Harrow, Inc.

Good morning, and welcome to HARO's second quarter 2025 earnings conference call. My name is Shannon, and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. As a reminder, this conference is being recorded. I would now like to turn the conference over to Mike Villegas, Vice President of Investor Relations and Communications for HARO.

Thank you, operator. Good morning, and welcome to HARO's second quarter 2025 earnings conference call. My name is Mike Biega, and I'm excited to be introducing today's call, having joined HARO as Vice President of Investor Relations and Communications in June. It's a pleasure to be part of the HARO family and to speak with all of you this morning. Before we begin today, I would like to highlight a few new items for our quarterly report. We will be presenting slides during the webcast today. If you have registered and joined through the live conference call link, I would highly recommend that you also join through the webcast. You can find the link in the Investors Events section of our website at www.harrow.com or in our earnings press release that was issued yesterday. We also have a new corporate deck that was posted on our website yesterday. All the slides we will be presenting today can be found in that deck. Moving forward, you should expect that our earnings process will mirror this format with potentially a few additional changes, and we will certainly update you on any future changes to this format. In addition, we recently launched a new corporate website, which I encourage all of you to explore. The company's remarks may include forward-looking statements within the meaning of federal securities laws. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond Harold's control, including risks and uncertainties described from time to time in its SEC filings, such as the risks and uncertainties related to the company's ability to make commercially available its FDA-approved products and compounded formulations and technologies and FDA approval of certain drug candidates in a timely manner or at all. For a list and description of those risks and uncertainties, please see the risk factors section of the company's most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission. HARO's results may differ materially from those projected. HARO 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, HARO 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. By now, you should have received a copy of the earnings press release. If you have not received a copy, please go to the Investors Relations page of the company's website, www.harrow.com. Joining me on today's call are Harrow's Chief Executive Officer, Mark L. Baum, and Harrow's Chief Financial Officer, Andrew Boll. With that, I would like to turn to call over to Mark to go over some prepared remarks prior to the question and answer session. Mark?

Thanks, Mike, and good morning, everyone. Thank you for joining us today. I hope you've had the opportunity to review our supplemental documents for the second quarter, including our earnings release, corporate presentation, and letter to stockholders, all of which are now available on the investor relations section of our newly designed harrow.com website. Aero is a leading provider of ophthalmic disease management solutions in North America, enhancing the ability of eye care professionals to manage sight-threatening ophthalmic diseases. To achieve this, we ensure that our products are safe and efficacious, accessible and affordable, and that they increase patient compliance, which in turn facilitates improved ophthalmic disease management. Today, our ophthalmic disease management solutions are all pharmaceuticals, but in the future, this may evolve. In any case, our focus will always be to provide leading-edge products and outstanding service to help eye care professionals best care for their patients. Our primary financial goal is to deliver a $250 million revenue quarter by the end of 2027. I believe this is achievable because of what we own, how we're performing, and where I see the business heading, and our demonstrated history of growth from literally no customers, no products, and no revenue about a dozen years ago. I intend to provide more color on how we intend to achieve this $250 million quarterly revenue goal on September 26th, during our inaugural Investor and Analyst Day, an event that Mike Biega is working to put together. This event, which we intend to make an annual event, will be hosted by Harrow Leadership after Labor Day each year. I'm looking forward to our stockholders and analysts meeting members of the Harrow Leadership team, seeing our products live, and learning more about how we partner with US eye care professionals to manage ophthalmic diseases. For more information, please reach out to Mike at mbiega, B-I-E-G-A, at harrowinc.com if you're interested in attending. Now, over the past five years, we have built a sophisticated and hard-to-replicate infrastructure. Today, we own one of the most extensive portfolios of ophthalmic products in the United States, now totaling more than 59 prescription products. We address both front and back of the eye diseases. We sell into both the insurance reimbursed market and the cash pay market. We sell to the eye care professional office, the ASC and hospital, and we ship directly to patients. I think one of the things I'm most excited about is Andrew and I look over the one or two year horizon is the incredible leverage we have in our model. Essentially, our commercial infrastructure is paid for in delivering profits as demand increases for key products like Viva and Iheso, and we add revenue-generating assets like the Samsung ophthalmic biosimilars portfolio, or we begin to sell triessence into a key large market, which I'll talk more about, we really aren't incurring meaningful additional costs, which means much of what we sow, we should reap. The second quarter was a great setup for the back half of the year, as we saw deeper market penetration across our core growth drivers. Largely due to the recently implemented V-VI Access for All initiative, V-VI saw a 66% growth in prescription volumes this quarter over the prior quarter, and we don't see any signs of that momentum slowing. Capitalizing on the growing demand for Vivi, today we announced a strategic alliance with ApolloCare, an innovative provider of patient access and commercial solutions that provides full nationwide coverage across the United States as HARO's second specialty pharmacy partner for the BAFA program. IHESO's RetinaPivot is taking hold with a 25% growth in unit volume quarter over quarter. Triessence continued to gain momentum with volumes accelerating and market share expanding, achieving 32% quarter-over-quarter growth. And by the way, the numbers for the third quarter for Triessence are also doing well. Our specialty branded product portfolio, well-known essential everyday therapies relied on by thousands of eye care professionals, delivered a strong quarter and a nice rebound from the first quarter. Finally, we recently announced two strategic acquisitions that fit in seamlessly with our commercial infrastructure. One, at the end of the second quarter, we secured the U.S. rights to Biclovi, which was a recently approved treatment for postoperative inflammation and pain following ocular surgery. This is the first new ophthalmic steroid in its class in over 15 years. And then second, We also recently acquired the U.S. rights to Samsung's ophthalmic biosimilars pipeline, including BioViz, an FDA-approved biosimilar referencing Lucentis, and OpioViz, an FDA-approved biosimilar referencing ILEA. Our total revenue for the second quarter was $63.7 million, a 30% increase over the second quarter of 2024, and a sequential increase of 33% from the first quarter of 2025. The first half of 2025 generated $111.6 million in revenue. To reach our guidance of more than $280 million for 2025, we need to generate approximately $169 million in revenue in the second half of the year. Given the math that I'm seeing today, I believe we are on track to meet our guidance goals. Now, I've repeatedly stated on prior calls that the second half of the year is always stronger than the first half of the year. And as you read from our letter to stockholders, and you will hear from my prepared remarks this morning, we are seeing momentum with our key growth drivers that should start to show meaningful revenue growth as early as the third quarter. I think next year, though, we will try to provide annual revenue guidance and split it into two halves, the first half of the year and then the second half of the year. I think that might work better for us. In any case, adjusted EBITDA was a great story. As second quarter adjusted EBITDA came in at $17 million with $5 million of net income. This, once again, highlights the operating leverage we've built into the business. HARO is at an inflection point. our revenue should reach new heights in the back half of this year. And as you saw from this quarter, our cost basis really remains fairly stable. This is a result of years of investment in building a strong, scalable commercial infrastructure that's designed to support this phase and level of growth. Vevi generated $18.6 million in revenue. a 13% decrease from the first quarter of 2025. As outlined in our letter to stockholders, the revenue reduction seen in the second quarter versus the first quarter of 2025 was driven by a normalization in average selling price, or ASP, which I called out during our first quarter conference call and in our Q1 letter to stockholders. We typically don't comment on changes in ASP quarter over quarter, but I think it's important to highlight that the ASP seen in the first quarter was an anomaly due to the changes in the business rules we implemented at the beginning of the year. With our present V-VI ASP reflective of those VAFA business rules, we expect to see and are seeing both V-VI volumes and revenues increase once again as we forecasted. Based on the ratios of the types of V-VI prescriptions we're seeing, we're confident that V-VI's ASP has stabilized, and we even see a path to modest improvement over the rest of the year. In addition to continuing to improve our business rules algorithm, as I shared in our earnings release, we've entered into a strategic alliance with ApolloCare, an innovative service provider with full national coverage. Now, this alliance significantly expands DVI's distribution network, improving both pharmacy access and insurance coverage for patients nationwide, and it should buttress our ASP at current levels and, as I said, provide an upward bias towards ASP improving over the coming quarters. Apollo Cares Pharmacy Network spans more than 500 pharmacies and is broadly contracted with major and smaller commercial plans, as well as TRICARE and Medicare. With coverage reaching every U.S. geography and payer type, this collaboration positions us to reach more patients than ever before. Importantly for our stockholders, nearly every prescription of Vivi that is dispensed is now profitable for HARO under the VAFA initiative, a notable shift from pre-VAFA times. These adjustments cause structural improvements that enhance the quality of our revenue and our ability to invest and further scale Vivi's long-term profitability. When we provided V-VI revenue guidance of more than $100 million for 2025, we accounted for the anticipated decline in subsequent stabilization of ASP from Q1 to Q2. Once again, we expect V-VI to generate over $60 million in revenue for the second half of 2025. If you straight line Q2 growth for the balance of the year with a stable ASP, this puts us ahead of where we need to be by the end of this year for the Vivi franchise. Ahizo generated $18.3 million in revenue, a 251% increase from the first quarter of 2025. Ahizo is gaining momentum and growing market share. The growth this quarter is driven by the momentum from our retina pivot and expanded distribution through the group purchasing organization agreements we've signed. IHESO is on the path to have a record year this year, and I'm confident it will surpass our guidance of $50 million or more in revenue. By essence in our specialty branded portfolio generated 5.2 million in revenue. That's a 447% increase from the first quarter of 2025. With TriEssence capturing more market share and a large market on the horizon, I'm confident the second half will outperform the first half by a wide margin. ImpromiseRx generated $21.5 million in revenue. That's a 7% increase from the first quarter of 2025. This is a stable, cash-generating business, and it is performing as expected and is on track to reach our guidance of $80 million or more this year. In sum, our 2025 guidance remains intact, and I remain very confident in our team's ability to hit that number. Since launching V-VI Access for All in late March of this year, the demand for V-VI has surged. The promise of the VAFA Market Access Program for V-VI is, one, increased access for patients, two, lower out-of-pocket costs for patients, and three, a reasonable and sustainable profit for HARO. As I detail more in the letter to stockholders, the VAFA program is meeting all of our commercial objectives. Vevi continues to exceed our prelaunch expectations in every category, new prescriptions, refill rates, patient satisfaction, and prescriber engagement. The impact of VAFA can be seen on this slide. Prescription volumes were up 66% sequentially for a total of 119,526 units. Of those, nearly 50,000 were new prescriptions, resulting in a 62% increase and new prescriptions over the first quarter of 2025. As prescription volumes grow, we're maintaining industry-leading refill rates, an important indicator of product adoption and satisfaction. In 2024, covered patients receiving Vivi through PhilRx received an average of nine refills, a figure that significantly outpaces the typical refill rates seen with other therapies in the dry eye disease market. This sustained refill behavior highlights not only VIVA's clinical value, but also its ability to foster ongoing patient engagement well beyond the initial prescription. The compounding effect of rising numbers of new prescriptions and consistently high refill rates positions us for sustained revenue growth. We anticipate the first meaningful financial impact as early as the third quarter of this year. driven by the continued momentum and new prescription volume, a more stable ASP, and a growing wave of refill activity. This surge is largely attributable to the strong demand generated since the launch of the VAFA program. To reiterate what I said earlier, under the VAFA initiative, nearly every prescription written for V-VI is now profitable. And this is a notable shift from before we had this program going. when that wasn't always the case. We've also secured additional manufacturing capacity for 2025, enabling us to further scale our commercial reach. In parallel, we are revisiting next year's forecasts, increasing our supply chain flexibility and ensuring that we are well-positioned to meet the sustained and growing demand we anticipate for both new and refill prescriptions of Vivi. Importantly, as noted earlier, We're also preparing to bring a second Vivi manufacturing site online next year, and this will further strengthen our supply chain and facilitate our growth strategy. Vivi's market penetration continues to accelerate. By the end of Q2, we had captured a 7.8% share of the national dry eye disease market. That's a 2.6 plus percent increase quarter over quarter. Notably, according to IQVIA and Filarex data, Vivi has now surpassed CEQA in national market share. This is an important milestone that reinforces the effectiveness of our commercial strategy and execution. According to IQVIA, Vivi is now the second largest cyclosporine-based dry eye brand being prescribed. Once again, a significant milestone that validates the strength of our primary strategy which is to win the cyclosporine category in dry eye. Vivi is beginning to also gain ground on Mibo, having surpassed Mibo in new prescriptions in four U.S. markets that are quite sizable. In summary, we're still in the early stages of a Vivi launch, and the growth trajectory is compelling. Demand continues to rise sharply. Refill rates remain industry leading, and with only 7.8% market share captured so far, the runway ahead is significant. With a best-in-class clinical profile, strong access infrastructure in place, and a robust commercial team, we believe VIVA is well-positioned to exceed $100 million in annual revenue this year, marking just the beginning of a multi-year growth opportunity. In June of 2025, we announced the acquisition of Biclovi from Formosa Pharmaceuticals. I'm particularly excited about Biclovi, an FDA-approved steroid indicated for the treatment of inflammation and pain after ocular surgery. And it's the first novel steroid introduced to the U.S. market in over a decade. Biclovi is a highly potent next-generation therapy And it's the only FDA-approved ocular steroid formulated with clovidazole, delivering robust clinical efficacy supported by a well-established safety profile. From a clinician's perspective, the typical risks associated with ophthalmic corticosteroids includes increased intraocular pressure, or ILP, And in this case, the resultant IOP increase was only 1.4% of the population exposed to the product during pivotal clinical studies. The incidence of increased IOP was substantially higher with products such as Dextenza and others, all comprised of less potent corticosteroids than Biclovi, but with a higher risk profile. Biclovi also has longer duration of action, allowing for reduced frequency of administration. In this case, twice daily versus four times daily. And in the ophthalmic market, when a product is to be administered four times daily, it's typically every four hours while awake, which could pose significant compliance issues. Therefore, we believe Biclovi may offer important patient compliance features. Finally, in terms of efficacy, both in terms of the percent of responders to full pain relief at the earliest regulatory time point of four days post-op, and in terms of complete clearance of inflammation post-op four days, Biclovi performed better than all other approved products for the same indication in the U.S., While this assessment is not based on head-to-head studies, it's based on a cross-comparison between approved product labels. With over 7 million ophthalmic surgeries performed annually in the U.S. and a wide range of additional clinical applications for topical steroids, we see a substantial market opportunity ahead. And I'm confident our commercial team is well-equipped to drive strong adoption of this differentiated product. We expect to launch by Clovey in the first quarter of 2026. I'm encouraged to see both IHESO's revenue and unit volumes return to near fourth quarter 2024 levels, a period that benefited from increased stocking, showing clear signs of momentum and growing market share. The second quarter showed new account growth and deeper utilization within existing practices, with 25% growth in unit volume over the first quarter of 2025. This surge in demand is being fueled by strong momentum from our retina pivot strategy and expanded distribution through new GPO relationships. This expansion led to the addition of 19 new accounts during the period, all of which were retina practices, underscoring the targeted success of our strategic focus and IHESO's growing adoption in this critical specialty. Notably, IHESO volume grew 33% quarter over quarter within the largest retina GPO, which represents approximately 70% of the retina market. Overall, distributor shipment volume for IHESO increased by an impressive 170% in Q2 compared to Q1 of 2025, underscoring the strong and accelerating demand we're seeing. IHESO currently enjoys broad coverage, with better than 81% of commercial and government payers providing reimbursement. Our data indicates that only 3% of IHESO claims are categorized as not covered, and only 4% require prior authorization. Amazing coverage data. In response to the strong access position, I recently developed the IHESO for all strategy, an initiative focused on expanding IHESO utilization and retina procedures across both existing and new accounts with the goal of driving near-term sales growth. Now, with all four major GPOs on board and strong clinical synergy between IHESO, TriEssence, and eventually our new anti-VEGF products, BioViz and OpioViz, I believe IHESO's growth is just beginning. These are still early days in its launch, but with four differentiated and highly complementary therapies in HARO's portfolio and a proven commercial team to execute our strategy, I expect IHESO is entering a new phase of accelerated growth. By the way, so far in the early days of the third quarter, we've already eclipsed the number of new IHESO account starts achieved in the entirety of the second quarter, with all of our new accounts being retina practices. Triessence is gaining strong traction within the retina community with accelerating volumes and growing market share. Year to date, Triessence added 870 new accounts and achieved 32% quarter over quarter growth. Triessence has also achieved 84% coverage with only 8% of claims requiring prior authorization and a mere 3% of documented claims being returned is uncovered. This is near completely pervasive coverage. Our go-to-market strategy with triessence is showing clear signs of momentum in the early days of our relaunch. Now that we have all the necessary buy-and-bill commercial infrastructure in place, we'll be expanding its use into the ocular inflammation market, such as cataract surgery, the largest market opportunity for triessence, and the one that we have not marketed into to date. We recently hired Chad Brines to lead our specialty brands sales team, which includes TriEssence. One of Chad's chief responsibilities is to drive our strategic efforts with TriEssence in the ocular inflammation market. Chad has extensive experience selling buy and build ophthalmic steroid products in this market, positioning him well to lead this critical initiative. Based on feedback from our physician customers, we believe these new go-to-market approaches will result in unit demand growth, which will begin to show in the fourth quarter and into 2026, especially as we move more resolutely into the ocular inflammation market. I couldn't be more excited about the transaction we announced in July with Samsung BioEpis. We secure the exclusive U.S. commercial rights to their biosimilars ophthalmology portfolio. That includes BioViz, an FDA-approved biosimilar referencing Lucentis, and OpioViz, an FDA-approved biosimilar referencing ILEA, two of the most widely used anti-VEGF therapies for retinal diseases. Importantly, both products have interchangeability status. These products will integrate seamlessly with our existing commercial infrastructure, and we expect to leverage our significant commercial flexibility to compete aggressively in this market. By combining HARO's deep retina expertise with Samsung's key learnings from its prior BioViz launch, we're uniquely positioned to refine our offering and compete effectively in this large, competitive, and contested market. We look forward to sharing more about our upcoming commercial launch soon. ImpromiseRx showed signs of sequential recovery following seasonal softness in Q1. April was a record month for the business, and momentum continued throughout the quarter, with steady growth across key product lines. The team is driving several initiatives to enhance gross margins, drive revenue growth, and improve operational efficiency. The business just continues to generate cash flow contributing meaningful value to our stockholders. To wrap up, Harrow is firmly in growth mode, and we're just at the beginning of an exciting journey. I couldn't be more energized by the incredible team we've assembled, the strategic products we've brought into our portfolio, and the tremendous opportunities that lie ahead. The best is yet to come for Harrow. With the accelerating performance of Vivi, TriEssence finally positioned to enter its largest market, IHESO hitting a growth stride, and the recent addition of Biclovia and a robust pipeline of biosimilars on deck, not to mention our proven compounding business, ImprimisRx, we now cover the full spectrum of high-value ocular conditions. Our nationwide GPO partnerships, specialty pharmacy reach, and track record of commercial execution create powerful leverage. Each new launch accelerates uptake of the others by deepening our presence in surgical centers and retina practices and general ophthalmic practices and even in optometry offices. Combined with a seasoned leadership team, strong balance sheet, well-defined R&D roadmap, and an active M&A strategy, our runway for growth is substantial. Simply put, we've assembled the right products, platforms, and people to redefine what success looks like in the ophthalmic market, and the most significant gains lie ahead. With that, I'll turn it over to our operator to open the line for questions. Operator,

We will now begin the question and answer session. To ask a question, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. We ask that you please limit yourself to one question and one follow-up. Please stand by while we compile the Q&A roster. Our first question comes from the line of Chase Knickerbocker with Craig Hallam. Your line is now open.

Good morning, guys. Thanks for taking the questions and congrats on the progress here. Mark, maybe just first on Vivi, can you help us a little bit with kind of any kind of business rule changes within there as you guys onboard ApolloCare, et cetera, as far as how we should be thinking about ASPs sequentially from here? Is it just kind of normal seasonality where less copay assistance kind of brings ASPs a little bit higher? Are there any other changes that you've made that you kind of expect some sequential improvement to ASPs through the year?

Thanks for the question, Chase, and good morning. Yes, so on V by ASP, I think, you know, a couple of things. One, in terms of new business rules going forward, we continue to tweak our algorithm, you know, but it's really, you know, these are really minor things. At this point, the business rules are, I think, performing very well. The reality, though, is that between Q1 and Q2, we kind of needed to wash, if you will, all of the existing VBI patients through those new business rules for the VBI access for all program. And what I mean by that is, you know, at the beginning of the year, you had a lot of patients, especially with copay resets that were paying three, four, $500 out of pocket for Vivi, and the reality is that many patients just can't afford that level of payment for a product like Vivi, or really any product for that matter. And what the Vivi Access for All program allowed those patients to do is to continue to stay on therapy and to be able to access the product at a much lower cost. Those are patients we probably would have lost anyway. But the bottom line is that as we got through Q2 and certainly now in Q3 with the existing business rules, we're really seeing what the ASP should look like. Now with ApolloCare, we have been losing patients. So we have patients that have coverage, but that are not able to use their coverage because the plan may have not been contracted with our existing pharmacy provider. And with this expansion of the network, we should be able to capture many more high-value patients into, you know, the overall ASP calculation. So we're thinking that, you know, certainly by the end of the year, we should see, as I said, a bias upward in terms of ASP, but we're also very confident from here given the fact that all of those existing patients have washed through these business rules, that we do have stability to our ASP.

Got it. And maybe just on the biosimilars, respect that we're going to get an annual stay in September, but any thoughts as far as kind of contribution to the model in 26 and 27? Because, you know, some of these biosimilar launches can be can be pretty quick uptake considering their existing markets. So any thoughts on particularly the Lucentis biosimilar as we think about 26 and 27?

Well, we're still working. By the way, I've done a lot of talking so far. So I'm very excited about the Samsung portfolio. But there's one person who's even more excited than me, and that's Andrew. So I'm going to let him take that question.

Hey, Chase. Thanks, Mark. Like Mark said, I'm really, really excited about the biosimilar portfolio. Samsung is a leader in biosimilars, and Harrow is, we think, a leader in ophthalmology. And definitely, we have a vision of being one of the top ophthalmology pharma companies in the U.S., and we see this really as a perfect marriage between the two companies. I think in regards to contribution at 26, our hope is that we'll be able to launch BioViz In 2026, with having immediate uptake in product demand for that product, there's an existing market for it. We've got a great strategy, go-to-market strategy. There's not a whole lot we can talk about right now as we're kind of working through this transition period with Samsung and their prior partner. But I think once we are through this transition period, we can talk a little bit more and be more specific about timing of that launch or relaunch. and also the other biosimilar in the portfolio. But I want to reiterate, I think out of all the deals we've done, this one is probably one of the ones I'm most excited about. It's incredibly synergistic, fits right into the commercial infrastructure, fits right into the relationships we have on the retina side, and it fits really well with Ahizo and with some of the other Bionabil products. And so we get a ton of leverage with the product. We know where these products are being used. We have relationships with those customers already. And I think it's going to be a really pleasant upside for a lot of investors and people looking at the long-term value of the company.

Thank you. Our next question comes from the line of Steve Seedhouse with Cantor. Your line is now open.

Good morning. Thanks so much. First question I just want to ask about the growth in new prescriptions in the second quarter for Vivi. How much of that was driven by Clarity C switchers? And are you largely through any expected bolus of patients from Clarity C now? And then just second part of that question, you mentioned you're sort of cautious about growing too much faster for the remainder of the year. for Vivi and your stockholder letter. I'm just wondering how much growth would slow naturally from the Clarity C patient bolus sort of unwinding, or are you also expecting a slowing of sort of the organic growth X Clarity C?

Hey, thanks for that question, Steve. I'll tell you just straight up how many units came from Clarity C. It was about 7,000 or so during the period. And in terms of those patients falling off, those patients typically have been as loyal, I think, refillers or even more loyal than the Vivi experience that we've seen so far. The other thing that I would mention that I think you're hitting on, which is true, and I kind of alluded to this a little bit in the stockholder letter, is that we really didn't count on vivi taking off in the way that it did in terms of our forecasting in terms of our production with our supply chain partners and i don't want to say that we got caught flat-footed these are very luxurious problems to have but we had purposely i would say not poured gasoline onto the vivi uh fire you know with intention because we want to make sure that if an existing patient needs Vivi or if an NRX comes in that we can supply the market. I think over the next couple of months, we're going to have far greater clarity in terms of acceptable levels of safety stock with Vivi. And as I said in the stockholder letter, because every unit of Vivi is profitable, nearly every unit is profitable, we feel really confident in entering a new investment cycle and, you know, dramatically, hopefully, you know, taking additional market share, probably starting that process at the end of the year and really setting us up well for 2026.

All right. Thanks for the color on that, Mark. And just I want to also follow up on the specialty branded and tri-essence segment. So the guidance here, obviously, is pretty assertive i mean like more than a 7x increase half over half from 6 million to to the incremental 44 million and i know you mentioned the ocular inflammation market but you did say that that would sort of kick in and force in fourth quarter so i guess what are the expectations for third quarter and what other assumptions do you make in there to to grow revenue so acutely in that segment really in fourth quarter it sounds like yes i would i would say that the x

tri-essence products from that basket has not performed to the levels that we expect. We are seeing a rebound and we need to, I would say, and we expect to probably double the revenue levels of those X tri-essence products. Certainly by the end of the year, we think that's achievable. But really what is not baked in, I think, is tri-essence revenue. You know, there is a reasonably decent WAC price there. You know, I covered the coverage levels in the opening remarks and in the stockholder letter. There is pervasive coverage for tri-essence. You know, without going into a whole lot of detail you know we don't need to capture a whole lot of market share, for example. In the post surgical ocular inflammation market in order to to hit those numbers but you're right, we do need some things to go our way we've got new leadership. you know, helping us drive value for that part of our portfolio. And, you know, we have work to do, to be clear. But when we look at the math, you know, we think it's achievable. We're also seeing meaningful improvement in triessence in the retina market, actually, in the third quarter. And I think I alluded to that both in the stockholder letter and the prepared remarks. So triessence is on the upswing. It really is. We have Great coverage. Same with IHESO, frankly. IHESO is probably more set up to exceed, and, you know, I think we can get there with triascents. It is going to be a challenge, though.

Thank you. Our next question comes from the line of Mayank Mamtani with B-Raleigh Securities. Your line is now open.

good morning team thanks for taking your questions and congrats on the progress uh my two questions are a follow-up to the the comments you had mark earlier so on the stabilizing of asp um you imply that the net price is sort of reset at where you've been in 2q uh is that sort of uh just to confirm is that kind of the case that you expect that to be sustained at the levels that you you kind of found yourself in 2q and And then, you know, how much do you anticipate the unit volume to expand, you know, particularly driven by new patient start so that I'm thinking longer term, you know, if your peak year sales assumption isn't materially altered, and then I have a follow-up.

Yeah, so in terms of the ASP for V-VI, we're comfortable with sort of the current levels of ASP. for the product. As I said, I think that we should see a bias to ASP, you know, possibly improving certainly by the end of the year. That's going to be bolstered by improved coverage and really this overall ratio of, you know, higher paid claims versus lower Uh, priced prescriptions, so all in all, though, I mean, and I think we've talked about this in the past. It's really about the average for us. We're going to get some. Some units, so we make a lot of money on or more money on and some that we make very little money on. But the average is very acceptable. In fact, the current. average is in excess of where we were certainly in 2024 and it's significantly ahead of what we had planned for you know pre-launch so we're actually very happy with where we are with asp and i think as as it does improve and i do believe it will improve we're seeing signs of that um you know i think uh you know we'll be in good shape on the asp side in terms of growth i see the weekly prescriptions come in it's kind of one of the cool things about working with these specialty pharmacies, I can literally monitor the prescriptions. And sometimes I do, you know, hour by hour. It's kind of like watching a ticker tape, frankly. You see the prescriptions come in. And, you know, we're doing really well on the NRX side of things. Those NRXs are not yielding. Even in the midst of the summer, kind of a summer lull, typically that you see with people going on vacation, patients going on vacations and prescribers, We're still seeing those NRXs come in, which is terrific. And by the way, we have a very modest sales organization. We have not, as I said to Steve earlier, we have not invested heavily as we intend to or more heavily into that organization. Once we shore up supply and get really comfortable with our safety stock and make those investments, I think you're going to see many years of growth. I think I've said to other investors, we're going to have many, many years of growth with DeVine. We don't see that yielding, and we're in a really good place with DeVine.

Understood. Thank you. And also it would be helpful to hear a bit more on the AHISO end of 2Q stocking dynamic, how similar or different it is to what we saw back in 4Q. I understand that was end of year. And if there's any other stocking dynamic we need to be aware of for any other branded products, thanks for taking the question.

Yeah, I would say that no concern on additional products. in terms of the stocking dynamic, but I will say this with IHESO, and I said this in the letter to stockholders, I returned from the ASRS meeting in Long Beach, California, and I remember when we acquired the product, we did some advisory board meetings, and I remember doctors saying, you know, what do I need this for? You know, what I'm doing is okay, and And I gave them my analogies of, you know, really loving my Blackberry until I ultimately got the iPhone and that what they were doing in terms of their anesthesia protocol for intravitreal injections is an example. In many cases, it's not an efficient process. It costs them not only in terms of supplies and materials, but more important for them, their time. And with one dose being required in order to anesthetize an eye for, for example, an intravitreal injection, IHESO just adds tremendous value to these practices. And when I went to this ASRS meeting, I really saw this thing catching on. It was clear. You know, the looks that we were getting when we initially were going to market were pronounced. And the reception that we're now receiving, for whatever reason, maybe it's the Samsung deal, maybe it's now, you know, people, more and more offices getting access to TriEssence, the great coverage that we have. It is a different ballgame. And more and more accounts are adopting IHESO. They're open to IHESO. They're seeing the benefits of this product. And this is one where I think there's really nice upside based on the guidance that we gave earlier this year. So we're excited about IHESO for the balance of the year. And really, once again, we still have a very, very small percentage of the overall number of intravitreal injections that use IHESO. So a lot of upside. And we have a great leadership team selling that product. Yeah.

Thank you. Our next question comes from the line of Tom Schrader with BTIG. Your line is now open.

Good morning. Thanks for all the details. A little bit on the difference between the two specialty farmers for you. Is Apollo better for you because they're more integrated with existing plans and can you steer them? patients that way. And IHESO for all, is that a – are you making it easy for people to try IHESO so we may have some average selling price swings for IHESO in the short term with the hope of growth down the road? Thank you.

Thanks, Tom. Yeah, so in terms of the difference between Phil and ApolloCare, Phil is – very well known, I think, within ophthalmic practices and even optometric offices in the United States. So a lot of the offices are very familiar with the fill platform. We use ApolloCare as a copay card vendor. And so they also are, once again, very I think well known within the ophthalmic market. And now they're expanding into the specialty pharmacy market. So the thing that they offer us, as I said earlier, is that they have contracted with so many plans. And we have seen in terms of how we manage ASP, you know, literally day to day and certainly week to week, that we get prescriptions in that could be covered by, for example, a commercial policy, but that ultimately become $59 prescriptions because Phil, for example, may not be contracted with that plan. And so for us, this is an opportunity, I think, to capture more commercial covered prescriptions through ApolloCare. And as I said, that's one of the reasons, and there are a few other reasons why we think ASP is stable and has a bias towards improving. In terms of IHESO for all, the point of IHESO for all is that we believe every patient who can benefit from IHESO should have access to it. And I think there has been a misnomer within even some of our customers that they need to pick and choose patients that IHESO should only be used for a fee-for-service patient or that they need to really do a deep dive into a benefits investigation before using IHESO. And we have such a powerful message in terms of coverage. It is really, I think, coverage that any product would envy. And when we spread that message and let our physician customers know that they can actually use IESO for all of their intravitreal injections, you know, and that there's no reason to pick and choose. That's really what this program is about. So it's about greater depth within existing accounts. And as I think that message gets spread in terms of, you know, not only the experience of what their colleagues are having with IESO, But the value that it offers these practices will have more and more new, new account starts. And that's what we're seeing in the third quarter, by the way, as I said, you know, I think just after, you know, early into August, we'd already eclipsed the number of new account starts for IHESO than we had in the entirety of the second quarter.

So, so more than free drug, it's help showing that they can get it covered.

Yeah, it's not, yeah, it's not about free drug. It's about, uh, reimbursement confidence. It's about confidence of coverage. I don't think that these practices know how pervasive our coverage is for Triessence, for Iheso, and even we're seeing improved coverage for Vivi. So coverage is our friend with those products. It's their friend with those products, and we're spreading that message.

Great. Thank you.

Our next question comes from the line of Lachlan Hanbury-Brown with William Blair. Your line is now open.

Hey, guys. Thanks for taking the questions. I guess, you know, if V-Buy is the number one prescribed product per prescriber in dry eye, does that kind of performance, you know, warrant more investment in the commercial team or the infrastructure to increase that? Or how do you sort of expand that to add new prescribers? I know you talked about investing in it. once you've secured supply, but can you elaborate on maybe what that looks like?

There are parts of the country where if you go to talk to an ophthalmologist or an optometrist, they don't even know about Vivi. Many of them have not even heard of Vivi. We don't have feet on the street. We haven't done a lot of marketing into many communities across the country, significant communities, and we need to be there. And we're not there because we haven't invested, I think, in feet on the street and in marketing, but that's been because we're a little bit weary of pouring fuel onto the V by fire, as I said earlier. We have got to get sufficient safety stock of this product consistent with our forecast and the new forecast that we have. All of that said, though, we have sufficient supply. I mean, if we sell and we very well likely may sell all of what we have, certainly for this year, our stockholders are going to be very, very happy. So we are in great shape, certainly through the end of the year. And then, as I said, we're setting up well from a supply chain side to be able to supply the market, I think, more robustly in the 2026 and beyond. That is going to allow us, and, you know, someone like Andrew, who's a pretty conservative person, is going to say, okay, now let's invest in Vivi. We're making money on these prescriptions. We've got the access figured out. We know where we need to be. We know where those markets are that, you know, they really haven't heard of Vivi or they're not prescribing it. And as you alluded to, the data shows that when we capture a prescriber, when they start using Vivi and they come in, you know, their patients come back and they say, wow, this product didn't burn. It didn't sting. I didn't get this weird taste in my mouth. I like this. Then the prescriber feels more comfortable using it on more and more of their patients. And as you said, it is the number one prescribed by medication per prescriber. um and you know we we uh we have a great clinical story to sell and uh we've got to get our supply chain dialed in a little bit more robustly and then and then we'll i think see even greater growth next year there you go thanks and then on the apollo agreement you said that expands your network and distribution can you give a sense of how much that expands the network or your distribution ability or is it

more about that coverage element you were talking about earlier of having more of those commercial scripts covered than it is the sort of physical distribution?

Thank you for that, Lachlan. the latter and not the former. It is about getting scripts covered. We have said to our prescriber partners, listen, we're going to help you get access to Vivi for the most difficult patients in your practice, for patients with no insurance. you know, patients that may not have means, we're going to partner with you and make sure that everybody in your practice who can benefit from this product will get access to it. And at the same time, you know, as part of that, you know, because they see the clinical benefits, they're also sending us the commercial scripts. As you said, we get more units per prescriber than any other medication. But the challenge for us in terms of delivering a sturdy ASP is to be able to take a commercial covered script and financially benefit from it. And the relationship with ApolloCare is going to help in that regard.

Thank you. Our next question comes from the line of Jeffrey Cohen with Lattenberg Thalman & Company. Your line is now open.

Hey, good morning, Mark and Andrew. It's been brought up a couple times, but I wanted to get back to it, and hopefully you can walk us through a bit of information as far as specialty sales team out there that you have now and how you'd expect that to grow into back half the year, Q3, Q4, and how that's helping on the awareness drive and education and actual number of feet on the street.

Thanks. Thanks, Jeff. You know, as I said, I don't think, you know, that we have done as well as we should have and could have with those non, well, even tri-essence, I would say. You know, it's been a fairly slow launch. But the question is what is possible. And our expectation is that by the end of the year and very likely into the fourth quarter, we should see a revenue run rate that is sort of consistent with where these products were when we took over them. Triessence is a totally different story. We do have very high, I have very high hopes for that product. I'm particularly excited about entering the ocular inflammation market. I think it's a very, very big, big opportunity for us. It's a great product. It's trusted. It's, you know, it's proprietary. But importantly, at the consumer level, it has a $37 copayment. It is the lowest out-of-pocket cost at the consumer level of any product in the category. And so if you're a prescriber and you want to save your patients money in terms of actual out-of-pocket costs at the consumer level on a month of per month of therapy, it's certainly the lowest of any product in the category. So it offers Tremendous value. That said, Chad is coming on, we're staffing him up, but I am going to, and we are focused on that tri-essence opportunity. We intend to launch Biclovie at the Hawaiian Eye meeting in the January timeframe. Early next year, we'll probably get some sales, some stocking orders in the fourth quarter for Biclovie, but modest. But we're really focused in, as a stockholder, they want us, I think, dialed in on that triessence opportunity in the ocular inflammation market. At the same time, Allie and her team are doing a terrific job, and I've seen it, I saw it at the ASRS meeting in Long Beach, you know, growing unit volumes of triessence in the retina market. So, I think we're in good shape. As I said earlier, we have work to do with that portfolio. But I think we're going to get there. I think we're going to get there. We're seeing good signs of growth in the third quarter, and I remain confident we can get to that number for that basket of products. I want to make one thing also clear. I said this in the letter to stockholders. We're going to underperform in certain parts of our business. But other parts of our business, we're going to overperform. And so all in all, I think we're going to do really well for the overall period. Triessence by the fourth quarter is one I think we could, you know, certainly overperform for the period. IESO is an overperformer, and VIVI could overperform well as well.

Got it. Thanks for taking the questions. Thank you, Jeff.

Our next question comes from the line of Thomas Flatton with Lake Street Capital Markets. Your line is now open.

Yeah, I appreciate you guys taking the question. Mark, in your prepared comments, you said something that caught my eye about, you know, right now your solutions are pharmaceuticals, but that might evolve. Can you dig into that a little bit for us?

Sure. We are – and this will be, I think, described further when we get to the – The investor and analyst day we never talk about our pipeline and at that investor day. You know we're going to talk about some of our pipeline products, some of the things that we're working on, and some of them are not pharmaceutical initiatives, and so I want. I want our investors to be aware of that. The key for us is to be an ophthalmic disease management solution business. And those solutions don't necessarily need to be pharmaceuticals per se. They might exist outside of purely a pharmaceutical product. But I have to say, because I've done so much talking today, and I promise on our next investor call, I'm going to have Amir talking about the science. We're going to have Robert Marlayson, head of commercial talking about commercial and Andrew talking about the financial so you'll hear a lot less of me on the next. Robert Marlayson, conference call and at that investor and analysts meeting you'll really have a great opportunity to meet all these people. Robert Marlayson, To meet commercial leadership, the folks that are selling ideas over selling tri essence. And we're also planning to have a number of customers there, physicians who use the product and experience these products, and they can talk to you about their experiences firsthand.

Excellent. And just one quick follow-up. You mentioned the refill rate in 2024. I was curious if in 2025, you know, seven and a bit months in, if the refill rates in 2025 are annualizing at kind of that nine refills per patient per year rate.

I think we're on track. I mean, you have to put – it's an amazing product. It just feels so good in the eye relative to other products. We just had a campaign. There was a terrific meeting called Women in Ophthalmology, and we had a campaign at that meeting that I came up with a long time ago. Our commercial team didn't like it, but it was called Cut the BS. Cut the BS. And it's kind of sort of a risky – But what BS stands for is burning and stinging. And these doctors really identified with the concept of cutting the burning and stinging. And a lot of other products out there, especially, you know, some of the recently launched products, they can't say that. They have problems with burning and stinging. And we don't. You know, we have a really terrific tolerability profile. And the person who cares most about that tolerability profile is the patient. When the patient gets relief, they don't have the burning and stinging, and their dry eye disease is being alleviated, they refill. And when you get that refill rate, and our refill rate's steady, Eddie, you know, you see, you know, and we don't anticipate that yielding anytime soon, Thomas.

Thank you. Our next question comes from the line of Yi Chen with H.C. Wainwright & Company. Your line is now open.

Thank you for taking my question. Could you provide some comments regarding the timing difference of the V-Bi prescription growth in the quarter and also the recorded revenue for the quarter? And also, do you have an estimate timeline as to when V-Bi could become the largest cyclosporine-based dry product?

Wow. Andrew, do you want to – I'm going to – you start. I gave you the first one. I'm going to give you maybe the last.

Hey, thanks for the question. With all the products this quarter, we didn't see a whole lot of stocking dynamics. So the unit demand and script numbers were pretty tight as related to the revenue recognition during the quarter.

And by the way, on the timing of being the top banana in dry eye, our primary goal with the franchise, as I said in the prepared remarks, is to be the number one cyclosporine in the U.S. market. Secondarily, we intend to be the number one anti-inflammatory in the U.S. market. And I think the tertiary goal would then be the number one most prescribed product in the U.S., And when I talk to Maria, who's sort of the CEO of that franchise, that's the goal. Primary is to be the number one cyclist sport, and that's what she's driving towards with her team every day.

Thank you. And we're currently out of time. I will now turn the call back to Mark Elbaum for closing remarks.

Thank you operator and thanks everyone for the questions and for joining us today as we continue to build on our strong momentum, we remain focused on driving sustained growth and expanding our impact across the ophthalmic space. The addition of experienced senior leaders to our team further strengthens our ability to execute with excellence and scale with confidence. Thanks to the efforts of our Harrow family, we're excited about what lies ahead and look forward to sharing more progress in the coming months to come. If you have any further questions or need additional information, please don't hesitate to reach out to Mike Biega. Once again, M-B-I-E-G-A at harrowinc.com. This will conclude our call.

This concludes today's conference call. Thank you for your participation. You may now disconnect.