Harrow - Q4 2023

Transcript

Operator (participant)

Good morning, and welcome to Harrow's fourth quarter and year-end 2023 earnings conference call. My name is Drew, 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. If you require operator assistance, please press star then zero. I would now like to turn the call over to Jamie Webb, Director of Communications and Investor Relations for Harrow.

Jamie Webb (Director of Communications and Investor Relations)

Thank you, operator. Good morning, and welcome to Harrow's fourth quarter and year-end 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 referred to non-GAAP financial metrics, specifically Adjusted EBITDA and/or Adjusted earnings, as well as core results such as Core gross margin, Core net income, and Core diluted net income per share. A reconciliation of any non-GAAP measures with the most directly comparable GAAP measures is included in the company's earnings release and letter to stockholders, both of which are available on the website. By now, you should have received a copy of the earnings press release. If you have not received a copy, please go to the investor relations page of the company's website, www.harrow.com.

Joining me on today's call are Harrow's Chief Executive Officer, Mark L. Baum, 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.

Mark L. Baum (CEO)

Thanks, Jamie, and thanks to everyone for joining us on today's call. I wanted to first address the change in cadence for our earnings release and conference calls. We believed it was in the best interest of our analysts and investors to extend the amount of time between when we issued our earnings release and hosted our calls. We hoped this would allow more time to digest the results and read through our corporate presentation and my letter to stockholders prior to the call. We hope you have found this timing change helpful. So if you're on this call, I assume you've reviewed these materials, and I'll use this time to augment your understanding through some high-level commentary. 2023, which is now more than 75 days in the rearview mirror, was a transformative year for Harrow.

It was a transformation that was 4 years in the making, all of which I pointed out in my letter to stockholders when I quoted what I said about 4 years ago, in 2020, when we were hatching our plan to become a leading North American ophthalmic pharmaceutical business. Here are a few of the 2023 fruits of that plan. Number one, we achieved record revenues, with 2023 revenues increasing 47% over 2022 revenues. Two, adjusted EBITDA more than doubled in 2023 from 2022. Three, the addition of numerous high-utility ophthalmic pharmaceutical products to our portfolio. Four, beginning to generate cash flow from our big three products, IHEEZO, VEVYE, and TRIESENCE, which made up our most significant short-term and long-term financial drivers.

Finally, delivering $8.7 million in cash from operating activities in the fourth quarter of last year and delivering our second consecutive year of positive cash flow from operations. You see, we strengthened our balance sheet last year, especially our cash position, ending the year with $83 million in cash and cash equivalents, and this includes our position in pharmaceuticals. We expect our cash pile to continue to grow over the coming years. Equally important, we fortified our talent base, adding new members to the Harrow family, professionals with the experience, commercial relationships, and fresh perspectives to further enhance our transformation. I have highlighted the names of a few of these folks in both the letter to stockholders and the new Harrow corporate deck. Our stockholders have been asking us for more granularity around our quarterly results.

They want to know why we're so bullish on our company and the growth trajectory we see in front of us. This cycle, I've tried to provide more granularity. This detailed information highlights, among other things, the amazing success we've had with our VEVYE launch. Based on our success to date, I am convinced that VEVYE has the potential to dominate the large U.S. chronic dry eye disease market as the leading cyclosporine and anti-inflammatory product.

The VEVYE adoption curve, driven by our small but mighty sales force, speaks volumes, as does the positive feedback about VEVYE from actual patients on social media. I would encourage you to think about the size of the cyclosporine market alone in the United States. It was about 8 million units last year. Without question, cyclosporine is the number one most trusted active ingredient for U.S. dry eye disease patients. Eye care professionals trust cyclosporine.

Payers trust cyclosporine. Patients trust cyclosporine. You see, the VEVYE train is rolling, with all of our key performance metrics moving in the right direction. In fact, the CEO of PhilRx, our specialty pharmacy partner, recently told me that VEVYE has been one of, if not the most successful launches he has seen. Mark my word, VEVYE will significantly benefit millions of U.S. dry eye disease patients and generate substantial value for Harrow stockholders over a very long period. I also discuss our progress in manufacturing TRIESENCE, including a production batch, which is set for next month. This is a PPQ batch, and to the extent that we're successful, meeting all the parameters would become a commercial batch. I talk about the number of units we expect to have available for sale when TRIESENCE is eventually reintroduced to the market.

I also lay out the expected addressable market in terms of unit volume and our new pricing, which combined, make clear why we believe TRIESENCE should be a multi-nine-figure revenue product, and hopefully soon. I hit on the continued uptake of IHEEZO since its May 2023 launch, and news about the recent publication by CMS of the IHEEZO ASP, or average selling price, in the physicians' ASP file. This is something that we had previously requested from CMS and that was not acted upon until soon after we met with them on January ninth of this year. I also talk about the return of ImprimisRx to its previous growth trajectory, fulfilling our performance promise that I made in our last stockholders letter. I also included quotes from actual users of our products.

You see, in recent conversations with fellow stockholders, I've noted the reliance on opinions of so-called key opinion leaders, KOLs, who, upon my further investigation, had actually not used our products. I thought it was important for you to hear from ophthalmologists and optometrists who, with 100% certainty, have actually used our products. I also want to mention that it's never been a better time to be a Harrow stockholder. I say this because of the amazing progress we made in 2023 and because of what is right in front of us, right in front of our eyes, a clear pathway to achieving our goals, including significant revenue and profitability growth, ultimately making us a leading strategic North American ophthalmic pharmaceutical company. Finally, as both a Harrow stockholder and a senior executive at this company, I continue to be perfectly fine eating my own cooking.

I have never sold a share of Harrow stock, and I do not plan to do so. In fact, recently, I purchased Harrow shares. In fact, 3 times in the past 12 months, precisely because I believe in Harrow's long-term value and because the shares have been available at an attractive price. We're now happy to answer your questions. I will pause to have our operator poll for questions. Operator?

Operator (participant)

We will now begin the question-and-answer session. To ask a question, you may press star then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. The first question comes from Mayank Mamtani with B. Riley Securities. Please go ahead.

Mayank Mamtani (Analyst)

Good morning, team. Thanks for taking our questions, and appreciate the granularity provided to both fourth quarter results and the forward-looking outlook. Maybe just on the 2024 guide and also the longer-term 2027 number that you put out, are you able to give some breakdown on the incremental contribution within there between your three growth drivers, IHEEZO, TRIESENCE, and VEVYE? And also, relatedly, notice you didn't give EBITDA guidance forward-looking. It would help to understand how you're thinking of spend in 2024. And then I have a couple of quick follow-ups.

Mark L. Baum (CEO)

Thank you, Mayank. Yeah, so look, we're, we're, standing behind the better than $180 million in revenue guidance that we put out for 2024. We don't guide by product. The one comment that I'll make is, you know, what I think is the, you know, 800 lb, you know, animal in the room, and that is what we put out today in our Form 8-K filing. And the confirmation from CMS that, in fact-

... IHEEZO will be paid for separately in the physician's office setting is, without question, the most positive consequential event I think that has happened to our company, you know, since I founded it with Andrew back in 2011. So this is a very big event. It certainly supports our confidence in our guidance, which is a number greater than $180 million. You know, and but once again, we're not going to guide by product. But, we're very excited about what we put out today in the Form 8-K. It's something that happened yesterday afternoon about 2:00 Central. It kind of hit us with a very, very positive surprise. But it certainly gives us far greater confidence in our guidance.

In terms of our spend in 2024, Andrew, do you want to kind of talk about our approach with some of the spend in the fourth quarter, maybe 2023, and how we're thinking about 2024, especially in light of what we put out in the 8-K this morning?

Andrew Boll (CFO)

Yeah, thanks, Mark. Mayank, thanks for the question. And you can kind of see some of the expense infrastructure changing in the Q4 numbers. You know, in November, we decided to make a shift in our plans for VEVYE launch. This resulted in a much heavier spend on the sales and marketing efforts than we initially planned for. In the 10-K, you can kind of read year-over-year, we added about 100 new employees. A vast majority of those were coming or came in during the fourth quarter and were really tied to the VEVYE launch on the commercial side. And so a lot of that expense is going to obviously continue into 2024.

One of the reasons we're not giving specific EBITDA guidance is as revenues grow, we'll invest in the operating expense. We'll invest in the sales and marketing efforts to further revenue growth. That said, we have a leverage ratio number that we wanna get to, which is having a leverage ratio of less than 5x, and so we're focused on that. But at the same time, we're gonna be focused on growing revenues and accelerating revenue growth in these product areas where we see an opportunity to invest further on the sales and marketing side. Like Mark said, IHEEZO is a great example of where now we've got this great outcome with CMS.

It's time to invest more heavily on the sales and marketing efforts there, and really kind of put the foot to the metal and try to grow revenues.

Mark L. Baum (CEO)

Yeah, I'd add one further comment to that, you know, and we said this in our Form 10-K, which we filed, you obviously know, and this is this kind of hits on one of the points Andrew made related to Oaktree, who is our senior lender, and, you probably know that they can receive warrants, if our leverage ratio exceeds 5x, in 2024. And, I think both Andrew and I have a far greater confidence, that as a result of the Form 8-K that was filed this morning, we sincerely doubt that, our friends at Oaktree will be receiving any warrants under our agreement with them.

Mayank Mamtani (Analyst)

Yep, that's very helpful color. Thank you. And on the cyberattack issue in February, could you just clarify if that is unique to Harrow? And also, what visibility you have on utility of IHEEZO in retina clinics year to date and expectation for that segment to expand? Including, I think you made some reference to the bilateral IVT procedures. Is that sort of organic demand you're getting from these retina specialists, you know, as they're using more eye injections on both eyes, that you can have separate billing for two units versus one unit? So, and maybe one final question on VEVYE.

Andrew Boll (CFO)

What was the first part, Mayank? I missed it.

Mayank Mamtani (Analyst)

The cyberattack issue, whether that is unique to Harrow or that's a broader pharma-wide issue of processing claims right now.

Mark L. Baum (CEO)

Sure. Yeah. So the issue with Change Healthcare has affected numerous companies, including us, that sell not only Part D, as in David, products, but also Part B, as in Bravo products. So the system is still sort of being unclogged, and the Change Healthcare issue has affected payments to our customers from the government. And you know, this has affected our sales temporarily in the first quarter, but we are seeing evidence that the system's beginning to be unclogged. We expect, you know, recovery and full normalization in the second quarter, but this is an issue, the cyberattack that has affected us, but it has affected many, many companies who sell into the pharma market.

In terms of retina, the reason why we went to CMS, and I talked about this in our last letter to stockholders, is because there was uptake in the retina market. The retina market is in the form of the intravitreal injection market, specifically, is a very large market, exceeding 10 million unit opportunities per year. We saw uptake in that market. We were seeing reimbursement happen in that market around the country. But the market is unique in that it is highly concentrated. There are very large groups of potential buyers for these products.

And so in the face of those sorts of opportunities in front of us, we thought it was prudent to confirm with CMS that, in fact, our J-code, which is a product-specific permanent J-code, would in fact be separately reimbursable in the physician's office setting. And so, as we promised in the last letter to stockholders, we requested a meeting with CMS. We had that meeting on January 9th, and we have been waiting patiently to hear from them. You know, as we said in the prepared remarks, we were added to the ASP file, the physicians' ASP file, recently, but we did not know whether or not that confirmed separate payment in the physician's office. And that happened just yesterday afternoon, which, as I said, is a very important event for the company.

Our expectation now is that we will be able to, with this news, open up the market for intravitreal injections that can benefit from the unique attributes of IHEEZO, and that is going to start here very, very soon, and that it will significantly change, I think, the trajectory for IHEEZO and also, I think, for our company. But IHEEZO is a fantastic product for that application. It's also obviously used in numerous other ophthalmic interventions. And you know, it's a very, very exciting opportunity for us.

Mayank Mamtani (Analyst)

And thank you. And lastly, on VEVYE, you put out some good launch metrics, yet you say it could take up to 18 months for ramp up. So just curious, what dynamics in play are here, you know, to follow to get visibility and what peak sales could be? And with that, I'll, I'll hop back in the queue. Thanks for taking my questions.

Mark L. Baum (CEO)

Thank you, Mayank. First of all, with respect to VEVYE, I want to mention a person, because VEVYE, the team, the commercial effort, is being led by a woman named Maria Lloyd, and she is extraordinary. The effort that she has put into this project is just amazing. So I'm really grateful to everything that she has done. She is very experienced. She was involved in the launch of Restasis. She knows the dry eye market extremely well, and she's brought a lot of wonderful people into our organization that are working on her team. But as you saw in our recent corporate presentation, all of the numbers, all of the metrics with respect to the VEVYE launch are up and to the right, which is fantastic. Importantly, the product is performing extremely well in the market.

I referenced the social media information that's out there and publicly available. And so we have very high hopes for that product. As I've said for several years, we've studied the dry eye market. We know it very well. We've compounded 0.1% cyclosporine with our ImprimisRx business now for over five years. And what VEVYE presents to the market is really a complete shift in the cyclosporine market, which is 8 million units strong last year in the U.S. market. So we think we have a product that can dominate the category.

And, you know, in terms of what the opportunity is, there's so many patients that have failed other cyclosporine products, whether it's the 0.05% branded version of cyclosporine, or its generic version, or even the 0.09% cyclosporine product that is branded and available. The tolerability profile of those products is very different from the tolerability profile of VEVYE. And so, there are a lot of people that have failed those products, and those are candidates to benefit from VEVYE.

In terms of what the size of the market can be, you know, this, this is a product that gives me far greater confidence that the number that I wrote about a couple of letters to stockholders ago, which was $1 billion in revenue in the aggregate for our product portfolio, that that can actually be met. I mean, that is a, that is a real target for us now. The uptake in VEVYE, certainly this Form 8-K that was filed this morning, this puts us in the zone of where we wanted to be. I talked about our revenue getting to $1 billion or more with our product portfolio if certain things went our way. Well, the, the things that we announced today, that certainly qualifies as something going our way.

So we're really excited about that and what Maria and her amazing team are doing with VEVYE.

Operator (participant)

The next question comes from Aaron Wukmir with Lake Street Capital Markets. Please go ahead.

Aaron Wukmir (Analyst)

Hey, good morning, guys. This is Aaron on the line for Brooks. Appreciate all the color so far. I guess related to TRIESENCE, have there been any more setbacks there? You know, I know you had a few comments in the prepared remarks, but I guess if you could just provide a bit more color on sort of the inventory timing and how you're thinking about that, and maybe just your confidence there to get that before year end, that'd be helpful.

Mark L. Baum (CEO)

Sure. Thank you, Aaron. So look, as I said in the letter to stockholders, TRIESENCE was not really being made for more than five years by our manufacturing partner. And the people and the processes that are involved in making that product were kind of dormant, and because they weren't practicing, that knowledge wasn't being produced. We knew that it was gonna be a challenge, you know, reintroducing the product into the market in terms of manufacturing it. But what I can tell you is that the progress that we've made in the last six months in particular is given everyone in our organization a very high degree of confidence that we're going to have success meeting all of the required parameters to make TRIESENCE here very soon.

There were people in our organization, by the way, that were somewhat doubtful. But what I can tell you is, at this point, because of the progress that we've made, there is no one in our organization, whether they're an employee or a consultant, who does not have a high degree of confidence that we're going to have TRIESENCE made successfully and very soon. We have a batch being produced, a PPQ batch, which is effectively a commercial batch, if it meets the production parameters, the performance specifications. That's gonna happen, as I said, in the middle of middle of April. So, we'll produce two more batches if that first one is successful, and then within, you know, a period of a couple of months, we should be able to be back on track.

There's quite a bit more information, as I said, in the letter to stockholders and also in our corporate presentation about TRIESENCE, but it is a very high utility product. It's an unusual product with an unusual label, and the physician community, I can tell you, is very interested in seeing it back in the market. We think it's gonna happen very soon. I can't predict whether it's gonna happen, you know, by June or by August. What I can tell you is that we're getting very strong help from our manufacturing partner, and our manufacturing partner, as you can see on the box for the product, is a very sophisticated organization and we, as I said, have a high degree of confidence we'll have TRIESENCE back here very, very soon.

Aaron Wukmir (Analyst)

Great. That's super helpful commentary. Thanks for taking the questions, guys.

Mark L. Baum (CEO)

Thanks, Aaron.

Operator (participant)

Before we take our next question, just a reminder, if you'd like to ask a question, please press star then one. The next question comes from Jeffrey Cohen with Ladenburg Thalmann. Please go ahead.

Jeffrey Cohen (Analyst)

Oh, hi there. Good morning. Thanks for taking our questions. I just have two for Mark and Andrew. Firstly, could you talk about perhaps the anticipated cadence on the top line for the year? Should we expect something somewhat linearly increasing as we did last year? And then secondly, could you touch upon anticipated margins for the year, inclusive of TRIESENCE?

Mark L. Baum (CEO)

Andrew, do you want to try and tackle that? I think we're gonna keep our numbers where we are, which is in over $180 million. And I think with, as I said, the news of this morning, you know, our margins should increase, not decrease. But Andrew, do you want to add anything?

Andrew Boll (CFO)

Yeah, Jeff, just to reiterate what Mark said, from a revenue perspective, we're sticking with what we said, which is more than $180 million this year. We feel that's strongly intact. And then on EBITDA margins or operating margins, the approach is gonna be kind of, you know, dependent upon revenue opportunity. And so we're gonna kinda temper revenue growth with EBITDA expectations. We mentioned the leverage ratio, so we wanna be sure we're coming in under 4x levered at the end of the year. But outside of that, we'll continue... If we see opportunities to invest in that revenue growth, for the out years, especially, thinking about VEVYE, thinking about IHEEZO, and TRIESENCE to an extent, we'll do it.

And so the actual margin % may be different depending on the revenue numbers for the year, but certainly we'll keep the leverage ratio in mind as we make investments and plan for the future.

Jeffrey Cohen (Analyst)

Okay, got it. And then, lastly for us, could you talk about pricing at all? Did you take any pricing in 2023, or is there any anticipated pricing for 2024? And, any comments there will be appreciated. Thank you.

Mark L. Baum (CEO)

Andrew, you want to touch on that? I'll just say to start and then... To be clear, our philosophy on pricing of any product is focused on access and affordability. That is the cornerstone of our company. And, you know, there are products that we have raised prices on. There are also other products in our portfolio we've actually lowered prices on, and made them even more accessible. But before we do anything, just philosophically, we always make sure that we have a patient assistance program in place that is aggressive, whether it's a branded product or a compounded product, to ensure access and affordability to anyone who can benefit from our products. Andrew, do you want to add anything on pricing?

Andrew Boll (CFO)

Yeah, Jeff, just more specifically, in the corporate deck, we have some wholesale acquisition cost pricing for some of the products. TRIESENCE probably being the most notable one, where WAC pricing for that product is going to be $944 at the time we relaunched the product into the market. But to Mark's point, you know, WAC is list price. There's a gross-to-net element to that. You see that in the accounting and the footnotes. You know, we talk a lot about the gross in our accounting, which factors in the patient assistance programs, the copay assistance programs, making sure we're living up to our mission, which is access and affordability for the patient.

And so ultimately, we're going to price the products to make sure we have steady supply of the products, that we can make money selling the products and getting them to the patients, but we're also keeping in mind that patient element, the access element.

Mark L. Baum (CEO)

A great example of that related to TRIESENCE is related to TRIESENCE. You know, the price of TRIESENCE had not seen any adjustment for 16 years since the product actually hit the market. And so, you know, one of the challenges is with a product that's on the FDA's drug shortage list, that's not being made, that has not been priced competitively. There's just not a profit incentive to actually make the product available, and therefore, it ends up on the drug shortage list year after year after year. And so when we thought about pricing for TRIESENCE, which is, you know, as Andrew said, $944 a unit, we looked at the other preservative-free triamcinolone product that's in the market.

It's not competitive with our product, but it is a preservative-free triamcinolone product, and it's priced, you know, at more than $1,800 per unit. And so we're almost half of that price. So we're always going to be lower in price and try to be more accessible and more affordable. There are other intravitreal steroid products that are, you know, certainly over $1,400-$1,500 per unit. And so we remain significantly lower than them. But we did adjust the price to create enough profit incentive for us to invest in the product and make sure that we have a steady supply of the product to provide to the market, which is considerable.

Jeffrey Cohen (Analyst)

Awesome. I think that does it for us. Thanks again for the comprehensive commentary and readout. Appreciate it.

Mark L. Baum (CEO)

Thank you, Jeff.

Andrew Boll (CFO)

Thanks, Jeff.

Operator (participant)

This concludes our question and answer session. I would like to turn the conference back over to Mark L. Baum for any closing remarks.

Mark L. Baum (CEO)

Thank you, Drew, and, I guess I kind of want to apologize to those of you who are waiting for the issuance of our fourth quarter and year-end earnings and letter to stockholders last yesterday, which we intended to publish immediately after the market closed. But as I said earlier, very fortunately, yes, fortunately, after drafting all of our documents and preparing our press release and getting everything ready to go, the most, positively consequential thing that has happened to our company actually happened. I mentioned, the news that we received from CMS yesterday, which is going to make IHEEZO, which is our low viscosity, patented, topical anesthetic gel, which is doing fantastic things in clinics and surgery centers across the country.

It's going to make it separately payable, separately reimbursable in the physician's office, and it opens up a very large market for IHEEZO, and it allows Medicare beneficiaries to experience the unique benefits of the product. So after we calmed down from that excitement, and we decided to not delay our filings, we made those filings and then ultimately put out a separate Form 8-K before the market opened, revealing this wonderful new development. So once again, we apologize for being slightly tardy yesterday in publishing everything. I heard from some of our stockholders, but we hope you appreciate that this was an example of no news being very good news. Indeed, yesterday was special for every member of the Harrow family, and it was an answer to some of our prayers, actually.

In past letters to stockholders, as I mentioned earlier, I've opined about aggregate revenue potential. I've said that our product portfolio could achieve $1 billion in annual revenue if, as I said, some things go our way. Yesterday's news was an example of a thing that went our way. It's a beautiful thing for many reasons, because we're seeing amazing stories, practical stories of how IHEEZO is positively changing anesthesia protocols around the country for ophthalmic procedures. It's even reducing patient exposure to dangerous opioids. Our team feels very good about what we believe is going to happen to IHEEZO and therefore, Harrow.

So as I close this communication from what has been a whirlwind couple of days, I want to acknowledge and thank all members of our Harrow family, our loyal employees, their families, who support our employees, and our stockholders for their patience and steadfast support. Your belief in our mission has been a cornerstone of our progress, and together, we're going to build a company that we can be proud of. Never been truer than today, that the very best is not only yet to come for Harrow, but it is soon to come. Thanks to everyone for attending today's call and for your interest in Harrow. If you have any investor-related questions, please email Jamie Webb at jwebb, J-W-E-B-B, @harrowinc.com. This will conclude our call.

Operator (participant)

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