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Operator
The conference will begin shortly. To raise your hand during Q&A, you can dial star 1 1. The conference will begin shortly. To raise your hand during Q&A, you can dial star 1 1.
spk11
Good day, and thank you for standing by.
Trey
Welcome to the Site Sciences Third Quarter 2022 Earnings Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during that session, you will need to press star 1-1 on your phone. Please be advised that today's conference is being recorded, and I would now like to hand the conference over to your speaker today, Mr. Tripp Taylor. Sir, please go ahead.
Tripp Taylor
Thank you for participating in today's call. Presenting today are SightSciences co-founder and chief executive officer, Paul Bedawi, and chief financial officer, Jesse Selnick. Earlier today, SightSciences released financial results for the three months ended September 30, 2022. A copy of the press release is available on the company's website at investors.sightssciences.com. I'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. Those include statements related to site sciences, anticipated financial performance and operating results, market opportunity, the future impact of COVID-19 on operations, business strategy, and plans for developing and marketing new products. Forward-looking statements are based on estimates and assumptions as of today and 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 of the annual report on Form 10-K filed March 24, 2022 and other filings 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. For more information, please refer to the forward-looking statements, notices, and risk factors in the recent SEC filings. I will now turn the call over to Paul.
Paul Bedawi
Thanks, Tripp, and thank you all for joining us. Our third quarter results reflect continued strength and execution across our entire business. We are pleased with the progress we are making, penetrating, and expanding both the MIGS and dry eye treatment markets while taking the necessary steps to position the business to reach positive free cash flow in 2025. In the period, we achieved total revenue of $18.7 million, representing 43% growth year over year and 8% growth sequentially. Surgical glaucoma revenue grew 37% year over year and 7% sequentially, to 17.1 million in the third quarter, and dry eye revenue grew 145% year over year and 21% sequentially. We ended the quarter with just under 200 million of cash, which we currently expect will be more than enough to support our growth plan until we reach cash flow break even. As Jesse will elaborate on in his remarks, we plan to achieve our intermediate growth targets with more moderate headcount growth and significant reductions in non-labor operating expenses. We expect to significantly reduce cash burn in 2023 and going forward while driving continued robust top-line growth. We achieved several milestones in the third quarter, including one, the successful introduction of Scion, our innovative bladeless goniotomy device, two, The complete enrollment of Sahara, our transformative dry eye RCT for the TierCare system. And three, the publication of multiple peer-reviewed articles featuring compelling clinical data that demonstrates expansive market opportunities for both Omni and TierCare. Each of these commercially-minded achievements strengthens our foundation for long-term market leadership and charts greenfield paths to growth in both glaucoma and dry eye. Now I would like to discuss the highly productive third quarter in detail for both of our business units, starting with surgical glaucoma. Our core mission in surgical glaucoma is to equip surgeons with the best possible solutions for their primary open angle glaucoma or POAG patients, regardless of severity of disease or cataract lens status. The bulk of today's penetrated MIGS market consists of procedures performed in conjunction with cataract surgery, due to the narrower indications for use of legacy implants. This has resulted in an artificial bifurcation of the MIGS market into combination cataract, a $1 billion opportunity, and standalone, a $5 billion opportunity. We further segment the market based on severity of disease with mild and moderate patients, each accounting for approximately 40% of the patient population, and advanced patients representing the remaining 20% of the patient population. for both the combination cataract and standalone segments. Mild and early moderate combination cataract patients comprise the most well-established segment of the MIGS market today, and surgeons have the broadest array of surgical device options to treat these patients. In rough numbers, this represents approximately a $400 million opportunity for patients with mild POAG and a $200 million opportunity for patients with early moderate POAG. This $600 million segment, representing just 10% of the overall MIGS opportunity, has attracted the most commercial interest thus far due to the narrower indications for use of first mover products, coupled with the lower expectations for disease impact and changes in patient site. We believe the remaining 90% of the market, a nearly $5.5 billion opportunity, requires a greater level of efficacy and consistency to satisfy the needs of these surgeons and patients. Stated another way, we believe the vast majority of MIGS market growth over the next decade will be driven by devices that offer increased and reliable efficacy within the rapidly expanding moderate to advanced combination cataract segment and the entirety of the growing standalone segment. This is where we excel. Today, we offer two best-in-class MIGS solutions that have rapidly gained market acceptance, our flagship OmniSurgical system and our newly introduced Scion surgical instrument. Scion, the world's first bladeless goniotomy device, has been extremely well received by our surgeon customers, and we expect it to thrive in the established, penetrated, and more competitive mild to early moderate combo cataract segment, especially in cases where considerations such as efficiency and ease of use may take priority. We anticipate that use of OMNI will continue to expand the combination cataract and standalone segments due to its proven efficacy, superior design, and intuitive use. It remains our flagship MIGS product. We believe use of OMNI has extended MIGS interventions to combo cataract patients beyond mild and well into moderate and even advanced disease. When doctors need a strong result, we believe using OMNI is the most effective and trusted solution due to its comprehensive mechanisms of action that can treat the entire 360 degrees of disease conventional outflow pathway, and address all sources of outflow resistance. We are confident that Omni possesses the requisite clinical functionality and clinical results to compel long-term market expansion and penetration of the remaining 5 billion plus MIGS market opportunity. Our surgical commercial goals are one, continue expanding the large and growing moderate to advanced disease combination cataract and standalone MIGS segments based on Omni's differentiated efficacy profile. Two, drive adoption and utilization of Scion among specific subsets of surgeons who may prioritize faster or simpler procedures. And three, increase our total share of MIGs with Omni and Scion while also growing the overall MIGs market. Omni's adoption and utilization continues to grow among existing MIG surgeons. We believe that our efforts to support this adoption and growth have not only resulted in continued shifts but have also expanded the combination cataract segment to include a broader spectrum of POAG patients due to Omni's superior and consistent efficacy. We continue training new surgeons with our technology while increasing Omni utilization in existing accounts. Because of Omni's differentiated efficacy position, we continue to enjoy outstanding surgical glaucoma count retention, especially in the market expansion segments where efficacy really drives decision making. Our brand and identity as the market-expanding efficacy leader in MIGS continues to grow as the surgical community, medical societies, and payers better understand the efficacy and consistency of Omni as demonstrated in real-world results and clinical trials. The support from both new and existing surgeons reaffirms our confidence that the use of Omni will continue to grow the MIGS market and serve as the foundational MIGS procedure. Omni is currently the only device with an FDA-cleared indication for ab interno use to lower IOP in post-cateract adults with POAG. Based on its differentiated usability and clinically demonstrated efficacy, we believe Omni has demonstrated optimal product-market fit for continued MIGS market expansion, and we strongly believe in its ability to remain atop of the efficacy-driven MIGS market expansion categories. Based on our analysis of third-party projected claims data and our observations in the field, lead us to believe that Omni continues to expand the MIGS market. Our claims analysis indicates that growth in U.S. Omni shipments outpaced the total MIGS utilization growth rate by over 40% for the LTM period ending in the third quarter of 2022. We are working to accelerate the adoption of OMNI as the leading standalone MIGS intervention, and we continue to focus our efforts on demonstrating the safety and efficacy of OMNI in all use cases through peer-reviewed publications, market education, and commercial execution. Over 1 million eyes have received trabecular bypass stents, primarily in mild to moderate combination cataract cases. As glaucoma is a progressive disease, over time these patients may require further intervention to lower their IOP. In October, International Ophthalmology published a peer-reviewed article based on data from TRAE, our multicenter IRB-approved study designed to evaluate the effectiveness and safety of omni and eyes with uncontrolled IOP despite a history of trabecular micro-bypass stent implantation in conjunction with cataract surgery and medication usage. Overall, the findings demonstrated significant benefits of standalone omni intervention for patients with a history of receiving combination cataract stent procedures. This unique clinical data provides strong validation of OMNI's potential to provide benefits throughout the entire lifecycle of POAG. At the European Glaucoma Society Congress in Greece, MIG surgeons presented OMNI data demonstrating durable safety and efficacy over three years with standalone use of OMNI in patients with open angle glaucoma. We expect to see further studies that corroborate these impressive long-term results in the future. We're also very excited about a significant clinical research project involving comparative real-world clinical data for the most common mixed procedures held within the AAO's IRIS real-world patient data registry that we believe will help stakeholders, including patients, providers, and payers, better understand the performance of leading MIGS devices in everyday clinical practice. We look forward to sharing the results of this very informative comparative analysis of clinical evidence based on thousands of real-world MIGS cases over the coming months. Commercially, our team of glaucoma clinical consultants continue driving standalone utilization of OMNI. We have seen uplift in certain GCC markets and have identified the initiatives that deliver the greatest impact. We have begun standardizing these best practices throughout our GCC territories to help drive omni-utilization within our growing installed base. We are learning fast, optimizing our market development, and institutionalizing best practices every single day, driving scale and leverage for our commercial efforts that is showing up ultimately in our continued customer stickiness and strong top line performance. The entire site sciences product portfolio was featured in presentations by top KOLs at the American Academy of Ophthalmology and European Society of Cataract and Refractive Surgeons meetings. We hosted peer discussions between surgeons and provided demonstrations of our products. The level of interest and engagement was very encouraging for both Omni and Scion, the focus of our third and newest growth initiative for surgical glaucoma. In mid-August, we launched Scion with a group of select surgeons. The initial feedback was extremely positive, and we are very pleased with the success of our broader commercial rollout in progress now. Scion enables a complementary revenue opportunity while allowing us to expand our reach to serve specific subsets of customers who may prioritize a faster or simpler procedure. Scion is the world's only bladeless goniotomy device and represents our third consecutive best-in-category device. Satisfying the American Academy of Ophthalmology definition of goniotomy and aligning with CPT code 65820, Scion is designed to allow surgeons to smoothly, efficiently, and reliably excise and remove several clock hours of diseased trabecular mesh or tissue via an ab interno approach. Our target customers for Scion include three types of combination cataract MIG surgeons that are distinct from target omni customers. Number one, high-volume cataract surgeons only looking to perform the quickest MIGS procedures. Number two, surgeons who are initially less experienced with MIGS, such as surgical fellows at academic institutions. And number three, surgeons looking for the most cost-effective MIGS procedures in facilities that may emphasize procedural profitability. These surgeons or use cases have very little overlap with our flagship Omni device. We have seen evidence that some Scion surgeons will also consider using Omni as they grow familiar with the best in class technologies we offer. Because our target customers for Scion fit within the existing call patterns for our surgical glaucoma sales team, the fixed investment necessary for customer acquisition is substantially already in place. Transitioning now to our dry eye business where we are focused on establishing fair market access and reimbursement for dry eye treatment procedures. While tear care continues to expand the current cash pay market, we remain committed to generating strong clinical data that will help us achieve appropriate reimbursement, which, if successful, would hugely expand the evaporative dry eye market. In August, Clinical Ophthalmology published comparative symptoms clinical data on advanced dry eye patients from the Olympia RCT, which represents further progress establishing tear care as a leading dry eye treatment. The authors of this analysis concluded that the tear care procedure delivered superior symptoms improvements, quality of vision, and symptom frequency over lipoflow in patients suffering from advanced dry eye disease. This data reinforces our confidence in the clinical and economic value that tear care brings to patients, providers, and payers. I'm pleased to announce that we completed patient enrollment for our Sahara RCT ahead of schedule. This keeps us on track to provide our randomized safety and efficacy readout of TierCare versus deleting prescription eyedrop medication Restasis by the second half of 2023. As a reminder, Sahara was designed with input from medical directors and payers to provide the clinical foundation of obtaining future reimbursement coverage if successful. In parallel, we are intentionally growing our installed base of TierCare users in today's cash pay market and believe reimbursement would stimulate immediate growth of care care procedures. In summary, we remain well-positioned to continue distancing ourselves as the market leader in MIGS and dry eye and to increase the number of patients we serve. Our commitment to growing physician adoption and utilization across our product portfolio can support strong growth over the coming years. Leveraging our strong revenue growth trajectory and gross margins, we are committed to a disciplined and lean operating budget that will allow us to optimize our considerable resources with a clear path to profitability. I will now turn the call over to Jesse Selnick, our CFO.
Jesse
Thanks, Paul. We posted record third quarter revenue of $18.7 million, representing 43% growth year over year and 8.4% growth sequentially. This is an extremely strong result in a weak seasonal quarter in our industry. As a point of comparison, in the third quarter of 2021, we grew only 4.5% sequentially, yet we achieved 77% revenue growth for the year. Both Omni and TierCare performed well in the quarter, and we comfortably exceeded consensus revenue estimates even without Scion's small revenue contribution in the tail end of the quarter. Overall, we are quite pleased with our progress as we strengthen our leading position through continued share growth and market expansion in our two more established products, and as Scion fully launches into the market in the fourth quarter and into 2023. Our surgical glaucoma revenues for the third quarter were $17.1 million, up 37% from $12.4 million in the third quarter of 2021, and sequentially up 7.4%. which represents a nearly 400 basis point improvement over our comparable sequential growth in the third quarter of 2021. We continue to show strong underlying growth fundamentals in retention and ordering facilities, while utilization increased notably, which is a critical measuring stick for our market expansion efforts behind Omni. 913 facilities ordered Omni during the third quarter, compared to 875 facilities in the second quarter. demonstrating the continued combination of strong new customer acquisition activity and our high retention rate. Our developed customer retention rate, which is designed to measure the percentage of our embedded facility base from the previous quarter that reorders in the most recent quarter, was over 99% in Q3. Surgical Glaucoma customer acquisition funnel remains strong for both products, which creates great momentum for the rest of 2022 and into 2023. In the third quarter of 2022, we trained over 160 new OMNI surgeons in the U.S., bringing us to a total of nearly 2,200 U.S. surgeons trained on OMNI and also trained over 120 surgeons on SCION. Given the universe of U.S. mixed-trained surgeons is estimated to be approximately 5,600, we obviously have a substantial amount of remaining runway to continue to roll out both products to targeted surgeons. Our dry ice segment revenues for the third quarter were $1.6 million, up 145% from $0.7 million in the third quarter of 2021, and a sequential increase of 20.7% from the second quarter of 2022. We grew our installed base to 881 facilities at September 30, 2022, from 762 as of June 30, 2022, and 497 at the end of the third quarter of 2021. We are at a super exciting time in our tier care commercial life cycle, as we have had great success this year in growing our installed base and are now complementing that activity with efforts to drive utilization and consumption in our base in anticipation of Sahara readouts in mid-2023 and potential reimbursement breakthroughs thereafter. Our combined growth margin for the third quarter was 84%, consistent with 84% for both the corresponding prior year period and the second quarter of 2022. Gross margin in surgical glaucoma was 89% in the third quarter compared to 87% in the prior year period and 88% in the second quarter of 2022. Gross margin in dry eye was 38% in the quarter versus 33% in the prior year period and 41% in the second quarter of 2022. We remain very pleased with the performance of our operations group on both sides of the business in the face of global supply chain issues. SG&A expenses for the quarter were $31.5 million, which was in line with our $31.4 million of SG&A in the second quarter and an increase of $20.8 million in the third quarter of 2021. This quarter exhibited the early impact of the cost optimization initiatives and modest headcount reduction we made in the third quarter. Those initiatives are still ongoing and will result in additional non-labor efficiencies in Q4 and into 2023. Q3 reported SG&A includes several non-recurring expense items related to our cost optimization program, such as severance, which I'll discuss in further detail shortly. Approximately 50% of our year-to-date SG&A expense is headcount related, which gives us great flexibility to accelerate or decelerate a large portion of our non-labor OPEX as needed to appropriately fuel our growth while managing liquidity. That being said, our FTE count will be a key driver of the SG&A line item. As of September 30th, 2022, we had 253 full-time employees versus 284 at June 30th, 2022, and 197 as of September 30th, 2021. R&D expenses for the quarter were $6.1 million compared to $4.3 million in the third quarter of 2021 and $5.9 million in the second quarter of 2022. In total, operating expenses for the third quarter were $37.6 million, a 50% increase from $25.1 million in the third quarter of 2021 and essentially flat to the second quarter of 2022. Included within the $37.6 million was $3.2 million of non-cash stock compensation and depreciation and amortization expense, $1.7 million of severance and pre-termination comp expense for positions eliminated during the quarter, $1.1 million of expense related to the termination of certain clinical programs, which we discussed in our second quarter call, and approximately $1 million of additional non-recurring items. Including these items, our operating expenses in the quarter would have been approximately $30.5 million, which we believe is a fair representation of our current cost structure going forward. Our leadership team is close to finalizing our operating budgets and investment envelope for 2023, with the twin pillars of cost discipline and smart investments in our future. We believe we can meet all of our goals in 2023. while maintaining quarterly normalized recurring cash operating expenses near the $30.5 million level from the third quarter. This investment in our business will support our near-term growth requirements and fund a number of high-value pipeline and market development activities to create long-term value. More than 10% of our operating expense budget in 2023 will be earmarked for discretionary investment projects that can be flexed and or canceled without any impact to our core operations. Our loss from operations for the three months ended September 30th, 2022 was 21.8 million compared to a loss of 22.9 million in the second quarter of 2022 and 14 million for the third quarter of 2021. We had a net loss of 22.2 million, 46 cents per share in the quarter based on a weighted average share count of 47.9 million shares compared to a net loss of 17.2 million, or 43 cents per share for the third quarter of 2021, based on a weighted average share count of 39.8 million shares. We ended the quarter with $199.8 million of cash and cash equivalents and 33 million of long-term debt, including 2 million of debt discounts. One note on our debt facilities that we fully expect to meet the requirements necessary to extend our principal amortization to December 2023, at which point we have the ability to further extend the amortization another year, subject to certain conditions. As evidenced in our discussion of our operating expenses, we continue to proactively manage our liquidity and operating expenses to maintain our strong cash position. We are confident that our strong balance sheet, leading gross margins, and disciplined spend can support positive free cash flow in 2025 while maintaining substantial cash cushion and reserves. Finally, turning to our outlook for 2022, we are tightening our full-year revenue guidance range to $70 million to $72 million based on the strength of our performance in Q3 and confidence in our trajectory in Q4 and heading into 2023. For the year, the range implies annual growth rates of approximately 43% to 47% over 2021. In summary, we continue to make substantial progress revolutionizing the glaucoma dry eye market. We remain committed to leveraging our technology to improve the lives of patients with dry disease and continue to produce excellent financial results similar to those in Q3. I'll now turn the call back over to Paul for some concluding comments before we open up the call for Q&A. Thanks, Jesse.
Paul Bedawi
Before we head into Q&A, some brief summary comments and why we are so enthusiastic on where our company is positioned today. Number one, We grew 8.4% sequentially in Q3, a much higher growth rate than third quarter of 2021 during a 77% revenue growth year. Number two, we've created an extremely robust growth funnel by training new surgeons and winning new accounts at levels that we believe will support our near and medium-term growth objectives. Number three, we are actively expanding the actionable addressable market with compelling real-world clinical data and studies like Trey. Number four, We will remain disciplined on OpEx and committed to our outstanding unit economics with another mid-80s gross margin result for the quarter, which placed us in a confident liquidity position. And lastly, we just want to thank all of our physicians, customers, and patients for their trust in us and our employees for executing our vision with excellence. This concludes our prepared remarks. Operator, please open up the call for questions.
Trey
Thank you. As a reminder, to ask a question, you will need to press star 1 1 on your phone. Please stand by as we compile the Q&A roster. One moment, please, for our first question. Our first question will come from Mike Ahrens of William Blair. Your line is open.
Mike Ahrens
Hi, guys. Thanks for taking the question and congrats on the quarter. Just wanted to ask an update on some of the trialing we've seen so far throughout the year. So you guys have previously said you expect this to continue into the second half, but now that we're heading towards the end of the year and nearing 2023, what have you guys seen recently on the competitive trialing front? Do you expect some of these headwinds to continue into next year at all?
Paul Bedawi
Yeah. Hi, I'll take that. I think it's quieter. The competition is out there and I'll just say this as it relates to competition. I've always found the best way to compete is to elevate your game to a level where others can't keep up. You know, I guess we should give our competition credit for their efforts this past year. But the simple reality for us is we've continued to elevate ourselves and our continued growth, our continued performance. It speaks for itself. The momentum we're generating will carry us straight into 2023. It's a site where we elevate and outperform through product design excellence, customer focus, and we never lose sight of the fact that helping our eye care professionals better treat their patients is our opportunity and our obligation. So today, they're the two fastest-growing segments in MIGs. It's goniotomy and canaloplasty, and we're fortunate. We believe we have the two best-in-class products for those two fast-growing segments, Omni Omni in the canaloplasty segment, and Zion in the goniotomy segment. And, you know, through our rapidly growing user base, we're hearing routinely that Omni is being referred to as the most efficacious product in MIGS. So why does that matter? It matters because preventing visual field loss progression with glaucoma requires efficacy, efficacy that Omni has proven to deliver in multiple peer-reviewed publications, and through real-world surge in outcomes. So with Scion leading the way in goniotomy, with Omni leading the way in canaloplasty and otomy and expanding the market, we feel very confident in our position. Again, our performance in the third quarter speaks for itself. The momentum we have right now speaks for itself, and I don't think we've ever been more bullish heading into a new year than we are today.
Mike Ahrens
Got it. And then maybe a quick one on the market development side of things. So you mentioned the GCC accounts. Some of them have seen higher growth than some of the non-GCC accounts. Are you guys planning on expanding the team of GCCs moving forward? And are there any other market development efforts that you're working on or plan that we should be thinking about? Thanks for taking the question.
Jesse
We're actually at the stage where what we're doing is we're taking the best practices of where there's been tangible successes within the GCC team and we're rolling them out and we're integrating it across the organization. So there's, we anticipate, you know, continued contribution and contribution increase from that investment, but we're not increasing our investment today because We've got several quarters of good learnings about where their efforts have been successful, and we'll generate a nice return by just institutionalizing that across the organization.
Paul Bedawi
I'd just like to add to that on standalone market development because it's important. It's really driven by two tactics. One, identifying and educating patients and primary care providers on Omni's unique design. It's It's got a design that allows doctors to address the entire disease outflow pathway and all three sources of resistance in that pathway. Those kinds of initiatives are scalable in their reach and impact via peer-to-peer tactics, direct-to-patient education initiatives, and they'll be executed by our entire team and highly competent external partners. And the second tactic, helping our trained Omni surgeons counsel and educate their patients on the value of the Omni procedure and how it can help them better treat their glaucoma. Yeah, this surgeon education initiative is prescriptive in nature, gives our surgeons a glaucoma treatment triage algorithm, helps them make a strong recommendation for when omni-surgical intervention is right for the patient. So all in all, when you combine patient education and identification initiatives with surgeon training and patient counseling initiatives, and you couple that with a growing library of really compelling standalone clinical data, like the TRADE data we just discussed, you end up with a really viable playbook that enables our eye care professionals to better treat more patients with Omni, whether that's at the time of cataract surgery or as a standalone procedure. Great. Thanks, guys.
Trey
Thanks.
spk11
Thank you. Thank you.
Trey
And one moment, please, for our next question. Our next question will come from Cecilia Verlon. Morgan Stanley, your line is open.
Scion
Great. Good afternoon. Thanks for taking the questions and congrats on the quarter. I wanted to start just with the implied 4Q guidance. If you could talk through really what's the underlying expectations from surgical glaucoma omni versus cyan contributions starting to ramp. And then as you think about 2020, we talked about previously kind of a 30% or so outlook for the business from a growth standpoint. But how you're thinking about that today and then really just the contributions Omni versus Scion as we think about 23.
Jesse
Yeah. Hi, Cecilia. It's Jesse. And I'll take the second part of that first. It's early in the launch to provide sort of much specific feedback, like particularly in a forum like this, like on Scion's contribution. So we're being conservative about it, you know, We indicate we trained over 120 surgeons on it just in the third quarter, which was really kind of like five weeks of a soft launch. So that shows a very healthy amount of interest. And we think that the position feedback on the instrument is pretty tremendous. So we are excited, but it's kind of called a new segment for us a bit. And so we're just being sort of conservative in our perspective and in providing, you know, any real specifics on what the contribution of that might be. You know, so at the end of the day, really what's embedded in the fourth quarter to be a little boring, but like is really the continuation of the trends that we see, you know, dominated by Omni in terms of new customer acquisition. There was nice utilization uplift. in the third quarter and customer retention. Q3 is a funky quarter. July and most of August are generally a bit soft, but it's really just based on what we saw called second half of the quarter and really throughout the whole quarter and that continuing into Q4 and beyond. And then on the 30%, Cecilia, You know, we're not providing guidance at this point, but that is a number we remain very comfortable with. You know, there's a number of growth drivers, as we've discussed, with real momentum heading into next year, Scion included. And we think sort of the core, our leading indicators of growth in terms of trained surgeons, ordering facilities, and retention stats were all quite positive in the third quarter.
Paul Bedawi
And just to add to that, hi, Cecilia, on the Omni and Scion question, and just to be crystal clear, Omni remains our flagship MIGS device, and I think that will always be the case. It's got a very, very compelling efficacy profile. And the reality is the vast majority of the MIGS market, and certainly all of the MIGS expansion opportunities, those are going to be efficacy-driven. That's where Omni's got a very tight product market fit. Scion is very distinct. It serves very separate and distinct subsets of the market, parts of the market where Omni, frankly, doesn't have the best product market fit, areas where efficacy might not be the top priority, and things like efficiency and ease and speed may take priority. And there's three very distinct subsets. Again, these subsets don't overlap with Omni. One is the high volume cataract surgeon that's prioritizing speed of procedure and efficiency. Number two are MIGS fellows in training. So think about academic institutions where fellows are learning MIGS for the first time. Goniotomy is kind of known as the training wheels of MIGS. So Scion's got a really nice offering for those folks who are in training. And then the last subset is facility profitability, right? Think about the private equity-owned type facilities where profitability is one of the main drivers. Goniotomy is one of the more profitable procedures. So in those distinct subsets of the market, Omni doesn't have the strongest product market fit. Omni does have the strongest product market fit where comprehensive procedures and differentiated efficacy are paramount. We believe that Scion customers, they open up, they open the door for us to new surging customers. And we have the opportunity then when we've got the Scion relationship to then sell Omni over time. So we think that actually Scion can expand our Omni market by opening doors that today aren't the easiest doors to open.
Scion
Thank you. And if I could follow up too, appreciate the commentary on OpEx. Just curious if you provide bit more color in terms of r d priorities both near term as well as over the intermediate term you talked about previously next gen omni some other pipeline products as well as clinical trials just as we're thinking about 23 how we should be thinking about just the contributions from an r d standpoint across those initiatives yeah so cecilia on on
Paul Bedawi
Pipeline, we're obviously, we love innovation at site. I think we've proven that we're good at it, and we're excited about next year releasing NextGen Omni in the first quarter. Early feedback from some surgeons who we've received feedback from has been very positive. We think that's going to be a very nice welcome addition to the mixed market next year. We also have an exciting next generation of TierCare, TierCare MGX. that we're excited to get out next year. And then beyond that, beyond MIGS and MGD procedures, we do, as we've discussed in the past, we are in deep R&D and do intend to bring to market a broad pipeline of innovative products that hopefully one day we'll address every every step of the way for the patient journey and and the eye care provider journey taking care of these patients these are chronic diseases lifelong diseases they don't have a cure and we expect to innovate just like we've done with omni with tier here and now with scion we're i think we're fortunate i think we're three for three here and uh we're looking forward to um sharing more about the stuff that we're working on um next year and and cecilia um
Jesse
You know, half of the R&D line item, right, that you see is, for us, is clinical, right? So, you know, other major projects that will be in our R&D investment envelope next year are Sahara and Precision, those trials, right, which are obviously very important to us.
Scion
Great. Thank you for taking the questions.
Trey
Thanks, Cecilia. Thank you. One more moment, please, for our next question. And the next question will come from David Saxon of Needham and Company. Your line is open.
David Saxon
Hi, good afternoon, Paul and Jesse. Thanks for taking my questions. Maybe one for Paul, one for Jesse. Paul, to Cecilia's question around Scion, you talked about the Scion launch strategy, you know, three prongs. Just wondering if you could tell us, you know, which buckets you're seeing the most traction launch to date. And based off the script, it sounds like some Scion users are being introduced to Omni, which is great to hear, especially so early on. Are you seeing anything about the reverse where Omni users are starting to switch some of their volumes to Scion?
Paul Bedawi
Hi, David. Great questions. On the first question around Scion, our reality, we're seeing adoption across all three of those subsets. We knew before we developed Scion, we knew these market subsets existed. We've got obviously a significant and highly talented commercial team, sales and marketing team, and these subsets of the market were known to us. These were not accounts that we could win. regardless of how how efficacious Omni is they weren't accounts that were available to us they are today so the answer is all three of those subsets we're having progress with Scion so the high volume cataract surgeon we brought on a number of those I think within the first few weeks I mean think think of like some of the very highest volume cataract surgeons in the country I know we have some of those who came on early. The academic institutions, those institutions take time to get products through the system, but we're having very healthy discussions there today. And then lastly, on the PEO and profitability-oriented facilities, we're selling Scion into those types of accounts today. Your second question, David, you know, omni-users... Yeah, Paul, I can take that.
Jesse
The utilization, the omni-utilization of the initial Scion orders looks very similar to the omni-utilization overall, David, if that makes sense, right? there's not a discernible difference that we can observe yet, like in their utilization trends versus the non-cyon, but Omni using base. And we're really encouraged, right? It's been a very targeted initial rollout. And we knew that the use case really might have some overlap, but honestly, the reason that users were using Omni Um, well, you know, was was such that, like, you know, it mitigated. The theoretical risk of sort of utilization cannibalization, right? So we're, we're, we are quite encouraged. With that comparison of utilization.
Paul Bedawi
Another way to think of it, David, another way to think of that is. our omni customers who are who are proficient with omni and they're now that the bar the efficacy bar and expectation has been set that they're not going to move off of that that's why they're using omni whereas so so omni customers don't necessarily become scion customers however. The opposite, Scion customers, we do have the opportunity to introduce them to Omni. Once they're using Scion, we've got that established regular sales rep to surgeon relationship, and they're in the OR with these surgeons. And then they're seeing patients that are a little more advanced. That's the ideal opportunity now that we're in there to sell them on Omni. So we don't see it the other way around. very, very happy Omni users who depend on the efficacy that Omni delivers switching off of Omni really to anything else.
David Saxon
Okay, great. And then Jesse, maybe just one on the cash burn. Looks like it was around 21 million for the quarter, 61 year to date. How should we think about the burn in the fourth quarter? And it sounds like that should improve in 23. So maybe just give us a framework with you know, how to think about the magnitude of that improvement as we, uh, progress to positive free cashflow in 25. Thanks so much.
Jesse
Yeah. I mean, you know, um, there's, I think we've given a lot of good piece parts to be able to kind of give our view, right. Um, we, um, we gave a directional, um, I'd say, uh, um, a true directional sort of view of what the operating expense envelope should look like next year, you know, our perspective on medium-term revenue growth, right? And then, you know, we are seeing margins, like, you know, the gross margins, right? I think the three periods, it was 84% for all three periods, right, that I discussed in sort of my prepared comments. um you sort of factor all those three things in without sort of giving specific cash burn guidance but you can get to like what our perspective is like on um what the burn envelope will be like next year right and what's important too like in those comments was um you know we've made a lot of the investment we think to to grow the net to grow the business the next 50 100 million dollars in terms of infrastructure investment support investment And we think this OpEx envelope, you know, scales very nicely with much less variable OpEx, like, you know, for the next $50, $100 million of growth than we have kind of – than we have experienced as we've invested heavily, like, in the recent past. And so that's why we continue to convey conviction about, you know, our balance sheet and the ability to hit our growth objectives within that balance sheet.
David Saxon
Got it. Thanks, and congrats on the quarter.
Trey
Thanks again.
David Saxon
Thank you.
Trey
Thank you. One moment, please, for our next question. Our next question will come from Tom Stephen of Stifel. Your line is open.
Tom Stephen
Great. Hey, guys, thanks for the questions. Maybe if I can start on reimbursement. With the Canaloplasty Professional fee cut for next year, I believe recently finalized, you know, maybe if you can provide just general thoughts or views around the volume impact in 2023 from these changes. And then, you know, I guess on top of that, you know, what are your thoughts on price and gross margins next year in that same context?
Paul Bedawi
Yeah. Hey, Tom. Happy to take that one. So canaloplasty CPT66174, as we've discussed in the past, I think two years ago, the ROC RVU process revalued canaloplasty 66174 as well as trabecular bypass denting on the 66174 prophy side. They proposed two-year reduction in the prophy from the historical rate of 900 plus to 750 this year down to about 600 next year starting on January 1st so while while this is never welcome for surgeons ophthalmologists they've been experiencing reimbursement cuts on things like cataract surgery for many, many years now. So it's certainly not good news. In terms of our business and in terms of doctors' decisions to use Omni, we don't see an impact there. And the reason why I say that is the relative positioning of the prophy, so moving from 750 to 600, again, it's not... welcome news but it doesn't change the level of reimbursement relative to any competing procedures to think about you know goniotomy goniotomy had had the highest pro fee you know that's that's scion for example um and it still will until that procedure is revalued in due course the stents got revalued so a reduced 66174 fee isn't going to change the relative better prophy compared to stents and cataract. So we think that as you try to assess the impact of any of these changes on utilization, obviously you think about, number one, relativity, and then number two, in a vacuum, does the prophy going forward sufficiently reimburse a provider that they'll continue doing these procedures? And we think that the answer is yes. So, you know, doctors are used to using Omni. They rely on Omni for its efficacy. We have a very sticky business, and we don't see a pro-fee change from $750 to $600 taking us off course.
Jesse
Yeah, on pricing and margin, you know, pricing time is really driven by the facility fee, which for 66174 actually went up. We're always cognizant of margin pressures. I think once Scion becomes a more prominent contributor to our revenue mix, as that gets production scale, right, there might be a very modest amount of pressure on our overall surgical glaucoma margins, right? But ultimately, you know, we don't feel like sort of there will be any cause and effect of price pressure just given how pricing is really set in the market based on professional fee.
Tom Stephen
Got it. That's great, Collar. And then my follow-up just on TierCare, Paul, you talked about the Sahara readout, I think by 2H23. Maybe sort of at that time, let's say the superiority endpoint were to hit, what can we expect maybe over the next six to 12 months after that? You know, it'd be great if you could just refresh us kind of on the longer-term market access strategy would be very helpful. Thanks, guys.
Paul Bedawi
Yeah, sure. Thanks, Tom. A couple considerations. Again, it completed enrollment in August, September timeframe. The readout, the – the randomization, tear care versus stasis readout, primary endpoints. That'll be late Q2, so maybe summer 2023, we'll have the data analyzed and ready for that readout. And then beyond that, you know, assuming, knock on wood, assuming success, we would begin, you know, we want to publish the data. We'll try to publish certainly the six-month data and then we continue. The study's not over at that point. It will continue for two years. There's another readout at two years. The two goals of the study, just to remind everybody, one, we want to assess how tear care compares to restasis at six months on signs and symptoms, and then the second goal of the study is to show durability of treatment effect. That's why we're running a two-year trial with Sahara at That's an eternity in the world of dry eye clinical trials. But again, this study was informed by payers themselves. We spoke to a number of payer medical directors before we designed and began executing this study. And those were the two things they needed to see. They need to see how does an interventional procedure for MGD compare to costly daily market-leading prescription RX? And number two, how long does tear care last? What is the durability of treatment effect? Because payers are going to want to decide if we're covering this, how many treatments per year are we paying for? And based on the thousands and thousands of cases we've done successfully commercially today in the cash pay world, we typically see one, two treatments in the first year and then a single treatment for maintenance every year thereafter. So we would Tom, it's a long answer. Those are the goals of the study. We would begin having hopefully, again, assuming success, very healthy discussions with payers with that six-month data. We're not going to wait for the two-year endpoint in late 2024. We're going to go with that six-month endpoint and talk to as many payers as we can. And I think hopefully we'll be able to pull in some payer wins in advance of that two-year 2024 final readout. Perfect. Thanks, Paul. Thanks.
Trey
Thank you. And one moment, please, for our next question. Our next question will come from Craig Bijou of Bank of America. Your line is open.
Craig
Good afternoon, guys. Thanks for squeezing me in here. Just one from me. I believe you guys said that you're seeing uplift on standalone utilization in certain markets. And maybe you bring those best practices to other markets. I was hoping you can expand a little bit and maybe on the characteristics of that market. Is there anything that's common that you're seeing and why standalone is seeing a little bit more uptick? And then maybe just a little bit more color on how you plan to kind of take those best practices and bring them to your other markets?
Paul Bedawi
Craig, I'll talk about the GCCs, what we've seen. We've seen the most successful GCCs historically the way we were organized prior to our reorg. The GCCs were more or less on an independent team with a mission to go and educate educate our omni surgeons educate the referring provider community etc but they are operating more independently what we saw again we're learning very quickly we're paying close attention to what's working and then we're trying to institutionalize those best practices we're doing that i think very well right now we saw that the gcc's who were working most closely with the local surgical sale that they were able to affect faster, better, higher quality, um, education of the entire surgical ecosystem, right? That, that, that, that surgical rep had already cultivated. And with the GCC and the rep working closely together, the GCC was better able to go and educate the important referring providers, educate the, the types of Omni surgeons that were more likely to be ready to go sooner. And so it's through that very tight collaboration between GCC and surgical sales rep. That more efficient, higher yield, better quality standalone market development was happening. So what we've done is we've taken that entire 20 member GCC team and recently integrated them entirely within the surgical sales infrastructure. And we're super excited now to replicate what we saw was already happening in a handful of territories. where we were seeing better productivity on standalone market development and better uplift there. We think that we're institutionalizing it now with the GCCs under the leadership of the regional directors on our sales force, and we expect now those other territories to follow suit.
Craig
Got it. One follow-up. I mean, any timing or, I mean, expected timing on how quickly you think... you can see some uptake in other territories?
Paul Bedawi
Yeah, go ahead, Paul. I think we're seeing standalone uptake now. I mean, if you just, some barometers, it's hard to track with any accuracy. Again, it's Omni, right? It's the same device. We don't have a combo cataract device and a standalone device. Omni has a very broad indication. uh for for combo cataract and standalone and eddy severity of disease so it's tricky it's tricky to track in that way uh because it's it's the same device but based on you know first of all our performance and our growth i think it's it gets all rolled up into that um so we can expect that to continue um and then and then just the the discussions we're having You know, we have a large commercial infrastructure and the discussions we're having with our surging customers and the awareness of standalone that we're driving and the feedback from our customers on standalone and the way that we're training doctors today from the get-go to, you know, when they do their first 10 cases, we're institutionalizing some best practices. We'll do seven combo cataract cases and three standalone cases if possible. So those are the kinds of things that are happening with increasing frequency. It's tangible to us. The chatter amongst the surgeon community around standalone continues to grow. And I think all of those things are very good barometers of standalone market development, standalone progress in an area that's otherwise tricky to assess with any, like right now, any real accuracy again, because the product Omni is the same successful product in combo cataract as it is in standalone.
Craig
Got it. Thanks for the color, guys. Sure.
Trey
Thank you. And I see no further questions in the queue. I would now like to turn the conference back to Paul Badawi for closing remarks.
Paul Bedawi
Well, thank you, Chris, and thank you all. Appreciate everyone's continued interest in site sciences. Appreciate your time. Hope everyone is well, and have a great rest of your day.
Trey
Thank you. This concludes today's conference call. Thank you all for participating.
spk11
You may now disconnect, and have a pleasant day.
Operator
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