Good afternoon, and welcome to Harrow Health's Fourth Quarter 2021 Earnings Conference Call. My name is Tom, and I will be your operator for today's call. [Operator Instructions] As a reminder, this conference is being recorded.

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

Thank you, operator. Good afternoon, and welcome to Harrow Health's fourth quarter and year-end 2021 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 Health's control, including risks and uncertainties described from 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 Health'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. A reconciliation of any non-GAAP measures with the most directly comparable GAAP measures is included in the company's letter to stockholders 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.harrowinc.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.

Mark?.

one, focusing on ophthalmic surgical, chronic and acute care prescription pharmaceuticals; two, serving institutional customers. These are doctors and hospitals and ambulatory surgery centers; and three, continuing to add high-value FDA-approved products to our portfolio.

We believe we made significant progress during 2021 and in the execution of our strategic plan, including increasing the cash on our balance sheet to record levels, which we accomplished without diluting our shareholders and completing several transformative transactions, all aimed at positioning us to move forward with the next steps in our strategic plan.

In 2022, we are focused on building the infrastructure to support the significant growth that we anticipate over the next few years, beginning this year, not only from recent acquisitions of drug candidates like AMP-100 and MAQ-100, if they're approved by the FDA, but also from internally developed formulations that we expect to launch commercially over the next 18 months or so.

Also, we continue to be on the hunt for additional M&A opportunities that could further increase our growth potential. In order to support this growth, we are expanding our existing commercial infrastructure, including adding eight experienced sales executives and a Head of Market access.

We expect our team to be further expanded during 2022 as we prepare for the approval and launch of AMP-100 and the relaunch of IOPIDINE, MAXITROL and MOXEZA under our company umbrella. In addition, we are focused on strengthening our internal expertise and capabilities within regulatory compliance, quality and supply chain management.

We are also in the process of establishing our own internal analytical lab, eliminating our reliance on third-party labs and enhancing our inventory management and self-distribution systems. This year is already shaping up to be a breakout year for Harrow. We continue to see strong daily revenues to this day.

As we previously announced, October 16 of this year is our PDUFA date for AMP-100. And if approved, we intend to be ready a few months thereafter to launch AMP-100 into a market in which we have commercial credibility. That would be the U.S. ophthalmic surgical or procedure market.

In addition, we expect to see value creation events from our noncontrolling equity positions in companies that were originally founded as Harrow Health subsidiaries before being deconsolidated. For example, in a few months, we expect Surface Opthalmics to report data on a major chronic dry eye study.

This was the first study of its kind to ever go head-to-head against the two category-leading FDA-approved products, a big study. Soon thereafter, we expect Melt Pharmaceuticals to report top line data on its MELT-300 clinical study.

As these events unfold, we will continue to grow our core ophthalmic pharmaceuticals business, launch new ophthalmic products we've been internally developing and review the potential for new accretive transactions in our area of focus. That's ophthalmic pharmaceuticals. Now let's take your questions. I'll pause to have our operator poll for questions.

Operator?.

We will now begin the question-and-answer session [Operator Instructions] And the first question comes from Brooks O'Neil with Lake Street Capital Markets. Please go ahead..

Good afternoon, Mark. And congratulations on a terrific finish to the year. A couple of questions. I guess I'd start off by saying it's notable that neither the press release, I think, your shareholder letter and your prepared comments seem to make any mention of COVID. So, I assume it wasn't a material factor for you in the quarter..

Yes. Thank you, Brooks. And yes, that would be correct. COVID was not a material effect on our business..

That's great. And did you see much of it in January? ..

We did. As I've said over the last couple of years now, the effect of COVID has very much been local in certain regions of the country where patients have been reticent to come into the office from time to time when there has been a rapid spread or when a new variant has hit. By and large, the fourth quarter, we really didn't detect a lot of that.

And then candidly, as we entered into the first quarter of this year, things have been sort of business as usual and even up until the month of March, which I tried to highlight in my prepared remarks. Business is very good, actually..

Great. Great, that's fantastic. You seem to be fairly optimistic, I guess, is the right way to characterize it about FDA response on AMP-100.

Are there some things that caused you to be so optimistic about the outlook for that product and the ability to get through the FDA?.

Well, first of all, we don't want to diminish the process of the product becoming FDA approved, and that's a process that we have to work through with the FDA with our partner. .

Sure..

The reason why we're excited about AMP-100, frankly, is, first of all, we do think we have a very strong chance of getting the product approved. Our PDUFA date is in the month of October, as I mentioned. So, it's coming up. And I think the reason why we're excited about the product, frankly, is, first of all, it's patented through 2037.

It is an intraoperative pain medication. There's a large market for products like this. The cataract surgery market alone is 4.5 million annual procedures and growing. In a few years, it will be six million procedures annually. And unlike a lot of companies that have had products like this get approved, we have a strong existing presence in that market.

We have thousands and thousands of customer relationships today. And we intend to apply for pass-through status if the product is approved.

And I think the bottom line is when we add up the size of the market, the potential revenue per unit, and the ability for this product to really make a big impact for patients and physicians around the country, we think it's not only great for our shareholders, but it will also be an incredible complementary product for the rest of our surgical portfolio.

So we are very excited about it..

Is that part of the reason that you're planning to invest fairly aggressively to build your infrastructure? Or is your thinking much broader than that about the long-term potential you have in the eye care services business?.

Yes. So, the investments that we're making, Brooks, for AMP-100 are consistent with the sort of infrastructure that we need, not only for AMP-100, but also for MAQ-100 and to further the successful relaunch of IOPIDINE, MOXEZA and MAXITROL as well as potentially other products that we're on the hunt for now. These are investments that we need to make.

Frankly, if we didn't make, it would be sort of CEO malpractice not to make those investments. And the good news for us is that the juice is definitely worth the squeeze in this case.

The market opportunity for us, for our shareholders, the value creation of an approved AMP-100 and the successful relaunch of some of those products is significant for our shareholders. That is why I've said with relative confidence that when these products get approved, we expect to see our revenues more than double in fairly short order.

So, this is an exciting time for us. This is a moment in the company's history that we've been working towards for over eight years. And there's a lot of energy within the company for what we're doing and where we're going. I always say some companies are going someplace and other companies are not.

We feel like we're definitely going somewhere and going somewhere good..

Great. Let me just ask one or two more. I appreciate the insights you're providing us. So, one thing I'm curious about is just if you could characterize the customer response. Obviously, the sales momentum is telling in and of itself.

But the broadening of your strategy to include the FDA-approved products and whatnot, could you describe the response you get from ophthalmic surgeons and their offices in terms of do they see this as a natural extension of what you do for them? Or how would you characterize the way they they're responding to your broadened product offering?.

Well, first and foremost, we view ourselves as a partner for the eye care professional, to the eye care professional. We are there to help them do a better job, a more successful job of caring for these patients across the United States. So, we view ourselves as a partner. That's the way we've built the business.

We are very much a bottoms-up organization. All of the ideas for the products that we have built over the last eight years have not come from me necessarily, they have come from conversations that we have had with our customers. They tell us what they need so that they can do a better job caring for their patients.

So that's the way we built the business. And what is clear is that they want, in addition to the first-in-class compounded products that we have made over the last eight years, we're now obviously the largest provider of those products in the country, they also want FDA-approved products as well.

And so we are going to have a unique portfolio of not only CGMP compounded products – that's products that are made in an FDA-registered facility to the highest federal standards, but we're also going to have FDA-approved products. And that's what our customers want.

And that's where we're going, and we will uniquely, I think, be the only ophthalmic pharmaceutical company in the country to have such a broad offering..

That's fantastic. Let me just ask one last one. So, you mentioned the exciting developments with Surface.

And I think you mentioned that they're preparing for a Phase 2 readout, what would be the natural sort of pathway to full approval for Surface's products or product?.

Yes. So, to be clear, the SURF-100 study is a readout for a seven-arm study in chronic dry eye. We believe that the dry eye market is a highly underserved market. There are products that are approved in that market. However, patients don't stay on those therapies for very long. Those products are very expensive.

And there are a number of challenges with those products. Yet they're good products, and they're FDA approved. So, we see a big opportunity there. The study that Surface has undertaken is completely unique in that it is going head-to-head against the two largest products in that market that are FDA approved. No one has had the will to do that.

And so, Surface has taken that on. And what I would suggest is the value of our interest in that company and the direction of the Phase 3 studies, the ultimate studies that the company does for approval will be determined by this readout. And we're really excited about this readout. And the readout is going to happen here very, very soon.

And that will, I think, be a very interesting – of interest to a lot of big companies who are interested in the dry eye market. So, we're excited about it. It's not six months away. It's a couple of months away or sooner, and it's exciting..

Great. Thank you very much. Appreciate all your answers..

Thank you, Brooks..

[Operator Instructions] The next question comes from Jeffrey Cohen with Ladenburg Thalmann. Please go ahead..

This is actually Destiny on for Jeff. Just a couple from us. In reading your letter to the stockholders, I noticed that you mentioned an electronic quality management system that you're planning on implementing through 2022.

What kind of efficiencies would you expect to see from that? And what kind of impact do you expect it having on your current facilities?.

Yes, thanks for the question, Destiny. And the EQMS system that we're integrating into our facility in New Jersey is really not unlike some of the other quality management systems that we're putting in place. We don't expect for them to be a big hit in terms of their cost.

They're really sort of an operational necessity as we prepare that facility, I think, for the volumes that we expect to dispense over the coming years. But we don't see it as a big operational cost or something that would impact our financials at all if that answers your question..

Yes, it does. Thank you. And I'm curious a little bit about how your supply chain is looking. I know we've heard from a few other companies that there's been disruptions and it didn't sound to me like in your prepared remarks, you mentioned anything about there being bottlenecks, so I'm just curious how that looks..

Yes. So, it was the case that over the last few years, we've really managed inventories of key supplies and active ingredients on a more of a just-in-time basis. But we've seen rumblings of this since the third quarter of last year. And so, we're now managing our supply chain a little bit differently.

We're increasing inventories of certain ingredients and components of what we build, but we really haven't seen huge cost increases, which is terrific. And I think it's just a slight change in the way we manage our supply chain. But no major issues to speak of..

Okay. That's great to hear.

Turning maybe to the Visionology platform, can you give us an update on that? Are you learning anything from the current experiences you are having with patients that have maybe formed or molded your strategy?.

We are. I still – and our team continues to be very excited about Visionology. I think one of the changes in strategy is that we have seen over the last 12 to 18 months, a lot of companies in the direct-to-consumer space spend, got awful amount of money on customer acquisition costs. So those costs are considerable.

And what we are doing with our platform is a little bit different. In that we have a database of customers that we already serve and so that number is greater than 1 million people.

And so we think there's tremendous value in leveraging the software, the platform that we've built, not in spending money on advertisements with Facebook and Google and others like that.

Rather, we intend to leverage our customer base for the existing customers that are purchasing our products day-in and day-out, tens of thousands of shipments on a monthly basis. That's the way we're going to leverage the Visionology platform. So Visionology is alive and well.

And this is probably, I hope to be expected from our management team, we're fairly parsimonious. Every dollar matters to us and the opportunity to leverage our customer base and offer the Visionology platform and services at a near zero customer acquisition cost is the way we're going to attack that market..

Yes, that makes total sense. I know what the changes to the iOS. We've been hearing a lot about higher customer acquisition costs. So I think it's great that you're able to leverage the database you already have. Just the last quickie for me.

What was that impairment charge that you reported for the quarter in your OpEx? Thank you so much for taking our questions..

Thank you so much, Destiny. Andrew, I'm going to flip that to you..

Sure. Hey Destiny, that impairment charge this is related to some trademarks that we are no longer using..

Okay. Got it. Thank you..

Thank you, Destiny..

The next question comes from Justin Walsh with B. Riley Securities. Please go ahead..

Hi. Congrats on the progress. Thanks for taking the question. To start, I think you addressed how your current customers seem excited to make use of AMP-100.

But I was wondering if you can comment on potential for the product to draw new customers who might also then tap into your broader offerings?.

Absolutely, Justin and that is a great observation. Great question because there are a lot of doctors out there. There are a lot of surgery centers that just do not want to use compounded products.

And even though we do a great job, we're incredibly innovative, we provide an amazing service and the results speak for themselves with the doctors that use the products that we make. All that said, as I said many accounts do not want to use compounded products. They prefer FDA-approved products, they prefer branded products.

Some are open to a mix and what we believe is that when we have AMP-100, when we have MOXEZA, when we have MAXITROL and IOPIDINE and hopefully some others over in due course, that we're going to have really what we feel is an unassailable way to serve our customers, to provide them with FDA-approved products if they want.

So that's a great new way to open accounts, to your point, but at the same time, it's a way for us to land and then hopefully expand and offer the rest of the portfolio that we have.

When we look at the products that the average ophthalmologist prescribes day in and day out, we overlay our portfolio on top of that, we make about 70% of the types of drugs various categories of drugs that the average ophthalmologist uses day in and day out in his or her practice.

So having the FDA-approved products, coupled with our existing compounded offerings is going to be, as we say fairly unassailable and highly unique in our market. I don't think anybody in the United States will have a portfolio like that..

Great. And my next question, you obviously can't and shouldn't try to speak for regulators, but I was wondering if you could provide some color on the MAQ-100 data package you plan to present.

Is that the clinical data solely from Japanese patients? And if so, do you think the FDA might give some pushback there? And then just to follow that up, if they do, what do you think the next steps would be, some sort of a bridging study?.

Yes. That's – I appreciate that question because when we took this project on, I think our assumption from the beginning was that we were going to have to do some sort of study. And that's the way we budgeted for things. That's the way we've approached the project from the beginning.

So if we're able to leverage the Japanese data, the Japanese experience that would be terrific.

If we have to do a small bridging study that is a fairly benign expense for us and a very benign risk given the active ingredient and the type of study that we would have to conduct? So we are planning to be in front of the FDA here fairly soon towards the middle part of this year, and we'll learn. We definitely are looking forward to that.

And as I said, to the extent that we cannot leverage the Japanese data, we are prepared to conduct a fairly small and relatively inexpensive and low-risk study to ultimately create an NDA filing..

Got it. Thanks. One more quick one for me. I'm wondering if you can provide any more color on what you look for in assets that you might acquire.

I mean, clearly, ophthalmic products that could have some synergies there, but wondering if there's sort of anything else that you look for in the types of products that you are interested in?.

Yes. I don't want to speak too much to that because we are in the process of looking at assets now, and I don't want to create any competition for those assets. But suffice it to say that – as I said in the stockholder letter, we're strong in surgical. We're very interested in surgical products.

We're very interested in segments of the chronic care market as well. And that would specifically relate to the dry eye space as well as the glaucoma market. The fastest-growing part of our business in terms of revenue and units shipped is in the dry eye space.

We've been serving hundreds and hundreds of additional patients on a daily basis who suffer from dry eye, and helping them with prescription medication. So those are the areas that we're interested in. And we're also interested, as I said in higher-value products historically.

When you look at the average cost of an ImprimisRx formulation, its sub-$30 on average. And the products, I think that you're going to see us come to market with over the next few years, including AMP-100 will be premium-priced products.

They'll be high-value products, not only for our stockholders but also for the clinicians and the patients who use them. So I don't know if that totally answers your question, but we're really on the hunt for those surgical and chronic care products and products that are approved or an extremely low risk of approval – to approval..

Great. Thank you. Thanks for answering the questions..

Thank you, Justin..

The next question comes from Nathan Weinstein with Aegis Capital. Please go ahead..

Hi, Mark, Andrew and Jamie and the overall Harrow team. So, thanks for taking my questions and firstly, congratulations on the very strong performance in the quarter and for the full year, it must be quite gratifying. And I just wanted to begin with a question about the drivers of revenue growth. Clearly, you mentioned record units, which is great.

But perhaps you could speak to some of the other factors such as pricing and new account openings and how those kind of trended in the quarter?.

Yes. I don't have any specific data to provide you, Nathan, and thanks for the questions.

On growth in customer accounts, or the like, what I can tell you is anecdotally that as we – as the end of the fourth quarter happened, as we came into the first quarter, when I start looking at internal data, new accounts that are being opened, it always amazes me that I think that we have saturated the market.

I questioned, "Have we saturated the market?" And what I can tell you is, over the last three months, I've had six friends get a lens exchange procedure. And of the six, none of them have actually used our products, and of course, none of the doctors who've used our products.

And so that always amazes me when I think that we've saturated the market, how many more opportunities are out there for us accounts to get in front of. And some of those accounts are like the ones I referenced with Justin's question. They just don't use compounded formulations.

And so those are accounts that we intend to hit up when we have an AMP-100. But we just continue to see and it's month in and month out, and this has been going on literally for eight years.

Our commercial team, John Saharek and Cindy and Adam and Hayne, the whole team there have just done such a fabulous job at continuing month-after-month, for year after-year-at opening new accounts. And it just keeps happening. And I think it's going to continue to happen for years to come, believe it or not..

Wow. Great. Mark, you actually preempted sort of my second and final question, which is that Slide 6 in your investor presentation has always been one of my favorite slides, which you could just hold the ruler over the company's revenue growth and margin expansion over the years. It's kind of what drew us to covering the company in the first place.

And I guess, structurally, and you sort of did just speak to this, but maybe I'll ask you to expand upon it.

Structurally, do you see any impediments, particularly in the base business where we could continue that trend of revenue growth and margin expansion ahead?.

Yes. Let me be clear, we see the base business continuing to grow. That is critical. Those are the customers that we're going to initially sell the AMP-100 product into and others that we plan to launch. So we see the base business continuing to grow.

We see as these new products get introduced and more revenue flows from those new products, we see margins actually rising, continuing to rise. To give you an idea, margins in the branded pharma space can be certainly north of 90%.

And so when you think of layering on more revenue, at that rate versus the level of revenue that we're at now or where we're going in 2022 at the reported rates, you can see how margins are going to continue to rise.

I think what's really exciting about the next year or two is that we've seen a lot of companies over the years get products approved, public companies. And then they have to go out and do two things. First of all, they've got to dilute shareholders or otherwise access the capital to launch a product commercially. Shareholders end up getting whacked.

It can be very expensive. And more importantly, it's risky because you just don't know whether the team that you assemble is going to be able to sell the product or that customers will adopt it. And in our case, we have that amazing commercial team and we have a large customer base. And we sell a lot of products in the same category as AMP-100 already.

And so the belief is that those customers will go from the compounded drug to an FDA-approved alternative. And when they do that, that's great for them and it's great for us. So it's a really exciting time. We're not going to have to dilute our shareholders necessarily to launch AMP-100.

We're in a position to be able to use the profits that this team has been able to generate through their hard work and creativity, to launch these high-margin, high-value products..

Fantastic. Thank you for the color, Mark and congrats to you and the whole team for the strong performance..

Thank you, Nathan. We really appreciate your interest..

[Operator Instructions] The next question comes from Shawn Boyd with Next Mark Capital. Please go ahead..

Can you hear me okay..

I can Shawn..

Mark, if I could, I want to – I'll just speak to the side just a little bit here. If we – and I might be doing this wrong, but if we back out the DEXYCU commission revenues, you did roughly $69 million.

That's after two years in the $50 million range on that kind of broad basket of products that we keep talking about and I know that we've talked quite a bit about the branded products and where we're going. But that last question was a great one, and you mentioned that the intent is, of course to continue to grow that.

Are we looking at 40% years? Are we looking at 20%? Help me on – we look at 10%.

Help me on what you think is a sustainable growth rate for that kind of broad existing portfolio that you intend to have in the background, while you layer on these incremental products?.

Yes. So first of all, we don't provide guidance at all. And so let me just say that. Secondly, obviously the – there were parts of the 2020 period that were affected by COVID for sure. But nevertheless, I think even if you were to normalize the 2020 period, we still did very well and grew nicely.

I can't tell you whether we're going to grow at 20%, 30% or 40% in 2022 over 2021. What I can tell you is that we continue to see, and I mentioned this to this very day, fantastic daily revenue numbers. So we don't see the business yielding in terms of its growth. That's the core business.

And that is necessary so that we have a successful launch of some of the other products that we've mentioned. I do want to put an exclamation point on what the opportunity is, though, with AMP-100 because products, for example, that are eligible for pass-through are generally premium-priced products.

And when you look at what the value is on a per-unit basis for a product like that, and you multiply that by the existing presence that we have in the cataract surgery market, for example, we're talking about north of two million units shipped, sterile ophthalmic units shipped last year and growing.

And if you were to just discount that slightly and say, "Hey, these guys are probably touching 1 million cataract surgeries a year already." And you multiply 1 million times what a pass-through eligible product sells for; you come up with a big number. And so that's what we're really swinging for. That's what the real opportunity is for us.

And so we're excited about the numbers that we're putting up with the base business. It will continue to grow. It is growing. We see that growth in the first quarter.

But what I think we want shareholders to focus in on is not only that continued growth, which is going to fund in a non-dilutive way the build-out of the infrastructure that's needed to launch AMP and MAQ and some of these other products. But what that 2023 number looks like 2024, 2025, that's where we think the real value is.

And I think if you look at the price of our stock, you have to determine whether or not all of that is baked into the price..

All right. One other if I may, and that is on the investment that you're ramping up this year. So the company spent, it looks like $52 million, $53 million in total operating expenses in 2021. Give us a ballpark.

Where are we going here? Is that substantially above as we go into next year? Are you going to run the company more on kind of a cash breakeven business and spend whatever upside you need to? What can you give us on that investment?.

Andrew, I'm going to throw it to you..

Shawn, like Mark said we don't provide guidance. One of the things we mentioned in the shareholder letter is that the business will produce positive adjusted EBITDA. We have a history of kind of being very parsimonious with the money we spend, so we're not going to go out and spend $20 million on things we don't need.

But a lot of that capital, a lot of the investment is going to go in head count. So we expect a pretty big growth in headcount this year. A lot of that on the sales and marketing side. I don't think we can hire fast enough where we'd be burning through all of the adjusted EBITDA. And I just don't think that would be possible.

So it's going to be – it's – like the letter says, it will affect the operating margin. It will still be positive. I think it will still be substantial, but certainly won't be the same number that we hit in 2021..

Got it. Okay. Thank you, Andrew. Thank you, Mark. And good luck guys..

Thank you, Shawn..

This concludes our question-and-answer session. I'll turn the conference back over to Mark Baum for any closing remarks..

Thank you, Tom. So in closing, I want to thank everyone on this call for your interest in Harrow Health. I would also like to personally thank all of our employees for their hard work and contributions to making this an exciting time to be a part of our company.

Internally, there is a growing positive energy, I would call it a buzz about what we've accomplished in the past, but importantly, what we're expecting to accomplish in the next few years, and really, what we're going to see happen in the next few months. This is a catalyst-rich period for us.

There's a lot of hard work ahead, but our employees have proven themselves to be up to the task, time and time again. I look forward to sharing the journey alongside each member of our growing employee base as well as each shareholder of Harrow Health to witness what we're truly capable of achieving.

Thanks to everyone for attending today's call and for your interest in Harrow Health. If you have any investor-related questions, please e-mail Jamie Webb at jwebb@harrowinc.com. Thank you. This will conclude our call..

The conference has now concluded. Thank you for attending today's presentation and you may now disconnect..