Paul Badawi
Analyst · Morgan Stanley. Your line is open
Thanks, Trip, 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 were 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 breakeven. And, 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 SION, our innovative bladeless goniotomy device; two, the complete enrollment of SAHARA, our transformative dry eye RCT for the TearCare system; and three, the publication of multiple peer-reviewed articles featuring compelling clinical data that demonstrates expansive market opportunities for both OMNI and TearCare. Each of these commercially minded achievements strengthens our foundation for long-term market leadership and charge 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 a 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. The $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 lower expectations for disease impact and changes in patients’ sight. We believe the remaining 90% of the market are nearly $5.5 billion opportunity requires a greater level of efficacy and consistency to satisfy the needs of the 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 2 best-in-class MIGS solutions that have rapidly gained market acceptance, our flagship OMNI Surgical System and our newly introduced SION surgical instrument. SION, 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 the 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 segment, based on OMNI’s differentiated efficacy profile; two, drive adoption and utilization of SION among specific subsets of surgeons, who may prioritize faster or simpler procedures; and three, increase our total share of MIGS with OMNI and SION, while also growing the overall MIGS market. OMNI’s adoption and utilization continues to grow among existing MIGS surgeons. We believe that our efforts to support this adoption and growth have not only resulted in continued shift [ph], but have also expanded the combination cataract segment to include a broader spectrum of POAG patients due to OMNI superior and consistent efficacy. We continue training new surgeons with our technology, while increasing OMNI utilization and existing accounts. Because of OMNI is 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 payors, 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 within FDA-cleared indication for ab interno use to lower IOP and post-cataract 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 a top of the efficacy driven MIGS market expansion categories. Based on our analysis of third-party projecting 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 TREY, our multicenter IRB approved study designed to evaluate the effectiveness and safety of OMNI in eyes with uncontrolled IOP, despite a history of trabecular microbypass 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 make surgeon presented OMNI data demonstrating durable safety and efficacy over 3 years with standalone use of OMNI and patients with open-angle glaucoma. We expect to see further studies to corroborate these impressive long-term results in the future. We’re also very excited about significant clinical research project involving comparative real world clinical data for the most common MIGS procedures held within the AAO’s IRIS real world patient data registry that we believe will help stakeholders including patients, providers and payors 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 1,000s 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 Sight 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 SION, the focus of our third and newest growth initiative for Surgical Glaucoma. In mid-August, we launched SION with a group of select surgeons. The initial feedback was extremely positive and we were very pleased with the success of our broader commercial rollout and progress now. SION 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. SION 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. SION is designed to allow surgeons to smoothly, efficiently and reliably excise and remove several clock-hours of diseased trabecular meshwork tissue via an ab interno approach. Our target customer for SION includes 3 types of combination cataract MIGS 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 and 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 SION surgeons will also consider using OMNI as they grow familiar with the best-in-class technologies we offer. Because our target customers for SION 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 TearCare 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 TearCare as a leading dry eye treatment. The authors of this analysis concluded that the TearCare procedure delivered superior symptoms improvements, quality of vision and symptom frequency over LipiFlow and patients suffering from advanced dry eye disease. This data reinforces our confidence in the clinical and economic value to TearCare brings to patients, providers and payors. I’m pleased to announce that we completed patient enrollment for our SAHARA RCT ahead of schedule. This keeps us on track to provide a randomized safety and efficacy readout of TearCare versus deleting prescription eye drop medication Restasis by the second half of 2023. As a reminder, SAHARA was designed with input from medical directors and payors to provide the clinical foundation of obtaining future reimbursement coverage, if successful. In parallel, we are intentionally growing our installed base of TearCare users in today’s cash pay market and believe reimbursement would stimulate immediate growth of TearCare 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.