8/1/2024

speaker
Operator
Conference Operator

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 1 1 on your telephone, and you will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 1 again. Please be advised that today's conference is being recorded. I would now like to turn it over to your first speaker today, Tripp Taylor, Investor Relations. Please go ahead.

speaker
Tripp Taylor
Investor Relations

Thank you for participating in today's call. Presenting today are SightScience's co-founder and chief executive officer, Paul Badawi, and chief financial officer, Allie Bauerlein. Also in attendance is SightScience's chief commercial officer, Matt Link. Earlier today, Site Sciences released financial results for the three months ended June 30th, 2024, and narrowed revenue and adjusted operating expense guidance for full year 2024. A copy of the press release is available on the company's website at investors.sitesciences.com. I would like to remind everyone that comments made by management today and answers to questions will include forward-looking statements within the meaning of the federal securities laws. These forward-looking statements include statements related to the company's anticipated financial performance, operating results, liquidity position, and ability to achieve cash flow breakeven, ability to achieve current and long-term strategic objectives, market opportunity, and ability to enter new markets and capture market share. Pricing strategy and the impact of proposed rules on payment rates, product reimbursement, coverage, and strategy. expectations regarding regaining commercial momentum, account utilization and engagement, clinical trial strategy and results, and the disposition of the patent infringement case. 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 its public filings with the Securities and Exchange Commission, including the risk factors section of the company's annual report on Form 10-K and quarterly reports on Form 10-Q. 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 prepared 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 financial measures, as well as additional information about the company's reliance on non-GAAP financial measures. I will now turn the call over to Paul.

speaker
Paul Badawi
Co-founder and Chief Executive Officer

Thanks, Tripp. Our second quarter results represent consistent commercial and operational execution throughout the quarter as we continue to advance our mission of developing transformative, interventional technologies that allow eye care providers to procedurally elevate the standards of care, empowering people to keep seeing. In the surgical glaucoma segment, we drove sequential increases in utilization and the number of accounts ordering our products. In our dry eye segment, the Sahara one-year data was published, which represents a critical milestone in support of our efforts to establish equitable market access for interventional dry eye treatments. Additionally, we continue to prioritize operational excellence as we maintain solid margins and exercise diligent expense management. Quarterly cash usage declined by almost 30% compared to the prior year period, reflecting disciplined spend while still allowing for investment in all of our critical value drivers. For the second quarter, we generated total revenue of $21.4 million, reflecting sequential growth of 11% in line with our expectations. We are excited about the tremendous opportunity to execute on our long-term goals and reestablish double-digit growth driven by continued adoption of both of our paradigm-shifting interventional technologies. I will now turn to a more detailed discussion of our business segments, starting with our surgical glaucoma segment. We are pleased with our quarterly performance with surgical glaucoma revenue of 20.2 million, representing sequential growth of 11% compared to the first quarter of 2024. The sequential improvement tracks to our expectations year to date, and we remain confident in double-digit growth in this segment in the second half of 2024 as compared to the same period in the prior year. As a reminder, if the recently proposed draft LCDs from May become effective in their current form, procedures that use our Omni and Scion technologies would continue to be eligible for Medicare coverage nationwide. We believe our technology is critical to the thousands of surgeons who use Omni routinely and is an important part of the glaucoma treatment continuum. We are extremely proud of Omni's differentiated clinical profile as demonstrated in high-quality, long-term, peer-reviewed data, which we believe will continue to support access to the technology for the appropriate patient population. Separately and importantly, on the reimbursement front in July, CMS published the 2025 proposed Medicare payment rules for hospital outpatient and ASC procedures, along with physician professional fees. The ASC payment rule for 2025 proposed to grant device intensive status and a related increase in Medicare's facility payment rate for procedures reported with CPT code 66174, a code that is currently used to report our comprehensive OMNI procedure. These proposed rules are not considered final until the final rule is published, which we expect to occur in the fourth quarter of 2024. We firmly believe device intensive status has always been appropriate for our Omni technology and procedure, and receiving confirmation of this status has been a long-term initiative for the company. As part of our Omni market access efforts, we have diligently worked to establish device intensive status for CPT code 66174, so we are very pleased with this proposal from CMS. If the rule is finalized with device intensive status for this code, effective January 1st, 2025, it will result in an increase to Medicare's ASC facility payment of approximately $600, or 29%, compared to Medicare's ASC payment rates for 2024. Should device intensive status be finalized for this code, we believe this would be a meaningful development that would enhance our value proposition from a facility economics perspective for Omnitechnology versus both MIG stent implants and goniotomy procedures. We are encouraged by this development and plan to provide further updates once the final rule is published. Now, I'll focus on the progress made against our core strategic initiative this quarter. Within our surgical glaucoma segment, we remain steadfastly focused on a few critical drivers that we believe are keys to solidifying long-term success for the business, which include increasing surgeon utilization across all accounts and reengaging with accounts that ceased or decreased orders during the LCD uncertainty period last year. In addition, we are working to increase the pipeline of new surgeons who will be trained on Omni and Scion. Looking first at utilization, as discussed before, the differentiated efficacy of our technology across the spectrum of disease severity has made Omni a leading minimally invasive interventional technology for surgeons managing primary open angle glaucoma patients. We are focused on increasing utilization with accounts already using Omni and have been successful here over the past two quarters. Utilization of ordering accounts was up 5% from the first quarter of 2024. We believe the recent improvement in utilization is evidence of recovery and is a testament to the unique benefits of Omni and Scion and their importance to surgeons and patients. Jumping to re-engagement with accounts. In the second quarter of 2024, we experienced an increase in the number of accounts ordering surgical glaucoma products compared to the first quarter of 2024, which highlights our growing momentum as the year has progressed. 1,131 customers ordered surgical glaucoma products in the second quarter, up 5% from the first quarter of 2024 and flat from the second quarter of 2023. While we are continuing to work to further increase this number, Our progress during this quarter represents a positive trend that we expect to continue moving forward and again highlights the importance of Omni and Scion in the marketplace. As we progress through the year, we are increasing the number of surgeons scheduled to be trained on Omni and Scion. The growing clarity on reimbursement following the newly proposed LCDs is enabling a more normal environment for new surgeon training. Increasing the trained surgeon base is an important step that will continue to be a vital aspect of our growth strategy. In the first half of 2024, we've trained over 150 surgeons on Omni and over 100 surgeons on Scion. We believe we are well positioned for growth due to the shifting mindset among glaucoma surgeons towards interventional glaucoma, the comprehensive nature of the Omni procedure, the proposed increase in facility reimbursement that would improve the overall economics of Omni versus our competitors, and our continued organizational optimization. Now I'll turn to our dry eye business. Since its inception, we established our long-term mission of pioneering the field of interventional dry eye with a three-pronged strategy, developing best-in-class technology delivering superior long-term clinical outcomes supported by RCTs, and executing an effective market access strategy. We have spent a decade developing and enhancing our transformative tear care technology, an effective procedural option for certain patients with meibomian gland disease, or MGD. We estimate there are over 11 million U.S. patients diagnosed with MGD, the leading cause of dry eye disease. The tear care procedure targets the diseased meibomian glands directly and comprehensively, thereby addressing the root cause of evaporative dry eye disease. Tear care technology has been used in over 60,000 dry eye procedures despite operating in a cash pay environment. Over the past six years, we executed two large RCTs for tear care, one designed for regulatory clearance purposes and the other designed for payer coverage determinations. both RCTs met their primary endpoint. Most recently, our second RCT, Sahara, demonstrated the superiority of tear care over the market-leading prescription dry eye therapeutic, Restasis, for the study's primary objective endpoint. The six- and 12-month data from the Sahara trial have been published and serve as the foundation for the third leg of our three-pronged strategy, establishing equitable market access based on our growing body of robust clinical evidence. From this, We will continue to lay the foundation for market access and deliver our technology to those who can benefit from the procedure. We recently published the 12-month results of the Sahara RCT, which demonstrated improved signs and symptoms of dry eye disease for tear care patients crossed over from Restasis. The Phase II crossover of the Sahara RCT included subjects who were previously treated with Restasis for six months and then subsequently taken off Restasis before receiving a single tear care treatment. These patients experienced further statistically significant improvements in the signs and symptoms of dry eye disease. The first two phases of the Sahara RCT, month 6 and month 12 endpoints, suggest the clinically significant efficacy of tear care appeared to be the same whether or not a study patient had prior treatment with Restasis and that similar results could be expected when tear cure is used as a primary or secondary treatment for dry eye disease. The next milestone for the Sahara RCT will be the publication of the results of the third and final phase of the trial. Phase three of the Sahara trial follows the TierCare crossover cohort through to 24 months, and we expect it to be published in 2025. The goal of this cohort is to gain more clarity on requisite treatment frequency and the clinical impact of repeat TierCare treatments as needed. With the six-month and 12-month data in hand, we are already having meaningful conversations with payers. Still, we are excited for the final trial phase and believe it will only continue to build on our growing library of compelling clinical data supporting the tear care procedure. Along with the support from our tear care clinical data, we have also recently begun introducing the results from our budget impact analysis to our discussions with payers. In May, we presented the analysis at ISPOR, the International Society for Pharmaco-Economics and Outcomes Research. And we are pleased with the early response to our model, which showcases the health economic impact and system savings for TierCare versus Restasis. As we have always intended, following the successful results of the Sahara RCT, we have positioned our technology to ensure that the clinical and economic value of the procedure is appropriately reflected. As TierCare's body of clinical evidence continues to grow, our investment and value proposition are also evolving. Following a thorough analysis, we'll be modifying our pricing structure to more accurately reflect the clinical and health economic value of the tier care procedure as demonstrated in both phase one and phase two of the Sahara RCT and our budget impact model. We have recently informed existing tier care customers of the future price increase, which will be effective October 1st, 2024. We expect our list price to increase to $1,200 per set of TierCare SmartLids. Appropriate reimbursement at the level supported by our evidence would still show compelling economics and value to patients, payers, and eye care providers, as well as to SightSciences, as the manufacturer that has invested over $100 million in developing and commercializing this technology. Our strategy within DryEye for the rest of 2024 and beyond has shifted to a targeted focus on achieving fair and equitable reimbursement. We are encouraged by the work we are doing now with payers, which we believe has put us on track toward long-term success. To this point, we've had a small number of tier care commercial claims paid on a case-by-case basis, and we continue to do the foundational work needed to establish broader coverage on a larger scale with commercial payers and Medicare. The critical drivers of conversations with payers are strong clinical data, and health economics, and we believe we have established a solid position from both perspectives. With high-impact peer-reviewed level one clinical evidence and demonstrated health economic benefits now in hand, we believe we are well positioned to drive forward coverage conversations and remain on track to begin receiving positive coverage policy decisions in 2025. As we look to the future, we remain committed to our long-term goals and feel we are currently operating from a position of strength with the ability to execute them successfully. Surgical glaucoma and dry eye represent significant opportunities to capture market share, develop new interventional markets, and drive a return to double-digit growth. We look forward to capitalizing on upcoming catalysts and delivering positive results. I will now turn the call over to Ali to discuss our financials.

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