Q2 2026 Harrow Inc Earnings Call
Operator: Good morning, and welcome to HARROW's Q2 2026 earnings conference call. My name is Michelle, and I will be the 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 Biega, Vice President of Investor Relations and Communications for HARROW. Please go ahead.
Operator: Good morning, and welcome to Harrow's Q2 2026 earnings conference call. My name is Michelle, and I will be the 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 Biega, Vice President of Investor Relations and Communications for Harrow. Please go ahead.
Speaker #1: 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.
Speaker #1: I would now like to turn the conference over to Mike Biega, Vice President of Investor Relations and Communications for HARROW. Please go ahead.
Speaker #2: Thank you, operator. Good morning, and welcome to HARROW's second quarter 2026 earnings conference call. My name is Mike Biega, Vice President of Investor Relations and Communications, and I'm excited to be introducing today's call.
Michael D. Biega: Thank you, operator. Good morning, and welcome to HARROW's Q2 2026 earnings conference call. My name is Mike Biega, Vice President of Investor Relations and Communications, and I am excited to be introducing today's call.
Michael Biega: Thank you, operator. Good morning, and welcome to Harrow's Q2 2026 earnings conference call. My name is Mike Biega, Vice President of Investor Relations and Communications, and I am excited to be introducing today's call.
Speaker #2: 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.
Michael D. Biega: 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.
Michael Biega: 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 #2: For a list and description of those risks and uncertainties, please see the risk factor 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.
Michael D. Biega: 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.
Michael Biega: 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 #2: 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.
Michael D. Biega: HARROW's results may differ materially from those projected. HARROW disclaims any intention or obligation to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information and is accurate only as of today.
Michael Biega: Harrow's results may differ materially from those projected. Harrow disclaims any intention or obligation to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information and is accurate only as of today.
Speaker #2: 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, 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.
Michael D. Biega: Additionally, HARROW will refer to non-GAAP financial metrics, specifically Adjusted EBITDA. 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. Joining me on today's call are Mark L. Baum, Chief Executive Officer, Andrew Boll, President and Chief Financial Officer, Patrick Sullivan, Chief Commercial Officer, and Amir H. Shojaei, Chief Scientific Officer. With that, I would like to turn the call over to Mark. Mark?
Michael Biega: Additionally, Harrow will refer to non-GAAP financial metrics, specifically adjusted EBITDA. 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. Joining me on today's call are Mark L. Baum, Chief Executive Officer, Andrew Boll, President and Chief Financial Officer, Patrick Sullivan, Chief Commercial Officer, and Amir H. Shojaei, Chief Scientific Officer. With that, I would like to turn the call over to Mark. Mark?
Speaker #2: Joining me on today's call are Mark L. Baum, Chief Executive Officer; Andrew Boll, President and Chief Financial Officer; Patrick Sullivan, Chief Commercial Officer; and Namir Sojayi, Chief Scientific Officer.
Speaker #2: With that, I would like to turn the call over to Mark. Mark?
Speaker #3: Thank you, Mike, and good morning, everyone. We spent the first half of 2026 building demand and strengthening the commercial foundation of our business. The second half is about converting that demand into accelerating revenue, growth, and profitability, and, of course, hitting our numbers.
Mark L. Baum: Thank you, Mike, and good morning, everyone. We spent the H1 2026 building demand and strengthening the commercial foundation of our business. The H2 is about converting that demand into accelerating revenue, growth, and profitability, and of course, hitting numbers.
Mark Baum: Thank you, Mike, and good morning, everyone. We spent the first half 2026 building demand and strengthening the commercial foundation of our business. The second half is about converting that demand into accelerating revenue, growth, and profitability, and of course, hitting numbers.
Speaker #3: Let me be direct: First half revenue of approximately $115 million was lighter than we expected entering the year, primarily because of the VVI net revenue impact we discussed last quarter. At the same time, we executed on major operating priorities we established for the first half—expanding our commercial organization, improving the economics of key products, strengthening our portfolio, launching Bioviz, and building physician demand across our key growth drivers.
Mark L. Baum: Let me be direct. H1 revenue of approximately $115 million was lighter than we expected entering the year, primarily because of the VEVYE net revenue impact we discussed last quarter. At the same time, we executed on major operating priorities we established for the H1, expanding our commercial organization, improving the economics of key products, strengthening our portfolio, launching BYOOVIZ, and building physician demand across our key growth drivers. Those actions have positioned us to deliver meaningfully stronger revenue, growth, and profitability during the H2 2026. IHEEZO is a good example.
Mark Baum: Let me be direct. first half revenue of approximately $115 million was lighter than we expected entering the year, primarily because of the VEVYE net revenue impact we discussed last quarter. At the same time, we executed on major operating priorities we established for the first half, expanding our commercial organization, improving the economics of key products, strengthening our portfolio, launching BYOOVIZ, and building physician demand across our key growth drivers.
Speaker #3: Those actions have positioned us to deliver meaningfully stronger revenue and growth and profitability during the second half of 2026. And I heso is a good example.
Mark Baum: Those actions have positioned us to deliver meaningfully stronger revenue, growth, and profitability during the second half 2026. IHEEZO is a good example. Despite the loss of pass-through on 1 April of this year, IHEEZO generated the highest quarterly unit demand in its history and delivered record new account growth. Channel inventory has now normalized and an approximately 25% improvement in net pricing became effective 1 July.
Speaker #3: Despite the loss of pass-through on April 1st of this year, IHEZO generated the highest quarterly unit demand in its history and delivered record new account growth. Channel inventory has now normalized, and an approximately 25% improvement in net pricing became effective July 1st.
Mark L. Baum: Despite the loss of pass-through on 1 April of this year, IHEEZO generated the highest quarterly unit demand in its history and delivered record new account growth. Channel inventory has now normalized and an approximately 25% improvement in net pricing became effective 1 July. With gross margins exceeding 90%, we expect IHEEZO to be a major contributor to both revenue growth and profitability during the H2. VEVYE is also positioned for stronger growth. During Q2, prescriptions increased 21% sequentially. Our prescriber base grew 15%, and the product delivered record quarterly revenue. The business rule changes we implemented at the end of April worked as intended. VEVYE's economics improved sequentially with meaningfully lower copay card utilization, which drove a higher ASP. Those results validated our ability to improve the economics of the franchise while continuing to grow prescription demand and physician adoption.
Speaker #3: With gross margins exceeding 90%, we expect IHEZO to be a major contributor to both revenue growth and profitability during the second half. VVI has also positioned for stronger growth.
Mark Baum: With gross margins exceeding 90%, we expect IHEEZO to be a major contributor to both revenue growth and profitability during the second half. VEVYE is also positioned for stronger growth. During Q2, prescriptions increased 21% sequentially. Our prescriber base grew 15%, and the product delivered record quarterly revenue.
Speaker #3: During the second quarter, prescriptions increased 21% sequentially. Our prescriber base grew 15%, and the product delivered record quarterly revenue. The business rule changes we implemented at the end of April worked as intended.
Mark Baum: The business rule changes we implemented at the end of April worked as intended. VEVYE's economics improved sequentially with meaningfully lower copay card utilization, which drove a higher ASP. Those results validated our ability to improve the economics of the franchise while continuing to grow prescription demand and physician adoption.
Speaker #3: VVI's economics improved sequentially, with meaningfully lower copay card utilization, which drove a higher ASP. Those results validated our ability to improve the economics of the franchise while continuing to grow prescription demand and physician adoption.
Speaker #3: During the second half, VVI will benefit from the full-period impact of those revised business rules, broader commercial coverage that became effective August 1, an expanded sampling program, and a sales organization that has doubled in size over the past year.
Mark L. Baum: During the H2, VEVYE will benefit from the full period impact of those revised business rules, broader commercial coverage that became effective 1 August, an expanded sampling program, and a sales organization that has doubled in size over the past year. Together, those factors position VEVYE for stronger prescription growth and improved net revenue realization. TRIESENCE also reached another quarterly demand record, with more than half of unit demand now coming from ocular surgery. We tripled our surgical commercial organization during Q2, and those representatives remain early in their productivity ramp. As they broaden account coverage and deepen utilization, we expect TRIESENCE revenue growth to build throughout the H2. BYOOVIZ represents another incremental growth driver that we launched on 1 July with encouraging early reception. Our specialty portfolio is similarly positioned to contribute more meaningfully.
Mark Baum: During the second half, VEVYE will benefit from the full period impact of those revised business rules, broader commercial coverage that became effective 1 August, an expanded sampling program, and a sales organization that has doubled in size over the past year. Together, those factors position VEVYE for stronger prescription growth and improved net revenue realization.
Speaker #3: Together, those factors position VVI for stronger prescription growth and improved net revenue realization. Priescence also reached another quarterly demand record, with more than half of unit demand now coming from ocular surgery.
Mark Baum: TRIESENCE also reached another quarterly demand record, with more than half of unit demand now coming from ocular surgery. We tripled our surgical commercial organization during Q2, and those representatives remain early in their productivity ramp. As they broaden account coverage and deepen utilization, we expect TRIESENCE revenue growth to build throughout the second half. BYOOVIZ represents another incremental growth driver that we launched on 1 July with encouraging early reception.
Speaker #3: We tripled our surgical commercial organization during the second quarter, and those representatives remain early in their productivity ramp. As they broaden account coverage and deepen utilization, we expect Priescence revenue growth to build throughout the second half, Bioviz represents another incremental growth driver that we launched on July 1st, with encouraging early reception.
Speaker #3: And our specialty portfolio is similarly positioned to contribute more meaningfully. FOR KZ has been relaunched, and interest is growing in the form of rising prescription volumes.
Mark Baum: Our specialty portfolio is similarly positioned to contribute more meaningfully. FORCASIA has been relaunched and interest is growing in the form of rising prescription volumes. IOPIDINE now benefits from a permanent J-code. We also expanded our AccessPlus commercial organization. Each of these initiatives was either absent or only partially reflected in our first half results. Finally, subject to closing, TYRVAYA will further strengthen our dry eye franchise.
Mark L. Baum: FORCASIA has been relaunched and interest is growing in the form of rising prescription volumes. IOPIDINE now benefits from a permanent J-code. We also expanded our AccessPlus commercial organization. Each of these initiatives was either absent or only partially reflected in our H1 results. Finally, subject to closing, TYRVAYA will further strengthen our dry eye franchise. We are acquiring global rights to the product, which is approved in the United States and China, and is under regulatory review in five additional countries. TYRVAYA also offers a distinctive tolerability profile, zero contraindications, zero ocular adverse events, and zero warnings on its label, with sneezing as its most common adverse reaction. From a strategic perspective, and given our commitment to relentlessly compete and win in the US dry eye market, this acquisition makes a ton of sense.
Speaker #3: And IOPD now benefits from a permanent J code. We also expanded our access plus commercial organization. Each of these initiatives was either absent or only partially reflected in our first half results.
Speaker #3: Finally, subject to closing, Tervia will further strengthen our dry eye franchise. We are acquiring global rights to the product, which is approved in the United States and China, and is under regulatory review in five additional countries.
Mark Baum: We are acquiring global rights to the product, which is approved in the United States and China, and is under regulatory review in five additional countries. TYRVAYA also offers a distinctive tolerability profile, zero contraindications, zero ocular adverse events, and zero warnings on its label, with sneezing as its most common adverse reaction.
Speaker #3: Tervia also offers a distinctive tolerability profile, zero contraindications, zero ocular adverse events, and zero warnings on its label, with sneezing as its most common adverse reaction.
Speaker #3: From a strategic perspective, and given our commitment to relentlessly compete and win in the U.S. dry eye market, this acquisition makes a ton of sense.
Mark Baum: From a strategic perspective, and given our commitment to relentlessly compete and win in the US dry eye market, this acquisition makes a ton of sense. I would encourage stockholders to check out slide 15 in our updated corporate deck on that subject. From an acquisition cost perspective also, this deal may be the best deal we've ever struck. From sales and marketing, to market access, to share a voice in the ophthalmologist and the optometrist office, we're a much stronger company with TYRVAYA in our bag.
Speaker #3: And I would encourage stockholders to check out slide 15 in our updated corporate deck on that subject. From an acquisition cost perspective, also, this deal may be the best deal we've ever struck.
Mark L. Baum: I would encourage stockholders to check out slide 15 in our updated corporate deck on that subject. From an acquisition cost perspective also, this deal may be the best deal we've ever struck. From sales and marketing, to market access, to share a voice in the ophthalmologist and the optometrist office, we're a much stronger company with TYRVAYA in our bag. In the past, I always wondered why people would be interested in a nasal spray for their dry eye disease. But after going through our due diligence process and speaking to committed prescribers, I finally get it. There is a very sizable patient base who benefits from this unique product, even down to the side effect profile.
Speaker #3: From sales and marketing to market access, to share of voice in the ophthalmologist and the optometrist's office, we're a much stronger company with Tervia in our bag.
Speaker #3: In the past, I wondered why people would be interested in a nasal spray for their dry eye disease, but after going through our due diligence process and speaking to committed prescribers, I finally get it.
Mark Baum: In the past, I always wondered why people would be interested in a nasal spray for their dry eye disease. But after going through our due diligence process and speaking to committed prescribers, I finally get it. There is a very sizable patient base who benefits from this unique product, even down to the side effect profile.
Speaker #3: There is a very sizable patient base who benefits from this unique product. Even down to the side effect profile. I had one fantastic dry eye specialist tell me that his patients just love Tervia, and would much rather have someone say, "God bless you," after a sneeze than to endure the stinging and burning or dysgeusia after applying eye drops multiple times a day.
Mark L. Baum: I had one fantastic dry eye specialist tell me that his patients just love TYRVAYA and would much rather have someone say "God bless you" after a sneeze than to endure the stinging and burning or dysgeusia after applying eye drops multiple times a day. Financially, while we expect only a modest revenue contribution this year based on the anticipated timing of the transaction, TYRVAYA and its experienced commercial organization will expand our reach and create additional opportunities to grow the entire dry eye franchise. In sum, taken together, our principal growth drivers enter the H2 with stronger demand, improved economics, broader access, and greater commercial support. Breadth matters. Our outlook is not dependent on one product, one launch, or one reimbursement event. We have multiple commercial growth drivers positioned to contribute more meaningfully during the H2. That is why we are reiterating our full year guidance.
Mark Baum: I had one fantastic dry eye specialist tell me that his patients just love TYRVAYA and would much rather have someone say "God bless you" after a sneeze than to endure the stinging and burning or dysgeusia after applying eye drops multiple times a day.
Speaker #3: Financially, while we expect only a modest revenue contribution this year, based on the anticipated timing of the transaction, Tervia and its experienced commercial organization will expand our reach and create additional opportunities to grow the entire dry eye franchise.
Mark Baum: Financially, while we expect only a modest revenue contribution this year based on the anticipated timing of the transaction, TYRVAYA and its experienced commercial organization will expand our reach and create additional opportunities to grow the entire dry eye franchise. In sum, taken together, our principal growth drivers enter the second half with stronger demand, improved economics, broader access, and greater commercial support. Breadth matters.
Speaker #3: In sum, taken together, our principal growth drivers enter the second half with stronger demand, improved economics, broader access, and greater commercial support. And breadth matters.
Speaker #3: Our outlook is not dependent on one product, one launch, or one reimbursement event. We have multiple commercial growth drivers positioned to contribute more meaningfully during the second half.
Mark Baum: Our outlook is not dependent on one product, one launch, or one reimbursement event. We have multiple commercial growth drivers positioned to contribute more meaningfully during the second half. That is why we are reiterating our full year guidance. We recognize the magnitude of the second half ramp, and Andrew will walk through the financial bridge in more detail.
Speaker #3: That is why we are reiterating our full-year guidance. We recognize the magnitude of the second-half ramp, and Andrew will walk through the financial bridge in more detail.
Mark L. Baum: We recognize the magnitude of the H2 ramp, and Andrew will walk through the financial bridge in more detail. We expect revenue to grow sequentially in both the Q3 and Q4, with the larger step-up occurring in the Q4 as these initiatives contribute more fully. The H1 was about doing the work required to create the opportunity in front of us. The H2 is about execution, converting that opportunity into revenue, earnings, and durable value for our stockholders. Before I turn it over to Andrew, I did want to share something that has only deepened my conviction about G-MELT. At this year's American Society of Retina Specialists meeting, I spoke with dozens of retina specialists and one theme came up again and again.
Speaker #3: We expect revenue to grow sequentially in both the third and fourth quarters, with the larger step-up occurring in the fourth quarter as these initiatives contribute more fully.
Mark Baum: We expect revenue to grow sequentially in both the Q3 and Q4, with the larger step-up occurring in the Q4 as these initiatives contribute more fully. The first half was about doing the work required to create the opportunity in front of us. The second half is about execution, converting that opportunity into revenue, earnings, and durable value for our stockholders. Before I turn it over to Andrew, I did want to share something that has only deepened my conviction about G-MELT. At this year's American Society of Retina Specialists meeting, I spoke with dozens of retina specialists and one theme came up again and again.
Speaker #3: The first half was about doing the work required to create the opportunity in front of us. The second half is about execution—converting that opportunity into revenue, earnings, and durable value for our stockholders.
Speaker #3: Before I turn it over to Andrew, I did want to share something that has only deepened my conviction about Gmail. At this year's American Society of Retina Specialists meeting, I spoke with dozens of retina specialists, and one theme came up again and again: practices are struggling to secure reliable anesthesia coverage for their procedures.
Mark L. Baum: Practices are struggling to secure reliable anesthesia coverage for their procedures, and many are now paying what they call stipends out of their own facility and global surgical fees just to keep anesthesia services available. We do not believe this is a short-term dislocation. We believe it is a reality that eye surgeons and physicians in other specialties will be managing for many years to come. G-MELT, if approved, could be part of a solution to this growing problem. In nearly 15 years of running this company, I have never seen as consistently positive a reaction to a HARROW product candidate, and that has got me extremely excited about the future of G-MELT. With that, I will turn the call over to Andrew. Andrew?
Mark Baum: Practices are struggling to secure reliable anesthesia coverage for their procedures, and many are now paying what they call stipends out of their own facility and global surgical fees just to keep anesthesia services available.
Speaker #3: And many are now paying what they call stipends out of their own facility and global surgical fees, just to keep anesthesia services available. We do not believe this is a short-term dislocation.
Mark Baum: We do not believe this is a short-term dislocation. We believe it is a reality that eye surgeons and physicians in other specialties will be managing for many years to come. G-MELT, if approved, could be part of a solution to this growing problem. In nearly 15 years of running this company, I have never seen as consistently positive a reaction to a Harrow product candidate, and that has got me extremely excited about the future of G-MELT. With that, I will turn the call over to Andrew. Andrew?
Speaker #3: We believe it is a reality that eye surgeons and physicians in other specialties will be managing for many years to come. Gmailed, if approved, could be part of the solution to this growing problem.
Speaker #3: In nearly 15 years of running this company, I've never seen as consistently positive a reaction to a Harrow product candidate. And that has got me extremely excited about the future of Gmaled.
Speaker #3: With that, I'll turn the call over to Andrew. Andrew?
Speaker #2: Thank you, Mark, and good morning, everyone. We reported revenue of $70.7 million, up 11% year-over-year and approximately 60% sequentially. That brings first half revenue to approximately $115 million.
Andrew R. Boll: Thank you, Mark, and good morning, everyone. We reported revenue of $70.7 million, up 11% year-over-year and approximately 60% sequentially. That brings H1 revenue to approximately $115 million. The year-over-year comparison understates the underlying trajectory. H1 results reflected limited IHEEZO revenue as channel inventory normalized, as well as only a partial quarter benefit from the VEVYE business rule changes. VEVYE delivered quarterly revenue of $29.4 million, up nearly 58% year-over-year. The result reflected continued prescription growth and improved net revenue realization following the business rule changes implemented at the end of April. IHEEZO generated $15.6 million of revenue, primarily related to wholesaler stocking orders of our new five-pack presentation. Unit demand for IHEEZO reached a quarterly record, but reported revenue continued to lag underlying demand as distributors sold through previously purchased inventory.
Andrew Boll: Thank you, Mark, and good morning, everyone. We reported revenue of $70.7 million, up 11% year-over-year and approximately 60% sequentially. That brings first half revenue to approximately $115 million. The year-over-year comparison understates the underlying trajectory. first half results reflected limited IHEEZO revenue as channel inventory normalized, as well as only a partial quarter benefit from the VEVYE business rule changes.
Speaker #2: The year-over-year comparison understates the underlying trajectory. First-half results reflected limited ADHESO revenue as channel inventory normalized, as well as only a partial quarter benefit from the BVI business rule changes.
Speaker #2: BVI delivered quarterly revenue of $29.4 million, up nearly 58% year-over-year. The result reflected continued prescription growth and improved net revenue realization following the business rule changes implemented at the end of April.
Andrew Boll: VEVYE delivered quarterly revenue of $29.4 million, up nearly 58% year-over-year. The result reflected continued prescription growth and improved net revenue realization following the business rule changes implemented at the end of April. IHEEZO generated $15.6 million of revenue, primarily related to wholesaler stocking orders of our new five-pack presentation. Unit demand for IHEEZO reached a quarterly record, but reported revenue continued to lag underlying demand as distributors sold through previously purchased inventory.
Speaker #2: Adheso generated $15.6 million of revenue, primarily related to wholesaler stocking orders of our new five-pack presentation. Unit demand for Adheso reached a quarterly record, but reported revenue continued to lag underlying demand as distributors sold through previously purchased inventory.
Speaker #2: We expect Adhesso to enter the third quarter with a normalized revenue cycle and improved economics. Our specialty portfolio and TriEssence generated approximately $11 million of revenue, while our compounded portfolio generated $14.6 million of revenue.
Andrew R. Boll: We expect IHEEZO to enter Q3 with a normalized revenue cycle and improved economics. Our specialty portfolio and TRIESENCE generated approximately $11 million of revenue, while our compounded portfolio generated $14.6 million of revenue. GAAP gross margin was 71%. For H2, we expect gross margins to trend back towards the high 70s, supported by IHEEZO's return to a normal revenue cycle, increased overall revenue, continued VEVYE growth, and more favorable product mix. SG&A was $53.3 million, which increased quarter-over-quarter, largely reflecting the commercial investments made during the quarter. Excluding the additional headcount expected to be added through the TYRVAYA transaction at closing, we expect base SG&A dollars to remain approximately flat with Q2 levels for the balance of the year. The core operating cost structure is largely in place, and our objective is to grow revenue against that expense base.
Andrew Boll: We expect IHEEZO to enter Q3 with a normalized revenue cycle and improved economics. Our specialty portfolio and TRIESENCE generated approximately $11 million of revenue, while our compounded portfolio generated $14.6 million of revenue. GAAP gross margin was 71%. For second half, we expect gross margins to trend back towards the high 70s, supported by IHEEZO's return to a normal revenue cycle, increased overall revenue, continued VEVYE growth, and more favorable product mix.
Speaker #2: GAAP gross margin was 71%. For the second half, we expect gross margins to trend back toward the high 70s, supported by ADESYO's return to a normal revenue cycle.
Speaker #2: Increased overall revenue continued BVI growth and a more favorable product mix. SG&A was $53.3 million, which increased quarter over quarter, largely reflecting the commercial investments made during the quarter.
Andrew Boll: SG&A was $53.3 million, which increased quarter-over-quarter, largely reflecting the commercial investments made during the quarter. Excluding the additional headcount expected to be added through the TYRVAYA transaction at closing, we expect base SG&A dollars to remain approximately flat with Q2 levels for the balance of the year. The core operating cost structure is largely in place, and our objective is to grow revenue against that expense base.
Speaker #2: Excluding the additional headcount expected to be added through the Tervia transaction at closing, we expect base SG&A dollars to remain approximately flat with second quarter levels for the balance of the year.
Speaker #2: The core operating cost structure is largely in place, and our objective is to grow revenue against that expense base. Adjusted EBITDA was negative $1.2 million.
Andrew R. Boll: Adjusted EBITDA was -$1.2 million. We ended the quarter with cash and cash equivalents of $83.9 million. For the TYRVAYA transaction, we expect to fund the upfront consideration of $30 million with cash on hand. Following closing, to the extent any of the contingent net sales milestones are hit, we expect the payment of those milestone amounts will essentially be self-funded. Turning now to our outlook. We are reiterating full year guidance of $350 million to $365 million in revenue and $80 million to $100 million in Adjusted EBITDA. Based on H1 revenue of approximately $115 million, our guidance implies H2 revenue of approximately $235 million to $250 million. We are not providing quarterly guidance, but we expect revenue to grow sequentially in both Q3 and Q4, with the larger step-up occurring in Q4.
Andrew Boll: Adjusted EBITDA was -$1.2 million. We ended the quarter with cash and cash equivalents of $83.9 million. For the TYRVAYA transaction, we expect to fund the upfront consideration of $30 million with cash on hand. Following closing, to the extent any of the contingent net sales milestones are hit, we expect the payment of those milestone amounts will essentially be self-funded.
Speaker #2: We ended the quarter with cash and cash equivalents of $83.9 million. For the Tervia transaction, we expect to fund the upfront consideration of $30 million with cash on hand, and following closing, to the extent any of the contingent net sales milestones are hit, we expect the payment of those milestone amounts will essentially be self-funded.
Speaker #2: Turning now to our outlook, we are reiterating full-year guidance of $350 million to $365 million in revenue and $80 million to $100 million in adjusted EBITDA.
Andrew Boll: Turning now to our outlook. We are reiterating full year guidance of $350 million to $365 million in revenue and $80 million to $100 million in Adjusted EBITDA. Based on first half revenue of approximately $115 million, our guidance implies second half revenue of approximately $235 million to $250 million. We are not providing quarterly guidance, but we expect revenue to grow sequentially in both Q3 and Q4, with the larger step-up occurring in Q4.
Speaker #2: Based on first half revenue of approximately $115 million, our guidance implies second half revenue of approximately $235 million to $250 million. We're not providing quarterly guidance, but we expect revenue to grow sequentially in both the third and fourth quarters, with the larger step-up occurring in the fourth quarter.
Speaker #2: That is a substantial step up. It's only to be specific about the bridge. The largest incremental contributor should be Adhoso. We enter the second half with some record demand.
Andrew R. Boll: That is a substantial step-up, so let me be specific about the bridge. The largest incremental contributor should be IHEEZO. We enter the H2 with record demand, normalized channel inventory, and an improvement in net pricing. Those factors should allow reported revenue to more closely reflect the strength of the underlying business beginning in the Q3. VEVYE is another major driver. Its expanded sales organization should begin to contribute in the Q3. The revised business rules will be in effect for the full H2 of the year. Expanded commercial coverage became effective 1 August, and net revenue realization should benefit as more patients satisfy their annual deductibles. TRIESENCE should also continue to grow. Demand reached another quarterly record, and the surgical organization we tripled during the Q2 remains early in its productivity curve.
Andrew Boll: That is a substantial step-up, so let me be specific about the bridge. The largest incremental contributor should be IHEEZO. We enter the second half with record demand, normalized channel inventory, and an improvement in net pricing. Those factors should allow reported revenue to more closely reflect the strength of the underlying business beginning in the Q3. VEVYE is another major driver. Its expanded sales organization should begin to contribute in the Q3. The revised business rules will be in effect for the full second half of the year.
Speaker #2: Normalized channel inventory and an improvement in net pricing. Those factors should allow reported revenue to more closely reflect the strength of the underlying business, beginning in the third quarter.
Speaker #2: BVI is another major driver. Its expanded sales organization should begin to contribute in the third quarter. The revised business rules will be in effect for the full second half of the year.
Speaker #2: Expanded commercial coverage became effective August 1, and net revenue realization should benefit as more patients satisfy their annual deductibles. TriEssence should also continue to grow.
Andrew Boll: Expanded commercial coverage became effective 1 August, and net revenue realization should benefit as more patients satisfy their annual deductibles. TRIESENCE should also continue to grow. Demand reached another quarterly record, and the surgical organization we tripled during the Q2 remains early in its productivity curve.
Speaker #2: Demand reached another quarterly record, and the surgical organization we tripled during the second quarter remains early in its productivity curve. BIOV was formally launched July 1, following modest initial stocking activity in the second quarter.
Andrew R. Boll: BYOOVIZ formally launched 1 July, following modest initial stocking activity in the Q2. Rhoncia has been relaunched. IOPIDINE benefits from the permanent J-code. Each contributes against the H1 revenue base that was either minimal or constrained. Subject to closing, TYRVAYA should also contribute modest revenue this year, in addition to revenue synergies with VEVYE that we expect to be realized following the close. Our guidance assumes only a limited 2026 contribution given the anticipated timing of the close and integration. Adjusted EBITDA bridge follows directly from the revenue bridge. Substantially higher revenue, increasing gross margins into the high 70s, and a base operating expense structure that remains approximately flat.
Andrew Boll: BYOOVIZ formally launched 1 July, following modest initial stocking activity in the Q2. Rhoncia has been relaunched. IOPIDINE benefits from the permanent J-code. Each contributes against the first half revenue base that was either minimal or constrained. Subject to closing, TYRVAYA should also contribute modest revenue this year, in addition to revenue synergies with VEVYE that we expect to be realized following the close.
Speaker #2: Merquezia has been relaunched, and now IOPD benefits from a permanent J code. Each contributes against the first-half revenue base that was either minimal or constrained.
Speaker #2: Subject to closing, Tervia should also contribute modest revenue this year, in addition to revenue synergies with BVI that we expect to be realized following the close.
Speaker #2: Our guidance assumes only a limited 2026 contribution, given the anticipated timing of the close and integration. The adjusted EBITDA bridge follows directly from the revenue bridge.
Andrew Boll: Our guidance assumes only a limited 2026 contribution given the anticipated timing of the close and integration. Adjusted EBITDA bridge follows directly from the revenue bridge. Substantially higher revenue, increasing gross margins into the high 70s, and a base operating expense structure that remains approximately flat.
Speaker #2: Substantially higher revenue, increasing gross margins into the high 70s, and a base operating expense structure that remains approximately flat. Upon closing, the Tervia transaction, we expect to expand our dry ice sales force and territories further by adding experienced professionals from the Beatrice Eye Care division, increasing SG&A expenses by approximately $20 million on an annualized basis once fully integrated.
Andrew R. Boll: Upon closing the TYRVAYA transaction, we expect to expand our dry eye sales force and territories further by adding experienced professionals from the Viatris Eye Care Division, increasing SG&A expenses by approximately $20 million on an annualized basis once fully integrated. Looking ahead, we expect TYRVAYA to contribute more than $30 million in revenue during 2027 and overall to be financially accretive. We recognize the magnitude of the H2 ramp. Our confidence is based on factors already visible in the business. Prescription growth, record product demand, normalized inventory, improved pricing, broader coverage, and a growing commercial organization that remains early in its productivity curve. On that note, I'll now ask Pat to discuss our commercial progress in more detail.
Andrew Boll: Upon closing the TYRVAYA transaction, we expect to expand our dry eye sales force and territories further by adding experienced professionals from the Viatris Eye Care Division, increasing SG&A expenses by approximately $20 million on an annualized basis once fully integrated.
Speaker #2: Looking ahead, we expect Tervia to contribute more than $30 million in revenue during 2027, and overall to be financially accretive. We recognize the magnitude of the second-half ramp.
Andrew Boll: Looking ahead, we expect TYRVAYA to contribute more than $30 million in revenue during 2027 and overall to be financially accretive. We recognize the magnitude of the second half ramp. Our confidence is based on factors already visible in the business. Prescription growth, record product demand, normalized inventory, improved pricing, broader coverage, and a growing commercial organization that remains early in its productivity curve. On that note, I'll now ask Pat to discuss our commercial progress in more detail.
Speaker #2: Our confidence is based on factors already visible in the business: prescription growth, record product demand, normalized inventory, improved pricing, broader coverage, and a growing commercial organization that remains early in its productivity curve.
Speaker #2: On that note, I'll now ask Pat to discuss our commercial progress in more detail.
Speaker #3: Thank you, Andrew. Before turning to BVI, I'll briefly discuss what the pending Tervia transaction means for our dry ice franchise. BVI remains the cornerstone of that franchise.
Patrick W. Sullivan: Thank you, Andrew. Before turning to VEVYE, I'll briefly discuss what the pending TYRVAYA transaction means for our dry eye franchise. VEVYE remains the cornerstone of that franchise. TYRVAYA is complementary, offering physicians a differentiated, drop-free option for patients who may struggle with eye drops, prefer another route of administration, or are among the 45 million Americans who wear contact lenses. Subject to closing, we expect to add a large number of experienced dry eye sales representatives from Viatris, whose territories are largely complementary to our existing coverage. This will expand our geographic reach, increase the frequency of our engagement with eye care professionals, and give our team more touchpoints through a broader portfolio. We expect to integrate those representatives during the Q4 and have them supporting both VEVYE and TYRVAYA.
Patrick Sullivan: Thank you, Andrew. Before turning to VEVYE, I'll briefly discuss what the pending TYRVAYA transaction means for our dry eye franchise. VEVYE remains the cornerstone of that franchise. TYRVAYA is complementary, offering physicians a differentiated, drop-free option for patients who may struggle with eye drops, prefer another route of administration, or are among the 45 million Americans who wear contact lenses.
Speaker #3: Tervia is complementary, offering physicians a differentiated, drop-free option for patients who may struggle with eye drops, prefer another route of administration, or are among the 45 million Americans who wear contact lenses.
Speaker #3: Subject to closing, we expect to add a large number of experienced dry ice sales representatives from Beatrice, whose territories are largely complementary to our existing coverage.
Patrick Sullivan: Subject to closing, we expect to add a large number of experienced dry eye sales representatives from Viatris, whose territories are largely complementary to our existing coverage. This will expand our geographic reach, increase the frequency of our engagement with eye care professionals, and give our team more touchpoints through a broader portfolio.
Speaker #3: This will expand our geographic reach, increase the frequency of our engagement with eye care professionals, and give our team more touchpoints through a broader portfolio.
Speaker #3: We expect to integrate those representatives during the fourth quarter and have them supporting both BVI and Tervia. Together, the products give us more treatment options, greater commercial reach, and additional opportunities to grow the entire portfolio.
Patrick Sullivan: We expect to integrate those representatives during the Q4 and have them supporting both VEVYE and TYRVAYA. Together, the products give us more treatment options, greater commercial reach, and additional opportunities to grow the entire portfolio. Turning to VEVYE, total prescriptions grew 21% sequentially, compared with 14% growth for the broader branded dry eye market based on IQVIA data.
Patrick W. Sullivan: Together, the products give us more treatment options, greater commercial reach, and additional opportunities to grow the entire portfolio. Turning to VEVYE, total prescriptions grew 21% sequentially, compared with 14% growth for the broader branded dry eye market based on IQVIA data. New prescription growth grew 4% sequentially, while prescriber base expanded 15%, and VEVYE exited June with a 14.6% share of the branded market, up from 14% at the end of March and 7.8% a year ago. Those results are particularly encouraging because they were achieved while we implemented significant new business rules designed to improve the economics of the franchise. Copay utilization declined meaningfully, yet physician adoption and prescription demand continued to grow.
Speaker #3: Turning to BVI, total prescriptions grew 21% sequentially, compared with 14% growth for the broader branded dry eye market, based on IQVIA data. New prescription growth grew 4% sequentially, while the prescriber base expanded 15%. BVI exited June with a 14.6% share of the branded market, up from 14% at the end of March and 7.8% a year ago.
Patrick Sullivan: New prescription growth grew 4% sequentially, while prescriber base expanded 15%, and VEVYE exited June with a 14.6% share of the branded market, up from 14% at the end of March and 7.8% a year ago. Those results are particularly encouraging because they were achieved while we implemented significant new business rules designed to improve the economics of the franchise. Copay utilization declined meaningfully, yet physician adoption and prescription demand continued to grow.
Speaker #3: Those results are particularly encouraging because they were achieved while we implemented significant new business rules designed to improve the economics of the franchise. Copay utilization declined meaningfully, yet physician adoption and prescription demand continued to grow.
Speaker #3: We are also still in the early stages of realizing the full potential of our expanded sales organization, with broader commercial coverage through a top-three pharmacy benefit manager effective August 1, and an expanded sampling program now underway. The active, prioritized initiative encouraging clinicians to use BVI earlier in the treatment paradigm means we have multiple meaningful growth drivers coming online at the same time.
Patrick W. Sullivan: We are also still in the early stages of realizing the full potential of our expanded sales organization with broader commercial coverage through a top-three pharmacy benefit manager effective 1 August, an expanded sampling program now underway. The active prioritized initiative encouraging clinicians to use VEVYE earlier in the treatment paradigm, we have multiple meaningful growth drivers coming online at the same time. Together, these initiatives position VEVYE to accelerate prescription growth and expand its share of the branded dry eye market during the H2. IHEEZO delivered one of the strongest commercial performances of the quarter. Despite the loss of pass-through reimbursement in the cataract surgery on 1 April, unit demand reached a record of 65,477 units, up 44% sequentially and 34% year over year.
Patrick Sullivan: We are also still in the early stages of realizing the full potential of our expanded sales organization with broader commercial coverage through a top-three pharmacy benefit manager effective 1 August, an expanded sampling program now underway. The active prioritized initiative encouraging clinicians to use VEVYE earlier in the treatment paradigm, we have multiple meaningful growth drivers coming online at the same time.
Speaker #3: Together, these initiatives position BVI to accelerate prescription growth and expand its share of the branded dry eye market during the second half. Adheso delivered one of the strongest commercial performances of the quarter.
Patrick Sullivan: Together, these initiatives position VEVYE to accelerate prescription growth and expand its share of the branded dry eye market during the second half. IHEEZO delivered one of the strongest commercial performances of the quarter. Despite the loss of pass-through reimbursement in the cataract surgery on 1 April, unit demand reached a record of 65,477 units, up 44% sequentially and 34% year over year.
Speaker #3: Despite the loss of passthrough reimbursement and the cataract surgery on April 1, unit demand reached a record of 65,477 units, up 44% sequentially and 34% year over year.
Speaker #3: We exited the quarter with 224 total ordering accounts, up 32% year over year and 62 of those accounts placed their first ever adheso order during that quarter.
Patrick W. Sullivan: We exited the quarter with 224 total ordering accounts, up 32% year over year, and 62 of those accounts placed their first-ever IHEEZO order during that quarter. The strongest quarter for a new account acquisition since launch. Paired with a trailing 12-month reorder rate of approximately 85.5%, that reinforces that adoption continues to broaden following the reimbursement transition. Our focus now is on increasing utilization within existing accounts while expanding IHEEZO into additional procedures and sites of care, including the broader in-office procedure market, which adds more than 2.5 million annual procedures to our addressable opportunity. We believe those factors position the franchise for a substantially stronger H2. Before moving to TRIESENCE, I want to briefly touch on BYOOVIZ. We formally launched the product on 1 July, and while it remains early, initial physician engagement has been encouraging.
Patrick Sullivan: We exited the quarter with 224 total ordering accounts, up 32% year over year, and 62 of those accounts placed their first-ever IHEEZO order during that quarter. The strongest quarter for a new account acquisition since launch.
Speaker #3: This was the strongest quarter for new account acquisition since launch. Paired with a trailing 12-month reorder rate of approximately 85.5%, this reinforces that adoption continues to broaden following the reimbursement transition.
Patrick Sullivan: Paired with a trailing 12-month reorder rate of approximately 85.5%, that reinforces that adoption continues to broaden following the reimbursement transition. Our focus now is on increasing utilization within existing accounts while expanding IHEEZO into additional procedures and sites of care, including the broader in-office procedure market, which adds more than 2.5 million annual procedures to our addressable opportunity. We believe those factors position the franchise for a substantially stronger second half.
Speaker #3: Our focus now is on increasing utilization within existing accounts while expanding adheso into additional procedures and sites of care, including the broader in-office procedure market, which adds more than 2.5 million annual procedures to our addressable opportunity.
Speaker #3: We believe those factors position the franchise for a substantially stronger second half. Before moving to TriEssence, I want to briefly touch on BIOV. We formally launched the product on July 1, and while it remains early, initial physician engagement has been encouraging.
Patrick Sullivan: Before moving to TRIESENCE, I want to briefly touch on BYOOVIZ. We formally launched the product on 1 July, and while it remains early, initial physician engagement has been encouraging. BYOOVIZ is a natural fit within our retinal organization, expands the options our team can bring to retina specialists, and increases the value of each customer interaction.
Patrick W. Sullivan: BYOOVIZ is a natural fit within our retinal organization, expands the options our team can bring to retina specialists, and increases the value of each customer interaction. TRIESENCE also continued its exceptional momentum. Demand reached another quarterly record of 14,529 units, up 162% year over year. Total ordering accounts reached 805, a net increase of 69 over the quarter, and 54% of unit demand now comes from ocular surgery. That mix shift demonstrates that TRIESENCE is expanding beyond its historical retina base. We tripled our surgical commercial organization during Q2, and those representatives remain early in their productivity ramp. As they expand account coverage and drive broader adoption, we expect their contribution to begin showing up in Q3 and build from there. Finally, our specialty portfolio continued to build momentum. The permanent J-code for IOPIDINE became effective on 1 July.
Speaker #3: BIOV is a natural fit within our retina organization, expands the options our team can bring to retina specialists, and increases the value of each customer interaction.
Patrick Sullivan: TRIESENCE also continued its exceptional momentum. Demand reached another quarterly record of 14,529 units, up 162% year over year. Total ordering accounts reached 805, a net increase of 69 over the quarter, and 54% of unit demand now comes from ocular surgery. That mix shift demonstrates that TRIESENCE is expanding beyond its historical retina base.
Speaker #3: TriEssence also continued its exceptional momentum. Demand reached another quarterly record of 14,529 units, up 162% year over year. Total ordering accounts reached 805, a net increase of 69 over the quarter, and 54% of unit demand now comes from ocular surgery.
Speaker #3: That mix shift demonstrates that TriEssence is expanding beyond its historical retina base. We tripled our surgical commercial organization during the second quarter, and those representatives remain early in their productivity ramp.
Patrick Sullivan: We tripled our surgical commercial organization during Q2, and those representatives remain early in their productivity ramp. As they expand account coverage and drive broader adoption, we expect their contribution to begin showing up in Q3 and build from there. Finally, our specialty portfolio continued to build momentum. The permanent J-code for IOPIDINE became effective on 1 July. VERKAZIA continues to progress following its relaunch, and we expanded our Access Plus commercial organization to support what we believe is the broadest ophthalmic cash pay portfolio in the industry.
Speaker #3: As they expand account coverage and drive broader adoption, we expect their contribution to begin showing up in the third quarter and build from there.
Speaker #3: Finally, our specialty portfolio continues to build momentum. The permanent J code for Iopidine became effective on July 1 for Cozia, continues to progress following its relaunch, and we expanded our access plus commercial organization to support what we believe is the broadest ophthalmic cash pay portfolio in the industry.
Patrick W. Sullivan: VERKAZIA continues to progress following its relaunch, and we expanded our Access Plus commercial organization to support what we believe is the broadest ophthalmic cash pay portfolio in the industry. Across each of these businesses, our focus remains the same, expanding physician access, improving reimbursement, and increasing commercial execution. As I step back and look across this portfolio, what stands out most is the breadth of our momentum. We are seeing growth across multiple franchises, continued physician adoption, and expanded commercial reach, and the benefits of the investments we made throughout the H1 of the year. I believe HARROW enters the H2 of 2026 in its strongest commercial position to date, and I am excited about the opportunities ahead. I will turn it over to Amir to discuss some exciting developments with our R&D pipeline.
Speaker #3: Across each of these businesses, our focus remains the same: expanding physician access, improving reimbursement, and increasing commercial execution. When I step back and look across this portfolio, what stands out most is the breadth of our momentum.
Patrick Sullivan: Across each of these businesses, our focus remains the same, expanding physician access, improving reimbursement, and increasing commercial execution. As I step back and look across this portfolio, what stands out most is the breadth of our momentum. We are seeing growth across multiple franchises, continued physician adoption, and expanded commercial reach, and the benefits of the investments we made throughout the first half of the year.
Speaker #3: We're seeing growth across multiple franchises, continued physician adoption, expanded commercial reach, and the benefits of the investments we made throughout the first half of the year.
Speaker #3: I believe HARROW enters the second half of 2026 in its strongest commercial position to date, and I'm excited about the opportunities ahead. I'll turn it over to Amir to discuss some exciting developments with our R&D pipeline.
Patrick Sullivan: I believe Harrow enters the second half of 2026 in its strongest commercial position to date, and I am excited about the opportunities ahead. I will turn it over to Amir to discuss some exciting developments with our R&D pipeline.
Speaker #4: Thank you, Pat. I'll start with Gmail for now—300. As I mentioned during our last quarterly webcast, we have now officially secured our pre-NDA meeting with the FDA, which is scheduled for early in the fourth quarter.
Amir H. Shojaei: Thank you, Pat. I will start with G-MELT, or MELT-300. As I mentioned during our last quarterly webcast, we have now officially secured our pre-NDA meeting with the FDA, which is scheduled for early in the Q4. We are currently preparing the meeting dossier, completing the remaining ancillary activities, and remain on track to submit our NDA during the H1 of 2027. This represents another important milestone for the program and keeps us on track for our anticipated regulatory timeline. The program continues to execute according to the development plan we outlined for the investors. From a scientific perspective, I remain very excited about G-MELT. We believe it has the potential to fundamentally change procedural sedation by offering a rapid IV-free, opioid-free alternative that addresses a significant unmet need across multiple procedural settings.
Amir Shojaei: Thank you, Pat. I will start with G-MELT, or MELT-300. As I mentioned during our last quarterly webcast, we have now officially secured our pre-NDA meeting with the FDA, which is scheduled for early in the Q4. We are currently preparing the meeting dossier, completing the remaining ancillary activities, and remain on track to submit our NDA during the first half of 2027.
Speaker #4: We are currently preparing the meeting dossier, completing the remaining ancillary activities, and remain on track to submit our NDA during the first half of 2027.
Speaker #4: This represents another important milestone for the program and keeps us on track for our anticipated regulatory timeline. The program continues to execute according to the development plan we outlined for the investors.
Amir Shojaei: This represents another important milestone for the program and keeps us on track for our anticipated regulatory timeline. The program continues to execute according to the development plan we outlined for the investors. From a scientific perspective, I remain very excited about G-MELT. We believe it has the potential to fundamentally change procedural sedation by offering a rapid IV-free, opioid-free alternative that addresses a significant unmet need across multiple procedural settings.
Speaker #4: From a scientific perspective, I remain very excited about Gmail. We believe it has the potential to fundamentally change procedural sedation by offering a rapid IV free opioid-free alternative that addresses the significant unmet need across multiple procedural settings.
Speaker #4: Assuming a successful regulatory review, we continue to target a potential FDA approval in the first half of 2028, followed by a commercial launch later that year.
Amir H. Shojaei: Assuming a successful regulatory review, we continue to target a potential FDA approval in the H1 of 2028, followed by a commercial launch later that year. Turning to MELT-210, the simplest way to think about the program is G-MELT for pediatric patients. MELT-210 is being developed for children undergoing diagnostic therapeutic endoscopic procedures. Today, oral midazolam is administered primarily as a syrup, which can be difficult for children to tolerate because of its taste and the challenges associated with administration. We believe an orally disintegrating tablet could provide a more convenient and child-friendly option while fitting within the dosing paradigm physicians already use for oral midazolam. Earlier this year, we completed our end of phase II meeting with the FDA. We are currently modifying our pharmacokinetic study protocol to align with the agency's feedback on this program.
Amir Shojaei: Assuming a successful regulatory review, we continue to target a potential FDA approval in the first half of 2028, followed by a commercial launch later that year. Turning to MELT-210, the simplest way to think about the program is G-MELT for pediatric patients. MELT-210 is being developed for children undergoing diagnostic therapeutic endoscopic procedures.
Speaker #4: Turning to Yutrepia, or MELC-210, the simplest way to think about the program is "Gmail for pediatric patients." Yutrepia is being developed for children undergoing diagnostic or therapeutic endoscopic procedures.
Speaker #4: Today, oral midazolam is administered primarily as a syrup, which can be difficult for children to tolerate because of its taste and the challenges associated with administration.
Amir Shojaei: Today, oral midazolam is administered primarily as a syrup, which can be difficult for children to tolerate because of its taste and the challenges associated with administration. We believe an orally disintegrating tablet could provide a more convenient and child-friendly option while fitting within the dosing paradigm physicians already use for oral midazolam. Earlier this year, we completed our end of phase II meeting with the FDA. We are currently modifying our pharmacokinetic study protocol to align with the agency's feedback on this program.
Speaker #4: We believe an orally disintegrating tablet could provide a more convenient and child-friendly option, while fitting within the dosing paradigm physicians already use for oral midazolam.
Speaker #4: Earlier this year, we completed our end-of-Phase 2 meeting with the FDA. We are currently modifying our pharmacokinetic study protocol to align with the agency's feedback on this program.
Speaker #4: Our development approach is a 505 B2 path to bridge to oral midazolam syrup through PK, and we expect to develop multiple dose strengths, likely four, to accommodate the current weight-based dosing paradigm.
Amir H. Shojaei: Our development approach is a 505(b)(2) path to bridge to oral midazolam syrup through PK, and we expect to develop multiple dose strengths, likely four, to accommodate the current weight-based dosing paradigm. MELT-210 also benefits from the formulation development and regulatory experience we have generated through MELT-300, including use of the Zydis orally disintegrating tablet platform. We continue to target an NDA submission in 2027. Together, G-MELT and MELT-210 represent the foundation of a broader procedural sedation platform addressing both adult and pediatric patients. We look forward to providing additional detail on the development plan for both programs at our investor day next March. With that, I will turn the call over to the operator for Q&A.
Amir Shojaei: Our development approach is a 505(b)(2) path to bridge to oral midazolam syrup through PK, and we expect to develop multiple dose strengths, likely four, to accommodate the current weight-based dosing paradigm. MELT-210 also benefits from the formulation development and regulatory experience we have generated through MELT-300, including use of the Zydis orally disintegrating tablet platform. We continue to target an NDA submission in 2027.
Speaker #4: Yochel also benefits from the formulation development and regulatory experience we have generated through MELC-300, including use of the Zydis orally disintegrating tablet platform. We're continuing to target an NDA submission in 2027.
Speaker #4: Together, Gmail and Yochel represent the foundation of a broader procedural sedation platform addressing both adult and pediatric patients. We look forward to providing additional detail on the development plan for both programs at our investor day next March.
Amir Shojaei: Together, G-MELT and MELT-210 represent the foundation of a broader procedural sedation platform addressing both adult and pediatric patients. We look forward to providing additional detail on the development plan for both programs at our investor day next March. With that, I will turn the call over to the operator for Q&A.
Speaker #4: With that, I'll turn the call over to the operator for Q&A.
Operator: Thank you. To ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. The first question will come from Chase Knickerbocker with Craig-Hallum. Your line is now open.
Operator: Thank you. To ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. The first question will come from Chase Knickerbocker with Craig-Hallum. Your line is now open.
Speaker #1: Thank you. To ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again.
Speaker #1: The first question will come from Chase Nickerbocker with Craig Hallum. Your line is now open.
Speaker #5: Good morning. Thanks for taking the questions. Mark, maybe just first to start on the national top three PBM win. Can you just maybe talk about exactly what that coverage constitutes?
Chase Knickerbocker: Good morning. Thanks for taking the questions. Mark, maybe just first to start on the national top 3 PBM win. Can you just maybe talk about exactly what that coverage constitutes? Is it tier 1 preferred like that other top 3 win that you already have?
Chase Knickerbocker: Good morning. Thanks for taking the questions. Mark, maybe just first to start on the national top 3 PBM win. Can you just maybe talk about exactly what that coverage constitutes? Is it tier 1 preferred like that other top 3 win that you already have?
Speaker #5: Is it kind of tier-one preferred, like that other top-three win that you already have?
Speaker #2: Yeah. I think the only thing we want to say about that coverage win is, number one, it's obviously a top three PBM. Number two, it's for commercial lives.
Mark L. Baum: Yeah. I think the only thing we want to say about that coverage win is, number one, it is obviously a top 3 PBM. Number two, it is for commercial lives. I think the third element is that these were lives that were formerly blocked that we did not have access to. The fourth item, Chase, is the number of lives that we now have access to is in the many millions. Other than that, I think that is about all I can say. I do not want to go into the specific positioning on the formulary, but we are really excited about this coverage win and it is something that we promised our stockholders, and we were able to deliver, actually, I think ahead of time. We did not think this would come until the first part of next year.
Mark Baum: Yeah. I think the only thing we want to say about that coverage win is, number one, it is obviously a top 3 PBM. Number two, it is for commercial lives. I think the third element is that these were lives that were formerly blocked that we did not have access to. The fourth item, Chase, is the number of lives that we now have access to is in the many millions.
Speaker #2: I think the third element is that these were lives that were formerly blocked that we did not have access to. And then the fourth item, Chase, is the number of lives that we now have access to is in the many millions.
Speaker #2: And other than that, I think that is about all I can say. I don't want to go into the specific positioning on the formulary, but we're really excited about this coverage win and it's something that we promised our stockholders and we were able to deliver.
Mark Baum: Other than that, I think that is about all I can say. I do not want to go into the specific positioning on the formulary, but we are really excited about this coverage win and it is something that we promised our stockholders, and we were able to deliver, actually, I think ahead of time. We did not think this would come until the first part of next year. I know the VEVYE teams are really pumped to have millions and millions of lives that they now have access to that were formerly blocked.
Speaker #2: Actually, I think ahead of time we didn't think this would come until the first part of next year, but I know the Vivi team's really pumped to have millions and millions of lives that they now have access to that were formerly blocked.
Mark L. Baum: I know the VEVYE teams are really pumped to have millions and millions of lives that they now have access to that were formerly blocked.
Speaker #5: Got it. And maybe just a two-parter one, he's the one on Vivi. So just as we think about kind of the recent volume acceleration for Aizo, can you just discuss what percentage of that business is now in office versus kind of retina as far as kind of characterizing that acceleration?
Chase Knickerbocker: Got it. And maybe just a two-parter, one on IHEEZO, one on VEVYE. Just as we think about the recent volume acceleration for IHEEZO, can you discuss what percentage of that business is now in-office versus retina as far as characterizing that acceleration. And then just on VEVYE, Andrew, if you could just comment on how you see ASP in the second half since there is still an impact from those pre-business rule changes in the second quarter. Is it fair to assume continued sequential improvement in VEVYE ASP? Thanks.
Chase Knickerbocker: Got it. And maybe just a two-parter, one on IHEEZO, one on VEVYE. Just as we think about the recent volume acceleration for IHEEZO, can you discuss what percentage of that business is now in-office versus retina as far as characterizing that acceleration. And then just on VEVYE, Andrew, if you could just comment on how you see ASP in the second half since there is still an impact from those pre-business rule changes in the Q2. Is it fair to assume continued sequential improvement in VEVYE ASP? Thanks.
Speaker #5: And then just on Vivi, Andrew, if you could just comment on how you see ASP in the second half, since there was still an impact from those pre-business rule changes in the second quarter.
Speaker #5: Is it fair to assume kind of continued sequential improvement in VIVI ASP? Thanks.
Speaker #4: Sure. Thanks for that, Chase.
Mark L. Baum: Sure. Thanks for that, Chase. So on IHEEZO, look, the ASC market is now effectively shut because of the loss of pass-through. I think the fact that we hit a record number in terms of unit demand for IHEEZO in the second quarter, which I don't think anyone expected, was an extraordinary result. It really goes to the focus that the team has put on the in-office market. That includes both retina as well as other in-office procedures. The in-office market, which we've talked about, which opens up about 2.5 million additional procedures for us, is a significant market, but it's one that we've really just barely scratched the surface on. A significant amount of the growth in IHEEZO for the second quarter came in these retina practices that we've been targeting for the last year and a half or so. We're really making progress.
Mark Baum: Sure. Thanks for that, Chase. So on IHEEZO, look, the ASC market is now effectively shut because of the loss of pass-through. I think the fact that we hit a record number in terms of unit demand for IHEEZO in the Q2, which I don't think anyone expected, was an extraordinary result. It really goes to the focus that the team has put on the in-office market. That includes both retina as well as other in-office procedures.
Speaker #2: So on Aizo, look, the ASC market is now effectively shut because of the loss of pass-through. I think the fact that we hit a record number in terms of unit demand for Aizo in the second quarter—which I don't think anyone expected—was an extraordinary result.
Speaker #2: And it really goes to the focus that the team has put on the in-office market. That includes both retina as well as other in-office procedures.
Speaker #2: The in-office market, which we've talked about, opens up about 2.5 million additional procedures for us. It's a significant market, but it's one that we've really just barely scratched the surface on.
Mark Baum: The in-office market, which we've talked about, which opens up about 2.5 million additional procedures for us, is a significant market, but it's one that we've really just barely scratched the surface on. A significant amount of the growth in IHEEZO for the Q2 came in these retina practices that we've been targeting for the last year and a half or so.
Speaker #2: A significant amount of the growth in Aizo for the second quarter came in these retina practices that we've been targeting for the last year and a half or so.
Mark Baum: We're really making progress. We forecasted that in the Q3, we would be set up well with the new five-pack, the new pricing, the data that's starting to come out, and that would cause this acceleration in the second half of this year. But IHEEZO is definitely exceeding all of our expectations. To be clear, we've really simply just scratched the surface. We have probably less than 2% market share in the overall addressable market, less than 2%.
Speaker #2: We're really making progress. We forecasted that in the third quarter (Q3), we would be set up well with the new five-pack, the new pricing, and the data that's starting to come out. We expect that this will cause an acceleration in the second half of this year.
Mark L. Baum: We forecasted that in the third quarter, we would be set up well with the new five-pack, the new pricing, the data that's starting to come out, and that would cause this acceleration in the second half of this year. But IHEEZO is definitely exceeding all of our expectations. To be clear, we've really simply just scratched the surface. We have probably less than 2% market share in the overall addressable market, less than 2%. We continue to grow and pick up record numbers of accounts. We're seeing that acceleration, by the way, in the third quarter. You'll see it in the numbers in the third quarter and in the fourth quarter, as Andrew discussed. But IHEEZO is going to be a really important part of us hitting our numbers for the second half. Andrew, do you want to talk about VEVYE?
Speaker #2: But Aizo is definitely exceeding all of our expectations, and to be clear, we've really just scratched the surface. We have probably less than 2% market share in the overall addressable market—less than 2%.
Speaker #2: And we continue to grow and pick up record numbers of accounts, and we're seeing that acceleration, by the way, in the third quarter. You'll see it in the numbers in the third quarter and then the fourth quarter, as Andrew discussed.
Mark Baum: We continue to grow and pick up record numbers of accounts. We're seeing that acceleration, by the way, in the Q3. You'll see it in the numbers in the Q3 and in the Q4, as Andrew discussed. But IHEEZO is going to be a really important part of us hitting our numbers for the second half. Andrew, do you want to talk about VEVYE?
Speaker #2: But Aizo is going to be a really important part of us hitting our numbers for the second half, Andrew, do you want to talk about Vivi?
Speaker #3: Yeah, absolutely. And hey, Chase, thanks for the question. So with Vivi ASP and generally anything going through the pharmacy benefit, we typically see improved pricing throughout the year as patients are hitting their deductible, and certainly we're expecting to see that with Vivi.
Andrew R. Boll: Yeah, absolutely. Hey, Chase. Thanks for the question. So with VEVYE ASP and generally anything going through the pharmacy benefit, we typically see improved pricing throughout the year as patients are hitting the deductible, and certainly we're expecting to see that with VEVYE. But to your point about the amended business rules, we didn't get a full quarter benefit of that. So now moving forward, obviously starting in Q3, we'll get the full benefit of those amended rules, which should add a little bit of additional positive momentum to VEVYE ASP going forward.
Andrew Boll: Yeah, absolutely. Hey, Chase. Thanks for the question. So with VEVYE ASP and generally anything going through the pharmacy benefit, we typically see improved pricing throughout the year as patients are hitting the deductible, and certainly we're expecting to see that with VEVYE. But to your point about the amended business rules, we didn't get a full quarter benefit of that. So now moving forward, obviously starting in Q3, we'll get the full benefit of those amended rules, which should add a little bit of additional positive momentum to VEVYE ASP going forward.
Speaker #3: But to your point about the amended business rules, we didn't get a full quarter benefit of that. And so now moving forward, obviously starting in Q3, we'll get the full benefit of those amended rules, which should add a little bit of additional positive momentum to Vivi ASP going forward.
Speaker #5: Thanks, guys.
Chase Knickerbocker: Thanks, guys.
Chase Knickerbocker: Thanks, guys.
Speaker #4: Thanks, Chase.
Mark L. Baum: Thanks, Chase.
Mark Baum: Thanks, Chase.
Operator: Thank you. The next question will come from Steve Seedhouse of Cantor. Your line is open.
Operator: Thank you. The next question will come from Steve Seedhouse of Cantor. Your line is open.
Speaker #1: Thank you. And the next question will come from Steve Seedhouse of Cantor. Your line is open.
Speaker #6: Hey, good morning. Thanks so much for taking the question. First, I just wanted to ask about Tervia, and if you can give us a sense of what the sales actually were for that product, maybe in 2025 and 2026 year to date, and whether it's growing, stable, or even declining slightly in recent years.
Steve Seedhouse: Yeah, good morning. Thanks so much for taking the question. First, I just wanted to ask on TYRVAYA, and if you can give us a sense of what actually were the sales for that product, maybe in 2025, 2026 year to date, and whether it is growing or if it is stable or even declining slightly in recent years before you take over. Also, what are you modeling for loss of exclusivity of that product?
Steve Seedhouse: Yeah, good morning. Thanks so much for taking the question. First, I just wanted to ask on TYRVAYA, and if you can give us a sense of what actually were the sales for that product, maybe in 2025, 2026 year to date, and whether it is growing or if it is stable or even declining slightly in recent years before you take over. Also, what are you modeling for loss of exclusivity of that product?
Speaker #6: Before you take over, and then also, what are you modeling for loss of exclusivity of that product?
Mark L. Baum: Andrew, do you want to talk about what we know? I know that we're trying to keep things quiet as we get to the closing, but is there anything you can discuss on that front?
Mark Baum: Andrew, do you want to talk about what we know? I know that we're trying to keep things quiet as we get to the closing, but is there anything you can discuss on that front?
Speaker #2: Andrew, do you want to talk about what we know? I know that we're trying to keep things quiet as we get to the closing, but is there anything you can discuss on that front?
Speaker #3: Yeah, Steve. There's not a whole lot we can say until we actually own the asset, and so I think you can take a look at some of Viatris's comments.
Andrew R. Boll: Yeah, Steve. There's not a whole lot we can say until we actually own the asset. I think you can take a look at some of the Viatris's comments. What our focus right now, though, is closing as quickly as possible. We think this is going to be strategically a really important asset for us. The primary focus is getting it closed. Then once closed, what we're guiding to is that it'll contribute more than $30 million of revenue. We're also adding additional heads on the sales and commercial front with the product. Those people are going to be not only promoting TYRVAYA but also VEVYE. So we think regardless of the trajectory of the product currently, we should have the ability to continue to grow it. Then in regards to loss of exclusivity, we're assuming the product will have exclusivity through 2034.
Andrew Boll: Yeah, Steve. There's not a whole lot we can say until we actually own the asset. I think you can take a look at some of the Viatris's comments. What our focus right now, though, is closing as quickly as possible. We think this is going to be strategically a really important asset for us. The primary focus is getting it closed. Then once closed, what we're guiding to is that it'll contribute more than $30 million of revenue. We're also adding additional heads on the sales and commercial front with the product.
Speaker #3: Our focus right now, though, is closing as quickly as possible. We think this is going to be a strategically really important asset for us.
Speaker #3: And so that's the primary focus is getting it closed. And then once closed, we're guiding to is that it'll contribute more than $30 million of revenue.
Speaker #3: We're also adding additional heads on the sales and commercial front with the product. And those people are going to be not only promoting Tervia, but also Vivi.
Andrew Boll: Those people are going to be not only promoting TYRVAYA but also VEVYE. So we think regardless of the trajectory of the product currently, we should have the ability to continue to grow it. Then in regards to loss of exclusivity, we're assuming the product will have exclusivity through 2034.
Speaker #3: So we should see we think regardless of the trajectory the product currently we're expecting we're expecting our ability we should have the ability to continue to grow it.
Speaker #3: And then in regards to loss of exclusivity, we're assuming the product will have exclusivity through 2034.
Speaker #2: Yeah, one other comment I would just add is that the operational synergy between these assets is remarkable. And I think you're going to see that probably as early as the fourth quarter.
Steve Seedhouse: Okay. Perfect. Thank you.
Steve Seedhouse: Okay. Perfect. Thank you.
Mark L. Baum: One other comment I would just add is that the operational synergy between these assets is remarkable, and I think you're going to see that probably as early as Q4. You'll also see that these assets are clinically complementary. In going out and talking to dry eye professionals, the ability to treat the disease with a chronic care product like VEVYE is our primary asset, I think is important. But also the interest in supplementing the treatment with a product that nearly immediately produces tears like TYRVAYA is very strong, and it's much stronger than we had anticipated before we did our diligence on this product. So I think you'll be surprised about the degree to which these are clinically complementary and operationally synergistic.
Mark Baum: One other comment I would just add is that the operational synergy between these assets is remarkable, and I think you're going to see that probably as early as Q4. You'll also see that these assets are clinically complementary. In going out and talking to dry eye professionals, the ability to treat the disease with a chronic care product like VEVYE is our primary
Speaker #2: And you'll also see that these assets are clinically complementary. In going out and talking to dry eye professionals, the ability to treat the disease with a chronic care product like Vivi is our primary asset.
Mark Baum: asset, I think is important. But also the interest in supplementing the treatment with a product that nearly immediately produces tears like TYRVAYA is very strong, and it's much stronger than we had anticipated before we did our diligence on this product. So I think you'll be surprised about the degree to which these are clinically complementary and operationally synergistic.
Speaker #2: I think it is important, but also, to supplement the treatment, the interest in supplementing the treatment with a product that immediately—nearly immediately—produces tears, like Tervia, is very strong, and it's much stronger than we had anticipated before we did our diligence on this product.
Speaker #2: So I think you'll be surprised about the degree to which these are clinically complementary and operationally synergistic.
Speaker #6: All right. Thanks. That's helpful color. And I wanted to also ask, on Aizo, I guess I'm just curious where this such strong demand has been coming from specifically, because a lot of the tailwinds the clinical data obviously Quell is still running and that data is in the fourth quarter.
Steve Seedhouse: All right, thanks. That is helpful color. I wanted to also ask on IHEEZO. I am curious where such strong demand has been coming from specifically, because a lot of the tailwinds, the clinical data, obviously QUELL is still running, and that data is in Q4. Even the launch of your biosimilars that maybe provide some sort of synergy in the marketing effort, that is on the come still. Yet, you still had this record demand amid all of this resetting of price and inventory and all this. Is there any way you can just articulate what specifically you think has been driving such strong demand and how likely that is to continue into these subsequent quarters as you have these additional tailwinds coming online? Thanks.
Steve Seedhouse: All right, thanks. That is helpful color. I wanted to also ask on IHEEZO. I am curious where such strong demand has been coming from specifically, because a lot of the tailwinds, the clinical data, obviously QUELL is still running, and that data is in Q4. Even the launch of your biosimilars that maybe provide some sort of synergy in the marketing effort, that is on the come still. Yet, you still had this record demand
Speaker #6: And even the launch of your biosimilars that may be provide some sort of synergy in the marketing effort, that's sort of on the come still.
Speaker #6: And yet you still had this record demand amid all of this resetting of price and inventory and all this. So is there any way you can just articulate what specifically you think has been driving such strong demand and how likely that is to sort of continue into these subsequent quarters as you have these additional tailwinds coming online?
Steve Seedhouse: amid all of this resetting of price and inventory and all this. Is there any way you can just articulate what specifically you think has been driving such strong demand and how likely that is to continue into these subsequent quarters as you have these additional tailwinds coming online? Thanks.
Speaker #6: Thanks.
Speaker #2: Yeah. Well, first of all, even though the demand is impressive—and you're right, it is—across the board, the team has just done a phenomenal job growing that business in terms of new accounts and then pushing units used within specific accounts.
Mark L. Baum: Well, first of all, even though the demand is impressive, and you are right, it is. Across the board, the team has just done a phenomenal job growing that business in terms of new accounts and then pushing through units used within specific accounts. We are also picking up larger accounts that are using higher volumes within their practices. Once again, even though we have achieved, I think, a phenomenal result in Q2, we have really just barely scratched the surface. In terms of why doctors are increasingly using IHEEZO, it is because the product is fantastic. It performs amazingly well clinically. It feels good on the patient's eye. It has predictable onset, predictable duration. The excipient that is in the product actually makes the eye feel better than the alternatives, which includes an injection into the eye of lidocaine to anesthetize the eye.
Mark Baum: Well, first of all, even though the demand is impressive, and you are right, it is. Across the board, the team has just done a phenomenal job growing that business in terms of new accounts and then pushing through units used within specific accounts. We are also picking up larger accounts that are using higher volumes within their practices.
Speaker #2: We're also picking up larger accounts that are using higher volumes within their practices. But once again, even though we've achieved, I think, a phenomenal result in the second quarter, we've really just barely scratched the surface.
Mark Baum: Once again, even though we have achieved, I think, a phenomenal result in Q2, we have really just barely scratched the surface. In terms of why doctors are increasingly using IHEEZO, it is because the product is fantastic. It performs amazingly well clinically. It feels good on the patient's eye. It has predictable onset, predictable duration. The excipient that is in the product actually makes the eye feel better than the alternatives, which includes an injection into the eye of lidocaine to anesthetize the eye.
Speaker #2: In terms of why doctors are increasingly using Aizo, it's because the product is fantastic. It performs amazingly well clinically, and it feels good on the patient's eye.
Speaker #2: It has predictable onset, predictable duration. And then the excipient that's in the product actually makes the eye feel better than the alternatives, which includes an injection into the eye of lidocaine to anesthetize the eye.
Speaker #2: So, there are tremendous product attributes that we think give us huge advantages. And the word is spreading, certainly among the retina community, but also within these multispecialty practices that we're increasingly opening up.
Mark L. Baum: There are tremendous product attributes that we think give us huge advantages, and the word is spreading, certainly among the retina community, but also within these multi-specialty practices that we are increasingly opening up. The in-office market is real. There is a growing market for cataract surgery, for example, in the office, and that is a market that we are picking up. Across the board, you should expect continued growth and acceleration for that product. Once again, we have really just barely scratched the surface. We are probably, as I said, less than 2% of the addressable market.
Mark Baum: There are tremendous product attributes that we think give us huge advantages, and the word is spreading, certainly among the retina community, but also within these multi-specialty practices that we are increasingly opening up. The in-office market is real. There is a growing market for cataract surgery, for example, in the office, and that is a market that we are picking up. Across the board, you should expect continued growth and acceleration for that product. Once again, we have really just barely scratched the surface. We are probably, as I said, less than 2% of the addressable market.
Speaker #2: So, the in-office market is real. There's a growing market for cataract surgery, for example, in the office, and that's a market that we're picking up.
Speaker #2: So, across the board, you should expect continued growth and acceleration for that product. And once again, we've really just barely scratched the surface—probably, as I said, less than 2% of the addressable market.
Speaker #6: Makes sense. Thanks, Mark.
Steve Seedhouse: Makes sense. Thanks, Mark.
Steve Seedhouse: Makes sense. Thanks, Mark.
Speaker #2: Thank you, Steve.
Mark L. Baum: Thank you, Steve.
Mark Baum: Thank you, Steve.
Operator: Thank you. The next question will come from Lachlan Hanbury-Brown with William Blair. Line's open.
Operator: Thank you. The next question will come from Lachlan Hanbury-Brown with William Blair. Line's open.
Speaker #1: Thank you. And the next question will come from Lakian Hanbury Brown with William Blair. Your line's open.
Lachlan Hanbury-Brown: Hey, guys. Thanks for the question. Maybe just a quick follow-up on Viatris and the sort of contribution to 2026. I appreciate that's obviously somewhat dependent on the exact timing of the close, but should we just be thinking about sort of pro-rata-ing what you said about 2027 for 2026? Maybe would it also be accretive to EBITDA in 2026 or are there some sort of initial cost associated with the sort of close and integration that would affect that?
Lachlan Hanbury-Brown: Hey, guys. Thanks for the question. Maybe just a quick follow-up on Viatris and the sort of contribution to 2026. I appreciate that's obviously somewhat dependent on the exact timing of the close, but should we just be thinking about sort of pro-rata-ing what you said about 2027 for 2026? Maybe would it also be accretive to EBITDA in 2026 or are there some sort of initial cost associated with the sort of close and integration that would affect that?
Speaker #4: Hey, guys. Thanks for the question. Maybe just a quick follow-up on Tervia. And those sort of contribution to 2026. I appreciate it. That's obviously somewhat dependent on the exact time of the close, but should we just be thinking about sort of pro-rutering what you said about 27 for 26?
Speaker #4: So and maybe would it also be a creative sort of EBITDA in 26, or are there some sort of initial maybe initial costs associated with the sort of close and integration that would affect that?
Mark L. Baum: Andrew, do you want to take that?
Mark Baum: Andrew, do you want to take that?
Speaker #2: Andrew, do you want to take that?
Speaker #3: Yeah. Yeah. Hey, Lachlan. I think that's a fair assessment to kind of pro-rata the guide for next year. Depending on closing, which like I said, we're rapidly trying to get that as close as fast as possible.
Andrew R. Boll: Yeah. Hey, Lachlan. I think that's a fair assessment to kind of pro rata the guide for next year, depending on closing, which, like I said, we're rapidly trying to get that as closed as fast as possible. As you think about operating margin and contribution this year, I think it's safe to say we don't expect it to pull down earnings this year. There may be some integration costs the first few months as we're implementing the product, getting it into our system. So I would expect a little bit higher cost in the first few months. But certainly beginning next year, those integration costs should largely have been cleared out and we should have positive contribution from the product day one starting next year.
Andrew Boll: Yeah. Hey, Lachlan. I think that's a fair assessment to kind of pro rata the guide for next year, depending on closing, which, like I said, we're rapidly trying to get that as closed as fast as possible. As you think about operating margin and contribution this year, I think it's safe to say we don't expect it to pull down earnings this year.
Speaker #3: And then, as you're thinking about operating margin and contribution this year, I think it's safe to say we don't expect it to pull down earnings this year.
Speaker #3: There may be some integration costs this first few months as we're implementing the product, getting it into our system. So I expect a little bit higher costs in the first few months.
Andrew Boll: There may be some integration costs the first few months as we're implementing the product, getting it into our system. So I would expect a little bit higher cost in the first few months. But certainly beginning next year, those integration costs should largely have been cleared out and we should have positive contribution from the product day one starting next year.
Speaker #3: But certainly beginning next year, that should those integration costs should largely have been cleared out. And we should have positive contributions from the product day one, starting next year.
Lachlan Hanbury-Brown: Got it. Thanks. Maybe another on VEVYE. Mark, I know you said you don't want to say too much about that new coverage. Can you at least give some commentary on where the ASP from that coverage may end up relative to the current coverage or what you've been realizing? Is that an improvement? Is it about the same? Or is it worse than the current coverage and what you've been seeing? Maybe also related to VEVYE. You talked about the sampling program. Can you give us a sense of how impactful that is and maybe how much of the current volume has been going through that $0 first fill that this can maybe help to convert more quickly?
Lachlan Hanbury-Brown: Got it. Thanks. Maybe another on VEVYE. Mark, I know you said you don't want to say too much about that new coverage. Can you at least give some commentary on where the ASP from that coverage may end up relative to the current coverage or what you've been realizing?
Speaker #4: Got it. Thanks. And maybe another on Vivi. Mark, I know you said you don't want to say too much about that new coverage. Can you at least give some commentary on where the ASP from that coverage may end up relative to the current coverage or what you've been realizing?
Speaker #4: Is that an improvement? Is it about the same? Or is it worse than the current coverage and what you've been seeing? And maybe also related to Vivi, you talked about the sampling program.
Lachlan Hanbury-Brown: Is that an improvement? Is it about the same? Or is it worse than the current coverage and what you've been seeing? Maybe also related to VEVYE. You talked about the sampling program. Can you give us a sense of how impactful that is and maybe how much of the current volume has been going through that $0 first fill that this can maybe help to convert more quickly?
Speaker #4: Can you give us a sense of how impactful that is and maybe how much of the current volume has been going through that $0 first fill that this can maybe help to convert more quickly?
Speaker #2: Yeah. So, in terms of the effect on ASP, simply put, we never sign deals unless there is an ASP. We're not going to sign a deal unless, at the end of the day, we're able to make up the difference.
Mark L. Baum: Yeah. So, in terms of the effect on ASP, simply put, we never sign deals unless there is a net improvement to ASP. We're not going to sign a deal unless at the end of the day, we're unable to make up the difference. So for example, if we take a lower net price, but we're massively able to increase volume, the amount of revenue that we're able to generate from the franchise ultimately improves. We have, I think, pretty good modeling on the effect now of these coverage opportunities. But in this one in particular, this is something that should improve our unit revenue for VEVYE. In terms of the $0 first fill, we've built the company on a foundation of access.
Mark Baum: Yeah. So, in terms of the effect on ASP, simply put, we never sign deals unless there is a net improvement to ASP. We're not going to sign a deal unless at the end of the day, we're unable to make up the difference. So for example, if we take a lower net price, but we're massively able to increase volume,
Speaker #2: So, for example, if we take a lower net price, but we're massively able to increase volume, the amount of revenue that we're able to generate from the franchise ultimately improves.
Mark Baum: the amount of revenue that we're able to generate from the franchise ultimately improves. We have, I think, pretty good modeling on the effect now of these coverage opportunities. But in this one in particular, this is something that should improve our unit revenue for VEVYE. In terms of the $0 first fill, we've built the company on a foundation of access.
Speaker #2: And so we have, I think, pretty good modeling on the effect now of these coverage opportunities. But in this one in particular, this is something that should improve our unit revenue.
Speaker #2: For Vivi. In terms of the $0 first fill, we built the company on a foundation of access. So for us, market access simply put means any patient in the United States that is in need of any of our medications will have affordable access to the product that they're in need of.
Mark L. Baum: For us, market access, simply put, means any patient in the United States that is in need of any of our medications will have affordable access to the product that they're in need of. For us, when we were launching VEVYE, without the coverage, and frankly, our coverage has been pretty poor. As I said, the recent coverage win came from a PBM where we were really blocked. But for us, we implemented a $0 first fill to ensure that everyone who needed VEVYE had access to VEVYE. The problem with that is it's very expensive for us financially. What we've, I think, realized is you'll see significant improvement financially with the sampling program that's now replacing the $0 first fill.
Mark Baum: For us, market access, simply put, means any patient in the United States that is in need of any of our medications will have affordable access to the product that they're in need of. For us, when we were launching VEVYE, without the coverage, and frankly, our coverage has been pretty poor. As I said, the recent coverage win came from a PBM where we were really blocked. But for us, we implemented a $0 first fill to ensure that everyone who needed VEVYE had access to VEVYE.
Speaker #2: And for us, when we were launching Vivi, without the coverage, and frankly, our coverage has been pretty poor, as I said, the recent coverage one came from a PBM where we were really blocked.
Speaker #2: But for us, we implemented a $0 first fill to ensure that everyone who needed Vivi had access to Vivi. The problem with that is it's very expensive for us financially.
Mark Baum: The problem with that is it's very expensive for us financially. What we've, I think, realized is you'll see significant improvement financially with the sampling program that's now replacing the $0 first fill. Not only do you have the COGS cost with the $0 first fill program, you have all the processing fees, the pharmacy fees, and distribution, and so on. You are really reliant on getting a meaningful number of refills from that patient in order to make up for those investments.
Speaker #2: And what we've, I think, realized is you'll see significant improvement financially with the sampling program that's now replacing the $0 first fill. Not only do you have the COGS cost with the $0 first fill program; you have all the processing fees, the pharmacy fees, and distribution, and so on.
Mark L. Baum: Not only do you have the COGS cost with the $0 first fill program, you have all the processing fees, the pharmacy fees, and distribution, and so on. You are really reliant on getting a meaningful number of refills from that patient in order to make up for those investments. The sampling program is, we believe, going to achieve the same effect in terms of giving patients access to the medication that they need at a far lower cost and ultimately a far more profitable structure for our stockholders.
Speaker #2: And you're really reliant on getting a meaningful number of refills from that patient in order to make up for those investments. And the sampling program is, we believe, going to achieve the same effect in terms of giving patients access to the medication that they need at a far lower cost and ultimately a far more profitable structure for our stockholders.
Mark Baum: The sampling program is, we believe, going to achieve the same effect in terms of giving patients access to the medication that they need at a far lower cost and ultimately a far more profitable structure for our stockholders.
Speaker #4: Okay, thanks. So I guess, should we just think about that showing through as maybe slightly lower actual scripts, per se, as they're written, but just a higher ASP per script that's written?
Lachlan Hanbury-Brown: Okay, thanks. I guess should we just think about that showing through as maybe slightly lower actual scripts per se as they are written, but just a higher ASP per script that is written. So it effectively increases-
Lachlan Hanbury-Brown: Okay, thanks. I guess should we just think about that showing through as maybe slightly lower actual scripts per se as they are written, but just a higher ASP per script that is written. So it effectively increases-
Speaker #4: So it effectively improves growth?
Mark L. Baum: I do not know that I would think about it that way. I think that we are seeing higher volumes of prescriptions, both new prescriptions and total prescriptions as a result of this program. I think what Andrew said in his remarks, and Pat reinforced this, is that the business rule changes that we made most recently, the expectation, I think, among some was that this would constrict prescribing. It would constrict dispensing. The opposite has happened. These business rules, and I think this actually has exceeded our expectations, these business rules have not affected at all the demand for the product and not only the demand, but our ability to ultimately process a prescription and dispense it. Both NRXs and TRXs moved up meaningfully in Q2. By the way, it is continuing even in Q3, which is extraordinary.
Mark Baum: I do not know that I would think about it that way. I think that we are seeing higher volumes of prescriptions, both new prescriptions and total prescriptions as a result of this program. I think what Andrew said in his remarks, and Pat reinforced this, is that the business rule changes that we made most recently, the expectation, I think, among some was that this would constrict
Speaker #2: I don't know that I would think about it that way. I mean, I think that we're seeing higher volumes of prescriptions both new prescriptions and total prescriptions as a result of this program.
Speaker #2: I think what Andrew said in his remarks, and Pat reinforced this, is that the business rule changes that we made most recently. The expectation, I think, among some was that this would constrict prescribing.
Mark Baum: prescribing. It would constrict dispensing. The opposite has happened. These business rules, and I think this actually has exceeded our expectations, these business rules have not affected at all the demand for the product and not only the demand, but our ability to ultimately process a prescription and dispense it. Both NRXs and TRXs moved up meaningfully in Q2. By the way, it is continuing even in Q3, which is extraordinary.
Speaker #2: It would constrict dispensing. And the opposite has happened. So these business rules, and I think this actually has exceeded our expectations, these business rules have not affected at all the demand for the product and not only the demand, but our ability to ultimately process a prescription and dispense it.
Speaker #2: Both in our exes and TRXs, moved up meaningfully in the second quarter. And by the way, it's continuing even in the third quarter, which is extraordinary.
Speaker #2: So we're getting great productivity from the Salesforce, the business rules that Andrew and the team implemented. I think we're extremely successful so far. And we're in really good shape with our Vivi franchise.
Mark L. Baum: We are getting great productivity from the sales force. The business rules that Andrew and the team implemented, I think, were extremely successful so far. We are in really good shape with our VEVYE franchise. The team is fantastic. There is also, by the way, a direct relationship, I think, between the investment in the field force and our ability to get new prescriptions in the door. So we are seeing that correlation, that connection, and more reps is going to mean more NRXs. When you have a product as extraordinary as VEVYE, that is going to mean more TRXs. With more coverage where you are making more money on a unit basis, that should give us increasing overall revenue for the franchise. Andrew, do you want to add to that at all?
Mark Baum: We are getting great productivity from the sales force. The business rules that Andrew and the team implemented, I think, were extremely successful so far. We are in really good shape with our VEVYE franchise. The team is fantastic. There is also, by the way, a direct relationship, I think, between the investment in the field force and our ability to get new prescriptions in the door.
Speaker #2: And the team is fantastic. There's also, by the way, a direct relationship, I think, between the investment in the field force and our ability to get new prescriptions in the door.
Speaker #2: So we're seeing that correlation, that connection. And more reps is going to mean more NRXs. And when you have a product that's extraordinary, as VEVYE, that's going to mean more TRXs.
Mark Baum: So we are seeing that correlation, that connection, and more reps is going to mean more NRXs. When you have a product as extraordinary as VEVYE, that is going to mean more TRXs. With more coverage where you are making more money on a unit basis, that should give us increasing overall revenue for the franchise. Andrew, do you want to add to that at all?
Speaker #2: And with more coverage, where you're making more money on a unit basis, that should give us increasing overall revenue for the franchise. Andrew, do you want to add to that at all?
Andrew R. Boll: Lachlan, I would just reinforce what I said in the previous questions, which is I think with the coverage win considered, we do still expect ASP to improve for VEVYE throughout the year.
Andrew Boll: Lachlan, I would just reinforce what I said in the previous questions, which is I think with the coverage win considered, we do still expect ASP to improve for VEVYE throughout the year.
Speaker #5: Block, I would just kind
Speaker #3: To reinforce what I said in the previous questions, which is, I think, with the coverage when considered, we do still expect ASP to improve for Vivi.
Speaker #3: Throughout the year.
Lachlan Hanbury-Brown: Got it. Thanks.
Lachlan Hanbury-Brown: Got it. Thanks.
Speaker #4: Got it. Thanks.
Speaker #2: Thanks, Lachlan.
Mark L. Baum: Thanks, Lachlan.
Mark Baum: Thanks, Lachlan.
Speaker #1: Thank you. And our next question is going to come from Tom Schrader with US Bank. Your line is open.
Operator: Thank you. Our next question is going to come from Tom Schrader with U.S. Bank. Your line is open.
Operator: Thank you. Our next question is going to come from Tom Schrader with U.S. Bank. Your line is open.
Speaker #4: Good morning. Congratulations. Seems like all 50 bowls are back in the air. So it's remarkable. A question on Trevaya and Vivi. Are they going to be in lock step, which is the Salesforce has both?
Tom Schrader: Good morning. Congratulations. Seems like all 50 balls are back in the air, so it is remarkable. A question on TYRVAYA and VEVYE. Are they going to be in lockstep, which is the sales force has both, and when you add a TYRVAYA sales force, they will also have VEVYE, they will have the same sampling? Is that the way to see it? You will have two products that essentially everybody in the sales force has?
Thomas Schrader: Good morning. Congratulations. Seems like all 50 balls are back in the air, so it is remarkable. A question on TYRVAYA and VEVYE. Are they going to be in lockstep, which is the sales force has both, and when you add a TYRVAYA sales force, they will also have VEVYE, they will have the same sampling? Is that the way to see it? You will have two products that essentially everybody in the sales force has?
Speaker #4: And when you add a Trevaya Salesforce, they'll also have Vivi. They'll have the same sampling. Is that the way to see it? You'll have two products that are essentially everybody in the Salesforce has?
Speaker #2: Yeah, I don't want to go into the specific strategy too much, Tom, but what I can tell you is Vivi is our primary product.
Mark L. Baum: I do not want to go into the specific strategy, Tom, too much, but what I can tell you is VEVYE is our primary product. It is the product. It is the lady that we went to the dance with, and it is the core focus of our team, and it will continue to be. But there is, as I said, tremendous operational synergy between these products, and they are clinically complementary. Pat, do you want to talk at all about what you intend to do on the VEVYE, TYRVAYA front?
Mark Baum: I do not want to go into the specific strategy, Tom, too much, but what I can tell you is VEVYE is our primary product. It is the product. It is the lady that we went to the dance with, and it is the core focus of our team, and it will continue to be. But there is, as I said, tremendous operational synergy between these products, and they are clinically complementary. Pat, do you want to talk at all about what you intend to do on the VEVYE, TYRVAYA front?
Speaker #2: It is the product. It's the lady that we went to the dance with. And it is the core focus of our team, and it will continue to be.
Speaker #2: But there is, as I said, tremendous operational synergy between these products, and they are clinically complementary. Pat, do you want to talk at all about what you intend to do on the VIVI and Trevaya front?
Speaker #5: Yeah, thanks, Mark. To the question, we're really excited about the complementary nature of these products. I mean, when you think about it, Vivi has performed really, really well.
Patrick W. Sullivan: Yeah. Thanks, Mark. To the question, we are really excited about the complementary nature of these products. When you think about it,
Patrick Sullivan: Yeah. Thanks, Mark. To the question, we are really excited about the complementary nature of these products. When you think about it,
Mark L. Baum: Yeah
Mark Baum: Yeah
Patrick W. Sullivan: VEVYE has performed really well, and I think what we are really excited about when you think about this, just some context, we are in a very large and active market. Just to give context, this time last year, we have a market that is up about 18%, and the brand that our RXs are representing over 75%.
Patrick Sullivan: VEVYE has performed really well, and I think what we are really excited about when you think about this, just some context, we are in a very large and active market. Just to give context, this time last year, we have a market that is up about 18%, and the brand that our RXs are representing over 75%.
Speaker #5: And I think what we're really excited about when you think about this, just some context, we're in a very large and active market, just to give context, this time last year, we have a market that's up about 18%.
Speaker #5: And the brand that our exes are representing is over 75%. With Vivi, the real key point here is we're focused on inflammation as the cornerstone to treating dry eye.
Patrick W. Sullivan: With VEVYE, the real key point here is we are focused on inflammation as the cornerstone to treating dry eye. We continue to see a positive experience and it performs well. As we have expanded the team, I think we continue to see a positive experience growing on our Rx, TRxs, as well as writers. TYRVAYA helps us, one, open up another segment opportunity when it comes to basal tear production, which often is similar presenting in the inflammation patients. We see an opportunity for both of these products to, one, grow our Harrow share and to further help these patients and doctors that we cover right now and actually bring in more writers and grow our business.
Patrick Sullivan: With VEVYE, the real key point here is we are focused on inflammation as the cornerstone to treating dry eye. We continue to see a positive experience and it performs well. As we have expanded the team, I think we continue to see a positive experience growing on our Rx, TRxs, as well as writers.
Speaker #5: And we continue to see a positive experience and performance as well. And as we've expanded the team, I think we continue to see a positive experience growing on our Rx’s, TRx’s, as well as writers.
Speaker #5: Trevaya helps us, one, open up another segment opportunity when it comes to basal tear production, which often is similar, presenting in the inflammation patient.
Patrick Sullivan: TYRVAYA helps us, one, open up another segment opportunity when it comes to basal tear production, which often is similar presenting in the inflammation patients. We see an opportunity for both of these products to, one, grow our Harrow share and to further help these patients and doctors that we cover right now and actually bring in more writers and grow our business.
Speaker #5: So we see an opportunity for both of these products to, one, grow our Harrow share and to further help these patients and doctors that we cover right now, and actually bring in more writers and grow our business.
Tom Schrader: Okay, on the biosimilars, obviously growing the brand is important, but protecting your price is a huge part of this game. Any thoughts on, Amgen seems to have done it, but any thoughts on your strategy there, or maybe one you want to answer even less, but I am just curious what you can say.
Thomas Schrader: Okay, on the biosimilars, obviously growing the brand is important, but protecting your price is a huge part of this game. Any thoughts on, Amgen seems to have done it, but any thoughts on your strategy there, or maybe one you want to answer even less, but I am just curious what you can say.
Speaker #4: Okay. And then on the biosimilars, obviously growing the brand is important, but protecting your price is a huge part of this game. Any thoughts on—I mean, Amgen seems to have done it—but any thoughts on your strategy there? Or maybe that's one you want to answer even less, but I'm just curious what you can say.
Speaker #2: I think right now, Tom, the team has received a tremendous amount of inbound interest in the product, and we're focused on really driving demand and revenue.
Mark L. Baum: I think right now, Tom, the team has received a tremendous amount of inbound interest in the product, and we are focused on really converting the interest to demand and revenue. Other than that, I think we have a phenomenal market access strategy that is designed to maximally preserve pricing. We have, I think, some unique advantages with our product over other choices, including the branded Lucentis as well as the other biosimilar. Andrew, do you want to comment on that at all?
Mark Baum: I think right now, Tom, the team has received a tremendous amount of inbound interest in the product, and we are focused on really converting the interest to demand and revenue. Other than that, I think we have a phenomenal market access strategy that is designed to maximally preserve pricing. We have, I think, some unique advantages with our product over other choices, including the branded Lucentis as well as the other biosimilar. Andrew, do you want to comment on that at all?
Speaker #2: Other than that, I think we have a phenomenal market access strategy that's designed to maximally preserve pricing. And we have I think some unique advantages with our product over other choices including the branded Lucentis as well as the other biosimilar.
Speaker #2: Andrew, do you want to comment on that at all?
Speaker #3: Well, not really. We're obviously really ASP and maintaining net revenue per unit durability for the product is super important, as you pointed out. And so we, like Mark is saying, we do have a strategy to do that.
Andrew R. Boll: Not really, Tom. We are obviously really ASC and maintaining net revenue per unit durability for the product is super important, as you pointed out. We, like Mark is saying, do have a strategy to do that. We have a lot of experience doing this too, with some of the other bio products. Obviously, this is a little bit different, but you are still in the same sort of, it is going through the medical benefit. It is reimbursed on its own J code or Q code, pardon me. Still a similar dynamic. We are using some of that experience to try to extend durability of both BYOOVIZ and when OPUVIZ launches, OPUVIZ.
Andrew Boll: Not really, Tom. We are obviously really ASC and maintaining net revenue per unit durability for the product is super important, as you pointed out. We, like Mark is saying, do have a strategy to do that. We have a lot of experience doing this too, with some of the other bio products. Obviously, this is a little bit different, but you are still in the same sort of, it is going through the medical benefit. It is reimbursed on its own J code or Q code, pardon me. Still a similar dynamic. We are using some of that experience to try to extend durability of both BYOOVIZ and when OPUVIZ launches, OPUVIZ.
Speaker #3: We have a lot of experience doing this too with some of the other buy-and-bill products. Obviously, this is a little bit different, but you're still kind of in the same sort of it's going through the medical benefit.
Speaker #3: It's reimbursed on its own J code, or Q code—pardon me. So still a similar dynamic, and we're using some of that experience to try to extend the durability of both BioVis and, when Optivis launches, Optivis.
Speaker #4: Okay. Last one, which may be yes/no. Ihizo in the surgical setting, is that gone forever or as you are generating clinical data, is there a way you might get some use back?
Tom Schrader: Okay, last one, which may be yes, no. IHEEZO in the surgical setting, is that gone forever? Or as you are generating clinical data, is there a way you might get some use back? It was a pretty decent market, and people loved the product. Is there any way back, or is that just not worth it at this point?
Thomas Schrader: Okay, last one, which may be yes, no. IHEEZO in the surgical setting, is that gone forever? Or as you are generating clinical data, is there a way you might get some use back? It was a pretty decent market, and people loved the product. Is there any way back, or is that just not worth it at this point?
Speaker #4: It was a pretty decent market, and people loved the product. Is there any way back, or is that just not worth it at this point?
Speaker #2: Yeah. To be very clear, if we have a minute of time to invest commercially, making a sale, given what we're seeing in terms of new account development and reach within these practices, we're going to focus on where we know we are winning and where we have a massive amount of room, headroom, which is in office in the retina market and in the in-office procedure market.
Mark L. Baum: Yeah. To be very clear, if we have a minute of time to invest commercially making a sale given what we are seeing in terms of new account development and reach within these practices, we are going to focus on where we know we are winning and where we have a massive amount of headroom, which is in-office, in the retina market, and in the in-office procedure market. We have literally well over 10 million more procedures that we can address with this product on an annual basis. Certainly the surgical market is an attractive market. It is how we launched the product, but we have a massive market ahead of us in the intravitreal injection market, as well as the in-office procedure market, where we have a permanent product-specific J-code reimbursement at better than 95% and a sub 5% prior authorization rate.
Mark Baum: Yeah. To be very clear, if we have a minute of time to invest commercially making a sale given what we are seeing in terms of new account development and reach within these practices, we are going to focus on where we know we are winning and where we have a massive amount of headroom, which is in-office, in the retina market, and in the in-office procedure market.
Speaker #2: So, we have literally well over 10 million more procedures that we can address with this product on an annual basis. And so, certainly, the surgical market is an attractive market.
Mark Baum: We have literally well over 10 million more procedures that we can address with this product on an annual basis. Certainly the surgical market is an attractive market. It is how we launched the product, but we have a massive market ahead of us in the intravitreal injection market, as well as the in-office procedure market, where we have a permanent
Speaker #2: It's how we launch the product. But we have a massive market ahead of us in the intravitreal injection market as well as the in-office procedure market where we have a permanent product-specific J code reimbursement.
Mark Baum: product-specific J-code reimbursement at better than 95% and a sub 5% prior authorization rate. We are having tremendous success in the office with retina professionals as well as other in-office procedures. So that is where we are focusing, and we are going to leave the surgical market alone right now.
Speaker #2: It's better than 95%, and a sub-5% prior authorization rate. So we're having tremendous success in the office with retina professionals, as well as other in-office procedures.
Mark L. Baum: We are having tremendous success in the office with retina professionals as well as other in-office procedures. So that is where we are focusing, and we are going to leave the surgical market alone right now.
Speaker #2: So that's where we're focusing, and we're going to leave the surgical market alone right now.
Speaker #4: Great. Thanks for all the details.
Tom Schrader: Great. Thanks for all the details.
Thomas Schrader: Great. Thanks for all the details.
Speaker #2: Thank you, Tom.
Mark L. Baum: Thank you, Tom.
Mark Baum: Thank you, Tom.
Operator: Thank you. The next question will come from Mayank Mandhani with B. Riley Securities. Your line's open.
Operator: Thank you. The next question will come from Mayank Mamtani with B. Riley Securities. Your line's open.
Speaker #1: Thank you. And the next question will come from Mayank Mamtani. With B. Raleigh Securities, your line's open.
Speaker #2: Oh, yes. Good morning, Dean. Thanks for the questions, and I appreciate a lot of detail here. So, on the shareholder letter, you mentioned that third-party data undercounts VY.
Mayank Mandhani: Yes. Good morning, team. Thanks for taking our questions and appreciate a lot of detail here. On the shareholder letter, you mentioned the third-party data undercounts VEVYE. Was just curious, Mark, if you could maybe comment on what you are seeing on the total dispense units that we may not see in IQVIA here and obviously trying to understand the volume demand to revenue conversion here. To the extent you can maybe also comment on volume, how you might be tracking versus another maybe incumbent brand, which is also helping expand the DAD market. Then on the new PBM win, did you comment on what percentage of the new lives that you have was previously filling as cash pay versus completely blocked?
Mayank Mamtani: Yes. Good morning, team. Thanks for taking our questions and appreciate a lot of detail here. On the shareholder letter, you mentioned the third-party data undercounts VEVYE. Was just curious, Mark, if you could maybe comment on what you are seeing on the total dispense units that we may not see in IQVIA here and obviously trying to understand the volume demand to revenue conversion here.
Speaker #2: I was just curious, Mark, if you could maybe comment on what you're seeing on the total dispense units that we may not see in IQVIA here, and obviously, trying to understand the volume demand to revenue conversion here.
Speaker #2: To the extent you can, maybe also comment on volume—how you might be tracking versus another, maybe incumbent, brand which is also helping expand the DAV market.
Mayank Mamtani: To the extent you can maybe also comment on volume, how you might be tracking versus another maybe incumbent brand, which is also helping expand the DAD market. Then on the new PBM win, did you comment on what percentage of the new lives that you have was previously filling as cash pay versus completely blocked?
Speaker #2: And then on the new PVM win, did you comment on what percentage of the new lives that you have was previously filling as cash pay versus completely blocked?
Mark L. Baum: Well, I will take the cash pay versus covered answer. We do not break that out specifically, and we do not really intend to. Obviously, this is an incredibly competitive market. Andrew, do you want to talk a little bit about the data issue on VEVYE and reporting specifically? Anything you want to add there?
Mark Baum: Well, I will take the cash pay versus covered answer. We do not break that out specifically, and we do not really intend to. Obviously, this is an incredibly competitive market. Andrew, do you want to talk a little bit about the data issue on VEVYE and reporting specifically? Anything you want to add there?
Speaker #4: Well, I'll take the cash pay versus covered answer. And so we don't break that out. Specifically, and we don't really intend to. Obviously, there's an incredibly competitive market.
Speaker #4: Andrew, do you want to talk a little bit about the data issue on VY and reporting specifically? Anything you want to add there?
Andrew R. Boll: Mark, I think that I'll just reiterate some of the things that we said. Like Mark was saying in the shareholder letter, that we are seeing an increase in, I would say, disparity between the data that the third-party aggregators are putting out and our internal data. We saw our total brand, the driver prescriptions, reach about 14.6% at the end of June. That's up from last quarter, and obviously almost nearly double from a year ago. That share that we're growing, especially when you look at the year-over-year numbers, that's with basically the old territory setup. We were able to grow that prescription amount with a much smaller sales force, and we're just barely getting productivity from the new reps.
Andrew Boll: Mark, I think that I'll just reiterate some of the things that we said. Like Mark was saying in the shareholder letter, that we are seeing an increase in, I would say, disparity between the data that the third-party aggregators are putting out and our internal data.
Speaker #3: Mark, I think that I'll just kind of reiterate some of the things that we said, and like Mark was saying in the shareholder letter, we are seeing an increase in, I would say, disparity between the data that the third-party aggregators are putting out and our internal data.
Speaker #3: We saw our total brand-to-drive prescriptions reach about 14.6% at the end of June. That's up from last quarter and, obviously, almost nearly double from a year ago.
Andrew Boll: We saw our total brand, the driver prescriptions, reach about 14.6% at the end of June. That's up from last quarter, and obviously almost nearly double from a year ago. That share that we're growing, especially when you look at the year-over-year numbers, that's with basically the old territory setup. We were able to grow that prescription amount with a much smaller sales force, and we're just barely getting productivity from the new reps.
Speaker #3: And so that share that we're growing especially when you look at the year-over-year numbers that's with basically the old territory setup. We were able to grow that prescription amount with a much smaller sales force.
Speaker #3: And we're just barely getting productivity from the new reps, and so we're excited about what we're expecting to see in Q3 and Q4. We're seeing this in the early days, as the reps are producing prescriptions.
Andrew R. Boll: We're excited about what we're expecting to see in Q3 and Q4, and we're seeing this in the early days, is the reps are producing prescriptions. There's a direct correlation to number of feet on the street and increase in NRXs and TRXs. That's only going to be furthered as we add TYRVAYA and some of the commercial organization from Viatris as well, which, as Pat was talking about, they're also going to be selling VEVYE as well as TYRVAYA, which should just further accelerate our market position within dry between VEVYE and TYRVAYA with the acquisition close pending.
Andrew Boll: We're excited about what we're expecting to see in Q3 and Q4, and we're seeing this in the early days, is the reps are producing prescriptions. There's a direct correlation to number of feet on the street and increase in NRXs and TRXs. That's only going to be furthered as we add TYRVAYA and some of the commercial organization from Viatris as well, which, as Pat was talking about, they're also going to be selling VEVYE as well as TYRVAYA, which should just further accelerate our market position within dry between VEVYE and TYRVAYA with the acquisition close pending.
Speaker #3: There's a direct correlation to the number of feet on the street. And increase in NRXs and TRXs. And that's only going to be furthered as we add Tervia and some of the commercial organization from Beatrice as well.
Speaker #3: Which Ms. Pal was talking about, they're also going to be selling VY as well as Tervia, which should just further accelerate our market position within dry between VY and Tervia.
Speaker #3: With the acquisition close pending.
Speaker #4: Yeah. The other thing I would add is that the dashboard I watch is our Fill Rx Dashboard. And as I've said on previous calls, I watch it like a hawk—almost like some investors might watch a stock ticker.
Mark L. Baum: The other thing I would add is that the dashboard that I watch is our Fill Rx dashboard, and as I've said on previous calls, I watch it like a hawk, almost like some investors might watch a stock ticker, I suppose. What I'm seeing and what gives me confidence in the franchise and the great work that the team is doing is that I'm seeing higher highs and higher lows in daily volume. Even tracking one Tuesday this week versus the prior Tuesday, just monitoring week-over-week data, once again, higher highs, higher lows. One week doesn't necessarily make a trend, but that's happening certainly on the monthly data. So we're really pleased with the work that the team is doing.
Mark Baum: The other thing I would add is that the dashboard that I watch is our Fill Rx dashboard, and as I've said on previous calls, I watch it like a hawk, almost like some investors might watch a stock ticker, I suppose. What I'm seeing and what gives me confidence in the franchise and the great work that the team is doing is that I'm seeing higher highs and higher lows in daily volume. Even tracking one Tuesday this week versus the prior Tuesday, just monitoring week-over-week data, once again, higher highs, higher lows.
Speaker #4: I suppose. And what I'm seeing—and what gives me confidence in the franchise and the great work that the team is doing—is that I'm seeing higher highs and higher lows in daily volume.
Speaker #4: And so, even tracking one Tuesday this week versus the prior Tuesday, just monitoring week-over-week data, once again, higher highs, higher lows. And one week doesn't necessarily make a trend, but that's happening certainly on the monthly data.
Mark Baum: One week doesn't necessarily make a trend, but that's happening certainly on the monthly data. So we're really pleased with the work that the team is doing. There's a lot more work left to do, I would say, and the second half is truly about commercial execution and Pat and Maria and that whole VEVYE team. I have just tremendous confidence in their ability to make it happen and continue the trends that we're seeing on VEVYE.
Speaker #4: So we're really pleased with the work that the team is doing. There's a lot more work left to do, I would say. And the second half is truly about commercial execution and PAT and Maria and that whole VY team I've just tremendous confidence in their ability to make it happen and continue the trends that we're seeing on VY.
Mark L. Baum: There's a lot more work left to do, I would say, and the second half is truly about commercial execution and Pat and Maria and that whole VEVYE team. I have just tremendous confidence in their ability to make it happen and continue the trends that we're seeing on VEVYE.
Speaker #2: Understood. And that's certainly what we are seeing on the IQVIA side. Just on pipeline, if I may, just a couple of quick ones. The ASRS interim data for AHIZA was encouraging, but obviously a small sample size.
Mayank Mandhani: Understood. That is certainly what we are seeing on the IQVIA side. Just on pipeline, if I may, just a couple of quick ones. The ASRS interim data for IHEEZO was encouraging, but obviously a small sample size. How do you see the QUELL data coming up to build on these learnings, including the comparator arm, I think the same comparator arm you are using of some subconjunctival lidocaine superiority, I think you are trying to demonstrate on post-procedural pain and maybe some of the other more retina clinic workflow relevant endpoints. Just maybe talk about what does win look like to drive utilization against obviously a generic sort of market backdrop. Then lastly, for G-MELT, what are key questions for this pre-NDA meeting coming up in early Q4, and do you anticipate most of your ancillary studies being wrapped up by the end of the year?
Mayank Mamtani: Understood. That is certainly what we are seeing on the IQVIA side. Just on pipeline, if I may, just a couple of quick ones. The ASRS interim data for IHEEZO was encouraging, but obviously a small sample size. How do you see the QUELL data coming up to build on these learnings, including the comparator arm, I think the same comparator arm you are using of some subconjunctival lidocaine superiority, I think you are trying to demonstrate on post-procedural pain and maybe some of the other more retina clinic workflow relevant endpoints. Just maybe
Speaker #2: So how do you see the square data coming up, build on this learnings including the comparator arm? I think the same comparator arm you are using of some subconjunctival lidocaine.
Speaker #2: Superiority, I think you're trying to demonstrate on post-procedural pain, and maybe some of the other more retina-clinic-workflow relevant endpoints. So just maybe talk about what has been your client to drive utilization against, obviously, a generic sort of market backdrop.
Mayank Mamtani: talk about what does win look like to drive utilization against obviously a generic sort of market backdrop. Then lastly, for G-MELT, what are key questions for this pre-NDA meeting coming up in early Q4, and do you anticipate most of your ancillary studies being wrapped up by the end of the year?
Speaker #2: And then lastly, for Gmail, what are key questions for this pre-NDA meeting coming up in early Q4? And do you anticipate most of your ancillary studies being wrapped up by the end of the year?
Speaker #4: Yeah, I'm going to turn both of those questions over to Amir, but I do want to say just briefly on the Quell data and the data that Dr. Dang made available at ASRS.
Mark L. Baum: Yeah. I am going to turn both of those questions over to Amir, but I do want to say just briefly on the QUELL data and the data that Dr. Deng made available at ASRS, that I always think of things from a patient's perspective. If I was a patient going in to get an intravitreal injection, and I am going to get another injection of lidocaine in my eye and deal with the consequences of that, I would much rather prefer a single dose of IHEEZO. What we are really trying to demonstrate is that in terms of the anesthetic effect, it is the same. So, you can either get a needle or you can get a topical drop. In terms of the anesthetic effect, it is the same. Whether there is any difference in pain and of course, patient preference.
Mark Baum: Yeah. I am going to turn both of those questions over to Amir, but I do want to say just briefly on the QUELL data and the data that Dr. Deng made available at ASRS, that I always think of things from a patient's perspective. If I was a patient going in to get an intravitreal injection, and I am going to get another injection of lidocaine in my eye and deal with the consequences of that, I would much rather prefer a single dose of IHEEZO.
Speaker #4: That I always think of things from a patient's perspective. If I was a patient going in to get an intravitreal injection, and I'm going to get another injection of lidocaine in my eye and deal with the consequences of that, I would much rather prefer a single dose of Iheso and so what we're really trying to demonstrate is that in terms of the anesthetic effect, it's the same.
Mark Baum: What we are really trying to demonstrate is that in terms of the anesthetic effect, it is the same. So, you can either get a needle or you can get a topical drop. In terms of the anesthetic effect, it is the same. Whether there is any difference in pain and of course, patient preference.
Speaker #4: So you can either get a needle or you can get a topical drop. In terms of the anesthetic effect, it's the same. And whether there's any difference in pain, and, of course, patient preference.
Speaker #4: And so we always think of things from a consumer perspective, and we think that patients ultimately are going to prefer IHEZO. That's got to be borne out in the data.
Mark L. Baum: We always think of things from a consumer perspective, and we think that patients ultimately were going to prefer IHEEZO. That has got to be borne out in the data, and that is really the focus of the great work that Amir and his team are doing. Amir, do you want to add to the QUELL study that is ongoing and then talk about anything you can about the pre-NDA meeting?
Mark Baum: We always think of things from a consumer perspective, and we think that patients ultimately were going to prefer IHEEZO. That has got to be borne out in the data, and that is really the focus of the great work that Amir and his team are doing. Amir, do you want to add to the QUELL study that is ongoing and then talk about anything you can about the pre-NDA meeting?
Speaker #4: And that's really the focus of the great work that Amir and his team are doing. Amir, do you want to add to the QUELL study that's ongoing and then talk about anything you can regarding the pre-NDA meeting?
Speaker #1: Thanks, Mark. Yeah. So, real quickly on Quell, this is a double-masked controlled trial. As far as any current data, we obviously don't have any, but the study is well-enrolling and we anticipate having the enrollment completed later this year. We'll have results later this year as well.
Amir H. Shojaei: Thanks, Mark. Yeah. So real quickly on QUELL, this is a double-masked controlled trial. As far as any current data, we obviously do not have any. But their study is well enrolling, and we anticipated to have the enrollment completion later this year, and then we will have results later this year. That said, the kind of endpoints we are looking at are substantially twofold. One, we are going to look at the numbing effect, where we want to show that the product obviously numbs just as good as the lidocaine subconj. But more importantly, we are looking at patient outcomes, right? So from a patient outcomes perspective, we have a whole slew of symptoms that we track, as well as the overall satisfaction
Amir Shojaei: Thanks, Mark. Yeah. So real quickly on QUELL, this is a double-masked controlled trial. As far as any current data, we obviously do not have any. But their study is well enrolling, and we anticipated to have the enrollment completion later this year, and then we will have results later this year.
Speaker #1: That said, the kind of endpoints we're looking at are substantially two-fold. One, we're going to look at the numbing effect, where we want to show that the product obviously numbs just as good as the lidocaine subconj.
Amir Shojaei: That said, the kind of endpoints we are looking at are substantially twofold. One, we are going to look at the numbing effect, where we want to show that the product obviously numbs just as good as the lidocaine subconj. But more importantly, we are looking at patient outcomes, right? So from a patient outcomes perspective, we have a whole slew of symptoms that we track, as well as the overall satisfaction By the patient all the way through 24 hours post-injection.
Speaker #1: But more importantly, we're looking at patient outcomes, right? So from a patient outcomes perspective, we have a whole slew of symptoms that we track as well as the overall satisfaction by the patient all the way through 24 hours post-injection.
Amir H. Shojaei: By the patient all the way through 24 hours post-injection. All of those metrics will come out, and we are pretty confident. Now, remember, everything that we are doing is based on what we have seen already. This is not just started necessarily this quarter. We started this journey on evidence generation about 20 months ago, and a lot of this data is trickling out and supporting our continued sort of benefit that we are seeing from the patients using IHEEZO or in procedures, especially. On G-MELT, this is a pre-NDA meeting, and the nature of a pre-NDA meeting is really oriented around the submission package. What is it you are putting in, and what is the format, some of the basic necessities as far as the review division is concerned.
Speaker #1: So all of those metrics will come out and we're pretty confident. Now, remember, everything that we are doing is based on what we've seen already.
Amir Shojaei: All of those metrics will come out, and we are pretty confident. Now, remember, everything that we are doing is based on what we have seen already. This is not just started necessarily this quarter. We started this journey on evidence generation about 20 months ago, and a lot of this data is trickling out and supporting our continued sort of benefit that we are seeing from the patients using IHEEZO or in procedures, especially.
Speaker #1: This didn't just start necessarily this quarter. We started this journey on evidence generation about 20 months ago. A lot of this data is trickling out and supporting the continued benefits that we are seeing from patients using IHEZO, or in procedures especially.
Speaker #1: On Gmail, this is a pre-NDA meeting and the nature of a pre-NDA meeting is really oriented around the submission package. What is it you're putting in and what is the format, some of the basic necessities as far as a review division is concerned.
Amir Shojaei: On G-MELT, this is a pre-NDA meeting, and the nature of a pre-NDA meeting is really oriented around the submission package. What is it you are putting in, and what is the format, some of the basic necessities as far as the review division is concerned.
Speaker #1: That said, we will have a CMC-oriented discussion, and most of the other ancillary programs—the PK studies, etc.—will be discussed during this meeting. So, it will be an important meeting. But that said, there isn't one specific thing in focus.
Amir H. Shojaei: That said, we will have CMC-oriented discussion and most of the other ancillary programs, the PK studies, et cetera, will be discussed during this meeting. So it will be an important meeting, but that said, there is not one specific thing in focus. It is the whole constellation of data that we are going to put into the NDA.
Amir Shojaei: That said, we will have CMC-oriented discussion and most of the other ancillary programs, the PK studies, et cetera, will be discussed during this meeting. So it will be an important meeting, but that said, there is not one specific thing in focus. It is the whole constellation of data that we are going to put into the NDA.
Speaker #1: It's the whole constellation of data that we're going to put into the NDA.
Speaker #4: Thank you.
Mayank Mandhani: Thank you.
Mayank Mamtani: Thank you.
Mark L. Baum: The only thing I would add, by the way, on QUELL is it is a study that is taking place under an IND, which is really important as well, and that could deliver some advantages pending the outcome of the data.
Mark Baum: The only thing I would add, by the way, on QUELL is it is a study that is taking place under an IND, which is really important as well, and that could deliver some advantages pending the outcome of the data.
Speaker #2: The only thing I would add, by the way, on Quell is it is a study that's taking place under an IND, which is really important as well.
Speaker #2: And that could give us some advantages. Pending the outcome of the data. Understood. Thank you.
Mayank Mandhani: Understood. Thank you.
Mayank Mamtani: Understood. Thank you.
Operator: Thank you. The next question comes from Jeffrey Cohen with Ladenburg. Your line is open.
Operator: Thank you. The next question comes from Jeffrey Cohen with Ladenburg. Your line is open.
Speaker #3: Thank you. And the next question comes from Jeffrey Cohen with Lattenberg. Your line is open.
Speaker #4: Hey, good morning. Thanks for taking our questions. Just two from our end. Could you talk about the contact lens wearers and Trevai and perhaps some pickup there from Viva and Jara?
Jeffrey Cohen: Good morning. Thanks for taking our questions. Just two from our end. Could you talk about the contact lens wearers and TYRVAYA and perhaps some pickup there from VEVYE dry eye? Then could you, I know it is a bit early, but do you expect any Access Plus program, sampling programs, couponing, et cetera, on TYRVAYA as you launch it in the back half?
Jeffrey Cohen: Good morning. Thanks for taking our questions. Just two from our end. Could you talk about the contact lens wearers and TYRVAYA and perhaps some pickup there from VEVYE dry eye? Then could you, I know it is a bit early, but do you expect any Access Plus program, sampling programs, couponing, et cetera, on TYRVAYA as you launch it in the back half?
Speaker #4: And then, could you—I know it's a bit early—but do you expect any access programs, sampling programs, couponing, etc. on Trevai as you launch it in the back half?
Mark L. Baum: What was the first question, Jeff? I am sorry. TYRVAYA?
Mark Baum: What was the first question, Jeff? I am sorry. TYRVAYA?
Speaker #2: What was the first question, Jeff? I'm sorry. Trevai?
Jeffrey Cohen: I wanted to know as far as contact lens wearers currently in your dry franchise.
Jeffrey Cohen: I wanted to know as far as contact lens wearers currently in your dry franchise.
Speaker #4: I wanted to know as far as contact lens wearers. Currently, in your dry franchise.
Speaker #2: Yeah. So look, all of the other products that are administered on the eye for contact lens wearers require the patient to remove their contact lenses.
Mark L. Baum: Yeah. So look, all of the other products that are administered on the eye for contact lens wearers require the patient to remove their contact lenses. That takes time, and it is probably true that some patients don't do that. But one of the great advantages to TYRVAYA is that for the 45 million folks in the United States that are contact lens wearers, this is a unique product for them specifically. This is a product, by the way, that over the last couple of years has had significant revenue. What we've been able to demonstrate and what we intend to show once we close on the product is that we can restore that revenue structure and grow the business, and we think that is certainly possible.
Mark Baum: Yeah. So look, all of the other products that are administered on the eye for contact lens wearers require the patient to remove their contact lenses. That takes time, and it is probably true that some patients don't do that. But one of the great advantages to TYRVAYA is that for the 45 million folks in the United States that are contact lens wearers, this is a unique product for them specifically.
Speaker #2: And that takes time, and it is probably true that some patients don't do that. But one of the great advantages to Trevai is that for the 45 million folks in the United States who are contact lens wearers, this is a unique product for them specifically.
Speaker #2: This is a product, by the way, that over the last couple of years, has had significant revenue. What we've been able to demonstrate and what we intend to show once we close on the product is that we can restore that revenue structure and grow the business.
Mark Baum: This is a product, by the way, that over the last couple of years has had significant revenue. What we've been able to demonstrate and what we intend to show once we close on the product is that we can restore that revenue structure and grow the business, and we think that is certainly possible. It hasn't gotten a lot of attention over the last couple of years, and we intend to really focus in on making sure that certainly the contact lens wearers have access to it, but also other patients that we can serve that are suffering from dry eye disease and who could benefit from TYRVAYA.
Speaker #2: And we think that that is certainly possible. It hasn't gotten a lot of attention, over the last couple of years. And we intend to really focus in on making sure that certainly the contact lens wearers have access to it, but also other patients that we can serve that are suffering from dry eye disease and who could benefit from Trevai.
Mark L. Baum: It hasn't gotten a lot of attention over the last couple of years, and we intend to really focus in on making sure that certainly the contact lens wearers have access to it, but also other patients that we can serve that are suffering from dry eye disease and who could benefit from TYRVAYA. So we have high hopes for TYRVAYA, but that said, VEVYE is going to continue to always be our baby. It's where we focus. It is the lady that we brought to the dance, and we think that VEVYE will continue to be the primary driver of our dry eye franchise for sure.
Speaker #2: So we have high hopes for Trevai, but that said, Viva is going to continue to always be our baby. It's where we focus. It is the lady that we brought to the dance.
Mark Baum: So we have high hopes for TYRVAYA, but that said, VEVYE is going to continue to always be our baby. It's where we focus. It is the lady that we brought to the dance, and we think that VEVYE will continue to be the primary driver of our dry eye franchise for sure.
Speaker #2: And we think that Viva will continue to be the primary driver of our dry eye franchise, for sure. In terms of the access programs, I don't want to get into specifics about what we intend to do to ensure access to Trevai, but I can say is that we will continue to implement access programs that ensure that every patient in need has access to all HAROW products, which are poor, good insurance, bad insurance, or no insurance.
Mark L. Baum: In terms of the Access programs, I don't want to get into specifics about what we intend to do to ensure access to TYRVAYA, but what I can say is that we will continue to implement Access programs that ensure that every patient in need has access to all HARROW products. Rich or poor, good insurance, bad insurance, or no insurance. That's how we built the business. That is the foundation of who we are culturally, and that's the way we'll continue to be. Some companies talk a lot about Access. We act a lot on Access and have programs to make sure patients get what they need, and that will certainly be the case with TYRVAYA.
Mark Baum: In terms of the Access programs, I don't want to get into specifics about what we intend to do to ensure access to TYRVAYA, but what I can say is that we will continue to implement Access programs that ensure that every patient in need has access to all Harrow products. Rich or poor, good insurance, bad insurance, or no insurance. That's how we built the business.
Speaker #2: That's how we built the business. That is the foundation of who we are culturally. And that's the way we'll continue to be. Some companies talk a lot about access.
Mark Baum: That is the foundation of who we are culturally, and that's the way we'll continue to be. Some companies talk a lot about Access. We act a lot on Access and have programs to make sure patients get what they need, and that will certainly be the case with TYRVAYA.
Speaker #2: We act a lot. On access and have programs to make sure patients get what they need. And that will certainly be the case with Trevai.
Speaker #4: Thanks, Mark. That's helpful. And then just one more quick question on the compounding business. I know we haven't touched upon that. Any changes there for the quarter, and as far as the second half outlook?
Jeffrey Cohen: Thanks, Mark. That's helpful. Just one more quick question on the compounded business. I know we haven't talked upon that. Any net changes there for the quarter? As far as the H2 outlook, should we expect a similar run rate to what we saw during Q2?
Jeffrey Cohen: Thanks, Mark. That's helpful. Just one more quick question on the compounded business. I know we haven't talked upon that. Any net changes there for the quarter? As far as the second half outlook, should we expect a similar run rate to what we saw during Q2?
Speaker #4: Should we expect a similar run rate to what we saw during
Mark L. Baum: Do you want to talk at all about the compounded? What I said in the letter is really, I think, important, and that is we've had an inventory recovery. So we now have inventory, which is half the battle. We've demonstrated that when we have inventory, we grow. That said, we've talked about on past calls that our interest is in converting compounded units to branded units where that is possible. We feel that that's not only in many cases better for the patient, but it's better financially for HARROW stockholders. But we do expect that business to grow in the Q3 and Q4. Andrew, do you want to add to that at all?
Mark Baum: Do you want to talk at all about the compounded? What I said in the letter is really, I think, important, and that is we've had an inventory recovery. So we now have inventory, which is half the battle. We've demonstrated that when we have inventory, we grow. That said, we've talked about on past calls that our interest is in converting compounded units to branded units where that is possible. We feel that that's not only in many cases better for the patient, but it's better financially for Harrow stockholders. But we do expect that business to grow in the Q3 and Q4. Andrew, do you want to add to that at all?
Speaker #2: Do you want to talk at all about the compounded? I mean, what I said in the letter is really, I think, important. And that is, we've had an inventory recovery.
Speaker #2: So we now have inventory, which is half the battle. We've demonstrated that when we have inventory, we grow. That said, we've talked about on past calls that our interest is in converting compounded units to branded units where that is possible.
Speaker #2: We feel that that's not only in many cases better for the patient, but it's better financially for HAROW stockholders. But we do expect that business to grow in the third and fourth quarters.
Speaker #2: Andrew, do you want to add to that at all?
Speaker #5: Yeah. Jeff, we guided I think in March on the March conference call, we guided that that business we thought would do about 60 to 65 million in revenue.
Andrew R. Boll: Yeah. Jeff, we guided, I think in March, on the March conference call, we guided that that business we thought would do about $60 million to $65 million in revenue. That guide is still in place, so that implies a continued increase in revenues through the H2. Importantly, we should see improvement in gross margins from that business as well, as we progress through the year, and start getting more revenue on top of the fixed costs that are built into that operating structure.
Andrew Boll: Yeah. Jeff, we guided, I think in March, on the March conference call, we guided that that business we thought would do about $60 million to $65 million in revenue. That guide is still in place, so that implies a continued increase in revenues through the second half. Importantly, we should see improvement in gross margins from that business as well, as we progress through the year, and start getting more revenue on top of the fixed costs that are built into that operating structure.
Speaker #5: That guide is still in place, so that implies a continued increase in revenues. Through the second half of the year, and then importantly, we should see improvement in gross margins from that business as well as we progress through the year.
Speaker #5: And start getting more revenue on top of the fixed costs that are built into that operating structure.
Speaker #4: Thank you. Thanks for taking the questions.
Mark L. Baum: Thank you. Thanks for taking the questions. Thank you, Jeff.
Mark Baum: Thank you. Thanks for taking the questions. Thank you, Jeff.
Speaker #2: Thank you, Jeff.
Operator: Thank you. The next question will come from Nelson Cox with Lake Street Capital. Your line's open.
Operator: Thank you. The next question will come from Nelson Cox with Lake Street Capital. Your line's open.
Speaker #3: Thank you. And the next question will come from Nelson Cox with Lake Street Capital. Your line is open.
Speaker #6: Hey, thanks for taking the questions. I'll just leave it to one here in the interest of time. But I wanted to ask about the $250 million revenue exit rate for 2027, which, when first issued, did not have some of the more recent adds to the portfolio included in it.
Nelson Cox: Hey, thanks for taking the questions. I will just leave it to one here in the interest of time. I wanted to ask on the $250 million revenue exit rate from 2027, which did not, when first issued, have some of the more recent adds to the portfolio included in it. I guess the question is why should we not view those incremental to the goal rather than being a part of it? Or had the $250 million goal always baked in some kind of business development activities to supplement that portfolio at the time when you initially made that guidance?
Nelson Cox: Hey, thanks for taking the questions. I will just leave it to one here in the interest of time. I wanted to ask on the $250 million revenue exit rate from 2027, which did not, when first issued, have some of the more recent adds to the portfolio included in it. I guess the question is why should we not view those incremental to the goal rather than being a part of it? Or had the $250 million goal always baked in some kind of business development activities to supplement that portfolio at the time when you initially made that guidance?
Speaker #6: So, I guess the question is, why should we not view those as incremental to the goal, rather than being a part of it? Or had the $250 million goal always baked in some kind of business development activities to supplement that portfolio at the time when you initially made that guidance?
Speaker #2: Well, thank you for that, Nelson. Yeah, we have a history of doing BD for products that generate revenue. And so certainly, I think it would be reasonable to believe that we would do BD, but that was really not baked into that goal.
Mark L. Baum: Well, thank you for that, Nelson. We have a history of doing BD for products that generate revenue. Certainly, I think it would be reasonable to believe that we would do BD, but that was really not baked into that goal. The belief is that we can achieve that with the products that we have. I must say, we have an incredible team, and they are all focused on hitting that number. It is a difficult thing to achieve, for sure, but I do believe we can do that. There is a pathway to achieving that with the products that we had ex-TYRVAYA. TYRVAYA certainly helps, though. We will see where we land. We got to get that product closed, but it definitely is additive and should be helpful ultimately in getting us to that number.
Mark Baum: Well, thank you for that, Nelson. We have a history of doing BD for products that generate revenue. Certainly, I think it would be reasonable to believe that we would do BD, but that was really not baked into that goal.
Speaker #2: The belief is that we can achieve that with the products that we have. We, I must say, have an incredible team, and they're all focused on hitting that number.
Mark Baum: The belief is that we can achieve that with the products that we have. I must say, we have an incredible team, and they are all focused on hitting that number. It is a difficult thing to achieve, for sure, but I do believe we can do that. There is a pathway to achieving that with the products that we had ex-TYRVAYA. TYRVAYA certainly helps, though. We will see where we land. We got to get that product closed, but it definitely is additive and should be helpful ultimately in getting us to that number. The idea was that we would hit that number without any business development activities.
Speaker #2: It is a difficult thing to achieve, for sure. But I do believe we can do that. And there is a pathway to achieving that with the products that we had X Trevai.
Speaker #2: Trevai certainly helps, though. So we'll see where we land. We've got to get that product closed, but it definitely is additive and should be helpful, ultimately, in getting us to that number.
Speaker #2: But the idea was that we would hit that number without any business development activities.
Mark L. Baum: The idea was that we would hit that number without any business development activities.
Speaker #6: Helpful. Thank you, guys.
Nelson Cox: Helpful. Thank you, guys.
Nelson Cox: Helpful. Thank you, guys.
Operator: Thank you. I am showing no further questions at this time. I will now turn the call back over to Mark for closing remarks.
Operator: Thank you. I am showing no further questions at this time. I will now turn the call back over to Mark for closing remarks.
Speaker #3: Thank you. I am showing no further questions at this time. I will now turn the call back over to Mark for closing remarks.
Speaker #2: Thank you, operator. I will close where I began the first half of 2026 was about setting the table, expanding our commercial organization, improving pricing, normalizing inventory, launching new products, and advancing our pipeline.
Mark L. Baum: Thank you, operator. I will close where I began. The H1 2026 was about setting the table. Expanding our commercial organization, improving pricing, normalizing inventory, launching new products, and advancing our pipeline. We did what we said we would do. The H2 is about serving the meal. Demand across every one of our growth drivers is strengthening. Our commercial organization is larger and more capable than it has ever been, and the investments we made in the H1 are already showing up in the business today. That is why we are reiterating our full year guidance and why I remain confident in our ability to deliver it. I want to end this call by letting our stockholders know that people within this organization matter. After nearly 15 years as the leader of this business, we have simply never had the level of talent we now have.
Mark Baum: Thank you, operator. I will close where I began. The first half 2026 was about setting the table. Expanding our commercial organization, improving pricing, normalizing inventory, launching new products, and advancing our pipeline.
Speaker #2: We did what we said we would do. The second half is about serving the meal. Demand across every one of our growth drivers is strengthening our commercial organization is larger and more capable than it has ever been.
Mark Baum: We did what we said we would do. The second half is about serving the meal. Demand across every one of our growth drivers is strengthening. Our commercial organization is larger and more capable than it has ever been, and the investments we made in the first half are already showing up in the business today. That is why we are reiterating our full year guidance and why I remain confident in our ability to deliver it. I want to end this call by letting our stockholders know that people within this organization matter. After nearly 15 years as the leader of this business, we have simply never had the level of talent we now have.
Speaker #2: And the investments we made in the first half are already showing up in the business today. That is why we're reiterating our full-year guidance and why I remain confident in our ability to deliver it.
Speaker #2: I want to end this call by letting our stockholders know that people within this organization matter. After nearly 15 years as the leader of this business, we have simply never had the level of talent we now have.
Speaker #2: Throughout the business, we have significantly upgraded our talent level. And this is most pronounced in our commercial group. I am betting on our commercial team to make it happen.
Mark L. Baum: Throughout the business, we have significantly upgraded our talent level, and this is most pronounced in our commercial group. I am betting on our commercial team to make it happen, and I believe you should too. The table is set. Now we serve. One final note. We announced our Investor Day on 22 March 2027 in New York City. It is going to be a tremendous event. Please mark your calendars. We hope to provide more information about this event later in the year. Thank you, and that will conclude our call.
Mark Baum: Throughout the business, we have significantly upgraded our talent level, and this is most pronounced in our commercial group. I am betting on our commercial team to make it happen, and I believe you should too. The table is set. Now we serve. One final note. We announced our Investor Day on 22 March 2027 in New York City. It is going to be a tremendous event. Please mark your calendars. We hope to provide more information about this event later in the year. Thank you, and that will conclude our call.
Speaker #2: And I believe you should, too. The table is set. Now we serve. One final note. We announced our investor day on March 22nd, 2027, in New York City.
Speaker #2: It's going to be a tremendous event. Please mark your calendars. We hope to provide more information about this event later in the year. Thank you.
Speaker #2: And that will conclude our call.
Operator: This concludes today's conference call. Thank you for participating, and you may now disconnect.
Operator: This concludes today's conference call. Thank you for participating, and you may now disconnect.