Harrow, Inc.

Good afternoon, and welcome to HARO's first quarter 2023 earnings conference call. My name is Joe, 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. And as a reminder, this conference is being recorded today. I would now like to turn the call over to Jamie Webb, Director of Communications and Investor Relations for HARO. Please go ahead.

Thank you, operator. Good afternoon and welcome to Harold's first quarter 2023 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 risk and uncertainties, many of which are beyond Harold's control, including risk and uncertainties described from time to time in its SEC filings. such as the risk 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 risk 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. HARO's results may differ materially from those projected. HARO 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, we 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 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 Elbaum, and Harrow's Chief Financial Officer, Andrew Bowles. With that, I turn the call over to Mark to go over some prepared remarks prior to the question and answer session.

Thanks, Jamie, and thanks to everyone for joining us on today's call. Consistent with our usual practice, our first quarter 2023 earnings release, corporate presentation, and letter to stockholders have all been posted to the investor relations section of our website. Please consider reviewing these documents for a better understanding of the company's results. In particular, our stockholder letters should be required reading if you want to track where we've been and where we're heading as we execute our most recent five-year plan. On past quarterly calls, either I or Andrew have read out the financial numbers for the quarter. However, all of these figures are in black and white on not only our Form 10-Q, but they're also summarized in our press release. And of course, they're also available in the stockholder letter, which includes additional commentary. Please forgive me for not covering what you have so many access points to see with your own eyes. With that said, I want to reaffirm 2023 guidance of $135 million to $143 million in net revenues and $44 million to $50 million in adjusted EBITDA. These figures approximate the revenues we believe we can achieve in connection with the first year of the aforementioned five-year plan, keeping in mind that we started a new five-year planning cycle this past January. I realize these days that only a select few public company stockholders have an overflowing loyalty to a business or their stock holdings. Of course, it has never been easier to buy or sell a share of stock, and thus, a share of the businesses that they own. Please know that my day-to-day focus is on achieving the goals of this five-year plan. In this regard, I realize that a five-year plan is made up of a series of one-year plans. Part of my job is to monitor our progress in real time. And these occasions, our quarterly calls, are an opportunity to report on our progress on the five-year plan, not the last quarter plan, the last month plan, or the last week plan. Of course, if something we thought was achievable is no longer likely to happen, count on me to do my best to identify those shortcomings on these calls. So what is that five-year objective? Well, put simply, I believe at the end of this five-year planning cycle, Harrow has the opportunity to be one of the largest, if not the largest, pure play ophthalmic pharmaceutical company in the United States. This is what our five-year plan calls for. If you as a stockholder believe that we as a management team can accomplish this, then please accept my thanks in advance for your patience, and my appreciation for your trust today and hopefully for many years to come. Now let's discuss the recent ASCRS meeting, which the HERO team just returned from, where we formally launched FDA-approved iHESO, the first branded ocular anesthetic approved for the U.S. ophthalmic market in nearly 14 years. We had the opportunity to talk with eye care professionals from all over the United States, to answer questions about iHESO, our Fab Five products, and our expanding portfolio of innovative compounded formulations such as Fortisite and those available on atropine.com. As usual, amazing things happen when you speak to your customers. They tell you how well you're doing and what you can do better or differently to serve their needs. Working the booth and speaking to customers is one of my favorite things to do, And it's one of the most productive things I get to do each year. Frankly, talking to customers is how we've built our company over the past nine years. It's our not-so-secret sauce, helping us to get us to this point in our development. Regarding iHESO, I had an opportunity to talk with early adopters about their experience to date. Overall, customers are getting the exact experience from iHESO that we had hoped. And there is more commentary on IHESO in our latest stockholder letter. We also had the opportunity to talk with customers about our Fab Five products. Generally, ophthalmologists were excited to see us again commit to support these important products and to revitalize them under the HARO name. And of course, we talked with many customers who were excited about ongoing product innovation within our compounded pharmaceutical products or CPP business, especially Fortisite, and our proprietary compounded atropine formulations, which are available, as I said earlier, at atropine.com. Related to our Imprimis Rx CPP business, I'm happy to share the good news about a recent agreement with a large U.S. healthcare insurer. which includes one of the nation's largest vision care networks. Under this agreement, which kicks off on June 1st of this year, Impromis Rx will provide its next-generation preservative-free and boric acid-free compounded atropine formulations and its innovative total tiers, ophthalmic formulations, such as Clarity C, to the over 9 million members of their vision care network, which includes approximately 36,000 private practice eye care professionals, local optical stores, and national retail stores, including well-known national brand names. We are looking forward to building our relationship with this new partner and making this new agreement a great success for everyone for many years to come. My summary observation from ASTRS is that there is a growing leadership vacuum in the ophthalmic pharmaceuticals market in the United States. That's aside from certain segments of the retina market, such as wet AMD, or age-related macular degeneration, or dry AMD, those markets. I believe Hero, though, is in a pole position to help fill this void, to provide leadership and serve ophthalmologists and optometrists as a market leader dedicated to serving the needs of their practices and their patients. Our team must continue to execute though, and that is what we intend to do. A few more comments on a few items we are focused on. One, the Harrow family, all of us, are all hands on deck for the continued rollout of iHESO. Two, we are now beginning commercial activities for three of the Fab Five products In other words, those products whose NDAs were recently transferred. Three, we expect the NDA for Vigamox to transfer towards the middle to latter part of the summer. Four, we continue to expect that Triessence will be back in stock later this year and that soon thereafter, the NDA for Triessence will transfer to Harrow. Five, In a matter of a few days, actually, next Tuesday at 3 p.m. Central, to be exact, Melt Pharmaceuticals is scheduled to meet with FDA regarding the proposed Phase III program for its Melt 300 program. Once again, there's more information about the Melt 300 program and that opportunity in our stockholder letter. Six, beginning June 1st, we're working on pull-through for our new agreement with this large national healthcare insurance provider related to sales and dispensing of our atropine formulations as well as our total tears formulations, specifically Clarity C. And seven, we continue to be on the hunt for accretive deals at attractive prices that will enhance our ability to serve our customers and in turn create value for our stockholders. 2023 has started out strong and we intend to continue to dig deeper and capitalize on the momentum that we have created. While there are absolutely no guarantees and a considerable amount of work lies ahead, we truly believe that HARO is well positioned to meet our five-year strategic plan objectives, to be one of the largest, if not the largest, pure play ophthalmic pharmaceutical company in the United States, uniquely providing both branded pharmaceutical products and compounded pharmaceutical products that meet the needs of our growing customer base and, of course, millions and millions of their patients. We are now happy to take your questions. I will pause to have our operator pull for questions. Operator?

We will now begin the question and answer session. To ask a question, you may press star, then 1 on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys. And to withdraw a question, please press star, then 2. At this time, we will take our first question, which will come from Jeffrey Cohen with Landenberg-Solomon. Please go ahead with your question.

Well, hi, Jamie, Mark, and Andrew. How are you? Good to speak with you, Jeffrey. Long time, no see. It looked like you had a strong presence at ASCRS, so that's nice to see. So I'll keep it just to a few for now. Talk a little bit about Atropine and Clarity C as far as the money flow. It looked like your commentary was cash pay, and then also around that, could you expand upon Clarity C a little bit? Is it being positioned from that specific payer steer people away from some of the branded dry eye products? One I can think of starting with an X, or is it being positioned otherwise?

Yeah, so first of all, thanks for the question. To be clear, the agreement is related to compounded formulations that our Imprimis Rx compounded business makes and dispenses. So these are products that are not FDA approved. They don't have a specific label or an indication for use to be clear. However, in the case of Clarity C, which is a proprietary product, the vehicle is patented and it contains 0.1% of cyclosporine. That is a compounded formulation that, believe it or not, has been prescribed in the United States to date by more than 6,000 eye care professionals. So this is a product formulation that has a tremendous history in helping many, many thousands of patients, tens of thousands of patients. And it is a cash paid product. Many of the patients who've been prescribed Clarity C have also been prescribed before Clarity C, they've been prescribed FDA approved products. And there are several of them out there, and we all know which products they are. And for whatever reason, they failed on those products and were ultimately prescribed Clarity C. Our objective is to not only sell a formulation to help these patients, but to also service these patients. We've realized that in the dry eye space in particular, these are patients that not only need the product, but they also need the service in order to create this continuity of the relationship with the patient. As far as the atropine formulations go, we talked a lot about the unique formulations that we've been able to make that are not only preservative-free but boric acid-free that are now available, and they're available through a 503B. So these are available from an outsourcing facility, and they're made to the highest federal standards. So This partner that we've created this relationship with is a very large entity, and they have an extremely large vision care network, and they're interested in providing access to their members to these formulations on a cash pay basis. For many years, I have said that we have been able to make available these compounded formulations at or below the co-pays that patients oftentimes pay for other alternatives. And so they realize that. And in this case, they've negotiated a deal with us to make these products available. And as I said, I think they're quite confident that these formulations will be compelling to their member base. And from a value perspective, will potentially save these patients money as they seek to take care of their specific needs.

Got it. And then, Mark, walk us through now what the commercial organization looks like in size or maybe geography, and then tie that into, I know they've got a lot of more products coming their way. Tie that into at least the three products coming their way, Levro, Devanac, and Maxidex, which arguably is in their hands, as well as Ahizo. Okay. How does that look like? And talk about their enthusiasm and maybe territories out there.

Yeah, so first and foremost, our number one priority within our commercial organization, without question, above all other opportunities, is iHESO. We've talked a lot about it. The product has this unique and permanent J code associated with it. I say in the stockholder letter, that I had these unique discussions with eye care professionals where, you know, originally we had thought that IHESA would be useful in not only cataract surgeries but also intravitreal injections. But eye care professionals had other ideas for its use that would be on label and that would potentially be able to be paid for using this J-code or even through the pass-through payments. As far as our commercial organization goes, I view our commercial organization not just as feet on the street external sales reps. At Harrow, we view the commercial organization more globally. It includes our customer service organization. It includes what we call pharmacy sales reps or PSRs. It also includes our sales reps that have these incredible relationships with eye care professionals across the country. Right now, if you aggregate all of those folks, I think the group is around 90 or so in total. And they cover all 50 states. And as I said in prior calls, we sell into every populated county throughout the United States. So it's a sizable organization. It is a mighty organization. These folks do a lot with relatively few resources. And then just philosophically, I would say that what you will not wake up and see us do is go out and, you know, raise $50 million to hire 150 reps to put out on the street to try and pitch some new product. That's not the way we have grown our organization. We're going to let market interest and sales opportunities and potential revenue drive the addition of additional costs within the sales organization. Right now, you know, these folks produce a lot of profit for us. And as the market grows and the market interest increases for Ahizo, for Nevenak, for Alevro, for TriEssence, when it comes back and so on, you will see us grow our commercial organization accordingly.

And then a couple quick ones for Andrew, if I may. Firstly, on the margins, how you're feeling about Q1 margins, and is that sustainable for the balance of 2023? And then secondly, on the guide, if you could put forth any commentary, which it's unchanged now, which leads me to believe that the extra few from the first quarter doesn't change the full year, but that may be the case in subsequent quarters?

Sure, Jeff. I'll let Mark talk about the guidance a little bit. But in regard to gross margins, and specifically core gross margins, I was pleased with where we came in at. I always think we can do better, and I know Mark feels the same way. But 76% on the core gross margin was a good number. We feel like there's room to grow definitely as the branded portfolio starts getting more sales from those products in particular, which are going to have higher gross margins tied to them. So it's definitely a number that we think is sustainable throughout the year. Mark, do you want to talk a little bit about the guidance?

Sure. And, you know, Jeffrey, we've been reticent to put out guidance for many, many years. Um, I think Andrew and I looked at each other earlier this year when we closed the Fab five deal. And when we received this permanent J code and we just said, you know, I think I feel comfortable, uh, and we felt comfortable putting out guidance. Um, we're not going to put out guidance that we don't have a fairly high degree of confidence. Uh, you know, we can achieve, um, we don't want to put out guidance for the first time, really. and more than a handful of years, and then just absolutely fall right on our face. And so we would like to put out a number, and we have put out a number that we think we can put smiles on the faces of our stockholders when we're actually able to deliver our quarterly results. And then ultimately, by the end of the year, hopefully they'll have an even much bigger smile on their face. I think the reality is that IHESO is going to be a growing phenomenon from a financial perspective and also within the market. This second calendar quarter, we're expecting, I wouldn't say necessarily modest, but the most modest certainly out of the second, third, or fourth quarter in terms of revenues. But that should grow markedly in the third calendar quarter and even more so in the fourth calendar quarter. And then, uh, we expect, uh, you know, even more considerable growth in the 2024 and beyond. So please forgive us for being conservative. That's just the nature of how we think. Um, but, uh, you know, we, we certainly could have adjusted guidance. We're not going to do that. Let us, uh, let us hit these numbers. Um, and then, uh, you know, we'll hopefully provide additional guidance, uh, as, as, uh,

please progress. Okay, super. Thanks for taking our questions. Thank you, Jeffrey.

And our next question will come from Mayank Mamtani with B Reilly.

Please go ahead with your question. Good afternoon, Tim. Thanks for taking our questions and congrats on the progress. So maybe just on the ACSRS KOL feedback, I think you mentioned you got some good traction on understanding where exactly, you know, the initial uptake for AHISA could be. So in terms of patient populations and also, you know, your clinical data that you have, the fast-run set of action, like could you just talk about like these early adopters, what they feel is really innovative for them, having had not seen a lot in the past two decades. And then also, we get a lot of questions on the importance of J-code and pass-through status. Could you talk a little bit about how the early grant of that is helpful to understand the trajectory of this drug? And then I have a quick follow-up.

Sure. And thank you for the question, Mike. the feedback from the folks I spoke to was extremely positive. You know, and I say this in the stockholder letter that my experience with the commercial launches that we've had over the last seven years or so is that the first thing that has to happen and it's paramount is that the product has got to work. It's got to not only work, for the physician who's prescribing it or administering it got to work for the patient who it's being administered to and frankly it's got to work for the office staff who are dealing with payment issues they're dealing with you know receiving inventory and setting up a surgery for the physician with a surgeon so what i heard repeatedly And it's not just from KOLs, but really everyone who has used it. And I hasten to say everyone, but it literally is everyone who I spoke to and who was referred to me as being a user from our commercial leadership had very positive experiences using iHESO. The drug works as it was promised You know, and the label, the label is fantastic. And so what I thought was unusual beyond the fact that it worked really well, like I said, not only for the doctors, the patients, and the staff, is that it was used more broadly than I had anticipated. A friend of ours who is an ophthalmologist, a very well-known ophthalmologist in the state of Wisconsin, used IHESO for glaucoma surgeries. There are doctors now using it for retina injection, you know, for intravitreal injections and retina procedures, other retina procedures. Doctors want to use this for laser, various laser procedures. And so all of those uses, I believe, are on label because the label is so broad as a novel ocular anesthetic. And so, you know, that was what we heard. And by the way, all of that was consistent with the clinical data. Now, I have had to learn something over the last, you know, couple of years as we've branched out beyond compounded formulations. And that is, I'm not going to talk about or promote an FDA approved product beyond what is in the four corners of the label. The doctors, of course, are free to say whatever they wish. But what I can tell you is that I'm very, very happy with the physician feedback, not only from KOLs, but from regular ophthalmologists that are taking care of patients who are customers of ours. And then in terms of the importance of the J code and pass-through, it means everything. The fact is, is that on the cataract surgery side, the policy of providing payment outside of a capitated fee for a product like IESO encourages innovation when innovation would otherwise not be, would not happen. And so the fact that these surgeons can now use IESO and experience its benefits, its unique benefits, and have it paid for outside of the capitated fee, I think is critical. And as I said, It is an innovation-encouraging policy, and it works. The J-code itself, though, outside of the ASC or the hospital, outside of cataract surgery, allows the formulation of product to be paid for in the office environment for many of these other procedures that I mentioned. And so we think that bodes very well We think that over time, more and more ophthalmic procedures are going to take place in the office, whether it's cataract surgery or even I was met with someone who's doing, they're doing retina procedures in office now. So retina surgeries in the office. So more and more procedures are going in office. And I think that is a great thing for IHESO use and certainly the J code that we have for it.

Appreciate the helpful color, very detailed. And then just quickly on the surface ophthalmics, the Phase II dry eye disease data that was presented at a retina meeting recently, or eye conference, could you just talk about what the next steps are there in terms of doing a late-stage registration enabling study? Thanks for taking our questions.

Thank you. You know, to be candid with you, I recently dropped off of the Surface Ophthalmics Board of Directors. I was on the Board of Directors since the founding of the company. And so I am not privy to any of that information any longer. What I can tell you is that Cameron was able to produce some extraordinary chronic dry disease data, but he also has produced extraordinary data with the other products that they've now completed phase two studies with. We think there's significant value there. They have unique drug candidates that are in the middle of developing, but I can't tell you specifically what the next steps are with Surface. We're hoping, though, that the company, sooner rather than later, will be a little bit more communicative Not necessarily at iConferences, but, you know, to the broader interested – more broadly to more interested parties, I'll say, including, frankly, me and the rest of our stockholders. So that's all I really have to say about Surface at this time.

That's helpful. Thank you, Mark.

Thank you, Mayank. And again, if you have a question, you may press star then one to join the queue. Our next question here will come from Brooks O'Neill with Lake Street Capital Markets. Please go ahead with your question.

Good afternoon, Mark and Andrew. I got on a few minutes late. So if I ask a question about something you've already talked about in detail, maybe you can just give me the quick answer and we can go into the details later. But I see you've written about and talked about the uh launch of a hizo in san diego and i'm just hoping you could maybe tell us a little bit about what you think the uh key key steps are for commercializing that product in the balance of 2023. yes thank you for that brooks as i said you know everybody on our team is all hands on deck for a hizo

We are now recording revenues for IHESO, which is exciting. Doctors are billing the J code for IHESO, and we have not had any reports, negative reports at all to date, which is exciting as well. And I think for us, we've got a very detailed commercial strategy. There are, on the cataract surgery side, certainly reports, accounts that are using other pass-through products in the market. And we're certainly talking to those folks first. And so there's sort of a strategic pecking order as we roll this out. But look, there are so many opportunities in terms of product units to sell into this market. When you think about cataract surgery, when you think about intravitreal injections, And now, as I've said in the stockholder letter and on this call, glaucoma surgeries and other ophthalmic procedures, including laser procedures. If you take a look at the overall bolus of what that number looks like, it's a big, big number. It's over 15 million unit opportunities annually. And so given the fact that we make drug currently for over a million cataract surgeries, I think We have a huge opportunity in front of us with this product, iHESO, and we need to, I think, in a stepwise fashion, execute this commercial strategy that we've laid out. The big, I think, issue for us is creating that buzz. It is these doctors telling their friends about their clinical experience. It is seeing more and more doctors try the product out and continue to order from us, which is happening now. That is also a very important phenomenon, and we need more of that. But, look, there's a big opportunity. It's a huge market. It's the first new topical anesthetic in almost 14 years, and doctors are having great experiences, and we're going to help more of them have more of those experiences throughout the year.

Great. Sounds perfect. And I think you guys know that I'm wildly excited about the many exciting things you have going on with IESO and Atropine and Fortisite and some of these additional formulations in various areas of Fab Five. I'm curious if you think about kind of not overreaching the size of your company and your organization. How do you think you'll know when there's enough on the plate and before you get to too much on the plate?

Yeah, that's, I appreciate the question. You know, look, everything's a question of priority. And as I said, you know, a few times on this call, our number one priority is IHESO. IHESO is, you know, the biggest opportunity within our company, not only, you know, from a revenue perspective, but also from a profitability perspective. We are not, though, going to let go of our Imprimis RX compounding business as an example. You know, that is a business that continues to churn day in and day out. I get the daily sales figures. And it's a great thing to see that thing continue to churn and produce cash and create value and to talk to doctors who love those products in their practices. You know, at the ASCRS meeting, I had the opportunity to listen to Dr. Neil Desai's presentation. And I actually put a link to it within the stockholder letter. And I would encourage you. to listen to how Fortisite has helped him in his practice. Now, I did say that he was paid a little under $1,000 for his time in giving that talk, but trust me, doctors like Dr. Desai and hundreds of others and a growing number really appreciate the value that this patent-pending formulation bring to their practice to help them take better care of their patients. If you do the math on what that opportunity looks like, it's a very large opportunity. I was actually talking to another doctor about Fortisite and I mentioned to him that we have a product replacement guarantee that if you have Fortisite in your refrigerator and you don't have a patient who needs it, then we would replace it if it expired. And he quickly said, there's no way that I would ever let that expire because I wouldn't just use that on, you know, and he laid out a few other procedures. There's so many other uses for Fortisite besides the specific, for example, central corneal ulcers that he was thinking about. And so, you know, when you think about atropine.com, you know, I've talked about the market opportunity for atropine, you know, the 5 million or so American market. patients who would benefit from an atropine-like therapy. And you start doing the math on that, it's a big, big number. And so we have a lot of these things going. It certainly is going to help to have this large insurance company helping us market these opportunities to their patient base. But I don't think that we're overwhelmed from a commercial perspective with The products that we have, you know, if you look at the portfolio, you know, we have Vigamox because we already sold a ton of moxifloxacin already before we owned Vigamox. And now to have Vigamox as an FDA-approved version of moxifloxacin only helps us. And if you look at the rest of the portfolio, with the Fab Five in particular, with the NSAIDs, Alevro and Nevenak, it's the same story. So I don't feel like we're overwhelmed, and, you know, I think all of these products in the aggregate just help us kind of circle the wagon around our customer to maximally provide for their needs.

Well, that sounds great. You guys have executed beautifully in the four or five years I've been following the company, and I'm pretty confident you're going to continue to execute beautifully going forward.

Thank you, Brooks.

Thank you. And this concludes our question and answer session. I'd like to turn the conference back over to Mark Baum for any closing remarks.

Thank you, operator. You know, even to talk a little bit more about the last question, you know, there really is sort of a vacuum in the ophthalmic pharmaceutical space in the United States. all of the major pharmaceutical companies, for whatever reason, are focused on other therapeutic areas, it seems. And the large and sort of high science players seem to be focused on wet or dry AMD within the ophthalmic pharmaceutical space. For the last 10 years or so, there's really been a domination in the pharmaceutical space by PBMs and insurance companies sort of derailed a lot of drug development in small to medium markets. Then we had COVID and now we've had massive inflation, not only for labor materials and other related costs like promotion. And we really believe that there has been a diminishment of competitive threats in the ophthalmic pharmaceutical space. It's sort of a unique phenomenon. And we want to be there with those assets. to serve this need. And by the way, the need has not diminished one bit. Competition, I think, has been reduced. The need has only increased. And as I said, for a number of reasons, there are fewer new products being developed that are threats. So today, you know, Harrell is in best financial and operational shape of its history. And that would not be possible without the support of our stockholders and the entirety of of our incredible team. So I offer all of you very, very sincere thanks. Thanks to everyone for attending today's call and for your interest in HARO. If you have any investor-related questions, please email Jamie Webb, that's jwebb, W-E-B-B, at haroinc.com. This will conclude our call.

The conference is now concluded. Thank you very much for attending today's presentation. You may now disconnect your lines and have a great day.