NASDAQ:SGHT Sight Sciences Q2 2023 Earnings Report $2.66 +0.05 (+1.92%) Closing price 04/17/2025 04:00 PM EasternExtended Trading$2.66 -0.01 (-0.19%) As of 04/17/2025 04:05 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast Sight Sciences EPS ResultsActual EPS-$0.30Consensus EPS -$0.35Beat/MissBeat by +$0.05One Year Ago EPSN/ASight Sciences Revenue ResultsActual Revenue$23.47 millionExpected Revenue$22.29 millionBeat/MissBeat by +$1.18 millionYoY Revenue GrowthN/ASight Sciences Announcement DetailsQuarterQ2 2023Date8/3/2023TimeN/AConference Call DateThursday, August 3, 2023Conference Call Time4:30PM ETUpcoming EarningsSight Sciences' Q1 2025 earnings is scheduled for Thursday, May 1, 2025, with a conference call scheduled at 4:30 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Q1 2025 Earnings ReportConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Sight Sciences Q2 2023 Earnings Call TranscriptProvided by QuartrAugust 3, 2023 ShareLink copied to clipboard.There are 6 speakers on the call. Operator00:00:00Good day, and thank you for standing by. Welcome to the SITE Sciences Second Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Tripp Taylor, Investment Relations. Operator00:00:39Please go ahead, Tripp. Speaker 100:00:43Thank you for participating in today's call. Presenting today are SiteSciences' Co Founder and Chief Executive Officer, Paul Badawi Chief Financial Officer, Ali Bauerlein and Head of Corporate Strategy, Tom Wonk. Earlier today, SiteSciences released financial results for the 3 months ended June 30, 2023. A copy of the press release is available on the company's website at investors. Sitesciences.com. Speaker 100:01:08I'd like to remind everyone that comments made by management today and answers to questions will include forward looking statements within the meaning of the federal securities laws. These forward looking statements include statements related to SiteSciences' anticipated financial performance and operating results, Market opportunity, business strategy and plans for developing and marketing new products. 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 by these statements. A description of some of the risks and uncertainties that could cause actual results To differ materially from those indicated by the forward looking statements on this call can be found in the Risk Factors section The annual report on Form 10 ks for the year ended December 31, 2022, filed with the Securities and Exchange Commission. The company undertakes no obligation to publicly update or revise any forward looking statements, except as required by law. Speaker 100:02:15I will now turn the call over to Paul. Speaker 200:02:20Thanks, Tripp. Our strong Q2 performance displayed the continued successful execution of our growth initiatives across surgical glaucoma and dry eye. We generated record total revenue of $23,500,000 growing 36% compared to the Q2 of 2022. We saw great revenue growth in both of our businesses propelled by strong commercial activity and expanding clinical evidence supporting the value proposition of our technologies. Most notably, we were thrilled to announce the success of Sahara, our landmark device versus drug Randomized controlled clinical trial comparing interventional eyelid procedures enabled by our TearCARE technology to RESTASIS for the treatment of dry eye. Speaker 200:03:10At the 6 month endpoint, interventional eyelid procedures enabled by TIER CARE technology were superior to RESTASIS and improving tear breakup time or TBUT, the primary objective signs endpoint. Tear Care was also non inferior to RESTASIS with respect As importantly, patients in the TIER Care group demonstrated clinically and statistically significant improvements Of all ten signs and symptoms endpoints measured at every observation interval. We are extremely excited about these clinical results I believe they will lay the foundation for us to help physicians rethink how they treat dry eye and transform the market by moving away from daily prescription eye drops and towards once or twice a year interventional dry eye procedures. An abstract of the 6 month Phase 1 results from Sahara has been accepted by the American Academy of Optometry for presentation at its annual meeting in October. We look forward to discussing the Sahara data with payers as a key part of our efforts to establish reimbursement and fair patient access for Tear Care treatments. Speaker 200:04:24To begin our surgical glaucoma discussion, I would like to address the draft LCDs for MIGS recently proposed by 5 MAX that could impact sales of our Omni and Scion products. These masks administer Part B Medicare benefits for Medicare fee for service patients on behalf of CMS. We believe these proposals have numerous serious flaws and would adversely affect Medicare patients and limit surgeons ability to provide proven Effective treatments for their glaucoma patients if implemented as currently drafted. In particular, the proposed LCDs have not All the available clinical data demonstrating the benefits of Omni procedures, which have been published in at least 18 peer reviewed publications. Our extensive clinical data, real world outcomes and broad FDA label reinforce the safe and effective use of our omni technology An adult patient with primary open angle glaucoma or POAG. Speaker 200:05:24These five masks have hosted public open comment meetings Regarding the proposed LCDs, medical societies, physicians and patients have provided overwhelming support for continued access to omni technology, expressing the critical nature of the benefits enabled by and the importance of continued access to our omni technology to help preserve the vision of POAG patients. In our presentations at the MAAC's open meetings, We reiterated the important role canaloplasty and trabeculotomy play in the treatment of glaucoma and highlighted additional clinical data which was not considered in the draft LCDs. Specifically, we presented results from the 2 year extension of our multicenter ROMEO study. This important study demonstrated the reductions in both intraocular pressure or IOP and glaucoma medication use And mild to moderate POAG patients treated with Omni that we originally observed at 12 months extended out to 24 months. This longer term data provides further evidence of the durability and efficacy of our omni technology. Speaker 200:06:31We also presented 12 month results from Gemini, our prospective multicenter trial of Omni in combination with cataract surgery. In Gemini, we observed significant reductions in both IOP and medication usage with Omni compared to the historical cataract control. Gemini had pre specified success criteria to exceed the IOP reduction due to cataract surgery alone as observed in the control arms of the pivotal MIGS implant studies. The prospective study successfully met its Pre specified efficacy endpoint with statistically significantly greater IOP reduction at 12 months than the historical control arm. Our presentations to the various MAX further highlighted and described the consistency of positive outcomes observed across the published articles. Speaker 200:07:22We appreciate the efforts made by all of the physicians, patients, Societies and other stakeholders who helped educate the MACs regarding the necessary and crucial role that our omni technology plays in the treatment of POAG. We would also like to thank all of the dedicated site employees, particularly in our clinical, commercial and market access groups who coordinated our exceptional response. We do not believe there is a supportable basis for the implementation of these proposed LCDs as they are currently drafted, Coverage criteria are based on published clinical evidence, significant clinical benefits that are equivalent or superior to other Medicare covered procedures, Consensus clinical guidelines, generally accepted standard of care and FDA clearance specific to glaucoma therapy, all of which favor and support continued coverage of the procedures enabled by Omni Technology. We plan to continue to communicate with all stakeholders regarding the published to preserve access to these treatment options for POAG patients. We don't have visibility at this time as to when the MACs will either revise, withdraw or finalize their proposed LCDs, But we believe we have provided clinical information sufficient to maintain coverage for procedures enabled by our omni technology. Speaker 200:08:49In other news, we were pleased to report in June that Cigna, one of the largest commercial health insurance companies in the United States with almost 15,000,000 covered lives, revised their glaucoma surgical procedures coverage policy to include procedures performed with our Omni Technology as medically necessary and covered as of June 15, 2023. This decision further validates Omni's clinical importance. We are excited to bring the benefits of Omni to the Cigna community. Commercially, our surgical glaucoma business growth continued to outpace the MIGS market overall as more clinicians adopted our omni technology. As evidenced by our record quarterly revenue, commercial activity for the Q2 exceeded our expectations. Speaker 200:09:40Notably, net account retention was particularly strong despite the current market considerations associated with the proposed LCDs. It's clear that with continued market access, we have a sticky, stable and expandable revenue opportunity via our growing surgeon base. Feedback from surgeons who use Omni continues to be very positive. We attribute this customer stability and stickiness to the differentiated consistency and degree of efficacy of our omni technology, its exceptional usability and our commercial excellence. I would like to congratulate the graduating class of 2023 ophthalmic surgical residents and fellows. Speaker 200:10:21Our outstanding strategic accounts team has worked hand in hand with over 160 of these new surgeons to develop their expertise using our technologies. We look forward to partnering with this latest generation of surgeons to improve the lives of patients with POA G in the years to come. Omni continues to perform well within the combo cataract segment And we are encouraged by the market expansion and accelerating penetration we're observing in standalone mix. Based on projected claims data From a 3rd party analytics provider, we observed expanded standalone activity as measured by the growth in standalone patient visits involving CPT codes associated with Omni. While standalone procedure volumes remain modest compared to the combo cataract segment, We remain confident in our ability to drive increasing awareness and growth of our omni technology in this segment through a comprehensive market development program, which leverages standalone clinical evidence, targeted field resources, comprehensive patient and physician education and marketing initiatives. Speaker 200:11:28The other product in our surgical glaucoma portfolio, SCION, also contributed to our growth in the 2nd quarter. SCION addresses the needs of surgeons seeking a simpler MIGS solution for certain patients. We are pleased with the positive industry reception for SCION, although it is still a small overall contributor to total revenue. Turning to our dry eye business. We designed our CareCare technology to address the serious unmet needs of patients with evaporative dry eye and meibomian gland disease or MGD, which is associated with up to 86% of dry eye cases. Speaker 200:12:06Historically, Treatment for dry eye has been dominated by artificial tears and prescription eye drops, both of which have clinical limitations and do not address the underlying causes of MGD. We believe the Phase 1 results observed in Sahara demonstrate that our Tear Care technology should play a prominent role in the dry eye treatment paradigm. During our controlled commercial launch, we have experienced growing adoption of Tear Care as a self pay treatment option, illustrating the pent up demand for a procedure that can offer safe and effective relief from MGD. We believe there is immense potential for our Tear Care technology with fair and appropriate reimbursement. We are thrilled by the success of Sahara, The first of its kind head to head device first drug RCT comparing treatments using our TearCare technology to twice daily use of prescription eye drop treatment with Restasis. Speaker 200:13:00In this trial, 345 patients at 25 sites in 14 states were randomized 1 to 1 between TierCare and Restasis groups. Sahara achieved its primary clinical signs 6 month endpoint Demonstrating the superiority of interventional eyelid procedures enabled by Tear Care over Restasis eye drops and improving tear breakup time, a key measure of aqueous retention, tear stability and the tear film's ability to protect the ocular surface. Throughout the study, interventional eyelid procedures with Tear Care demonstrated clinically and statistically significant improvements Of all 10 endpoints at every measurement interval evaluated to date, 1 week, 1 month, 3 months, and 6 months. We designed the Sahara RCT with exacting standards to minimize potential bias and to ensure that the results if successful would provide meaningful support for healthy payer coverage discussions. These measures included setting the superiority endpoint at 6 months rather than the 1 or 3 month periods common in dry eye studies. Speaker 200:14:10We did this intentionally to help ensure Restasis had sufficient time to reach peak effect. Endpoint assessments were carried out by assessors masked to treatment assignment to further minimize potential bias. In coordination with the study's principal investigators, we plan to submit Phase 1 results from Sahara to leading peer reviewed journals. We are also preparing associated health economics and outcomes research and a budget impact model for publication. If successfully published, we believe these articles will encourage doctors to revamp the treatment of dry eye disease and provide payers with persuasive evidence to support patient access and reimbursement. Speaker 200:14:54To date, payers have not received the rigorous RCT data for dry eye procedures that we believe Sahara provides. Sahara highlights our commitment to rigorous clinical evidence And we are very pleased with the results. I would like to recognize the exceptional efforts of our clinical team, our team of investigators And all the patients involved with this important trial. The Tear Care technology was designed to intervene at the root cause of MGD comprehensively in a user friendly way and has now demonstrated the ability to consistently produce best in class clinical outcomes in 2 RCTs. We look forward to advancing our CareCare market access strategy, expanding usage of our omni technology and improving the lives of patients suffering from chronic eye diseases. Speaker 200:15:44I will now turn the call over to Ali to discuss our financials. Speaker 300:15:50Thanks, Paul. I'm excited by the progress we have made this quarter across both surgical glaucoma and dry eye. Total revenue for the Q2 was $23,500,000 representing 36% growth compared to the Q2 of 2022. Surgical glaucoma revenues for the 2nd quarter were $21,400,000 up 35% versus the comparable period. Over 1100 customers ordered surgical glaucoma products in the 2nd quarter, up 30% compared to the prior year period. Speaker 300:16:26Our commercial team did a tremendous job introducing our technologies to new customers and maintaining strong relationships with existing customers in the Q2, particularly given the uncertainty associated with the proposed LCD. Our dry eye revenue for the Q2 was $2,100,000 up 56% compared to the Q2 of 2022. As we prepare to evolve TURE Care beyond the controlled launch phase in the coming quarters, we would like to help investors better understand our dry eye business by introducing new operating metrics and a more targeted view of our core addressable market. We see vast Potential to improve the lives of patients across the spectrum of mild, moderate and advanced dry eye disease. Our market research indicates that of the approximately 17,800,000 patients with dry eye disease, There are between 11,600,000 15,500,000 diagnosed MGD patients in the U. Speaker 300:17:28S. Approximately 55% of these patients or 6,400,000 to 8,500,000 patients would be categorized with moderate to severe MGD, and we believe these patients are the most likely candidates for treatments like Tear Care. While patients with mild MGD can also benefit from treatments such as Tear Care, these patients and their eye care providers may not feel the same urgency to seek out a Tier Care procedure until the patient symptoms progress. Given the significant MGD patient population, we believe it is important to initially target the patients that eye doctors can most easily identify and are more likely to proactively seek treatment. Consistent with the patient enrollment criteria in our Sahara pivotal RCT and the corresponding coverage we will initially pursue in the United States. Speaker 300:18:24This core opportunity generally consists of moderate and advanced MGD patients. Assuming moderate patients receive 1 treatment per year and severe patients receive 2 treatments per year, resulting in an average of 1.3 treatments per year and our current SmartLids average selling price. This would yield a core addressable moderate to advanced Treatment market of approximately $2,500,000,000 Currently, over the counter and prescription eye drops are the dominant treatment for dry eye, with the cost to payers and patients estimated to exceed $2,000,000,000 annually. We believe the superior results from Sahara, coupled with ongoing technology enhancements, could allow us to increase overall prices in the future. In addition, there are opportunities for us to pursue mild MGD patients over time and expand into new markets worldwide, which would further increase our opportunity. Speaker 300:19:22We believe informative metrics to measure the performance of our dry eye segment, including dry eye active customers, which we define as the number of customers who have ordered eyelid treatment units or SmartLids during the preceding 3 month period and the number of eyelid treatment units sold. This data provides a broad picture of account activity and product utilization that we believe will be important as we expand. For the Q2 of 2023, we had 370 active dry eye customers, a 75% increase versus the Q2 of 2022. Additionally, we sold almost 6,000 eyelid treatment units in the quarter, a 69% increase versus the prior year period. Gross margin for the 2nd quarter was 85.6% compared to 84.1% in the prior year period. Speaker 300:20:17Gross margin improvement was attributed to improvement in both surgical glaucoma gross margin and dry eye gross margin. Surgical glaucoma gross margin improved primarily due to manufacturing efficiencies generated as a result of higher production volumes, partially offset by lower average selling price due to product mix. Dryeye gross margin improved primarily due due to an increased mix of higher gross margin smartLids versus smart hubs and higher average selling price of smart hubs. R and D expenses were $5,200,000 compared to $5,900,000 in the Q2 of 2022, And SG and A expenses were $30,100,000 compared to $31,400,000 in the prior year period. Total operating expenses for the Q2 were $35,300,000 a decrease of 6% compared to $37,400,000 in the Q2 of 2022 and in line with our expectations. Speaker 300:21:21We continue to monitor operating expenses closely and are pleased with the results. Adjusted operating expenses for the quarter were $31,500,000 As expected, adjusted operating expenses were slightly higher than our estimated 2023 quarterly average target of $30,500,000 given the timing of certain expenditures within the year. Our loss from operations for the Q2 was $15,200,000 compared to a loss of $22,900,000 in the Q2 of 2022. We had a net loss of $14,800,000 or $0.30 per share in the quarter compared to a net loss of 23,800,000 or $0.50 per share for the Q2 of 2022. We ended the quarter with $154,500,000 of cash and cash equivalents and $35,000,000 of long term debt, excluding debt discounts and amortized debt issuance costs. Speaker 300:22:22In July, we terminated our unused $5,000,000 debt revolver facility since we had no intention to draw it. Demonstrating our progress to cash flow breakeven, cash usage decreased to $12,800,000 in the Q2 of 2023, compared to $17,700,000 in the Q1 of 2023 $18,500,000 in the Q2 of 2022. Overall, we expect operating loss and cash usage will continue to decrease over time as operating leverage increases, driven by our high gross margins and targeted operating spend. Based on our solid year to date results, We are reaffirming our annual revenue guidance of $89,000,000 to $94,000,000 We believe it is prudent to maintain our guidance range despite the solid year to date results, primarily due to the uncertainty associated with the proposed coverage changes in our surgical glaucoma segment. In addition, we expect the seasonality of our revenue to begin to align with typical industry patterns to see lower procedure volumes in the summer months. Speaker 300:23:34We continue to expect that average quarterly adjusted operating expenses of approximately $30,500,000 per quarter will allow us to achieve our plans for the year. We continue to target approximately 30 Revenue growth in the medium term and positive free cash flow by year end 2025, while maintaining a substantial cash cushion. Our medium term financial outlook assumes that the 7 MAX continue to cover Omni procedures largely to the extent they are currently covered. With that, operator, you may open the line for questions. Tom Wong, our Head of Corporate Strategy, will also join us for Q and A. Operator00:24:17Thank you, Ali. We will now conduct the question Please standby while we compile the Q and A roster. Our first question comes from Craig Bijou from BofA. Go ahead, Craig. Speaker 400:24:51Thank you. Good afternoon, everyone. Thank you for taking the questions. Maybe just wanted to start, obviously, you have this overhang with the MAX and the LCDs and Appreciate the fact that you don't know what timing what the timing is to get an update. But maybe if we can provide a little bit of color on what would happen If the LCDs were put into place, what are some of the options that you have if that were To happen and maybe just kind of how to think about the timing of some of those? Speaker 300:25:36Sure. Be happy to take that question. Jen, and first of all, what I would say is I'd remind everyone that we feel like we've done a very Good job outlining our case to each of the MACs on why coverage should be maintained for our products. And I think that that's really important for investors to understand that we believe that the proposed LCDs will not be put in place as they currently stand and will be revised in some capacity. We don't have, as we said in the prepared remarks, Visibility on exactly when the MACs will decide to make a decision. Speaker 300:26:18They could individually make Decisions of what they want to do for their coverage areas or they together could get together as a CAC meeting again and have another Discussion about options there. Of course, as we've said in our previous coverage of these issues, this is a significant portion of our surgical glaucoma revenue from 2022 are in the states covered by these MAX, over 60%. So that is a significant portion of our revenue at risk, but we believe that it is a low chance that these LCDs will move forward in their current Speaker 500:27:00form. Speaker 300:27:01Our options, if they do, would be, of course, to go through an appeals process associated with those LCDs. Of course, we could also pursue an NCD or other coding options. So Those would really be our main options if these do progress in the unlikely scenario that these move forward. Speaker 400:27:28Great. Thank you, Ali. And I appreciate all of the color on the market opportunity for Tear Care and Would love to now that you have the strong data from Sahara and the opportunity is kind of Now out there in front of you, would love to get your updated thoughts or I know it's early, but feedback on Sahara From the docs, what you think Sahara could do for insurance coverage going forward? And then I think you guys have talked about a similar growth between surgical glaucoma and dry eye Going forward as part of your medium range plan. So is that still the case? Speaker 400:28:17Or how should we think about The opportunity to grow the dry eye franchise in 'twenty four and beyond. Speaker 200:28:27Yes. Hi, Craig. I'll take the first part of that question and maybe Ali can add on. I think the feedback from Sahara, from our investigators has been Very, very strong. There's a lot of excitement. Speaker 200:28:38There's a lot of excitement internally here at Site Sciences. I do want to remind everybody Sahara is our second RCT, Our first RCT, which was also very successful called Olympia, we randomized TierCare against the 1st mover leading MGD procedure And last year published superiority of symptoms in that trial. This trial SOHARO was another very ambitious study Designed to transform treatment towards interventional procedures and away from drops, artificial tears and prescription eye drops, Very rigorously designed. We spoke to a number of payer medical directors in advance Of embarking on this journey, we wanted to make sure that the data that we would be able to provide payers if the study was successful Would be meaningful to them making hopefully positive coverage decisions. We demonstrated As we had mentioned in the prepared remarks, very consistent improvements in all signs and all symptoms. Speaker 200:29:43The study was a success. We demonstrated superiority to RESTASIS in our primary signs endpoint of cure breakup time. In terms of the plan, We will be publishing or submitting for publication within the next few months. Hopefully by the Tamber timeframe we'll submit to a top journal, if not the very top journal. In eye care, we'd hope to get the publication By the end of the year, if all goes to plan, and we're in parallel assembling a very strong payer relations team. Speaker 200:30:21They're mapping out the strategy for 2024 in terms of which payers we're going to target first. So 2024 hopefully with publication in hand, Not just the publication in terms of the clinical data, but also health economics research and the budget impact model With those publications and a strong payer relations team, we'll be working hard in 2024 With payers to hopefully start securing some coverage wins, which I would think in the 2025 timeframe, Allie, you can cover that what we would expect To see maybe with success. Speaker 300:30:55Yes, sure. So happy to talk a little bit about where we see the trends going here. Obviously, we aren't prepared today to give any specific guidance for 2024 or 2025 associated with where we see the dry eye portion of the business going. We would be fairly cautious in expanding our commercial resources until we start seeing some market access wins. So for us, the priority in terms of our Resources right now is to really go about securing appropriate and fair market access for Tear Care. Speaker 300:31:37And as we get wins On that front, we would expect those to be accelerants to our revenue growth. Already you see On our dry eye side of the business, because it's growing from a small base, it is growing quicker than our corporate average revenue growth rate. And we would expect just given still the small base in the business that that could continue. Now I think it will just depend on the timing of these market access agreements and how quickly We can ramp those up, but we see this as a very large market opportunity for us. We think we have great Clinical results that we can share with the payers on why this is appropriate for coverage, but we need to go execute on that before we'll start talking about specific guidance and where we can take this opportunity. Speaker 400:32:33Great. Very helpful. Thank you for taking the questions. Operator00:32:39Thank you. Please stand by. Our next question comes from Tom Steffen from Stifel. Speaker 500:32:55Jim? Great. Hi, everyone. Thanks for the questions. I'll start with Tear Care and Sahara more specifically. Speaker 500:33:04In regards to kind of the payer discussions and ultimately trying to secure reimbursement, Could you maybe put a little bit of a finer point around roughly, I guess, where you believe base case reimbursement For a single procedure might be, for it to be viable. I guess your ASP on the SmartLid is A good starting point, but maybe if you can just help us with how to think about when the reimbursement decisions come in, what's a good outcome, It's a great outcome, what you're targeting, etcetera, that'd be helpful. Speaker 300:33:41Yes. Tom, what I'd say is at this point is really too early. We are just now starting to think about engaging payers on that And we need to have those conversations and do the appropriate health economics and outcomes assessment to be able to set Fair and reasonable reimbursement. I would say that even with our current business, we believe that this is a viable business on the self pay market that we've already been accessing in the controlled launch, and we think that Establishing fair reimbursement will only accelerate that patient access, but we aren't going to give specific ASP targets today, because it's just too early for us to comment on that and provide anything realistic. Speaker 200:34:36And I'll just add one comment to that, Tom. The design of Sahara was deliberate. We randomized against the market leading dry eye prescription Rx, which has sold 1,000,000,000 of dollars over the years. And in discussions with payers, they naturally want to understand what they're paying for today, how it's working for the patients, is it addressing Their patient signs and symptoms, is it addressing the underlying cause of disease? We know that TiaraCare does all of these things exceptionally well And that PrescriptionRx can sometimes be prescribed to patients who really are in need of an interventional procedure addressing the underlying disease So there's a lot of economics at stake right now. Speaker 200:35:27The design of Sahara to randomize against costly Prescription Rx was deliberate and those prescriptions can cost 1,000 of dollars per year to the system and to patients. So just you can rest assured on one thing that there's plenty of value here in terms of what the results look like for Tear Care, the Clinical value, the health economics value, so we're confident that should we be successful in our payer coverage discussions That there are there's a very attractive business model for all stakeholders, good value for all stakeholders. Speaker 500:36:07Got it. That's helpful. And if I can send it to the glaucoma side of the business, maybe a 2 parter. First, Quickly, just on the iris registry data, when can we expect to see the next tranche or set? I believe there were multiple Analysis that were being explored, that's part 1. Speaker 500:36:28And then part 2 to this is just on competition in the U. S. Paul or Ali or Tom, just your latest thoughts and observations. More specifically, are you seeing Infinite A little bit more in the field. And then maybe how would you compare this year's competitive landscape in 2023 To last year where I think there were some challenges with new products. Speaker 200:36:58Yes, Tom, I'll take a couple of those. First, starting off with Iris, we're very excited about this data. Well, we partnered with Verana, who's got a license to this Iris real world evidence database that's A, American Academy of Ophthalmology's real world Outcomes database, thousands of cases of MIGS real world. We did our investigators have presented this year at various conferences 1 year outcomes, Which are very exciting, that show Omni is very consistently effective, in primary open angle glaucoma. And We're really looking forward to the 2 year outcomes and getting those published. Speaker 200:37:48Very, very good results in terms of both IOP P reduction as well as medication reduction. Omni is the data showed Omni was numerically greater Then all of them and reach statistical significance across several of those arms. So it will be very, Very important data I think for the field of MIGS to see. It will be submitted hopefully very soon within hopefully within a month or so, will be submitted to A very top journal and we would hope to see publication by the end of the year. Yes, that study, just to be more specific, it included Omni cases, hundreds of Omni cases, many, many Hydrus cases, many iStent cases And cataract alone cases and all of the MIGS interventions, Omni, Hydrus and iStent were performed in combination with cataract surgery. Speaker 200:38:55So that's Iris. Hopefully, if all goes to plan, we could see a publication In a top tier journal by the end of the year or early 2024. That's 2 year outcomes on both IOP reduction and medication reduction and It's very favorable to Omni. In terms of competition, what are we seeing out there? We are seeing some use of standalone stents. Speaker 200:39:23Frankly, we welcome it. The standalone market opportunity, as we've said many times, it's a huge market opportunity. There are many, many patients Who need earlier effective surgical interventions. This market needs to be transformed away from Meds, meds, meds and lasers and then invasive surgery, just like the combo cataract, MIGS market has developed over the past decade. The standalone early intervention market needs to develop. Speaker 200:39:54It's a heavy lift. We've been doing a lot of that heavy lift on our own. For the past several years, we welcome others Who can help in that lift? As far as our position, we've been taking share and growing our business In the established MIGS market based on efficacy, we have very high confidence that's why our surgeons and our customers are using Omni and the standalone market based on that differentiated efficacy profile. So because we feel so confident that our surgeons Love the clinical outcomes and rely on the clinical outcomes that they see with Omni and it's such a sticky business. Speaker 200:40:31It's in our interest to have competition come in To the market and help develop the market and teach everybody, it's a very significant teaching exercise and education exercise to move from Standards of care of meds and lasers, while patients are progressing to earlier surgical interventions. And then lastly, in terms of the competition 2022 versus 2023, I think 2022 It was frankly noisier. There were a number of different products that were released that were new in terms of what they did and It's harder to assess that market as those newer things were being introduced. I think this year 2023 while there's Introduction of standalone stenting as an example, that's something that's a little more familiar, been around for a long time and it's something we understand and welcome. Speaker 500:41:28Got it. And then if maybe I can ask one follow-up to that. I wanted to ask about Doctor trainings and facilities ordering on the MIG side. I don't think we've received those figures for Maybe a couple of quarters now. So Paul, if you can just talk to what have doctor trainings on Omni and I guess Science as well looked like over the past couple of quarters, maybe has competition or have the LCD noise slowed that a bit? Speaker 300:41:59Yes, I'll take that one. We haven't disclosed the specific numbers on surgeon training. Q2 was also strong, saw great growth on a year over year basis, and we're pleased with that. And that's obviously a portion of what's Driving our growth in overall surgical glaucoma up 35% year over year. But we think the more important metric is active ordering accounts, and that is a number we do disclose that was up over 1100 versus $8.75 in the Q2 last year, so up 30% year over year. Speaker 300:42:41In terms of impact associated with the proposed LCDs, we did have some sales rep Just time impact in June associated with the proposed LCDs, our staff spent time Covering those changes, and that did have a small impact on surgeons trained and ordering accounts in the period, but not a material one. Obviously, we still exceeded expectations for the quarter and we're happy with the overall growth rate in surgical glaucoma. Speaker 500:43:18Perfect. Thanks, everyone. Speaker 200:43:20Thanks. Operator00:43:23Same deal. I am showing no further questions at this time. So I would like to turn the conference back over to Paul for closing remarks. Speaker 200:43:36Thank you all for your time and attention and interest in SITE Sciences. We appreciate it. Thank you and have a great day. Operator00:43:46This concludes today's conference call. Thank you for participating. You may now disconnect.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallSight Sciences Q2 202300:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Sight Sciences Earnings HeadlinesSight Sciences, Inc. (NASDAQ:SGHT) Receives $3.83 Average PT from AnalystsApril 13, 2025 | americanbankingnews.comSight Sciences (NASDAQ:SGHT) Given "Hold" Rating at Needham & Company LLCApril 11, 2025 | americanbankingnews.comGet Your Bank Account “Fed Invasion” Ready with THESE 4 Simple StepsStarting as soon as a few months from now, the United States government will make a sweeping change to bank accounts nationwide. It will give them unprecedented powers to control your bank account.April 19, 2025 | Weiss Ratings (Ad)Needham Sticks to Its Hold Rating for Sight Sciences (SGHT)April 10, 2025 | markets.businessinsider.comSight Sciences to Present at the 24th Annual Needham Healthcare Conference on April 8thMarch 25, 2025 | globenewswire.comSight Sciences Reports Fourth Quarter and Full Year 2024 Financial Results and Provides 2025 GuidanceMarch 7, 2025 | nasdaq.comSee More Sight Sciences Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Sight Sciences? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Sight Sciences and other key companies, straight to your email. Email Address About Sight SciencesSight Sciences (NASDAQ:SGHT), an ophthalmic medical device company, engages in the development and commercialization of surgical and nonsurgical technologies for the treatment of eye diseases. It operates through two segments, Surgical Glaucoma and Dry Eye. The company's products include OMNI Surgical System, an implant-free glaucoma surgery technology indicated to reduce intraocular pressure in adult patients with primary open-angle glaucoma; and SION Surgical Instrument, a manually operated device used in ophthalmic surgical procedures to excise trabecular meshwork. It also offers TearCare System, a wearable eyelid technology for adult patients with evaporative dry eye disease due to meibomian gland dysfunction, as well as related components. It offers its products through sales representatives and distributors to hospitals, medical centers, and eyecare professionals in the United States. Sight Sciences, Inc. was incorporated in 2010 and is headquartered in Menlo Park, California.View Sight Sciences ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Archer Aviation Unveils NYC Network Ahead of Key Earnings Report3 Reasons to Like the Look of Amazon Ahead of EarningsTesla Stock Eyes Breakout With Earnings on DeckJohnson & Johnson Earnings Were More Good Than Bad—Time to Buy? Why Analysts Boosted United Airlines Stock Ahead of EarningsLamb Weston Stock Rises, Earnings Provide Calm Amidst ChaosIntuitive Machines Gains After Earnings Beat, NASA Missions Ahead Upcoming Earnings Tesla (4/22/2025)Intuitive Surgical (4/22/2025)Verizon Communications (4/22/2025)Canadian National Railway (4/22/2025)Novartis (4/22/2025)RTX (4/22/2025)3M (4/22/2025)Capital One Financial (4/22/2025)General Electric (4/22/2025)Danaher (4/22/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. Start Your 30-Day Trial MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
There are 6 speakers on the call. Operator00:00:00Good day, and thank you for standing by. Welcome to the SITE Sciences Second Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Tripp Taylor, Investment Relations. Operator00:00:39Please go ahead, Tripp. Speaker 100:00:43Thank you for participating in today's call. Presenting today are SiteSciences' Co Founder and Chief Executive Officer, Paul Badawi Chief Financial Officer, Ali Bauerlein and Head of Corporate Strategy, Tom Wonk. Earlier today, SiteSciences released financial results for the 3 months ended June 30, 2023. A copy of the press release is available on the company's website at investors. Sitesciences.com. Speaker 100:01:08I'd like to remind everyone that comments made by management today and answers to questions will include forward looking statements within the meaning of the federal securities laws. These forward looking statements include statements related to SiteSciences' anticipated financial performance and operating results, Market opportunity, business strategy and plans for developing and marketing new products. 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 by these statements. A description of some of the risks and uncertainties that could cause actual results To differ materially from those indicated by the forward looking statements on this call can be found in the Risk Factors section The annual report on Form 10 ks for the year ended December 31, 2022, filed with the Securities and Exchange Commission. The company undertakes no obligation to publicly update or revise any forward looking statements, except as required by law. Speaker 100:02:15I will now turn the call over to Paul. Speaker 200:02:20Thanks, Tripp. Our strong Q2 performance displayed the continued successful execution of our growth initiatives across surgical glaucoma and dry eye. We generated record total revenue of $23,500,000 growing 36% compared to the Q2 of 2022. We saw great revenue growth in both of our businesses propelled by strong commercial activity and expanding clinical evidence supporting the value proposition of our technologies. Most notably, we were thrilled to announce the success of Sahara, our landmark device versus drug Randomized controlled clinical trial comparing interventional eyelid procedures enabled by our TearCARE technology to RESTASIS for the treatment of dry eye. Speaker 200:03:10At the 6 month endpoint, interventional eyelid procedures enabled by TIER CARE technology were superior to RESTASIS and improving tear breakup time or TBUT, the primary objective signs endpoint. Tear Care was also non inferior to RESTASIS with respect As importantly, patients in the TIER Care group demonstrated clinically and statistically significant improvements Of all ten signs and symptoms endpoints measured at every observation interval. We are extremely excited about these clinical results I believe they will lay the foundation for us to help physicians rethink how they treat dry eye and transform the market by moving away from daily prescription eye drops and towards once or twice a year interventional dry eye procedures. An abstract of the 6 month Phase 1 results from Sahara has been accepted by the American Academy of Optometry for presentation at its annual meeting in October. We look forward to discussing the Sahara data with payers as a key part of our efforts to establish reimbursement and fair patient access for Tear Care treatments. Speaker 200:04:24To begin our surgical glaucoma discussion, I would like to address the draft LCDs for MIGS recently proposed by 5 MAX that could impact sales of our Omni and Scion products. These masks administer Part B Medicare benefits for Medicare fee for service patients on behalf of CMS. We believe these proposals have numerous serious flaws and would adversely affect Medicare patients and limit surgeons ability to provide proven Effective treatments for their glaucoma patients if implemented as currently drafted. In particular, the proposed LCDs have not All the available clinical data demonstrating the benefits of Omni procedures, which have been published in at least 18 peer reviewed publications. Our extensive clinical data, real world outcomes and broad FDA label reinforce the safe and effective use of our omni technology An adult patient with primary open angle glaucoma or POAG. Speaker 200:05:24These five masks have hosted public open comment meetings Regarding the proposed LCDs, medical societies, physicians and patients have provided overwhelming support for continued access to omni technology, expressing the critical nature of the benefits enabled by and the importance of continued access to our omni technology to help preserve the vision of POAG patients. In our presentations at the MAAC's open meetings, We reiterated the important role canaloplasty and trabeculotomy play in the treatment of glaucoma and highlighted additional clinical data which was not considered in the draft LCDs. Specifically, we presented results from the 2 year extension of our multicenter ROMEO study. This important study demonstrated the reductions in both intraocular pressure or IOP and glaucoma medication use And mild to moderate POAG patients treated with Omni that we originally observed at 12 months extended out to 24 months. This longer term data provides further evidence of the durability and efficacy of our omni technology. Speaker 200:06:31We also presented 12 month results from Gemini, our prospective multicenter trial of Omni in combination with cataract surgery. In Gemini, we observed significant reductions in both IOP and medication usage with Omni compared to the historical cataract control. Gemini had pre specified success criteria to exceed the IOP reduction due to cataract surgery alone as observed in the control arms of the pivotal MIGS implant studies. The prospective study successfully met its Pre specified efficacy endpoint with statistically significantly greater IOP reduction at 12 months than the historical control arm. Our presentations to the various MAX further highlighted and described the consistency of positive outcomes observed across the published articles. Speaker 200:07:22We appreciate the efforts made by all of the physicians, patients, Societies and other stakeholders who helped educate the MACs regarding the necessary and crucial role that our omni technology plays in the treatment of POAG. We would also like to thank all of the dedicated site employees, particularly in our clinical, commercial and market access groups who coordinated our exceptional response. We do not believe there is a supportable basis for the implementation of these proposed LCDs as they are currently drafted, Coverage criteria are based on published clinical evidence, significant clinical benefits that are equivalent or superior to other Medicare covered procedures, Consensus clinical guidelines, generally accepted standard of care and FDA clearance specific to glaucoma therapy, all of which favor and support continued coverage of the procedures enabled by Omni Technology. We plan to continue to communicate with all stakeholders regarding the published to preserve access to these treatment options for POAG patients. We don't have visibility at this time as to when the MACs will either revise, withdraw or finalize their proposed LCDs, But we believe we have provided clinical information sufficient to maintain coverage for procedures enabled by our omni technology. Speaker 200:08:49In other news, we were pleased to report in June that Cigna, one of the largest commercial health insurance companies in the United States with almost 15,000,000 covered lives, revised their glaucoma surgical procedures coverage policy to include procedures performed with our Omni Technology as medically necessary and covered as of June 15, 2023. This decision further validates Omni's clinical importance. We are excited to bring the benefits of Omni to the Cigna community. Commercially, our surgical glaucoma business growth continued to outpace the MIGS market overall as more clinicians adopted our omni technology. As evidenced by our record quarterly revenue, commercial activity for the Q2 exceeded our expectations. Speaker 200:09:40Notably, net account retention was particularly strong despite the current market considerations associated with the proposed LCDs. It's clear that with continued market access, we have a sticky, stable and expandable revenue opportunity via our growing surgeon base. Feedback from surgeons who use Omni continues to be very positive. We attribute this customer stability and stickiness to the differentiated consistency and degree of efficacy of our omni technology, its exceptional usability and our commercial excellence. I would like to congratulate the graduating class of 2023 ophthalmic surgical residents and fellows. Speaker 200:10:21Our outstanding strategic accounts team has worked hand in hand with over 160 of these new surgeons to develop their expertise using our technologies. We look forward to partnering with this latest generation of surgeons to improve the lives of patients with POA G in the years to come. Omni continues to perform well within the combo cataract segment And we are encouraged by the market expansion and accelerating penetration we're observing in standalone mix. Based on projected claims data From a 3rd party analytics provider, we observed expanded standalone activity as measured by the growth in standalone patient visits involving CPT codes associated with Omni. While standalone procedure volumes remain modest compared to the combo cataract segment, We remain confident in our ability to drive increasing awareness and growth of our omni technology in this segment through a comprehensive market development program, which leverages standalone clinical evidence, targeted field resources, comprehensive patient and physician education and marketing initiatives. Speaker 200:11:28The other product in our surgical glaucoma portfolio, SCION, also contributed to our growth in the 2nd quarter. SCION addresses the needs of surgeons seeking a simpler MIGS solution for certain patients. We are pleased with the positive industry reception for SCION, although it is still a small overall contributor to total revenue. Turning to our dry eye business. We designed our CareCare technology to address the serious unmet needs of patients with evaporative dry eye and meibomian gland disease or MGD, which is associated with up to 86% of dry eye cases. Speaker 200:12:06Historically, Treatment for dry eye has been dominated by artificial tears and prescription eye drops, both of which have clinical limitations and do not address the underlying causes of MGD. We believe the Phase 1 results observed in Sahara demonstrate that our Tear Care technology should play a prominent role in the dry eye treatment paradigm. During our controlled commercial launch, we have experienced growing adoption of Tear Care as a self pay treatment option, illustrating the pent up demand for a procedure that can offer safe and effective relief from MGD. We believe there is immense potential for our Tear Care technology with fair and appropriate reimbursement. We are thrilled by the success of Sahara, The first of its kind head to head device first drug RCT comparing treatments using our TearCare technology to twice daily use of prescription eye drop treatment with Restasis. Speaker 200:13:00In this trial, 345 patients at 25 sites in 14 states were randomized 1 to 1 between TierCare and Restasis groups. Sahara achieved its primary clinical signs 6 month endpoint Demonstrating the superiority of interventional eyelid procedures enabled by Tear Care over Restasis eye drops and improving tear breakup time, a key measure of aqueous retention, tear stability and the tear film's ability to protect the ocular surface. Throughout the study, interventional eyelid procedures with Tear Care demonstrated clinically and statistically significant improvements Of all 10 endpoints at every measurement interval evaluated to date, 1 week, 1 month, 3 months, and 6 months. We designed the Sahara RCT with exacting standards to minimize potential bias and to ensure that the results if successful would provide meaningful support for healthy payer coverage discussions. These measures included setting the superiority endpoint at 6 months rather than the 1 or 3 month periods common in dry eye studies. Speaker 200:14:10We did this intentionally to help ensure Restasis had sufficient time to reach peak effect. Endpoint assessments were carried out by assessors masked to treatment assignment to further minimize potential bias. In coordination with the study's principal investigators, we plan to submit Phase 1 results from Sahara to leading peer reviewed journals. We are also preparing associated health economics and outcomes research and a budget impact model for publication. If successfully published, we believe these articles will encourage doctors to revamp the treatment of dry eye disease and provide payers with persuasive evidence to support patient access and reimbursement. Speaker 200:14:54To date, payers have not received the rigorous RCT data for dry eye procedures that we believe Sahara provides. Sahara highlights our commitment to rigorous clinical evidence And we are very pleased with the results. I would like to recognize the exceptional efforts of our clinical team, our team of investigators And all the patients involved with this important trial. The Tear Care technology was designed to intervene at the root cause of MGD comprehensively in a user friendly way and has now demonstrated the ability to consistently produce best in class clinical outcomes in 2 RCTs. We look forward to advancing our CareCare market access strategy, expanding usage of our omni technology and improving the lives of patients suffering from chronic eye diseases. Speaker 200:15:44I will now turn the call over to Ali to discuss our financials. Speaker 300:15:50Thanks, Paul. I'm excited by the progress we have made this quarter across both surgical glaucoma and dry eye. Total revenue for the Q2 was $23,500,000 representing 36% growth compared to the Q2 of 2022. Surgical glaucoma revenues for the 2nd quarter were $21,400,000 up 35% versus the comparable period. Over 1100 customers ordered surgical glaucoma products in the 2nd quarter, up 30% compared to the prior year period. Speaker 300:16:26Our commercial team did a tremendous job introducing our technologies to new customers and maintaining strong relationships with existing customers in the Q2, particularly given the uncertainty associated with the proposed LCD. Our dry eye revenue for the Q2 was $2,100,000 up 56% compared to the Q2 of 2022. As we prepare to evolve TURE Care beyond the controlled launch phase in the coming quarters, we would like to help investors better understand our dry eye business by introducing new operating metrics and a more targeted view of our core addressable market. We see vast Potential to improve the lives of patients across the spectrum of mild, moderate and advanced dry eye disease. Our market research indicates that of the approximately 17,800,000 patients with dry eye disease, There are between 11,600,000 15,500,000 diagnosed MGD patients in the U. Speaker 300:17:28S. Approximately 55% of these patients or 6,400,000 to 8,500,000 patients would be categorized with moderate to severe MGD, and we believe these patients are the most likely candidates for treatments like Tear Care. While patients with mild MGD can also benefit from treatments such as Tear Care, these patients and their eye care providers may not feel the same urgency to seek out a Tier Care procedure until the patient symptoms progress. Given the significant MGD patient population, we believe it is important to initially target the patients that eye doctors can most easily identify and are more likely to proactively seek treatment. Consistent with the patient enrollment criteria in our Sahara pivotal RCT and the corresponding coverage we will initially pursue in the United States. Speaker 300:18:24This core opportunity generally consists of moderate and advanced MGD patients. Assuming moderate patients receive 1 treatment per year and severe patients receive 2 treatments per year, resulting in an average of 1.3 treatments per year and our current SmartLids average selling price. This would yield a core addressable moderate to advanced Treatment market of approximately $2,500,000,000 Currently, over the counter and prescription eye drops are the dominant treatment for dry eye, with the cost to payers and patients estimated to exceed $2,000,000,000 annually. We believe the superior results from Sahara, coupled with ongoing technology enhancements, could allow us to increase overall prices in the future. In addition, there are opportunities for us to pursue mild MGD patients over time and expand into new markets worldwide, which would further increase our opportunity. Speaker 300:19:22We believe informative metrics to measure the performance of our dry eye segment, including dry eye active customers, which we define as the number of customers who have ordered eyelid treatment units or SmartLids during the preceding 3 month period and the number of eyelid treatment units sold. This data provides a broad picture of account activity and product utilization that we believe will be important as we expand. For the Q2 of 2023, we had 370 active dry eye customers, a 75% increase versus the Q2 of 2022. Additionally, we sold almost 6,000 eyelid treatment units in the quarter, a 69% increase versus the prior year period. Gross margin for the 2nd quarter was 85.6% compared to 84.1% in the prior year period. Speaker 300:20:17Gross margin improvement was attributed to improvement in both surgical glaucoma gross margin and dry eye gross margin. Surgical glaucoma gross margin improved primarily due to manufacturing efficiencies generated as a result of higher production volumes, partially offset by lower average selling price due to product mix. Dryeye gross margin improved primarily due due to an increased mix of higher gross margin smartLids versus smart hubs and higher average selling price of smart hubs. R and D expenses were $5,200,000 compared to $5,900,000 in the Q2 of 2022, And SG and A expenses were $30,100,000 compared to $31,400,000 in the prior year period. Total operating expenses for the Q2 were $35,300,000 a decrease of 6% compared to $37,400,000 in the Q2 of 2022 and in line with our expectations. Speaker 300:21:21We continue to monitor operating expenses closely and are pleased with the results. Adjusted operating expenses for the quarter were $31,500,000 As expected, adjusted operating expenses were slightly higher than our estimated 2023 quarterly average target of $30,500,000 given the timing of certain expenditures within the year. Our loss from operations for the Q2 was $15,200,000 compared to a loss of $22,900,000 in the Q2 of 2022. We had a net loss of $14,800,000 or $0.30 per share in the quarter compared to a net loss of 23,800,000 or $0.50 per share for the Q2 of 2022. We ended the quarter with $154,500,000 of cash and cash equivalents and $35,000,000 of long term debt, excluding debt discounts and amortized debt issuance costs. Speaker 300:22:22In July, we terminated our unused $5,000,000 debt revolver facility since we had no intention to draw it. Demonstrating our progress to cash flow breakeven, cash usage decreased to $12,800,000 in the Q2 of 2023, compared to $17,700,000 in the Q1 of 2023 $18,500,000 in the Q2 of 2022. Overall, we expect operating loss and cash usage will continue to decrease over time as operating leverage increases, driven by our high gross margins and targeted operating spend. Based on our solid year to date results, We are reaffirming our annual revenue guidance of $89,000,000 to $94,000,000 We believe it is prudent to maintain our guidance range despite the solid year to date results, primarily due to the uncertainty associated with the proposed coverage changes in our surgical glaucoma segment. In addition, we expect the seasonality of our revenue to begin to align with typical industry patterns to see lower procedure volumes in the summer months. Speaker 300:23:34We continue to expect that average quarterly adjusted operating expenses of approximately $30,500,000 per quarter will allow us to achieve our plans for the year. We continue to target approximately 30 Revenue growth in the medium term and positive free cash flow by year end 2025, while maintaining a substantial cash cushion. Our medium term financial outlook assumes that the 7 MAX continue to cover Omni procedures largely to the extent they are currently covered. With that, operator, you may open the line for questions. Tom Wong, our Head of Corporate Strategy, will also join us for Q and A. Operator00:24:17Thank you, Ali. We will now conduct the question Please standby while we compile the Q and A roster. Our first question comes from Craig Bijou from BofA. Go ahead, Craig. Speaker 400:24:51Thank you. Good afternoon, everyone. Thank you for taking the questions. Maybe just wanted to start, obviously, you have this overhang with the MAX and the LCDs and Appreciate the fact that you don't know what timing what the timing is to get an update. But maybe if we can provide a little bit of color on what would happen If the LCDs were put into place, what are some of the options that you have if that were To happen and maybe just kind of how to think about the timing of some of those? Speaker 300:25:36Sure. Be happy to take that question. Jen, and first of all, what I would say is I'd remind everyone that we feel like we've done a very Good job outlining our case to each of the MACs on why coverage should be maintained for our products. And I think that that's really important for investors to understand that we believe that the proposed LCDs will not be put in place as they currently stand and will be revised in some capacity. We don't have, as we said in the prepared remarks, Visibility on exactly when the MACs will decide to make a decision. Speaker 300:26:18They could individually make Decisions of what they want to do for their coverage areas or they together could get together as a CAC meeting again and have another Discussion about options there. Of course, as we've said in our previous coverage of these issues, this is a significant portion of our surgical glaucoma revenue from 2022 are in the states covered by these MAX, over 60%. So that is a significant portion of our revenue at risk, but we believe that it is a low chance that these LCDs will move forward in their current Speaker 500:27:00form. Speaker 300:27:01Our options, if they do, would be, of course, to go through an appeals process associated with those LCDs. Of course, we could also pursue an NCD or other coding options. So Those would really be our main options if these do progress in the unlikely scenario that these move forward. Speaker 400:27:28Great. Thank you, Ali. And I appreciate all of the color on the market opportunity for Tear Care and Would love to now that you have the strong data from Sahara and the opportunity is kind of Now out there in front of you, would love to get your updated thoughts or I know it's early, but feedback on Sahara From the docs, what you think Sahara could do for insurance coverage going forward? And then I think you guys have talked about a similar growth between surgical glaucoma and dry eye Going forward as part of your medium range plan. So is that still the case? Speaker 400:28:17Or how should we think about The opportunity to grow the dry eye franchise in 'twenty four and beyond. Speaker 200:28:27Yes. Hi, Craig. I'll take the first part of that question and maybe Ali can add on. I think the feedback from Sahara, from our investigators has been Very, very strong. There's a lot of excitement. Speaker 200:28:38There's a lot of excitement internally here at Site Sciences. I do want to remind everybody Sahara is our second RCT, Our first RCT, which was also very successful called Olympia, we randomized TierCare against the 1st mover leading MGD procedure And last year published superiority of symptoms in that trial. This trial SOHARO was another very ambitious study Designed to transform treatment towards interventional procedures and away from drops, artificial tears and prescription eye drops, Very rigorously designed. We spoke to a number of payer medical directors in advance Of embarking on this journey, we wanted to make sure that the data that we would be able to provide payers if the study was successful Would be meaningful to them making hopefully positive coverage decisions. We demonstrated As we had mentioned in the prepared remarks, very consistent improvements in all signs and all symptoms. Speaker 200:29:43The study was a success. We demonstrated superiority to RESTASIS in our primary signs endpoint of cure breakup time. In terms of the plan, We will be publishing or submitting for publication within the next few months. Hopefully by the Tamber timeframe we'll submit to a top journal, if not the very top journal. In eye care, we'd hope to get the publication By the end of the year, if all goes to plan, and we're in parallel assembling a very strong payer relations team. Speaker 200:30:21They're mapping out the strategy for 2024 in terms of which payers we're going to target first. So 2024 hopefully with publication in hand, Not just the publication in terms of the clinical data, but also health economics research and the budget impact model With those publications and a strong payer relations team, we'll be working hard in 2024 With payers to hopefully start securing some coverage wins, which I would think in the 2025 timeframe, Allie, you can cover that what we would expect To see maybe with success. Speaker 300:30:55Yes, sure. So happy to talk a little bit about where we see the trends going here. Obviously, we aren't prepared today to give any specific guidance for 2024 or 2025 associated with where we see the dry eye portion of the business going. We would be fairly cautious in expanding our commercial resources until we start seeing some market access wins. So for us, the priority in terms of our Resources right now is to really go about securing appropriate and fair market access for Tear Care. Speaker 300:31:37And as we get wins On that front, we would expect those to be accelerants to our revenue growth. Already you see On our dry eye side of the business, because it's growing from a small base, it is growing quicker than our corporate average revenue growth rate. And we would expect just given still the small base in the business that that could continue. Now I think it will just depend on the timing of these market access agreements and how quickly We can ramp those up, but we see this as a very large market opportunity for us. We think we have great Clinical results that we can share with the payers on why this is appropriate for coverage, but we need to go execute on that before we'll start talking about specific guidance and where we can take this opportunity. Speaker 400:32:33Great. Very helpful. Thank you for taking the questions. Operator00:32:39Thank you. Please stand by. Our next question comes from Tom Steffen from Stifel. Speaker 500:32:55Jim? Great. Hi, everyone. Thanks for the questions. I'll start with Tear Care and Sahara more specifically. Speaker 500:33:04In regards to kind of the payer discussions and ultimately trying to secure reimbursement, Could you maybe put a little bit of a finer point around roughly, I guess, where you believe base case reimbursement For a single procedure might be, for it to be viable. I guess your ASP on the SmartLid is A good starting point, but maybe if you can just help us with how to think about when the reimbursement decisions come in, what's a good outcome, It's a great outcome, what you're targeting, etcetera, that'd be helpful. Speaker 300:33:41Yes. Tom, what I'd say is at this point is really too early. We are just now starting to think about engaging payers on that And we need to have those conversations and do the appropriate health economics and outcomes assessment to be able to set Fair and reasonable reimbursement. I would say that even with our current business, we believe that this is a viable business on the self pay market that we've already been accessing in the controlled launch, and we think that Establishing fair reimbursement will only accelerate that patient access, but we aren't going to give specific ASP targets today, because it's just too early for us to comment on that and provide anything realistic. Speaker 200:34:36And I'll just add one comment to that, Tom. The design of Sahara was deliberate. We randomized against the market leading dry eye prescription Rx, which has sold 1,000,000,000 of dollars over the years. And in discussions with payers, they naturally want to understand what they're paying for today, how it's working for the patients, is it addressing Their patient signs and symptoms, is it addressing the underlying cause of disease? We know that TiaraCare does all of these things exceptionally well And that PrescriptionRx can sometimes be prescribed to patients who really are in need of an interventional procedure addressing the underlying disease So there's a lot of economics at stake right now. Speaker 200:35:27The design of Sahara to randomize against costly Prescription Rx was deliberate and those prescriptions can cost 1,000 of dollars per year to the system and to patients. So just you can rest assured on one thing that there's plenty of value here in terms of what the results look like for Tear Care, the Clinical value, the health economics value, so we're confident that should we be successful in our payer coverage discussions That there are there's a very attractive business model for all stakeholders, good value for all stakeholders. Speaker 500:36:07Got it. That's helpful. And if I can send it to the glaucoma side of the business, maybe a 2 parter. First, Quickly, just on the iris registry data, when can we expect to see the next tranche or set? I believe there were multiple Analysis that were being explored, that's part 1. Speaker 500:36:28And then part 2 to this is just on competition in the U. S. Paul or Ali or Tom, just your latest thoughts and observations. More specifically, are you seeing Infinite A little bit more in the field. And then maybe how would you compare this year's competitive landscape in 2023 To last year where I think there were some challenges with new products. Speaker 200:36:58Yes, Tom, I'll take a couple of those. First, starting off with Iris, we're very excited about this data. Well, we partnered with Verana, who's got a license to this Iris real world evidence database that's A, American Academy of Ophthalmology's real world Outcomes database, thousands of cases of MIGS real world. We did our investigators have presented this year at various conferences 1 year outcomes, Which are very exciting, that show Omni is very consistently effective, in primary open angle glaucoma. And We're really looking forward to the 2 year outcomes and getting those published. Speaker 200:37:48Very, very good results in terms of both IOP P reduction as well as medication reduction. Omni is the data showed Omni was numerically greater Then all of them and reach statistical significance across several of those arms. So it will be very, Very important data I think for the field of MIGS to see. It will be submitted hopefully very soon within hopefully within a month or so, will be submitted to A very top journal and we would hope to see publication by the end of the year. Yes, that study, just to be more specific, it included Omni cases, hundreds of Omni cases, many, many Hydrus cases, many iStent cases And cataract alone cases and all of the MIGS interventions, Omni, Hydrus and iStent were performed in combination with cataract surgery. Speaker 200:38:55So that's Iris. Hopefully, if all goes to plan, we could see a publication In a top tier journal by the end of the year or early 2024. That's 2 year outcomes on both IOP reduction and medication reduction and It's very favorable to Omni. In terms of competition, what are we seeing out there? We are seeing some use of standalone stents. Speaker 200:39:23Frankly, we welcome it. The standalone market opportunity, as we've said many times, it's a huge market opportunity. There are many, many patients Who need earlier effective surgical interventions. This market needs to be transformed away from Meds, meds, meds and lasers and then invasive surgery, just like the combo cataract, MIGS market has developed over the past decade. The standalone early intervention market needs to develop. Speaker 200:39:54It's a heavy lift. We've been doing a lot of that heavy lift on our own. For the past several years, we welcome others Who can help in that lift? As far as our position, we've been taking share and growing our business In the established MIGS market based on efficacy, we have very high confidence that's why our surgeons and our customers are using Omni and the standalone market based on that differentiated efficacy profile. So because we feel so confident that our surgeons Love the clinical outcomes and rely on the clinical outcomes that they see with Omni and it's such a sticky business. Speaker 200:40:31It's in our interest to have competition come in To the market and help develop the market and teach everybody, it's a very significant teaching exercise and education exercise to move from Standards of care of meds and lasers, while patients are progressing to earlier surgical interventions. And then lastly, in terms of the competition 2022 versus 2023, I think 2022 It was frankly noisier. There were a number of different products that were released that were new in terms of what they did and It's harder to assess that market as those newer things were being introduced. I think this year 2023 while there's Introduction of standalone stenting as an example, that's something that's a little more familiar, been around for a long time and it's something we understand and welcome. Speaker 500:41:28Got it. And then if maybe I can ask one follow-up to that. I wanted to ask about Doctor trainings and facilities ordering on the MIG side. I don't think we've received those figures for Maybe a couple of quarters now. So Paul, if you can just talk to what have doctor trainings on Omni and I guess Science as well looked like over the past couple of quarters, maybe has competition or have the LCD noise slowed that a bit? Speaker 300:41:59Yes, I'll take that one. We haven't disclosed the specific numbers on surgeon training. Q2 was also strong, saw great growth on a year over year basis, and we're pleased with that. And that's obviously a portion of what's Driving our growth in overall surgical glaucoma up 35% year over year. But we think the more important metric is active ordering accounts, and that is a number we do disclose that was up over 1100 versus $8.75 in the Q2 last year, so up 30% year over year. Speaker 300:42:41In terms of impact associated with the proposed LCDs, we did have some sales rep Just time impact in June associated with the proposed LCDs, our staff spent time Covering those changes, and that did have a small impact on surgeons trained and ordering accounts in the period, but not a material one. Obviously, we still exceeded expectations for the quarter and we're happy with the overall growth rate in surgical glaucoma. Speaker 500:43:18Perfect. Thanks, everyone. Speaker 200:43:20Thanks. Operator00:43:23Same deal. I am showing no further questions at this time. So I would like to turn the conference back over to Paul for closing remarks. Speaker 200:43:36Thank you all for your time and attention and interest in SITE Sciences. We appreciate it. Thank you and have a great day. Operator00:43:46This concludes today's conference call. Thank you for participating. You may now disconnect.Read morePowered by