Paul Badawi
Analyst · William Blair
Thanks, Trip, and thank you all for joining us. Our first quarter 2022 revenue increased to $14.9 million, representing 72% growth compared to the prior year period and 1% sequential growth compared to the fourth quarter of 2021. A strong continued pace of new customer wins and extremely high customer retention resulted in surgical glaucoma revenue of $13.9 million, in line with the prior quarter's revenue and exceeding our internal expectations given Omicron, seasonality and competitive trial. Surgical glaucoma year-over-year revenue growth accelerated to 70% in the quarter, compared to 60% in the fourth quarter of 2021. As a point of comparison, our surgical glaucoma revenue sequentially declined 7% from the fourth quarter of 2020 to the first quarter of 2021, yet we still grew surgical glaucoma revenue 79% for the year. Our dry eye revenues for the first quarter were $1 million, up over 100% year-over-year, and 33% sequentially from the fourth quarter of 2021. We are very pleased with the fundamental progress and the leading indicators we use to monitor each business. Before delving into details on our quarterly performance, I want to take a step back and comment on the broader market environment. There are a handful of new instruments that are being marketed to perform clinically unproven procedures. Launches of any new products from companies with established commercial relationships will naturally generate initial surgeon interest and stimulate trial. This results in transient shifts in case mix and operating room schedule allocation as these products are evaluated. We experienced this in the first quarter and expect these dynamics to continue through the second quarter as well, with the impact to our business manifesting in an extension in the adoption ramp for newer OMNI facilities, and pockets of reduced ordering in certain accounts that we believe will be short term in nature. In our experience, these trialing periods can take anywhere from two to six months. Over this time, surgeons and facilities typically gain a more complete understanding of the clinical outcomes and reimbursement characteristics of the new procedures. Said differently, they learn firsthand what these procedures are and are not from a clinical usability and payer perspective. What we have seen in Q1 and into the current quarter is that despite ongoing trialing, we are achieving extremely strong customer retention and new customer wins, both of which are as solid as ever. Simply put, OMNI is extraordinarily sticky and its growth funnel remains robust. As the year progresses, we are confident that OMNI's clear and differentiated benefits will become even more apparent to surgeons. As early evidence of this, we are starting to experience this full cycle play out in some accounts where trialing impacts have proven to be short term in nature. Four simple concepts can explain why OMNI will continue to win: Efficacy, indication, reimbursement and usability. We designed OMNI to safely and effectively treat the conventional outflow pathway with a minimally invasive procedure. Our growing body of clinical and real-world evidence supports OMNI's superior performance as does OMNI's best-in-class indication to reduce IOP in all adults with POAG. Our customers bill OMNI using a well-established Category 1 CPT code that reimburses at competitive rates and was revalued just last year. These revaluations for Category 1 CPT codes typically last for five years or more, so we expect payment rates to be stable for several years, though the facility payment could increase if the canaloplasty code is granted device-intensive status. We have spent many years innovating and improving OMNI's functionality and usability, resulting in a product surgeons love to use. Our continuing and highly proprietary innovation and enhancements to OMNI keep us ahead of the competition. OMNI's mastering of these four simple concepts drives our confidence in OMNI's ability to win in the mix market. Moreover, with $238 million of cash on our balance sheet, we have more than enough capital to execute our financial plan, and we are fortunate to have the financial flexibility to make smart, long-term value-maximizing decisions and be resolute in our long-term approach. Let's move on now to an update on our three primary strategic growth initiatives, which as a reminder are: number one, increasing adoption and utilization of OMNI and the established combination cataract MIGS segment; number two, pioneering the $5 billion U.S. market for stand-alone MIGS interventions; and number three, developing the market for reimbursed dry eye treatment procedures. We continue to deepen our penetration into the established combination cataract segment by training more surgeons, winning new accounts and retaining existing ones. Jesse will provide more color on these KPIs in his remarks but I'll summarize just by saying we are extremely pleased with the trends. To provide additional context on our business performance, we recently began a proprietary analysis of historical billing claims projections from a well-respected advanced analytics provider. While the results we have seen thus far appear to track with what we have observed historically, the analysis relies on a projection of overall U.S. claims based on the subset of claims accessible to our analytics provider, and availability of the data lags our reporting period by about a quarter. We urge caution in citing or relying on the data to guide business or investment decisions due to the inherent limitations of the analysis, and would like to point out that the underlying data attracts procedure costs and not usage of any particular device, including OMNI. All that being said, we have gained insights into OMNI's impact on the MIGS market, and we intend to share our analysis with you. Importantly, the analysis validates MIGS as a large and growing market. U.S. combination cataract claims grew at a healthy 17% CAGR from 2018 to 2021. CPT code 66174 is the canaloplasty code used to bill OMNI procedures. The increasing prevalence of 66174 usage in claims that also includes the CPT code for routine cataract surgery, 66984, demonstrates OMNI's expanding presence in the combination cataract segment. Claims that included cataract surgery and canaloplasty grew at an 81% CAGR from 2018 to 2021 compared to the 17% CAGR for all combination cataract claims. In the fourth quarter of 2021, there were over 18,000 projected claims using both 66174 and 66984, which represented over 19% of projected claims using the 66984 cataract code and all MIGS procedures combined. While true share is complex to calculate, given all the permutations and combinations of devices and codes using combination cataract procedures, when taken together, we believe these figures show a significant penetration of OMNI's code, 66174. We can further parse out OMNI's share of the canaloplasty code by comparing claims to OMNI shipments. Total canaloplasty claims had a very healthy 71% CAGR from 2018 to 2021, while OMNI shipments grew 122%. It is clear to us that the launch of OMNI in 2018 has propelled the growth of canaloplasty claims. This leads us to our second strategic initiative, expanding adoption of OMNI as a stand-alone intervention to treat POAG earlier. Currently, if a POAG patient does not require cataract surgery, the treatment algorithm relies on increasing use of topical eye drop medications to slow the progression of the disease with the goal of saving off conventional surgical procedures for as long as possible. We believe OMNI alone, due to its indication for use, safety and consistent efficacy, has the ideal product market fit for earlier stand-alone interventions in mild to moderate POAG patients. Our clinical studies have demonstrated that OMNI can safely and reliably reduce IOP and medication burden with or without concomitant cataract surgery. Our market research on stand-alone MIGS indicates that there is strong interest in OMNI. 85% of glaucoma patients would likely choose a stand-alone intervention using OMNI if it was recommended by their doctor. 85%. We also analyzed claims data for the stand-alone segment, which we define as claims with common glaucoma surgery CPT codes that did not include cataract surgery CPT codes. This category includes both mild to moderate surgical glaucoma options like canaloplasty, CPT-66174 and goniotomy, CPT-65820, as well as advanced surgical glaucoma options like ab interno or ab externo trabeculectomy. Due to the smaller current size of the stand-alone segment compared to the combination cataract segment, the limitations of the analytics data I mentioned previously could be even more pronounced, but we believe they serve as a very interesting and exciting leading indicator of what we are building right now in the $5 billion stand-alone segment. Of the four common standalone glaucoma surgery CPT codes, canaloplasty is the only one that is growing. The number of claims using the three other codes shrank 12% in 2021, while stand-alone canaloplasty claims grew 29%, more than doubling since the introduction of OMNI in 2018. This point is worth emphasizing. Based on our claims analysis, canaloplasty is the only stand-alone glaucoma surgery that is growing. This insight highlights the compelling product market fit between OMNI and stand-alone surgical glaucoma. Canaloplasty also appears to have propelled the overall level of claims in the stand-alone MIGS segment. In the second half of 2021, projected stand-alone canaloplasty claims were included in almost half of all projected stand-alone MIGS claims. We expect these organically generated stand-alone OMNI growth trends, which prove for us that the OMNI stand-alone market is very real, to accelerate as the impacts of our 2022 stand-alone investments are realized in this significant and lightly penetrated $5 billion market segment. Overall use of 66174 grew 66% last year, by far the fastest-growing segment in all of surgical glaucoma. The current estimated mix of combo cataract 66174 versus stand-alone 66174 is approximately 90-10, though we believe the mix for OMNI is more heavily weighted towards stand-alone. We have the unique perspective of viewing combination cataract and stand-alone as a single market and are very pleased with the overall growth of 66174 driven by OMNI and we'll measure our success based on our ability to increase overall adoption of OMNI and grow the exciting stand-alone opportunity. To propel stand-alone usage, we are focused on educating the glaucoma community that an earlier intervention performed by a local OMNI-trained surgeon could be an effective alternative to prescribing a second or third eye drop. We are approaching this strategy through both manpower and non-manpower initiatives. From a non-manpower perspective, we are continuing to drive education and awareness of the mild to moderate stand-alone opportunity through stand-alone clinical studies such as TRIDENT and TREY, events such as the OMNI symposium at ASCRS and our Don't Wait for Too Late marketing campaign. We recently submitted a paper for publication in a peer-review journal based on data from TREY, which studied OMNI stand-alone procedures in patients who had previously had a combination cataract stent procedure. We're very excited about TREY and plan to expand on its findings. From a manpower perspective, our newly trained team of 20 glaucoma clinical consultants will articulate this alternative treatment path to the tens of thousands of office-based primary eye care providers who first diagnose and treat POAG patients. We have strategically placed our GCCs in territories that have multiple qualified OMNI-trained surgeons with strong comprehensive practices or established practitioner networks and seek to improve communications and ultimately referral patterns within this network. If successful, we hope to create a POAG analog to the efficient cataract ecosystem. We expect to see the benefits from our GCC team begin to materialize in the second half of the year. Our third strategic growth initiative is to improve patient access to effective dry eye treatment procedures, supported by results from our OLYMPIA RCT. Late last year, our TearCare system received FDA clearance for the application of localized heat therapy in adult patients with evaporative dry eye disease due to Meibomian gland dysfunction when used in conjunction with manual expression of the Meibomian glands. This expanded label allows our commercial team to communicate the benefits of TearCare more effectively. Our reps have already reported increased customer receptivity in the field and are achieving increasingly strong results. Compelling clinical evidence is a pillar for all of our commercial efforts. Our dry eye market access initiative is underpinned by our SAHARA RCT, which we expect to complete enrolling later this year. As a reminder, SAHARA aims to demonstrate the superiority of TearCare treatments compared to the market-leading prescription eye drop for stasis at six months. We hope to be able to report back on the key superiority endpoint by the second half of next year. Our other clinical trials are progressing nicely, and we look forward to sharing more news with you in the coming quarters. The deep relationships we have formed with the eye care community have never been more evident than the engagement and positive feedback we received at the ASCRS Annual Meeting at the end of April. We are proud to report that the abstract presented by [ Dr. Mark Piper ] on reduced fluctuation of IOP and POAG patients who had canaloplasty followed by trabeculotomy using OMNI, won best paper at its session. We are also very pleased with our efforts to commercialize OMNI internationally. Our U.K. market, in particular, has performed quite well since we established a direct presence last year. We look forward to updating you as we make progress entering additional markets. Our mission, to improve the lives of patients with glaucoma and dry eye disease, drives our continued pursuit of innovation. As we discussed in our last call, we are developing a broad product portfolio that aims to offer market-leading treatment options along every step of the patient's journey for living with these incurable life-long diseases. I will now turn the call over to Jesse to discuss our first quarter financial results and more detail on our outlook for 2022. Jesse?