Q2 2021 Sight Sciences Inc Earnings Call

[music].

Yeah.

Good day, ladies and gentlemen, and welcome to the site Sciences' second quarter.

2020, one financial results conference call.

At this time all participants are in a listen only mode.

Later, we will conduct a question and answer session and instruction will follow follow at that time.

If anyone should require operator assistance. Please press star then the zero key on your Touchtone telephone.

As a reminder, this call maybe recorded.

I would now like to introduce your host for today's conference Mr. Philip Taylor Investor Relations you may begin.

Thank you and thank you all for participating in today's call presenting today are site Sciences, co founder and Chief Executive Officer, Paul <unk>, and Chief Financial Officer, Jesse Celnik earlier today, <unk> Sciences released financial results for the three months and six months ended June 32020.

A copy of the press release is available on the company's website before we begin I'd like to remind everyone that comments made by management today and answers to questions will include forward looking statements. Those include statements related to <unk> future financial and operating results and plans for developing and marketing new.

Forward looking statements are based on estimates and assumptions as of today and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied by these statements, including the risks and uncertainties described in <unk> Sciences filings made with the SEC.

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 in risk factors in our recent SEC filings and with that I will turn the call over to Paul.

Okay.

Thank you trip and thank you to everyone joining us on our first earnings call as a publicly traded company, our chief financial Officer of Jesse Celnik and I look forward to updating you on our performance in the second quarter and our Chief Commercial Officer, Shaun O'neil is also with us today.

Her story may be new to many of you I'd like to start by providing an overview of site Sciences, our mission, our guiding principles and our growth strategy.

We are gratified and humbled that many new and existing investors participated in our IPO and are joining us on our journey to transform the lives of patients suffering from the world's most prevalent eye diseases.

Eyesight is fundamental to our quality of life.

Over 50% of the human brain is devoted to vision and over 80% of the information we need to perceive the world interest through our eyes.

Our overarching goal is to improve quality of life by protecting and enhancing our most precious sense vision.

So at times it is not a conventional eye care company I started site over a decade ago with my brother, David a world class ophthalmologist we.

We came up with the all encompassing named site sciences, while performing simulated glaucoma experiments out of the garage of Dan O'keefe, our first outside employee in our current vice President of research and development.

We believe from the very beginning that if we did things right and had some good fortune along the way we could methodically build a platform eye care company, serving many disease categories through the development of novel and improve medical devices.

To fully address the breath and importance of our mission, we built our company for the long run from day one.

Many years later and thanks to the efforts of our now almost 200 talented team members, we've created and commercialized two differentiated products and what we believe to be very underserved areas of eye care.

And we intend to create many more in the coming years.

We thrive on transforming ophthalmology and optometry through product to target the underlying causes of the world's most prevalent diseases, we seek to develop interventional solutions and in interventional mindset in eye care. They can replace conventional outdated approaches, thereby creating new treatment paradigms, while also maintaining a laser.

Our focus on optimized patient care as our utmost priority.

Many investors and industry participants are curious.

While we are initially chosen to pursue and tackle both primary open angle glaucoma and dry eye.

Very different disease categories.

The simple answer is that we will pursue opportunities wherever we can leverage our organic clinically differentiated problem solving methods and expertise to develop and commercialize products for improved clinical outcomes that empower eyecare providers or <unk> to take the best care of their patients.

Moving on now to our four pillars of product development.

Days at site or spent competing head on against serious eye diseases with an obsession on developing devices to meeting meaningfully improve the standard of care in eyecare, we are hyper focused on developing and commercializing clinically transformative products that maximally empower care providers to take the best care of their patients are focused on product.

Development is governed by four fundamental requirements that we believe are mission critical to delivering the most robust and consistent clinical outcomes for patients.

Number one.

Disease Physiology mastery, we review and analyze all available clinical data science and literature that is relevant to a disease to achieve a sound understanding of its underlying causes which we then used to guide the development of our product.

Number two treatment of underlying causes healthy.

<unk>, our self regulating marvels of evolution biomechanics chemistry, and physiology, we believe that restoring the natural functionality of disease site by comprehensively treating underlying causes of diseases provides the optimal combination of effectiveness and safety.

Number three intuitive design.

Our products are designed to transform complex and practical or invasive treatment approaches and to intuitive minimally invasive user friendly procedures.

Our product development goals are focused on delivering a preferred go to treatment of choice to ophthalmologists and optometrists.

Number four patient access we seek to maximize the availability and accessibility of our products for as many patients as possible.

We believe that our devices have the potential to offer differentiated clinical experiential and economic value to all <unk> stakeholders.

With the goal and expectation to clinically lead any category. We enter we must have conviction that all four criteria are attainable before we begin a new project.

Most of our ideas do not advance into development because they fail to satisfy all of our requirements. Today. We've commercialized two products that successfully ran the gauntlet of our rigorous product development process for use in adults with primary open angle glaucoma or.

The world's leading cause of irreversible blindness and in situations, where the medical community recommend to application of a warm compress including dry eye disease. The number one reason for a patient visit to an eye care provider.

We believe both army and tier care are poised to have tremendous global clinical impact in the years ahead.

Maximizing global clinical impact requires more than a transformative product it requires meticulous ECP training and commercial excellence.

Over the past three years, our commercial leadership team has built distinct sales and marketing teams and training programs for both omni and tier care.

Our commercial team works passionately with thousands of ophthalmologists and optometrists prospect and customers.

We hear that we have a reputation among eyecare providers and within the industry as the team doing great things the right way and the team do you want to join we strive to continue to earn this reputation everyday.

Because of our commitment to the relentless pursuit of improved patient care and outcomes. We are rewarded with the best gift possible customers choosing our products as the reliable go to intervention when the clinical Stakes are high and when we believe we can have significant impact on patient quality of life.

Our passion and commitment to help our customers fight disease rises in lockstep with the clinical severity of the situation not just with the size of the market.

There is no greater satisfaction or joy to me personally or to the dedicated people of <unk> sciences tend to be blessed with a meaningful role in improving the lives of patients.

We are gratified and humbled that many of you have chosen to join us on our mission to protect and enhance the eyesight of patients around the world in the years to come we.

We believe that substantial shareholder value accrues disproportionately to those select health care companies that can rely on putting the patient first as their competitive advantage.

Now moving on to our three key strategic value drivers.

Our strategy will always include further innovation in devices intended for use in our two core disease areas primary open angle glaucoma and dry eye disease as well as potential expansion of our pipeline into other eye diseases, both in the U S and internationally.

In the near term however, we will be laser focused on advancing three key strategic imperatives for our two current commercial products number one continuing to expand omnis adoption and usage by surgeons for adult patients with G. India establish combination cataract segment of the minimally invasive glaucoma surgery.

Or migs market.

Please keep in mind that the share expansion will prepare these surgeons to perform procedures within the Standalone segment, which brings us to number two.

Continued development of the virtually greenfield and substantially larger Standalone <unk> segment of the mixed market.

And number three expanding our labeling and indications for use for tier care for the treatment of evaporative dry eye disease, while also advancing market access among Medicare and commercial payors.

In the second quarter, we made substantial progress in all three of these goals are first two goals related to advancing the treatment of adult patients with <unk> by offering a device that can be used for a minimally invasive intervention.

<unk> is a pressure based disease and elevated intraocular pressure or IOP is the greatest risk factor associated with <unk> and therefore, the focus of treatment cataract surgery on it on its own is known to have IOP lowering benefits and today. The migs market is segmented into two into procedures performed in combination with <unk>.

Cataract surgery, which we refer to as the combination cataract segment and procedures performed on their own which we referred to as a standalone segment.

This segmentation is largely artificial and primarily the result of mix bypass stents only being indicated for use in combination cataract procedures, which has necessitated this unnatural division for the past decade, and their pivotal clinical trials trabecular bypass stents demonstrated modest incremental efficacy over the IOP lowering effect of cataract care.

<unk> alone.

Trabecular bypass stents are not indicated for use in Standalone makes procedures in the U S.

The surgical decision, making criteria and clinical effectiveness and consistency requirements for Standalone Migs are elevated beyond those for combination cataract procedures.

We believe both the degree of effectiveness and the consistency of effectiveness are crucial factors for both patients and surgeons when considering a procedure for patients. We believe the anxiety that may accompany the need for ocular surgery can be tempered with the knowledge that there is a high likelihood of success.

For surgeons consistent outcomes simplify the treatment choice and the decision to perform a procedure.

We believe this is especially important for stand alone makes procedures, which must deliver a very high consistency of effectiveness and a very high degree of effectiveness.

So not only justify the procedure, but also provide surgeons with enough confidence to recommend standalone surgery to their patients and take them to the operating room for a singular reason.

We believe devices capable of delivering consistently effective results will be crucial to unlocking the standalone market as well as capitalizing on the full potential of the combination cataract market, which we believe is currently capturing less than one third of its potential procedure volume in the U S.

In March of this year.

The FDA cleared and expanded indications for use for omni that we believe bridges the unnatural divide between combination cataract and Standalone mix and which we believe covers the broadest patient population among all migs devices supported.

And FDA cleared based on App and turnover clinical data.

Fortunately this indication for use broadly covers the reduction of intraocular pressure for all adult patients with <unk> without limitation with respect to severity of disease mild moderate and advanced or lend status fake patients combination cataract patients and pseudo vacate patients.

We believe this is the Holy Grail indication in Migs, and we intend to invest very aggressively in the clinical and commercial development of omni.

So why did Amit clinical performance achieved such a broad indication in mix.

We believe that omni has two critical physiological and clinical advantages number one omni is capable of comprehensively addressing up to all 360 degrees of the disease conventional outflow pathway implantable focal treatment address a smaller segment of the disease outflow pathway and.

And number two.

He is capable of addressing all three points of resistance in the conventional outflow pathway trabecular meshwork, Schlumpf canal and the distal collector channels.

As shown in our Romeo Multicenter study used for FDA clearance and label expansion use of omni for sequential combined and comprehensive Canelo Plasty and trabecular <unk> has been demonstrated to safely effectively and consistently lower IOP in adult patients with <unk> and both combination cataract and standalone.

One settings.

We have always viewed makes as a single market that seeks to improve the lives of any patient with <unk>.

Yeah.

Despite the intense entrenched competition since omnis launch in early 2018, we have deliberately chosen the universe of over 3000 makes trained surgeons as our highest priority customer targets. We have successfully trained a large number of these surgeons and brought them up the omni learning curve in the second quarter of.

<unk> 2021, we sold omni to nearly 700 ordering facilities and we still have many more to go.

While our commercial team deserving Lee received so much praise for their incredible achievements, we collectively believe it all starts with our clinically transformative mission and a clinically differentiated surgical technology, we developed and perfected over a 10 year period or.

Our focus on putting the patient first and mastering the physiology of glaucoma allowed us to create a product that comprehensively.

And effectively it reduces IOP and that we believe surgeons love to use.

We painstakingly designed omni with the goal of transforming effective a complex and invasive surgeries into safer routine and minimally invasive yet equally effective procedures with an elegant device that surgeons can master within an intuitive learning curve.

Our goal in pursuing exist existing makes trained surgeons was to facilitate an exceptional training and support experience that would allow a surgeon to achieve such high levels of confidence in the safety effectiveness and consistency of omni that they would prefer the device to reduce IOP in adult <unk> patients in all settings consistent with.

It's broad clearance, including Standalone cases, which have a higher clinical bar.

And then add on combination cataract mix procedures.

As we have made tremendous inroads in the established combination cataract segment. We believe this phenomenon is already starting to occur many of our surgeons have indeed chosen to expand their use case for omni to treat adult <unk> patients in standalone settings.

Based on the results of an internal field study, we conduct conducted late last year, we estimate that approximately 20% of the procedures using omni were standalone cases in 2020.

I would like to note that our surgeons early increased usage of omni was achieved even without the benefit of our Standalone marketing campaign, which we launched after omni received its expanded FDA label in March of this year.

We believe the U S. Standalone makes segment is approximately five times larger than the $1 billion U S combination cataract segment, and a substantially undeveloped or plan to fully develop standalone usage among both comprehensive ophthalmic surgeons, who perform the vast majority of eye surgeries, including cataract surgeries as well as glaucoma.

<unk> includes a first of its kind market education awareness and development program that seeks to introduce and educate the primary care providers, who first diagnose and treat <unk> patients both general ophthalmologists and optometrists to the possibility and benefits of earlier make the intervention regardless of the patient's <unk> status.

<unk>.

We are currently developing methods to track our progress in the Standalone segment on a more consistent and reportable basis and look forward to sharing more information about our progress in the coming quarters.

We believe the standalone mild to moderate <unk> segment is the most exciting and all of mix, we couldnt be more thrilled to be in a position to deliver the power of site two adult <unk> sufferers, who do not require cataract surgery.

So that summarizes our first two value drivers continuing to take share in the existing combination cataract mix segment and leading the development of the much larger Standalone makes segment.

Moving on now to our third value driver is our tier care system in development program. We currently market tier care at the power heating pad for the application of localized heat where the current medical community recommends the application of a warm compress to the islands, we purposefully built here care to deliver a precise and tightly controlled level of <unk>.

<unk> energy through the outer islands over a 15 minute period and a comfortable office based procedure.

After over five years of product and clinical development and multiple rounds of iteration and product optimization. We introduced here care in mid 2019, and a controlled launch with approximately 10 reps covering the entire United States gathering additional data to demonstrate tier care safety and effectiveness through clinical trials.

Advancing dialogue with third party payers regarding appropriate coverage and payment for tier care treatments and working with the FDA to obtain clearance for an expanded indication for use for dry eye disease, and Mgd are key pillars of our tiered care strategy.

Dry eye complaints are the number one reason for patient visits to an eye care provider and there are over 17 million people diagnosed with dry eye in the U S out of an estimated nearly $40 million total dry eye patients in the U S and $739 million global suffers we believe the U S market for effective mgd treatment procedures could exceed 10 billion.

Annually.

Dry eye is a multifactorial disease that is typically characterized by insufficient tear production known as aqueous deficient dry eye.

Or poor quality tiers that evaporate too quickly nunez evaporated dry eye.

Recent studies have determined that evaporative dry eye, which is most commonly associated with my ability and gland disease or mgd.

Associated with 86% of dry eye cases, yet.

Yet dry eye treatment that aim to treat aqueous deficiency or inflammation represent 95% of manufacturer revenues.

This represents a huge disconnect between the way you dry eye is treated today and the actual underlying cause of disease. We studied dry eye extensively and concluded that the optimal way to help patients suffering from this potentially debilitating disease, what to develop an effective way to treat mgd. The most common cause of dry eye.

<unk> glands line, the top and bottom eyelets and producing oil lease accretion called Michael.

<unk> <unk> has a clear olive oil like consistency and formed the outer most lipid layer of tears.

<unk> released with each blank and forms a protective barrier over the tears and prevents premature tier evaporation.

One the glands become blocked or obstruct it Michael and gets trapped into glands and hardens as the disease progresses. The consistency of my bump can degrade to a toothpaste like consistency, which precludes you from reaching the tear film and providing protection against premature tier evaporation.

Despite the prevalence of Mgd is the leading cause of dry eye treatments are focused on over the counter and prescription eyedrops that either treat aqueous deficiency or inflammation.

Leading prescription dry eye drops have annual revenue in excess of $1.5 billion.

Yet none are indicated for or have a mechanism targeting the number one cause of dry eye mgd.

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

We had sites scientists have developed a very thoughtful well informed and long term strategy designed to change that.

Although we believe that a patient pay business model for tier care exist based on our own experience to date. We also believe that to maximize the reach of our procedure in technology and provide a comprehensive solution for the broadest range of Mgd suffers patient access and appropriate reimbursement for clinicians utilizing tier care must improve.

We are seeking to expand tier carriers indication for use and are working with the FDA on this front. Our current controlled launch of the product for its indication has allowed us to begin commercialization with specialized and reputable customers. While also initiating our long term focused tier care market access strategy Chuck.

Adjusted we built site sciences for the long term, we are taking a long term approach to developing devices for potential mgd indications, we have chosen not to maximize short term revenue in favor of a more thoughtful strategy that has the potential to provide access to tier care for the largest number of patients with mgd if cleared.

For an expanded label.

Now moving on to clinical evidence, which is critical to everything we do.

Generating robust clinical evidence is crucial to development and commercialization of our products.

Beginning with dry eye and our Olympia RCT tier care was associated with statistically significant clinical improvements in all assessed signs and symptoms of dry eye disease.

The results of Olympia were published in a leading peer reviewed journal and we expect two other articles to be published in other leading journals in the coming months.

We are also pleased to announce that enrollment in our second tier care RCT Sahara is progressing nicely Sahara is a crucial part of our market access and development strategy for tier care.

Last year, we convened a panel of medical directors from eight payers to understand their criteria for establishing an appropriate coverage and payment program for tier care.

We used very clear and consistent feedback from these numerous payer discussion to design. The Sahara protocol in this head to head RCT that has begun we are evaluating the efficacy of care care as compared to a leading prescription dry eye medication and are also assessing the durability of tier care treatments over.

A 24 month period.

We look forward to providing you further updates on Sahara and the other facets of our care care market access development plan over the coming quarters as we continue to make progress. Please.

Please do keep in mind, the patient access for tier carriers, a long term endeavor. It may not always progressing a linear fashion each quarter, but it's certainly the right strategy to ensure patients have access to treatment as we pioneer procedure based reimbursed dry eye and unlock this multibillion dollar segment in the process.

We also have multiple clinical trials ongoing or planned in mix with omni.

Among the ongoing and planned clinical trials for omni are several exciting head to head <unk> versus either the leading trabecular bypass stents or eventually versus the standard of care early intervention prescription hypertensive medications.

These studies will evaluate the effectiveness.

Of omni in reducing and profit pressure, the only treatable risk factor associated with.

And alleviating the burden of hypertensive medications.

As compared to these alternatives.

In terms of completed Omni studies, the 12 month primary endpoint data from our Gemini study, our first prospective multicenter clinical trial of omni in the U S.

As presented at the <unk> conference in Las Vegas last month.

We observed that sequentially performed 360 degree can alloplasty and 180 degree trabeculectomy procedures using omni in combination cataract surgeries resulted in clinically significant reductions in both IOP and the need for IOP lowering medications through 12 months we.

We plan to submit the results of Gemini for publication in peer reviewed journals and present the results at other major ophthalmology conferences in the future.

We are also pleased with the progress we are making with the FDA on our upcoming IDE trial for Ami that if approved and finalized will allow us to study the safety and effectiveness of canal opacity, only procedures, using omni and U S clinical trials.

We expect to have further updates, resulting from our discussions with the FDA on our <unk> alone I E within the coming months.

As a reminder, omni is currently cleared for <unk>, followed by Trabeculectomy to reduce IOP in adult patients with <unk>.

The purpose of a can alloplasty alone study under ITE would be to seek FDA clearance for a new indication for use for omni for Houston Canal opacity, only procedures to reduce IOP and adult patients with <unk>.

If omni is cleared for this new canal pasty only indication we believe this new indication for use would provide surgeons with additional flexibility to customize treatment based on the needs of each <unk>.

Patient.

We have also made significant progress with Trident, our multinational European RCT, we expect to begin enrolling patients in the fourth quarter across seven countries in Europe.

This 12 month RCT aims to study a total of 459 mild to moderate open angle glaucoma patients who will receive on a standalone basis.

Either can alabaster, followed by Trabeculectomy using omni <unk>.

<unk>, the only using omni for implantation of trabecular bypass stents.

We are particularly excited about tried and because it represents our very first opportunity to compare the performance of omni against makes sense on a standalone basis across a large population.

And we are eager to complete enrollment.

At the annual meeting of the American Society of Cataract and refractive surgeons, our Aas Crs last month physician presented the results from five of our clinical studies, featuring omni and tier care.

Participation and leadership at important meetings like <unk> Crs are great opportunities for us to present, our clinical trial results to a broad audience of ophthalmologists and optometrists and connect with long time thought leaders customers surgeons and brands.

We will continue to make our presence felt at other eye care industry events in the future, including the annual meeting of the American Academy of Ophthalmology in November and major Optometry optometry conferences like <unk>.

Oh.

And finally, moving on to reimbursement and market access.

Last month as many of you may be aware of as it relates to make the nominee CMS.

CMS released new proposed fee schedule rules for payments to physicians in outpatient facilities for 2022.

These results are subject to a 60 day review period, and maybe further revise before finalized in November and taking effect on January one.

Proposed payments related to CPT code 66, $1.74, which is used for omni procedures were among those that were revised the proposed national payment to physicians for $66.74 would be $739 a $211 reduction from the current rate. While we are disappointed in the proposed reduction and plan.

To engage with CMS to increase the recognized value of this procedure in the final rule. We believe the proposed payment if finalized we will still provide an adequate payment to physicians.

We note that this proposed payment still exceeds the proposed payment to physician for cataract surgery by over $200.

The proposed payment schedule for outpatient facility is billing CPT code 6174 featured modest increases of about 3% in both the ASC setting, which accounts for approximately 80% of omni as revenues and the <unk> setting Cms's proposed a three 5% increase to $1937.

<unk> in the ASC setting and a two 6% increase to $4019 for canal opacity in the <unk> setting.

Under the proposed fee schedule Asc's would receive over $800 more for a standalone omni procedure than for a standalone cataract procedure and the H O PD setting the differences over $1800.

As we have discussed previously we continue to seek device intensive status for CPT code $66, 74, which covers devices, including omni in the ASC setting device intensive status for code six 670, <unk>. If approved could result in a meaningful increase in payments to <unk>, we continue to work with our.

Societies.

And other stakeholders to encourage assignment of device intensive status and we will report back when we have more clarity on the subject.

The proposed rates cited above do not include device intensive designation for omni procedures.

CMS and other payers rely in part on review of relevant medical literature, when making coverage and payment decisions. We believe there are clinical trial program and subsequent associated peer reviewed articles, who will provide further evidence regarding the effectiveness and safety of our products and support decision regarding coverage and appropriate.

Appropriate payments related to use of our products. Additionally.

Additionally, our market access team intends to supplement clinical efficacy and safety data packages with quantifiable health economic and outcomes information to illustrate the value of our product to Payors and more importantly, our patients' quality of life.

We will continue to work with the major ophthalmology societies patient advocacy groups and influential physicians to advocate for appropriate patient access on behalf of omni and tier care.

The proposed fee schedule also included changes to the billing cogent payments to physicians and facilities related to trabecular bypass stent implantation performed in combination with cataract procedures. The category III CPT code of 190, <unk> used for trabecular bypass stent implantation since 2000.

<unk> will be replaced with new permanent category, one CPT codes, describing trabecular bypass stent implantation in combination with cataract surgery.

While we have analyzed these new codes and proposed payment amounts internally, we will not speculate on proposals related to other products or any impact such proposals could have on surgeons and facilities. The proposed fee schedule rules are publicly available and we urge investors to draw their own conclusions after careful analysis.

I will now turn the call over to Jeff <unk>, Our Chief financial Officer to discuss our second quarter financial results Jesse.

Jesse.

Thanks, Paul and good afternoon, everyone. Our total revenue for the three months ended June 32021 was $12.5 million, which was a 258% increase from $3.5 million in the same period of 2020, and a 45% sequential increase from $8.6 million.

In the first quarter of 2021.

Our results in the second quarter of 2021.

In the second quarter of 2020 were materially impacted by COVID-19 related elective procedures shut down during that period and to a lesser extent were impacted during the first quarter of 2021 due to what we observed to be patient driven cancellation.

We were encouraged in the second quarter of 2021 that the operating environment closely resembled that during pre COVID-19 period with what we have learned to be normalized cataracts, and glaucoma procedural volumes and controlled but open commercial access to facilities for prospecting and training I care providers on the entire care all of that being said we are.

We're closely monitoring the delta variant and its impact on our end markets. The days the primary observable impacts from the Delta variance has been related to operating practice restriction as opposed to noticeable widespread procedural volume impacts. However, just this week, we've been informed of some delta variant related cancellations of omni cases.

By both patients and surgeons again, we continue to monitor these developments extremely closely.

Our combined gross margin for the second quarter of 2021 was 82% as compared to 40% in the corresponding prior year period and 73% in the first quarter of 2021. The drivers of this increase will discuss more in depth as we get into the segment performance.

Our our surgical glaucoma segment revenues.

Is from the omni product for the second quarter of 2021 or $12 million up 263% from $3.3 million in the second quarter of 2020.

Sequential increase of 47% from $8.1 million in the first quarter of 2021.

Sales of omni benefited from a number of factors, primarily driven by an increase in the number of new accounts sold in the quarter due in part to what I mentioned is a selling environment that they had more normalized commercial access to customer facilities as well as increased utilization per active account.

In addition, the comparative results benefit from seasonality factors in the second quarter and fewer COVID-19 related impacts during the quarter.

Gross margin in surgical glaucoma was 85% in the second quarter of 2021 compared to 54% in the prior year period.

77% in the first quarter of 2021.

The observable sequential improvement from the first quarter of 2021 was primarily the result of our transition in the first half of this year from a more specialized R&D oriented development partner for our production to our low cost high volume contract manufacturer further as we continue to scale scale, the omni business within surgical glaucoma.

Our gross margins will benefit from greater absorption of fixed cost labor and overhead.

And our drive segment revenues were $5 million in the second quarter of 2021, which was up 169% from $2 million in the corresponding prior year period, and an increase of 10% or 51000 sequentially from the first quarter of 2021.

Similar to our surgical glaucoma segment, our drive sales benefited from a more normalized selling environment with respect to COVID-19, the comparative periods and seasonality factors. In addition, our second quarter of 2021 results benefited from a growing number of new facilities sold vis a vis prior periods as well as a larger base of reordering customers as we continue to build.

Our embedded customer base on a focused basis.

Gross margin in dry was 3% in the second quarter of 2021 versus negative 184% in the second quarter of 2020 and 11% in the first quarter of 2021 the improvement in gross margin from the comparable 2020 period was due to the significant increase in units sold in the 2021 period in general we expect to hear care grew.

Margins are driving gross margins to run in this year to date earnings until we begin to accelerate our commercial investment and increase our revenue base for dry eye, which will cover fixed labor and overhead costs as well as grow our installed base of eye care providers, which will shift our mix more towards smart lids sales, which are the higher margin.

We'll use component of the system.

We typically sell our smart hubs on a cost plus basis.

Total operating expenses for the second quarter of 2021 were $21.6 million, which is a 138% increase from $9.1 million in the second quarter of 2020, and an 18% increase from $18 million in the first quarter of 2021, not surprisingly as we've gained traction in the launches of both omni and peer care.

And then preparation for our initial public offering we have been consistently scaling our business and our business investment.

Another specific factor, which contributed contributed to the increase of year over year Opex was the accounting treatment of our $2.2 million Paycheck protection program or PPP loan, which we received in the second quarter of 2020 bushel was forgiven in the second quarter of 2021, our PPP loan was accounted for similar to a government grant.

And where specifically the earnings impact of the loan was recognizing the earnings in the period in which we recognize the cost.

And so really.

That's what the loan with the comp.

We utilize the loan proceeds in full and the SEC.

Second quarter of 2020, because effectively result in expense offset of $2.2 million to our second quarter 2020 operating expenses are understanding what was actually incurred.

For the principal amount of the PPP loans I will now walk through the primary packaging future areas of our opex investments in greater detail.

SG&A expenses for the second quarter of 2021 were $17.8 million compared to $7.7 million in the second quarter of 2020, and $14.6 million in the first quarter of 2021. The increase in SG&A expenses was primarily due to our continued investment in scaling of operations and corporate head count to support our growth as an example.

In the first quarter of 2021, we expanded our omni field team from 38 quota bearing hunter reps to 61 at the same time added marketing training and support personnel to support the growth.

While we do not have a specific plan to expand reps for either business section segment. At this point in time, we will continue to be opportunistic when and if we see the opportunity to further accelerate our growth with attractive returns on incremental investment.

Over the periods presented we made meaningful investment in our corporate systems and personnel in finance accounting human resources legal and compliance.

Separation for operating as a public company and our continued business growth.

R&D expenses for the second quarter of 2021 were $3.5 million compared to $1.4 million in the second quarter of 2020, and $3.4 million in the first quarter of 2021.

A majority of the increase in R&D expense from 2000.22021 was due to three factors and increase in personnel expenses as a result of increased headcount as we built out our clinical regulatory and R&D departments contract.

Manufacturing lab supplies and product prototype development expenses for tier care.

And costs associated with clinical trials, we expect our R&D expense to continue to grow over the near term as we execute our clinical roadmap across both core products and as we build out our internal R&D operational team to enable us to execute our product enhancement.

And development roadmap.

Overall loss from operations for the three months ended June 32021 was $11.1 million compared to a loss of $7.7 million for the same period in 2020, and a loss of $11.7 million in the first quarter of 2021, we had a net loss of $17.6 million or $1.83 per share for the second quarter of 2021.

Based upon a weighted average pre IPO share count of $9.6 million shares compared to a loss of $8.3 million or 88.

For the second quarter of 2020 based on a weighted average pre IPO share count I'm not in a half mile of chairs.

We ended the second quarter of 2021 was $35.6 million of cash and equivalents and $32.3 million of long term debt. We were very pleased to complete our initial public offering last month, which generated net proceeds of approximately $253 million, which obviously puts us in an excellent financial position to make the necessary investments to <unk>.

Given the scale of our existing <unk> business to actually execute robust clinical trials to expand the indications for use for our products and to advance our market access initiatives.

Ultimately it to develop new products.

Such as new product markets, such as Standalone mix and procedure based trial.

One of the financial accomplishments, we take a lot of pride in place classes has been our return on invested capital.

As of June 32021, we've invested approximately $120 million into our business and that and put that capital we've been able to create a substantial return when you consider the that level of investment is available to us to bring two disruptive products to market with strong clinical support and commercial traction and further when you compare it to our current market value.

We intend to continue to maintain this discipline and focus and focus as we invest our IPO proceeds and the high ROI areas.

Turning to our outlook for 2021, we expect full year 2021 revenue to be in the range of $46 million or <unk> $48 million representing growth of 66% to 74% over our 2020 revenue. This guidance reflects the continuation of the growth trends, we've been seeing in each business in recent quarters through the remainder of the year with no incremental.

It'll benefit from additional sales resources, although we are actively evaluating the potential to increase that opportunistically.

Guidance takes into account seasonality patterns and our presumption of the operating environment that we saw in the second quarter of 2021 and to date in the third quarter as it pertains to COVID-19 related restrictions and the scheduling of elective procedures and our teams access to customer facilities remains consistent through year end, specifically, meaning no pronounce force.

I think from the current commercial environment that we see.

Further we are not assuming any explicit in your step function benefit from the proposed CMS payment rules. These rules are still in proposed form it will not be finalized until November 2021, and are subject to change in the interim and will go into effect only on July one 2022, as we get greater visibility on the potential for acceleration.

A surgeon switching to our increasing utilization of omni we will of course update our view on that on the potential Robyn revenue impact to you.

So with that I'd like to turn the call back over to Paul for closing comments.

And.

After that we'll open it up for Q&A.

Thank you Jesse.

As I said earlier, we built site sciences for the long term and our pledge to deliver the power of site to patients with eye disease is unwavering.

We are grateful for the support from all of our investors customers eyecare providers team members societies payers and other stakeholders.

While we were thrilled by the outcome of our successful IPO.

The most important result is that our newest investors entrusted us with their capital, which we will deploy with a singular focus on achieving our full potential.

We look forward to updating you on our business again in a few months.

We will now open up the call for questions Jessie and I will be joined by Shaun O'neil, Our chief commercial officer to answer your questions operator.

Thank you Sir as a reminder, if you have questions. Please press star one.

Again that is star one to ask a question.

Our first question comes from the line of Cecilia furlong of Morgan Stanley You May ask your question now.

Okay. Thank you and good afternoon, and thanks for taking the questions I wanted to start off with.

On me and really just ask what you've seen since you've seen the new label in terms of Standalone volume trends as a percentage of your total omni procedures, especially for <unk> 2020 at the 20% just how that label, it's really resonating with physicians and then and then the impact on being able to extend into stand alone.

Hi, Cecilia.

Maybe Sean Jessie and I can I'll tag team. This one I'll just start off with.

Just some comments on the label itself to make sure that everyone's on the same page.

The omni surgical system is indicated for canal Plasty micro catheter as Asian, and Trans Luminal Visco dilation echelons canal, followed by trabecular <unk> cutting up trabecular meshwork.

To reduce intraocular pressure in adult patients with <unk>.

Importantly.

What you don't see in our label as a restriction to advanced refractory disease.

You also don't see anything about lend status or in combination with cataract surgery. So omni is broadly indicated for IOP lowering in adults with <unk>.

We believe our label is the Holy Grail indication within the mix category and we were very appreciative.

Our highly productive thoughtful collab.

Collaborative FDA review process late last year and early this year.

Which ultimately resulted in our expanded label in March.

Omni has been many years in the making and it's it's comprehensive and reproducible procedure profile.

And 360 degrees.

Of treatment.

Through two procedures targeting all three sources of alpha resistance.

And the result, resulting clinical data we provided to the FDA was fortunately compelling enough to warrant this very strong clearance.

The expanded label is particularly important for us at site.

And omni because we differentiate ourselves on efficacy.

We asked our surgeons to do more and performed significantly more angle surgery again, Q2 sequential procedures up to 360 degrees each to hopefully drive more consistency of efficacy and more robust efficacy.

This consistency is particularly important in standalone surgery, where omni angle surgery would be the only reason for the visit to the operating room. So we couldnt be more thrilled about our label that now allows us to educate the market, referring ecp's and surgeons on omni it allows us to share our compelling clinical data and combo cataract and standalone.

And thereby effectively develop the much bigger and largely greenfield mild to moderate standalone market.

Sean Jesse do you guys want to talk about.

What <unk> seen in the market and as it relates to increasing use of omni in standalone.

Yeah, absolutely Paul.

This facility or this is Sean.

Now one of the things that we have always leverage in and discuss with you have been right at the beginning of the demand creation and bringing on new surgeons as the value proposition of Standalone. The label since the label, it's really gives us an opportunity to hone in on that part of the value proposition.

And with that it's been well received I think it's been accelerating against new surgeons onboard, but also has been well received from an adopted surgeon standpoint, and we are currently as Paul mentioned in the opening comments preparing and launching a and the industry leadership level education disease state.

Education campaign around mild moderate standalone patients to the eye care provider primary care providers as well as to patients and that will be forthcoming as well, which we believe will have additional.

The additional impact of expanding into that Standalone space.

Great. Thank you for the color if I could ask just in terms of account openings being able to leverage the new label that you have can you just walk through what you saw.

In <unk> and really assay <unk>, either with Covid headwinds abating being able to access sites, but really the ability for yourselves for us to leverage this new label to open new accounts and thank you very much.

Yes.

This is John again.

The opportunity that the new label really provides us is the ability.

Not only share the value proposition that I spoke of a second ago, but also.

To share the data behind the product and really demonstrate the.

The consistency and the efficacy that you get with omni when treating primary open angle glaucoma in adult patients and that's what's really been allowing us I believe to be the accelerated in a normalized selling environment. When our sales reps have the opportunity to share that data the compelling data.

To that we have.

Get the surgeon and the administrators of the facility's excited about bringing omni and for.

Additional patient care for the primary open angle glaucoma patients.

Thank you.

Our next question comes from the line of Joanne Wuensch of Citibank. Your line is open.

Thank you for taking the question can you hear me okay.

We can.

Excellent wonderful.

Two things the first one was.

With the reimbursement changes that are on the table. What do you think the impact will be tier business model and do you anticipate that it will start as we exit this year or sort of you know.

Once it's finalized or maybe even in January like I guess I'm, just trying to understand given your conversations with physicians the type of feedback that you've been receiving.

Yeah, Hi, Joanne.

I'll comment a bit and then John if you want to add some color.

I think.

We discussed the.

The adjusts for the proposed adjustments are not yet finalized, but if finalized there is an adjustment to <unk>.

<unk> six 674.

The reduction to $739.

In speaking with surgeons and Kols during <unk>, a couple of weeks ago.

They were very encourage by omnis 12 months prospective multicenter U S clinical data on IOP lowering effect.

Duration, and maintaining target IOP levels and the ability for patients to lower the number of their topical drop medications or go completely off drop therapy.

We're ultimately confident that given on these clinical benefits. This proposed fee reduction if implemented next year will not lead to an active disrupt romney utilization given its proven efficacy and safety profile in a real world setting of care now that being said.

We think the rocks recommendation with thoughtful and thorough and we fully support that recommendation that would have resulted in a more accurate work value.

We will be providing comments to CMS additional information.

Hopefully inform a more appropriate work value and believe there is room for improvement for the 6617 for physician fee. Since we don't believe the proposed value takes into.

For consideration the value of omni technology climate intensity required to perform.

<unk> more specifically a circumferential canal fussy, followed by circling back to automate the devaluation of <unk>. Six 674, we don't think takes into account the <unk> and.

And skills involved and the concomitant trabeculectomy procedure performed using <unk> for their label.

Okay Sean.

Any problems.

Yes. Thank you.

Hi, This is Shawn Joanne Yeah, I agree with Paul's comments, especially around the feedback that we did receive it is Crs is the proposed rule is very fresh on everyone's minds.

Surgeons that we spoke with we're really pleased with the responses that they had in terms of the increase on the facility side of the three 5%. Obviously is favorable from a facility standpoint for surgeons that have financial ownership in some of their facilities and then to Paul.

At this point, we believe we have additional opportunity on the physician side, but overall from a relative standpoint to other alternatives. The surgeons were still very positive on the reimbursement amount relative to alternatives for 66174.

Thank you My second question has to do.

At the beginning of this.

Conversation, you talked about investing aggressively in clinical and commercial.

That gives us two or three examples of that with levels of investments that you are looking towards thank you.

Yeah. So.

Hey, Duane it's Paul on the clinical side, we have a very rigorous clinical road map.

Across both omni and tier care.

I think of it.

In three buckets, one omni standalone <unk>.

Clinical studies and publications number two omni combination cataract clinical studies and publications and number three tier care.

So I'll just talk about the the.

The larger studies in an omni stand alone we have.

One prospective RCT.

Under way in Europe.

That's omni.

Loan versus trabecular micro bypass stenting stand alone.

Three arm study about 450 patients at 22 sites across seven countries in Europe, and then we have three additional studies for omni stand alone that are retrospective studies.

We're really excited about initiating this large RCT and guidance Ah patients should enroll by the end of the year.

Then in omni in combination with cataract, we have a prospective single arm study Thats concluded Gemini I discussed that in the prepared remarks, and we're looking forward to publishing that 12 month data.

Soon we have a prospective RCT that we hoped to.

Kick off soon we are in discussions.

With the FDA around E for.

For that study and I had mentioned it in my prepared remarks, and that will hopefully if successful lead to a can alloplasty alone indication, we're looking forward to executing that trial.

In due course and then we also have two additional retrospective studies.

But we're gonna be executing all of these studies I'm mentioning they should have some important milestones.

Either either study initiation and patient enrollment <unk> publications.

Within 12 months to 18 months timeframe.

And then lastly on tier care.

Another four studies that should have some milestones in the next 12 months to 18 months. One is the prospective RCT that we're super excited about and I talked about in the prepared remarks, thats tier care versus Restasis. It's a two year trial with two goals one to compare to Restasis and hopefully we can show to your care suite.

<unk> already at the six month endpoint and then the second goal of the study again based on feedback from discussions with payers to show durability of treatment effect.

So we're going to cross over all of the Restasis patient two tier care at six months and then run that study through to two years to show durability of treatment effect. In addition to that prospective RCT in the U S. Sahara. We also have three retrospective studies.

That are either underway or will soon be underway again with with milestones and hopefully publications in the next 12 to 18 month timeframe. So again we're.

Super excited to execute all of these trials, we spend a lot of time again as I had mentioned on product development and truly addressing the underlying causes of disease. We believe that puts us in a very competitive safety and efficacy position and so we love to invest heavily in the clinical.

Data that validates our thesis.

Yeah.

Thank you.

Sure.

Once again, if you have questions. Please press star one.

Our next question comes from the line of Matthew O'brien.

Oh.

Your line is now open.

Okay. Thanks, Thanks for taking my question. So Paul can can we just flush out.

You know a little bit more on the reimbursement side just to follow up on Joanne question. So you're talking about this one COVID-19 potentially.

Essentially impact than the proposal, but I think you're the market leader in Migs has proposals at a couple of areas that are scheduled to be down.

Anyway so.

I'd just stick on a relative basis, youre, probably at a little bit better position than the again the market leader and then another another player in the space. So.

I'm just curious if you've seen any.

And maybe Sean can you talk a little bit about this just an increase in the number of competitive clinicians that are coming to you just asked about omni in response to this maybe its too early and then.

Even in the near term here I know these are all proposed but is there something you can do from a marketing perspective to really highlight the potential difference here in and really drive more clinicians over to site in the near term.

Yeah, Hey, Matt, Sean maybe you and I can tag team on that one.

And I think all along we are.

We built <unk> sciences.

<unk>.

A laser focus on.

Trying to be best in class clinically and best in class from an efficacy position. So that's.

That's how we view our jobs.

And we've been commercializing omni, especially since that label expansion that allows us to.

To share that differentiated clinical data.

Really excited to lead first as we always do.

With with the safety and efficacy first so as it relates to what's happened in the field and with respect to the new codes and proposed values for combination cataract and 10 procedures are understanding CMS proposed to reduce the independent value of inserting stent carrying a cataract procedure.

As compared to current payment amounts.

Okay.

We think that if you.

If you look at the overall clinical and economic value that.

That that surgeons may reconsider I mean, that's.

That's kind of what what we've seen at least Sean probably has more insight into it but again I think you got to add up the clinical and economic value.

Surgeons will make their termination Sean do you have any color on.

Yes, Matt.

To give some additional color to that so you know.

Obviously, they are proposed rules right now so I think it's too early to one of your questions was on the timing I think it's too early to say that.

There is a meaningful change and the transition of customers outside of the demand that we're already creating which is as Jesse shared with the the numbers has been really really positive for omni.

And to that Stan we're obviously, focusing our marketing efforts on making sure that demand creation is built off of the consistent efficacy delivered by addressing all three points of resistance in the conventional outflow pathway and we're obviously sharing are known economics for 66174. So.

That all stakeholders the facility.

Managers as well as the surgeons understand what's the financial aspect of performing an omni procedure is and.

Again, the sentiment right now versus even under the proposed rule that those are positive opportunities for both those stakeholders and so we're going to just continue to focus our message on on those things and we feel like that puts us in a position to not only compete in that combo space, but also.

And developed a leadership position in the mild to moderate Standalone arena.

Okay. Thanks for that and then progestin only fulfill totally left out here.

For you if it's got a couple of parts to it the guidance for the year is completely understandable that should kind of keep it in this range. It doesn't assume much sequential improvement throughout the back half of the year is that really COVID-19, specifically and you mentioned some cases that were getting canceled or you're just kind of assuming now that those get pushed into <unk>.

2022 at this point.

I just wanted to hear a little bit more on that and then with the size of the of the IPO I think you talked a little bit about this too I mean is there any potential for you guys to accelerate sales force expansion other marketing activities et cetera here in the near term, which we could see impacting 2002. Thanks.

A couple of things Matt.

Thanks for that and thanks for letting me know feel left out I was getting a little sad.

So.

Yeah.

Second quarter, we believe is the seasonally strongest quarter, alright, and I think when you couple.

That that factor with the fact that.

We believe that the second quarter for us at least was a greater than 100%.

Quarter kind of something we talked about on the road show a lot given that we have a preliminary number.

We didn't expect much sequentially from the third quarter, which is actually a sequentially week quarter.

Heightened a lot less.

I think just given the the delta noise, but also just in terms of.

Patient and surgeon availability for procedures.

And so it does we do anticipate some nice sequential growth, but we're really kind of with that one exception and that exception being.

So we had already discussed that we thought second quarter.

Second quarter results were or extra strong and that the third quarter is seasonally a weaker quarter than the second quarter in terms of procedure volume.

With respect to the proceeds.

I will say this we're keeping a close eye on the market dynamics that you have the guys about.

We want to be opportunistic.

You know we had a plan that we presented last month and then obviously during the roadshow process.

Some potential changes to the competitive dynamics cropped up and we haven't we're still watching right.

But if we see pockets or verticals or geographies, where we can accelerate we will same thing I'm a tier care side.

But you know, it's kind of still that kind of cruise.

Prudently aggressive philosophy <unk> taken them historically about how we'll spend it but obviously, we will keep a very close eye on the market in the near term two thirds.

Some some attractive opportunities that pop up.

Got it thank you.

Our last question comes from the line of cleaning the Marcus from Bank of America, You May ask your question now.

Yeah.

Hey, guys. Congratulations on my first earnings call and thanks for taking the questions.

Q2 for me first one kind of building on <unk> earlier question.

When you think about the guide in that 20% of your mix coming from stand alone last year.

How do you think about that mix being reflected in the 2021 guide and then longer term also how do you expect that mix to kind of shift tissue further pursue the standalone opportunity.

And then the.

Second question, if you could.

Just to expand a little bit on the can alloplasty only label how significant do you think that could be an offering positions further flexibility.

Hey, Kelly.

Good to reconnect.

Jesse your Sean do you want to tackle the first question I can.

Tackle the second.

I mean, clearly I can tackle the second question first.

We think the.

<unk> D alone.

<unk>.

Well will be helpful.

We view the overall migs category, just to generalize or simplify them.

Uh huh.

Think of six buckets. So you have combo cataract and standalone and within each of those you've got mild moderate or severe.

And.

In that in that my own combo cataract.

Segment I think surge ends are really serious about insuring day, one post op visual acuity they want perfect outcomes and they want their patients to be really really stoked about.

Their vision on day, one post op, so offering something.

Got it.

More gentle Alloplasty procedure I think would.

It would be very well received in that and that mile combo cataract segment, I think as it relates to <unk>.

Moderate or advanced combo, cataract or mild moderate severe stand alone.

Yeah.

We like our position by the current label for Canal Boston Trabeculectomy.

And.

Having the surge in.

Perform two sequential procedures that allows them to address all three sources of outflow resistance and do so for up to all 360 degrees of the disease conventional outflow pathway.

We think that that functionality is.

GAAP net dairy in those other categories. So.

Hopefully that helps explain.

Where we think it as that.

Can help us get alone has a nice positioning again, if successful with our <unk>.

E <unk> clinical trial.

And Clay's, Jesse I'll I'll tackle the.

First one.

<unk>.

So second quarter was very strong in terms of utilization per per our customer.

Perfect facility so we.

We believe it was.

When we look at it.

Probably beyond Worldview actually happened, which is which would inform sort of my comments to Matt about.

So we thought that the second quarter had some you know was it.

It was a little bit greater than 100 per cent quarter right. We just saw some volumes from some very steadily ordering customers that were beyond what we were used to seeing from them.

That being said I.

I think a big part of that is expanded use cases as well it's not all.

Killing patient backlog or anything like that.

And there was a kind of a cross across the board very strong.

You know in terms of relative utilization to previous periods.

That comes all that comes into one of two ways right or one of three ways.

We are gaining more share.

Within sort of the profile that had been using omni for.

They are expanding their use case for severity or they're moving in the standalone procedures. So we we know it's uplifting.

Definitely was uplifting on an accelerated basis and as Youre aware and anyone that <unk> spent a lot of time with us and the roadshow or prep process, we're still figuring out a way to be able to more systematically measure our standalone mix.

As a percentage of the whole so a lot of the leading indicators in like the.

What she would infer from the result were.

Nice progress on Finland, we just don't have the ability to sort of convey that was.

With a car.

Confident metric.

That's repeatable at this point in time.

Okay. Thanks.

And that concludes the Q&A session I will now turn the call over back to Paul Vitale for closing remarks.

Well. Thank you all we enjoyed our first earnings call hopefully it was informative for everyone and we look forward to.

Keeping everyone up to date on all the progress it's life Sciences. Thank you very much.

And that concludes today's conference call. Thank you again for participating you may now disconnect.

[music].

Sure.

Okay.

[music].

[music].

[music].

Good day, ladies and gentlemen, and welcome to the site Sciences' second quarter 'twenty.

2021 financial results conference call.

At this time all participants are in a listen only mode.

Peter We will conduct a question and answer session and instruction will follow a follow at that time.

If anyone should require operator assistance please press star.

And then the zero key on your Touchtone telephone.

As a reminder, this call may be recorded.

I would now like to introduce your host for today's conference Mr. Philip Taylor Investor Relations you may begin.

Thank you and thank you all for participating in today's call presenting today are safe Sciences, co founder and Chief Executive Officer, Paul Modality, and Chief Financial Officer, Jackie Stelmach earlier today <unk> Sciences released financial results for the three months and six months ended June 32020.

A copy of the press release is available on the company's website before we begin I would like to remind everyone that comments made by management today and answers to questions will include forward looking statements. Those include statements related to <unk> future financial and operating results and plans for developing and marketing new.

<unk>.

We're looking statements are based on estimates and assumptions as of today and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied by these statements, including the risks and uncertainties described in <unk> Sciences filings made with the SEC.

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 our recent SEC filings and with that I will turn the call over to Paul.

Okay.

Thank you trip and thank you to everyone joining us on our first earnings call as a publicly traded company, our Chief Financial Officer, Jeff You saw Nick and I look forward to updating you on our performance in the second quarter and our Chief Commercial Officer, Shaun O'neil is also with us today.

Our story may be new to many of you I'd like to start by providing an overview of site Sciences, our mission, our guiding principles and our growth strategy.

We are gratified and humbled that many new and existing investors participated in our IPO and are joining us on our journey to transform the lives of patients suffering from the world's most prevalent eye diseases.

I cited is fundamental to our quality of life over 50% of the human brain is devoted to vision and over 80% of the information we need to perceive the world enters through our eyes.

Our overarching goal is to improve quality of life by protecting and enhancing our most precious sense vision.

Yeah.

So is it not a conventional eye care company I started site over a decade ago with my brother, David a world class ophthalmologist.

We came up with the all encompassing names lifesciences, while performing simulated glaucoma experiments out of the garage of Dan O'keefe, our first outside employee in our current vice President of research and development.

We believe from the very beginning that if we did things right and had some good fortune along the way we could methodically build a platform eye care company, serving many disease categories through the development of novel and improve medical devices.

To fully address the breath and importance of our mission, we built our company for the long run from day one.

Many years later and thanks to the efforts of our now almost 200 talented team members, we've created and commercialized two differentiated products and what we believe to be very underserved areas of Ikea.

And we intend to create many more in the coming years.

We thrive on transforming ophthalmology and optometry through products that target the underlying causes of the world's most prevalent diseases, we seek to develop interventional solutions and an interventional mindset in eye care. They can replace conventional outdated approaches, thereby creating new treatment paradigms, while also maintaining a laser.

Our focus on optimized patient care as our utmost priority.

Many investors and industry participants are curious why do we have initially chosen to pursue and tackle both primary open angle glaucoma and dry eye two very different disease categories.

The simple answer is that we will pursue opportunities wherever we can leverage our organic clinically differentiated problem solving methods and expertise to develop and commercialize products for improved clinical outcomes that empower eyecare providers are ecp's could take the best care of their patients.

Moving on now to our four pillars of product development.

Is it site or spent competing head on against serious eye diseases with an obsession on developing devices to meeting meaningfully improve the standard of care in eye care, we are hyper focused on developing and commercializing clinically transformative products.

Massimo empower eye care providers to take the best care of their patients our focus on product development is governed governed by four fundamental requirements that we believe are mission critical to delivering the most robust and consistent clinical outcomes for patients.

Number one.

Disease Physiology mastery, we review and analyze all available clinical data science and literature that is relevant to a disease.

A sound understanding of its underlying causes which we then used to guide the development of our products number two treatment of underlying causes health.

Healthy eyes are self regulating marvels of evolution biomechanics chemistry, and physiology, we believe that restoring the natural functionality of disease is by comprehensively treating underlying causes of diseases provides the optimal combination of effectiveness and safety.

Number three intuitive design.

Our products are designed to transform complex and practical or invasive treatment approaches and to intuitive minimally invasive user friendly procedures.

Our product development goals are focused on delivering a preferred go to treatment of choice to ophthalmologists and optometrists.

Number four patient access we seek to maximize the availability and accessibility of our products for as many patients as possible.

We believe that our devices have the potential to offer differentiated clinical experiential and economic value to all <unk> stakeholders.

With the goal and expectation to clinically lead any category. We enter we must have conviction that all four criteria are attainable before we begin a new project.

Most of our ideas do not advance into development because they fail to satisfy all of our requirements. Today. We've commercialized two products that successfully ran the gauntlet of our rigorous product development process for use in adults with primary open angle glaucoma.

The world's leading cause of irreversible blindness and in situations, where the medical community recommend to application of a warm compress including dry eye disease. The number one reason for a patient visit to an eye care provider.

We believe both army and tier care are poised to have tremendous global clinical impact in the years ahead.

Maximizing global clinical impact requires more than a transformative product it requires meticulous ECP training and commercial excellence.

Over the past three years, our commercial leadership team has built distinct sales and marketing teams and training programs for both omni and tier care.

Our commercial team works passionately with thousands of ophthalmologists and optometrists prospect and customers.

We hear that we have a reputation among eyecare providers and within the industry as the team doing great things the right way and the team do you want to join we strive to continue to earn this reputation everyday.

Because of our commitment to the relentless pursuit of improved patient care and outcomes. We are rewarded with the best gift possible customers choosing our products as the reliable go to intervention when the clinical Stakes are high and when we believe we can have significant impact on patient quality of life.

Our passion and commitment to help our customers fight disease rises in lock step with the clinical severity of the situation not just with the size of the market.

There is no greater satisfaction or joy to me personally or to the dedicated people of site sciences than to be blessed with a meaningful role in improving the lives of patients.

We are gratified and humbled that many of you have chosen to join us on our mission to protect and enhance the eyesight of patients around the world in the years to come.

We believe that substantial shareholder value accrues disproportionately to those select health care companies that can rely on putting the patient first is there a competitive advantage.

Now moving on to our three key strategic value drivers.

Our strategy will always include further innovation in devices intended for use in our two core disease areas primary open angle glaucoma and dry eye disease as well as potential expansion of our pipeline into other eye diseases, both in the U S and internationally.

In the near term however, we will be laser focused on advancing three key strategic imperatives for our two current commercial products number one continuing to expand omnis adoption and usage by surgeons for adult patients with India.

Can be established combination cataract segment of the minimally invasive glaucoma surgery or migs market.

Please keep in mind that this share expansion will prepare these surgeons to perform procedures within the Standalone segment, which brings us to number two.

Continued development of the virtually greenfield and substantially larger Standalone <unk> segment of the mixed market.

And number three expanding our labeling and indications for use for tier care for the treatment of evaporative dry eye disease, while also advancing market access among Medicare and commercial payors.

In the second quarter, we made substantial progress in all three of these goals are first two goals related to advancing the treatment of adult patients with <unk> by offering a device that can be used for a minimally invasive intervention.

He is a pressure based disease and elevated intraocular pressure or IOP is the greatest risk factor associated with <unk> and therefore, the focus of treatment cataract surgery on its on its own is known to have IOP lowering benefits and today. The migs market is segmented into two into procedures performed in combination with <unk>.

<unk> surgery, which we refer to as the combination cataract segment.

And procedures performed on their own which we referred to as a standalone segment.

This segmentation is largely artificial and primarily the result of mix bypass stents only being indicated for use in combination cataract procedures, which has necessitated this unnatural division for the past decade, and their pivotal clinical trials trabecular bypass stents demonstrated modest incremental efficacy over the IOP lowering effect of cataract care.

<unk> a lot.

Trabecular bypass stents are not indicated for use in Standalone makes procedures in the U S.

The surgical decision, making criteria and clinical effectiveness and consistency requirements for Standalone mix are elevated beyond those for combination cataract procedures.

We believe both the degree of effectiveness and the consistency of effectiveness are crucial factors for both patients and surgeons when considering a procedure.

For patients we believe the anxiety that may accompany the need for ocular surgery can be tempered with the knowledge that there is a high likelihood of success.

For surgeons consistent outcomes simplify the treatment choice and the decision to perform a procedure.

We believe this is especially important for standalone makes procedures, which must deliver a very high consistency of effectiveness and a very high degree of effectiveness.

To not only justify the procedure, but also provide surgeons with enough confidence to recommend standalone surgery to their patients and take them to the operating room for a singular reason.

We believe devices capable of delivering consistently effective results will be crucial to unlocking the standalone market as well as capitalizing on the full potential of the combination cataract market, which we believe is currently capturing less than one third of its potential procedure volume in the U S.

In March of this year the.

The FDA cleared an expanded indication for use for omni that we believe bridges the unnatural divide between combination cataract and Standalone mix and which we believe covers the broadest patient population among all migs devices supported.

And FDA cleared based on avid turned out clinical data importantly, this indication for use broadly covers the reduction of intraocular pressure for all adult patients with <unk>.

Without limitation with respect to severity of disease mild moderate and advanced or lend status fake patients combination cataract patients and pseudo baking patients.

We believe this is the Holy Grail indication in Migs, and we intend to invest very aggressively and the clinical and commercial development of omni.

So why did Amit clinical performance achieved such a broad indication in mix.

We believe that omni has two critical physiological and clinical advantages number one omni is capable of comprehensively addressing up to all 360 degrees of the disease conventional outflow pathway implantable focal treatment to address a smaller segment of the diseased outflow pathway and.

And number two.

Omni is capable of addressing all three points of resistance in the conventional outflow pathway trabecular meshwork, Schlumpf canal and the distal collector channels.

As shown in our Romeo Multicenter study used for FDA clearance and label expansion use of omni for sequential combined and comprehensive can alloplasty and Trabeculectomy has been demonstrated to safely effectively and consistently lower IOP in adult patients with <unk> and both combination cataract and standalone.

One settings, we have always viewed makes it as a single market that seeks to improve the lives of any patient with <unk>.

Despite the intense entrenched competition since Omnia launch in early 2018, we have deliberately chosen the universe of over 3000 makes trained surgeons as our highest priority customer targets. We have successfully trained a large number of these surgeons and brought them up the omni learning curve and the.

Second quarter of 2021, we sold omni to nearly 700 ordering facilities and we still have many more to go.

While our commercial team deserving Lee received so much praise for their incredible achievements, we collectively believe it all starts with our clinically transformative mission and a clinically differentiated surgical technology, we developed and perfected over a 10 year period.

Our focus on putting the patient first and mastering the physiology of glaucoma allowed us to create a product that comprehensively.

And effectively it reduces IOP and that we believe surgeons love to use.

We painstakingly designed omni with the goal of transforming effective a complex and invasive surgeries into safer routine and minimally invasive yet equally effective procedures with an elegant device that surgeons can master within an intuitive learning curve.

Our goal in pursuing exist existing makes trained surgeons, what's to facilitate an exceptional training and support experience that would allow surgeons to achieve such high levels of confidence in the safety effectiveness and consistency of omni that they would prefer the device to reduce IOP in adult <unk> patients in all settings consistent with it.

It's broad clearance, including Standalone cases, which have a higher clinical bar.

Then add on combination cataract mix procedures.

As we have made tremendous inroads in the established combination cataract segment. We believe this phenomenon is already starting to occur many of our surgeons have indeed chosen to expand their use case for omni to treat adult <unk> patients in standalone settings.

Based on the results of an internal field study, we conduct conducted late last year, we estimate that approximately 20% of the procedures using omni were standalone cases in 2020.

I would like to note that our surgeons early increased usage of omni was achieved even without the benefit of our Standalone marketing campaign, which we launched after omni received its expanded FDA label in March of this year.

We believe the U S. Standalone makes segment is approximately five times larger than the $1 billion U S combination cataract segment, and a substantially undeveloped or plan to fully develop standalone usage among both comprehensive ophthalmic surgeons, who perform the vast majority of eye surgeries, including cataract surgeries as well as glaucoma spa.

This includes a first of its kind market education awareness and development program that seeks to introduce and educate the primary care providers, who first diagnose and treat <unk>.

Patients, both general ophthalmologists and optometrists to the possibility and benefits of earlier makes intervention regardless of the patient's <unk> status.

We are currently developing methods to track our progress in the Standalone segment on a more consistent and reportable basis and look forward to sharing more information about our progress in the coming quarters.

We believe the standalone mild to moderate <unk> segment is the most exciting and all of mix, we couldnt be more thrilled to be in a position to deliver the power of site to adult <unk> sufferers, who do not require cataract surgery.

So that summarizes our first two value drivers continuing to take share in the existing combination cataract mix segment and leading the development of the much larger standalone make segment.

Moving on now to our third value driver is our tier care system in development program. We currently market tier care as a powered heating pad for the application of localized heat where the current medical community recommends the application of a warm compress to the islands, we purposefully built here care to deliver a precise and tightly controlled level of <unk>.

Thermal energy through the outer islands over a 15 minute period and a comfortable office based procedure.

After over five years of product and clinical development and multiple rounds of iteration and product optimization. We introduced here care in mid 2019, and a controlled launch with approximately 10 reps covering the entire United States gathering additional data to demonstrate tier care safety and effectiveness through clinical trials.

Advancing dialogue with third party payers regarding appropriate coverage and payment for tier care treatments and working with the FDA to obtain clearance for an expanded indication for use for dry eye disease, and Mgd are key pillars of our tiered care strategy.

Dry eye complaints are the number one reason for patient visits to an eye care provider and there are over 17 million people diagnosed with dry eye in the U S out of an estimated nearly $40 million total dry eye patients in the U S and $739 million global suffers we believe the U S market for effective mgd treatment procedures could exceed 10 billion.

Annually.

Dry eye is a multi factorial disease that is typically characterized by insufficient tear production known as aqueous deficient dry eye.

Or poor quality tiers that evaporate too quickly.

If operative dry eye.

Recent studies have determined that evaporative dry eye, which is most commonly associated with my bulimia gland disease or mgd.

So it created with 86% of dry eye cases, yet.

Yet dry eye treatment that aim to treat aqueous deficiency or inflammation represent 95% of manufacturer revenues.

This represents a huge disconnect between the way you dry eye is treated today and the actual underlying cause of disease. We studied dry eye extensively and concluded that the optimal way to help patients suffering from this potentially debilitating disease, what to develop an effective way to treat mgd. The most common cause of dry eye.

My Beaumont landline, the top and bottom islands and produce an oily secretion called Michael.

And healthy eyes, My mom had the clear olive oil like consistency and formed the outer most lipid layer of tears.

<unk> released with each blank and forms a protective barrier over the tears and prevents premature tier evaporation.

One the glands become blocked or obstruct it Michael and gets trapped into glands and hardens as the disease progresses. The consistency of my bump can degrade to a toothpaste like consistency, which preclude you from reaching the tear film and providing protection against premature tier evaporation.

Despite the prevalence of Mgd is the leading cause of dry eye treatments are focused on over the counter and prescription eye drop that either treat aqueous deficiency or inflammation.

Leading prescription dry eye drops have annual revenue in excess of $1.5 billion yes.

Yet none are indicated for or have a mechanism targeting the number one cause of dry eye mgd.

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

We had some scientists have developed a very thoughtful well informed and long term strategy designed to change that.

Although we believe that a patient pay business model for tier care exist based on our own experience to date. We also believe that to maximize the reach of our procedure in technology and provide a comprehensive solution for the broadest range of Mgd suffers patient access and appropriate reimbursement for clinicians utilizing tier care must improve.

We are seeking to expand tier carriers indication for use and are working with the FDA on this front. Our current controlled launch of the product for its indication has allowed us to begin commercialization with specialized and reputable customers. While also initiating our long term focused care care market access strategy.

As we built site sciences for the long term, we are taking a long term approach to developing devices for potential mgd indications, we have chosen not to maximize short term revenue in favor of a more thoughtful strategy that has the potential to provide access to tier care for the largest number of patients with mgd if cleared for.

An expanded label.

Now moving on to clinical evidence, which is critical to everything we do.

Generating robust clinical evidence is crucial to development and commercialization of our products beginning with dry eye and our Olympia RCT tier care was associated with statistically significant clinical improvement and all assessed signs and symptoms of dry eye disease.

As a result of Olympia were published in a leading peer reviewed journal and we expect two other articles to be published in other leading journals in the coming months.

We are also pleased to announce that enrollment in our second tier care RCT Sahara is progressing nicely Sahara is a crucial part of our market access and development strategy for tier care.

Last year, we convened a panel of medical directors from eight payers to understand their criteria for establishing an appropriate coverage and payment program for tier care.

We used very clear and consistent feedback from these numerous payer discussion to design the Sahara protocol and this head to head RCT that has begun we are evaluating the efficacy of tier care as compared to a leading prescription dry eye medication and are also assessing the durability of tier care treatments over.

A 24 month period.

We look forward to providing you further updates on Sahara and the other facets of our care care market access development plan over the coming quarters as we continue to make progress.

Please do keep in mind, the patient access for tier carriers, a long term endeavor. It may not always progressing a linear fashion each quarter, but it's certainly the right strategy to ensure patients have access to treatment as we pioneer procedure based reimbursed dry eye and unlock this multibillion dollar segment in the process.

We also have multiple clinical trials ongoing or planned in mix with omni.

Among the ongoing and planned clinical trials for omni are several exciting head to head <unk> <unk>.

Versus either the leading trabecular bypass stents or eventually versus the standard of care early intervention prescription hypertensive medications.

These studies will evaluate the effectiveness.

Omni and reducing and profit pressure the only treatable risk factor associated with G and alleviating the burden of hypertensive medications as compared to these alternatives.

In terms of completed Omni studies, the 12 month primary endpoint data from our Gemini study, our first prospective multicenter clinical trial of omni in the U S was presented at the <unk> Conference in Las Vegas last month.

We observed that sequentially performed 360 degree can alloplasty and 180 degree trabeculectomy procedures using omni in combination cataract surgeries resulted in clinically significant reductions in both IOP and the need for IOP lowering medications through 12 months.

We plan to submit the results of Gemini for publication in peer reviewed journals and present the results at other major ophthalmology conferences in the future.

We are also pleased with the progress we are making with the FDA on our upcoming IDE trial for Ami that if approved and finalized will allow us to study the safety and effectiveness of canal opacity, only procedures, using omni and U S clinical trials.

We expect to have further updates, resulting from our discussions with the FDA on our can alloplasty alone E within the coming months.

As a reminder, omni is currently cleared for <unk>, followed by Trabeculectomy to reduce IOP in adult patients with <unk>.

The purpose of a can alloplasty alone study under ITE would be to seek FDA clearance for a new indication for use for omni for Houston Canal opacity, only procedures to reduce IOP and adult patients with <unk>.

If omni is cleared for this new canal pasty only indication we believe this new indication for use would provide surgeons with additional flexibility to customize treatment based on the needs of each patient.

We have also made significant progress with tri deck, our multinational European RCT, we expect to begin enrolling patients in the fourth quarter across seven countries in Europe.

This 12 month RCT aims to study a total of 459 mild to moderate open angle glaucoma patients who will receive on a standalone basis.

There can alloplasty, followed by Trabeculectomy using omni.

<unk>, only using omni or implantation of trabecular bypass stents.

We are particularly excited about tried and because it represents our very first opportunity to compare the performance of omni against makes sense on a standalone basis across a large population.

And we are eager to complete enrollment.

At the annual meeting of the American Society of cataract, and refractive surgeons or Crs last month physician presented the results from five of our clinical studies, featuring omni and tier care.

Participation and leadership at important meetings like <unk> Crs are great opportunities for us to present, our clinical trial results to a broad audience of ophthalmologists and optometrists and connect with long time thought leaders customers surgeons and brands.

We'll continue to make our presence felt at other eye care industry events in the future, including the annual meeting of the American Academy of Ophthalmology in November and major Optometry optometry conferences like <unk> and.

Oh.

And finally, moving on to reimbursement and market access.

Last month as many of you may be aware of as it relates to make the nominee cm.

CMS released new proposed fee schedule rules for payments to physicians in outpatient facilities for 2022.

Results are subject to a 60 day review period, and maybe further revise before finalized in November and taking effect on January one.

Proposed payments related to CPT code $66.74, which is used for omni procedures were among those that were revised the proposed national payment to physicians for $66.74 would be $739, a $211 reduction from the current rate.

While we are disappointed in the proposed reduction and plan to engage with CMS to increase the recognized value of this procedure in the final rule. We believe the proposed payment if finalized we will still provide an adequate payment to physicians.

We note that this proposed payments still exceeds the proposed payment to physician for cataract surgery by over $200.

The proposed payment schedule for outpatient facility is billing CPT code 6174 featured modest increases of about 3% in both the ASC setting, which accounts for approximately 80% of omni as revenues and the <unk> setting.

CMS has proposed a three 5% increase to $1937 for <unk> in the ASC setting and a two 6% increase to $4019 for <unk> in the <unk> setting.

Under the proposed fee schedule Asc's would receive over $800 more for a standalone omni procedure than for a standalone cataract procedure and the H O P. D setting the difference is over $1800.

Okay.

As we have discussed previously we continue to seek device intensive status for CPT code $66, 74, which covers devices, including omni in the ASC setting device intensive status for <unk> six 670, <unk>. If approved could result in a meaningful increase in payments to <unk>, we continue to work with our society.

<unk> CMS and other stakeholders to encourage assignment of device intensive status and we will report back when we have more clarity on the subject.

The proposed rates cited above do not include device intensive designation for omni procedures.

Okay.

CMS and other payers rely in part on review of relevant medical literature, when making coverage and payment decisions. We believe that our clinical trial program and subsequent associated peer reviewed articles, who will provide further evidence regarding the effectiveness and safety of our products and support decision regarding coverage and appropriate appropriate payments.

Related to use of our products. Additionally.

Additionally, our market access team intends to supplement clinical efficacy and safety data packages with quantifiable health economic and outcomes information to illustrate the value of our product to Payors and more importantly, our patients' quality of life.

We will continue to work with the major ophthalmology societies patient advocacy groups and influential physicians to advocate for appropriate patient access on behalf of omni and tier care.

The proposed fee schedule also included changes to the billing cogent payments to physicians and facilities related to trabecular bypass stent implantation performed in combination with cataract procedures. The category three CPT code of 190, <unk> used for trabecular bypass stent implantation since 2000.

<unk> will be replaced with new permanent category, one CPT codes, describing trabecular bypass stent implantation in combination with cataract surgery.

While we have analyzed these new codes and proposed payment amounts internally, we will not speculate on proposals related to other products or any impact such proposals could have on surgeons and facilities. The proposed fee schedule rules are publicly available and we urge investors to draw their own conclusions after careful analysis.

I will now turn the call over to Jessie sell Nick our Chief Financial Officer to discuss our second quarter financial results Jesse.

Jesse.

Thanks, Paul and good afternoon, everyone.

<unk> revenue for the three months ended June 32021 was $12.5 million, which was a 258% increase from $3.5 million in the same period of 2020, and a 45% sequential increase from $8.6 million in the first quarter of 2021.

Our results in the second quarter of 2021 and the.

The second quarter of 2020 were materially impacted by COVID-19 related elective procedures shut down during that period.

To a lesser extent were impacted during the first quarter of 2021 due to what we observed to be patient driven cancellation.

We're encouraged in the second quarter of 2021 that the operating environment closely resembled that during pre COVID-19 periods with what we observed to be normalized cataracts, and glaucoma procedural volumes and controlled but open commercial access to facilities for prospecting and training I care providers on the entire care.

All of that being said, we are closely monitoring the delta variant and its impact on our end markets to date. The primary observable impacts from the Delta variance has been related to operating practice restriction as opposed to a noticeable widespread procedural volume impacts. However, just this week, we've been informed of some delta variant related <unk>.

Solutions of omni cases by both patients and surgeons again, we continue to monitor these developments extremely closely.

Our combined gross margin for the second quarter of 2021 was 82% as compared to 40% in the corresponding prior year period and 73% in the first quarter of 2021. The drivers of this increase will discuss more in depth as we get into the segment performance.

Our our surgical glaucoma segment revenues, which is from the omni product for the second quarter of 2021 were $12 million up 263% from $3.3 million in the second quarter of 2026.

Sequential increase of 47% from $8.1 million in the first quarter of 2021.

Sales of omni benefited from a number of factors, primarily driven by an increase in the number of new accounts sold in the quarter due in part to what I mentioned is a selling environment that they have more normalized commercial access to customer facilities as well as increased utilization per active account.

In addition, the comparative results benefit from seasonality factors in the second quarter and fewer COVID-19 related impacts during the quarter.

Gross margin in surgical glaucoma was 85% in the second quarter of 2021 compared to 54% in the prior year period and 77% in the first quarter of 2021.

The observable sequential improvement from the first quarter of 2021 was primarily the result of our transition in the first half of this year from a more specialized R&D oriented development partner for our production to our low cost high volume contract manufacturer further as we continue to scale scale, the omni business within surgical glaucoma.

Our gross margins will benefit from greater absorption of fixed costs labor and overhead.

And our drive segment revenues were $5 million in the second quarter of 2021, which was up 169% from $2 million in the corresponding prior year period, and an increase of 10% or 51000 sequentially from the first quarter of 2021.

Similar to our surgical glaucoma segment, our drive sales benefited from a more normalized selling environment with respect to COVID-19, the comparative periods and seasonality factors. In addition, our second quarter of 2021 results benefited from a growing number of new facilities sold vis vis prior periods as well as a larger base of reordering customers as we continue to bill.

Our embedded customer base on a focused basis.

Gross margin in dry was 3% in the second quarter of 2021 versus negative 184% in the second quarter of 2020 and 11% in the first quarter of 2021 the improvement in gross margin from the comparable 2020 period was due to the significant increase in units sold in the 2021 period in general we expect to hear care grew.

Margins are dry high gross margins to run in this year to date earnings until we begin to accelerate our commercial investment and increase our revenue base for dry eye, which will cover fixed labor and overhead costs as well as grow our installed base of eye care providers, which will shift our mix more towards smart live sales, which are the higher margin.

I'll use component of the system, we typically sell our smart hubs on a cost plus basis.

Total operating expenses for the second quarter of 2021 were $21.6 million, which is 138% increase from $9.1 million in the second quarter of 2020, and an 18% increase from $18 million in the first quarter of 2021, not surprisingly as we've gained traction in the launches of both omni and peer care.

And then preparation for our initial public offering we have been consistently scaling our business and our business investment.

Another specific factor, which contributed contributed to the increase of year over year Opex was the accounting treatment of our $2.2 million Paycheck protection program or PPP loan, which we received in the second quarter of 2020 bushel was forgiven in the second quarter of 2021, our PPP loan was accounted for similar to a government grant.

And where specifically the earnings impact of the loan was recognizing the earnings in the period in which we recognize the cost.

And so really that.

What's the comp.

Because we utilize the loan proceeds in full in the second quarter of 2020, because effectively resulting from expense offset of $2.2 million to our second quarter 2020 operating expenses were understanding what was actually incurred.

For the principal amount of the PPP loan I will now walk through the primary passing future areas of our opex investments in greater detail.

SG&A expenses for the second quarter of 2021 were $17.8 million compared to $7.7 million in the second quarter of 2020, and $14.6 million in the first quarter of 2021. The increase in SG&A expenses was primarily due to our continued investment in scaling of operations and corporate head count to support our growth as an example.

In the first quarter of 2021, we expanded our omni field team from 38 quota bearing hunter reps to 61, but at the same time added marketing training and support personnel to <unk>.

Support the growth.

While we do not have a specific plan to expand reps for either business section segment. At this point in time, we will continue to be opportunistic when and if we see the opportunity to further accelerate our growth with attractive returns on incremental investment.

Was there a shift over the periods presented we made meaningful investment in our corporate systems and personnel in finance accounting human resources legal and compliance and preparation for operating as a public company and our continued business growth.

R&D expenses for the second quarter of 2021 were three and a half million dollars compared to $1.4 million in the second quarter of 2020, and $3.4 million in the first quarter of 2021. The majority of the increase in R&D expense from 2022, and 2021 was due to three factors and increase in personnel expenses as a result of increased head.

Count as we built out our clinical regulatory and R&D departments contract.

Manufacturing lab supplies and product prototype development expenses for tier care.

And costs associated with clinical trials, we expect our R&D expense to continue to grow over the near term as we execute our clinical roadmap across both core products and as we build out our internal R&D operational team.

To enable us to execute our product enhancement.

And development roadmap.

Overall loss from operations for the three months ended June 32021 was $11.1 million compared to a loss of $7.7 million for the same period in 2020, and a loss of $11.7 million in the first quarter of 2021, we had a net loss of $17.6 million or $1.83 per share for the second quarter of 2021.

Based upon a weighted average pre IPO share count of $9.6 million shares compared to a loss of $8.3 million or 88 for the second quarter of 2020 based on a weighted average pre IPO share count I'm not in a half a million shares.

We ended the second quarter of 2021 was $35.6 million of cash and equivalents and $32.3 million of long term debt. We were very pleased to complete our initial public offering last month, which generated net proceeds of approximately $253 million, which obviously puts us in an excellent financial position to make the necessary investments to <unk>.

You need to scale, our existing business to actually execute robust clinical trials to expand the indications for use for our products and to advance our market access initiatives.

Ultimately it's to develop new products.

Such as the new product market, such as Standalone mix and procedure based trial.

One of the financial accomplishments, we take a lot of pride in place Sciences has been a return on invested capital as.

As of June 32021, we've invested approximately $120 million into our business and that.

With that capital, we've been able to create a substantial return when you consider that that level of investment is available to us to bring two disruptive products to market with strong clinical support and commercial traction and further when you compare it to our current market value.

We intend to continue to maintain this discipline and focus and focus as we invest our IPO proceeds and the high ROI areas.

Turning to our outlook for 2021, we expect full year 2021 revenue to be in the range of $46 million of $48 million representing growth of 66% to 74% over our 2020 revenue. This guidance reflects the continuation of the growth trends, we've been seeing each business in recent quarters through the remainder of the year with no incremental.

Benefit from additional sales resources, although we are actively evaluating the potential to increase that opportunistically. This guidance takes into account the seasonality patterns in a presumption that the operating environment that we saw in the second quarter of 2021 and to date in the third quarter as it pertains to COVID-19 related restrictions and the scheduling of elective procedures.

<unk> and our teams access to customer facilities remains consistent through year end, specifically, meaning no pronounced worsening from the current commercial environment that we see.

Further we are not assuming any explicit in your step function benefit from the proposed CMS payment rules, whose roles are still a proposed form it will not be finalized until November 2021, and are subject to change in the interim and will go into effect only on July one 2022, as we get greater visibility on the potential for acceleration.

A surgeon switching to our increasing utilization of omni we will of course update our view on that on the potential revenue revenue impact to you.

So with that I'd like to turn the call back over to Paul for closing comments.

And.

After that we'll open it up for Q&A.

Yeah.

Thank you Jesse.

As I said earlier, we built <unk> sciences for the long term and our pledge to deliver the power of site to patients with eye disease is unwavering.

We're grateful for the support from all of our investors customers eye care providers team members societies payers and other stakeholders.

While we were thrilled by the outcome of our successful IPO the.

The most important result is that our newest investors entrusted us with their capital, which we will deploy with a singular focus on achieving our full potential.

We look forward to updating you on our business again in a few months.

We will now open up the call for questions Jessie and I will be joined by Shaun O'neil, Our chief commercial officer to answer your questions operator.

Thank you Sir.

If you have questions. Please press star one.

Again that is star one to ask a question. Our first question comes from the line of Cecilia furlong of Morgan Stanley You May ask your question now.

Okay. Thank you and good afternoon, and thanks for taking the questions I wanted to start off with on.

On me and really just ask what you've seen since he received the new label in terms of Standalone volume trends as a percentage of your total omni procedures versus what you saw on 2020 at the 20% just how that label, it's really resonating with physicians and then the impact on being able to expand into stand alone.

Hi, Cecilia.

Maybe Sean Jonathan I can I'll tag team. This one I'll just start off with.

Just some comments on the label itself to make sure that everyone's on the same page.

The omni surgical system is indicated for canal philosophy, micro catheter as Asian, and Trans Luminal Biscoe dilation echelons canal, followed by Trabeculectomy cutting up trabecular meshwork.

To reduce intraocular pressure in adult patients with <unk>.

Importantly.

What you don't see in our label as a restriction to advanced refractory disease.

You also don't see anything about <unk> status or in combination with cataract surgery. So omni is broadly indicated for IOP lowering in adults with <unk>.

We believe our label is the Holy Grail indication within the <unk> category and we were very appreciative.

Of our highly productive thoughtful.

Collaborative FDA review process late last year and early this year.

Which ultimately resulted in our expanded label in March.

He has been many years in the making and it's it's comprehensive and reproducible procedure profile.

And 360 degrees.

Of treatment.

Through two procedures targeting all three sources of alpha resistance.

And the result, resulting clinical data we provided to the FDA was fortunately compelling enough to warrant this very strong clearance.

The expanded label is particularly important for us at site.

And omni because we differentiate ourselves on efficacy.

We ask our surgeon to do more and performed significantly more angle surgery again, Q2 sequential procedures up to 360 degrees each to hopefully drive more consistency of efficacy and more robust efficacy.

This consistency is particularly important in standalone surgery, where omni angle surgery would be the only reason for the visit to the operating room. So we couldn't be more thrilled about our label that now allows us to educate the market, referring ecp's an urgent on omni it allows us to share our compelling clinical data and combo cataract and standalone.

And thereby effectively develop the much bigger and largely greenfield mild to moderate standalone market.

Sean Jesse do you guys want to talk about.

What <unk> seen in the market and as it relates to increasing use of omni in standalone.

Yeah, absolutely Paul.

This facility or this is Sean.

Now one of the things that we have always leverage in and discuss with you have been right at the beginning of the demand creation and bringing on new surgeons as the value proposition of Standalone. The label since the label, it's really gives us an opportunity to hone in on that part of the value proposition and with that it's been well received.

I think it's been accelerated against new surgeons on board, but also its been well received from an adopted surgeon standpoint, and we are currently as Paul mentioned in the opening comments preparing and launching a and the industry leadership level education disease State education campaign around.

Mild moderate standalone patients to the eye care provider primary care providers as well as to patients and that'll be forthcoming as well, which we believe will have additional.

Additional impact on they are expanding into that Standalone space.

Great. Thank you for that color and if I could ask just in terms of account openings being able to leverage the new label that you have can you just walk through what you saw.

In Q2, and really after <unk>, either with Covid headwinds abating being able to access sites, but really the ability for yourselves for us to leverage this new label to open new accounts and thank you very much.

Yes.

This is John again.

The opportunity that the new label really provides us is the ability.

Not only share the value proposition that I spoke of a second ago, but also.

To share the data behind the product and really demonstrate the.

<unk> C and the efficacy that you get with omni when treating primary open angle glaucoma and adult patients.

That's what's really been allowing us I believe to be the accelerated in a normalized selling environment. When our sales reps have the opportunity to share that data the compelling data that we have and get the surgeon and the administrators of the facility's excited about bringing omni in for.

No additional patient care for their primary open angle glaucoma patients.

Thank you.

Our next question comes from the line of Joanne Wuensch of Citibank. Your line is open.

Thank you for taking the question can you hear me okay.

We can.

Excellent I wonder from two.

Two things the first one was.

Sure.

With the reimbursement changes that are on the table. What do you think the impact will be tier business model and do you anticipate that it will start as we exit this year or sort of.

Once it's finalized maybe even in January like I, just I'm, just trying to understand given your conversations with physicians the type of feedback that you've been receiving.

Yeah, Hi, Joanne.

I'll, just I'll comment a bit and then John if you want to add some color.

Thank you.

We discussed the.

We adjust for the proposed adjustments are not yet finalized, but if finalized there is an adjustment to two ppt $661.74.

The reduction to $739.

And speaking with surgeons and Kols during <unk>, a couple of weeks ago.

They were very encourage by omnis 12 month prospective multicenter U S clinical data on IOP lowering effect.

Duration and maintaining target IOP levels.

And the ability for patients to lower the number of their topical drop medications or go completely off drop therapy.

We're ultimately confidence that given on these clinical benefits. This proposal three a reduction if implemented next year will not lead to a market disruption Romney utilization given its proven efficacy and safety profile.

Real world setting of care now that being said.

We think the rocks recommendation with thoughtful and thorough and we fully support that recommendation that would have resulted in a more accurate work value.

We will be providing comments to CMS for additional information.

To hopefully inform a more appropriate work value and believe there is room for improvement for the 6617 for physician fee. Since we don't believe the proposed value takes into.

For consideration the value of omni technology and climate intensity required to perform.

And more specifically a circumferential canal authority, followed by surface circumspect about specular automate the devaluation of GBP. Six 674, we don't think takes into account that in skills involved and the concomitant trabeculectomy procedure performed using omni for their label.

Okay Sean.

Okay.

Yes. Thank you.

Hi, This is Shawn Joanne Yeah, I agree with Paul's comments, especially around the feedback that we did receive it is Crs is the proposal is very fresh on everyone's minds.

Surgeons that we spoke with we're really pleased with the responses that they had in terms of the increase on the facility side of the three 5%. Obviously is favorable from a facility standpoint for surgeons that have financial ownership in some of their facilities.

Then.

To Paul's point, we believe we have additional opportunity on the physician side, but overall from a relative standpoint to other alternatives. The surgeons were still very positive on the reimbursement amount is relative to alternatives for 66174.

Thank you My second question has to do at the beginning of this.

Conversation, you talked about investing aggressively in clinical and commercial.

It does give us two or three examples of both levels of investments that you are looking towards thank you.

Yeah. So.

Hey, Duane it's Paul on the clinical side, we have a very rigorous clinical road map.

Across both omni and tier care.

I think of it in.

In three buckets, one omni standalone.

Clinical studies and publications number two omni combination cataract.

Clinical studies and publications and number three tier care.

So I'll just talk about the the.

The larger studies in an omni stand alone we have.

One prospective RCT.

Underway in Europe.

That's omni standalone versus trabecular micro bypass stenting standalone.

Three arm study about 450 patients at 22 sites across seven countries in Europe, and then we have three additional studies for omni stand alone that are retrospective studies.

We're really excited about initiating this large RCT and patient should enroll by the end of the year.

Then in omni in combination with cataract, we have a prospective single arm study Thats concluded Gemini I discussed that in the prepared remarks, and we're looking forward to publishing that 12 month data.

Soon we have a prospective RCT that we hoped to.

Kick off soon we are in discussions.

With the FDA around an E for.

For that study and I've mentioned it in my prepared remarks, and that will hopefully if successful lead to a can alloplasty alone indication, we're looking forward to executing that trial.

In due course and then we also have two additional retrospective studies.

But we're gonna be executing all of these studies I'm mentioning they should have some important milestones.

Either either study initiation and patient enrollment <unk> publications.

Within 12 months to 18 months timeframe.

And then lastly onto your care.

Another four studies that should have some milestones in the next 12 months to 18 months. One is the prospective RCT that we're super excited about and I talked about in the prepared remarks, that's tier care versus Restasis is a two year trial with two goals one to compare to Restasis and hopefully we can show to your careful.

Appear you're already at the six month endpoint and then the second goal of the study again based on feedback from discussions with tires was to show durability of treatment effect.

So we're going to cross over all of the Restasis patient two tier care at six months and then run that study through to two years to show durability of treatment effect. In addition to that prospective RCT in the U S. Sahara. We also have three retrospective studies.

That are either underway or will soon be underway again with with milestones and hopefully publications and the next 12 to 18 month timeframe. So again we're.

Super excited to execute all of these trials, we spend a lot of time again as I had mentioned on product development and truly addressing the underlying causes of disease. We believe that puts us in a very competitive safety and efficacy position and so we love to invest heavily in the clinical.

Data that validates our thesis.

Yeah.

Thank you.

Sure.

Once again, if you have questions. Please press star one.

Our next question comes from the line of Matthew O'brien.

Oh.

Your line is now open.

Okay. Thanks, Thanks for taking my question. So Paul can we just flush out.

You know a little bit more on the reimbursement side just to follow up on Joanne <unk> question.

Youre talking about this one.

Essentially impact than the proposal, but I think you're the market leader in Migs has proposals at a couple of areas that are scheduled to be down meaningfully so.

Let's just stick on a relative basis, youre, probably at a little bit better position than the again the market leader and then another another player in the space. So.

I'm just curious if you've seen maybe.

Maybe Sean can you talk a little bit about this just an increase in the number of competitive clinicians that are coming to you just asked about omni in response to this maybe its too early and then.

Even in the near term here I know these are all proposed but is there something you can do from a marketing perspective to really highlight the potential difference here in and really drive more clinicians over to site in the near term.

Yeah, Hey, Matt, Sean maybe you and I can tag team on that one.

And I think all along we've.

We built <unk> sciences.

A laser focus on.

Trying to be best in class clinically and best in class from an efficacy position. So that's.

That's how we view kind of our jobs.

And we've been commercializing omni, especially since that label expansion that allows us to.

To share that differentiated clinical data.

Really excited to lead first as we always do.

With with the safety and efficacy first so as it relates to what's happened in the field and with respect to the new codes and proposed values for combination cataract and 10 procedures are understanding CMS proposed to reduce the independent value of inserting stent during a cataract procedure.

As compared to current payment amounts.

Okay.

We think that if.

If you if you look at the overall clinical and economic value.

That that surgeons may reconsider I mean, that's.

That's kind of what what we've seen at least Sean probably has more insight into it but again I think.

You got to add up the clinical and economic value.

Surgeons will make their termination Sean do you have any color on.

Yes.

Happy to give some additional color to that so.

Obviously, they are proposed rules right now so I think it's too early to one of your questions was on the timing I think it's too early to say that that are.

There is a meaningful change and the transition of customers outside of the demand that we're already creating which is as Jesse shared with the the numbers has been really really positive for omni.

And to that Stan we are obviously, focusing our marketing efforts on making sure that demand creation is built off of the consistent efficacy delivered by addressing all three points of resistance in the conventional outflow pathway and we're obviously sharing are known economics at 466174. So.

That all.

All stakeholders the facility.

<unk> facility managers as well as the surgeons understand what's the financial aspect of performing an omni procedure is and.

Again, the sentiment right now this is even under the proposed rule that those are positive opportunities for both those stakeholders and so we're going to just continue to focus our message on on those things and we feel like that puts us in a position to not only compete in that combo space, but also.

And develop the leadership position in the mild to moderate Standalone arena.

Okay. Thanks for that and then progesterone only fulfill totally left out here.

For you, but it's got a couple of parts to it the guidance for the year is completely understandable that should kind of keep it in this range. It doesn't assume much sequential improvement throughout the back half of the year or is that really COVID-19, specifically and you mentioned some cases that were getting canceled or you're just kind of assuming now that those get pushed into.

2022 at this point.

To hear a little bit more on that and then with the size of the of the IPO I think you talked a little bit about this too I mean is there any potential for you guys to accelerate sales force expansion other marketing activities et cetera here in the near term, which we could see impacting 2002.

A couple of things, Matt and thanks for that thanks for letting me know till left out I was getting a little sad.

So.

Yeah.

Second quarter, we believe is the seasonally strongest quarter, alright, and I think when you couple.

That factor with the fact that.

We believe that the second quarter for us at least was a greater than 100%.

Quarter, it's kind of something we talked about on the road show a lot given that we have a preliminary number.

We didn't expect much sequentially from the third quarter, which is actually sequentially week quarter.

Heightened a lot this quarter I think just given the delta noise, but also just in terms of.

Patient and surgeon availability for procedures.

And so it does we do anticipate.

Sequential growth, but we're really kind of with that one exception and that exception being.

So we had already discussed that we thought second quarter.

Second quarter omni results were or extra strong and that the third quarter is seasonally a weaker quarter than the second quarter in terms of procedure volume.

With respect to the proceeds.

You know I will say this we're keeping a close eye on the market dynamics that you have the guys about.

We want to be opportunistic.

You know we had a plan that we presented last month and then obviously during that road show process.

Some potential changes to the competitive dynamics cropped up and we haven't we're still watching right.

But if we see pockets or verticals or geographies, where we can accelerate we will same thing on the tier care side.

But it's kind of still that kind of <unk>.

Prudently aggressive philosophy, we've taken historically about how.

We'll spend it but obviously, we will keep a very close eye on the market in the near term if there is.

Some some attractive opportunities that pop up.

Got it thank you.

Our last question comes from the line of clearly the markets from Bank of America. You May ask your question now.

Hey, guys. Congratulations on the first earnings call and thanks for taking the questions.

Q2 for me first one kind of building on.

<unk> earlier question.

Think about the guide on that 20% of your mix coming from Standalone last year.

Do you think about that mix being.

Being reflected in the 2021 guide and then longer term also how do you expect that mix to kind of shift because you're further pursue the standalone opportunity.

And then the.

Second question if you can.

Just to expand a little bit on the can alloplasty only label how significant do you think that could be an offering positions further flexibility.

Hey, Kelly.

Good to reconnect.

Jesse your Sean do you want to tackle the first question I can.

Tackle the second.

I mean clay I can tackle the second question first.

We think the.

The canal plus D alone.

Label.

Well will be helpful.

We view the overall migs category, just to generalize or simplify them.

Uh huh.

Kick up six buckets. So you have combo cataract and standalone and within each of those you've got mild moderate or severe.

And.

In that in that my old combo cataract.

SEC demand I think surge ends are really serious about insuring day, one post op visual acuity they want perfect outcomes and they want their patients to be really really stoked about.

Their vision on day, one post op, so offering something.

Got it.

More gentle Alloplasty procedure I think.

It would be very well received in that and that mile. A combo cataract segment I think as it relates to <unk>.

Moderate or advanced combo, cataract or mild moderate severe stand alone.

Yeah.

We like our position by the current label for Canal Boston Trabeculectomy.

And.

Having the surge in.

Perform two sequential procedures that allows them to address all three sources of outflow resistance and do so for up to all 360 degrees of the disease conventional outflow pathway.

We think that that functionality is.

Net dairy in those other categories. So.

Hopefully that helps explain.

Where we think that can help us be alone has a nice positioning again, if successful with our <unk>.

E <unk> clinical trial.

And Clay's, Jesse I'll I'll tackle the.

First one.

So second quarter was very strong in terms of utilization per per customer per.

Perfect facility so we.

We believe it was.

And when we look at it.

Probably be onward, worldview actually happen, which is which would inform sort of my comments to Matt about that we thought that the second quarter had some.

It was a little bit greater than 100% quarter right. We just saw some volumes from some very steadily ordering customers that were beyond what we were used to seeing from them.

That being said I.

I think a big part of that is expanded use cases as well it's not at all.

Drilling drilling patient backlog or anything like that.

And there was a kind of a cross across the board very strong.

You know in terms of relative utilization to previous periods.

That comes all of that comes in one or two ways right or one of three ways.

We are gaining more share.

Within sort of the profile that had been using omni for.

They are expanding their use case for severity or they're moving in the standalone procedures.

So we we know it's uplifting.

It definitely was uplifting on an accelerated basis, unless youre aware of anyone that <unk> spent a lot of time with us and the roadshow or prep process, we're still figuring out a way to be able to more systematically measure our standalone mix.

As a percentage of the whole so a lot of the leading indicators in like the the you know what she would infer from our results were.

Nice progress on Finland, we just don't have the ability to sort of convey that was.

With.

Confident metric.

The repeatable at this point in time.

Okay. Thanks.

And that concludes the Q&A session I will now turn the call over back to Paul Vitaly FERC closing remarks.

Well. Thank you all we enjoyed our first earnings call hopefully it was informative for everyone and we look forward to keep.

Keeping everyone up to date on all the progress it's life Sciences. Thank you very much.

And that concludes today's conference call. Thank you again for participating you may now disconnect.

Q2 2021 Sight Sciences Inc Earnings Call

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Sight Sciences

Earnings

Q2 2021 Sight Sciences Inc Earnings Call

SGHT

Thursday, August 12th, 2021 at 8:30 PM

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