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spk06: Good day, ladies and gentlemen, and welcome to the Sight Sciences fourth quarter and full year 2021 financial results conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. If anyone should require operator's assistance, please press star, then the zero key on your touchtone telephone. As a reminder, this call is being recorded. I would now like to introduce your host for today's conference, Philip Taylor. You may begin.
spk03: Thank you for participating in today's call. Presenting today are Site Sciences co-founder and chief executive officer, Paul Bedawi, chief financial officer, Jesse Selnick, and chief commercial officer, Sean O'Neill. Earlier today, Site Sciences released financial results for the three months and 12 months ended December 31st, 2021. 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 in answers to questions will include forward-looking statements within the meaning of the federal securities laws. Those include statements related to SiteScience's anticipated financial performance and operating results, market opportunity, the future impact of COVID-19 on operations, business strategy, and plans for developing and marketing new products. Forward-looking statements are based on estimates and assumptions as of today and 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 factors section of the annual report on Form 10-K filed today and other filings 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. For more information, please refer to the forward-looking statement notices and risk factors in the recent SEC filings. I will now turn the call over to Paul.
spk05: Thanks, Tripp, and thank you all for joining us today. I'm very excited to provide an update on our business and the progress we have made delivering the power of sites. I will touch on the accomplishments that made 2021 a huge success and how we are positioning site sciences for continued success going forward, including an introduction to some of the exciting new products we are developing. Omni and TierCare are well on their way to becoming breakthrough products, yet we have never stopped innovating. We are employing our rigorous product development process to develop a portfolio of new products that will enable us to serve an even broader array of patients, suffering from glaucoma and dry eye disease. These programs, which we anticipate will include controlled product releases and launches this year, will help us drive organic growth for the next decade and beyond. But first, I'd like to start by reviewing our strong performance in the fourth quarter. Our total revenue increased to $14.7 million, representing growth of 63% compared to the fourth quarter of 2020, and 12% growth compared to the third quarter of 2021. Despite headwinds from resurgent COVID disruptions and shifting reimbursement dynamics, we delivered meaningful sequential growth in the fourth quarter, driven by continued new customer wins and higher utilization in our surgical glaucoma segment, which grew 12% sequentially and 60% year-over-year to 13.9 million. As others across our industry have discussed, we experienced a similar slowdown in activity in mid-December due to Omicron and the holidays that dampened what could have been an even more exceptional quarter. Fundamentally, our four principles position us to succeed and underpin the growth of our business. Our efforts are always focused on the needs of patients and protecting and enhancing mankind's most precious sense, sight. We have continued to propel our three strategic initiatives that we believe will unlock the full potential of omni and tear care and drive our growth over the near and medium term. Number one, our first initiative aims to increase the number of surgeons using omni. MIGS-trained surgeons who are already performing combination cataract procedures comprise our most fertile target segment. The bulk of our surgical glaucoma sales team consists of territory-based reps who sell omni to facilities and trained surgeons. We also have a strategic accounts team that focuses on selling to and training surgeons at teaching institutions and government hospitals. These teams have delivered exceptional results converting surgeons to Omni, and we are modestly increasing our investment in these groups in 2022. We believe Omni's strong safety profile, intuitive usability, and demonstrated efficacy in reducing IOP and medication usage have helped us penetrate the combination cataract segment and gain share. despite intense competition from legacy implant-based procedures. Only Omni allows surgeons to treat all three points of resistance within the conventional outflow pathway using a single device to perform two sequential procedures in a single surgical setting. According to MarketScope, there are over 5,600 surgeons performing mixed procedures in the U.S. We've trained approximately 1,500 of these surgeons, so we still have a lot of work to reach our full potential. In the fourth quarter of 2021, over 750 facilities ordered omni surgical systems, with over one-third of these representing new omni facilities. We continue to see increased utilization as our facilities-based tenure increases. Based on the increasing number of ordering facilities and their utilization, we believe we are continuing to take share in combination cataract procedures. Our reps typically train surgeons in combination cataract cases, because they already have cataract patients who also have primary open-angle glaucoma on their operating room schedules. Once a surgeon is proficient with OMNI in the combination cataract setting, they are positioned to perform standalone OMNI cases as well. These surgeons have built their practices around a robust practitioner network for cataract patients. To expand their practices to include interventions in the $5 billion U.S. standalone glaucoma segment, Our customers will require a similar practitioner network for POAG patients. Number two, our second initiative focuses on educating these POAG practitioner networks to better understand when glaucoma patients may benefit from standalone procedures performed by OMNI trained surgeons. We are in the early stages of educating the broader POAG community, including primary eye care professionals and patients, regarding the possibility and potential benefits of early intervention with OMNI. We believe Omni, due to its indication for use, safety, high degree of efficacy, and high consistency of efficacy, has the ideal product market fit for standalone interventions. Our clinical trials have demonstrated that Omni can safely and reliably reduce IOP and medication burden. Primary eye care professionals are the first to diagnose and treat POAG patients. Currently, if a POAG patient does not require cataract surgery, the treatment algorithm relies on increasing use of topical eyedrop medication to slow the progression of the disease, with the goal of staving off conventional surgical procedures for as long as possible. These highly invasive surgeries are effective at reducing IOP, but carry a high risk of complications and side effects, and are typically only attempted by glaucoma specialists. Our mission is to let the glaucoma community know that an earlier intervention performed by a local, omni-trained surgeon could be a better alternative than prescribing a second or third eye drop. To this end, we're fielding a dedicated team of glaucoma clinical consultants that will deliver our message to the tens of thousands of office-based primary care optometrists and ophthalmologists who treat POAG patients with medications. We have strategically placed our GCCs in territories that have multiple qualified omni-trained surgeons with strong comprehensive practices or established practitioner networks. Our market research indicates that 85% of glaucoma patients would likely choose an intervention using Omni if it was recommended by their doctor. We expanded our GCC field team from a beta launch of four last year to 20 in the first quarter of 2022. Eventually, we believe each of our traditional territories could benefit from one or more GCCs, building relationships in the broader glaucoma and provider community. We are supplementing these field efforts with our Don't Wait for Too Late educational campaign that emphasizes the value of early MIGS intervention and with patient education and outreach materials available in doctors' offices and online. We believe the commercial impact from our standalone market development efforts will be evident in the back half of this year. Number three, our third key strategic initiative, involves developing the market for effective dry eye treatment procedures. We achieved a major milestone in December when TierCare received FDA clearance for an expanded label 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. MGD is the leading cause of dry eye disease. This clearance was supported by data from our Olympia RCT, which demonstrated clinically significant improvements in all signs and symptoms of dry eye disease. This expanded label allows our commercial team to communicate the benefits of TierCare more completely. Our reps have already reported increased customer receptivity in the field. Improving reimbursed patient access to TierCare is our ultimate goal. Our Sahara clinical trial was developed with input from eight payer medical directors from eight different major insurance companies. to provide the specific data they would require to reimburse tier care procedures. We expect to complete enrollment in Sahara later this year. As a reminder, Sahara aims to demonstrate the superiority of tier care treatments compared to the market-leading prescription eye drop, Restasis, at six months. We hope to be able to report back on this key superiority endpoint by the middle of next year. We are very pleased with the progress we have made advancing these initiatives, which we believe will create tremendous value. We are also making investments in other areas that will contribute to our growth in the coming years. Outside the U.S., we have established a direct selling effort in the U.K. and have seen substantial traction in Germany. Both of these markets are progressing nicely. We plan to expand our presence in Europe and other geographies. We spent a lot of time discussing changes to reimbursement over the past nine months, so I'll be very brief in my remarks now. In summary, surgeon and ASC reimbursement for OMNI are both in better positions relative to implantable procedures in 2022 than 2021. With our professional and facility reimbursement levels recently revalued and fully stabilized under broad and dependable Category 1 CPT coding, We look forward to devoting more time discussing fundamental patient-focused drivers of our business going forward. We know the investor and glaucoma communities also have questions regarding some of the newer entrants to canal surgery. Our recently published March 2022 investor presentation includes a comparison of the clinical history of canaloplasty, trabeculotomy or goniotomy, and the newer, less understood procedures enabled by some of these tools. We continue to make significant investments in our expansive clinical trial program, which includes 10 ongoing and planned trials. We just announced the first patient treatment in our Trident European study, and we'll soon begin enrolling patients in our U.S. Precision IDE trial. These twin 459-patient, 24-month head-to-head RCTs will compare three arms. One, canaloplasty alone using OMNI. Two, canaloplasty followed by trabeculotomy using OMNI. And three, the leading trabecular bypass implant. Because of the label limitations of trabecular bypass stents in the U.S., Precision will study combination cataract procedures, while Trident in Europe will examine standalone procedures. As a reminder, OMNI's current label calls for canaloplasty followed by trabeculotomy, the second arm of these studies. We hope to use the results of these studies, if successful, to expand the indication for OMNI to include usage for canaloplasty alone, which may provide surgeons with another valuable on-label surgical option to titrate treatment for their patients with POAG. Unlike recent entrance into angle-based procedures, we sought and received FDA clearance for an IDE to study canaloplasty alone. We believe that FDA clearance for an expanded canaloplasty alone label could further differentiate Omni from the competition. As the market leader in canal surgery, we're executing our canaloplasty alone IDE the right way from the start by demonstrating, if successful, clinical efficacy and safety, securing our desired label from the FDA, and putting our patients' needs first. We believe this is the only way to build the canaloplasty category for meaningful long-term value and unshakable leadership. Due to their large study populations and two-year endpoints, final data for Trident and Precision will be available in three years. In the meantime, we are preparing numerous other articles for publication, including one based on the results of our multicenter TRACE study that examines the safety and efficacy of standalone omni procedures in POA GIs with uncontrolled IOP and a previous history of combination cataract surgery with trabecular bypass implants. Trey will examine the potential benefits of OMNI interventions in the over 1 million now pseudophagic trabecular micro-bypassed dentites that may require further treatment, as well as the general standalone population. Our publication plan in peer-reviewed journals includes numerous articles based on data from our clinical trials. Earlier this week, Clinical Ophthalmology published an article that reported 12-month outcomes for OMNI canaloplasty followed by trabeculotomy, in conjunction with cataract surgery in a population of adult Hispanic patients with mild to moderate open-angle glaucoma. The article reported a reduction in unmedicated mean IOP of 35% and a 93% reduction in average medications. Adverse events were mild, self-limiting, and typical of MIGs combined with cataract surgery. We're very pleased with these outstanding results. In parallel with our clinical efforts, We have also made a push to expand our presence at key industry conferences, such as the American Glaucoma Society meeting earlier this month and the upcoming ASCRS meeting at the end of April. We plan to expand our presence at ophthalmologists and optometrists meetings to help educate the eye care community about the benefits of our products and our company's mission. Our desire to improve the lives of all patients with glaucoma and dry eye disease drives our innovations. We are developing a broad portfolio in both categories, and our goal is to offer market-leading treatment options along every step of a patient's journey living with these incurable, lifelong diseases. To do so, we will be expanding beyond devices into pharma, drug-device combinations, and sustained-release pharmaceuticals. We recognize that medications can be an effective first-line glaucoma treatment if administered properly. We believe that sustained delivery of hypotensive medications is a very promising area to innovate and have filed IP on a product that we believe could have a superior product market fit in terms of ease of application, efficacy, and safety compared to existing and announced competing products. Our early results in animal testing have been promising, and we are very excited to continue developing this product, and we'll share more in due course. As the patient advances beyond medications and requires microinvasive glaucoma surgery, where we have Omni today, we are pleased to announce our plans to introduce two new MIGS products in the coming year, and that we have two more in earlier stages of development. Ultimately, we would have four surgical devices that would represent five distinct procedures, representing the broadest and most compelling product portfolio in the MIGS category. First, We have continued to innovate our flagship Omni product and plan to launch the third generation of the Omni device that will feature numerous design improvements. We expect a controlled release in the second half of this year and a full launch in 2023. We will continue to improve and update Omni on a regular basis to ensure its continued leadership position in microinvasive canal surgery. If our IDE is successful, we believe the clinical data would serve as a strong basis for us to seek FDA clearance of an expanded indication covering canaloplasty alone. Second, while we believe OMNI's ability to circumferentially treat all three points of resistance in the conventional outflow pathway cannot be surpassed, and the market is increasingly recognizing canaloplasty as the foundational procedure of MIGS, we do recognize that there is interest in the market for various types of procedures. To that end, we will be introducing a dedicated and differentiated, ab internotrabeculotomy or goniotomy device in the second half of the year. Third, moving beyond our third-generation Omni device and the goniotomy device that we intend to release this year, we also resume development of our implantable canalicular scaffold. The ultimate goal of this development program is to improve the long-term efficacy of canalicular implants and scaffolds by adding new innovations for which we have already filed IP. Fourth, And last but not least, we are also developing an implantable solution for advanced or refractory glaucoma. We believe this product would be appropriate for patients whose conventional outflow pathway options have been exhausted. In summary, we believe that circumferential canal surgery is quickly becoming the foundational procedure in MIGS, both on a standalone basis and in combination with other MIGS procedures. We are the first mover in microinvasive canal surgery and intend to keep the lead with our third-generation Omni release later this year. We are also in the process of developing an incredible portfolio of products around Omni that would offer our surgeons a complete armamentarium and a full expansion of the customer-company relationship with Site Sciences. We're also innovating in dry eye. As with Omni, we'll continue to update and improve our flagship tear care system, We have a next-generation tear care system in development that will include several new features, such as an improved tablet-based user interface and further enhancements to our smart lids. We plan to introduce this product in 2023. Longer term, we are also working on several products that will help patients suffering from MGD to maintain healthy meibomian glands between office-based tear care treatments. These include OTC eye drops, a prescription ointment applied to the eyelids for MGD, and an at-home consumer version of TierCare. We believe this dry eye portfolio will offer physicians and the 14 million patients diagnosed with MGD a comprehensive range of solutions to combat dry eye. We plan to schedule an investor day or analyst day or both to discuss these pipeline products in greater detail later this year. I will now turn the call over to Jesse to discuss our fourth quarter financial results and our outlook for 2022.
spk01: Thank you, Paul. I will start with the discussion of the fourth quarter results, and then I'll move on to our 2022 guidance, including an update on our year-to-date performance, trends in the operating environment, and our outlook. Our total revenue for the three extended December 31st, 2021 was $14.7 million, a 63% increase from $9 million in the same period of 2020, and a 12% sequential increase from $13.1 million in the third quarter of 2020. Our combined gross margin for the fourth quarter was 87%, compared to 74% in the corresponding prior year period and 84% in the third quarter of 2021. Our surgical glaucoma segment revenues for the fourth quarter were $13.9 million, up 60% from $8.7 million in the fourth quarter of 2020 and a sequential increase of 12%, from $12.4 million in the third quarter of 2021. Underlying fundamental business trends, including utilization and ordering facilities, were very encouraging until the second half of December, as we experienced business disruptions similar to our peers due to the surge in the Omicron variant. Sequentially in the quarter, our number of ordering accounts grew by approximately 5%. The remainder of our sequential growth came from an increase in utilization from ordering accounts, which we achieved despite 3% fewer OR days in the fourth quarter versus the third quarter. So we did a very nice job both adding to our user base and leveraging our existing user base to expand usage. Through the first half of December, we generated extremely strong sales, and we were actually on pace to grow sequentially by between 17% and 19% for the quarter, inclusive of the historical slowdown of bookings around the holiday season. which in our experience, the first half of December generates approximately 60% of the whole month's bookings. Over the second half of the month, however, we experienced a significant slowdown driven by the coinciding increase in Omicron cases, which for the first time since the second quarter of 2020 resulted in significant facility closures and restrictions on elective procedures that impacted our commercial opportunity, as opposed to patient-driven deferrals that we saw earlier in 2021. Sales for the first half of December 2021 accounted for 75% of the total month's sales versus the rule of thumb I just mentioned of approximately 60% of sales typically occurring in the first half of December. Average daily sales were over 40% lower in the second half of December than they were in the first half of the month. Growth margin in surgical glaucoma was 89% in the fourth quarter compared to 76% in the prior year period and 87% in the third quarter. I would like to salute our operations group for improving our operating efficiency, even exceeding our ambitious internal goals, while maintaining uninterrupted supply of finished goods in the face of supply chain challenges throughout the global economy. Our dry ice segment revenue for the fourth quarter were $0.8 million, up 179% from $0.3 million in the fourth quarter of 2020, and a sequential increase of 16% from $0.7 million in the third quarter of 2021. This year-over-year comparison is the first true apples-to-apples comparison we had in 2021. Since we implemented specific account targeting guidelines and pursued a premium pricing strategy versus other procedure-based MGD-oriented solutions in the fourth quarter of 2020. For the year, we added approximately 240 accounts, and we ended December with over 550 facilities with the tier care system. We are pleased with the great receptivity and results from our small, focused sales effort in dry eye. Gross margin in dry eye was 52% in the quarter versus negative 1% in the fourth quarter of 2020 and 33% in the third quarter of 2021. As we've discussed previously, dry eye gross margins will be noisy until we scale the business, and our sales mix matures to a higher proportion of higher margin smart lists. Therefore, things like sales mix between new customers and reorders can impact gross margins in any period, even with improvement in contribution margins for each individual component. Operating expenses for the fourth quarter of 2021 were $27.5 million, an 82% increase from $15 million in the fourth quarter of 2020 to and a 10 percent increase from $25.1 million in the third quarter of 2021. Operating expenses include non-cash stock-based compensation of $2 million compared to $1.9 million in the third quarter of 2021 and approximately $200,000 in the prior year period. SG&A expenses for the quarter were $23.1 million compared to $12.2 million in the fourth quarter of 2020 and $20.8 million in the third quarter of 2021. The increase in SG&A was primarily due to our continued investment in and the scaling of operations and corporate headcounts that support our growth. At 12-31-21, we had 212 full-time employees, as opposed to 197 as of September 30, 2021, and 140 at year-end 2020. As part of our 2022 plan, we've continued to identify opportunities to augment our team in areas to further accelerate our growth. enhance our ability to develop the standalone MIGs and MGD markets, and to protect our strength in a competitive position in both segments of our business. I will get into some more specifics about those investment areas when I discuss our 2022 outlook. R&D expenses for the quarter were $4.4 million compared to $2.9 million in the fourth quarter of 2020 and $4.3 million in the third quarter of 2021. The majority of the increase in R&D expense from 20 to 21 was attributable to three factors. One, an increase in personnel expenses as we build out our clinical and regulatory and R&D departments. Two, higher contract manufacturing, lab supplies, and prototype development expenses. And three, increased clinical trial activity. All three areas detailed by Paul in his comments. We expect our R&D expense to continue to modestly increase over the near term as we execute our clinical roadmap and develop the pipeline that Paul previewed. But in a manner similar to how we developed Omni and TierCare, our R&D process is efficient vis-a-vis what you would assume it would take to develop groundbreaking products, which is the ultimate core competency of our company. As a result of the aforementioned drivers, our loss from operations for the three months ended December 31st, 2021, was $14.7 million compared to a loss of $8.4 million for the same period in 2020 and a loss of $14 million in the third quarter of 2021. We had a net loss of $15.9 million for $0.34 per share in the fourth quarter of 2021 based on a weighted average post-IPO share count of 47.4 million shares. This compares to a net loss of $9.2 million or $0.97 per share for the fourth quarter of 2020 based on a weighted average pre-IPO share count of 9.4 million shares. We ended the quarter with $260.7 million of cash and equivalents and $32.7 million of long-term debt, including $2.3 million of debt discount, so $35 million of principal amount. We're in an attractive position to execute upon our base plan and to opportunistically consider levers to accelerate business. Turning to our outlook for 2022, We expect our full-year revenue to be in the range of $67 million to $75 million, representing growth of approximately 45% over 2021 at the midpoint of this guidance. This guidance for continued market-leading revenue growth reflects our level of confidence in the trajectory of both of our current products. One of the most attractive attributes of Omni's business model is that the expansion of its use case across disease severities and into standalone procedures is generates a compelling source of organic growth on its own, even without new customer acquisition. When we compare the fourth quarter of 2021 to the same period in 2020, our ordering facility base grew by over 45%. At its simplest, the remainder of our 60% of year-over-year revenue growth was driven by use case expansion. So, quote, unquote, same-store sales, for lack of a better term, has a robust growth profile by itself. Coupling that with the fact that we added 98 new ordering facilities in the fourth quarter of 2021 versus only 72 in the same period of 2020 means that the growth engine of customers beginning their trial phase with our company is better primed going into 2022 than it was entering 2021. All that being said, our guidance also factors in the impact of slower activity due to the Omicron variant that began in December and carried into the new year. The variant impacted us in two ways. The obvious impact is that it reduced our procedure volumes in the first part of the first quarter. The disruption to operating room schedules has also lengthened the time it takes to get surgeons through our product adoption cycle. Our in-depth surgeon training model involves reps proctoring a new surgeon's first 10 cases. Procedure cancellations or postponements can have cascading knock-on effects that delay getting surgeons up the learning curve in a timely manner, and moving from the trial phase to an established higher volume account. Typically, our reps spend three OR days with a surgeon to trial and train. If the average time to get on the calendar for trial day two and trial day three is extended by 30 days over the course of a year, however, this delay, the 30-day delay for day two and day three, could have a greater than $2 million impact on our in-year revenues. So Omicron limited physical access to customer facilities for our reps and then hindered their ability to move customers through the adoption cycle, and this is reflected in our guidance. Our guidance also takes into account the introduction of several new entrants into the MIGS market. While we strongly believe that Omni's combination of safety and efficacy continues to be unmatched by legacy or new competitive products, the reality is, as we also witnessed amongst investors and research analysts, these new entrants have created noise and, frankly, a bit of confusion in terms of what they do, how they will be reimbursed, et cetera, that will take a few months to become more clear to the market. In the interim, we've witnessed recent delays in our ability to move customers along the adoption curve and delaying the expansion of usage due to certain surgeons trialing these other products. It's kind of a phenomenon that's similar to the COVID-related surgical schedule disruptions that I mentioned earlier in terms of a one-time delay in moving along the curve as opposed to something that we think has any permanent impact on our growth trajectory. Part of what you see reflected in our revenue guidance is the range in our estimates for how long it will take for the market to revert to the more normalized and, in many ways from our perspective, a better informed commercial environment that was in place through 2021. On a quarter-by-quarter basis, we expect our revenue breakout in 2022 will be quite similar to 2021. The first quarter for both years reflects typical industry seasonality, and in both years, COVID-related impacts of January results. And similar to last year, we expect revenues to be modestly sequentially declined from Q4 2021. That being said, we fully expect the last three quarters of each year to exhibit a truer view of the underlying organic growth trends in our business. We believe that 45% top-line growth in 2022 at our guidance midpoint, along with the continued development of what are our true long-term growth opportunities, which is the standalone MIGS market, and procedure-based MGD with widespread patient access keeps us in the very top tier of med tech companies. I'd now like to provide some color on our anticipated investment levels in 2022. There are three primary sources of incremental investment that we've made heading into the year. The first area is in R&D, where we've built out our R&D team and are making project-level investments to support the pipeline that Paul previewed. Given the multiple programs we are pursuing, We estimate the in-year incremental investment from R&D will be in the mid-teens of millions for 2022. We have extraordinary conviction in the potential ROI of this incremental investment, to say the least. Secondly, we have scaled up our investment in glaucoma clinical consultants, whose primary objective is to educate the broader POAG community about the benefits of standalone MIGS intervention with Omni, so as to drive appropriate standalone cases to omni-trained surgeons. As Paul mentioned, we've expanded our team to 20 GCCs in the field, plus associated management infrastructure, up from a beta group of four who delivered encouraging results last year in select major markets. This is a critical investment in enhancing awareness, which we believe will accelerate standalone market development and surgeon adoption. The final area is in market development support resources for both the standalone market opportunity and our market access-driven execution strategy for MGD. This includes increases in our clinical spend in terms of headcount and trial costs for key trials such as Sahara, Precision, and Trident, as we've discussed, and the build-out of a world-class market access team to educate the field, payers, and our customer base on the reimbursement landscape, as well as marketing resources more explicitly aligned to market education and development. As evidenced by our recently launched Don't Wait for Too Late stainless mix campaign. All in all, we anticipate these incremental investments, partially offset by higher gross profits from our growing revenues, will result in about $10 to $15 million of annualized cash burn increase over and above the levels we've been operating at post-IPO. Given we ended the year with a $260 million cash balance and a modest amount of debt and a rapidly growing revenue base, We feel very well capitalized to execute our growth plan and to fund this, frankly, digestible level of incremental investment. As a reminder, with blended gross margins in the mid-80s, omni-gross margins approaching 90%, and a highly productive hunter sales force, our direct profit or cash flow contribution from our sales is very healthy. And much of this investment is truly discretionary. We believe that it will generate compelling ROIs and enable us to maintain robust growth rates for a long time. So with that, this concludes the prepared comments that we have for the call. Paul and I will now be joined by Sean O'Neill, our Chief Commercial Officer, to answer and take some questions. So operator, please open up the call for questions.
spk06: Thank you. If you have a question at this time, please press star then 1 on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. And our first question comes from the line of Joanne Wanch with Citibank. Your line is open. Please go ahead. Hi. Can you hear me okay?
spk01: Yes, we can. Hey, Joanne.
spk07: Hi. How are you doing? I just want to make sure I caught a couple of the numbers that you were talking about. I got the number of active accounts, 750 in the quarter for MIGS. I got... that there are roughly 550 facilities doing dry eye, but I'm looking for a couple of other pieces of information, particularly, and I apologize if I missed this, of those 750 active accounts, can you back us into either the number of physicians and or the percentage of procedures that are standalone versus concomitant?
spk01: So I'll take the first. You know, we can't track, we track trained surgeons, Joanne, but we can't track utilizing surgeons, right? So we've trained, we're currently around 1,500 trained surgeons. And there's actually recently some research that came out that estimated the total number of mixed trained surgeons to be 5,000. So still a lot of runway there. And then, you know, there's, We kind of estimate about 1.3 to 1.5 surgeons per, utilizing surgeons per facility at this point in time, but that's just an estimate. And then Paul, standalone combination?
spk05: Yeah, it's hard for us to track with any specificity right now, standalone penetration. We obviously have a number of investments we talked about that we're making. In parallel with those investments, we continue to explore ways to track our progress, both internally for ourselves and also to report publicly to you all, Joanne, especially around the GCCs, the team of 20 that we've hired. They're fully trained now. We hired them in this quarter, and we've been training them over the past several months. We'd expect for their contributions – to start showing up meaningfully later this year, and Sean can talk about that and kind of, Sean, the metrics we'll use to track the progress there.
spk02: Yeah, Julian, as we've mentioned before, you know, the CPT codes do not differentiate between a combination character or standalone case. So, you know, we're still looking at that data at a high level to try and gain insights, but it's not obvious. One thing that we are doing with our GCC team is is they do have a finite target list that they are going to be focusing on. And obviously we know what the baseline sales and activity are in those facilities, and we'll be able to track that over time and identify incremental growth, which is obviously one of the KPIs that we're going to be focused on. So we believe we'll be able to take several of these data sets and then be able to, you know, crystallize them into a better answer.
spk07: Okay, I'll leave it there.
spk06: Thank you. Thank you, and our next question comes from the line of Cecilia Furlong with Morgan Stanley. Your line is open. Please go ahead.
spk08: Great. Good afternoon, and thank you for taking the questions. I wanted to ask on 22 guidance, one, how you're thinking about continued expansion in your established accounts into standalone, how that contributes to your outlook, as well as your expectation for new center ads throughout the year?
spk01: So, gave you my comments. Probably it was a mouthful, Cecilia. But we added 98 new facilities, brand-new facilities, first-time orders in the fourth quarter. That kind of pace is a – is a pace that I think, you know, we expect to continue, you know, at a baseline minimum, right? So that should give you some color around that. And, you know, as Sean alluded to and Paul, like, you know, the way we build our model is we look at utilization overall. Stainless steel is obviously a really important driver. And, yeah, I mean, everything – all of our trends point very positively towards that. You know, we decompartmentalize our growth in terms of customer acquisition growth and use case growth. And we feel, honestly, we feel like with these investments that we're making and the growing market presence that that sort of natural organic growth and use case is going to see tailwind, actually, you know, as we continue to progress through the year and see the results of the GCCs and a lot of the really focused marketing that we're doing around the opportunity.
spk08: Great. Thank you. And if I could follow up as well, just on R&D, both near term but more so as you think over the next several years with the pipeline updates you provided today, how you're thinking about just the level of R&D investment incremental to what we were previously contemplating with the aforementioned product portfolio and clinical trials that you had previously planned?
spk01: Yeah, so low double-digit millions in terms of pipeline investment. That's both headcount and project investment this year. So it's fair to look at how we were trending in that area and add that to it as a good proxy for that line item. You know, the reality is our development process itself is very efficient. and practical, kind of similar to we were very capital efficient getting Omni Interior Care to market. I'm proud of that fact, and I think we're working on these projects with a real similar mentality. So I think there's a lot of opportunity for a very reasonable amount of spend there.
spk08: Thank you for taking the questions.
spk05: Thanks, Cecilia. Thank you.
spk06: Thank you. And our next question comes from the line of Andrew Brockman with William Blair. Your line is open. Please go ahead.
spk04: Yes. Hey, guys. Good afternoon, and thanks for taking the questions. Maybe just start there on the competitive front and the trialing you're expected. Jesse, I didn't hear sort of a specific number that you're sort of anticipating in your guidance for the year, so maybe just a housekeeping around that if you have a specific number. But I guess Then bigger picture, I guess from your perspective, how do you see all of these sort of new, newer, non-implantable devices or tools sort of impacting the market broadly? Anything that you can sort of share from a surgeon sort of perspective that you're hearing given those announcements over the last handful of months? Thanks.
spk01: Yeah, I'll go to the specific question, and then I'll let Paul and Sean take the bigger picture question. And on the specific, Andrew, like, you know, it's a factor in how we look at our model, right? Like, I do think that what it does is it creates an adoption lag. What we haven't seen is we haven't seen share loss because of it, but what we've seen is it's harder, you know, there are cases where it's harder to get on the the calendar to move people along the trial and curve. So when you look at our range, that reflects a range of thinking about what our trial period might be. And as you kind of know from our model, that's just a really key driver given how high growth it is in terms of when we get people to move along to that sort of steady ordering cadence. And so, you know, I wanted to kind of flag what the impact of that is in our model, just as sort of an order of magnitude, but it doesn't, it's not like there's a bridge that says competitive products and competitive trialing has had X dollars of impact on us.
spk05: Yeah, I'll add a couple of comments. I know Sean has other comments to add as well, but, you know, we're seeing it, first of all, these new entrants primarily in combination with cataract surgery and primarily in being bundled or used in combination with stents. I believe that's all we're seeing to date. And so for us, in response to that, as we always do, we highlight the benefits of OMNI, right? And that's usually enough. The comprehensive outflow procedure that addresses uniquely all three points of resistance, the usability and procedural predictability, based on many, many years of design iterations, a best-in-class indication for use, based on highly compelling clinical data in all adult patients with POAG. So think combo cataract, standalone, mild, moderate, advanced. So, you know, all in all for us as we look at these things, we think it's hard to compete with what we offer, and our commercial team does a really, really excellent job of developing unshakable relationships with our customers. They're always doing the right things, highlighting the right things, the clinical value of Omni always first and foremost, and frankly, the lack of clinical evidence with some of these new entrants. John, I don't know if you've got anything else to add.
spk02: From a commercial standpoint, obviously focusing on our execution for the sales, marketing, and training standpoint, we are definitely continuing to focus on the value of Omni and I think the thing that's important in the trial setting, per your question, is, you know, these being new products, they do not have clinical data, nor do they have a track record of a reimbursement pathway. So we continue to focus on the value of OMNI, the ability to lower IOP in adult patients with primary open angle glaucoma. Also, the additional benefit of the medication, potential medication reduction, all within that stable, clear reimbursement pathway with 66174. So our team is focused on mitigating any of that trial activity and then quickly pivoting back over to demand creation for Omni and ultimately keeping the patient at the center of the conversation and providing the best option for the patient.
spk04: That's great. Thank you all for that. And then maybe just sort of pivoting here to the pipeline, obviously a lot of new things sort of being unveiled here today and definitely warrant an investor day later this year. So excited about that. But I guess maybe from your perspective, sort of on those non-implantable newer devices, those seem to be the ones that are probably closest to market. How should we be thinking about sort of the differentiation of those devices versus the sort of aforementioned newer entrants in the canal-based sort of surgery that we've been talking about here? Thanks, guys.
spk05: Andrew, sorry, are you referring to our pipeline versus some of the new entrants or something else? I didn't follow that exactly.
spk04: Yeah, so your pipeline exactly, so the new Guineatomy device and then also the second generation or third generation Omni device, how are those expected to sort of compete with those newer pipeline products from competitors?
spk05: Thanks. Yeah, we're – yep, yep. Well, I'll say that we don't enter any category without a whole lot of thought. We don't enter any category without the expectation to be best in class. That is the expectation that's from before we even file a patent. These are the things going through our minds. So we're not disclosing details, Andrew, on this call of that product or some of the other products in detail. We did want to preview it. and everybody because we've been thinking about these things for several years. Some of them we filed IP on them. We are now beginning to invest in them. We've recently hired a very talented head of pipeline strategy and development. And so we wanted to preview it with you. We will be speaking in detail later this year, either at an analyst day or investor day or both, about those details that you're asking about. But just expect whatever we're going to disclose will be compelling. You know, we've done it twice with Omni and TierCare. We have a history of internally developing breakthrough products. The pipeline that we're talking about here has all been internally developed. Obviously, in the future, we will look externally. But for now, what we're talking about is internal development. We'll share details, Andrew, on it in due course.
spk04: Okay. Thanks, guys, and thanks for the color today. Sure. Thanks.
spk06: Thank you. And our next question comes from the line of Matt O'Brien with Piper Sandler. Your line is open. Please go ahead.
spk04: Hi, guys. Good afternoon. This is Drew on for Matt, and thanks for taking the questions. I do just want to follow up. Hi, I do just want to follow up a little bit on the comments on the commercial delays related to the competitors. I guess just, you know, just to be clear, I mean, what's informing your view that, you know, gives you confidence that those delays are temporary? And then I guess, too, have you made any tweaks at all to the commercial strategy until you have the Canalplasty label or unlabeled for Omni? Or is it just about, you know, weather in this period until things get back to normal?
spk02: So from a commercial strategy standpoint, we continue to stand behind the value of OMNI addressing all three points of resistance as a key differentiator, addressing the conventional offload pathway in that manner. So, you know, what we're doing is really being focused on continuing to drive demand and focusing our strategy, especially with our investments in GCCs, to expand, you know, use our SSRs to mitigate trial and continue to create demand and train new surgeons, and then utilize our investments in GCCs to expand use case by educating the broader medical ECP community on making sure their patients are aware that there is another alternative for their earlier surgical intervention for their mild to moderate glaucoma needs. So, you know, from that standpoint, we're being consistent and continue to drive value with that strategy.
spk05: And as for the canaloplasty alone indication and the studies, the Trident precision trials, you know, let's see what the clinical data looks like. We're excited about them and We think that, as you can tell from at least the high-level description of the portfolio that we're building out here, we want to offer the broadest, deepest, most rich portfolio of solutions for every doctor. Different doctors have different preferences. Some may prefer to do canaloplasty alone. Some may prefer to do canaloplasty with trabeculotomy. Some may prefer to do either of those procedures in combination with an implant. We've seen everything in the market, and we have a very, very good R&D team and manufacturing and operations team here. I can tell you that the Menlo Park office is buzzing with pipeline development right now, a ton of good energy here, and we want and can more capitalized to bring this portfolio to market, again, addressing all of these different use cases.
spk01: And you asked a question about why we're confident. We're using our eyes and ears to be confident. You know, it was very noisy to try to assess January, given the variance, but, you know, we have a really high touch sales model. We get great field intelligence about, what's out there, and I think we pretty have conviction that in terms of what we're seeing and seeing ordering patterns through, you know, three-quarters of March as well, that kind of that characterization is accurate.
spk04: Okay. That's very helpful. Thank you for that. And then I understand your comments on how, you know, it's difficult to bifurcate the guidance into standalone and combo cataract. But I guess to maybe just ask it simply, you know, does standalone need to post similar growth last year? Does it need to accelerate from some of those investments you're making? You know, what's needed to get to the midpoint of the guidance range?
spk02: You know, we do believe that it will accelerate. It's been part of our objectives as we brought Omni out, especially when we received its broadest label. And we're confident that as we execute correctly, that that is what will occur.
spk01: Yeah, I mean, Sean's answer is the right one. We're confident that's why we're making that investment. But, you know, there's not a – There's a lot of – one of the great things about this product is there's a lot of different drivers of growth. And it's still at, you know, even with a, you know, $14 million-ish fourth quarter, there's so much room to grow in terms of, like, the low amount of market penetration and standalone and combination cataract. And so there's a ton of conviction and a ton of investment and belief, but – Omni's ability to sort of help try to achieve this guidance, there's multiple ways to get there.
spk04: Okay, thank you.
spk06: Thank you, and I'm showing no further questions at this time, and I would like to turn the conference back over to Paul Bedawi for any further remarks.
spk05: Thank you. Thank everyone for their time and questions and attention and interest in site sciences, and thank our team for a stellar year in 2021 and what's looking like a really amazing year ahead with everything that we discussed today. So thank you all.
spk06: This concludes today's conference call. Thank you for participating. You may now disconnect. Everyone, have a great day.
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