Good morning. Welcome to the H.C. Wainwright Fifth Annual Ophthalmology Virtual Conference. My name is Li Chen, and I'm an Equity Research Analyst at H.C. Wainwright. For this session, we'll have a fireside chat with Mr. Mark Baum, Chief Executive Officer and Chairman of the Board of Harrow, and Mr. Andrew Boll, Chief Financial Officer of Harrow. Welcome. Thank you, Li. Last month, Harrow acquired the commercial rights to biosimilar drugs referencing Lucentis and Eylea from Samsung Bioepis. Could you comment on the rationale behind this deal and why the previous commercial partner decided not to continue to market these drugs? Yeah, so thanks for the question, Li, and we really appreciate the audience and appreciate H.C. Wainwright's sponsorship and interest in Harrow. The rationale for the current partner of Samsung deciding to not market the drugs is really something that, you know, I can't discuss. What I can tell you is that Harrow is very interested in retina. As you know, last year we made a retina pivot. We invested heavily building a world-class commercial organization to leverage our product, IHEEZO. IHEEZO is a topical anesthetic that's used to anesthetize the eye for intravitreal injections. Andrew and I have been looking for a therapeutic to marry with the anesthetic because every one of these intravitreal injections of a therapeutic also requires an anesthetic. We really feel like we found the perfect partner in Samsung. We think they have the best assets in the market. These are interchangeable assets with the reference products. Samsung's not an ophthalmology-only company. Biogen, their former partner, is not an ophthalmic-focused company. We are. We have those relationships in retina, and this is just the perfect marriage for us with our product, IHEEZO. Got it. When do you expect these biosimilar drugs to become available to your sales team, and do you expect them to generate any synergy with your existing product portfolio? We're going to hopefully launch in the middle of next year. We expect for the commercial rights to be transitioned to us hopefully by the end of this year. As I said, we'll launch in the middle of next year. OPUVIZ is going to launch as soon as probably the middle of 2027. As I said before, there is tremendous clinical synergy between these therapeutics and IHEEZO. Every one of these injections obviously requires an anesthetic. Now we're going to have both. We'll have both the anesthetic and the therapeutic to offer to our retina customers. We also own TRIESENCE, by the way, which we sell into the retina market. I think now with OPUVIZ, BYOOVIZ, IHEEZO, and TRIESENCE, I've been told I think we have the largest retina ophthalmic pharmaceutical portfolio in the U.S. market. Got it. That's very helpful. How many direct competitors are currently in the market as Lucentis or Eylea biosimilar, and how is your marketing approach differentiated from the previous commercial partner or any other company that are selling biosimilars? Andrew? Yeah, hey, Li. You know, there's a couple of biosimilars on the market currently for Lucentis, including BYOOVIZ, and about five for Eylea, although only one is on the market currently, PAVBLU. We're expecting more to come to market around the same time we'll be coming to market with our Eylea biosimilar, hopefully in 2027. We look at this biosimilar market and our approach is sort of unique compared to some of these other companies. We see these products not necessarily as a generic, not necessarily as a branded product, but sort of a hybrid as a biosimilar. Our approach is much more bespoke, I would say. It's much more customer-oriented. We think that this approach is going to give us a very big competitive edge where we can leverage our existing commercial infrastructure that has these deep relationships with the retina clinics and office and specialists. We also have incredible flexibility from a commercial perspective with our cost structure because we have that infrastructure in place to leverage and really build off of from the sales approach we've built with IHEEZO. We're really excited to leverage that experienced commercial team, leverage these call points that we're already making, and really have a portfolio on the buy and bill side to offer these retina offices with the anesthetic, the therapeutic, and even TRIESENCE. Got it. In Got it. In your view, is there a specific segment of the Wet AMD or DME market that you are going to target with BYOOVIZ and OPUVIZ? The way we think about the market is that it's divided into three segments. There is sort of the low-cost option, which is repackaged Avastin, and people use that product not because it's the most efficacious, but because it's the lowest in cost. There's a middle category, which is the main category of branded products, which would include those that we're going to bring to market. That also includes Eylea and Lucentis and all of the other branded products in the category. The third category is really what you use when nothing is working. That's a very, very small market. They use products like BioView even, but very rarely. We anticipate focusing on taking market share in the two largest areas of this market, the first two segments. Believe it or not, we intend to compete with Avastin, repackaged Avastin. Of course, we're going to compete in the middle category with these branded products. Every percentage point of market share is north of $80 million. It's a very large revenue opportunity for us. We're excited, given our cost structure, to take as many of those percentage points as we possibly can. Got it. Thank you. Can you talk about the current reimbursement landscape for biosimilars and how large a contribution will these drugs be able to make to your top line growth in the 2026 or 2027 timeframe? Yeah, for these products, you have these product-specific Q codes that are reimbursed at ASP. They're similar to the rest of our buy and bill portfolio where you have this product-specific reimbursement. The Q codes for BYOOVIZ and OPUVIZ are already established. They're out there, and we're excited to kind of leverage that profile. As for revenue contribution, with the first launch expected in 2026, we don't anticipate massive contribution in 2026. As we get closer to the launch date, we should be able to provide a little bit better visibility in what that anticipated revenue input will be. Probably more importantly, though, is as we look into 2027 and 2028 and sort of the medium term for these products, and we get OPUVIZ to the market as well, we really think that's when revenues will start increasingly show up, show up more increasingly in our total top line numbers in 2027 and definitely in 2028. Thank you. In your view, do you think the six months TKI treatment for Wet AMD that is currently in the phase three stage of development may potentially present an existential threat to Lucentis and Eylea market? How does this going to affect your marketing strategy in the short and long term? You know, I'll take that, Li. The reality is, if there's something that's going to come to market that's going to help patients, we're all for it. These are conditions which cause blindness. To the extent that ocular therapeutics or EyePoint or any company can come to market with something that works really well and benefits patients, that's accessible and affordable, we are all for it. I think that's part of our commitment to putting patients first. As to those specific products, the reality is that the anti-VEGF therapies these days work really well. When I think about markets, I think of them in terms of whether they're contested or competitive. Certainly, the anti-VEGF market is a contested market, and it's a competitive market. On the competitive side, you have to also think about access. Who's going to pay for these things? What are they going to cost? What are the out-of-pocket costs for patients going to be? I've heard scuttlebutt about inflammation and what the real duration of these therapies is going to actually be. I think some are concerned about the business model that exists within the retina market and how difficult it's going to be to disrupt that with any new product. When we got into this market, we analyzed all of those issues. Whether it's a gene therapy or a TKI or anything that might be on the horizon, our perspective is we want to have stability in our presence in the market and durability of revenue. The way that we're going to launch these products, I think you'll see next year, is very unique and is consistent with how we've built our business. We've always not been afraid of doing things a little bit different and thinking outside of the box. We're going to enter these markets. I think we're going to have a stable presence. I think we'll have a growing presence. We're going to take market share. When the TKIs come out, if they can benefit patients and they're affordable and accessible, that's great. There are really, really good anti-VEGF therapies, and I think they're going to be the low-cost option. Even the most expensive anti-VEGF will be a low-cost, high-quality option for patients, probably relative to a TKI. Got it. Thank you. Harrow also acquired last month the U.S. commercial rights to BYQLOVI for the treatment of postoperative inflammation and pain following ocular surgery. Is this market already crowded? How is this drug differentiated from other drugs that are currently being marketed for the same indication? It is a, I wouldn't say it's a crowded market. It's a very crowded market. There are a lot of, there are a lot of topical corticosteroids out there. We did not have an interest in competing in that market unless we had a product that was truly clinically differentiated. That is what BYQLOVI is. It is the first novel differentiated steroid on the market in well over a decade. It has a super potent classification with its active ingredient, which is clobetasol. It's the first FDA-approved steroid that uses clobetasol. In terms of its best-in-class features, why do I say that? It's because of the robust clinical efficacy. Over 80% of the patients in their clinical studies reported a pain-free status on day four following surgery. In terms of its safety profile, very low incidence of intraocular pressure elevation. It had, frankly, a similar safety profile to placebo. It's also BID dosing, so it's easy for patients to administer. If I was in need of a topical steroid or my mother or someone that I love, I would want them to have BYQLOVI over really any of the other old products in the market. BYQLOVI is differentiated. We're excited to bring it to market, and we're going to do that beginning in Q1 of 2026. We're going to probably launch at the Hawaiian Eye Meeting in January. We'll probably have some stocking orders, hopefully in the fourth quarter, but minor stuff. BYQLOVI is going to be a great product, and it's a very large market opportunity, over 7 million use cases per year in the U.S. Got it. Switching the topic to your existing product portfolio, you just reported second-quarter results, and VEVYE for July has been showing really impressive growth. Can you comment on VEVYE's current market share compared to competitors such as Restasis, Xiidra, and Miebo? Do you expect VEVYE's prescription growth momentum to continue in 2026? Yeah, so we reported our earnings yesterday. We reported that we had, at the end of the second calendar quarter, a 7.8% share with VEVYE of the U.S. dry eye market. That's about 2.6 percentage points of improvement from Q1 to Q2. We are rapidly, I would say, gaining share. Our primary strategic goal is to become the number one most prescribed cyclosporine. Believe it or not, Restasis is a big product still. I don't know why doctors prescribe Restasis. I mean, I have some ideas. If I was a patient, once again, I would not want to use this legacy product. It would be like almost buying a BlackBerry when you can buy the latest iPhone. We think the future is going to be moving towards cyclosporines like VEVYE. We're excited with the progress we're making. We're actually en route to becoming the number one cyclosporine. We officially passed CEQUA in national market share already. Our intention is to take over the Restasis spot soon. The next goal will be to be the number one anti-inflammatory. That would add Xiidra and then to eventually be the number one most prescribed dry eye product in the U.S. That would include even taking share and being larger than Miebo. We have a long way to go. We're only at 7.8%. We're growing. I see the new prescriptions coming in every day, and we don't see that yielding. We think we're going to grow for, you know, many, many years to come with this product. It has a long runway. We have great IP. Besides all of that, it's really helping a lot of patients, and it's accessible and affordable. There's no reason to prescribe Restasis when you can get access to VEVYE. I think VEVYE at a max out-of-pocket of $59 is less expensive than what patients would pay for generic Restasis on the Mark Cuban pharmacy website if you go there. It's really accessible and affordable, and it's a great product. Got it. In the second quarter, IHEEZO sales really showed a very strong and impressive growth rate compared to the first quarter. Can you talk about how the sales trend is going to continue in the coming quarters? Yeah, I think people thought IHEEZO was, you know, not going to get to where we thought it was. We've continued to have faith that, you know, we have the right product in the right market. It's a very large market opportunity. It is on pace to have a record revenue year. We reported $18.3 million in revenue for that product in the second quarter. That was 25% sequential quarterly growth. The growth, though, is in retina, which is exactly where we thought it would be back in August of last year. We've expanded our distribution through new GPO relationships, new agreements, and 100% of our new accounts actually in the third quarter even, and in the second quarter were retina accounts. We've grown 33%, for example, quarter- to- quarter within the largest retina GPO. That one GPO represents 70% of the retina market. That's a strong relationship, and that's showing a lot of promise. Distributor volume increased by 170% in Q2 compared to Q1. That just underscores the strong and accelerating demand. I witnessed this when I was at the 8th in Long Beach recently. The reception the product is receiving now, more and more doctors have used it. They have seen what it's done for their practices in terms of time and motion savings, which is really precious to them. I think it's just at the beginning of this growth inflection. There is tremendous clinical synergy with the biosimilars that we're going to bring to market beginning next year. We're very bullish on IHEEZO going forward. We think Ali, who runs that sales organization, is doing a terrific job. Even in Q3, in our call, we've actually eclipsed in about the first month or so of the third quarter the total number of new accounts that had started in all of the second quarter. There's momentum there. With respect to TRIESENCE, I think Harrow is going to launch it for a new indication, right? How is the growth potential there? We're going to make it available really in the ocular inflammation market in general. It has a very broad label, and it is reimbursed in the ASC, in the hospital, and in the office. The ocular inflammation market for inflammation connected to surgical injuries, for example, or inflammation associated with surgery, is the largest market for this product, and it is reimbursed. One of the things I think I tried to highlight yesterday on our call, and I'll mention today, I think it's very important, is the tremendous coverage that both IHEEZO and TRIESENCE have. If you just look at the number of claims presented that were rejected, it's under 5% for each one of those products. When you have a product where there's a very low percentage of claims that require a prior authorization or that are ultimately rejected, you have better than 92%, 95% coverage. That's unheard of. It's pervasive coverage. The opportunity to make TRIESENCE available, as I said, in that ocular inflammation market, really connected to surgical inflammation and IHEEZO, these are going to be major growth drivers, I think, beginning in the, oh, IHEEZO is already going. TRIESENCE should pick up in the fourth quarter and certainly in 2026 and beyond. Coverage is really important, and we have phenomenal coverage, and that shouldn't be understated. Yep, that's very helpful. How is the ImprimisRx business going to be positioned in your product portfolio going forward? Is it going to continue to generate a stable level of revenue every year in the coming years? It is a stable, mature, cash-generating business. It's also more than that. It is a business that builds products that our customers love and that they use day in and day out. It makes their practices more efficient. It helps patients. We sell unique products like fortified antibiotics that are refrigeration stable, proprietary products in that business. When a patient comes in with a sight-threatening corneal ulcer on a Friday afternoon, it's that ImprimisRx product that's in the refrigerator that the doctor can put on that patient's eye to know that the medication's on board before the patient leaves. That makes the doctor feel terrific that they've been able to help the patient. Those are the types of products that ImprimisRx makes. That business is actually doing really well. It just, as I said, generates a lot of cash. What I think you're going to see us do with that business is continue to find pockets of revenue, pockets of products that we can transition to FDA-approved products. We've been able to do that successfully. Actually, the numbers that we posted yesterday for ImprimisRx, if you were to add back the revenue from Klarity-C, which, you know, we began to transition to VEVYE, those patients from Klarity-C to VEVYE, ImprimisRx did much better than the numbers that we even posted. That business is doing well. John's doing a great job and the rest of his team. It's not an easy business to operate, but it's an important business to our customers. It's the business that allowed us to build what is now, I think, one of the largest portfolios of ophthalmic pharmaceutical products in the U.S. market. We love the business, and it'll continue to be an important part of our company. Could you tell us the current development status for MELT- 300? Do you think the commercial launch could occur in the coming year? Yeah, so MELT has a SPA with the FDA. They have an agreement with the FDA as to what they need to do in order to put an NDA together, a dossier that would be acceptable for approval. The toughest part of those requirements were really in the clinical efficacy studies, which are completed. That was the real risk, the real difficulty. There are a few studies that need to be completed, data sets that need to be built. Those are, I would say, almost perfunctory in nature, low risk. They should be completed hopefully by maybe the first quarter of next year. They'll get an NDA filed. It's possible they can get that approved by the end of next year. I think that's a 2027 launch. Boy, is that a really exciting product opportunity. We once again make the MKO Melt. That's a compounded product. I think there's going to be a lot of customers that are going to be interested in sublingual sedation for cataract surgery using something like the MELT- 300, assuming it's ultimately approved. It's a really exciting opportunity. The biggest opportunities for that are actually outside of ophthalmology. The initial market will be in ophthalmology, assuming it can get approved. We'll have a launch hopefully in early 2027 with that. In terms of the company's overall operations, when will it become sustainably profitable? Does your current cash position provide a runway to the profitability? I think the short answer here is soon. Certainly, the current cash position is more than enough to provide us a runway to get to where we want to be from a cash flow generation standpoint on a consistent basis. This last quarter, we were able to show off that operating leverage that we expect to continue to see from the business. We're certainly confident we can continue to see expanding the operating leverage as our revenue goals are met through the course of this year and certainly into next year. We talked a lot about the synergies commercially with IHEEZO and the biosimilar portfolio. Certainly, every new piece of revenue that we get from all the products and with the launch of the biosimilars, we expect to be more accretive from an operating leverage perspective than prior revenue. Thank you, Andrew. Could you talk about your current criteria for potential additional acquisitions? Any new deals that you expect to occur during the remainder of 2025 or maybe the first half of 2026? Yeah, so I think we've done more deals in the ophthalmology space than anyone over the last five years. We're always looking at deals. I think we've become a bit of a magnet for developers that are looking for commercial infrastructure to begin to monetize the assets they've invested in and worked so hard to get to later stages or even a commercial stage. There are a lot of products out there, technologies that I think fit into this infrastructure that we've built. It is a hard-to-replicate commercial infrastructure, candidly, because we touch the front of the eye, the back of the eye. We have all the hubs and, whether it's part D or part B, we just have a lot of commercial infrastructure in place for these ophthalmic disease management solutions. If you look at the acquisitions we've done, we don't like to take folks out of all of their costs and getting into development. We'll put a little bit up front, and we ask our partners to take a back end to take a share of our success. This provides us with a low-cost structure. It gives us flexibility to compete in a market, particularly if it's a competitive market. We're interested in later-stage assets. We're not going to do phase I type work or preclinical work. It's got to be in an area that we really understand. We think we know the eye fairly well and vision and this specific market. There are a lot of interesting things out there. Andrew and I, after we do a deal, we always look at each other and say, "That's the last one." Then there are two or three more on our plate that we get really excited about. There's a lot of stuff that we're working on currently. We will do more. I'm very excited about actually what we're looking at. Stay tuned. Got it. Thank you, Mark. We are getting to the end of this session. Would you like to provide a summary of upcoming catalysts or any closing remarks for the audience? Yeah, once again, I want to thank H.C. Wainwright for the audience and thank you, Li, for the questions. You know, we're at an inflection point, I think, in terms of the key growth drivers. VEVYE is doing incredibly well. We have a unique market access program called the VEVYE Access for All program. It's doing really well. IHEEZO is ramping. It's real. We just implemented a program called IHEEZO Access for All because there is no reason to do an intravitreal injection and not use IHEEZO, especially given the pervasive coverage that we have. TRIESENCE is about to expand into its largest market. These are really interesting developments. BYQLOVI is launching in the first quarter of 2026. We're bringing BYOOVIZ out in the middle of 2026. We have some really exciting acquisitions on board. We're going to talk all about this at our first inaugural Investor and Analyst Day. We hope we'll see you there in New York on the 26th of September. We're also going to talk about our pipeline. We never talk about our pipeline publicly, but our Chief Science Officer, Amir Shojaei, is going to be there talking about some really exciting, fairly advanced programs that I think our stockholders, you know, they don't know about, but they're going to be excited to learn about. Once again, thank you for the audience, Li, and thank you to H.C. Wainwright. Thanks, Li. Thank you, Mark. Thank you, Andrew. Best wishes to your commercial efforts as well as the clinical development. Thank you. Thank you.