Harrow Health at H.C. Wainwright Conference: Strategic Moves in Ophthalmology

On Wednesday, 13 August 2025, Harrow Health (NASDAQ:HROW) participated in the H.C. Wainwright 5th Annual Ophthalmology Virtual Conference. The company outlined its strategic initiatives, focusing on acquisitions and product launches in the ophthalmic market. While Harrow Health shared optimistic growth projections, it also faces challenges in a competitive landscape.

Key Takeaways

• Harrow Health aims to launch biosimilars referencing Lucentis and Eylea by mid-2026 and Opuviz in 2027.
• The company acquired US commercial rights to Biclovy, targeting a launch in early 2026.
• iHizo sales increased by 25% sequentially in Q2 2024, with revenues reaching $18.3 million.
• Harrow Health plans to expand into the ocular inflammation market with Triessence.
• An inaugural investor and analyst day is scheduled for 26 September in New York.

Financial Results

• iHizo revenue reached $18.3 million in Q2, marking a 25% quarterly growth.
• Vevi’s market share in the US dry eye market grew to 7.8% by the end of Q2.
• Distributor volume for iHizo surged by 170% in Q2 compared to Q1.
• Future revenue growth is expected from biosimilars, with significant contributions projected for 2027 and 2028.

Operational Updates

• Harrow Health is preparing for the launch of biosimilars and Biclovy in 2026.
• The company is strengthening its presence in the retina market with iHizo and expanding Triessence into ocular inflammation.
• Access programs for Veevae and iHizo have been implemented to enhance product availability.

Future Outlook

• Harrow Health aims to surpass Restasis and Xiidra as the top prescribed cyclosporine.
• The company plans to compete with both low-cost Avastin and branded anti-VEGF products.
• Strategic acquisitions focusing on later-stage ophthalmic assets are a priority.
• More details on Harrow Health’s pipeline will be unveiled at the upcoming investor day in New York.

Q&A Highlights

• Harrow Health views the biosimilar market as a hybrid between generics and branded products.
• The company is focused on maintaining market presence and ensuring revenue stability.
• Transitioning revenue streams to FDA-approved products is a key focus.

Readers are invited to refer to the full transcript for more detailed insights into Harrow Health’s strategic plans.

Full transcript - H.C. Wainwright 5th Annual Ophthalmology Virtual Conference:

Lee Chen, Research Analyst, HC Wainwright: Good morning. Welcome to the HC Wainwright fifth annual ophthalmology virtual conference. My name is Lee Chen, and I’m an accurate research analyst at HC Wainwright. For this session, we’ll have a fireside chat with mister Mark Wong, chief executive officer and chairman of the board of HARO, and mister Andrew Wong, chief financial officer of HARO. Welcome.

Mark Wong, CEO and Chairman, HARO: Thank you, Yi.

Lee Chen, Research Analyst, HC Wainwright: Last month, HARO acquired the commercial rights to biosimilar drugs referencing Lucentis and Eylea from Sensome Bioethics. Could you comment on the rationale behind this deal and why the previous commercial partner decided not to continue to market these drugs?

Mark Wong, CEO and Chairman, HARO: Yeah. So thanks for the question, Ian, and we really appreciate the audience and appreciate H. C. Wainwright’s sponsorship and interest in Harrow. The 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, iHizo. And iHizo 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.

And 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. And, you know, Samsung’s not a a an ophthalmology only company. Biogen, their former partner, is not an ophthalmic focused company, and we are.

We have those relationships in retina, and this is just the perfect marriage for us with our product, Aeza.

Lee Chen, Research Analyst, HC Wainwright: Got it. So 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?

Mark Wong, CEO and Chairman, HARO: Well, we’re gonna hopefully launch in the middle of next year. So we expect for the commercial rights to be transitioned to us, hopefully, by the end of this year. And as I said, we’ll launch in the middle of next year. Opiviz is gonna launch as soon as probably the 2027. And as I said before, there is tremendous clinical synergy between these therapeutics and iHizo, and every one of these injections obviously requires an anesthetic.

And now we’re gonna have both. We’ll have both the anesthetic and the therapeutic to offer to our retina customers. We also own Triessence, by the way, which we sell into the retina market. So I think now with op OPVIZ, BioViz, AHIZO, and Triessence, I’ve been told I think we have the largest retina ophthalmic pharmaceutical portfolio in The US market.

Lee Chen, Research Analyst, HC Wainwright: Got it. That’s very helpful. How many direct competitors are currently in the market as Los Santos or Idea biosimilar? And how is your marketing approach differentiated from the previous commercial partner or any other company that are selling biosimilars? Andrew?

Andrew Wong, CFO, HARO: Yeah. Hey, Yi. I you know, there’s a there’s a couple biosimilars on the market currently for Lucentis, including BioViz and about five for EYLEA, although only one is on the market currently, PABLUE. But 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 and our approach is sort of unique compared to some of these other companies.

We see these products not necessarily as a a generic, not necessarily as a branded product, but sort of a hybrid, as a biosimilar. And so our approach is much more bespoke, I would say. It’s much more customer oriented, and we think that this approach is gonna 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 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 the the sales, the sales approach we’ve built with iHizo. And so we’re really excited to to leverage the 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 Triassins.

Lee Chen, Research Analyst, HC Wainwright: Got it. In your view, is there a specific segment of the wet AMD or DME market that you are going to target with Vylevis and OpuVis?

Mark Wong, CEO and Chairman, HARO: So the 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. The there’s a a middle category, which is the main category of branded products, which would include those that we’re gonna bring to market. That also includes Eylea and and and Lucentis and and, you know, all of the other branded products in the category.

And then the third category is really what you use when nothing is working, and, you know, that’s a very, very small market, and, you know, they use products like Bayovu even, but very rarely. We anticipate focusing on taking market share in the two largest areas of this market, the the first two segments. So believe it or not, we intend to compete with Avastin, repackaged Avastin. And, of course, we’re gonna compete in the middle category with these branded products. So every percentage point of market share is north of $80,000,000.

It’s a very large revenue opportunity for us, and we’re excited given our cost structure to take as many of those percentage points as we possibly can.

Lee Chen, Research Analyst, HC Wainwright: Got it. Thank you. So okay. 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 2026 or 2027 time frame?

Andrew Wong, CFO, HARO: Yeah. You for for these products, the you have these product specific q codes that are reimbursed at ASP, so they’re they’re similar to to the rest of our buy and bill portfolio where you have a this product specific reimbursement. The queue codes for BioViz and and, Obiviz are already established. They’re out there, and we’re excited to kinda leverage that that that profile. As for revenue contribution, with with the first launch expected in 2026, we don’t anticipate massive contribution in 2026.

But as we get closer to the launch date, we should be able to provide a little bit better visibility in what that, what that anticipated revenue, input will be. Probably more importantly, though, is as we look into ’27 and ’28 and sort of the the the medium term for these products and we get Opivis to the market as well, we really think that’s when revenues will start increasingly, show up show up more increasingly in in our total top line numbers, in ’27 and and definitely in in ’28.

Lee Chen, Research Analyst, HC Wainwright: Thank you. In your view, do you think, the six months TKI treatment 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? And how does this going to affect your marketing strategy in in the short and long term?

Mark Wong, CEO and Chairman, HARO: You know, I’ll I’ll take that, Yi. The the reality is is if there’s something that’s gonna come to market that’s going to help patients, we’re all for it. These are conditions which cause blindness. And to the extent that Ocular Therapeutix 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. And I think that’s part of our commitment to putting patients first.

As to those specific products, you know, the reality is is that the anti VEGF therapies these days work really well. And, you know, when I think about markets, I think of them in in terms of whether they’re contested or competitive. And, certainly, the anti VEGF market is a contested market, and it’s a competitive market. But on the competitive side, you have to also think about access and who’s gonna pay for these things. What are they gonna cost?

What are the out of pocket costs for patients going to be? I’ve heard scuttlebutt about inflammation and what the 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, you know, how difficult it’s going to be to disrupt that, you know, with any new product. So when we got into this market, we analyzed all of those issues. And whether it’s a gene therapy or a TKI or anything that might be on the horizon, our perspective is we wanna have stability in our presence in the market and durability of revenue.

And the way that we’re gonna 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 been you know, we’ve always not been afraid of doing things a little bit different and thinking outside of the box. So we’re gonna enter these markets. I think we’re gonna have a stable presence. I think we’ll have a growing presence, and, you know, we’re gonna we’re gonna take market share.

And when the TKIs come out, if they can benefit patients and they’re affordable and accessible, that’s great. But there are really, really good anti VEGF therapies, and I think they’re gonna 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.

Lee Chen, Research Analyst, HC Wainwright: Got it. Thank you. Herro also acquired last month The US commercial rights to Biclovy for the treatment of postoperative inflammation and pain following ocular surgery. Is this market already crowded, and how is this drug differentiate from other drugs that are currently being marketed for the same indication?

Mark Wong, CEO and Chairman, HARO: Well, 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

Lee Chen, Research Analyst, HC Wainwright: lot of

Mark Wong, CEO and Chairman, HARO: topical corticosteroids out there, and we did not have an interest in in competing in that market unless we had a product that was truly clinically differentiated. And that is what Biclovy 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.

And in terms of its best in class features, why do I say that? It’s because of the robust clinical efficacy. Over eighty percent 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, and 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 Biclovy over really any of the other old products in the market. Biclovy is differentiated. We’re excited to bring it to market, and we’re gonna do that beginning in 2026. We’re gonna probably launch at the Hawaiian I meeting in January. We’ll probably have some stocking orders hopefully in the fourth quarter, but minor stuff.

But, Biclovy is gonna be a great product, and it’s a very large market opportunity. Over 7,000,000 use cases per year in The United States.

Lee Chen, Research Analyst, HC Wainwright: Got it. Got it. So, switching the topic to your, existing product pro portfolio. You just reported second quarter results, and VY for July has been showing really impressive growth. So can you comment on vVY’s current market share compared to competitors such as Restasis, Xiidra, and MyBull?

And do you expect vVY’s prescription growth momentum to continue in 2026?

Mark Wong, CEO and Chairman, HARO: Yes. So we reported our earnings yesterday. We reported that we had, at the end of the second calendar quarter, a 7.8% share with Vevi of The US dry market. That’s about 2.6 percentage points of improvement from q one to q two. So we are rapidly, I would say, gaining share.

But our primary strategic goal is to become the number one most prescribed cyclosporine. Believe it or not, Restasis is a big product still, and I don’t know why doctors prescribe Restasis. You know, I mean, I have some re I I have some ideas. But if if I was a patient, once again, I would not wanna use this legacy product. It would be like almost buying a, you know, a BlackBerry when you can buy the latest iPhone.

And so we think the future is going to be moving towards cyclosporins like VeeVai. We’re excited with the progress we’re making. We’re actually on you know, en route to becoming the number one cyclosporine. We officially passed CEQUA in national market share already, and, you know, we’re 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 US, and that would include even taking share and being larger than MIBO.

But we have a long way to go. We’re only at 7.8%. We’re growing. You know, I see the new prescriptions coming in every day, and we don’t see that yielding. We think we’re gonna grow for, you know, many, many years to come with this product.

It is a long runway. We have great IP. And, you know, besides all of that, it’s really helping a lot of patients, and it’s accessible and affordable. So there’s no reason to prescribe Restasis when you can get access to Veeva. I think Veevae 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.

So it’s really accessible and affordable, and it’s a great product.

Lee Chen, Research Analyst, HC Wainwright: Got it. And in the second quarter, iHiso sales really showed, you know, a very strong and impressive growth rates compared to the first quarter. Can you talk about how the sales trend is going to continue in the coming quarters?

Mark Wong, CEO and Chairman, HARO: Yeah. I think people thought iHizo was, you know, not gonna 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 18,300,000.0 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. We’ve expanded our distribution through new GPO relationships, new agreements, and 100 of our new accounts, actually, the third quarter even and in the second quarter were retina accounts. So we’re we’ve grown 33%, for example, quarter over quarter within the largest retina GPO, and and that one GPO represents 70% of the retina market.

So that’s a strong relationship, and and that’s showing a lot of promise. Distributor volume increased by a 170% in q two compared to q one, and that just underscores the strong and accelerating demand. And I witnessed this when I was at the in Long Beach recently. The reception the product is receiving now. More and more doctors have used it.

They’ve they have seen what it’s done for their practices in terms of time and motion savings, which is really precious to them. And, you know, it it’s, I think just at the beginning of this in this growth inflection. There is tremendous clinical synergy with the biosimilars that we’re gonna bring to market beginning next year, and, we’re very bullish on, on iEZO going forward. We think, Ali, who runs that sales organization, is doing a terrific job. And and, you know, even in q three in our call, we’ve actually eclipsed in about the first month or so of the third quarter of the total number of new accounts that had started in all of the second quarter.

So there’s momentum there.

Lee Chen, Research Analyst, HC Wainwright: And with respect to Triassence, I think Cara is going to launch it for a new indication. Right? How is the growth potential there?

Mark Wong, CEO and Chairman, HARO: Well, we’re gonna we’re gonna 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. And, 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 iHizo and Tri Essence have. The if you if you just look at the the number of of claims presented that were rejected, it’s under five percent for each one of those products.

And so 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 know, you have better than 92, 95% coverage. That’s unheard of. I mean, it’s pervasive coverage. So the the opportunity to make Triassins available, as I said, in that ocular inflammation market really connected to surgical inflammation and and iHiso, these are gonna be major growth drivers, I think, beginning in the oh, iHiso’s already going. Triassence should pick up in the fourth quarter and certainly in in 2026 and beyond.

Coverage is really important, and we have phenomenal coverage, and that shouldn’t be understated.

Lee Chen, Research Analyst, HC Wainwright: Yep. That’s very helpful. So how’s the in premise Rx business going to be positioned in your product full portfolio going forward? Is it going to continue to generate a stable level of revenue every year in the coming years?

Mark Wong, CEO and Chairman, HARO: It is a stable, mature, cash generating business, but 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 it helps patients. You know, we sell unique products like fortified antibiotics that are refrigeration stable, proprietary products in that business.

And, you know, when a patient comes in with a a sight threatening corneal ulcer on a Friday afternoon, it’s that Imprimis 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 Imprimis makes. That business is actually doing really well. It just, as I said, generates a lot of cash. And what I think you’re gonna 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 Clarity C, which, you know, we began to transition to Veevae, those patients from Clarity C to Veevae, ImprimisRx did much better than the numbers that we even posted. So that business is doing well. John’s doing a great job and the rest of his team. And, you know, it’s not an easy business to operate, but it’s an important business to our customers.

And it 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 US market. So we’re we love the business, and it’ll continue to be important an important part of our our company.

Lee Chen, Research Analyst, HC Wainwright: Got it. And, Kate, could you tell us the current development status for MELT 300? And do you think the commercial launch could occur in the coming year?

Mark Wong, CEO and Chairman, HARO: Yeah. So MELT has a a SPA with the FDA. So they have an agreement with the FDA in as to what they need to do in order to put a an NDA together, a dossier that would be acceptable for approval. And the toughest part of those requirements were really in the clinical efficacy studies, which are completed. That was, you know, the real risk, the the the real difficulty.

And there are a few studies that need to be, completed, datasets that need to be built. Those are, I would say, you know, almost perfunctory in nature, low risk. And they they should be completed, hopefully, by the maybe the first quarter of of next year, and then they’ll get an NDA filed. And, you know, it’s possible they can get that approved by the by the end of next year. I think that’s a 2027 launch, but, boy, is that a really exciting product opportunity.

You know, we we once again make the MKO Melt. That’s a compounded product. And, you know, I think there’s gonna be a lot of of customers that are gonna be interested in sublingual sedation for cataract surgery using something like the Melt 300, you know, assuming it it’s ultimately approved. But it’s a really exciting opportunity. The biggest opportunities for that are actually outside of ophthalmology, but the initial market will be in ophthalmology assuming it can get approved.

But we’ll have a launch hopefully in early twenty twenty seven with that.

Lee Chen, Research Analyst, HC Wainwright: No. Mhmm. So in terms of the company’s overall operations, when will the when will it become sustainably profitable, and does your current cash position provide a runway to the profitability?

Andrew Wong, CFO, HARO: Hey. So the I think the short answer here is soon, and, certainly, the the current cash position is is more than enough to to provide us runway to get to where we wanna be from a cash flow generation standpoint on a consistent basis. This last quarter, we were able to kinda show off that operating leverage that we expect to continue to see from the business, and we’re certainly confident we can continue to to see expanding the operating leverage as our revenue goals are met through the course of this year and and certainly into next year. We talked a lot about the the synergies commercially with iHiso and the the biosimilar portfolio. And, certainly, every every kind of 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 than prior revenue.

Lee Chen, Research Analyst, HC Wainwright: Thank you, Andrew. And could you talk about your current criteria for, you know, potential additional acquisitions? Any new deals that you expect to occur during the remainder of 2025 or maybe the ’26?

Mark Wong, CEO and Chairman, HARO: Yeah. So, you know, we I think we’ve done more deals in in the ophthalmology space than anyone over the last five years. So 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 they’ve invested and worked so hard to get to later stages or even, you know, a a commercial stage. So there’s a lot of products out there, technologies that that I think fits 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 under you know, we have all the hubs and, you know, the whether it’s part d or part b, we just have a lot of commercial infrastructure in place for these ophthalmic disease management solutions. But if you look at the acquisitions we’ve done, we don’t like to to take folks out of all of their costs in getting into development. So we’ll put a little bit upfront, and we ask our partners to take a back end to take a share of our success. And, you know, this provides us with a low cost structure.

It gives us flexibility to compete in in in a in a market, particularly if it’s a competitive market. And we’re interested in later stage assets. We’re not gonna do, you know, phase one type work or preclinical work. And it’s gotta be in an area that we really understand. We think we know the eye fairly well and and vision and and this this specific market.

So 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. And then, you know, there’s two or three more on our plate that we get really excited about. So there’s a lot of stuff that we’re working on currently. We will do more, and I’m very excited about actually what we’re looking at.

So stay tuned.

Lee Chen, Research Analyst, HC Wainwright: Got it. Thank you, Mark. So we are getting to the end of this session. And would you like to provide a summary of upcoming catalysts or any closing remarks for the audience?

Mark Wong, CEO and Chairman, HARO: Yeah. Once again, I wanna thank HC Wainwright for the audience, and thank you, Yi, for the questions. You know, we’re at an inflection point, I think, in terms of the key growth drivers. Veevae is doing incredibly well. We have a unique market access program called the Veevae Access for All program.

It’s doing really well. IHizo is ramping. It’s it’s real. We just implemented a program called iHizo Access for All because there is no reason to do an intravitreal injection and not use iHizo, especially given the pervasive coverage that we have. And then Triessence is about to expand into its largest market.

So these are really interesting developments by Clovis launching in the 2026. We’re bringing BioViz out in the 2026, and we have some really exciting acquisitions on board. And we’re gonna talk all about this at our first inaugural investor and analyst day. We hope we’ll see you there in New York on the September 26. We’re also gonna talk about our pipeline.

We never talk about our pipeline publicly, but our chief science offers officer, Amir Shojae, is gonna 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 gonna be excited to learn about. So once again, thank you for the audience, Yi, and thank you to HC Wainwright.

Andrew Wong, CFO, HARO: Thanks, Yi.

Lee Chen, Research Analyst, HC Wainwright: Thank you, Bob. Thank you, Andrew. Best wishes to your commercial efforts and as well as the clinical development.

Mark Wong, CEO and Chairman, HARO: Thank you.

Andrew Wong, CFO, HARO: Thank you.

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