Harrow Q1 2025 Earnings Call Transcript

Quartr
Provided by Quartr
May 9, 2025

There are 9 speakers on the call.

Operator

Good morning, and welcome to Harrow's First Quarter twenty twenty five 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.

Operator

I would now like to turn the call over to Jamie Webb, Director of Communications and Investor Relations for Harrow.

Speaker 1

Thank you, operator. Good morning, and welcome to Harrow's First Quarter twenty twenty five 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 Harold'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.

Speaker 1

Results may differ materially from those projected. Herald 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, Harold 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.

Speaker 1

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.

Speaker 2

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 Harold stockholders, the first quarter is always the toughest revenue period for the company. However, it is now in the rearview mirror.

Speaker 2

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 $280,000,000 To get there, we'll need to generate approximately $232,000,000 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 twenty twenty five by 38% year over year, and that's growth that is nothing to sneeze at. We also delivered a record $19,700,000 in cash flow from operations. Another bright spot, a very bright spot was Vevi.

Speaker 2

Vevi revenue rose 35% sequentially from $16,000,000 in the fourth quarter of twenty twenty four to $21,500,000 in the first quarter of twenty twenty five. And that was even before the launch of the VIVI Access for All program, which happened at the very end of the first quarter. We also completed our critical market access initiatives for Triassic, 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 which totaled 3,700,000 in the aggregate. We also continue to invest in building out our commercial infrastructure to support both current operations and future growth, particularly in sales and marketing.

Speaker 2

The vBuy team now exceeds 80 sales and marketing professionals. The buy and build team for iHiso and Triestin 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. And 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.

Speaker 2

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.

Speaker 2

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. So here we go. Continues to outperform expectations. As I said in my letter to stockholders, after launching more than 40 ophthalmic prescription products over the past twelve years, including VeeVai, I can say with confidence, one, given the consistent weekly growth in new prescriptions, new prescribers, and the stability we see with VeeVai refills, this product is poised to be our largest revenue product.

Speaker 2

And number two, the VeeVai Access for All program is the most successful market access strategy I've been a part of. And finally, three, without question, vVi is presently HARO's most valuable asset. We launched the vVi Access for All program or VAPA 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 VVAI prescribers at FillRx have quadrupled. If things continue at the current pace, a year or two from now, I expect VBAI to be right at or near the top of the leading US prescription dry eye medications.

Speaker 2

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 seeing 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 HARO stockholder to come up with some very large potential revenue numbers for VeeVi, especially as we get into the third quarter. Those numbers are real, and that is what is possible. And 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.

Speaker 2

So we don't expect this growth to abate in the near term. These are still early days, but the Veevae Access for All Programs 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. And by the way, when I talked about producing $250,000,000 in revenue in a calendar quarter by the end of twenty twenty seven, 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. But what about iHizo? IHizo's first quarter sales were impacted by an elevated stocking activity at the end of twenty twenty four.

Speaker 2

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 iEZO. 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.

Speaker 2

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 iHESO institutional accounts and the top 10 accounts in our pipeline, representing an estimated 80,000 incremental annual units of iHizo unit demand, we are confident in seeing meaningful unit demand growth through the remainder of the year and a sizable increase in iHizo revenue in 2025 versus 2024. So what about Triassence? When is that going to blossom? Well, the first quarter was truly a pivotal period for the long term plans that we have for this product.

Speaker 2

We were able to complete market access initiatives, including the publication of Triassence'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 Triassent. This all happened in the first quarter. These changes have greatly increased purchasers confidence in their ability to obtain reimbursement for Triassent. So these market access initiatives took effect April 1, effectively unlocking, you know, about 40% of the overall market for Triassence. And this is being reflected in sales momentum that we're seeing in the second quarter accelerating meaningfully.

Speaker 2

Already, the number of accounts ordering Tri Essence 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 Tri will be reimbursed outside of the bundled fee, a reimbursement feature that we saw directly positively impact the success of IEZO. We now have that for Triassence. 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.

Speaker 2

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. So 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 $280,000,000. Remember, we have 232,000,000 left to go, and here's how I break things down. On we believe we are on a glide path to generate at least a hundred million dollars in VBAI revenues this year and perhaps much more.

Speaker 2

We've already reported over $21,000,000 in revenue for the first quarter. Given VEVY's refill profile, averaging nine refills per year per covered patient and VAPA's strong momentum, we expect revenues from VEVY to consistently grow quarter to 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 iHizo, we're on track.

Speaker 2

We expect to deliver over $50,000,000 in 2025 revenue for this product with quarter over quarter increases expected now that distributor inventory levels have normalized. Our specialty branded products, which includes Triassins, in the aggregate, we expect them to deliver at least $50,000,000 in revenue this year. And in terms of our ImprimisRx compounding business, it is a consistent performer on track once again to deliver more than $80,000,000 in revenue in 2025. So if you add all of this up, these expected contributions, you will get to that $280,000,000 or more in 2025 revenue with a clear runway for upside. Again, we're expecting to see overall quarter over quarter growth this year.

Speaker 2

And while the third quarter can be a historically softer period, this year, we anticipate stronger numbers driven by the compounding effect from new Levi prescriptions under this program. Finally, we expect fourth quarter to be our strongest revenue quarter as it was last year. So 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 V Buy Access for All program, and accelerating momentum across multiple franchises, Harrow is distinguishing itself as a leading U. S.

Speaker 2

Ophthalmic pharmaceutical company. Now we're happy to answer your questions. I'll pause to have our operator poll for questions. Operator?

Operator

Thank you. Our first question comes from the line of Thomas Flaten with Lake Street Capital Markets. Your line is now open.

Speaker 3

Good morning. I appreciate you taking the questions. Mark or Andrew, 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 iEZO.

Speaker 2

Andrew, do you want

Speaker 4

to take that on?

Speaker 5

Yeah. Thomas, we we did we did not do much for for price increases on the products. He's so in fact, the lowest price stayed the same.

Speaker 3

Got it.

Speaker 2

I would add earlier in 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.

Speaker 3

Understood. And then switching over, I was wondering, I know you mentioned Project Depot, Mark, in your letter. You didn't address it today, but any particular initiatives we should be aware of other than Clarity 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?

Speaker 3

Is that taking it way too far?

Speaker 2

Yes, I appreciate the question. I mean, the initial impetus for Project Beagle was to transition the CLARITY C patients to VEVY. You know, 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 Clarity C, for example, doing, you know, about 9,000,000 or so, you know, a little under $10,000,000 in revenue, we're gonna very obviously see a reduction in imprimis revenue by that number, but on a corresponding basis, we'll see a significant increase in HARO revenue.

Speaker 2

What's really interesting financially, is that even if every single one of the CLARITY C patients came over to VeeVai at the $59 cash pay price, we estimate that our profit would be more than two times what it is on the Clarity C formulation. And that's with nobody that is Clarity C patient having access to insurance coverage. So, there's a lot of upside there for us with Project Beagle and implementing this transition from Clarity C to VeeVi. 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.

Speaker 2

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, serve thousands and thousands of doctors, ophthalmologists, optometrists in The United States. They rely on our best in class compounded formulations.

Speaker 2

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, you know, it's a business that has served us incredibly well. It's been the foundation of our company for many years.

Speaker 2

So not planning to exit.

Speaker 3

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

Operator

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

Speaker 6

Good morning. Thanks for taking the questions. Mark, I just want to start on Ahizo 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 $9,000,000 And then is that all from that unwinding of some potential stocking in Q4? Or was there any other kind of movers there?

Speaker 6

Thanks.

Speaker 2

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

Speaker 5

Yes, absolutely. Good morning. Think way I think the 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's softness in the numbers between Q4 and Q1 on a HEISO and unit demand. But then we started seeing that increase in Q2 and getting back to sort of a growth mode as Mark was talking about in the prepared remarks. And that's what we're seeing again with AESO.

Speaker 5

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 going at and as well as some of these new accounts that will come online. As for like that exact impact that was stock that where you had some stocking events, I don't think we know the exact numbers there, but happy to have additional conversation later with you, Chase.

Speaker 2

Yeah, I would add to that, if you look at the difference between Q4 of twenty three and Q1 of twenty four, 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 probably five to six percentage points lower this year in Q1 of twenty five versus Q4 of twenty four. So we did a little bit better. But look, it's wobbly.

Speaker 2

There is stocking at the end of the year for this product. And I think the 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.

Speaker 6

Got it. And it sounds like in April, you know, 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 on Tri Essence, you spoke to kind of better fundamentals in April. Are you seeing a meaningful inflection in volumes?

Speaker 6

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?

Speaker 2

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. And 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 Triassence does, know, they're very familiar with the product.

Speaker 2

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 number one intraocular, you know, injectable steroid in the market in fairly short order.

Speaker 2

But, know, 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 forty 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 expect to see greater density within those accounts.

Speaker 6

Got it. And then on VBAI, 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 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.

Speaker 6

Is that the right way to think about it, Mark?

Speaker 2

Yeah, I wouldn't say gross to nets moderate down and then begin to improve. 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 VIVI. 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.

Speaker 2

I mean, this is a level that you see, 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 gonna kinda settle out at. But 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. 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 thirty plus million Americans who suffer from this disease.

Speaker 2

Andrew, do wanna add to that at all?

Speaker 5

Nothing to add Mark.

Speaker 6

I'll leave it there. Thank you guys.

Speaker 2

Thank you Chase.

Operator

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

Speaker 7

Hi, Mark and Andrew. Thanks for taking our questions. I wanted to poke you a little bit further on the compounding business as some of the transition of the compounding products to prescription. Could you talk about, the base that exists as far as, infamous and, the base opportunity, both internal and perhaps external?

Speaker 2

Yeah, so, yeah, I think I tried to, you know, discuss the promise of the compounding business. And 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 use to transact with EyePoint ultimately to take on DEXYCU, you know, several years ago, and we're 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 Ihezo from Synthetica, and that has driven a tremendous amount of value for our company.

Speaker 2

And that success ultimately led to the people at Novoleak having the confidence in us to offer us Veeva at a very attractive price with, you know, most of the economics on the back end. And you can see what we're doing with Veeva 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 Clarity C patients to Veevae, 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, you know, well over 25,000 highly targeted consumers that have a nearly 100% chance of purchasing a product that is chronic in nature, you know, 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.

Speaker 2

Well, ImprimisRx has those. More than 25,000 of those potential V. Vi patients and we have them as a result of the success of the ImprimisRx business over the last twelve years. There are other products within the ImprimisRx portfolio that are highly correlated and highly related to branded products that we now sell. You know, whether it's an NSAID, whether it's an antibiotic or a topical steroid, whether it's an injectable product, you know, there are a lot of there's a lot of overlap between the two portfolios.

Speaker 2

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 gonna, I think, you know, continue to proceed with this project, Beagle.

Speaker 7

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?

Speaker 2

Well, I mean, you know, 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, you know, we intend to do better.

Speaker 2

One of the nice things about the way I operate the business, the way Andrew and I have partnered over the years is, you know, we take action 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.

Speaker 2

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.

Speaker 7

Got it. Super. Thanks for taking our questions.

Operator

Thank you. Our next question comes from the line of Yi Chen with H. C. Wainwright. Your line is now open.

Operator

Yi Chen, your line is open. Please check your mute button.

Speaker 8

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

Speaker 2

Yes. Hi, Yi. Good morning.

Speaker 8

You mentioned that Levi 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 Levi's sales?

Speaker 2

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

Speaker 5

Yeah. For the question. And I want to make sure I understood the question correctly. But our revenue recognition obviously is well correlated to prescription volume isn't a perfect match. Yes.

Speaker 5

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 March with the introduction of VY Access for All. And so as Mark was talking about in an earlier question, when we look forward, volumes are increasing rapidly, especially from a new prescription perspective. And we will see some of the, as a result, 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 VY Access for All than it was prior last year.

Speaker 5

And then importantly, volumes that we're seeing from an increased perspective are incredible. And one of the things that I love about Veeva 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 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.

Speaker 5

And then for us and for shareholders, we're going to be netting more on a per prescription basis than we were last year.

Speaker 8

Okay, got it. Thank you. And could you also let us know whether any of Harold's products are affected by current tariff policy?

Speaker 2

You know, we actually addressed that. I tried to address it. Andrew had done some analysis on tariff impact and it's on page six 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 margin. So for us, it's fairly negligible.

Speaker 2

You know, I've been asked this by a couple of other folks. I think people know, for example, what our cost is on iHizo, which is in fact made outside The United States. And if you were to tack on 25% or 10% or even a 25% onto that cost, you know, 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 existing tariff structure. And then we're also working to, you know, at least on some of our compounding formulations, bring more of our excipients and APIs in from domestic sources.

Speaker 2

We'll see even a slightly smaller impact, but the overall impact our estimate was about 50 basis points. Not too much.

Speaker 8

Got it. Thank you very much.

Speaker 2

Thank Our

Operator

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

Speaker 4

Good morning, team. Thanks for taking our questions and appreciate the comprehensive update on business. Sorry, one more question on Aghi. 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. You know, I know there's a 1Q patient co pay assistant support dynamic, that other eye care retina players kind of faced, but was also curious, on a count by count basis, including the new GPOs that you have, anything we need to factor in?

Speaker 4

And if you can confirm, there was no major, customer we lost in 1Q? And I have a follow-up on Yuan.

Speaker 2

Yeah. I I would just say that the the, you know, 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 in addition to, you know, getting the products out, opening accounts, servicing accounts. At at at our level, at the executive level, we think about managing the ASP, and and that is mission critical. So that is top of mind here.

Speaker 2

Clearly, if you saw, you know, some some shift in ASP and that that affecting revenues quarter to quarter, you know, it's typically because of, you know, those those features of of buying the the fact that it's a buy and bill product. And, you know, I I that aside, and and as I said, to be clear, we are thinking about ASP. I mean, and I talk about ASP management nearly every day, and are thinking about ways to do that compliantly with the team. But what 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.

Speaker 2

The, you know, we're seeing anecdotally more retina counts consider the clinical benefits of IHIZO and, you know, 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, you know, clinical benefits that are, you know, not as strong as VeeVai. And with VeeVai, they can actually seek reimbursement for that. And so, we're seeing positive dynamics in the marketplace, increased interest in IHIZO. You know, in terms of losing major accounts, you know, 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 AHIZO.

Speaker 2

And and I'm, you know, pretty can be highly convicted on that.

Speaker 4

Very helpful color. Thank you, Mark. And and regarding VY, we're also hearing a similar momentum from KOL calls we did post RAFA. Could you touch on what proportion of the 25,000 patients have already moved over from CLARITY sort of quarter to date? And trying to understand how sequentially you could get you know, in terms of NRx volume growth and if, you know, anything you could comment on the dynamic share you have right now in the broader Cyclosporin market?

Speaker 2

Yeah. I mean, I can't comment on the specific share, and I'm glad, you know, you're seeing when you do your independent calls, the kind of feedback that we're also receiving with respect to VIVI, not only clinically, but with respect to this program. It is making a huge impact. I've always, you know, looked at the dry eye market. We've talked about this offline many times.

Speaker 2

If I was a patient, what

Speaker 4

would I want?

Speaker 2

Or if my mother was a patient, what would I want my mother to have access to? And I wouldn't want, you know, one of these old cyclosporins 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 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 matter whether it was a branded version of that or a generic version of that, because, you know, it wouldn't matter at all.

Speaker 2

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. You know, I wouldn't want to compete against Vevi. But the most interesting thing I think I learned over the last quarter is that Mark Cuban has a pharmacy business.

Speaker 2

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 Veeva, 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 Veevae, 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.

Speaker 2

So, I wouldn't want to compete with us on V. V. I. 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.

Speaker 2

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 Evi 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.

Speaker 2

And I think we're going to win the market.

Speaker 4

Understood, Mark. Thank you. And then maybe 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 are watching out for, including maybe a milestone with a potential strategic acquisition?

Speaker 4

If you could comment on that. Thanks again for taking my questions. Thank you, Mayank.

Speaker 5

You bet, Mayank. The on the debt refi, I'm gonna be somewhat guarded just because I'm more in active discussions with 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 But 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 delever the entire business.

Speaker 5

But key, Milink, 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 refi ed. The quality of institutions that we're talking to are really great institutions, great financing partners. And we think we'll be able to get something done here in either late summer, early fall.

Speaker 8

Makes sense. Thank you, David. Thank

Speaker 2

you, Mike.

Operator

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.

Speaker 2

Thank you. And thank you for the questions. And once again, 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.

Speaker 2

As I mentioned earlier, you know, we've been at this for over twelve years. We've 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.

Speaker 2

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.

Speaker 2

And I want to thank the Farrell 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 JWEDBheroinc dot com. This will conclude our call.

Operator

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

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Earnings Conference Call
Harrow Q1 2025
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