Good afternoon, and welcome to Harrow's First Quarter 2023 Earnings Conference Call. My name is Joe, and I will be your operator for today's call. [Operator Instructions] 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 Harrow.

Please go ahead..

Thank you, operator. Good afternoon, and welcome to Harrow'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 risks and uncertainties, many of which are beyond Harrow's control, including risks and uncertainties described from time to time in its SEC filings, such as the risks and uncertainties related to the company's ability to make commercially available its FDA approved products and compounded formulations and technologies, and FDA approval of certain drug candidates in a timely manner or at all.

For a list and description of those risks and uncertainties, please see the Risk Factors section of the company's most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission. Harrow's results may differ materially from those projected.

Harrow disclaims any intention or obligation to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise. This conference call contains time-sensitive information and is accurate only as of today.

Additionally, Harrow will refer to non-GAAP financial metrics, specifically adjusted EBITDA and/or adjusted earnings as well as core results such as core gross margin, core net income and core diluted net income per share.

A reconciliation of any non-GAAP measures 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; and Harrow's Chief Financial Officer, Andrew Boll.

With that, I'll turn the call over to Mark to go over some prepared remarks prior to the question-and-answer session..

One, the Harrow family, all of us, are all hands on deck for the continued rollout of IHEEZO. 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 TRIESENCE will be back in stock later this year and that soon thereafter, the NDA for TRIESENCE will transfer to Harrow. Five, in a matter of a few days, actually, next Tuesday at 3:00 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.

Sixth, beginning June 1, 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 Klarity-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 Harrow is well positioned to meet our 5-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 poll for questions.

Operator?.

[Operator Instructions] At this time, we will take our first question, which will come from Jeffrey Cohen with Ladenburg Thalmann..

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 Klarity-C as far as the money flow. It looked like your commentary was cash pay and also around that, could you expand upon Klarity-C a little bit.

Is it being positioned from the -- from that specific payor to 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?.

Yes. No. So first of all, thanks for the question. To be clear, the agreement is related to compounded formulations that our ImprimisRx 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 Klarity-C, which is a proprietary product, the vehicle is patented, and it contains 0.1% of cyclosporin. 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, a formulation that has a tremendous history in helping many, many thousands of patients, tens of thousands of patients. And it is a cash pay product.

Many of the patients who have been prescribed Klarity-C have also been prescribed -- before Klarity-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 Klarity-C.

Our objective is to not only sell a formulation to help these patients, but to also service these patients. We've realize 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 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 you have got a lot of more products coming away, tied at least into the three products coming the way ILEVRO, NEVANAC and MAXIDEX, which arguably in their hands as well as IHEEZO.

How does that look like and talk about their enthusiasm and maybe territories out there?.

Yes. So first and foremost, our number one priority within our commercial organization without question above all other opportunities is IHEEZO. 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 this unique -- these unique discussions with eye care professionals where originally, we had thought that IHEEZO 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 payment. 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 -- 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 raise $50 million to hire 150 reps to put out on the street to try and pitch some new products. 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, these folks produce a lot of profit for us.

And as the market grows and the market interest increases for IHEEZO, for NEVANAC, for ILEVRO, for TRIESENCE when it comes back and so on, you will see us grow our commercial organization accordingly..

Got it. And then a couple of 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. 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. Jeffrey, we have -- we've been reticent to put out guidance for many, many years. 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, I think I feel comfortable and we felt comfortable putting out guidance.

We're not going to put out guidance that we don't have a fairly high degree of confidence we can achieve. We don't want to put out guidance for the first time really in 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, we'll have an even much bigger smile on their face.

I think the reality is that IHEEZO 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 for the -- 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 we expect even more considerable growth into 2024 and beyond. So please forgive us for being conservative. That's just the nature of how we think, but we certainly could have adjusted guidance. We're not going to do that. Let us hit these numbers. And then we'll hopefully provide additional guidance as things progress..

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

Congrats on the progress. So maybe just on the ASCRS KOL feedback. I think you mentioned you got some good traction on understanding where exactly the initial uptake for IHEEZO could be.

So in terms of patient populations, and also, your clinical data that you have, the faster onset 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, Mayank. The -- the feedback from the folks I spoke to was extremely positive. 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 and/or administering it, got to work for the patient, who is being administered to, and frankly, it's got to work for the office staff, who are dealing with payment issues. They're dealing with receiving inventory and setting up a surgery for the physician or the surgeon.

So what I heard repeatedly, and it's not just from KOLs, but really everyone who is using and I hate 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 IHEEZO. The drug works as it was promised on 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 IHEEZO for glaucoma surgeries.

There are doctors now using it for retina injections, 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. It's a novel ocular anesthetic. And so 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 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 that on the cataract surgery side, the policy of providing payment outside of a capitated fee for a product like IHEEZO encourages innovation, when innovation would otherwise not be -- would not happen.

And so the fact that these surgeons can now use IHEEZO 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, the 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 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 IHEEZO use and certainly the J-Code that we have for it..

I 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?.

Thank you. 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 give that information any longer.

What I can tell you is that Cameron was able to produce some extraordinary chronic dry eye disease data, but he also has produced extraordinary data with the other products that they've now completed Phase II studies with. We think there's significant value there.

They have unique drug candidates that they're 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 eye conferences, but 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..

[Operator Instructions] Our next question here will come from Brooks O'Neil with Lake Street Capital Markets..

I got on a few minutes late. So if I ask a question about something you've already talked about, indeed then 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 launch of IHEEZO in San Diego, and I'm just hoping you could maybe tell us a little bit about what you think the key steps are for commercializing that product in the balance of 2023?.

Yes. Thank you for that, Brooks. As I said, everybody on our team is all hands on deck for IHEEZO. We are now recording revenues for IHEEZO, which is exciting. Doctors are billing the J-Code for IHEEZO. 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, 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..

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 IHEEZO and atropine and Fortisite and some of these additional formulations in various areas, the Fab Five. I'm curious to 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?.

Yes, that's -- I appreciate the question. Look, everything is a question of priority. And as I've said a few times on this call, our number one priority is IHEEZO. IHEEZO is the biggest opportunity within our company, not only from a revenue perspective, but also from a profitability perspective.

We are not, though, going to let go of our ImprimisRx compounding business as an example. 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.

At the ASCRS meeting, I had the opportunity to listen to Dr. Neel 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 and 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 and laid out a few other procedures, because there's so many other uses for Fortisite besides the specific, for example, central corneal ulcers that he was thinking about.

And so when you think about atropine.com, I've talked about the market opportunity for atropine. The five million or so American patients, who are -- 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.

If you look at the portfolio, 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, the Fab Five, in particular, with the NSAIDS, ILEVRO, NEVANAC, the same story.

So I don't feel like we're overwhelmed. And 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..

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. Even to talk a little bit more about the last question, 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.

The large and sort of high science players seem to be focused on wet or dry AMD within the ophthalmic pharmaceutical space. The last 10 years or so, there's really been a domination in the pharmaceutical space by PBMs and insurance companies.

It 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 and materials and other related costs like promotion..

So today, Harrow 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 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 Harrow.

If you have any investor related questions, please e-mail Jamie Webb that's jwebb@harrowinc.com. This will conclude our call..

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