Q3 2021 Sight Sciences Inc Earnings Call

Greetings and welcome to the site Sciences third quarter 2021 earnings result conference call.

Speaker 1: Greetings and welcome to the Site Science's third quarter 2021 earnings results conference call. At this time, our participants will be able to participate in the event.

At this time.

Thank you Kim.

Speaker 1: and this call is recorded. It is my pleasure to introduce your host, Trip Taylor from Gilmartin Group. Thank you. You may begin.

And then.

It's my pleasure.

Sure.

Taylor from Gilmartin group. Thank you you may begin.

Thank you for participating in today's call presenting today are safe Sciences, co founder and Chief Executive Officer, Paul Modality, Chief Financial Officer, Jackie sell neck, and Chief Commercial Officer, Shaun O'neil earlier today <unk> Sciences released financial results for the three months and nine months ended September 32020.

Speaker 2: Thank you for participating in today's call. Presenting today are Site Science's co-founder and chief executive officer Paul Badawi, chief financial officer Jesse Selnick, and chief commercial officer Sean O'Neill. Earlier today, Site Science has released financial results for the three months and nine months ended September 30, 2021. A copy of the press release is available on the company's website at investors.sitesciences.com.

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A copy of the press release is available on the company's web site at investors <unk> Sciences Dotcom.

Speaker 2: I would 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 law.

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.

Speaker 2: Those include statements related to site sciences 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.

Those include statements related to <unk> Sciences anticipated financial performance and operating results market opportunity the future impact of COVID-19 on the operation business strategy and plans for developing and marketing new products.

Speaker 2: Board-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 states.

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.

Speaker 2: A description of some of the risks and uncertainties that could cause actual results to differ materially from those indicated by the forward-looking statements on this call can be found in the risk factor section of the form 10Q filed today and other filings with the Securities and Exchange Commission.

Description of some of the risks and uncertainties that could cause actual results to differ materially from those indicated by the forward looking statements on this call can be found in the risk factors section of the Form 10-Q filed today and other filings with the Securities and Exchange Commission.

Speaker 2: The company undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law. For more information, please refer to the forward-looking statement notices and risk factors in the recent SEC filings. I will now turn the call over to Paul.

The company undertakes no obligation to publicly update or revise any forward looking statements, except as required by law for more information. Please refer to the forward looking statement notices and risk factors in the recent SEC filings I will now turn the call over to Paul.

Thank you trip.

Speaker 2: And thanks to everyone for joining us on our second earnings call as a public company. I'm very excited to update you on our business.

And thanks to everyone for joining us on our second earnings call as a public company.

I'm very excited to update you on our business.

Speaker 2: and share our significant accomplishments across our commercial, clinical, regulatory, and patient access initiatives.

Sure our significant accomplishments across our commercial clinical regulatory and patient access initiatives.

Speaker 2: as well as our thoughts on the 2022 payment rules released by CMS last week.

As well as our thoughts on the 2022 payment rules released by CMS last week.

Speaker 2: Jesse will then discuss our third quarter financial results before we open up the call for questions.

He will then discuss our third quarter financial results before we open up the call for questions.

To start I will highlight.

Performance.

Speaker 2: certainty, our resilient site team persevered. And we set new records for quarterly revenue at the company and for our surgical Vel sled.

Certainty.

More resilient site team persevere.

We set new records for quarterly revenue at the company and for our surgical glaucoma segment.

Speaker 2: Our total revenue increased to 13.1 million, representing growth of 51% compared to the third quarter of last.

Our total revenue increased to $13 1 million representing growth of 51% compared to the third quarter of last year.

Speaker 2: We believe we are also one of the very few I care businesses to report meaningful sequential U.S. growth in 2-3 over 2-2-2021. Despite significant reimbursement always in surgical glaucoma and the continuing impacts of COVID.

We believe we are also one of the very you eye care business is to report meaningful sequential U S growth in Q3 over Q2 2021.

Quite significant reimbursement noise in surgical glaucoma, and the continuing impacts of Covid.

Although the third quarter is typically seasonally lower than the second quarter.

Speaker 2: Although the third quarter is typically seasonally lower than the second quarter, our surgical glaucoma segment revenue increased to 12.4 million, representing 4% sequential growth from our then record, second quarter revenues, and growth of 58% versus the third quarter of last year, driven by strong new account growth and increased utilization of our surgical glaucoma product on this.

Surgical glaucoma segment revenue increase to $12 4 million, representing 4% sequential growth from our then record second quarter revenues and growth of 58% versus the third quarter of last year.

And by strong new account growth and increased utilization of our surgical glaucoma product.

Speaker 2: I'd like to remind everyone of the core principles of our company that allow us to persevere and succeed in any operating environment. We focus on the patient first, always.

I'd like to remind everyone of the core principles of our company that allow us to persevere and succeed in any operating environment. We focus on the patient first always we improve the lives of patients suffering from eye diseases by protecting and enhancing their most precious sense.

Speaker 2: We improve the lives of patients suffering from eye diseases by protecting and enhancing their most precious sense, vision.

Yeah.

Speaker 2: We aim to develop safe and effective products that address the underlying causes of the world's most prevalent eye disease.

We aim to develop safe and effective products that address the underlying causes of the world's most prevalent eye diseases.

Speaker 2: Our current commercial products are omni and tear care. Both products are the result of our rigorous product development process, which incorporates four key pillars. First, we master the physiology of a disease to gain a full understanding of the often multifactorial cause.

Current commercial products or omni in hair care. Both products were the result of our rigorous product development process, which incorporates four key pillars first we master the physiology of the disease to gain a full understanding of the orphan multifactorial causes.

Speaker 2: We use this foundational knowledge base to guide our development of solutions that optimize treatment of the underlying causes of the disease.

We use this foundational knowledge base to guide our development of solutions that optimize treatment of the underlying causes of the disease.

Speaker 2: We then apply our iterative design process to develop products that are intuitive for the positions to use.

We then apply our iterative design process to develop products that are intuitive for the physicians to use.

Speaker 2: To pass the final test of our rigorous product development process, we must prove out a viable patient access strategy, either through existing avenues or by pioneering new...

To pass the final test of our rigorous product development process, we must prove out a viable patient access strategy either through existing avenues or by pioneering new routes.

Speaker 2: Leveraging these four pillars, we have created our first two products that have demonstrated improved clinical and real-world outcomes, empowering I care providers to offer the best care for their patients.

Leveraging these four pillars, we've created our first two products that have demonstrated improved clinical and real world outcomes empowering eye care providers to offer the best care for their patients.

Speaker 2: Having passed the rigorous test posed by our four product development pillars, we believe that both Omni and Tier Care are competitively differentiated within their respective eye care marks.

Having passed a rigorous test posed by our four product development pillars, we believe that both omni and tier care, a competitively differentiated within their respective eye care markets.

Speaker 2: This product differentiation is substantiated by the commercial performance, market receptivity, and ECP feedback on both Omni and Tiercare.

Product differentiation is substantiated by the commercial performance market receptivity and ECP feedback on both omni and tier care.

Speaker 2: Our organic innovation and product development model works very well.

Our organic innovation and product development model works very well.

Speaker 2: So expect to hear more from us on the product development brought into court.

So expect to hear more from us on the product development brought in due course.

Speaker 2: Over the near and medium term, we will continue to prioritize three key strategic value drivers. Number one, continuing to expand omnidoption and usage by surgeons for adult patients with primary open angle glaucoma or POAG in the established combination cataract segment of the minimally invasive glaucoma surgery or MIGs market.

Over the near and medium term, we will continue to prioritize three key strategic value drivers number one.

Continuing to expand omnis adoption and usage by surgeons for adult patients with primary open angle glaucoma or G. India established combination cataract segment of the minimally invasive glaucoma surgery or migs market.

Converting this key group of surgeon paved the way for them to perform standalone procedures, which brings up to number two.

Speaker 2: Converting this T group of surgeons paved the way for them to perform standalone procedures, which brings us to number two.

Speaker 2: continue development of the virtually green field and substantially larger standalone segment of the mix market

<unk> development of the virtually greenfield and substantially larger standalone segment of the Migs market.

Speaker 2: And number three, seeking an expanded indication for use for tear care for the application of localized heat therapy in adult patients with evaporative dry eye disease when used in conjunction with manual expression of the myelomian gland.

And number three seeking an expanded indication for use for tier care for the application of localized <unk> T therapy in adult patients with evaporative dry eye disease when used in conjunction with annual expression of the myeloma and plans.

Speaker 2: while also advancing market active initiatives, including payer tailored RCTs that can help create tear care insurance practice, the patients whose eye care professionals believe tear care is appropriate for them.

While also advancing market access initiatives, including payer tailored RCT that can help create year care insurance access.

Patients, whose eyecare professionals believe tier care is appropriate for them.

Speaker 2: We are pleased with our progress advancing each of these objectives.

We are pleased with our progress advancing each of these objectives.

Speaker 2: Our success requires cross-functional collaboration and teamwork through outside science.

Our success requires cross functional collaboration and teamwork throughout by scientists.

Speaker 2: including commercial performance and expansion, the design, execution, and publication of clinical studies, achieving key regulatory milestones, and finally expanding the view of clinical research applications formi. And finally, expanding the view of clinical research applications that

Including commercial performance and expansion.

The design execution and publication of clinical studies achieved.

Achieving key regulatory milestones.

And finally expanding market access.

Our first two goals relate to advancing the treatment of adult patients with <unk> Army.

Speaker 2: Our first two goals relate to advancing the treatment of adult patients with POAG. OMNI has been clinically demonstrated to be safe and effective for intraocular pressure reduction for adult patients with POAG.

Harmony has been clinically demonstrated to be safe and effective for intraocular pressure reduction for adult patients with <unk>.

Speaker 2: Today the mixed market has segmented into procedures performing combination with cataract surgery, which we refer to as the combination cataract segment, and procedures performed on their own, which we refer to as the standalone sex.

Today, the mixed market is segmented into procedures performed in combination with pad rock surgery, which we referred to as the combination cataract segment and procedure performed on their own which we referred to as a standalone segment.

This segmentation is superficial and primarily the result of make bypass stents only being indicated for use in combination cataract procedures.

Speaker 2: This segmentation is superficial and primarily the result of MIGS bypass stents only being indicated for use in combination cataract procedures.

In March of this year, the FDA cleared an expanded indication for use Romney that we believe bridges the unnatural divide between combination cataract and standalone.

Speaker 2: In March of this year, the FDA cleared an expanded indication for use for omni that we believe bridges the unnatural divide between combination cataract and stand-alone.

Speaker 2: This indication for use broadly covers the reduction of infracurricular pressure for all adult patients with POAG without limitation with respect to severity of disease, mild, moderate, and advanced, or lend status, fake it, which refers to patients who have not had cataract surgery, combination cataract, as well as pseudo-fake it, which refers to patients who have that cataract surgery.

This indication for use broadly covers the reduction of intraocular pressure for all adult patients with P. O E G without limitation with respect to severity of disease mild moderate and advanced or lend status Vega, which refers to patients who have not had cataract surgery combination cataract as well, it's pseudo bacon, which refers to <unk>.

<unk>, who have that cataract surgery.

We believe this clearance in omnis expanded indication represented a significant clarifying step forward.

Speaker 2: We believe this clearance and Omnies expanded indication represented a significant clarifying step forward and identifying which makes procedures or appropriate for certain broad indications. Rather than as they do know harm add on to widespread cataractors.

And identifying which makes procedures are appropriate for certain broad indications rather than as they do no harm add on the widespread cataract surgeries.

Speaker 2: This clearance was supported by a substantial body of real world multi-fender clinical data. We continue to invest very aggressively in the clinical and commercial development of Omni, including further enhancements to Omni's indication for use, which I will describe in more detail later.

This clearance was supported by substantial body of real World Multicenter clinical data, we continue to invest very aggressively in the clinical clinical and commercial development of army, including further enhancements to omni as indication for use which I will describe in more detail later.

Speaker 2: We believe that OMNI has two critical physiological and clinical advantages. Number one, OMNI can comprehensively address up to 360 degrees of the disease conventional outflow pathway. But canal implants address a much smaller segment.

We believe that omni has two critical physiological and clinical advantages number one omni can comprehensively address up to 360 degrees of the disease conventional outflow pathway.

All implants address a much smaller segment.

Speaker 2: And number two, Omni can address all three points of resistance in the conventional flow pathway, while canal implants cannot.

And number two omni can address all three points of resistance in the conventional outflow pathway, while canal implants cannot.

Speaker 2: We believe Omnies differentiated efficacy and indication for use coupled with our commercial excellence have driven our best in class commercial performance as evidenced by our share gain in combo cataract and market expansion with standalone.

We believe omni is differentiated efficacy and indication for use coupled with our commercial excellence have driven a best in class commercial performance as evidenced by our share gain and combo cataract and market expansion with Standalone.

Speaker 2: We've made significant inroads penetrating the adult POAG segment of the mix market with our exceptional customer experience initiative, which includes a meticulous surgeon and facility training program. We have already trained a substantial portion of our highest priority customers. The universe of over 3,000 mix trains urgent.

We've made significant inroads penetrating the adult segment of the mixed market with our exceptional customer experience initiative, which includes a meticulous surgeon and facility training program. We have already trained a substantial portion of our highest priority customers a universe of over 3000 makes trained surgeons in the third quarter of <unk>.

Speaker 2: In the third quarter of 2021, approximately 725 facilities ordered omni-surgical systems, which included very healthy growth in new customers.

2021 approximately 725 facilities ordered omni surgical systems, which included very healthy growth in new customers.

The most exciting opportunity to expand the usage of omni lies into five times larger standalone segment, where surgical intervention decisions rely far more heavily on procedure effectiveness and consistency relative to combination cataract procedures, and which we believe the concomitant canal implant procedure is often viewed.

Speaker 2: The most exciting opportunity to expand the usage of Omni lies in the five times larger standalone segment where surgical intervention decisions rely far more heavily on procedure effectiveness and consistency relative to combination cataract procedures in which we believe that consummations canal implant procedure is often viewed as a duno arm add on in the mild patient.

The Juno arm add on in the mild patients.

Speaker 2: to even be considered as the sole reason to take a patient to the operating room. Standalone Migs interventions like Omni must safely deliver a very high consistency and degree of effect.

Even be considered as the sole reason to take a patient to the operating room.

Sand alone makes interventions like omni most safely deliver a very high consistency and degree of effectiveness.

Speaker 2: Typically, surgeons first master using omni and combination cataract procedures because they have already been trained in that setting.

Typically surgeons first master using omni in combination cataract procedures, because they have already been trained and that makes setting.

Speaker 2: As surgeons can confidence in Omni, we have observed a natural progression towards also using Omni in standalone procedure.

Our surgeons gain confidence and omni we have observed a natural progression towards also using omni and standalone procedures.

Speaker 2: In two sequential procedures, Omni allows surgeons to address up to 360 degrees of the conventional outflow channel, dilating and expanding schlem's canal and the collector channels with canaloplasty, followed by unroofing of diseased trabecular meshwork during a single surgical session.

And two sequential procedures omni allows surgeons to address up to 360 degrees of the conventional outflow channel dilating and expanding slums canal and the collector channels with can Alloplasty, followed by Unruh thing of diseased trabecular meshwork during a single surgical session.

Speaker 2: supported by favorable safety data from clinical studies and post-market use.

Courted by favorable safety data from clinical studies and post market use.

Although our customers and surgeons will largely be the same in both segments. We believe the estimated $5 billion Standalone segment requires a new go to market approach to improve awareness and educate the broader community about the new treatment possibilities enabled by all of them.

Speaker 2: Although our customers and surgeons will largely be the same in both segments, we believe the estimated $5 billion standalone segment requires a new go-to-market approach to improve awareness and educate the broader P O A G community about the new treatment possibilities enabled by ONCE.

This outreach program expands our contact points beyond cataract surgeons in glaucoma specialists to also encompass primary ikea providers, who typically first diagnose and treat poa G with medications.

Speaker 2: This outreach program expands our contact points beyond cataract surgeons and glaucoma specialists to also encompass primary eye care providers who typically first diagnose and treat POAG with medications.

As well as patients.

Speaker 2: We are excited to help ophthalmologists, optometrists, and patients better understand the potential advantages of intervention with ophthalmologists.

We are excited to help ophthalmologists optometrists and patients better understand the potential advantages of intervention with Ami.

We continue to see significant potential to expand do you think of omni and are executing a plan to take full advantage of the opportunity that will include targeted expansion of our sales team in 2022 with incremental investments in reps, who will focus specifically on office based clinical education and stand alone.

Speaker 2: We continue to see significant potential to expand usage of Omni and are executing a plan to take full advantage of the opportunity that will include targeted expansion of our sales team in 2022 with incremental investment in reps who will focus specifically on office based clinical education and stand-alone.

Speaker 2: We also made significant progress advancing clinical trials and augmenting the body of published literature and high quality peer-reviewed journals that support the safety and efficacy of Omni for use in future expanded indications for which we are developing the product.

We also made significant progress advancing clinical trials and augmenting the body of published literature in high quality peer reviewed journals that support the safety and efficacy of omni for use in future expanded indications for which we are developing the product.

In August we announced the publication of an article in clinical Ophthalmology analyzing 24 month outcomes from a single Center open label study of the omni surgical system conducted in Germany.

Speaker 2: In August , we announced the publication of an article on clinical ophthalmology analyzing 24-month outcomes from a single-center open-label study of the omni-surgical system conducted in Germany.

Speaker 2: The study reported that use of Omni to perform a standalone mix procedure in mild to moderate open angle glaucoma patients resulted in statistically significant reductions in both IOP and IOP lowering medication use at 24 months.

The study reported that use of omni to perform a standalone makes procedure in mild to moderate open angle glaucoma patients resulted in statistically significant reductions in both IOP and IOP lowering medication use at 24 months mean.

Speaker 2: Meaning baseline IOP in the study decreased from 24.6 millimeters mercury preoperatively to 14.9 millimeters mercury at 24 months or approximately a 40% IOP reduction.

I mean baseline IOP in the study decreased from $24 six millimeters Mercury preoperatively to $14 nine millimeters of Mercury at 24 months were approximately a 40% IOP reduction.

Mean baseline IOP lowering medication also decreased from $1 nine average medications per patient to <unk>.

Speaker 2: Mean baseline IOP lowering medication also decreased from 1.9 average medications per patient to 0.5 medications at month 24 with nearly 60% of eyes free of IOP lowering medication.

Five medications at month 24, with nearly 60% of ice free of IOP lowering medications.

Last week, we announced the publication of another article in clinical ophthalmology that associated Mig using omni with suppressed diurnal fluctuations in IOP.

Speaker 2: Last week, we announced the publication of another article on clinical ophthalmology that associated MIGs using Omni with suppressed diurnal fluctuations in IOP, a clinically meaningful and independent risk factor for the progression of glaucoma.

Cynically meaningful an independent risk factor for the progression of glaucoma.

Speaker 2: In that study, 95% of patients had a diminished P-IOP postoperatively when compared to preoperative measures.

And that study, 95% of patients had a diminished peak IOP post operatively when compared to preoperative measurements.

Speaker 2: And finally, earlier today, we announced FDA authorization to proceed with our precision RCT under IDE. We designed this trial to evaluate the safety and effectiveness of OMNI for use in canaloplasty alone procedure.

And finally earlier today, we announced FDA authorization to proceed with our precision RCT under I E. We designed this trial to evaluate the safety and effectiveness of omni for use in canola plasty alone procedures.

Speaker 2: In precision, we will compare results from combination cataract procedures and three trial on.

In precision we will compare results from combination cataract procedures procedures in three trial arms.

Speaker 2: Canaloplasty alone using Omni, Canaloplasty followed by trabeculotomy using Omni, and Canaloplasty.

Canola pasty alone using omni <unk>, followed by Trabeculectomy, using omni and canal implants.

Speaker 2: We believe precision will represent the largest prospective MIGS RCT ever initiated based on our target of 459 subjects receiving a MIGS procedure.

We believe precision will represent the largest prospective migs RCT ever initiated based on our target of 459 subjects, receiving a mixed procedure.

We plan to use the results of precision to support a premarket submission to the FDA seeking clearance for an expanded indication for use of omni and can alloplasty alone procedures to reduce IOP and adult patients with <unk>.

Speaker 2: We plan to use the results of precision to support a premarket submission to the FDA, seeking clearance for an expanded indication for use of OMNI in canaloplasty alone procedures to reduce IOP in adult patients with POH.

Speaker 2: If we are successful, surgeons would have additional flexibility to use Omni to customize treatment and expand their preferred use case, particularly for milder cases.

If we are successful surgeons would have additional flexibility to use omni to customize treatment and expand their preferred use case, particularly for milder cases.

Speaker 2: Additionally, we hope to share data from Precision with payers who are influential arbiters of patient access. CMS and other payers rely in part on review of relevant medical data published in peer review journals when making coverage and payment policy decisions.

Additionally, we hope to share data from precision with payers, who are influential arbiters of patient access CMS and other payers rely in part on review of relevant medical data published in peer reviewed journals were making coverage and payment policy decisions. We believe our clinical trials would demonstrate clinically significant improvements in health and economic outcomes.

Speaker 2: We believe our clinical trials will demonstrate clinically significant improvements in health and economic outcomes.

Yes.

Our market access team made significant progress securing coverage among private payers for omni procedures in recent months.

Speaker 2: Our market asset team made significant progress securing coverage among private payers for omniprocedures in recent months. We're pleased to report that the omniprocedure is now covered in reimbursed by NAFTS and private payers representing an estimated 75% of all medical benefits covered live.

We're pleased to report that the omni procedure is now covered and reimbursed by Max and private payers, representing an estimated 75% of all medical benefit covered lives.

Speaker 2: We are grateful for the support of the AAL and AGS. We continue to support our efforts.

We are grateful for the support of the Ao and Ags, who continue to support our efforts we continue to make progress and look forward to providing further updates over the coming quarters.

Speaker 2: We continue to make progress and look forward to providing further updates over the coming quarter.

Last week, the centers for Medicare and Medicaid services issued a final rule that includes updates on policy changes for Medicare payments to physicians and facilities. These final rules will go into effect on January one 2022.

Speaker 2: Last week, the Centers for Medicare and Medicaid Services issued a final rule that includes updates on policy changes for Medicare payments to physicians and facilities. These final rules will go into effect on January 1, 2022. Subject to the issue into any updates or corrections by CMS.

Object to the issuance of any updates or corrections by CMS.

Speaker 2: Payments related to CPT Code 66174, which is used to report procedures performed with Omni, were among those that were revised.

Payments related to CPT code 6174, which is used to report procedures performed with omni were among those that were revised.

As a whole we are quite pleased with the Medicare payment landscape that will bring modest increases in payment <unk> and the <unk> settings from 2021 to 2022, our preliminary assessment of the physician fee and facility fee payment rates remains the same as when the proposed rules came out in July as we are going.

Speaker 2: As a whole, we are quite pleased with the Medicare Payment Landscape that will bring modest increases in payment for canaloplastia and for mechilotomy in the ASD and HOPD settings from 2021 to 2022. Our preliminary assessment of the physician fee and facility fee payment rates remains the same as when the proposed rules came out in July as we are going public.

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Speaker 2: We believe Omnib's professional fees will be in a better relative position in 2022 versus 2021 compared to its combination cataract implant competitive.

We believe omnis professional fees will be in a better relative position in 2022 versus 2021 compared to its combination cataract implant competitors.

Speaker 2: Although the approximate professional payment for Canaloplasti will decrease by $209 to $739, which was expected given the elegant procedural advancements made by the Omni Technology for this procedure, the focus of our discussions with physicians continues to center on the strength of our clinical data.

Although the approximate professional payment for <unk> decreased by $209 to $739, which was expected given the elegant procedural advancements made by the omni technology for this procedure.

The focus of our discussions with physicians continues to center on the strength of our clinical data.

Speaker 2: Nonetheless, physician reimbursement for canalopathy will remain significantly superior to reimbursements for both standalone cataract surgery, as well as cataract surgery and combination with canal-based implants.

Nonetheless physician reimbursement for canola policy will remain significantly superior to reimbursements for both Standalone cataract surgery as well as cataract surgery in combination with canal based implants.

Speaker 2: And routine, in routine combination cataract procedures using Omni, the approximate total physician fee will be $1,03 versus $664 for the new canal implant combination cataract code, CPT669-1, and $529 for standalone routine cataract surgery, CPT669-84.

And routine and routine combination cataract procedures using omni.

<unk> total physician fee will be 1000 at $3 versus $664 for the new Canal implant combination cataract code CPT six six to 99 one.

$529 for Standalone routine cataract surgery CPT six six 904.

And complex combination cataract procedures using omni.

Speaker 2: In complex combination cataract procedures using Omni, the approximate position fee will be $1,101 versus $832 for the new Canal and Planting combination with complex cataract codes, CPP, 66989.

<unk> physician fee will be $1101 versus $832. Four then you can allen planting combination with complex cataract codes CPT six $6 99.

Yes.

Speaker 2: Our near-term reimbursement objective is to continually improve the competitive competitiveness of payments for procedures performed with Omni. We believe the combination of one, Omni's highly differentiated efficacy, two, the relative advantage of the 2022 physician fees and modest increase in facility fees for 66174, three ongoing clinical feedback from Omni users, and four are demonstrated historical growth projectors.

Our near term reimbursement objective is to continually improve.

The competitive competitiveness of payments for procedures performed with omni we believe the combination of one omni it's highly differentiated efficacy to the relative advantage of the 2022 position feeds and modest increase in facility fees for 667 for three ongoing clinical feedback from omni users.

And for our demonstrated historical growth trajectory.

Speaker 2: will allow us to continue to take share from the combo powder act in all implants and advance our leadership in the five times larger standalone segment.

Allow us to continue to take share from the combo cataract Canal implants and advance our leadership in the five times larger Standalone segment.

We are pleased that CPT code six 674 will realize a modest increase of about 2% in both the ASC setting, which accounts for over 80% of Omnis U S revenues and the H O PD setting.

Speaker 2: We are pleased that CPT code 66174 will realize a modest increase of about 2% in both the ASC setting, which accounts for over 80% of OMNI's U.S. revenues, and the HOPD setting. Payments for canal posse will increase 2.5% to $1,919 in the ASC setting and 2.1% to $4,000 in the ASC setting.

I'm in for Canal biofuel increased two 5% to $1919 in the ASC setting and two 1%.

To $4000 in the <unk> setting.

Speaker 2: In 2022, AFDs will receive over $850 more for a standalone nominee procedure than for a standalone cataract procedure. For HOPDs, the difference for these same two procedures will exceed $1800.

In 2022, <unk> will receive over $850 more for a standalone omni procedure than for a standalone cataract procedure for <unk>. The difference for the same two procedures will exceed $800.

Speaker 2: In 2021, ASDs received 953 more for combination cataract procedures using canal implants and for combination cataract canalopathy procedures. This gap will be reduced by $158 for 2022, and we will continue our efforts alongside the medical society, patient advocacy groups, and the surgical community to seek more equitable reimbursement.

In 2021, Asce's received 953 more for combination cataract procedures using canal implants and for combination cataract and Alloplasty procedures. This gap will be reduced by $158 for 2022, and we will continue our efforts alongside the medical societies patient advocacy groups.

In the surgical community to seek more equitable reimbursement.

Yeah.

Speaker 2: We saw device intensive status for CPT code 61674 in the ASC setting, which would have resulted in an increase in payments to ASC's. CMS declined to assign device intensive designation for 61674 for 2022. We believe this decision is incorrect and stems from inaccurate hospital reporting of device costs for CPT 61674.

We thought device intensive status for CPT code six $6 74 in the ASC setting, which would have resulted in an increase in payments ASC.

<unk> declined to assign device intensive designation for six 674 for 2022. We believe this decision is incorrect and stems from inaccurate hospital reporting of device cost for CPT six 674.

Speaker 2: We will continue to work with the medical societies, patient advocacy groups, CMS, and other op-domics stakeholders to help ensure the accuracy of the billing data that CMS will rely on when deciding whether CPT-661-7-4 merits device intensive status in the future.

We will continue to work with the medical societies and patient advocacy groups CMS and other ophthalmic stakeholders to help ensure the accuracy of the billing data that CMS will rely on when deciding whether CPT six 674 merits device intensive status in the future.

Speaker 2: Our third value driver focuses on tear care, which is currently marketed as a power heating pad for the application of localized heat, where the medical community recommends the application of a warm compress to the island.

Our third value driver focuses on tier two which is currently marketed as a powered heating pad for the application of localized heat or the medical community recommend to the application of a warm compress to the islands we.

Speaker 2: We purposefully built tier care to deliver a precise and tightly controlled level of penetrating thermal energy through the outer eyelids and into the mybomian glands on the posterior side of the eyelids in a comfortable office-based procedure.

We purposefully built here care to deliver a precise and tightly controlled level of penetrating thermal energy through the outer islands and into my Bellamy at glance on the post here your side of the islands and a comfortable office based procedure.

Speaker 2: We introduced tier care in a controlled launch two years ago, with approximately 10 reps covering the United States. Our plan for 2022 includes modest expansion of our tier care sales force to fill in high value geographic white space, our controlled launch team cannot fully cover.

We introduced here carrying a controlled launch two years ago with approximately 10 reps covering the United States are planned for 2022 includes modest expansion of our care care salesforce to fill in high value geographic White space, our controlled launch team cannot fully cover.

We are developing and seeking FDA clearance of an expanded indication appear care for the application of localized heat therapy in adult patients with evaporative dry eye disease due to Michael and me and gland dysfunction when used in conjunction with annual expression of my bromine glands.

Speaker 2: We are developing and seeking FDA clearance of an expanded indication of peer care for the application of localized heat therapy and adult patients with evaporative ri-i disease due to mybomian gland dysfunction, when you use a conjunction with manual expression of mybomian.

Speaker 2: So IE is a multi-factorial disease that is most commonly characterized by poor quality tears that evaporate too quickly.

Dry eye is a multifactorial disease that is most commonly characterized by poor quality tiers that are evaporate too quickly.

Speaker 2: study data show that 86% of dry eye cases are associated with MGD. Yet, the most common dry eye treatments used today address aqueous deficiency or inflammation and represent 95% of manufacturer rep.

Study data showed that 86% of dry eye cases are associated with mgd, yet the most common dry eye treatments used today address aqueous sufficiency for inflammation and represent 95% of manufacturer revenues.

None of the leading prescription eye drop medications are indicated for or have a mechanism targeting the most prevalent underlying cause of dry eye M. D D.

Speaker 2: None of the leading prescription eyedrop medications are indicated for or have a mechanism targeting the most prevalent underlying cause of tri-i. M-G-D.

Speaker 2: to compound this issue, Medicare and commercial insurance have not established any meaningful reimbursement for MGD treatment.

Compounding this issue Medicare and commercial insurers have not established any meaningful reimbursement for mgd treatment.

Dry eye is the number one reason for visits to an eye care provider and we believe the U S market for effective mgd treatment could exceed $10 billion annually we.

Speaker 2: Try the number one reason for visits to an I care provider and we believe the US market for effective NGD treatment could exceed $10 billion.

Speaker 2: We are executing a very thoughtful and well-informed strategy to unlock the potential market for tear care and its authorized indications by pioneering optimal patient access to effective MGD care through health insurance.

We are executing a very thoughtful and well informed strategy to unlock the potential market for tier care.

And it's authorized indications by pioneering optimal patient access to effective mgd care through health insurance.

Speaker 2: We want to maximize the reach of our peer care technology and intend to provide a comprehensive solution for the broadest range of MDD sufferers.

We want to maximize the reach of our tiered care technology and intend to provide a comprehensive solution for the broadest range of MTV suffers.

Speaker 2: As with our value drivers for surgical glaucoma, our dry eye strategic initiative also involves cross-functional support from our clinical regulatory, market access and commercial teams.

As with our value drivers for surgical glaucoma, our dry eye strategic initiative also involves cross functional support from our clinical regulatory market access and commercial teams.

Speaker 2: On the regulatory front, we submitted a pre-market notification to the FDA in September that we hope will result in clearance for an expanded indication for use of peer care in the coming months.

On the regulatory front, we submitted a premarket notification to the FDA in September that we.

We hope will result in clearance for an expanded indication for use of tier care in the coming months.

Speaker 2: In parallel with our Tier Care regulatory efforts, enrollment continues nicely in our second Tier Care RCT, Sahara, which will evaluate the efficacy of Tier Care compared to a leading prescription briy medication and assess the durability of Tier Care treatments over a 24-month period.

In parallel with our tier to a regulatory efforts enrollment continues nicely and our second tier care RCT Sahara.

Which will evaluate the efficacy of tier care compared to a leading prescription dry eye medication and assess the durability of care care treatments over a 24 month period.

Particles based on results from our first RCT Olympia had been published in two leading peer reviewed journals and Olympia care care was compared to liberal flow. Among the recent publications was an article in cornea.

Speaker 2: Articles based on results from our first RCT, Olympia, have been published in two leading peer review journals. In Olympia, peer care was compared to lipoplo. Among the recent publications was an article in Cornia, reporting that a single use of peer care significantly alleviated the signs and symptoms of dry eye disease and patients with MGD. We expect data from Olympia, Sahara, and other studies will support several several additional articles in peer review journals.

<unk> got a single use of tier care significantly alleviated the signs and symptoms of dry eye disease in patients with Mg a day.

We expect data from Olympia Tahira and other studies will support several several additional articles in peer reviewed journals.

Speaker 2: I would like to conclude my remarks by addressing why we sued I-

I would like to conclude my remarks by addressing why we see diagnosis.

Speaker 2: In brief, we sued to protect our investments in research and development and to protect the market share and margins of our products.

In brief.

We sued to protect our investments in research and development and to protect the market share and margins of our products.

Speaker 2: My brother and co-founder David and I began developing breakthrough up ophthalmology technologies over 15 years ago. In the years that followed, we have continuously invested in research and development. We incorporated many of these innovations in successful commercial products like omnivac care. Our continuing ability

Brother, and co founder, David and I began developing breakthrough ophthalmology technologies over 15 years ago.

In the years that followed we have continuously invested in research and development. We incorporated many of these innovation and successful commercial products like Omnia in tier care.

Our continuing ability to grow site sciences, and invest in R&D depends on obtaining and enforcing intellectual property rights.

Speaker 2: and invest in R&D depends on obtaining and enforcing intellectual property rights. Our investors deserve to realize that

Our investors deserve to realize value from our inventions.

Speaker 2: Where we see blatant encroachment on our intellectual property, we must vigorously defend our rights. We owe it to our patients, our company, and our shareholders to hold accountable competitors who speak to profit from our investment. We cannot sit idly by while a competitor uses our intellectual property to compete against our own products.

Where we see blatant encroachment on our intellectual property, we must vigorously defend our rights, we owe it to our patients our company and our shareholders to hold accountable competitors, who seek to profit from our investment we cannot sit idly by while a competitor uses our intellectual property to compete against our own products.

I would also like to note that the patents asserted against I've asked this or not associated with omni the four patents in suit relate to our implantable circumferential Enel scaffolding intellectual property.

Speaker 2: I would also like to note that the patents asserted against Ivantis are not associated with Omni. The four patents in suit relate to our implantable, circumferential, canal scaffolding intellectual property.

Speaker 2: The Hydrus MicroStent competes directly with Omni and the combination padwreck.

The hydrus Microstat competes directly with omni in the combination cataract segment.

Speaker 2: Our law should seek to enjoy an event as from a infringing competition.

Our lawsuits seek to enjoin Ivy on tests from its infringing competition.

With that I will I'll now turn the call over to Jesse to discuss our third quarter financial results Jesse.

Speaker 2: With that, I will now turn the call over to Jesse to discuss our third quarter financial results. Jesse.

Speaker 3: Thank you, Paul. Our total revenue for the three months September 30, 2021 was a record 13.1.

Thank you Paul our total revenue for the three months ended September 32021 was a record $13 1 million, a 51% increase from the $8 7 million.

Speaker 3: a 51% increase from the 8.7 million in the same period of 2020, and a 5% sequential increase from 12.5.

Same period of 2025% sequential increase from $12 5 million in the second quarter of 2021, and what normally is a seasonally weak sequential quarter in our industry.

Speaker 3: the second quarter of 2021, and what normally is a seasonally weak sequential quarter in our industry. Our combined growth

Our combined gross margin for the third quarter was 84% compared to 70% in the corresponding prior year period, and 82% from the second quarter of 2021.

Speaker 3: Compared to 70% of the corresponding prior year periods and 82% in the second quarter of 2021.

Speaker 3: Our surgeon, Hogan, will come as segment revenue to the third quarter, or a record 12.4 million.

Our surgical glaucoma segment revenues for the third quarter were a record $12 $4 million.

Speaker 3: up 58% from 7.9 million in the third quarter of 2020. That sequential increase of 4% from 12 million in the second quarter of 2021.

58% from $7 $9 million in this third quarter of 2020, and a sequential increase of 4% from 12 million in the second quarter of 2021.

Speaker 3: But we believe that COVID remains the factor in how all companies now

While we believe the Covid remains a factor in how all companies now conduct business its impact on our commercial opportunities, but not significantly changed from when we spoke to you in August.

Speaker 3: It's impact on our commercial opportunity did not significantly change from when we spoke to you in August . Further, we did not observe...

Speaker 3: increased Omni-Trial in due to the proposed rate changes at CMS that were announced in July . We trained modestly more surgeons than the third quarter than we did in the second.

Speaker 3: It reflected more of the long-term growth trajectory in our business rather than any one-time.

Speaker 3: As I said, rather than enjoying any one-time gross benefit, we believe a number of customers actually offset the hypothetical reimbursement tail when by deferring these trainings until they could work through their canal implant image.

Speaker 3: There was concern that reimbursement for canal implants will lose significant value action.

Speaker 3: Very simply, our results point to the continuation of exemplary, consistent commercial like...

Speaker 3: Paul is to in his comments, we have said a standard of consistent market leading growth at the center of a dynamically changing matrix.

Speaker 3: And once we are gaining dollar in volume share quarter after quarter after.

Speaker 3: I also growing the overall makes market pie with each omnistandle

Speaker 3: More specifically for this period, our surgical glaucoma sales benefited from an increase in the number of new accounts sold to in the quarter, doing part to a selling environment that had more normalized commercial access to customer facilities than we had seen last year, as well as increased utilization per act.

Utilization per active account the results for the quarter were challenged by seasonality factors, such a surgeon vacation that increased COVID-19 related impacts compared to the second quarter that we believe were associated with the Delta variant in July specifically.

Speaker 3: The results for the quarter were challenged by sea valley factors, such as surge invacations that increased COVID related impacts compared to the second quarter that we believe were associated with the Delta variant in July .

Speaker 3: Growth margin in Certicals at home was 87% in the third quarter compared to 75% in the prior year period, and 85% in the second.

Most margin in surgical glaucoma was 87% in the third quarter compared to 75% in the prior year period and 85% in the second quarter.

Speaker 3: The potential improvement was primarily the transition of production to a low cost high-line contract community factor in the first step.

Sensual improvement was primarily the result of the transition of production to a low cost high volume contract manufacturer in the first half of the year.

Speaker 3: In our dry segment, revenues were more 700,000, or 0.7 million in the third quarter of 2020.

And our dry segment revenues were were 700000 or $7 million in the third quarter of 2021. Although this represents a decrease from the point $8 million in the prior year period, we believe we improve the quality of the revenue by focusing more on specialized dry I accounts that can help us with our long term strategy a pioneering market.

Speaker 3: Although this represents a decrease from the point eight million in the prior year period, we believe we improved the quality of the revenue by focusing more on specialized dry eye accounts that can help us with our long-term strategy of pioneering market access for MGD.

Access for M. G D.

Speaker 3: The understanding of this strategy is not necessarily aligned with the public market valuation environment largely driven by revenue. We maintain our absolute conviction and care cared long term value and this approach to maximize.

We understand this strategy is not necessarily the line with the public market valuation environment, largely driven by revenue.

We maintain our absolute conviction tier cared long term value in this approach to maximize value.

Speaker 3: Beginning in the fourth quarter of 2020, we refocus our dry sales team on accounts that would better align with our long-term goal of pioneering optimal access to effective MGD patients.

Beginning in the fourth quarter of 2020, we refocus our drive sales team on account that would better align with our long term goal of pioneering optimal access so affected mgd patient care, we anticipated that the strategy would negatively impact near term result of the time, while our team adjusted before re establishing strategic long term growth.

Speaker 3: We anticipated that the strategy would negatively impact near-term results of the time, while our team adjusted before reestablishing strategic long-term growth. Emphasizing this point into the highlights of strength of the effort. Following the initial decrease in sales in the fourth quarter of 2020, our dry-eye sequential growth has increased 37.

Emphasizing this point them to us and the highlights the strength of the effort.

Following an initial decrease in sales in the fourth quarter of 2020 or dry ice sequential growth has increased 37% per quarter.

Speaker 3: Revenue for the third quarter of 2021, we're 2.4 times the fourth quarter of 2020. And we began this initiative.

Revenues for the third quarter of 2021 or two four times, the fourth quarter of 2020 and we'd be in this initiative.

Speaker 3: The on the financials, we are pleased with the results of our market access driven strategy, which has resulted in improved targeting of new customers to fit tier-care's value problems.

Beyond the financials, we're pleased with the results of our Mac market access driven strategy, which has resulted in improved targeting of new customers to fit here cares value proposition.

Speaker 3: Our sequencer was of 20% in the third quarter, benefited from a growing number of new facilities sold compared to the second quarter, as well as a larger base of reordering costs.

Or sequential growth of 20% in the third quarter benefited from a growing number of do facilities sold compared to the second quarter as well as a larger base of reordering customers gross margin and dry was 33% in the quarter versus 12% in the third quarter of 2023% in the second quarter of 2021.

Speaker 3: Gross margin in dry was 33% in the quarter versus 12% in the third quarter of 2020 and 3% in the second quarter of 2020.

Speaker 3: as we discussed on previous calls, dry, aggres, mart

As we discussed on previous calls dry gross margins will be noisy until we constantly scale the business at which point. We believe we will be able to generate gross margins approaching those enjoyed by the surgical back home or business.

Speaker 3: will be able to generate gross margin, approaching those enjoyed by the surgical box.

Operating expenses in the third quarter of 2021, or $25 $1 million and 87% increase from $13.4 million in the third quarter of 2020, and 18% increase from $21.3 million in the second quarter of 2021.

Speaker 3: Operating expenses in the third quarter of 2021 were 25

Speaker 3: and 87% increase from 13.4 million to the third quarter of 2020, and 18% increase from 21.3 million in the second quarter of 2021.

Speaker 3: It's important as the operating expenses for the quarter included non-cash stock-based of $1.9 million.

It's important to note that the operating expenses for the quarter included non-cash stock based compensation of $1.9 million, which on a comparative basis versus.

Speaker 3: comparative basis versus 0.2 million in the prior year and 0.9 million in the second quarter of 2021 both as ladder periods being pre-iped

$2 million in the prior year and point 9 million in the second quarter of 2021, both of those latter periods being pre IPO.

SG&A expenses for the quarter or $28 million compared to $11.2 million in the third quarter of 2020 and $17.8 million in the second quarter of 2021. The increase in SG&A was primarily due to our continued investment in scaling of operations and corporate head count to support our growth.

Speaker 3: SGNA expenses for the quarter were 20.8 million compared to 11.2 million in the third quarter of 2020 and 17.8 million in the second quarter of 2021 The increase in SGNA was primarily due to our continued investment in scaling of operations and corporate headcounts

Speaker 3: As part of our planning process for 2022, we identified opportunities to augment our team and further accelerator.

Part of our planning process for 2022, we identify opportunities to augment our team in further accelerated growth will continue to make significant investment in our corporate systems and personnel to ensure we make the most of our best opportunity to improve patients' lives.

Speaker 3: continue to make significant investment in our corporate systems and personnel to ensure we make the most of our vast opportunity to improve pace.

Speaker 3: R&D expenses for the quarter were $4.3 million compared to $2.2 million in the third quarter of 2020 and $3.5 million in the second quarter of 2021.

R&D expenses for the quarter or $4.3 million compared to $2 $2 million in the third quarter of 2023, and a half million dollars in the second quarter of 2021.

Speaker 3: The majority being increased in R&D expense from 2020 to 2021 was due to three factors. One, an increase in personal expenses as we build out our clinical and regulatory and R&D departments.

The majority of the increase in R&D expense from 2000 22021 was due to three factors one an increase in personnel expenses as we build out our clinical and regulatory N R&D departments.

Speaker 3: Two, contract manufacturing, last supplies and prototype development expenses, and three, clinical studies, which Paul highlighted.

Two contract manufacturing last supplies and prototype development expenses and three clinical studies, which Paul.

Which Paul highlighted in his comments.

Speaker 3: The second R&D expense to continue to grow over the near term as we execute our chemical roadmap and build out our internal R&D capes.

Second R&D expense to continue to grow over the near term as we execute our clinical roadmap and build out our internal R&D capabilities.

Loss from operations for the for the three months ended September 30th 2021 of those 14 million, which compares to a loss of seven $4 million for the same period in 2020 and a losses 11, one nine in the second quarter of 2021 also uniquely in this quarter, we recognize other expense of $2 million.

Speaker 3: Lost from operations for the three months ended September 30th, 2021 was 14 million, which compares to a loss of 7.4 million for the same period in 2020, and a loss of 11.1 million in the second quarter of 2020.

Speaker 3: Also uniquely in this quarter we recognize other expenses of $2 million compared to

Compared to.

Speaker 3: 2 million in the prior year period. And this was due to a final fair value free measurement of since exercise for Fertstock Horn since upon our IPF.

$2 million in the prior year period, and this was due to a final fair value.

Measurement of since exercise preferred stockhorn since our upon our IPO the.

Speaker 3: state the obvious this will not be a expense that will recur going forward given the change in our cap structure post.

The state the obvious this this will not be a expense that will recur going forward given the changing our cap structure post ikea.

We had a net loss of $17.2 million or four three per share or 43 cents per share for the.

Speaker 3: The net loss of $17.2 million or 0.43 cents per share or 43 cents.

Speaker 3: for the third quarter of 2021. Based on a weighted average post IPO share count of 39.8 million shares. This compares to net loss of 8.1 million or 85 cents.

Third quarter of 2021 based on a weighted average post ipos share kind of 39 8 million shares. This comparison that lots of $8 $1 million.85 per share in the third quarter of 2020 based on a weighted average pre ipos sure kind of nine and a half moon chairs.

Speaker 3: the third quarter of 2020, based on our weighted average pre-IPI share count of 90 and a half.

Speaker 3: We ended the quarter with $271.5 million of cash and equivalent and $32.5 million of loans.

We ended the quarter was 271, and a half million dollars of cash and equivalents and 32 and a half million dollars of long term debt.

Speaker 3: As a reminder, we completed our initial public offering in mid-July, which generated net proceeds of approximately $252.2 million.

As a reminder, we completed our initial public offering in mid July which generated net proceeds of approximately $262 $2 million.

Speaker 3: Turning to our outlet for 2021, we were revising our full year revenue guidance to $47.5 million to $48.5.

Turning to our outlook for 2021, we're revising our full year revenue guidance of 47, and a half million dollars to 48, and a half million dollars, which will represent growth of approximately 74% over 2020 at the midpoint.

Speaker 3: which will represent growth of approximately 74% over 2020.

Speaker 3: This guidance reflects the continuation of the growth trends leading to our we observe in recent quarters.

This guidance reflects the continuation of the growth trends weakens her we observed in recent quarters.

Speaker 3: MTAXNO can't continue outstanding growth upon the metals while factoring in feasibility patterns, including fewer selling days that are remaining with 50,000, 21 due to holidays and vacations, and a presumption of the operating environment that we saw in the third quarter of 2021, and to date in the fourth quarter remains consistent through the year end. With that, I'd like to turn the topic on.

And it takes no can't continue outstanding growth fundamentals, while factoring in seasonality patterns, including fewer selling days of the remaining weeks of 2021 due to holidays and vacations and a presumption of the operating environment that we saw in the third quarter of 2021 and the date in the fourth quarter remains consistent through the year and.

With that I'd like to turn the call back over to call for some closing comments.

Thank you Jessie.

Speaker 2: I hope we've made it very clear how our fundamental commitment to delivering the power of sight to patients with eye disease informs every decision we make.

Hope we've made it very clear how our fundamental commitment to delivering the power of site to patient with eye disease informs every decision we make.

Speaker 2: We believe we are one of the very few companies in the medical device sector.

We believe we are one of the very few companies and the medical device sector.

Speaker 2: with the demonstrated capabilities to both innovate disruptively and commercialize with excellence.

With the demonstrated capabilities to both innovate disruptive Lee.

And commercialized with excellence.

Speaker 2: We tried to operate at an entirely different level, and that was on display this past quarter, where we rose to the occasion, excelled on all fronts, and set commercial record.

We strive to operate at an entirely different level and that was on display this past quarter, where we rode to the occasion excelled on all fronts.

That commercial records across the board.

Jesse and I will now be joined by Sean O'neil or cheap commercial officer to answer your questions.

Speaker 2: Jeffie and I will now be joined by Sean O'Neill, our Chief Commercial Officer to answer your questions. Operator, please open.

<unk>. Please open up the call for questions.

Speaker 1: Yes sir. At this time we will be conducting a question and answer session. To ask a question, press star one on your telephone. To ensure that everyone has an opportunity to participate, we ask that you ask one question and one follow-up. Our first question comes from the line of Ms. Cecilia, for long, for Morgan Stanley . The line is now open.

At this time, we will be conducting a question and answer session to ask a question that's Taiwan on your telephone.

Sure everyone has an opportunity to participate we ask.

If you ask one question and one follow up.

Our first question comes from the line of Mr. Syria play long from like in Sandy. Your line is now open.

Speaker 4: Great, good afternoon and thank you for taking the questions. I wanted to start with the account growth that you highlighted in the quarter for Omni. And if you could just walk through and what you saw both from a headwind standpoint, anything due to COVID, seasonality, but then also how you were able to open the accounts you were, the trajectory you saw and as you look into 4Q as well, and see the road map you see there for further accounts.

Good afternoon, and thank you for taking my questions I wanted to start with the account. Okay that you highlighted in cricket on me.

And if you could just walk too he was like you saw listen the headland sandpoint anything you need to Covid seasonality, but then also.

How you are able to open the account you wanted the trajectory, Utah and as you look into like you as well as the the road map you see there for for the account opening.

Speaker 5: Actually it's guessy, I'll take the first stab at that.

Yeah, I'll take the first stab at that.

We had a very strong quarter. It was a quarter in line with the second quarter in terms of.

Speaker 3: He had a very strong quarter. He was a quarter in line with the second quarter in terms of new account openings. I'm out.

New account openings amount of trial activities.

Speaker 3: and the like, you know, our retention metrics are very strong as well. You know,

The like you know our respect and our retention metrics, we're very strong as well.

We.

Well, we didn't see as we didn't see a.

Speaker 3: Well, we didn't see a, you know, my comments were really around the fact that,

My comments were really around the fact that it's not a one off level of growth based on sort of noise in terms of the reimbursement market Uhm, there's very much in line with the trajectory that we've been going.

Speaker 3: Not a one-off level growth based on sort of noise in terms of the reimbursement market. It was just very much in line with the trajectory that we've enjoyed over the course.

Over the course of the year and so.

Speaker 5: So, you know, I think COVID is based into how we operate and our customers operate at this point in time and we have the opportunity to continue to sell in the growth and we're taking advantage of that opportunity. And so that's why we were able to put up the results that we did.

I think COVID-19 is baked into how we operate and our customers operate at this point in time and we have the opportunity to continue to tell them to grow and we're taking advantage of that opportunity and so.

That's why we were able to put up the results that we did.

Yeah, So <unk> I would add on that did it continues you know our trajectory and confidence continues to be fueled by our focus on with exceptional customer experience.

Speaker 6: Yes, the facility of the Sushon, I would add on that, that it continues our trajectory and confidence continues to be fueled by our focus on the exceptional customer experience.

Speaker 6: that we demonstrate actually across both businesses, Omni and tear care. And it's really the care in the training of the surgeon, doctor, and staff to ensure positive outcomes from their perspective as well as positive outcomes for their patients. And with that just continues to grow the confidence for greater utilization. And it brownies specifically then in the standalone market as I'll discuss in this.

That we demonstrate actually caused both businesses on me into your care and it's really the care and the training of of the surgeon darker and staff to ensure positive outcomes from their perspective as well as positive outcomes for their patients and with with that just continues to grow the couch with his for greater you.

Elevation.

And if romney specifically than in the Standalone marketers Paul discusses his comments.

Speaker 4: Great, thank you. And I guess too, I wanted to ask just in terms of for Q-Gyden, what you're factoring in, both from a reimbursement now that everything's been finalized. But any...

Okay. Thank you in and then it gets too I I wanted to ask just contends before I can get in late affecting them both sound that Ah reimbursement now that everything's been finalize but any potential benefit from that and do you think about four Q. Just ahead of 22 implementation backlog impact.

Speaker 4: potential benefits and that is you think about 4Q, just ahead of 22 implementation, backlog impact, COVID pressures, just any other dynamic you would call out, as well as what you expect with the new label to be able to see just from the standalone opportunity and continuing to drive that. And thank you. Thank you.

The pressures with any other dynamic he would call out. That's all is what you expect with the new label to be able to see just send a standalone opportune continuing to drive that and thank you.

Yeah, I'll I'll start then Paul I'm Sean.

Obviously pile on.

Speaker 5: The guidance is based on...

The the guidance is based on the continuation of the growth metrics that we've been posting largely obviously in the third of walk home or business.

Speaker 3: of the growth metrics that we've been posting, largely obviously in the surgical accommod business.

Speaker 3: or not, doesn't reflect anything. It reflects the current operation.

Or not it doesn't reflect anything added reflect the current operating about.

Speaker 3: We're not facility like guessing as the competitive reaction based on 2022 changes.

We're not phacelia like guessing as to competitive reaction based on 2022 changes.

Speaker 5: You know, our view is that those changes will benefit us, but, you know, the 2021 rates are still in place and our guidance reflects really just the continuation of...

We our view is that those changes will benefit us, but you know the 2021 rates are still in place and.

Men are.

<unk> guidance reflects really just a continuation of of the.

Speaker 5: The result that we put forward and sort of the forward leading API to attract both.

The results that we put forward and sort of the forward, leaving kpis to attract closely.

Yeah, I'll, just add onto that Jessie as it relates to CMS in the final rule in our outlook.

Speaker 2: I'll just add on to that, Jeffy. As it relates to CMS and the final rule and our outlook, like the first state, our outlook was, has always been extremely strong prior to our IPL, leading up to it and through it, which coincided with the proposed rule.

I'd like the first day at our outlook was has always been extremely strong prior to our IPO, leading up to it and threw it uhm, which coincided with the proposal.

Speaker 2: The proposed rule and more importantly, the final rule improved our relative position vis-a-vis our competition on both the professional fee for our 66174 Surgeon fee premium, widened over canal and plant injection fees.

The proposed rule and more importantly, the final rule improved a relative position visa via <unk> competition on both the professional fee for.

Four or 66174 surgeon fee premium widened over canal implant injection fees.

Speaker 2: Following a thoughtful rock survey of almost 100 off-down mixed surge.

Following a thoughtful rock survey of almost 100 ophthalmic surgeons.

Speaker 2: You know, the surgeon survey results, placing a premium on 661.74 over implant injections, which frankly expected, since we know we ask our surgeons to perform more time intensive, skillful, circumfrontial, multi-procedural work that ultimately drives up the consistency and degree of IOP lowering clinical effects for patients.

And you know the surgeon survey results, placing a premium on 66174 over implant injections, which frankly expected since we know we ask our surgeons to perform more time intensive skillful circumferential multi procedural work that ultimately drives up the consistency of degree of IOP lowering clinical effects for patients.

On the facility beside to think we were pleased to see our 66174 facility fee disadvantage narrowed.

Speaker 2: On the facility beside the thing, we are pleased to see our 6-6-174 facility be disadvantaged in error.

Speaker 2: The Cadar Extensive always had an advantage on the facility fee and that advantage narrowed in the final rule. So, NetNet, your questions were relatively better off in 2022 versus 2021 relative to our Cadar Extensive.

Cataracts dense have always had an advantage on the facility and that advantage narrowed in the final rule. So net net to your question, we're relatively better off in 2022 versus 2021 relative to a cataract than competitors outlook for commercial scale and growth.

Speaker 2: Our outlook for commercial scale and growth has only been reinforced with more wind behind our backs as we enter 2022 and build on the on the acceleration.

It's only been reinforced with more wind behind our boxes, we under 2022 and build on the omni acceleration, we've seen quarter after quarter in 2021 without those CMS relative improvement to 66174 and the last thing I just want to mention quickly is there's a lot of comparison when these rules come out they are important in there.

Speaker 2: We've seen quarter after quarter in 2021 without those CMS relatives improvement six, six, one, seven, four. And the last thing I just want to mention quickly is there's a lot of comparison. When these rules come out, they're important and there's a lot of comparisons between us and the combo-catter act and competition. I think it's really important to remind everybody

There's a lot of comparisons between us and the combo patter accident competition I think it's really important to.

Remind everybody.

Speaker 2: that our focus and growth market at site is the five times larger stand-alone.

But our focus and growth market a site, it's the five times larger Standalone Margaret.

Speaker 2: where we stand alone and are pioneering that space. So on that front in standalone, the 66174 Pro-Fee and Facility Fee in the final rule is very competitive and attractive compared to cataract surgery alone, both on the professional fee and ASC fee. So generally, we are very bullish in both the combo cataract segment, as well as the much larger standalone segment.

Where we stand alone and a pioneering that space so on that front and stand alone.

66174 protein and facility and the final rule is very competitive and attractive compared to cataract surgery alone both on the professional <unk> and a SEC. So generally we are very bullish in both the combos address segment as well as the much larger Standalone segment.

This facility is John I would add on your your question around the label. The label continues to be a positive force as well with the expanded label from the and the breath of the adult tastes with a primary openings all come with an iced tea lowering they'd really is going to be the corners.

Speaker 6: Yes, Cecilia Sean, I would add on your question around the label, but the label continues to be a positive for us as well with the expanded label from the in the breadth of the adult patient primary opening of the glaucoma and lowering.

Speaker 6: that really is going to be the cornerstone of our market leading disease state education campaign, as well as is where we're going to be investing resources to educate the primary care provider. So we are definitely leveraging that expanded label to educate the community on standalone and continue to pioneer and create leadership role in the standalone space.

And those are market, leading disease state education campaign as well as is where we're gonna be investing resources to educate the primary care I care provider. So we are definitely leveraging that expanded label to educate the community Standalone and can.

Two new to pioneer and create leadership role in the Standalone space.

Thank you.

Speaker 1: Our next question comes from the line of Mr. Mathur Ryan from Piper Sandler. Your line is now open.

Our next question comes from the Linus Mister Mac and Brian from Cyprus handling your line is now open.

Oh afternoon, Thanks for taking my questions I.

Speaker 2: Afternoon. Thanks for taking my questions. I guess just to follow up on what Cecilia was asking you as far as new accounts go, can you kind of frame up what you saw in terms of training competitive clinicians versus kind of those new to MIGs? And then what did you see in Q3 as far as standalone sales versus combo cataract?

I guess, just a follow up on what phacelia was asking as far as.

New accounts go can you kind of frame up what you saw in terms of.

Training competitive clinicians versus kind of those new to Mig and then what did you see in Q3 as far as stand alone.

Uhm sales versus.

<unk>.

And then this is shaun yeah, so as far as.

Speaker 6: And Matt, this is Sean. Yes, so as far as the training of new surgeons, we continue to focus on the high volume of make surgeons as the bolus of our trained universe. As we continue to penetrate into those roughly 3,000 make trained comprehensive surgeons in the United States.

Training of new Surgeons, we continue to focus on the high volume make surgeons. There's some bullets are are are trained universe as we continue to penetrate into those roughly 3000. Thanks trained comprehensive surgeons in the United States. So.

Speaker 6: So we've definitely seen, you know, as we continue to penetrate into that group.

So we've we've definitely seen as we continue to penetrate into that group because they are the ones that are already well informed on me and they had me and Angel surgery, and we're gaining confidence with them in that combo space ultimately leading into our expansion of the Standalone space.

Speaker 6: because they are the ones that are already well informed on the anatomy and ankle surgery. And we're gaining confidence with them in that combo space, ultimately leading into our expansion of the standalone space.

Speaker 6: I know that we are getting some additional data, CPT level data to really quantify our penetration in the standalone space as we've mentioned before. We do have, you know, internal information that shows that we are growing in that space based on our training and conversation with surgeons. And we look forward to providing more detailed information of the future as we get that additional data.

I know that we are getting some additional data CPT level data to really quantify or penetration understandable space. As we've mentioned before we do have an internal information that shows that we are growing in the space based on our training in conversation with where surgeons we look.

Forward to providing more detailed information in the future we get that additional data.

Speaker 2: Yep. Hi, Matt. Hi, Matt. Sorry. So, get that on that real quick.

Yeah.

Okay.

On that real quick.

We do want to get.

Speaker 7: granular data to report quarterly on our standalone progress market development progress. We have done some initial CPT analysis for now just annual results and we can say that the year of omnilonged in 2018, when we look at CPT66174 used alone.

Granular data.

To report quarterly on or Standalone progress market development progress we have done some initial.

CPT analyses for now just.

Annual.

Results and we can we can say that the year of omni launch in 2018, when we look at Cpt's 6617 or used alone.

Speaker 2: So stand alone, 661-7-4. There were approximately 11,800 claims.

So standalone 66174, there were approximately 11800 claims.

Speaker 2: In 2018, back road in 2019, the second year of Omni.

In 2018, Zachary in 2019, the second year of omni.

Speaker 2: after I'm these launch. This number doubled to just over 26,900 claims.

After all these launch this number a double to just over 26900 claims.

Speaker 2: And then in 2020, despite the COVID pandemic, obviously impacting non-life threatening surgical procedures, saw that number gross significantly again. And there were 30,000...

And then in 2020.

Despite the Covid pandemic, obviously impacting on life threatening surgical procedures saw that number grow significantly again and there were 30000.

Speaker 2: just over 30,000 claims process for standalone use of fix6174.

Just over 30 Belgian claims process for Standalone use of 66174, So we've asked our market access team to get.

Speaker 2: So we've asked our market access team to get even more granular data, and we believe that we're going to be able to have at least quarterly data almost current very soon. And so we look forward to, in the not too distant future, hopefully being able to share quarterly standalone growth of 66174 if we can get that data.

Even more granular data and we believe that we're gonna be able to have at least quarterly data almost current very soon and so we look forward to them in the not too distant future hopefully being able to share quarterly Standalone grew up at 66174, if we can get that data.

Speaker 2: Okay, very helpful. And then, you know, I don't know if this is for Paula or Jesse, but as we think about the fourth quarter, you know, again, it's a nice progression versus Q3 and it sounds like you probably had some headwinds here, and so you three.

Okay very helpful. And then you know I don't know if this is for Paul or for Jesse but.

Think about the fourth quarter, you know again, it's a nice progression versus Q3 and it sounds like you probably had some headwinds hearing to three but the guidance. It's a nice little step up it's not a huge step up.

Speaker 2: but you know the game is a nice little step up if not a huge step up

Speaker 2: versus Q3 which again is a seasonally softer quarter. So why not a little bit more on the guidance side for Q4 and then what I'm really trying to get to. If you just analyze Q4, you know, you're not, there's a lot of growth that needs to happen to kind of get to where the streets are for 22 and I know there's new reps coming in but you know just what gives you the confidence or what can you help us see that you give us all the confidence in hitting some of these 22 numbers that are pretty speed ramps.

Versus Q3, which again is a seasonally software quarter.

So why not a little bit more on the guys inside for Q4, and then what I'm really trying to get to as if you just daniella annualized Q4.

You are not <unk>, there's a lot of growth that needs to happen to kind of get to where the streets at for 22, and I know, there's new reps coming in but.

What gives you the confidence or what what can you help us see that should give us all confidence in hitting some of these 22 numbers that are pretty pretty steep ramp X.

Even that I would I would encourage you to take a look at it this way how much how much quarterly dollar growth.

Speaker 3: You know man, I would, I would encourage you to take a look at it this way. How much, how much quarterly dollar growth?

Speaker 3: Does the guidance imply in 2000?

The guidance imply in 2000.

Speaker 3: 2021 versus how we exit of 2020. And we're then given all the factors and momentum in the business, where does it actually imply a slope increase or not, as you look to sort of get comfortable to 2022 number. We're exiting when we develop our forecast. And

21 versus how we exited 2020.

And given all the factors and momentum in the business, whereas.

Does it actually imply a slope increase or not.

As you look to sort of get comfortable 2022 number.

We're exiting when we developed our our forecast.

Speaker 3: We're going to be actually the year stronger than giving the step-ups and guidance. We initially thought to be able to confidently support that number.

We were going to be actually the year stronger than given sort of a step up and guidance than we initially thought to be able to confidently support that number.

Speaker 3: And, you know, we feel pretty confident we're gonna be able to be here and to break that place. Get out.

And you know we.

We feel pretty confident we're gonna be accident ear and spreading that place.

You know it's.

Speaker 3: The first half of a year is healthier in terms of step functions of growth often, what our experience has been in this market. I think it's gonna be a little bit of a noisy December , to be honest, like in terms of...

The back half the first half of a of a year healthier in terms of step functions of growth often like you will what our experience has been in this market I think it's going to be a little bit of a noisy December to be honest like in terms of Ah.

Speaker 5: vacations taken vacation days true selling opportunity in the back half of the month, but um

Vacations taken vacation days true selling opportunity in the back half of the month, but.

Speaker 3: You know, we think, you know, as we said about the third quarter, when you look at the comps, that this guidance or when thisipts this 10th quarter-

We think you know as we said about the third quarter when you look at the comps.

This guidance implies uhm.

Speaker 3: know, a very healthy and honest and cultural growth for an I care business, particularly a surgical I care business.

A very healthy amount of sequential growth for.

For an eyecare business, particularly a surgical I care business.

Okay. Thank you.

[noise]. Our last question comes from the lineup Joanne Wrenched from CD now Wilson.

Speaker 1: Our last question comes from the line of Joanne Winsh from City. Your line is now open.

Alright. This is Anthony offer Joanne. Thank you up for screwing us and I just have one question. It's a bit more open ended what surprised you the most and the least over the past three months, especially just given all the rambles reimburse to parse thanks for taking my question.

Speaker 8: This is Anthony Alfred-Johann. Thank you for excusing us, Andrea. I just have one question. It's a bit more open-ended with surprise you than most analysts over the past three months, especially just given all the reimbursement points. Thanks for taking the question.

Sorry can you could you repeat that what's your fries us the most or.

Speaker 9: Sorry, can you could you repeat that? What surprised us the most?

Speaker 2: Yeah, sorry. Yes, sorry if I was bringing up. I just asked what surprised you the most in the least over the past three months?

Yeah, let's surprise.

Yeah, sorry, if I was breaking up I just asked what surprised you the most and the least over the past three months.

Mmm.

I mean, I don't know we've been.

Speaker 9: We've been executing to our fundamentals across our three value drivers in a very predictable way, and as you can tell.

We've been executing to our fundamentals across our three value drivers and a very predictable way and as you can tell from.

Speaker 9: our top performance this quarter. So we've been frankly just focused on taking, continuing to take sharing.

Our top performance this quarter, so and we've been frankly just focused on tape.

Taking continuing to take sharing combo cataract.

Speaker 9: expanding use in standalone and advancing all of our tear care initiative and I think we've done that in a very predictable and compelling way I don't look back at the last quarter seeing too many surprises. Sorry, that's not an exciting answer but Sean or Jesse, maybe you guys

Expanding Houston, Standalone and advancing all of our tier care initiatives and I think we've done that in a very predictable and compelling way so.

So I don't I don't look back at the last quarter seeing too many surprises I'm sorry, that's normal non exciting answered that Sean or Jesse maybe maybe you guys.

We're surprised by something.

Speaker 6: No, I would agree, Paul, Anthony, this is Sean. I would say it's not a surprise, but I think the thing that's really been...

No I would agree Paula Anthony this is Shawn that I would say, it's not a surprise right thing to do that that's.

Really been been you know.

Speaker 6: you know, a pleasure for us from an execution, commercial execution standpoint is just the advocacy that we've received from our customer base and the, you know, acceptance of the technical technologies, omnivind tear care within our strategies to develop the standalone market with the multimotoric standalone market with omnivind and to execute against our strategy for patient access.

A pleasure for us from an execution commercial execution standpoint at just the advocacy that we received from our customer base and the.

Acceptance of the Tech both technologies Omni interior care within our strategies to develop to stay low market with the multi moderate standalone market with with omni and to execute against our strategy for patient access.

Speaker 6: with peer care and MGD. So I think the acceptance and just the advocacy that we've had from our customer base with these technologies and our go-to-market strategy has been really a high point for us and continues to appeal our confidence as we continue to forward in both these markets.

With Tyr care in M. G. D. So I think the acceptance and just the advocacy that we've had from our customer base with these technologies and our go to market strategy has been really a high point for us and continues to peel or confidence as we continue to move forward in both these market.

It's.

Speaker 5: My answer quickly is I was surprised about how strong our results were relative to peers and competitors that I've also...

My my answer quickly as I was surprised about how strong our results for relative to.

Peers and competitors that have also recorded results.

Okay.

Speaker 1: We have a question from the line of Matt O'Brien for 5% where your line is now open.

We have a question from the line of Mats O'brien said Piper Sandler Your line is now open.

Oh. Thanks, just two quick follow ups, there's been some consolidation in this space earlier. This week I'm just curious as far as how you think about.

Speaker 2: Thanks just to quick follow ups there's been there was some consolidation in the space earlier this week. I'm just curious as far as how you think about that consolidation and the impact of the business in 22 and then there's also a little bit more competition on the On the canal plastic side that that was recently approved and I'm just curious as far as your thoughts as far as It better be a headwind for you guys or if it's just it maybe maybe opens up the market just because there is so much opportunity in that category. Thanks.

That consolidation and the impact of the business and.

In 22, and then there's also a little bit more competition on the on that can alloplasty side that that was recently approved and I'm just curious as far as your thoughts as far as if that'd be a headwind for you guys or if it just it maybe maybe opens up the market just because there is so much opportunity.

In that category. Thanks.

Yes, I'll take a crack at that mad to support on the consolidation side.

Speaker 9: So I'll take a crack at that, Matt, on the consolidation side, obviously, I'm guessing you're referring to the acquisition of the event is by Alconn. I think what for me, what comes to mind, two things come to mind. One, one, the...

Obviously, I'm guessing you're referring to the acquisition months of advantage by Alcon I think.

What what for me what comes to mind, two things come to mind.

One.

One the.

Speaker 9: or extents, whether it's hydrists or ice-dense. Those are products indicated in combination with cataract surgery where we've already demonstrated an ability to take share effectively. And it's, you know.

Stance, whether it's high address or for I stand.

Those are those are products indicated in combination with cataract surgery, where we've already demonstrated an ability to to take care of effectively.

And it's yeah.

Speaker 9: That's one fifth of the market. We have the five times larger standalone market that we are focused on and penetrating effectively.

That's one of the market we have the five times larger standalone market that we are focused on and penetrating effectively.

Speaker 9: So, that doesn't affect us there. And also, you know, we have Sean on the line. Sean was at Alconn for 20 plus years. He's best in class commercially. He's built out of best in class commercial leadership team and team throughout the organization. So, as it relates to our ability to compete effectively and win. Sean.

So it's that doesn't affect doesn't affect up there.

And also we have shown on the line Sean was at Alcon for 20 plus years, He's best in class commercially he's built out a best in class commercial leadership team and then team throughout the organization. So as it relates to our our ability to compete.

Compete effectively and win.

Speaker 9: I think our confidence grows every day, Sean, if you want to comment a bit on that.

I.

I think our confidence grows every day, Sean if you want to comment a bit on on that.

Yeah, absolutely call things in that yeah, we obviously anticipated outcomes presence to need additional investment in it and just recognition of the importance of the big space for patient care.

Speaker 6: Yeah, absolutely. All thanks. And yeah, we obviously anticipate outcomes presence to community additional investment and just recognition of the importance of the big space for patient care. But I think that additional investment and education awareness is overall positive to the marketplace.

But you know I think that additional investment in education awareness is overall a positive for the marketplace.

Speaker 6: And because of the performance of only today in our confidence and is differentiated, that's because you've got file and with the broad indication for use that we have to enter into the standalone mix market. We're still really confident in our ability to leave that standalone mix market.

And because of the performance of on me today and her confidence in his differentiated that's gonna see profile and was abroad indication for use that we have to enter a new stand will mixed market.

We're still really confident in our ability to leave the state will miss market and continue to leverage our top commercial talent that we have here and continue to invest and expand here <unk> sciences to meet our strategic objectives. So I think overall, it's a positive and frankly those are the same things that are going to allow us to.

Speaker 6: and continue to leverage our top commercial talent that we have here and continue to invest and expand here at Site Sciences to meet our strategic objectives. So I think overall it's a positive and frankly those are the same things that are going to allow us to compete regardless of what competitor comes into the marketplace.

<unk>, regardless of what competitor it comes into the marketplace is going to continue to be focusing on our points of differentiation of bombings ability to address all three points of resistance for those mild moderate either in combination correct and most definitely in the Standalone space and just continue to <unk>.

Speaker 6: It's going to continue to be focusing on our points of differentiation, the bombings ability to address all three points of resistance for those mild to moderate.

Speaker 6: either in combination with KERECS and most definitely in the standalone space.

Speaker 6: and just continue to leverage that in our exceptional customer experience to continue to build that leadership position in standalone.

<unk> said in our exceptional customer experience to.

Continue to build a leadership position in Standalone.

Speaker 9: to Matt on your second question regarding

And Matt on on your second question regarding.

Speaker 9: potential canaloplasty and trans. I think a couple of things come to mind. Maybe four things. Number one is R&D and I'll get into, we are the pioneers of EbonTerno canaloplasty. EbonTerno canaloplasty for baculotomy. We've been at it for many, many years and have been iterating. So the...

[noise] potential can alloplasty entrance I think a couple of things come to mind, maybe maybe four things uhm.

Number one is R&D and I'll get into we are the pioneers of I've been turned out <unk> I've been turned off now Buffy Trabeculectomy, we've been at it for many many years and have been iterating. So the.

The clinical excellence that is omni is the result of.

Speaker 9: The clinical excellence that is omnivis the result of

Tens of thousands of cases significant clinician feedback significant iteration I can tell you it's been a long road to get to.

Speaker 9: tens of thousands of cases, significant clinician feedback, significant iteration. I can tell you it's been a long road to get to the device that we have today that is delivering such incredible results for surgeons and their patients. So it's not easy. So generating a prototype, showing a prototype, maybe even getting a clearance.

The the device that we have today that is delivering.

Such incredible results for surgeons and their patients. So it is not easy so generating a prototype.

Uhm, showing a prototype maybe even getting a clearance.

Speaker 9: maybe straightforward but delivering a

May be straightforward, but uhm delivering a.

Highly dependable reproducible canal poppy device that is capable of.

Speaker 9: Highly dependable, reproducible, canal-ploppy device that is capable of

Speaker 9: consistently helping the surgeon circumnavigate 100 200 micron diameter delicate canal for 36 to 40 millimeters around consistently is not easy period On the clinical front I haven't seen

Consistently helping the surge in circumnavigate 100, 200 micron diameter delicate canal for 36 to 40 millimeters around consistently is not easy period on the clinical front I haven't seen.

Speaker 9: I personally haven't seen any clinical data from anybody on another AB in turn, you know, canala-plasty entrance. I think if we're gonna be talking about canala-plasty and labels, I think we need to see clinical data. I think it brings us to the third point from a regulatory perspective.

I personally haven't seen any clinical data from anybody.

Another Robyn curnow can alloplasty entrant.

I think if we're going to be talking about canal pasty and labels I think we need to see clinical data I think it brings us to the third point from a regulatory perspective.

Speaker 9: I would ask whichever companies are brought up.

I would ask well whichever of companies or products.

Speaker 9: that we're discussing here, I would ask on what is the indication for use? Is it for a canaloposte? Is it for pressure lowering? Is it for primary okay and the welcome? I'm pretty sure into the pathway that we've gone through requires significant clinical data. To have a canaloposte indication and to promote for canaloposte, and we just announced earlier today, maybe some of you have seen it, you put out a press release just before this call.

That we're discussing here I would ask them what what is the indication for use is it for a canal pasty is at four pressure lowering as a core primary opening of all coma. So I'm pretty sure. The pathway that we've gone through requires significant clinical data to be to have a canal indication to promote <unk>.

I mean, we have we just announced earlier today, maybe some of you have seen it you put out a press release just before this call on our I D E for a can alloplasty alone indications. So we have a very large make try I think the largest there will ever be conducted 469 patients.

Speaker 9: on our IDE for a canalopostial wound indication. So we have a very large make trial. It's the largest that will ever be conducted for 159 patients.

To seek.

Speaker 9: This can arraplasty alone indication.

Yes can alloplasty alone indication.

Speaker 9: And then lastly, beyond R&D clinical and regulatory, again, I haven't seen any of these devices, but I will say we've been at this for over a decade and we have a very broad and deep, partner state and intellectual property covering methods and devices of, you know, circumstantial, cantalricular, colicoma surgery. So, those are the four things that come to mind. Does it relate to any potential entrance?

And then lastly, beyond R&D clinical and regulatory again, I don't I haven't seen any of these devices, but I will say we've been at this for over a decade, and we have a very broad and deep patent estate and intellectual property hovering methods and devices of.

Circumstantial Canalicular, Oklahoma surgery. So those are the four things that come to mind as it relates to any potential entrants.

Great. Thanks, so much.

Sure.

This concludes that question and answer any questions I would like to tend to call back to follow the count me like I was saying like.

Speaker 1: This concludes our question and answer session. I would like to turn the call back to Paul Badali for closing remarks.

Speaker 9: I want to say thank you all for your time, attention and interest in flow sciences.

Just Wanna say, thank you all for your time attention and interest in sight Sciences.

This concludes today's conference call you may now disconnect.

Speaker 1: This concludes today's conference call. You may now disconnect.

[music].

Speaker 10: music

[music].

[music].

Greetings and welcome to the site's Sciences third quarter 2021 earnings result conference call.

Speaker 1: Greetings and welcome to the site's Sciences 3rd quarter 2021 earnings results conference call. At this time, I'll participate.

At this time all participant.

Speaker 1: and this is all for you. It is my pleasure to introduce your host, Tripp Taylor from Gilmarden Group. Thank you. You may begin.

But the amount and then.

Probably it would be my bullish did you reduce your hosts chip Taylor from Gilmartin group.

You may begin.

Speaker 9: Thank you for participating in today's call. Presenting today our site sciences co-founder and chief executive officer Paul Badawi, chief financial officer Jesse Selnick and chief commercial officer Sean O'Neill. Earlier today, site sciences release financial results for the three months and nine months ended September 30th, 2021. A copy of the press release is available on the company's website at investors.siteciences.

Thank you for participating in today's call presenting today are safe Sciences, co founder and Chief Executive Officer, Paul Modality, Chief Financial Officer, Jackie sell neck, and Chief commercial Officer Shaun O'neil.

Earlier today <unk> Sciences released financial results for the three months and nine months ended September 32021, a copy of the press release is available on the company's web site at investors <unk> Sciences Dot com.

Speaker 9: I would 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 law.

I would 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.

Speaker 9: Those include statements related to site sciences 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.

Those include statements related to <unk> Sciences anticipated financial performance and operating results market opportunity the future impact of COVID-19 on the operations business strategy and plans for developing and marketing new products.

Speaker 9: Board-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 states.

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.

Speaker 9: a description of some of the risks and uncertainties that can cause actual results to differ materially from those indicated by the forward-looking statements on this call can be found in the risk factors section of the Form 10Q filed today and other filings with the Securities and Exchange Commission.

Scripture end of <unk>.

Some of the risks and uncertainties that could cause actual results to differ materially from those indicated by the forward looking statements on this call can be found in the risk factors section of the Form 10-Q filed today and other filings with the Securities and Exchange Commission.

Speaker 9: The company undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law. For more information, please refer to the forward-looking statement notices and risk factors in the recent SEC filings. I will now turn the call over to Paul.

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.

Thank you trip.

Speaker 7: And thanks to everyone for joining us on our second earnings call as a public company. I'm very excited to update you on our business.

And thanks to everyone for joining us on our second earnings call as a public company.

I'm very excited to update you on our business.

Speaker 7: and share our significant accomplishments across our commercial, clinical, regulatory, and patient access initiative.

Sure our significant accomplishments across our commercial clinical regulatory and patient access initiatives.

Speaker 7: As well as our thoughts on the 2022 payment rules released by CMS last week.

As well as our thoughts on the 2022 payment rules released by CMS last week.

Speaker 7: Jesse will then discuss our third quarter financial results before we open up the call for questions. Just... First...

He will then discuss our third quarter financial results before we open up the call for questions.

To start I will highlight.

Performance.

Speaker 7: certainty, our resilient tight team persevered. And we set new records for quarterly revenue as a company and for our surgical glaucoma site.

Certainty.

More resilient site team persevere.

And we set new records for quarterly revenue at the company and for our surgical glaucoma segment.

Speaker 7: Our total revenue increased to 13.1 million, representing growth of 51% compared to the third quarter of last.

Our total revenue increased to $13 1 million representing growth of 51% compared to the third quarter of last year.

Speaker 7: We believe we are also one of the very few I care businesses to report meaningful sequential U.S. growth in 2-3 over a Q-2-2021. Despite significant reimbursement always in surgical glaucoma and the continuing impacts of COVID.

We believe we are also one of the very you eye care businesses to report meaningful sequential U S growth in Q3 over Q2 2021.

Despite significant reimbursement always been surgical glaucoma and the continuing impacts of Covid.

Speaker 7: Although the third quarter is typically seasonally lower, then the second quarter, our surgical glaucoma segment revenue increase to 12.4 million, representing 4% sequential growth from our then record, second quarter revenues, and growth of 58% versus the third quarter of last year, driven by strong new account growth and increased utilization of our surgical glaucoma product on this.

Although the third quarter is typically seasonally lower than the second quarter, our surgical glaucoma segment revenue increased to $12 4 million, representing 4% sequential growth from our Dan record second quarter revenues and growth of 58% versus the third quarter of last year.

And by strong new account growth and increased utilization of our surgical glaucoma product.

I'd like to remind everyone of the core principles of our company that allow us to persevere and succeed in any operating environment. We focus on the patient first always we improved the lives of patients suffering from diseases by protecting and enhancing their most precious sense.

Speaker 7: I'd like to remind everyone of the core principles of our company that allow us to persevere and succeed in any operating environment. We focus on the patient first. Always.

Speaker 7: We improve the lives of patients suffering from eye diseases by protecting and enhancing their most precious sense. Vision.

Yeah.

Speaker 7: We aim to develop safe and effective products that address the underlying causes of the world's most prevalent high-disease.

We aim to develop safe and effective products that address the underlying causes of the world's most prevalent eye diseases.

Speaker 7: Our current commercial products are omniple care. Those products are the results of our rigorous product development process, which incorporates four key pillars. First, we master the physiology of a disease to gain a full understanding of the often multifactorial causes.

Our current commercial products, our omni and hair care.

Those products are the result of our rigorous product development process, which incorporates four key pillars first we master the physiology of the disease to gain a full understanding of the orphan multifactorial causes.

Speaker 7: We use this foundational knowledge base to guide our development of solutions that optimize treatment of the underlying causes of the disease.

We use this foundational knowledge base to guide our development of solutions that optimize treatment of the underlying causes of the disease.

Speaker 7: We then apply our iterative design process to develop products that are intuitive for the position to use.

We then apply our iterative design process to develop products that are intuitive for the physicians to use.

Speaker 7: To pass the final test of our rigorous product development process, we must prove out a viable patient access strategy, either through existing avenues or by pioneering new rules.

To pass the final test of a rigorous product development process, we must prove out a viable patient access strategy.

Through existing avenues or by pioneering new routes.

Speaker 7: Leveraging these four pillars, we have created our first two products. They've demonstrated improved clinical and real world outcomes, empowering I care providers to offer the best care for their patients.

Bridging these four pillars, we've created our first two products that have demonstrated improved clinical and real world outcomes empowering eye care providers to offer the best care for their patients.

Speaker 7: Having passed the rigorous test posed by our four product development pillars, we believe that both Omni and Tier Care are competitively differentiated within their respective eye care marks.

Having passed a rigorous test posed by our four product development pillars, we believe that both omni anti air care, a competitively differentiated within their respective eyecare markets. This product differentiation is substantiated by the commercial performance market receptivity and E. C. P feedback on both omni on hair care.

Speaker 7: This product differentiation is substantiated by the commercial performance, market receptivity, and ECP feedback on both on the anterior care.

Our organic innovation and product development model works very well.

Speaker 7: Our organic innovation and product development model works very well.

Speaker 7: So expect to hear more from us on the product development products in DooCore.

So expect to hear more from us on the product development brought in due course.

Speaker 7: Over the near and medium term, we will continue to prioritize three key strategic value drivers. Number one, continuing to expand omnidoption and usage by surgeons for adult patients with primary open angle glaucoma or POAG in the established combination cataract segment of the minimally invasive glaucoma surgery or MIGs market.

Over the near and medium term, we will continue to prioritize three key strategic value drivers number one.

Continuing to expand omni the adoption and usage by surgeons for adult patients with primary open angle glaucoma or P. O. A G. N D establish combination cataract segment of the minimally invasive glaucoma surgery or migs market.

Converting this key group of surging paved the way for them to perform standalone procedures, which brings up the number two.

Speaker 7: Converting this two group of surgeons paved the way for them to perform stand-alone procedures, which brings us to number two.

Speaker 7: continue development of the virtually green field and substantially larger standalone segment of the Mixmar.

Continued development of the virtually greenfield and substantially larger standalone segment of the mixed market.

Speaker 7: And number three, speaking in expanded indication for use for tear care, for the application of localized seed therapy and adult patients with evaporative dry eye disease, when used in conjunction with manual expression of the mybalamine class.

And number three seeking an expanded indication for use for gear care for the application of localized heat therapy in adult patients with evaporative dry eye disease when used in conjunction with annual expression of the micro ambient glance.

Speaker 7: while also advancing market access initiatives, including payer tailored RCTs that can help create care insurance access to patients whose eye care professionals believe tear care is appropriate for that.

While also advancing market access initiatives, including payer tailored RCT that can help create care care insurance access the patients whose eye care professionals believe tier care is appropriate for them.

We are pleased with our progress advancing each of these objectives.

Speaker 7: We are pleased with our progress advancing each of these in objective.

Speaker 7: Our success requires cross-functional collaboration and teamwork through outside science.

Our success requires cross functional collaboration and teamwork throughout life Sciences include.

Speaker 7: including commercial performance and expansion, the design, execution, and publication of clinical studies, achieving key regulatory milestones, and finally, expanding...

Including commercial performance and expansion.

The design execution and publication of clinical studies achieved.

Achieving key regulatory milestones.

And finally expanding market access.

Speaker 7: Our first two goals relate to advancing the treatment of adult patients with POAG. Omni had been clinically demonstrated to be safe and effective for intraocular pressure reduction for adult patients with POAG.

Our first two goals related to advancing the treatment of adult patients with P. O G omni.

Omni has been clinically demonstrated to be safe and effective for intraocular pressure reduction for adult patients with T O N E.

Speaker 7: Today the mixed market is segmented into procedures performed in combination with cataract surgery, which we referred to as the combination cataract segment, and procedures performed on their own, which we referred to as the standalone segment.

Today, the mixed market is segmented into procedures performed in combination with pattern surgery, which we referred to as the combination cataract segment and procedure performed on their own which we referred to as a standalone segment.

Speaker 7: This segmentation is superficial, and primarily the result of MIGS bypass sense, only being indicated for use in combination cataract proceed.

This segmentation is superficial and primarily the result of make bypass stents only being indicated for use in combination cataract procedures.

Speaker 7: In March of this year, the FDA cleared an expanded indication for use for Omni that we believe bridges the unnatural divide between combination, cataract and stand alone.

In March of this year, the FDA cleared an expanded indication for use Romney that we believe bridges the unnatural divide between combination cataract and standalone.

Speaker 7: This indication for use broadly covers the reduction of intraocular pressure for all adult patients with POAG without limitation with respect to severity of disease, mild, moderate, and advanced, or lend status, fake it, which refers to patients who have not had cataract surgery, combination cataract, as well as pseudo-fake it, which refers to patients who have had cataract surgery.

This indication for use broadly covers the reduction of intraocular pressure for all adult patients with P. O E G without limitation with respect to severity of disease mild moderate and advanced or lend status, they get which refers to patients who have not had cataract surgery combination cataract as well, it's pseudo bacon, which refers to <unk>.

Patients who have had cataract surgery.

We believe this clearance in omnis expanded indication represented a significant clarifying step forward.

Speaker 7: We believe this clearance and Omnies expanded indication represented a significant clarifying step forward and identifying which mixed procedures are appropriate for certain broad indications. Rather than as they do know harm add-on to widespread cataractors.

And identifying which makes procedures are appropriate for certain broad indications rather than as they do no harm add on the widespread cataract surgeries.

Speaker 7: This clearance was supported by the substantial body of real world multi-fender clinical data. We continue to invest very aggressively in the clinical and commercial development of Omni, including further enhancements to Omni's indication for use, which I will describe in more detail later.

It's clearance was supported by substantial body of real World Multicenter clinical data, we continue to invest very aggressively in the clinical clinical and commercial development of omni, including further enhancements to omni as indication for use which I will describe in more detail later.

We believe that omni has two critical physiological and clinical advantages number one omni can comprehensively address up to 360 degrees of a disease conventional outflow pathway.

Speaker 7: We believe that Omni has two critical physiological and clinical advantages. Number one, Omni can comprehensively address up to 360 degrees of the disease conventional outflow pathway. Can all implants address a much smaller segment?

All implants address a much smaller signals.

Speaker 7: And number two, Omni can address all three points of resistance in the conventional flow pathway, while canal implants cannot.

And number two on <unk>.

And address all three points of resistance in the conventional outflow pathway, while canal implants cannot.

We believe omnis differentiated efficacy and indication for use coupled with our commercial excellence.

Speaker 7: We believe Omnies differentiated efficacy and indication for use coupled with our commercial excellence have driven our best in class commercial performance as evidenced by our share gain in combo cataract and market expansion with standalone.

Driven a best in class commercial performance as evidenced by our share gain and combo cataract and market expansion with Standalone.

We've made significant inroads penetrating the adult segment of the Migs market with our exceptional customer experience initiative, which includes a meticulous surgeon and facility training program. We've already trained a substantial portion of our highest priority customers. The universe of over 3000 makes trained surgeons in the third quarter of.

Speaker 7: We've made significant inroads penetrating the adult POAG segment of the mix market with our exceptional customer experience initiative, which includes a meticulous surgeon and facility training program. We've already trained a substantial portion of our highest priority customers. The universe of over 3,000 mix trained search.

Speaker 7: In the third quarter of 2021, approximately 725 facilities ordered knee surgical systems, which included very healthy growth in new cuts.

2021, approximately 725 facilities order omni surgical systems, which included very healthy growth in new customers.

The most exciting opportunity to expand the usage of omni lies into five times larger standalone segment, where surgical intervention decisions rely far more heavily on procedure effectiveness and consistency relative to combination cataract procedures, and which we believe the concomitant canal implant procedure is often viewed.

Speaker 7: The most exciting opportunity to expand the usage of Omni lies in the five times larger standalone segment where surgical intervention decisions rely far more heavily on procedure effectiveness and consistency relative to combination cataract procedures in which we believe that Comcomitant canal implant procedure is often viewed as a duno harm add on in the mild patient.

The Juno arm add on in the mild patients to.

Speaker 7: to even be considered as the sole reason to take a patient to the operating room. Standalone makes interventions like Omni must safely deliver a very high consistency and degree of effecting.

Even be considered as the sole reason to take a patient to the operating room Standalone makes interventions like omni Ms safely deliver a very high consistency and degree of effectiveness.

Speaker 7: Typically, surgeons first master using Omni and combination cataract procedures because they have already been trained in that makes that

Typically surgeons first master using omni in combination cataract procedures, because they have already been trained and that makes that up.

Speaker 7: As surgeons can confidence in Omni, we have observed a natural progression towards also using Omni in standalone procedures.

Surgeons gain confidence and omni we have observed a natural progression towards also using omni and standalone procedures.

Speaker 7: and choose the Quantial Procedures, omnilell surge into address up to 360 degrees of the conventional Outflow Channel, dilating and expanding slums canal and the collector channels with canaloplasty, followed by unrufing of disease, trabecular meshwork during a single surgical session.

And two sequential procedures omni allow surgeons to address up to 360 degrees of the conventional outflow channel dilating and expanding slumped canal and the collector channels with can Alloplasty, followed by Unruh thing of diseased trabecular meshwork during a single surgical session.

Speaker 7: supported by favorable safety data from clinical studies and post-market use.

Courted by favorable safety data from clinical studies and post market use.

Speaker 7: Although our customers' insurgents will largely be the same in both segments, we believe the estimated $5 billion standalone segment requires a new good-to-market approach to improve awareness and educate the broader P O A G community about the new treatment possibilities enabled by ONCE.

Although our customers and surgeons will largely be the same in both segments. We believe the estimated $5 billion Standalone segment requires a new go to market approach to improve awareness and educate the broader community about the new treatment possibilities enabled by omni.

Speaker 7: This outreach program expands our contact points beyond Cateractory Agents and Glaucoma specialists to also encompass primary eye care providers who typically first diagnose and treat POAG with medications.

This outreach program expands our contact points beyond cataract surgeons in glaucoma specialists to also encompass primary ikea providers, who typically first diagnose and treat poa G with medications.

As well as patients.

Speaker 7: We are excited to help ophthalmologists, optometrist and patients better understand the potential advantages of intervention with them.

We are excited to help ophthalmologists optometrists and patients better understand the potential advantages of intervention with Ami.

Speaker 7: We continue to see significant potential to expand usage of Omni and are executing a plan to take full advantage of the opportunity that will include targeted expansion of our sales team in 2022 with incremental investments and reps who will focus specifically on office-based clinical education and stand-alone.

We continue to see significant potential to expand do you think of omni and are executing a plan to take full advantage of the opportunity that will include targeted expansion of our sales team in 2022 with incremental investments in reps, who will focus specifically on office based clinical education and Standalone.

Speaker 7: We also made significant progress advancing clinical trials and augmenting the body of published literature and high quality peer reviewed journals that support the safety and efficacy of OMNI for use in future expanded indications for which we are developing the product.

We also made significant progress advancing clinical trials and augmenting the body of published literature in high quality peer reviewed journals that support the safety and efficacy of omni for use in future expanded indications for which we are developing the product.

Speaker 7: In August , we announced the publication of an article on clinical ophthalmology, analyzing 24-month outcomes from a single-center open-label study of the Omnissurgical System conducted in Germany.

In August we announced the publication of an article in clinical Ophthalmology analyzing 24 month outcomes from a single Center open label study of the omni surgical <unk> conducted in Germany.

Speaker 7: The study reported that use of Omni to perform a standalone mix procedure in mild to moderate open angle glaucoma patients resulted in statistically significant reductions in both IOP and IOP lowering medication use at 24 months.

The study reported that use of omni to perform a standalone makes procedure in mild to moderate open angle glaucoma patients resulted in statistically significant reductions in both IOP and IOP lowering medication use at 24 months, meaning.

Speaker 7: New baseline IOP in the study decreased from 24.6 millimeters mercury preoperatively to 14.9 millimeters mercury at 24 months or approximately a 40% IOP reduction.

I mean baseline IOP in the study decreased from $24 six millimeters Mercury preoperatively to $14 nine millimeters of Mercury at 24 months were approximately a 40% IOP reduction.

Speaker 7: Mean baseline IOP lowering medication also decreased from 1.9 average medications per patient to 0.5 medication at month 24, with nearly 60% of eyes for your IOP lowering medication.

Mean baseline IOP lowering medication also decreased from one nine average medications per patient.

Five medications that month 24, with nearly 60% of ice free of IOP lowering medications.

Speaker 7: Last week, we announced the publication of another article on clinical ophthalmology that associated MIGs using Omni with suppressed diurnal fluctuations in IOP, a clinically meaningful and independent risk factor for the progression of glaucoma.

Last week, we announced the publication of another article in clinical ophthalmology that associated Mig using omni with suppressed diurnal fluctuations in IOP.

Clinically meaningful an independent risk factor for the progression of glaucoma.

And that study, 95% of patients had a diminished peak IOP post operatively when compared to preoperative measurements.

Speaker 7: In that study, 95% of patients had a diminished peak IOP postoperatively when compared to preoperative measures.

Speaker 7: And finally, earlier today, we announced FDA authorization to proceed with our precision RCT under IDE. We designed this trial to evaluate the safety and effectiveness of Omni for use in Canaloplasty alone procedure.

And finally earlier today, we announced FDA authorization to proceed with our precision RCT under I E. We designed this trial to evaluate the safety and effectiveness of omni for use in canola pasty alone procedures.

Speaker 7: In precision, we will compare results from combination cataract procedures and three trial on.

In precision, we will compare results from combination cataract procedures procedures and three trial arms.

Speaker 7: Canaloplasty alone using Omni. Canaloplasty followed by trabeculotomy using Omni. And canalum.

And our posture alone using omni can alloplasty, followed by Trabeculectomy, using omni and canal implants.

Speaker 7: We believe precision will represent the largest prospective MIGS RCT ever initiated. Based on our target of 459 subject receiving, a MIGS procedure.

We believe precision will represent the largest prospective migs RCT ever initiated based on our target of 459 subjects, receiving a mixed procedure.

Speaker 7: We plan to use the results of provisions to support a pre-market submission to the FDA, seeking clearance for an expanded indication for use of Omni in Canalopostia loan procedures to reduce IOP and adult patients with POH.

We plan to use the results of precision to support a premarket submission to the FDA seeking clearance for an expanded indication for use of omni and can alloplasty alone procedures to reduce IOP and adult patients with <unk>.

Speaker 7: If we are successful, surgeons would have additional flexibility to use Omni to customize treatment and expand their preferred use case, particularly for milder cases.

If we are successful surgeons would have additional flexibility to use omni to customize treatment and expand their preferred use case, particularly for milder cases.

Speaker 7: Additionally, we hope to share data from precision with PAYERS, who are influential arbiters of patient access. CMS and other PAYERS rely in part on review of relevant medical data, published in peer-review journals when making coverage, entertainment policy decisions.

Additionally, we hope to share data from precision with payers, who are influential arbiters of patient access CMS and other payers rely in part on review of relevant medical data published in peer reviewed journals were making coverage and payment policy decisions. We believe our clinical trials would demonstrate clinically significant improvements in health and economic outcomes.

Speaker 7: We believe our clinical trials would demonstrate clinically significant improvements in health and economic outcomes.

Okay.

Our market access team made significant progress securing coverage among private payers for omni procedures in recent months.

Speaker 7: A market-access team made significant progress securing coverage among private payers for omniprocedures in recent months. We're pleased to report that the omniprocedure is now covered in reimbursed by masks, and private payers representing an estimated 75% of all medical benefits covered live.

We're pleased to report that the omni procedure is now covered and reimbursed by Max and private payers, representing an estimated 75% of all medical benefit covered lives.

Speaker 7: We are grateful for the support of the AAL and AGS. We continue to support our efforts.

We are grateful for the support of the Ao and Ags, who continue to support our efforts we continue to make progress and look forward to providing further updates over the coming quarters.

Speaker 7: We continue to make progress and look forward to providing further updates over the coming quarter.

Speaker 7: Last week, the Centers for Medicare and Medicaid Services issued a final rule that includes updates on policy changes for Medicare payments to physicians and facilities. These final rules will go into effect on January 1, 2022, subject to the issue of any updates or corrections by CMS.

Last week, the centers for Medicare and Medicaid services issued a final rule that includes updates on policy changes for Medicare payments to physicians and facilities. These final rules will go into effect on January one 2022.

Subject to the issuance of any updates or corrections by CMS.

Speaker 7: Payments related to CPT code 66174, which is used to report procedures performed with OMNI, were among those that were revised.

Payments related to CPT code 661 hundred 74, which is used to report procedures performed with omni were among those that were revised.

As a whole we are quite pleased with the Medicare payment landscape that will bring modest increases in payment Brooklyn, Alloplasty intramuscular <unk> and the <unk> settings from 2021 to 2022 our preliminary assessment of the physician fee and facility fee payment rates remain the same as one of the proposed rules came out in July and we are going.

Speaker 7: As a whole, we are quite pleased with the Medicare payment landscape that will bring modest increases in payment for canalepas, the intramaculotomy, in the ASC and HOPD settings from 2021 to 2022. Our preliminary assessment of the physician fee and facility fee payment rates remain the same as when the proposed rules came out in July as we are going public.

<unk>.

We believe omnis professional fees will be in a better relative position in 2022 versus 2021 compared to its combination cataract implant competitors.

Speaker 7: We believe Omnib's professional fees will be in a better relative position in 2022 versus 2021 compared to its combination Cadar Act implant competitive.

Speaker 7: Although the approximate professional payment for Canaloplasti will decrease by $209 to $739, which was expected given the elegant procedural advancements made by the Omni Technology for this procedure, the focus of our discussions with physicians continues to center on the strength of our clinical data.

Although the approximate professional payment for <unk> will decrease by $209 to $739, which was expected given the elegant procedural advancements made by the omni technology for this procedure.

The focus of our discussions with physicians continues to center on the strength of our clinical data.

Speaker 7: Nonetheless, physician reimbursement for canaloplasty will remain significantly superior to reimbursements for both standalone cataract surgery, as well as cataract surgery in combination with canal-based embolism.

Nonetheless physician reimbursement for <unk> will remain significantly superior to reimbursements for both Standalone cataract surgery as well as cataract surgery in combination with canal based implants.

Speaker 7: And routine, and routine combination cataract procedures using Omni, the approximate total position fee will be $1,03 versus $664 for the new Camel implant combination cataract code, CPT669-1, and $529 for standalone routine cataract surgery, CPT669-8-4.

And routine and routine combination cataract procedures using omni the approximate total physician fee will be 1000 or $3 versus $664 for the new canal implant combination cataract code CPT 669 91.

$529 for Standalone routine pattern surgery CPT 66984.

Speaker 7: In complex combination cataract procedures using Omni, the approximate position fee will be $1,101 versus $832 for the new Camel and Planting combination with complex cataract codes, CPT 666989.

And complex combination cataract procedures using omni.

<unk> will be $1101 versus $832 for the new canal implant in combination with complex cataract code CPT 66989.

Speaker 7: Our near-term reimbursement objective is to continually improve the competitiveness of payments for procedures performed with Omni. We believe the combination of one, Omni's highly differentiated efficacy, two, the relative advantage of the 2022 position fees and modded increase in facility fees for 661.4, three ongoing clinical feedback from Omni users, and four are demonstrated historical growth projectors.

Our near term reimbursement objective is to continually improve.

The competitive competitiveness of payments for procedures performed with omni we believe the combination of one omni is highly differentiated efficacy to the relative advantage of the 2022 position feeds and modest increase in facility fees for 6617 for three ongoing clinical feedback from omni users.

And for our demonstrated historical growth trajectory.

Speaker 7: will allow us to continue to take share from the combo-catter act and all implants and advance our leadership in the five times larger standalone segments.

Will allow us to continue to take share from the combo cataract and al implants and advance our leadership in the five times larger Standalone segment.

Speaker 7: We are pleased that CPT code 66174 will realize a modest increase of about 2% in both the ASC setting, which accounts for over 80% of OMNI's U.S. revenues, and the HOPD setting. Payments for canal posse will increase 2.5% to $1,919 in the ASC setting, and 2.1% to $4,000 in the ASC setting.

We are pleased that CPT code <unk> hundred 74 will realize a modest increase of about 2% in both the ASC setting, which accounts for over 80% of Omnis U S revenues and the H O P D setting.

Payments for Canal biofuel increased two 5% to $1919 in the ASC setting and two 1%.

$4000 in the <unk> setting.

Speaker 7: In 2022, ASCs will receive over $850 more for a standalone nominee procedure than for a standalone cataract procedure. For HOPDs, the difference for the same two procedures will exceed $1800.

In 2022, <unk> will receive over $850 more for a standalone omni procedure than for a standalone cataract procedure for <unk>. The difference for the same two procedures will exceed $800.

Speaker 7: In 2021, ASDs received 953 more for combination cataract procedures using canal implants and for combination cataract canaloplasti procedures. This gap will be reduced by $158 for 2022, and we will continue our efforts alongside the medical society's patient advocacy groups and the surgical community to seek more equitable reimbursement.

In 2021, Asce's received 953 more a combination cataract procedures using canal implants.

The combination cataract and Alloplasty procedures. This gap will be reduced by $158 for 2022, and we will continue our efforts alongside the medical societies patient advocacy groups and the surgical community to seek more equitable reimbursement.

Speaker 7: We thought device-intensive status for CPT code 66174 in the ASC setting, which would have resulted in an increase in payment to ASCs. CMS declined to assign device-intensive designation for 66174 for 2022. We believe this decision is incorrect and stems from inaccurate hospital reporting of device costs for CPT 66174.

We thought device incentive status for CPT code six $6 74 in the ASC setting, which would have resulted in an increase in payments to ASC CMS.

CMS declined to assign device incentive designation for six 674 for 2022. We believe this decision is incorrect and stems from inaccurate hospital reporting of device cost for CPT six 674.

We will continue to work with the medical societies and patient advocacy groups CMS and other ophthalmic stakeholders to help ensure the accuracy of the billing data that CMS will rely on when deciding whether CPT six 674 merits device intensive status in the future.

Speaker 7: We will continue to work with the medical societies, patient advocacy groups, CMS, and other ophthalmic stakeholders to help ensure the accuracy of the billing data that CMS will rely on when deciding whether CPT-6614 merits device intensive status in the future.

Speaker 7: Our third value driver focuses on tear care, which is currently marketed as a powered heating pad for the application of localized heat where the medical community recommends the application of a warm compress to the island.

Our third value driver focuses on tier two which is currently marketed as a powered feeding pad for the application of localized heat where the medical community recommend to the application of a warm compress to the islands.

Speaker 7: We purposefully built tier care to deliver a precise and tightly controlled level of penetrating thermal energy through the outer eyelids and into the mibomium glands on the posterior side of the eyelids in a comfortable office-based procedure.

We purposefully built here care to deliver a precise and tightly controlled level of penetrating thermal energy through the outer islands and into my bulimia glance on the coast here your side of the islands and a comfortable office based procedure.

Speaker 7: We introduced tier care in a controlled launch two years ago, with approximately 10 reps covering the United States. Our plan for 2022 includes modest expansion of our tier care sales force to fill in high value geographic white space. Our controlled launch team cannot fully cover.

We introduced here carrying a controlled launch two years ago with approximately 10 reps covering the United States are planned for 2022 includes modest expansion of our care care salesforce to fill in high value geographic White space, our controlled launch team cannot fully cover.

We are developing and seeking FDA clearance of an expanded indication appear care for the application of localized therapy in adult patients with evaporative dry eye disease due to my Colombian gland dysfunction when used in conjunction with manual expression of my bromine glands.

Speaker 7: We are developing and seeking FDA clearance of an expanded indication of peer care for the application of localized heat therapy in adult patients with evaporative dry eye disease due to myelomian gland dysfunction when used in conjunction with manual expression of myelomian.

Speaker 7: Fry eye is a multifactorial disease that is most commonly characterized by poor quality tears that evaporate too quickly.

Brian is a multifactorial disease that is most commonly characterized by poor quality tiers that are evaporate too quickly.

Speaker 7: study data shows that 86% of dry eye cases are associated with MGD. Yet, the most common dry eye treatments used today address aqueous deficiency or inflammation and represent 95% of manufacturer records.

Study data showed that 86% of dry eye cases are associated with mgd, yet the most common dry eye treatments used today address aqueous sufficiency for inflammation and represent 95% of manufacturer revenues.

Speaker 7: None of the leading prescription eyedrops medications are indicated for or have a mechanism targeting the most prevalent underlying cause of dry eye. MGD.

None of the leading prescription eye drop medications are indicated for or have a mechanism targeting the most prevalent underlying cause of dry eye mgd.

Speaker 7: to compound this issue, Medicare and commercial insurers have not established any meaningful reimbursement for MGD treatment.

The compounded this issue.

Medicare and commercial insurers have not established any meaningful reimbursement for mgd treatment.

Speaker 7: Thri.ai is the number one reason for visits to an eye care provider, and we believe the U.S. market for effective MGD treatment could exceed $10 billion.

Dry eye is the number one reason for visits to an eye care provider and we believe the U S market for effective mgd treatment could exceed $10 billion annually we.

Speaker 7: We are executing a very thoughtful and well-informed strategy to unlock the potential market for tear care in its authorized indications by pioneering optimal patient access to effective MGD care through health insurance.

We are executing a very thoughtful and well informed strategy to unlock the potential market for tier care.

And it's authorized indications by pioneering optimal patient access to effective mgd care through health insurance.

Speaker 7: We want to maximize the reach of our care care technology and intend to provide a comprehensive solution for the broadest range of MDD sufferers.

We want to maximize the reach of our care care technology and intend to provide a comprehensive solution for the broadest range of MTB suffers.

Speaker 7: As with our value drivers for surgical glaucoma, our dry eye strategic initiative also involves cross-functional support from our clinical, regulatory, market access, and commercial teams.

As with our value drivers for surgical glaucoma, our dry eye strategic initiative also involves cross functional support from a clinical regulatory market access and commercial teams.

Speaker 7: On the regulatory front, we submitted a premarket notification to the FDA in September that we hope will result in clearance for an expanded indication for use of tiered care in the coming lot.

On the regulatory front, we submitted a premarket notification to the FDA in September that we have.

Hope will result in clearance for an expanded indication for use of care care in the coming months.

In parallel with our tier care regulatory efforts enrollment continues nicely and our second tier care RCT Sahara.

Speaker 7: In parallel with our tier care regulatory efforts, enrollment continues nicely in our second tier care RCT, Sahara, which will evaluate the efficacy of tier care compared to a leading prescription Bri-I medication and assess the durability of tier care treatments over a 24 month period.

We will evaluate the efficacy of tier care compared to a leading prescription dry eye medication and assess the durability of care care treatments over a 24 month period.

Speaker 7: Articles based on results from our first RCT, Olympia, have been published in two leading peer-reviewed journals. In Olympia, care care was compared to LipoFlow. Among the recent publications was an article in Cornea reporting that a single use of peer care significantly alleviated the signs and symptoms of dry eye disease in patients with MGD. We expect data from Olympia, Sahara, and other studies will support several additional articles in peer-reviewed journals.

Articles based on result.

Our first RCT Olympia had been published in two leading peer reviewed journals and Olympia care care was compared to liberal flow. Among the recent publications was an article in cornea.

<unk> got a single use of tier care significantly alleviated the signs and symptoms of dry eye disease in patients with M. J D.

We expect data from Olympia Sahara and other studies will support several several additional articles in peer reviewed journals.

I would like to conclude my remarks by addressing why we see diagnosis and.

Speaker 7: I would like to conclude my remarks by addressing why we sued IBM.

Speaker 7: In brief, we sued to protect our investments in research and development and to protect the market share and margins of our products.

In brief.

We sued to protect our investments in research and development and to protect the market share and margins of our products.

Speaker 7: My brother and co-founder David and I began developing breakthrough ophthalmology technologies over 15 years ago. In the years that followed, we have continuously invested in research and development. We incorporated many of these innovations in successful commercial products like Omni and Tiercare. A continuing ability to

Brother, and co founder, David and I began developing breakthrough ophthalmology technologies over 15 years ago.

In the years that followed we have continuously invested in research and development. We incorporated many of these innovation and successful commercial products like omni and hair care.

Our continuing ability to grow site sciences, and invest in R&D depends on obtaining and enforcing intellectual property rights.

Speaker 7: and invest in R&D depends on obtaining and enforcing intellectual property rights. Our investors deserve to realize that.

Our investors deserve to realize value from our inventions.

Speaker 7: where we see blatant encroachment on our intellectual property, we must vigorously defend our rights. We owe it to our patients, our company, and our shareholders. To hold accountable competitors who seek to profit from our investment, we cannot sit idly by while a competitor uses our intellectual property to compete against our own product.

Where we see blatant encroachment on our intellectual property, we must vigorously defend our rights, we owe it to our patients our company and our shareholders to hold accountable competitors, who seek to profit from our investment we cannot sit idly by while a competitor uses our intellectual property to compete against our own products.

Speaker 7: I would also like to note that the patents assurge against eye-dance are not associated with omni. The four patents in suit relate to our implantable, circumfrontial, canal scaffolding, and collectible properties.

I would also like to note that the patents asserted against diophantus are not associated with omni the four patents in suit relate to our implantable circumferential Enel scaffolding intellectual property.

Speaker 7: The hydrismicrystent competes directly with Omni and the combination padwreck deck.

The hydrus Microstat competes directly with omni in the combination cataract segment.

Speaker 7: Our law should seek to enjoy an event this from its infringing competition.

Our lawsuits seek to enjoin Ivy on tests from its infringing competition.

Speaker 7: With that, I will now turn the call over to Jesse to discuss our third quarter financial results. Jesse.

With that I will I'll now turn the call over to Jesse to discuss our third quarter financial results Jesse.

Thank you Paul our total revenues for the three months ended September 32021 was a record $13 1 million, a 51% increase from the $8 7 million.

Speaker 5: Thank you, Paul. Our total revenue for the three months ended September 30, 2021 with a record 13.1.

Speaker 5: a 51% increase from the 8.7 million in the same period of 2020, and a 5% sequential increase from 12.5.

Same period of 2025% sequential increase from $12 5 million in the second quarter of 2021, and what normally is a seasonally weak sequential quarter in our industry.

Speaker 5: second quarter of 2021 in what normally is a seasonally weak sequential quarter in our industry.

Our combined gross margin for the third quarter was 84% compared to 70% in the corresponding prior year period, and 82% from the second quarter of 2021.

Speaker 3: compared to 70% in the corresponding prior year period and 82% in the second quarter of 2021.

Speaker 5: Our surgical glaucoma segment revenue is for the third quarter, or a record 12.4 million.

Our surgical glaucoma segment revenues for the third quarter were a record $12 4 million up 58% from $7 9 million in the third quarter of 2020, and a sequential increase of 4% from $12 million in the second quarter of 2021.

Speaker 5: of 58% from $7.9 million in the third quarter of 2020, and a sequential increase of 4% from $12 million in the second quarter of 2021.

Speaker 5: While we believe that COVID remains a factor in how all companies now...

While we believe the Covid remains a factor in how all companies now conduct business its impact on our commercial opportunities, but not significantly changed from when we spoke to you in August.

Speaker 5: It impacts on our commercial opportunity, but not significantly changed from when we spoke to you in August . Further, we did not have-

Further we did not observe any tailwind in the quarter from increased omni trialing due to the proposed raising rate changes that CMS that were announced in July.

Speaker 3: increased army trialling due to the proposed rate changes at CMS that were announced in July . We trained modestly more surgeons than the third quarter than we did in the second.

Modestly more surgeons in the third quarter than we did in the second quarter reflected more of a long term growth trajectory in our business rather than any one time improvement.

Speaker 5: Reflected more of the long-term growth trajectory in our business rather than any one time.

Speaker 5: As I said, rather than enjoying any one-time growth benefit, we believe a number of customers actually offset the hypothetical reimbursement tailwind by deferring omni-trainings until they could work through their canal implant in the...

As I said rather than enjoying at any one time gross benefit we believe a number of customers actually offset the hypothetical reimbursement tailwind by deferring. These trains until they could work through their canal implant inventory.

Speaker 5: There was concern that reimbursement for canal implants will lose significant valueestone.

There was concern that reimbursement for canal and implants will lose significant value. After the year end very simply our results point to the continuation of exemplary consistent commercial execution as Paul is two of his comments, we have set a standard of consistent market leading growth at the center of a dynamically changing migs market in which we are gaining dollar in <unk>.

Speaker 3: Very simply, our results points to the continuation of exemplary, consistent commercial and our personal participation.

Speaker 3: Paul is to his comments, we have said a standard of consistent mark-a-leading growth at the center of a dynamically changing matrix.

Speaker 5: And what we are getting dollar and volume share quarter after quarter after

<unk> share quarter after quarter after quarter, while also growing the overall market pie with each army standalone pace more.

Speaker 3: I also growing the overall makes market pie with each omnistandle

Speaker 5: More specifically for this period, our surgical glaucoma sales benefited from an increase in the number of new accounts sold to in the quarter, doing part to its selling environment that had more normal access to customer facilities than we had seen last year, as well as increased utilization per act.

More specifically for this period, our surgical glaucoma sales benefited from an increase in the number of new accounts sold two in the quarter due in part to a strong environment to that more normalized commercial access to.

Customer facilities than we had seen last year as well as the increased utilization per active account.

Speaker 3: The results for the quarter were challenged by seasonal leaf actors, such as surge invacations that increased COVID related impacts compared to the second quarter that we believe were associated with the Delta variant in July .

The results for the quarter were challenged by seasonality factors, such as certain vacations that increased COVID-19 related impacts compared to the second quarter that we believe were associated with the Delta variant in July specifically.

Speaker 3: Growth margin in surgical glaucoma was 87% in the third quarter compared to 75% in the prior year period, and 85% in the second.

Gross margin in surgical glaucoma was 87% in the third quarter compared to 75% in the prior year period and 85% in the second quarter.

Speaker 5: The potential improvement was primarily the result of the transition of production to a low cost, high volume, contract manufacturer in the first half.

Improvement was primarily the result of the transition of production to our low cost high volume contract manufacturer in the first half of the year.

Speaker 3: In our dry segment, revenues were more 700,000 or 0.7 million in the third quarter of 2020.

And our drive segment revenues were.

$700000 7 million in the third quarter of 2021, although this represents a decrease from $1 8 million in the prior year period. We believe we improved the quality of the revenue by focusing more on specialized dry eye accounts that can help us with our long term strategy of pioneering market access for <unk>.

Speaker 5: Although this represents a decrease from the point eight million in the prior year period, we believe we improved the quality of the revenue by focusing more on specialized dry eye accounts that can help us with our long-term strategy of pioneering market access for MGD.

We understand what the strategy is not necessarily in line with our public market valuation environment, largely driven by revenue, but we maintain our absolute conviction tiered tiered long term value in this approach to maximize value.

Speaker 3: We understand this strategy is not necessarily aligned with the public market valuation environment largely driven by revenue. We maintain our absolute conviction in tier-tier's long-term value and in this approach to maximize.

Speaker 3: Beginning in the fourth quarter of 2020, we refocused our dry sales team on accounts that would better align with our long-term goal of pioneering optimal access to effective MGD patients.

I think in the fourth quarter of 2020.

Refocus our dry salespeople on accounts that would better align with our long term goal of pioneering optimal access to effective mgd patient care, we anticipated that this strategy would negatively impact near term results of the time our team adjusted before reestablishing strategic long term growth.

Speaker 3: We anticipated that this strategy would negatively impact near-term results of the time, while our team adjusted before re-establishing strategic long-term growth. Emphasizing this point in the highlights of strength of the effort, following an initial decrease in sales in the fourth quarter of 2020, our dry ice sequential growth has increased 37.6% in 2020.

Emphasizing this point them to us and to highlight the strength of the effort. Following an initial decrease in sales in the fourth quarter of 2020, our dry eye sequential growth has increased 37% per quarter.

Speaker 5: Revenues for the third quarter of 2021 were 2.4 times the fourth quarter of 2020 when we began this initiative.

Revenues for the third quarter of 2021 or two four times in the fourth quarter of 2020, when we began this initiative.

Speaker 5: The on the financials, we are pleased with the results of our market access driven strategy, which has resulted in improved targeting of new customers to fit tier-care's value problems.

Beyond the financials, we are pleased with the results of our Mac market access driven strategy, which has resulted in improved targeting of new customers to fifth tier carriers value proposition.

Speaker 5: Our sequencer was at 20% in the third quarter, benefited from a growing number of new facilities sold compared to the second quarter, as well as a larger base of reordering costs.

Sequential growth of 20% in the third quarter benefited from a growing number of new facility sold compared to the second quarter as well as a larger base of reordering customers gross margin and drive it was 33% in the quarter versus 12% in the third quarter of 2023% in the second quarter of 2021.

Speaker 5: Gross margin in dry was 33% in the quarter versus 12% in the third quarter of 2020, and 3% in the second quarter of 2020.

Speaker 5: As we discussed on previous calls, dry aggres marks.

As discussed on previous calls drag gross margins will be noisy until we consciously scaled the business at which point, we believe we will be able to generate gross margins approaching those enjoyed by the surgical glaucoma business.

Speaker 3: Helicopter, the scale of the business, at which point we believe will be able to generate gross margins, approaching those enjoyed by the search for code blocks.

Speaker 5: Operating expenses in the third quarter of 2021 were 25.

Operating expenses in the third quarter of 2021 were $25 1 million and 87% increase from $13 4 million in the third quarter of 2020.

Speaker 5: and 87% increase from 13.4 million to the third quarter of 2020, and 18% increase from 21.3 million in the second quarter of 2021.

18% increase from $21 3 million in the second quarter of 2021.

Speaker 5: It's important to note that the operating expenses for the quarter included non-cash stock-based compensation of $1.9 million.

And note that the operating expenses for the quarter included noncash stock based compensation of $1 $9 million, which on a comparative basis versus.

Speaker 3: comparative basis versus 0.2 million in the prior year and 0.9 million in the second quarter of 2021, both those latter periods being pre-I.

$2 million in the prior year and <unk> 9 million in the second quarter of 2021, both of those latter periods being pre IPO.

Speaker 5: SGNA expenses for the quarter were 20.8 million compared to 11.2 million in the third quarter of 2020 and 17.8 million in the second quarter of 2021. The increase in SGNA was primarily due to our continued investment in scaling of operations and corporate headcounts.

SG&A expenses for the quarter were $20 8 million compared to $11 2 million in the third quarter of 2020, and $17 8 million in the second quarter of 2021.

Increase in SG&A was primarily due to our continued investment in scaling of operations and corporate head count to support our growth.

Speaker 3: As part of our planning process for 2022, we identified opportunities to augment our team and further accelerate our...

As part of our planning process for 2022, we identified opportunities to augment our team and further accelerate our growth.

Speaker 3: to make significant investment in our corporate systems and personnel to ensure we make the most of our vast opportunity to improve base.

We continue to make significant investment in our corporate systems and personnel to ensure we make the most of our vast opportunity to improve patients' lives.

R&D expenses for the quarter were $4 $3 million compared to $2 2 million in the third quarter of 2020 in three and a half million dollars in the second quarter of 2021.

Speaker 3: R&D expenses for the quarter were $4.3 million compared to $2.2 million in the third quarter of 2020 and $3.5 million in the second quarter of 2021.

Speaker 3: Majority of the increase in R&D expense from 2020 to 2021 was due to three factors. One, an increase in personnel expenses as we build out our clinical and regulatory and R&D departments.

The majority of the increase in R&D expense from 2000 22021 was due to three factors one an increase in personnel expenses as we build out our clinical and regulatory and R&D departments.

Speaker 3: to contract manufacturing last supplies and prototype development expenses and three clinical studies, which Paul highlighted.

Two contract manufacturing lab supplies and prototype development expenses, and three clinical studies, which Paul.

Which Paul highlighted in his comments.

Speaker 5: We expect our R&D expense to continue to grow over the near term as we execute our clinical roadmap and build out our internal R&D capes.

Second R&D expense to continue to grow over the near term as we execute our clinical roadmap and build out our internal R&D capabilities.

Speaker 3: Loss from operations for the three month ended September 30th, 2021 was 14 million, which compared to a loss of 7.4 million for the same period in 2020, and a loss of 11.1 million and a second quarter of 2020.

Loss from operations for the three months ended September 32021 was $14 million, which compares to a loss of $7 4 million for the same period in 2020, and a loss of $11 1 million in second quarter of 2021.

Speaker 3: Also uniquely in this quarter we recognize other expensive two million dollars compared to

Also uniquely in this quarter, we recognized other expense of $2 million compared to.

<unk> 2 million in the prior year period, and this was due to a final fair value.

Speaker 3: 2 million in the prior year period. And this was due to a final fair value three measurement of synth exercise for Fertstock Horn since upon our IPF.

The measurement of since exercise preferred stock warrants since our IPO.

Speaker 3: state the obvious this will not be a expense that will recur going forward given the change in our cap structure post

The obvious that this will not be a expense that will recur going forward given the change in our cap structure post IPO.

Speaker 3: We had a net loss of $17.2 million or 0.43 cents per share or $0.43 per share for the third quarter of 2021, based on a weighted average post IPO share count of 39.8 million shares. This compares to a net loss of $8.1 million or 85 cents.

We had a net loss of $17 2 million or <unk> 43 per share or <unk> 43 per share for the third quarter of 2021 based on a weighted average post IPO share count of $39 8 million shares. This compares to a net loss of $8 1 million or <unk> 85 per share for the third quarter of 2020.

Speaker 3: a third quarter of 2020, based on our weighted average pre-IPO share count of 9.5.

Based on a weighted average pre IPO share count of 95 million shares.

Speaker 3: We ended the quarter with $271.5 million of cash in equivalent and $32.5 million of loan.

We ended the quarter with 271 $5 million of cash and equivalents and $32 $5 million of long term debt.

Speaker 3: As a reminder, we completed our initial public offering in mid July , which generated net proceeds of approximately $252.2 million.

As a reminder, we completed our initial public offering in mid July which generated net proceeds of approximately $252 $2 million.

Turning to our outlook for 2021, we are revising our full year revenue guidance of 47 $5 million to $40 $5 million, which will represent growth of approximately 74% over 2020 at the midpoint.

Speaker 5: Turning to our outlook for 2021, we were revising our full year revenue guidance to $47.5 million to $48.5 million.

Speaker 5: which will represent growth of approximately 74% over 2020.

Speaker 5: This guidance reflects the continuation of the growth trends we observe in recent quarters.

This guidance reflects the continuation of the growth trends, we've observed we observed in recent quarters.

Speaker 5: M takes no account continued outstanding growth fundamentals while factoring and feasibility patterns including fewer selling days in our remaining week to 2021 due to holidays and vacations and a presumption of the operating environment so we saw in the third quarter of 2021 and to date in the fourth quarter remains consistent through the year end. With that I'd like to turn the topic on.

And it takes into account continued outstanding growth fundamentals, while factoring in seasonality patterns, including fewer selling days and the remaining 50021 due to holidays and vacations and a presumption of the operating environment that we saw in the third quarter of 2021 and to date in the fourth quarter remained consistent through the year end.

With that I'd like to turn the call back over to Paul for some closing comments.

Thank you Jesse.

Speaker 7: I hope we've made it very clear how our fundamental commitment to delivering the power of sight to patients with eye disease informs every decision we make.

I hope we've made it very clear how our fundamental commitment to delivering the power of site to patient with eye disease informs every decision we make.

Speaker 7: We believe we are one of the very few companies in the medical device sector.

We believe we are one of the very few companies in the medical device sector.

Speaker 7: with the demonstrated capabilities to both innovate disruptively and commercialize with excellent

With the demonstrated capabilities to both innovate disruptive Lee.

And commercialize with excellence.

Speaker 7: We strive to operate at an entirely different level, and that was on display this past quarter, where we rose to the occasion, excelled on all fronts, and set commercial records.

We strive to operate at an entirely different level and that was on display this past quarter, where we rose to the occasion excelled on all fronts.

Commercial records across the board.

Speaker 7: Jeffy and I will now be joined by Sean O'Neill, our Chief Commercial Officer to answer your questions. Operator, please open.

Jessie and I will now be joined by Shaun O'neil, our chief commercial officer to answer your questions.

Operator, please open up the call for questions.

Speaker 1: Yes sir, at this time we will be conducting a question and answer session. To ask a question, press star one on your telephone. To ensure that everyone has an opportunity to participate, we ask that you ask one question and one follow-up. Our first question comes from the line of Ms. Cecilia, for long from Oregon Stanley, the line is now open.

Yes.

This time, we'll be conducting a question and answer session to ask a question Thats star one on your telephone.

To ensure everyone has an opportunity to participate.

If you ask one question and one follow up.

Our first question comes from the line of MS. Cecilia furlong from Morgan Stanley. Your line is now open.

Speaker 4: Great, good afternoon and thank you for taking the questions. I wanted to start with the account growth that you highlighted in the quarter for Omni. And if you could just walk through and what you saw both from a headwind standpoint, anything due to COVID, seasonality, but then also how you were able to open the account to where the trajectory you saw and as you look into 4Q as well, and the road map you see there for further account.

Okay. Good afternoon, and thank you for taking the questions I wanted to start with the account growth that you highlight in cricket on me and if you could just walk through what you saw both from a headwind standpoint anything due to COVID-19 seasonality, but then also.

How you were able to open the times, where the trajectory you saw and as you look into <unk> as well as the.

Now if you see there for further account opening.

Right.

Speaker 5: Actually it's Jesse, I'll take the first stab at that.

I'd say, it's Jess Yeah, I'll take the first stab at that.

We had a very strong quarter it was our COO.

Speaker 3: He had a very strong quarter. He was a quarter in line with the second quarter in terms of new account opening, the amount.

In line with the second quarter in terms of.

New account openings amount of trial activities.

Speaker 3: and the like. Our retention metrics are very strong as well.

And the like.

Our retention our retention metrics are very strong as well.

We are.

But what we didn't see as we didn't see a.

Speaker 5: Well, we didn't see a, well, you know, my comments were really around the fact that,

My comments were really around the fact that.

It's not a one off level of growth from sort of noise in terms of the reimbursement market is very much in line with the trajectory that we've enjoyed.

Speaker 5: not a one-off level of growth based on sort of noise in terms of the reimbursement market. It was just very much in line with the trajectory that we've enjoyed over the course.

Over the course of the year.

Speaker 3: So, you know, I think COVID is based into how we operate and our customers operate at this point in time and we have the opportunity to continue to sell in the growth and we're taking advantage of that opportunity. And so that's why we were able to put up the results that we did.

So.

I think COVID-19 is baked into how.

We operate and our customers operate at this point in time, and we have the opportunity to continue to sell them to grow and we're taking advantage of that opportunity and CRO.

That's why we were able to put up the results that we did.

Speaker 6: Yes, Cecilia. This is Sean. I would add on that that it continues. Our trajectory and confidence continues to be fueled by our focus on the exceptional customer experience.

Yes.

This is Shawn I would add on that that continues in our trajectory and confidence continues to be fueled by our focus on exceptional customer experience.

Speaker 6: that we demonstrate actually cost both businesses, Omni and tear care. And it's really the care in the training of the surgeon, doctor, and staff to ensure positive outcomes from their perspective as well as positive outcomes for their patients. And with that, just continues to grow the confidence for greater utilization. And the problem is specifically then in the standalone market as Paul discussed in this.

That we demonstrated actually across both businesses omni and tier care and it's really the care and the training of the surgeon Doctor and staff to ensure positive outcomes from their perspective as well as positive outcomes for their patients and with that just continues to grow the confidence for greater Utah.

Elevation.

For omni specifically then in the Standalone marketers Paul discussed in his comments.

Okay. Thank you and I guess I wanted to ask just in terms of <unk> guidance, what you're factoring in.

Speaker 4: Great, thank you. And I guess, too, I wanted to ask, just in terms of 4Q guidance, what you're factoring in, both from a reimbursement now that everything's been finalized, but any

Both from a reimbursement now that everything has been finalized but any potential benefit from that as you think about for Q. Just ahead of 'twenty two implementation backlog impact Covid pressures just any other dynamics you would call out that's others.

Speaker 4: potential benefits and that is you think about 4Q, just ahead of 22 implementation, backlog impact, COVID pressures, just any other dynamics you would call out, as well as what you expect with the new label to be able to see just from the standalone opportunity and continuing to drive that. And thank you. Yeah.

Do you expect with the new label to be able to see just from the standalone opportunity in continuing to drive that and thank you.

Yeah, I'll start and then Paul and Sean.

Speaker 3: pile on. You know the guidance is based on.

Honestly pile on.

The guidance is based on.

Speaker 5: of the growth metrics that we've been posting, largely obviously in the surgical accommod business.

The continuation of the growth metrics that we've been posting largely obviously in the surgical glaucoma business.

Speaker 5: or not, doesn't reflect anything. It reflects the current operation.

We're not it doesn't reflect anything and it reflects the current operating environment.

Speaker 5: We're not, Cecilia, like guessing as to competitive reaction based on 2022 changes.

We're not fulfill yeah like guessing as to competitive reaction based on 2022 changes.

<unk>.

Speaker 9: You know, we our view is that those changes will benefit us. But, you know, the 2021 rates are still in place. And our guidance reflects really just a continuation of

We.

Our view is that those changes will benefit us but.

The 2021 rates are still in place.

Our guidance reflects really just a continuation of of.

The results that we put forward in sort of a forward leading kpis that we track closely.

Speaker 9: The result that we put forward and the forward leading API to attract close.

Speaker 7: I'll just add on to that, Jeffy. As it relates to CMS and the final rule and our outlook, like the first state, our outlook was, has always been extremely strong prior to our IPO, leading up to it and through it, which coincided with the proposed rule.

I'll just add on to that Jeff as it relates to CMS in the final rule in our outlook.

I'd like to first state our outlook was has always been extremely strong prior to our IPO, leading up to it and through it which coincided with the proposed rule.

The proposed rule and more importantly, the final rule improved our relative position vis vis our competition on both the professional fee for.

Speaker 7: The proposed rule and more importantly, the final rule improved our relative position vis-a-vis our competition on both the professional fee for our 66174 Surgeon fee premium, widened over canal and plant injection fees.

Where our six 674 surgeon fee premium widened over canal implant injection fees.

Speaker 7: Following a thoughtful rupture of almost 100 off-down mixtures.

Following a thoughtful rock survey of almost 100 ophthalmic surgeons.

Speaker 7: You know, the surgeon survey results, placing a premium on 661-74 over implant injections, which frankly expected. Since we know we ask our surgeons to perform more time intensive, skillful, circumfrontial, multi-procedural work that ultimately drives up the consistency and degree of IOP lowering clinical effects for patients.

The surge in survey results, placing a premium on six 674 over implant injections, which frankly expected since we know we asked our surgeons to perform more time intensive skillful circumferential multi procedural work that ultimately drives up the consistency and degree of IOP lowering clinical effects for patients.

Speaker 7: On the facility beside the thing we are pleased to see our 6674 facility feed disadvantage in error.

On the facility side of things, we were pleased to see our six 674 facility fee disadvantage narrowed.

Speaker 7: The Cadar Extensive always had an advantage on the facility fee and that advantage narrowed in the final rule. So net net, your questions were relatively better off in 2022 versus 2021 relative to our Cadar Extensive.

Cataract dense have always had an advantage on the facility fee and that advantage narrowed in the final rule. So net net to your question.

We're relatively better off in 2022 versus 2021 relative to a cataract <unk> competitors are outlook for commercial scale and growth.

Speaker 7: Our outlook for commercial scale and growth has only been reinforced with more wind behind our backs as we enter 2022 and build on the on the acceleration.

It has only been reinforced with more wind behind our backs as we enter 2022 and build on the omni acceleration, we've seen quarter after quarter in 2021 without those CMS relative improvement to six 674 and the last thing I just want to mention quickly is theres a lot of comparison when these rules come out they are important and theirs.

Speaker 7: We've seen quarter after quarter in 2021 without those CMS relative improvements to 6174. And the last thing I just wanna mention quickly is there's a lot of comparison, when these rules come out they're important and there's a lot of comparisons between us and the combo cataract standpoint competition. I think it's really important to remind everybody

There's a lot of comparisons between us.

And the combo cataract stand competition, I think it's really important to remind.

Everybody.

Speaker 7: that our focus and growth market at site is the five times larger stand-alone.

That's our focus and growth market that site, it's the five times larger standalone market.

Speaker 7: where we stand alone and are pioneering that space. So on that front in standalone, the 66174 Pro-FEE and Facility FEE in the final rule is very competitive and attractive compared to cataract surgery alone, both on the professional FEE and ASCFEE. So generally, we are very bullish in both the combo cataract segment, as well as the much larger standalone segment.

Where we stand alone and our pioneering that space, so on that front and standalone.

674 process and facilities to be in the final rule is very competitive and attractive compared to cataract surgery alone both on the professional fee and a SEC. So generally we are very bullish in both the combo cataract segment as well as the much larger Standalone segment.

Speaker 6: Yes, the studio is Sean. I would add on your question around the label. The label continues to be a positive for us as well with the expanded label thromney and the breadth of the adult patient primary opening of the Wacumba and IOP lowering.

This facility Shawn I would add on your question around the label. The label continues to be a positive for us as well with the expanded label for omni and the breadth of the adult patients with primary open angle glaucoma and IOP lowering.

Speaker 6: that really is going to be the cornerstone of our market leading disease state education campaign, as well as is where we're going to be investing resources to educate the primary care provider. So we are definitely leveraging that expanded label to educate the community on standalone and continue to pioneer and create leadership role in the standalone space.

It really is going to be the cornerstone of our.

Market, leading disease state education campaign as well as.

Is where we're going to be investing resources to educate the primary care providers. So we are definitely leveraging that expanded label to educate the community on the Standalone and continue to pioneer and create leadership role in the Standalone space.

Thank you.

Speaker 1: Our next question comes from the line of Mr. Mather Brian from Piper Sandler. Your line is now open.

Our next question comes from the line of Mr. Matthew O'brien from Piper Sandler Your line is now open.

Speaker 2: Oh, afternoon. Thanks for taking my questions. I guess just to follow up on what Cecilia was asking you as far as new accounts go, can you kind of frame up what you saw in terms of training competitive clinicians versus kind of those new to MIGs? And then what did you see in Q3 as far as standalone sales versus combo cattle?

Good afternoon, Thanks for taking my questions.

I guess just to follow up on the affiliate was asking as far as.

New accounts go can you kind of frame up what you saw in terms of.

Training competitive clinicians versus kind of those new to Migs and then what did you see in Q3 as far as Standalone.

Sales versus.

Combo cataract.

Hey, Matt This is Sean yes, so as far as the.

Speaker 6: And that this is Sean yeah, so as far as you know the training of new surgeons, we continue to focus on the high volume surgeons is the bullets of our trained universe as we continue to penetrate into those roughly 3000 makes trained comprehensive surgeons in the United States.

The training of new Surgeons, we continue to focus on the high volume surgeons.

Most of our trained universe as we continue to penetrate into those roughly 3000 page trained comprehensive surgeons in the United States.

Speaker 6: So we've definitely seen, you know, as we continue to penetrate into that group.

We've definitely seen as we can.

Continue to penetrate into that group.

Speaker 6: because they are the ones that are already well informed on the anatomy and ankle surgery. And we're gaining confidence with them in that combo space, ultimately leading into our expansion into the standalone space.

Because they are the ones that are already well informed on the anatomy and the Haynesville surgery, and we're gaining confidence with them in that combo space ultimately leading into our expansion in the Standalone space.

Speaker 6: I know that we are getting some additional data, CPT level data to really quantify our penetration in the standalone space as we've mentioned before. We do have internal information that shows that we are growing in that space based on our training and conversation with surgeons. And we look forward to providing more detailed information in the future as we get that additional data.

No that we are getting some additional data CPT level data to really quantify our penetration of the standalone space as we've mentioned before we do have.

Internal information that shows that we are growing in that space based on our training and conversations with surgeons.

And we look forward to providing more detailed information in the future as we get that additional data.

Yeah.

Speaker 2: Yeah. Hi, man. Hi, man. Sorry. Oh, shoot that on that real quick.

Okay.

On that real quick.

We do want to get.

Speaker 7: granular data to report quarterly on our standalone progress, market development progress. We have done some initial CPT analyses for now, just annual results. And we can, we can say that the year of Omni launch in 2018, when we look at CPT 66174 used alone.

Granular data.

To report quarterly on our Standalone progress market development progress we have done some initial.

CPT analyses for now.

Annual.

Results and we can we can say that the year of omni launch in 2018, when we look at CPT 661 hundred 74 used alone.

Speaker 7: So standalone 66174, there were approximately 11,800 claims.

Stand alone six 674, there were approximately 11800 claims and.

Speaker 7: in 2018, that grew in 2019, the second year of OMNI.

In 2018 that grew in 2019 in the second year of omni.

Speaker 7: after Omni's launch. This number doubled to just over 26,900 claims.

After all these launch this number doubled to just over 26900 claims.

Speaker 7: And then in 2020, despite the COVID pandemic, obviously impacting non-life threatening surgical procedures, saw that number gross significantly again. And there were 30,000...

And then in 2020.

Despite the Covid pandemic, obviously impacting non life threatening surgical procedures.

That number grow significantly again and there were 30000.

Speaker 7: just over 30,000 claims process for standalone use of 66174.

Just over $30 in claims process for Standalone use of six 674, So we've asked our market access team to get.

Speaker 7: So we've asked our market access team to get even more granular data and we believe that we're going to be able to have at least quarterly data, almost current very soon. And so we look forward to, and then not too distant future hopefully being able to share quarterly standalone growth of six, six, one, seven, four. If we can get that data.

Even more granular data and we believe that we're going to be able to have at least quarterly data almost current.

<unk> soon and so we look forward to.

Not too distant future hopefully being able to share quarterly Standalone grew up at six 674, if we can get that data.

Okay very helpful. And then I don't know if this is for Paul or for Jesse.

Speaker 2: Okay, very helpful. And then, you know, I don't know if this is for Paula for Jesse, but as we think about the fourth quarter, you know, again, it's a nice progression versus Q3 and it sounds like you probably had some headwind sharing, Q3.

As we think about the fourth quarter again, its a nice progression versus Q3 and it sounds like you probably had some headwinds here in Q3, but the guidance. It's a nice little step up it's not a huge step up.

Speaker 2: but you know the game is a nice little step up, it's not a huge step up.

Speaker 2: versus Q3, which again is a seasonally softer quarter. So why not a little bit more on the guidance side for Q4? And then what I'm really trying to get to is if you just annualize Q4, there's a lot of growth that needs to happen to kind of get to where the streets at for 22. And I know there's new reps coming in, but just what gives you the confidence or what can you help us see that should give us all the confidence in hitting some of these 22 numbers that are pretty steep ramps. Thanks.

Versus Q3, which again is a seasonally softer quarter.

So why not a little bit more on the guidance side for Q4, and then what I'm really trying to get to is if you just annualize Q4.

Youre not theres, a lot of growth that needs to happen to kind of get to where the street's at for 'twenty, two and I know theres, new reps coming in but.

What gives you the confidence or what can you help us see that should give us all the confidence in hitting some of these 22 numbers that are pretty pretty steep ramp. Thanks.

Speaker 3: You know man, I would, I would encourage you to take a look at it this way. How much, how much quarterly dollar growth?

You know, Matt I would.

I would encourage you to take a look at it this way how much how much quarterly dollar growth.

Speaker 5: Does the guidance imply in 2000?

Does the guidance imply in 2000.

Speaker 5: 21 versus how we exit the 2020. And where did it then given all the factors and momentum in the business, where does it actually imply a slope increase or not as you look to sort of get comfortable to the 2022 number. We're exiting when we develop our forecast. Yeah.

'twenty one versus how we exited 2020.

And given all the factors and momentum in the business where it is.

Does it actually implies slope increase or not.

As you look to sort of get comfortable 2022 number.

We're exiting when we developed our.

<unk> forecast.

We were gonna be actually the year stronger than given sort of the step up in guidance than we initially thought to be able to confidently support that number.

Speaker 5: we're going to be actually the year stronger than given sort of the step ups and guidance than we initially thought to be able to confidently support that number.

Speaker 5: And, you know, we feel pretty confident we're going to be actually going to be yearnth to break that place. Get out.

And we.

We feel pretty confident we're going to be accident year and spread in that place.

No.

The back half.

Speaker 5: The first half of a year is healthier in terms of step functions of growth, often like what our experience has been in this market. I think it's going to be a little bit of a noisy December , to be honest, like in terms of...

First half of the year is healthier in terms of step functions of growth often like what.

Our experience has been in this market.

I think it's going to be a little bit of a noisy December to be honest like in terms of.

Vacations taken vacation days true selling opportunity in the back half of the month, but.

Speaker 9: Vacation is taken, vacation days, true selling opportunity in the back half of the month.

Speaker 5: you know we think you know as we said about the third quarter when you look at the comps um... that this guidance

We think you know as we said about the third quarter when you look at the comps.

This guidance implies.

Speaker 5: a very healthy amount of sequential growth for an eye-care business, particularly a surgical eye-care business.

A very healthy amount of sequential growth.

For an eye care business, particularly a surgical eye care business.

Okay. Thank you.

Our last question comes from the line of Joanne Wuensch from Citi. Your line is now open.

Speaker 1: Our last question comes from the line of Joanne Winsh from City. Your line is now open.

Speaker 8: This is Anthony on for Joe Ann. Thank you for excusing us, and here. I just have one question. It's a bit more open-ended with surprised you and most end of the least over the past three months, especially just given all the reimbursement points. Thanks for taking the question.

Alright. This is Anthony on for Joanne. Thank you for squeezing us in here.

I just have one question and it's a bit more open ended.

<unk> surprised you the most over the past three months, especially just given all the ramp of our reimbursement price. Thanks for taking the question.

Speaker 7: Sorry, can you could you repeat that? What surprised us the most?

Sorry can you could you repeat that whats your prized us the most are.

Yes, what surprise.

Speaker 2: Yeah, sorry. Sorry if I was bringing up. I just asked what surprised you the most in the least over the past three months?

Yes, sorry, if I was breaking up but I just ask what surprised you the most or at least.

Over the past three months.

Yes.

I mean, I don't know we've been.

We've been executing to our fundamentals.

Speaker 7: We've been executing to our fundamentals across our three value drivers in a very predictable way. And as you can tell,

With our three value drivers.

A very predictable way and as you can tell from.

Speaker 7: our top performance this quarter. So we've been frankly just focused on taking, continuing to take sharing.

Our.

Top performance this quarter so.

And we've been frankly just focused on.

Taking continuing to take share in combo cataract.

Speaker 7: expanding use in standalone and advancing all of our peer care initiative and I think we've done that in a very predictable and compelling way So I don't I don't look back at the last quarter I'm seeing too many surprises. Sorry. That's not a not an exciting answer, but Sean or Jesse maybe you guys

Expanding use in Standalone and advancing all of our tier care initiative and I think we've done that in a very predictable and compelling way.

So I don't I don't look back at the last quarter.

Seeing too many surprises sorry, that's novel non exciting answer that Sean or Josh maybe you guys.

We're surprised by something.

Okay.

No I would agree Paul Anthony This is Sean I would say is it's not a surprise, but I think the thing.

Speaker 6: No, I would agree, Paul, and Anthony, I just a shana. I would say it's not a surprise, but I think the thing that's really been been

<unk> really been then.

Speaker 6: you know, a pleasure for us from an execution, commercial execution standpoint, it's just the advocacy that we've received from our customer base and the, you know, acceptance of both technologies, Omni and tear care within our strategies to develop the standalone market with the multimotoric standalone market with Omni and to execute against our strategy for patient access.

A pleasure for us from an execution commercial execution standpoint is just the advocacy that we received from our customer base and the.

Acceptance of both technologies Omnia in tier care within our strategies to develop to stay at a low market with multi moderate standalone market with the army and to execute against our strategy for patient access.

Speaker 6: with with tear care and MGD. So I think the the acceptance and just the advocacy that we've had from our customer base with these technologies and our go-to-market strategy has been really a high point for us and continues to feel our confidence as we continue forward in both these markets.

With tier care and Mgd, So I think the acceptance and just the advocacy that we've had from our customer base with these technologies and our go to market strategy has been really.

You know a high point for us and continues to fuel our confidence as we continue to move forward in both these markets.

My My answer quickly is I was surprised about how strong our results were.

Speaker 5: My answer quickly is I was surprised about how strong our results were relative to peers and competitors that have also.

Relative to <unk>.

Our peers and competitors that are also recorded results.

Thanks.

We have a question from the line of Matt O'brien from Piper Sandler Your line is now open.

Speaker 1: We have a question from the line of Matt O'Brien for Bipers Sandler. Your line is now open.

Speaker 2: Thanks, just two quick follow ups. There's been there was some consolidation in the space earlier this week I'm just curious as far as how you think about That consolidation in the impact of the business in 22 and then there's also a little bit more competition on the on the canaloplasty side that was recently approved and I'm just curious as far as your thoughts as far as If that'll be a headwind for you guys, or if it's just it maybe maybe opens up the market Just because there is so much opportunity in that category

Oh. Thanks, just two quick follow ups, there's been there was some consolidation in this space earlier. This week I'm just curious as far as how you think about.

That consolidation and the impact of the business and.

In 'twenty two and then there's also a little bit more competition on the.

And that can Alloplasty side that was recently approved and I'm just curious as far as your thoughts as far as if that would be a headwind for you guys or just maybe maybe opens up the market just because there is so much opportunity.

In that category. Thanks.

Speaker 7: so i'll take a crack at that matter to call on the consolidation side uh... obviously i'm guessing you're referring to the acquisition of so uh... event is by alkan i think what what for me what comes to mind to things come to mind uh... one one the

Yes, I'll take a crack at that Matt This is Paul.

The consolidation side.

Obviously, I'm guessing you're referring to the acquisition.

I vantage by Alcon, I think what for me what comes to mind, two things come to mind.

One.

One the.

Stents, whether its hydrous or for.

Speaker 7: Whether it's hydrists or ice-dense, those are products indicated in combination with cataract surgery where we've already demonstrated an ability to take share effectively. And it's, you know,

I spent those are those are products indicated in combination with cataract surgery, where we've already demonstrated an ability to take share effectively.

And it's.

Speaker 7: That's one fifth of the market. We have the five times larger standalone market that we are focused on and penetrating effectively.

That's one of the market we have the five times larger standalone market that we are focused on a.

Penetrating effectively.

Speaker 7: So that doesn't affect us there. And also, we have Sean on the line. Sean was at Alconn for 20 plus years. He's best in class commercially. He's built out a best in class commercial leadership team and team throughout the organization. So as it relates to our ability to compete effectively and win,

So that.

It doesn't affect doesn't affect us there.

And also we have shown on the line Shawn was at Alcon for 20 plus years. He has best in class commercially.

He has built out a best in class.

Commercial leadership team and team throughout the organization so as it relates to our ability to.

Compete effectively and win.

<unk>.

Speaker 7: I think our confidence grows every day Sean if you want to comment a bit on that.

Our confidence grows every day, Sean if you want to comment a bit on that.

Speaker 6: Yeah, absolutely. All thanks. And yeah, we obviously anticipate outcomes presence to community additional investment and just recognition of the importance of the big space for patient care. But I think that additional investment and education awareness is overall positive for the marketplace.

Yeah, absolutely Paul thinks and yeah, we are.

Obviously anticipated outcomes presence to meet additional investment.

And just recognition of the importance of the mix space for patient care.

But I think that additional investment in education awareness as the overall positive for the marketplace and because of the performance of bonding to date and our confidence in this differentiated efficacy profile and with a broad indication for use that we have to enter into the standalone Migs market.

Speaker 6: And because of the performance of bonding to date and our confidence in this differentiated efficacy profile and with the broad indication for use that we have to enter into the standalone MiG market, we're still really confident in our ability to lead that standalone MiG market.

We're still really confident in our ability to lead the standalone migs market and continue to leverage our top commercial talent that we have here to continue to invest and expand here at <unk> sciences to meet our strategic objectives. So I think overall, it's a positive and frankly those are the same things that are going to allow us to.

Speaker 6: and continue to leverage our top commercial talent that we have here and continue to invest and expand here at Site Sciences to meet our strategic objectives. So I think overall it's a positive and frankly those are the same things that are going to allow us to compete regardless of what competitor comes into marketplace.

Regardless of what competitor comes into the marketplace is going to continue to be focusing on our points of differentiation of <unk> ability to address all three points of resistance for those mild moderate either in combination with cataract and most definitely in the Standalone space.

Speaker 6: is going to continue to be focusing on our points of differentiation, the bombing's ability to address all three points of resistance for those mild to moderate.

Speaker 6: either in combination with K-Rex and most definitely in the standalone space.

Speaker 6: and just continue to leverage that in our exceptional customer experience to continue to build that leadership position and standaline.

And just continue to leverage that in our exceptional customer experience to continue.

Continue to build our leadership position in Standalone.

And Matt on your second question regarding.

Speaker 7: The mat on your second question regarding

Potential Canal Plaza and trends I think a couple of things come to mind, maybe maybe four things.

Speaker 7: Potential canaloplastia entrance. I think a couple of things come to mind, maybe four things. Number one is R&D and I'll get into, we are the pioneers of Abinternal canaloplastia. Abinternal canaloplastia for baculotomy. We've been at it for many, many years and have been iterating. So the

Number one is R&D and I'll get into we are the pioneers of been turnover now policy had been turned up now bucking trabeculectomy, we've been at it for many many years and have been iterating. So the.

Speaker 7: The clinical excellence that is omnivis the result of

The clinical excellence that is omni is the result of.

Yeah.

Speaker 7: tens of thousands of cases, significant clinician feedback, significant iteration. I can tell you it's been a long road to get to the device that we have today that is delivering such incredible results for surgeons and their patients. So it's not easy. So generating a prototype, showing a prototype, maybe even getting a clear end.

Tens of thousands of cases.

<unk> clinician feedback significant iteration I can tell you it's been a long road to get to.

The the device that we have today that is delivering.

Such incredible results for surgeons and their patients.

It's not easy so generating a prototype.

Showing a prototype maybe even getting a clearance.

Speaker 7: maybe straightforward, but delivering a

May be straightforward, but.

Delivering a.

Speaker 7: highly dependable reproducible canal property device that is capable of

Highly dependable reproducible canal floppy device that is capable of.

Speaker 7: consistently helping the surgeon circumnavigate 100 200 micron diameter Delicate canal for 36 to 40 millimeters around Consistently is not easy period On the clinical front I haven't seen

<unk>, helping the surgeon circumnavigate 100, 200, micron diameter delicate canal for 36% to 40 millimeters around consistently did not easy period.

On the clinical front I haven't seen.

Speaker 7: I personally haven't seen any clinical data from anybody on another Ab-interno, you know, canaloplasty entrant. I think if we're going to be talking about canaloplasty and labels, I think we need to see clinical data. I think it brings us to the third point from a regulatory perspective.

I personally haven't seen any clinical data from anybody.

Another AB internal.

Canola Plasty and trend.

Think if we're going to be talking about can alloplasty and labels I think we need to see clinical data I think it brings us to the third point from a regulatory perspective.

I would ask.

Speaker 7: I would ask whichever companies are brought up.

Or are companies or products.

Speaker 7: that we're discussing here, I would ask them, what is the indication for use? Is it for a canaloplasty? Is it for pressure lowering? Is it for primary open angle welcome? I'm pretty sure into the pathway that we've gone through, requires significant clinical data. To have a canaloplasty indication and to promote for canaloplasty, and we just announced earlier today, maybe some of you have seen it, you put out a press release just before this call.

We are discussing here I would ask him what what is the indication for use is it for <unk> is it for pressure lowering as a co primary open angle glaucoma, because I'm pretty sure the pathway that we've gone through requires significant clinical data.

To be to have Okinawa path indication into promoting <unk>.

We just announced earlier today, maybe some of you have seen it we put out a press release just before this call on our I D E. Four Ocala posture alone indication. So we have a very large make trial I think the largest there will ever be conducted 469 patients.

Speaker 7: on our IDE for a canaloplastial wound indication. So we have a very large mic trial, he's the largest that will ever be conducted for 159 patients.

To seek.

Speaker 7: this canaroplasty alone indication.

This can now apply the alone indication.

Speaker 7: And then lastly, beyond R&D clinical and regulatory, again, I haven't seen any of these devices, but I will say we've been at this for over a decade and we have a very broad and deep partner state and intellectual property covering methods and devices of circumstantial, cantalricular, colchoma surgery. So those are the four things to come to mind as it relates to any potential entrance.

And then lastly, beyond R&D clinical and regulatory.

Again, I don't I haven't seen any of these devices, but I will say we've been at this for over a decade, and we have a very broad and deep patent estate and intellectual property.

During methods and devices.

Circumstantial cannot let Europe arkoma surgery. So those are the four things that come to mind.

As it relates to any potential entrants.

Great. Thanks, so much.

Sure.

Speaker 1: This concludes our question and answer session. I would like to turn the call back to Paul Vidalvi for closing remarks.

This concludes our question and answer session I would like to turn the call back to Paul <unk> for closing remarks.

Just wanted to say thank you all for your time attention and interest in flight Sciences.

Speaker 7: I just want to say thank you all for your time, attention, and interest in play sciences.

Speaker 1: This concludes today's conference call. You may now disconnect.

This concludes today's conference call.

May now disconnect.