Harrow Health, Inc. (HROW) Q3 2025 Earnings Report, Transcript and Summary

Good day, and welcome to the Harrow Third Quarter 2025 Earnings Conference Call. [Operator Instructions] As a reminder, this call may be recorded. I would like to turn the call over to Mike Biega, Vice President of Investor Relations and Communications. Please go ahead.

Thank you, operator. Good morning, and welcome to Harrow's third quarter 2025 earnings conference call. My name is Mike Biega, Vice President of Investor Relations and Communications, and I'm excited to be introducing today's call. Similar to our last quarterly call, we will be presenting slides during the webcast today. If you have registered and joined through the live conference call link, I would highly recommend that you also join through the webcast. You can find the link in the Investors Section of our website at www.harrow.com or in our earnings press release that was issued yesterday. 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 technology and FDA approval of certain drug candidates in a timely manner or at all. For a list and description of those risks and uncertainties, please see the Risk Factors section of the company's most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission. Harrow's results may differ materially from those projected. Harrow disclaims any intention or obligation to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise. This conference call contains time-sensitive information and is accurate only as of today. Additionally, Harrow will refer to non-GAAP financial metrics, specifically adjusted EBITDA and/or adjusted earnings as well as core results such as core gross margin, core net income and core diluted net income per share. 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. Now joining me on today's call are Mark L. Baum, Chief Executive Officer; Andrew Boll, President and Chief Financial Officer; and Patrick Sullivan, Head of Commercial. With that, I would like to turn the call over to Mark. Mark?

Thanks, Mike, and good morning to everyone. Thanks for joining us today. As always, please review our supplemental documents for the third quarter, including our earnings release, corporate presentation and Letter to Stockholders, all of which are now available on the Investor Relations section of our corporate website. During this call and in future quarterly conference calls, I'm pleased to have Pat Sullivan, Harrow's Head of Commercial, join us. Next quarter, I intend to have our Chief Scientific Officer, Amir Shojaei, join us as well. Today, Harrow is one of the leading providers of ophthalmic disease management solutions in North America. Our portfolio helps manage both front and back of the eye conditions. And I believe we are the only ophthalmic company in the world to offer branded, generic, over-the-counter, compounded and biosimilars, literally every legally available type of ophthalmic medication. At the center of everything we do is our vision to become the next great U.S. ophthalmic company. Now 12 years into building this patient and physician-centric business, I believe we're still just getting started. Our key products are in their early stages of launch with tremendous and durable growth ahead as adoption continues to accelerate. Over the next 2 years, we have 4 new product launches scheduled, each representing a significant opportunity to expand our reach, strengthen our leadership and pave the way for even greater growth in the future. I am particularly proud of the fully scalable commercial infrastructure we've built, which will soon support multiple launches and continued expansion without requiring heavy additional investment. Combine that with a low-risk, capital-efficient pipeline development and M&A strategy and it's clear, Harrow's growth and market impact are in their infancy. Now our momentum continued during the third quarter with rising revenue and clear evidence of the operating leverage in our business model. As I've mentioned before, some areas of our business will overperform while others may lag, sometimes due to seasonal factors. And the third quarter was no exception. What matters most, though, is the overall trajectory of the business and that trajectory remains very strong. Our key growth engines such as VEVYE, IHEEZO and to a certain extent, beginning very recently, TRIESENCE are rolling and momentum continues to build across the business, especially as we approach the launch of the Samsung biosimilar portfolio and conclude the acquisition of Melt Pharmaceuticals, which I'm very excited about. Now VEVYE and IHEEZO continue to lead the way and are on track to finish the year very strong. In fact, 2025 is expected to be a record year for both products. They've shown consistent momentum and continue to drive the majority of our growth. Driven by strong demand and best-in-class clinical performance, VEVYE delivered 22% quarter-over-quarter revenue growth. Perhaps a key highlight of my remarks, though, should be the news that we have recently signed agreements with several leading national payers for VEVYE. Beginning in January 2026, only a couple of months away, VEVYE will be listed on multiple new formularies with a preferred product status, including the largest U.S. pharmacy benefit manager. This means that certain products are becoming uncovered and that creates an opportunity for prescription transfers. And going forward, VEVYE will be covered on those formularies. This particular PBM covers tens of millions of lives and I view this as a major development for VEVYE and for Harrow. With major improvements in coverage and the addition of Apollo Care and Alto joining our specialty pharmacy network this quarter, we expect a higher proportion of patients will receive VEVYE as a covered therapy. These advancements strengthen VEVYE's market access foundation and fuel continued prescription growth, resulting in an improved ratio of covered to cash pay prescriptions. This includes estimates of current cash pay patients who are likely to convert to covered prescriptions and that gives us confidence in VEVYE's pricing stability and long-term growth. IHEEZO also had an excellent quarter, delivering 20% quarter-over-quarter revenue growth. That's an impressive performance, given the typical seasonal slowdown for that product in the third quarter. Meanwhile, TRIESENCE in our rare and specialty portfolio underperformed this year, as I talk more about in our stockholder letter and that also included the third quarter. The good news, though, is that we have the right leadership and strategies in place, I believe, to get both on track in short order. TRIESENCE, in particular, is gaining traction in retina. And as of October of this year, we launched it in its largest market opportunity yet, ocular inflammation. Our rare and specialty portfolio also has new leadership and they are supporting our Harrow Access for All program, which is positioned to return this portfolio to growth, beginning in the fourth quarter and into 2026. Please review the Letter to Stockholders for more specific thoughts, though, on TRIESENCE and our rare and specialty products portfolio. We also made important strategic moves this quarter as we work to complete the acquisition of Melt Pharmaceuticals and its non-opioid procedural sedation candidate, MELT-300 and we also expanded our Access for All model across our entire ophthalmic portfolio. We're also preparing for 4 product launches over the next 3 years, BYOOVIZ, OPUVIZ, BYQLOVI and MELT-300, which I'm particularly excited about. In short, our strategy is bearing fruit. We're executing with discipline, scaling with purpose and building a company defined by innovation, access and sustainable growth, creating meaningful, long-term value for both patients and shareholders. Before I hand it over to Andrew, I want to take a moment to address our ImprimisRx business in California, where, as many of you know, we have been engaged in a dispute with the California Board of Pharmacy for many years. ImprimisRx remains licensed to operate in California, but its license is up for renewal on December 1, 2025. We are actively communicating with the California Board towards a global resolution, which would include a renewal of our license. Because these discussions are ongoing and frankly, no outcome can be certain, I can't comment on other specific details, but this is top of mind for us and we believe a solution may be at hand. As more information becomes available, we will communicate with our stockholders. With that, I would like to now turn it over to our President and Chief Financial Officer, Andrew Boll. Andrew?

Thanks, Mark. And thank you to everyone joining the call today. Turning now to our financial performance. Total revenue for the third quarter was $71.6 million, representing a 45% increase over the same period in 2024 and a 12% sequential increase from the second quarter of this year. For the first 9 months of 2025, total revenue reached $183.2 million. We remain firmly on track for another strong year of revenue growth, advancing toward our long-term financial targets with disciplined execution. Based on what we're seeing across the business today and which I'll walk through in greater detail on the next slide, we are updating our full year revenue outlook to a range of $270 million to $280 million. While hitting our original target of over $280 million is still within reach, we want to take a slightly more conservative approach and update guidance to a range we believe we can deliver on. Adjusted EBITDA for the third quarter was $22.7 million with GAAP-based net income of $1 million. Operating expenses continue to be relatively stable quarter-to-quarter and we are seeing more operating leverage manifest itself within the new revenue gains. As we continue to scale, our ability to translate revenue growth into earnings remains a core strength of Harrow's model. As we advance into the fourth quarter, we expect to see operating expenses moderately increase as further investments are made in our commercial infrastructure to accelerate sales and that trend should continue into 2026. Let's turn to our product performance. VEVYE continues to outperform, generating approximately $22.6 million in revenue during the third quarter. This is a 22% increase from the second quarter of 2025. This revenue increase was driven on continued increase in unit volumes year-over-year and quarter-over-quarter. VEVYE is set up for a record fourth quarter. October hit an all-time high in prescriptions and that momentum has carried right through the first week of November. Q4 was VEVYE's strongest period last year. And with the trends we're seeing, I'm confident we're on track to finish near our $100 million annual revenue target for 2025, with additional, meaningful growth expected in 2026 as improved coverage kicks in and we further invest into VEVYE's commercial infrastructure to fuel the next phase of growth. Turning to IHEEZO. Revenue for the third quarter came in at $21.9 million. This is up 20% from the second quarter. As we've seen in prior years, the third quarter tends to be seasonally softer due to the July and August slowdown as both patients and physicians take time off. That said, demand rebounded sharply in September and remained strong through October. IHEEZO has significantly outperformed our expectations this year and is also on track for a very strong fourth quarter and a record year. The fourth quarter has historically been IHEEZO's highest volume quarter, supported by end-of-year ordering patterns and stocking activity and we've already seen large orders placed early in the period. Based on those dynamics, we expect IHEEZO to deliver a strong close to 2025. Our TRIESENCE and broader specialty branded portfolio generated $6.9 million in revenue. This is a 33% sequential increase. As Mark discussed and highlighted in our Letter to Stockholders, with new leadership in place, a dedicated sales force, the launch of Harrow Access for All and TRIESENCE's launch into ocular inflammation, we now have the focus and strategies in place to reignite growth starting as early as the fourth quarter of this year. ImprimisRx products continue to provide stable recurring revenue, generating approximately $20.1 million of revenue in the third quarter. As Mark mentioned earlier, if we are unable to resolve the dispute with the California Board of Pharmacy, we may see a minor impact on ImprimisRx's fourth quarter revenue. In addition, ImprimisRx had an inventory shortage during the month of October, causing a onetime decrease of about $4 million to $6 million in its revenue for the fourth quarter. In summary, we are fully focused on achieving our third consecutive year of 40% or higher annual revenue growth with all hands on deck across the organization. VEVYE and IHEEZO are both positioned for a strong finish to the year and a record quarter. However, given the certain near-term factors, we're updating our full year outlook to a range of $270 million to $280 million. While our original target is still within reach, this new range is one I believe we can deliver on based on where we are today. That said, the fundamentals of our business remain strong and I couldn't be more confident in the long-term growth trajectory. Looking ahead, following what we expect to be a strong fourth quarter, we anticipate a typical seasonal decline from Q4 2025 to Q1 2026, likely consistent with the pattern we saw earlier this year. This doesn't mean that we won't achieve record results next year, which is what we expect to happen. However, we want to establish that Q1 presents a seasonality that we need to consider. I'll provide more color on the magnitude of that dynamic when we report full year results, including the expected impact from the fourth quarter stocking activities.

Thanks, Andrew. My responsibility as Harrow's commercial leader is crystal clear, unlock the massive commercial potential in our portfolio and position Harrow for sustained, profitable growth. As many of you know, I've been in this role for less than 6 months, but I am not new to commercial leadership, building successful teams to execute thoughtful strategies and ultimately delivering extraordinary results. I would like to highlight the 5 commercial priorities that will drive my team's efforts. First, we're activating our advanced, key account management initiative. This is about deepening relationships with high-value accounts, fueling trial, accelerating adoption and building long-term loyalty across the brands. Second, we're elevating our focus on driving depth and breadth, expanding our reach to more prescribers and new accounts while going deeper within existing users. This is key to unlocking the full potential of our portfolio. Third, we have a scalable investment model across the commercial organization, one that allows us to grow efficiently, invest intelligently and maximize return on every dollar spent. Fourth, we're expanding awareness of our Harrow Access solutions program to ensure a smooth and positive experience for both eyecare professionals and their patients. Removing barriers to access remains a cornerstone of our strategy. And finally, we're sustaining operational discipline and stability, maintaining an efficient cost-base, while continuing to execute at a high level. These commercial acceleration priorities position us to drive stronger adoption, profitable growth and continue our journey as an emerging leader in the ophthalmic market. VEVYE continued to strengthen and expand its position in the dry eye market during the third quarter, delivering strong and sustained growth. Our commercial strategy is working. We're seeing increasing physician confidence, excellent patient outcomes and faster, more affordable access to therapy. By the end of September, we saw a 36% increase in prescribing physicians, a strong indicator of continued growth and expanding physician adoption. Our VEVYE Access For All initiative remains a key enabler of growth for VEVYE, simplifying the patient experience and fueling demand. Starting in January, VEVYE will appear on several new national formularies with preferred status, including the largest pharmacy benefit manager, the United States. VEVYE's improving coverage serves as another catalyst to expand utilization among eyecare physicians and among more patients with dry eye disease. We anticipate that these increased coverage wins, many current cash pay patients will take advantage of VEVYE's improved coverage in their plans. We also expanded our specialty pharmacy network. PhilRx handled all prescriptions in Q3, while Apollo Care went live in Q4 and [ AltoRx ] will follow later this quarter, steps to further improve patient access for patients. Combined with the broader payer coverage coming in 2026, these developments favorably position VEVYE for continued growth and pricing stability. Let's look at VEVYE's outlook. Looking at the chart on the top left, the picture is clear. The dry eye disease market is large, active and growing. Branded segment is the key driver for growth in the overall market. By the end of the third quarter, VEVYE captured 10.5% of the total dry eye market, up 2.7 share points from the prior quarter, effectively doubling its market share in just 2 quarters. It's a clear sign of strong, sustained growth and proof that our strategy is delivering results. Our goal remains the same, to make VEVYE the number one prescribed cyclosporine therapy in the U.S. and we're making steady progress toward that. We're building momentum every quarter, increasing adoption, improving access and expanding coverage and we remain confident in our path to becoming the leading cyclosporine therapy in the dry eye space. Looking ahead, we're focused on accelerating growth through both depth and breadth, deepening utilization with existing eyecare physicians, while expanding use among new physicians and their patients. Now that we are comfortable with our supply, we are also preparing for the next phase of expansion with plans to invest in VEVYE's commercial infrastructure and open 10 additional sales territories to fuel the next phase of growth. We anticipate that more territories will open during the first half of 2026 and we are going to focus on markets served by the new plans that will cover VEVYE. The momentum behind VEVYE is clear. With growing adoption, strong clinical outcomes, a patient-centric access model and improving coverage, we're just getting started. VEVYE has doubled its market share over the past 2 quarters and with new investments in our commercial infrastructure to support the next phase of expansion, the opportunity ahead is tremendous. I'm confident our team is fully aligned and focused on making VEVYE the new standard of care for dry eye disease. Let's look at IHEEZO. IHEEZO had another excellent quarter. Unit demand was up 47% from last year and 3% sequentially. That's strong, sustained growth and continued proof that IHEEZO's value proposition is resonating in the market. As expected, the third quarter followed normal seasonality, a brief slowdown in July and August, but demand rebounded quickly in September and continued through October. With a large order already placed in October, entering its strongest quarter of the year when we typically see increased stocking activity, IHEEZO is well positioned for a strong finish to 2025 and real momentum heading into 2026. Our strategy is working exactly as planned. The retina pivot we executed last year, along with our new IHEEZO For All education initiative is driving awareness, engagement and adoption across retina practices. Nearly half of the accounts ordering IHEEZO this year are brand new, a clear sign that we're expanding reach and deepening loyalty. With an 86% reorder rate, IHEEZO is not only winning new users, but also keeping them, a strong foundation for sustained growth ahead. Looking ahead, we're still just scratching the surface of IHEEZO's potential. We're in the very early stages of this growth story and the opportunity ahead is tremendous. Our retina team is focused on both driving both breadth and depth, reaching new accounts and deepening relationships with existing customers and expanding awareness among retina specialists. As adoption continues to grow, we're confident that IHEEZO will become an even stronger growth engine for Harrow, especially once we introduce our biosimilars starting in mid-2026. Shifting to TRIESENCE. TRIESENCE is showing real progress in the retina market. The trends we're seeing now indicate an acceleration in adoption and growing traction across the retinal community. Since relaunching TRIESENCE last October in 2024, there has been a 4x growth factor with significant headroom remaining. TRIESENCE unit demand grew 67% sequentially. Importantly, more than half of the accounts ordering TRIESENCE in the third quarter, about 53% were new customers. That tells us our reach is expanding and physicians are responding to TRIESENCE strong clinical performance and favorable reimbursement profile. With its proven safety, excellent efficacy and broad payer coverage, TRIESENCE is well positioned to continue gaining share in the retina market. The big news is our official launch of TRIESENCE into the ocular inflammation market, the largest and most promising opportunity for the brand to date. We're still early in the launch, but the response from the field has been encouraging. Physicians are giving strong, positive feedback and early utilization trends are moving in the right direction. The early traction reinforced exactly what we believe from the start that TRIESENCE delivers real clinical value and fits seamlessly into physician workflows. We see this launch as a true catalyst, opening a major new growth channel for TRIESENCE. With proven safety, strong efficacy and broad payer coverage, TRIESENCE is gaining traction in the retina market and has just entered its largest opportunity yet, ocular inflammation with positive early feedback. As awareness builds and adoption expands, I'm confident TRIESENCE will become a key growth driver and increasingly important contributor to Harrow's leadership in ophthalmic care. Turning to Rare & Specialty products. This is an area of untapped potential for Harrow. Earlier this quarter, we're excited to welcome Tom Pertallo as the Vice President of this segment. Tom brings deep commercial experience and a proven track record of driving growth and his leadership comes at exactly the right time as we work to unlock the full value of this portfolio. Right now these products represent less than 1% of the total market volume, which means the upside is significant. With Tom leading the charge and a dedicated sales force being built to focus exclusively on this business, we're tightening execution, reenergizing our commercial approach and positioning these brands to return to growth. We're also launching the Harrow Access for All program this quarter, which will improve affordability and expand patient access, key levers to drive sustainable growth across the portfolio. This portfolio once generated nearly $10 million quarterly revenue and we see a clear path to reignite that growth and ultimately exceed those levels. With strong leadership now in place, renewed focus and clear strategies in place, I'm confident this business is positioned to return for growth and deliver stronger, more consistent performance moving forward. To close, I couldn't be more excited about where Harrow is headed. We're still very early in the growth stage across all of our key growth drivers with significant catalysts and ample room for further growth. We are well positioned for our next stage of growth. Our commercial momentum is strong. The plan is clear and the opportunities in front of us are huge. In dry eye, VEVYE continues to lead the charge, expanding its share, broadening access, improving coverage and deepening adoption among prescribers. In retina, we're strengthening relationships, expanding awareness and gearing up for 2 major launches, BYOOVIZ in mid-2026 and OPUVIZ in mid-2027. In the Surgical segment, we're building a differentiated portfolio that supports the perioperative space, delivering efficiency and value for practices. In Rare & Specialty, new leadership, a focused plan of action and the launch of Harrow Access for All, are unlocking the potential of a diverse portfolio that represents less than 1% of its addressable market today. The opportunity across these 4 segments is tremendous. With best-in-class products, a scalable commercial platform and a disciplined strategy for execution, we're building a company with durable, long-term growth potential. Harrow's path forward is clear, stronger execution, expanding leadership and sustained momentum across every part of the business. With that, we can turn it over to the operator for Q&A.

[Operator Instructions] Our first question comes from Jeffrey Cohen with Ladenburg.

Congrats on the quarter. A couple from our end. Firstly, could you talk about VEVYE prescription data and why we don't see it this quarter?

Jeff, this is Mark. What we decided to do is to make sure that we have the most accurate information available. As you know, we withdrew from some of the reporting services, some of the data reporting services a few quarters ago. And it's really important that we have confidence, absolute confidence that what we're putting out is accurate as possible. And from our perspective, I think, the key metric was revenue generated from these products and not necessarily IQVIA data or data from a data feed that may or may not be completely accurate. So because of that, we decided to change the way that we're reporting. Andrew, do you want to add to that at all?

Yes. The only other part of that to add to what Mark was saying is really one of the reasons we're pulling out of these third-party aggregators were for competitive reasons. And so if we're doing that, it didn't really make sense to us to present the data and make it available to all of our competitors in our earnings release. That's driven a lot of the decision-making with presentation of the [ TRx ] data. But to Mark's point, we're going to do our best to be transparent about the progress of VEVYE without giving up competitive positioning.

Okay. That's perfect. And then secondly, maybe for you, Andrew, could you talk about the leverage that you're achieving? You had some pretty nice leverage on the SG&A in the third quarter. But as you continue to expand your commercial teams, how should we think about leverage overall into 2026, mainly as a percent of revenues?

Yes. And this has been a topic for us that we brought up for a long time now where we expected to see operating leverage, especially this year in the model on the new revenue growth we expected. We spent a lot of money on the operational and commercial infrastructure to support the branded group. That is mostly in place and we're seeing that leverage show up in the numbers. Obviously, Q3, we had great adjusted EBITDA just under $23 million. The business is producing a lot of cash, I think about $16 million of cash in the third quarter from operations. And as we look out, Pat talked a little bit about adding to that commercial infrastructure to drive revenue. The additional OpEx that we're looking at is revenue-generating OpEx, so we should start seeing immediate return on that expense. So again, even though we're going to be making investments in the commercial infrastructure, it's not like it's going to be a 50% increase in OpEx, it's going to be a moderate increase. And importantly and this is probably the most important thing, that investment in the expense should see almost an immediate impact and return on revenue.

Our next question comes from Chase Knickerbocker with Craig-Hallum.

Maybe just first to start, a couple on VEVYE. Mark, you had mentioned in the stockholder letter that ASP was down modestly sequentially in Q3. Could you just define the magnitude of that modest decline for us just so we can kind of understand that? And then just as we think about, you kind of spoke to stabilization in the near term. Can you just walk us through some of your modeling assumptions on VEVYE that kind of lead to that ASP stabilization in the near term? Is it improving mix that you're seeing so far in October? And then I've got a follow-up.

In terms of defining what modestly means, I can't give you a definition with precision. I mean, it's -- I think it's less than 10%. But I think the more important issue is how is ASP or net revenue per unit, how is that going to stabilize in the near term and then as I said on prior calls, begin to float up? What is the justification for that? And to be very clear, we are really counting on coverage coming through. We're counting on the ratio of covered prescriptions versus cash pay prescriptions to flip or begin to change so that there's more of a bias towards covered prescriptions versus cash pay prescriptions. If that happens, that's when you see the stabilization happen, that's when you see the ASP begin to float up. And the beautiful thing, I think, the exciting thing for us and I think you've actually noted this in your notes that I've seen is that that increase will affect the entire corpus, every single unit of VEVYE. And so the question is how and when is that going to happen? And I tried to address that in the Letter to Stockholders. We discussed that in our prepared remarks. And we now have landed this coverage win with the largest pharmacy benefit manager in the U.S. and specifically their commercial lives group, you're talking about tens of millions of new potential lives covered. And when you think about that ratio of covered prescriptions versus cash pay prescriptions, beginning January 1, we anticipate that ratio is going to begin to flip. Actually, to be candid with you, I've had doctors send me letters that I know that have already gone out from this benefit manager to the physicians, letting them know about the plan changes that will take effect, drugs that will not be covered and the specific patients' names who will no longer be covered for that product and letting them know what the new formulary looks like. So this is really exciting for VEVYE. We expect to start seeing some of those changes, those prescription flips from other dry eye products to VEVYE in the fourth quarter. We expect that will start to happen, but it will really kick in, in the first quarter. And as I said, once that takes place, that ratio of covered versus cash pay will begin to change, you'll see that stabilization happen and I think, as I said in the last call, we'll start to see, I think, a bias towards ASP improving and potentially improving maybe even more than modestly.

Yes, that's what I was hoping to follow-up on is just any more specifics you'd be willing to share as far as the largest PBM, that win? Was it the commercial plans? Was it commercial and Medicare? Just any sort of details there. And then as we think about that ASP improvement, to your point, any way you can help us kind of define how you see your current volume and kind of the amount of your current volume that could benefit from that win and how that affects ASP? And any thoughts you'd be willing to give there as we enter next year?

Yes. I would say that these are commercial lives, number one. So they're, I would say, the most attractive of those lives that you can get. So it's a major coverage one. I was talking to our team earlier and I said, I hope that our investors, the main takeaway from the stockholder letter, I think, it's the most important part of the stockholder letter is this coverage win, because it dramatically changes things. I mean, if you get a $20 or $30 or $40 improvement and I'm not suggesting that we'll see a $40 improvement on ASP, but if it's a $20 improvement as an example, it affects every single one of those units. And as units are growing and they will grow regardless, we are going to see significant improvement in total units for VEVYE. But the question is how much money are we going to make from all of those units. And I think that this improvement in coverage is going to be a major factor at the beginning of this coming year. And you also know that we are very conservative in terms of how we invest commercially. We don't do extravaganza launches because we dip our toes into the water, we kind of get in, we see what works. It's just our style and it's the way that we've been able to invest in new product launches. And for us to now make investments in VEVYE and specifically open up 10 new territories in the very near term and then I think by the middle part of next year, we're going to have upwards of about 100 total territories for VEVYE. The reason why we're making those investments is because candidly, it would be malpractice for us not to make those investments now that we have such strong coverage in these specific markets. So we're very bullish on VEVYE next year. I think you can expect to see some improvements in ASP as this ratio begins to flip and bias more covered versus cash pay prescriptions. And it's a really good time for VEVYE and the drug, by the way, is phenomenal. If you've ever put the drug in your eye, it's phenomenal. I think it's the best product in the class. So it does a great job and patients love it and the refill rates are absolutely extraordinary, I believe, best-in-class.

Our next question comes from Steve Seedhouse with Cantor.

Hoping just to start you could give us a sense of what proportion of the VEVYE cash pay patients currently you'd actually expect to transition to insurance coverage in 2026 and just ballpark the expected impact that that particular variable would have on net price per unit.

Yes, I can't -- I don't know that we can give you the answer with precision. We actually have built internal models to try and estimate what that would look like. This is the largest commercial PBM. And if you just model out how many dry eye patients they have and we do know how many dry eye prescriptions come from those plans, we can see a couple of things happening. One, as I said, there are patients that have been denied coverage from those plans who are paying cash, who we will be able to reach out to and hopefully transition them from cash pay to covered because this is not just a nonpreferred brand status. This is a preferred status. So this is the lowest or in some cases, no co-pay type coverage. So it's really favorable coverage for VEVYE. And then, of course, we, as I said, seeing the letters that have already gone out to physicians, letting them know that legacy products that patients were being prescribed are no longer covered. I know what those specific products are. And I mean, I was looking at the number of patients, of course, not looking at the specific patients' names or any of that. But just one physician in one small community on one street, the number of patients and you start adding up these letters going out to thousands and thousands of physicians and it could be -- it could absolutely hit what we are thinking about internally in our modeling. Andrew, do you want to add to that at all?

Yes. I think the one thing that I'm really excited about this coverage win is it kind of shows what -- and then I think we're going to really see it next year as we demonstrate the power of VAFA, which is really a long -- it's -- the VAFA program is, I almost call it a temporary program. It's not meant to be the program forever. The goal of the program is to gain coverage wins and to increase patient access through insurance reimbursement. And through that, we think ASP will improve. What's great about the program, though, is it also sets us up where we kind of have a base to work off of when we're negotiating with PBMs and payers. There's no reason for us to take less money from a payer. So when we're bidding, we're not going to bid ourselves into a hole. The VAFA program is working really well. I mean, it's exceeding our expectations on the cash pay side. And what that's doing is setting us up for a lot of long-term growth for the product, especially as the insurance wins come in and we think they will. And we think that the program itself, just with the volume and demand we're seeing, brings us more negotiating power when we go to the payers and go through these bid cycles. And I think this -- like I said, this first coverage win is a good demonstration of that and we should see more of that in '26 and '27.

I just want to ask, just focusing on, I guess, fourth quarter specifically and on that point, you were just noting like you're in this moment, right, where the volume growth is tremendous and you have this sort of couple of month window between now and 2026, where it would be critical to keep people on drug until their insurance coverage kicks in. So are you doing anything like providing free prescriptions beyond the first month to VAFA patients? Or just anything new to bridge that gap given the new coverage decisions that would impact fourth quarter revenue? And then on the flip side, just with the addition of the new specialty pharmacies, is there any expected like inventory or stocking or sort of onetime impact to fourth quarter that we should be considering for our models?

Andrew, why don't you take the last question and I'll touch on the first question and ask Pat for some guidance as well.

Yes. On the -- on any inventory stocking, Steve, I don't think we'll see anything really that impactful with VEVYE in particular for the fourth quarter. These guys are ordering pretty almost just-in-time type ordering, not quite that regularly, but it's -- I would say they're taking less inventory than wholesalers typically would. So no real end of year impact related to that.

And specifically on keeping patients on therapy, I don't know that we want to go into any specific tactics, but I know that the dry eye team, Maria and her entire team are hustling. Pat, do you want to add to that at all?

Yes. Thanks, Mark. I think this is a super exciting opportunity and this is part of the plan. So I think to me, we have a very, very clear activation plan to really take advantage of evolving from VAFA to support these patients to really capitalizing on our managed care wins. And I think to me, it's very much focused on the communications that are happening from the plans at this point in time to their patients, making sure that doctors know about our VAFA program and these wins that are going to be taking place to ultimately support the patient end of the year. So we have a very robust high-touch program that is taking place and activating as we speak now that will continue to wrap up the year to support these patients and really accelerate growth at the end of the year. I think in addition, our program right now, our fill program in VAFA is a very high-touch program. So we have a very, very clear view into who the patients are that are coming on our product and that are eligible for conversion to this commercial win. So super exciting time. But to answer your question, we have a very clear plan to really drive conversion and help these patients.

And I'll just add that I was excited. As soon as we got the coverage win, we got that information, I'll tell you, it gave me a lot of confidence in Pat and Maria and the team. I mean they had -- I think they even had a name for the plan internally that they were going to begin to execute. And it was just a text message. It was just like, okay, let's fire it up. And it just gave me a lot of confidence that we have the right people, we have the right strategy to take advantage of this great opportunity and continue the growth in VEVYE. So kudos to the work that Pat and Maria are doing.

Our next question comes from Mayank Mamtani with B. Riley Securities.

Appreciate the detail on business momentum. So maybe just a high-level question on sort of this 3Q to 4Q dynamics. Some you observed last year versus others you were talking to are unique to -- you have this year. Was just curious if you could comment a little bit on the notably high sort of $80 million revenue threshold in 4Q. It's sort of sequentially double versus what you had in 3Q. And it seems a lot to be still driven by VEVYE, I think, 60% over sequentially. Any color, Mark, you can give on volume versus price kind of dynamic here that you're assuming across the different lines -- different product lines? And then I have a follow-up.

On Q4, what I would say is I think last year, Andrew, Q4 was probably upwards of 1/3, maybe a smidge higher than 1/3 of our overall revenue for the annual period. That will -- I wouldn't expect that to change this year. I think that we can do around that range this year. I think the exciting thing about Q4 for what it's worth is the emergence of TRIESENCE finally. I think we -- I was quite candid in the letter. We could have done a lot better. We should have done a lot better with TRIESENCE in every period this year, the first 3 periods and the same is true with our Rare & Specialty portfolio. But the key is, is that we've taken action. TRIESENCE, I think we're seeing really exciting things, not just in words, but in deeds. As I was telling the team, we're not at a point where Mark can get on a conference call and say, "Hey, I'm really excited about TRIESENCE. I think this is going to be fantastic." It's time for orders. It's time for revenue. It's time for reorders. It's time for new accounts starting and adopting. And because I'm seeing that, I'm actually -- I've been involved in the sales process myself. I've been communicating with high-volume surgeons and talking to them about TRIESENCE specifically and I'm actually seeing surgeries start with it. And that's exciting. I've been through that cycle. I've seen that cycle. And so that gives me a lot of confidence in where we're going with that product, not only beginning to feather in, in the fourth quarter, but really for next year. It's going to get to where we thought it would be and that's super important. In terms of other dynamics between Q3 and Q4, Andrew, do you want to comment on any of that?

Yes, Mayank, I think we've kind of talked about VEVYE on the ASP side and expecting at least stabilization there. Typically, at the end of the year, your patients are out of that co-pay deductible and amounts like that. So our co-pay buydowns are a little bit lower on a per unit basis. So hopefully, that helps to see a little bit of price improvement. But in general, the expectation is we're going to see volume improve across the portfolio that will drive most of the revenue growth for the quarter.

Great. And then one -- actually a couple of specific product level questions. So Project Beagle enabled patients who crossed over to branded VEVYE. You may have some information there on the conversion rate from cash pay maybe to commercial insurance covered scripts. I don't know if that was something you can share or has given you some learnings moving forward? And then on TRIESENCE, are you able to comment on what the new price point is? Looks like you're really focused on access to enable significant volume growth as you enter the ocular inflammation market. And obviously, very curious to hear your goal here to -- how close you're trying to get to when the product was not on the shortage list a few years ago?

In terms of Project Beagle and specifically the transition from Klarity-C to VEVYE, we really don't have much more to add to that. I think we had more than 25,000 patients that were using cash pay Klarity-C. We stopped making Klarity-C in the summertime. And I think largely, those conversions have taken place. There's probably some units out in the field in various offices around the country. But I expect for that to be kind of mopped up by the end of the year for sure. And those patients who will have transitioned to VEVYE will have made that transition. In terms of TRIESENCE pricing, the pricing was at $9.44. You're moving into the ocular inflammation market. The products in that category are probably 20%, 25% lower in price. And I believe and I think our team believes that price was -- would have affected adoption and in particular, as we focused on that ocular inflammation market. It was a good move, by the way. New orders are coming. As I said, it's not Mark talking about what might happen, what could happen. It's Mark talking about orders coming in, revenue reorders. And as I said in the stockholder letter, we have now confirmed reimbursement. So you're talking about a product that is -- has tremendous coverage, an extraordinarily low prior authorization rate, a multi-decade track record of performance. It's a product that is, I would say, beloved by ocular surgeons. And there are a number of other reasons why -- clinical reasons as well as economic reasons why TRIESENCE is so exciting to these physicians that really didn't know that this level of reimbursement was available for this product. So we are seeing really positive things. I have been through this before. Our first product was a product called Tri-Moxi. It was a compounded combination of triamcinolone acetonide and moxifloxacin hydrochloride and I remember the adoption cycle there. What happens in the surgical environment, in particular, is you get a few cases and I tried to describe it in the letter of stockholders and then they see that it performs terrific clinically. Now we've gone through the reimbursement cycle. There's really no reason why these physicians can't use this pervasively throughout their practice. And so there is this cycle to adoption and we're going through those cycles right now. What's really neat is once those physicians adopt this and it starts working so well for their patients and they see their patients coming in with clean white eyes on their post-op day 1, they don't want to change. And then when they talk to their administrators at their surgery centers and they hear that they were reimbursed and they didn't have to deal with prior authorizations, they just don't want to change. And then it grows and grows and grows. At our peak with a non-FDA-approved compounded product, we were doing in excess of probably 300,000 units of Tri-Moxi and Tri-Moxi-Vanc years ago and some of these other sterile injectables. And so when I think about what TRIESENCE had done many years ago versus what we were doing with a non-FDA-approved product, which was significantly more than TRIESENCE in terms of annual unit volumes, I say that the units that we were doing with a non-FDA-approved product were miniscule relative to what the overall market opportunity is. And I just wonder why more -- why any surgeon would not use TRIESENCE. And so we think that this is going to become, hopefully, the new standard of care for these patients. And if it was my mother, if it was someone that I love that was having a procedure and they could have the physician inject the medication to ensure that they had the medication on board and that they would not have to as a 75, 78, 80-year-old patient with comorbidities, have to administer eye drops post-surgery, I think I would want my mother's physician to choose TRIESENCE. So we think more and more physicians will. It's an exciting time for that product and we're just scratching the surface. I don't even know that you could even call it a scratch at this point.

Our next question comes from Tom Shrader with BTIG.

Congratulations on the quarter. The TRIESENCE, that had a pretty good user base before and we agree people loved the drug. Is it easy to move back into those people? Or have they moved on? Could you just give us a sense of is that low-hanging fruit? Are those people waiting for the drug? And then you commented on fueling commercial operations for VEVYE. Does that mean adding conventional salespeople? And if so what other products do you think they could most easily help? Is TRIESENCE too far away for someone to market both VEVYE and TRIESENCE?

Yes. I don't want to keep talking, but if you don't mind, I'm going to take both, if that's all right. In terms of how easy it is to reengage and whether these physicians have moved on, when TRIESENCE was not available, without question they moved on. They started using [indiscernible] which has preservatives. It's got benzyl alcohol in it. If you're the patient, if the patient is someone you love, you don't want the doctor putting a chemical in their eye that could potentially blind them. And so that is why Alcon many years ago sought FDA approval for TRIESENCE because there was a clear unmet need in the marketplace for a preservative-free triamcinolone acetonide and that is TRIESENCE. That's what makes the product very special. And if you knew that an iPhone 17 was not available, maybe you go back to the BlackBerry. But boy, as soon as you found out that the iPhone 17 was available, you're going to switch back. It does take time to reengage with these physicians. Many of them, even to this day, don't know that TRIESENCE is available, that it's in stock. They don't know about the low prior authorization rate, the reimbursement and coverage. But that's our job. That's Chad's job. That's the job of this team that is going out, [ Aly ] and her folks and Adam and really making it happen for this product. And it takes time. I mean, you're talking about thousands and thousands of call points, but they're doing a great job. They're making progress. I think Pat talked about that. And for Harrow and our stockholders, the juice will be worth a squeeze. I mean, this is a tremendous product. I've always said that I saw TRIESENCE as a 9-figure revenue product. I think we're going to get there in due course. You wouldn't think that from the first quarter to the second quarter and the third quarter. But I think if we speak this time next year, you will see that I was not delusional. And then finally, in terms of commercial ops for VEVYE, we're making those investments because we have coverage. When you have coverage, when you have the ability to have a prescription written and to get it filled in sort of a friction-free way and what we do know, by the way, and we've talked about this in prior stockholder letters is that when we get a commercially covered VEVYE patient through our process, we retain them. Our refill rate is amazing for a commercially covered patient. So once we get that patient now that we can get them covered, we can retain them because the product is so spectacular. It provides us with a sort of a compounding effect as we get more new patients and retain them, you'll see that continued growth. In terms of other products that we're going to put in their bag, if you go through the corporate deck, one of the things I'm really excited about is we actually did add 2 products to the bag of our dry eye team. We have an amazing dry eye team. It will be growing. As I said, by the middle of next year, we'll have 100 territories. So Maria is going to have a much larger group of folks to manage. And they will also be helping patients and giving them access to FLAREX and they'll be getting -- they'll have FRESHKOTE in their bag as well. And so the combination of a chronic care dry eye medication with other related products that cover ocular inflammation and FRESHKOTE in particular, which I think if you Google FRESHKOTE, you start looking at some of the marketing materials and its ability through polyvinyl alcohol base to actually help patients retain their tears and prevent evaporation, I think that's a really terrific product that the team is excited about. And by the way, it's over the counter. I think you can get it for under $30 a unit. It's over the counter. So you don't need a prescription for it. So we're going to do some exciting things with FRESHKOTE. Maria has got FLAREX now. And of course, the cornerstone product in her portfolio was VEVYE.

Our next question comes from Lachlan Hanbury-Brown with William Blair.

I guess I'd be curious on the new coverage for VEVYE. Can you just talk about how the economics there shake up or stack up compared to the current net pricing you're seeing? Because I know you've been sort of vocal, Mark, in the past about the economics that PBMs try to extract. So would be interested to know just sort of where that shakes out. And also once those new plans come online in '26, what kind of coverage level are you looking at? Like what proportion of commercial lives nationally are covered for VEVYE?

Yes. What I can tell you, and Andrew mentioned this, is that when you have a VAFA program and you establish a base, it takes you out of what we would call desperation mode to do bad deals with PBMs. Andrew, do you want to kind of add to that? You talked about it a little while earlier.

Yes, without giving away the kind of bid, like Mark is saying, like I was saying that we kind of start with a base and we say, okay, if we're going to get a coverage win, what we want -- what does the economics need to be? And it obviously has to be an improvement on the cash number that we have. And so what that means and what I think -- and without getting -- being specific about what that impact is going to be, the expectation is it's going to be an improvement for those patients over what they -- over the cash price that we would net on a per unit basis. And we've talked a lot about just the ASP impact of the coverage win and that will help stabilize and certainly increase that number in 2026. But there's another aspect to this, which is VEVYE was not preferred in this plan and Mark kind of talked about this. The fact that now it is preferred and another product got pulled out of that preferred status, the payer is letting the physicians know, hey, your patient was on this product and it's not going to be preferred next year, but VEVYE is. So not only are we going to get the increase in ASP, but just getting that preferred status, the PBM is helping us drive volume. And so you're going to -- it kind of one begets the other, but it's going to be an increase in ASP. It should also be an increase in volume as well for the product.

Great. And maybe a quick one on the VEVYE expansion, the new territory. So just to make sure I heard correctly, is that you're adding 10 new reps this quarter and then we'll keep adding more until you get to about 100 next year, which if I have my numbers right, is sort of roughly double where you're at now?

Yes. So we're going to increase by 10. We'll get to a little bit more than 60 here in the very near term. And then by the second quarter, we'll hopefully have -- we'll reach the century mark, we'll have about 100 territories.

Our next question comes from Thomas Flaten with Lake Street Capital Markets.

Mark, just a follow-up. You mentioned the refill rates are great. Could you give us a sense of duration of therapy that some of these long-duration patients are on products for?

I think last time that we looked at the data for a commercially covered patient, if you look at their initial prescription plus the refills and you add -- you just think about the number of drops per bottle and the number of dosages per day. I mean, I think we were almost -- we were right at these commercially covered patients getting therapy for the entirety of the year. I mean, I think it was only a few weeks away from, on average, refilling for the entirety of the year. I mean, we would have never ever thought that we would get that sort of affinity of refill rate for that patient. I mean, that was not anywhere even in the highest, the boldest of bold cases in our models. So that's what we've seen. And Andrew, do you want to add to that at all?

No, nothing to add.

And then maybe if I could, bigger picture. You guys have been pretty busy on the BD front and have kind of created a really impressive to-do list for yourselves over the next couple of years. What should we anticipate in '26, '27? Is this more of an absorb, digest and act? Or is it more deals, more deals? Where do you land on that?

Well, I think at our office today and over the next week or so, we are over the moon excited about Melt. And I don't think we've talked about Melt really at all, but we're hoping to get this closed here in the very near term. And I don't think people really understand the value of Melt and what the potential is there. It's really transformative for us. And so yes, we can -- we look at deals constantly. We're always evaluating things. But if you look at our portfolio and you think about some of the strategic goals that we've discussed and I've laid out even in the letter, in particular, around cataract surgery, the vision for ophthalmic surgery that we have, which is to have opioid IV and drop-free cataract surgery, that's exciting for patients. That's transformative. The idea that you can probably go into an office, have office space, maybe even bilateral same-day cataract surgery and on the pharma side, have no IVs, no opioids and not need eye drops post-surgery, that's extraordinary. And that's what Melt and some of the other products that we have will enable. That's transformative for the nearly 5 million surgeries that occur annually in the U.S. So we are looking at other deals. We're very interested in other deals. But right now we're super pumped about Melt. We want to get that closed. We want to get the balance of the data collected and put into a dossier so that we can submit an NDA and get that product approved and help realize this vision that we have to really transform ophthalmic surgery. And then eventually, hopefully see the MELT-300 drug candidate used outside of ophthalmology, which is really a much bigger market opportunity in dental and GI and claustrophobia for MRIs and the tens of millions of annual uses in the U.S. where we think the MELT-300 will be impactful. And then, of course, what's also interesting is this will be the first global play that we have. Historically, we've been a U.S.-focused business. And as you, I think, know, MELT-300 is not only patented, multiple patents issued domestically, but in all of the -- many of the major markets around the world. So it's a global opportunity as well that we hope to discuss with partners in other markets around the world. So lots to look at, but I'll tell you, when we look at what we have with Melt and the products that we've acquired over the years recently, we have just something very, very special that we need to execute on. And I'm really pleased to have Pat as my partner, our partner to help us do that.

Our next question comes from Yi Chen with H.C. Wainwright.

Mark, you mentioned that with the coverage win, some prescription flipped to VEVYE. Could you give some additional color on market dynamics, whether those prescriptions flip to VEVYE, they originally came from prescription for other cyclosporine formulations or they could be -- they came from non-cyclosporine prescriptions as well?

Yes. So the -- in terms of who is who -- which product was the -- incurred the loss to our potential win, it was really -- and I don't want to go into the specific products, but they were not cyclosporine-based products, but they were anti-inflammatories. And you might be able to figure out which ones they were. But in any case, for us, we are really focused on being the #1 cyclosporine in the market. And I think this really adds to that momentum. I think to be the #1 cyclosporine in the market, you're talking about, I think, with generics, probably 22%, 23% market share. We're a little over 10%. We do expect to see NTP improvement as we get more and more coverage and that ratio flips. But this is going to really help us I think drive not only new prescriptions from patients naturally, but I think from these flips. As I said, I've seen the letters that have gone out to the eyecare professionals. It lists the product that is no longer covered and it lists the patients. And I know from the few physicians that I've spoken to that their intention is to move them to VEVYE. However, I have to say, if you go around the country, there are many physicians in many markets all over the country that have no idea what VEVYE is. And it's our job to make sure that they not only know about the clinical value that VEVYE brings, but also now the new coverage, which will, I think, create a more friction-free process for prescribing.

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

Thank you, operator, and thanks, everyone, for their questions. And we really appreciate you joining us today. As we look into the future, I remain confident in where we're heading. We've built a solid foundation. We've brought together an outstanding leadership team and defined a clear strategy that touches every part of our business. And we have a portfolio of best-in-class products and expanding access for patients and physicians and driving a culture that thrives on focus and execution. It positions Harrow for sustained growth and long-term value creation. The opportunities that we have ahead of us with TRIESENCE and VEVYE and IHEEZO are tremendous and we are ready to capture them. If you have any further questions or you need additional information, please don't hesitate to reach out to Mike Biega. His e-mail address is m as in Mary, b as in bravo, iega@harrowoinc.com. This will conclude our call.

Thank you for your participation. You may now disconnect. Good day.