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Image source: The Motley Fool. Tuesday, Aug. 11, 2026 at 8:00 a.m. ET Vice President of Investor Relations and Communications - Michael Biega Chief Executive Officer - Mark L. Baum Chief Financial Officer - Andrew Boll Chief Commercial Officer - Patrick Sullivan Chief Scientific Officer - Amir Shojaei 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. [Operator Instructions] 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. Michael Biega: 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. 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 the 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, Chief Financial Officer; Patrick Sullivan, Chief Commercial Officer; and Amir Shojaei, Chief Scientific Officer. With that, I would like to turn the call over to Mark. Mark? Mark L. Baum: 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 and 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. And IHEEZO is a good example. Despite the loss of pass-through 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 will be a major contributor to both revenue growth and profitability during the second half. These are the 2 major, and 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 and 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. During the second half, VEVYE will benefit from the full period 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 that we launched on July 1 with encouraging early reception. And 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. And IOPIDINE now benefits from a permanent J-code. We also expanded our AccessPlus commercial organization. This 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 United States and China and is under regulatory review in 5 additional countries. TYRVAYA also offers a distinctive tolerability profile, 0 contraindications, 0 ocular adverse events, and 0 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. 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. 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 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 1 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. 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. Our outlook is not dependent on 1 product, 1 launch, or 1 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 1 theme came up again and again. Practices are struggling to secure reliable anesthesia coverage for their procedures. 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 and other specialties will be managing for many years to come. [ G-MELT ], if approved, could be part of the solution to this growing problem. 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 [ G-MELT ]. With that, I'll turn the call over to Andrew. Andrew Boll: Thank you, Mark, and good morning, everyone. We reported a 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 5-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, while 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. 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 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 negative $1.2 million. We ended the quarter with cash and cash equivalents of $83.9 million. With 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 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. 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. VERKAZIA 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. The 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'll now ask Pat to discuss our commercial progress in more detail. 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 complimentary, 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 our prescriber base expanded 15%, and VEVYE exited June with a 14.6% share of the branded dry eye 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, and the ACTIVATE 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 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 retina 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 AccessPlus commercial organization to support what we believe is the broadest ophthalmic cash pay portfolio in the industry. Across each of these, 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. I'm excited about the opportunities ahead. Amir Shojaei: I'll turn it over to Amir to discuss some exciting developments with our R&D pipeline. Thank you, Pat. I'll 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 MELT-300. 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 continued to target a potential FDA approval in the first half of '28, followed by a commercial launch later that year. Turning to [ YoChill ] or MELT-210, the simplest way to think about the program is [ G-MELT ] for pediatric patients. [ YoChill ] is being developed for children undergoing diagnostic and 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 2 meeting with the FDA. We are currently modifying our pharmacokinetics study protocol to align with the agency's feedback on this program. The development approach is a 505(b)(2) pathway to bridge to oral midazolam syrup through PK, and we expect to develop multiple dose strengths, likely 4, to accommodate the current weight-based dosing paradigm. [ YoChill ] 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 [ YoChill ] 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'll turn the call over to the operator for questions. Operator: Thank you. Unknown Analyst: Mark, maybe just first to start on the national top 3 PBM win. Just maybe talk about exactly what that coverage constitutes. Is it, you know, kind of tier 1 preferred, like that other, you know, top 3 win that you already have? Mark L. Baum: Yes, I think the only thing we want to say about that coverage win is number 1, it's obviously a top 3 PBM. Number 2, it's for commercial lives. 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. And other than that, I think that's 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, you know, it's something that we promised our stockholders, and we were able to deliver actually, I think, ahead of time. We didn't think this would come until the first part of next year, but 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. Unknown Analyst: 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? And 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: 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. And it really goes to the focus that the team has put on the in-office market, and 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 forecast that in the third quarter we would be set up well with the new 5-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. And 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%. 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. 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? Andrew Boll: Yes, absolutely. Thanks for the question. So with VEVYE ASP and generally anything going through the pharmacy benefit, we typically 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. 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 VEVYE ASP going forward. Unknown Analyst: Thanks, guys. Operator: Thank you. And the next question will come from Steven Seedhouse of Cantor. Steven Seedhouse: 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's growing or if it's stable or even declining slightly in recent years 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? Andrew Boll: Yes, 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 the Viatris' comments. Our focus right now though is closing as quickly as possible. I think those are going to be strategically really important assets for us. And so that's the primary focus is getting it closed. And then once closed, what we're guiding to is, you know, that it will 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 should see, regardless of the trajectory of the product currently, we're expecting our ability, we should have the ability to continue to grow it. And then in regards to loss of exclusivity, we're assuming the product will have exclusivity through 2034. 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 the fourth quarter. And you'll also see that these assets are clinically complementary. In going out and talking to dry eye professionals, you know, the ability to treat the disease with a chronic care product like VEVYE is our primary asset, I think is important, but also to supplement the treatment, 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. And, you know, you'll be surprised about the degree to which these are clinically complementary and operationally synergistic. Steven Seedhouse: All right, thanks. That's helpful color. And I wanted to also ask, on IHEEZO, I guess I'm just curious where such strong demand has been coming from specifically, because a lot of the tailwinds, the clinical data, obviously, QUEL is still running and that data is in the fourth quarter. And even the launch of your biosimilars that maybe provide some sort of synergy in the marketing effort, like that's sort of on the come still. And yet you still had this record demand amid all of this, you know, 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? Thanks. Mark L. Baum: Yes. Well, first of all, even though the demand is impressive and you're right, it is across the board, you know, the team has just done a phenomenal job growing that business in terms of new accounts and then pushing through, you know, units used within specific accounts. We're also picking up larger accounts that are using higher volumes within their practices. 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 encouraging us increasingly using IHEEZO, it's because the product is fantastic. It performs amazingly well clinically. It feels good on the patient's eye. You know, it has predictable onset, predictable duration. And then, you know, 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. 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 multi-specialty practices that we're increasingly opening up. So, you know, 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. And once again, we've really just barely scratched the surface, but probably, as I said, less than 2% of the addressable market. Steven Seedhouse: Makes sense. Thanks, Mark. Operator: Thank you. And the next question will come from Lachlan Hanbury-Brown with William Blair. Lachlan Hanbury-Brown: Maybe just a quick follow-up there on TYRVAYA 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 '27 for '26? And maybe would it also be accretive EBITDA in '26, or are there some sort of initial maybe like the initial cost associated with the sort of closing integration that would affect that? Andrew Boll: Yes. 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 closed as fast as possible. And then do you think about operating margin and contribution this year? I think it's safe to say it's not going to, we don't expect it to pull down earnings this year. There may be some integration costs this first few months as we're implementing the product, getting it into our system. So 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 contributions from the product data. Lachlan Hanbury-Brown: Got it. Thanks. And 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, like, where the ASP from that coverage may end up relative to, you know, the current coverage or what you've been realizing? You know, 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 like, how much of the current volume has been going through that $0 first fill that this can maybe help to convert more quickly? Mark L. Baum: Yes, so, you know, in terms of the effect on ASP, simply put, we never sign deals unless there is a net improvement, you know, to ASP. We're not going to, you know, sign a deal unless at the end of the day we're not unable to make a 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. And so we have, I think, a 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. So, you know, 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. 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 win came from a PBM where we were really blocked. But, you know, for us, you know, 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. And what we've, I think, realized is, you know, 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, distribution, and so on. And you're really reliant on getting a meaningful number of refills for 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. Lachlan Hanbury-Brown: Okay, thanks. So I guess should we just think about that showing through as maybe slightly lower actual like scripts per se that are written, but just a higher ASP per script that's written? Mark L. Baum: So it effectively, 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. 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, you know, prescribing, 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. You know, both NRx and TRx moved up meaningfully in the second quarter. And by the way, it's continuing even in the third quarter, which is extraordinary. So we're getting great productivity from the sales force. The business rules that Andrew and the team implemented, I think, were extremely successful so far. And we're in really good shape with our VEVYE franchise. 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. So we're seeing that correlation, that connection. More reps is going to mean more NRx, and when you have a product as extraordinary as VEVYE, that's going to mean more TRx. 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 Boll: I would just kind of reinforce what I said in the previous questions, which is, I think, considered, we do still expect ASP to improve for VEVYE throughout the year. Lachlan Hanbury-Brown: Thanks. Operator: Thank you. And our next question is going to come from Thomas Schrader with [ U.S. Bank ]. Thomas Schrader: Seems like all 50 balls are back in the air. 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'll also have VEVYE, they'll have the same sampling. Is that the way to see it? You'll have 2 products that are essentially everybody in the sales force has? Mark L. Baum: Yes, I don't 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'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. 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: Yes, thanks, Mark. You know, to the question, we're really excited about the complementary nature of these products. I mean, when you think about it, VEVYE has performed really, really well. 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%. And the branded RXs are representing over 75%. With VEVYE, the real key point here is we're focused on inflammation as the cornerstone to treating dry eye. We continue to see a positive experience and performs well. And as we've expanded the team, I think we continue to see a positive experience growing on NRx, TRx, as well as writers. TYRVAYA helps us, 1, open up another segment opportunity when it comes to basal tear production, which often is, you know, similar presenting in the inflammation patients. So we see an opportunity for both of these products to, 1, grow our Harrow share to further help these patients and doctors that we cover right now and actually bring in more writers and grow our business. Thomas Schrader: 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, you know, your strategy there or maybe one you want to answer even less, but I'm just curious what you can say. Mark L. Baum: I think right now, Tom, the team has received a tremendous amount of inbound interest in the product, and we're focused on really converting that interest to demand and revenue. Other than that, you know, I think we have a phenomenal market access strategy that's designed to, you know, maximally preserve pricing. And we have, I think, some unique advantages with our product over other choices, you know, including the branded Lucentis as well as the other biosimilar. Andrew, do you want to comment on that at all? Andrew Boll: 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 was saying, we do have a strategy to do that. 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, you know, it's going through the medical benefit. It's reimbursed on its own J-code or Q-code. Pardon me. So still a similar dynamic, and so we're using some of that experience to try to extend durability of both Byooviz and when Opuviz launches Opuviz. 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? Mark L. Baum: Yes, 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. So, you know, 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. It's how we launched the product, but we have a massive market ahead of us in the interventional 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. So we're having tremendous success in the office with retina professionals, as well as other in-office procedures. So that's where we're focusing and we're going to leave the surgical market alone right now. Thomas Schrader: Great. Thanks for all the details. Operator: Thank you. And the next question will come from Mayank Mamtani with B. Riley Securities. Mayank Mamtani: On the shareholder letter, you mentioned the third-party data undercounts VEVYE. Was this 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, you know, obviously trying to understand the volume demand to revenue conversion here. You know, to the extent you can maybe also comment on volume, how you might be tracking, you know, versus another maybe incumbent brand, which is also helping expand the dry eye disease market. And then on the new PBM win, did you comment on what percentage, you know, of the new lives that you have was previously filling as cash pay versus completely blocked? Mark L. Baum: I'll take the cash pay versus covered answer, and so we don't break that out, you know, 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: 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. You know, 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. And so that share that we're drawing, especially when you look at the year-over-year numbers, that's what's 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. So 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 NRx and TRx. And 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 eye between VEVYE and TYRVAYA. Mark L. Baum: To provide with the acquisition close pending. The other thing I would add is that the dashboard that I watch is our FillRX 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. 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. And so even tracking 1 Tuesday this week versus the prior Tuesday, just monitoring week-over-week data, once again, higher highs, higher lows, and, you know, 1 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. 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. Mayank Mamtani: 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 IHEEZO was encouraging, but obviously a small sample size. So how do you see, you know, this data coming up, build on this learning, you know, including the comparator I think you are using of some subconjunctival lidocaine superiority. I think you're trying to demonstrate on post-procedure pain and maybe some of the other more retina clinic works for relevant endpoints. So just maybe talk about what is going to look like to drive utilization against obviously a generic sort of market backdrop. And then lastly, for [ G-MELT ], what are key questions for this pre-NDA meeting coming up in early 4Q? And do you anticipate most of your ancillary studies being wrapped up by the end of the year? Mark L. Baum: Yes, I'm going to turn both those questions over to Amir, but I do want to say just briefly on the QUEL 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'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 IHEEZO. And so what we're really trying to demonstrate is that in terms of the anesthetic effect, it's the same. So, you know, you can either get a needle or you can get a topical drop. In terms of the anesthetic effect, it's the same. And, you know, whether there's any difference in pain and, of course, patient preference. And so we always think of things from a consumer perspective, and we think that patients ultimately were going to prefer IHEEZO, and that's got to be borne out in the data, 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 QUEL study that's ongoing and then talk about anything you can about the pre-NDA meeting? Amir Shojaei: Thanks, Mark. Yes. So, real quickly, on QUEL, this is a double-masked control trial. So, as far as any current data, we obviously don't have any, but the study is well-enrolling, and we anticipate to have the enrollment completed later this year, and then we'll have results later this year. That said, the kind of endpoints we're looking at are substantially twofold. 1, 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. 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. So all of those metrics will come out, and we're pretty confident. Remember, everything that we are doing is based on what we've seen already. This isn't 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're 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 isn't 1 specific thing in focus. It's the whole constellation of data that we're going to put into the NDA. Mark L. Baum: Thank you. The only thing I would add, by the way, on QUEL is it is a study that's taking place under an IND, which is really important as well, and that could have a significant impact, some advantages pending the outcome of the data. Mayank Mamtani: Understood. Thank you. Operator: Thank you. And the next question comes from Jeffrey Cohen with Ladenburg Thalmann. Jeffrey Cohen: Could you talk about the contact lens wearers and TYRVAYA and perhaps some pickup there from VEVYE in dry eye? I know it's a bit early, but do you expect any access program sampling programs, couponing, et cetera, on TYRVAYA as you launch it in the back half? Mark L. Baum: What was the first question, Jeff? I'm sorry. Jeffrey Cohen: I wanted to know as far as contact lens wearers in your dry eye franchise. Mark L. Baum: Yes. 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. And, you know, that takes time, and it is probably true that some patients don't do that. But 1 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, you know, over the last couple of years has had, you know, 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, you know, 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, whether they have poor, good insurance, bad insurance, or no insurance. 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. That will certainly be the case with TYRVAYA. Jeffrey Cohen: Thanks, Mark, that's helpful. And then just 1 more quick question on the compounding business. I know we haven't talked about that. Any net changes there for the quarter? And as far as the second half outlook, should we expect a similar run rate to what we saw during Q2? Mark L. Baum: 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. So we now have inventory, which is half the battle. We've demonstrated that when we have inventory, we grow. You know, 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'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: Yes, Jeff, we guided, I think in March, the March conference call we guided that business. We thought we'd 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 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: Thank you. Thanks for taking the questions. Operator: Thank you. And the next question will come from [ Nelson Cox ] with Lake Street Capital. Unknown Analyst: I wanted to ask on the $250 million revenue exit rate from 2027, what are the, which did not when first issued have some of the more recent adds to the portfolio included in it. 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: Well, thank you for that, [ Nelson ]. Yes, we have a history of doing BD for products to 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. The belief is that we can achieve that with the products that we have. We, you know, I must say, have an incredible team, and they're 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. So we'll see where we land. We've got to get that product closed. But it definitely is additive and should be helpful in getting us to that number. But the idea was that we would hit that number without any business development activities. Unknown Analyst: 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. Mark L. Baum: 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 1 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'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. Operator: This concludes today's conference call. Thank you for participating. You may now disconnect. Before you buy stock in Harrow, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Harrow wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $421,511!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,381,960!* That performance is why people listen. With a track record of beating the S&P 500 by nearly 5x, Stock Advisor offers a distinct advantage. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built for the long haul. See the 10 stocks » *Stock Advisor returns as of August 17, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Harrow (HROW) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management characterized the first half of 2026 as a foundational period focused on expanding the commercial organization and improving product economics to support a second-half revenue ramp. VEVYE performance was driven by a 21% sequential increase in prescriptions and improved net revenue realization following the implementation of new business rules in April. IHEEZO achieved record quarterly unit demand despite the loss of pass-through reimbursement, which management attributed to successful penetration of the in-office retina and procedure markets. TRIESENCE growth was fueled by a tripling of the surgical commercial organization, with over half of unit demand now originating from ocular surgery rather than its traditional retina base. The company executed a strategic relaunch of VERKAZIA and secured a permanent J-code for IOPIDINE to bolster the specialty portfolio's contribution to overall growth. Management emphasized that the current growth trajectory is diversified across multiple franchises, reducing dependency on any single product launch or reimbursement event. Full-year revenue guidance of $350 million to $365 million was reiterated, implying a significant step-up to approximately $235 million to $250 million in the second half. Revenue growth is expected to accelerate sequentially in both Q3 and Q4, with the largest contribution anticipated in the final quarter as commercial investments reach full productivity. Gross margins are projected to return to the high 70s, supported by normalized IHEEZO inventory cycles, continued VEVYE growth, and a more favorable product mix. The pending TYRVAYA acquisition is expected to provide modest 2026 revenue but will add approximately $20 million to annualized SG&A once the Viatris Eye Care Division is integrated. R&D efforts remain on track for a pre-NDA meeting with the FDA for MELT-300 in early Q4 2026, targeting a formal NDA submission in the first half of 2027. The acquisition of TYRVAYA global rights is viewed as a highly synergistic addition to the dry eye franchise, offering a differentiated nasal spray option for the 45 million U.S. contact lens wearers. Management identified a growing macro trend of anesthesia coverage shortages in retina practices, positioning the MELT-300 candidate as a potential long-term solution for IV-free sedation. A transition from a $0 first-fill program to a sampling program for VEVYE is intended to improve profitability by reducing processing and pharmacy fees while maintaining patient access. The company noted that while first-half revenue was lighter than expected due to VEVYE net revenue impacts, the underlying demand metrics remain ahead of third-party aggregator data. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management confirmed the win provides access to millions of formerly blocked commercial lives, effective August 1. The deal is expected to improve net revenue per unit for VEVYE, as the company only enters agreements that offer a net improvement to ASP or significant volume advantages. Management expects the product to contribute over $30 million in revenue in 2027 and be financially accretive following integration. The product is modeled to have market exclusivity through 2034, providing a long-term complementary asset to the VEVYE franchise. Record demand is coming from the in-office market, where Harrow has less than 2% market share, representing significant remaining headroom. Management stated they are intentionally leaving the ASC surgical market alone to focus on the higher-margin, 10-million-procedure interventional injection and office market. ASP is expected to improve throughout the second half as patients satisfy annual deductibles and the full benefit of April's business rule changes is realized. Management noted that tightening business rules did not constrict demand, as both new and total prescriptions continued to move up meaningfully.

Interested in Harrow, Inc.? Here are five stocks we like better. Q2 revenue rose 11% year over year to $70.7 million, driven by stronger demand for VEVYE, IHEEZO and specialty products. Harrow reiterated its full-year revenue guidance of $350 million–$365 million and adjusted EBITDA guidance of $80 million–$100 million. Management expects second-half growth from improved VEVYE pricing and expanded commercial coverage, IHEEZO’s 25% net price increase, BYOOVIZ and the relaunch of VERKAZIA. Gross margins are expected to recover toward the high-70% range. Harrow plans to acquire global rights to TYRVAYA for $30 million in cash, with more than $30 million of revenue expected in 2027 if the deal closes. The company also advanced pipeline programs G-MELT and YOCHIL, targeting future FDA submissions. Harrow (NASDAQ:HROW) reported second-quarter revenue of $70.7 million, up 11% from a year earlier and about 60% sequentially, as the ophthalmic pharmaceutical company said it entered the second half of 2026 with stronger demand across several products, improved pricing and expanded commercial infrastructure. First-half revenue totaled about $115 million, which Chief Executive Officer Mark L. Baum said was below the company’s expectations entering the year, primarily because of the net revenue impact from VEVYE. Harrow nevertheless reiterated its full-year guidance for revenue of $350 million to $365 million and adjusted EBITDA of $80 million to $100 million. → SoundHound AI Sends a Loud Signal After Its Q2 Earnings Beat The outlook implies second-half revenue of roughly $235 million to $250 million. President and Chief Financial Officer Andrew Boll said the company expects sequential revenue growth in both the third and fourth quarters, with the larger increase expected in the fourth quarter. VEVYE generated quarterly revenue of $29.4 million, up nearly 58% year over year. Baum said prescriptions increased 21% sequentially, while the prescriber base expanded 15%. The product ended June with a 14.6% share of the branded dry eye market, according to IQVIA data cited by Chief Commercial Officer Patrick Sullivan. → 3 Dividend Champion Utilities for a Market That Can't Sit Still Harrow changed VEVYE business rules at the end of April, reducing co-pay card utilization and improving the product’s average selling price, according to management. Boll said the company expects additional pricing improvement in the second half as the updated rules apply for a full period, patients meet annual deductibles and expanded commercial coverage takes effect. IHEEZO generated $15.6 million in second-quarter revenue, largely from wholesaler stocking orders for a new five-pack presentation. Revenue lagged underlying demand because distributors were selling through previously acquired inventory, Boll said. Unit demand reached a quarterly record of 65,477 units, up 44% sequentially and 34% year over year. → Take-Two’s Q1 Results Leave GTA 6 Bulls Stuck in the Fog of War Management said IHEEZO channel inventory has normalized, and approximately 25% higher net pricing became effective July 1. Baum said the product’s gross margin exceeds 90% and should make a significant contribution to second-half revenue growth and profitability. The specialty portfolio and TRIESENCE contributed approximately $11 million of revenue, while the compounded portfolio contributed $14.6 million. TRIESENCE demand rose 162% year over year to 14,529 units, with 54% of demand coming from ocular surgery, Sullivan said. GAAP gross margin was 71% in the quarter. Harrow expects gross margins to return toward the high-70% range in the second half, supported by IHEEZO’s normalizing revenue cycle, rising revenue, VEVYE growth and product mix. SG&A expense was $53.3 million, reflecting commercial investments made during the quarter. Excluding employees expected to join through the pending TYRVAYA transaction, Boll said base SG&A is expected to remain approximately flat for the rest of 2026. Adjusted EBITDA was negative $1.2 million, and Harrow ended the quarter with $83.9 million in cash and cash equivalents. Harrow formally launched BYOOVIZ on July 1, following modest stocking activity during the second quarter. Management said early physician engagement has been encouraging and that the biosimilar product fits within the company’s retinal commercial organization. The company also cited the relaunch of VERKAZIA, a permanent J-code for IOPIDINE effective July 1, and an expanded Access Plus commercial organization as incremental growth drivers. Harrow tripled its surgical commercial organization during the second quarter to support TRIESENCE, though management said the new representatives remain early in their productivity ramp. For IHEEZO, Baum said Harrow is concentrating on in-office retina and other procedures following the loss of pass-through reimbursement in cataract surgery on April 1. He said the company estimates it has less than 2% share of its overall addressable IHEEZO market and sees more than 10 million annual procedures across intravitreal injections and other in-office uses as opportunities. Harrow also secured expanded commercial coverage for VEVYE through a top-three pharmacy benefit manager, effective Aug. 1. Baum said the agreement opens access to “many millions” of commercial lives that had previously been blocked, though he did not disclose formulary positioning. Management said the company expects the coverage agreement to improve unit revenue for VEVYE. Subject to closing, Harrow plans to acquire global rights to TYRVAYA, a dry eye treatment approved in the U.S. and China and under regulatory review in five additional countries. The company expects to use $30 million of cash on hand for the upfront consideration. Management expects only a modest TYRVAYA revenue contribution in 2026 due to the anticipated timing of closing and integration. For 2027, Boll said Harrow expects TYRVAYA to generate more than $30 million in revenue and be financially accretive. The company anticipates that adding commercial personnel from Viatris Eye Care will increase annualized SG&A by about $20 million once fully integrated. Sullivan said TYRVAYA would complement VEVYE by offering a drop-free treatment option, including for contact lens wearers. Harrow expects to integrate experienced dry eye sales representatives from Viatris during the fourth quarter, with the added team supporting both products. Chief Scientific Officer Amir Shojaei said Harrow has secured a pre-new drug application meeting with the U.S. Food and Drug Administration for G-MELT, or MELT-300, scheduled for early in the fourth quarter. The company remains on track to submit a new drug application during the first half of 2027. G-MELT is being developed as an IV-free, opioid-free procedural sedation option. Assuming a successful regulatory review, Harrow continues to target potential FDA approval in the first half of 2028 and a commercial launch later that year. Harrow is also advancing YOCHIL, or MELT-210, an orally disintegrating midazolam tablet under development for pediatric patients undergoing diagnostic and therapeutic endoscopic procedures. Shojaei said the company completed an end-of-phase II meeting with the FDA earlier this year and continues to target an NDA submission in 2027. In addition, Harrow said its QUELL study of IHEEZO is enrolling and is expected to complete enrollment later in 2026, with results anticipated by year-end. The double-masked controlled trial is evaluating anesthetic effect and patient outcomes compared with subconjunctival lidocaine in intravitreal injection procedures. Harrow Health, Inc (NASDAQ: HROW) is a U.S.-based commercial-stage biopharmaceutical company specializing in ophthalmic therapeutics and diagnostics. The company focuses on the development, manufacturing and distribution of proprietary, generic and branded eye care products designed to treat a range of ocular conditions, including glaucoma, ocular hypertension, dry eye disease and other anterior segment disorders. Through its wholly owned affiliate ImprimisRx, Harrow Health offers a direct-to-physician model for customized formulations as well as low-cost generic alternatives. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Harrow Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

This article first appeared on GuruFocus. Release Date: August 11, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Harrow Inc (NASDAQ:HROW) reported Q2 2026 revenue of $70.7 million, up 11% year-over-year and approximately 60% sequentially, with first-half revenue reaching about $115 million. IHISO achieved record quarterly unit demand of 65,477 units, up 44% sequentially and 34% year-over-year, despite the loss of pass-through reimbursement, and saw record new account growth with a 32% increase in total ordering accounts. Vevi (VIVI) delivered record quarterly revenue of $29.4 million, up nearly 58% year-over-year, with prescriptions growing 21% sequentially and prescriber base expanding 15%, while improving net revenue realization through revised business rules. Triessence reached another quarterly demand record of 14,529 units, up 162% year-over-year, with 54% of unit demand now coming from ocular surgery, supported by a tripled surgical commercial organization. The company reiterated full-year 2026 guidance of $350-$365 million in revenue and $80-$100 million in adjusted EBITDA, citing multiple growth drivers and improved economics entering the second half. The pending Tervaya acquisition is expected to be financially accretive, with projected revenue contribution of more than $30 million in 2027, and offers operational synergies with the existing dry eye franchise. First-half 2026 revenue of approximately $115 million was lighter than expected, primarily due to the Vevi net revenue impact and IHISO channel inventory normalization. IHISO reported revenue of $15.6 million lagged underlying demand as distributors sold through previously purchased inventory, with the loss of pass-through reimbursement in cataract surgery impacting the surgical market. Adjusted EBITDA was negative $1.2 million in Q2 2026, reflecting increased SG&A expenses from commercial investments. The company faces a substantial second-half revenue ramp, with guidance implying $235-$250 million in revenue for the second half, which requires significant execution across multiple initiatives. The Tervaya transaction is expected to add approximately $20 million in annualized SG&A expenses once fully integrated, and the company expects only a modest revenue contribution from the product in 2026 due to the anticipated timing of the close. The company's reliance on third-party data may undercount Vevi prescriptions, and the impact of new business rules on prescription growth remains uncertain, though early results have been positive. Warning! GuruFocus has detected 4 Warning Signs with HROW. Is HROW fairly valued? Test your thesis with our free DCF calculator. Q: Can you provide more detail on the new top-three PBM coverage win for Vevi, specifically what it constitutes and how it compares to existing coverage? A: Mark Baum (CEO) confirmed it's a top-three PBM for commercial lives that were formerly blocked, now providing access to millions of new lives. He declined to specify formulary tiering but noted the win came ahead of expectations, as it wasn't anticipated until early next year. The team is "really pumped" about the expanded access. Q: Can you discuss the drivers behind the record IHISO demand and the percentage of business now coming from in-office versus retina, and how should we think about Vevi's ASP in the second half? A: Mark Baum (CEO) noted the ASC market is effectively shut due to loss of pass-through, yet IHISO hit a record 65,477 units, driven by the in-office market (retina and other procedures), which adds 2.5 million annual procedures. He emphasized the company has less than 2% market share in the addressable market, leaving significant headroom. Andrew Boll (CFO) added that Vevi's ASP should improve sequentially in Q3 and Q4 due to full-quarter benefits of revised business rules and patients hitting deductibles. Q: What were Tervaya's recent sales trends, and what are you modeling for loss of exclusivity? A: Andrew Boll (CFO) declined to provide specific sales figures until closing, but reiterated guidance for over $30 million in 2027 revenue. He confirmed the company assumes exclusivity through 2034. Mark Baum (CEO) added that the products are clinically complementary, with Tervaya offering a drop-free option for patients who struggle with eye drops, and operational synergies should be visible as early as Q4. Q: Can you articulate what specifically drove the strong IHISO demand and how sustainable it is? A: Mark Baum (CEO) attributed the demand to the product's superior clinical attributespredictable onset, duration, and patient comfortwhich are spreading by word-of-mouth in the retina community and multi-specialty practices. He noted the company is picking up larger accounts and expanding into the in-office cataract surgery market. With less than 2% penetration, he expects continued acceleration in Q3 and Q4. Q: Should we think about Tervaya's 2026 contribution as a pro-rata share of the 2027 guidance, and will it be accretive to EBITDA this year? A: Andrew Boll (CFO) confirmed that's a fair assessment, depending on closing timing. He stated the product should not pull down earnings this year, though there may be some integration costs in the first few months. Starting next year, integration costs will be cleared, and the product should have positive contribution from day one. Q: Can you comment on the ASP impact of the new PBM coverage relative to current coverage, and how impactful is the sampling program replacing the $0 first fill? A: Mark Baum (CEO) stated the company never signs deals unless there's a net improvement to ASP or overall revenue. The new coverage should improve unit revenue for Vevi. He explained the sampling program replaces the expensive $0 first fill, reducing COGS and processing fees while achieving the same patient access. The business rule changes have not constricted prescribing; instead, NRx and TRx moved up meaningfully in Q2 and continue to grow in Q3. Q: Will Tervaya and Vevi be sold in lockstep by the same sales force, and what's the strategy for both products? A: Mark Baum (CEO) confirmed Vevi remains the primary product, but Tervaya offers operational synergy and clinical complementarity. Pat Sullivan (Chief Commercial Officer) added that Tervaya opens up a new segment for basal tear production, often presenting similarly to inflammation patients. The combined portfolio will grow Harrow's share, bring in more writers, and expand the business. Q: What is the strategy for BioViz to protect pricing, and how are you approaching the biosimilar market? A: Mark Baum (CEO) noted the team has received significant inbound interest and is focused on converting it to demand. He highlighted a "phenomenal market access strategy" designed to maximally preserve pricing, with unique advantages over branded Lucentis and other biosimilars. Andrew Boll (CFO) added that the company is leveraging experience from other buy-and-bill products to extend net revenue per unit durability. Q: Is the IHISO surgical setting market gone forever, or could clinical data bring it back? A: Mark Baum (CEO) stated the company is focusing on the in-office market, which has over 10 million more annual procedures to address, with a permanent J-code and better than 95% reimbursement. He said they are leaving the surgical market alone for now, prioritizing where they are winning and have massive headroom. Q: Can you comment on the third-party data undercounting Vevi, and what are you seeing in total dispense units? A: Andrew Boll (CFO) noted an increasing disparity between third-party aggregator data and internal data. Vevi's total branded dry eye prescriptions reached 14.6% share at the end of June, up from 14% in March and 7.8% a year ago. Mark Baum (CEO) added that his internal FillRx dashboard shows "higher highs and higher lows" in daily volume, giving confidence in the franchise's momentum. Q: What are the key questions for the pre-NDA meeting for Gmail, and will ancillary studies be ramped up by year-end? A: Amir Sujai (Chief Scientific Officer) explained the pre-NDA meeting will focus on the submission package format, CMC discussions, and ancillary programs like PK studies. He noted the Quell study is enrolling well, with completion and results expected later this year. Mark Baum (CEO) added the study is under an IND, which could offer advantages pending outcomes. Q: Can you discuss the contact lens wearer opportunity for Tervaya and any access programs planned for the launch? A: Mark Baum (CEO) highlighted Tervaya's unique advantage for the 45 million contact lens wearers in the U.S., as other products require lens removal. He expects to restore and For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Second Quarter 2026 and Selected Highlights: Quarterly revenue of $70.7 million, an increase of 60% sequentially, and 11% year over year Reiterated full-year 2026 financial guidance of $350 million to $365 million in revenue and $80 million to $100 million in Adjusted EBITDA (a non-GAAP measure) VEVYE® delivered quarterly revenue of $29.4 million, up approximately 40% sequentially and approximately 58% year over year, with continued prescription, prescriber, and market-share growth VEVYE secured another coverage win, after gaining expanded formulary coverage with a top-three national commercial pharmacy benefit manager effective August 1, 2026 IHEEZO® delivered quarterly revenue of $15.6 million, and achieved record quarterly unit demand, with unit demand increasing 44% sequentially and 34% year over year TRIESENCE® delivered record quarterly unit demand, increasing 39% sequentially and 162% year over year Announced the acquisition of TYRVAYA®, which is expected to close during the second half of 2026 Cash and cash equivalents of $83.9 million as of June 30, 2026 A Media Snippet accompanying this announcement is available by clicking on this link. NASHVILLE, Tenn., Aug. 10, 2026 (GLOBE NEWSWIRE) -- Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, announced results for the second quarter ended June 30, 2026. The Company also posted its second-quarter Letter to Stockholders and corporate presentation in the “Investors” section of its website at harrow.com. The Company encourages Harrow stockholders to review these documents, which provide additional details concerning the historical results and future expectations for the business. "We spent the first half of 2026 building demand and positioning the business to achieve our 2026 and 2027 financial objectives. The second half of 2026 is about converting that demand into accelerating revenue growth and profitability," said Mark L. Baum, Chairman and Chief Executive Officer of Harrow. "Over the past six months, we expanded our commercial organization, strengthened our portfolio, improved pricing across key products, launched BYOOVIZ®, advanced multiple clinical programs, and announced the acquisition of TYRVAYA. VEVYE delivered record quarterly revenue while improving its underlying economics, and momentum continues to build, supported by our recent coverage win that went into effect August 1. IHEEZO achieved the strongest commercial quarter in its history despite the loss of pass-through reimbursement, and TRIESENCE continued to generate exceptional demand growth – reinforcing our conviction that physician demand continues to strengthen across our portfolio.” Baum continued, “As we enter the second half of the year, the business looks fundamentally different than it did just a few months ago: IHEEZO's pricing improvements are now in effect, IHEEZO’s channel inventories have normalized, VEVYE's updated business rules have been fully implemented, BYOOVIZ has launched, and TYRVAYA is expected to join our portfolio later this year. Our commercial organization, which already expanded this year (and is now helping to fueling our growth), will increase further with the addition of experienced eye care sales professionals from Viatris. Together, these steps position us to convert the demand we've built into meaningful revenue growth and profitability. I believe Harrow has reached an important inflection point. The heavy lifting required to position the business for accelerated growth has largely been completed. The table is set. Now it's about execution. Based on what we're seeing across the business today, I remain confident in our ability to deliver our full-year guidance of $350 million to $365 million in revenue and $80 million to $100 million in adjusted EBITDA." Key Second Quarter Commercial Metrics: VEVYE: Total prescriptions (TRx) increased approximately 21% sequentially, ahead of branded dry eye disease sequential market growth of 14% New prescriptions (NRx) increased approximately 4% sequentially Unique prescribers increased approximately 15% sequentially Branded TRx market share expanded to 14.6%, nearly doubling from 7.8% one year ago IHEEZO: Unit demand of 65,477 units, up 44% sequentially and 34% year-over-year — the product's highest unit volume quarter to date, achieved despite the April 1, 2026 loss of pass-through reimbursement status for cataract surgery Total ordering accounts reached 224, up 32% year-over-year, with 62 accounts placing their first-ever IHEEZO order in the quarter — the strongest new-account quarter since launch Reorder rate of approximately 85.5%, reflecting durable account retention and continued strength in the retina segment Effective July 1, 2026, IHEEZO net price per unit improved by approximately 25% Channel inventories have normalized, and the Company expects reported revenue to more closely reflect underlying demand going forward TRIESENCE: Unit demand of 14,529 units, the strongest quarter ever — up 39% sequentially and 162% year-over-year Total ordering accounts reached 805, a net addition of 69 accounts sequentially, with ocular surgery accounts representing 54% of Q2 unit volume May 2026 was the strongest single month in the product's commercial history, up 151% versus May 2025 Business Highlights: VEVYE Expanded Coverage: Effective August 1, 2026, VEVYE gained expanded formulary coverage with a top-three national commercial pharmacy benefit manager, representing a meaningful expansion in patient access and another important milestone in the Company's long-term growth strategy for VEVYE. The Company also expects an increasing proportion of VEVYE prescriptions to shift to the commercial channel over the balance of 2026. TYRVAYA Acquisition: Expands Harrow's dry eye disease portfolio with a highly complementary and synergistic therapy Expected to expand Harrow's commercial organization with new experienced dry eye sales representatives Creates one of ophthalmology's most comprehensive branded dry eye disease portfolios Creates additional opportunities to expand VEVYE adoption across new and existing accounts Expected to contribute more than $30 million in revenue in 2027, with revenue expected to exceed the incremental operating costs required to support the business Given the anticipated timing of the transaction close and integration into Harrow's portfolio, TYRVAYA is expected to contribute modestly to 2026 revenue BYOOVIZ Launch: Successfully launched BYOOVIZ (ranibizumab-nuna), a biosimilar to LUCENTIS®, expanding Harrow's retina portfolio and marking the Company's entry into the U.S. retinal anti-VEGF market. BYOOVIZ complements Harrow's growing retina franchise alongside IHEEZO® and TRIESENCE®, with OPUVIZ™ (aflibercept biosimilar) expected to further expand the portfolio in 2027. BYOOVIZ launched in July 2026, and the Company expects revenue to build over the balance of the year. Pipeline and Regulatory Highlights: Prospective Launches: The Company expects to launch at least one new product every year through 2029, within its existing cost structure and commercial footprint. G-MELT: The FDA has granted Harrow a pre-NDA meeting, an important milestone that will help finalize the Company's regulatory strategy as it works toward an NDA submission. IHEEZO (QUELL): Topline data from QUELL, a prospective, randomized, multi-center clinical trial evaluating IHEEZO in patients undergoing intravitreal injections, are expected in the fourth quarter of 2026. TRIESENCE: The Company's Phase 3 trial evaluating TRIESENCE for the treatment of ocular inflammation and pain following cataract surgery is on track to fully enroll in 2026, with topline data expected in early 2027. NATACYN®: The first patients were enrolled in an investigator-initiated clinical study during the second quarter, with topline data expected in the fourth quarter of 2026. YOCHIL™: The Company completed its End-of-Phase 2 meeting with the FDA and is incorporating the Agency's feedback into refinements of its Phase 3 study design and protocol. IOPIDINE®: A permanent J-code went into effect on July 1, 2026, removing a reimbursement barrier that the Company believes has constrained broader utilization. VERKAZIA®: Successfully re-launched with growing prescription volumes. Second Quarter 2026 Financial Results: (1)  Adjusted EBITDA is a non-GAAP measure. For additional information, including a reconciliation of Adjusted EBITDA to the most directly comparable measure presented in accordance with GAAP, see the explanation of non-GAAP measures and reconciliation tables at the end of this release. Conference Call and Webcast Harrow will host a conference call to discuss the results at 8:00 a.m. ET on Tuesday, August 11, 2026. Participants can access the live webcast of Harrow’s presentation on the “Investors” page of Harrow’s website. A replay of the webcast will be available on the Company’s website for one year. To participate via telephone, please register in advance using this link. Upon registration, all telephone participants will receive a confirmation email with detailed instructions, including a unique dial-in number and PIN, to access the call. About HarrowHarrow, Inc. (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America, offering a comprehensive portfolio of products that address conditions affecting both the front and back of the eye, such as dry eye disease, wet (or neovascular) age-related macular degeneration, cataracts, refractive errors, glaucoma, and a range of other ocular surface conditions and retina diseases. Harrow was founded with a commitment to deliver safe, effective, accessible, and affordable medications that enhance patient compliance and improve clinical outcomes. For more information about Harrow, please visit harrow.com and connect with us on LinkedIn. Forward-Looking StatementsThis press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward-‑looking statements.” Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, risks related to: liquidity or results of operations; our ability to successfully implement our business plan, develop and commercialize our products, product candidates and proprietary formulations in a timely manner or at all, identify and acquire additional products, or complete pending acquisitions on terms and in the timeframe expected, or at all, manage our pharmacy operations, service our debt, obtain financing necessary to operate our business, recruit and retain qualified personnel, manage any growth we may experience and successfully realize the benefits of our previous acquisitions and any other acquisitions and collaborative arrangements we may pursue; competition from pharmaceutical companies, outsourcing facilities and pharmacies; general economic and business conditions, including inflation and supply chain challenges; regulatory and legal risks and uncertainties related to our pharmacy operations and the pharmacy and pharmaceutical business in general, including the ongoing communications with the U.S. Food and Drug Administration relating to compliance and quality plans at our outsourcing facility in New Jersey; and physician interest in and market acceptance of our current and any future formulations and compounding pharmacies generally. These and additional risks and uncertainties are more fully described in Harrow’s filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2025, subsequent Quarterly Reports on Form 10-Q and other filings with the SEC. Such documents may be read free of charge on the SEC's website at sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow undertakes no obligation to update any forward-looking‑ statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Contact:Mike Biega, VP of Investor Relations and Communications [email protected] Non-GAAP Financial Measures In addition to the Company’s results of operations determined in accordance with U.S. generally accepted accounting principles (GAAP), which are presented and discussed above, management also utilizes Adjusted EBITDA, an unaudited financial measure that is not calculated in accordance with GAAP, to evaluate the Company’s financial results and performance and to plan and forecast future periods. Adjusted EBITDA is considered a “non-GAAP” financial measure within the meaning of Regulation G promulgated by the SEC. Management believes that this non-GAAP financial measure reflects an additional way of viewing aspects of the Company’s operations that, when viewed with GAAP results, provides a more complete understanding of the Company’s results of operations and the factors and trends affecting its business. Management believes Adjusted EBITDA provides meaningful supplemental information regarding the Company’s performance because (i) it allows for greater transparency with respect to key metrics used by management in its financial and operational decision-making; (ii) it excludes the impact of non-cash or, when specified, non-recurring items that are not directly attributable to the Company’s core operating performance and that may obscure trends in the Company’s core operating performance; and (iii) it is used by institutional investors and the analyst community to help analyze the Company’s results. However, Adjusted EBITDA, and any other non-GAAP financial measure should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. Further, non-GAAP financial measures used by the Company and the way they are calculated may differ from the non-GAAP financial measures or the calculations of the same non-GAAP financial measures used by other companies, including the Company’s competitors. Adjusted EBITDA The Company defines Adjusted EBITDA as net (loss) income, excluding the effects of stock-based compensation and expenses, impairment of intangible assets, interest, taxes, depreciation, amortization, investment loss, net, and, if any and when specified, other non-recurring income or expense items. Management believes that the most directly comparable GAAP financial measure to Adjusted EBITDA is net (loss) income. Adjusted EBITDA has limitations and should not be considered as an alternative to gross profit or net (loss) income as a measure of operating performance or to net cash provided by (used in) operating, investing, or financing activities as a measure of ability to meet cash needs. The following is a reconciliation of Adjusted EBITDA, a non-GAAP measure, to the most comparable GAAP measure, net (loss) income, for the three and six months ended June 30, 2026 and for the same periods in 2025: The Company is unable to provide a reconciliation of projected Adjusted EBITDA to expected results due to the unknown effect, timing and potential significance of expenses and the tax effect of such expenses.

Ironwood Pharmaceuticals (IRWD) came out with quarterly earnings of $0.31 per share, beating the Zacks Consensus Estimate of $0.26 per share. This compares to earnings of $0.14 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +19.23%. A quarter ago, it was expected that this drugmaker would post earnings of $0.07 per share when it actually produced earnings of $0.24, delivering a surprise of +242.86%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Ironwood, which belongs to the Zacks Medical - Drugs industry, posted revenues of $113.04 million for the quarter ended June 2026, missing the Zacks Consensus Estimate by 5.66%. This compares to year-ago revenues of $85.24 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Ironwood shares have added about 23.2% since the beginning of the year versus the S&P 500's gain of 12.8%. While Ironwood has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Ironwood was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.30 on $149.24 million in revenues for the coming quarter and $1.04 on $473.42 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Drugs is currently in the bottom 39% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Another stock from the same industry, Harrow (HROW), has yet to report results for the quarter ended June 2026. The results are expected to be released on August 10. This pharmaceutical and drug compounding company is expected to post quarterly loss of $0.23 per share in its upcoming report, which represents a year-over-year change of -195.8%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Harrow's revenues are expected to be $71.1 million, up 11.5% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Ironwood Pharmaceuticals, Inc. (IRWD) : Free Stock Analysis Report Harrow, Inc. (HROW) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Harrow, Inc. (NASDAQ:HROW) missed earnings with its latest quarterly results, disappointing overly-optimistic forecasters. Unfortunately, Harrow delivered a serious earnings miss. Revenues of US$44m were 16% below expectations, and statutory losses ballooned 84% to US$0.74 per share. Earnings are an important time for investors, as they can track a company's performance, look at what the analysts are forecasting for next year, and see if there's been a change in sentiment towards the company. We've gathered the most recent statutory forecasts to see whether the analysts have changed their earnings models, following these results. Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. Taking into account the latest results, the consensus forecast from Harrow's eight analysts is for revenues of US$348.6m in 2026. This reflects a substantial 30% improvement in revenue compared to the last 12 months. Harrow is also expected to turn profitable, with statutory earnings of US$0.29 per share. In the lead-up to this report, the analysts had been modelling revenues of US$351.3m and earnings per share (EPS) of US$0.44 in 2026. The analysts seem to have become more bearish following the latest results. While there were no changes to revenue forecasts, there was a large cut to EPS estimates. Check out our latest analysis for Harrow It might be a surprise to learn that the consensus price target was broadly unchanged at US$68.38, with the analysts clearly implying that the forecast decline in earnings is not expected to have much of an impact on valuation. There's another way to think about price targets though, and that's to look at the range of price targets put forward by analysts, because a wide range of estimates could suggest a diverse view on possible outcomes for the business. Currently, the most bullish analyst values Harrow at US$88.00 per share, while the most bearish prices it at US$59.00. Analysts definitely have varying views on the business, but the spread of estimates is not wide enough in our view to suggest that extreme outcomes could await Harrow shareholders. Taking a look at the bigger picture now, one of the ways we can understand these forecasts is to see how they compare to both past performance and industry growth estimates. The analysts are definitely expecting Harrow's growth to accelerate, with the forecast 42% annualised growth to the end of 2026 ranking favourably alongside historical growth of 32% per annum over the past five years. Compare this with other companies in the same industry, which are forecast to grow their revenue 8.7% annually. It seems obvious that, while the growth outlook is brighter than the recent past, the analysts also expect Harrow to grow faster than the wider industry. The biggest concern is that the analysts reduced their earnings per share estimates, suggesting business headwinds could lay ahead for Harrow. Happily, there were no major changes to revenue forecasts, with the business still expected to grow faster than the wider industry. The consensus price target held steady at US$68.38, with the latest estimates not enough to have an impact on their price targets. With that in mind, we wouldn't be too quick to come to a conclusion on Harrow. Long-term earnings power is much more important than next year's profits. We have estimates - from multiple Harrow analysts - going out to 2028, and you can see them free on our platform here. Even so, be aware that Harrow is showing 1 warning sign in our investment analysis , you should know about... Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Image source: The Motley Fool. Tuesday, May 12, 2026 at 8 a.m. ET Chief Executive Officer — Mark L. Baum President and Chief Financial Officer — Andrew Boll Chief Commercial Officer — Patrick Sullivan Chief Scientific Officer — Amir Shojaei Mark L. Baum, Chief Executive Officer; Andrew Boll, President and Chief Financial Officer; Pat Sullivan, Chief Commercial Officer; and Amir Shojaei, Chief Scientific Officer. With that, I would like to turn the call over to Mark. Mark? Mark Baum: Thank you, and good morning, everyone. To begin, as a growth-oriented business, the fuel for our success is and will always be demand. Without buyers seeing value in Harrow's products, ordering and reordering them, we wouldn't have a business. So demand is the key. And from that standpoint, the underlying fundamentals of Harrow have never been stronger. While the headline revenue number this quarter reflects a specific isolated dynamic, let me be clear to my fellow stockholders, our data demonstrates that demand for our key growth drivers is accelerating. Further, our market share capture is sustainable and will translate into profitable revenue growth. The $8 million revenue reduction in the first quarter was specifically tied to VEVYE. As detailed in my letter to stockholders, the surge that we saw in demand from patients with high deductibles from this new band of commercial coverage that we were so excited about, it just outpaced our initial financial modeling assumptions. Andrew will discuss this in greater detail shortly. However, we identified this issue. We corrected it. And importantly, our fix to return to our net pricing assumptions has shown negligible impact on the underlying new prescription VEVYE demand. That's the key. With the high deductible season largely behind us and new business rules in place, we expect to realize the full financial benefit of our expanded coverage moving forward, starting in the second quarter. I want to go back to demand, though, because a lack of demand in the face of a concerted commercial effort is nearly impossible to remedy. Across our portfolio and specifically with our key growth driver products, we do not have that problem. In fact, demand trends are strong, even for what is traditionally a weaker first quarter period due to standard industry seasonality. Moreover, you've probably seen on LinkedIn that we've hired more than 90 new sales professionals. So our promised commercial investments, that is doubling our sales forces in dry eye and surgical and bolstering other teams, are complete. We are now entering a period where the work we've been doing over the past several years is translating into meaningful sustained growth in demand, and this will in turn convert to revenue. Across VEVYE, IHEEZO, and TRIESENCE, our core growth drivers, we are seeing strong durable demand trends that are at or above our internal expectations. And in our business, once again, operational issues, they can be fixed. A lack of demand cannot. Let me provide some additional color on a few key products. On VEVYE, we are seeing record prescription growth, continued market share gains and increasing prescriber adoption. The product has now reached a highly meaningful position in the market, having officially surpassed XIIDRA in total prescriptions as of the end of March as we continue to close the gap with other category leaders. Crucially, this happened with half the number of reps we now have deployed. We are positioned to see this momentum accelerate, especially as we continue to successfully gain additional positive coverage changes, which we expect over the next 12 to 18 months. I'm especially pleased that more recently, we are seeing higher daily new prescription highs and higher lows. Breaking demand trend lines for a chronic care product to the upside is a very good thing. IHEEZO demand continues to build across both retina and in-office accounts. We're seeing record numbers of new accounts, and this trend has continued into the second quarter. We are still early in unlocking the full opportunity here. And as we move into the second half of the year with improved pricing, new packaging and upcoming clinical data specific to IHEEZO in retina procedures, we're positioning IHEEZO for a step change in growth. TRIESENCE is also demonstrating the kind of consistency that we expect. Even in what is typically a more challenging seasonal period for surgery, demand continued to grow sequentially with increasing adoption and strong reorder behavior. These are clear indicators that the product is gaining traction in clinical practice. Following my recent time in the field with several large new TRIESENCE accounts, it is clear to me that our expansion into the surgical inflammation market is bearing fruit and will be a part of our long-term revenue growth strategy. Our Access+ cash pay business, which includes both our branded and compounded products, having successfully worked through prior inventory constraints, is also on track. We are currently increasing safety stock and expanding the Access+ sales team, positioning this team to enter growth mode so we can deliver essential, affordable cash pay products that our customers rely on. As Pat will discuss shortly, these are the exact demand trends we look for across our portfolio, growing demand signals expanding account adoption and improving execution, leading to greater breadth and depth within those accounts. As I look at Harrow today, I've never been more confident about where we are or where we're going. Simply put, the business is positioned beautifully for the balance of this year and has never been more valuable. A few more points on the second half setup though. One, as I mentioned, we made targeted high conviction investments to scale our commercial platform and unlock the full potential of our portfolio. We recruited top talent to Harrow. That work is now complete. We've built the commercial infrastructure, expanded our reach and attracted the exact kind of talent that wins in this industry. What that means is straightforward. We now have the engine in place to convert the demand that we're seeing into sustained revenue and profitability performance. As we move forward, several factors support strong and sustainable growth. First, our core products operate in large, underpenetrated markets with significant runways ahead. These are not short-cycle opportunities. These are durable growth platforms. Second, awareness is building. New account starts are accelerating. Breadth and depth within accounts are expanding, and these factors drive the value of our products within our customers' practices in a highly meaningful way. Third, refill rates and reorder rates that are at or above our internal estimates support bullish demand metrics for our key products. And fourth, the most challenging part of the year is behind us. Some of you have heard one of my mantras, and that is that at Harrow, we're not interested in mere activity. We celebrate economic accomplishment. We focus on economic accomplishment. And as we move through the balance of 2026, we expect to see accelerating momentum as our commercial investments fully translate into financial results or economic accomplishment. The nonrecurring VEVYE revenue modeling dynamic does not change Harrow's trajectory. If anything, it reinforces how powerful the underlying business is and what can come from VEVYE, especially as these new patients refill their prescriptions in a profitable way for our stockholders. We are executing, building momentum and it is clearly showing in the demand data. Because of this, underlying demand is tracking in line with or above our expectations. And therefore, we're fully reaffirming our 2026 revenue guidance of between $350 million to $365 million for the full year. Furthermore, this accelerating commercial engine underpins our unified corporate initiative to achieve $250 million in quarterly revenue by the end of 2027. I will now turn the call over to Andrew Boll, our President and Chief Financial Officer. Andrew? Andrew Boll: Good morning, everyone. For the first quarter of 2026, we reported consolidated revenues of $44.2 million and adjusted EBITDA of negative $12.7 million. As we previously communicated, Q1 was expected to be the lowest revenue quarter of the year. This reflects several factors, as expected, a minimal GAAP contribution from IHEEZO as channel inventories absorbed, and softer revenue from the compounding business as we work through prior inventory constraints. Breaking down Q1 performance by product, VEVYE generated about $20.9 million in revenue. IHEEZO contributed $1.9 million, in line with expectations. Our specialty and TRIESENCE portfolio delivered $7.8 million and Access+ revenue was $13.5 million. As Mark noted, during the quarter, we experienced a gross to net modeling dynamic related to the VEVYE coverage rollout, which resulted in a discrete reduction of reported revenue by approximately $8 million. To provide additional financial context, ahead of the January 1 coverage launch, we implemented business rules based on specific assumptions regarding patient mix and patient out-of-pocket costs. While January net pricing tracked in line with our forecast, the mix shifted sharply as the quarter progressed. We saw a significantly higher-than-anticipated proportion of high deductible patients filling prescriptions through their pharmacy benefit and our average out-of-pocket buydowns increased rapidly. This growing utilization drove incremental gross to net pressure beyond our internal assumptions, resulting in lower realized net revenue per unit for the period. Due to the standard industry lag in claims reporting, the full magnitude of this mix shift was confirmed in mid-April. We act immediately, implementing targeted business rule changes, including strict caps and co-pay buydowns and other program refinements to protect our net pricing going forward. These program changes have isolated this to be primarily a first quarter issue, and we are now well positioned to receive the complete economic benefit we expect from our expanded coverage moving forward beginning in Q2. Based on updated modeling and what we have seen through April, net pricing is much better aligned with our internal expectations and should be notably higher than in the first quarter. Importantly, early indicators prove these changes have not negatively impacted underlying demand or patient access to VEVYE. Given these adjustments and current demand trends, we expect VEVYE to deliver sequential growth and remain fully on track to exceed our $100 million revenue outlook for the year. Looking ahead to the second quarter, we expect total revenues to be in the range of $71 million to $81 million. At the product level, VEVYE is expected to show sequential growth. We should see IHEEZO revenue start back in Q2, though likely still below prior year levels due to channel dynamics and dependent upon stocking levels associated with our new 5-pack presentation. We will also begin to recognize initial revenues from BYOOVIZ as distributors take on initial stocking orders. As Mark already stated, we are reiterating our full year 2026 revenue guidance of $350 million to $365 million. Based on current demand trends and customer interactions, we expect the second half of the year to be even stronger than initially anticipated. We have clear visibility into several catalysts that support this robust second half, including continued growth in demand across our core commercial drivers, full deployment of the expanded VEVYE sales force with a modest impact in Q2 and a highly meaningful contribution beginning in the second half of the year. Realization of the full financial benefit from expanded coverage for VEVYE following our mid-April business rule adjustments, the commercial launch of BYOOVIZ on July 1, the permanent J-code for IOPIDINE 1% becoming effective July 1, potentially expanding utilization and in-office procedural setting, an approximate 20% to 25% improvement in IHEEZO net pricing, along with the introduction of multiunit packaging beginning in Q3. Upcoming clinical milestones for IHEEZO, including initial retina data at the ASRS meeting in July and top line results from the QUELL study in the fourth quarter. And finally, continued growth in TRIESENCE, building on the momentum in ocular inflammation with a dedicated sales force that recently doubled in size. Taken together, these drivers give us high confidence in accelerating growth and improved financial performance as we move through the remainder of 2026. I'll now turn it over to Chief Commercial Officer, Pat Sullivan. Patrick Sullivan: Thanks, Andrew. Good morning, everyone. I will detail the commercial execution across our portfolio. The thread that runs through every one of these slides is exactly the same. Demand is accelerating, access is improving, and our scaled commercial organization is now actively converting that demand into revenue. Starting with VEVYE. The 4 numbers at the top of this slide tell the demand story. New prescriptions grew approximately 25% sequentially. Total prescriptions grew about 11%. Our prescriber base expanded by another 12% sequentially, and we exited March at roughly 14% branded share, officially surpassing XIIDRA on a monthly TRx basis and steadily gaining ground on MIEBO. Crucially, all of this was achieved with a smaller sales force of fewer than 50 representatives. Now that we have doubled the VEVYE team, we are aggressively deploying these new reps into both uncovered and underserved territories, which will directly fuel further growth in NRx and TRx. This is happening in a market that has real underlying tailwinds. The dry eye category has grown 20% year-over-year in prescription volume in each of the last 2 years, and VEVYE was effectively the only branded product to grow in Q1. We are actively taking share in an expanding market, and that is the absolute cleanest signal you can get that the brand is winning on its own merit. Moving to IHEEZO. Demand continues to build. Unit demand grew 18% year-over-year. New ordering accounts increased 21% in the quarter and total accounts are up nearly 50% versus last year. Retina remains the core driver, representing over 80% of volume and the momentum we saw in Q1 has continued in the early part of Q2. Interest in IHEEZO continues to build with demand increasing and new accounts continuing to come on board. There is substantial runway ahead within the retina market, and we are starting to see early and encouraging signs of adoption in the in-office setting. That expanding interest across settings reflects growing physician familiarity and confidence in the product and reinforces our view of the broader long-term opportunity for IHEEZO. Looking ahead, this growth story is driven by 2 engines: continued momentum in retina; and expansion into the broader in-office market. What underpins both is a very strong refill dynamic. Once a practice adopts IHEEZO, they continue to reorder. We also have 4 distinct catalysts that will drive the next step change in growth. First, expanding into the full in-office market adds more than 2.5 million procedures to the addressable opportunity. This expansion is underway and off to a strong start. Second, the first available retina-specific clinical data begins reading out in July, followed by additional data in the fourth quarter, which is designed to accelerate adoption. Third, we are launching multiunit packaging tailored for high-volume practices. And fourth, we expect a meaningful improvement in net pricing in the second half of the year. These 4 catalysts completely underpin our conviction in IHEEZO's accelerating trajectory from Q3 onwards. On TRIESENCE, the headline number is 136% year-over-year unit volume. March alone was up 113% year-over-year. This is now our sixth consecutive quarter of demand growth and unit demand has grown roughly 250% over those 6 quarters. The composition of this growth matters. 44% of Q1 volume came from the ocular surgery accounts, and we expect that segment to drive the majority of new volume going forward. New account growth was approximately 28% sequentially. We are seeing increasing integration into the procedural workflows, particularly among cataract surgeons, driven by the product's ability to simplify postoperative care and improve the patient experience. That value proposition is directly translating into reordering. In addition, our label expansion study in cataract surgery and pain is underway, which is positioned to materially expand the long-term opportunity. This slide is a reminder of the sheer breadth of what sits behind our 3 lead products. We have one of, if not the largest, portfolios of ophthalmic prescription medications in the U.S. market, spanning specialty steroids, NSAIDs and anti-inflammatories, antihistamines, antibiotics, plus the most comprehensive ophthalmic compounded portfolio in the U.S. market. Two highlights from Q1. We secured the IOPIDINE J-code, which I will cover in a moment, and we are unlocking the value of 2 additional historically underappreciated assets. Each of these assets is positioned to enter new on-label markets and contribute meaningful incremental revenue. VERKAZIA is the first and only label product for vernal keratoconjunctivitis, a devastating form of severe ocular allergies that affects children and adults. Our research clearly shows the degree to which the disease is underdiagnosed. We intend to share our plans regarding VERKAZIA opportunity in the near term. The second is NATACYN, a product for fungal blepharitis and other sight-threatening fungal infections. We are conducting a study for that product, and we'll share more information later this year. Lastly, within our Access+ cash pay business, our supply chain operations successfully cleared the back orders accumulated last year for certain compounded products, rebuilt inventory across the key stockkeeping units and completely restored the operational confidence our customers expect. Let me close on IOPIDINE 1%, the only FDA-approved therapy to prevent intraocular pressure spikes following various in-office procedures, backed by strong, well-established clinical data supporting its use in this setting. Despite that clinical profile, IOPIDINE has historically been underutilized for one specific reason. Physicians have no reimbursement pathway and the product sat as a cost center within capitated fees. That fundamentally changes on July 1 when the permanent J-code takes effect at ASP plus 6%. Physician incentives are now perfectly aligned with evidence-based practice. The addressable market for laser procedures alone exceeds 1.5 million annual use cases. There is no FDA-approved alternative with an established J-code. Critically, IOPIDINE runs through the exact same in-office call point as IHEEZO, meaning we are directly leveraging existing commercial relationships rather than building new ones. We expect this to be highly incremental, high-margin contributor as we move through the second half of this year. To summarize the commercial picture, VEVYE is taking share in a growing market and now has the access and sales force density to dramatically accelerate. IHEEZO's demand continues to grow sequentially, armed with 4 independent growth catalysts landing in the second half, alongside continued strength in retina and a highly successful expansion into the in-office setting. TRIESENCE has delivered 6 straight quarters of growth with a major label expansion in motion. And IOPIDINE hits a critical reimbursement inflection on July 1 that unlocks a market that has been waiting for it. Demand across the entire portfolio is robust, and our commercial organization has never been better positioned to convert it. With that, I will now turn the call over to Amir to discuss the assets we recently acquired from Melt Pharmaceuticals. Amir Shojaei: Thanks, Pat. I wanted to spend a few minutes on G-MELT, our IV and opioid-free procedural sedation candidate. Having spent nearly 30 years in drug development, advancing major global assets, I view G-MELT as a pipeline candidate of the highest caliber. It is uniquely positioned to disrupt standard procedural sedation and positively impact millions of patients. Regarding our clinical and regulatory progress, following the acquisition of Melt, the program's required deliverables included 3 pharmacokinetic studies and a nonclinical toxicology study. We have successfully initiated all of these programs. The nonclinical study is now in the reporting phase and the first pharmacokinetic study has also been completed and is in the CSR drafting stage. The other 2 PK studies are the renal and hepatic impairment study, both of which are underway, and we anticipate final reports in Q4 2026. On the manufacturing front, our integration and scale-up activities are advancing rapidly. A major manufacturing campaign scheduled for later this quarter will formalize the data package required for our NDA submission. Based on our current trajectory, we remain firmly on track with our targeted time lines. By our next quarterly call, we expect to provide a definitive update regarding our pre-NDA meeting date with the FDA. With that, I would now like to turn it over to our operator for Q&A. Operator: [Operator Instructions] Our first question will come from Timur Ivannikov with Cantor. Timur Ivannikov: This is Timur Ivannikov on for Steve Seedhouse. So in terms of VEVYE, could you talk about the gross to net adjustment in more detail? And to what extent this was driven by typical seasonality? And maybe what were the major buckets such as co-pay assistance, high deductible buydowns, cash pay economics? And to what extent this gross to net adjustment is isolated to Q1? Mark Baum: Thank you, Timur. First of all, the first quarter typically for Part D products with the deductibles resetting is always a challenging period for these types of products. As we noted, I think, in one of our documents, the dry eye category for the first quarter was actually down in total prescriptions. In fact, the branded market was down 18%. That's in the face of the overall category improving better than 20% for the last 2 years. But what we highlighted and what I think is important is that our NRx growth, our new prescription growth was actually up 25% sequentially in the face of a branded market that was down 18%. Our TRx growth was up 11% once again in the face of a branded market that was down 18%. And with CVS specifically, the new Benefit Manager that we brought on, the new coverage on the commercial side, we were up 170% in sequential growth with that set of plans alone. So we did very well. What I would say is, and I want Andrew to comment on this, is that we had to make a bet with our model in terms of what the likely volume would be for patients with high deductibles. And frankly, the surge in volume that we saw was so large that it really just exceeded the modeling that Andrew and his team had done. On the one hand, it's a bad thing to see this $8 million revenue reduction as a result of this. But on the other hand, we do know that we retain these commercial patients for a long time. And while we didn't do as well with these patients during the month of January and February and March, we're going to do very well with them on a go-forward basis. Andrew, do you want to specifically add to that regarding gross to net in the first quarter and any co-pay assistance? Andrew Boll: Yes. Timur, thanks for the question. Just to kind of add on to what Mark was saying, as we kind of looked at the average net pricing for these CVS patients in particular, and our out-of-pocket paydown for patients in general, the CVS patients were coming in about 40% higher out-of-pocket buydown amount than any other covered patient for us. And so as -- obviously, when we modeled things, we didn't model -- we didn't expect that buydown to be significantly higher for these patients. And so once we accumulated all the data and can make a decision based on the trends in mid-April, we adjusted those rules to basically take down the amount of out-of-pocket buydowns that we were putting into that patient bucket. We also made some tweaks that will affect patients on other plans as well, but should improve net pricing. I think it will have minimal impact on what that patient's actual out-of-pocket is. I think in some cases, actually the patient's out-of-pocket will get better based on just some of these tweaks we did to the business rule. And so as we kind of talked through the initial trends that we're seeing importantly is that there's minimal to no impact to demand, at least what we're seeing here the -- these first few weeks of implementation of the new business rules. And importantly, we will now go from those CVS patients essentially being on average negative revenue to much more positive and contributing to overall net revenue for -- on a go-forward basis. Operator: And the next question is going to come from Chase Knickerbocker with Craig-Hallum. Chase Knickerbocker: Maybe just to kind of ask it directly on VEVYE around ASPs. You had mentioned kind of an $8 million impact if the business rules have been changed for the entirety of the first quarter. So as we look kind of in Q2 and onward, I mean, that's about a, call it, mid-30s percent kind of impact. Is that what we should be assuming sort of from an increase and potential increase of ASP or maybe just making sure that I'm kind of thinking about that the right way? Mark Baum: Andrew, I don't know that we can give a specific answer regarding ASP, but I know that you've done some calculations on what the likely improvement is, and it's impressive. Do you want to try and tackle that one? Andrew Boll: Yes. And Chase, obviously, that's assuming status quo. But I think that's a reasonable assumption to assume, roughly 30% increase. Chase Knickerbocker: Helpful. And maybe just you guys have a couple of weeks of additional visibility relative to us, obviously, on kind of the VEVYE data. So far, since those business rule changes, could you maybe just give us some commentary as far as what you've seen in recent weeks as it relates to volume, just kind of confirming the -- this isn't having an impact? And maybe around those -- around that, Andrew, if you could kind of explain in a little bit greater detail how the out-of-pockets could actually kind of be coming down for these patients with these business changes, respecting the fact that there's a lot of detail here? Mark Baum: Thanks for that, Chase. In terms of VEVYE volumes more recently in the last, let's say, 20 days even, and I think I mentioned this in my stockholder letter, but I watch the new prescription volumes like a hawk. I mean, literally, multiple times a day, we have a dashboard that gives us real-time data as to what's coming in. And I know, for example, at 4:00 Central what the likely total day volume will be because we've got a lot of data in our system in terms of what the balance of the day would look like as the Mountain Time and Pacific physicians begin to write for VEVYE. But I think what I'm really pleased with, and I mentioned this in my opening remarks, is that I am seeing higher highs and higher lows in the last 15 days, especially. And I think that's as a result of these new reps actually being out in the field, making the calls and beginning to bear -- their work beginning to bear fruit. That's really exciting. In particular, I'm seeing days in the week that are usually lower in volume than other days in the week. And now all of a sudden, they're popping up, breaking trend lines and becoming much better days in the week. So we're having record days, record weeks and as I said, higher highs and higher lows. That's really positive, and we can see those trend lines breaking. So the work that we are doing out in the field with this doubling of the sales force is beginning to have an impact. Andrew, do you want to talk about patient out-of-pocket? Andrew Boll: Yes. And Chase, I'm going to try to speak to this without giving too much detail because a lot of our competitors listen to this call as well. But what I would say is we are going to leverage our VAFA program and cash pay program with some of those patients as well, which, as you know, the cash pay price there is $59 for the product. Operator: And the next question comes from Lachlan Hanbury-Brown with William Blair. Lachlan Hanbury-Brown: I guess, maybe I'll ask one on IHEEZO. Just how should we think about the dynamics in Q2? Is channel inventory sort of largely normalized at this point? And then how do we think about the sort of sunsetting of the current packaging versus the introduction of the new packaging and how that may impact Q2? Mark Baum: Yes. I'll make a few comments, Lachlan, and then turn it over to Andrew. But I think a couple of important data points. One is 2025, we saw 30% of our unit volume come from the ASC setting. I think you know that. The ASC setting in the Q1 period was down to 18%. And I think as I said in the stockholder letter, we should be able to eclipse the entirety of that ASC volume through the in-office sales that we're beginning to see flow by the end of the year. So that's very promising. Obviously, we've now moved to a 5-pack presentation. We've made some, I think, very significant improvements to ASP that will begin to kick in, in the third quarter. And I think we even referenced the figure of better than 20% improvement. So that's really, I think, important. And I think what our sales force is particularly excited about is finally having some retina-specific data to be able to present to accounts. So everything that we've done, we've got a few percentage points of market share, but not many. The vast, vast majority of the market opportunity is -- remains underpenetrated -- unpenetrated. And we believe that this data is going to certainly help us -- and that's showing up, by the way, in Q2. We're seeing record new account starts. And that, I think, bodes well for not only the second quarter, but the third quarter and beyond. That's what I think gives us so much confidence in our -- reiteration of our guidance. Andrew, do you want to talk about the stocking dynamic and what to expect in Q2 versus Q3? Andrew Boll: Yes, absolutely. Lachlan. So second quarter revenue for IHEEZO, we're expecting to be -- still be somewhat muted, especially compared to the second quarter last year. We're still working through that remainder of channel inventory that was taken in Q4 and the loss of pass-through. But to Mark and Pat's points, we're seeing a big increase in demand, especially on the retina side, a lot of new accounts coming through. So a lot of the -- any revenue that we're going to be booking will be below last year, but we should start seeing revenue start increasing from IHEEZO and then get to more of a normalized level beginning in Q3 and Q4, especially as we introduce this new multipack option, which we will commercially launch in July of this year. Lachlan Hanbury-Brown: And maybe if I could just also ask on IOPIDINE 1% with the new J-code. So how should we think about that adoption and the market opportunity? Obviously, a lot of procedures out there where it could be used, but just as we think about how it changes in terms of the contribution it makes starting in Q3, is that going to be a meaningful driver of the back half, or is it more incremental, especially in light of some of the changes with VEVYE and IHEEZO trials? Mark Baum: Yes. I would definitely say it's going to be an incremental contributor on the launch in the third quarter and the fourth quarter of this year. We're more bullish on the contribution in terms of it showing up relative to our overall size in 2027. But we're really pleased to have a J-code. It is a sizable market. And frankly, the laser procedure market, which is what we kind of quote in terms of the overall TAM at better than 1.5 million annual procedures, is really only a fraction of the potential use cases of the product. There are a lot of procedures that occur in the office that can induce a pressure spike. And right now, these offices are using a variety of off-label products, once again, that are paid for out of a capitated fee. And I think that the opportunity to use something that is on label, that is reimbursable at ASP plus is very attractive. And we've done a meaningful amount of market research to validate that. So we're pleased to get that launched. It will be incremental this year. It will show up, I think, with bigger numbers in 2027. Operator: And our next question is going to come from Tom Shrader with BTIG. Thomas Shrader: Kind of one more on VEVYE. Can you give us a remedial rundown of the information flow, why you learned so late, why it took 4 months for you to get a hint that this problem was going on? Because I feel like you warned on everything this quarter, but then this one hit. And is that solved? And then one quick one on IHEEZO. It's interesting to see you still have 18% ASC use. Do you think that's stable? Do you think that's people who like it enough that are eating the cost? Or is that 18% going to continue to decline? Mark Baum: Thank you for that, Tom. I'm going to take the last question first, and then I'll ask Andrew to talk about timing because I think it's really important. Our stockholders, I think, hopefully will appreciate after Andrew explains this, Why? This is not a real-time situation. You can't just make a decision, change business rules on a real-time basis and that we actually acted expeditiously once we figure this out, and Andrew will talk on that. But in terms of IHEEZO and the ASC, the IHEEZO business in the ASC is going to go and probably is now at 0. So these ASCs are not going to be purchasing IHEEZO for procedures in that environment. What we can say is that the unit volumes that we formally had -- and I'm not talking about the 18% that we had in the first quarter, but I'm talking about a more normalized view of what we had in the year 2025 in the ASC environment when those units represented 30% of the overall volume. Those are the unit volumes that we expect to replace with in-office use cases by the end of the year. So it's a larger number overall, and it will contribute meaningfully, I think, to our revenue in 2026 and certainly in 2027. But yes, the ASC business is going to go to 0. The good news for us is that we have durable sustainable reimbursement in the in-office market. And I would say we have nearly pervasive coverage, nearly pervasive coverage, better than 95% coverage and a prior authorization rate that is sub-5%. So extraordinary coverage in office, and that is durable. Andrew, do you want to describe, I think, in more detail, the timing of the work that you and your team did on the business rules? Andrew Boll: Yes, absolutely, Tom. I appreciate the question. So first of all, there's -- it's more than just one data set that we use to assess and calculate a lot of these figures. And so it's co-pay data, it's the claims data from the payer, it's script data from our partners and IQVIA that we're using. And so as we're getting that data, we're making assumptions. But January, which came in -- middle of February, when you have all of the data and you can calculate and analyze it, that came in pretty much in line with what we were anticipating. And so middle of February, we thought we were in pretty good shape. When the February data came in, that's when sort of our, I would say, our incentives went up. These numbers are coming in much higher than we thought or anticipated. But we didn't want to make a decision based on that single data point. That single data point being in the month of February. So we wanted to see how March came in. And unfortunately, when March came in, which the final accumulation of data came in mid- to late April, we knew we had to make changes. And so I think we had a final data set that we were able to act on, on a Friday, and we worked over the weekend and had the new business rules out to the partners Sunday night. So we make -- we try to make decisions based on trends and not data points, and that's what we did in this case. We worked as quickly as possible to get those changes in place. And I think going forward, we should see much better improvement on pricing for the product, especially in the case of some of these covered scripts that we've been talking about. Operator: And our next question will come from Mayank Mamtani with B. Riley Securities. Mayank Mamtani: Regarding the 100 reps hired in a relatively short period of time, Mark, could you touch on what sort of experience they bring in and how you anticipate demand to inflect further as a result of that in the second half? And I don't know if I heard a commercial mix of the total NRx that you're seeing. If you could maybe give a little bit more color on also how these reps can have an impact on improving commercial mix? And I think in prepared remarks, Mark, you said there are some positive insurance reimbursement developments for VEVYE, if you could maybe lay that out in this 12- to 18-month period? Mark Baum: Pat, do you want to talk about the tenure of some of these new reps? Patrick Sullivan: Thanks, Mark. Thanks for the question. As we talked about, this is all about demand and the indicators that we're seeing are very positive. And as Mark mentioned in the letter and previously on the call, we were able to deliver in Q1 the growth with a generally small team of 50 representatives. What we're most excited about in our expansion is the recruitment approach that we use. We have -- many, many reps we recruited have ophthalmic experience in their exact areas. I think we have a range of experience on the anterior side that I think is going to position us well for many of the other competitors in our space right now as we sit today. So we're super excited about that team that's been out there, arguably a few weeks as it sits right now. And as Mark mentioned, our early indicators in Q2, we're showing positive signs, and we are just getting started. So I would expect ongoing growth acceleration because of the unique profile we have. Our representatives are out there. I think, as Mark mentioned, in Q1, we wanted to get them out as soon as possible, but I can tell you that we took a very diligent approach to make sure that we've recruited the right reps, at the same time put them through a very rigorous approach to make sure that they were stepping the field to make impact immediately to grow VEVYE and the signs are very positive for us at this point in time. And like I said, I mean, we're super encouraged on the prospect for growth going forward. And the team, as we've said, has been out there for only a few weeks. So I think more to follow here in Q2 about the progress they make with their customers. But early signs, expect more growth. Mark Baum: And Mayank, in terms of how do you improve the commercial mix, one of the things I like most about Pat is he really believes in incentives very strongly, and he buys into this whole concept of what you incentivize, you end up getting. And so we value a commercial covered prescription in our company, certainly more than we do, for example, a cash pay consignment prescription in terms of the economic value. And so Pat is a big supporter of that. In terms of new insurance reimbursement, new coverage, the team is actively bidding on that coverage and those processes are in place. And we have some idea, that we should see improved coverage over the next 12 to 18 months. I think that's why we made the statement. We can't get more specific with which benefit managers or which payers. But we do believe that we're going to have some decent coverage wins over the next 12 to 18 months, and we'll see -- And to the extent that they're meaningful, we'll certainly make our stockholders aware of those. Mayank Mamtani: Great. And then on the IHEEZO growth catalyst for second half, I appreciate the color on which ones are demand versus net pricing improvement related. But I was just trying to understand the full year revenue target for that brand because second half revenue uplift needed to get to the full year target. If you just look outside of VEVYE and compounding business, there's a lot of growth, including from IHEEZO and other products. If you could maybe just help us understand how do you get to the second half number throughout the different parts of your portfolio? That would be very helpful. Mark Baum: Yes. I'll ask Andrew to kind of give some additional color on that. But what I can tell you is that even in the second quarter number for IHEEZO in particular, you're not going to see the same level of revenue, we believe, for the second quarter as you did, for example, in the first quarter. So we do expect to see a meaningful step-up in terms of revenue from IHEEZO even in the second quarter and the big improvement to not only unit demand -- the big conversion of unit demand to revenue is going to happen in the third and fourth quarter for that product. Andrew, do you want to comment on second half revenue and the guide? Andrew Boll: Yes. I will. Mayank, so I think in the second half, number one, you also get a new product, which is BYOOVIZ coming to market, which we expect to have, let's say, a meaningful contribution to revenue. IHEEZO we expect from a revenue perspective to be close to last year's number, hopefully in excess of it from a revenue standpoint, depending on demand. VEVYE revenue will continue to ramp quarter-over-quarter, we expect. Hopefully seeing a meaningful improvement in Q2 over Q1. And then in the second half of the year, we really -- we expect to really see the benefit of that sales force expansion, accelerating unit volumes and importantly, net pricing being stabilized on the product. And then as Pat kind of mentioned, we should also start seeing contribution from some of these other products that are going to get some attention this year, VERKAZIA, NATACYN and then as well as IOPIDINE with the J-code being issued. And then we've got Imprimis on the compounding side and the Access+ side. That business has been sort of out of that inventory issue that had been occurring in Q4 and Q1 of this year, and that business should return to a growth trajectory this year, although more sequentially quarter-over-quarter versus year-over-year. Operator: And the next question comes from Thomas Flaten with Lake Street Capital Markets. Thomas Flaten: Just to confirm on the sales force expansion. So in your letter, you talked about hiring about a 100 folks. If I'm understanding, 50 of them went to the VEVYE sales team to effectively double that team. And the distribution of the balance of those new hires, was it all to the retina team? Or was there -- is there something else we should understand about that? Mark Baum: No. And thank you for that question, and I'm glad that I have the chance to clarify. So we did hire about 50 new reps for the dry eye team. We also tripled the sales force for TRIESENCE, so that sales organization is now 3 times the size that it once was. We've also made a few incremental hires in retina. And as I said, I think in my prepared remarks, we've also begun to -- we decided to bolster some of the Access+ team. So -- and then finally, VERKAZIA and NATACYN, in particular, historically have not had any inventory. They've had inventory problems with that product, and I'm talking about pre-Harrow ownership. It had not really had any dedicated sales and promotion. And frankly, with both VERKAZIA and NATACYN, once again, the -- any marketing that was done was really done on only part of the label. So we're going to make a big push with those products. We're going to talk a little bit more about VERKAZIA in the coming weeks. I'm particularly very excited about VERKAZIA. We have great pricing on that product. It's a very powerful product in terms of its clinical efficacy and the results that it provides, particularly for children. It's the only cyclosporine that's actually on label for pediatrics. And we're going to make a big push in that category. And so we did build out what we call a specialty team around both of those products, and that team makes up the balance of that 100. Thomas Flaten: That's super helpful. And then, Mark, previously, I think you've mentioned -- I want to say you used the word bounty for pulling the G-MELT submission into 2026. I heard early 2027 today. I'm just curious if there was a chance that, that could get pulled forward if we should really think about an early '27 NDA submission for G-MELT? Mark Baum: Right now, I think -- let's think about a Q1 2027 submission. We're working really hard. I know the team is to complete the balance of the data gathering and to build the dossier for submission. So I think by our next conference call, we'll have a lot more information, and I'll be able to, I think, specify as to whether or not we'll be able to get a submission made at the end of the year. If we did, it would be at the very, very end of the year. But I have to tell you, whether we make the submission in late December or early January or even early February, the potential that we see for that product is just extraordinary, absolutely extraordinary. And I do believe in due course that, that product will be perhaps our largest selling product by revenue. So we're really excited to get that NDA filed. All the really difficult risky work is behind us. The work that Amir discussed is, I don't want to say perfunctory, but it is ultra-low-risk data gathering. And we're excited to meet with the FDA in a pre-NDA meeting. We'll have more information about that in August when we have our next call. Operator: And the next question will come from Yi Chen with H.C. Wainwright. Yi Chen: Could you comment on whether BYQLOVI has already been launched and whether your current full year revenue guidance including -- includes sales of BYQLOVI and BYOOVIZ? Mark Baum: Thank you, Yi. The BYQLOVI launch, strictly speaking, when we say launch, we mean trade launch. We mean actual sales of the product. Believe it or not, from a sampling perspective, BYQLOVI is actually launched. We've begun to distribute BYQLOVI samples to select customers. I think there are several thousand of those samples out. We're going to spend the next couple of months continuing that process of sampling and talking to customers about BYQLOVI, which we think is a best-in-class topical steroid. The topical steroid category is a very large category. And we're going to begin the trade portion of the launch, actually selling the product, driving revenue. That will begin in the third quarter. But strictly speaking, if you were to go into the offices of some of these doctors that are a part of this program, they will have access to BYQLOVI right now. So samples are out, trade is going to begin in the third quarter of this year. And in terms of the numbers that we're quoting, they are inclusive of BYQLOVI for sure. Yi Chen: Okay. Can you also comment on how much contribution do you expect these 2 drugs to make in -- beyond 2026? Mark Baum: Yes. So we're not giving revenue-specific guidance on each product. Especially in a new launch, I think that would -- we would have a tough time doing that externally. We certainly have internally a model built, but we're not prepared with either BYQLOVI or even BYOOVIZ at this point to provide what the expected revenue contribution will be for this year or next year. Operator: I show no further questions at this time. I would now like to turn the call back over to Mark for closing remarks. Mark Baum: Thank you, operator, and thank you all for joining us today. Let me close with what matters most, and that is Harrow's demand strength is stable. It's a foundation that supports my confidence in our future. With the high deductible season now behind us, we're moving into a period of accelerating growth and execution. The first quarter included a discrete issue that we have resolved, and that does not impact the long-term trajectory of this business. We spent the past several years building this platform, expanding access, scaling our commercial organization, and positioning our portfolio for growth. That work is largely behind us. We're now entering a period where the foundation translates into sustained revenue growth and increasing profitability. Looking ahead, we have clear visibility into the drivers of our performance from improving access and pricing to new product contributions and clinical milestones. Beyond that, we're actively shaping our next 5-year strategic plan with a clear path to scale our core assets, unlock additional value across the portfolio and hopefully complete some accretive and exciting acquisitions. When I step back, this is a stronger, more scalable and in my view, a more valuable company than at any point in our history. And we truly appreciate your continued trust and support. Thank you, and this will conclude our call. Operator: This concludes today's conference call. Thank you for participating, and you may now disconnect. 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While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Harrow (HROW) Q1 2026 Earnings Transcript was originally published by The Motley Fool

This article first appeared on GuruFocus. Consolidated Revenue: $44.2 million for Q1 2026. Adjusted EBITDA: Negative $12.7 million for Q1 2026. VEVYE Revenue: $20.9 million for Q1 2026. IHEEZO Revenue: $1.9 million for Q1 2026. Specialty and TRIESENCE Portfolio Revenue: $7.8 million for Q1 2026. Access Plus Revenue: $13.5 million for Q1 2026. Revenue Guidance for 2026: Reaffirmed at $350 million to $365 million. Q2 2026 Revenue Expectation: $71 million to $81 million. VEVYE Prescription Growth: New prescriptions grew approximately 25% sequentially. TRX Growth: Total prescriptions grew about 11% sequentially. Prescriber Base Expansion: Expanded by 12% sequentially. TRX Share: Exited March at roughly 14% branded share. TRIESENCE Unit Volume Growth: 136% year-over-year for Q1 2026. TRX Growth in March: Up 113% year-over-year. Warning! GuruFocus has detected 4 Warning Signs with HROW. Is HROW fairly valued? Test your thesis with our free DCF calculator. Release Date: May 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Harrow Inc (NASDAQ:HROW) reported strong demand trends for its key growth driver products, including VEVYE, IHEEZO, and TRIESENCE, which are at or above internal expectations. The company successfully doubled its sales force, hiring over 90 new sales professionals, which is expected to further accelerate demand and revenue growth. VEVYE has surpassed Xiidra in total prescriptions and is gaining market share, with expectations for continued positive coverage changes over the next 12 to 18 months. Harrow Inc (NASDAQ:HROW) is expanding its Access Plus cash-pay business, increasing safety stock, and positioning the team for growth to deliver essential, affordable products. The company reaffirmed its 2026 revenue guidance of $350 million to $365 million, with expectations for a strong second half driven by several catalysts, including new product launches and improved pricing. Harrow Inc (NASDAQ:HROW) experienced an $8 million revenue reduction in Q1 due to a gross to net modeling issue related to VEVYE's coverage rollout, impacting net revenue per unit. The company reported a negative adjusted EBITDA of $12.7 million for the first quarter of 2026. IHEEZO's revenue contribution was minimal in Q1 due to channel inventory absorption and is expected to remain below prior year levels in Q2. The ASC setting for IHEEZO is expected to go to zero, requiring replacement with in-office use cases by the end of the year. The company faced challenges with high-deductible patients impacting net pricing, requiring mid-April business rule adjustments to protect future net revenue. Q: Could you talk about the gross to net adjustment for VEVYE and to what extent this was driven by typical seasonality? A: Mark Baum, CEO, explained that the first quarter is typically challenging for Part D products due to deductible resets. The surge in volume from high-deductible patients exceeded their financial modeling, leading to an $8 million revenue reduction. Andrew Boll, CFO, added that adjustments were made to business rules to improve net pricing, with minimal impact on demand. Q: Regarding VEVYE, should we assume a 30% increase in ASP moving forward? A: Andrew Boll, CFO, confirmed that assuming a 30% increase in ASP is reasonable, given the adjustments made to business rules. Q: How have recent business rule changes affected VEVYE's volume and patient out-of-pocket costs? A: Mark Baum, CEO, noted that recent data shows higher highs and higher lows in prescription volumes, indicating positive trends. Andrew Boll, CFO, mentioned leveraging the VAFA program and cash pay options to potentially reduce patient out-of-pocket costs. Q: How should we think about IHEEZO's channel inventory and new packaging introduction in Q2? A: Mark Baum, CEO, stated that ASC use of IHEEZO is expected to decline to zero, with in-office use cases replacing it. Andrew Boll, CFO, added that Q2 revenue for IHEEZO will be muted but should normalize in Q3 with the introduction of new multi-pack options. Q: Can you provide more details on the sales force expansion and its expected impact? A: Patrick Sullivan, CCO, explained that 50 new reps were hired for the dry eye team, tripling the TRIESENCE sales force, and making incremental hires in Retina and Access Plus teams. The expansion is expected to accelerate growth, with early indicators showing positive signs. Q: What is the expected contribution of IOPIDINE 1% with the new J-code? A: Mark Baum, CEO, stated that IOPIDINE 1% will be an incremental contributor in the second half of 2026, with a more significant impact expected in 2027. The J-code aligns physician incentives with evidence-based practice, unlocking a sizable market. Q: Could you comment on the timing of the GMLT NDA submission? A: Mark Baum, CEO, mentioned that the GMLT NDA submission is targeted for Q1 2027. The team is working on completing data gathering, with more information expected in the next quarterly call. Q: Has BYQLOVI been launched, and is it included in the full-year revenue guidance? A: Mark Baum, CEO, confirmed that BYQLOVI has been launched for sampling, with trade sales beginning in Q3. The full-year revenue guidance includes contributions from BYQLOVI. For the complete transcript of the earnings call, please refer to the full earnings call transcript.