing locations is more relevant. So we do expect that to have that additional facility up and running within nine to 12 months from now. So really, we expect relatively minor impacts to gross margin in 2026. We will also phase in our other impacted product lines in the first and second quarter next year. So the impact, again, assuming that these tariffs stay in effect at the current rates, would still be rather modest in 2026 as we shift to alternative manufacturing locations.

speaker
Angela
Analyst (UBS, representing Danielle Antalfi)

Great.

speaker
Conference Operator
Call Moderator

Thank you. Thank you. Our next question comes from Frank Tacketing from Lake Street Capital Markets. Please go ahead.

speaker
Frank Tacketing
Analyst (Lake Street Capital Markets)

Nate, thanks for taking the questions. I was hoping to start on one related to reimbursement. I know last year you were potentially up for device intensive. I believe that's coming up again this year in the July timeframe. Any thoughts around whether or not you may qualify for device intensive for the 2026 year?

speaker
Aoi Bowerly
Chief Financial Officer

Yeah, we aren't going to speculate today on whether we'll see device intensive. Obviously, that's something that we all will see in July as a proposed rule and then a final rule in the November timeframe. which would then be effective January 1st. What I will say is that we still have strong conviction that our device should qualify for device intensive given the cost of the procedure and the overall economics. So we still feel strongly on that. This is an active project for us that we're engaged in, but we really can't speculate on whether that will be achieved or not.

speaker
Frank Tacketing
Analyst (Lake Street Capital Markets)

Okay. That's fair enough. And then maybe just one on the outlook for the year. Obviously, it came a little bit ahead of street expectations for the first quarter. Congrats on that. And then maybe talk through kind of cadencing of revenue. And I apologize if this has came up. I've been jumping between a couple of calls, but any help on cadencing of revenue would be helpful for us.

speaker
Aoi Bowerly
Chief Financial Officer

Yeah, sure. Happy to take that. And as you said, we are pleased with the start to the year. We do think that We started strong here. We expect to continue to see growth throughout the year. You know, we do expect to see an increase sequentially in the second quarter versus the first quarter. And that is typical in the business that you would see that type of cadence. Typically, the third quarter is a small step back from the second quarter. And then, you know, a little bit higher seasonality in the fourth quarter as well. We do expect, as we continue to make progress on pseudophagic standalone, that we'll see some tailwinds associated with that. And then, of course, from a comp perspective, the easiest comp for us is the fourth quarter, since we already had half a quarter of the multiple MIG stacking impact built into that baseline. And then, of course, as we've said multiple times, Guidance includes the million dollars for dry eye. So that is also an opportunity as we plan to have these market access coverage and or payment decisions this year. If those are material in nature, those will be opportunities for us to accelerate that revenue growth in that channel as well.

speaker
Frank Tacketing
Analyst (Lake Street Capital Markets)

Got it. That's helpful. I'll stop there. Thank you.

speaker
Conference Operator
Call Moderator

Thank you. Our next question comes from Macaulay Kilbane from William Blair. Please go ahead.

speaker
Macaulay Kilbane
Analyst (William Blair)

Hey, everyone. This is Macaulay. I'm from Margaret tonight. Thanks for taking our questions. I wanted to double down on the tier care question from earlier, and I obviously understand payer decisions can take time, but You guys have been out in front of this for over a year, year plus, if not more. And at least from our perspective, the data seems pretty clear from the budget analysis. So I guess, you know, I appreciate you saying, you know, conversations have been positive, but is there one or two points that, you know, they're pushing back on? Or I guess what's left in kind of making that final jump to get coverage here?

speaker
Paul Badawi
Co-founder and Chief Executive Officer

Hey, Macaulay, this is Paul. Yeah. We feel strongly we're having quality conversations and they're progressing nicely. It does take time. But again, those conversations are progressing. We're, as Ali mentioned, speaking with smaller regional commercial plans, larger national plans, as well as a handful of MACs. We continue to believe we are going to have successful coverage and repayment decisions this year we've been stating that we're continuing to state that and those conversations the quality of those conversations and the fact that they are progressing despite the fact that they do take time or progressing nicely we're we're trying to do something pretty significant here as you can imagine to create create a category and pioneer a reimbursed MGD procedures. This is a disease that is growing in prevalence. It's a serious problem. There is no meaningful reimbursement today. Patients need access to this. And the data needed to create reimbursement in a category that pretty much doesn't exist is significant. And we have that data and the conversations with payers, they're responding very well to that data. That's why these conversations are progressing the way that they're progressing. We're not surprised that they're responding very well to the data, but we're pleased. We're not surprised because we spoke with payers prior to executing the Sahara RCT. We spoke with a variety of different payers and a variety of different medical directors, all from different backgrounds, and we asked them, We said patients need access to a treatment that addresses the root underlying cause of this prevalent problematic condition. What clinical data do you need to see that if we are able to bring it to you will result in successful coverage and payment decisions? They helped us design the blueprint for the Sahara RCT. And so we've been able to share not only the published phase one and phase two data, that's extremely compelling, comparing us and demonstrating superiority to a dry eye standard of care. But also now we've been able to share with them our phase three data. It's in the process of being published, but we have been able to share it with payers. We discussed it at the recent ASCRS conference. The high level data and the phase three data is also very compelling. While these things do take time, I think all of us should be confident that we are progressing nicely and as we had hoped.

speaker
Matt Link
Chief Commercial Officer

Yeah, Macaulay, this is Matt. I'll just add, first of all, I appreciate the question because I think it underscores an interest and enthusiasm for what this opportunity represents, and we certainly share that enthusiasm. In addition to Paul's comments, I think what's really important about the timing is, first of all, the timing is still in line with our expectations as we enter the year in terms of how these conversations are progressing. The other thing is when you're thinking about timing, it's not just the completion and publication of the data that Paul mentioned. It's also then going into the market and demonstrating demand and that there's a need for this intervention in patients. And that's reflected through claims submitted by providers. And we've talked about some pocketed success in terms of individual claims being processed. And one of the things we want to continue to emphasizes equally, if not more important, are the claims in process. And these are claims that are submitted, oftentimes denied, required to go through multiple levels of appeals. We've had remarkable partnership from our clinical advocates, surgeons and providers, working with our commercial team and our market access team. And in many instances, that process can take in excess of 180 days. When you start to think about this timeline, it's consistent with what our expectations were coming into this, and we continue to create the appropriate upward pressure and awareness on the need for positive coverage decisions through the efforts of our commercial and market access team. So, appreciate the interest, the excitement, and as Ali mentioned earlier, we're very much excited to come back and be able to announce positive coverage decisions later in the year.

speaker
Macaulay Kilbane
Analyst (William Blair)

No, that's That's great and really appreciate the thorough response from both of you there. And then maybe just to follow up on the guidance, and sorry if I missed some of this, Allie, but at least from our perspective, the active facilities decline was a bit more than we had modeled in the quarter. So was there anything to call out this quarter specifically or how to think about those accounts recovering throughout the remainder of the year? And then is there anything factored into guidance as we think about pricing, especially as edge becomes a larger contributor throughout the year? Thanks again for taking the questions.

speaker
Aoi Bowerly
Chief Financial Officer

Yeah, sure. No problem. And just at a high level, first, I would say that this was in line with our expectations. We knew that there would be some accounts in this process. And we're talking pretty small net numbers here in terms of accounts. we are really proud of the fact that we still saw an increase year over year of 3% in accounts, in ordering accounts. So we see that as a positive and we'll continue to look for opportunities to engage accounts. From here though, we do think The bigger driver here is going to be increasing utilization, in particular, the pseudophagic standalone opportunity, as well as the combination cataract opportunity. These are the ones that are going to drive revenue more so than adding accounts. We have the large majority of the accounts in terms of ones that are doing high volume MIGs. And really, we just need to drive higher utilization as the primary focus. Now, on the second question on pricing, we aren't going to comment specifically on our pricing strategy. But with OmniEdge, it will be priced at a premium to ergo. But really, there's nothing specific that you need to really factor into your model. We'll see how launch goes here. So far, it's been very positively received. But we know that some accounts still prefer ergo as well. So we will see a mix in the business that is, you know, now two product options in our portfolio that based on physician preference, they can choose what's right for them.

speaker
Macaulay Kilbane
Analyst (William Blair)

Great. Thanks again, Allie.

speaker
Aoi Bowerly
Chief Financial Officer

Yeah.

speaker
Conference Operator
Call Moderator

Thank you. Our next question comes from David Saxon from Needham & Company. Please go ahead.

speaker
David Saxon
Analyst (Needham & Company)

Great. Good afternoon, Paul, Ellie, and Matt. Thanks for taking my questions. And apologies, I've been juggling some calls. But I wanted to start with DryEye. So by my math, at least, it looks like you shipped around like $235 under the $1,200 list price. I guess, one, is that in the right ballpark? And then, two, you know, is that across all 75 locations? active accounts or are some of those accounts kind of under the legacy pricing schedule? And then I'll have a follow-up.

speaker
Aoi Bowerly
Chief Financial Officer

Yeah. So we still have a portion of our volume that are under the prior cash pay business. We had about a thousand smart leads sold in the period. We don't break out the specifics between the different areas, but we did see an increasing portion of SmartLibs used for under the new pricing for reimbursed claims submission. So we feel like we're in a good spot. Obviously, you see that translating into our gross margin on the dry eye side, but we would expect that to continue to improve over time as we see an increased mix there.

speaker
David Saxon
Analyst (Needham & Company)

Okay, great. Thanks for that. And then I just wanted to ask on, you know, some of the competitive launches out there, specifically this canaloplasty launch. So, you know, our checks suggest it's ramping fairly quickly. So wondering what's baked into guidance in terms of that launch, if you're seeing it show up in omni volumes, and then, you know, maybe more importantly, you know, what are your thoughts on, you know, how much is trialing versus more durable share shifts? Thanks so much.

speaker
Matt Link
Chief Commercial Officer

Yeah, this is Matt. I'll tackle that one. So we had line of sight and visibility to this product launch prior to the start of the year, and so certainly took that into consideration in setting the operating plan and guidance for a full year. And I'd say at this stage, nothing about that is unchanged. There was a soft launch, and I believe you're referring to the New World product. There was a soft launch prior to the most recent meeting ASCRS, where we actually had a chance to speak briefly. And so we were able to get some feedback on the product. There was certainly discussion of that at the meeting. I think what I'm most pleased about coming out of that meeting is affirmation of Omni's position in the market. As a market leader in this category, the creator of this category, the product that has the product label is supported through multiple publications for comprehensive clinical efficacy. And even through conversations with clinicians and in different settings throughout the course of the meeting where this very topic was being discussed, Omni continues to be identified as the product that is easiest for surgeons to use, safest, most reproducible in the hands of surgeons based on the technical sophistication and obviously the iterative advancements the company has made. And so that certainly gives us strong confidence as we continue to move through the year. that while there may be some additional competitive trialing, we're confident that we can continue to execute against our plan for the full year. Our team's fully engaged. As we've referenced multiple times, we also have the benefit of the recent launch of OmniEdge, which is, again, part of a multi-generational effort in Omni platform to continue to advance our surgical sophistication and precision to meet the varied needs of our surgeon customers. So we're certainly going to stay on top of the competitive dynamics, but have every reason to believe we remain on track for the year.

speaker
David Saxon
Analyst (Needham & Company)

Great. Thanks so much.

speaker
Conference Operator
Call Moderator

Thank you. I am showing no further questions at this time. I will now pass it over to Paul Badawi for closing remarks.

speaker
Paul Badawi
Co-founder and Chief Executive Officer

Thank you all for attending today's call. We appreciate your interest in site sciences, and we look forward to updating you on our progress in the future. Thank you.

speaker
Conference Operator
Call Moderator

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

Disclaimer

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