Good morning, and welcome to Harrow's First 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 the question-and-answer session. As a reminder, this conference is being recorded. I would now like to turn the call over to Jamie Webb, Director of Communications and Investor Relations for Harrow.

Thank you, operator. Good morning, and welcome to Harrow's first quarter 2025 earnings conference call. Before we begin today, let me remind you that 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 and uncertainties, please see the Risk Factors section of the company's most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission. Harrow's results may differ materially from those projected. Harrow disclaims any intention or obligation to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise. This conference call contains time-sensitive information and is accurate only as of today. Additionally, Harrow will refer to non-GAAP financial metrics, specifically adjusted EBITDA and/or adjusted earnings as well as core results such as core gross margin, core net income and core diluted net income per share. A reconciliation of any non-GAAP measures to 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 Investor 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'd like to turn the call over to Mark to go over some prepared remarks prior to the question-and-answer session.

Thanks, Jamie, and good morning, everyone. Thank you for joining us today. I hope you've had an opportunity to review our supplemental documents for the first quarter, including our earnings release, corporate presentation and letter to stockholders, all of which are now available on the Investor Relations section of our corporate website. Let me begin by stating that as Harrow stockholders, the first quarter is always the toughest revenue period for the company. However, it is now in the rearview mirror. And as I will discuss in more detail shortly, we are very well positioned to achieve and hopefully exceed our 2025 directional revenue guidance of more than $280 million. To get there, we'll need to generate approximately $232 million in revenue over the remaining 3 quarters of the year. In the next few minutes, my intention is to discuss the key drivers underpinning my confidence in meeting our guidance for the year. As you know, the Harrow team grew revenues in the first quarter of 2025 by 38% year-over-year, and that's growth that is nothing to sneeze at. We also delivered a record $19.7 million in cash flow from operations. Another bright spot, a very bright spot was VEVYE. VEVYE revenue rose 35% sequentially from $16 million in the fourth quarter of 2024 to $21.5 million in the first quarter of 2025. And that was even before the launch of the VEVYE Access for All program, which happened at the very end of the first quarter. We also completed our critical market access initiatives for TRIESENCE, allowing us to finally begin to realize this product's potential. On the expense side, the first quarter was challenged by a few onetime expenses, including increased costs related to our annual audit and a onetime special project, all which totaled $3.7 million in…

[Operator Instructions] Our first question comes from the line of Thomas Flaten with Lake Street Capital Markets.

Mark or Andrew, I was curious if you could maybe walk us through some of the price increase initiatives you took at the end of the year going into 2025, particularly as it relates to IHEEZO?

Andrew, do you want to take that on?

Yes, Thomas, we did not do much for price increases on the products. IHEEZO, in fact, the list price stayed the same.

I would add earlier in the year we actually -- and I think we made this public, Thomas, we actually took some price decreases to make some of our products more accessible and affordable.

Understood. And then switching over, I was wondering, I know you mentioned Project Eagle, Mark, in your letter, you didn't address it today, but any particular initiatives we should be aware of other than Klarity-C? And then I'm trying to understand the scope and scale of that project. Would it, for example, include divesting the compounding business altogether? Or is that taking it way too far?

Yes, I appreciate the question. The -- I mean the initial impetus for Project Eagle was to transition the Klarity-C patients to VEVYE. Financially, it makes a lot of sense for us. But I think even clinically for the patient, they have an incredible opportunity to get access to an FDA-approved 0.1% cyclosporine product. But as I said, financially, it makes a lot of sense for us. Certainly, with Klarity-C, for example, doing about $9 million or so, a little under $10 million in revenue, we're going to very obviously see a reduction in Imprimis revenue by that number. But on a corresponding basis, we'll see a significant increase in Harrow revenue. What's really interesting financially is that even if every single one of the Klarity-C patients came over to VEVYE at the $59 cash pay price, we estimate that our profit would be more than 2 times what it is on the Klarity-C formulation. And that's with nobody that is a Klarity-C patient having access to insurance coverage. So there's a lot of upside there for us with Project Eagle and implementing this transition from Klarity-C to VEVYE. And as I said, it's great for the consumer, the patient as well. But there are other formulations that we make within the Imprimis portfolio, that I think work really well as FDA-approved products. We've talked in the past about Melt to the extent that Melt is ultimately available as an FDA-approved product that would certainly qualify. And there are several others that we're working on. But we're not planning to exit compounding. As I said in the letter to stockholders, we serve thousands and thousands of doctors, ophthalmologists, optometrists in the United States. They rely on our best-in-class compounded formulations. We have the broadest portfolio in the United States. We have the number one national brand. It is a consistent driver of not only revenue, but profits, and it's a business that has served us incredibly well. It's been the foundation of our company for many years. So not planning to exit.

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

Mark, I just want to start on IHEEZO to make sure I kind of understand the sequential changes. So if I kind of normalize ASP to account for what the potential stocking was, it looks like the impact was about $9 million. And then is that all from that unwinding of some potential stocking in Q4? Or was there any other kind of movers there?

Yes, I don't have your numbers in front of me. Andrew, do you want to kind of talk through the impact of stocking and destocking from Q4 to Q1?

Yes, absolutely, Chase. Absolutely. I think -- well, I think it's easiest to address it as maybe on a go-forward basis and what we're seeing from a unit volume and unit demand perspective, which is Q4 to Q1, we saw this last year, too, there is softness in the numbers between Q4 and Q1 on IHEEZO on unit demand. But then we started seeing that increase in Q2 and getting back to sort of growth mode, as Mark was talking about in the prepared remarks. And that's what we're seeing again with IHEEZO. So the unit demand is getting back to that mode where we'll see incremental growth quarter-over-quarter should -- assuming customer reorder rates continue at a normal pace that they've been growing at as well as some of these new accounts that will come online. As for like that exact impact that was stock -- where you had some stocking events, I don't think we know the exact numbers there, but happy to have an additional conversation later with you, Chase.

Yes.

Yes. I would add too, that if you look at the difference between Q4 of '23 and Q1 of '24, there was about an 80% decline. And we actually saw a better decline, if that's worth mentioning, but we actually had a lower decline. So it was probably 5 to 6 percentage points lower this year in Q1 of '25 versus Q4 of '24. So we did a little bit better. But look, it's wobbly. There is stocking at the end of the year for this product. And I think the focus here is the continued unit demand growth throughout the year, 2025 for the product, which is what we expect and ultimately delivering more revenue for that product and more growth for that product this year relative to last year.

Got it. And it sounds like in April, shipments to distributors are -- is now kind of winding up with end user demand. And then I guess, just kind of confirmation there. And then on TRIESENCE, you spoke to kind of better fundamentals in April. Are you seeing a meaningful inflection in volumes? And then kind of can you split that between kind of the ASC and the retina opportunity and kind of where you're seeing some early signs of inflection and progress?

Yes. I would say that what I'm seeing is that we're opening a lot of accounts. There are a lot of accounts dabbling and picking off small numbers of units to begin using the product and seeking reimbursement for it. And that's a typical pattern that you see with these buy and bill products. The account gets opened, they buy a few units, they use them. They know what TRIESENCE does. They're very familiar with the product. But the back office, which drives a lot of the purchasing of buy and bill products, wants to make sure that they're going to get reimbursed. And the reimbursement work that we did in the first quarter was critical for the long-term success. We are seeing the product being used in the ASC. We're seeing it used in the hospital. We're seeing it being used by cataract surgeons. We're seeing it being used by retina specialists. So there's a lot of upside. We think this is going to be the #1 intraocular injectable steroid in the market in fairly short order. But the team is really -- has just been given the tools from a reimbursement perspective that they need in order to be successful. They're really only about 40 days into that. So we are seeing the right signs with lots of new account openings, but dabblers at this point. And then as the year progresses, we will -- we expect to see greater density within those accounts.

Got it. And then on VEVYE, obviously, continued impressive progress there. If I think about the improvement sequentially in gross to nets, again, it's pretty impressive kind of sequential improvement there. Can you kind of speak to the drivers? And then in '25, you kind of spoke to it a little bit, but basically, gross to nets moderate a little bit in Q2 and then improve sequentially from there? Is that the right way to think about it, Mark?

Yes. I wouldn't say gross to nets moderate down and then begin to improve. I would say -- well, first of all, we, I think, said in prior conference calls that we were making changes to our business rules that we expected to significantly improve our ASP for VEVYE. And I think we've delivered 100% on that promise. That said, as I said in the letter to stockholders, we do expect certainly at the levels that we're currently at to see some reduction in the ASP over the next quarter or so. And then we expect it to stabilize at a very attractive level. I mean, this is a level that even when Andrew and I think about, our initial models before the launch, this was an aspirational level for us. So we're really happy at where we think the ASP is going to kind of settle out at. But I think the key, which is also way beyond even our aspirational data prelaunch is what we're seeing in NRx growth and the refill rate and so on. It's just been an amazing ride in the last 7 weeks. And this is really, I would say, a company maker type product and really has the potential to lead the category in dry eye and realize the promise of treating more of the 30-plus million Americans who suffer from this disease. Andrew, do you want to add to that at all?

Nothing to add, Mark.

Our next question comes from Jeffrey Cohen with Ladenburg.

I wanted to poke you a little bit further on the compounding business and some of the transition of the compounding products to prescription. Could you talk about the base that's existing as far as Imprimis and the base opportunity, both internal and perhaps external?

Yes. So I think I tried to discuss the promise of the compounding business. I've been talking about this for many years now that there was a lot of hidden value in the compounding business. First of all, the commercial relationships that we created with more than 10,000 eye care professionals around the United States gave us tremendous commercial credibility. That's the commercial credibility that we used to transact with EyePoint ultimately to take on DEXYCU several years ago, and we were able to increase sales of that product by more than 400% in short order. That credibility led to us being able to get access to IHEEZO from Sintetica, and that has driven a tremendous amount of value for our company. And that success ultimately led to the people at Novaliq having the confidence in us to offer us VEVYE at a very attractive price with most of the economics on the back end. And you can see what we're doing with VEVYE now. All of that success, all of those opportunities were born from the compounding business, frankly. And even within the compounding business today, as I mentioned, we're in the process of transitioning these Klarity-C patients to VEVYE. There are more than 25,000 of them. Believe me, if I called a marketing company up and I asked them what the cost would be to get access to well over 25,000 highly targeted consumers that have a nearly 100% chance of purchasing a product that is chronic in nature, that can deliver the kind of net ASP that we're seeing, it would be extremely expensive for me to get access to those consumers. Well, ImprimisRx has those, more than 25,000 of those potential VEVYE patients, and we have them as a result of the success of the ImprimisRx business over the last 12 years. There are other products within the ImprimisRx portfolio that are highly correlated and highly related to branded products that we now sell, whether it's an NSAID, whether it's an antibiotic or a topical steroid, whether it's an injectable product. There are a lot of -- there's a lot of overlap between the 2 portfolios. And so for us, our preference always if the customer wants and is interested is to offer them an FDA-approved product for at or around the same economics as a compounded product would be. And to the extent we can do that, we're going to do that. And that's how we're going to, I think, continue to proceed with this Project Beagle.

Got it. That's helpful. And then secondly, can you talk about the Interior segment a bit as far as Q4 to Q1, looked a little bit weak. Is that seasonality? Or could you maybe expand upon that a bit?

Well, I mean, I appreciate the question. And just to be clear, I'm not right now -- and if you were in my shoes, you wouldn't be happy either with the current strategy. I think the results, the numbers are speaking for themselves. We should be doing much better, and we intend to do better. One of the nice things about the way I operate the business, the way Andrew and I have partnered over the years is we take action when we see something obvious in front of our eyes, which is that these products should be doing quite a bit better, and we intend to review and reconsider the current strategy. I think that's certainly in order, and that's what we intend to do. But you should expect as stockholders to see significant improvement from the levels that you saw in the first quarter. There's some technical revenue recognition issues and accounting issues that are related to the showing in the first quarter specifically. So that's as bad as it can get financially. You should see significant improvement from there. But overall, I'm not happy with the strategy, and we intend to do a few things here to make some improvements.

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

You mentioned that VEVYE revenue grew sequentially, but I noticed that the quarterly prescription was lower in the first quarter. So could you comment on the current average collection cycle for VEVYE sales?

Yes. Andrew, do you want to cover that? I mean obviously, the revenues were up. We had significant improvements in our ASP -- net ASP. Andrew, do you want to talk about volumes?

Yi, thanks for the question. And I want to make sure I understood the question correctly. But the -- our revenue recognition, obviously, is correlated to prescription volume, isn't a perfect match. And so -- but we did see on the prescription side, Mark mentioned some business rules that were implemented at the beginning of the year that changed and helped improve ASP as a result, that also had an impact on access for some patients. Those business rules and the whole market access and patient access program changed at the end of March with the introduction of VEVYE Access for All. And so, just as Mark was talking about in an earlier question, the -- when we look forward, volumes are increasing rapidly, especially from a new prescription perspective. And we will see some of the -- we will, as a result, have to sacrifice some of the gross to net improvements that we saw in Q1. But importantly, number one, our expectation is that ASP is going to be higher with VEVYE Access for All than it was prior, last year. And then importantly, the volumes that we're seeing from an increase perspective are incredible. And one of the things that I love about VEVYE and why I always say it's my favorite product is that mathematical compounding you get on the refills, that sort of annuity that you get with the refills. And so all of these new prescriptions that we're getting in April and continuing to see in May. Where we really see value is in the third quarter and fourth quarter when we start getting the prescriptions compounding on each other for those -- for the new Rxs we're getting in the immediate. So we're excited about the program. We think it's a win-win for everyone, better access for patients, lower prices for patients and then for us and for shareholders. We're going to be netting more on a per prescription basis than we were last year.

Okay. Got it. And could you also let us know whether any of Harrow's products are affected by current tariff policy?

We actually addressed that -- I tried to address it. Andrew had done some analysis on tariff impact. And it's on Page 6 of the letter to stockholders. And I think we estimated that our 2024 gross margins, and this is all based on what we currently know about the tariff programs that are in place, but the impact would have been about 50 basis points on gross margins. So for us, it's fairly negligible. I've been asked this by a couple of other folks. I think people know, for example, what our cost is on IHEEZO, which is, in fact, made outside the United States. And if you were to tack on 25% or 10% or even 125% onto that cost based on what we receive, it really doesn't impact gross margins that much. So we don't estimate much impact with our portfolio as a result of the existing -- and the existing tariff structure. And then we're also working to, at least on some of our compounding formulations, bring more of our excipients and APIs in from domestic sources. So we'll see even a slightly smaller impact. But the overall impact, our estimate was about 50 basis points, not too much.

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

I appreciate the comprehensive update on business. Sorry, one more question on IHEEZO. So it looks like your unit volume demand was comparable to 3Q, but revenues came in a little lighter than that, actually a lot lighter than that, which makes you wonder if anything we need to account for existing and new accounts sort of going forward? I know there's a 1Q patient co-pay assistant support dynamic that other eye care retina players kind of faced. But I was also curious on an account-by-account basis, including the new GPOs that you have, anything we need to factor in? And if you can confirm there was no major customer we lost in 1Q? And I have a follow-up on VEVYE.

Yes. I would just say that the overall play, if you will, with buy and bill products where there are discounts and rebates, is to manage the ASP. I think that's -- in addition to getting the products out, opening accounts, servicing accounts, at our level, at the executive level, we think about managing the ASP, and that is mission-critical. So that is top of mind here. Clearly, if you saw some shift in ASP and that affecting revenues quarter-to-quarter, it's typically because of those features of buy and bill -- the fact that it's a buy and bill product. And I -- that aside, and as I said, to be clear, we are thinking about ASP. I mean, Andrew and I talk about ASP management nearly every day and are thinking about ways to do that compliantly with the team. But what I would say that to me is more important, and I think you kind of touched on it a little bit, which is what happened in the retina market, in particular, over the last 6 months with the complete loss of foundation support for -- good days as an example. That is interestingly having, we think, a positive impact as we get into the second quarter, and it should have more of an impact later on this year. We're seeing anecdotally more retina accounts consider the clinical benefits of IHEEZO and the opportunity to not have to pay for the anesthetic cost. And so the overall reduction in revenue, I think that some retina practices are seeing as a result of the depletion of the good days funds is causing retina practices to rethink whether they want to go out of pocket for, for example, an anesthetic that may have clinical benefits that are not as strong as VEVYE. And with VEVYE, they can actually seek reimbursement for that. And so we're seeing positive dynamics in the marketplace, increased interest in IHEEZO in terms of losing major accounts. We don't comment on specific accounts, but what I did comment on is that we intend to see revenue growth and unit demand growth from '24 to '25 with IHEEZO, and I'm pretty highly convicted on that.

Very helpful color. And regarding VEVYE, we are also hearing a similar momentum from some KOL calls we did post-VAFA. Could you touch on what proportion of the 25,000 patients have already moved over from Klarity sort of quarter-to-date? And trying to understand how sequentially you could get to, in terms of NRx volume growth? And anything you could comment on the dynamic share you have right now in the broader cyclosporine market?

I can't comment on the specific share, and I'm glad you're seeing, when you do your independent calls, the kind of feedback that we're also receiving with respect to VEVYE, not only clinically, but with respect to this program. It is making a huge impact. I've always looked at the dry eye market, and we've talked about this offline many times. If I was a patient, what would I want or if my mother was a patient, what would I want my mother to have access to? And I wouldn't want one of these old cyclosporines that took 9 clinical studies to get approved, that doesn't have a label for signs and symptoms. I wouldn't want something that causes pain upon installation to a significant number of patients that put it in their eye. That's not the cyclosporine that I would want my mother to have. And it wouldn't matter whether it was a branded version of that or a generic version of that, because it wouldn't matter at all. Bad is bad, or not great is not great, if you will, to be more politically correct. So we think that we can win the cyclosporine market. There's a lot of units available. I wouldn't want to compete against VEVYE. But the most interesting thing I think I learned over the last quarter is that Mark Cuban has a pharmacy business. I think it's called Cost Plus. And if you go to Mark Cuban Cost Plus and you look at what the out-of-pocket cost is at the consumer level for generic cyclosporine, which if you put in your eye, doesn't feel very good. And you look at what the cost is of VEVYE, which I assure you feels probably a lot better and has much better data, it's actually less expensive these days to get access to VEVYE without a prior authorization being required and without the need for step therapy. And we're quite happy that so many patients are now moving in that direction. And we don't think that's going to abate, as I said in my prepared remarks. So I wouldn't want to compete with us on VEVYE in the cyclosporine market. And frankly, I think we're going to win the anti-inflammatory market within the category as well because I think we've got the best anti-inflammatory. I think cyclosporine is highly trusted, and it's more trusted, I think, than anything else. And -- so anyway, look, we're real proud of VEVYE as a product. We think it delivers clinically. We're proud of the team that is executing our commercial strategy. And I wouldn't want to compete against us. And I think we're going to win the market.

Understood. And then maybe for Andrew, a bit more color on debt refinancing since that is viewed as a little bit of an overhang on stock. If you could comment on what precisely are you looking to get to by summer to fall, kind of time frame you've said in the stockholder letter. And is it something you want to get fundamentally with your business internally or something externally you're watching out for, including maybe a milestone with a potential strategic acquisition, if you could comment on that?

You bet Mayank. The -- On the debt refi, I'm going to be somewhat guarded just because we're in active discussions with lenders, including Oaktree. And so I don't want to be handing -- giving away information in the middle of trying to get the best terms we can possibly get. But I would just -- I'm just going to say that we've had really positive discussions. I think we've got a lot of positive momentum going into the spring and certainly summer to get something done and have a good result for shareholders where the facilities is restructured. We have -- and we'll have plenty of room from a capital perspective to service the debt. And certainly, from an operational perspective, the business -- we will be operating at a great level where we'll be in a good position to eventually delever the entire business. But the key, Mayank, and I think this is important for all shareholders to know, we have a lot of confidence in our ability to get the debt refi. The quality of institutions that we're talking to are really great institutions, great financing partners. And we have -- we think we'll be able to get something done here in either late summer or early fall.

That's all the time we have for questions. I will now turn the call back to Mark L. Baum for closing remarks.

Thank you, and thank you for the questions. And once again, thank you for joining us today. So success really requires -- and this is long-term success, which is what we're after building a business that we can be proud of. It requires a clear strategic vision, relentless execution, a dedicated team. And unfortunately, it requires a little bit of time. As I mentioned earlier, we've been at this for over 12 years. We built that Imprimis business. That Imprimis business led to all of these opportunities coming to fruition for us to build this great company and we think the leading eye care ophthalmic -- eye care pharmaceutical company in the United States. We do expect some products to outperform others. Some will overperform, some will underperform. There will be fluctuations, and these are natural in any dynamic business. But overall, we're confident in the strength of our foundation, the fundamentals of our business model. And the momentum that we're seeing today really reinforces our belief that the best is yet to come. We're going to deliver record numbers this year. And I want to thank the Harrow family for all of their hard work. We are going to, I think, knock out our 2025 directional guidance, but we're also going to create a lot of long-term value for our stockholders onward and upward. And if you have any other questions, please feel free to reach out to Jamie Webb, that's jwebb@harrowinc.com. This will conclude our call.

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