This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk04: Welcome to Glaucos Corporation's third quarter 2021 financial results conference call. A copy of the company's press release issued after the market closed today is available at www.glaucos.com. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you'd like to ask a question during this time, simply press star then the number one on your telephone keypad. If you'd like to withdraw your question, please press star one again. This call is being recorded, and an archived replay will be available online in the Investor Relations section at www.glaucus.com. I would now like to turn the call over to Chris Lewis, Senior Director of Investor Relations and Corporate Strategy and Development. Please go ahead.
spk11: Thank you, and good afternoon. Joining me today are Glaucus President and CEO Tom Burns, CFO Joe Gilliam, and COO Chris Calcaterra. While in our prepared remarks, we'll open the call to questions. To ensure ample time and opportunity to address everyone's questions, we request that you limit yourself to one question and one follow-up. If you still have additional questions, you may get back into the queue. Please note that all statements other than statements of historical facts made on this call that address activities, events, or developments we expect, believe, or anticipate will or may occur in the future are forward-looking statements. These include statements about our plans, objectives, strategies, and prospects regarding, among other things, our sales, our products, our pipeline technologies, our US and international commercialization, integration, and market development efforts, the efficacy of our current and future products, our competitive market position, reimbursement for our products, financial condition, and results of operations, as well as the expected impact of the COVID-19 pandemic on our business and operations. These statements are based on current expectations about future events affecting us and are subject to risks, uncertainties, and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control. Therefore, they may cause our actual results to differ materially from those expressed or implied by forward-looking statements. Review today's press release and our recent SEC filings for more information about these risk factors. You'll find these documents in the investor section of our website at www.glaucos.com. Finally, please note that during today's call, we will also discuss certain non-GAAP financial measures, including results on an adjusted basis. We believe these financial measures can facilitate a more complete analysis and greater transparency into Glaucos' ongoing results of operations, particularly when comparing underlying results from period to period. Please refer to the tables in our earnings press release that is available in the investor relations section of our website for reconciliation of these measures to the most directly comparable GAAP financial measure. With that, I will turn the call over to Glockos President and CEO, Tom Burns.
spk08: Thank you, Chris. Good afternoon, and thank you all for joining us today. We hope everybody is staying safe and doing well. Today, Glockos reported third quarter net sales of 74.7 million. representing growth of 15% versus the comparable year-ago period. These results exceeded the top end of our guidance range and reflect solid execution across our glaucoma and corneal health franchises amidst both continued COVID-related volatility and headwinds globally and U.S. combination cataract glaucoma dynamics associated with the originally proposed CMS rules from July. I'd like to take a moment to recognize the continued dedication and resiliency of our teams around the globe who remain steadfastly committed to their work throughout the ongoing pandemic. It is clear that the pandemic and subsequent global recovery from it continues to pressure labor markets and the global supply chain. We and our customers are not immune to these realities and risk as we move forward, but we have been pleased with our continued ability to attract world-class talent and the resiliency of our supply chain thus far. We remain focused on our near-term execution as we drive new adoption and deeper penetration globally for our transformative MIGS and ILINC solutions. Importantly, we continue to self-fund and successfully advance our robust pipeline of novel, promising platform technologies that we believe have the ability to significantly expand our addressable markets and to transform our company into a leading hybrid ophthalmic pharmaceutical and device player over time. Pioneering innovation, scientific evidence, and clinical rigor play a vital role within our organization. During the third quarter, we accomplished a market-leading clinical milestone, surpassing 200 peer-reviewed publications on our iStent technologies. This represents the most robust diverse, and longest-term body of clinical evidence for any mixed technology. This robust library is comprised of over 20,000 eyes across a range of studies over nearly 20 years, including 15 publications analyzing long-term, four- to eight-year follow-up data. Outcomes from these studies reinforce the powerful benefit-to-risk calculus of iSTEM Technologies' microinvasive tissue-sparing approach supporting the utilization of Iceland globally. An important aspect of pioneering new markets the way we have is the ability to protect our proprietary inventions with a formidable portfolio of intellectual property. To that end, during the third quarter, we announced the settlement of patent litigation with Ivantis, under which Ivantis has agreed to pay Glaucos $60 million in two payments and a 10% ongoing royalty through April 2025. We are pleased with this outcome. remain confident in the strength of our robust intellectual property portfolio, and believe this settlement allows us to focus our full attention and resources on executing our long-term growth strategy by bringing transformative new technologies to the market for the benefit of patients worldwide. Within our U.S. Glaucoma franchise, our commercial team continues to successfully train and educate our current and prospective surgeon customers on the favorable risk-to-benefit profile of our iStent family of technologies and advance MIGs towards standard of care for glaucoma. Regarding CMS, earlier this week, on November 2nd, CMS issued its final calendar year 2022 Medicare physician fee and facility fee schedules, respectively. The final 2020 rule updates the payment policies, physician fee, and facility payment rates and other provisions for services furnished under the Medicare Physician Fee Schedule in both the HOPD and ASC settings. These final rules supersede the proposed rates that were issued in July 2021 and are subject to the issuance of any updates or corrections by CMS prior to or around January 1, 2022, the date these final rules take effect. Over the past three months following the July proposals, Gloucester Alarm was sick key national industry societies, 31 patient advocacy groups, 20 state societies, 16 congressional districts, many ophthalmic surgeons and others have directly engaged with CMS and undertaken a comprehensive and coordinated response that led to over 1,300 unique submissions to CMS. A positive recommendation by the CMS advisory panel on hospital outpatient payment in favor of our proposals and broad bipartisan support from policymakers in Washington. As a reminder, the CMS 2022 final rules include physician fee and facility fee payment rates for two new Category 1 CPT codes, including 66991 for non-complex cataract extraction in combination with the insertion of an aqueous drainage device, and 66989 for complex cataract extraction in combination with the insertion of an aqueous drainage device. CPT codes 66991 and 66989 will replace category 3 code 0191T as the primary code that physicians, hospitals, and ASC will use to seek reimbursement utilizing Glaucus' trabecular micro bypass technologies, including for our iStent and iStent inject W devices when used as approved in combination with cataract surgery. Starting on the physician fee, often referred to as the professional or pro fee, which is the rate surgeons are paid directly for doing a procedure, the final rule indicates a 2022 physician fee for CPT code 66991 of approximately $664, representing an incremental physician fee payment of approximately $135 above non-complex cataract surgery alone. This reflects an improvement of roughly $100 versus the July proposal, yet still implies a decrease compared to a median physician fee today for 0191T of approximately $350, which, as a Category 3 CPT code, is priced independently by each Medicare administrative contractor or MAC. Moving to the facility fee, which is the payment that a facility receives to cover the cost of a procedure, including the cost of the devices used, The final rule indicates that 2022 facility fee payment rate in the ASC setting for CPT codes 66991 and 66989 of $3,246, which reflects an improvement of $730 versus the July proposed rate of $2,516. And compares to the combined ASC facility fee under the existing Category 3 code today, of $3,353. We estimate that approximately 80% of procedures utilizing our trabecular micro bypass technologies in the United States are performed in the ASD setting. For the remaining estimated 20% of procedures performed in the HOPD setting, the final rule indicates a 2022 facility fee payment rate for CPT code 66991 and 66989 of $4,251, an increase of $333 over today's current HOPC facility fee rate of $3,918. We are pleased to see that our actions over the past several months materialize into notable improvements in the final rule for combo cataract MIGs versus the proposals but we still have work to do going forward to ensure physicians and facilities are fully compensated for utilizing our site-saving technologies in standalone and combo cat-arc procedures. We remain focused on various execution strategies to maximize the access and overall care for glaucoma patients here in the United States. Shifting gears to our international glaucoma franchise where our year-over-year growth during the third quarter was broad-based across the European and Asia-Pacific regions, but it is worth noting that we have continued to experience intermittent COVID disruptions in nearly all of our global markets. We remain early in our international penetration and are continuing to invest in our expanding teams as we drive broader adoptions of MIGS around the globe. These efforts were on full display at our recent ESCRS annual meeting where our technologies were featured in various scientific programming. Additionally, we held two educational symposiums on our iCent in JECW and iLink technologies that were widely attended and continue to help us drive new physician interest and adoption through clinical education and sales initiatives to support long-term growth. Colonial health growth during the third quarter was driven by record U.S. Betrexa sales of 12.8 million and continued healthy momentum in the new U.S. account starts. We continue to opportunistically expand our U.S. corneal health commercial team to fuel the execution of our commercial strategies and market develop initiatives that are being well received. As you know, behind the scenes, we've invested considerable time and resources over the past 18 months to successfully integrate our AVIDRO acquisition. I am happy to report that these corneal health franchise activities are now largely complete, that Boston is integrated within our corporate enterprise systems. Moving forward, our focus remains on building upon the strong momentum we're experiencing within this emerging growth driver for Galcos. We've also been investing considerable time and resources in our facility infrastructure to support our growth, key capabilities and pipeline development. And as such, we are rapidly advancing towards the expansion and enhancement of our facilities in Southern California. And we'll shortly kick off similar investments in our Burlington, Massachusetts facility. The strong capital position we have built has allowed us to remain on offense when it comes to successfully investing for our future. As a testament to this, we are continuing to invest in and advance our fulsome pipeline of core novel platforms where we anticipate in our planning for a robust cadence of new platform and product introductions over the coming years that have the potential to fundamentally transform Glock Home over time. On iStent Infinite, a 3-stent micro-bypass stent technology designed to be used in a standalone procedure, we now expect potential FDA clearance in the first half of 2022 based upon the pace of our review with the agency to date. Supported by strong, pivotal data highlighting favorable safety and effectiveness, we are bullish on iStent Infinite's long-term prospects as a highly compelling new treatment alternative in a standalone procedure for severe and refractory glaucoma patients. We also continue to advance our late-stage development of iPrime, a highly complementary new visco-delivery device designed to be a truly minimally invasive system to further support the needs of our physicians and patients. Regarding the PressorFlow Microsumpt, the FDA continues to gather additional input from glaucoma surgeons to ensure a complete evaluation of the clinical data submitted in the PMA. In the meantime, we are launching PressorFlow in Canada and are preparing for launch in Australia, given the recent regulatory approvals in both geographies. For IDOS-TR and Epion, we remain on track with our previous expectations for NDA submission in 2022 and FDA approval in 2023, respectively. Beyond these important near- to medium-term pipeline programs, we also continue to invest in and advance our key earlier-stage R&D programs, including in dry eye, retina, glaucoma, presbyopia, and additional undisclosed projects. During the third quarter, we added yet another early but exciting pharmaceutical opportunity to our pipeline portfolio through a licensing agreement with Adelap's Holdings. Under this agreement, Glaucus has secured global exclusive rights to develop, manufacture, and commercialize Adelap's proprietary library of investigational pharmaceutical compounds that target the eradication of demodex mites. Demodex mites are the root cause of demodex blepharitis and often associated with meibomian gland dysfunction and related ophthalmic diseases. Demodex blepharitis and demodex-driven meibomian gland dysfunction are caused by an infestation of these mites, the most common ectoparasite found on human skin. Demodex blepharitis is characterized by eyelid inflammation and irritation resulting in eyelid redness, discomfort, and debris. And demodex-driven meibomian gland dysfunction is characterized by decreased lipid secretion into the tear film and is a leading cause of dry eye disease. Adelap's lead compounds have demonstrated promising in vitro results in preclinical settings. This licensing agreement adds a promising therapeutic class that expands the focus of our emerging corneal health franchise into new and globally underserved disease indications and represents a highly synergistic fit within our ongoing corneal health R&D initiatives. While this program and other earlier stage opportunities remain in preclinical developmental stages, we are encouraged with the initial progress we're demonstrating within these platforms and are hopeful to advance a number of these programs into the clinic over the next 12 months. In conclusion, I'd like to reiterate our commitment to challenge the conventional way of thinking by driving meaningful innovation for the benefit of patients as we aspire to build a world-class company. I'm confident we have the right people, strategy, infrastructure, pipeline, and balance sheet to execute our plans and deliver on our future aspirations. So with that, I'm going to turn the call over to Joe and discuss our third quarter 2021 financial results. Joe.
spk14: Thanks, Tom. As a reminder, I will be discussing our financial performance on a non-GAAP or pro forma basis and will summarize our GAAP performance later in my prepared remarks. I encourage each of you to review our GAAP to non-GAAP reconciliation, which can be found in today's press release, as well as the investor relations section of our website. Cloudcoast global consolidated net sales for the third quarter of 2021 were 74.7 million, representing year-over-year growth of 15% and growth of 7% compared to the third quarter of 2019 pro forma for our acquisition of Avidro. Our third quarter performance reflects improved market conditions versus 2020, but we did experience headwinds globally this quarter due to COVID-19, most notably in July and August. We've been encouraged with improving market recovery trends in September and October, But pandemic-related volatility and risks remain, particularly as we enter the winter months of the fourth quarter. Now, turning to our U.S. glaucoma franchise specifically, our third quarter U.S. glaucoma sales were approximately 43.4 million, representing year-over-year growth of 11%, which we believe reflects a combination of pandemic-related dynamics and the impact of the originally proposed 2022 CMS combination cataract reimbursement. on customer ordering patterns and competitive trialing activities in advance of any potential changes. Internationally, our Glaucoma franchise delivered third quarter sales of approximately 15.1 million, representing year-over-year growth of 18% and 38% growth compared to the third quarter of 2019. This performance reflects growing demand globally, offset by pandemic headwinds that reemerged in key European and Asia Pacific markets, combined with the continued challenges in Latin America. In Cordial Health, third quarter net sales were $16.2 million, representing year-over-year growth of 26% and 47% growth compared to 2019 pro forma for our Avigdor acquisition. The third quarter performance was driven by US Potrexa record sales of $12.8 million on year-over-year sales growth of 23% or 52% versus pro forma 2019, along with a continued trend of healthy new US Potrexa account starts as our commercial integration and strategies continued to deliver. Shifting gears toward the remainder of our P&L, our non-GAAP gross margin in the third quarter was approximately 87.1% versus 84.9% in the same quarter in 2020 and 84.4% in the second quarter of 2021. This reflects continued strong corneal health and glaucoma gross margin performance and a non-recurring higher allocation of cost to R&D in the quarter. Excluding these costs, our non-GAAP gross margin for the quarter would have been approximately 85.3%. It is worth noting that our non-GAAP adjustments to COGS include substantial amounts related to AVIDRO acquisition accounting. Our overall non-GAAP operating expenses were approximately 69.9 million in the third quarter of 2021, a 3% sequential increase versus the second quarter of 2021, as we continue to restore expansionary spending as the recovery warrants, a trend that we would expect to continue moving forward. Our non-GAAP SG&A expenses in the third quarter were approximately $41.2 million, down 6% sequentially compared to the second quarter, reflecting consistent commercial spending offset by lower administrative costs. And our non-GAAP R&D expenses in the third quarter were approximately $28.7 million, up 19% sequentially compared to the second quarter, as we continue to restore core R&D spending, earlier stage pipeline programs, and human capital investments across the organization. Our third quarter GAAP operating expenses reflect a one-time in-process R&D charge of $5 million associated with the Adelaps Holdings licensing transaction and a $30 million payment received during the quarter related to the IVANTIS litigation settlement. We finished the third quarter with a non-GAAP operating loss of $4.9 million and non-GAAP net loss of $9.7 million or 21 cents per diluted share. Our gap net income was 6.2 million or 13 cents per diluted share for the third quarter of 2021. We invested in approximately 9.9 million of capital expenditures in the third quarter, which as expected remains elevated versus historical levels as we've advanced through the construction phase of the enhancement and expansion of our facilities in Southern California and Boston to meet our growing development and operational needs, a trend that we would expect to continue through the first half of 2022. As of September 30th, 2021, we had cash, cash equivalents, short-term investments, and restricted cash of approximately $438 million, compared to $414 million at the end of 2020 and $428 million at the end of the second quarter of 2021. Looking forward, first as it relates to COVID-19, we experienced incremental global headwinds during the third quarter, with some improvement in September and October, which I discussed earlier. But the situation remains fluid, and we would caution conservatism as you consider any potential impact this may have on elective procedure markets throughout the remainder of 2021 and into 2022, particularly as we progress through the winter months. Regarding CMS and the reimbursement for our combination cataract products here in the U.S., while we are pleased with much of what improved in the final rule that was just released, Disruption of customer ordering patterns and competitive trialing that resulted from the original proposed rules had continued and we expect will ultimately still impact our fourth quarter results. As we put this all together in the context of our expectations going forward, our 2021 net sales guidance of 285 to 290 million remains unchanged. This guidance takes into account our typical underlying seasonality patterns, COVID-related trends and risks, and potential U.S. combo cataract glaucoma headwinds. Moving forward, we will complete a thorough assessment of any impact that the lower 2022 CMS physician fee and ASC facility fee may have on our U.S. combo cataract glaucoma franchise in 2022 and reflect those estimates in our overall guidance when we provide it on our fourth quarter call in late February. With that, I'll now turn things back to Tom for a few closing remarks.
spk08: All right. Thanks, Joe. So in closing, I'd like to reiterate our conviction in our long-term vision. We are continuing to invest in Glaucos, scaling our team, and driving true innovation. We believe these are the foundational pillars to long-term value creation for all of our stakeholders. We have pioneered the Combo, Cataract, MIGS, and iLink markets, and we are just beginning. The funding from these franchises has enabled us to build a pipeline with a breadth and magnitude that may be unmatched in this industry. And we believe we are at the dawn of a robust cadence of new product launches over the next several years, assuming FDA approval, including iStand Infinite, iPrime, Press-to-Flow Microshunt, IDOS-TR, Epion, and potentially other exciting new complementary technologies. The investments we're committed to over the last or the past decade have materialized into a potentially transformational period for our company in the years to come. We would encourage investors to evaluate closely our self-funded pipeline and our highly leverageable global commercial infrastructure, along with the growth and scale of our glaucoma and corneal health franchises. And we are confident that many of you will come to the same conclusions and enthusiasm we have for the future of Glaucus. So with that, I'm going to open the call to questions. Operator?
spk04: Thank you. As a reminder, if you'd like to ask a question, please press star 1 on your telephone keypad. And our first question is from Andrew Brackman with William Blair. Your line is open.
spk12: Hey, guys. Good afternoon, and thanks for taking the questions. Sorry for any background noise here. Maybe to start here first on your updated sort of reimbursement stats post the final decision earlier this week. Certainly, I appreciate that you don't want to talk necessarily specifics about 2022, but maybe just conceptually, can you give us an idea about how you're thinking about some of the different variables that are at play here and how that's changed now that this has gone final? Thanks.
spk14: Yeah, thanks, Andrew. It's Joe. As we think about, you know, and I really said this in my prepared remarks, we're going to take our time here. Obviously, as you can imagine, we just got these rules 48 hours ago. We're going to take a thoughtful assessment of what it all means, clearly encouraged by the relative move on the facility fee reimbursement side and also really the move on the professional fee side to $135 from where it had been proposed. But it's important to remember that that's still at a substantial discount to where we've enjoyed reimbursement on the pro-fee side historically here. We're going to take all that into consideration and take our time and really, you know, analyze all this with our customers and, you know, also provide that update as a part of our fourth quarter call and our 22 guidance.
spk12: Thanks. Completely understandable. And maybe secondly on the pipeline here, I don't think it comes as much as a surprise at Infinite's getting pushed to the first half of next year, but maybe as we sort of think about the opportunity for that and the standalone opportunity, And when you couple that with iPrime, can you just talk about at a high level, you know, why those two products sort of make sense as you move into that standalone opportunity and why sort of a hybrid model might be compelling to docs? Thanks for the question.
spk02: Sure. Hey, Andrew, it's Chris. Let me start out by just saying, you know, the standalone opportunity is certainly bigger than the combo cataract. And having both iPrime And Infinite gives us an opportunity to play in that standalone segment. And there is a trend of utilizing these products in combination with each other. So by having these products in our bag, we're better able to position ourselves and play in that big standalone market.
spk06: Our next question is from Chris Cooley with Stevens. Your line is open.
spk10: Good afternoon. Thanks for taking the questions and congratulations on the progress you made with CMS. Maybe just one on reimbursement and then one when we think about core business growth. On the reimbursement side, I realize you want to take some time to digest what the combo cataract market looks like, but I think maybe one of the more surprising data points was the reimbursement for Iced and Infinite. And while I know that the pro fee has to be set by the max, I was curious kind of what you thought you had to see there to make that economically viable. And similarly, your take on the facility fee, which was actually lower than what was initially proposed. Just thinking about how that may or may not impact your thoughts on commercialization once that device is most likely approved in the first half of next year. And I've got a follow-up.
spk08: Yeah, Chris, I'm happy to take that question. I mean, we gained so much ground during the commentary period and the final rule in the aspects with regards to combination cataract surgery. And we are disappointed with the initial position of CMS with regards to how they have approached the APC for the standalone use of trabecular bypass devices. And so, if you think about it, they've always conditioned and translated the iStent products into APC 5492, and for some reason they have taken a position that it would be now translated into 5491. We think that that decision was made in error, and we'll be looking at their commentary on why they made that decision. We'll be working with CMS over the course of the next several months, much like we have here to gain ground and combo cataract. to see if we can't upgrade the payment for that transitional pass-through as we move forward. So I would say this is the position that they've taken. We'll work hard, much like we have done with patient advocacy groups and with industrial or industry societies to be able to take another bite of the apple to be able to move that code up.
spk10: Super. So it's a starting point, if I hear you correctly, and you'll basically work to see how that gets resolved going forward. If I shift gears just to the core business today and corneal health in particular, record for Drexel sales during the course of the quarter, and that's despite still seeing some COVID-related challenges in markets across the U.S., Just curious if you would kind of assess where that franchise is today relative to where you had expected it pre-COVID and what type of growth you think the existing install base here in the States can really kind of sustain going forward. Just kind of trying to get a better feel for how that business normalizes as we maybe normalize post-COVID. Thanks for taking the questions.
spk02: Hey, Chris. I'll take the first part of that. And we're pleased with what we've been able to accomplish. And that is certainly a result of all the different initiatives that we put into place, mostly around early detection of keratoconus and referral patterns of getting these patients into i-Link customers, good integration of the Abidro and Glockos team and and the power that we have of working together. So, I'm not surprised by the record sales for Trexa in the third quarter, but there's still a big opportunity ahead of us, and we're working to capture more of that opportunity. Pleased that it's growing, pleased that we've made progress, but optimistic about the future of this product portfolio and what we can do with it.
spk14: I think, Chris, as we think about the growth prospects of this, and Chris is alluding to it, you know, the first phase of our integration was all about increasing access to the technology, making sure that as many of our customers that are in this business or potentially in this business get access to the technology. And quickly, you turn your attention to the second phase, which is increasing utilization, driving additional awareness of the condition, driving that additional foot traffic from the optometrist into the corneal specialist that do these procedures. And that's something where, as we go on the other side of COVID, we hope we'll really start to increase our access to those accounts in person and really increase those overall utilization trends. But sitting here today, we're still focused on both those. And as we move forward here, we'll increase our efforts around the utilization side substantially.
spk06: Thank you. Our next question is from Matthew O'Brien with Piper Sandler.
spk04: Your line is open.
spk03: Hi. Good afternoon, guys. Thanks for taking the questions. This is Simran on for Matt. I guess I just kind of wanted to maybe touch on the reimbursement update here. So given the improvement in the facility fee, does that mean you no longer will need to take maybe as deep of a pricing cut as you guys were initially anticipating to take in 2022? Hi, Tim.
spk14: It's Joe. I'll start. If Tom and Chris want to add anything, they can. I'd say we don't obviously get into our pricing deliberations on a public call like this. If you look back at what we talked about in the second quarter call, you know, we did assume, given the substantial decreases, that, you know, we might have to share in that pain with our customers. So clearly the improvement in the ultimate outcome here is a net positive for us from a pricing standpoint as we go into 2022.
spk03: Okay. And maybe touching on that previous kind of outlook you guys gave on the last call, maybe how much of that was related to pricing versus share loss? I think you guys had lowered numbers by about 70 million for the year. You know, is there an update on that? And, you know, can you speak to that split?
spk14: Sure, Senator. Well, I think maybe first I should just, as a reminder, you know, we didn't lower anything, right? The numbers we talked about, the $90 to $110 million range for the U.S. combo cataract was really based on, you know, math that was based on the Wall Street commentary that, you know, followed those initial 2022 proposals. You know, within that, we've gotten the question of sort of what did that, you know, what were those inputs from the various, you know, street estimates that had existed. And I would tell you that, you know, in general, the proposed rule had an over $800 price decrease built into it. And we said that a material portion of that reduction could be realized in lower pricing. On the professional fee side, you know, there was a variety of estimates out there from analysts in terms of the potential impact. that range from anywhere from 25 to 50% based upon the proposed rules as they stood. So, you know, we looked at a lot of different scenarios in there. You have to factor in the fact that about 80% of our business is done in the ASC setting, and about 80% of that business is Medicare. You put all that together, and what we said at the time was the math sort of centered around that 90 to $110 million range at the time.
spk03: Okay. Got it. And then one quick one on the pipeline. Do we have an update on IDOS or what we should be expecting from that program in 2022?
spk08: Yeah, I'm happy to take the IDOS question. And so, as I've said before, and we'll continue to reiterate, we are very, very pleased with the two-year data from the Phase 2b study that I've shared with the investment community, and it's my intention to share the three-year data with the investment community in the first half of 2022. Okay.
spk03: Perfect. Thank you, guys.
spk04: You're welcome. Our next question is from John Block with Stifel. Your line is open.
spk13: Perfect. Thanks, guys. Good afternoon. The first question might be more of a Wall Street concern than real world, but, you know, the company really faced a lot of uncertainty over the past four months prior to earlier this week. And can you just talk to your sales force and the ability to keep the strong reps that you had prior to the preliminary fee? Do you feel like it cost you any talent amongst the reps when the company had some uncertainty over the past three to four months? And then I got to follow up.
spk02: Sure. Hey, John, it's Chris. You know, we've been dealing with potential loss of reps for a long time. We've got a very good sales organization, and it's not uncommon for competitors to try and pick off our people. So it's something that we've dealt with, and we have a tremendous track record of keeping our talent. So it's in line with where we've been. We've lost a couple people here and there, but nothing out of the ordinary. And I think they're really excited about our pipeline. and where we're headed. It's a wonderful cadence of new products coming out over the next couple years. And they see that, and I think it's also important that they have trust in the management team and what we're trying to do here. And we just have a really low, supremely low attrition rate here. So, all in all, we're doing well.
spk13: Perfect, Chris. That's very helpful. Thank you. And maybe to shift gears, I'll try to Maybe jamming two questions. Just on the competitive trialing, Joe, that you called out, have you seen anything so far? In other words, someone tries a competitive device and, you know, any defections or loss of share in that account that's trialing the competitive procedures? And then sort of the bolt on, but admittedly separate question is, just can you remind us of the percent of your dog customers that own an ASC or have an equity ownership in an ASC? I think it's very high, and clearly that's the case. it would better shield you guys from just a step down in the pro-fee because they'd be looking at the overall economics of pro-fee versus ASC where the percentage drop is much lower than pro-fee alone. Hopefully that made sense. Thanks.
spk14: Yeah, it did, John. I'll answer, and Chris went to add in there. You know, we've talked in the past, and I'm not sure it's meaningfully changed, that about 75% of the docs who operate ASC have some degree of equity ownership in the overall practice. Some own it, you know, fully outright, some in partnership with others, some in partnership with private equity, but they have an equity stake in the business itself. The second part of your question, maybe the first part of your question was around loss of share. I'd say it's a little premature for that, right? I mean, if you think about this, the July was when the proposals came out. The reaction there in some accounts were they want to be prepared for a worst-case scenario and try and trial other products. you know, that takes place over the course of, you know, August, September, October. It's a little early to say whether that is indeed a share shift. And we look forward now to reengaging with many of those folks now that the final rules are out.
spk06: Got it.
spk14: Thanks, Joe.
spk04: Our next question is from Ravi Misra with Berenberg Capital Management. Your line is open.
spk00: Hey, Devin, for Ravi here. Thanks for taking my questions. Joe, I guess I just wanted to focus here. I'm trying to put a couple of things together. So, you know, guidance hasn't really moved since last time, but, you know, Q3 came in maybe a little bit better than expected. And we had the reimbursement news, which is, you know, somewhat of a positive here. And it sounds like, you know, that there's not an incremental kind of loss of share in the markets. So I'm just trying to put all that together and, you know, to me it seems like there may be some upside to Q4, you know, if those patterns change upon, you know, this reimbursement news. So could you just give some color into that guidance for the full year here?
spk14: Sure, Deb. I think it's a fair question. You know, first and foremost, our guidance, we try to take into account you know, seasonality patterns, what we're seeing from a COVID standpoint, and obviously some of the combo cataract headwinds that we talked about. You know, it's important to remember on that last point that the final rules here took place and came out just this week in November. So a portion of the quarter has already played out, and these things don't necessarily, these in-market trends, they take time to change. So I still think there will be an impact in the fourth quarter from the original CMS proposals, and we tried to factor that in. As it relates to COVID, I don't think it should be maybe a surprise to anyone on this call that the current, you know, procedure environment is a little bit tougher than maybe we saw, for example, in the second quarter of this year. You know, we've seen that in our business, and I think that's consistent with what we've seen across, you know, medical technology companies across all of them. So, you know, ultimately, I guess you put all that together. And, you know, we think it should be taken favorably that amidst all of this, we're able to hold our previously provided, you know, 2021 guidance amidst a lot of, you know, external and in-market noise.
spk00: Okay, great. Thanks. And then in regards to those, you know, elective procedures, you know, has there been maybe a difference between what you saw, you know, late in Q3 versus what you're seeing here in, you know, October and November? And then just the last question here. On the ICEN Infinite, you know, approval kind of looking at H-122, how does the commercialization wrap there look like in terms of timing? Thanks.
spk14: Yeah. Okay, so I'll start with the elective procedures. You know, as we said in the prepared remarks, and it is factored into the guidance we gave in the fourth quarter, it appeared to trough in that – you know, late July, August timeframe from I'll call it a COVID headwind standpoint. And we've seen recovery in, you know, the months of September and October, particularly here in the U.S. and actually internationally as well. But I think within that, we still have to be careful as we think about the coming months here as we turn towards, you know, winter and what that could or couldn't mean from a COVID standpoint.
spk02: And this is Chris. I'll address your second part of your question around Infinite. Keep in mind, this is a Category 3 device, so the pro fee for this has not been established. But it's like we did with iStent. We'll have to work with all the MACs to secure a consistent payment for that. So you can expect a controlled strategic launch, very calculated in what we do, spending time with the MACs to get that reimbursement for our physicians, and that's when you'll start to see a launch or, excuse me, a lift in the sales of that product.
spk06: Okay? All right. Thanks.
spk04: Our next question is from Ryan Zimmerman with VTIG. Your line is open.
spk07: Good afternoon. Thank you for taking the question. Yeah, follow up for Chris or Tom around the standalone market. I wanted to spend a moment discussing that because I know obviously, you know, the timing on incidents helpful, but as you think about the market and the development of the market and the ability for that market, uh, I appreciate that it's bigger than the combo cataract market by a lot, but is it, is it developed? And, and I'd love your thoughts around that because at least when we talk to physicians, Their definition of standalone in terms of what's applicable is far more narrow today than maybe what would suggest in terms of market size. And so, you know, I'd love to get your thoughts on that, and then I would follow up. Thank you.
spk08: Yeah, Ryan, I'm happy to address your question. And I think what I would do is point to some legacy positions. So many of you may not be aware, but in 2010, they held a plenary session of the American Glaucoma Society. And the question was asked from the podium, how many people either were using or plan to use iStent over the next 12 months? And the answer came back about 15 percent of the audience thought that this was an applicable procedure. And then a fast track three years hence after we had FDA approval and had some ground to gain in the marketplace and could present the data and begin our marketing, same question was asked to an AGS plenary session in Washington, D.C. How many either are using the device or would use it in the next 12 months? The answer came back completely reversed. Over 80% had either used iStent or planned to use it in the next 12 months amongst the same clinical audience. So what you're describing to me is entirely expected. We'll see an area where we'll enter, where the market, I think, initial reaction of your surveys will show some skepticism or resistance. And much like we've done here with MIGS to build the marketplace, we will plow right through that. And we will create this marketplace over time. It won't happen overnight. But we'll be able to create iStent, iStent Inject, and supplementary products as a meaningful alternative to the use of both surgeries and medications over time.
spk14: And, you know, Ryan, I was going to add, because I think analytically speaking, what you're asking in the heart of it is consistent with what we've said for a long time. If you think about iSent Infinite and the initial indications that we plan to pursue or are pursuing, that's a 1 to 200,000, you know, patient or procedure market out of the gate. That's smaller, obviously, than the combo cataract mix that exists today. But over time, as we develop additional data, hopefully additional, you know, label, et cetera, and really expand the utilization within that market, It's then that, as Chris says, we see a much larger market opportunity than combo cataract MIG. So to Tom's point, it will take market development efforts, market development efforts that we're experienced in, and we look forward to expanding that market over time.
spk07: Okay. No, it's totally fair. And look, you know, you guys are the market leader in MIG, so you have that history behind you. In terms of, you know, behaviors for physicians, Do you anticipate, obviously I understand the guidance and I appreciate the caution on the fourth quarter, but do you anticipate a reversion, you know, come January 1, 2022, or is this going to be more of a methodical kind of gradual improvement in behavior once the rates are kind of communicated out to the community? Thank you for taking the questions.
spk14: I think if I'm understanding your question right, you're asking, is this going to be more of a cliff-based thing or is it going to be something that gradually changes over time? Is that fair?
spk07: Your fourth quarter guidance implies a worsening off of the third quarter, right? And I appreciate that we just got this update midway through November. So the question is, come January 22, are we back to old behaviors or are we Or is it going to take some wood? Do you have some wood to chop to get back, you know, some of the dynamics that you had before?
spk14: Yeah, I think that the simple answer is, of course, there's some wood to chop. I mean, the professional fees at $135 versus the prior range of $300 to $500. But I guess I would answer it in two ways. The first one is, in the fourth quarter, you have to think about the fact that for the biggest month, typically of the fourth quarter, October, the proposed rules were still the prevailing wisdom in the community, right, and in the market. And so that obviously has an impact. And no matter how quickly you are able to get closer back to normal over the remainder of the year, you're still going to deal with that when we ultimately report the fourth quarter results, right? And as it relates to 2022, you know, as I sort of said in my prepared remarks, We're going to take our time to analyze that, right? There's a lot of moving parts here that we want to make sure we have our arms fully around, not just the reimbursements themselves, but our strategies and how we plan to go to market in 2022. And as we have our view there solidified, we'll share them with the street.
spk07: Okay. I'll pause there and hop back in queue. Thanks for taking the questions. Appreciate all the answers. Thanks, Ryan.
spk04: Thanks, Ryan. Our next question is from Anthony Patron with Jefferies. Your line is open.
spk01: Great. Thanks for taking the questions. One on just market conditions and then a follow-up on reimbursement, and I guess they're interrelated. So, A, just on market conditions, we're hearing a lot about staffing and just wondering how that's playing out in the ophthalmology world and then specific to glaucoma. And then second, on the final ruling CMS, hospital outpatient goes higher. ASC is lower. We have an 80% mix to the ASC. You know, there's an incentive then to shift to the outpatient setting. You know, do you envision that could happen? But we also have to consider that they're now dealing with shortages. So it's almost as if they've incentivized some shift in behavior just at the wrong time. So the last one would be if this kind of backfires, do you see a potential reversal? you know, in 2023, 2024. Thanks. I know I threw a lot at you there, but wanted to get it all in. Thanks.
spk02: That's all right. Hey, Anthony, this is Chris. Yeah, we're seeing staffing issues at ASCs, hospitals, and in the clinics. And the system is stretched a bit. And it does at times affect capacity and then certainly the ability to do the number of procedures and see the number of patients that these doctors would like to do. That's not all across the board. In some areas, we're actually seeing practices where their volumes are up, and it's a mixed bag. But I consistently hear that labor and staffing is a challenge in all of those areas, hospitals, facilities, and the practices as such. In terms of the reimbursement, Hospitals have always consistently had a higher reimbursement, and a lot of times they get a higher percentage increase. I think that's more of a function of the inefficiencies and costs that you see within the hospital system versus an ASC. Given that 80 to 85% of these procedures are done in ASCs, and given that of those procedures, 75% of them have the physicians having an equity position within the ASC, it's very unlikely that you will see procedures move from surgery centers to the hospital market.
spk06: Thank you. Our next question is from Alan Gong with JPMorgan. Your line is open. Alan Gong with JP Morgan. Your line is open. Please go ahead.
spk04: We'll move on to the next question, which is from Steve Linthman with Oppenheimer. Your line is open.
spk09: Hi. This is David on for Steve. Thanks for taking our questions. Just maybe starting off with Infinite. It looks like approval was pushed out slightly from initial expectations. So just curious, any sense from your side on whether that's related to the product or submission itself or just limited resources on the FDA's part?
spk08: Yeah, I'm happy to answer that. So there's no relation to the data. The data is supremely stellar. As we talked about, just a reminder to the investment community, 76% of the patients who were treated with iStat Infinite achieved 20% or greater reductions in mean IOP at 12 months and over 50% achieved mean reductions greater than 30%. So we remain really supremely confident in the data. I think this was more of a logistics issue and how we submitted. We submitted the data as a PMA supplement and the FDA requested that we turn around and submit it as a 510 . So it causes a slight delay in the review cycle and approval. but we remain confident of this potential approval in the first half of 2022.
spk09: Okay, great. Appreciate the color there. And then just one on the P&L. Obviously, very strong gross margins for the quarter, but as we think about sort of the positive reimbursement dynamics, particularly on the AFC payments, any reason to think that margins should deviate significantly from current levels going forward? Thanks.
spk14: Yeah, thanks, David. You know, I think if you take the sort of adjusted view, the gross margin of the quarter would have been around 85%. I think at this stage, we're still most comfortable saying that you should expect gross margins in that 83%, 84% zip code. Until I see, you know, an established trend otherwise, it's best to stay in that area.
spk09: Okay, great. Thanks.
spk06: Our next question is from Alan Gong with JP Morgan. Your line is open. Alan Gong with JP Morgan. Your line is open.
spk04: And it appears he is having some audio issues. So with that, there are no further questions. I'll turn the call back to the presenters.
spk08: Okay. Well, I want to thank everyone for your time and attention today. We do hope that everyone is staying safe. And thank you for your continued interest and support of Glockos Corporation. Goodbye.
spk04: Ladies and gentlemen, this concludes today's conference call. You may now disconnect. Thank you.
Disclaimer