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Harrow - Earnings Call - Q1 2025

May 9, 2025

Executive Summary

  • Q1 2025 revenue was $47.8M, up 38% YoY but down sequentially versus Q4’s seasonally strong $66.8M; GAAP EPS was -$0.50, and Adjusted EBITDA was -$2.0M.
  • VEVYE revenue accelerated to $21.5M, +35% QoQ from $16.0M, driven by the late‑March launch of the VEVYE Access for All program (VAFA); management highlighted quadrupling of new prescriptions and prescribers seven weeks post‑launch.
  • TRIESENCE received CMS transitional pass‑through status effective April 1, unlocking separate reimbursement in ASC/HOPD and materially expanding market access; management expects adoption to accelerate through 2025.
  • Harrow reaffirmed 2025 revenue guidance of “more than $280M,” citing momentum in VEVYE, normalization in IHEEZO buying patterns, and improved TRIESENCE reimbursement; debt refinancing targeted by late summer/early fall 2025.

What Went Well and What Went Wrong

What Went Well

  • VEVYE momentum and VAFA impact: “Both new prescriptions and weekly VEVYE prescribers at PhilRx have quadrupled” seven weeks post‑launch; refill rates remain strong, with the average covered patient receiving nine refills.
  • Record operating cash flow: Cash flow from operations reached $19.7M in Q1 2025, aided by AR collections from Q4 distributor term extensions.
  • TRIESENCE market access: CMS approved pass‑through (J3300) with ASP+6% reimbursement in ASC/HOPD; management sees accelerated account openings and adoption across retina/cataract use cases beginning in Q2.

What Went Wrong

  • Seasonal softness and destocking: Sequential decline from Q4’s record results; IHEEZO shipments were impacted by year‑end stocking, with management noting normalization and April units more than doubled vs Q1 monthly average.
  • Specialty Branded volatility: Gross‑to‑net volatility reduced recognizable revenue in Q1; management intends to revisit strategy and expects improvement from the depressed Q1 baseline.
  • Higher OpEx: SG&A rose to $40.5M vs $28.8M in Q1 2024, including ~$3.7M of seasonal audit/special project costs and investments in sales/marketing headcount.

Transcript

Operator (participant)

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 a 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.

Jamie Webb (Director of Communications and Investor Relations)

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 law. 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 referred to non-GAAP financial metrics, specifically adjusted EBITDA and/or adjusted earnings, as well as core results such as core gross margin, core net income, and core diluted net income per share. A reconciliation of any non-GAAP measures with the most directly comparable GAAP measures is included in the company's earnings release and letter to stockholders, both of which are available on the website. By now, you should have received a copy of the earnings press release. If you have not received a copy, please go to the 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, andHarrow'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.

Mark Baum (CEO)

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. 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 three 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. 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 one-time expenses, including increased costs related to our annual audit and a one-time special project, all of which totaled $3.7 million in the aggregate. We also continued to invest in building out our commercial infrastructure to support both current operations and future growth, particularly in sales and marketing. The VEVYE team now exceeds 80 sales and marketing professionals. The buy-and-bill team for IHEEZO and TRIESENCE is just shy of 50 experienced commercial professionals. We're very comfortable with our current cost structure and believe investments in commercial labor, in particular, will be favorably viewed as we deliver quarterly results throughout the year. On the revenue side, first quarter revenues for some segments of our business were softer than we had hoped.

As I explained in my letter to stockholders, there is seasonality to our business, and the first quarter, as I mentioned before, is always our weakest, especially this year, which followed such a strong fourth quarter in 2024. Our specially branded products stand out because of volatility in gross-to-net estimates, which caused a reduction in recognizable revenue for the period. Now, with the above said, you've heard me describe myself as a glass-half-empty kind of guy. I'm always striving for performance improvement. I'm never really completely satisfied, especially when I know we could do a little bit better. That said, the first quarter will go down as one of the most important periods in our company's history, and I'm very proud of the work our team did.

Importantly, I am truly excited about the remainder of the year, and I want to spend the rest of my prepared remarks discussing specific products and the setup for the balance of the year and how we intend to deliver and hopefully exceed our 2025 revenue guidance. Here we go.

VEVYE continues to outperform expectations. As I said in my letter to stockholders, after launching more than 40 ophthalmic prescription products over the past 12 years, including VEVYE, I can say with confidence, one, given the consistent weekly growth in new prescriptions, new prescribers, and the stability we see with VEVYE refills, this product is poised to be our largest revenue product. Number two, the VAFA program is the most successful market access strategy I have been a part of. Finally, three, without question, VEVYE is presently Harrow's most valuable asset.

We launched the VEVYE Access for All program, or VAFA, late in the first quarter, so there was little or no impact in the first quarter results. However, as of today, just seven weeks post-launch of this program, both new prescriptions and weekly VEVYE prescribers at Fill-Rx have quadrupled. If things continue at the current pace, a year or two from now, I expect VEVYE to be right at or near the top of the leading U.S. prescription-dry medications. In fact, it should be at the top if we continue at this pace.

In the more immediate term, assuming we can maintain our refill rates, even with our ASP expected to moderate a bit and then stabilize over the coming quarters, as we get into the third quarter and see more new prescriptions that we've been filling over the last seven weeks begin to stack or compound, it is very easy for you as a Harrow stockholder to come up with some very large potential revenue numbers for VEVYE, especially as we get into the third quarter. Those numbers are real, and that is what is possible. That's without much NRX growth or new prescription growth from our current daily new prescription levels. The reality, though, is that we're seeing consistent weekly NRX growth, and we have been for the past seven weeks. We don't expect this growth to abate in the near term.

These are still early days, but the VEVYE Access for All program's early momentum is surpassing our expectations, and it's reinforcing my conviction that this groundbreaking initiative is one of the most impactful and potentially financially transformative in Harrow's history. By the way, when I talked about producing $250 million in revenue in a calendar quarter by the end of 2027, this is the type of product, given the success we're seeing in this program, that is going to help us deliver on that promise and that belief that we can hit those numbers.

What about IHEEZO? IHEEZO's first quarter sales were impacted by an elevated stocking activity at the end of 2024. Many of you know that. That dynamic, though, has now normalized with significant destocking occurring during the first quarter. We're now back in growth mode for IHEEZO. For example, in April, unit sales more than doubled compared to the monthly average in the first quarter. This rebound indicates a return to typical ordering behavior, and it reflects strengthening demand as downstream inventory levels rebalance and new accounts begin to ramp up utilization. We also made solid commercial headway in the first quarter with our sales team engaging with several new and potentially large accounts moving through the various early stages of onboarding, such as sample evaluations, formulary discussions, and initial orders.

With a quarterly average of 30 new IHEEZO institutional accounts and the top 10 accounts in our pipeline representing an estimated 80,000 incremental annual units of IHEEZO unit demand, we are confident in seeing meaningful unit demand growth through the remainder of the year and a sizable increase in IHEEZO revenue in 2025 versus 2024. What about TRIESENCE? When is that going to blossom?

The first quarter was truly a pivotal period for the long-term plans that we have for this product. We were able to complete market access initiatives, including the publication of TRIESENCE's average selling price, the granting of pass-through status for the product, opening the market for ASC use and hospital and outpatient department use, as well as the authorization for bilateral use case reimbursement for TRIESENCE. This all happened in the first quarter. These changes have greatly increased purchasers' confidence in their ability to obtain reimbursement for TRIESENCE. These market access initiatives took effect April 1st, effectively unlocking about 40% of the overall market for TRIESENCE. This is being reflected in sales momentum that we are seeing in the second quarter, accelerating meaningfully.

Already, the number of accounts ordering TRIESENCE has more than doubled since the beginning of the year, a strong signal of growing market confidence and adoption. Ophthalmologists and retina specialists, in particular, are performing procedures in the ASC and hospital and outpatient department settings of care, now have the assurance that TRIESENCE will be reimbursed outside of the bundled fee, a reimbursement feature that we saw directly positively impact the success of IHEEZO. We now have that for TRIESENCE. We believe this momentum will accelerate throughout the year. Now, outside of our lead brands, our specially branded products, which faced gross-to-net challenges during the first quarter, are picking up in the second quarter. In addition, our ImprimisRx compounding business continues to perform well, showing consistent revenue and operational reliability. In fact, April appears to be a record month for ImprimisRx.

Let's bring this back to the original objective for today's call, to show you how we expect to achieve our 2025 revenue guidance of more than $280 million. Remember, we have $232 million left to go, and here's how I break things down. On VEVYE, we believe we are on a glide path to generate at least $100 million in VEVYE revenues this year, and perhaps much more. We've already reported over $21 million in revenue for the first quarter. Given VEVYE's refill profile, averaging nine refills per year per covered patient and VAFA's strong momentum, we expect revenues from VEVYE to consistently grow quarter-over-quarter, with accelerated growth expected in the third and fourth quarters.

Based on the number of refills and the growth and the number of new prescriptions and prescribers since launching this program, you should be able to build a model with some very big numbers, large numbers similar to what we're seeing in our internal models. However, we will try to be conservative and leave the opportunity to surprise stockholders meaningfully as the year progresses.

On IHEEZO, we're on track. We expect to deliver over $50 million in 2025 revenue for this product, with quarter-over-quarter increases expected now that distributor inventory levels have normalized. Our specially branded products, which includes TRIESENCE, in the aggregate, we expect them to deliver at least $50 million in revenue this year. In terms of our ImprimisRx compounding business, it is a consistent performer, on track once again to deliver more than $80 million in revenue in 2025.

If you add all of this up, these expected contributions, you will get to that $280 million or more in 2025 revenue, with a clear runway for upside. Again, we're expecting to see overall quarter-over-quarter growth this year. While the third quarter can be a historically softer period, this year, we anticipate stronger numbers driven by the compounding effect from new VEVYE prescriptions under this program. Finally, we expect fourth quarter to be our strongest revenue quarter, as it was last year. In sum, I hope after today's discussion, combined with our letter to stockholders and other supporting materials, you have a clear view of where our growth is coming from and why we're confident in its acceleration and durability.

With a diverse portfolio of category-leading products, innovative market access initiatives like the VEVYE Access for All program, and accelerating momentum across multiple franchises, Harrow is distinguishing itself as a leading U.S. ophthalmic pharmaceutical company. Now, we're happy to answer your questions. I'll pause to have our operator poll for questions. Operator?

Operator (participant)

Thank you. We will now begin the question and answer session. To ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Thomas Flaten with Lake Street Capital Markets. Your line is now open.

Thomas Flaten (Senior Research Analyst)

Good morning. I appreciate you taking the question. 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.

Mark Baum (CEO)

Andrew, do you want to take that on?

Andrew Boll (CFO)

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

Thomas Flaten (Senior Research Analyst)

Got it.

Mark Baum (CEO)

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

Thomas Flaten (Senior Research Analyst)

Understood. Then switching over, I was wondering—I know you mentioned Project Beetle, Mark, in your letter. You did not address it today, but any particular initiatives we should be aware of other than Klarity-C? I am 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?

Mark Baum (CEO)

Yeah, I appreciate the question. I mean, the initial impetus for Project Beetle 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. 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 ImprimisRx revenue by that number. 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 two times what it is on the Klarity-C formulation. That's with nobody that is a Klarity-C patient having access to insurance coverage. There is a lot of upside there for us with Project Beetle and implementing this transition from Klarity-C to VEVYE. As I said, it's great for the consumer, the patient as well. There are other formulations that we make within the ImprimisRx 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. There are several others that we're working on.

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. It's a business that has served us incredibly well. It's been the foundation of our company for many years. Not planning to exit.

Thomas Flaten (Senior Research Analyst)

Excellent. I appreciate you taking the questions. Thank you.

Operator (participant)

Thank you. Our next question comes from the line of Chase Knickerbocker with Craig-Hallum. Your line is now open.

Chase Knickerbocker (Senior Equity Research Analyst)

Good morning. Thanks for taking the questions. 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 is that all from, is that all from that unwinding of some potential stocking in Q4, or was there any other kind of movers there? Thanks.

Mark Baum (CEO)

Yeah, 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?

Andrew Boll (CFO)

Yeah, absolutely. Chase. Absolutely. Chase, good morning. I think the way I think it's easiest to address it is 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 was softness in the numbers between Q4 and Q1 on IHEEZO and unit demand. 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. That is what we're seeing again with IHEEZO. The unit demand is getting back to that mode where we'll see incremental growth quarter-over-quarter or should, assuming customer reorder rates continue at a normal pace that they've been going at, as well as some of these new accounts that will come online.

As for that exact impact that was stocked where you had some stocking events, I do not think we know the exact numbers there. Happy to have an additional conversation later with you, Chase.

Mark Baum (CEO)

Yeah, I would add too that if you look at the difference between Q4 of 2023 and Q1 of 2024, there was about an 80% decline. We actually saw a better decline, if that's worth mentioning. We actually had a lower decline. It was probably five to six percentage points lower this year in Q1 of 2025 versus Q4 of 2024. We did a little bit better. Look, it's wobbly. There is stocking at the end of the year for this product. 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.

Chase Knickerbocker (Senior Equity Research Analyst)

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

Mark Baum (CEO)

Yeah, 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. That's a typical pattern that you see with these buy-and-bill products. The account gets open, they buy a few units, they use them. They know what TRIESENCE does. They're very familiar with the product. 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. 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.

There's a lot of upside. We think this is going to be the number one intraocular injectable steroid in the market in fairly short order. The team has really 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. We are seeing the right signs with lots of new account openings, but dabblers at this point. As the year progresses, we expect to see greater density within those accounts.

Chase Knickerbocker (Senior Equity Research Analyst)

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 a pretty impressive kind of sequential improvement there. Can you kind of speak to the drivers? And then in 2025, 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?

Mark Baum (CEO)

Yeah, I would not say gross to nets moderate down and then begin to improve. I would say, 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. I think we have delivered 100% on that promise. That said, as I said in the letter to stockholders, we do expect, certainly at the levels that we are currently at, to see some reduction in the ASP over the next quarter or so. 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. We are really happy at where we think the ASP is going to kind of settle out at.

I think the key, which is also way beyond even our aspirational data pre-launch, is what we're seeing in NRX growth and the refill rate and so on. It's just been an amazing ride the last seven weeks. 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?

Andrew Boll (CFO)

Nothing to add, Mark.

Chase Knickerbocker (Senior Equity Research Analyst)

I'll leave it there. Thank you, guys.

Mark Baum (CEO)

Thank you, Chase.

Operator (participant)

Our next question comes from Jeffrey Cohen with Ladenburg. Your line is now open.

Jeffrey Cohen (Director of Research)

Hi, Mark and Andrew. Thanks for taking our questions. 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 existed as far as ImprimisRx and the base opportunity, both internal and perhaps external?

Mark Baum (CEO)

Yeah. 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. 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 Synthetica. That has driven a tremendous amount of value for our company.

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. You can see what we are doing with VEVYE now. All of that success, all of those opportunities were born from the compounding business, frankly. Even within the compounding business today, as I mentioned, we are 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. 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 is a lot of overlap between the two portfolios. 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. To the extent we can do that, we are going to do that. That is how we are going to, I think, continue to proceed with this Project Beagle.

Jeffrey Cohen (Director of Research)

Got it. That's helpful. And then secondly, can you talk about the anterior 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?

Mark Baum (CEO)

I mean, I appreciate the question. 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. 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. We intend to review and reconsider the current strategy. I think that's certainly in order, and that's what we intend to do. 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. That's as bad as it can get financially. You should see significant improvement from there. Overall, I'm not happy with the strategy, and we intend to do a few things here to make some improvements.

Jeffrey Cohen (Director of Research)

Got it. Super. Thanks for taking our questions.

Operator (participant)

Thank you. Our next question comes from the line of Yi Chen with H.C. Wainwright. Your line is now open. Ye Chen, your line is open. Please check your mute button.

Yi Chen (Managing Director of Equity Research)

Hi. Thank you for taking my questions. Can you hear me?

Mark Baum (CEO)

Yes. Good morning.

Yi Chen (Managing Director of Equity Research)

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

Mark Baum (CEO)

Yeah. Andrew, do you want to cover that? Obviously, the revenues were up. We had significant improvements in our ASP, net ASP. Andrew, do you want to talk about volumes?

Andrew Boll (CFO)

Yeah. Thanks for the question. I want to make sure I understood the question correctly. Our revenue recognition, obviously, is well correlated to prescription volume, is not a perfect match. 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 right at the end of March with the introduction of VAFA. As Mark was talking about in an earlier question, when we look forward, volumes are increasing rapidly, especially from a new prescription perspective. We will see some of the, as a result, have to sacrifice some of the gross to net improvements that we saw in Q1.

Importantly, number one, our expectation is that ASP is going to be higher with VEVYE Access for All than it was prior last year. Importantly, the volumes that we're seeing from an increase perspective are incredible. 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. 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 the new RXs we're getting in the immediate.

We're excited about the program. We think it's a win-win for everyone, better access for patients, lower prices for patients. For us and for shareholders, we're going to be netting more on a per-prescription basis than we were last year.

Yi Chen (Managing Director of Equity Research)

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

Mark Baum (CEO)

We actually addressed that. I tried to address it. Andrew had done some analysis on tariff impact. It is on page six of the letter to stockholders. 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. For us, it is fairly negligible. I have 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. If you were to tack on 25% or 10% or even 125% onto that cost, based on what we receive, it really does not impact gross margins that much.

We do not estimate much impact with our portfolio as a result of the existing and the existing tariff structure. We are also working to, at least on some of our compounding formulations, bring more of our excipients and APIs in from domestic sources. We will see even a slightly smaller impact. The overall impact, our estimate was about 50 basis points. Not too much.

Yi Chen (Managing Director of Equity Research)

Got it. Thank you very much.

Mark Baum (CEO)

Thank you.

Jamie Webb (Director of Communications and Investor Relations)

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

Mayank Mamtani (Senior Managing Director and Group Head of Healthcare Equity Research)

Good morning, team. Thanks for taking our questions. I appreciate the comprehensive update on business. Sorry, one more question on IHEEZO. 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 is a 1Q patient copay assistance support dynamic that other eye care retina players kind of faced. I was also curious on an account-by-account basis, including the new GPOs that you have, anything we need to factor in? If you can confirm, there was no major customer we lost in 1Q. I have a follow-up on VEVYE.

Mark Baum (CEO)

Yeah. 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. 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 the fact that it's a buy-and-bill product. 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.

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 six 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.

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. With VEVYE, they can actually seek reimbursement for that. We are seeing positive dynamics in the marketplace, increased interest in IHEEZO. In terms of losing major accounts, we do not comment on specific accounts, but what I did comment on is that we intend to see revenue growth and unit demand growth from 2024 to 2025 with IHEEZO. I am pretty highly convicted on that.

Mayank Mamtani (Senior Managing Director and Group Head of Healthcare Equity Research)

Very helpful. Thank you, Mark. 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-C sort of quarter to date? Trying to understand how sequentially you could get to in terms of NRX volume growth and if anything you could comment on the dynamic share you have right now in the broader cyclosporine market.

Mark Baum (CEO)

Yeah. I mean, 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 nine clinical studies to get approved that doesn't have a label for signs and symptoms. I wouldn't want something that causes pain upon instillation 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.

It would not matter whether it was a branded version of that or a generic version of that because it would not matter at all. Bad is bad, or not great is not great, if you will, to be more politically correct. We think that we can win the cyclosporine market. There are a lot of units available. I would not want to compete against VEVYE. The most interesting thing I think I learned over the last quarter is that Mark Cuban has a pharmacy business. I think it is called Cost Plus Drugs.

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 does not 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 is actually less expensive these days to get access to VEVYE without a prior authorization being required and without the need for step therapy. We are quite happy that so many patients are now moving in that direction. We do not think that is going to abate, as I said in my prepared remarks. I would not want to compete with us on VEVYE in the cyclosporine market.

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. 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. I wouldn't want to compete against us. I think we're going to win the market.

Mayank Mamtani (Senior Managing Director and Group Head of Healthcare Equity Research)

Understood, Mark. Thank you. 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 timeframe you have said in the stockholder letter? Is it something you want to get fundamentally with your business internally or something externally you are watching out for, including maybe a milestone with a potential strategic acquisition, if you could comment on that? Thanks again for taking our questions.

Mark Baum (CEO)

Thank you, Mayank.

Andrew Boll (CFO)

You bet, Mayank. On the debt refi, I'm going to be somewhat guarded just because we're in active discussions with lenders, including Oaktree. I don't want to be giving away information in the middle of trying to get the best terms we can possibly get. 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 facility is restructured. We have plenty of room from a capital perspective to service the debt and certainly from an operational perspective. The business will be operating at a great level where we'll be in a good position to eventually deliver the entire business.

The key, Mayank, and I think this is important for all shareholders to know, is we have a lot of confidence in our ability to get the debt refined. The quality of institutions that we're talking to are really great institutions, great financing partners. We think we'll be able to get something done here in either late summer or early fall.

Mayank Mamtani (Senior Managing Director and Group Head of Healthcare Equity Research)

Makes sense. Thank you, team.

Mark Baum (CEO)

Thank you, Mayank.

Operator (participant)

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

Mark Baum (CEO)

Thank you. Thank you for the questions. Once again, thank you for joining us today. 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. Unfortunately, it requires a little bit of time. As I mentioned earlier, we've been at this for over 12 years. We've built that infamous business. That infamous business led to all of these opportunities coming to fruition for us to build this great company. 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. These are natural in any dynamic business.

Overall, we're confident in the strength of our foundation, the fundamentals of our business model. 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. I want to thank the Carroll 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. If you have any other questions, please feel free to reach out to Jamie Webb. That's J-W-E-B-B at harrowinc.com. This will conclude our call.

Operator (participant)

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