8/3/2023

speaker
Operator
Conference Operator

Good 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 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. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Tripp Taylor, Investment Relations. Please go ahead, Tripp.

speaker
Tripp Taylor
Investor Relations

Thank you for participating in today's call. Presenting today are Site Sciences Co-Founder and Chief Executive Officer, Paul Badawi, Chief Financial Officer, Allie Bauerlein, and Head of Corporate Strategy, Tom Hwang. Earlier today, Site Sciences released financial results for the three months ended June 30, 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 of the federal securities laws. These forward-looking statements include statements related to Site Sciences' 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 factor section of the annual report on Form 10-K for the year ended December 31st, 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. I will now turn the call over to Paul.

speaker
Paul Badawi
Co-Founder and Chief Executive Officer

Thanks, Tripp. Our strong second quarter performance displayed the continued successful execution of our growth initiatives across surgical glaucoma and dry eye. We generated record total revenue of $23.5 million, growing 36% compared to the second quarter 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 tear care technology to Restasis for the treatment of dry eye. At the six-month endpoint, interventional eyelid procedures enabled by tear care technology were superior to Restasis in improving tear breakup time, or TBUT, the primary objective signs endpoint. Tear care was also non-inferior to Restasis with respect to improvement in ocular surface disease index, or OSDI, the primary subjective symptoms endpoint. As importantly, patients in the tear care group demonstrated clinically and statistically significant improvements of all 10 signs and symptoms endpoints measured at every observation interval. We are extremely excited about these clinical results and 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 six-month phase one 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. To begin our surgical glaucoma discussion, I would like to address the draft LCDs for MIGS recently proposed by 5MACs that could impact sales of our Omni and Scion products. These MACs 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 considered 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 in adult patients with primary open-angle glaucoma, or POAG. These five MACs 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 MAX 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 two-year extension of our multicenter ROMEO study. This important study demonstrated the reductions in both intraocular pressure, or IOP, and glaucoma medication use in 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. We 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 MACs further highlighted and described the consistency of positive outcomes observed across the published articles. We 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 Omnitechnology. We plan to continue to communicate with all stakeholders regarding the published clinical evidence and real-world results, supporting the safety and efficacy of Omnitechnology and the importance of continued and appropriate coverage 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. In 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 million 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 mixed market overall as more clinicians adopted our Omni technology. As evidenced by our record quarterly revenue, commercial activity for the second quarter exceeded our expectations. Notably, 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. Our 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 POAG 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 MIGs. Based on projected claims data from a third-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. The other product in our surgical glaucoma portfolio, Scion, also contributed to our growth in the second quarter. Scion addresses the needs of surgeons seeking a simpler MIG 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 tear care 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. Historically, 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 one 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 TierCare 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 TierCare 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 TierCare technology to twice daily use of prescription eyedrop treatment with Restasis. In this trial, 345 patients at 25 sites in 14 states were randomized one-to-one between tear care and Restasis groups. Sahara achieved its primary clinical sign six-month endpoint, demonstrating the superiority of interventional eyelid procedures enabled by tear care over Restasis eyedrops 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, one week, one month, three months, and six 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 six months rather than the one- or three-month periods common in dry eye studies. We 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 one 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. To 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 TierCare 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 two RCTs. We look forward to advancing our TierCare market access strategy, expanding usage of our Omni technology, and improving the lives of patients suffering from chronic eye diseases. I will now turn the call over to Ali to discuss our financials.

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