Sight Sciences, Inc.

Q1 2022 Earnings Conference Call

5/10/2022

spk05: Ladies and gentlemen, thank you for standing by and welcome to the SightScience's first quarter 2022 earnings results call. At this time, all participants are in a listen-only mode. Following the speaker's presentation, there will be a question and answer session. To ask a question during the session, you need to press star 1 on your telephone. If you require any further assistance, please press star 0. I would now like to turn the call over to your host, Philip Taylor, Investor Relations. You may begin.
spk08: Thank you for participating in today's call. Presenting today are SightSciences co-founder and chief executive officer, Paul Bedawi, chief financial officer, Jesse Selnick, and chief commercial officer, Sean O'Neill. Earlier today, SightSciences released financial results for the three months ended March 31, 2022. A copy of the press release is available on the company's website at investors.sightssciences.com. I'd like to remind everyone that comments made by management today and answers to questions will include forward-looking statements within the meaning of the federal securities laws. 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 the 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 March 24, 2022, 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 statements, notices, and risk factors in the recent SEC filings. I will now turn the call over to Paul.
spk07: Thanks, Tripp, 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 trialing. 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 revenues 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 surge in interest and stimulate trialing. 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 canalopathy 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 mastery of these four simple concepts drives our confidence in Omni's ability to win in the mixed markets. 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 in the established combination cataract MIG segment. Number two, pioneering the $5 billion U.S. market for standalone 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 US claims based on the subset of claims accessible to our analytics provider, and availability of the data lags our reporting periods 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 tracks procedure codes and not usage of any particular device, including Omni. All that being said, we have gained insights into Omni's impact on the mixed 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 include 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 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 standalone intervention to treat POAG earlier. Currently, if a POAG patient does not require cataract surgery, The treatment algorithm relies on increasing use of topical eyedrop medications to slow the progression of the disease, with the goal of staving 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 standalone 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 standalone MIGs indicates that there is strong interest in Omni. Eighty-five percent of glaucoma patients would likely choose a standalone intervention using Omni if it was recommended by their doctor, 85 percent. We also analyzed claims data for the standalone 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, CPT66174, and goniotomy, CPT65820, as well as advanced surgical glaucoma options like ab interno or ab externo trabeculectomy. Due to the smaller current size of the standalone 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 standalone 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 standalone 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 standalone glaucoma surgery that is growing. This insight highlights the compelling product-market fit between OMNI and standalone surgical glaucoma. Canaloplasty also appears to have propelled the overall level of claims in the standalone MIGS segment. In the second half of 2021, projected standalone canaloplasty claims were included in almost half of all projected standalone MIGS claims. We expect these organically generated standalone Omni growth trends, which prove to us that the Omni standalone market is very real, to accelerate as the impacts of our 2022 standalone 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 standalone 66174 is approximately 90-10, though we believe the mix for Omni is more heavily weighted towards standalone. We have the unique perspective of viewing combination cataract and standalone 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 standalone opportunity. To propel standalone 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 standalone opportunity through standalone clinical studies such as Trident and Trey, events such as the Omni Symposium at ASCRAS, and our Don't Wait for Too Late marketing campaigns. We recently submitted a paper for publication in a peer-reviewed journal based on data from Trey, which studied omni-standalone 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 care care 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 tear care 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 tear care treatments compared to the market-leading prescription eyedropper 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 ASCRIS annual meeting at the end of April. We are proud to report that the abstract presented by Dr. Mark Pfeiffer 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 UK 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 a patient's journey for living with these incurable lifelong 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?
spk10: Thanks, Paul. I'll start with a discussion of the first quarter results, and then I'll move on to our 2022 guidance. Our total revenue for the three months ended March 31st, 2022 was $14.9 million, a 72% increase from $8.6 million in the same period of 2021, and up 1% versus the fourth quarter of 2021. despite Q1 seasonality typically representing the lowest quarterly portion of our annual revenue. Illustrating this point, our total revenues sequentially declined 4% in the first quarter of 2021. Our surgical glaucoma segment revenues for the fourth quarter were $13.9 million, up 70% from $8.1 million in the first quarter of 2021, and sequentially flat compared to the fourth quarter of 2021. Underlying fundamental business trends, including utilization and ordering facilities, improved in the second half of the quarter as business disruptions due to the surge in the Omicron variant subsided. Our surgical glaucoma growth drivers remain very strong. Two key leading indicators for our growth funnel are trained surgeons and new ordering facilities. In the first quarter of 2022, we trained 118 new surgeons. This compares to an average of 90 surgeons trained per quarter in 2021 and 96 trained in the first quarter of 2021, illustrating continuing robust surgeon interest. We believe growth in trained surgeons will continue to increase as product awareness of OMNI and our library of differentiated clinical data in both combo cataract and standalone grows. While we are making great progress, we still have a long runway. At the end of the first quarter, we had trained nearly 1,600 surgeons on Omni. MarketScope estimates that over 5,600 surgeons currently perform MIGS procedures in the U.S. We have made a significant investment in our internal training team and overall technical field capabilities to achieve our twin goals, providing an outstanding initial user experience and creating long-term customers. Our investment continues to yield strong results for us. as 105 new facilities ordered Omni in the first quarter of 2022. This compares to a quarterly average of 99 new facilities in 2021, which included 98 new ordering facilities in the fourth quarter and 67 in the comparable first quarter. Our commercial success can also be measured by our consistently growing and extraordinarily sticky embedded ordering base. Because ordering patterns can vary widely among facilities, We believe the appropriate period to measure order activity is over a trailing three-month period, and we consider any customer that has ordered in the past three months to be active. In the first quarter of 2022, 811 facilities ordered Omni, an increase of 51 from the fourth quarter of 2021. By comparison, our ordering facility base grew by only 18 to 548 in the first quarter of 2021. We feel great about how the base continues to grow. Customer retention is obviously another important metric. We calculate developed customer retention using the ratio of net inactive accounts to ordering accounts relative to the number of active customers that placed their first order at least nine months prior. We use nine months as a proxy for customers that on average will have completed training and progressed into our developed account base. Throughout 2021 and thus far in 2022, Approximately two-thirds of our active customer base has this level of experience with Omni. Over the history of Omni, our developed customer retention rate has been 99.8%, which means that we have had as many customers return as go inactive each quarter, which we believe is remarkable. In the first quarter of 2022, our base customer retention rate was 99.7%, exactly in line with what we've enjoyed since launch, and what has helped us to achieve tremendous growth throughout Omni's ramp. Our dry eye segment revenues for the first quarter were $1 million, up 104% from $0.5 million in the first quarter of 2021, and a sequential increase of 33% from $0.8 million in the fourth quarter of 2021. We are pleased with the great receptivity and results from our small-focused sales effort in dry eye that has now resulted in well over 600 ordering accounts, and sequential growth acceleration in recent periods. Our combined gross margin for the first quarter was 80% compared to 73% in the corresponding prior year period and 87% in the fourth quarter of 2021. Gross margin in surgical glaucoma was 89% in the first quarter compared to 77% in the prior year period. Our operations group continues to execute at a very high level, even in the face of supply chain challenges throughout the global economy. Gross margin in dry eye was negative 53% in the quarter versus 11% in the first quarter of 2021. Our dry eye cost of goods sold in the quarter included 0.9 million of charges related to a voluntary program we put in place to swap out first-generation TierCare smart hubs for upgraded smart hubs to ensure regulatory compliance with product classification codes following TierCare's 510K clearance with the FDA in December 2021. Absent the charges associated with this one-time program, dry-eye gross margins for the quarter would have been positive 32%, and our overall gross margin would have been 85%. Operating expenses for the first quarter of 2022 were $34 million, an 89% increase from $18 million in the first quarter of 2021. Operating expenses included non-cash stock-based comp of $3 million compared to $0.3 million in the prior year period. SG&A expenses for the quarter were $28.4 million, compared to $14.6 million in the first quarter of 2021. The increase in SGA was primarily due to our continued investment in the scaling of our operations and corporate headcount to support our growth. As of March 31, 2022, we had 264 full-time employees versus 212 at the end of 2021. The sequential increase in Q1 was larger than we anticipate our rate of quarterly incremental investment will be for the remainder of the year. R&D expenses for the quarter were $5.6 million compared to $3.4 million in the first quarter of 2021. We expect our R&D expense to continue to modestly increase over the near term as we execute our clinical roadmap and develop our pipeline. As a result of the aforementioned expense increases, Our loss from operations for the three months ended March 31st, 2022, was $22.2 million, compared to a loss of $11.7 million for the same period in 2021. We had a net loss of $23.3 million, or 49 cents per share, for the first quarter, based on a weighted average post-IPO share count of 47.6 million shares. This compares to a net loss of $12.2 million, or $1.29 per share for the first quarter of 2021 based on a weighted average pre-IPO share count of 9.5 million shares. We ended the quarter with $238.6 million of cash and equivalents and $32.8 million of long-term debt, which includes $2.2 million of debt discount. To restate what Paul said earlier, we have more than enough capital to execute our plan and retain the flexibility to make decisions based on maximizing long-term value. Turning to our outlook for 2022, we are affirming our full-year revenue guidance range of $67 million to $75 million, representing growth of approximately 37% to 53% over 2021 revenues. We expect that our sequential growth in the second quarter will be more modest than in previous years, but given the strength of the leading growth drivers that I discussed and what we are observing to be a better informed commercial environment, We remain confident in our guidance for the full year and in our significant growth potential beyond. This concludes the prepared comments for the call. Paul and I will now be joined by Sean O'Neill, our Chief Commercial Officer, to answer your questions. Operator, please open up the call for questions.
spk05: Ladies and gentlemen, if you have a question or a comment at this time, please press the star, then the one key on your touchtone telephone. If your question has been answered and you wish to move yourself from the queue, please press the pound key. Our first question comes from Cecilia Furlong with Morgan Stanley.
spk00: Great. Good afternoon and thank you for taking the questions. I wanted to continue with Jesse's comments recently on guidance and dig a little further into the cadence that you're expecting. But just if you could talk about expectations for 2Q specifically associated with trialing and then trialing of competitive products that you talked about. And then as you look at the back half of the year too, any contributions that you're contemplating either from your goniotomy device or else your third gen Omni in terms of just your outlook for the balance of the year?
spk10: Thanks, Lucille. I'll take it out of order just because the latter question is simpler. Very limited contribution, none in terms of like the next generation Omni. We just kind of look at Omni sort of holistically. and very limited. We have a very conservative view of conionomy contribution. In terms of cadence of guidance, you know, I think the reality is that we've had some very exceptional growth in second quarters previously. Some of that is seasonality. Some of that is sort of fact and circumstance. You know, we got our expanded label in March of 2021, which was an accelerator in the second quarter. Paul talked about some of the dynamics specifically. Our view is very confident. We think that the growth drivers we outlined in the metrics are fantastic and have really held firm with recent periods that were strong. But we just think that the growth won't resemble sort of the trajectory in the second quarter and that the acceleration to hit guidance will occur in the back half of the year.
spk00: Okay, great. And if I could follow up too, just on, you talked about 105 new facilities ordered Omni in the quarter. Can you talk about just the headwinds from a COVID standpoint in terms of accessing new accounts that you saw in the quarter or else competitive dynamics from a trialing standpoint? And as you think through the balance of the year, just expectations either for this level or the potential to accelerate given those headwinds potentially. Thank you.
spk10: You know, again, Cecilia, the 105 is a very strong result. It's actually stronger than what we averaged last year. Right. Um, you know, and, um, I think that that number for us has been pretty consistent, right? It's a high touch model. Um, and given that in our, in our desire to be there and hands-on for the, for the initial user experience throughout initial cases and trialing, um, that that we'd expect to be a consistent number. Where COVID impacted us was in opening up sort of that time for multiple trialing sessions and then the overall caseload, right, like just in terms of overall utilization. And so, you know, really the first four to six weeks, four weeks more pronounced, but six weeks of the quarter were impacted by us. So, you know, when I think about that level of new facility ads, That's good execution holistically, even sort of taking COVID disruption out of the equation.
spk00: Great. Thank you for taking the questions.
spk05: Our next question comes from Andrew Brackman with William Blair.
spk04: Hey, guys. Afternoon. Thanks for taking the questions, and I really appreciate some of the exposures here today. Maybe just to sort of piggyback off of Cecilia's line of questioning sort of around the competitive environment and what you're seeing out there, You know, Paul, maybe just from a commercial or strategic standpoint, you know, are there any sort of actions that you as an organization can sort of do or sort of enact to maybe shorten that trialing period that you're seeing, maybe closer to that two months rather than that six months that you sort of referenced? Thanks.
spk07: Yeah. Hi, Andrew. You know, I think as it relates to competitive trialing, I think, you know, we – We inform the field with the most current and complete information that we have. We remind the field, and the field reminds surgeons about why OMNI wins. And I think this is, you know, it's a really simple way to think about things, but just go through those four criteria that I walked through in the prepared remarks. It's all about efficacy, indication, reimbursement and usability, right? Omni's, we've been iterating on Omni for many years now. It's very proven. So if you look at it from an efficacy perspective, there aren't any new entrants that can do what Omni does. There aren't any new entrants that can address all three points of resistance in the outflow system. And the clinical data speaks for itself. From an indication, If you look at Omni's indication, it's the Holy Grail indication that allows us to train the market effectively, to promote effectively, and to win surgeons and generate that sticky base of business.
spk06: It's indicated to treat all adult patients with POAG.
spk07: And I think if you look at the indications for existing products or the new entrants, there's a lot to be desired. From a reimbursement perspective, Again, we remind everyone of the benefits of Omni. Omni enjoys a very stable, dependable, well-understood Category 1 CPT code. That Cat 1 code was revalued last year, so there's no billing confusion. I think for a lot of the other products or new entrants, I think there's a ton of confusion around what they are, what they are not, what code should be billed, what code should not be billed. And lastly, from a usability perspective, and we're on, you know, depending on whether you count our predicates or not, we're on our fourth generation, fifth generation of Omni offering the surgeon that perfect user experience. So for all those things, I mean, we tend to stick to our fundamentals, reminding our team and the team reminding our surgeons and facility customers of the benefits of Omni. And we've been doing that since day one. You can see the robust, predictable business that we've generated, and we expect that to continue to serve us well.
spk04: Okay, that's helpful. Thanks for that. And then maybe just one on the don't wait until too late campaign. Obviously, that was just recently launched. What can you sort of tell us as it relates to how that's faring, I guess, specifically within the optometrist community? How are you thinking about that as a demand driver for the back half of the year? And then if I could just sneak one more in. anything that you can tell us as it relates to sort of the device-intensive offset that we should be expecting here as we enter sort of the middle part of 2022. Thanks.
spk07: Sean, you want to take the campaign, and I'll do device-intensive?
spk01: That sounds great. Yeah, I was thinking the same thing. So, hey, Andrew, Sean. Yeah, as far as the don't wait too late, we're really proud of that campaign. We're proud of the leadership position that Site Sciences is taking in terms of educating the referral source, educating both the doctor who is managing the glaucoma patient, as well as then also allowing us to really communicate with the patient, to the patient, within office patient materials that are ancillary to that campaign. So we're seeing a lot of really positive response from it. We've been heavy in the advertisement of it in optometric journals. We've been heavy with it at optometry meetings as well, and just really creating a lot of buzz around it, but really, you know, again, reinforcing our investment in the education of the, you know, primary eye care provider who's seeing a lot of those glaucoma patients so that they can share that there is an intervention for mild to moderate likely pseudophagic patient where a mixed procedure like Omni that addresses all three points of resistance, could possibly be the right opportunity for them, and then get that patient over to a surgeon that is confident in performing the procedure. So overall, really excited about it and looking forward to continuing to see how that activates the standalone market in the second half of the year.
spk07: Andrew, on device intensive, I wish I had an answer for you today, and I wish that was a positive answer, but we're just going to have to wait and see in the proposed rule usually at the end of June. That said, we've been very engaged over the past several quarters with CMS, MDMA, patient advocacy groups, and obviously the ophthalmic societies. Very productive dialogues, and we feel very good about the broad support we're receiving in those discussions. In particular, we're gratified that our leading society, AAO, has strongly supported our request for device-intensive So, just overall, we feel good about the support and its impact on the outcome, but ultimately, as you know, we'll just have to wait and see until we can review the proposed rule sometime this summer.
spk05: Great. Thank you.
spk06: Thanks, Andrew.
spk05: Our next question comes from Matt O'Brien with Piper Sandler.
spk09: Hi, good afternoon. It's Adam on for Matt. Thank you for taking the questions. Two from me. First, would love just to get a little bit more color on U.S. surgical glaucoma. You know, nice start to the year, but was hoping you could kind of flesh out the mix of growth between utilization versus the impact from adding new docs. And then also talk a little bit about just kind of the usage of Omni between combo cataract and standalone. And then I had a follow-up. Thanks.
spk10: Hey, Adam, you know, the quarter's a little funky, right? Because, you know, the number of ordering facilities increased nicely, right? But the sort of, you know, it was a flat quarter sequentially. So the implication, right, is average ordering down. Remember that January was a highly disrupted month in terms of OR activity. So at the highest level... you know, you look at it and you're like, well, how do you get flat? Ordering facilities up, new ads up nicely, utilization down. But as we dig in and look at it, you know, a big impact was January. So hence, you know, our optimism about how that turns around for the rest of the year.
spk09: And then, sorry, the other part of your question was, just any color on combo cataract versus standalone volumes.
spk07: Yeah, we, we, hi Adam. Sorry, Jesse, go ahead. I was just going to say, you know, we, I think we were, we're, we believe we're low to mid teens in, in standalone versus combo cataract. That being said, that's, that's kind of organic historical, I think just based on, strong product market fit between Omni and standalone, given all of the initiatives we have underway and the investments we're making. We expect to accelerate the growth in standalone beyond the organic growth that we're already seeing. So we're super excited. One thing I want to point out is For the near term, we really shouldn't assess site science's success as, you know, a percentage of mix. And the reason why I say that, you know, the two business segments are very related. As we bring on Happy Omni Surgeon and Combo Cataract, it's those same surgeons that serve as standalone surgeons, right? So it's the same surgeons, same device, same procedure. just a different pool of patients. And so we're going to continue to add surgeons who are using OMNI in combination with cataract for the foreseeable future. Obviously, we've demonstrated very significant growth over the past few years in combo cataract that makes our standalone growth or our mix what it is. So for us, site sciences, we measure ourselves as long as we are attractively growing both segments, combo cataract, as well as standalone, I'd say that we will be pleased with our performance.
spk09: That's really helpful color. And if I can sneak in just one more, I'll ask about the guidance and not trying to push too much here, but you beat in Q1 by over a million, you know, so why not take up the low end of the guidance range, given the momentum that you're seeing in the business and, Is that just some conservatism at this stage in the year? And then maybe just talk about kind of what gets you to the midpoint versus the high end of the range. Just any puts and takes there would be much appreciated. Thanks so much for taking the questions.
spk10: Yeah, well, you know, first of all, not a ton of time has elapsed, right, just a little over a month, right, since we did our – uh, year end call, right. Just, we were reported late as a first time, uh, 10 K filer. Um, you know, the, the, the reality of, you know, Paul, Paul walked through, there are, you know, um, judgment calls in sort of as the operating environment, you know, um, in information is, um, more sort of uniformly absorbed into the end user market. Um, that's part of it. And so we do think it's kind of prudent to kind of maintain the range where it is, um, as you kind of hear from our comments. And I think as you take the time to absorb our metrics, the growth funnel is tremendous, right? So, um, you know, as we think about it with, um, with proper execution, you know, um, you know, that we've putting on the number that we believe, well, high degree of confidence is very achievable. You know, it requires a normalized operating environment for us to function and really is the requirement. So, you know, we feel good about it, you know, holistically. It's hard to point to like a metric that would like turn us from to the midpoint or the high end. We kind of think the growth drivers point us sort of confidently, you know, to be able to provide that range while there's still some you know, uncertain elements out there in the macro market. Okay.
spk05: Thank you for taking the questions. Appreciate it. Our next question comes from Joy in Wedgwood City.
spk03: Good evening, and thank you for taking the questions. There's been some, I think the right word is noise, regarding reimbursement for canaloplasty and other types of procedures. And I'm talking specifically on the competitive front. And I'm curious if you can comment to that and or maybe give some feedback on the most recent reimbursement report from Corcoran.
spk07: Yeah. Hi, Joanne. This is Paul. You know, I'll just speak to what we know very well, which is reimbursement for Omni and the
spk06: CPT code that's used when OMNI procedures are performed. You know, OMNI is indicated for canaloplasty followed by trabeculotomy, and I think the definition of canaloplasty is pretty clear, and it's naturally what OMNI physically performs, which is the microcatheterization and transluminal visco-dilation of up to 360 degrees of Schlemm's canal. So I think
spk07: The code is clear. The requirements are clear. The procedure is clear. And Omni was designed specifically to offer a consistent and reliable canaloplasty procedure followed by trabeculotomy as it's defined.
spk06: I'm not sure other products we've seen to date do just that.
spk03: And then as my second question, I want to talk a little bit about Salesforce build out. Um, can you remind us where we are today versus a year ago and goals for the rest of the year? Thank you. Yeah.
spk10: Hey, it's doing this, Jesse. Um, we last year, uh, had 53, uh, Hunter reps and surgical about 10 Hunter reps and peer care. And then we had eight strategic account managers that focused on the teaching institutions and the VAs. And then we had like a beta, three to four beta glaucoma clinical consultants, the group that Paul talked about in terms of standalone. We added a handful of territories where there was great opportunity to the hunters on surgical and We added a handful of strategic account managers for the teaching institutions and the VAs. The big investment for us was we went to 20 glaucoma clinical consultants, right, and those are the standalone-focused, you know, field support team for the reps. And, you know, Paul talked a lot about sort of their – our expectations and optimism about their contributions and comments. Tier care, we added five. They're super highly productive. They're productive off the bat. So we actually made the decision we're going to edge that out by another five. So we're going to be by the end of Q2 at least at about 20 tier care reps. The label there in terms of the expanded label that we got in December has really helped the ability for them to market that product properly. So in terms of overall field resources, that's where we stand today, and that will likely be the case throughout the year.
spk03: Okay, thank you.
spk05: And I'm not showing any further questions at this time. I'd like to turn the call back to Paul for any closing remarks.
spk07: Well, thank you all for your participation, and thank you all for your interest in site sciences. Have a good day.
spk05: Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.
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