Q2 2025 Harrow Earnings Call
Shannon: Good morning and welcome to Harrow Inc.'s second quarter of 2025 earnings conference call. My name is Shannon, and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session. As a reminder, this conference is being recorded. I would now like to turn the conference over to Mike Viega, Vice President of Investor Relations and Communications for Harrow Inc.
Speaker #2: Good morning, and welcome to HARROW's second quarter 2025 earnings conference call. My name is Shannon, and I will be your operator for today's call.
Speaker #2: At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session. As a reminder, this conference is being recorded.
Speaker #2: I would now like to turn the conference over to Mike Viega, Vice President of Investor Relations and Communications for HARROW.
Mike Viega: Thank you, Operator. Good morning and welcome to Harrow's second quarter 2025 earnings conference call. My name is Mike Viega, and I am excited to be introducing today's call, having joined Harrow as Vice President of Investor Relations and Communications in June. It is a pleasure to be part of the Harrow family and to speak with all of you this morning. Before we begin today, I would like to highlight a few new items for our quarterly report. We will be presenting slides during the webcast today. If you have registered and joined through the live conference call link, I would highly recommend that you also join through the webcast. You can find the link in the Investors Events section of our website at www.harrow.com or in our earnings press release that was issued yesterday. We also have a new corporate deck that was posted on our website yesterday.
Speaker #3: Thank you, operator. Good morning, and welcome to Harrow's second quarter 2025 earnings conference call. My name is Mike Viega, and I'm excited to be introducing today's call.
Speaker #3: Having joined HARROW as Vice President of Investor Relations and Communications in June, it's a pleasure to be part of the HARROW family and to speak with all of you this morning.
Speaker #3: Before we begin today, I would like to highlight a few new items for our quarterly report. We will be presenting slides during the webcast today.
Speaker #3: If you have registered and joined through the live conference call link, I would highly recommend that you also join through the webcast. You can find the link in the Investors Events section of our website, at www.harrow.com, or in our earnings press release that was issued yesterday.
Speaker #3: We also have a new corporate deck that was posted on our website yesterday. All of the slides we will be presenting today can be found in that deck.
Mike Viega: All of the slides we will be presenting today can be found in that deck. Moving forward, you should expect that our earnings process will mirror this format with potentially a few additional changes, and we will certainly update you on any future changes to this format. In addition, we recently launched a new corporate website, which I encourage all of you to explore. 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.
Speaker #3: Moving forward, you should expect that our earnings process will mirror this format, with potentially a few additional changes. We will certainly update you on any future changes to this format.
Speaker #3: In addition, we recently launched a new corporate website, which I encourage all of you to explore. The company's remarks may include forward-looking statements, within the meaning of federal securities laws.
Speaker #3: 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 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.
Mike Viega: 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 and subsequent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission. 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. Additionally, Harrow will refer to non-GAAP financial metrics, specifically adjusted EBITDA and/or adjusted earnings, as well as core results such as core gross margin, core net income, and core diluted net income per share.
Speaker #3: 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, and subsequent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission.
Speaker #3: 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 #3: This conference call contains time-sensitive information and is accurate only as of today. Additionally, HARROW will refer to non-GAAP financial metrics, specifically adjusted EBITDA and/or adjusted earnings, as well as core results, such as core gross margin, core net income, and core diluted net income per share.
Mike Viega: A reconciliation of any non-GAAP measures with the most directly comparable GAAP measures is included in the company's earnings release and letter to stockholders, both of which are available on the website. By now, you should have received a copy of the earnings press release. If you have not received a copy, please go to the Investor Relations page of the company's website, www.harrow.com. Joining me on today's call are Harrow's Chief Executive Officer, Mark L. Baum, and Harrow's Chief Financial Officer, Andrew Bull. With that, I would like to turn the call over to Mark to go over some prepared remarks prior to the question and answer session. Mark.
Speaker #3: A reconciliation of any non-GAAP measures with the most directly comparable GAAP measures is included in the company's earnings release and letter to stockholders, both of which are available on the website.
Speaker #3: By now, you should have received a copy of the earnings press release. If you have not received a copy, please go to the Investor Relations page of the company's website, www.harrow.com.
Speaker #3: Joining me on today's call are HARROW's Chief Executive Officer, Mark L. Baum, and HARROW's Chief Financial Officer, Andrew Bolt. With that, I would like to turn the call over to Mark to go over some prepared remarks prior to the question and answer session.
Speaker #3: Mark?
Mark L. Baum: Thanks, Mike, and good morning, everyone. Thank you for joining us today. I hope you have had the opportunity to review our supplemental documents for the second quarter, including our earnings release, corporate presentation, and letter to stockholders, all of which are now available on the Investor Relations section of our newly designed harrow.com website. Harrow is a leading provider of ophthalmic disease management solutions in North America, enhancing the ability of eye care professionals to manage sight-threatening ophthalmic diseases. To achieve this, we ensure that our products are safe and efficacious, accessible and affordable, and that they increase patient compliance, which in turn facilitates improved ophthalmic disease management. Today, our ophthalmic disease management solutions are all pharmaceuticals, but in the future, this may evolve. In any case, our focus will always be to provide leading-edge products and outstanding service to help eye care professionals best care for their patients.
Speaker #4: Thanks, Mike, and good morning, everyone. Thank you for joining us today. I hope you've had the opportunity to review our supplemental documents for the second quarter, including our earnings release, corporate presentation, and letter to stockholders.
Speaker #4: All of which are now available on the Investor Relations section of our newly designed harrow.com website. HARROW is a leading provider of ophthalmic disease management solutions, in North America, enhancing the ability of eye care professionals to manage sight-threatening ophthalmic diseases.
Speaker #4: To achieve this, we ensure that our products are safe and efficacious, accessible and affordable, and that they increase patient compliance, which, in turn, facilitates improved ophthalmic disease management.
Speaker #4: Today, our ophthalmic disease management solutions are all pharmaceuticals. But in the future, this may evolve. In any case, our focus will always be to provide leading-edge products and outstanding service to help eye care professionals best care for their patients.
Mark L. Baum: Our primary financial goal is to deliver a $250 million revenue quarter by the end of 2027. I believe this is achievable because of what we own, how we are performing, and where I see the business heading, and our demonstrated history of growth from literally no customers, no products, and no revenue about a dozen years ago. I intend to provide more color on how we intend to achieve this $250 million quarterly revenue goal on September 26th during our inaugural Investor and Analyst Day, an event that Mike Viega is working to put together. This event, which we intend to make an annual event, will be hosted by Harrow Leadership after Labor Day each year. I am looking forward to our stockholders and analysts meeting members of the Harrow Leadership team, seeing our products live, and learning more about how we partner with U.S.
Speaker #4: Our primary financial goal is to deliver a $250 million revenue quarter by the end of 2027. I believe this is achievable because of what we own, how we're performing, and where I see the business heading.
Speaker #4: And our demonstrated history of growth—from literally no customers, no products, and no revenue—about a dozen years ago. I intend to provide more color on how we intend to achieve this $250 million quarterly revenue goal on September 26th during our inaugural Investor and Analyst Day, an event that Mike Viega is working to put together.
Speaker #4: This event, which we intend to make an annual event, will be hosted by HARROW leadership after Labor Day each year. I'm looking forward to our stockholders and analysts meeting members of the HARROW leadership team, seeing our products live and learning more about how we partner with U.S.
Mark L. Baum: eye care professionals to manage ophthalmic diseases. For more information, please reach out to Mike at mviega, V-I-E-G-A, at harrowinc.com if you are interested in attending. Over the past five years, we have built a sophisticated and hard-to-replicate infrastructure. Today, we own one of the most extensive portfolios of ophthalmic products in the United States, now totaling more than 59 prescription products. We address both front and back of the eye diseases. We sell into both the insurance reimbursed market and the cash-pay market. We sell to the eye care professional office, the ASC, and hospital, and we ship directly to patients. I think one of the things I am most excited about, as Andrew Bull and I look over the one or two-year horizon, is the incredible leverage we have in our model.
Speaker #4: eye care professionals to manage ophthalmic diseases. For more information, please reach out to Mike at m.viega@harrowinc.com. If you're interested in attending, now, over the past five years, we have built a sophisticated and hard-to-replicate infrastructure.
Speaker #4: Today, we own one of the most extensive portfolios of ophthalmic products in the United States, now totaling more than $59,000 prescription products. We address both front and back of the eye diseases.
Speaker #4: We sell into both the insurance reimbursed market and the cash pay market. We sell to the eye care professional office, the ASC, and hospital.
Speaker #4: And we ship directly to patients. I think one of the things I'm most excited about is Andrew and I look over the one or two-year horizon is the incredible leverage we have in our model.
Mark L. Baum: Essentially, our commercial infrastructure is paid for in delivering profits as demand increases for key products like VEVYE and IHEEZO, and we add revenue-generating assets like the Samsung ophthalmic biosimilars portfolio, or we begin to sell TRIESENCE into a key large market, which I will talk more about. We really are not incurring meaningful additional costs, which means much of what we sow, we should reap. The second quarter was a great setup for the back half of the year as we saw deeper market penetration across our core growth drivers. Largely due to the recently implemented VEVYE Access for All initiative, VEVYE saw a 66% growth in prescription volumes this quarter over the prior quarter, and we do not see any signs of that momentum slowing.
Speaker #4: Essentially, our commercial infrastructure is paid for in delivering profits. As demand increases for key products like Viva and EyeHeso, and we add revenue-generating assets like the Samsung ophthalmic biosimilars portfolio, or we begin to sell Triesence into a key large market, which I'll talk more about, we really aren't incurring meaningful additional costs. This means much of what we sow, we should reap.
Speaker #4: The second quarter was a great setup for the back half of the year, as we saw deeper market penetration across our core growth drivers.
Speaker #4: Largely due to the recently implemented Viva Access for All initiative, Viva saw a 66% growth in prescription volumes this quarter over the prior quarter.
Speaker #4: And we don't see any signs of that momentum slowing. Capitalizing on the growing demand for Viva today, we announced a strategic alliance with Apollo Care.
Mark L. Baum: Capitalizing on the growing demand for VEVYE, today we announced a strategic alliance with ApolloCare, an innovative provider of patient access and commercial solutions that provides full nationwide coverage across the U.S. as Harrow Inc.'s second specialty pharmacy partner for the VAFA program. IHEEZO's Retina Pivot is taking hold with a 25% growth in unit volume quarter over quarter. TRIESENCE continued to gain momentum with volumes accelerating and market share expanding, achieving 32% quarter over quarter growth. The numbers for the third quarter for TRIESENCE are also doing well. Our specialty branded product portfolio, well-known essential everyday therapies relied on by thousands of eye care professionals, delivered a strong quarter and a nice rebound from the first quarter. Finally, we recently announced two strategic acquisitions that fit in seamlessly with our commercial infrastructure. One, at the end of the second quarter, we secured the U.S.
Speaker #4: An innovative provider of patient access and commercial solutions, that provides full nationwide coverage across the United States. As HARROW's second specialty pharmacy partner for the BAFA program.
Speaker #4: EyeHeso's RetinaPivot is taking hold, with a 25% growth in unit volume quarter over quarter. Triesence continued to gain momentum, with volumes accelerating and market share expanding.
Speaker #4: Achieving 32% quarter over quarter growth. And by the way, the numbers for the third quarter for Triesence are also doing well. Our specialty branded product portfolio, well-known, essential, everyday therapies, relied on by thousands of eye care professionals, delivered a strong quarter and a nice rebound for the first quarter.
Speaker #4: Finally, we recently announced two strategic acquisitions that fit in seamlessly with our commercial infrastructure. One, at the end of the second quarter, we secured the U.S.
Mark L. Baum: rights to BICLOVI, which was a recently approved treatment for postoperative inflammation and pain following ocular surgery. This is the first new ophthalmic steroid in its class in over 15 years. Second, we also recently acquired the U.S. rights to Samsung's ophthalmic biosimilars pipeline, including BioViz, an FDA-approved biosimilar referencing Lucentis, and Opuviz, an FDA-approved biosimilar referencing Eylea. Our total revenue for the second quarter was $63.7 million, a 30% increase over the second quarter of 2024, and a sequential increase of 33% from the first quarter of 2025. The first half of 2025 generated $111.6 million in revenue. To reach our guidance of more than $280 million for 2025, we need to generate approximately $169 million in revenue in the second half of the year. Given the math that I am seeing today, I believe we are on track to meet our guidance goals.
Speaker #4: rights to buy Clovy, which was a recently approved treatment for post-operative inflammation and pain following ocular surgery. This is the first new ophthalmic steroid in its class in over 15 years.
Speaker #4: And then, second, we also recently acquired the U.S. rights to Samsung's ophthalmic biosimilars pipeline, including BioViz, an FDA-approved biosimilar referencing Lucentis, and Opuviz, an FDA-approved biosimilar referencing Eylea.
Speaker #4: Our total revenue for the second quarter was $63.7 million, a 30% increase over the second quarter of 2024, and a sequential increase of 33% from the first quarter of 2025.
Speaker #4: The first half of 2025 generated $111.6 million in revenue. To reach our guidance of more than $280 million, for 2025, we need to generate approximately $169 million in revenue in the second half of the year.
Speaker #4: Given the math that I'm seeing today, I believe we are on track to meet our guidance goals. Now, I have repeatedly stated on prior calls that the second half of the year is always stronger than the first half of the year.
Mark L. Baum: I have repeatedly stated on prior calls that the second half of the year is always stronger than the first half of the year. As you read from our letter to stockholders, and you will hear from my prepared remarks this morning, we are seeing momentum with our key growth drivers that should start to show meaningful revenue growth as early as the third quarter. I think next year, though, we will try to provide annual revenue guidance and split it into two halves, the first half of the year and then the second half of the year. I think that might work better for us. In any case, adjusted EBITDA was a great story as second quarter adjusted EBITDA came in at $17 million with $5 million of net income. This once again highlights the operating leverage we have built into the business. Harrow Inc.
Speaker #4: As you read from our letter to stockholders, and you will hear from my prepared remarks this morning, we are seeing momentum with our key growth drivers that should start to show meaningful revenue growth as early as the third quarter.
Speaker #4: I think next year, though, we will try to provide annual revenue guidance and split it into two halves. The first half of the year and then the second half of the year, I think that might work better for us.
Speaker #4: In any case, adjusted EBITDA was a great story as second quarter adjusted EBITDA came in at $17 million, with $5 million of net income.
Speaker #4: This once again highlights the operating leverage we've built into the business. Harrow is at an inflection point. Our revenues should reach new heights in the back half of this year.
Mark L. Baum: is at an inflection point. Our revenue should reach new heights in the back half of this year. As you saw from this quarter, our cost basis really remains fairly stable. This is a result of years of investment in building a strong, scalable commercial infrastructure that is designed to support this phase and level of growth. VEVYE generated $18.6 million in revenue, a 13% decrease from the first quarter of 2025. As outlined in our letter to stockholders, the revenue reduction seen in the second quarter versus the first quarter of 2025 was driven by a normalization in average selling price or ASP, which I called out during our first quarter conference call and in our Q1 letter to stockholders.
Speaker #4: And as you saw from this quarter, our cost basis really remains fairly stable. This is a result of years of investment in building a strong scalable commercial infrastructure that's designed to support this phase and level of growth.
Speaker #4: Viva generated $18.6 million in revenue, a 13% decrease from the first quarter of 2025. As outlined in our letter to stockholders, the revenue reduction seen in the second quarter versus the first quarter of 2025 was driven by a normalization in average selling price, or ASP, which I called out during our first quarter conference call.
Speaker #4: And in our Q1 letter to stockholders. We typically don't comment on changes in ASP quarter over quarter, but I think it's important to highlight that the ASP seen in the first quarter was an anomaly.
Mark L. Baum: We typically do not comment on changes in ASP quarter over quarter, but I think it is important to highlight that the ASP seen in the first quarter was an anomaly due to the changes in the business rules we implemented at the beginning of the year. With our present VEVYE ASP reflective of those VEVYE Access for All business rules, we expect to see and are seeing both VEVYE volumes and revenues increase once again as we forecasted. Based on the ratios of the types of VEVYE prescriptions we are seeing, we are confident that VEVYE’s ASP has stabilized, and we even see a path to modest improvement over the rest of the year. In addition to continuing to improve our business rules algorithm, as I shared in our earnings release, we have entered into a strategic alliance with ApolloCare, an innovative service provider with full national coverage.
Speaker #4: Due to the changes in the business rules we implemented at the beginning of the year, with our present Viva ASP reflective of those BAFA business rules, we expect to see, and are seeing, both Viva volumes and revenues increase once again, as we forecasted.
Speaker #4: Based on the ratios of the types of Viva prescriptions we're seeing, we're confident that Viva's ASP has stabilized. We even see a path to modest improvement over the rest of the year.
Speaker #4: In addition to continuing to improve our business rules algorithm, as I shared in our earnings release, we've entered into a strategic alliance with Apollo Care.
Speaker #4: An innovative service provider with full national coverage. Now, this alliance significantly expands Viva's distribution network, improving both pharmacy access and insurance coverage for patients nationwide and it should buttress our ASP at current levels and, as I said, provide an upward bias towards ASP improving over the coming quarters.
Mark L. Baum: This alliance significantly expands VEVYE’s distribution network, improving both pharmacy access and insurance coverage for patients nationwide, and it should buttress our ASP at current levels and, as I said, provide an upward bias towards ASP improving over the coming quarters. ApolloCare’s pharmacy network spans more than 500 pharmacies and is broadly contracted with major and smaller commercial plans, as well as Tricare and Medicare. With coverage reaching every U.S. geography and payer type, this collaboration positions us to reach more patients than ever before. Importantly, for our stockholders, nearly every prescription of VEVYE that is dispensed is now profitable for Harrow under the VEVYE Access for All (VAFA) program initiative, a notable shift from pre-VAFA times. These adjustments cause structural improvements that enhance the quality of our revenue and our ability to invest and further scale VEVYE’s long-term profitability.
Speaker #4: Apollo Care's pharmacy network spans more than 500 pharmacies and is broadly contracted with major and smaller commercial plans, as well as TriCare and Medicare.
Speaker #4: With coverage reaching every U.S. geography and payer type, this collaboration positions us to reach more patients than ever before. Importantly, for our stockholders, nearly every prescription of Viva that is dispensed is now profitable for HARROW under the BAFA initiative, a notable shift from pre-BAFA times.
Speaker #4: These adjustments cause structural improvements that enhance the quality of our revenue and our ability to invest and further scale Viva's long-term profitability. When we provided Viva revenue guidance of more than $100 million for 2025, we accounted for the anticipated decline in subsequent stabilization of ASP from Q1 to Q2.
Mark L. Baum: When we provided VEVYE revenue guidance of more than $100 million for 2025, we accounted for the anticipated decline and subsequent stabilization of ASP from Q1 to Q2. Once again, we expect VEVYE to generate over $60 million in revenue for the second half of 2025. If you straight line Q2 growth for the balance of the year with a stable ASP, this puts us ahead of where we need to be by the end of this year for the VEVYE franchise. IHEEZO generated $18.3 million in revenue, a 251% increase from the first quarter of 2025. IHEEZO is gaining momentum and growing market share. The growth this quarter is driven by the momentum from our Retina Pivot and expanded distribution through the group purchasing organization agreements we have signed.
Speaker #4: Once again, we expect Viva to generate over $60 million in revenue for the second half of 2025. If you straight-line Q2 growth for the balance of the year, with a stable ASP, this puts us ahead of where we need to be by the end of this year for the Viva franchise.
Speaker #4: EyeHeso generated $18.3 million in revenue, a $251% increase from the first quarter of 2025. EyeHeso is gaining momentum, and growing market share. The growth this quarter is driven by the momentum from our RetinaPivot and expanded distribution through the group purchasing organization agreements we've signed.
Mark L. Baum: IHEEZO is on the path to have a record year this year, and I am confident it will surpass our guidance of $50 million or more in revenue. TRIESENCE and our specially branded portfolio generated $5.2 million in revenue. That is a 447% increase from the first quarter of 2025. With TRIESENCE capturing more market share and a large market on the horizon, I am confident the second half will outperform the first half by a wide margin. ImprimisRx generated $21.5 million in revenue. That is a 7% increase from the first quarter of 2025. This is a stable, cash-generating business, and it is performing as expected and is on track to reach our guidance of $80 million or more this year. In sum, our 2025 guidance remains intact, and I remain very confident in our team's ability to hit that number.
Speaker #4: EyeHeso is on the path to have a record year this year, and I'm confident it will surpass our guidance of $50 million or more in revenue.
Speaker #4: Triesence and our specialty branded portfolio generated $5.2 million in revenue, that's a $447% increase from the first quarter of 2025. With Triesence capturing more market share and a large market on the horizon, I'm confident the second half will outperform the first half by a wide margin.
Speaker #4: Imprimis RX generated $21.5 million in revenue, that's a 7% increase from the first quarter of 2025. This is a stable cash-generating business, and it is performing as expected and is on track to reach our guidance of $80 million or more this year.
Speaker #4: In sum, our 2025 guidance remains intact. And I remain very confident in our team's ability to hit that number. Since launching Viva Access for All in late March of this year, the demand for Viva has surged.
Mark L. Baum: Since launching VEVYE Access for All in late March of this year, the demand for VEVYE has surged. The promise of the VEVYE Access for All market access program for VEVYE is, one, increased access for patients, two, lower out-of-pocket costs for patients, and three, a reasonable and sustainable profit for Harrow. As I detail more in the letter to stockholders, the VEVYE Access for All program is meeting all of our commercial objectives. VEVYE continues to exceed our pre-launch expectations in every category: new prescriptions, refill rates, patient satisfaction, and prescriber engagement. The impact of VEVYE Access for All can be seen on this slide. Prescription volumes were up 66% sequentially for a total of 119,526 units. Of those, nearly 50,000 were new prescriptions, resulting in a 62% increase in new prescriptions over the first quarter of 2025.
Speaker #4: The promise of the BAFA market access program for Viva is, one, increased access for patients; two, lower out-of-pocket costs for patients; and three, a reasonable and sustainable profit for HARROW.
Speaker #4: As I detail more in the letter to stockholders, the BAFA program is meeting all of our commercial objectives. Viva continues to exceed our pre-launch expectations in every category, new prescriptions, refill rates, patient satisfaction, and prescriber engagement.
Speaker #4: The impact of BAFA can be seen on this slide. Prescription volumes were up 66% sequentially for a total of $119,526 units. Of those, nearly 50,000 were new prescriptions, resulting in a 62% increase in new prescriptions over the first quarter of 2025.
Mark L. Baum: As prescription volumes grow, we are maintaining industry-leading refill rates, an important indicator of product adoption and satisfaction. In 2024, covered patients receiving VEVYE through ImprimisRx received an average of nine refills, a figure that significantly outpaces the typical refill rates seen with other therapies in the dry eye disease market. This sustained refill behavior highlights not only VEVYE's clinical value but also its ability to foster ongoing patient engagement well beyond the initial prescription. The compounding effect of rising numbers of new prescriptions and consistently high refill rates positions us for sustained revenue growth. We anticipate the first meaningful financial impact as early as the third quarter of this year, driven by the continued momentum in new prescription volume, a more stable ASP, and a growing wave of refill activity.
Speaker #4: As prescription volumes grow, we're maintaining industry-leading refill rates and important indicator of product adoption and satisfaction. In 2024, covered patients receiving Viva through PhilRx received an average of nine refills, a figure that significantly outpaces the typical refill rates seen with other therapies in the dry eye disease market.
Speaker #4: This sustained refill behavior highlights not only Viva's clinical value, but also its ability to foster ongoing patient engagement, well beyond the initial prescription. The compounding effect of rising numbers of new prescriptions and consistently high refill rates positions us for sustained revenue growth.
Speaker #4: We anticipate the first meaningful financial impact as early as the third quarter of this year, driven by the continued momentum in new prescription volume, a more stable ASP, and a growing wave of refill activity.
Mark L. Baum: This surge is largely attributable to the strong demand generated since the launch of the VEVYE Access for All program. To reiterate what I said earlier, under the VEVYE Access for All initiative, nearly every prescription written for VEVYE is now profitable, and this is a notable shift from before we had this program going, when that was not always the case. We have also secured additional manufacturing capacity for 2025, enabling us to further scale our commercial reach. In parallel, we are revisiting next year's forecasts, increasing our supply chain flexibility, and ensuring that we are well positioned to meet the sustained and growing demand we anticipate for both new and refill prescriptions of VEVYE. Importantly, as noted earlier, we are also preparing to bring a second VEVYE manufacturing site online next year, and this will further strengthen our supply chain and facilitate our growth strategy.
Speaker #4: This surge is largely attributable to the strong demand generated since the launch of the BAFA program. To reiterate what I said earlier, under the BAFA initiative, nearly every prescription written for Viva is now profitable.
Speaker #4: And this is a notable shift from before we had this program going, when that wasn't always the case. We've also secured additional manufacturing capacity for 2025, enabling us to further scale our commercial reach.
Speaker #4: In parallel, we are revisiting next year's forecasts, increasing our supply chain flexibility and ensuring that we are well-positioned to meet the sustained and growing demand we anticipate for both new and refill prescriptions of Viva.
Speaker #4: Importantly, as noted earlier, we're also preparing to bring a second Viva manufacturing site online next year. This will further strengthen our supply chain and facilitate our growth strategy.
Mark L. Baum: VEVYE's market penetration continues to accelerate. By the end of Q2, we had captured a 7.8% share of the national dry eye disease market. That is a 2.6% increase quarter over quarter. Notably, according to IQVIA and FillRx data, VEVYE has now surpassed CEQA in national market share. This is an important milestone that reinforces the effectiveness of our commercial strategy and execution. According to IQVIA, VEVYE is now the second largest cyclosporin-based dry eye brand being prescribed, once again a significant milestone that validates the strength of our primary strategy, which is to win the cyclosporin category in dry eye. VEVYE is beginning to also gain ground on MIBO, having surpassed MIBO in new prescriptions in four U.S. markets that are quite sizable. In summary, we are still in the early stages of a VEVYE launch, and the growth trajectory is compelling.
Speaker #4: Viva's market penetration continues to accelerate. By the end of Q2, we had captured a 7.8% share of the national dry eye disease market, which represents a 2.6% increase quarter over quarter.
Speaker #4: Notably, according to IQVIA and PhilRx data, Viva has now surpassed Sequa in national market share. This is an important milestone that reinforces the effectiveness of our commercial strategy and execution.
Speaker #4: According to IQVIA, Viva is now the second largest cyclosporin-based dry eye brand being prescribed. Once again, a significant milestone that validates the strength of our primary strategy, which is to win the cyclosporin category in dry eye.
Speaker #4: Viva is beginning to also gain ground on MIBO, having surpassed MIBO in new prescriptions in four sizable U.S. markets. In summary, we're still in the early stages of a Viva launch, and the growth trajectory is compelling.
Mark L. Baum: Demand continues to rise sharply, refill rates remain industry-leading, and with only 7.8% market share captured so far, the runway ahead is significant. With a best-in-class clinical profile, strong access infrastructure in place, and a robust commercial team, we believe VEVYE is well positioned to exceed $100 million in annual revenue this year, marking just the beginning of a multi-year growth opportunity. In June of 2025, we announced the acquisition of BICLOVI from Formosa Pharmaceuticals. I am particularly excited about BICLOVI, an FDA-approved steroid indicated for the treatment of inflammation and pain after ocular surgery, and it is the first novel steroid introduced to the U.S. market in over a decade. BICLOVI is a highly potent next-generation therapy, and it is the only FDA-approved ocular steroid formulated with clobetasol, delivering robust clinical efficacy supported by a well-established safety profile.
Speaker #4: Demand continues to rise sharply, refill rates remain industry-leading, and with only 7.8% market share captured so far, the runway ahead is significant. With a best-in-class clinical profile, strong access infrastructure in place, and a robust commercial team, we believe Viva is well-positioned to exceed $100 million in annual revenue this year, marking just the beginning of a multi-year growth opportunity.
Speaker #4: In June of 2025, we announced the acquisition of Biclovy from Formosa Pharmaceuticals. I'm particularly excited about Biclovy, an FDA-approved steroid indicated for the treatment of inflammation and pain after ocular surgery.
Speaker #4: And it's the first novel steroid introduced to the U.S. market in over a decade. Biclovy is a highly potent, next-generation therapy, and it's the only FDA-approved ocular steroid formulated with clobetasol.
Speaker #4: Delivering robust clinical efficacy, supported by a well-established safety profile. From a clinician's perspective, the typical risks associated with ophthalmic corticosteroids include increased intraocular pressure, or IOP, and in this case, the resultant IOP increase was only 1.4% of the population exposed to the product during pivotal clinical studies.
Mark L. Baum: From a clinician's perspective, the typical risks associated with ophthalmic corticosteroids include increased intraocular pressure, or IOP. In this case, the resultant IOP increase was only 1.4% of the population exposed to the product during pivotal clinical studies. The incidence of increased IOP was substantially higher with products such as Dextenza and others, all comprised of less potent corticosteroids than BICLOVI, but with a higher risk profile. BICLOVI also has a longer duration of action, allowing for reduced frequency of administration, in this case, twice daily versus four times daily. In the ophthalmic market, when a product is to be administered four times daily, it is typically every four hours while awake, which could pose significant compliance issues. Therefore, we believe BICLOVI may offer important patient compliance features.
Speaker #4: The incidence of increased IOP was substantially higher with products such as Dextenza and others, all comprised of less potent corticosteroids than Biclovy, but with a higher risk profile.
Speaker #4: Biclovy also has a longer duration of action, allowing for reduced frequency of administration—twice daily versus four times daily. In the ophthalmic market, when a product is to be administered four times daily, it's typically every four hours while awake, which could pose significant compliance issues.
Speaker #4: Therefore, we believe Biclovy may offer important patient compliance features. Finally, in terms of efficacy—both in terms of the percent of responders to full pain relief at the earliest regulatory time point of four days post-op, and in terms of complete clearance of inflammation post-op four days—Biclovy performed better than all other approved products for the same indication in the U.S.
Mark L. Baum: Finally, in terms of efficacy, both in terms of the percent of responders to full pain relief at the earliest regulatory time point of four days post-op, and in terms of complete clearance of inflammation post-op four days, BICLOVI performed better than all other approved products for the same indication in the U.S. While this assessment is not based on head-to-head studies, it is based on a cross-comparison between approved product labels. With over 7 million ophthalmic surgeries performed annually in the U.S. and a wide range of additional clinical applications for topical steroids, we see a substantial market opportunity ahead. I am confident our commercial team is well-equipped to drive strong adoption of this differentiated product. We expect to launch BICLOVI in the first quarter of 2026.
Speaker #4: While this assessment is not based on head-to-head studies, it's based on a cross-comparison between approved product labels. With over 7 million ophthalmic surgeries performed annually in the U.S. and a wide range of additional clinical applications for topical steroids, we see a substantial market opportunity ahead.
Speaker #4: And I'm confident our commercial team is well-equipped to drive strong adoption of this differentiated product. We expect to launch Biclovy in the first quarter of 2026.
Mark L. Baum: I am encouraged to see both IHEEZO's revenue and unit volumes return to near Q4 2024 levels, a period that benefited from increased stocking, showing clear signs of momentum and growing market share. The second quarter showed new account growth and deeper utilization within existing practices, with 25% growth in unit volume over the first quarter of 2025. This surge in demand is being fueled by strong momentum from our Retina Pivot strategy and expanded distribution through new GPO relationships. This expansion led to the addition of 19 new accounts during the period, all of which were retina practices, underscoring the targeted success of our strategic focus and IHEEZO's growing adoption in this critical specialty. Notably, IHEEZO volume grew 33% quarter over quarter within the largest retina GPO, which represents approximately 70% of the retina market.
Speaker #4: I'm encouraged to see both EyeHeso's revenue and unit volumes return to near fourth quarter 2024 levels, a period that benefited from increased stocking. This shows clear signs of momentum and growing market share.
Speaker #4: The second quarter showed new account growth and deeper utilization within existing practices, with a 25% growth in unit volume over the first quarter of 2025.
Speaker #4: This surge in demand is being fueled by strong momentum from our RetinaPivot strategy and expanded distribution through new GPO relationships. This expansion led to the addition of 19 new accounts during the period, all of which were Retina practices.
Speaker #4: Underscoring the targeted success of our strategic focus and EyeHeso's growing adoption in this critical specialty. Notably, EyeHeso volume grew 33% quarter over quarter within the largest Retina GPO, which represents approximately 70% of the Retina market.
Mark L. Baum: Overall, distributor shipment volume for IHEEZO increased by an impressive 170% in Q2 compared to Q1 of 2025, underscoring the strong and accelerating demand we are seeing. IHEEZO currently enjoys broad coverage, with better than 81% of commercial and government payers providing reimbursement. Our data indicates that only 3% of IHEEZO claims are categorized as not covered, and only 4% require prior authorization. Amazing coverage data. In response to the strong access position, I recently developed the IHEEZO for All strategy, an initiative focused on expanding IHEEZO utilization and retina procedures across both existing and new accounts, with the goal of driving near-term sales growth. Now, with all four major GPOs on board and strong clinical synergy between IHEEZO, TRIESENCE, and eventually our new anti-VEGF products, BioViz and Opuviz, I believe IHEEZO's growth is just beginning.
Speaker #4: Overall, distributor shipment volume for EyeHeso increased by an impressive 170% in Q2 compared to Q1 of 2025, underscoring the strong and accelerating demand we're seeing.
Speaker #4: EyeHeso currently enjoys broad coverage, with better than 81% of commercial and government payers providing reimbursement. Our data indicates that only 3% of EyeHeso claims are categorized as not covered, and only 4% require prior authorization.
Speaker #4: Amazing coverage data. In response to this strong access position, I recently developed the EyeHeso for All strategy—an initiative focused on expanding EyeHeso utilization in retina procedures across both existing and new accounts, with the goal of driving near-term sales growth.
Speaker #4: Now, with all four major GPOs on board and strong clinical synergy between EyeHeso, Triesence, and eventually our new anti-VEGF products, BioViz and Opuviz, I believe EyeHeso's growth is just beginning.
Mark L. Baum: These are still early days in its launch, but with four differentiated and highly complementary therapies in Harrow's ophthalmic portfolio and a proven commercial team to execute our strategy, I expect IHEEZO is entering a new phase of accelerated growth. By the way, so far in the early days of the third quarter, we have already eclipsed the number of new IHEEZO account starts achieved in the entirety of the second quarter, with all of our new accounts being retina practices. TRIESENCE is gaining strong traction within the retina community, with accelerating volumes and growing market share. Year to date, TRIESENCE added 870 new accounts and achieved 32% quarter over quarter growth. TRIESENCE has also achieved 84% coverage, with only 8% of claims requiring prior authorization and a mere 3% of documented claims being returned as uncovered. This is near completely pervasive coverage.
Speaker #4: These are still early days in its launch, but with four differentiated and highly complementary therapies in HARROW's portfolio, and a proven commercial team to execute our strategy, I expect EyeHeso is entering a new phase of accelerated growth.
Speaker #4: By the way, so far in the early days of the third quarter, we've already eclipsed the number of new EyeHeso account starts achieved in the entirety of the second quarter, with all of our new accounts being Retina practices.
Speaker #4: Triesence is gaining strong traction within the Retina community. With accelerating volumes and growing market share. Year to date, Triesence added $870 new accounts. And achieved 32% quarter over quarter growth.
Speaker #4: Triesence has also achieved 84% coverage, with only 8% of claims requiring prior authorization and a mere 3% of documented claims being returned as uncovered.
Speaker #4: This is near completely pervasive coverage. Our go-to-market strategy with Triesence is showing clear signs of momentum in the early days of our relaunch. Now that we have all the necessary buy-and-bill commercial infrastructure in place, we'll be expanding its use into the ocular inflammation market, such as cataract surgery.
Mark L. Baum: Our go-to-market strategy with TRIESENCE is showing clear signs of momentum in the early days of our relaunch. Now that we have all the necessary buy-and-bill commercial infrastructure in place, we will be expanding its use into the ocular inflammation market, such as cataract surgery, the largest market opportunity for TRIESENCE and the one that we have not marketed into to date. We recently hired Chad Bryans to lead our specialty brand sales team, which includes TRIESENCE. One of Chad's chief responsibilities is to drive our strategic efforts with TRIESENCE in the ocular inflammation market. Chad has extensive experience selling buy-and-bill ophthalmic steroid products in this market, positioning him well to lead this critical initiative.
Speaker #4: The largest market opportunity for Triesence. And the one that we have not marketed into to date. We recently hired Chad Bryant to lead our specialty brands sales team, which includes Triesence.
Speaker #4: One of Chad's chief responsibilities is to drive our strategic efforts with Triesence in the ocular inflammation market. Chad has extensive experience selling buy-and-bill ophthalmic steroid products in this market.
Speaker #4: Positioning him well to lead this critical initiative. Based on feedback from our physician customers, we believe these new go-to-market approaches will result in unit demand growth, which will begin to show in Q4 and into 2026.
Mark L. Baum: Based on feedback from our physician customers, we believe these new go-to-market approaches will result in unit demand growth, which will begin to show in the Q4 and into 2026, especially as we move more resolutely into the ocular inflammation market. I couldn't be more excited about the transaction we announced in July with Samsung Bioepis. We secured the exclusive U.S. commercial rights to their biosimilars ophthalmology portfolio. That includes BioViz, an FDA-approved biosimilar referencing Lucentis, and Opuviz, an FDA-approved biosimilar referencing Eylea, two of the most widely used anti-VEGF therapies for retinal diseases. Importantly, both products have interchangeability status. These products will integrate seamlessly with our existing commercial infrastructure, and we expect to leverage our significant commercial flexibility to compete aggressively in this market.
Speaker #4: Especially as we move more resolutely into the ocular inflammation market. I couldn't be more excited about the transaction we announced in July with Samsung Bioepis.
Speaker #4: We secured the exclusive U.S. commercial rights to their biosimilars ophthalmology portfolio. That includes BioViz, an FDA-approved biosimilar referencing Lucentis, and Opuviz, an FDA-approved biosimilar referencing Eylea.
Speaker #4: Two of the most widely used anti-VEGF therapies for retinal diseases. Importantly, both products have interchangeability status. These products will integrate seamlessly with our existing commercial infrastructure, and we expect to leverage our significant commercial flexibility to compete aggressively in this market.
Mark L. Baum: By combining Harrow's deep retina expertise with Samsung's key learnings from its prior BioViz launch, we're uniquely positioned to refine our offering and compete effectively in this large, competitive, and contested market. We look forward to sharing more about our upcoming commercial launch soon. ImprimisRx showed signs of sequential recovery following seasonal softness in Q1. April was a record month for the business, and momentum continued throughout the quarter with steady growth across key product lines. The team is driving several initiatives to enhance gross margins, drive revenue growth, and improve operational efficiency. The business just continues to generate cash flow, contributing meaningful value to our stockholders. To wrap up, Harrow is firmly in growth mode, and we're just at the beginning of an exciting journey.
Speaker #4: By combining HARROW's deep retina expertise with Samsung's key learnings from its prior BioViz launch, we're uniquely positioned to refine our offering and compete effectively in this large, competitive, and contested market.
Speaker #4: We look forward to sharing more about our upcoming commercial launch soon. Imprimis RX showed signs of sequential recovery following seasonal softness in Q1. April was a record month for the business, and momentum continued throughout the quarter.
Speaker #4: With steady growth across key product lines, the team is driving several initiatives to enhance gross margins, drive revenue growth, and improve operational efficiency. The business continues to generate cash flow, contributing meaningful value to our stockholders.
Speaker #4: To wrap up, HARROW is firmly in growth mode, and we're just at the beginning of an exciting journey. I couldn't be more energized by the incredible team we've assembled, the strategic products we've brought into our portfolio, and the tremendous opportunities that lie ahead.
Mark L. Baum: I couldn't be more energized by the incredible team we've assembled, the strategic products we've brought into our portfolio, and the tremendous opportunities that lie ahead. The best is yet to come for Harrow. With the accelerating performance of VEVYE, TRIESENCE finally positioned to enter its largest market, IHEEZO hitting a growth stride, and the recent addition of BICLOVI and a robust pipeline of biosimilars on deck, not to mention our proven compounding business, ImprimisRx, we now cover the full spectrum of high-value ocular conditions. Our nationwide GPO partnership, specialty pharmacy reach, and track record of commercial execution create powerful leverage. Each new launch accelerates uptake of the others by deepening our presence in surgical centers and retina practices and general ophthalmic practices and even in optometry offices.
Speaker #4: The best is yet to come for HARROW. With the accelerating performance of Viva, Triesence, finally positioned to enter its largest market, EyeHeso hitting a growth stride, and the recent addition of Biclovy and a robust pipeline of biosimilars on deck, not to mention our proven compounding business, Imprimis RX, we now cover the full spectrum of high-value ocular conditions.
Speaker #4: Our nationwide GPO partnership, specialty pharmacy reach, and track record of commercial execution create powerful leverage each new launch accelerates uptake of the others by deepening our presence and surgical centers and Retina practices in general ophthalmic practices and even in optometry offices.
Mark L. Baum: Combined with a seasoned leadership team, strong balance sheet, well-defined R&D roadmap, and an active M&A strategy, our runway for growth is substantial. Simply put, we have assembled the right products, platforms, and people to redefine what success looks like in the ophthalmic market, and the most significant gains lie ahead. With that, I will turn it over to our operator to open the line for questions. Operator?
Speaker #4: Combined with a seasoned leadership team, strong balance sheet, well-defined R&D roadmap, and an active M&A strategy, our runway for growth is substantial. Simply put, we've assembled the right products, platforms, and people to redefine what success looks like and the ophthalmic market.
Speaker #4: And the most significant gains lie ahead. With that, I'll turn it over to our operator to open the line for questions. Operator?
Shannon: We will now begin the question and answer session. To ask a question, you will need to press star one-one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one-one again. We ask that you please limit yourself to one question and one follow-up. Please stand by while we compile the Q&A roster. Our first question comes from the line of Chase Knickerbocker with Craig Hallam. Your line is now open.
Speaker #2: We will now begin the question and answer session. To ask a question, you will need to press *11 on your telephone. You will then hear an automated message advising your hand is raised.
Speaker #2: To withdraw your question, please press *11 again. We ask that you please limit yourself to one question and one follow-up. Please stand by while we compile the Q&A roster.
Speaker #2: Our first question comes from the line of Chase Nickerbocker with Craig Hallam. Your line is now open.
Mike Viega: Good morning, guys. Thanks for taking the questions, and congrats on the progress here. Mark, maybe just first on VEVYE, can you help us a little bit with any business rule changes within there as you guys onboard ApolloCare, et cetera, as far as how we should be thinking about ASPs sequentially from here? Is it just normal seasonality where less copay assistance brings ASPs a little bit higher? Are there any other changes that you have made that you expect some sequential improvement to ASPs through the year?
Speaker #3: Good Good morning, guys. Thanks for taking the questions. And congrats on the progress here. Mark, maybe just first on Viva, can you help us a little bit with kind of any any kind of business rule changes within their as you guys onboard Apollo Care, et cetera, as far as how we should be thinking about ASP sequentially from here?
Speaker #3: Is it just kind of normal seasonality where less copay assistance kind of brings ASPs a little bit higher? Are there any other changes that you've made that you kind of expect some sequential improvement to ASPs through the year?
Mark L. Baum: Thanks for the question, Chase, and good morning. On VEVYE average selling prices, I think, a couple of things. One, in terms of new business rules going forward, we continue to tweak our algorithm, but these are really minor things. At this point, the business rules are, I think, performing very well. The reality, though, is that between Q1 and Q2, we kind of needed to wash, if you will, all of the existing VEVYE patients through those new business rules for the VEVYE Access for All program. What I mean by that is, at the beginning of the year, you had a lot of patients, especially with copay resets, that were paying $300, $400, $500 out of pocket for VEVYE. The reality is that many patients just can't afford that level of payment for a product like VEVYE, or really any product for that matter.
Speaker #4: Yeah, thanks for the question, Chase. And good morning. Yes, so the on Viva ASP, I think, you know, a couple of things. One, in terms of new business rules going forward, we continue to tweak our algorithm, you know, but it's really these are really minor things.
Speaker #4: At this point, the business rules are, I think, performing very well. The reality, though, is that between Q1 and Q2, we kind of needed to wash, if you will, all of the existing Viva patients through those new business rules for the Viva Access for All program.
Speaker #4: And what I mean by that is, you know, at the beginning of the year, you had a lot of patients, especially with copay resets, that were paying three, four, five hundred dollars out of pocket for Viva.
Speaker #4: And the reality is, is that many patients just can't afford that level of payment for a product like Viva. But really, any product for that matter.
Mark L. Baum: The VEVYE Access for All program allowed those patients to do is to continue to stay on therapy and to be able to access the product at a much lower cost. Those are patients we probably would have lost anyway. The bottom line is that as we got through Q2 and certainly now in Q3 with the existing business rules, we're really seeing what the average selling prices should look like. With ApolloCare, we have been losing patients. We have patients that have coverage but that are not able to use their coverage because the plan may have not been contracted with our existing pharmacy provider. With this expansion of the network, we should be able to capture many more high-value patients into the overall average selling price calculation.
Speaker #4: And what the Viva Access for All program allowed those patients to do is to continue to stay on therapy. And to be able to access the product at a much lower cost.
Speaker #4: Those are patients we probably would have lost anyway. But the bottom line is that as we got through Q2 and certainly now in Q3, with the existing business rules, we're really seeing what the ASP should look like.
Speaker #4: Now, with Apollo Care, we have been losing patients. So we have patients that have coverage, but that are not able to use their coverage because the plan may have not been contracted with our existing pharmacy provider.
Speaker #4: And with this expansion of the network, we should be able to capture many more high-value patients into the overall ASP calculation. So we're thinking that, you know, certainly by the end of the year, we should see, as I said, a bias upward in terms of ASP.
Mark L. Baum: We're thinking that, certainly by the end of the year, we should see, as I said, a bias upward in terms of average selling prices, but we're also very confident from here, given the fact that all of those existing patients have washed through these business rules, that we do have stability to our average selling prices.
Speaker #4: But we're also very confident that from here, given the fact that all of those existing patients have washed through these business rules, that we do have stability to our ASP.
Mike Viega: Got it. And maybe just on the biosimilars respect that we are going to get an annual stay in September, but any thoughts as far as kind of contribution to the model in 2026 and 2027? Because, you know, some of these biosimilar launches can be pretty quick uptake considering their, you know, existing markets. So any thoughts on, you know, particularly the Lucentis biosimilar as we think about 2026 and 2027?
Speaker #3: Got it. And maybe just on the biosimilars, respect that we're going to get an annual stay in September, but any thoughts as far as kind of contribution to the model in '26 and '27?
Speaker #3: Because, you know, some of these biosimilar launches can be equipped pretty quick uptake considering they're, you know, existing markets. So any thoughts on, you know, particularly the Lucentis biosimilar as we think about '26 and '27?
Mark L. Baum: Well, we are still working on it. By the way, I have done a lot of talking so far, so I am very excited about the Samsung portfolio, but there is one person who is even more excited than me, and that is Andrew. So I am going to let him take that question.
Speaker #4: Well, we're still working on it. By the way, I've done a lot of talking so far, so I'm very excited about the Samsung portfolio, but there's one person who's even more excited than me, and that's Andrew, so I'm going to let him take that question.
Andrew Bull: Hey, Chase. Thanks, Mark. Mark said, I am really, really excited about the biosimilar portfolio. Samsung Bioepis is a leader in biosimilars, and Harrow Inc. is, we think, a leader in ophthalmology. We definitely have a vision of being one of the top ophthalmology pharma companies in the U.S. We see this really as a perfect marriage between the two companies. I think in regards to contribution in 2026, our hope is that we will be able to launch BioViz in 2026, having an immediate uptick in product demand for that product. There is an existing market for it. We have a great strategy, go-to-market strategy. There is not a whole lot we can talk about right now as we are kind of working through this transition period with Samsung Bioepis and their prior partner.
Speaker #5: Hey, Chase. Thanks, Mark. Like Mark said, I'm really, really excited about the biosimilar portfolio. Samsung is a leader in biosimilars, and HARROW is, we think, a leader in ophthalmology.
Speaker #5: And definitely we have a vision of being one of the top ophthalmology pharma companies in the U.S. And we see this really as a perfect marriage between the two companies.
Speaker #5: I think in regards to contribution in '26, our hope is that we'll be able to launch BioViz in 2026, with having immediate uptake in product demand for that product.
Speaker #5: There's an existing market for it. We've got a great strategy and go-to-market strategy. There's not a whole lot we can talk about right now as we're kind of working through this transition period with Samsung and their prior partner.
Andrew Bull: I think once we are through this transition period, we can talk a little bit more and be more specific about timing of that launch or relaunch and also the other biosimilar in the portfolio. I want to reiterate, I think out of all the deals we have done, this one is probably one of the ones I am most excited about. It is incredibly synergistic, fits right into the commercial infrastructure, fits right into the relationships we have on the retina side. It fits really well with IHEEZO and with some of the other buy-and-buy products. We get a ton of leverage with the product. We know where these products are being used. We have relationships with those customers already.
Speaker #5: But I think once we are through this transition period, we can talk a little bit more and be more specific about timing of that launch or relaunch and also the other biosimilar in the portfolio.
Speaker #5: But I want to reiterate, I think out of all the deals we've done, this one is probably one of the ones I'm most excited about.
Speaker #5: It's incredibly synergistic. Fits right into the commercial infrastructure. Fits right into the relationships we have on the Retina side. And it fits really well with EyeHeso.
Speaker #5: And with some of the other buy-and-bill products. And so we get a ton of leverage with the product. We know where these products are being used.
Speaker #5: We have relationships with those customers already. And I think it's going to be a lot of, it'll be a really pleasant upside for a lot of investors and people looking at the long-term value of the company.
Andrew Bull: I think it is going to be a lot of, it will be a really pleasant upside for a lot of investors and people looking at the long-term value of the company.
Shannon: Thank you. Our next question comes from the line of Steve Seedhouse with Cantor. Your line is now open.
Speaker #2: Thank you. Our next question comes from the line of Steve Seedhouse with Cantor. Your line is now open.
Speaker 6: Good morning. Thanks so much. First question, I just wanted to ask about the growth in new prescriptions in Q2 for VEVYE. How much of that was driven by Clarity C switchers? Are you largely through any expected bolus of patients from Clarity C now? For the second part of that question, you mentioned you are cautious about growing too much faster for the remainder of the year for VEVYE in your stockholder letter. I am just wondering how much growth would slow naturally from the Clarity C patient bolus unwinding. Are you also expecting a slowing of the organic growth ex-Clarity C?
Speaker #6: Good Good morning. Thanks so much. First question I just wanted to ask about the growth in new prescriptions in the second quarter for Viva.
Speaker #6: How much of that was driven by clarity C-switchers and are you largely through any expected bolus of patients from clarity C now? And then just second part of that question, you mentioned you're sort of cautious about growing too much faster for the remainder of the year.
Speaker #6: For Viva and your stockholder letter, I'm just wondering how much growth would slow naturally from the Clarity C patient bolus sort of unwinding? Or are you also expecting a slowing of sort of the organic growth, excluding Clarity C?
Mark L. Baum: Hey, thanks for that question, Steve. I am going to tell you just straight up how many units came from Clarity C. It was about 7,000 or so, during the period. In terms of those patients falling off, those patients typically have been as loyal, I think, refillers, or even more loyal than the VEVYE experience that we have seen so far. The other thing that I would mention that I think you are hitting on, which is true, and I kind of alluded to this a little bit in the stockholder letter, is that we really did not count on VEVYE taking off in the way that it did in terms of our forecasting, in terms of our production, with our supply chain partners. I do not want to say that we got caught flat-footed.
Speaker #4: Hey, thanks for that question, Steve. The, I'm going to, I'll tell you just straight up how many units came from clarity C. It was about 7,000.
Speaker #4: Or so. During the period. And in terms of those patients falling off, you know, those patients typically have been as loyal, I think, refillers or even more loyal than the Viva experience, that we've seen so far.
Speaker #4: The other thing that I would mention that I think you're hitting on, which is true, and I kind of allude to this a little bit in the stockholder letter, is that we really didn't count on Viva taking off in the way that it did in terms of our forecasting, in terms of our production, with our supply chain partners.
Speaker #4: And I don't want to say that we got caught flat-footed. These are very luxurious problems to have, but we have purposely I would say not poured gasoline onto the Viva fire, you know, with intention because, you know, we really don't, we want to make sure that if an existing patient needs Viva, or if an NRX comes in that we can supply the market.
Mark L. Baum: These are very luxurious problems to have, but we have purposely, I would say, not poured gasoline onto the VEVYE fire, with intention because we really do not want to make sure that if an existing patient needs VEVYE or if an NRX comes in that we can supply the market. I think over the next couple of months, we are going to have far greater clarity in terms of acceptable levels of safety stock with VEVYE. As I said in the stockholder letter, because every unit of VEVYE is profitable, nearly every unit is profitable, we feel really confident in entering a new investment cycle and dramatically, hopefully, taking additional market share, probably starting that process at the end of the year and really setting us up well for 2026.
Speaker #4: I think over the next couple of months, we're going to have far greater clarity in terms of acceptable levels of safety stock with Viva.
Speaker #4: And as I said in the stockholder letter, because every unit of Viva is profit, nearly every unit is profitable. We feel really confident in entering a new investment cycle and, you know, dramatically, hopefully, you know, taking additional market share.
Speaker #4: Probably starting that process at the end of the year and really setting us up well for 2026.
Speaker 6: All right. Thanks for the color on that, Mark. I wanted to also follow up on the specialty branded and TRIESENCE segment. The guidance here, obviously, is pretty assertive. More than a 7X increase, half over half, from $6 million to the incremental $44 million. I know you mentioned the ocular inflammation market, but you did say that that would sort of kick in in force in Q4. What are the expectations for Q3? What other assumptions are you making there to grow revenue so acutely in that segment, really in Q4, it sounds like?
Speaker #6: Thanks for the color on that, Mark. And just I wanted to also follow up on the specialty branded and Triesence segment. So the guidance here obviously is pretty assertive.
Speaker #6: I mean, like more than a 7X increase half over half from 6 million to the incremental 44 million. And I know you mentioned the ocular inflammation market, but you did say that that would sort of kick in and force in fourth quarter.
Speaker #6: So, I guess, what are the expectations for the third quarter? And what other assumptions do you make to grow revenue so acutely in that segment?
Speaker #6: Really in fourth quarter, it sounds like.
Mark L. Baum: Yeah. So, I would say that the ex-TRIESENCE products from that basket have not performed to the levels that we expect. We are seeing a rebound, and we need to.
Speaker #4: Yes, I would say that the X Triesence products from that basket have not performed to the levels that we expect. However, we are seeing a rebound.
Speaker #4: And we need to, I would say, and we expect to probably double the revenue levels of those X Triesence products, certainly by the end of the year.
Mark L. Baum: We expect to probably double the revenue levels of those ex-TRIESENCE products, certainly by the end of the year. We think that's achievable. What really is not baked in, I think, is TRIESENCE revenue. There is a reasonably decent WACC price there. I covered the coverage levels in the opening remarks and in the stockholder letter. There is pervasive coverage for TRIESENCE. Without going into a whole lot of detail, we do not need to capture a whole lot of market share, for example, in the post-surgical ocular inflammation market in order to hit those numbers. You are right. We do need some things to go our way. We have got new leadership helping us drive value for that part of our ophthalmic portfolio. We have work to do, to be clear. When we look at the math, we think it is achievable.
Speaker #4: We think that's achievable. But what really what is not baked in, I think, is Triesence revenue. You know, there is a reasonably decent WAC price there.
Speaker #4: You know, I covered the coverage levels. In the opening remarks and in the stockholder letter, there is pervasive coverage. For Triesence. And you know, without going into a whole lot of detail, you know, we don't need to capture a whole lot of market share for example, in the post-surgical ocular inflammation market.
Mark L. Baum: We are also seeing meaningful improvement in TRIESENCE in the retina market, actually, in Q3. I think I alluded to that both in the stockholder letter and the prepared remarks. TRIESENCE is on the upswing. It really is. We have great coverage. Same with IHEEZO, frankly. IHEEZO is probably more set up to exceed. I think we can get there with TRIESENCE. It is going to be a challenge, though.
Shannon: Thank you. Our next question comes from the line of Mayank Mamthani with B. Riley Securities. Your line is now open.
Mike Viega: Good morning, team. Thanks for taking your questions and congrats on the progress. My two questions are a follow-up to the comments you had, Mark Baum, earlier. On the stabilizing of average selling prices, you implied that the net price is sort of reset at where you have been in Q2. Just to confirm, is that kind of the case that you expect that to be sustained at the levels that you kind of found yourself in Q2? How much do you anticipate the unit volume to expand, particularly driven by new patient stats? I am thinking longer term, if your PKR sales assumption is immaterially altered. Then I have a follow-up.
Mark L. Baum: Yeah. So in terms of the ASP for VEVYE, we are comfortable with the current levels of ASP for the product. As I said, I think that we should see a bias to ASP, you know, possibly improving, certainly by the end of the year. That is going to be bolstered by improved coverage and really this overall ratio of, of, you know, higher paid claims versus lower priced prescriptions. All in all, though, I mean, and I think we have talked about this in the past, it is really about the average for us. We are going to get some units that we make a lot of money on or more money on and some that we make very little money on. But the average is very acceptable.
Yeah. So, in terms of the ASP, for Vivi, we are comfortable with sort of the current levels of ASP, for for the product. Um, as I said, I think that we should see a, a, a bias, uh, to ASP, you know, possibly improving certainly by the end of the year. Um,
Mark L. Baum: In fact, the current average is in excess of where we were, certainly in 2024, and it is significantly ahead of what we had planned for, you know, pre-launch. So we are actually very happy with where we are with ASP. I think as it does improve, and I do believe it will improve, we are seeing signs of that. You know, I think, you know, we will be in good shape on the ASP side. In terms of growth, I see the weekly prescriptions come in. It is kind of one of the cool things about working with these specialty pharmacies. I can literally monitor the prescriptions. Sometimes I do, you know, hour by hour. It is kind of like watching a ticker tape, frankly. You see the prescriptions come in. You know, we are doing really well on the NRX side of things. Those NRXs are not yielding.
That that's going to be bolstered by improved coverage and really this overall ratio of of uh you know, higher paid claims versus lower uh priced uh prescriptions. So, um, all in all though, I mean, and, and I think we've talked about this in the past, it's really about the average for us. Um, we're going to get some some units that we make a lot of money on, or more money on and some that we make, uh, very little money on. Uh, but uh, the average is, is, is very acceptable. In fact, the current
Average is in excess of where we were certainly in 2024, and it's significantly ahead of what we had planned for, you know, pre-launch. So, we're actually very happy with where we are with ASP. And I think as it does improve, and I do believe it will improve, we're seeing signs of that. Um, you know, I think, uh,
Mark L. Baum: Even in the midst of the summer, kind of a summer low, typically that you see with people going on vacation, patients going on vacations and prescribers, we are still seeing those NRXs come in, which is terrific. By the way, we have a very modest sales organization. We have not, as I said to Steve earlier, we have not invested heavily as we intend to, or more heavily into that organization. Once we once we shore up supply and get really comfortable with our safety stock and make those investments, you know, I think you are going to see, you know, many years of growth. I think I have said to other investors, I mean, we are going to have many, many years of growth with VEVYE. We do not see that yielding. You know, we are in a really good place with VEVYE.
You know, we we'll be in good shape on the ASP side. In terms of growth, I see the weekly prescriptions come in, its kind of 1 of the cool things about working. With uh, these specialty pharmacies, I can literally monitor, uh, the prescriptions and and sometimes I do, you know, hour by hour, it's kind of like watching a ticker tape. Frankly, you see the prescriptions come in and, you know, we're doing really well on the nrx side of things. Uh, those nrx are not yielding, um, even in the midst of the summer kind of a summer low typically that you see with
Mike Viega: Understood. Thank you. It would also be helpful to hear a bit more on the IHEEZO end of Q2 stocking dynamic, how similar or different it is to what we saw back in Q4. I understand that was the end of year. If there is any other stocking dynamic we need to be aware of for any other branded products, thanks for taking the question.
With Levi.
Mark L. Baum: I would say that no concern on additional products in terms of the stocking dynamic. I will say this with IHEEZO, because I just, and I said this in the letter to stockholders, I returned from the ASRS meeting in Long Beach, California. I remember when we acquired the product, we did some advisory board meetings. I remember doctors saying, "What do I need this for? What I'm doing is okay." I gave them my analogies of really loving my BlackBerry until I ultimately got the iPhone. What they were doing in terms of their anesthesia protocol for intravitreal injections is an example. In many cases, it is not an efficient process. It costs them not only in terms of supplies and materials, but more important for them, their time.
Understood. Thank you and also would be helpful to hear a bit more on the izo end of 2q stocking Dynamics. How similar or different it is to what we saw back in full queue. Understand that was the end of year and and and if if there's any other stocking Dynamic we need to be aware of for any other branded products. Um uh thanks for taking a question.
I would say that no concern on additional products.
Mark L. Baum: With one dose being required in order to anesthetize an eye for, for example, an intravitreal injection, IHEEZO just adds tremendous value to these practices. When I went to this ASRS meeting, I really saw this thing catching on. It was clear. The looks that we were getting when we initially were going to market were pronounced. The reception that we are now receiving, for whatever reason, maybe it is the Samsung deal, maybe it is now more and more offices getting access to TRIESENCE, the great coverage that we have, it is a different ballgame. More and more accounts are adopting IHEEZO. They are open to IHEEZO. They are seeing the benefits of this product. This is one where I think there is really nice upside based on the guidance that we gave earlier this year. We are excited about IHEEZO for the balance of the year.
In terms of a stocking Dynamic but I I will say this without heizo because I just and I said this in the letter to stockholders uh I returned from the asrs meeting in Long Beach, California. And I remember when we acquired the product we did some Advisory board meetings. And and I remember doctors saying, you know, what do I need this for? You know what I'm doing is okay? And and I gave them my analogies of, you know, really loving my Blackberry until I ultimately got the iPhone and and that what they were doing in terms of their anesthesia protocol for intravitreal injections is an example in, in many cases is not an efficient process. It it costs them not only in terms of supplies and materials, but but more important for them, their time. And with 1 dose being required in order to anesthetize an eye for, for example, an intravitreal injection. Um, Izzo.
Just is, is, is of tremendous value to these practices and.
Mark L. Baum: Once again, we still have a very, very small percentage of the overall number of intravitreal injections that use IHEEZO. So, a lot of upside. We have a great leadership team selling that product.
When I went to this asrs meeting, I really saw this thing catching on that was clear. You know, the, the, uh, the looks that we were getting when we initially were going to Market, um, were pronounced and the reception that we're now receiving, uh, for whatever reason, maybe it's the Samsung deal, maybe it's now, you know, people more and more offices getting access to trials, it's the great coverage that we have. Um, it is a different ballgame and more and more accounts are adopting. I use other opened, I use other seeing the benefits of this product. And, um, this is 1 where I think there's really nice upside based on the guidance that we gave earlier this year. So we're we're excited about izo for the balance of the year. And really once again we still have a very very small percentage of the overall number of intravitreal injections that you use izo. So a lot of upside and we have a great leadership team.
Shannon: Thank you. Our next question comes from the line of Tom Schrader with BTIG. Your line is now open.
Selling that product, so.
Mark L. Baum: Good morning. Thanks for all the details. A little bit on the difference between the two specialty pharmas for you. Is ApolloCare better for you because they are more integrated with existing plans? Can you steer patients that way? Is IHEEZO for all, are you making it easy for people to try IHEEZO? So we may have some average selling price swings for IHEEZO in the short term with the hope of growth down the road. Thank you.
Thank you. Our next question comes from the line of Tom shraider, with btig. Your line is now open.
Mark L. Baum: Thanks, Tom. So, in terms of the difference between ImprimisRx and ApolloCare, ImprimisRx is very well known, I think, within ophthalmic practices and even optometric offices in the U.S. A lot of the offices are very familiar with the ImprimisRx platform. We use ApolloCare as a copay card vendor. They are, once again, very, I think, well known within the ophthalmic market. Now they are expanding into the specialty pharmacy market. The thing that they offer us, as I said earlier, is that they have contracted with so many plans. We have seen, in terms of how we manage average selling prices, literally day to day and certainly week to week, that we get prescriptions in that could be covered by, for example, a commercial policy, but that ultimately become $59 prescriptions because ImprimisRx, for example, may not be contracted with that plan.
Good morning, thanks for all the details. Uh, a little bit on the difference between the 2 specialty Farmers for you is is Apollo better for you because they're more integrated with existing plans and can you steer patients that way and I he's over for all? Is that a? Are you making it easy for people to try izo? So we may have some uh every selling price swings for ieso in the short term with the hope of growth down Road. Thank you.
Thank thanks, Tom. Yeah, so in terms of the difference between Phil and Apollo care Phil is, is uh, very well known. I think, within atholic practices, and even Optometric offices in the United States. So, a lot of, uh, a lot of offices are very familiar with the Phil platform. Um, we used a polo care as a, as a co-pay card vendor. And so they also are once again, very I think well known in within the the Opthalmic market and now they're expanding into the specialty pharmacy market. So, um, the thing that they offer us, as I said earlier, is that they have contracted with so many plans. And we have seen in terms of how we manage ASP. You know, literally day-to-day and certainly week to week that we get prescriptions in, um, that could be covered by, for example, a commercial policy, but that ultimately become 59 prescriptions
Mark L. Baum: For us, this is an opportunity, I think, to capture more commercial covered prescriptions through ApolloCare. As I said, that is one of the reasons, and there are a few other reasons why we think average selling prices are stable and have a bias towards improving. In terms of IHEEZO for all, the point of IHEEZO for all is that we believe every patient who can benefit from IHEEZO should have access to it. I think there has been a misnomer within even some of our customers that they need to pick and choose patients, that IHEEZO should only be used for a fee-for-service patient, or that they need to really do a deep dive into a benefits investigation before using IHEEZO. We have such a powerful message in terms of coverage. It is really, I think, coverage that any product would envy.
Mark L. Baum: When we spread that message and let our physician customers know that they can actually use IHEEZO for all of their intravitreal injections, there is no reason to pick and choose. That is really what this program is about. It is about greater depth within existing accounts. As I think that message gets spread in terms of not only the experience of what their colleagues are having with IHEEZO, but the value that it offers, these practices will have more and more new account starts. That is what we are seeing in Q3, by the way. As I said, I think just after, early into August, we had already eclipsed the number of new account starts for IHEEZO than we had in the entirety of Q2.
And even some of our, uh, customers that they need a pick and choose patients that, um, izo should only be used for, you know, a fee for service patient or that they need to really do a, uh, a deep dive into a benefits investigation, uh, before using izo. And we have such a powerful message in terms of coverage, uh, it is really I think coverage that any product with envy and when we spread that message and let our physician customers know that they can actually use Vivi uh use aiso for all of their intra vitual injections. Um you know, and that there's no reason to to pick and choose. That's really what this this program is about. So it's about uh, greater depth within existing accounts and as I think that message gets spread in terms of, you know, not only the, the experience of what their colleagues are having with.
Mark L. Baum: More than free drug, it's helping show that they can get it covered.
With izo. But the value that it offers these practices will have more and more new new accounts starts and that's what we're seeing in the third quarter. By the way, as I said, uh, you know, I think just after July, you know, early into August, we had already eclipsed the number of new accounts starts, right heizo and we had in the entirety of the second quarter.
Mark L. Baum: Yeah, it is not about free drug. It is about reimbursement confidence. It is about confidence of coverage. I do not think that these practices know how pervasive our coverage is for TRIESENCE, for IHEEZO, and even we are seeing improved coverage for VEVYE. So, coverage is our friend with those products. It is their friend with those products, and we are spreading that message.
So, so more than free drug, it's helped showing that they can get it covered.
Mark L. Baum: Great. Thank you.
Yeah, it's not yeah it's not about free drug. It's about uh reimbursement confidence, it's about confidence of coverage. I don't think that these practices know how uh pervasive our coverage is for triesence for izo and and you know, even we're seeing improved coverage for for Vivi. So you know we coverage is is a is our friend with those products. It's their friend with those products and we're spreading that message.
Shannon: Our next question comes from the line of Lachlan Hanbury-Brown with William Blair. Your line is now open.
Great. Thank you.
Andrew Bull: Hey, guys. Thanks for taking the questions. I guess, you know, if VEVYE is the number one prescribed product per prescriber in dry eye, does that kind of performance, you know, warrant more investment in the commercial team or the infrastructure to increase that? Or how do you sort of expand that to add new prescribers? I know you talked about investing in it once you have secured supplier, but can you elaborate on maybe what that looks like?
Our next question comes from the line of Lachlan Hanbury brown with William. Blair, your line is now open.
Hey guys, thanks for taking the questions. Um,
I guess you, if they buy is the number 1 pres product of prescriber and dry eye, does that kind of performance
You know, more and more investment in the commercial team or the infrastructure to increase that. Or how do you sort of expand that to add new prescribers? I know you talked about.
Investing in a supply you've secured, but can you elaborate on what that looks like?
Mark L. Baum: There are parts of the country where if you go to talk to an ophthalmologist or an optometrist, they do not even know about VEVYE. Many of them have not even heard of VEVYE. We do not have feet on the street. We have not done a lot of marketing into many communities across the country, significant communities. We need to be there. We are not there because we have not invested, I think, in feet on the street and in marketing. That has been because we are a little bit weary of pouring fuel onto the VEVYE fire, as I said earlier. We have got to get sufficient safety stock of this product consistent with our forecast and the new forecast that we have. All of that said, though, we have sufficient supply.
There are parts of the country where, if you go to, uh, talk to an ophthalmologist or an optometrist, and I don't even know about Vivi.
Many of them have not even heard of Vivi, we don't have feet on the street, we haven't done a lot of marketing into many communities across the country significant communities.
Mark L. Baum: I mean, if we sell, and we very well likely may sell all of what we have, certainly for this year, our stockholders are going to be very, very happy. We are in great shape, certainly through the end of the year. Then, as I said, we are setting up well from a supply chain side to be able to supply the market, I think, more robustly into 2026 and beyond. That is going to allow us, and you know, if someone like Andrew Bull, who is a pretty conservative person, is going to say, "Okay, now let us invest in VEVYE. We are making money on these prescriptions. We have got the access figured out. We know where we need to be.
And we need to be there and we're not there because we haven't invested, I think in in, uh, in feed on the street and marketing. But you know, that's been because we're a little bit weary of pouring fuel onto the vvi fire. As I said earlier, um, we have got to get sufficient, uh, Safety stock of this product, uh, the consistent with our, our, our forecasts, and, and the new forecasts that we have. All of that said though, we have sufficient Supply, I mean, if we sell and we very well likely, uh, may sell, all of what we have certainly for this year, our stockholders are going to be very, very happy. So we, we are in great shape and certainly through the end of the year. And then as I said, we're um, we're setting up well from a supply chain side to uh to be able to supply the market. I think more robustly into 2026 and Beyond
Mark L. Baum: We know where those markets are that, you know, they really have not heard of VEVYE or they are not prescribing it." As you alluded to, the data shows that when we capture a prescriber, when they start using VEVYE and they come in, you know, the patients come back and they say, "Wow, this product did not burn. It did not sting. I did not get this weird taste in my mouth. I like this." Then the prescriber feels more comfortable using it on more and more of their patients. As you said, it is the number one prescribed dry eye medication per prescriber. We have a great clinical story to sell. We have got to get our supply chain dialed in a little bit more robustly. Then we will, I think, see even greater growth next year.
That is going to allow us. And, you know, if someone like Andrew, who's a pretty conservative person is going to say, okay, now, let's invest in Vivi, we're making money on these prescriptions, we've got the access figured out, um, we know where we need to be, we know where those markets are that, you know, they really haven't heard of Vivi um, or they're not prescribing it.
See, even greater growth next year.
Andrew Bull: Thanks. On the ApolloCare agreement, you said that expands your network and distribution. Can you give a sense of how much that expands the network or your distribution ability? Or is it more about that coverage element you were talking about earlier of having more of those commercial scripts covered than it is the physical distribution?
There you go. Thanks. And then on the Apollo agreement, you said that expands your...
Network and distribution. Can you give a sense of how much that expands the network, or your distribution ability? Or is it more about that coverage element? You were talking about earlier.
Commercial scripts, cover than it is.
Mark L. Baum: Thank you for that, Lachlan. It is the latter and not the former. It is about getting scripts covered. We have said to our prescriber partners, "Listen, we are going to help you get access to VEVYE for the most difficult patients in your practice, for patients with no insurance, patients that may not have means. We are going to partner with you and make sure that everybody in your practice who can benefit from this product will get access to it." At the same time, as part of that, because they see the clinical benefits, they are also sending us the commercial scripts. As you said, we get more units per prescriber than any other medication. The challenge for us in terms of delivering a sturdy ASP is to be able to take a commercial-covered script and financially benefit from it.
Distribution.
It's thank you for that, Lackland. It's the it's the, the, uh, the, the ladder and not the former, it is about getting scripts covered. Um, it's you know, we have said to our prescriber partners. Listen, we're going to help you uh get access to Vivi, for the most difficult patients in your practice, for patients with no insurance.
Mark L. Baum: The relationship with ApolloCare is going to help in that regard.
You know, patients that may not have means, we're going to partner with you and make sure that everybody in your practice who can benefit from this product will get access to it. And at the same time, you know, as part of that, you know, because they see the, the clinical benefits, they're also sending us the commercial scripts. As you said, we get more units per prescriber than any other medication. Um, but the challenge for us, in terms of of delivering, a a, uh, a sturdy ASP is to be able to take a commercial covered script and financially benefit from it and the relationship.
Shannon: Thank you. Our next question comes from the line of Jeffrey Cohen with Latimer Thalman & Company. Your line is now open.
With a polo, care is going to help in that regard.
Speaker 6: Hey, good morning, Mark and Andrew. It has been brought up a couple of times, but I wanted to get back to it. Hopefully, you can walk us through a bit of information as far as the specialty sales team out there that you have now and how you would expect that to grow into the back half of the year, Q3, Q4, and how that is helping on the awareness drive and education and actual number of feet on the street. Thanks.
Thank you. Our next question comes from the line of Jeffrey Cohen with Vladimir Thalman and Company. Your line is now open.
Hey, good morning, Mark. And Andrew, um, it's been brought up a couple times, but I wanted to get back to it. And hopefully uh, you can walk us through.
bit of information as far as specialty sales team out there that you have now and how you'd expect that to grow into uh
Back half of the Year Q3 Q4 and how that's helping on the uh, awareness drive and and education and actual number of feet on the street, thanks.
Mark L. Baum: Thanks, Jeff. You know, as I said, I do not think that we have done as well as we should have and could have with those non-well, even TRIESENCE, I would say. You know, it has been a fairly slow launch. But the question is, what is possible? Our expectation is that by the end of the year and very likely into the Q4, we should see a revenue run rate that is sort of consistent with where these products were when we took over them. TRIESENCE is a totally different story. We do have very high, I have very high hopes for that product. I am particularly excited about entering the ocular inflammation market. I think it is a very, very big opportunity for us. It is a great product. It is trusted. It is proprietary. Importantly, at the consumer level, it has a $37 co-payment.
Thanks, Jeff. Uh, you know, as as I said, I I I don't think, you know that we have done as well as we should have and could have with those, uh, non well, even even try assets. I would say, you know, it's been a, it's been a fairly slow launch. Um, but the question is, what is possible? And and our expectation is, is that by the end of the year and, and very likely into the fourth quarter, we should see a a revenue run rate, that is sort of consistent with where these products were when we took over them. Um, try Essence is a, is a totally different story. We do have very high. I have very high hopes for that product. I'm particularly excited about, um, entering the, uh, ocular inflammation Market. I think it's a a very
Mark L. Baum: It is the lowest out-of-pocket cost at the consumer level of any product in the category. If you are a prescriber and you want to save your patients' money, in terms of actual out-of-pocket costs at the consumer level on a month of per month of therapy, it is certainly the lowest of any product in the category. So it offers tremendous value. You know, that said, Chad is coming on. We are staffing him up. But I am going to, and we are focused on that TRIESENCE opportunity. We intend to launch BICLOVI at the Hawaiian Eye meeting in the January timeframe, early next year. We will probably get some sales, some stocking orders in the Q4 for BICLOVI, but you know, modest. We are really focused in, as a stockholder, they want us, I think, dialed in on that TRIESENCE opportunity in the ocular inflammation market.
Very uh big big opportunity for us. Um it's a great product. It's trusted it's uh you know, it's proprietary. But importantly at the consumer level, it has a 37 co- payment. It is the lowest out-of-pocket cost at the consumer level of any product in the category. And so if you're a prescriber and you want to save your patients money in terms of actual out-of-pocket costs at the consumer level on a month of per month of therapy. It's certainly the lowest of any product in the category. So it offers
Mark L. Baum: At the same time, Allie and her team are doing a terrific job. I have seen it, I saw it at the ASRS meeting in Long Beach, you know, growing unit volumes of TRIESENCE in the retina market. So I think we are in good shape. As I said earlier, we have work to do with that portfolio. But I think there is, we are going to get there. I think we are going to get there. We are seeing good signs of growth in the Q3. I remain confident we can get to that number for that basket of products. Guys, I want to make one thing also clear. I said this in a letter to stockholders. We are going to underperform in certain parts of our business, but other parts of our business, we are going to overperform.
tremendous value, you know, that said, um, Chad is coming on for Staffing, him up. Um, but uh, I am going to and and we are focused on that try assessence opportunity. Uh, we intend to launch by clove at the Hawaiian Eye meeting and and, uh, the January time frame, uh, early next year, we'll probably get some sales some stocking orders in the fourth quarter for by clovey, but, you know, modest, um, but we're really focused in is a, is a stockholder. They want us, I think, dialed in on that, try Essence opportunity in the ocular inflammation Market at the same time. Ally, and her team are doing a terrific job. And I've seen it uh I saw it at at the asrs meeting uh, in in Long Beach. You know, growing unit volumes of triac in the rat in the market. So
Holders.
Mark L. Baum: All in all, I think we are going to do really well for the overall period. TRIESENCE by the Q4 is when I think we could, you know, certainly overperform for the period. IHEEZO is an overperformer. VEVYE could overperform as well.
We're going to underperform in certain parts of our business, but other parts of our business, we're going to over-perform. And so, um, all in all, I think we're going to, we're going to do really well for the overall period. Um, try Essence by the fourth quarter is when I think we could, uh, you know, certainly over-perform for the period. Ieo is an over performer in Vivi could could uh, over-perform well as as, as well.
Speaker 6: Got it. Thanks for taking the questions.
Mark L. Baum: Thank you, Jeff.
Got it. Thanks for taking the question.
Shannon: Our next question comes from the line of Thomas Flatten with Lake Street Capital Markets. Your line is now open.
Thank you, Jeff.
Our next question.
Speaker 7: I appreciate you guys taking the questions.
On the line of Thomas, we have Flatten with Lake Street Capital Markets. Your line is now open.
Mark L. Baum: Baum, in your prepared comments, you said something that caught my eye about, you know, right now your solutions are pharmaceuticals, but that might evolve. Can you dig into that a little bit for us?
Speaker 7: Sure. We are, and this will be, I think, described further when we get to the investor and analyst day. We never talk about our pipeline. At that investor day, we are going to talk about some of our pipeline products, some of the things that we are working on. Some of them are not pharmaceutical initiatives. I want our investors to be aware of that. The key for us is to be an ophthalmic disease management solution business. Those solutions do not necessarily need to be pharmaceuticals per se. They might exist outside of purely a pharmaceutical product. I have to say, because I have done so much talking today, I promise on our next investor call, I am going to have Amir talking about the science. We are going to have Head of Commercial talking about commercial and Andrew talking about the financials.
Yeah, I appreciate you guys taking the questions, uh, Mark and you're prepared comments. You said something that caught my, uh, I about, you know, right now your, your Solutions or Pharmaceuticals, but that might evolve. Can you, can you dig into that a little bit for us?
Uh, sure we are and and this will be I think described further when we get to uh the the investor and analyst day, we never talked about our Pipeline and uh at that investor day. Um you know, we're going to talk about some of our pipeline products. Some of the things that we're working on and some of them are not pharmaceutical initiatives. Um, and so, you know, I want I want our investors to, uh, you know, to be aware of that the key for us.
Speaker 7: You will hear a lot less of me on the next conference call. At that investor and analyst meeting, you will really have a great opportunity to meet all these people, to meet commercial leadership, the folks that are selling IHEEZO, that are selling TRIESENCE. We are also planning to have a number of customers there, physicians who use the product and experience these products, and they can talk to you about their experiences firsthand.
Andrew Bull: Excellent. There is one quick follow-up. You mentioned the refill rate in 2024. I was curious if in 2025, seven and a bit months in, if the refill rates in 2025 are annualizing at that nine refills per patient per year rate.
Is to be an Opthalmic disease, management solution business. And those Solutions don't necessarily need to be Pharmaceuticals per se. They, they might, you know, exists outside of purely a pharmaceutical product. Um, but I I have to say, because I've done so much talking today and I promise on our next investor call, I'm going to have a mirror talking about the science. We're going to have head of commercial talking about commercial and Andrew talking about the financials. So you'll hear a lot less for of me on the next conference call. And at that investor and analysts meeting, you'll really have a great opportunity to meet all these people, um, to meet commercial leadership, the folks that are selling ideas or that are selling try assets. Um, and we're also planning to have a number of customers their Physicians, who use the product and experience these products, and they can talk to you about their experiences firsthand.
Mark L. Baum: I think we are on track. I mean, you have to put, it is so, it is an amazing product. It just feels so good in the eye relative to other products. We just had a campaign. There was a terrific meeting called Women in Ophthalmology. We had a campaign at that meeting that I came up with a long time ago. Our commercial team did not like it, but it was called Cut the BS. Cut the BS. It is kind of sort of a risky title. What BS stands for is burning and stinging. These doctors really identified with the concept of cutting the burning and stinging. A lot of other products out there, especially, you know, some of the recently launched products, they cannot say that. They have problems with burning and stinging. We do not. You know, we have a really terrific tolerability profile.
Excellent, and there's 1, quick followup, uh, you mentioned the refill rate from 2024. I was curious if in 2025, you know, uh, you know, 7 in a bit months in if the refill rates in 2025 are annualizing at kind of that 9, refills per patient per year rate,
I think I think we're on track. I mean, you have to put, it's so it's, it's an amazing Pro. It just feels so good in the eye relative to other products. We just had a campaign, there was a, a terrific meeting called women in Ophthalmology. And we had a campaign at that meeting that uh, I came up with a a long time ago. Our, our commercial team didn't like it, but it was called cut the BS. Cut the BS. And it's kind of sort of a risky, uh, title, but what BS stands for is burning and stinging
And these doctors really identified with the concept of cutting the burning and stinging.
Mark L. Baum: The person who cares most about that tolerability profile is the patient. When the patient gets relief, they do not have the burning and stinging, and their dry eye disease is being alleviated, they refill. When you get that refill rate and our refill rate steady eddy, you know, you see, you know, we do not, and we do not anticipate that yielding anytime soon, Thomas.
Shannon: Thank you. Our next question comes from the line of Yee Chen with HC Wainwright & Company. Your line is now open.
And a lot of other products out there, especially, you know, some of the recently launched products, they can't say that they have problems with burning and stinging and we don't, you know, we have a really terrific uh, uh, tolerability profile. And the person who cares most about that tolerability profile is the patient when the patient gets released, they don't have the burning and stinging and they're, they're, they're dry eye disease as being, uh, alleviated, they refill. And when you get that refill rate and our refill rate's Steady Eddy, um, you know, you you see, uh, you know, we don't we we don't anticipate that yielding anytime soon. Thomas,
Thank you. Our next question comes from the line of gin with HC. Wayne writing company, your line is now open.
Andrew Bull: Thank you for taking the question. Could you provide some comments regarding the timing difference of the VEVYE prescription growth in a quarter and also the recorded revenue for the quarter? Do you have an estimated timeline as to when VEVYE could become the largest cyclosporin-based dry product?
Mark L. Baum: Andrew, do you want to, I am going to, you started, I gave you the first one. I am going to give you maybe the last.
Thank you for rotating my question. Uh, could you provide some comments regarding the timing difference of the vine prescription gross in quarter? And also, the recorded revenue for the quarter and also do you have an estimate timeline as to when Vivi could become the largest cyclosporine based dry product?
Wow. Andrew, do you want to? I'm going to you start. I give you the first. I'm going to give you.
Andrew Bull: Hey, thanks for the question. With all the products this quarter, we didn't see a whole lot of stocking dynamics. So the unit demand and script numbers were pretty tight as related to the revenue recognition during the quarter.
Maybe the last.
Stocking Dynamics. So the the unit demand and and script numbers are pretty tight. Um, as related to the the revenue recognition during the quarter.
Mark L. Baum: On the timing of being the top banana in dry eye, our primary goal with the franchise, as I said in the prepared remarks, is to be the number one cyclosporin in the U.S. market. Secondarily, we intend to be the number one anti-inflammatory in the U.S. market. I think the tertiary goal would then be the number one most prescribed product in the U.S. That is when I talked to Maria, who is sort of the CEO of that franchise, that is the goal. Primary is to be the number one cyclosporin. That is what she is driving towards with her team every day.
Timing. And by the way, on the timing of being, you know, the top banana in dry eye.
Shannon: Thank you. We are currently out of time. I will now turn the call back to Mark L. Baum for closing remarks.
Our primary goal with the franchise. As I said in the prepared remarks is to be the number 1 cycle sporran, uh, in the US market. Secondarily, we intend to be the number 1, anti-inflammatory in the US market. And I think the tertiary goal would then be the, you know, the number 1. Most prescribed product in the US and, you know, that that's when I, when I talked to Maria who's uh, sort of the CEO of that franchise, that's the goal, you know, uh primary is to be the number 1 cyclist born and that's what she's driving towards with her uh her team every day.
Thank you, and we're currently out of time. I want to turn the call back to Mark Baum for closing remarks.
Mark L. Baum: Thank you, operator. Thanks, everyone, for the questions and for joining us today. As we continue to build on our strong momentum, we remain focused on driving sustained growth and expanding our impact across the ophthalmic space. The addition of experienced senior leaders to our team further strengthens our ability to execute with excellence and scale with confidence. Thanks to the efforts of our Harrow family, we are excited about what lies ahead and look forward to sharing more progress in the coming months. If you have any further questions or need additional information, please do not hesitate to reach out to Mike Viega, once again, M-V-I-E-G-A at harrowinc.com. This will conclude our call.
Thank you, operator. And thanks everyone for the questions. And, and for joining us today, as we continue to build on our strong momentum, we remain focused on driving sustained growth and expanding our impact across. The Opthalmic space. The addition of experienced senior leaders to our team further. Strengthens our ability to execute with excellence and scale with confidence.
Shannon: This concludes today's conference call. Thank you for your participation. You may now disconnect.
Thanks to the efforts of our hero family, we're excited about what lies ahead and look forward to sharing more progress in the coming months. If you have any further questions or need additional information, please don't hesitate to reach out to Mike at VGA, once again, mbie@gaataroinc.com. This will conclude our call.
call, thank you for your
patient. You may now disconnect