Thank you, operator. Good morning, and welcome to Harrow's second quarter 2025 earnings conference call. My name is Mike Biega, and I'm excited to be introducing today's call, having joined Harrow as Vice President of Investor Relations and Communications in June. It's a pleasure to be part of the Harrow 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 of 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 Harrow's control, including risks and uncertainties described from time to time in its SEC filings, such as the risks and uncertainties related to the company's ability to make commercially available its FDA-approved products and compounded formulations and technologies and FDA approval of certain drug candidates in a timely manner or at all. For a list and description of those risks…

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. Harrow 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 26 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 U.S. eye care professionals to manage ophthalmic diseases.…

[Operator Instructions] Our first question comes from the line of Chase Knickerbocker with Craig-Hallum.

Congrats on the progress here. Mark, maybe just first on VEVYE. Can you help us a little bit with kind of any kind of business rule changes within there as you guys onboard Apollo Care, et cetera, as far as how we should be thinking about ASPs sequentially from here? Is it just kind of normal seasonality where less co-pay 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. Yes. So on VEVYE ASP, I think a couple of things. One, in terms of new business rules going forward, we continue to tweak our algorithm, but it's really -- 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 VEVYE patients through those new business rules for the VEVYE Access for All program. And what I mean by that is, at the beginning of the year, you had a lot of patients, especially with co-pay resets that were paying $300, $400, $500 out of pocket for VEVYE. And the reality is that many patients just can't afford that level of payment for a product like VEVYE or really any product for that matter. And what the VEVYE 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 Apollo Care, 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 the overall ASP calculation. So we're thinking that 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 that 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 we expect that we're going to get an Analyst Day in September. But any thoughts as far as kind of contribution to the model in '26 and '27 because some of these biosimilar launches 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.

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 company -- ophthalmology pharma companies in the U.S., and we see this really as a perfect marriage between the 2 companies. I think in regards to contribution in '26, our hope is that we'll be able to launch BYOOVIZ in 2026 with having an immediate uptick 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 IHEEZO and with some of the other buy-and-bill 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 lot of -- it will be a really pleasant upside for a lot of investors and people looking at the long-term value of the company.

Our next question comes from the line of Steve Seedhouse with Cantor.

First question, I just want to ask about the growth in new prescriptions in the second quarter for VEVYE. How much of that was driven by Klarity-C switchers? And are you largely through any expected bolus of patients from Klarity-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 VEVYE in your stockholder letter. I'm just wondering how much growth would slow naturally from the Klarity-C patient bolus sort of unwinding? Or are you also expecting a slowing of sort of the organic growth ex Klarity-C?

Thanks for that question, Steve. I'm going to -- I'll tell you just straight up how many units came from Klarity-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 VEVYE 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 VEVYE 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 VEVYE fire with intention because we really -- we want to make sure that if an existing patient needs VEVYE 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 VEVYE. And as I said in the stockholder letter, because every unit of VEVYE is -- nearly every unit is profitable, we feel really confident in entering a new investment cycle and dramatically hopefully taking additional market share, probably starting that process at the end of the year and really setting us up well for 2026.

And just I wanted to also follow up on the Specialty Branded and TRIESENCE segment. So the guidance here, obviously, is pretty assertive, I mean, like more than a 7x increase half-over-half from $6 million 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, in force in fourth quarter. So I guess what are the expectations for third quarter? And what other assumptions are you making there to grow revenue so acutely in that segment really in fourth quarter, it sounds like?

Yes. So I would say that the ex TRIESENCE 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 ex TRIESENCE products certainly by the end of the year. We think that's achievable. But what -- really what is not baked in, I think, is TRIESENCE revenue. There is a reasonably decent WACC price there. I covered the coverage levels in the opening remarks and in the stockholder letter. There is pervasive coverage for TRIESENCE. And without going into a whole lot of detail, we don't need to capture a whole lot of market share, for example, in the postsurgical ocular inflammation market in order to hit those numbers. But you're right, we do need some things to go our way. We've got new leadership helping us drive value for that part of our portfolio. And we have work to do, to be clear. But when we look at the math, we think it's achievable. We're also seeing meaningful improvement in TRIESENCE 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 TRIESENCE is on the upswing. It really is. We have great coverage, same with IHEEZO, frankly. IHEEZO is probably more set up to exceed. And I think we can get there with TRIESENCE. It is going to be a challenge, though.

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

Congrats on the progress. My 2 questions are a follow-up to the comments you had, Mark, earlier. So on the stabilizing of ASP, you imply that the net price is sort of reset at where you've been in 2Q. Is that sort of -- just to confirm, is that kind of the case that you expect that to be sustained at the levels that you kind of found yourself in 2Q? And then how much do you anticipate the unit volume to expand, particularly driven by new patient starts so that I'm thinking longer term, if your peak sales assumption isn't materially altered? And then I have a follow-up.

Yes. So in terms of the ASP for VEVYE, we are 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 possibly improving certainly by the end of the year. That's going to be bolstered by improved coverage and really this overall ratio of higher paid claims versus lower-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 units that 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 prelaunch. So we're actually very happy with where we are with ASP. And I think as it does improve, and I do believe it will improve, we're seeing signs of that. I think 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 hour by hour. It's kind of like watching a ticker tape, frankly. You see the prescriptions come in. And 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, I mean, we're going to have many, many years of growth with VEVYE. We don't see that yielding. And we're in a really good place with VEVYE.

Understood. And also would be helpful to hear a bit more on the IHEEZO 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.

Yes, I would say that no concern on additional products in terms of the stocking dynamic. But I will say this with IHEEZO, I just -- 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, what do I need this for? What I'm doing is okay. And I gave them my analogies of 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 as an example, in many cases, is 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, IHEEZO 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. 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 people -- more and more offices getting access to TRIESENCE, the great coverage that we have. It is a different ball game. And more and more accounts are adopting IHEEZO, they're open to IHEEZO. 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 IHEEZO 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 IHEEZO. So a lot of upside. And we have a great leadership team selling that product.

Our next question comes from the line of Tom Shrader with BTIG.

A little bit on the difference between the 2 specialty pharmas for you. Is Apollo better for you because they're more integrated with existing plans? And can you steer patients that way? And IHEEZO for All, is that -- are you making it easy for people to try IHEEZO so we may have some average selling price swings for IHEEZO in the short term with the hope of growth down the road?

Thanks, Tom. Yes. So in terms of the difference between Phil and Apollo Care, 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 Phil platform. We use Apollo Care as a co-pay 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 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 Apollo Care. 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 IHEEZO for All, the point of IHEEZO for All is that we believe every patient who can benefit from IHEEZO 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 IHEEZO 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 IHEEZO. 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 IHEEZO for All of their intravitreal injections 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 not only the experience of what their colleagues are having with IHEEZO, but the value that it offers these practices, we'll have more and more new account starts. And that's what we're seeing in the third quarter, by the way. As I said, I think just after early into August, we'd already eclipsed the number of new account starts for IHEEZO than we had in the entirety of the second quarter.

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

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

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

I guess VEVYE is the #1 prescribed product per prescriber in dry eye, does that kind of performance 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 VEVYE. Many of them have not even heard of VEVYE. 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 wary of pouring fuel onto the VEVYE 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 into 2026 and beyond. That is going to allow us and if someone like Andrew, who's a pretty conservative person is going to say, okay, now let's invest in VEVYE. 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 they really haven't heard of VEVYE or they're not prescribing it. And as you alluded to, the data shows that when we capture a prescriber, when they start using VEVYE and they come in -- the 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 #1 prescribed dry eye medication per prescriber. And we have a great clinical story to sell, and we've got to get our supply chain dialed in a little bit more robustly, and then we'll, I think, see even greater growth next year.

Got it. And then on the Apollo agreement, you said that expands your sort of 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. It's 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 VEVYE for the most difficult patients in your practice for patients with no insurance. 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, as part of that, 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 Apollo Care is going to help in that regard.

Our next question comes from the line of Jeffrey Cohen with Ladenburg Thalman & Company.

And it's been brought up a couple of times, but I wanted to get back to it and hopefully, you can walk us through 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 of the year, Q3, Q4 and how that's helping on the awareness drive and education and actual number of feet on the street.

Thanks, Jeff. As I said, I don't think that we have done as well as we should have and could have with those non -- well, even TRIESENCE I would say. 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. TRIESENCE 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 opportunity for us. It's a great product. It's trusted. It's proprietary. But importantly, at the consumer level, it has a $37 co-payment. 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 cost at the consumer level on a month -- 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 TRIESENCE opportunity. We intend to launch BYQLOVI at the Hawaiian Eye meeting in the January time frame, early next year, we'll probably get some sales, some stocking orders in the fourth quarter for BYQLOVI, but modest. But we're really focused in. As a stockholder, they want us, I think, dialed in on that TRIESENCE opportunity in the ocular inflammation market. At the same time, Ali and her team are doing a terrific job, and I've seen it -- I saw it at the ASRS meeting in Long Beach, growing unit volumes of TRIESENCE 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 there's -- 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. And 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. TRIESENCE by the fourth quarter is when I think we could certainly overperform for the period. IHEEZO is an overperformer and VEVYE could overperform well as well.

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

Mark, in your prepared comments, you said something that caught my eye about right now, your solutions or 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 Investor and Analyst Day. We never talk about our pipeline. And at that Investor Day, 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 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 Head of Commercial talking about commercial and Andrew talking about the financials. So you'll hear a lot less of me on the next conference call. And at that investor and analyst meeting, you'll really have a great opportunity to meet all these people to meet commercial leadership, the folks that are selling IHEEZO that are selling TRIESENCE. 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 rates in 2024. I was curious if in 2025, 7 and a bit months in, if the refill rates in 2025 are annualizing at kind of that 9 refills per patient per year rate.

I think we're on track. I mean you have to put -- so 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 -- our commercial team didn't like it. It was called the Cut the BS and it's kind of sort of a risky title. 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 some of the recently launched products, they can't say that. They have problems with burning and stinging. And we don't -- 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 is steady Eddie, you see -- and we don't anticipate that yielding anytime soon, Thomas.

Our next question comes from the line of Yi Chen with H.C. Wainwright & Company.

Could you provide some comments regarding the timing difference of the VEVYE prescription growth in the quarter and also the recorded revenue for the quarter? And also, do you have an estimate time line as to when VEVYE could become the largest cyclosporine-based dry product?

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

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 it related to the revenue recognition during the quarter.

Timing -- 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 #1 cyclosporine in the U.S. market. Secondarily, we intend to be the #1 anti-inflammatory in the U.S. market. And I think the tertiary goal would then be the #1 most prescribed product in the U.S. And that's -- when I talk to Maria, who's sort of the CEO of that franchise, that's the goal. Primary is to be the #1 cyclosporine, 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 L. Baum 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, mbiega@harrowoinc.com. This will conclude our call.

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