Q4 2025 Harrow Inc Earnings Call

March 3, 2026

Operator: Good day, welcome to the Harrow Q4 2025 Earnings Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there'll be a question-and-answer session. Please note that this call may be recorded. I would like to turn the call over to Mike Viega, Vice President, Investor Relations and Communications. Please go ahead.

Speaker #1: Please note that this call may be recorded. I would like to turn the call over to Mike Biega, Vice President of Investor Relations and Communications.

Speaker #1: Please go ahead. Good morning and welcome to Harrow's Fourth Quarter and Full Year 2025 earnings conference call. My name is Mike Biega, Vice President of Investor Relations and Communications and I'm excited to be introducing today's call.

Michael D. Biega: Good morning, and welcome to Harrow's Q4 and full year 2025 earnings conference call. My name is Mike Viega, Vice President of Investor Relations and Communications, and I'm excited to be introducing today's call. The company's remarks may include forward-looking statements within the meaning of federal securities laws. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond Harrow's control, including risks and uncertainties described from time to time in its SEC filings, such as the risks and uncertainties related to the company's ability to make commercially available its FDA-approved products and compounded formulations and technologies and FDA approval of certain drug candidates in a timely manner or at all. For a list and description of those risks and uncertainties, please see the Risk Factors section of the company's most recent annual report on Form 10-K filed with the Securities and Exchange Commission.

Speaker #1: The company's remarks may include forward-looking statements within the meaning of federal securities laws. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond Harrow's control, including risks and uncertainties described in time-to-time in its SEC filings, such as the risk and uncertainties related to the company's ability to make commercially available its FDA-approved products and compounded formulations and technologies and FDA approval of certain drug candidates in a timely manner or at all.

Speaker #1: For a list and description of those risks and uncertainties, please see the risk factors section of the company's most recent annual report on Form 10-K filed with the Securities and Exchange Commission.

Michael D. Biega: Harrow's results may differ materially from those projected. Harrow disclaims any intention or obligation to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information and is accurate only as of today. Joining me on today's call are Mark Baum, Chief Executive Officer, Andrew Boll, President and Chief Financial Officer, Patrick Sullivan, Chief Commercial Officer, and Amir Joda, Chief Scientific Officer. With that, I would like to turn the call over to Mark. Mark.

Speaker #1: Harrow's results may differ materially from those projected. Harrow disclaims any intention or obligation to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise.

Speaker #1: This conference call contains time-sensitive information and is accurate only as of today. Joining me on today's call are Mark Baum, Chief Executive Officer; Andrew Boll, President and Chief Financial Officer; Patrick Sullivan, Chief Commercial Officer; and Amir Jodayi, Chief Scientific Officer.

Speaker #1: With that, I would like to turn the call over to Mark. Mark? Good morning, and thank you for joining us. Over the past five years, Harrow has undergone a fundamental transformation.

Mark Baum: Good morning, and thank you for joining us. Over the past five years, Harrow has undergone a fundamental transformation. Harrow now owns one of the largest portfolios of prescription ophthalmic products in the United States market. We have been the most prolific acquirer of ophthalmic pharmaceutical products in the US market, having completed more than a half a dozen transactions, integrating over 15 branded products into our scalable commercial platform that reaches every populated county within the United States and touches with impact nearly every key ophthalmic disease segment. As you'll note in my letter to stockholders, I am proud of the fact that during the last five years, hundreds of members of the Harrow family, including my incredible leadership team, drove real economic accomplishment and stockholder value creation, which resulted in a more than 700% appreciation in the Harrow stock price during this period.

Speaker #1: Harrow now owns one of the largest portfolios of prescription ophthalmic products in the United States market, and we have been the most prolific acquirer of ophthalmic pharmaceutical products in the US market, having completed more than a half a dozen transactions integrating over 15 branded products into our scalable commercial platform that reaches every population county within the United States and touches with impact nearly every key ophthalmic disease segment.

Speaker #1: As you'll note, in my letter to stockholders, I am proud of the fact that during the last five years, hundreds of members of the Harrow family, including my incredible leadership team, drove real economic accomplishment and stockholder value creation, which resulted in a more than 700% appreciation in the Harrow stock price during this period.

Speaker #1: As a founder and a large Harrow shareholder, I am proud of our track record and the returns we are providing to stockholders who have had the patience to let this team do its thing.

Mark Baum: As a founder and a large Harrow shareholder, I am proud of our track record and the returns we are providing to stockholders who have had the patience to let this team do its thing. This team isn't done, and frankly, we've only just begun. I can't guarantee where our stock price will be five years from now. However, I can say with nearly absolute certainty that Harrow will be a larger and more powerful enterprise, positively impacting the lives of millions of Americans. I resolutely believe that then we will be selling more of every one of our key products like VEVYE, IHEEZO, and TRIESENCE. I predict we will also sell many more units of other products that many stockholders haven't thought too much about.

Speaker #1: But this team isn't done, and frankly, we've only just begun. I can't guarantee where our stock price will be five years from now; however, I can say with nearly absolute certainty that Harrow will be a larger and more powerful enterprise positively impacting the lives of millions of Americans.

Speaker #1: I resolutely believe that then we will be selling more of every one of our key products like Vivi, IHESO, and Triessence. But I predict we will also sell many more units of other products than many stockholders haven't thought too much about.

Speaker #1: I also predict that we will complete compelling new acquisitions of products and/or businesses structured to appropriately balance risk and potential reward. And finally, I can say confidently that one or two product candidates from our recent Melt Pharmaceuticals acquisition, specifically what we are now calling G-Melt, and Yocho, will be approved for marketing.

Mark Baum: I also predict that we will complete compelling new acquisitions of products and or businesses structured to appropriately balance risk and potential reward. Finally, I can say confidently that one or two product candidates from our recent Melt Pharmaceuticals acquisition, specifically what we are now calling G-MELT and YOCHIL, will be approved for marketing, and that if they are coded and reimbursed in the way that we expect, they will make massive improvements to the standard of care in ocular surgery and more generally in the lives of so many Americans in need of an alternative to IV and opioid-based medicaments for sedation and anxiety. It's a very large market. Of course, these assets, as I reflected in my letter to stockholders, should in due course become our largest revenue products.

Speaker #1: And that if they are coded and reimbursed in the way that we expect, they will make massive improvements to the standard of care and ocular surgery and, more generally, in the lives of so many Americans in need of an alternative to IV and opioid-based medicaments for sedation, and anxiety.

Speaker #1: It's a very large market. And of course, these assets, as I reflected in my letter to stockholders, should and do course become our largest revenue products.

Speaker #1: My bet is that if we do all of that, and maybe even a little bit more, patient stockholders should be handsomely rewarded. I invite you to join me for the ride, because our best days are absolutely ahead of us.

Mark Baum: My bet is that if we do all of that and maybe even a little bit more, patient stockholders should be handsomely rewarded. I invite you to join me for the ride because our best days are absolutely ahead of us. Now, let me provide a bit of color on our business as things stand today. We are entering the final phase of our current five-year plan, and we are doing so with momentum. The portfolio we've assembled, the pipeline we've advanced, and the commercial infrastructure we've built were designed for scale. This is not a single product company or a single product story. We are meaningfully diversified, and our commercial platform is built for durability, operating leverage, and sustained growth. Today, Harrow operates as one Harrow, one strategy, one commercial engine, one unified organization.

Speaker #1: Now, let me provide a bit of color on our business as things stand today. We are entering the final phase of our current five-year plan, and we are doing so with momentum.

Speaker #1: The portfolio we've assembled, the pipeline we've advanced, and the commercial infrastructure we've built were designed for scale. This is not a single-product company or a single-product story.

Speaker #1: We are meaningfully diversified, and our commercial platform is built for durability, operating leverage, and sustained growth. Today, Harrow operates as one Harrow, one strategy, one commercial engine, one unified organization.

Speaker #1: We have constructed a diversified ophthalmic franchise focused on expanding patient access, improving affordability, and delivering strong clinical outcomes. In the fourth quarter of 2025, we saw clear validation of that strategy.

Mark Baum: We have constructed a diversified ophthalmic franchise focused on expanding patient access, improving affordability, and delivering strong clinical outcomes. In Q4 of 2025, we saw clear validation of that strategy. For the first time, all of our core growth drivers accelerated simultaneously. That alignment reinforces our confidence and supports our goal of exceeding $250 million in quarterly revenue by the end of 2027. Financially, 2025 was a strong year. We delivered great top-line growth and demonstrated operating leverage, underscoring the earnings power embedded in our model as revenue scales. Let me briefly highlight some of the key drivers. VEVYE is positioned for revenue acceleration and increasing new prescription velocity.

Speaker #1: For the first time, all of our core growth drivers accelerated simultaneously. That alignment reinforces our confidence and supports our goal of exceeding 250 million dollars in quarterly revenue by the end of 2027.

Speaker #1: Financially, 2025 was a strong year. We delivered great top-line growth and demonstrated operating leverage, underscoring the earnings power embedded in our model as revenue scales.

Speaker #1: Let me briefly highlight some of the key drivers. Vivi is positioned for revenue acceleration and increasing new prescription velocity. Expanded payer coverage is now in effect, so we are doubling the Vivi sales force to ensure that we fully capture the opportunity to build a product with peak sales potential of multiples of last year's numbers.

Mark Baum: Expanded payer coverage is now in effect, we are doubling the VEVYE sales force to ensure that we fully capture the opportunity to build a product with peak sales potential of multiples of last year's numbers. More sales professionals will equal more prescriptions, and this should correlate to increasing profitable revenue growth. Our data backs this up. With covered patients averaging approximately 9 refills annually, effectively a full year of therapy, this reinforces the durability of the demand for VEVYE. As access continues to expand and commercial intensity increases, we expect total prescription growth to continue this year and for many years to come as VEVYE finally becomes a 9-figure revenue product this year. IHEEZO delivered a record quarter driven by real traction in a growing number of retina specialists' offices.

Speaker #1: More sales professionals will equal more prescriptions, and this should correlate to increasing profitable revenue growth. Our data backs this up. With covered patients averaging approximately nine refills annually, effectively a full year of therapy, this reinforces the durability of the demand for Vivi.

Speaker #1: As access continues to expand and commercial intensity increases, we expect total prescription growth to continue this year and for many years to come, as Vivi finally becomes a nine-figure revenue product this year.

Speaker #1: IHESO delivered a record quarter, driven by real traction and a growing number of retina specialists' offices. We have broadened our addressable market by focusing on in-office procedures, effectively increasing our procedure volume TAM by more than two and a half million units annually.

Mark Baum: We have broadened our addressable market by focusing on in-office procedures, effectively increasing our procedure volume TAM by more than 2.5 million units annually. We're also expecting IHEEZO price improvements to begin in the second half of this year as we release a new retina-focused packaging format. At around the same time, we expect retina-specific data readouts from studies underway to show from a patient's perspective the difference between IHEEZO and legacy anesthesia modalities. This is only going to help us, we believe. We got to see what the data says. These 2026 activities should further enhance financial performance. With multiple growth levers now in place, IHEEZO represents a durable and critical part of our long-term strategy. TRIESENCE generated its strongest quarter since relaunch, reflecting accelerating adoption in the very large ocular inflammation market.

Mark Baum: We have broadened our addressable market by focusing on in-office procedures, effectively increasing our procedure volume TAM by more than 2.5 million units annually. We're also expecting IHEEZO price improvements to begin in the H2 of this year as we release a new retina-focused packaging format. At around the same time, we expect retina-specific data readouts from studies underway to show from a patient's perspective the difference between IHEEZO and legacy anesthesia modalities. This is only going to help us, we believe. We got to see what the data says. These 2026 activities should further enhance financial performance. With multiple growth levers now in place, IHEEZO represents a durable and critical part of our long-term strategy. TRIESENCE generated its strongest quarter since relaunch, reflecting accelerating adoption in the very large ocular inflammation market.

Speaker #1: We're also expecting IHESO price improvements to begin in the second half of this year. As we release a new retina-focused packaging format, at around the same time, we expect retina-specific data readouts from studies underway to show, from a patient's perspective, the difference between IHESO and legacy anesthesia modalities.

Speaker #1: This is only going to help us, we believe. We got to see what the data says. These 2026 activities should further enhance financial performance and, with multiple growth levers now in place, IHESO represents a durable and critical part of our long-term strategy.

Speaker #1: Triessence generated its strongest quarter since relaunch, reflecting accelerating adoption and the very large ocular inflammation market. Based on what I am seeing this quarter, with new account trials starting and numerous potentially very large accounts and growing confidence in market access, I have asked our talent team to at least double.

Mark Baum: Based on what I am seeing this quarter, with new account trials starting in numerous potentially very large accounts and growing confidence in market access, I have asked our talent team to at least double the dedicated TRIESENCE sales force to deepen penetration in what remains a very large market. Momentum here is early, but it looks meaningful. Because of the origin of the revenue, it is likely highly sustainable. It's not easy to get a product like TRIESENCE added to a surgical treatment protocol. Once you do, and I have seen this happen many times over the years, if the product delivers exceptional outcomes, as TRIESENCE appears to be doing, then surgeons are often reticent to change. This is what I mean by the sustainability of the TRIESENCE momentum. On a related topic, for years, I've spoken about tracking the migration of elite sales representatives.

Speaker #1: The dedicated Triessence sales force to deepen penetration in what remains a very large market. Momentum here is early, but it looks meaningful. And because of the origin of the revenue, it is likely highly sustainable.

Speaker #1: It's not easy to get a product like Triessence added to a surgical treatment protocol, but once you do, and I have seen this happen many times over the years, if the product delivers exceptional outcomes, as Triessence appears to be doing, then surgeons are often reticent to change.

Speaker #1: This is what I mean by the sustainability of the Triessence momentum. On a related topic, for years, I've spoken about tracking the migration of elite sales representatives.

Speaker #1: This is nearly a surefire leading indicator of future success. You see, sales reps go where they can win, where they can make money, and provide for themselves and their families.

Mark Baum: This is nearly a surefire leading indicator of future success. You see, sales reps go where they can win, where they can make money and provide for themselves and their families. Well, the word is getting out that TRIESENCE is on the move. These elite reps from around the country are hearing about our commitment to this product, they know they will also be selling the G-MELT too, if they can make it onto our team. A lot of folks want to get in on the G-MELT, believe me. We are seeing a mushrooming inbound interest from some of the most prolific ocular surgery pharmaceutical representatives who want to take these coveted surgical positions at Harrow on the TRIESENCE team. This is really good news. Now on to our rare specialty and compounded products.

Speaker #1: Well, the word is getting out, the Triessence is on the move. These elite reps from around the country are hearing about our commitment to this product and they know they will also be selling the Gmail too if they can make it onto our team.

Speaker #1: A lot of folks want to get in on the Gmail, believe me. So we are seeing a mushrooming inbound interest from some of the most prolific ocular surgery pharmaceutical representatives who want to take these coveted surgical positions at Harrow on the Triessence team.

Speaker #1: This is really good news. Now, onto our rare specialty and compounded products. Behind the scenes, believe it or not, we've been planning a few positive surprises for our stockholders.

Mark Baum: Behind the scenes, believe it or not, we've been planning a few positive surprises for our stockholders from the part of our portfolio they would probably least expect. Yes, our rare specialty and compounded products. This portfolio is now under new sales leadership. It will benefit from new resources we are providing to finally wring out the value we expect from this exciting and unique group of products. As I discussed more in my letter to stockholders, there are 3 products from within this portfolio that our team has been quietly doing great work on. One product is awaiting a coding decision from CMS, which we expect in April. There are no guarantees, but if this comes through next month, it will open up a very nice, attractive market for this product.

Speaker #1: From the part of our portfolio they would probably least expect—yes, our rare specialty and compounded products. This portfolio is now under new sales leadership, and it will benefit from new resources we are providing to finally wring out the value we expect from this exciting and unique group of products.

Speaker #1: As I discuss more in my letter to stockholders, there are three products from within this portfolio that our team has been quietly doing great work on.

Speaker #1: One product is awaiting a coding decision from CMS, which we expect in April. There are no guarantees, but if this comes through next month, it will open up a very nice attractive market for this product.

Speaker #1: Regarding another product in this portfolio, we have a key study underway that we expect to read out later this year. Our entire team is super excited about this opportunity.

Mark Baum: Regarding another product in this portfolio, we have a key study underway that we expect to read out later this year. Our entire team is super excited about this opportunity. This is a big one. Based on what we know about this product, we expect the study to be able to highlight the opportunity that we have uncovered, and once the data is announced, it should fuel opening up, as I said, a very sizable and compelling market for this product. In fact, we are also simultaneously working out supply chain issues to ensure that if things work out the way we expect, that we'll be able to supply the market adequately given the historically lower volumes that this product has required.

Speaker #1: This is a big one. And based on what we know about this product, we expect the study to be able to highlight the opportunity that we have uncovered and, once the data is announced, it should fuel opening up, as I said, a very sizable and compelling market for this product.

Speaker #1: In fact, we are also simultaneously working out supply chain issues to ensure that, if things work out the way we expect, we'll be able to supply the market adequately, given the historically lower volumes that this product has required.

Speaker #1: And there is a third product that we expect to be revived from this portfolio, to also fill yet another nice but happens to be a smaller market opportunity.

Mark Baum: There is a third product that we expect to be revived from this portfolio to also fill yet another nice, but happens to be a smaller market opportunity, but a good one nevertheless. The bottom line is that I believe our stockholders may be positively surprised throughout the year and into next year as our plans for this portfolio are revealed. A few final points. In 2026, we will also launch two important products BYQLOVI and BYOOVIZ, further expanding our retina and specialty footprint and leveraging our commercial platform. Beyond commercialization, our pipeline continues to advance, and Amir will shortly speak about the great work he and his team are doing. In summary, Harrow is a diversified ophthalmic platform with multiple accelerating growth drivers and increasing operating leverage.

Speaker #1: But a good one, nevertheless. The bottom line is that I believe our stockholders may be positively surprised throughout the year and into next year as our plans for this portfolio are revealed.

Speaker #1: A few final points. In 2026, we will also launch two important products by Clovey and Bioviz. Further expanding our retina and specialty footprint and leveraging our commercial platform.

Speaker #1: Beyond commercialization, our pipeline continues to advance and Amir will shortly speak about the great work he and his team are doing. In summary, Harrow is a diversified ophthalmic platform with multiple accelerating growth drivers and increasing operating leverage we have demonstrated the ability to build, integrate, and grow and generate a heck of a great return for our patient stockholders as our five-year track record demonstrates.

Mark Baum: We have demonstrated the ability to build, integrate, and grow, and generate a heck of a great return for our patient stockholders as our five-year track record demonstrates. As I said at the outset, I really believe that we are still in the early innings of our growth and stockholder value creation story. With that said, I will turn it over to Andrew. Andrew?

Speaker #1: But as I said at the outset, I really believe that we are still in the early innings of our growth and stockholder value creation story.

Speaker #1: With that said, I will turn it over to Andrew. Andrew?

Speaker #2: Good morning, everyone. I'll begin with our fourth quarter and full year 2025 financial results. For the fourth quarter of 2025, consolidated revenues were $89.1 million, representing 33% year-over-year growth.

Andrew R. Boll: Good morning, everyone. I'll begin with our Q4 and full year 2025 financial results. For Q4 of 2025, consolidated revenues were $89.1 million, representing 33% year-over-year growth. For the full year, revenue was $272 million, up 36% versus 2024. The growth reflected continued strength across our brand portfolio and expanding commercial execution, particularly in the second half of the year. Adjusted EBITDA was $24.2 million in Q4 and $61.9 million for the full year, reflecting 54% year-over-year growth. This margin expansion demonstrates the operating leverage in our model as revenue scales faster than costs, even as we continue investing in commercialization and R&D.

Andrew R. Boll: Good morning, everyone. I'll begin with our Q4 and full year 2025 financial results. For Q4 of 2025, consolidated revenues were $89.1 million, representing 33% year-over-year growth. For the full year, revenue was $272 million, up 36% versus 2024. The growth reflected continued strength across our brand portfolio and expanding commercial execution, particularly in the H2 of the year. Adjusted EBITDA was $24.2 million in Q4 and $61.9 million for the full year, reflecting 54% year-over-year growth. This margin expansion demonstrates the operating leverage in our model as revenue scales faster than costs, even as we continue investing in commercialization and R&D.

Speaker #2: For the full year, revenue was 272 million dollars up 36% versus 2024. Gross reflected continued strength across our brand portfolio and expanding commercial execution.

Speaker #2: Particularly in the second half of the year. Adjusted EBITDA was 24.2 million in Q4 and 61.9 million for the full year, reflecting 54% year-over-year growth.

Speaker #2: This margin expansion demonstrates the operating leverage in our model, as revenue scales faster than costs, even as we continue investing in commercialization and R&D.

Speaker #2: In addition, during 2025, we generated just under $44 million of cash from operations, which helped us end the year with $72.9 million in cash and cash equivalents.

Andrew R. Boll: In addition, during 2025, we generated just under $44 million of cash from operations, which helped us end the year with $72.9 million in cash and cash equivalents. Overall, 2025 was a year of strong execution, improving profitability, and disciplined capital allocation. Moving on to our core growth drivers. Starting with VEVYE, Q4 revenues were $25.9 million, up 14% sequentially, bringing full-year revenue to $88.7 million, a 216% increase over 2024. Growth reflects expanding demand. IHEEZO generated $35.9 million in Q4 and $81.3 million for the full year, representing 64% quarter-over-quarter growth and 65% year-over-year growth. Performance was driven by increasing penetration across new and existing accounts, particularly in Retina.

Speaker #2: Overall, 2025 was a year of strong execution, improving profitability, and disciplined capital allocation. Moving on to our core growth drivers. Starting with Vivi, fourth quarter revenues were 25.9 million dollars up 14% sequentially, bringing full-year revenue to 88.7 million, a 216% increase over 2024.

Speaker #2: Gross reflects expanding demand. IHESO generated $35.9 million in Q4 and $81.3 million for the full year, representing 64% quarter-over-quarter growth and 65% year-over-year growth.

Speaker #2: Performance was driven by increasing penetration across new and existing accounts, particularly in retina. Based on the momentum we are seeing with Triessence and other modest investments we intend to make in this franchise, we are disclosing this revenue separately for the first time.

Andrew R. Boll: Based on the momentum we are seeing with TRIESENCE and other modest investments we intend to make in this franchise, we are disclosing this revenue separately for the first time. TRIESENCE Q4 revenue was $5.1 million, a 36% increase from Q3, totaling $9.9 million for the year, a 193% increase from 2024. The growth was primarily driven by accelerating adoption of TRIESENCE and ocular inflammation. Our rare specialty and compounded portfolio generated $22.2 million in Q4 and $92.3 million for the full year. The temporary compounding inventory constraint discussed last quarter is expected to be resolved in the coming weeks, and we expect inventory levels to normalize near the end of Q1. We do not anticipate a recurrence of this issue.

Speaker #2: Triessence fourth quarter revenue was 5.1 million dollars, a 36% increase from the third quarter, totaling 9.9 million for the year, a 193% increase from 2024.

Speaker #2: The growth was primarily driven by accelerating adoption of Triessence Inocular Inflammation. Our rare specialty and compounding portfolio generated $22.2 million in Q4 and $92.3 million for the full year.

Speaker #2: The temporary compounding inventory constraint discussed last quarter is expected to be resolved in the coming weeks, and we expect inventory levels to normalize near the end of the first quarter.

Speaker #2: We do not anticipate a recurrence of this issue. For 2026, we are approaching guidance with greater transparency and structure, and are committed to providing greater insight into the seasonality of our business and how we expect performance to build throughout the year.

Andrew R. Boll: For 2026, we are approaching guidance with greater transparency and structure and are committed to providing greater insight into the seasonality of our business and how we expect performance to build throughout the year. We expect full year 2026 revenue between $350 million and $365 million. For modeling purposes, we currently expect first half revenue in the range of $133 million to $153 million, and the second half revenue in the range of $203 million to $226 million, reflecting the expected phasing of demand, channel dynamics, and launch timing across the year. Adjusted EBITDA is expected to be between $80 million to $100 million for the full year, with the majority of the EBITDA generated in the second half of 2026.

Andrew R. Boll: For 2026, we are approaching guidance with greater transparency and structure and are committed to providing greater insight into the seasonality of our business and how we expect performance to build throughout the year. We expect full year 2026 revenue between $350 million and $365 million. For modeling purposes, we currently expect first half revenue in the range of $133 million to $153 million, and the H2 revenue in the range of $203 million to $226 million, reflecting the expected phasing of demand, channel dynamics, and launch timing across the year. Adjusted EBITDA is expected to be between $80 million to $100 million for the full year, with the majority of the EBITDA generated in the H2 of 2026.

Speaker #2: We expect full year 2026 revenue between 350 million and 365 million dollars. For modeling purposes, we currently expect first-half revenue in the range of 133 million to 153 million dollars, and the second half revenue in the range of 203 million dollars to 226 million, reflecting the expected phasing of demand channel dynamics and launch timing across the year.

Speaker #2: Adjusted EBITDA is expected to be between 80 million to 100 million dollars for the full year, with a majority of the EBITDA generated in the second half of 2026.

Speaker #2: As in prior years, the second half is expected to be stronger, with that weighting being more pronounced in 2026. Historically, quarterly revenue patterns have been consistent.

Andrew R. Boll: As in prior years, the second half is expected to be stronger, with that weighting being more pronounced in 2026. Historically, quarterly revenue patterns have been consistent, though 2026 will be slightly more second half weighted. Like the past two years, Q1 is expected to be our lowest revenue quarter, primarily due to stocking activity from Q4 and insurance resets and a higher concentration of high-deductible plans. The estimated Q4 demand for IHEEZO resulted in approximately one and a half quarters of incremental inventory being built across the channel. That inventory is expected to be drawn down largely during Q1. As a result, although we are seeing demand grow for IHEEZO similar to Q1 of 2025, because we are drawing down on Q4 2025 inventory within the channel, we do not anticipate meaningful IHEEZO revenue in Q1.

Andrew R. Boll: As in prior years, the H2 is expected to be stronger, with that weighting being more pronounced in 2026. Historically, quarterly revenue patterns have been consistent, though 2026 will be slightly more H2 weighted. Like the past two years, Q1 is expected to be our lowest revenue quarter, primarily due to stocking activity from Q4 and insurance resets and a higher concentration of high-deductible plans. The estimated Q4 demand for IHEEZO resulted in approximately one and a half quarters of incremental inventory being built across the channel. That inventory is expected to be drawn down largely during Q1. As a result, although we are seeing demand grow for IHEEZO similar to Q1 of 2025, because we are drawing down on Q4 2025 inventory within the channel, we do not anticipate meaningful IHEEZO revenue in Q1.

Speaker #2: Though 2026 will be slightly more second-half weighted. Like the past two years, the first quarter is expected to be our lowest revenue quarter, primarily due to stocking activity from the fourth quarter and insurance resets, and a higher concentration of high-deductible plans.

Speaker #2: We estimated fourth quarter demand for IHESO resulted in approximately one and a half quarters of incremental inventory being built across the channel. That inventory is expected to be drawn down largely during Q1.

Speaker #2: As a result, although we are seeing demand grow for IHESO, similar to the first quarter of 2025, because we are drawing down on Q4 2025 inventory within the channel, we do not anticipate meaningful IHESO revenue in the first quarter.

Andrew R. Boll: VEVYE entered the year with expanded coverage effective 1 January. While we expect improved access will increasingly drive prescription growth throughout the year, the Q1 typically reflects an increased mix of high-deductible plans, which creates near-term pressure for VEVYE and our branded portfolio. The financial impact of the coverage win will start to be more pronounced as the year progresses and once our expanded sales force is fully deployed. We typically operate with a disciplined, methodical approach to spend, and we have done that for a reason: to protect profitability, drive ROI, and preserve strong cash flow. This year, however, we see a clear opportunity to maintain that discipline while increasing the pace and level of investment to expand our revenue base for years to come.

Speaker #2: Vivi entered the year with expanded coverage effective January 1, while we expect improved access will increasingly drive prescription growth throughout the year, the first quarter typically reflects an increased mix of high-deductible plans, which creates near-term pressure for Vivi and our brand portfolio.

Speaker #2: The financial impact of the coverage will start to be more pronounced as the year progresses, and once our expanded sales force is fully deployed.

Speaker #2: We typically operate with a disciplined methodical approach to spend, and we have done that for a reason. To protect profitability, drive ROI, and preserve strong cash flow.

Speaker #2: This year, however, we see a clear opportunity to maintain that discipline while increasing the pace and level of investment to expand our revenue base for years to come.

Speaker #2: As a result, we expect SG&A to increase to approximately 185 million to 205 million dollars in the year, as we expand our sales force across our major products and categories.

Andrew R. Boll: As a result, we expect SG&A to increase to approximately $185 million to 205 million in the year as we expand our sales force across our major products and categories, including VEVYE and TRIESENCE, and prepare to support the launches of BYOOVIZ and BYQLOVI. We plan to add roughly 100 new sales roles in the first half of the year, and we'll pair that with increased promotional and marketing investment to drive awareness, adoption, and sustained growth in the back half of the year and into 2027. Importantly, even as we invest, we will continue to manage expenses with a careful eye toward profitability and cash flow, holding ourselves accountable to returns and managing the spend accordingly.

Speaker #2: Including Vivi and Triessence, and preparing to support the launches of Biovis and Biclovy. We plan to add roughly 100 new sales roles in the first half of the year, and we'll pair that with increased promotional and marketing investment to drive awareness, adoption, and sustained growth in the back half of the year and into 2027.

Speaker #2: Importantly, even as we invest, we will continue to manage expenses with a careful eye toward profitability and cash flow. Holding ourselves accountable to returns and managing the spend accordingly.

Speaker #2: We also expect R&D expenses to increase this year to approximately 30 million to 35 million dollars, as we complete studies required for the product candidate's NDA submissions, and as we invest in post-market studies at a mirror we'll discuss later.

Andrew R. Boll: We also expect R&D expenses to increase this year to approximately $30 million to $35 million as we complete studies required for the product candidates NDA submissions and as we invest in post-market studies that Amir will discuss later. Efforts we believe can support near and long-term growth across key products. Looking to Q2, we expect IHEEZO will lose pass-through status effective 1 April, impacting the ASC market. Approximately 30% of 2025 units were generated in the ASC setting. We've been preparing for this transition through our retina pivot in 2024 and the recently announced in-office expansion strategy, which, as Mark said, added about 2.5 million annual procedures to our TAM. The continued growth in retina and the in-office utilization is expected to offset and ultimately exceed the ASC impact.

Speaker #2: Efforts we believe can support near and long-term growth across key products. Looking to the second quarter, we expect IHESO will lose path through status effective April 1, impacting the ASC markets.

Speaker #2: Approximately 30% of 2025 units were generated in the ASC setting. We've been preparing for this transition through our retina pivot in 2024, and the recently announced in-office expansion strategy, which, as Mark said, added about 2.5 million annual procedures to our TAM.

Speaker #2: The continued growth in retina and the in-office utilization is expected to offset and ultimately exceed the ASC impact. We also plan to launch Biclovy in Q2, which will support incremental growth in our specialty portfolio.

Andrew R. Boll: We also plan to launch BYQLOVI in Q2, which will support incremental growth in our specialty portfolio. Looking at Q3. We typically experience some late summer softness due to both doctors, staff, and patients going on vacation. Q3 will include the first full quarter of BYOOVIZ revenue contribution, which should provide incremental growth. We are anticipating that IHEEZO will also catch some of the additional tailwind as a complementary product to BYOOVIZ. Beginning in Q3, we expect to start to see the impact of our expanded and fully deployed VEVYE and TRIESENCE sales force driving growth for both products. Starting in Q3, we are expecting a pricing improvement for IHEEZO to go into effect.

Speaker #2: Now looking at the third quarter. We typically experience some late summer softness due to both doctors, staff, and patients going on vacations. The third quarter will include the first full quarter of Biovis revenue contribution.

Speaker #2: Which should provide incremental growth. We are anticipating that IHESO will also catch some of the additional tailwinds as a complementary product to Biovis. In addition, beginning in the third quarter, we expect to start to see the impact of our expanded and fully deployed Vivi and Triessence sales force.

Speaker #2: Driving growth for both products. Also, starting in the third quarter, we're expecting a pricing improvement for IHESO to go into effect. When you combine that with the continued retina growths, IHESO will have a strong second half of 2026 and position us very well for 2027.

Andrew R. Boll: When you combine that with the continued retina growth and the in-office expansion, we expect IHEEZO to have a strong second half of 2026 and position us very well for 2027. Q4 should remain our strongest quarter, driven by demand patterns, stocking activity, and patients reaching out-of-pocket maximums. Finally, as Mark discussed in his letter, as we intentionally transition compounded volume to FDA-approved branded alternatives, shifting revenue into our specialty portfolio, we expect compounded revenue to be approximately $60 million to $65 million for the full year, with Q1 the softest quarter as we exit the final stages of the inventory shortage. In summary, we expect a softer first half as we work through channel inventory, absorb the ASC transition, and navigate seasonal deductible dynamics.

Andrew R. Boll: When you combine that with the continued retina growth and the in-office expansion, we expect IHEEZO to have a strong H2 of 2026 and position us very well for 2027. Q4 should remain our strongest quarter, driven by demand patterns, stocking activity, and patients reaching out-of-pocket maximums. Finally, as Mark discussed in his letter, as we intentionally transition compounded volume to FDA-approved branded alternatives, shifting revenue into our specialty portfolio, we expect compounded revenue to be approximately $60 million to $65 million for the full year, with Q1 the softest quarter as we exit the final stages of the inventory shortage. In summary, we expect a softer first half as we work through channel inventory, absorb the ASC transition, and navigate seasonal deductible dynamics.

Speaker #2: The fourth quarter should remain our strongest quarter, driven by demand patterns, stocking activity, and patients reaching out-of-pocket maximums. Finally, as Mark discussed in his letter, as we intentionally transition compounded volume to FDA-approved branded alternatives, shifting revenue into our specialty portfolio, we expect compounded revenue to be approximately 60 million to 65 million dollars for the full year, with Q1 the softest quarter, as we exit the final stages of the inventory shortage.

Speaker #2: In summary, we expect a softer first half as we work through channel inventory, absorb the ASC transition, and navigate seasonal deductible dynamics. In the second half, we expect meaningful acceleration, driven by a fully deployed Vivi and Triessence sales force, contributions from Biovis and Biclovy, improved IHESO pricing, expanding retina and in-office adoption, and incremental contribution from specialty products.

Andrew R. Boll: In the second half, we expect meaningful acceleration driven by a fully deployed VIVAI and TRIESENCE sales force, contributions from BYOOVIZ and BYQLOVI, improved IHEEZO pricing, expanding retina and in-office adoption, and incremental contribution from specialty products. I'll turn the call over to Pat Sullivan.

Andrew R. Boll: In the H2, we expect meaningful acceleration driven by a fully deployed VIVAI and TRIESENCE sales force, contributions from BYOOVIZ and BYQLOVI, improved IHEEZO pricing, expanding retina and in-office adoption, and incremental contribution from specialty products. I'll turn the call over to Pat Sullivan.

Speaker #2: Now I'll turn the call over to Pat Sullivan.

Speaker #1: Thank you, Andrew. Starting with Vivi, we exited 2025 with strong fourth-quarter momentum at a clear inflection point, as expanded coverage went live. Despite limited coverage throughout 2025, we delivered 115% increase in prescribers writing Vivi, underscoring strong underlying demand for the product.

Patrick Sullivan: Thank you, Andrew. Starting with VEVYE, we exited 2025 with strong Q4 momentum at a clear inflection point as expanded coverage went live. Despite limited coverage throughout 2025, we delivered 115% increase in prescribers writing VEVYE, underscoring strong underlying demand for the product. There is so much more opportunity for VEVYE growth in the large and growing US dry eye category. With broader coverage now in place for our sales force expanse underway, we expect prescriber growth to continue. Consistent with the data shared in 2024, covered patients average approximately nine refills in 2025, effectively a full year of therapy. That level of persistence underscores VEVYE's differentiated clinical profile, rapid onset, sustained efficacy, and comfortable on-eye experience without the stinging and burning commonly associated with other treatments.

Speaker #1: But there is so much more opportunity for Vivi growth in the large and growing US dry eye category. With broader coverage now in place for our sales force expansion underway, we expect prescriber growth to continue.

Speaker #1: Consistent with the data shared in 2024, covered patients' average approximately nine refills in 2025, effectively a full year of therapy. That level of persistence underscores Vivi's differentiated clinical profile, rapid onset, sustained efficacy, and comfortable on-eye experience without the stinging and burning commonly associated with other treatments.

Speaker #1: The bottom line, though, is that we do not believe that any product in the category has this level of refill persistence. Since coverage expansion began, we have seen acceleration in new prescription trends despite navigating a challenging period with insurance benefits resetting and high deductible plans.

Patrick Sullivan: The bottom line, though, is that we do not believe that any product in the category has this level of refill persistence. Since coverage expansion began, we have seen acceleration in new prescription trends despite navigating a challenging period with insurance benefits resetting and high deductible plans. We expect continued improvement as the year progresses. To fully capitalize on this opportunity, we remain on track to double the VEVYE sales force by Memorial Day, expanding our VEVYE presence among eye care professionals to drive higher prescription volume through 2026. Turning to IHEEZO. This product materially outperformed our expectations in 2025 with an impressive 56% growth in unit demand year-over-year. Growth was driven by our expansion in the new retina practices and deeper utilization within existing accounts.

Speaker #1: And we expect continued improvement as the year progresses. To fully capitalize on this opportunity, we remain on track to double the Vivi sales force by Memorial Day.

Speaker #1: Expanding our Vivi presence among eye care professionals to drive higher prescription volume through 2026. Turning to IHESO, this product materially outperformed our expectations in 2025, with an impressive 56% growth in unit demand year over year.

Speaker #1: Growth was driven by our expansion and the new retina practices, as well as deeper utilization within existing accounts. Ordering accounts increased 49% year over year, and retina specialists represented approximately 70% of fourth-quarter unit volume, underscoring where adoption and clinical traction are strongest.

Patrick Sullivan: Ordering accounts increased 49% year-over-year, and retina specialists represented approximately 70% of Q4 unit volume, underscoring where adoption and clinical traction are strongest. Importantly, we believe we're still in the early innings of penetration with significant untapped market opportunity ahead as we continue to expand utilization and drive broader adoption. Looking ahead, in the second half of 2026, we expect a net price improvement which we expect will further enhance the product's revenue and overall financial profile. Importantly, this comes as we prepare to launch BYOOVIZ in mid-2026, further accelerating IHEEZO's expansion into new retina accounts while deepening penetration within our existing customer base. We are also expanding IHEEZO into the office-based setting to broad utilization beyond retina. This initiative targets more than 2.5 million anesthesia relevant procedures that already benefit from established reimbursement pathways, reducing access friction.

Patrick Sullivan: Ordering accounts increased 49% year-over-year, and retina specialists represented approximately 70% of Q4 unit volume, underscoring where adoption and clinical traction are strongest. Importantly, we believe we're still in the early innings of penetration with significant untapped market opportunity ahead as we continue to expand utilization and drive broader adoption. Looking ahead, in the H2 of 2026, we expect a net price improvement which we expect will further enhance the product's revenue and overall financial profile. Importantly, this comes as we prepare to launch BYOOVIZ in mid-2026, further accelerating IHEEZO's expansion into new retina accounts while deepening penetration within our existing customer base. We are also expanding IHEEZO into the office-based setting to broad utilization beyond retina. This initiative targets more than 2.5 million anesthesia relevant procedures that already benefit from established reimbursement pathways, reducing access friction.

Speaker #1: Importantly, we believe we are still in the early innings of penetration, with significant untapped market opportunity ahead, as we continue to expand utilization and drive broader adoption.

Speaker #1: Looking ahead, in the second half of 2026, we expect a net price improvement, which we expect will further enhance the product's revenue and overall financial profile.

Speaker #1: Importantly, this comes as we prepare to launch Biovis in mid-2026, further accelerating IHESO's expansion into new retina accounts while deepening penetration within our existing customer base.

Speaker #1: We are also expanding IHESO into the office-based setting to broaden utilization beyond retina. This initiative targets more than 2.5 million anesthesia-relevant procedures that already benefit from established reimbursement pathways, reducing access friction.

Speaker #1: Earlier engagement has been encouraging, supported by a dedicated commercial effort and our existing relationship in the office-based channel. Turning to Triessence, we delivered a record quarter, driven by accelerating momentum in ocular inflammation and continued strength in retina.

Patrick Sullivan: Earlier engagement has been encouraging, supported by a dedicated commercial effort and our existing relationship in the office-based channel. Turning to TRIESENCE. We delivered a record quarter driven by accelerating momentum in ocular inflammation and continued strength in retina. Despite formally launching in market on 1 October, we saw a good portion of the Q4 unit volume come from ocular surgery accounts, and we expect this large market will drive the majority of new volume going forward. Nearly half of the Q4 ordering accounts were new and helped drive quarter-over-quarter growth in unit volume. To extend this trajectory, we are in the process of doubling the dedicated TRIESENCE sales force. Based on current trends, we see substantial runway for continued growth in 2026 and beyond.

Speaker #1: Despite formally launching in-market on October 1, we saw good portions of the Q4 unit volume come from ocular surgery accounts, and we expect this large market will drive the majority of new volume going forward.

Speaker #1: Nearly half of the fourth quarter ordering accounts were new, and helped drive quarter-over-quarter growth in unit volume. To extend this trajectory, we are in the process of doubling the dedicated Triessence sales force based on current trends.

Speaker #1: We see substantial runway for continued growth in 2026 and beyond. Finally, our rare specialty and compounded portfolio performance rebounded in the fourth quarter as new commercial leadership took hold and execution improved.

Patrick Sullivan: Finally, our rare, specialty, and compounded portfolio performance rebounded in the Q4 as new commercial leadership took hold and execution improved. While we are encouraged by that momentum, I believe there is substantial room to grow this portfolio of everyday workforce products from current share levels. We are implementing several revenue-generating initiatives tied to these assets, which we expect to detail later this year. In parallel, as Mark discussed in his letter, we are focused on converting compounded utilization into FDA-approved branded products through the launch of PharmaPack Max and PharmaPack Prime, further strengthening the long-term revenue profile of this segment. In closing, each of our core growth drivers accelerated in the Q4, and we entered 2026 with clear commercial momentum.

Speaker #1: While we are encouraged by that momentum, I believe there is substantial room to grow this portfolio of everyday workforce products from current share levels.

Speaker #1: We are implementing several revenue-generating initiatives tied to these assets, which we expect to detail later this year. In parallel, as Mark discussed in his letter, we are focused on converting compounded utilization into FDA-approved branded products through the launch of Pharmapack Max and Pharmapack Prime.

Speaker #1: Further strengthening the long-term revenue profile of this segment. In closing, each of our core growth drivers accelerated in the fourth quarter, and we entered 2026 with clear commercial momentum.

Speaker #1: We are scaling the organization to support the trajectory, doubling the sales forces behind Vivi and Triessence, expanding IHESO into the office-based setting and preparing for important launches this year.

Patrick Sullivan: We are scaling the organization to support the trajectory, doubling the sales forces behind VEVYE and TRIESENCE, expanding IHEEZO into the office-based setting and preparing for important launches this year. With strengthened infrastructure, expanding access, and a diversified ophthalmic portfolio, we believe we are well-positioned to drive sustained growth and delivering increased value to patients and shareholders. With that, I'll turn it over to Amir.

Speaker #1: With strengthened infrastructure, expanding access, and a diversified ophthalmic portfolio, we believe we are well positioned to drive sustained growth and deliver increased value to patients and shareholders.

Speaker #1: With that, I'll turn it over to Amir.

Speaker #2: Thanks, Pat. I'd like to turn to our pipeline, which we believe represents a compelling long-term value driver for Harrow. The next phase of growth is highly focused and capital efficient.

Amir H. Shojaei: Thanks, Pat. I'd like to turn to our pipeline, which we believe represents a compelling long-term value driver for Harrow. The next phase of growth is highly focused and capital efficient. We're advancing clinically relevant programs aligned with clear unmet needs in ophthalmology and tightly integrated with our commercial infrastructure and regulatory expertise. While there are several programs on this slide and more that you don't know about yet, I'm only going to focus today on G-MELT, formerly known as MELT-300, and the ongoing IHEEZO studies. G-MELT exemplifies our strategy. It is a fully opioid-free and IV-sparing procedural sedation candidate that has the potential to redefine that standard of care, and I believe has the potential to become our largest product. Today, procedural sedation often requires IV access and uses opioid-based regimens, introducing complexity, staffing burden, monitoring requirements, and longer recovery times.

Speaker #2: We're advancing clinically relevant programs aligned with clear unmet needs in ophthalmology and tightly integrated with our commercial infrastructure and regulatory expertise. While there are several programs on this slide, and more that you don't know about yet, I'm only going to focus today on Gmailed, formerly known as Melt 300, and the ongoing IHESO studies.

Speaker #2: Gmailed exemplifies our strategy. It is a fully opioid-free and IV-sparing procedural sedation candidate that has the potential to redefine that standard of care. And I believe it has the potential to become our largest product.

Speaker #2: Today, procedural sedation often requires IV access and uses opioid-based regimens introducing complexity, staffing burden, monitoring requirements, and longer recovery times. Gmailed has the potential to simplify that model.

Amir H. Shojaei: G-MELT has the potential to simplify that model. From a development perspective, we initiated the remaining pharmacokinetic work earlier this year and are advancing CMC activities with our CDMO partner. We remain on track for an NDA submission in early 2027 while continuing to evaluate opportunities to accelerate timelines. We view G-MELT as platform-level upside, a differentiated sedation solution with the potential to broadly improve procedural efficiency and create meaningful long-term value in the ophthalmic market and eventually beyond. Pipeline value also comes from expanding the evidence base for marketed products, including IHEEZO. I'm amazed that our team has been so successful with IHEEZO on retina, given its supporting data was in cataract surgery. I know from my experience developing back of the eye products that retina professionals who are the primary users of IHEEZO want to see specific data based on procedures they need IHEEZO for, namely intravitreal injections.

Speaker #2: From a development perspective, we initiated the remaining pharmacokinetic work earlier this year and are advancing CMC activities with our CDMO partner. We remain on track for an NDA submission in early 2027 while continuing to evaluate opportunities to accelerate timelines.

Speaker #2: We view Gmailed as platform-level upside that differentiated sedation solution with the potential to broadly improve procedural efficiency and create meaningful long-term value in the ophthalmic market and eventually beyond.

Speaker #2: Pipeline value also comes from expanding the evidence base for marketed products. Including IHESO, I'm amazed that our team has been so successful with IHESO on retina given its supporting data was in cataract surgery.

Speaker #2: I know from my experience developing back of the eye products, that retina professionals who are the primary users of IHESO want to see specific data based on procedures they need IHESO for, namely intravitreal injections.

Amir H. Shojaei: Therefore, we are investing in clinical data generation to support adoption, strength, and differentiation, and reinforce long-term positioning with both clinicians and payers. While this slide highlights IHEEZO, similar work is underway across the portfolio. High-quality evidence builds clinical confidence, drives utilization, and supports sustained reinvestment in the franchise. For IHEEZO, we are sponsoring multiple complementary studies in intravitreal injection procedures. The first and most near-term data is an investigator-initiated randomized trial led by Dr. Sabin Dang comparing IHEEZO to standard anesthetic approaches, evaluating pain and ocular symptoms with data expected at ASRS this year in July. You can see the quote he provided us with on the bottom left of the slide. As for our own Harrow-sponsored IHEEZO study, my team has put together a Phase IV multi-center randomized trial assessing patient-reported pain and safety across approximately 240 patients.

Speaker #2: Therefore, we are investing in clinical data generation to support adoption, strengthen differentiation, and reinforce long-term positioning with both clinicians and payers. While this slide highlights IHESO, similar work is underway across the portfolio.

Speaker #2: High-quality evidence builds clinical confidence, drives utilization, and supports sustained reinvestment in the franchise. For IHESO, we are sponsoring multiple complementary studies in intravitreal injection procedures.

Speaker #2: The first and most near-term data is an investigator-initiated randomized trial led by Dr. Sabin Dang comparing IHESO to standard anesthetic approaches evaluating pain and ocular symptoms with data expected at ASRS this year in July.

Speaker #2: You could see the quote he provided us with on the bottom left of the slide. As for our own Harrow-sponsored IHESO study, my team has put together a phase four multi-center randomized trial assessing patient-reported pain and safety across approximately 240 patients.

Speaker #2: We initiated the study in the first quarter of 2026 under the IND and expect to have data available by the end of 2026. Together, these studies are designed to generate clinically meaningful, practice-relevant evidence that supports further and more broad-based adoption, reinforcing IHESO as a durable, long-term growth driver.

Amir H. Shojaei: We initiated the study in Q1 2026 under the IND and expect to have data available by the end of 2026. Together, these studies are designed to generate clinically meaningful practice-relevant evidence that supports further and more broad-based adoption, reinforcing IHEEZO as a durable long-term growth driver. In summary, Harrow's pipeline is focused, efficient, and impactful. It complements our commercial momentum, expands our addressable markets, and creates multiple pathways for long-term value creation. We are building not just individual products, but a sustainable innovation engine that positions Harrow for continued growth. With that, I'll turn it over for questions.

Speaker #2: In summary, Harrow's pipeline is focused, efficient, and impactful. It complements our commercial momentum, expands our addressable markets, and creates multiple pathways for long-term value creation.

Speaker #2: We are building not just individual products, but a sustainable innovation engine that positions Harrow for continued growth. With that, I'll turn it over for questions.

Operator: Thank you. If you'd like to ask a question, please press star one one. If your question has been answered and you'd like to remove yourself from the queue, please press star one one again. Our first question comes from Chase Knickerbocker with Craig-Hallum. Your line is open.

Speaker #1: Thank you. If you'd like to ask a question, please press star 11. If your question has been answered and you'd like to remove yourself from the queue, please press star 11 again.

Speaker #1: Our first question comes from Chase Knickerbocker with Craig Hallam, your line is open.

Speaker #3: Good morning, team. Appreciate the candidate thoughts and the shareholder letter, and thanks for taking the questions here. So Mark, you kind of mentioned in the letter that you expect kind of continued commercial growth and commercial mix improvement for Vivi, kind of through the year.

Chase Knickerbocker: Good morning, team. Appreciate the candid thoughts in the shareholder letter, and thanks for taking the questions here. Mark, you kind of mentioned in the letter that you expect, you know, kind of continued commercial growth and commercial mix improvement for Vbi kind of through the year. What have you seen so far from a commercial mix perspective in Q1? Can you walk us through what your ASP assumptions or direction of ASP for Vbi is in the 2026 guide kind of versus volume? Thanks.

Speaker #3: What have you seen so far from a commercial mix perspective in Q1? And then can you walk us through what your ASP assumptions or direction of ASP for Vivi is in the 2026 guide kind of versus volume?

Speaker #3: Thanks.

Mark Baum: Yes. Regarding ASP, I think I'll answer the second question first. On ASP and net pricing, you know, the only comment that we've made and that we intend to make is regarding the buoyancy and the slight uptick in ASP, which I had forecasted probably a quarter or 2 late. Nevertheless, as I said in the letter to stockholders, we saw that direction of travel and we eventually got there. With a more sustainable and buoyant net pricing for Vbi, that coupled with some of the things that we're seeing on the commercial side with this new coverage, we have initiated this program to more than double the Vbi sales force.

Speaker #4: Yeah. So regarding ASP, I think the only—I'll answer the second question first. On ASP and net pricing, the only comment that we've made—and that we intend to make—is regarding the buoyancy and the slight uptick in ASP, which I had forecasted probably a quarter or two late.

Speaker #4: But nevertheless, as I said in the letter, to stockholders, we saw that direction of travel and we eventually got there. So with a more sustainable and buoyant net pricing for Vivi, that coupled with some of the things that we're seeing on the commercial side with this new coverage, we have initiated this program to more than double the Vivi sales force.

Mark Baum: In terms of the build and what we're seeing on the ground today for Vbi, as I said also in the letter to stockholders, even in Q4, we started to see a little bit of momentum build. I think I've said in the past that CVS had actually sent out letters to thousands and thousands of eye care professionals around the United States alerting them to the new positioning, the preferred positioning for Vbi on their formulary. That alone, I think began the positive momentum that we're also seeing a little bit in Q1.

Speaker #4: In terms of the build and what we're seeing on the ground today, for Vivi, as I said also in the letter to stockholders, even in the fourth quarter, we started to see a little bit of momentum build.

Speaker #4: I think I've said in the past that CVS had actually sent out letters to thousands and thousands of eye care professionals around the United States, alerting them to the new positioning, the preferred positioning for Vivi on their formulary.

Speaker #4: And that alone I think began a positive momentum that we're also seeing a little bit in the first quarter. What I can say regarding the first quarter is that typically it's a weaker period.

Mark Baum: What I can say regarding Q1 is that typically it's a weaker period, and, you know, we're quite surprised with the new prescription volumes that we're seeing today relative to what we thought we would see, which is to say that the new prescription volumes are meaningfully better than what we thought we would be receiving at this point in the year. We expect that to build throughout the year. As I said in my prepared remarks, we have data that demonstrates very clearly that more reps in the field for this particular product, given the persistence of the product and the market interest in the product, yields more prescriptions. Building those new prescriptions ultimately leads to more and more total prescriptions and more revenue.

Speaker #4: And we're quite surprised with the new prescription volumes that we're seeing today relative to what we thought we would see, which is to say that the new prescription volumes are meaningfully better than what we thought we would be receiving at this point in the year.

Speaker #4: So we expect that to build throughout the year. As I said in my prepared remarks, we have data that demonstrates very clearly that more reps in the field for this particular product, given the persistence of the product and the market interest in the product, yields more prescriptions.

Speaker #4: And for us, building those new prescriptions ultimately leads to more and more total prescriptions and more revenue. So we're very much bent towards building volume in Vivi, and that's how we're set up for this year.

Mark Baum: We're very much bent towards building volume in VY, and that's how we're set up for this year, and that's what you should expect.

Speaker #4: And that's what you should expect.

Chase Knickerbocker: Helpful, Mark. Just for my second question, another multipart. Just on the TRIESENCE phase III and cataract announced this morning. You know, obviously a large potential volume opportunity. Just a couple of questions to help us understand the magnitude. What % of the cataract market do you think is kind of the sweet spot for TRIESENCE as it relates to kind of the value prop versus the multi-drop regimens that are pretty pervasive today? How should investors kind of think about the TAM expansion from this label expansion kind of within cataract for TRIESENCE? Second, I think investors often have kind of questioned on duration of opportunity with pass-through products in the ASC.

Speaker #3: Helpful, Mark. And just for my second question, another multi-parter, sorry, but just on the Triessen's phase three and cataract announced this morning, obviously a large potential volume opportunity just a couple of questions to help us understand the magnitude.

Speaker #3: So what percentage of the cataract market do you think is kind of the sweet spot for Triessen's as it relates to kind of the value prop versus the multi-drop regimens that are pretty pervasive today?

Speaker #3: How should investors kind of think about the TAM expansion from this label expansion, kind of within cataract, for Triesse's? And then second, I think investors often have questions on the duration of opportunity with pass-through products in the ASC.

Chase Knickerbocker: Can you just remind us or discuss the unique aspects of TRIESENCE that may allow for longer term payment outside the bundle or how you plan to approach pricing there?

Speaker #3: Can you just remind us or discuss the unique aspects of Triessen's that may allow for longer-term payment outside the bundle or how you plan to approach pricing there?

Mark Baum: Sure. You know, once again, I'll take the second question, the second part first. In terms of reimbursement for the product, TRIESENCE has a very unique label in that it is both used in the office setting of care and it's also used in the hospital and outpatient department setting of care. As a result of that, I don't wanna go into the nuances of reimbursement policy, but we believe that TRIESENCE will not be limited by a TPT or a temporary pass-through period. Regarding the first part of the question, in terms of what the TAM expansion might be for this study that, you know, Amir just received clearance on, I believe, yesterday.

Speaker #4: Sure. Once again, I'll take the second question or the second part first. In terms of reimbursement for the product, Triessen's has a very unique label in that it is both used in the office setting of care and it's also used in the hospital and outpatient department setting of care.

Speaker #4: And as a result of that, and I don't want to go into the nuances of reimbursement policy, but we believe that Triessen's will not be limited by a TPT or a temporary pass-through period.

Speaker #4: And regarding the first part of the question, in terms of what the TAM expansion might be for this study that Amir just received clearance on, I believe yesterday, I go back to, I think, another comment that I made in my prepared remarks, and that is that our vision for cataract surgery is that in the future, patients in the United States should have an IV-free opioid-free and even an eyedrop-free procedure.

Mark Baum: I go back to, I think, another comment that I made in my prepared remarks, and that is that our vision for cataract surgery is that in the future, patients in the United States should have an IV-free, opioid-free, and even an eye drop-free procedure. That is what I would want my mother to have. That's what I would want anyone that I love to have. Not to have to put eye drops in their eye multiple times per day, multiple different eye drop bottles. That's assuming you're using an FDA-approved product, of course. That should be the ideal, and that's what we're working towards. That's what the G-MELT is about, and that's what this expansion with TRIESENCE is about.

Speaker #4: That is what I would want my mother to have. That's what I would want anyone that I love to have, not to have to put eyedrops in their eye multiple times per day.

Speaker #4: Multiple different eyedrop bottles. That's assuming you're using an FDA-approved product, of course. And so that should be the ideal. And that's what we're working towards.

Speaker #4: That's what the GMelt is about. And that's what this expansion with Triessen's is about. It's about putting power in the hands of the surgeon to deliver the anti-inflammatory into the eye so that the patient doesn't need to administer these post-surgical eye drops.

Mark Baum: It's about putting power in the hands of the surgeon to deliver the anti-inflammatory into the eye so that the patient doesn't need to administer these post-surgical eye drops. What's interesting is anecdotally, what we see is that for patients who are using this on label, which is a subsegment of the cataract surgery population, it's those patients who really can't administer eye drops, who have other comorbidities. What we decided to do, because those patients are having such exceptional results, is to invest in expanding the label so that all cataract surgery patients have access to this therapy.

Speaker #4: What's interesting is, anecdotally, what we've seen is that for patients who are using this on label—which is a subsegment of the cataract surgery population, it's those patients who really can't administer eyedrops, who have other comorbidities—what we decided to do, because those patients are having such exceptional results, is to invest in expanding the label so that all cataract surgery patients have access to this therapy.

Mark Baum: What's terrific is, as I said, we've got reimbursement, we have an exceptional clinical outcome, and with this amazing study that Amir and his team are going to execute, we're going to have a very broad-based label that will finally give cataract surgeons access to an easy-to-administer, highly efficacious post-cataract surgery anti-inflammatory that they themselves can inject. Here's the best thing for consumers, for patients: It has the lowest out-of-pocket of any injectable steroid at around $37 per unit. It's affordable, it's accessible, it's highly efficacious, and we're going to invest for a very small amount of money in a study that will significantly expand the number of patients who will have access to it. In the United States, by the time this data reads out, that should be about 5 million procedures annually. It's a very large market opportunity.

Speaker #4: And what's terrific is, as I said, we've got reimbursement. We have an exceptional clinical outcome. And with this amazing study that Amir and his team are going to execute, we're going to have a very broad-based label that will finally give cataract surgeons access to an easy-to-administer highly efficacious post-cataract surgery anti-inflammatory that they themselves can inject.

Speaker #4: And here's the best thing for consumers, for patients. It has the lowest out-of-pocket of any injectable steroid. At around $37 per unit. So it's affordable.

Speaker #4: It's accessible. It's highly efficacious. And we're going to invest for a very small amount of money in a study that will significantly expand the number of patients who will have access to it.

Speaker #4: And in the United States, by the time this data reads out, that should be about 5 million procedures annually. So it's a very large market opportunity.

Mark Baum: As I've said for a couple of years, you know, TRIESENCE is a slow grower. We've got a lot to prove there for sure. This is a product that in the next couple of years is gonna be a meaningful value driver for our stockholders.

Speaker #4: And as I've said for a couple of years, Triessen's is a slow grower. We've got a lot to prove there for sure. But this is a product that in the next couple of years is going to be a meaningful value driver for our stockholders.

Chase Knickerbocker: Very helpful, Mark. Thank you very much.

Speaker #3: Very helpful, Mark. Thank you very much.

Operator: Thank you. Our next question comes from Timur Ivannikov with Cantor Fitzgerald. Your line is open.

Speaker #1: Thank you. Our next question comes from Tamir Avanakov with Candra Fitzgerald. Your line is open.

Timur Ivannikov: Yes. Hi, thank you. This is Timur Ivannikov on for Steve Seedhouse. First on IHEEZO, I think you mentioned price improvements in the second half of 2026. Could you clarify, is that a price improvement from Q2 2026 or from Q4 2025? Do you expect Q2 2026 ASP to be significantly lower? Thank you.

Timur Ivannikov: Yes. Hi, thank you. This is Timur Ivannikov on for Steve Seedhouse. First on IHEEZO, I think you mentioned price improvements in the H2 of 2026. Could you clarify, is that a price improvement from Q2 2026 or from Q4 2025? Do you expect Q2 2026 ASP to be significantly lower? Thank you.

Speaker #5: Yes. Hi. Thank you. This is Tamir Avanakov on for Steve Seedhouse. So first, on IHESO, I think you mentioned price improvements in the second half of 2026.

Speaker #5: Could you clarify, is that a price improvement from Q2 '26 or from Q4 '25? And do you expect Q2 '26 ASP to be significantly lower?

Speaker #5: Thank you.

Mark Baum: Andrew, you wanna take that?

Speaker #4: Andrew, you want to take that?

Andrew R. Boll: Yeah. I try to make sure I answer the question correctly. We expect by the time we get to Q3 of 2026, pricing for IHEEZO will be better than what it was in 2025 and in the first part of 2026.

Speaker #6: Yeah. So and just to try to make sure I answer the question correctly, we expect by the time we get to Q3 of 2026, pricing for IHESO will be better than what it was in 2025 and in the first part of 2026.

Timur Ivannikov: Okay, got it. Second question is on the TRIESENCE cataract trial design. I just wanted to understand the trial a little better. I think you mentioned, the trial design versus placebo. Could you talk about the use of droplets, anti-inflammatory eye droplets in both groups? I mean, are you allowed to, you know, to dose the droplets in the treatment arm and the control arm? Thank you.

Speaker #5: Okay. Okay. Got it. And then the second question is on Triessen's cataract trial design. I just wanted to understand the trial a little better.

Speaker #5: I think you mentioned the trial design versus placebo. Could you talk about the use of droplets and anti-inflammatory eyedroplets in both groups? I mean, are you allowed to dose the droplets in the treatment arm and the control arm?

Speaker #5: Thank you.

Mark Baum: Amir, can you handle that one?

Speaker #4: Amir, can you handle that one?

Patrick Sullivan: Yeah. Hi. I think the protocol design is pretty clear. We're gonna have a control arm which will not get the TRIESENCE. What we do have rescue criteria already built in, and those rescue criteria would allow drops again, per protocol.

Amir H. Shojaei: Yeah. Hi. I think the protocol design is pretty clear. We're gonna have a control arm which will not get the TRIESENCE. What we do have rescue criteria already built in, and those rescue criteria would allow drops again, per protocol.

Speaker #3: Yeah. Hi. I think the protocol design is pretty clear. We're going to have control arm, which will not get Triessen's and then what we do have rescue criteria, already built in.

Speaker #3: And those rescue criteria would allow drops again, per protocol.

Timur Ivannikov: Okay. Thank you. Appreciate that.

Speaker #5: Okay. Thank you. Appreciate that.

Operator: Thank you. Our next question comes from Mayank Mamtani with B. Riley Securities. Your line is open.

Speaker #1: Thank you. Our next question comes from Mayank Momtani with B. Raleigh Securities. Your line is open.

Mayank Mamtani: Yes. Good morning, team. Thanks for taking the questions, and appreciate the helpful go forward guidance framework. On BYQLOVI, NRx improving and the commercial mix also improving, Mark Baum, are you able to share with us any end of year or Q2 loaded kind of market share targets that you may have so, you know, we can understand, you know, the growth in the market? Obviously, you know, multiple companies investing here on the penetration side, but also want to understand how you're thinking about share gains in both the cash pay and also obviously the commercial mix markets. I have a follow-up on IHEEZO as well.

Speaker #4: Yes. Good morning, team. Thanks for taking a question. And I appreciate the helpful go-forward guidance framework. So VY NRX improving in the commercial mix also improving, Mark.

Speaker #4: Are you able to share with us any end-of-year or second-half loaded kind of market share targets that you may have? So we can understand the growth in the market.

Speaker #4: Obviously, multiple companies investing here on the penetration side, but also want to understand how you're thinking about share gains in both the cash pay and also, obviously, the commercial mix markets.

Speaker #4: And then I have a follow-up on IHESO. Yes. So we have three goals for VY. First of all, I just want to say that the dry eye market in the US is, pat-set, a very large market.

Mark Baum: Sure. Yeah. we have 3 goals for VEVYE. First of all, I just wanna say that the dry eye market in the US is, Pat said, a very large market. We believe it still continues to be under-penetrated, and we continue to see data that demonstrates that there are large segments of the dry eye patient population that are receiving products on a monthly basis that burn and sting, cause pain, sneeze. I mean, the list of these effects are too long.

Speaker #4: We believe it still continues to be underpenetrated. And we continue to see data that demonstrates that there are large segments of the dry eye patient population that are receiving products on a monthly basis that burn and sting, cause pain, sneeze.

Speaker #4: I mean, the list of these effects are too long. And so when we see that patients are getting access to these non-optimal therapies, for whatever reason, whether it's coverage or they're just not aware of VY, we see that as opportunity to convert those patients to a therapy that doesn't burn and sting and that has all of the positive benefits that VY offers, including now these enhanced coverage metrics.

Mark Baum: When we see that patients are getting access to these non-optimal therapies, for whatever reason, whether it's coverage or they're just not aware of VEVYE, we see that as opportunity to convert those patients to a therapy that doesn't burn and sting and that has all of the positive benefits that VEVYE offers, including now these enhanced coverage metrics. But in terms of what our goals are, to be clear, the first goal is we believe VEVYE will be the number one cyclosporine in the US market. Cyclosporine is the most trusted active ingredient in the dry eye market, and we aim to be the number one cyclosporine. Second to that, we believe we can capture the anti-inflammatory market, so any product that actually has an active ingredient in it that would be an anti-inflammatory.

Speaker #4: But in terms of what our goals are to be clear, the first goal is we believe VY will be the number one cyclosporin in the US market.

Speaker #4: Cyclosporin is the most trusted active ingredient in the dry eye market. And we aim to be the number one cyclosporin. Second to that, we believe we can capture the anti-inflammatory market.

Speaker #4: So any product that actually has an active ingredient and that would be an anti-inflammatory. And we believe all forms of dry eye disease we don't care which one you choose.

Mark Baum: We believe all forms of dry eye disease, you know, we don't care which one you choose, have an inflammatory component to them. We aim to be secondarily the number one anti-inflammatory. Eventually, and it's not gonna happen overnight, we think we have the opportunity with this particular product to be the number one most prescribed dry eye product. Now, for the last couple of years, our competition has had a sales organization, you know, that even the most inferior products in the market have had much larger sales organizations than we've had. We are now, as I said, more than doubling our sales force. I think we're more than halfway there, so I'm actually surprised.

Speaker #4: Have an inflammatory component to them. And so we aim to be secondarily the number one anti-inflammatory. And then eventually, and it's not going to happen overnight.

Speaker #4: We think we have the opportunity with this particular product to be the number one most prescribed dry eye product. Now, for the last couple of years, our competition has had a sales organization that even the most inferior products in the market have had much larger sales organizations than we've had.

Speaker #4: And we are now, as I said, more than doubling our sales force. I think we're more than halfway there. So I'm actually surprised that talent team is doing a great job.

Mark Baum: The talent team is doing a great job, and there's just a lot of people that wanna join Maria's team and sell VEVYE. In terms of specific market share percentages, we're not giving those goals. I think to be the number one cyclosporine in the market, we probably need to have just north of 20% market share. That gives you a sense of what we think is achievable. By the way, in many markets, we are already there. The problem is that we touched historically so few markets with a sales organization of just under 50 people that even if you have better than 20% market share in the greater Cincinnati area, which happens to be the case, you...

Speaker #4: And there's just a lot of people that want to join this Maria's team and sell VY. But in terms of specific market share percentages, we're not giving those goals.

Speaker #4: I think to be the number one cyclosporin in the market, we probably need to have just north of 20% market share. So that gives you a sense of what we think is achievable.

Speaker #4: And by the way, in many markets, we are already there. The problem is that we touched, historically, so few markets with a sales organization of just under 50 people that, even if you have better than 20% market share in the greater Cincinnati area—which happens to be the case—there are many other markets where you just simply don't have that level of market share.

Mark Baum: There are many other markets where you just simply don't have that level of market share. With this enhanced sales force now, numbering close to about 100, we'll touch more markets. We will increase our market share, I believe, and we'll get closer and closer to that goal of being the number one cyclosporine. Pat, do you wanna add to that at all?

Speaker #4: So with this enhanced sales force, now numbering close to about 100, we'll touch more markets. We will increase our market share, I believe. And we'll get closer and closer to that goal of being the number one cyclosporin.

Speaker #4: Pat, do you want to add to that at all?

Patrick Sullivan: Thanks, Mark. I think, you know, one of the things we're most optimistic about as we stated in our earnings, is the increase in writing that we see. We saw 115% growth in our writing. I think as Mark mentioned, the feedback that we receive from our eye care professionals and from their patients is extremely positive around the fact that VEVYE uniquely manages inflammation, how rapid it works, and at the same time, is the unique tolerability profile. We are extremely encouraged at our next phase of expansion to cover a much larger portion of the market and increase VEVYE's presence to really grow this product to be the number one cyclosporine. Mark, we're well on our way to building our next phase of growth for VEVYE.

Speaker #3: Thanks, Mark. I think one of the things we're most optimistic about, as we stated in our earnings, is the increase in writing that we see.

Speaker #3: We saw 115% growth in our writing. And I think as Mark mentioned, the feedback that we receive from our eye care professionals from their patients is extremely positive around the fact that VY uniquely manages inflammation, how rapid it works, and at the same time is the unique tolerability profile.

Speaker #3: We are extremely encouraged that our next phase of expansion will cover a much larger portion of the market and increase VY's presence, to really grow this product to be the number one cyclosporin.

Speaker #3: So, Mark, we're well on our way to building our next phase of growth for VY.

Mayank Mamtani: Then on IHEEZO, obviously a lot going on here. ASC pass-through status expiration, but also price per unit improvement that you mentioned. There's also some data generation activity you noted at ASRS conference middle of the year. Was just curious, you know, to contextualize its contribution to the guidance. Are you also thinking like VEVYE, this is a 9-digit revenue contributor for this year, or is it more a reasonable target for next year?

Speaker #4: And then on IHESO, obviously a lot going on here. ASC passed through status expiration, but also price-per-unit improvement that you mentioned. And there's also some data generation activity you noted at the ASRS conference, middle of the year.

Speaker #4: Was this curious to contextualize its contribution to the guidance? Are you also thinking like VY, this is a nine-digit revenue contributor for this year?

Speaker #4: Or is it more a reasonable target for next year?

Mark Baum: Yeah, I don't wanna comment on the revenues for that product. I think the only product we've given guidance on specifically is VEVYE, which is clearly, you know, on the road to nine figures. What I will tell you is this: Just as a reminder, in 2024, we had absolutely zero retina presence. We didn't have a retina sales force, we didn't have any products in that market. Only a couple of years ago did we hire that sales organization. In really August of 2024, we began what we call the Retina Pivot, where we were able to attract great people from much larger companies that had tremendous backgrounds in retina, and we built this organization. I remember going to ASRS in Stockholm. Nobody knew who Harrow was.

Speaker #5: Yeah, I don't want to comment on the revenues for that product. I think the only product we've given guidance on specifically is VY, which is clearly on the road to nine figures.

Speaker #5: What I will tell you is this. Just as a reminder, in 2024, we had absolutely zero retina presence. We didn't have a retina sales force.

Speaker #5: We didn't have any products in that market. And only a couple of years ago, did we hire that sales organization. So in really August of 2024, we began what we call the retina pivot.

Speaker #5: We were able to attract great people from much larger companies that had tremendous backgrounds in retina, and we built this organization. I remember going to ASRS in Stockholm—nobody knew who Harrow was.

Mark Baum: We had no presence in that market, and it's a very tight community, the retina community. What I can tell you is over the last year and a half, two years or so, I think if you go to retina professionals now and ask them if they know who Harrow is, they really know who Harrow is. I have to say another thing about IHEEZO specifically, because it is amazing what Ali and her team have done. Taking a product where the clinical studies supporting the NDA were in cataract surgery, and they have been able to adapt that data to the intravitreal injection market now with more than 70% of the unit volume for IHEEZO in the retina market. What's really exciting is what Amir talked about with the Dang study.

Speaker #5: They had no presence in that market. And it's a very tight community, the retina community. And what I can tell you is over the last year and a half, two years or so, I think if you go to retina professionals now and ask them if they know who Harrow is, they really know who Harrow is.

Speaker #5: I have to say another thing about IHESO specifically, because it is amazing what Ali and her team have done. Taking a product where the clinical studies supporting the NDA were in cataract surgery, and they have been able to adapt that data to the intravitreal injection market.

Speaker #5: Now, with more than 70% of the unit volume for IHESO in the retina market. What's really exciting is what Amir talked about with the DANG study.

Mark Baum: What Ali has wanted for well over a year, we've had numerous conversations, is specific data related to the performance of IHEEZO in the intravitreal injection procedure. We had all this anecdotal information, you know, doctors would tell us how it performed. You know, some doctors had other benefits that they experienced from the product, including efficiency in their workflow. What I think you're gonna see in the middle of the year, finally, for Ali and her team, is a data set that will demonstrate the real difference between IHEEZO and these legacy modes of providing these patients with anesthesia for these intravitreal injections. I have to tell you, if you're a patient getting these injections, the anesthesia and pain control really matters.

Speaker #5: What Ali has wanted for well over a year have had numerous conversations is specific data related to the performance of IHESO in the intravitreal injection procedure.

Speaker #5: And we had all this anecdotal information, doctors would tell us how it performed, some doctors had other benefits that they experienced from the product, including efficiency in their workflow.

Speaker #5: But what I think you’re going to see in the middle of the year finally for Ali and her team is a data set that will demonstrate the real difference between IHESO and these legacy modes of providing these patients with anesthesia for these intravitreal injections.

Speaker #5: And I have to tell you, if you're a patient getting these injections, the anesthesia and pain control really matters. And we think we have a product, at least anecdotally, we've received tremendous information from accounts that use this product about its performance.

Mark Baum: We think we have a product, at least anecdotally, we've received tremendous information from accounts that use this product about its performance. In the middle of the year at ASRS, he got a late breaker, by the way. I mean, it's not easy to get these, but, you know, he is going to present this data, and I think that is going to fuel significant demand in the retina market for this product. In terms of how IHEEZO fits into our overall guide this year and certainly in 2027, depending on how this data comes out, this is an opportunity, I think, to significantly improve the unit volume demand for IHEEZO.

Speaker #5: And in the middle of the year at ASRS, and he got a late breaker, by the way. I mean, it's not easy to get these.

Speaker #5: But he is going to present this data. And I think that is going to fuel significant demand in the retina market for this product.

Speaker #5: So in terms of how we how IHESO fits into our overall guide this year, and certainly in 2027, depending on how this data comes out, this is an opportunity, I think, to significantly improve the unit volume demand for IHESO, and then as Andrew said, that coupled with this new packaging format that's specifically for retina, and a meaningfully improved price, I think that by the end of next year, you're going to hopefully be surprised at what we think we can generate from this particular product.

Mark Baum: As Andrew said, that coupled with this new packaging format that's specifically for retina and a meaningfully improved price, you know, I think that by the end of next year, you know, you're gonna hopefully be surprised at what we think we can generate from this particular product.

Mayank Mamtani: Thank you, Mark. Lastly, very quickly, the OpEx expansion, you know, that you're seeing your R&D was higher in Q4. Is it sort of a first-half loaded kind of dynamic and is it a steady state OpEx spend, Andrew, you're trying to get at some point this year? Thanks for taking my question.

Speaker #4: Thank you, Mark. And lastly, very quickly, the OPEX expansion that you're seeing—your R&D was higher in the fourth quarter. Is it sort of a first-half-loaded kind of dynamic?

Speaker #4: And is there a steady-state OPEX spend, Andrew, you're trying to get to at some point this year? Thanks for taking that question.

Mark Baum: Thank you, Mike. Andrew, do you wanna tackle the OpEx?

Speaker #5: Thank you, Mike. Andrew, do you want to tackle the OPEX?

Andrew R. Boll: Yeah, absolutely. Thanks, Mike. I want to be sure to note in Q4, in the P&L, there's an $8.5 million charge for acquired and processed R&D, which was associated with the Melt acquisition. Those are upfront costs and some of the transaction costs associated with the deal. None of that acquisition cost was capitalized. It all ran through the P&L and ran through R&D according to GAAP rules. We also didn't back it out or add it back in, I should say, to the EBITDA number for 2024. Kind of looking forward.

Speaker #3: Yeah, absolutely. Thanks, Mike. And I want to be sure to note in Q4, in the P&L, there's an $8.5 million charge for acquired and processed R&D, which was associated with the Mount acquisition.

Speaker #3: Those are upfront costs and some of the transaction costs associated with the deal. But none of that acquisition cost was capitalized. It all ran through the P&L and ran through R&D.

Speaker #3: According to GAAP rules, and we also didn't back it out or add it back in, I should say, to the EBITDA number for 2024.

Speaker #3: But kind of looking forward, they adjusted EBITDA. Pardon me.

Mark Baum: The adjusted-

Andrew R. Boll: The adjusted EBITDA part.

Mark Baum: Go ahead.

Andrew R. Boll: Looking forward at the OpEx spend, and Mike, I'm going to kind of break it into two parts. You've got the SG&A side, which we're adding that sales, those sales heads right now. We've been adding them aggressively in Q1. We'll continue to add them in Q2. We've also been preparing. We're preparing from a marketing and promotion standpoint, which is also increasing that spend. We're kind of trying to get ahead of a lot of that as well, so that when these people get hired and trained, they're hitting the ground running with VEVYE and TRIESENCE for that matter. From an R&D perspective, it's a lot of that cost, as you know, is going to be trial dependent. We sort of have a base here of R&D spend year-over-year.

Speaker #5: Go ahead.

Speaker #3: The looking forward at the OPEX spend, and Mike, I'm going to kind of break it into two parts. You've got the SG&A side, which we're adding that sales that those sales heads right now.

Speaker #3: We've been adding them aggressively in Q1. We'll continue to add them in Q2. And then we've also been preparing. So we're preparing from a marketing and promotion standpoint, which is also increasing that spend.

Speaker #3: And we're kind of trying to get ahead of a lot of that as well so that when these people get hired and trained, they're hitting the ground running with BY.

Speaker #3: And Triessen, for that matter. From an R&D perspective, it's a lot of that cost, as you know, is going to be trial dependent. We sort of have a base here of R&D spend year over year.

Andrew R. Boll: As we put out this announcement this morning regarding the TRIESENCE IND being accepted and that study picking up, those costs will kind of show up in the middle part of the year, so Q2, Q3. We'll have a little bit of a ramp in the middle part of the year and then it should come down a little bit on the R&D side in Q4, as you sort of wrap up those studies along with some of the Melt studies.

Speaker #3: But as we put out this announcement this morning regarding the Triessen's I&D being accepted, and that study picking up, those costs will kind of show up in the middle part of the year.

Speaker #3: So Q2, Q3. So we'll have a little bit of a ramp in the middle part of the year. And then it should come down a little bit on the R&D side in Q4.

Speaker #3: As you sort of wrap up those studies, along with some of the MELT studies.

Operator: Got it. Thank you. Thank you. Our next question comes from Lachlan Hanbury-Brown with William Blair. Your line is open.

Mayank Mamtani: Got it. Thank you.

Operator: Thank you. Our next question comes from Lachlan Hanbury-Brown with William Blair. Your line is open.

Speaker #5: Got it. Thank you.

Speaker #1: Thank you. Our next question comes from Lachlan Hanbury Brown with William Blair. Your line is open.

Lachlan Hanbury-Brown: Hey, guys. Thanks for taking the questions. I guess first would appreciate maybe a little more color on how you're thinking about the IHEEZO dynamics in 2026. You said you think the in-office procedure expansion beyond retina can offset the ASC loss. Is that sort of specifically talking about Q2, or is that more of a longer term, you think, you know, looking a year or so out, it will have more than offset that? I guess should we expect maybe a drop in Q2 in unit demand?

Speaker #6: Hey, guys. Thanks for taking the questions. I guess first, we'd appreciate maybe a little more color on how you're thinking about the IHESO dynamics in 2026.

Speaker #6: So you said you think the in-office procedure expansion beyond retina can offset the ASC loss. Is that sort of specifically talking about Q2, or is that more of a longer-term, you think, looking a year or so out, it will have more than offset that?

Speaker #6: So I guess, should we expect maybe a drop in Q2 in unit demand?

Mark Baum: Yeah. I don't want to be specific about demand in any particular quarter other than to say that in Q4, Q1, Q2, Q3, I think I've said this, we expect demand to continue to increase. Demand continues to increase. That's separate from revenue recognition, but demand for the product does continue to increase. In terms of when we're likely to see the offset from the loss of the ASC units. When I looked at the ASC units specifically, the number of units that we're that we're losing relative to the overall opportunity that we're adding when we add these in-office opportunities of this 2.5 million unit increase to our TAM, it's such a small level of success.

Speaker #5: Yeah. I don't want to be specific about demand in any particular quarter other than to say that in Q4, Q1, Q2, Q3, I think of I've said this.

Speaker #5: We expect demand to continue to increase. So demand continues to increase. That's separate from revenue recognition. But demand for the product does continue to increase.

Speaker #5: In terms of when we're likely to see the offset, from the loss of the ASC units, when I looked at the ASC units specifically, the number of units that were losing relative to the overall opportunity that we're adding when we add these in-office opportunities with this two and a half million unit increase to our TAM, it's such a small level of success.

Mark Baum: We have a discrete team going into, the same customers that are using it in the ASC that don't know that they can use it also in their clinics. You know, remember, every one of the doctors that's using it in the ASC is a surgeon, but they also only spend a day or two a week in the surgery, operating room, the surgical operating room. The rest of the week they spend in their office doing procedures. It's a simple idea.

Speaker #5: And we have a discrete team going into the same customers that are using it in the ASC that don't know that they can use it also in their clinics.

Speaker #5: Remember, every one of the doctors that's using it in the ASC is a surgeon, but they also only spend a day or two a week in the surgery operating room.

Speaker #5: The surgical operating room. The rest of the week, they spend in their office, doing procedures. And so it's a simple idea. We're going to the same customers that are using the product, satisfactorily, in the ASC, and we're saying, "Hey, you're doing more procedures in your office than you're doing in the surgical suite." And it's not for every procedure, but for those procedures where this can be impactful, we're going to the same customers and trying to convert their in-office business.

Mark Baum: We're going to the same customers that are using the product satisfactorily in the ASC, and we're saying, Hey, you're doing more procedures in your office than you're doing in the surgical suite. It's not for every procedure, but for those procedures where this can be impactful, we're going to the same customers and trying to convert their in-office business. It's such a small number of units, as I said, that we don't have to really be that successful to fully offset, the entirety of what we're losing when we lose the temporary pass-through code. Is that going to happen in Q1 or Q2? No, I doubt it. It should happen throughout the year.

Speaker #5: And it's such a small number of units, as I said, that we don't have to really be that successful to fully offset the entirety of what we're losing when we lose the temporary pass-through code.

Speaker #5: So is that going to happen in the first quarter or the second quarter? No. I doubt it. It should happen throughout the year. And as I said, it's such a small number of units relative to what the overall opportunity is that we can fail and fail and fail again and still end up eating up all of those lost units from the ASC.

Mark Baum: As I said, it's such a small number of units relative to what the overall opportunity is that we can fail and fail and fail again and still end up eating up all of those lost units from the ASC.

Lachlan Hanbury-Brown: Okay, thanks for that. It's good color. I guess second question is just on VEVYE and the new coverage. Just wondering what you're seeing in terms of the patients that are sort of getting scripts filled under that coverage. Are they new to brand patients or is there a sizable chunk of them who were, you know, previously paying cash pay or maybe you previously managed to get coverage for them who are now just converting to be, you know, sort of covered more easily?

Speaker #6: Okay. Thanks for that. That's good color. I guess second question is just on BY and the new coverage. I'm just wondering what you're seeing in terms of the patients that are sort of getting scripts filled under that coverage.

Speaker #6: Are they new-to-brand patients, or is there a sizable chunk of them who were previously paying cash pay, or maybe you'd previously managed to get coverage for them who are now just converting to be covered more easily?

Mark Baum: Yeah. I can't say specifically with numbers, you know, what percentage or what number of patients are converting. You know, I can sort of echo what we've said in the past and that, you know, in 2025 there were a lot of patients who we received prescriptions for, but, you know, legal prescriptions, but who were denied access to the product for one reason or another, who chose not to get their prescription filled. We're going out to those patients. Now, those patients still have legal prescriptions, and we can contact them and make them aware of the existence of coverage and try to capture as many of those as possible.

Speaker #5: Yeah. I can't say specifically with numbers what percentage or what number of patients are converting. I can sort of echo what we said in the past, in that in 2025, there were a lot of patients who we received prescriptions for, denied access to the product for one reason or another, who chose not to get their prescription filled.

Speaker #5: And so we're going out to those patients. Now, those patients still have legal prescriptions, and we can contact them and make them aware of the existence of coverage.

Speaker #5: And try to capture as many of those as possible. At the same time, there are patients who are paying cash, as you said, so these consignment patients, who do have coverage, now, but formerly did not.

Mark Baum: At the same time, there are patients who are paying cash, as you said, so these consignment patients who do have coverage now but formerly did not, and we can go to them. We know exactly who those folks are as well and convert them. This is a sizable number of people. You know, you're talking about, you know, well north of 30 million new covered lives where you have, you know, the best access for VEVYE now. We have to see how things play out. I think based on what we're seeing in Q1, we thought we would not be where we are. We're in a better place than where we thought we would be in terms of new prescriptions.

Speaker #5: And we can go to them. We know exactly who those folks are as well, and convert them. This is a sizable number of people.

Speaker #5: And you're talking about a well north of 30 million new covered lives where you have the best access for Viva see how things play out.

Speaker #5: I think based on what we're seeing in the first quarter, we thought we would not be where we are. We're in a better place.

Speaker #5: And where we thought we would be in terms of new prescriptions—the new-to-brand side of things—I think is going to come once we get these new bodies out, these new sales reps.

Mark Baum: The new to brand side of things I think is going to come once we get these new bodies out, these new sales reps. You'll have more and more of that new to brand. I can say, and I don't want to steal Pat's thunder, Pat, do you want to actually talk about the whole new to brand? I know that's really been a focus of yours.

Speaker #5: You'll have more and more of that new-to-brand. And I can say, and I don't want to steal Pat's thunder, but Pat, do you want to actually talk about the whole new-to-brand?

Speaker #5: Because I know that's really been a focus of yours?

Patrick Sullivan: Yeah. Thanks, Mark. I think, you know, the core to our next phase of growth for VEVYE is really around, you know, driving new growth for VEVYE. We know better is possible when it comes to managing dry eye disease, as Mark mentioned. Our main focus going forward is ultimately to, you know, win the new-to-brand patients. I think, you know, that's gonna be a heavy focus for us. Obviously, beginning of this year in our conversion from CVS, we are really in our expansion and leading up to our expansion, heavily focused on the right patient and working with our physicians and our communication approach to make sure that we are targeting these patients.

Speaker #3: Yeah. Thanks, Mark. And I think the core to our next phase of growth for Viva is really around driving new growth for Viva. We know better as possible when it comes to managing dry disease, as Mark mentioned.

Speaker #3: And our main focus going forward is ultimately to win the new-to-brand patients. And I think that's going to be a heavy focus for us.

Speaker #3: And obviously, the beginning of this year and our conversion from CVS, we are really in our expansion and leading up to our expansion heavily focused on the right patient and working with our physicians and our communication approach to make sure that we are targeting these patients.

Patrick Sullivan: Because what we do know is those that are having either coming in, that are having dry eye disease symptoms or are having unresolved or persistent symptoms on other suboptimal treatments, VEVYE is the perfect treatment for that. Our goal moving forward is to make sure that we have the right presence with our customers and ultimately target the right patients going forward. Mark, to your point, new to brand for us is a huge focus and will really start to come to life for us as we go to our next phase of expansion.

Speaker #3: Because what we do know is those that are having either coming in that are having dry disease symptoms or are having unresolved or persistent symptoms on other suboptimal treatments, Viva is the perfect treatment for that.

Speaker #3: Our goal moving forward is to make sure that we have the right presence with our customers and ultimately target the right patients going forward.

Speaker #3: So, Mark, to your point, new-to-brand for us is a huge focus, and we'll really start to come to life for us as we go to our next phase of expansion.

Mark Baum: Great. Thanks.

Lachlan Hanbury-Brown: Great. Thanks.

Operator: Thank you. Our next question comes from Tom Schrader with BTIG. Your line is open.

Speaker #6: Great. Thanks.

Speaker #1: Thank you. Our next question comes from Tom Schrader with BTIG, your line is open.

Thomas Schrader: Good morning. Thanks for all the updates. This is a fascinating time. On the VEVYE sales force, after your increase, where does that put you relative to competitors like MIEBO? Would you be on an equal playing field? Then, just a remedial question on the Melt franchise. Are you still wedded to two products? It seems like the first product is the bigger product, it's the combination. Does your compounding business inform you that there really is a need for two products? Thank you.

Speaker #4: Good morning. Thanks for all the updates. The fascinating time. On the Viva Salesforce, after your increase, where does that put you relative to competitors like MyBo?

Speaker #4: Would you be on an equal playing field? And then just a remedial question on the melt franchise. Are you still wedded to two products?

Speaker #4: It seems like the first product is the bigger product. It's the combination. Does your compounding business inform you that there really is a need for two products?

Mark Baum: Yeah. You know, I'll take the first question. In terms of the BYQLOVI sales force, I actually. You know, we don't know exactly how many reps, you know, these competitors have out in the field. You know, we've heard that, you know, one of our competitors that has, you know, a pretty sizable market share has upwards of 300 people. We're gonna have around 100 ourselves. What I can tell you is that our reps are so powerful that one Harrow rep with BYQLOVI is equal to four of theirs. I'm kidding. We really do have a terrific sales organization that's well-trained, and they have an outstanding product to sell. This is the second phase of our expansion.

Speaker #4: Thank you.

Speaker #5: Yeah. So I'll take the first question. In terms of the Viva Salesforce, I actually we don't know exactly how many reps these competitors have.

Speaker #5: Out in the field, we've heard that one of our competitors that's competitors that has a pretty sizable market share has upwards of 300 people.

Speaker #5: So we're going to have around 100 ourselves. What I can tell you is that our reps are so powerful that one Harrow rep with Viva is equal to four of theirs.

Speaker #5: I'm kidding. But we really do have a terrific sales organization that's well trained, and they have an outstanding product to sell. This is the second phase of our expansion.

Mark Baum: You know, we had the initial hiring for this product. This is the second phase, taking us up to around 100 territories or so. There very likely could be a slight increase in the number of territories as we see this investment pay off. But, you know, we're excited to have these, this sales force more than doubling here in the near term. I'm also pleased with the quality of people we've been able to attract, and those that we've, you know, continued to retain who are on Maria's team. In terms of Melt and the need for both products, the MKO Melt, which is a compounded formulation that we've sold for a number of years, has really informed the entirety of the development program.

Speaker #5: So, we had the initial hiring for this product. This is the second phase, taking us up to around 100 territories or so. There very likely could be a slight increase in the number of territories as we see this investment pay off.

Speaker #5: And so we're excited to have these Salesforce more than doubling here in the near term. And I'm also pleased with the quality of people we've been able to attract and those that we've continued to retain who are on Maria's team.

Speaker #5: In terms of melt and the need for both products, the MKO melt, which is a compounded formulation that we've sold for a number of years, is really informed the entirety of the development program.

Mark Baum: One of the nice things about the G-MELT when it is approved is that we're gonna discontinue the compounded version of the product, and we'll hopefully convert all of that business into, you know, an FDA-approved and hopefully reimbursable product. It is very hard, as I've said over the years, to sell compounded medications. They're not FDA-approved. They don't have a label, particularly in anesthesia and sedation, where an anesthesia professional is, you know, gonna think twice or three times about whether or not they're gonna use a compounded formulation. When we have an on-label FDA-approved product that is also hopefully reimbursed, this should significantly expand the market opportunity for the G-MELT in cataract surgery, but also for other procedures where, you know, and a sublingual non-opioid sedation choice can prevail.

Speaker #5: One of the nice things about the GMelt when it is approved is that we're going to discontinue the compounded version of the product, and we'll hopefully convert all of that business into an FDA-approved and hopefully reimbursable product.

Speaker #5: It is very hard, as I've said over the years, to sell compounded medications. They're not FDA-approved. They don't have a label. Particularly in anesthesia and sedation, where an anesthesia professional is going to think twice or three times about whether or not they're going to use a compounded formulation.

Speaker #5: So when we have an on-label FDA-approved product that is also hopefully reimbursed, this should significantly expand the market opportunity for the GMelt. In cataract surgery, but also for other procedures where a sublingual non-opioid sedation choice can prevail.

Mark Baum: In terms of why we need also the two ten program, the two ten program addresses a different market segment. Believe it or not, in terms of the total number of units of opportunity for it, based on the expected label, and we still need to discuss that, you know, with the FDA and come to a resolution around what ultimately a label might look like for what is now called Yochil. That product, in terms of unit demand, is bigger in unit volume demand, we believe, than even the G-MELT. The G-MELT will be used certainly in cataract surgery, which is what we're studying it for. We also believe it will be used, as the compounded product is used in ENT, in, you know, for endoscopy. It's used in dermatology, plastics, dental, widely used in dental.

Speaker #5: In terms of why we need also the 210 program, the 210 program addresses a different market segment. And believe it or not, in terms of the total number of units of opportunity for it, based on the expected label - and we still need to discuss that with the FDA and come to a resolution around what ultimately a label might look like for what is now called Yochill - that product, in terms of unit demand, is bigger in unit volume demand.

Speaker #5: We believe than even the GMelt. The GMelt will be used certainly in cataract surgery, which is what we're studying it for. We also believe it will be used as the compounded product is used in ENT and for endoscopy; it's used in dermatology; plastics; dental; widely used in dental; it's used to deal with claustrophobia and MRI tubes.

Mark Baum: It's used to deal with claustrophobia in MRI tubes. That's the experience that we have with the MKO Melt, the compounded version. Our expectation is that the G Melt, when it's approved, eventually will be used in markets outside of ophthalmology, which happen to be even bigger markets than the ophthalmic market. The answer is yes, we need two products. They serve different markets. One is specifically related to anxiety, and it will also, as I said, be available, and I said this, I think, in the letter to stockholders ultimately be available in a number of different strengths.

Speaker #5: And so that's the experience that we have with the MKO melt, the compounded version. And our expectation is that the GMelt, when it's approved, eventually will be used in markets outside of ophthalmology, which happen to be even bigger markets than the ophthalmic market.

Speaker #5: But the answer is yes, we need two products. They serve different markets. One is specifically related to anxiety, and it will also - as I said - be available.

Speaker #5: And I said this, I think, in the letter to stockholders in three different ultimately be available in a number of different strengths.

Thomas Schrader: If I can sneak in one follow-up. The new TRIESENCE, I mean, it seems like it's much easier product to make and use. Do you think you might expand that outside the eye where that steroid is used, or is this entirely a formulation for the eye?

Speaker #4: If I can sneak in one follow-up. The new Triessence, I mean, it seems like it's much easier product to make and use. Do you think you might expand that outside the eye?

Speaker #4: Where that steroid is used? Or is this entirely a formulation for the eye?

Mark Baum: It's purely for the eye. It's... You know, we started our company in 2014. Our first sale was with triamcinolone acetonide for injection. This is a product category, an active ingredient we know really, really well. You know, our compounded formulation, once again, the enthusiasm for TRIESENCE for us comes from our experience having sold Tri-Moxi in, you know, well over 1 million cataract surgeries. It's a market we know well. It's just this product is just going to be for the eye. We have real high hopes that we can once again create this protocol, which is IV-free, opioid-free, and even eye-drop-free eventually for cataract surgery patients, which is really where the market needs to go.

Speaker #5: It's purely for the eye. We started our company in 2014. Our first sale was with Triamcinolone acedonide for injection. And this is a product category and an active ingredient we know really, really well.

Speaker #5: Our compounded formulation—once again, the enthusiasm for Triessence for us comes from our experience having sold Trimoxy in well over a million cataract surgeries.

Speaker #5: So, it's a market we know well. It's just this product is just going to be for the eye. But we have real high hopes that creating this protocol, which is IV-free, opioid-free, and even eyedrop-free eventually, for the cataract market needs to—

Thomas Schrader: Thanks for all the color.

Mark Baum: Thanks, Tom.

Speaker #4: Great. Thanks for all the calls.

Operator: Thank you. Our next question comes from Thomas Slaton with Lake Street Capital Markets. Your line is open.

Speaker #5: Thanks, Tom.

Speaker #1: Thank you. Our next question comes from Thomas Flatten with Lake Street Capital Markets. Your line is open.

Thomas Slaton: Hey, good morning, guys. Appreciate you taking the question. Following up on VEVYE, with respect to the sales force expansion, can you talk a little bit about, and I think you alluded to this, Mark, that it's a lot of new territory, but new territory versus territory splitting because of overload, and then how you see the dynamics between the ophthalmology and optometry community playing into that growth expectation?

Thomas Flaten: Hey, good morning, guys. Appreciate you taking the question. Following up on VEVYE, with respect to the sales force expansion, can you talk a little bit about, and I think you alluded to this, Mark, that it's a lot of new territory, but new territory versus territory splitting because of overload, and then how you see the dynamics between the ophthalmology and optometry community playing into that growth expectation?

Speaker #6: Hey, good morning, guys. Appreciate you taking the question. Following up on Vivi, with respect to the Salesforce expansion, can you talk a little bit about—and I think you alluded to this, Mark—that it's a lot of new territory?

Speaker #6: But new territory versus territory splitting because of overload and then how you see the dynamics between the ophthalmology and optometry community playing into that growth expectation?

Mark Baum: I'll take the second one first, and then I'll flip the first to Pat. You know, in terms of the sales force, actually, pardon me. Your second sales force expansion and what else, Thomas?

Speaker #5: Well, I'll take the second one first, and then I'll flip the first to Pat. But in terms of the Salesforce actually, pardon me. Your second Salesforce expansion and what else, Thomas?

Thomas Slaton: The ophthalmology versus optometry component.

Thomas Flaten: The ophthalmology versus optometry component.

Mark Baum: Yeah. Ophthalmology. Yeah. Ophthalmology and optometry, believe it or not, you know, the optometric market is a critical market. I would say that, you know, I would be slightly biased towards the optometric market. I think now, optometrists are writing as many or probably more prescriptions for dry eye medications than ophthalmologists. That's what the data that I'm seeing shows. Pat, do you want to talk about the sales force expansion specifically?

Speaker #6: The ophthalmology versus optometry component.

Speaker #5: Yeah, ophthalmology. Yeah. So, ophthalmology and optometry, believe it or not, the optometric market is a critical market. I would say that I would be slightly biased towards the optometric market.

Speaker #5: I think now optometrists are writing as many or probably more prescriptions for dry eye medications than ophthalmologists. That's what the data that I'm seeing shows.

Speaker #5: But Pat, do you want to talk about the Salesforce expansion specifically?

Patrick Sullivan: Yeah. Thanks, Mark. I think when we think about the expansion, I mean, this is a real great opportunity for us to look at the great progress that VEVYE has done for dry eye disease patients to date. I think, you know, one of the first things we do is, you know, look at this to your point, you were talking about, like, basically business interruption versus business continuity. It sounded like your question was around. I think we're taking a very methodical approach to make sure that we are, one, relooking at making sure that this approach going forward. It is sales force expansion, but it is about VEVYE's brand presence and promotional efficiency in front of our customers going forward. This is a very active category that is large, growing, and active.

Speaker #4: Yeah, thanks, Mark. And I think when we think about the expansion, I mean, this is a really great opportunity for us to look at the great progress that Vivi has made for dry disease patients to date.

Speaker #4: And I think one of the first things we do is look at this to your point. You were talking about basically business interruption versus business continuity.

Speaker #4: It sounded like your question was around—I think we're taking a very methodical approach to make sure that we are, one, re-looking at making sure that this approach going forward, it is Salesforce expansion, but it is about Vivi's brand presence and promotional efficiency in front of our customers going forward.

Patrick Sullivan: For us, like to the prior question by one of your colleagues around, you know, playing in that dynamic part of the market where that new to brand is, it's gonna take not only having our current territories be very efficient, but also our expansions. We are being very, very thoughtful in how we're, one, putting our footprint together. I think the key takeaway here is VEVYE is poised for significant growth going forward, but it'll be about how we, one, put a new VEVYE presence in front of our customers. That one is, you know, is really about differentiation, new to brand, and having the right presence that is commensurate with being a number one goal of being a number one cyclosporine and number one dry disease treatment.

Speaker #4: This is a very, very active category that is large, growing, and active. And for us, to the prior question by one of your colleagues around playing in that dynamic part of the market where that new-to-brand is, it's going to take not only having our current territories be very efficient, but also our expansions.

Speaker #4: We are being very, very thoughtful in how we're, one, putting our footprint together. But I think the key takeaway here is Vivi is poised for significant growth going forward, but it'll be about how we want to put a new Vivi presence in front of our customers that, one, is really about differentiation, new-to-brand, and having the right presence that is commensurate with being a number one goal of being a number one cyclosporine, a number one dry disease treatment.

Patrick Sullivan: To your question, very thoughtful on how we'll drive that business to maintain our aims and our growth going forward.

Speaker #4: So to your question, very thoughtful in how we'll drive that business to maintain our aims and our growth going forward.

Thomas Slaton: Got it.

Thomas Flaten: Got it.

Mark Baum: Thomas, as a practical matter, look, we need to get salespeople in these offices. They need to see their VEVYE reps more frequently. That's what this is about. We know where the high-value targets are. We know who's prescribing dry eye disease. We know who is looking for dry eye disease. This expansion is gonna allow more Harrow VEVYE reps to get in those offices far more frequently. You know, our data demonstrates very clearly that when we do that, we end up with more prescriptions for VEVYE. I think you're gonna see that throughout the year.

Speaker #6: Got it. And Thomas, just to add, as a practical matter, look, we need to get salespeople in these offices. They need to see their Vivi reps more frequently.

Speaker #6: And that's what this is about. We know where the high-value targets are. We know who's prescribing dry disease. We know who is looking for dry eye disease.

Speaker #6: And this expansion is going to allow more Harrow VIvi reps to get in those offices far more frequently. And our data demonstrates very clearly that when we do that, we end up with more prescriptions.

Speaker #6: For Vivi. And I think you're going to see that throughout the year. And Mark, to follow up on the last commentary around melts being used or MKO being used a lot outside of ophthalmology indications, what can we expect with respect to deal-making to get melt appropriately exploited in those opportunities that are outside ophthalmology?

Thomas Slaton: Mark, to follow up on the last commentary on Melt being used or MKO being used a lot outside of ophthalmology indications, what can we expect with respect to deal making to get Melt, you know, appropriately exploited in those opportunities that are outside ophthalmology?

Thomas Flaten: Mark, to follow up on the last commentary on Melt being used or MKO being used a lot outside of ophthalmology indications, what can we expect with respect to deal making to get Melt, you know, appropriately exploited in those opportunities that are outside ophthalmology?

Mark Baum: Well, right now, we are completely focused on two things. One is Amir and his team building this data set. I've put a bounty on him getting that NDA in sooner than he even thinks he's able to get it in. I'm hopeful that, you know, we can hopefully, you know, we can beat some of these timelines that we've laid out. It's all about getting the NDA in and getting the data in front of the FDA so that we can hopefully get this approved and then ultimately get it coded for reimbursement. The second thing is that the market, even in ophthalmology, and you're talking about 5 million use cases minimally per year, and that's just really cataract surgery. If you tack on glaucoma surgeries and other relevant procedures, you know you can add another couple of million procedures.

Speaker #5: Well, right now, we are completely focused on two things. One is Amir and his team building this data set. I've put a bounty on him getting that NDA in sooner than he even thinks he's able to get it in.

Speaker #5: And I'm hopeful that we can hopefully we can beat some of these timelines that we've laid out. So it's all about getting the NDA in and getting the data in front of the FDA so that we can hopefully get this approved and then ultimately get it coded for reimbursement.

Speaker #5: The second thing is that the market, even in ophthalmology and you're talking about 5 million use cases, minimally, per year. And that's just really cataract surgery.

Speaker #5: If you tack on glaucoma surgeries and other relevant procedures, you can add another couple of million procedures. So for a reimbursed non-opioid non-IV sedation medicament, the opportunity in ophthalmology is very large.

Mark Baum: For a reimbursed non-opioid, non-IV sedation medicament, the opportunity in ophthalmology is very large. You know, it's billions of dollars per year, where our competition is IVs and opioids. The data, there's a Duke study, there's a Mayo study, the data is clear. Patients today are getting dosed with fentanyl for sedation during cataract surgery in particular. We aim to change that. We've got to build our commercial strategy for the G-MELT, and that is underway, so that's the second component. Other than that, outside of the US market in ophthalmology and getting the studies completed and filing the NDA, you know, something happens where there's a partnership that is revealed or an opportunity like that that's revealed, we'll certainly pursue it.

Speaker #5: It's billions of dollars per year, where our competition is IVs and opioids. I mean, the data there was a Duke study. There was a Mayo study.

Speaker #5: The data is clear. Patients today are getting dosed with fentanyl for sedation during cataract surgery, in particular. And so we aim to change that.

Speaker #5: We've got a build our commercial strategy for the GMelt, and that is underway. So that's the second component. Other than that, outside of the US market in ophthalmology, and getting the studies completed and filing the NDA, something happens where there's a partnership that is revealed or an opportunity like that that's revealed will certainly pursue it.

Mark Baum: We have such a big revenue opportunity with the G-MELT in ophthalmology that we need to really stay focused on that, and that's what we're gonna do.

Speaker #5: But we have such a big revenue opportunity with the GMelt in ophthalmology that we need to really stay focused on that. And that's what we're going to do.

Amir H. Shojaei: Got it. Appreciate it. Thank you.

Thomas Flaten: Got it. Appreciate it. Thank you.

Operator: Thank you. Our next question comes from Jeffrey Cohen with Ladenburg Thalmann & Co. Inc. Your line is open.

Speaker #4: Got it. Appreciate it. Thank you.

Speaker #1: Thank you. Our next question comes from Jeffrey Cohen with Leidenburg Dallman & Company, your line is open.

Jeffrey S. Cohen: Hey, good morning. Thanks for taking our questions. I guess two from our end. Firstly, Mark or Andrew, could you comment any on margins and/or tariffs and ramifications throughout 2026 or any net changes that you're seeing now from 2025?

Speaker #7: Hey, good morning. Thanks for taking our questions. I guess, true from our own, firstly—Mark or Andrew, could you comment any on margins and/or tariffs, and ramifications throughout 2026, or any net changes that you're seeing now from '25?

Mark Baum: Andrew, you want to tackle tariffs and margins?

Andrew R. Boll: Yeah. Hey, Jeff.

Speaker #5: Andrew, you want to tackle tariffs? Margins?

Jeffrey S. Cohen: Hey

Andrew R. Boll: ... from a yeah, on the tariff side, we're not expecting much impact. I think the analysis we did last year was kinda almost in a worst-case scenario when we kind of re-looked at things, and we're doing that on a continual basis. The analysis we did last year is still holding strong, and actually we're in better shape than we would've been last year in that worst-case scenario around Liberation Day. Not to answer your question more directly, just we're not expecting to see any impact on margins as it relates to tariffs this year.

Speaker #8: Yeah, Andrew, from a—yeah, on the tariff side, we're not expecting much impact. I think the analysis we did last year was almost in a worst-case scenario when we kind of relooked at things, and we're doing that on a continual basis.

Speaker #8: The analysis we did last year is still holding strong, and actually, we're in better shape than we would have been last year in that worst-case scenario around deliberation day.

Speaker #8: So to answer your question more directly, we're not expecting to see any impact on margins as it relates to tariffs this year.

Jeffrey S. Cohen: Got it. Then secondly, any commentary on your midyear expected launch on BYOOVIZ as far as preparations and commercial organization and how that might look like midyear?

Speaker #7: Got it. And then secondly, any commentary on your major expected launch on Biovis as far as preparations and commercial organization and how that might look like mid-year?

Mark Baum: Andrew, you wanna touch on that at all? Anything you wanna add there? I think we're ready to go. We're, I think, gonna start realizing revenue, and the team's got a very unique strategy. Andrew, do you wanna touch on that or Pat?

Speaker #5: Andrew, you want to? Touch on that at all? Anything you want to add there? I think we're ready to go. I think we start realizing revenue.

Speaker #5: And the team's got a very unique strategy. Andrew, do you want to touch on that or Pat?

Andrew R. Boll: I can touch on it a little bit and then hand it over to Pat. Jeff, we're really leveraging the existing retina team with that launch. There's some incremental costs that'll go into that. We'll have some variable costs as we get the hub up to help support the product. We're really excited to get that thing going. We've got a great partner in Samsung as well, that's helping us, helping us as we prep. This is a very dynamic market. We're gonna be getting in with BYOOVIZ right away in the middle of this year, which is a LUCENTIS-referenced biosimilar. You may have recently seen that Samsung announced they've entered into a settlement with the innovator drug for EYLEA.

Speaker #8: Yeah, I can touch on a little bit and then hand it over to Pat. Jeff, we're really leveraging the existing retina team with that launch.

Speaker #8: There's some incremental costs that'll go into that. We'll have some variable costs as we get the hub up to help support the product. But we're really excited to get that thing going.

Speaker #8: We've got a great partner in Samsung as well that's helping us as we prep this is a very dynamic market. We're going to be getting in with Biovis right away.

Speaker #8: In the middle of this year, which is the Lucentis reference biosimilar, and then you may have recently seen the Samsung announced it's entered into a settlement with the Innovator drug for Eylea.

Andrew R. Boll: We'll be able to get into the market a little earlier than we expected with that product as well at the beginning of next year, which will be in January. From a spend perspective, like I said, we'll leverage most of the existing sales force. There will be some small incremental costs there, and maybe some variable costs related to the hub activity for the products. Should be highly accretive to earnings on new revenues. Pat, do you wanna add anything?

Speaker #8: And so we'll be able to get into the market a little earlier than we expected with that product as well at the beginning of next year, which will be in January.

Speaker #8: But from a spend perspective, like I said, we'll leverage most of the existing sales force or be some small incremental costs there. And maybe some variable costs related to the hub activity for the products.

Speaker #8: But it should be highly, highly accretive to earnings on new revenues. Pat, do you want to add anything?

Patrick Sullivan: Thanks, Andrew. I think the one thing to add is, you know, as Mark mentioned, you know, we're really excited to get this going. You know, thinking about back to Mark's comments about the team that we have here, a very deep set of heritage in the retina space. I think to me, we will capitalize on that very quickly. I think in addition, when you think about our current portfolio, we've made significant strides in growing our retina business, and this is gonna, you know, help us significantly with our presence in growing the value of that franchise. We are actively right now preparing the market and targeting our business to take off here in the middle of this year. You know, we're super excited about BYOOVIZ going forward.

Speaker #4: Thanks, Andrew. I think the one thing to add is as Mark mentioned, we're really excited to get this going. Thinking about back to Mark's comments about the team that we have here, a very deep set of heritage in the retina space.

Speaker #4: So I think to me, we will capitalize on that very quickly. I think in addition, when you think about our current portfolio, we made significant strides in growing our retina business.

Speaker #4: And this is going to help us significantly with our presence in growing the value of that franchise. And we are actively right now preparing the market and targeting our business to take off here in the middle of this year.

Speaker #4: So we're super excited about Biovis going forward.

Jeffrey S. Cohen: Perfect. Thanks. Take more questions.

Mark Baum: Thanks, Jeff.

Speaker #7: Perfect. Thanks for taking my questions.

Operator: Thank you. Our next question is from Yi Chen with H.C. Wainwright.

Speaker #5: Thanks, Jeff.

Speaker #1: Thank you. Our next question from Lee Chen with HP Wainwright.

Operator: Thank you for taking my questions. Could you comment on your marketing strategy for the biosimilar, whether they will have a dedicated sales force and how you are going to present your biosimilar as a differentiated product from other biosimilar competitors? Thank you.

Yi Chen: Thank you for taking my questions. Could you comment on your marketing strategy for the biosimilar, whether they will have a dedicated sales force and how you are going to present your biosimilar as a differentiated product from other biosimilar competitors? Thank you.

Speaker #9: Thank you for taking my questions. Could you comment on your marketing strategy for the biosimilar? Whether they will have a dedicated sales force and how you are going to present your biosimilar as a differentiated product from other biosimilar competitors?

Mark Baum: Yes. Thanks for the question, Yi. You know, as I think Andrew referenced and as Pat discussed, and I think as you know, it is a highly dynamic market. It is competitive, and we have a unique place in the market with our LUCENTIS reference biosimilar. At this point, I really don't wanna reveal specifically how we're going to, you know, attain the market share that we expect to drive towards. What I have said in the past is that based on our cost in getting into the deal, the level of success that we need to achieve to make this highly profitable is quite low. We're not playing to get 30% market share with BYOOVIZ.

Speaker #9: Thank you.

Speaker #5: Yes, so thanks for the question, Lee. As I think Andrew referenced, and as Pat discussed—and I think as you know—it is a highly dynamic market.

Speaker #5: It is competitive. And we have a unique place in the market with our Lucentis reference biosimilar. And at this point, I really don't want to reveal specifically how we're going to attain the market share that we expect to drive towards.

Speaker #5: What I have said in the past is that, based on our cost in getting into the deal, the level of success that we need to achieve to make this highly profitable is quite low.

Speaker #5: We're not playing to get 30% market share. With Biovis, we're playing to get a handful of percentage points of market share in this market, which is the largest market in ophthalmology by revenue.

Mark Baum: We're playing to get a handful of percentage points of market share in this market, which is the largest market in ophthalmology by revenue. Our expectations are quite modest, and we believe that the strategy that we're going to employ, with the team that we have, which as Pat said, has a tremendous background in relationships, and this market is gonna be successful in helping us get to our goals. We don't have, you know, you know, we're trying to get about a handful of percentage points of market share, which is what we've said historically.

Speaker #5: And so, our expectations are quite modest. We believe that the strategy we're going to employ with the team that we have—which, as Pat said, has a tremendous background in relationships in this market—is going to be successful in helping us get to our goals.

Speaker #5: But we don't have we're trying to get about a handful of percentage points of market share, which is what we've said historically. Thank you.

Operator: Thank you.

Yi Chen: Thank you.

Andrew R. Boll: Gee, I can add a little bit too. You know, the one big advantage we have compared to everyone else in this market is we have other products that we're selling these doctors. It allows us to provide a really comprehensive offering. We can talk about the patient experience with our anesthetic. No one else has that anesthetic in the biosimilars. It's more than just the biosimilar products that we're gonna be selling. It's this comprehensive package of products where we totally support the practice and focusing on the patient experience.

Speaker #8: See, I can add a little bit too. The one big advantage we have compared to everyone else in this market is we have other products that we're selling in these doctors.

Speaker #8: And so it allows us to provide a really comprehensive offering. We can talk about the patient experience with our anesthetic. No one else has that anesthetic in the biosimilars.

Speaker #8: And so it's more than just the biosimilar products that we're going to be selling. It's this comprehensive package of products where we totally support the practice and focus in on the patient experience.

Operator: Got it. Thank you. Thank you. I'm showing no further questions. I'd like to turn the call back over to Mark Baum, CEO, for closing remarks.

Yi Chen: Got it. Thank you.

Operator: Thank you. I'm showing no further questions. I'd like to turn the call back over to Mark Baum, CEO, for closing remarks.

Speaker #9: Got it. Thank you.

Speaker #1: Thank you. I'm showing no further questions. I'd like to turn the call back over to Mark Baum, CEO, for closing remarks.

Mark Baum: Well, first, this is not in my script, I have to say that this call was the longest call I think we've ever had. It reminds me of our recent State of the Union. It set a record. We're gonna definitely work next time to try and make this call a little bit more efficient. We apologize for the time that this call took, but I think it was worthwhile. Hopefully, anyone who is listening feels a lot more knowledgeable about where this company is and where we're going over the coming quarters and years. Across the portfolio, we're seeing tangible momentum, improved access, expanding adoption, and growing commercial execution. We've got a great new commercial leadership team. Multiple products are scaling meaningfully.

Speaker #7: Well, first, and this is not in my script, I have to say that this call is the longest call I think we've ever had.

Speaker #7: It reminds me of our recent State of the Union. It set a record. And so we're going to definitely work next time to try and make this call a little bit more efficient.

Speaker #7: So we apologize for the time that this call took. But I think it was worthwhile and hopefully anyone who is listening feels a lot more knowledgeable about where this company is and where we're going over the coming quarters and years.

Speaker #7: Across the portfolio, we're seeing tangible momentum, improved success, expanding adoption, and growing commercial execution. We've got a great new commercial leadership team. Multiple products are scaling meaningfully.

Mark Baum: Key franchises are gaining depth. We're seeing early signs of inflection where we've been patient and disciplined. The result is that you own a business with increasing revenue concentration that is in durable high-value assets and that we have multiple pathways with other products for continued growth. I wanna thank you for your continued confidence in Harrow. We're building something durable and lasting and valuable. We believe the most exciting part of our story is still ahead. This will conclude our call. Thank you.

Speaker #7: Key franchises are gaining depth. And we're seeing early signs of inflection where we've been patient and disciplined. And the result is that you own a business with increasing revenue concentration that is in durable high-value assets.

Speaker #7: And that we have multiple pathways with other products for continued growth. I want to thank you for your continued confidence in HARROW. We're building something durable and lasting and valuable.

Speaker #7: And we believe the most exciting part of our story is still ahead. This will conclude our call. Thank you.

Operator: Thank you for your participation. You may now disconnect. Everyone, have a great day.

Q4 2025 Harrow Inc Earnings Call

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