Paul Badawi
Analyst · Stifel. Your line is open
Thanks, Trip. In our first full year as a public company, we made great strides fulfilling our mission to improve the lives of patients with glaucoma and dry eye. We are grateful for the trust and partnership our customers, physicians and patients have placed in us. In 2022, we grew total revenue by 46% to $71.3 million and executed our commercial and operational initiative to further solidify our position as the innovation and efficacy leader in MIGS and dry eye. We exercised a rigorous financial discipline to rationalize operating expenses and reduce burn as planned in the third quarter, which bolsters our belief that our $185 million cash balance at the end of 2022 is sufficient to support our growth plans and achieve cash flow breakeven in 2025 with a substantial cash cushion. On the commercial front, we continue to propel market penetration and expansion with both the OMNI Surgical System and TearCare System, expand our current addressable markets with the successful launch of SION, our innovative bladeless goniotomy technology, and advance our efforts to establish fair market access and reimbursement for our dry eye treatment technology. We also announced several publications providing clinical support for broadening the use case for our core products and make great progress with our ongoing clinical trial programs. Our fourth quarter results exhibited strong sustained revenue growth and meaningful impacts from our cost rationalization program. Our fourth quarter total revenue increased to $20.5 million, up 40% compared to the fourth quarter of 2021. Notably, we grew revenue 10% sequentially, while decreasing both quarterly cash burn by 27% or $5.5 million and quarterly OpEx by 10%, a $3.7 million versus the third quarter. Surgical Glaucoma revenue was $18.8 million in Q4 2022, growing 35% year-over-year and 10% compared to Q3. And Dry Eye revenue was $1.8 million, growing 135% year-over-year and 12% compared to Q3. I will now discuss the progress and strategic focus for our business units, starting with Surgical Glaucoma. Our growth metrics demonstrate further adoption and utilization of our OMNI and SION technologies as surgeons continue to embrace the new minimally invasive [indiscernible] glaucoma surgery techniques enabled by these important innovations. As a reminder, our core mission in surgical glaucoma is to provide surgeons with the best solutions for their patients, regardless of severity of disease or lens status. We continue to advance our growth initiatives which include: one, expanding the large and growing moderate to advanced combination cataract segment and the considerably larger standalone MIGS segment with OMNI’s differentiated efficacy profile; two, driving adoption and utilization of SION among specific subsets of surgeons, who choose a more basic procedure; and three, increasing our total share of MIGS with our OMNI and SION technologies. Our growth has significantly outpaced the overall MIGS market. We are taking share in combination cataract procedures and expanding MIGS beyond its narrow legacy confines. We believe OMNI is the only technology that offers the efficacy, functionality and clinical results to support long-term market expansion and penetration of the entire $6 billion plus MIGS market opportunity as evidenced by our growing penetration and sticky customer base. We continue to see a natural progression of surgeons who first learned to use OMNI technology in combination with cataract for patients with less severe POAG, then expand their use cases to patients with more severe POAG and to standalone use in patients that do not require cataract surgery. In the fourth quarter, we maintained a greater than 99% developed customer retention rate for OMNI, while growing active accounts by 24% since the end of 2021. Among the [indiscernible] placed OMNI orders in both the fourth quarter of 2022 and the fourth quarter of 2021, OMNI utilization increased 28%. We believe we are both increasing our market share and legacy combination cataract and expanding the market beyond legacy combination cataract procedures and towards standalone procedures. These market expansion opportunities are substantial and very sticky for our OMNI technology due to its proven degree and consistency of efficacy. These important long-term efficacy minded customers are among the most attractive in MIGS. To accelerate adoption and facilitate broader patient access, we have created a comprehensive program that includes targeted field resources, patients and physician education and programs focused on improving patient access to these new combination cataracts and standalone procedures made possible by our OMNI technology. As part of this program, our team is actively educating the glaucoma community on our new real-world data recently published in International Ophthalmology from TREY, our multicenter study that evaluated the safety and efficacy of OMNI in patients with uncontrolled IOP, despite a history of trabecular bypass stent implantation at the time of cataract surgery. Pre-highlighted a significant in intraocular pressure reductions were achieved with a standalone OMNI technology intervention in patients who already had stents implanted at the time of cataract surgery. This study suggests OMNI could be a natural fit for standalone interventions for the over 1 million patients who have undergone combination cataract stent implantations. Here is an example of what we are regularly seeing in the real world. One recent case at a prestigious West Coast medical school involved a patient with low 20s IOP on three medications after combo cataract stent implantation. Standalone intervention with our OMNI technology decreases patients IOP to 14 millimeters mercury on just one medication after 6 months. Needless to say, the patient and surgeon were very happy to avoid an invasive conventional surgery. This is just one example of the type of results that we believe OMNI can consistently deliver. To further demonstrate our market leading efficacy, we have partnered with the data and technology provider Verana Health. Our partnership leverages the American Academy of Ophthalmology's Iris registry of real world data to analyze post surgical outcomes for the leading MIGS technologies in the U.S., including OMNI, iStent and Hydrus. The first phase of the study analyzes IOP and medication reduction in 77,391 patients out to 2 years. This is the largest collection of MIGS data ever studied and offers compelling real-world evidence that we believe will demonstrate the clinical superiority of our OMNI technology. We plan to present and publish these groundbreaking study results including comparative IOP and medication reduction outcomes at the 1 and 2-year marks at multiple medical meetings and in peer reviewed literature throughout 2023. We believe our four other ongoing implant studies will further corroborate the results of Trey and Iris in both combination cataract and standalone settings to further propel our share taking and market expansion progress. Surgeon feedback from our clinical trials and real-world usage informs our innovation. We seek to continually improve clinical outcomes by improving functionality and usability, innovating creatively, and raising the technological bar within mix. Earlier this month, we announced the launch of our newest OMNI technology, called the Ergo-Series at the recent American Glaucoma Society meeting. As with our other technologies, the Ergo-Series incorporates direct input from many of our customers and was designed entirely in-house. We're very pleased with the enthusiastic reception it has received thus far and the feedback confirms that our continuous enhancements to usability are key reasons surgeons love OMNI and choose it as their preferred mix technology. The Ergo-Series technology sets a new standard in circumferential glaucoma surgery and it's just the latest in our long line of best-in-class technologies. This brings us to our newest product, the SION Surgical Instrument, the world's first bladeless goniotomy technology. We designed SION to allow surgeons to smoothly, efficiently and reliably excise and remove several clock hours of diseased trabecular meshwork tissue via an ab interno approach. SION is an ideal solution for a subset of patients prioritizing a simpler goniotomy procedure, complementing our OMNI technologies broad indication for use and leading efficacy. The fourth quarter with our commercial team's first full quarter offering SION following its limited launch in August of 2022. Surgeon feedback on the instrument continues to be extremely positive, particularly around procedural smoothness, a less traumatic goniotomy and improve the ease of use. The ideal customers for SION fall outside of OMNI's optimal product market fit, and we have observed minimal overlap in our analysis of early ordering patterns for SION customers. In addition to adding completely new accounts and reviving dormant accounts, we saw significant uplift in accounts that use both OMNI and SION technologies. Among accounts that ordered OMNI in the fourth quarter of 2021, and both OMNI and SION in the fourth quarter of 2022, average revenue per facility increased by 32%. Encouragingly, we saw utilization of our OMNI technology increased 12% and these accounts even as they added SION to their armamentarium. Our portfolio approach has already increased revenue per account. We also continue to make progress bringing OMNI technology to international markets. We launched direct operations in Germany, our second direct OUS market in January of this year. Germany, along with the U.K., our first direct OUS market are two of the largest MIGS markets in the world. We've begun laying the groundwork in several other OUS markets and plan to proceed as prudently and aggressively as market access, regulatory and commercial conditions permit. We couldn't be more excited to deliver the power of Sight to improve patient lives around the world. Transitioning now to our Dry Eye business where we continue to focus on establishing fair market access and reimbursement for Dry Eye treatment procedures. Our success introducing TearCare to over 1,000 accounts, including over 400 new accounts in 2022 spotlights the pent-up demand for effective Dry Eye treatments, especially interventional eyelid procedures. Note that we accomplished the thousand account milestone while still in a controlled launch deploying only 20 sales representatives. Given the 14 million diagnosed evaporative Dry Eye sufferers in the U.S and the growing prevalence of the disease, we believe the lack of fair market access to reimburse effective Dry Eye treatments is one of the greatest problems and opportunities in eyecare today. We have built a foundation from which TearCare can scale rapidly. Adding just one single additional treatment per week for our existing customer base would quadruple the size of our Dry Eye revenues. So it is very easy to appreciate just how big this market can become with appropriate reimbursement. Pioneering fair market access will require strong payer centric clinical data to demonstrate TearCare's health benefits to patients and economic benefits to insurers. We custom tailored our SAHARA RCT with extensive input from medical directors at eight different payers to understand and form the clinical foundation required to successfully support reimbursement coverage For TearCare. After completing enrollment of SAHARA in the third quarter of 2022, we remain on track to provide the initial 6- month data readout by the second half of 2023. As a reminder, this 6-month endpoint is powered to evaluate the superiority of TearCare treatments versus the leading multi-billion dollar Dry Eye prescription eye drop Restasis. With over 300 subjects, we believe SAHARA is the largest Dry Eye device study ever and the first to attempt to demonstrate the superiority of a device versus the most successful daily prescription eye drop. The 6-month study period designed to allow Restasis to achieve maximum efficacy also covers a much longer study period than the one to three month endpoints typical in other Dry Eye studies. SAHARA is in all respect a very ambitious study, but one that is also very worthwhile given the unmet need that we were seeking to address. In summary, we drove significant growth with all three of our category leading products and made substantial progress expanding our opportunities in MIGS and Dry Eye. We remain dedicated to increasing physician adoption and utilization across our portfolio and increasing the number of customers and patients we serve. Looking ahead, we are focused on leveraging our procedure field, productive field team, and increasing body of clinical evidence to train new customers and broaden use cases with each of our products. With the ultimate goal of generating sustainable growth, while continually improving operating efficiency and maintaining strict financial discipline. With these factors in mind, we are providing revenue guidance for 2023 of $89 million to $94 million. We expect 2023 to exhibit similar seasonal impacts and quarterly revenue distribution that we saw in 2022 with the first quarter stepping down sequentially versus the last quarter of 2022, then increasing as the year progresses. Specifically, we expect first quarter revenue to comprise 20% to 21% of the midpoint of our 2023 guidance, consistent with the first quarter of 2022. As it relates to operating expense, we continue to believe our reduced quarterly cash OpEx of approximately $30.5 million is an appropriate level of spend to meet our growth plan for the year. Before I turn the call over to Jim Rodberg, our interim CFO to detail the fourth quarter financial results, I'd like to thank Jim and his team for stepping up and doing an absolutely phenomenal job, Jim.