HROW August 11, 2026

Harrow Health Q2 2026 Earnings Call - Second Half Revenue Ramp Anchored by IHEEZO and VEVYE Momentum

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Summary

Harrow Health delivered a pivotal second quarter, reporting $70.7 million in revenue, up 11% year-over-year and 60% sequentially. While first-half revenue of $115 million fell short of initial expectations due to IHEEZO inventory normalization and VEVYE business rule transitions, the underlying commercial engine is firing on all cylinders. The company is positioning for a substantial second-half acceleration, driven by normalized channel inventory for IHEEZO, improved net pricing, and broader PBM coverage for VEVYE. Management reiterated full-year guidance of $350 million to $365 million in revenue, signaling confidence that the commercial investments made in the first half will convert into significant earnings leverage in the second half.

Key Takeaways

  • Harrow reported Q2 revenue of $70.7 million, an 11% year-over-year increase and a 60% sequential jump, bringing H1 revenue to approximately $115 million.
  • The company reiterated full-year guidance of $350 million to $365 million in revenue and $80 million to $100 million in adjusted EBITDA, implying a massive second-half ramp.
  • VEVYE generated $29.4 million in revenue, up nearly 58% year-over-year, with prescriptions growing 21% sequentially and prescriber base expanding 15%.
  • IHEEZO unit demand hit a record 65,477 units despite the loss of pass-through reimbursement in April, with revenue lagging due to channel inventory normalization.
  • Gross margins for IHEEZO are expected to exceed 90% in the second half following a 25% net pricing improvement effective July 1.
  • Harrow secured a major commercial coverage win with a top-3 PBM for VEVYE, adding millions of previously blocked commercial lives effective August 1.
  • The company launched BYOOVIZ on July 1 and is acquiring global rights to TYRVAYA for $30 million upfront, expecting it to contribute over $30 million in revenue by 2027.
  • VEVYE ASPs are expected to improve sequentially as revised business rules lower co-pay card utilization and patients hit annual deductibles.
  • Management highlighted that IHEEZO has less than 2% market share in its addressable in-office and retina markets, indicating significant headroom for growth.
  • The G-MELT (MELT-300) NDA submission is targeted for the first half of 2027, with a pre-NDA meeting scheduled for early Q4, aiming for approval in H1 2028.

Full Transcript

Operator: Good morning, and welcome to Harrow’s second quarter 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.

Mike Biega, Vice President of Investor Relations and Communications, Harrow: 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 am excited to be introducing today’s call. The company’s remarks may include forward-looking statements within the meaning of federal securities laws. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond Harrow’s control, including risks and uncertainties described from time to time in its SEC filings, such as the risks and uncertainties related to the company’s ability to make commercially available its FDA-approved products and compounded formulations and technologies, and FDA approval of certain drug candidates in a timely manner or at all.

For a list and description of those risks and uncertainties, please see the Risk Factors section of the company’s most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission. Harrow’s results may differ materially from those projected. Harrow disclaims any intention or obligation to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information and is accurate only as of today. Additionally, Harrow will refer to non-GAAP financial metrics, specifically adjusted EBITDA. 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?

Mark L. Baum, Chief Executive Officer, Harrow: 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 and growth and profitability and, of course, hitting numbers. 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. Those actions have positioned us to deliver meaningfully stronger revenue and growth and profitability during the second half of 2026. IHEEZO is a good example.

Despite the loss of passthrough on April 1 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 July 1. 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 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. VEVYE’s economics improved sequentially with meaningfully lower co-pay 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.

During the second half, VEVYE 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. 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 the second quarter, 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 July 1 with encouraging early reception. Our specialty portfolio is similarly positioned to contribute more meaningfully.

VERKAZIA 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 Access Plus 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. We are acquiring global rights to the product, which is approved in the U.S. 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 U.S. 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 have ever struck. From sales and marketing to market access to share a voice in the ophthalmologist and the optometrist’s office, we are 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.

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 second half 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 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. 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. 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.

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?

Andrew Boll, President and Chief Financial Officer, Harrow: 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. 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.

We expect IHEEZO to enter the third quarter with a normalized revenue cycle and improved economics. Our specialty portfolio and TRIESENCE generated approximately $11 million of revenue. Our compounded portfolio generated $14.6 million of revenue. GAAP gross margin was 71%. For the 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. SGA 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 SGA dollars to remain approximately flat with second quarter 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.

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-$365 million in revenue and $80 million-$100 million in adjusted EBITDA. Based on first half revenue of approximately $115 million, our guidance implies second half revenue of approximately $235 million-$250 million. We are 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.

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 third quarter. VEVYE 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. Expanded commercial coverage became effective August 1, 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 second quarter remains early in its productivity curve.

BYOOVIZ formally launched July 1 following modest initial stocking activity in the second quarter. RIAGESIC has been relaunched and now IOPIDINE benefits from a permanent J-code. Each contributes against a 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. 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.

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 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 will now ask Pat to discuss our commercial progress in more detail.

Patrick Sullivan, Chief Commercial Officer, Harrow: Thank you, Andrew. Before turning to VEVYE, I will 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 touch points through a broader portfolio. We expect to integrate those representatives during the fourth quarter 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. 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. Co-pay utilization declined meaningfully, yet physician adoption and prescription demand continued to grow.

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 3 pharmacy benefit manager effective August 1, 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 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 April 1, unit demand reached a record of 65,477 units, up 44% sequentially and 34% year-over-year.

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 second half. Before moving to TRIESENCE, I want to briefly touch on BYOOVIZ. We formally launched the product on July 1, 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. 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 the second quarter, 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 the third quarter and build from there. Finally, our specialty portfolio continues to build momentum.

The permanent J-code for IOPIDINE became effective on July 1. 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. While I step back and look across this portfolio, what stands out most is the breadth of our momentum. We’re 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. 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.

Amir H. Shojaei, Chief Scientific Officer, Harrow: 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 fourth quarter. 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. 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.

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 YOCHIL or MELT-210, the simplest way to think about the program is G-MELT for pediatric patients. YOCHIL 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.

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. YOCHIL 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 YOCHIL 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.

Operator: 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. The first question will come from Chase Knickerbocker with Craig-Hallum. Your line is now open.

Chase Knickerbocker, Analyst, Craig-Hallum: Good morning. Thanks for taking the questions. Mark L. Baum, 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 kind of tier 1 preferred, like that other top 3 win that you already have?

Mark L. Baum, Chief Executive Officer, Harrow: Yeah. I think the only thing we want to say about that coverage win is, number 1, it is obviously a top 3 PBM. Number 2, 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. 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 team is really pumped to have millions and millions of lives that they now have access to that were formerly blocked.

Chase Knickerbocker, Analyst, Craig-Hallum: Got it. And maybe just a two-parter, one on IHEEZO, one on VEVYE. Just as we think about kind of the recent volume acceleration for IHEEZO, 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? Then just on VEVYE, Andrew, if you could just comment on kind of how you see ASP in the second half since there is still an impact from those kind of pre-business rule changes in the second quarter. Is it fair to assume kind of continued sequential improvement in VEVYE ASP? Thanks.

Mark L. Baum, Chief Executive Officer, Harrow: Sure. Thanks for that, Chase. 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.

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 that would cause this acceleration in the second half of this year. 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. 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?

Andrew Boll, President and Chief Financial Officer, Harrow: Yeah, absolutely. Hey, Chase. Thanks for the question. 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. 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.

Chase Knickerbocker, Analyst, Craig-Hallum: Thanks, guys.

Mark L. Baum, Chief Executive Officer, Harrow: Thanks, Chase.

Operator: Thank you. The next question will come from Steve Seedhouse of Cantor. Your line is open.

Steve Seedhouse, Analyst, Cantor: Hey, good morning. Thanks so much for taking the question. Firstly, 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’s growing or if it’s stable or even declining slightly in recent years before you take over. Also, what are you modeling for loss of exclusivity of that product?

Mark L. Baum, Chief Executive Officer, Harrow: 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?

Andrew Boll, President and Chief Financial Officer, Harrow: 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 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, and 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, and 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.

Steve Seedhouse, Analyst, Cantor: Okay. Perfect. Thank you.

Mark L. Baum, Chief Executive Officer, Harrow: 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, 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 VEVYE as 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.

Steve Seedhouse, Analyst, Cantor: All right, thanks. That’s helpful color. I wanted to also ask, on IHEEZO, I guess I’m 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 the fourth quarter. Even the launch of your biosimilars that maybe provide some sort of synergy in the marketing effort that’s sort of on the come still, and 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 sort of continue into these subsequent quarters as you have these additional tailwinds coming online? Thanks.

Mark L. Baum, Chief Executive Officer, Harrow: 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 through units used within specific accounts. 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. In terms of why doctors are increasingly using IHEEZO, it’s because the product is fantastic. It performs amazingly well clinically. It feels good on the patient’s eye. It has predictable onset, predictable duration. 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.

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’re increasingly opening up. 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. So across the board, you should expect continued growth and acceleration for that product. Once again, we’ve really just barely scratched the surface, but probably, as I said, less than 2% of the addressable market.

Steve Seedhouse, Analyst, Cantor: Makes sense. Thanks, Mark.

Mark L. Baum, Chief Executive Officer, Harrow: Thank you, Steve.

Operator: Thank you. The next question will come from Lachlan Hanbury-Brown with William Blair. Your line’s open.

Lachlan Hanbury-Brown, Analyst, William Blair: Hey, guys. Thanks for the question. Maybe just a quick follow-up on TYRVAYA and the contribution to 2026. I appreciate that’s obviously somewhat dependent on the exact timing of the close, but should we just be thinking about pro rata-ing what you said about 2027 for 2026? Maybe would it also be accretive EBITDA in 2026, or are there some initial costs associated with the close and integration that would affect that?

Mark L. Baum, Chief Executive Officer, Harrow: Andrew, do you want to take that?

Andrew Boll, President and Chief Financial Officer, Harrow: Yeah. Hey, Lachlan. I think that’s a fair assessment to kind of pore out of 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.

Lachlan Hanbury-Brown, Analyst, William Blair: Got it. Thanks. And maybe another on VEVYE. Mark L. Baum, 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? And 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 zero dollar first fill that this can maybe help to convert more quickly?

Mark L. Baum, Chief Executive Officer, Harrow: 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 on this one in particular, this is something that should improve our unit revenue for VEVYE. In terms of the zero dollar first fill, we’ve built the company on a foundation of access.

So for us, market access, simply put, means any patient in the U.S. that is in need of any of our medications will have affordable access to the product that they’re in need of. And for us, when we were launching VEVYE, 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. But for us, we implemented a zero dollar 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. And what we’ve, I think, realized is you’ll see significant improvement financially with the sampling program that’s now replacing the zero dollar first fill.

Not only do you have the COGS cost with the zero dollar first fill program, you have all the processing fees, the pharmacy fees, and distribution and so on, and 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.

Lachlan Hanbury-Brown, Analyst, William Blair: 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? It effectively increases demand.

Mark L. Baum, Chief Executive Officer, Harrow: 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 NRx and TRx moved up meaningfully in the second quarter. By the way, it is continuing even in the third quarter, which is extraordinary.

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, and the team is fantastic. There is also, by the way, a direct relationship between the investment in the field force and our ability to get new prescriptions in the door. We are seeing that correlation, that connection, and more reps is going to mean more NRx. When you have a product as extraordinary as VEVYE, that is going to mean more TRx. 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?

Andrew Boll, President and Chief Financial Officer, Harrow: Lachlan, I would just 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 VEVYE throughout the year.

Lachlan Hanbury-Brown, Analyst, William Blair: Got it. Thanks.

Mark L. Baum, Chief Executive Officer, Harrow: Thanks, Lachlan.

Operator: Thank you. Our next question is going to come from Thomas Shrader with U.S. Bank. Your line is open.

Thomas Shrader, Analyst, U.S. Bank: 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 are essentially everybody in the sales force has.

Mark L. Baum, Chief Executive Officer, Harrow: I do not want to go into the specific strategy, Tom, too much. 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?

Patrick Sullivan, Chief Commercial Officer, Harrow: Yeah. Thanks, Mark. To the question, we are really excited about the complementary nature of these products. When you think about it, 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 TRx are representing over 75%. 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 performs well. As we have expanded the team, I think we continue to see a positive experience growing NRx, TRx, as well as writers.

TYRVAYA helps us, one, open up another segment opportunity when it comes to basal tier production, which often is similar presenting in the inflammation patient. 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.

Thomas Shrader, Analyst, U.S. Bank: 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.

Mark L. Baum, Chief Executive Officer, Harrow: 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?

Andrew Boll, President and Chief Financial Officer, Harrow: Not really. Tom, we are obviously really ASP and maintaining net revenue per unit durability of the product is super important, as you pointed out. We, like Mark L. Baum is saying, we 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, and so we are using some of that experience to try to extend durability of both BYOOVIZ and when OPUVIZ launches OPUVIZ.

Thomas Shrader, Analyst, U.S. Bank: 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?

Mark L. Baum, Chief Executive Officer, Harrow: 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 office procedure market where we have a permanent 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 for other in-office procedures. That is where we are focusing, and we are going to leave the surgical market alone right now.

Thomas Shrader, Analyst, U.S. Bank: Great. Thanks for all the detail.

Mark L. Baum, Chief Executive Officer, Harrow: Thank you, Tom.

Operator: Thank you. The next question will come from Mayank Mamtani with B. Riley Securities. Your line’s open.

Mayank Mamtani, Analyst, B. Riley Securities: 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’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. 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 DED 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?

Mark L. Baum, Chief Executive Officer, Harrow: Well, I’ll take the cash pay versus covered answer. We don’t break that out specifically, and we don’t 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?

Andrew Boll, President and Chief Financial Officer, Harrow: Mark, I think that I’ll just kind of 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-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. 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.

We are excited about what we are expecting to see in Q3 and Q4, and we are seeing this in the early days, is the reps are producing prescriptions. There is a direct correlation to number of feet on the street and increase in NRx and TRx. That is 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 are also going to be selling VEVYE as well as TYRVAYA, which should just further accelerate our market position within DED between VEVYE and TYRVAYA with the acquisition close pending.

Mark L. Baum, Chief Executive Officer, Harrow: The other thing I would add is that the dashboard that I watch is our Fill Rx dashboard. As I have said on previous calls, I watch it like a hawk, almost like some investors might watch a stock ticker, I suppose. What I am seeing and what gives me confidence in the franchise and the great work that the team is doing is that I am 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 does not necessarily make a trend, but that is happening certainly on the monthly data. So we are really pleased with the work that the team is doing.

There is 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 are seeing on VEVYE.

Mayank Mamtani, Analyst, B. Riley Securities: 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. So 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. Lastly, for G-MELT, what are key questions for this pre-NDA meeting coming up in early 4Q? Do you anticipate most of your ancillary studies being wrapped up by the end of the year?

Mark L. Baum, Chief Executive Officer, Harrow: Yeah. I am going to turn both of those questions over to Amir. I do want to say just briefly on the QUELL data and the data that Dr. Dang 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.

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?

Amir H. Shojaei, Chief Scientific Officer, Harrow: Thanks, Mark. Yeah. So real quickly on QUELL, this is a double-mask controlled trial. As far as any current data, we obviously do not have any. But the 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 subconjunctival lidocaine. 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. So 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. 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’s the whole constellation of data that we’re going to put into the NDA.

Mayank Mamtani, Analyst, B. Riley Securities: Thank you.

Mark L. Baum, Chief Executive Officer, Harrow: 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, and that could deliver some advantages pending the outcome of the data.

Mayank Mamtani, Analyst, B. Riley Securities: Understood. Thank you.

Operator: Thank you. The next question comes from Jeffrey Cohen with Ladenburg. Your line is open.

Jeffrey Cohen, Analyst, Ladenburg: 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? Could you, I know it’s 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?

Mark L. Baum, Chief Executive Officer, Harrow: What was the first question, Jeff? I’m sorry. TYRVAYA?

Jeffrey Cohen, Analyst, Ladenburg: I wanted to know as far as contact lens wearers currently in your dry eye franchise.

Mark L. Baum, Chief Executive Officer, Harrow: Yeah. 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 U.S. 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.

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. 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.

Jeffrey Cohen, Analyst, Ladenburg: 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?

Mark L. Baum, Chief Executive Officer, Harrow: 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 third and fourth quarters. Andrew, do you want to add to that at all?

Andrew Boll, President and Chief Financial Officer, Harrow: 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-$65 million in revenue. 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 and start getting more revenue on top of the fixed costs that are built into that operating structure.

Jeffrey Cohen, Analyst, Ladenburg: Thank you. Thanks for taking the questions.

Mark L. Baum, Chief Executive Officer, Harrow: Thank you, Jeff.

Operator: Thank you. The next question will come from Nelson Cox with Lake Street Capital. Your line’s open.

Nelson Cox, Analyst, Lake Street Capital: Hey, thanks for taking the questions. I will just leave it to one here in the interest of time, but 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?

Mark L. Baum, Chief Executive Officer, Harrow: Well, thank you for that, Nelson. Yeah, 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. We, I must say, 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, and 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.

But the idea was that we would hit that number without any business development activities.

Nelson Cox, Analyst, Lake Street Capital: 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 L. Baum for closing remarks.

Mark L. Baum, Chief Executive Officer, Harrow: 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. 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.

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 March 22, 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.

Operator: This concludes today’s conference call. Thank you for participating, and you may now disconnect.