Q4 2023 Sight Sciences Inc Earnings Call

March 7, 2024

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Operator: Ladies and gentlemen, thank you for standing by, and welcome to the Sight Sciences fourth quarter 2023 earnings results. At this time, all participants are in a listen-only mode.

Yeah.

Ladies and gentlemen, thank you for standing by and welcome to the site Sciences fourth quarter 2023 earnings results.

At this time all participants are in a listen only mode. After the presentation. There will be a question and answer session to ask a question. During the session you will need to press star one one on your telephone you wound down here in the automated message of dicing. Your hand. This race to withdraw your question. Please press star one again and please.

Operator: After the presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising that your hand is raised.

Operator: To withdraw your question, please press star 11 again. And please be advised that today's conference is being recorded. I would now like to turn the conference over to your speaker today, Trip Taylor with Investor Relations. Thank you for participating in today's call. Presenting today are Sight Sciences co-founder and chief executive officer, Paul Badawi, chief financial officer, Ali Bauerlein, and chief commercial officer, Matt Link. Earlier today, Sight Sciences released financial results for the three months and full year ended December 31st, 2023 and initiated guidance for full year 2024. A copy of the press release is available on the company's website at investors.sightsciences.com.

Be advised that today's conference is being recorded I would now like to turn the conference over to your speaker today Chip Taylor with Investor Relations.

Thank you for participating in today's call presenting today are site Sciences, co founder and Chief Executive Officer, Paul, But Alley, Chief Financial Officer, Ali Bauerlein, and Chief Commercial Officer, Matt Lake earlier today, <unk> Sciences released financial results for the three months and full year ended December 31.

2023, and initiated guidance for full year 2020 for a.

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

Operator: I would like to remind everyone that comments made by management today and answers to questions will include forward-looking statements within the meaning of the federal securities laws. These forward-looking statements include statements related to the company's anticipated financial performance, operating results, and liquidity position, current and long-term strategic objectives, market opportunity, business and commercial strategy, product reimbursement strategy, clinical trial results, and costs associated with pending litigation. Forward-looking statements are based on estimates and assumptions as of today, are neither promises nor guarantees, and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied by these statements. A description of some of the risks and uncertainties that could cause actual results to differ materially from those indicated by the forward-looking statements on this call can be found in its public filings with the Securities and Exchange Commission, including in the risk factors section of the company The company undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law. On the call, management may refer to financial measures that were not prepared in accordance with generally accepted accounting principles in the United States, including adjusted operating expenses.

I'd like to remind everyone that comments made by management today and answers to questions will include forward looking statements within the meaning of the federal Securities laws.

Forward looking statements include statements related to the company's anticipated financial performance operating results and liquidity position current and long term strategic objectives market opportunity business and commercial strategy product reimbursement strategy clinical trial results and costs associated with pending litigation forward look.

Statements are based on estimates and assumptions as of today are neither promises nor guarantees and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied by these statements a description of some of the risks and uncertainties that could cause actual results to differ materially from those indicated by the forward looking.

<unk> on this call can be found in its public filings with the Securities and Exchange Commission, including in the risk factors section of the company's annual report on Form 10-K, and quarterly reports on Form 10-Q. The company undertakes no obligation to publicly update or revise any forward looking statements except as required by law.

On the call management may refer to financial measures that were not prepared in accordance with generally accepted accounting principles in the United States, including adjusted operating expenses.

Operator: The company believes these non-GAAP financial measures are important indicators of its operating performance because they exclude items that are unrelated to, and may not be indicative of, its core operating results. See the company's earnings release for reconciliation of these non-GAAP financial measures to the most directly comparable GAAP financial measures, as well as additional information about the company's reliance on non-GAAP financial measures. I will now turn the call over to Paul. Thanks, Trip. I'm extremely proud of the progress we made in both the fourth quarter and full year, twenty-three. This year has reinforced the importance of our mission to develop transformative interventional technologies that allow i care providers to procedurally elevate the standards of care, empowering people to keep seeing.

Company believes these non-GAAP financial measures are important indicators of its operating performance because they exclude items that are unrelated to and may not be indicative of its core operating results.

See the company's earnings release for a reconciliation of these non-GAAP financial measures to the most directly comparable GAAP financial measures.

As well as additional information about the company's reliance on non-GAAP financial measures.

I will now I will now turn the call over to Paul.

Thanks Tripp.

I'm extremely proud of the progress we made in both the fourth quarter and full year 2023. This year has reinforced the importance of our mission to develop transformative intervention technologies that allow eye care providers to procedurally elevate the standards of care.

<unk> people to keep seeing.

Operator: 2023 was a pivotal year for us as we executed on key strategic initiatives. We're very pleased to have accomplished several milestones throughout the year, including enhancing our executive team with proven high growth med tech leadership experience with the additions of Ali Bauerlein, our chief financial officer, and Matt Link, our chief commercial officer. Both Ali and Matt have integrated seamlessly into their roles and have been vital to our many organizational enhancements.

2023 was a pivotal year for us as we execute on key strategic initiatives. We are very pleased to have accomplished several milestones throughout the year, including enhancing our executive team with proven high growth Med Tech leadership experience with the additions of Alibaba line, our Chief Financial Officer, and Matt Link our Chief commercial officer.

Both Ali and Matt have integrated seamlessly into their roles and have been vital to our many organizational enhancements following their hires we realigned our structure to be more effective and laid the foundation for the next level of scale over the coming years.

Paul Badawi: Following their hires, we realigned our structure to be more effective and laid the foundation for the next level of scale over the coming year. We also expanded the body of long-term clinical evidence supporting our technology. Importantly, we announced the publication of long-term clinical data in a leading peer-reviewed journal, including two-year follow-up data from the ROMEO study, three-year follow-up data from the GEMII-2 study, and six-month data from the Sahara RCT.

We also expanded the body of long term clinical evidence supporting our technologies importantly, we announced the publication of long term clinical data in a leading peer reviewed journal, including two year follow up data from the Romeo study three year follow up data from the Gemini two study and six month data from the Sahara RCT.

Paul Badawi: We believe differentiated long-term clinical data will help us drive coverage, equitable reimbursement, and commercialization success over time. In 2023, we generated revenue growth in the mid-teens, our gross margins improved to all-time highs, and we significantly reduced our operating expenses and cash usage in the face of reimbursement uncertainty while maintaining focus on critical areas. In a major development late in December, we were pleased with the withdrawal of the finalized LCDs from five Medicare Administrative Contractors, or MACs, that were scheduled to go into effect in late January 2024. These MACs had previously identified certain mixed procedures as investigational for glaucoma management in patients over the age of 18, including canaloplasty in combination with trabeculotomy avant-terno, which is a procedural description associated with our omni-surgical system.

We believe differentiated long term clinical data will help us drive coverage equitable reimbursement and commercialization success over time.

In 2023, we generated revenue growth in the mid teens, our gross margins improved to all time highs and we significantly reduced our operating expenses and cash usage in the face of reimbursement uncertainty.

While maintaining focus spend on critical areas.

And a major development late in December we were pleased with the withdrawal of the finalized LCD from five Medicare administrative contractors or Macs that were scheduled to go effective in late January 2024.

These Max had previously identified certain makes procedures at an investigational for glaucoma management in patients over the age of 18, including <unk> in combination with trabecular <unk> turn out which is a procedural description associated with our omni surgical system.

Paul Badawi: Throughout the process, we worked closely with all key stakeholders, including national and state societies, congressional offices, medical device associations, and hundreds of MIG surgeons, to help educate the MACs and CMS about the importance of MIG procedures involving our Omni system and the long-term clinical evidence available. We executed this multi-pronged approach to challenge the LCDs while navigating new and complex dynamics with our soaring customers resulting from the potential implications of these LCDs and our customers' preparations to adhere to potential coverage restrictions. Even with the reimbursement uncertainty, sales of our surgical glaucoma products have proven very resilient. We believe this is a testament to the clinical efficacy of the Comprehensive Omni procedure, as surgeons rely on its IOP and medication reduction capabilities to treat their patients.

Throughout the process, we work closely with all key stakeholders, including National and state societies congressional offices medical device associations and hundreds of mixed surgeons to help educate the Max and CMS about the importance of make procedures involving our omni system and the long term clinical evidence available.

We executed this multipronged approach to challenge the Lcd's, while navigating new and complex dynamics with our surgeon customers, resulting from the potential implications of these lcd's and our customers' preparations to adhere to potential coverage restrictions.

Even with the reimbursement uncertainty sales of our surgical glaucoma products proved very resilient. We believe this is a testament to the clinical efficacy of the comprehensive omni procedure as surgeons rely on its IOP in medication reduction capabilities to treat their patients again, we are thankful that our team and other industry.

Stakeholders, we're steadfast in their alignment.

On the important role omni plays in treating their glaucoma patients.

We will continue to advocate to ensured that there is equitable patient access to this critical technology.

Coverage decisions are heavily governed by compelling long term clinical data, we provided the matched with a significant body of peer reviewed long term clinical evidence throughout the process, which was further strengthened by the publication of our Gemini two study in December.

Paul Badawi: Again, we are thankful that our team and other industry stakeholders are steadfast in their alignment on the important role OMNI plays in treating their glaucoma patients. We will continue to advocate to ensure that there is equitable patient access to this critical technology. Coverage decisions are heavily governed by compelling long-term clinical data. We provided the match with a significant body of peer-reviewed, long-term clinical evidence throughout the process, which was further strengthened by the publication of our GEMII-2 study in December. Favorable results from this prospective multi-center study demonstrated sustained and clinically significant IOP reduction of 29% from baseline at 36 months and clinically significant IOP lowering medication reduction with 74% of the study patients medication-free at 36 months. The prospective three-year clinical outcomes in the GEMIII-2 trial confirm and extend the previously published 12-month data from the original GEMIII trial.

Favorable results from this prospective multicenter study demonstrated sustained and clinically significant IOP reduction of 29% from baseline at 36 months and clinically significant IOP lowering medication reduction with 74% of the study patients medication free at 36 months.

The prospective three year clinical outcomes in the Gemini two trial confirm and extend the previously published 12 month data from the original Gemini trial Gemini two included 66 patients across 11 participating sites and any patients who are not already medication free from the omni procedure underwent medica.

<unk> wash out at the two year and three year end points, so that the IOP lowering effect of the omni procedure could be isolated and assessed.

There is demonstrated consistency with clinical outcomes across all published omni studies and this longer term prospective multicenter trial data further supports the need for continued access to omni technology.

We believe that new <unk> LCD is may be proposed in the future. While we are uncertain as to the timing and process that would be followed if new LCD as are finalized we are confident our body of published high quality long term data, including the Gemini. Two study supports continued coverage of procedures enabled by omni for the App.

Paul Badawi: GEMIII-2 included 66 patients across 11 participating sites, and any patients who were not already medication-free from the OMNI procedure underwent medication washout at the two-year and three-year endpoints so that the IOP lowering effect of the OMNI procedure could be isolated and assessed. There is demonstrated consistency with clinical outcomes across all published Omni studies, and this longer-term prospective multicenter trial data further supports the need for continued access to Omni technology. We believe that new MIGS LCDs may be proposed in the future.

Appropriate patient population.

We also plan to publish additional clinical data throughout 2024 that will further strengthen the body of evidence illustrating omni as clinical efficacy and we believe will support favorable coverage determinations.

We look forward to continued engagement with the Max CMS and other stakeholders to ensure glaucoma patients and their physicians maintain appropriate and equitable access to medically reasonable and necessary makes procedures and technologies.

Looking ahead, we are working to Reengage those accounts impacted by the LCD is drive increased utilization and train new surgeons.

Despite the uncertainty associated with the LCD we.

We had minimal employee attrition in the fourth quarter and we are now back filling those roles in the first quarter.

Paul Badawi: While we are uncertain as to the timing and process that would be followed if new LCDs are finalized, we are confident our body of published, high-quality, long-term data, including the GemIIni2 study, supports continued coverage of procedures enabled by Omni for the appropriate patient population. We also plan to publish additional clinical data throughout 2024 that will further strengthen the body of evidence illustrating Omni's clinical efficacy and, we believe, will support favorable coverage and termination. We look forward to continued engagement with the MACs, CMS, and other stakeholders to ensure glaucoma patients and their physicians maintain appropriate and equitable access to medically reasonable and necessary mixed procedures and technology. Looking ahead, we are working to re-engage those accounts impacted by the LCDs, drive increased utilization, and train new surgeons. Despite the uncertainty associated with LCDs,

As expected given the fourth quarter LCD uncertainty the surgeon training funnel was lighter than our historical average to end. The year. We are still in the early stages of re growing the funnel as surgeons now have visibility on coverage. We are confident in our ability to recapture accounts lost add new accounts and surgeons.

And improved utilization over time.

Our main commercial focus is increasing utilization across our customer base and re engaging with accounts that have not ordered omni over the past two quarters due to the reimbursement uncertainty.

The changes we made to our commercial organization in the fourth quarter are already proving beneficial in this regard. We believe we have a solid foundation in place to efficiently drive strong growth over the long term, including our anticipated return to double digit revenue growth in the second half of 2024 and into 2025.

I want to close our surgical glaucoma discussion by touching on our recent European launch in February we initiated the European launch of the Ergo series of the omni surgical system.

Following its U S launch in March 2023, the Ergo series has been broadly adopted due to its improved ergonomics and an optimized cannula tip that provide gentle and precise access to Schlumpf canal.

Paul Badawi: We had minimal employee attrition in the fourth quarter, and we are now backfilling those roles in the first quarter. As expected, given the fourth quarter LCD uncertainty, the Surgeon Training Funnel was lighter than our historical average to end the year. We are still in the early stages of regrowing the funnel, as surgeons now have visibility on coverage. We are confident in our ability to recapture lost accounts, add new accounts and surgeons, and improve utilization over time. Our main commercial focus is increasing utilization across our customer base and reengaging with accounts that have not ordered Omni over the past two quarters due to reimbursement uncertainty. The changes we made to our commercial organization in the fourth quarter are already proving beneficial in this regard.

We believe these design features will be invaluable to our European partners.

Turning now to our dry eye business, our tier care technology provides a clinically proven safe and effective procedural intervention for patients suffering from evaporative dry eye disease, which is a multibillion dollar annual U S market opportunity with over 11 million patients diagnosed.

Interventional dry eye procedures with tier care address the root underlying cause of evaporative dry eye disease, and we believe <unk> represents a major advancement, providing patients with a more comprehensive consistent fast acting and long term dry eye treatment.

As discussed on our last call, we have streamlined our commercial focus and taken measures to reduce the commercial spend within our dry eye business and strategically shift some of that spend towards building out our market access and payer team that's now in place.

Paul Badawi: We believe we have a solid foundation in place to efficiently drive strong growth over the long term, including our anticipated return to double-digit revenue growth in the second half of 2024 and into 2025. I want to close our surgical glaucoma discussion by touching on our recent European launch. In February, we initiated the European launch of the Ergo series of the Omni Surgical System.

We are actively working in 2024 to drive equitable market access for dry eye patients, who can benefit from an interventional procedure with tier care.

Importantly, our market access team has significant experience, establishing reimbursement for new and innovative technologies and procedures.

In 2024, we're focused on leveraging our foundational work with commercial Payors and Max to advocate for coverage of Interventional island procedures enabled by tier care.

The publication of our compelling Sahara six month, RCT data and budget impact model are the focal points of our discussions with payers.

Paul Badawi: Following its U.S. launch in March 2023, the Ergo series has been broadly adopted due to its improved ergonomics and an optimized cannula tip that provides gentle and precise access to Schlem's canal. We believe these design features will be invaluable to our European partners. Turning now to our Dry Eye Dismissal. Our Tier Care technology provides a clinically proven, safe, and effective procedural intervention for patients suffering from evaporative dry eye disease, which is a multi-billion dollar annual U.S. market opportunity with over 11 million patients diagnosed. Interventional dry eye procedures with tear care address the root underlying cause of evaporative dry eye disease, and we believe tear care represents a major advancement, providing patients with a more comprehensive, consistent, fast acting, and long term dry eye treatment.

These discussions will be ongoing throughout the year and beyond and coverage decisions will be subject to payer standard policy update timelines.

Our goal is to begin receiving coverage decisions from payers starting in 2025 as we pursue this large market opportunity.

At that point, we will expand tier care commercialization in geographies, where coverage has been established.

The publication of successful six month results of the Sahara RCT comparing tear characteristics as the market, leading dry eye therapeutic for the treatment of dry eye disease was published in clinical ophthalmology in December.

Data from the RCT shows the tier care technology successfully delivered clinically and statistically significant improvements in every sign and symptom at all measured time points over a six month period.

<unk> was also superior to Restasis and the improvement of tear film breakup time, the study's primary objective endpoint and a key measure of aqueous retention tier stability and the tier films ability to protect the ocular surface.

Paul Badawi: As discussed on our last call, we have streamlined our commercial focus and taken measures to reduce the commercial spend within our dry eye business and strategically shift some of that spend towards building out our market access and payer team that is now in place. We are actively working in 2024 to drive equitable market access for dry eye patients who can benefit from an interventional procedure with tear care. Importantly, our market access team has significant experience establishing reimbursement for new and innovative technologies and procedures. In 2024, we are focused on leveraging our foundational work with commercial payers and managed care organizations to advocate for coverage of interventional eyelid procedures enabled by tear care. The publication of our compelling Sahara six-month RCT data and budget impact model are the focal points of our discussions with payers.

This trial was designed with feedback from medical directors of insurance companies to demonstrate safety efficacy and long term performance, which are important in their coverage determinations.

We believe the data generated by this trial is a critical building block for tier care and offers the most robust validation of tier tier carriers clinical efficacy to date.

In closing.

We have incredible interventional technologies within both our surgical glaucoma and dry eye business is that elevate the standard of care and improve treatment paradigms for millions of patients we value. The solid foundation, we have built over the past decade, and all of the learning and Knowhow, we have acquired along the way.

Paul Badawi: These discussions will be ongoing throughout the year and beyond, and coverage decisions will be subject to payer standard policy update timelines. Our goal is to begin receiving coverage decisions from payers starting in 2025 as we pursue this large market opportunity. At that point, we will expand peer-to-peer commercialization in geographies where coverage has been established. The publication of successful six month results of the Sahara RCT, comparing tear care to Restasis, the market-leading dry eye therapeutic for the treatment of dry eye disease, was published in Clinical Ophthalmology in December. Data from the RCT shows the Tier Care technology successfully delivered clinically and statistically significant improvements in every sign and symptom at all measured time points over a six-month period. Tear care was also superior to rhistasis in the improvement of tear film breakup time, the study's primary objective endpoint, and a key measure of aqueous retention, tear stability, and the tear film's ability to protect the ocular surface

We have many things to be excited about this year in particular as 2024 is a transformational year for us and our surgical glaucoma segment, we expect to publish additional long term large scale real world data on the differentiated clinical efficacy of omni, including disease severity outcomes ethnic.

Minority is outcomes and standalone outcomes.

In addition, we are conducting a meta analysis based on all omni clinical studies and are also starting a multinational omni RCT further demonstrating our long standing commitment to generating market leading clinical evidence.

We believe we are well situated if any LCD as may return and we remain critically focused and actively engaged with the payers and our many societies on our omni market access strategy based on our differentiated technology efficacy and clinical data.

We saw the resiliency of our customer base and sales in the fourth quarter and we are now seeing increased utilization in the first quarter.

This is an encouraging indicator of the return to growth we expect to deliver in the second half of the year, we expect omni to continue to take share in the combo cataract market and continue to lead the growth of the growing standalone market.

Paul Badawi: This trial was designed with feedback from medical directors of insurance companies to demonstrate safety, efficacy, and long-term performance, which are important in their coverage determination. We believe the data generated by this trial is a critical building block for tear care and offers the most robust validation of tear care's clinical efficacy to date.

And our dry ice segment. We also expect to soon publish our Sahara, a one year RCT results, which continue to show the superior benefits of tier care versus restasis in the treatment of dry eye disease.

We plan to also publish a compelling budget impact model this year, showing the health economic impact and system savings for tier care versus Restasis.

This year, we also expect to start seeing claims paid for tier care a critical step in our journey to ultimately establish broad coverage for tier care and for care care to become a leading interventional treatment and dry eye.

Paul Badawi: We have incredible interventional technologies within both our surgical, glaucoma, and dry eye businesses that elevate the standard of care and improve treatment paradigms for millions of patients. We value the solid foundation we have built over the past decade and all of the learning and know-how we have acquired along the way. We have many things to be excited about this year, in particular, as 2024 is a transformational year for us. In our surgical glaucoma segment, we expect to publish additional long-term, large-scale, real-world data on the differentiated clinical efficacy of OMNI, including disease severity outcomes. Ethnic Minorities Outcomes and Standalone Outcomes

With so many important catalysts on our horizon and a strong experienced team in place we are very well positioned to reliably execute our plan and create value. We are particularly excited about the rest of this year as we continue to build and optimize our business returned to high growth and.

Drive towards profitability.

I'll now turn the call over to Ali to discuss our financials.

Thanks, Paul.

Before I dive into the fourth quarter financial results I want to reiterate that we are extremely proud of both our commercial and operational execution as we navigated significant challenges brought on by the LCD.

Our expense management and reduction in cash yields reflected our swift execution and the flexibility of our model. We feel these adjustments were essential and have well positioned us to support our future financial goals without limiting our strategic plan.

Paul Badawi: In addition, we are conducting a meta-analysis based on all omni-clinical studies and are also starting a multinational omni-RCT, further demonstrating our long-standing commitment to generating market-leading clinical evidence. We believe we are well situated if any LCDs may return, and we remain critically focused and actively engaged with payers and our many societies on our omni-market access strategy based on our differentiated technology, efficacy, We saw the resilience of our customer base and sales in the fourth quarter, and we are now seeing increased utilization in the first quarter. This is an encouraging indicator of the return to growth we expect to deliver in the second half of the year. We expect Omni to continue to take share in the combo cataract market and continue to lead the growth of the growing standalone market. In our dry eye segment, we also expect to soon publish our Sahara one-year RCT results, which continue to show the superior benefits of tear care versus restasis in the treatment of dry eye disease.

As we announced in January we closed our senior secured credit facility for up to $65 million with Hercules capital, including an initially funded 35 million tranche under the facility.

The new facility provides us with improved commercial terms and stronger financial flexibility as we execute our strategic goal, while maintaining current debt outstanding.

Combined with our disciplined expense management, we believe we are well positioned with strong financial footing and plan to achieve cash flow breakeven without the need to raise additional equity capital, while still investing in R&D and commercial expansion opportunities to support our long term growth.

Lastly, before turning the quarterly result, I want to briefly touch on the ongoing patent infringement case with alpine and.

In April 2023, we reported that we had defeated all four patent invalidity challenges filed by Alpine which are not appealable. The next steps include a trial that is currently scheduled to commence in April 2024, as a result, we expect to incur higher operating expenses in the first quarter of 2024 due to trial.

Paul Badawi: We plan to also publish a compelling budget impact model this year, showing the health economic impact and system savings for tier care versus restation. This year, we also expect to start seeing claims paid for tear care, a critical step in our journey to ultimately establish broad coverage for tear care and for tear care to become a leading interventional treatment for dry eyes. With so many important catalysts on our horizon and a strong, experienced team in place, we are very well positioned to reliably execute our plan and create value. We are particularly excited about the rest of this year as we continue to build and optimize our business, return to high growth, and drive towards profitability. I will now turn the call over to Ali to discuss our finances. Thanks, Paul.

Preparation work.

Moving back to the fourth quarter total revenue for the fourth quarter with $18 8 million at the top end of the revenue range, we announced in January.

This reflects a decrease of 9% compared to the fourth quarter of 2020, Q, but stronger than we expected with the LCD uncertainty. During this period, which was primarily driven by continued utilization of omni by our customers.

Surgical glaucoma revenues for the fourth quarter were $17 2 million down 9% versus the comparable period.

1064 customers ordered surgical glaucoma products in the fourth quarter down about 4% from the third quarter of 2023, but still up about 5% from the fourth quarter of 2022.

Utilization of ordering accounts was down about 5% sequentially and down about 16% from the fourth quarter of 2020, Q, but still stronger than expected given the transient LCD dynamic.

Alison Perry Bauerlein: Before I dive into the fourth quarter financial results, I want to reiterate that we are extremely proud of both our commercial and operational execution as we navigated significant challenges brought on by the LPP. Our expense management and reduction in cash used reflected our swift execution and the flexibility of our model. We feel these adjustments were essential and have well positioned us to support our future financial goals without limiting our strategic plan. As we announced in January, we closed a senior secured credit facility for up to $65 million with Hercules Capital, including an initially funded $35 million tranche under the facility.

We believe this continued utilization shows the importance of omni to our search and.

And emphasizes the unique benefit this comprehensive procedure provides for their patient.

Similar to last quarter, our customer retention was solid but utilization was down slightly we believe these dynamics were primarily the result of the uncertainty surrounding the <unk> as we saw higher impact in the areas covered by the <unk>.

Since the Ltvs were withdrawn our priority has been to Reengage and expand our customer base and drive increased utilization back to pre LCD levels and beyond.

Our dry eye revenues for the fourth quarter were $1 6 million down 11% compared to the fourth quarter of 2020 to the.

Alison Perry Bauerlein: The new facility provides us with improved commercial terms and stronger financial flexibility as we execute our strategic goals while maintaining current debt outstanding. Combined with our disciplined expense management, we believe we are well positioned with a strong financial footing and plan to achieve cash flow breakeven without the need to raise additional equity capital while still investing in R&D and commercial expansion opportunities to support our long-term growth. Lastly, before turning to quarterly results, I want to briefly touch on the ongoing patent infringement case with Althon. In April 2023, we reported that we had defeated all four patent invalidity challenges filed by Alcon, which are not appealable.

The decline was primarily due to the evolution of our commercial strategy to focus on achieving market access and higher account utilization, which led to fewer new accounts and related Mark hub sale.

And due to our reduced sales infrastructure after our restructuring in October 2023.

For the fourth quarter of 2023, we had 327 active dry eye customers, a 20% increase versus the fourth quarter of 2022.

Additionally, we sold over 5200 dry eye treatment late in the quarter, a 2% increase versus the comparable period.

Gross margin for the fourth quarter with 85% compared to 82% in the same period in the prior year.

Our overall gross margin profile remains strong. However, there was a slight impact sequentially compared to the third quarter, driven by lower production volumes and higher overhead per unit.

Total operating expenses for the fourth quarter were $27 1 million, a decrease of 20% compared to $33 9 million in the fourth quarter of 2022.

Alison Perry Bauerlein: The next steps include a trial that is currently scheduled to commence in April 2024. As a result, we expect to incur higher operating expenses in the first quarter of 2024 due to trial preparation work. Moving back to the fourth quarter, total revenue for the fourth quarter was $18.8 million, at the top end of the revenue range we announced in January. This reflects a decrease of 9% compared to the fourth quarter of 2022 but is stronger than we expected with the LCD uncertainty during this period, which was primarily driven by continued utilization of Omni by our customers. Surgical glaucoma revenues for the fourth quarter were $17.2 million, down 9% versus the comparable period.

Adjusted operating expenses were $22 3 million in the fourth quarter, a decrease of 27% compared to $30 6 million in the same period in the prior year and well below expectation.

The decrease in total operating expenses in the comparable period was primarily driven by $3 8 million reduction in non personnel related operating expenses, primarily due to lower sales related and R&D expenses and a $2 8 million reduction in personnel related expenses, including lower incentive based commit.

<unk> expense of $2 million, mostly due to lower than expected revenue, partially offset by a one 2 million cash restructuring costs incurred in the fourth quarter of 2023.

R&D expenses were $3 4 million in the fourth quarter of 2023 compared to $5 2 million in the fourth quarter of 2022.

SG&A expenses were $23 7 million in the fourth quarter of 2023 compared to $28 7 million in the fourth quarter of 2022.

Alison Perry Bauerlein: 1064 customers ordered surgical glaucoma products in the fourth quarter, down about 4% from the third quarter of 2023 but still up about 5% from the fourth quarter of 2022. Utilization of ordering accounts was down about 5% sequentially and down about 16% from the fourth quarter of 2022, but still stronger than expected, given the transient LCD dynamics. We believe this continued utilization shows the importance of OMNI to our surgeons and emphasizes the unique benefits this comprehensive procedure provides for their patients. Similar to last quarter, our customer retention was solid, but utilization was down slightly. We believe these dynamics were primarily the result of the uncertainty surrounding the LCDs, as we saw higher impact in the areas covered by the five maps.

We're proud of the cost containment efforts taken in the fourth quarter of 2023, and our ability to be agile without compromising on our commercial and R&D value drivers.

Our loss from operations for the fourth quarter was $11 1 million compared to a loss of $17 1 million in the fourth quarter of 2022.

Our net loss was $10 7 million or 22 per share in the quarter compared to a net loss of $16 9 million or <unk> 35 per share for the fourth quarter of 2022.

We ended the quarter with $138 1 million of cash and cash equivalents and $35 million of debt, excluding debt discounts and amortized debt issuance costs.

We used just $6 4 million of cash in the quarter, reflecting continued operational discipline and a sequential improvement from $10 million of cash used in the third quarter of 2023, and a decrease versus $14 8 million in the fourth quarter of 2022.

Alison Perry Bauerlein: Since the LCDs were withdrawn, our priority has been to re-engage and expand our customer base and drive increased utilization back to pre-LCD levels and beyond. Our dry eye revenues for the fourth quarter were $1.6 million, down 11% compared to the fourth quarter of 2022. The decline was primarily due to the evolution of our commercial strategy to focus on achieving market access and higher account utilization, which led to fewer new accounts and related smart hub sales, and due to our reduced sales infrastructure after our restructuring in October 2020. For the fourth quarter of 2023, we had 327 active dry eye customers, a 20% increase versus the fourth quarter of 2022. Additionally, we sold over 5,200 dry eye treatment lids in the quarter, a 2% increase versus the comparable period. Gross margin for the fourth quarter was 85% compared to 82% for the same period last year.

This continues a strong trend of reduced cash usage that was evident throughout 2023 with $46 9 million of cash use in 2023 compared to $75 7 million of cash used in 2022, reflecting a 38% production.

Moving to our outlook for the full year 2024, we are initiating revenue guidance of 81 to 85 million, representing a range of zero to 5% growth compared to 2023.

We expect the first half of 2020 for revenues to be lower than the comparative period in the prior year as we recover and rebuild following the impact of the Ltvs in the second half of 2023.

We expect this will be followed by double digit growth in the second half of the year versus the comparative period in the prior year as we regain commercial momentum and expand utilization in our customer base.

We expect typical seasonality in 2024, where the second and fourth quarters tend to have stronger utilization than the first and third quarters.

We do expect <unk> revenue to decline significantly and full year 2024, compared to full year 2023, due to the evolution of our commercial strategy restructuring of our dry eye team and the refocus on market access activities. This year.

Alison Perry Bauerlein: Our overall gross margin profile remains strong. However, there was a slight impact sequentially compared to the third quarter driven by lower production volumes and higher overhead per year. Total operating expenses for the fourth quarter were $27.1 million, a decrease of 20% compared to $33.9 million in the fourth quarter of 2022. Adjusted operating expenses were $22.3 million in the fourth quarter, a decrease of 27% compared to $30.6 million in the same period of the prior year and well below expectations.

We expect dry eye revenue to have accelerated growth in 2025 with reimbursement coverage and an expense expanded commercial presence.

In terms of gross margin, we continue to expect expect overall gross margins to be in the mid 80, but we do anticipate increased overhead cost per unit due to lower production builds planned in 2024 for both segments the larger impact in the dry eye segment.

We expect full year 2024, adjusted operating expenses of $107 million to $110 million, representing a range of zero to 3% decline compared to 2023 with higher first quarter adjusted operating expenses, primarily due to higher legal expenses for pending litigation.

Alison Perry Bauerlein: The decrease in total operating expenses in the comparable period was primarily driven by a $3.8 million reduction in non-personnel related operating expenses, primarily due to lower sales related and R&D expenses, and a $2.8 million reduction in personnel-related expenses, including lower incentive-based commission expense of $2 million, mostly due to lower than expected revenue, partially offset by $1.2 million cash restructuring costs incurred in the fourth quarter of 2023. R&D expenses were $3.4 million in the fourth quarter of 2023 compared to $5.2 million in the fourth quarter of 2022. SG&A expenses were $23.7 million in the fourth quarter of 2023, compared to $28.7 million in the fourth quarter of 2022. We are proud of the cost containment efforts taken in the fourth quarter of 2023 and our ability to be agile without compromising on our commercial and R&D value drive.

While our guidance implies lower total revenue growth in 2024 than we saw in 2023. We believe it is prudent to put achievable revenue guidance in place and are focused on the right long term value drivers in the organization by maintaining and establishing equitable market access for our products continue.

To expand our clinical portfolio, showing strong efficacy and building the right commercial infrastructure to produce consistent and predictable growth.

We are proud of the resiliency as seen in our customer base and sales, which is a testament to the benefit of our omni technology.

We believe we will return to double digit revenue growth in the second half of 2024 with execution of these initiatives.

We are still in the early stages of penetration in both our surgical glaucoma and dry eye market opportunity.

Operator, please open the line for questions.

Thank you and as a reminder to ask a question simply press Star one one on your telephone and wait for your name to be announced.

To withdraw your question Press Star one again, our first question is from Matthew O'brien with Piper Sandler. Please proceed.

Oh afternoon. Thanks, so much for taking my questions.

Good to hear that things are supposed to pick up this year, especially on the.

Surgical glaucoma side, but I'm just curious.

Alison Perry Bauerlein: Our loss from operations for the fourth quarter was $11.1 million, compared to a loss of $17.1 million in the fourth quarter of 2022. Our net loss was $10.7 million, or $0.22 per share, in the quarter, compared to a net loss of $16.9 million, or $0.35 per share, for the fourth quarter of 2022. We ended the quarter with $138.1 million of cash and cash equivalents and $35 million of debt, excluding debt discounts and amortized debt issuance.

What youre seeing maybe early days here in Q1 from a clinician.

Recovery, how many of those.

Docs that were not using at the end of last year. They have come back to you and then what youre seeing from a utilization perspective.

Hey, Matt This is Matt here I. Appreciate the question I think as reflected in the comments both from falling Ali we're seeing a steady state of recovery and all of the areas that you just asked about in terms of.

Individual accounts ordering the percent of active accounts ordering in a steady state.

Reengagement in utilization from our customers, which is what I think you would expect considering the uncertainty.

Alison Perry Bauerlein: We used just $6.4 million of cash in the quarter, reflecting continued operational discipline and a sequential improvement from $10 million of cash used in the third quarter of 2023 and a decrease versus $14.8 million used in the fourth quarter of 2022. This continues the strong trend of reduced cash usage that was evident throughout 2023, with $46.9 million of cash used in 2023 compared to $75.7 million of cash used in 2022, reflecting a 38% reduction. Moving to our outlook for the full year 2024, we are initiating revenue guidance of $81 to $85 million, representing a range of 0 to 5% growth compared to 2023. We expect revenue in the first half of 2024 to be lower than the comparative period in the prior year as we recover and rebuild following the impact of the LCDs in the second half of 2020.

<unk> was created with the LCD in the second half of last year and just to reiterate the comments from both Paul and I as well I think that we saw remarkable resiliency from our organization our sales organization and also from our customers.

And ultimately we believe that's a reflection of the comprehensive nature of omni.

Medical value it delivers and so again.

Early signs are a consistent state of recovery consistent with our expectations.

Okay.

Matt Good to talk to you again.

And then what's implied and I'm trying to run through the model I didn't get to it in time here on the call, but I guess to get to the double digit growth in the back half of the year and then into next year, what's implied from a recovery perspective in terms of the <unk>.

Previous commission getting new clinicians training utilization all of that on settlement Ali I guess I'm just trying to.

Reconcile the growth outlook with some of the cuts that you've made from a.

Alison Perry Bauerlein: We expect this will be followed by double-digit growth in the second half of the year versus the comparative period in the prior year, as we regain commercial momentum and expand utilization and our customers. We expect typical seasonality in 2024, where the second and fourth quarters tend to have higher utilization than the first and third quarters. We do expect dry eye revenue to decline significantly in full year 2024, compared to full year 2023, due to the evolution of our commercial strategy, the restructuring of our dry eye team, and the refocus on market access activities.

From a spending perspective.

Getting to free cash flow positive with your existing.

Cash levels, just putting all that together it just it's just difficult to reconcile all of that together. So just maybe help bridge us.

To that point thanks.

Sure happy happy to take that so we're not going to get into the level of granularity down to the modeling perspective of number of accounts or utilization, but we would expect all of those metrics to improve throughout the year subject to of course typical seasonality in the business, where you would typically see.

Q2, and Q4 utilization higher but we do expect to increase the cadence of new accounts being added in the period as well as recovery of the account losses, and then also improve our overall utilization both combo cataract as well as stand alone.

Alison Perry Bauerlein: We expect dry eye revenue to have accelerated growth in 2025 with reimbursement coverage and an expanded commercial presence. In terms of gross margin, we continue to expect overall gross margin to be in the mid-80s, but we do anticipate increased overhead costs per unit due to lower production builds planned in 2024 for both segments, with a larger impact on the dry ice segment. We expect full year 2024 adjusted operating expenses of 107 to 110 million, representing a range of 0 to 3% decline compared to 2023, with higher first quarter adjusted operating expenses, primarily due to higher legal expenses for pending litigation.

All of those are areas that we are expecting to see improvements in 2020 for I would say that the toughest comp for us.

Of course be the second quarter since that was our record sales last year.

But outside of that we expect to be able to continue to show nice progress in the business and that's really how you get to that double digit growth in the back half of the year.

So before we move to the question on cash did that answer your question on kind of the puts and takes on the revenue side.

Yes, I, just I wouldn't mind, a little bit more color on just what's implied from a clinician perspective in terms of what you need to do especially it's still a pretty competitive market generally speaking of somebody coming in on a standalone side in a big way.

Alison Perry Bauerlein: While our guidance implies lower total revenue growth in 2024 than we saw in 2023, we believe it is prudent to put achievable revenue guidance in place and are focused on the right long-term value drivers in the organization by maintaining and establishing equitable market access for our products, continuing to expand our clinical portfolio, showing strong efficacy, and building the right commercial infrastructure to produce consistent and predictable growth. We are proud of the resilience seen in our customer base and sales, which is a testament to the benefits of our Omni technology. We believe we will return to double-digit revenue growth in the second half of 2024 with the execution of these initiatives, as we are still in the early stages of penetration in both our surgical glaucoma and dry eye market opportunities. Operator, please open the line for questions. Thank you, and as a reminder, to ask a question, simply press star 11 on your telephone and wait for your name to be announced. To withdraw the question, press star one one again.

That's all implied there to get us to that double digit number because I think it's better than people were expecting for the back half and especially for next year as well. Thanks.

Yes, I think the majority of the increase is really utilization related. So of course, we do expect to continue to add accounts, but utilization will be a primary driver of those double digit increases.

Got it okay.

Okay.

So moving to your question on our commentary around.

Our level of investments obviously, we expect to continue to show progress. This year in terms of our operating expense leverage solid gross margins of the business and of course.

Looking to increase revenue as well as particularly in the second half of 2024, so looking into the future we expect to continue to be.

Growing double digit growing company into 2025, and so looking at the investments needed to run our business and the level of spend needed we expect to get leverage on our operating expense base. So that is really where when you look at your modeling for cash flows over time.

With growing revenues and operating expenses growing at a lower rate than revenue of course is still growing and then.

Operator: Our first question is from Matthew O'Brien with Piper Sandler. Please proceed. Good afternoon.

A small improvement on gross margin, although that's more incremental in nature, the real leverage to get to a cash flow breakeven is associated with opex.

Okay. Thanks, so much.

Thank you one moment for our next question. Please.

And it comes from the line of Tom Stefan with Stifel. Please proceed.

Great Hey, guys. Thanks for the questions.

Go back to the double digit growth in 2025.

Matt Link: I appreciate the question. I think, as reflected in the comments both from Paul and Ali, you know, we're seeing a steady state of recovery in all the areas that you've just asked about in terms of individual accounts, order, the percent of active accounts, order, and a steady state of re-engagement and utilization from our customers, which is what I think you would expect, considering the uncertainty that sort of was created with the LCDs in the second half of the year. And just to reiterate the comments from both Paul and Ali as well, I think that we saw remarkable resilience from our organization, our sales organization, and also from our customers. And ultimately, we believe that's a reflection of the comprehensive nature of Omni and the clinical value it delivers. And so, again, early signs are a consistent state of recovery, consistent with our expectations. Okay, I appreciate that, Matt. It will be good to talk to you again.

Paul our alley.

Could you potentially.

A little bit of a finer point around what that might look like it'd be great to just hear your thoughts on sort of a targeted medium term growth rate.

As we look into the out years.

Yes, I don't think were prepared to give detailed guidance today on 2025, we are still very early in 2024, and I think we will want to also see real visibility on the opportunities for care care in our business because that is a potential accelerant of our growth. So I think as we get.

Further into 2024, and really understand that opportunity will be able to provide more guidance, but both of our markets are very large there is huge potential for us.

On the Standalone side and surgical glaucoma.

<unk> to take share in the combo cataract market and then also on the dry eye side with really our new interventional procedure that.

Really should be a market that we can.

Really create over time so.

Those are really the drivers of course, we also have a small contributor associated with our U S business as well.

But we believe the U S markets will be the primary growth driver for the foreseeable future for us.

Matt Link: And then what's implied, and I'm trying to run through the model, I didn't get to it in time here on the call, but I guess to get to this double-digit growth in the back half of the year and then into next year, what's implied from a recovery perspective in terms of the previous clinicians getting new clinicians, training them, utilization, all that fun stuff. And then, Allie, I guess I'm just trying to reconcile the growth outlook with some of the cuts that you've made from a spending perspective, then to like, you know, getting the free cash flow positive with your existing cash levels, just putting all that together. It's just difficult to reconcile all that together. So maybe it can help bridge us to that point.

Got it that's helpful and then.

Ali I appreciate all the color on guidance.

But I was wondering if maybe you could potentially give us a little bit more on the quarterly cadence I know <unk>.

Bears.

Seasonal benefit, but I guess for <unk>, specifically, how should we be thinking about revenue growth and then my tack onto that would just be will there be any sort of.

Yes call it a stocking benefit to consider as customers worked down inventory in the back from the west.

Last year.

Yeah sure so taking the stocking question first.

Really haven't seen material changes in stocking yet we've seen a return of regular ordering and improvement of utilization tied to procedure volume, but we haven't seen that.

Alison Perry Bauerlein: Sure, happy to take that. So we're not gonna get into the level of granularity down to the modeling perspective of number of accounts or utilization, but we would expect all of those metrics to improve throughout the year, subject to, of course, typical seasonality in the business where you would typically see Q2 and Q4 utilization higher. But we do expect to increase the cadence of new accounts being added in the period as well as recovery of the accounts lost, and then also improve our overall utilization, both combo cataract as well as standalone. So all of those are areas that we are expecting to see improvements in 2024. I would say that the toughest comp for us will, of course, be the second quarter since that was our record sales last year.

Uptick associated with just increasing their inventory levels.

That may be something that we see in the future that's not something that inherently baked into guidance or we think would be.

Two material in nature, but that certainly is a potential that could occur at some point in time.

In terms of the quarterly cadence as we said we do expect the first half to be down primarily the second quarter is the biggest challenge from a comp perspective for us. So looking at the first quarter with the increasing utilization in the recovery that we're seeing typically you would see Q1.

Down from Q4.

I don't think that we will see that this year it may be similar.

Matt Link: But outside of that, we expect to be able to continue to show nice progress in the business, and that's really how you get to that double-digit growth in the back half. So before we move to the question on cash, did that answer your question on kind of the puts and takes on the revenue side? Yeah, I just wouldn't mind a little bit more color on just what's implied from a clinician perspective in terms of what you need to do, especially, you know, it's still a pretty competitive market. Generally speaking, there's somebody coming in on the standalone side, you know, in a big way, just what it all implied there to get you to that double digit number because I think it's better than people were expecting Yeah, I think the majority of the increase is really utilization related. So, of course, we do expect to continue to add accounts, but utilization will be a primary driver of those double digits. I got it.

But we do expect to see nice start to the year.

Given those overall dynamics of usually utilization being down sequentially versus the fourth quarter.

That's perfect thanks, and congrats on the results.

Do you.

Thank you and as a reminder to ask a question simply press star one one to get in the queue. Our next question is from David Saxon with Needham and company. Please proceed.

Great Good afternoon, Paul and Ali Thanks for taking my questions.

I wanted to.

Follow up on utilization specifically for the accounts that are coming back to omni that maybe dropped off in the back half of last year.

Are they going back to levels that they were at before.

How does that typically trend I know, it's early days still but would love to kind of hear what youre, saying there.

Hi, This is Matt I'll take that so as sort of reiterated.

Earlier comments I mean, it's obviously early but.

But I think we're encouraged by seeing a steady cadence of a return to more sort of natural ordering patterns and so I think everybody can appreciate it under the sort of cloud or uncertainty of the LCD in the second half of last year in particular Q4.

Alison Perry Bauerlein: Okay, so moving to your question on our commentary around, you know, our level of investments, obviously, we expect to continue to show progress this year in terms of our operating expense leverage, solid gross margins in the business, and, of course, looking to increase revenue as well, particularly in the second half of twenty twenty four. So, looking into the future, we expect to continue to be a growing double-digit, growing company into twenty, twenty-five. And so, looking at the investments needed to run our business and the level of spend needed, we expect to get leverage on our operating expense phase. So, that is really where when you look at your modeling for cash flows over time with growing revenues and operating expenses, growing at a lower rate than revenue, of course, still growing. And then the small improvements in gross margin, although that's more incremental in nature, the real leverage to get to a cash flow break even is associated with op-ex spend. Okay, thanks so much.

Uncertainty as to the final effective date of those Ltvs, which obviously, we're fortunately alternate withdrawn.

There definitely was some efforts by accounts to manage inventory and ensuring that there wasn't excess inventory on the shelf and again I think our sales organization did a phenomenal job staying in front of our customers and supporting them through that period of uncertainty. It obviously contributed to a decline not just an omni utilization.

But <unk> in general in the second half or fourth quarter of last year. So again early early days, but what we are seeing is a steady state of recovery trending towards what we anticipate will be more normal ordering patterns into the question around stocking not so much bulk stocking, but again, a regular cadence of ordering maintaining them.

Inventory in support of a broader utilization of <unk> and that's what we're building towards through the balance of the year.

Okay.

Thanks for that Super helpful. And then I wanted to ask on dry eye Ali.

Operator: Thank you. One moment for our next question, please. And it comes from the line of Tom Stephan with TFL.

Ali I think you said, it's going to be down significantly.

Thomas M. Stephan: Please proceed. Great. Hey guys, thanks for the questions. To go back to the double-digit growth in 2025, Paul or Ali, could you possibly put a little bit of a finer point around what that might look like? You know, it'd be great to just hear your thoughts on sort of a targeted medium-term growth rate as we look into the outcome. Yeah, I don't think we're prepared to give detailed guidance today on 2025. You know, we're still very early in 2024.

I guess whats assumed in terms of smart home placements are or is the sales force being incentivized.

Put out new placements, whereas revenue essentially being driven just by tier care consumables.

Then just on the reimbursement front.

When you talk to.

You're on.

Through 70 or whatever it was active accounts about reimbursement what are they saying in terms of where that needs to shake out in order for it to be unattractive procedure. Thanks, so much.

Yes, so looking at the peer care side of the business and inherent in guidance, it's really our 'twenty 'twenty four guidance assumes that most of the revenue was coming from the sale of smart lids and there is still a minimal number of new accounts being added but that is.

Alison Perry Bauerlein: And I think we will want to also see real visibility on the opportunities for cheer care in our business because that is a potential accelerant of our growth. So I think as we get farther into 2024 and really understand that opportunity, we'll be able to provide more guidance. But both of our markets are very large; there's huge potential for us on the standalone side and surgical glaucoma, continuing to take share in the combo cataract market. And then also on the dry eye side, with a really new interventional procedure that really should be a market that we can really create over time. So those are really the drivers.

Significantly smaller than what we saw in 2023 and 2022. So that is the shift and that is the reason that we expect to see the decline in revenue of that business along with the resizing of the sales force that occurred in October.

In terms of the.

That's 327 accounts that we had on the tier care side of the business.

In the fourth quarter.

We don't.

We're still working with payers, it's too early for us to say, what the appropriate reimbursement will be for that we think we have a compelling value proposition compelling clinical data, but those conversations are just starting really now so to talk about pricing would be would be premature but.

Thomas M. Stephan: Of course, we also have a small contributor associated with our OUS business, as well, but we believe the US markets will be the primary growth driver for the foreseeable future. That's helpful. And then, Allie, I appreciate all the color on guidance. But I was wondering if maybe you could potentially give us a little bit more on the quarterly cadence. I know 2Q and 4Q have a seasonal benefit, but I guess for 1Q specifically, how should we be thinking about revenue or growth? And then my tack on to that would just be, will there be any sort of, I guess call it, a stocking benefit to consider as customers worked down inventory in the back from the last, last year? Yeah, sure.

We know that already the business model was effective on a cash pay market.

So we think that there is a financial model that will work for us will work for the patients the providers and of course our customers.

Yes.

That are doing those procedures.

Yes, I'd just like to add to that on the on the health Economics front, we've prepared a very solid budget impact model for tier care, comparing the health economics of.

Alison Perry Bauerlein: So taking the stocking question first, we really haven't seen material changes in stocking yet. We've seen a return of regular ordering and improvement of utilization tied to procedure volume, but we haven't seen that uptick associated with just increasing their inventory levels. In terms of the quarterly cadence, as we said, you know, we do expect the first half to be down. Primarily, the second quarter is the biggest challenge from a comp perspective for us. So looking at the first quarter, with the increasing utilization and the recovery that we're seeing, typically, you would see Q1 down from Q4. I don't think that we'll see that this year. It may be similar, but we do expect to see a nice start to the year, given the overall dynamics of usually utilization being down sequentially versus the first quarter. That's perfect.

<unk> care to other prescription eyedrops like Restasis and others.

And what the ultimate system savings would be.

<unk> submitted that budget impact model for presentation at the leading society meeting in this area is for International Society of formal go economic and outcomes research.

That will be presented in may in Atlanta, we're excited about that the budget impact model should be submitted for publication very soon to leading managed care journal.

So between the Sahara six month data the Sahara 12 month data crossover, where all the restasis patients who crossed over to tier care got a single tier care treatments and the compelling outcomes. We saw there that should hopefully soon also be published coupled with the budget impact model, coupled with our market access team across the country that is.

Working with leading dry eye accounts, and our sales team and providers and payers across the country, both commercial and Mack.

Very excited about what.

Thomas M. Stephan: Thanks. And congratulations on the result. Thank you. Thank you. And as a reminder to ask a question, simply press star one one to get in the queue.

What progress we're going to make this year on the reimbursement side patients need access to these treatment they need reimbursed access, we're creating a big new category and interventional dry eye.

Operator: Our next question is from David Saxon with Needham and Company. Please proceed. Oh, great. Good afternoon, Paul and Ali.

Great. Thank you so much.

Thank you one moment for our last question. Please.

David Joshua Saxon: Thanks for taking my questions. I wanted to follow up on utilization, specifically for the accounts that are coming back to Omni that maybe dropped off in the back half of last year. Are they going back to levels that they were at before? How's that typically trend? I know it's early days still, but would love to kind of hear what you're saying there. Hi, this is Matt.

And it comes from the line of Joanne Wuensch with Citi. Please proceed.

Good afternoon. This is anthony on for Joanne Thanks for taking our questions.

Just going back to the guidance I just wanted to clarify.

The guidance, you put out and surgical glaucoma that assumes that.

Reimbursement.

Essentially unchanged for the year, so there's none of LCB.

Matt Link: I'll take that. So, as sort of reiterated in the earlier comments, I mean, it's obviously early, but I think we're encouraged by seeing a steady cadence of a return to more sort of natural ordering patterns. And so I think everybody could appreciate the uncertainty as to the final effective date of those LCDs, which obviously were fortunately ultimately withdrawn. There definitely were some efforts by accounts to manage inventory, ensuring that there wasn't excess inventory on the shelf.

And then in dry eye.

Could you maybe just talk about what your expectations are going into 2025 do you expect to start the year with a larger amount of covered lives are dupes.

These payer wins to be more on a rolling basis. Thank you.

Yes, so inherent in guidance is.

Under the assumption that we are in the current operating environment of LCD comprehends, where omni continues to have broad access and coverage in the market, which we think is fair and reasonable expectations for 2024.

David Joshua Saxon: And again, while I think our sales organization did a phenomenal job staying in front of our customers and supporting them through that period of uncertainty, it obviously contributed to a decline, not just in omni-utilization but maybe in general, in the second half and fourth quarter of last year. So again, these are early, early days, but what we are seeing is a steady state of recovery, trending towards what we anticipate will be more normal ordering patterns. And to the question around stocking, not so much bulk stocking but again, a regular cadence of ordering, maintaining inventory in support of a broader utilization of Omni. And that's what we're building towards through the balance. Okay, great. Thanks, Matt.

I'm sorry, what was the rough from a tier care tier care perspective, the work I described earlier.

Our payer our payer team.

He is engaged there is a lot of engagement with our providers and payers across the country right now thats more on the claims level, so working with providers and payers to ensure tier care claims get reimbursed appropriately.

Over time in parallel with that effort.

Market access team will be working on coverage policies now these policies have annual cycles.

But we will be doing that work this year engaging with payers on policy type coverage discussions and we'd expect to hopefully generate coverage policy wins in 2025 at that point.

David Joshua Saxon: Super helpful. And then I wanted to ask on dry eye, Ali, I think you said it's going to be down significantly. I guess, you know, what's assumed in terms of smart hub placements?

We have great expectations for the business.

Great. Thank you.

And as a reminder, that is star one one to get into Q1 moment. Please.

Alison Perry Bauerlein: Is the salesforce being incentivized to, you know, put out new placements? Or is revenue essentially being driven just by peer care consumables? And then just on the reimbursement front, you know, when you talk to your, I don't know, 370 or whatever it was, active accounts about reimbursement, what are they saying in terms of where that needs to shake out in order for it to be an attractive procedure? Thanks so much.

I have a question from me.

Margaret Andrew with William Blair. Please your line is open.

Hey, good afternoon, guys. Thanks for taking the questions.

I wanted to maybe talk a little bit about some of the dynamics around getting formal coverage for kind of a classic goniotomy.

Steps have you taken at this point.

Kind of trying to push that further and any kind of other updates that you can share on the LCD is in the last several months.

Any expectations for when we might hear any update would be helpful. Thanks.

Hi, Hi, Margaret So just to quickly recap.

What happened in the second half of 2023 was an opportunity for us to engage with with the five Max helped better educate them on site sciences on the omni surgical system on the comprehensive outflow procedure furnished by the army surgical system.

And the most importantly compelling long term clinical evidence.

That we've generated for omni over the years.

At the end of the year it culminated with two important developments.

Alison Perry Bauerlein: It's too early for us to say what the appropriate reimbursement will be for that. We think we have a compelling value proposition, compelling clinical data, but those conversations are just starting really now. So to talk about pricing would be premature, but we know that the business model was already effective in a cash-paying market.

The publication of our even longer term three year prospective Gemini study.

As well as our meeting with the Max following the societies meeting with the Max.

Which was another opportunity for us and our clinical stakeholders in a number of our glaucoma surgeon Kols to help help further educate the Max on on site Sciences, omni and our clinical data.

Paul Badawi: So we think that there is a financial model that will work for us, will work for the patients, the providers, and, of course, our customers that are doing this. Yeah, I just want to add on the health economics front: we've prepared a very solid budget impact model for tier care, comparing the health economics of peer care to other prescription eyedrops like Restasis and others. And what the ultimate system savings would be; we submitted that budget impact model for presentation at the leading society meeting in this area, it's the International Society of Pharmacoeconomic and Outcomes Research. That will be presented in May in Atlanta; we're excited about that.

We've been able to follow up we intend to stay engaged with the payers throughout this year, we have followed up with the five Max in due course, we will continue to engage with other payors such as the other the other two Max.

And we believe in addition to the clinical data that we had.

Provided throughout 2023, which was substantial we're continuing to generate really meaningful clinical data. This year and we should expect to see a number of compelling publications I had mentioned earlier such as.

These results and ethnic minorities, a meta analysis of omni, which reaches the level of hopefully level, one clinical evidence a long term standalone omni outcomes.

Paul Badawi: The budget impact model should be submitted for publication very soon in a leading managed care journal. So between the Sahara six month data, and the Sahara 12 month data crossover, where all the Restasis patients were crossed over to tear care, got a single tear care treatment, and the compelling outcomes we saw there, should hopefully also be published. Together with the budget impact model, coupled with our market access team across the country, that's working with leading dry eye accounts, and our sales team and providers and payers across the country, both commercial and Medicare, very excited about what progress we're going to make this year on the reimbursement side. Patients need access to these treatments; they need reimbursed access. We're creating a big new category in interventional dry eye. Great. Thank you so much.

So with further clinical evidence continued engagement with the payers. This year, we feel that we're very well prepared if and when LCD or proposed again.

Okay, and then just to hit on the competitive standpoint, one more time and relative to what's assumed in guidance both for this year as well.

For next year.

What conversations are you guys, having with clinicians and accounts in the field around using omni for Standalone cases, youre, assuming utilization growth clearly you're hopefully hearing that within the field from your accounts. This competition will come up at all do you guys feel a need to change any commercial strategy.

Or what kind of assurances can you kind of give us of what you are hearing to.

Support that utilization growth thanks, guys.

Yes. This is Matt I appreciate the question maybe taking the second part of that question first in terms of commercial strategy.

Talked a bit about the restructuring of the organization in the second half of last year and it really is intended to optimize our approach to the market as we continue to further segment the market based on the opportunities and given what we believe are unique opportunities.

David Joshua Saxon: Thank you. One moment for our last question, please. And it comes from the line of Joanne Wench with Citi. Please proceed. Good afternoon, this is Anthony on behalf of Joanne Wench.

Operator: Thanks for taking our questions. Just going back to guidance, I just want to clarify the guidance you put out on surgical glaucoma that assumes that reimbursement is essentially unchanged for the year. So there's no LCDs.

For us our bioscience is uniquely positioned for given the comprehensive nature of omni and the associated efficacy. So from a competition standpoint from a sales perspective, I believe we are well positioned and strongly engaged in the market and consistently receive the type of feedback we wanted here given the comprehensive nature of omni.

Joanne Wench: And then, in dry eye, could you maybe just talk about what your expectations are going into 2025? Do you expect to start the year with a larger number of covered lives, or do you expect these two ones to be more on a rolling basis? Thank you. Yeah, inherent in the guidance is the assumption that we are in the current operating environment of LCD coverage, where Omni continues to have broad access and coverage in the market, which we think is fair and reasonable expectations for 2024. I'm sorry. What was the question?

And its ability to treat.

And both combination Meg as well as <unk> on a standalone basis.

As it relates to stand alone. We're obviously in a an evolving marketplace and so we see sort of a rapid expansion of the opportunity for interventional procedures Migs in particular in the treatment of glaucoma and ultimately stand alone as a part of that and so given the comprehensive nature of omni the broad label and our.

Alison Perry Bauerlein: From a tier care perspective, the work I described earlier, our payer team is engaged. There's a lot of engagement with our providers and payers across the country. Right now, that's more on the claims level, so working with providers and payers to ensure tier care claims get reimbursed appropriately. Over time, in parallel with that effort, our market access team will be working on coverage policies. Now, these policies have annual cycles, but we will be doing that work this year, engaging with payers on policy-type coverage discussions, and we'd expect to hopefully generate coverage policy wins in 2025. At that point, we have great expectations for the business. Great

<unk> to pursue those opportunities we see we continue to see significant opportunity there we see strong engagement from <unk>.

Physicians broadly and physician advocate, but ultimately that's something that we will continue to develop.

In the marketplace and the market is receptive to that again with the evolution of this interventional mindset. So.

From a competitive standpoint, I'd say the market condition seem.

<unk> with prior periods in which case.

<unk> Sciences, as an organization and particularly omni procedure I think is well positioned to continue to compete effectively and take share.

Paul Badawi: Thank you. Thank you. And as a reminder, that is star 11 to get in the queue. One moment, please. I have a question from Margaret Andrew about William Blair.

And Margaret we're in the as you know the very early days.

Standalone market development, while it's been growing in omnis proven a very strong product market fit.

Joanne Wench: Please, your line is open. Hey, good afternoon, guys. Thanks for taking the questions. I wanted to maybe talk a little bit about some of the dynamics around getting formal coverage for canalplasty-goniatomy. You know, what steps have you taken at this point to kind of try to push that further? And any kind of other updates that you can share on the LCDs in the last several months, you know, any expectations for when we might hear any updates would be helpful. Hi Margaret.

<unk> and efficacy.

It's early days and we welcome we welcome additional entrants who can help really the challenge right now is.

Changing the treatment paradigm, so moving from a medication mindset may be S. LTE medications and esselte and patients are then progressing adding another medication or third medication, a fourth medication and progressing and ultimately needing an invasive procedure.

Paul Badawi: So just to quickly recap, what happened in the second half of 2023 was an opportunity for us to engage with the five MACs, help better educate them on sight sciences, on the omni-surgical system, on the comprehensive outflow procedure provided by the omni-surgical system, and the most importantly, compelling long-term clinical evidence that we've generated for Omni over the years. At the end of the year, it culminated with two important developments. One, the publication of our even longer-term, three-year prospective Gemini study, as well as a meeting with the MACs following the society's meeting with the MACs, which was another opportunity for us and our clinical stakeholders and a number of our glaucoma surgeon KOLs to help further educate the MACs on sight sciences, Omni, and our clinical data.

We need to change the treatment paradigm to intervene in a minimally invasive but effective way sooner.

There is a tremendous opportunity there it's going to take a lot of effort we have been over the past few years working on it we've been making progress we'd love for that progress will be accelerated with additional entrants and more people working to help change that mindset.

To change it from a <unk>.

<unk> medication pharmaceutical disease to a surgical disease and we just returned from the American American Glaucoma Society meeting and I can say the buzz there around interventions glaucoma the desire for glaucoma specialists to lead the shift in this treatment paradigm towards minimally invasive earlier interventions.

Paul Badawi: We've been able to follow up, and we intend to stay engaged with the payers throughout this year. We followed up with the five MACs in due course. We'll continue to engage with other payers, such as the other two MACs. And we believe, in addition to the clinical data that we provided throughout 2023, which was substantial, we're continuing to generate really meaningful clinical data this year. We should expect to see a number of compelling publications I had mentioned earlier, such as Omni's results in ethnic minorities, a meta-analysis of Omni, which reaches a level of, you know, hopefully level one clinical evidence, long-term standalone Omni outcomes.

It's alive and well and I expect the next few years to be very exciting.

Great. Thanks, guys.

Thank you and I'm not showing any further questions at this time I would like to turn the call back to pull back.

For final comments.

Thank you for attending today's call coming into 2024, we have compelling commercial strategies in our two large market opportunities robust clinical efficacy across our differentiated interventional portfolio and an experienced management team ready to execute our plan we look.

Malgorzata Maria Kaczor Andrew: So, with further clinical evidence and continued engagement with payers this year, we feel that we're very well prepared if and when LCDs are proposed. Okay, and then, you know, just to hit on the competitive standpoint one more time, and relative to, you know, what's assumed in guidance both for this year as well as for next year. You know, what conversations are you guys having with clinicians and accounts in the field around using Omni for standalone cases? You're assuming utilization grows. So, clearly, you're, you're hopefully hearing that within the field from your accounts. Does competition come up at all?

Forward to engaging with the investment community around these exciting opportunities. Thank you.

And with that we thank you for participating and you may now disconnect.

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Paul Badawi: Do you guys feel a need to change any commercial strategy or, you know, what kind of assurances can you kind of give us of what you're hearing to, you know, support that utilization growth? Thanks, guys.

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Matt Link: I appreciate the question. Maybe taking the second part of that question first, in terms of commercial strategy, we talked a bit about the restructuring of the organization in the second half of last year, and it really is intended to optimize our approach to the market as we continue to further segment the market based on the opportunities and given what we believe are unique opportunities for us, or that Sight Sciences is uniquely positioned for, given the comprehensive nature of Omni and the associated efficacy. So from a competition standpoint, from a sales perspective, I believe we're well positioned and strongly engaging the market and consistently receive the type of feedback we want to hear, given the comprehensive nature of Omni and its ability to treat glaucoma in both combination MIGs as well as on a standalone basis.

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Matt Link: As it relates to standalone, we're obviously in an evolving marketplace, and so we see sort of a rapid expansion of the opportunity for interventional procedures, MIGS in particular, and the treatment of glaucoma, and ultimately standalone as a part of that. And so given the comprehensive nature of OMNI, the broad label, and our ability to pursue those opportunities, we continue to see significant opportunity there. We see strong engagement from physicians broadly and physician advocates.

Malgorzata Maria Kaczor Andrew: But ultimately, that's something that we will continue to develop in the marketplace, and the market is receptive to that, again, with the evolution of this interventional mindset. So from a competitive standpoint, I'd say the market conditions seem consistent with prior periods, in which case Sight Sciences as an organization, and particularly OMNI, the procedure, I think it is well-positioned to continue to compete effectively and take share. And Margaret, we're in the, as you know, the very early days of standalone market development, while it's been growing, and Omni's proven a very strong product market fit, leading in efficacy. It's early days, and we welcome, we welcome additional entrants who can help. Really, the challenge right now is changing the treatment paradox.

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Paul Badawi: So moving from a medication mindset, maybe SLT, medication, and SLT, and patients are then progressing, adding another medication, a third medication, a fourth medication, and progressing, and ultimately needing an invasive procedure. We need to change the treatment paradigm to intervene in a minimally invasive but effective way sooner. There's a tremendous opportunity there. It's going to take a lot of effort.

Malgorzata Maria Kaczor Andrew: We've been working on it for the past few years. We've been making progress. We'd love for that progress to be accelerated with additional entrants and more people working to help change that mindset to change it from a medication pharmaceutical disease to a surgical disease. And we just returned from the American Glaucoma Society meeting, and I can say the buzz there around interventional glaucoma, the desire for glaucoma specialists to lead the shift in this treatment paradigm towards minimally invasive earlier interventions. It's alive and well, and I'd expect the next few years to be very exciting. Great

Okay.

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Operator: Thanks, guys. Thank you. And I'm not asking any further questions at this time.

Operator: I would like to turn the call back to Paul Badawi for final comments. Thank you for attending today's call. Coming into 2024, we have compelling commercial strategies in our two large market opportunities, robust clinical efficacy across our differentiated interventional portfolio, and an experienced management team ready to execute our plan. We look forward to engaging with the investment community around these exciting opportunities.

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Operator: And with that, we thank you for participating, and you may now disconnect. Phone Ringing, ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? Ladies and gentlemen, thank you for standing by, and welcome to the Sight Sciences fourth quarter 2023 earnings results. At this time, all participants are in a listen-only mode.

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Operator: To withdraw your question, please press star 11 again, and please be advised that today's conference is being recorded. I would now like to turn the conference over to your speaker today, Trip Taylor from Investor Relations. Thank you for participating in today's call. Presenting today are Sight Sciences co-founder and chief executive officer, Paul Badawi, chief financial officer, Ali Bauerlein, and chief commercial officer, Matt Link. Earlier today, Sight Sciences released financial results for the three months and full year ended December 31st, 2023 and initiated guidance for the full year 2024. A copy of the press release is available on the company's website at investors.sightsciences.com.

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Operator: A description of some of the risks and uncertainties that could cause actual results to differ materially from those indicated by the forward-looking statements on this call can be found in its public filings with the Securities and Exchange Commission, including in the risk factors section of the company's annual report on Form 10-K and quarterly reports on Form 10-Q. The company undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law. On the call, management may refer to financial measures that were not prepared in accordance with generally accepted accounting principles in the United States, including adjusted operating expenses.

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Operator: The company believes these non-GAAP financial measures are important indicators of its operating performance because they exclude items that are unrelated to and may not be indicative of its core operating results. See the company's earnings release for reconciliation of these non-GAAP financial measures to the most directly comparable GAAP financial measures, as well as additional information about the company's reliance on non-GAAP financial measures. I will now turn the call over to Paul. Thanks, Trip.

Thanks.

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Paul Badawi: I'm extremely proud of the progress we made in both the fourth quarter and full year, twenty-three. This year has reinforced the importance of our mission to develop transformative interventional technologies that allow i care providers to procedurally elevate the standards of care, empowering people to keep seeing. 2023 was a pivotal year for us as we executed on key strategic initiatives. We're very pleased to have accomplished several milestones throughout the year, including enhancing our executive team with proven high growth med tech leadership experience with the additions of Ali Bauerlein, our chief financial officer, and Matt Link, our chief commercial officer. Both Ali and Matt have integrated seamlessly into their roles and have been vital to our many organizational enhancements.

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Paul Badawi: We believe differentiated, long-term clinical data will help us drive coverage, equitable reimbursement, and commercialization success over time. [inaudible] In 2023, we generated revenue growth in the mid-teens, our gross margins improved to all-time highs, and we significantly reduced our operating expenses and cash usage in the face of reimbursement uncertainty, while maintaining focus spanned across critical areas. In a major development late in December, we were pleased with the withdrawal of the finalized LCDs from five Medicare Administrative Contractors, or MACs, that were scheduled to go effective in late January 2024. These MACs had previously identified certain MIGS procedures as investigational for glaucoma management in patients over the age of 18, including canaloplasty in combination with trabeculotomy ab interno, which is a procedural description associated with our

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Ladies and gentlemen, thank you for standing by and welcome to the <unk> Sciences fourth quarter 2023 earnings results.

At this time all participants are in a listen only mode. After the presentation. There will be a question and answer session to ask a question. During the session you will need to press star one on your telephone you will Dan here, an automated message advising your hand this waste to withdraw your question. Please press star one again and please.

We advised that today's conference is being recorded I would now like to turn the conference over to your Speaker today, Tim Taylor with Investor Relations.

Yes.

Thank you for participating in today's call presenting today are site Sciences co founder and Chief Executive Officer, Paul <unk>, Chief Financial Officer, Ali Bauerlein, and Chief Commercial Officer, Matt Link earlier today, <unk> Sciences released financial results for the three months and full year ended December 31 2023.

Paul Badawi: Throughout the process, we worked closely with all key stakeholders, including national and state societies, congressional offices, medical device associations, and hundreds of MIG surgeons, to help educate the MACs and CMS about the importance of MIG procedures involving our Omni system and the long-term clinical evidence available. We executed this multi-pronged approach to challenge the LCDs while navigating new and complex dynamics with our soaring customers, resulting from the potential implications of these LCDs and our customers' preparations to adhere to potential coverage restrictions. Even with the reimbursement uncertainty, sales of our surgical glaucoma products have proven very resilient. We believe this is a testament to the clinical efficacy of the Comprehensive Omni procedure as surgeons rely on its IOP and medication reduction capabilities to treat their patients.

<unk> and initiated guidance for full year 2020 for.

A copy of the press release is available on the company's website at investors <unk> Sciences Dot com.

I would like to remind everyone that comments made by management today and answers to questions will include forward looking statements within the meaning of the federal Securities laws. These forward looking statements include statements related to the company's anticipated financial performance operating results and liquidity position current and long term strategic objectives.

Market opportunity business and commercial strategy product reimbursement strategy clinical trial results and costs associated with pending litigation.

Paul Badawi: Again, we are thankful that our team and other industry stakeholders are steadfast in their alignment on the important role OMNI plays in treating their glaucoma patients. We will continue to advocate to ensure that there is equitable patient access to this critical technology. Coverage decisions are heavily governed by compelling long-term clinical data. We provided the match with a significant body of peer-reviewed, long-term clinical evidence throughout the process, which was further strengthened by the publication of our GEMII-2 study in December. Favorable results from this prospective multi-center study demonstrated sustained and clinically significant IOP reduction of 29% from baseline at 36 months and clinically significant IOP lowering medication reduction with 74% of the study patients medication free at 36 months. The prospective three-year clinical outcomes in the GEMII-2 trial confirm and extend the previously published 12-month data from the original GEMII-2 trial.

Forward looking statements are based on estimates and assumptions as of today are neither promises nor guarantees and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied by these statements a description of some of the risks and uncertainties that could cause actual results to differ materially from those indicated by the forward.

Looking statements on this call can be found in its public filings with the Securities and Exchange Commission, including in the risk factors section of the company's annual report on Form 10-K, and quarterly reports on Form 10-Q. The company undertakes no obligation to publicly update or revise any forward looking statements except as required by.

Law.

On the call management may refer to financial measures that were not prepared in accordance with generally accepted accounting principles in the United States, including adjusted operating expenses.

Paul Badawi: GEMII-2 included 66 patients across 11 participating sites, and any patients who were not already medication-free from the OMNI procedure underwent medication washout at the two-year and three-year endpoints so that the IOP lowering effect of the OMNI procedure could be isolated and assessed. There is demonstrated consistency with clinical outcomes across all published Omni studies, and this longer-term prospective multi-center trial data further supports the need for continued access to Omni technology We believe that new MIGS LCDs may be proposed in the future.

The company's earnings release for a reconciliation of these non-GAAP financial measures to the most directly comparable GAAP financial measures as well as additional information about the company's reliance on non-GAAP financial measures.

I will now I will now turn the call over to Paul.

Thanks Tripp.

Im extremely proud of the progress we made in both the fourth quarter and full year 2023. This year has reinforced the importance of our mission to develop transformative intervention technologies that allow eye care providers to procedurally elevate the standards of care and <unk>.

Paul Badawi: While we are uncertain as to the timing and process that would be followed if new LCDs are finalized, we are confident our body of published, high-quality, long-term data, including the GemIIni2 study, supports continued coverage of procedures enabled by Omni for the appropriate patient population. We also plan to publish additional clinical data throughout 2024 that will further strengthen the body of evidence illustrating Omni's clinical efficacy and, we believe, will support favorable coverage and determination. We look forward to continued engagement with the MACS, CMS, and other stakeholders to ensure glaucoma patients and their physicians maintain appropriate and equitable access to medically reasonable and necessary mixed procedures and technology. Looking ahead, we are working to re-engage those accounts impacted by the LCDs, drive increased utilization, and train new surgeons. Despite the uncertainty associated with LCDs, We had minimal employee attrition in the fourth quarter, and we are now backfilling those roles in the first quarter. As expected, given the fourth quarter LCD uncertainty, the surgeon training funnel was lighter than our historical average to end the year.

<unk> people to keep seeing.

2023 was a pivotal year for us as we execute on key strategic initiatives. We're very pleased to accomplish several milestones throughout the year, including enhancing our executive team with proven high growth Med Tech leadership experience with the additions of Alibaba line, our Chief Financial Officer, and Matt Link our Chief commercial officer.

We believe differentiated long term clinical data will help us drive coverage equitable reimbursement and commercialization success over time.

Paul Badawi: We are still in the early stages of regrowing the funnel, as surgeons now have visibility on coverage. We are confident in our ability to recapture lost accounts, add new accounts and surgeons, and improve utilization over time. Our main commercial focus is increasing utilization across our customer base and re-engaging with accounts that have not ordered Omni over the past two quarters due to reimbursement uncertainty. The changes we made to our commercial organization in the fourth quarter are already proving beneficial in this regard.

While maintaining focus spend on critical areas.

And a major development late in December we were pleased with the withdrawal of the finalized lcd's from five Medicare administrative contractors or Macs that were scheduled to go effective in late January 2024.

These Max had previously identified certain mix procedures at an investigational for glaucoma management in patients over the age of 18, including can alloplasty in combination with trabecular <unk> in Toronto, which is a procedural description associated with our omni surgical system.

Paul Badawi: Following its U.S. launch in March 2023, the Ergo series has been broadly adopted due to its improved ergonomics and an optimized cannula tip that provides gentle and precise access to Schlem's canal. We believe these design features will be invaluable to our European partners. Turning now to our dry eye dis- Our Tier Care technology provides a clinically proven, safe, and effective procedural intervention for patients suffering from evaporative dry eye disease, which is a multi-billion dollar annual U.S. market opportunity with over 11 million patients diagnosed. Interventional dry eye procedures with tear care address the root underlying cause of evaporative dry eye disease, and we believe tear care represents a major advancement, providing patients with a more comprehensive, consistent, fast acting, and long term dry eye treatment.

Stakeholders, we're steadfast in their alignment.

On the important role omni plays in treating their glaucoma patients.

We will continue to advocate to ensure that there is equitable patient access to this critical technology.

The prospective three year clinical outcomes in the Gemini two trial confirm and extend the previously published 12 month data from the original Gemini trial.

<unk> included 66 patients across 11 participating sites and any patients who are not already medication free from the omni procedure underwent medication wash out at the two year and three year end points. So that the IOP lowering effect of the omni procedure could be isolated NSS.

Paul Badawi: These discussions will be ongoing throughout the year and beyond, and coverage decisions will be subject to payer standard policy update timelines. Our goal is to begin receiving coverage decisions from payers starting in 2025 as we pursue this large market opportunity. At that point, we will expand peer-to-peer commercialization in geographies where coverage has been established. The publication of successful six-month results of the Sahara RCT, Comparing Tear Care to Restasis, the market-leading dry eye therapeutic for the treatment of dry eye disease, was published in Clinical Ophthalmology in December. Data from the RCT shows the Tier Care technology successfully delivered clinically and statistically significant improvements in every sign and symptom at all measured time points over a six-month period. Tear Care was also superior to Restasis in the improvement of tear film breakup time, the study's primary objective endpoint, and a key measure of aqueous retention, tear stability, and the tear film's ability to protect the ocular surface.

Opiate patient population.

Looking ahead, we are working to Reengage those accounts impacted by the LCD is drive increased utilization and train new surgeons. Despite the uncertainty associated with the <unk>.

Paul Badawi: This trial was designed with feedback from medical directors of insurance companies to demonstrate safety, efficacy, and long-term performance, which are important in their coverage determination. We believe the data generated by this trial is a critical building block for tier care and offers the most robust validation of tier care's clinical efficacy to date.

We had minimal employee attrition in the fourth quarter and we are now back filling those roles in the first quarter.

Paul Badawi: We have incredible interventional technologies within both our surgical, glaucoma, and dry eye businesses that elevate the standard of care and improve treatment paradigms for millions of patients. We value the solid foundation we have built over the past decade and all of the learning and know-how we have acquired along the way. We have many things to be excited about this year, in particular, as 2024 is a transformational year for us. In our surgical glaucoma segment, we expect to publish additional long-term, large-scale, real-world data on the differentiated clinical efficacy of OMNI, including disease severity outcomes, ethnic minority outcomes, and standalone outcomes.

And improved utilization over time.

Our main commercial focus is increasing utilization across our customer base and re engaging with accounts that have not ordered omni over the past two quarters due to the reimbursement uncertainty.

I want to close our surgical glaucoma discussion by touching on our recent European launch in February we initiated the European launch of the Ergo series of the omni surgical system.

Following its U S launch in March 2023, the Ergo series has been broadly adopted due to its improved ergonomics and an optimized cannula tip that provides gentle and precise access to Schlumpf canal.

We believe these design features will be invaluable to our European partners.

Interventional dry eye procedures with tier care address the root underlying cause of evaporative dry eye disease, and we believe tier care represents a major advancement, providing patients with a more comprehensive consistent fast acting and long term dry eye treatment.

We are actively working in 2024 to drive equitable market access for dry eye patients, who can benefit from an interventional procedure with tier care.

Importantly, our market access team has significant experience, establishing reimbursement for new and innovative technologies and procedures.

Paul Badawi: We plan to also publish a compelling budget impact model this year, showing the health economic impact and system savings for tier care versus restation. This year, we also expect to start seeing claims paid for tear care, a critical step in our journey to ultimately establish broad coverage for tear care and for tear care to become a leading interventional treatment for dry eyes. With so many important catalysts on our horizon and a strong, experienced team in place, we are very well positioned to reliably execute our plan and create value. We are particularly excited about the rest of this year as we continue to build and optimize our business, return to high growth, and drive towards profitability. I'll now turn the call over to Ali to discuss our finances. Thanks, Paul.

In 2024, we're focused on leveraging our foundational work with commercial Payors and Max to advocate for coverage of Interventional island procedures enabled by tier care.

The publication of our compelling Sahara six month, RCT data and budget impact model are the focal points of our discussions with payers.

These discussions will be ongoing throughout the year and beyond and coverage decisions will be subject to payer standard policy update timelines.

Our goal is to begin receiving coverage decisions from payers starting in 2025 as we pursue this large market opportunity.

At that point, we will expand to your care commercialization in geographies where coverage has been established.

The publication of successful six month results of the Sahara RCT comparing tier care to restate. This the market leading dry eye therapeutic for the treatment of dry eye disease was published in clinical ophthalmology in December.

Alison Perry Bauerlein: Before I dive into the fourth quarter financial results, I want to reiterate that we are extremely proud of both our commercial and operational execution as we navigated significant challenges brought on by the LPF. Our expense management and reduction in cash used reflected our swift execution and the flexibility of our model. We feel these adjustments were essential and have well positioned us to support our future financial goals without limiting our strategic plan. As we announced in January, we closed a senior secured credit facility for up to $65 million with Hercules Capital, including an initially funded $35 million tranche under the facility.

This trial was designed with feedback from medical directors of insurance companies to demonstrate safety efficacy and long term performance, which are important in their coverage determinations.

We believe the data generated by this trial is a critical building block for tier care and offers the most robust validation of tier two tier carriers clinical efficacy to date.

Alison Perry Bauerlein: The new facility provides us with improved commercial terms and stronger financial flexibility as we execute our strategic goals while maintaining current debt outstanding. Combined with our disciplined expense management, we believe we are well positioned with a strong financial footing and plan to achieve cash flow breakeven without the need to raise additional equity capital while still investing in R&D and commercial expansion opportunities to support our long-term growth. Lastly, before turning to quarterly results, I want to briefly touch on the ongoing patent infringement case with Alcon. In April 2023, we reported that we had defeated all four patent invalidity challenges filed by Alcon, which are not appealable.

In closing.

We have incredible intervention technologies within both our surgical glaucoma and dry eye business is that elevate the standard of care and improved treatment paradigms for millions of patients we value. The solid foundation, we have built over the past decade, and all of the learning of Knowhow, We have acquired along the way.

Minority is outcomes and standalone outcomes.

We saw the resiliency of our customer base and sales in the fourth quarter and we are now seeing increased utilization in the first quarter.

And our dry ice segment. We also expect to soon publish our Sahara, a one year RCT results, which continued to show the superior benefits of tier care versus restasis in the treatment of dry eye disease.

We plan to also publish a compelling budget impact model this year, showing the health economic impact and system savings for tier care versus Restasis.

Alison Perry Bauerlein: 1064 customers ordered surgical glaucoma products in the fourth quarter, down about 4% from the third quarter of 2023 but still up about 5% from the fourth quarter of 2022. Utilization of ordering accounts was down about 5% sequentially and down about 16% from the fourth quarter of 2022, but still stronger than expected given the transient LCD dynamics. We believe this continued utilization shows the importance of OMNI to our surgeons and emphasizes the unique benefits this comprehensive procedure provides for their patients. Similar to last quarter, our customer retention was solid, but utilization was downslide. We believe these dynamics were primarily the result of the uncertainty surrounding the LCDs, as we saw higher impact in the areas covered by the five maps.

This year, we also expect to start seeing claims paid for tier care a critical step in our journey to ultimately establish broad coverage for tier care and for tier care to become a leading interventional treatment and dry eye.

Drive towards profitability.

I'll now turn the call over to Ali to discuss our financials.

Thanks, Paul.

Our expense management and reduction in cash used reflected our swift execution and the flexibility of our model. We feel these adjustments were a central and have well positioned us to support our future financial goals without limiting our strategic plan.

Alison Perry Bauerlein: Since the LCDs were withdrawn, our priority has been to re-engage and expand our customer base and drive increased utilization back to pre-LCD levels and beyond. Our dry eye revenues for the fourth quarter were $1.6 million, down 11% compared to the fourth quarter of 2022. The decline was primarily due to the evolution of our commercial strategy to focus on achieving market access and higher account utilization, which led to fewer new accounts and related smart hub sales, and due to our reduced sales infrastructure after our restructuring in October 2020. For the fourth quarter of 2023, we had 327 active dry eye customers, a 20% increase versus the fourth quarter of 2022. Additionally, we sold over 5200 dry eye treatment lids in the quarter, a 2% increase versus the comparable period. Gross margin for the fourth quarter was 85% compared to 82% for the same period in the prior year.

As we announced in January we closed our senior secured credit facility for up to $65 million with Hercules capital, including an initially funded 35 million tranche under the facility.

The new facility provides us with improved commercial terms and stronger financial flexibility as we execute our strategic goal, while maintaining current debt outstanding.

Lastly, before turning the quarterly result, I want to briefly touch on the ongoing patent infringement case with alpine and.

Preparation work.

Moving back to the fourth quarter total revenue for the fourth quarter with $18 8 million at the top end of the revenue range, we announced in January.

Alison Perry Bauerlein: Our overall gross margin profile remains strong. However, there was a slight impact sequentially compared to the third quarter, driven by lower production volumes and higher overhead per year. Total operating expenses for the fourth quarter were $27.1 million, a decrease of 20% compared to $33.9 million in the fourth quarter of 2022. Adjusted operating expenses were $22.3 million in the fourth quarter, a decrease of 27% compared to $30.6 million in the same period of the prior year and well below expectations.

Surgical glaucoma revenues for the fourth quarter were $17 2 million down 9% versus the comparable period.

1064 customers ordered surgical glaucoma products in the fourth quarter down about 4% from the third quarter of 2023, but still up about 5% from the fourth quarter of 2022.

Utilization of ordering accounts was down about 5% sequentially and down about 16% from the fourth quarter of 2022, but still stronger than expected given the transient LCD dynamic.

Alison Perry Bauerlein: The decrease in total operating expenses in the comparable period was primarily driven by a $3.8 million reduction in non-personnel related operating expenses, primarily due to lower sales-related and R&D expenses, and a $2.8 million reduction in personnel-related expenses, including lower incentive-based commission expense of $2 million, mostly due to lower than expected revenue, partially offset by a $1.2 million cash restructuring cost incurred in the fourth quarter of 2023. R&D expenses were $3.4 million in the fourth quarter of 2023 compared to $5.2 million in the fourth quarter of 2022. SG&A expenses were $23.7 million in the fourth quarter of 2023, compared to $28.7 million in the fourth quarter of 2022. We are proud of the cost containment efforts taken in the fourth quarter of 2023 and our ability to be agile without compromising on our commercial and R&D value drive.

We believe this continued utilization shows the importance of omni to our circuit and emphasizes the unique benefit. This comprehensive procedure provides for their patient.

Since the Ltvs were withdrawn our priority has been to Reengage and expand our customer base and drive increased utilization back to pre LTV levels and beyond.

Our dry eye revenues for the fourth quarter were $1 6 million down 11% compared to the fourth quarter of 2020 to the.

And due to our reduced sales infrastructure after our restructuring in October 2023.

For the fourth quarter of 2023, we had 327 active dry eye customers, a 20% increase versus the fourth quarter of 2022.

Additionally, we sold over 5200 dry eye treatment late in the quarter, a 2% increase versus the comparable period.

Gross margin for the fourth quarter was 85% compared to 82% in the same period in the prior year.

Our overall gross margin profile remains strong. However, there was a slight impact sequentially compared to the third quarter, driven by lower production volumes and higher overhead per unit.

Total operating expenses for the fourth quarter were $27 1 million, a decrease of 20% compared to $33 9 million in the fourth quarter of 2022.

Adjusted operating expenses were $22 3 million in the fourth quarter, a decrease of 27% compared to $30 6 million in the same period in the prior year and well below expectation.

Alison Perry Bauerlein: We used just $6.4 million of cash in the quarter, reflecting continued operational discipline and a sequential improvement from $10 million of cash used in the third quarter of 2023 and a decrease versus $14.8 million used in the fourth quarter of 2022. This continues the strong trend of reduced cash usage that was evident throughout 2023, with 46.9 million of cash used in 2023 compared to 75.7 million of cash used in 2022, reflecting a 38% reduction. Moving to our outlook for the full year 2024, we are initiating revenue guidance of $81 to $85 million, representing a range of 0 to 5% growth compared to 2023. We expect the first half of 2024 revenues to be lower than the comparative period in the prior year as we recover and rebuild following the impact of the LCDs in the second half of 2020.

<unk> expense of $2 million, mostly due to lower than expected revenue, partially offset by a one 2 million cash restructuring costs incurred in the fourth quarter of 2023.

R&D expenses were $3 4 million in the fourth quarter of 2023 compared to $5 2 million in the fourth quarter of 2022.

G&A expenses were $23 7 million in the fourth quarter of 2023 compared to $28 7 million in the fourth quarter of 2020 Q. We are proud of the cost containment efforts taken in the fourth quarter of 2023, and our ability to be agile without compromising on our commercial and R&D value drivers.

Yeah.

Our loss from operations for the fourth quarter was $11 1 million compared to a loss of $17 1 million in the fourth quarter of 2022.

Our net loss was $10 7 million or 22 per share in the quarter compared to a net loss of $16 9 million or <unk> 35 per share for the fourth quarter of 2022.

We ended the quarter with $138 1 million of cash and cash equivalents and $35 million of debt, excluding debt discounts and amortized debt issuance costs.

This continues a strong trend of reduced cash usage that was evident throughout 2023 with $46 9 million of cash use in 2023 compared to $75 7 million of cash used in 2022, reflecting a 38% reduction.

Moving to our outlook for the full year 2024, we are initiating revenue guidance of $81 million to $85 million, representing a range of zero to 5% growth compared to 2023.

Alison Perry Bauerlein: We expect Dry Eye Revenue to have accelerated growth in 2025 with reimbursement coverage and an expanded commercial presence. In terms of gross margin, we continue to expect overall gross margin to be in the mid-80s, but we do anticipate increased overhead costs per unit due to lower production builds planned in 2024 for both segments, with a larger impact on the dry ice segment. We expect full year 2024 adjusted operating expenses of 107 to 110 million, representing a range of 0 to 3% decline compared to 2023, with higher first quarter adjusted operating expenses, primarily due to higher legal expenses for pending litigation.

We expect the first half of 2020 for revenues to be lower than the comparative period in the prior year as we recover and rebuild following the impact of the Ltvs in the second half of 2023.

We expect typical seasonality in 2024, where the second and fourth quarters tend to have stronger utilization than the first and third quarters.

We do expect revenues to decline significantly and full year 2024, compared to full year 2023, due to the evolution of our commercial strategy the restructuring of our dry eye team and the refocus on market access activities. This year.

We expect dry eye revenue to have accelerated growth in 2025 with reimbursement coverage.

Expanded commercial presence.

In terms of gross margin, we continue to expect expect overall gross margin to be in the mid 80, but we do anticipate increased overhead cost per unit due to lower production builds planned in 2024 for both segments the larger impact in the dry eye segment.

<unk> to expand our clinical portfolio, showing strong efficacy and building the right commercial infrastructure to produce consistent and predictable growth.

We are proud of the resiliency as seen in our customer base and sales, which is a testament to the benefit of our omni technology.

We believe we will return to double digit revenue growth in the second half of 2024 with execution of these initiatives as we are still in the early stages of penetration in both our surgical glaucoma and dry eye market opportunity.

Operator: Our first question is from Matthew O'Brien with Piper Sandler. Please proceed. Good afternoon.

Operator, please open the line for questions.

Matt Link: Thanks so much for taking the questions. You know, good to hear that things are supposed to perk up this year, especially on the surgical glaucoma side, but I'm just curious, you know, what you're seeing maybe in the early days here in Q1 from a clinician, you know, recovery, you know, how many of those stocks that we weren't using at the end of last year have come back to you and then what you're seeing from a utilization standpoint. I appreciate the question. I think, as reflected in the comments both from Paul and Ali, you know, we're seeing a steady state of recovery in all the areas that you just asked about in terms of individual accounts, order the percent of active accounts, order and a steady state of re-engagement and utilization from our customers, which is what I think you would expect, considering the uncertainty that sort of was created with the LCDs in the second half of the year.

And as a reminder to ask a question simply press Star one one on your telephone and wait for your name to be announced.

To withdraw your question Press Star one again, our first question is from Matthew O'brien with Piper Sandler. Please proceed.

Oh afternoon. Thanks, so much for taking my questions.

Good to hear that things are supposed to pick up this year, especially on the.

Surgical glaucoma side, but I'm just curious.

Whats Youre seeing maybe early days here in Q1 from a clinician.

Recovery, how many of those.

Docs that were not using at the end of last year and I'll come back to you and then what youre seeing from a from a utilization perspective.

Hey, Matt This is Matt here I. Appreciate the question I think as reflected in the comments both from Paul and Ali we're seeing a steady state of recovery and all the areas that you just asked about in terms of.

Individual accounts ordering the percent of active accounts ordering in a steady state.

Reengagement in utilization from our customers, which is what I think you would expect considering the uncertainty.

Matt Link: And just to reiterate the comments from both Paul and Ali as well, I think that we saw remarkable resiliency from our organization, our sales organization, and also from our customers. And ultimately, we believe that's a reflection of the comprehensive nature of Omni and the clinical value it delivers. And so, again, early signs are a consistent state of recovery, consistent with our expectations. Okay, appreciate that, Matt. Good to talk to you again.

<unk> was created with the LCD in the second half of last year and just to reiterate the comments from both Paul and Ali as well I think that we saw remarkable resiliency from our organization our sales organization and also from our customers.

And ultimately we believe that's a reflection of the comprehensive nature of omni and the clinical value is delivered and so again.

Early signs are a consistent state of recovery consistent with our expectations.

Okay I appreciate that Matt good property again.

Previous commission getting new clinicians training utilization all of that on settlement Ali I guess I'm just trying to wreck.

Reconcile the growth outlook with some of the cuts that you've made from a.

From a spending perspective.

Getting to free cash flow positive with your existing.

Our cash levels, just just putting all that together, it's just it's difficult to reconcile all of that together. So just maybe help bridge us.

To that point thanks.

Matt Link: Sure, happy to take that. So we're not gonna get into the level of granularity down to the modeling perspective of number of accounts or utilization, but we would expect all of those metrics to improve throughout the year, subject to, of course, typical seasonality in the business where you would typically see Q2 and Q4 utilization higher. But we do expect to increase the cadence of new accounts being added in the period as well as recovery of the accounts lost, and then also improve our overall utilization, both combo cataract as well as standalone. So all of those are areas that we are expecting to see improvements in 2024. I would say that the toughest comp for us will, of course, be the second quarter since that was our record sales last year.

Sure happy happy to take that so we're not going to get into the level of granularity.

The modeling perspective of number of accounts or utilization, but we would expect all of those metrics to improve throughout the year subject to of course typical seasonality in the business, where you would typically see Q2, and Q4 utilization higher but we do expect to increase the cadence of new account.

Being added in the period as well as recovery of the account loss and then also improve our overall utilization both combo cataract as well as stand alone.

So all of those are areas that we are expecting to see improvements in 2020 for I would say that the toughest comp for us.

Of course be the second quarter since that was our record sales last year.

Alison Perry Bauerlein: But outside of that, we expect to be able to continue to show nice progress in the business, and that's really how you get to that double-digit growth in the back half. So before we move to the question on cash, did that answer your question on kind of the puts and takes on the revenue side? Yeah, I just wouldn't mind a little bit more color on just what's implied from a clinician perspective in terms of what you need to do, especially, you know, it's still a pretty competitive market. Generally speaking, there's somebody coming in on the standalone side, you know, in a big way, just what it all implied there to get you to that double digit number because I think it's better than people were expecting Yeah, I think the majority of the increase is really utilization related. So, of course, we do expect to continue to add accounts, but utilization will be a primary driver of those double digits. I got it.

But outside of that we expect to be able to continue to show nice progress in the business and Thats really how you get to that double digit growth in the back half of the year.

So before we move to the question on cash did that answer your question on kind of the puts and takes on the revenue side.

That's all implied there to get to that double digit number because I think it's better than people were expecting for the back half and especially for next year as well. Thanks.

Matt Link: Okay, so moving to your question on our commentary around, you know, our level of investments, obviously, we expect to continue to show progress this year in terms of our operating expense leverage, solid gross margins in the business, and, of course, looking to increase revenue as well, particularly in the second half of twenty-two and twenty-four. So, looking into the future, we expect to continue to be a growing double-digit, growing company into twenty, twenty-five. And so, looking at the investments needed to run our business and the level of spend needed, we expect to get leverage on our operating expense phase. So, that is really where when you look at your modeling for cash flows over time with growing revenues and operating expenses, growing at a lower rate than revenue, but still growing.

Got it okay.

Okay. So moving to your question on our commentary around.

Our level of investments obviously, we expect to continue to show progress. This year in terms of our operating expense leverage solid gross margins of the business and of course.

Looking to increase revenue as well as particularly in the second half of 2024, so looking into the future we expect to continue to be.

With growing revenues and operating expenses growing at a lower rate than revenue of course is still growing and then.

Alison Perry Bauerlein: And then small improvements in gross margin, although that's more incremental in nature, the real leverage to get to a cash flow break even is associated with op-ex spend. Okay, thanks so much. Thank you. One moment for our next question, please. And it comes from the line of Tom Stephan with TFL.

A small improvement on gross margin, although that's more incremental in nature, the real leverage to get to a cash flow breakeven is associated with opex.

Okay. Thanks, so much.

Thank you one moment for our next question. Please.

And it comes from the line of Tom Stefan with Stifel. Please proceed.

Thomas M. Stephan: Please proceed. Great. Hey, guys, thanks for the questions. To go back to the double-digit growth in 2025, Paul or Ali, could you possibly put a little bit of a finer point around what that might look like?

Great Hey, guys. Thanks for the questions.

Go back to the double digit growth in 2025.

Paul our alley.

Could you potentially.

A little bit of a finer point around what that might look like it'd be great to just hear your thoughts on sort of a targeted medium term growth rate.

Alison Perry Bauerlein: You know, it'd be great to just hear your thoughts on sort of a targeted medium-term growth rate as we look into the outcome. Yeah, I don't think we're prepared to give detailed guidance today on 2025. You know, we're still very early in 2024.

As we look into the out years.

Yes, I don't think we're prepared to give detailed guidance today on 2025, we are still very early in 2024, and I think we will want to also see real visibility on the opportunities for tier care in our business because that is a potential accelerant of our growth. So I think as we get.

Thomas M. Stephan: And I think we will want to also see real visibility on the opportunities for care in our business because that is a potential accelerant of our growth. So I think as we get farther into 2024 and really understand that opportunity, we'll be able to provide more guidance. But both of our markets are very large; there's huge potential for us on the standalone side and surgical glaucoma, continuing to take share in the combo cataract market. And then also on the dry eye side, with a really new interventional procedure that really should be a market that we can really create over time. So those are really the drivers.

Further into 2024, and really understand that opportunity will be able to provide more guidance, but both of our markets are very large there is huge potential for us.

On the Standalone side and surgical glaucoma.

<unk> to take share in the combo cataract market and then also on the dry eye side with really a new intervention all procedure that really should be a market that we can.

Really create over time so.

Those are really the drivers of course, we also have a small contributor associated with our <unk> business as well.

Alison Perry Bauerlein: Of course, we also have a small contributor associated with our OUS business as well. But we believe the US markets will be the primary growth driver for the foreseeable. Got it. That's helpful. And then, Allie, appreciate all the color on guys.

But we believe the U S market will be the primary growth driver for the foreseeable future for us.

Got it that's helpful and then.

Ali appreciate all the color on guidance.

Thomas M. Stephan: But I was wondering if maybe you could potentially give us a little bit more on the quarterly cadence. I know 2Q and 4Q have seasonal benefits, but I guess for 1Q specifically, how should we be thinking about revenue or growth? And then my tack on to that would just be, will there be any sort of, I guess call it, a stocking benefit to consider as customers work down inventory in the back from the last, last year? Yeah, sure. So taking the stocking question first, we really haven't seen material changes in stock prices yet. We've seen a return of regular ordering and improvement in utilization tied to procedure volume, but we haven't seen that uptick associated with just increasing their inventory levels. That may be something that we see in the future.

But I was wondering if maybe you could potentially give us a little bit more on the quarterly cadence I know <unk>.

Bears.

Seasonal benefit, but I guess for <unk>, specifically, how should we be thinking about revenue growth and then my tack onto that would just be will there be any sort of.

Call it a stocking benefit to consider as customers work down inventory in the back from blast.

Last year.

Yeah sure so taking the stocking question first.

Really haven't seen material changes in stocking yet we've seen a return of regular ordering and improvement of utilization tie to procedure volume, but we haven't seen that uptick associated with just increasing their inventory levels.

That may be something that we see in the future that's not something that inherently baked into guidance or we think would be.

Thomas M. Stephan: That's not something that we've inherently baked into guidance or that we think would be, you know, too material in nature, but that certainly is a potential that could occur at some point in time. In terms of the quarterly cadence, as we said, we do expect the first half to be down. Primarily, the second quarter is the biggest challenge from a comp perspective for us. So looking at the first quarter, with the increasing utilization and the recovery that we're seeing, typically, you would see Q1 down from Q4. I don't think that we'll see that this year.

Two material in nature, but that certainly is a potential that could occur at some point in time.

Down from Q4.

I don't think that we will see that this year it may be similar.

Alison Perry Bauerlein: It may be similar, but we do expect to see a nice start to the year, given the overall dynamics of usually utilization being down sequentially versus the first quarter. That's perfect. Thanks, and congratulations on the results. Thank you. Thank you. And as a reminder to ask a question, simply press star one one to get in the queue.

But we do expect to see nice start to the year.

Given those overall dynamics of usually utilization being down sequentially versus the fourth quarter.

That's perfect thanks, and congrats on the results.

Kim.

Thank you and as a reminder to ask a question simply press star one one to get in the queue. Our next question is from David Saxon with Needham and company. Please proceed.

David Joshua Saxon: Our next question is from David Saxon with Needham and Company. Please proceed. Oh, great. Good afternoon, Paul and Ali.

Great Good afternoon, Paul and Ali Thanks for taking my questions.

Matt Link: Thanks for taking my questions. I wanted to follow up on utilization specifically for the accounts that are coming back to Omni that maybe dropped off in the back half of last year. Are they going back to levels that they were at before? How's that typically trend? I know it's early days, still, but would love to kind of hear what you're saying there. Hi, this is Matt.

I wanted to.

A follow up on utilization specifically for the accounts that are coming back to omni that maybe dropped off in the back half of last year.

Going back to levels that they were at before.

How does that typically trend I know, it's early days still but would love to kind of hear what youre, saying there.

Hi, This is Matt I'll take that so.

David Joshua Saxon: I'll take that. So, as sort of reiterated in the earlier comments, I mean, it's obviously early, but I think we're encouraged by seeing a steady cadence of a return to more sort of natural ordering patterns. And so I think everybody could appreciate the uncertainty as to the final effective date of those LCDs, which obviously were fortunately ultimately withdrawn. There definitely were some efforts by accounts to manage inventory, ensuring that there wasn't excess inventory on the shelf.

As sort of reiterating the.

Earlier comments I mean, it's obviously early.

The uncertainty as to the final effective date of those Ltvs, which obviously, we're fortunately ultimate withdrawn.

David Joshua Saxon: And again, while I think our sales organization did a phenomenal job staying in front of our customers and supporting them through that period of uncertainty, it obviously contributed to a decline, not just in omni-utilization but maybe in general, in the second half and fourth quarter of last year. So, again, these are early, early days, but what we are seeing is a steady state of recovery trending towards what we anticipate will be more normal ordering patterns. And to the question around stocking, not so much bulk stocking, but again, a regular cadence of ordering, maintaining inventory in support of a broader utilization of Omni, and that's what we're building towards through the balance of equity. Okay, great. Thanks, Matt. Super helpful. And then I wanted to ask on dry eye, Ali, I think you said it's going to be down significantly. I guess, you know, what's assumed in terms of smart hub placements?

Inventory in support of a broader utilization of <unk> and that's what we're building towards through the balance of the year.

Okay, great. Thanks, that's Super helpful. And then I wanted to ask on dry eye Ali.

Ali I think you said, it's going to be down significantly.

I guess whats assumed in terms of smart hub placements are or is the sales force being incentivized.

Alison Perry Bauerlein: Is the salesforce being incentivized to, you know, put out new placements? Or is revenue essentially being driven just by the number of peer care consumed goals? And then just on the reimbursement front, you know, when you talk to your, I don't know, 370 or whatever it was, active accounts about reimbursement, what are they saying in terms of where that needs to shake out in order for it to be an attractive procedure? Thanks so much.

Put out new placements, whereas revenue SM.

Essentially being driven just by tier care consumables.

And then just on the reimbursement front.

When you talk to.

Your.

Through 70 or whatever it was active.

About reimbursement what are they saying.

In terms of where that needs to shake out in order for it to be unattractive procedure. Thanks, so much.

Alison Perry Bauerlein: Yeah, so looking at the peer care side of the business, and inherent in guidance, our 2024 guidance assumes that most of the revenue is coming from the sale of smart lids, and there is still a minimal number of new accounts being added, but that is significantly smaller than what we saw in 2023 and 2022. So that is the shift, and that is the reason that we expect to see the decline in revenue for that business, along with the resizing of the sales force that occurred in October. In terms of the 327 accounts that we had on the peer care side of the business in the fourth quarter, You know, we don't. We're still working with payers. It's too early for us to say what the appropriate reimbursement will be for that. We think we have a compelling value proposition, compelling clinical data, but those conversations are just starting really now. So to talk about pricing would be premature, but we know that the business model was already effective in a cash-pay market.

Yeah, So looking at the peer care side of the business and inherent in guidance.

Really our 2024 guidance assumes that most of the revenue was coming from the sale of Marc Litz and there is still a minimal number of new accounts being added but that is significantly smaller than what we saw in 2023 and 2022. So that is the shift and that is the <unk>.

And that we expect to see the decline in revenue.

That business along with the resizing of the sales force that occurred in October.

In terms of the.

At 327 accounts that we had on the tier care side of the business in the fourth quarter.

We don't.

Talk about pricing would be would be premature, but we know that already the business model was effective on a cash pay market.

Paul Badawi: So we think that there is a financial model that will work for us, will work for the patients, the providers, and, of course, our customers that are doing this. Yeah, I just want to add on the health economics front. We've prepared a very solid budget impact model for Tier Care, comparing the health economics of Tier Care to other prescription eyedrops like Restasis and others. And what the ultimate system savings would be; we submitted that budget impact model for presentation at the leading society meeting in this area, the International Society of Pharmacoeconomic and Outcomes Research. That will be presented in May in Atlanta. We're excited about that. The budget impact model should be submitted for publication very soon in a leading managed care journal. So between the Sahara six month data, and the Sahara 12 month data crossover, where all the Restasis patients were crossed over to Tier Care, got a single Tier Care treatment.

We think that there is a financial model that will work for us will work for the patients the providers and of course our customers.

That are doing those procedures.

Yes, I'd, just like to add to that.

On the health Economics front, we've prepared a very solid budget impact model for tier care, comparing the health economics of.

Tier care to other prescription eyedrops like Restasis and others.

And what the ultimate system savings would be.

Submitted that budget impact model for presentation at the leading society meeting in this area is for International Society of formal go economic and outcomes research.

That will be presented in may in Atlanta, we're excited about that the budget impact model should be submitted for publication very soon to leading managed care journal.

So between the Sahara six month data the Sahara 12 month data crossover, where all the restasis patients who crossed over to <unk> got a single tier care treatment and the compelling outcomes. We saw there that should hopefully soon also be published coupled with the budget impact model, coupled with our market access team across the country.

Paul Badawi: And the compelling outcomes we saw there that should hopefully soon also be published, coupled with the budget impact model, coupled with our market access team across the country, which is working with leading dry eye accounts and our sales team and providers and payers across the country, both commercial and Medicare. I'm very excited about what progress we're going to make this year on the reimbursement side. Patients need access to these treatments. They need reimbursed access.

Working with leading dry eye accounts, and our sales team and providers and payers across the country, both commercial and Mack.

Very excited about what.

David Joshua Saxon: We're creating a big new category and interventional dry eye. Great. Thank you so much.

Great. Thank you so much.

Operator: Thank you. One moment for our last question, please. And it comes from the line of Joanne Wensch with Citi. Please proceed. Good afternoon, this is Anthony on behalf of Joanne Wensch.

Thank you one moment for our last question. Please.

And it comes from the line of Joanne Wuensch with Citi. Please proceed.

Good afternoon. This is anthony on for Joanne Thanks for taking our questions.

Joanne Wench: Thanks for taking our questions. Just going back to guidance, I just want to clarify the guidance you put out on surgical glaucoma that assumes that reimbursement is essentially unchanged for the year. So there's no LCDs.

Just going back to the guidance I just want to clarify.

The guidance, you put out and surgical glaucoma that assumes that.

Reimbursement is.

Centrally unchanged for the year. So there's no LCD is.

Alison Perry Bauerlein: And then, in a dry eye, could you maybe just talk about what your expectations are going into 2025? Do you expect to start the year with a larger number of covered lives, or do you expect these two ones to be more on a rolling basis? Thank you. Yeah, inherent in the guidance is the assumption that we are in the current operating environment of LCD coverage, where Omni continues to have broad access and coverage in the market, which we think is fair and reasonable expectations for 2024. I'm sorry. What was the question?

And then drive could you maybe just talk about what your expectations are going into 2025 do you expect to start the year with a larger amount of covered lives.

These payer wins to be more on a rolling basis. Thank you.

Yes, so inherent in guidance is.

Under the assumption that we are in the current operating environment of LTE comprehends, where omni continues to have broad access and coverage in the market, which we think is fair and reasonable expectations for 2024.

Im sorry, what was from a tier care tier care perspective, the work I described earlier.

Paul Badawi: From a tier care perspective, the work I described earlier, our payer team is engaged. There's a lot of engagement with our providers and payers across the country, but right now, that's more on the claims level.

Our payer our payer team is engaged there is a lot of engagement with our providers and payers across the country right now thats more on the claims level, so working with providers and payers to ensure tier care claims get reimbursed appropriately.

Paul Badawi: So, working with providers and payers to ensure tier care claims get reimbursed appropriately. Over time, in parallel with that effort, our market access team will be working on coverage policies. Now, these policies have annual cycles, but we will be doing that work this year, engaging with payers on policy-type coverage discussions, and we'd expect to hopefully generate coverage policy wins in 2025.

Over time in parallel with that effort.

Our market access team will be working on coverage policies now these policies have annual cycles.

But we will be doing that work this year engaging with payers on policy type coverage discussions and we'd expect to hopefully generate coverage policy wins in 2025 at that point.

Paul Badawi: At that point, we have great expectations for the business. Great. Thank you. Thank you. And as a reminder, that is star 11 to get in the queue. One moment, please. I have a question from Margaret Andrew with William Blair.

We have great expectations for the business.

Great. Thank you.

And as a reminder, that is star one one to get into Q1 moment. Please.

I have a question from me.

Margaret Andrew with William Blair. Please your line is open.

Malgorzata Maria Kaczor Andrew: Please, your line is open. Hey, good afternoon, guys. Thanks for taking the questions. I wanted to maybe talk a little bit about some of the dynamics around getting formal coverage for canalplasty goniotomy.

Hey, good afternoon, guys. Thanks for taking the questions.

I wanted to maybe talk a little bit about some of the dynamics around getting formal coverage for canal classic Goniotomy.

Paul Badawi: You know, what steps have you taken at this point to kind of try to push that further and any kind of other updates that you can share on the LCDs in the last several months? Also, any expectations for when we might hear any updates would be helpful. Hi Margaret.

Steps have you taken at this point.

Kind of trying to push that further and any kind of other updates that you can share on the LCD is in the last several months.

Any expectations for when we might hear any update would be helpful. Thanks.

Hi, Margaret So just to quickly recap.

Paul Badawi: So just to quickly recap, what happened in the second half of 2023 was an opportunity for us to engage with the five MACs, help better educate them on sight sciences, on the omni-surgical system, on the comprehensive outflow procedure provided by the omni-surgical system, and the most importantly, compelling long-term clinical evidence that we've generated for OMNI over the years. At the end of the year, it culminated with two important developments. One, the publication of our even longer-term three-year prospective GemIIni study, as well as a meeting with the MACs following the Society's meeting with the MACs, which was another opportunity for us and our clinical stakeholders and a number of our glaucoma surgeon KOLs to help further educate the MACs on sight sciences, OMNI, and our clinical data. We've been able to follow up. We intend to stay engaged with payers throughout this year. We have followed up with five MACs.

What happened in the second half of 2023 with an opportunity for us to engage with with the five Max helped better educate them on site sciences on the omni surgical system on the comprehensive outflow procedure furnished by the army surgical system.

The most importantly compelling long term clinical evidence.

That we've generated for omni over the years.

The end of the year it culminated with two important developments.

The publication of our even longer term three year prospective Gemini study.

As well as our meeting with the Max following the societies meeting with the Max.

Which was another opportunity for us and our clinical stakeholders in a number of our glaucoma surgeon Kols to help help further educate the Max on on site Sciences, omni and our clinical data.

Malgorzata Maria Kaczor Andrew: In due course, we'll continue to engage with other payers, such as the other two MACs. And we believe, in addition to the clinical data that we provided throughout 2023, which was substantial, we're continuing to generate really meaningful clinical data this year, and we should expect to see a number of compelling publications I had mentioned earlier, such as Omni's results in ethnic minorities, a meta-analysis of Omni, which reaches a level of, you know, hopefully level one clinical evidence, long-term standalone Omni outcomes. So, with further clinical evidence and continued engagement with payers this year, we feel that we're very well prepared if and when LCDs are proposed. Okay, and then, you know, just to hit on the competitive standpoint one more time and relative to, you know, what's assumed in guidance both for this year as well as for next year. You know, what conversations are you guys having with clinicians and accounts in the field around using Omni for standalone cases? You're assuming utilization growth.

And we believe in addition to the clinical data that we had.

These results and ethnic minorities, a meta analysis of omni, which reaches the level of hopefully level, one clinical evidence a long term standalone omni outcomes.

So with with further clinical evidence continued engagement with the payers. This year, we feel that we're very well prepared if and when LCD or proposed again.

Okay.

Okay, and then just to hit on the competitive standpoint, one more time and relative to what's assumed in guidance both for this year as well.

For next year.

Conversations are you guys, having with clinicians and accounts in the field around using omni for Standalone cases, youre, assuming utilization growth clearly Europe.

Matt Link: So clearly, you're hopefully hearing that within the field from your accounts. Does competition come up at all? Do you guys feel a need to change any commercial strategy or, you know, what kind of assurances can you kind of give us of what you're hearing to support that utilization? Thanks, guys.

Hearing that within the field Premier accounts.

Competition come up at all do you guys feel a need to.

Change any commercial strategy.

Or what kind of assurances can you kind of gave us of what you're hearing.

Port that utilization growth thanks, guys.

Yes. This is Matt I appreciate the question.

Malgorzata Maria Kaczor Andrew: I appreciate the question. Maybe taking the second part of that question first, in terms of commercial strategy, we talked a bit about the restructuring of the organization in the second half of last year, and it really is intended to optimize our approach to the market as we continue to further segment the market based on the opportunities and given what we believe are unique opportunities for us, or that Sight Sciences is uniquely positioned for, given the comprehensive nature of Omni and the associated efficacy. So from a competition standpoint, from a sales perspective, I believe we're well positioned and strongly engaging the market and consistently receive the type of feedback we want to hear, given the comprehensive nature of Omni and its ability to treat glaucoma in both combination MIGs, as well as on a standalone basis. As it relates to standalone, we're obviously in an evolving marketplace, and so we see sort of a rapid expansion of the opportunity for interventional procedures, MIGs, in particular in the treatment of glaucoma, and ultimately standalone as a part of that.

Maybe taking the second part of that question first in terms of commercial strategy, we talked a bit about the restructuring of the organization in the second half of last year and it really is intended to optimize our approach to the market as we continue to further segment the market based on the opportunities and given what we believe are unique opportunities.

For us our best by Science is uniquely.

Positioned for given the comprehensive nature of omni and the associated efficacy. So from a competition standpoint from a sales perspective, I believe we are well positioned and strongly engaged in the market and consistently receive the type of feedback. We wanted here given the comprehensive nature of omni and its ability to treat.

Glaucoma and both combination Meg as well as in <unk> on a standalone basis.

As it relates to stand alone. We're obviously in a an evolving marketplace and so we see sort of a rapid expansion of the opportunity for interventional procedures Migs in particular in the treatment of glaucoma and ultimately standalone as a part of that and so given the comprehensive nature of omni the broad label in <unk>.

Matt Link: And so given the comprehensive nature of OMNI, the broad label, and our ability to pursue those opportunities, we see, we continue to see significant opportunity there. We see strong engagement from physicians broadly and physician advocates. But ultimately, that's something that we will continue to develop in the marketplace, and the market is receptive to that, again, with the evolution of this interventional mindset. So, you know, from a competitive standpoint, I'd say the market conditions seem consistent with prior periods, in which case, you know, Sight Sciences as an organization, and particularly OMNI, the procedure, I think it is well positioned to continue to compete effectively and take

<unk> to pursue those opportunities we see we continue to see significant opportunity there we see strong engagement from <unk>.

Physicians broadly and physician advocate, but ultimately that's something that we will continue to develop in.

In the marketplace and the market is receptive to that again with the evolution of this interventional mindset. So yes.

From a competitive standpoint, I'd say the market condition seem.

Consistent with prior periods in which case.

<unk> Sciences, as an organization and particularly on the procedure I think is well positioned to continue to compete effectively and take share.

Paul Badawi: And Margaret, we're in the, as you know, the very early days of standalone market development, while it's been growing and Omni's proven a very strong product market fit, leading in efficacy. It's early days, and we welcome, we welcome additional entrants who can help. Really, the challenge right now is changing the treatment paradigm. So moving from a medication mindset, maybe SLT, medication, and SLT, and patients are then progressing, adding another medication, a third medication, a fourth medication, and progressing, and ultimately needing an invasive procedure, we need to change the treatment paradigm to intervene in a minimally invasive but effective way sooner. There's a tremendous opportunity there, but it's going to take a lot of effort.

And Margaret we're in the as you know the very early days.

Standalone market development, while it's been growing in omnis proven a very strong product market fit.

Leading in efficacy.

It's early days and we welcome we welcome additional entrants who can help really the challenge right now is changing the treatment paradigm. So moving from a medication mindset may be S. LTE medications and esselte and patients are then progressing adding another medication or third medication.

Fourth medication and progressing and ultimately needing an invasive procedure.

We need to change the treatment paradigm to intervene in a minimally invasive but effective way sooner.

As a tremendous opportunity there it's going to take a lot of effort we've been over the past few years working on it we've been making progress we'd love for that progress will be accelerated with additional entrants and more people working to help change that mindset to change it from a <unk>.

Paul Badawi: We've been working on it for the past few years. We've been making progress. We'd love for that progress to be accelerated with additional entrants and more people working to help change that mindset to change it from a medication pharmaceutical disease to a surgical disease. And we just returned from the American Glaucoma Society meeting, and I can say the buzz there around interventional glaucoma, the desire for glaucoma specialists to lead the shift in this treatment paradigm towards minimally invasive earlier interventions. It's alive and well, and I expect the next few years to be very exciting.

<unk> pharmaceutical disease to a surgical disease and we just returned from the American American Glaucoma Society meeting and I can say the buzz there around interventions glaucoma the desire for glaucoma specialists to lead the shift in this treatment paradigm towards minimally invasive earlier interventions.

It's alive and well and I would expect the next few years to be very exciting.

Malgorzata Maria Kaczor Andrew: Great. Thanks, guys. Thank you. And I'm not asking any further questions at this time. I would like to turn the call back to Paul Badawi for final comments. Thank you for attending today's call. Coming into 2024, we have compelling commercial strategies for our two large market opportunities, robust clinical efficacy across our differentiated interventional portfolio, and an experienced management team ready to execute our plan. We look forward to engaging with the investment community around these exciting opportunities. Thank you. And with that, we thank you for participating, and you may now disconnect.

Great. Thanks, guys.

Thank you and I'm not showing any further questions at this time I would like to turn the call back to pull back for final comments.

Okay.

Thank you for attending today's call coming into 2024, we have compelling commercial strategies and our two large market opportunities robust clinical efficacy across our differentiated interventional portfolio and an experienced management team ready to execute our plan, we look forward to engaging with the investment community.

<unk> around these exciting opportunities. Thank you.

And with that we thank you for participating and you may now disconnect.

Q4 2023 Sight Sciences Inc Earnings Call

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