Harrow - Q2 2023
August 9, 2023
Transcript
Operator (participant)
Good afternoon, welcome to Harrow's 2nd quarter 2023 earnings conference call. My name is Kate, 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. I would now like to turn the call over to Jamie Webb, Director of Communications and Investor Relations for Harrow. Please go ahead.
Jamie Webb (Director of Communications and Investor Relations)
Thank you, operator. Good afternoon, and welcome to Harrow's 2Q 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, 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'd like to 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, thanks to everyone for joining us on today's call. As always, I would recommend that you review our second quarter 2023 earnings release, corporate presentation, and letter to stockholders, all of which have been posted to the investor relations section of our corporate website. These documents are important to review as we continue to use our time on these calls to provide color on the operational highlights from the quarter and, of course, taking your questions. To begin, based on our results to date, we remain confident in our 2023 financial guidance of $135 million-$143 million in net revenues and $44 million-$50 million in adjusted EBITDA.
We intend to provide an update to our financial guidance later in the year, after a few months of operations with our recently launched and newly acquired branded products. As I said in my stockholder letter, what a difference a few months makes! Since our last quarterly earnings call, we've added numerous products to our portfolio, including substantially all of the products in the North American Santen Ophthalmic pharmaceutical portfolio, as well as VEVYE from Novaliq. This is on top of the Fab Five portfolio we acquired from Novartis and closed on in the first quarter of 2023. Through the Santen acquisition, we acquired the rights to five branded prescription products and one OTC product for the US market, as well as Canadian rights to one branded prescription product and one OTC product.
Demand trends for all of the Santen products are positive, and most assets have IP through 2028 or beyond. We expect this transaction to be immediately accretive to earnings following the NDA, New Drug Application, or MA, Marketing Authorization transfers, which we are currently working on. Under the Novaliq transaction, we acquired the North American rights to FDA-approved VEVYE, the first and only cyclosporine-based product indicated for both signs and symptoms of dry eye disease. VEVYE is based on Novaliq's proprietary water-free EyeSol technology. In my view, Novaliq, through EyeSol, has essentially reinvented the eye drop. I have put water-free Novaliq products on my eye, and they feel completely different, almost like a puff of air is hitting your eye. In fact, my experience is that you barely know the drop has hit your eye. It's a totally unique feel that I believe prescribers and patients will love.
Those who have followed Harrow's growth and development know that we have been keenly interested in and have studied the dry eye space for many years... My view is that the US dry eye market will consist of two camps. On the one side, you'll have products from what I'm calling the water world, and on the other side, you'll have products from the water-free world. Based on what I have seen in the data and my experience putting an EyeSol-based product on my eye, I am 100% all in as a water-free believer. I believe it will be challenging to sell what I am calling water world products when the water-free options are soon available.
We believe VEVYE can be a game changer, not only because of EyeSol technology, but also because VEVYE contains a 0.1% concentration of the immunosuppressant cyclosporine, No other active pharmaceutical ingredient has been prescribed to treat dry eye disease globally and in the U.S. more than cyclosporine. It is the number 1 most prescribed active pharmaceutical ingredient for this patient population. Before VEVYE, though, the product profiles for cyclosporine-based products are challenging. You can review slide 10 of our corporate deck, which is on our website, for a label comparison of these products. You'll get a sense of what dry eye patients and their prescribers have been dealing with, with these legacy products for many years. We believe U.S. prescribers want a cyclosporine-based dry eye formulation with a new product profile, and that's what VEVYE delivers.
VEVYE offers exceptional patient comfort, provides rapid clinical onset of 29 days, it has an extraordinarily mild adverse event profile. Data has shown that it continues to help patients with both signs and symptoms of dry eye disease out to 1 year. As I said in my letter to stockholders, I view the US dry eye market as totally wide open. This is despite the handful or so of products that are currently approved and others that are in development. The market is large and growing and includes over 16+ million diagnosed dry eye disease patients, of which about 9 million are diagnosed with moderate to severe disease.
For a number of reasons, including the suboptimal profiles of the existing prescription choices, which, by the way, still do over $1 billion in annual revenue in the U.S. market alone, only about 10% of the patient population, the dry eye patient population, is benefiting from a prescription dry eye therapy. We intend to upend the U.S. dry eye market by providing this new choice, VEVYE, to those dry eye patients who have tried and failed one or more of the existing dry eye prescription products. We also want to increase the overall pool of diagnosed patients who are on a prescription therapy, who can benefit from a prescription therapy. Importantly, because of VEVYE's unique comfort and efficacy of attributes, we believe a meaningful number of VEVYE patients will also choose to maintain VEVYE therapy to treat their disease.
With VEVYE and the other adjacent ocular surface disease products we now own, including FRESHKOTE, Tobradex ST, and Flarex, Harrow is planting a flag in the U.S. dry eye and ocular surface disease markets, and we intend to compete vigorously to win meaningful market share and ultimately help millions of suffering American dry eye disease patients. Of course, we remain resolutely focused on and excited about IHEEZO, which we officially launched in May of this year at the American Society of Cataract and Refractive Surgery annual meeting in San Diego. While it is still very early in its launch, we are encouraged, especially given the math on the IHEEZO market opportunity, which is very straightforward. There are two main anesthetic use cases for IHEEZO.
One, for surgical interventions such as cataract surgery, glaucoma surgery, and retina procedures, all of which take place in a hospital or an outpatient setting of care. Secondly, an intervention in a physician's office, such as an intravitreal injection. We estimate that in the aggregate, there are more than 12 million such use cases in the US each year, and we were granted a product-specific J-code, that's J2403, for all such use cases. The current wholesale acquisition cost or WAC pricing on IHEEZO is $544 per unit. The positive feedback we're getting from early adopters of IHEEZO on its clinical value is adding to our enthusiasm about the product. IHEEZO just works, and it works well.
IHEEZO users have indicated that there are even more potential applications than we had previously anticipated, that eye care professionals are even eliminating opioids from many of their surgeries, and that IHEEZO is getting reimbursed in both the ambulatory surgery center setting of care as well as for in-office applications as well, that second setting of care. In summary, we've been hard at work building a company that we believe, with the current Harrow product portfolio and continued execution by the Harrow team, can become a top-tier US-focused ophthalmic pharmaceutical company. We now believe that we have five discrete, what I call, revenue buckets, with 9-figure annual revenue potential.
These revenue buckets, which are described in full detail in our stockholders letter, include bucket one, just IHEEZO. Bucket two is our dry eye disease and other ocular surface conditions bucket, which is led by VEVYE. Bucket three has one product, TRIESENCE. Bucket four consists of our specialty anterior segment products. Bucket five is our tried-and-true cornerstone, ImprimisRx compounded pharmaceutical products business. Those are the five buckets. As I said, more fully described in our stockholder letter. Some of the revenue buckets consist of a single product, and others contain groups of products. I believe IHEEZO and VEVYE are our largest revenue opportunities without question.
That said, they are also new sources of revenue, with IHEEZO only launching a few months ago, and VEVYE expected to launch later in the year. Regardless of the exact timing of the start and steady build of revenue flow from these two exciting products, the key is that, number one, Harrow now has them both, two, we have an incredibly strong conviction of market need and ultimately market acceptance of both products. Of course, now we have one of the most comprehensive ophthalmic portfolios of products in the US market, a position we always wanted to be in and a position that we now are in. We're happy to take your questions. I'll 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 touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw from the question queue, please press Star then Two. The first question is from Jeffrey Cohen of Ladenburg Thalmann. Please go ahead.
Jeffrey Cohen (Managing Director and Director of Equity Research)
Well, hi, Jamie, Mark, and Andrew. How are you?
Mark L. Baum (CEO)
Great. Great. Good to speak with you, Jeff.
Jeffrey Cohen (Managing Director and Director of Equity Research)
I know it's been a while. Just a few questions from our end. Maybe, could you just expand a little bit and clarify, I guess, Andrew, on the core versus the regular on the on the margin front? Is the core the historical products up to recent, and then the other gross margin number includes all the recent additions?
Andrew Boll (CFO)
Yeah. Hey, Jeff. Thanks, thanks for the question. On the, the core, and we've got a, a pretty good reconciliation table in the back of the shareholder letter, but the, the basic difference between core and GAAP on gross margin is the amortization of those NDAs, so the non-cash amortization of the capitalized purchase price of the Fab Five products, primarily, and there are a couple other, capitalized expenses that we're, we're amortizing through cost of goods sold. That's- that, that amortization is reflected in the GAAP number. The core number, we're pulling that amortization out.
Jeffrey Cohen (Managing Director and Director of Equity Research)
Okay, got it. Mark, any specific commentary on the IHEEZO launch thus far from April, as far as physician acceptance and any relevant bullet points to communicate thus far?
Mark L. Baum (CEO)
No, I think the color that's provided in the letter to stockholders on IHEEZO is fairly detailed. I mentioned in my prepared remarks that, you know, the performance of the product has been exceptional. We haven't had anyone who has used the product say that it doesn't perform exceptionally well. People who try the product, like the product. With a product like IHEEZO, and you have such a large market opportunity, you know, the, the, the real key is reimbursement and actually getting claims paid. That was sort of the last piece of the IHEEZO puzzle. You know, we recognize that we're not gonna win over every customer account. We're not gonna win every unit opportunity.
Given the total number of unit opportunities, even winning a very small percentage of those, creates a tremendous amount of value, for our stockholders and for the company. You know, we're really pleased now, that the doctors who are using it, we're seeing them get reimbursed, not only in the ASC setting of care, the hospital setting of care, but also, for the in-office setting of care. These are intravitreal injections. The in-office setting of care, you know, our permanent J-code is, is powerful. That was sort of the last piece of the reimbursement puzzle for us, and I'm really, really pleased that the reports back from retina doctors are very positive. Just got one actually earlier today.
We're seeing claims paid for commercial payers, Medicare, of course, and then also Advantage, so Medicare Advantage Plans. I'm really excited about the payment side of it. The product's performing really well. As I said, I gave an analogy in the letter to stockholders about my old BlackBerry that I used 15 years ago and said, "Hey, you know, when I had my BlackBerry, I loved the texting features. The phone was good, the camera was good, and I had great access to my email. I probably would not have been interested in the iPhone, this thing called the iPhone. Of course, once I experienced the benefits of the iPhone, I never went back to the BlackBerry." We're seeing that same sort of pattern happen for users of IHEEZO.
Doctors are thinking about their old way of doing anesthesia, ocular anesthesia, and they're seeing, I think, a better way to do it. Of course, we're the only reimbursable topical anesthetic in the U.S. market, which, I think is a, is a boon for the product.
Jeffrey Cohen (Managing Director and Director of Equity Research)
Then lastly, for us, could you bring us up to speed on how the commercial team currently looks as far as total FTEs and maybe demographic presence, and then tie that into the recent acquisitions, the Santen portfolios and VEVYE, and if they came with any commercial folks and how they would be integrated?
Mark L. Baum (CEO)
I see. I think the first of all, we're all dedicated W-2s. We've transitioned away from 1099. The sales organization, they're all employees of Harrow. That's point one. Secondly, I think in terms of FTEs, I believe we're getting close to 50 folks now. As we've talked about in the past, our strategy here is to let revenue and demand sort of drive increases in expense, and that includes expenses related to sales folks. We are building the team out slowly. I mean, you can look on LinkedIn, and you see that there are open positions. I think, you know, one other comment, my sense from our commercial leadership is that the quality of candidates that we're seeing is very different today than it was years ago.
There is a bit of a buzz, I think, in the ophthalmic pharmaceutical community, and very strong sales leaders are wanting to join the Harrow team. They're seeing the activity, they're seeing the portfolio that we've built, and so we're getting better candidates to join the team as well. Andrew, do you want to add to that at all?
Andrew Boll (CFO)
No, Mark, nothing to add on my side. I'll just echo kind of what you were saying, though, that importantly, Jeff, we're gonna make sure that when we're doing this work on the analytic side, that market access, that, that reimbursement is gonna drive hiring. We're not gonna go and hire, you know, another 50 reps when we don't have the revenue to support it. We'll let that revenue and demand sort of create and build and fill in behind it with, with additional expense.
Jeffrey Cohen (Managing Director and Director of Equity Research)
Got it. Okay, super helpful. Nice readout. Thanks for taking our questions.
Mark L. Baum (CEO)
Thank you, Jeff.
Andrew Boll (CFO)
Thanks, Jeff.
Operator (participant)
The next question is from Brooks O'Neil of Lake Street Capital Markets. Please go ahead.
Brooks O'Neil (Senior Research Analyst)
Thank you very much. Good afternoon, everyone. I confess, I skimmed the shareholder letter as quickly and thoroughly as I could, but I did have three companies report after the close of guide, so you can appreciate I might ask you about something that's well documented in the letter, and I apologize in advance for that. I just want to start, maybe down the path Jeff was going with IHEEZO. I saw and read much of the commentary in the letter, but I just want to ask a little bit about you. You mentioned specifically the $544, I think it's wholesale acquisition cost, that's, that's called for. You mentioned specifically that doctors have indicated they're being reimbursed by Medicare and MA and commercial plans.
Can you help us just get a sense for what that $544 price means to you guys? Is that a price that you guys would realize for each vial of IHEEZO that you sell? Help us understand that dynamic, and then help us to understand how, how much a doctor gets reimbursed in these various sites of setting for, for IHEEZO.
Mark L. Baum (CEO)
Sure. Just to start, you know, we don't sell, the doctors on the spread and, you know, any benefit, economic benefit that a physician or an ASC gets is not part of, you know, the, the sales process or the marketing process, to be clear.
Brooks O'Neil (Senior Research Analyst)
Yeah.
Mark L. Baum (CEO)
In terms of the costs, we don't get the entire $544. There are distribution costs and other related expenses. Andrew can kinda give you a rough breakdown of how that works, you know, in with a broad brush.
Andrew Boll (CFO)
Yeah, Brooke, we're, like Mark said, we're not seeing the whole growth, and this is, this goes for all of our branded products. As Mark mentioned, our net revenues is gonna be net of estimated rebates, wholesaler chargebacks, discounts, you know, any other deduction. That can run the gamut on, on, on products from, you know, 12% up to we've, we've seen products that we've done acquisition diligence on, where their gross-to-net is 80% discount. I'm not saying ours are 80%, but it, it ranges based on the product, where it's used, and how heavily it's discounted, especially with the payers.
Brooks O'Neil (Senior Research Analyst)
Okay. I, I get all that, and, and that's very helpful, guys. Any sense for, for what the doctor gets reimbursed in these various sites? I, again, I understand it's, it's various buckets, whether we're talking hospitals or physician offices, whether we're talking commercial Medicare or Medicare Advantage, but just help us with a general sense. It's, If I understand it correctly, it's $544 plus some margin, right?
Mark L. Baum (CEO)
Yeah. There is obviously a price that the ASC hospital or physician is paying for the product.
Brooks O'Neil (Senior Research Analyst)
Yeah.
Mark L. Baum (CEO)
There is, you know, and, and that is, that is typically a lower amount than, you know, the reimbursed amount. Sometimes there is, you know, an extra fee, so a so-called gap, that can be billed to a supplemental. You know, what we're seeing is, is that the payments are coming in through the J-code, and the supplementals are being paid as well, if that coverage is available. We're not hearing, any complaints, and when I say any, I, I literally mean any complaints. There are always cases where, you know, the wrong NDC is billed or, you know, there, there are issues like that. Those are sort of administrative, but the code itself is being paid, and the supplementals, even commercial and the Advantages are, are covering the, the, delta.
Brooks O'Neil (Senior Research Analyst)
Great. Your sense is that the, the physicians in their office have had reasonable success getting paid, too, which is really the big market, right?
Mark L. Baum (CEO)
The in-office market is about twice the size, we estimate, to the cataract and sort of surgical market. The intravitreal injection market, in particular, is double the size of the ASC hospital market, and so we're seeing coverage there as well. As I said, I think the big picture message with IHEEZO is that, that you need that last piece of the puzzle to ensure adoption of the product. When you have a product that works like IHEEZO, you wanna make sure... And it's, and it does have a J-code, which IHEEZO has, you wanna make sure that physicians are able to bill the code, and that was sort of the last piece of the puzzle, and we're seeing the code get paid.
There are really no barriers to doctors now adopting the product, and that's, I think, very, very positive.
Brooks O'Neil (Senior Research Analyst)
Very positive. That's great. Let me shift gears and just ask you, I don't know nearly as much, I don't know much about IHEEZO. I know almost nothing about VEVYE, which I apologize for, and I'm going to learn a lot more about it both today and in the near future. Can you help me understand or us understand the reimbursement picture for VEVYE in terms of where you stand with regard to getting, you know, the same kind of of a reimbursement established for that product or whatever is required for that product? In round numbers, what the amount of reimbursement might be for that product?
Mark L. Baum (CEO)
Yeah. IHEEZO is a buy and bill product, and it's.
Brooks O'Neil (Senior Research Analyst)
Yeah
Mark L. Baum (CEO)
... a Part, Part B, as in Bravo product, and VEVYE is, is different. You know, it, it is, you know, a Part B, as in Delta. It's a, it's a drug product, and it'll be billed to a different part of the coverage. Now, VEVYE is newly FDA approved. The key activity now, you know, in addition to all of the marketing work that's going on behind the scenes, that's already started, is really market access. Our team is, is working and focused on market access activities for VEVYE.
Brooks O'Neil (Senior Research Analyst)
Mm-hmm.
Mark L. Baum (CEO)
Beginning those, those activities now, we'll go through a contracting price, not only with public payers, but also private payers as well. We have an amazing market access team, this product, VEVYE, is certainly a priority for them. We have not priced the product yet. Products in this category, I think, range anywhere from, you know, in the $600-$800 range. We have not actually priced VEVYE yet, and so that'll take, you know, that'll happen over the coming months. As I said, regardless of the price and regardless of the access status, what I can tell you, because we will work through the market access issues. We are going to, you know, vigorously compete.
One of the benefits with the VEVYE transaction is our cost in acquiring the rights that we have is low relative to the costs, for example, of other competing companies. So that gives us, I think, some leverage, some flexibility in terms of pricing, in terms of rebates and so on. We're going to compete. We're gonna compete hard. We're gonna try and, and get as many patients access to what we feel is an extraordinary therapy. You know, this is not something that's going to impact our 2023 revenues.
Brooks O'Neil (Senior Research Analyst)
Mm-hmm.
Mark L. Baum (CEO)
really beyond activity. The market's massive. We have an amazing IP estate behind VEVYE. It is an unusual product, the feel of the product, the efficacy. So the key for us is that we have it, it's totally unique, it's FDA approved. We will work through the access issues, and we have a large market and a completely, really wide-open playing field, we believe, to create value, not only for patients, but for our stockholders
Brooks O'Neil (Senior Research Analyst)
That's fantastic. That's great. Let me just shift gears one more time, and then I'll jump back. TRIESENCE, I think you mentioned in the letter and in your comments, is also a product with enormous potential. My sense is, historically, one issue has been manufacturability, and I saw in the letter that you commented that you made some test batches and had some success. Just give us a little more color about the status there and sort of broadly, what you expect the timing to be. My sense is, if you can get that product to be available to your customers, there's a pretty big market opportunity for you there.
Mark L. Baum (CEO)
Without question, we're we, and I said this in the stockholder letter, you know, we've had a lot of inbound from ophthalmologists, you know, every week about TRIESENCE. They want it back, they want access to it, for all of the various uses of the product. You know, you can tell from the stockholder letter that we've been doing a lot of work in that regard with our manufacturing partner. I think the good news is that a batch of the material has been successfully produced. So, what we're doing now is we're replicating that, our partner is, and we expect that activity to really kinda conclude in the early part of the fourth quarter.
We should have some results from these PPQ batches, and assuming those results match the results of the batch that was already successfully produced, you know, we should have material available to us, you know, hopefully by the end of the year, if not, you know, in the early part of the first quarter of next year. One final point, the deal that we struck with Novartis has a financial incentive for them to provide us with a release of a commercial batch by or before the middle of January. The payment that is owed to Novartis in connection with the NDA transfer for TRIESENCE is $45 million.
However, if the batch is not produced by that time period, so that's sort of the middle of January, the payment that is owed is reduced from $45 million to $37 million. There's an $8 million incentive to get this right and to provide us with inventory by the middle of January.
Brooks O'Neil (Senior Research Analyst)
Will they, just so I understand, will they manufacture it for you for a period of time, or are they just helping you and your commercial partner get over the hump?
Mark L. Baum (CEO)
We have.
Brooks O'Neil (Senior Research Analyst)
of being able to manufacture it?
Mark L. Baum (CEO)
With all of the products that we've acquired, whether it's from Novartis or Santen, we always ensure that we have an ongoing multiyear contract manufacturing agreement in place. Of course, we have flexibility to move the manufacturing to another partner if we so choose. We do have a partner in place for Alpha, for TRIESENCE, and, we intend to, you know, continue that relationship, and we're excited to hopefully have some inventory by the end of the year. I think the nice thing about TRIESENCE is we don't need a lot of salespeople to sell TRIESENCE. It'll pretty much sell itself. If we have the inventory, I think our wholesalers will take as much as we could produce, and, you know, we'll be able to produce a lot of value for our stockholders.
Brooks O'Neil (Senior Research Analyst)
Great. I appreciate your taking all my questions and your patience with me, and I look forward to talking to you guys again soon.
Mark L. Baum (CEO)
Thank you, Brooks.
Operator (participant)
The next question is from Mayank Mamtani of B. Riley. Please go ahead.
Mayank Mamtani (Senior Managing Director and Group Head of Healthcare Research)
Good afternoon, team. Congrats on a strong quarter, and good to see the 5-year strategic plan in your shareholder letter. A couple of fairly targeted questions from us. Maybe to start and, you know, picking your thoughts regarding the full year guidance, we get a lot of question on the push and pull there, you know, in terms of how much IHEEZO might be driving that. Also your Fab Five products seem to be, you know, ramping up relatively ahead of plan. Wonder also how much accretion you're able to have from Santen, you know, within the calendar year 2023. If you could just comment on that, that would be great.
Mark L. Baum (CEO)
Yeah. Thank you for the question. The revenue growth is being driven, you know, broadly speaking, by our branded portfolio. That's Vigamox, it's Maxitrol, Maxidex, ILEVRO, Nevanac, and of course, IHEEZO. That's where we're seeing the growth. You know, we expect the Santen portfolio to also provide, you know, not only sort of the revenue base that we acquired when we brought the products on, but we also expect to see some, you know, meaningful growth in that portfolio once we have the marketing authorizations under our control. That's not going to happen tomorrow. It's gonna take a few months, so there's sort of a transition period that we're undergoing. You know, you should see, I think, in 2024 a pickup from the Santen portfolio in terms of revenues and overall contribution.
I think the real growth drivers in the business in 2024 are going to come from IHEEZO. We expect significant, you know, continued growth in 2024 and 2025 and beyond for for IHEEZO. We're very excited about VEVYE, and really beginning the market access work there. This is just a market, you know, I personally have spent a lot of time trying to understand. We have interviewed hundreds and hundreds of chronic dry eye disease patients, conducted telephonic interviews, so we, we, we think we understand this patient population very well and what the nuances are that, that you have to overcome to, to help these folks. So we just are very, very excited about VEVYE and what it will offer to this patient population.
This is going to be a product that will build in 2024 and for many, many years to come. I mean, you've got very strong IP on VEVYE out into 2039 and beyond, actually. It's a, it's a product that we're gonna offer for a long, long time. It's gonna help a lot of people.
Mayank Mamtani (Senior Managing Director and Group Head of Healthcare Research)
Great. Thank you. Maybe staying on your, this, this, DED marketplace entry, and by the way, love the water versus water-free analogy. In, for VEVYE, you know, the product differentiation relative to maybe some more recent drug launches that have created this perception of, you know, the uptake being slow, the market opportunity being limited, which, which is a function of, you know, a lot of sub patients, to your point, going undertreated, they don't comply as well. Maybe just purely from a clinical data standpoint, you know, what, what, what sort of profile we are talking about relative to some, some of these recent drugs? Obviously, you know, folks are also curious to know how it differentiates against the space, which is generic cyclosporine.
Mark L. Baum (CEO)
As I said, the reason for our enthusiasm is twofold: One, because of what we have, which is exceptional, so we have a great product. Our enthusiasm is buttressed by the competition that we face. On the one hand, you may look at the products that are in the market and say there's a lot of them, but if you're a dry eye patient and you have pain in your eye, you're feeling grittiness and, and redness and, you know, you're, you're aggravated and it's hard to work, and you go to put a product in your eye and, you know, 22% of the patients experience pain when you instill a product in your eye. You know, the adverse event profiles even get worse than that for some of the products that are in development. So.
you know, you're that patient, and you need something that soothes your, your pain. I don't think that these products that live in the so-called water world are really helping them. We have a, a totally unique, different approach. As I said, I personally have put an EyeSol product in my eye, on my eye, and there's just nothing that feels like it. Having listened to literally hundreds of interviews of chronic dry eye disease patients, I just think we have something that's gonna really benefit them. Not on the margin, like some of the existing products may benefit patients, but we're talking about, you know, in a completely new way.
Something that doesn't have that burning and stinging, doesn't cause dysgeusia, it doesn't cause pain at installation, something you don't have to spray up your nose or doesn't cause sneezing when you put it up your nose. This is a different approach. We're gonna patiently execute a strategy to make sure patients have access to VEVYE. It is, it is a totally new world. It's the water-free world.
Mayank Mamtani (Senior Managing Director and Group Head of Healthcare Research)
Got it. Maybe just last one for Andrew. Is there sort of a target range for, you know, leverage ratio you're trying to get to in the, in the near to medium, medium term? Obviously, it's improved, but is there a sort of range you're working towards, Andrew?
Andrew Boll (CFO)
I think, think that's a good question, and thanks for that. You know, it depends, is the answer. I think, what I mean by that is, we're, we're obviously sort of deal-focused in our DNA. If there are transactions that we can transact on and lever into it, we're not gonna pass it up. That's what I'm saying, is we're not gonna. It's, obviously, it's got to be an attractive deal to do that. To the current, just based on the current leverage ratio, especially on an annualized basis, I, I, I personally would like to see it lower. We're definitely working towards that.
I think if you, you see it in the guidance, even, you know, our expectation is, even it's gonna continue to grow throughout the year in order for us to hit the guidance number. At the same time, we like to use debt as a way to fund these transactions. If there are additional transactions for us to do, we'll do that, and we'll take advantage of the instrument and our partners on the debt side.
Mayank Mamtani (Senior Managing Director and Group Head of Healthcare Research)
Listen, makes a lot of sense. Thanks again for taking my questions.
Mark L. Baum (CEO)
Thank you, Mayank.
Operator (participant)
The next question is from Jim Roumell of Roumell Asset Management. Please go ahead.
Jim Roumell (Partner and Lead Portfolio Manager)
Thanks. Just a quick question. New to the story, but been following it. Your net equity dropped, nearly 20% in the quarter. I haven't had a chance to look at really the, the pushes and the pulls, but can you give a little color as to kinda what decisions you're balance sheet decisions you're making, expansion of, of credit, to, to, to, for growth? Just a, a little color on why your net equity dropped nearly 20% in the quarter or in the first half of the year.
Andrew Boll (CFO)
Hey, hey, Jim. Yeah, this is Andrew. Happy to, happy to talk about that and address it. On a GAAP basis, for the year, we've lost about just under $11 million. There are a lot of non-cash impacts related to that, such as amortization of, of, of the NDAs, as we talked about at the beginning of the call with Jeff. Importantly, you know, subsequent to quarter end, we also did raised about $69 million of new capital that will increase that equity balance in the subsequent periods.
Jim Roumell (Partner and Lead Portfolio Manager)
A lot of non-cash charges in the first half of the year?
Andrew Boll (CFO)
That's right.
Jim Roumell (Partner and Lead Portfolio Manager)
What are you, what are you writing off? Are these, are you just kind of amortizing acquisitions, or are you actually writing things down?
Andrew Boll (CFO)
Sure. I can go through a couple examples. A big, a big chunk of that, about $4.7 million of it so far, is amortization of, of these intangible assets. Non-cash amortization. There's some investment losses related to our, our holding in, in Eton. We also had a debt extinguishment cost of about $5.6 million. All of that is essentially non, non-cash or, or non-operating.
Jim Roumell (Partner and Lead Portfolio Manager)
Okay. Okay, well, I'll appreciate that. I'll probably follow up later.
Mark L. Baum (CEO)
Thank you, Jim.
Jim Roumell (Partner and Lead Portfolio Manager)
Okay. Thank you.
Operator (participant)
That is all the time we have for questions today. I will now turn the call back to Mark Baum for closing remarks.
Mark L. Baum (CEO)
Thank you, operator. The first half of 2023 has proven to be a productive and exciting period for Harrow. Momentum is continuing to build in 2023. We expect it to continue for many years to come. I know that we would never have achieved this or had a shot at achieving our goals without the trust of our loyal employees, customers, vendors, and stockholders who have supported us throughout this journey. 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 [email protected]. Thank you. This will conclude our call.
Operator (participant)
The conference has now concluded. Thank you for attending today's presentation. You may disconnect.