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Sight Sciences, Inc.
11/7/2023
Ladies and gentlemen, thank you for standing by. Welcome to the Sight Sciences third quarter 2023 earnings results 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 the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would like now to turn the conference over to your speaker today, Tripp Taylor, Investor Relations. Please go ahead.
Thank you for participating in today's call. Presenting today are Site Sciences Co-Founder and Chief Executive Officer, Paul Bedali, Chief Financial Officer, Allie Bauerlein, and Chief Commercial Officer Matt Link. Earlier today, Site Sciences released financial results for the three months ended September 30th, 2023. A copy of the press release is available on the company's website at investors.sitesciences.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 the federal securities laws those include statements related to site science's anticipated financial performance and operating results cost savings initiatives market opportunity business and product reimbursement strategy clinical trial results 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 of the company's public 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. On this call, management may refer to financial measures that were not compared in accordance with generally accepted accounting principles in the United States. including adjusted operating expenses. The company believes these non-GAAP financial measures are important indicators of its operating performance because they exclude items that are unrelated to and may not be indicative of its core operating results. See the company's earnings release for a reconciliation of these non-GAAP financial measures to the most directly comparable GAAP measures. I will now turn the call over to Paul.
Thanks, Tripp. SightScience's mission is to elevate the standard of care for glaucoma and dry eye patients by providing eye doctors with market-leading interventional technologies focused on the preservation of sight and improving the quality of life for all patients. We are confident that we are redefining the glaucoma and dry eye treatment paradigms. To continue these efforts, currently our main focus is on establishing, maintaining, and enhancing market access to our innovative technologies and clinically effective procedures to ensure the best treatment options are available to all patients. Based on the clinical efficacy profile of our products, coupled with demonstrated integration into routine clinical practice, we strongly believe our surgical glaucoma products should continue to have broad reimbursed access. Turning to discuss where we stand with market access in our surgical glaucoma segment, We were extremely disappointed with the final LCD that was published by WPS on October 26th that identified certain procedures as investigational in patients over the age of 18 for glaucoma management, including canaloplasty in combination with trabeculotomy ab interno, which is a procedural description WPS associates with Omni. We strongly disagree with the LCD's coverage limitations with respect to these procedures, and we are pursuing all remediation possibilities to maintain Medicare coverage in the states administered by WPS. We do not have any further updates at this time about the draft LCDs published by the other four MACs in June. If these proposed LCDs are implemented as currently drafted, many non-implantable MIGS technologies would be considered investigational and non-covered for Medicare beneficiaries in the states administered by these MACs. We believe coverage for Omni is supported by a significant body of peer-reviewed clinical evidence demonstrating consistent safety and efficacy, a broad FDA-cleared indication for use for IOP lowering in adults with POAG, primary open-angle glaucoma, and broad adoption by ophthalmic surgeons. We strongly disagree with the LCD and are working tirelessly to prevent loss of coverage for canaloplasty in combination with trabeculotomy ab interna. With regard to our Scion technology used for goniotomy procedures, we are seeking further clarity as to whether it falls within the coverage limitations of WPS's final LCD as well as the other draft LCDs. Gemini 2, a prospective multicenter study to obtain 36-month follow-up for patients treated in the original 12-month Gemini study, has been completed. and favorable results demonstrate sustained IOP and medication reduction at 36 months for Omni. These results have been submitted for peer-reviewed publication, and we expect they will be published in the coming months, which will add further long-term evidence of the safety and effectiveness for Omni that we believe should meet WPS's coverage requirements to be deemed medically necessary and reasonable. Our position is that WPS should pause implementation of its final LCD, and the other four MACs should institute a temporary hold on publishing additional future effective MIGS LCDs to allow for full consideration of multiple missing studies, pending studies for Gemini 2 and IRIS registry data, as well as resolution of what we believe are material, substantive, and procedural flaws in the WPS LCD and LCD process. As a result of the uncertainty in the reimbursement environment, we are also actively taking steps to protect our cash reserves and reduce our operating expenses while driving enhanced focus on our key strategic priorities. Separately, as part of our long-term market access strategy, back in May of this year, we applied to CMS to establish new procedure codes and assign them to new technology ambulatory payment classifications, or new technology APCs, for the unique multimodal and comprehensive interventional procedures enabled by our Omnitechnology, which we call TCOR, or Trabeculocanalicular Outflow Restoration. New technology APC designation is provided by CMS to establish payment for facilities, like hospitals and ASCs, for procedures that are not fully and appropriately reported with existing codes. We believe the TCOR procedure falls squarely into this category. In our applications, we requested that CMS create three new C codes to describe the standalone T-Core procedure and the T-Core procedure when performed in conjunction with routine or complex cataract surgery. We also requested that CMS assign the standalone T-Core procedure and combination cataract T-Core procedures to new technology APCs consistent with the cost data and invoices provided to CMS associated with furnishing these procedures. We are awaiting feedback from CMS on our requests to establish new C codes as part of the new technology APC designation process. CMS issues these determinations on a rolling quarterly basis. In summary, we believe WPS should pause implementation and revise its final LCD. The other four MACs should stay their publication and revise future effective MIGS LCDs. And CMS should create new C codes to describe TCOR. While we do not control the timing or ultimate outcomes, we believe the evidence clearly and convincingly supports continued fair access to our Omni technology for patients and providers. On other fronts, in one of the more exciting clinical developments for Omni this year, we collaborated with Verona Health to leverage the AAO's IRIS registry to better understand the clinical value proposition of mixed technologies in real-world settings on a very large scale. We believe this represents the most comprehensive MIGS dataset ever assembled. Verona Health compiled data from over 100,000 glaucoma patient eyes to evaluate long-term, two-year, post-surgical outcomes for the three most commonly used FDA-approved or cleared MIGS devices in the United States, as well as cataract surgery alone. 9,000 of these eyes were treated with either Omni, hydrous microstent or iStent inject combined with cataract surgery. The remaining eyes received cataract surgery alone. The complete details of this study have been submitted and are under peer review by a top-tier journal. At the two-year endpoint and in the full Omni cohort of 428 patients and 541 eyes treated specifically with Omni technology, the T-Core procedure delivered clinically and statistically significant improvements, in mean IOP and medication reduction. Moving to the larger cohort of all patients in the study receiving any of the MIGS interventions, at the two-year endpoint, the T-Core procedure with Omnitechnology delivered the numerically greatest IOP and medication reductions compared to hydrous, iStent inject, and cataract surgery alone. This study corroborates existing peer-reviewed literature and supports our thesis that technologies that enable comprehensive interventional procedures by targeting the underlying causes of disease in a minimally invasive manner can deliver highly compelling long-term safety and efficacy outcomes for patients. This analysis developed from the independent IRIS data is extremely valuable, and we think it can help inform surgeons' decision-making when considering treatment options for their glaucoma patients going forward. We expect to continue our work with Verona Health to explore additional data sets that leverage the IRIS registry to further validate the clinical efficacy of our technologies. Turning now to our dry eye business. Our tear care technology can provide safe and effective procedural intervention for millions of patients suffering from meibomian gland disease. The traction generated by our controlled commercial launch in a cash pay environment is evidence of not only the technology's market fit with our eye care provider customers, but also the consumer demand for interventional dry eye procedures which address the root underlying cause of evaporative dry eye disease. With extensive clinical experience and feedback from the market, we believe this demand would accelerate with appropriate insurance reimbursement. On our last call, we reviewed the top-line success of our Sahara RCT. Six-month results were presented last month at the American Academy of Optometry's annual meeting, and we also held an investor event last Friday at the American Academy of Ophthalmology meeting to review these results in more detail. The Sahara trial achieved its primary objective six-month endpoint, demonstrating the superiority of interventional eyelid procedures enabled by TierCare over Restasis prescription eye drops and the improvement of tear breakup time, or TBUT, at all measured time points, one week, one month, three months, and six months. TBUT is a key measure of aqueous retention, tear stability, and the tear film's ability to protect the ocular surface. Patients receiving tear care treatments exhibited statistically significant improvements in TBUT from baseline that increased from a one and a half second improvement from baseline at one week to a two and a half second improvement from baseline at six months. TierCare and Restasis also delivered comparable clinically and statistically significant improvements at every time point measured in patient reported outcomes measured by ocular surface disease index or OSDI scores, the trial's primary subjective endpoint. We believe the combination of clinical outcomes from this groundbreaking RCT and a rigorous budget impact model that demonstrates the compelling comparative health economic value of TierCare will together serve as the foundational building block to achieve fair market access for tear care. We plan to begin payer discussions in early 2024 upon publication of the six-month Sahara clinical data and completion of our budget impact model. Although the reimbursement process requires considerable time, effort, and investment, we are confident the results of our efforts can improve the lives of the millions of dry eye sufferers who lack access to effective MGD treatment. We are happy to be leading the way for this important clinical cause and societal need. Our highest priorities for TierCare are market access execution, payer education, and existing account support. As a result, we have scaled down dry eye commercial resources by approximately 50% to focus more on market access execution and the publication of additional clinical data from Sahara such as the one-year crossover data that we expect will further enhance our market access initiatives as we await market access wins. We expect dry eye sales in 2024 to be modest as we focus instead on building long-term value through market access and payer education throughout the year. In summary, at Sight Sciences, we create and commercialize interventional technologies and procedures that comprehensively address the underlying causes of eye disease. we have produced substantial bodies of clinical evidence that demonstrate the clinical value of both our interventional T-core glaucoma procedure with omni technology and interventional dry eye procedures with tear care technology. Both procedures have demonstrated substantial potential to improve treatment paradigms and elevate the standards of care. As we work to maintain and achieve fair market access for both technologies, We are poised to positively impact millions of patients' lives while driving more profitable growth. I will now turn the call over to Ali to discuss our financials.
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