NASDAQ:HROW Harrow Q2 2023 Earnings Report $39.57 +0.38 (+0.97%) As of 04/17/2025 03:59 PM Eastern Earnings HistoryForecast Allianz EPS ResultsActual EPS-$0.02Consensus EPS -$0.01Beat/MissMissed by -$0.01One Year Ago EPS$0.01Allianz Revenue ResultsActual Revenue$33.47 millionExpected Revenue$31.04 millionBeat/MissBeat by +$2.43 millionYoY Revenue Growth+43.50%Allianz Announcement DetailsQuarterQ2 2023Date8/9/2023TimeAfter Market ClosesConference Call DateWednesday, August 9, 2023Conference Call Time4:45PM ETUpcoming EarningsAllianz's next earnings date is estimated for Wednesday, May 21, 2025, based on past reporting schedules. Conference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by Allianz Q2 2023 Earnings Call TranscriptProvided by QuartrAugust 9, 2023 ShareLink copied to clipboard.There are 8 speakers on the call. Operator00:00:00Good afternoon, and welcome to Harrow's Second Quarter 2023 Earnings Conference Call. My name is Kate, 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. Operator00:00:17I would now like to turn the call over to Jamie Webb, Director of Communications and Investor Relations for Harrow. Please go ahead. Speaker 100:00:27Thank you, operator. Good afternoon, and welcome to Harrow's Q2 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 from time to time in its SEC filings, such as the risks and uncertainties related to the company's ability to make commercially available It's 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 ks and subsequent quarterly reports on Form 10 Q filed with the Securities and Exchange Commission. Speaker 100:01:28Harrow's results may differ materially from those projected. Harrow disclaims any intention or obligation to update or revise any financial projections Are forward looking statements whether because of new information, future events or otherwise. This conference call contains time sensitive information and is accurate only as of today. Additionally, Harold referred to non GAAP financial metrics, specifically adjusted EBITDA And our 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 stock Both of which are available on the website. Speaker 100:02:19By 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.harro.com. Joining me on today's call are Harrow's Chief Executive Officer, Mark Elbaum and Harrow's Chief Financial Officer, Andrew Voll. 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. Speaker 200:02:49Thanks, Jamie, and thanks to everyone for joining us on today's call. As always, I would recommend that you review our Our Q2 2023 earnings release, corporate presentation and letter to stockholders, all of which have been posted to the Investor Relations 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 $135,000,000 to $143,000,000 in net revenues And $44,000,000 to $50,000,000 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. Speaker 200:03:54Since 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 VIVI from Novoleak. This is on top of The Fab 5 portfolio we acquired from Novartis and closed on in the Q1 of 2023. Through the Santen acquisition, We acquired the rights to 5 branded prescription products and 1 OTC product for the U. S. Market As well as Canadian rights to 1 branded prescription product and 1 OTC product. Speaker 200:04:35Demand trends for all of the Santen products 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. Now under the NovoLEAK transaction, we acquired the North American rights to FDA approved VIVI, the first and only cyclosporin based product indicated for both Signs and symptoms of dry eye disease. VIVI is based on Novoleak's proprietary water free eyesol technology. In my view, Novoleak through eyesol has essentially reinvented the eye drop. Speaker 200:05:31I 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 U. Speaker 200:06:07S. Dry eye market will consist of 2 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 eyesore based Product on my eye, I am 100% all in as a water free believer. Speaker 200:06:37I believe it will be challenging to sell what I am calling Waterworld products when the water free options are soon available. We believe vVy can be a game changer, not only because of ISOL Technology, But also because VIVI contains a 0.1% concentration of the immunosuppressant cyclosporin And no other active pharmaceutical ingredient has been prescribed to treat dry eye disease globally and in the United States More than cyclosporine, it is the number one most prescribed active pharmaceutical ingredient for this patient population. Before VIVO, the product profiles for cyclosporin 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 Scribers have been dealing with these legacy products for many years. Speaker 200:07:42We believe U. S. Prescribers want a cyclosporin foreign based dry eye formulation with a new product profile and that's what VeeVai delivers. VeeVai offers exceptional patient comfort, provides rapid clinical onset of 29 days. It has an extraordinarily mild adverse event profile And data has shown that it continues to help patients with both signs and symptoms of dry eye disease out to 1 year. Speaker 200:08:12As I said in my letter to stockholders, I view the U. S. Dry iron market as totally wide open And 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 +1000000 diagnosed dry eye disease patients, Of which about 9,000,000 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 $1,000,000,000 in annual revenue in the U. S. Speaker 200:08:53Market alone. Only about 10% of the patient population, the dry eye patient population is benefiting from a prescription dry eye therapy. And we intend to upend the U. S. Dry eye market by providing this new choice, VIVI, To those dry eye patients who have tried and failed 1 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. Speaker 200:09:29Importantly, because of VVY's unique comfort and efficacy of attributes, we believe a meaningful number of VVY patients We'll also choose to maintain V Vi therapy to treat their disease. With VIVI and the other adjacent ocular surface disease products we now own, including FreshCoat, Tobradex ST and Flarex, ARO is planting a flag in the U. S. Dry eye and ocular surface disease markets. We intend to compete vigorously to win meaningful market share and ultimately help millions of suffering American dry eye disease patients. Speaker 200:10:17And of course, we remain resolutely focused on and excited about IHANZELL, Which we officially launched in May of this year at the American Society of Cataract and Refractive Surgeons Annual Meeting in San Diego. While it is still very early in its launch, we are encouraged, especially given the math on the iHESO market opportunity, which is very straightforward. There are 2 main anesthetic use cases for IHESO. 1, 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. And then secondly, an intervention in a physician's office, such as an intravitreal injection. Speaker 200:11:07We estimate that in the aggregate there are more than 12,000,000 such use cases in the U. S. Each year. Now we were granted a product specific J code, that's J2403, for all such use cases. And the current wholesale acquisition cost or WACC pricing on IHESO is $5.44 per unit. Speaker 200:11:32The positive feedback we're getting from early adopters of IHESO on its clinical value is Adding to our enthusiasm about the product. IHESO just works and it works well. IHEZO users have indicated that there are even more potential applications than we had previously anticipated, that eye care professionals Or even eliminating opioids from many of their surgeries and that IHESO 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 U. S. Speaker 200:12:27Focused We now believe that we have 5 discrete, what I call, revenue buckets With 9 figure annual revenue potential, these revenue buckets, which are described in full detail And our stockholders' letter include bucket 1, just Iezo Bucket 2 is our dry eye disease and other ocular surface conditions bucket, which is led by VIVI. Bucket 3 has one product, Tri Essence. Bucket 4 consists of our specialty anterior segment products. And bucket 5 is our tried and true Cornerstone ImprimisRx compounded pharmaceutical products business. So those are the 5 buckets. Speaker 200:13:20As 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 IHIZO and VIVI are our largest revenue opportunities without question. That said, they are also new sources of revenue with IHIZO only launching a few months ago and VeeVai 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 1, HERO now has them both and 2, we have an incredibly strong conviction of market need and ultimately market acceptance of both products. Speaker 200:14:09And of course, now we have one of the most Comprehensive ophthalmic portfolios of products in the U. S. 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. Speaker 200:14:30Operator? Operator00:14:33We will now begin the question and answer session. The first question is from Jeffrey Cohen of Ladenburg Thalmann. Please go ahead. Speaker 300:14:55Hi, Jamie, Mark, Andrew. How are you? Speaker 200:14:58Great, great. Good to speak with you, Jeff. Speaker 300:15:01So I know it's been a while. So 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 margin front, is the core, the historical products up to recent And then the other gross margin number includes all the recent additions? Speaker 400:15:30Yes. Hey, Jeff. Thanks for the question. So on the core, we've got a pretty good reconciliation table in the back of the shareholder letter. But 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 5 products Primarily and there are a couple of other capitalized expenses that we're amortizing through cost of goods sold. Speaker 400:16:01And so that's That amortization is reflected in the GAAP number, the core number we're pulling that amortization out. Speaker 300:16:12Okay, got it. And Mark, any specific commentary on the AHEZLA launch Thus far from April as far as physician acceptance and any relevant bullet points to communicate thus far? Speaker 400:16:28No, I think Speaker 200:16:30the color that's provided in the letter to stockholders on IHESO is fairly detailed. I mentioned in my prepared remarks that 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. So people who try the product like the product. With a product like IHO, and you have such a large market opportunity, The real key is reimbursement and actually getting claims paid. Speaker 200:17:11That was sort of the last Piece of the IHESO puzzle. We recognize that we're not going to win over every customer account. We're not going to win Every unit opportunity, but 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. And so we are 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 in the for the in office setting of Karen, so these are intravitreal injections and the in office setting of care, our permanent J code is powerful. And so 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. Speaker 200:18:21Just Got one actually earlier today. So we're seeing claims paid for commercial payers, Medicare, of course, and then also Advantage. So Medicare Advantage Plans. So, really excited about the payment side of it. The product is Performing really well. Speaker 200:18:40And 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, when I had my BlackBerry, I loved the texting features. The phone was good. The camera was good and had great access to my e mail. I probably would not have been interested in the iPhone, this thing called the iPhone. But of course, once I the benefits of the iPhone, I never went back to the BlackBerry. Speaker 200:19:16And we're seeing that same sort of pattern happen For users of IHEZO, doctors are thinking about their old way of doing anesthesia, ocular anesthesia and they're seeing, I think a better way to do it and of course we're the only reimbursable topical anesthetic in the U. S. Market which I think Speaker 300:19:41Got it. And 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 VeeVai and if they came with any commercial folks and how they would be integrated? Speaker 200:20:06I think the first of all, we're all dedicated W-2s. We've transitioned Away from 1099. So the sales organization, they're all employees of Harrow. That's point 1. Secondly, I think in terms of FTEs, I believe we're getting close to 50 folks now. Speaker 200:20:29And 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. But we are Building the team out slowly, I mean you can look on LinkedIn and you see that there are open positions. And I think 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. Speaker 200:21:27Andrew, do you want to add to that at all? Speaker 400:21:32No, Mark. Nothing to add on my side. I'll just echo kind of what you're saying though that importantly, Jeff, we're going to make sure that and we're doing this work on the analytics side that market access, That reimbursement is going to drive hiring. We're not going to go and hire 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 additional expense. Speaker 300:22:03Got it. Okay, super helpful. Nice readout. Thanks for taking my questions. Speaker 200:22:07Thank you, Jeff. Operator00:22:11The next question is from Brooks O'Neil of Lake Street Capital Markets. Please go ahead. Speaker 500:22:16Thank you very much. Good afternoon, everyone. I confess I skimmed the shareholder letter as quickly and thoroughly as I could, but I did have 3 companies Report after the close of the 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. But I just want to start maybe down the path Jeff was going with a heso. Speaker 500:22:45I Saw and read much of the commentary in the letter, but I just want to ask a little bit about you mentioned Specifically the $5.44 I think it's wholesale acquisition cost It's called 4 and 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 $5.44 price means to you guys? Is that a price That you guys would realize for each vial of IHANZEO that you sell or help us understand that dynamic And then help us to understand how much a doctor gets reimbursed in these various sites of setting Speaker 200:23:46Sure. Just to start, we don't sell The doctors on the spread and any benefit, economic benefit that a physician or an ASC Gads is not part of the sales process or the marketing process to be clear. Yes. In terms of the costs, we don't get the entire $5.44 and so there are Distribution costs and other related expenses. So Andrew can kind of Give you a rough breakdown of how that works with a broad brush. Speaker 400:24:30Yes, Brooks. So we're like Mark said, we're not seeing the whole growth and this goes for all of our branded products. As Mark mentioned, we're going to our net revenues is going to be net of estimated rebates, wholesaler charge backs, Discounts, any other deduction. And so that can run the gamut on products from 12% Up to, 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 ranges based on the product where it's used and how heavily it's discounted especially With the payers. Speaker 500:25:16Okay. I get all that and that's very helpful guys. Any sense For what the doctor gets reimbursed in these various sites, again, I understand 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. If I understand it correctly, it's 544 Plus some margin, right? Speaker 200:25:55Yes. There is so there's obviously a price that the ASC hospital or physician is paying for the product. Yes. And then there is and that is typically a lower amount The reimbursed amount, sometimes there is an extra fee, so called GAAP That can be billed to a supplemental. And so what we're seeing is that the payments are coming in through the J code And the supplementals are being paid as well if that coverage is available. Speaker 200:26:33So we're not hearing Any complaints, and when I say any, I literally mean any complaints. There are always cases where the long NDC is billed or 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 covering the delta. Speaker 500:27:03Great. And your sense is that the physicians in their office have had reasonable success getting paid too, Which is really the big market, right? Speaker 200:27:17The in office market is about twice the size we estimate To the cataract and sort of surgical markets. So the intravitreal injection market in particular is double the size of the ASC hospital market. And so we're seeing coverage there as well. And as I said, I think the big picture message with IHIMZO is That last piece of the puzzle to ensure adoption of the product, when you have a product It works like AYIZO, you want to make sure and it does have a J code, which AYIZO has. You want to make sure that physicians are able to build the code And that was sort of the last piece of the puzzle and we're seeing the code get paid. Speaker 200:28:11And so there are really no Barriers to doctors now adopting the product and that's I think very, very positive. Speaker 500:28:22Very 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 Heso. I know Nothing about Viva, which I apologize for and I'm going to learn a lot more about it both today and in the near future. Speaker 500:28:40But can Can you help me understand or us understand the reimbursement picture for VBuy In terms of where you stand with regard to getting the same kind of reimbursement established For that product or whatever is required for that product and in round numbers what the Amount of reimbursement might be for that product? Speaker 200:29:10Yes. So, IHESO is a buy and bill product And it's a Part D product and VIVI is different. It is Part D as in Delta, it's a drug product and it will be billed to a different Part of the coverage now, Levi is newly FDA approved And the key activity now in addition to all of the marketing work that's going on behind the scenes, it's already started, It's really market access. And so our team is working and focused on market access Activities for VIVI and be in those activities now and 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 And this product, VeeVaya, is certainly a priority for them. Speaker 200:30:19So we have not priced the product Yes. Products in this category, I think range anywhere from in the $600 to $800 range. So we have not actually priced Veeva yet and so that will take that will happen over the coming months. But 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 vigorously compete. Speaker 200:31:00One of the benefits with the VVY transaction is our cost in Acquiring the rights that we have is low relative to the costs, for example, of Other competing companies. And so that gives us, I think, some leverage, some flexibility in terms of Pricing in terms of rebates and so on. So we're going to compete. We're going to compete hard. We're going to try and get as many patients access to what we feel is an extraordinary therapy. Speaker 200:31:35But this is not something that's going to Our 2023 revenues, this is a 2024 and really beyond sort of Activity. The market is massive. We have an amazing IP estate behind VIVI. It is an unusual product, the feel of the product, the efficacy. And so the key for us is that we have it. Speaker 200:32:05It'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. Speaker 500:32:25That's fantastic. That's great. So let me just shift gears one more time and then I'll jump back. Triasence, 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've made some test batches and had some success, but Just give us a little more color about the status there and sort of broadly what you expect the timing to be As 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. Speaker 200:33:18Without question, we're we and I said this in the stockholder letter, We've had a lot of inbound from ophthalmologists every week about Tri Essence. They want it Back, they want access to it for all of the various uses of the product. And 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. And so, what we're doing now is We're replicating that, our partner is and we expect that activity to really Kind of conclude in the early part of Q4. Speaker 200:34:12And so we should have some results from these PPQ PQ batches and assuming those results match the results of the batch that was already successfully produced, We should have material available to us hopefully by the end of the year, if not In the early part of the Q1 of next year. One final point, the deals that we struck with Novartis Has a financial incentive for them to provide us with a release Of a commercial batch buyer before the middle of January, the payment that is owed to Novartis In connection with the NDA transfer for Tri Essence is $45,000,000 However, if the Batch is not produced by that time period, so that sort of the middle of January, the Payment that is owed is reduced from $45,000,000 to $37,000,000 So there is an $8,000,000 incentive To get this right and to provide us with inventory by the middle of June quarter. Speaker 500:35:32So 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 being able to manufacture Speaker 200:35:48it? With all of the products that we've acquired, Whether it's from Novartis or Santen, we always ensure that we have an ongoing Multi year contract manufacturing agreement in place. And of course, we have ability to move the manufacturing to another partner if we so choose. But we do have a partner in place For Tri Essence and we intend to continue that relationship and we're excited to hopefully have some inventory by the end of the year. And I think the nice thing about Tri Essence is we don't need a lot of salespeople to sell Tri Essence. Speaker 200:36:33It will Pretty much sell itself. So if we have the inventory, I think our wholesalers will take as much as we could produce And we'll be able to produce a lot of value for our stockholders. Speaker 500:36:46Great. I appreciate you taking all my questions and Your patience with me and I look forward to talking to you guys again Speaker 200:36:55soon. Thank you, Brooks. Operator00:36:59The next question is from Mayank Mamtani of B. Riley. Please go ahead. Speaker 600:37:06Good afternoon, team. Congrats on a Strong quarter and good to see the 5 year strategic plan in your shareholder letter. So a couple of fairly targeted questions from us. Maybe to start and picking your thoughts regarding the full year guidance, we get a lot of question on the push and pull there In terms of how much IHisa might be driving that, but also your fab five products seem to be ramping up relatively Ahead of plan and wonder also how much accretion you're able to have from Santen within the calendar year 2023. If you could just comment on that, that would be great. Speaker 200:37:47Yes. So thank you for the question. The revenue growth is being driven Broadly speaking by our branded portfolio, that's VIGAMOX, it's Maxetrol, Maxidex, Alevo, Nevanac And of course, IHIMZO. So that's where we're seeing the growth. And We expect the Santen portfolio to also provide not only Sort of the revenue base that we acquired when we brought the products on, but we also expect to see some meaningful growth in that Once we have the marketing authorizations under our control. Speaker 200:38:32That's not going to happen tomorrow. It's going to take A few months, so there's sort of a transition period that we're undergoing. And you Should see, I think in 2024, a pickup from the Santen portfolio in terms of revenues and overall Contribution, but I think the real growth drivers in the business in 2024 are going to come from IHESO. We expect significant continued growth In 2024 2025 and beyond for IHESO. And we're very excited about VeeVai And really beginning the market access work there. Speaker 200:39:24And this is just a market. I personally have spent a lot of time Trying to understand, we have interviewed 100 and 100 of Chronic dry eye disease patients conducted telephonic interviews and so we think we understand this patient population very well and what the nuances are that you have to overcome to help these folks. And so we just are very, very excited about VIVI and what it will offer to this patient And 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 VVY out into 2,039 and beyond actually. So it's a product that we're going to offer For a long, long time, it's going to help a lot of people. Speaker 600:40:31Great. Thank you. And maybe staying on your business, DED Marketplace entry and by the way, love the water versus water free analogy. For VY, the product differentiation And relative to maybe some more recent drug launches that have created this perception of The update being slow, the market opportunity being limited, which is a function of a lot of sub patients to your point going under treated, They don't comply as well. So maybe just clearly from a clinical data standpoint, what Sort of profile we are talking about relative to some of these recent drugs. Speaker 600:41:14And obviously, folks are also curious to know how it Differentiates against the space that is genetic cyclosporin? Speaker 200:41:24Yes. As I said, The reason for our enthusiasm is twofold. 1, because of what we have, which is Exceptional. So we have a great product, but our enthusiasm is buttressed by the competition that we face. And so 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 redness and you're aggravated and it's hard to work. Speaker 200:42:12And You go to put a product in your eye and 22% of the patients experience Pain when you instill a product in your eye or The adverse event profiles even get worse than that for some of the products that are in development. You're that patient and you need something that soothes your pain. I don't think that these products that live in the so called water world are really helping them. And we have a Totally unique different approach. And as I said, I personally have put an eyesore product in my eye, On my eye and there's just nothing that feels like it. Speaker 200:43:03And having listened to literally hundreds of Interviews of chronic dry eye disease patients, I just think we have something that's going to really benefit them, not on the margin, like Some of the existing products may benefit patients, but we're talking about in a completely new way, something that doesn't Have that burning and stinging doesn't cause to excuse you, 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 and We're going to patiently execute a strategy to make sure patients have access to VIVI. It is a totally new world. It's the water free world. Speaker 600:43:57Got it. And maybe just last one for Andrew, is there sort of a target range for leverage ratio you're trying to get to in the near to medium term? Obviously, It's improved, but is there some is there a sort of range you're working towards, Andrew? Speaker 400:44:16I think that's a good question and thanks for that. It depends is the answer. And I think what I mean by that is We're obviously sort of deal focused in our DNA. And so if there are transactions that we can Transact on and lever into it, we're not going to pass it up. And so that's what I'm saying is we're not going to and it's obviously it's got to be an attractive deal to do that. Speaker 400:44:48But to the current just based on the current leverage ratio, On an annualized basis, I personally would like to see it lower. We're definitely working towards that. I think as you see it in the guidance even our expectation is EBITDA is going to continue to grow throughout the year in order for us to hit the guidance number. But 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. Operator00:45:35The next question is from Jim Romo of Romo Asset Management. Please go ahead. Speaker 700:45:42Thanks. 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 pushes and the pulls, but can you give a little color as to Kind of what decisions your balance sheet decisions you're making, expansion of credit For growth, but just a little color on why your net equity dropped nearly 20% in the quarter or in the first half of the year? Speaker 400:46:22Hey, Jim. Yes, this is Andrew. Happy to talk about that and address it. So on a GAAP basis for the year, we've lost about just under $11,000,000 There are a lot of non cash Impacts related to that such as amortization of the NDAs that we got at the beginning of the call with Jeff. Importantly, Subsequent to quarter end, we also did raised about $69,000,000 of new capital that will increase that debt equity balance Speaker 700:47:00Okay. So A lot of non cash charges in the first half of the year? Speaker 400:47:09That's right. Speaker 700:47:11So What are you writing off? Are these are you is this just kind of amortizing acquisitions or are you actually writing things down? Speaker 400:47:23Sure. So I can go through a couple of examples. A big chunk of that, about $4,700,000 of it So far is amortization of these intangible assets, non cash amortization. There's some investment losses related to our holding in Eaton. And then we also had a debt extinguishment cost of about $5,600,000 Oh, that is essentially non cash or non operating. Speaker 700:47:52Okay. Okay. Well, I'll appreciate that. I'll probably follow-up later. Speaker 200:48:05Thank you, Jim. Speaker 700:48:06Okay. Thank you. Operator00:48:09That is all the time we have for questions today. I will now turn the call back to Mark Baum for closing remarks. Speaker 200:48:17Thank you, operator. The first half of twenty twenty three is proven to be a productive and exciting period for Harrow. Momentum is continuing to build in 2023 and 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. Speaker 200:48:49If you have any investor related Questions, please email jameyweb@jwebbharrowinc .com. Thank you, and this will conclude our call. Operator00:49:04The conference has now concluded. 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There are 8 speakers on the call. Operator00:00:00Good afternoon, and welcome to Harrow's Second Quarter 2023 Earnings Conference Call. My name is Kate, 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. Operator00:00:17I would now like to turn the call over to Jamie Webb, Director of Communications and Investor Relations for Harrow. Please go ahead. Speaker 100:00:27Thank you, operator. Good afternoon, and welcome to Harrow's Q2 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 from time to time in its SEC filings, such as the risks and uncertainties related to the company's ability to make commercially available It's 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 ks and subsequent quarterly reports on Form 10 Q filed with the Securities and Exchange Commission. Speaker 100:01:28Harrow's results may differ materially from those projected. Harrow disclaims any intention or obligation to update or revise any financial projections Are forward looking statements whether because of new information, future events or otherwise. This conference call contains time sensitive information and is accurate only as of today. Additionally, Harold referred to non GAAP financial metrics, specifically adjusted EBITDA And our 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 stock Both of which are available on the website. Speaker 100:02:19By 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.harro.com. Joining me on today's call are Harrow's Chief Executive Officer, Mark Elbaum and Harrow's Chief Financial Officer, Andrew Voll. 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. Speaker 200:02:49Thanks, Jamie, and thanks to everyone for joining us on today's call. As always, I would recommend that you review our Our Q2 2023 earnings release, corporate presentation and letter to stockholders, all of which have been posted to the Investor Relations 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 $135,000,000 to $143,000,000 in net revenues And $44,000,000 to $50,000,000 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. Speaker 200:03:54Since 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 VIVI from Novoleak. This is on top of The Fab 5 portfolio we acquired from Novartis and closed on in the Q1 of 2023. Through the Santen acquisition, We acquired the rights to 5 branded prescription products and 1 OTC product for the U. S. Market As well as Canadian rights to 1 branded prescription product and 1 OTC product. Speaker 200:04:35Demand trends for all of the Santen products 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. Now under the NovoLEAK transaction, we acquired the North American rights to FDA approved VIVI, the first and only cyclosporin based product indicated for both Signs and symptoms of dry eye disease. VIVI is based on Novoleak's proprietary water free eyesol technology. In my view, Novoleak through eyesol has essentially reinvented the eye drop. Speaker 200:05:31I 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 U. Speaker 200:06:07S. Dry eye market will consist of 2 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 eyesore based Product on my eye, I am 100% all in as a water free believer. Speaker 200:06:37I believe it will be challenging to sell what I am calling Waterworld products when the water free options are soon available. We believe vVy can be a game changer, not only because of ISOL Technology, But also because VIVI contains a 0.1% concentration of the immunosuppressant cyclosporin And no other active pharmaceutical ingredient has been prescribed to treat dry eye disease globally and in the United States More than cyclosporine, it is the number one most prescribed active pharmaceutical ingredient for this patient population. Before VIVO, the product profiles for cyclosporin 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 Scribers have been dealing with these legacy products for many years. Speaker 200:07:42We believe U. S. Prescribers want a cyclosporin foreign based dry eye formulation with a new product profile and that's what VeeVai delivers. VeeVai offers exceptional patient comfort, provides rapid clinical onset of 29 days. It has an extraordinarily mild adverse event profile And data has shown that it continues to help patients with both signs and symptoms of dry eye disease out to 1 year. Speaker 200:08:12As I said in my letter to stockholders, I view the U. S. Dry iron market as totally wide open And 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 +1000000 diagnosed dry eye disease patients, Of which about 9,000,000 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 $1,000,000,000 in annual revenue in the U. S. Speaker 200:08:53Market alone. Only about 10% of the patient population, the dry eye patient population is benefiting from a prescription dry eye therapy. And we intend to upend the U. S. Dry eye market by providing this new choice, VIVI, To those dry eye patients who have tried and failed 1 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. Speaker 200:09:29Importantly, because of VVY's unique comfort and efficacy of attributes, we believe a meaningful number of VVY patients We'll also choose to maintain V Vi therapy to treat their disease. With VIVI and the other adjacent ocular surface disease products we now own, including FreshCoat, Tobradex ST and Flarex, ARO is planting a flag in the U. S. Dry eye and ocular surface disease markets. We intend to compete vigorously to win meaningful market share and ultimately help millions of suffering American dry eye disease patients. Speaker 200:10:17And of course, we remain resolutely focused on and excited about IHANZELL, Which we officially launched in May of this year at the American Society of Cataract and Refractive Surgeons Annual Meeting in San Diego. While it is still very early in its launch, we are encouraged, especially given the math on the iHESO market opportunity, which is very straightforward. There are 2 main anesthetic use cases for IHESO. 1, 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. And then secondly, an intervention in a physician's office, such as an intravitreal injection. Speaker 200:11:07We estimate that in the aggregate there are more than 12,000,000 such use cases in the U. S. Each year. Now we were granted a product specific J code, that's J2403, for all such use cases. And the current wholesale acquisition cost or WACC pricing on IHESO is $5.44 per unit. Speaker 200:11:32The positive feedback we're getting from early adopters of IHESO on its clinical value is Adding to our enthusiasm about the product. IHESO just works and it works well. IHEZO users have indicated that there are even more potential applications than we had previously anticipated, that eye care professionals Or even eliminating opioids from many of their surgeries and that IHESO 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 U. S. Speaker 200:12:27Focused We now believe that we have 5 discrete, what I call, revenue buckets With 9 figure annual revenue potential, these revenue buckets, which are described in full detail And our stockholders' letter include bucket 1, just Iezo Bucket 2 is our dry eye disease and other ocular surface conditions bucket, which is led by VIVI. Bucket 3 has one product, Tri Essence. Bucket 4 consists of our specialty anterior segment products. And bucket 5 is our tried and true Cornerstone ImprimisRx compounded pharmaceutical products business. So those are the 5 buckets. Speaker 200:13:20As 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 IHIZO and VIVI are our largest revenue opportunities without question. That said, they are also new sources of revenue with IHIZO only launching a few months ago and VeeVai 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 1, HERO now has them both and 2, we have an incredibly strong conviction of market need and ultimately market acceptance of both products. Speaker 200:14:09And of course, now we have one of the most Comprehensive ophthalmic portfolios of products in the U. S. 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. Speaker 200:14:30Operator? Operator00:14:33We will now begin the question and answer session. The first question is from Jeffrey Cohen of Ladenburg Thalmann. Please go ahead. Speaker 300:14:55Hi, Jamie, Mark, Andrew. How are you? Speaker 200:14:58Great, great. Good to speak with you, Jeff. Speaker 300:15:01So I know it's been a while. So 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 margin front, is the core, the historical products up to recent And then the other gross margin number includes all the recent additions? Speaker 400:15:30Yes. Hey, Jeff. Thanks for the question. So on the core, we've got a pretty good reconciliation table in the back of the shareholder letter. But 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 5 products Primarily and there are a couple of other capitalized expenses that we're amortizing through cost of goods sold. Speaker 400:16:01And so that's That amortization is reflected in the GAAP number, the core number we're pulling that amortization out. Speaker 300:16:12Okay, got it. And Mark, any specific commentary on the AHEZLA launch Thus far from April as far as physician acceptance and any relevant bullet points to communicate thus far? Speaker 400:16:28No, I think Speaker 200:16:30the color that's provided in the letter to stockholders on IHESO is fairly detailed. I mentioned in my prepared remarks that 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. So people who try the product like the product. With a product like IHO, and you have such a large market opportunity, The real key is reimbursement and actually getting claims paid. Speaker 200:17:11That was sort of the last Piece of the IHESO puzzle. We recognize that we're not going to win over every customer account. We're not going to win Every unit opportunity, but 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. And so we are 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 in the for the in office setting of Karen, so these are intravitreal injections and the in office setting of care, our permanent J code is powerful. And so 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. Speaker 200:18:21Just Got one actually earlier today. So we're seeing claims paid for commercial payers, Medicare, of course, and then also Advantage. So Medicare Advantage Plans. So, really excited about the payment side of it. The product is Performing really well. Speaker 200:18:40And 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, when I had my BlackBerry, I loved the texting features. The phone was good. The camera was good and had great access to my e mail. I probably would not have been interested in the iPhone, this thing called the iPhone. But of course, once I the benefits of the iPhone, I never went back to the BlackBerry. Speaker 200:19:16And we're seeing that same sort of pattern happen For users of IHEZO, doctors are thinking about their old way of doing anesthesia, ocular anesthesia and they're seeing, I think a better way to do it and of course we're the only reimbursable topical anesthetic in the U. S. Market which I think Speaker 300:19:41Got it. And 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 VeeVai and if they came with any commercial folks and how they would be integrated? Speaker 200:20:06I think the first of all, we're all dedicated W-2s. We've transitioned Away from 1099. So the sales organization, they're all employees of Harrow. That's point 1. Secondly, I think in terms of FTEs, I believe we're getting close to 50 folks now. Speaker 200:20:29And 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. But we are Building the team out slowly, I mean you can look on LinkedIn and you see that there are open positions. And I think 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. Speaker 200:21:27Andrew, do you want to add to that at all? Speaker 400:21:32No, Mark. Nothing to add on my side. I'll just echo kind of what you're saying though that importantly, Jeff, we're going to make sure that and we're doing this work on the analytics side that market access, That reimbursement is going to drive hiring. We're not going to go and hire 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 additional expense. Speaker 300:22:03Got it. Okay, super helpful. Nice readout. Thanks for taking my questions. Speaker 200:22:07Thank you, Jeff. Operator00:22:11The next question is from Brooks O'Neil of Lake Street Capital Markets. Please go ahead. Speaker 500:22:16Thank you very much. Good afternoon, everyone. I confess I skimmed the shareholder letter as quickly and thoroughly as I could, but I did have 3 companies Report after the close of the 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. But I just want to start maybe down the path Jeff was going with a heso. Speaker 500:22:45I Saw and read much of the commentary in the letter, but I just want to ask a little bit about you mentioned Specifically the $5.44 I think it's wholesale acquisition cost It's called 4 and 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 $5.44 price means to you guys? Is that a price That you guys would realize for each vial of IHANZEO that you sell or help us understand that dynamic And then help us to understand how much a doctor gets reimbursed in these various sites of setting Speaker 200:23:46Sure. Just to start, we don't sell The doctors on the spread and any benefit, economic benefit that a physician or an ASC Gads is not part of the sales process or the marketing process to be clear. Yes. In terms of the costs, we don't get the entire $5.44 and so there are Distribution costs and other related expenses. So Andrew can kind of Give you a rough breakdown of how that works with a broad brush. Speaker 400:24:30Yes, Brooks. So we're like Mark said, we're not seeing the whole growth and this goes for all of our branded products. As Mark mentioned, we're going to our net revenues is going to be net of estimated rebates, wholesaler charge backs, Discounts, any other deduction. And so that can run the gamut on products from 12% Up to, 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 ranges based on the product where it's used and how heavily it's discounted especially With the payers. Speaker 500:25:16Okay. I get all that and that's very helpful guys. Any sense For what the doctor gets reimbursed in these various sites, again, I understand 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. If I understand it correctly, it's 544 Plus some margin, right? Speaker 200:25:55Yes. There is so there's obviously a price that the ASC hospital or physician is paying for the product. Yes. And then there is and that is typically a lower amount The reimbursed amount, sometimes there is an extra fee, so called GAAP That can be billed to a supplemental. And so what we're seeing is that the payments are coming in through the J code And the supplementals are being paid as well if that coverage is available. Speaker 200:26:33So we're not hearing Any complaints, and when I say any, I literally mean any complaints. There are always cases where the long NDC is billed or 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 covering the delta. Speaker 500:27:03Great. And your sense is that the physicians in their office have had reasonable success getting paid too, Which is really the big market, right? Speaker 200:27:17The in office market is about twice the size we estimate To the cataract and sort of surgical markets. So the intravitreal injection market in particular is double the size of the ASC hospital market. And so we're seeing coverage there as well. And as I said, I think the big picture message with IHIMZO is That last piece of the puzzle to ensure adoption of the product, when you have a product It works like AYIZO, you want to make sure and it does have a J code, which AYIZO has. You want to make sure that physicians are able to build the code And that was sort of the last piece of the puzzle and we're seeing the code get paid. Speaker 200:28:11And so there are really no Barriers to doctors now adopting the product and that's I think very, very positive. Speaker 500:28:22Very 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 Heso. I know Nothing about Viva, which I apologize for and I'm going to learn a lot more about it both today and in the near future. Speaker 500:28:40But can Can you help me understand or us understand the reimbursement picture for VBuy In terms of where you stand with regard to getting the same kind of reimbursement established For that product or whatever is required for that product and in round numbers what the Amount of reimbursement might be for that product? Speaker 200:29:10Yes. So, IHESO is a buy and bill product And it's a Part D product and VIVI is different. It is Part D as in Delta, it's a drug product and it will be billed to a different Part of the coverage now, Levi is newly FDA approved And the key activity now in addition to all of the marketing work that's going on behind the scenes, it's already started, It's really market access. And so our team is working and focused on market access Activities for VIVI and be in those activities now and 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 And this product, VeeVaya, is certainly a priority for them. Speaker 200:30:19So we have not priced the product Yes. Products in this category, I think range anywhere from in the $600 to $800 range. So we have not actually priced Veeva yet and so that will take that will happen over the coming months. But 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 vigorously compete. Speaker 200:31:00One of the benefits with the VVY transaction is our cost in Acquiring the rights that we have is low relative to the costs, for example, of Other competing companies. And so that gives us, I think, some leverage, some flexibility in terms of Pricing in terms of rebates and so on. So we're going to compete. We're going to compete hard. We're going to try and get as many patients access to what we feel is an extraordinary therapy. Speaker 200:31:35But this is not something that's going to Our 2023 revenues, this is a 2024 and really beyond sort of Activity. The market is massive. We have an amazing IP estate behind VIVI. It is an unusual product, the feel of the product, the efficacy. And so the key for us is that we have it. Speaker 200:32:05It'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. Speaker 500:32:25That's fantastic. That's great. So let me just shift gears one more time and then I'll jump back. Triasence, 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've made some test batches and had some success, but Just give us a little more color about the status there and sort of broadly what you expect the timing to be As 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. Speaker 200:33:18Without question, we're we and I said this in the stockholder letter, We've had a lot of inbound from ophthalmologists every week about Tri Essence. They want it Back, they want access to it for all of the various uses of the product. And 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. And so, what we're doing now is We're replicating that, our partner is and we expect that activity to really Kind of conclude in the early part of Q4. Speaker 200:34:12And so we should have some results from these PPQ PQ batches and assuming those results match the results of the batch that was already successfully produced, We should have material available to us hopefully by the end of the year, if not In the early part of the Q1 of next year. One final point, the deals that we struck with Novartis Has a financial incentive for them to provide us with a release Of a commercial batch buyer before the middle of January, the payment that is owed to Novartis In connection with the NDA transfer for Tri Essence is $45,000,000 However, if the Batch is not produced by that time period, so that sort of the middle of January, the Payment that is owed is reduced from $45,000,000 to $37,000,000 So there is an $8,000,000 incentive To get this right and to provide us with inventory by the middle of June quarter. Speaker 500:35:32So 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 being able to manufacture Speaker 200:35:48it? With all of the products that we've acquired, Whether it's from Novartis or Santen, we always ensure that we have an ongoing Multi year contract manufacturing agreement in place. And of course, we have ability to move the manufacturing to another partner if we so choose. But we do have a partner in place For Tri Essence and we intend to continue that relationship and we're excited to hopefully have some inventory by the end of the year. And I think the nice thing about Tri Essence is we don't need a lot of salespeople to sell Tri Essence. Speaker 200:36:33It will Pretty much sell itself. So if we have the inventory, I think our wholesalers will take as much as we could produce And we'll be able to produce a lot of value for our stockholders. Speaker 500:36:46Great. I appreciate you taking all my questions and Your patience with me and I look forward to talking to you guys again Speaker 200:36:55soon. Thank you, Brooks. Operator00:36:59The next question is from Mayank Mamtani of B. Riley. Please go ahead. Speaker 600:37:06Good afternoon, team. Congrats on a Strong quarter and good to see the 5 year strategic plan in your shareholder letter. So a couple of fairly targeted questions from us. Maybe to start and picking your thoughts regarding the full year guidance, we get a lot of question on the push and pull there In terms of how much IHisa might be driving that, but also your fab five products seem to be ramping up relatively Ahead of plan and wonder also how much accretion you're able to have from Santen within the calendar year 2023. If you could just comment on that, that would be great. Speaker 200:37:47Yes. So thank you for the question. The revenue growth is being driven Broadly speaking by our branded portfolio, that's VIGAMOX, it's Maxetrol, Maxidex, Alevo, Nevanac And of course, IHIMZO. So that's where we're seeing the growth. And We expect the Santen portfolio to also provide not only Sort of the revenue base that we acquired when we brought the products on, but we also expect to see some meaningful growth in that Once we have the marketing authorizations under our control. Speaker 200:38:32That's not going to happen tomorrow. It's going to take A few months, so there's sort of a transition period that we're undergoing. And you Should see, I think in 2024, a pickup from the Santen portfolio in terms of revenues and overall Contribution, but I think the real growth drivers in the business in 2024 are going to come from IHESO. We expect significant continued growth In 2024 2025 and beyond for IHESO. And we're very excited about VeeVai And really beginning the market access work there. Speaker 200:39:24And this is just a market. I personally have spent a lot of time Trying to understand, we have interviewed 100 and 100 of Chronic dry eye disease patients conducted telephonic interviews and so we think we understand this patient population very well and what the nuances are that you have to overcome to help these folks. And so we just are very, very excited about VIVI and what it will offer to this patient And 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 VVY out into 2,039 and beyond actually. So it's a product that we're going to offer For a long, long time, it's going to help a lot of people. Speaker 600:40:31Great. Thank you. And maybe staying on your business, DED Marketplace entry and by the way, love the water versus water free analogy. For VY, the product differentiation And relative to maybe some more recent drug launches that have created this perception of The update being slow, the market opportunity being limited, which is a function of a lot of sub patients to your point going under treated, They don't comply as well. So maybe just clearly from a clinical data standpoint, what Sort of profile we are talking about relative to some of these recent drugs. Speaker 600:41:14And obviously, folks are also curious to know how it Differentiates against the space that is genetic cyclosporin? Speaker 200:41:24Yes. As I said, The reason for our enthusiasm is twofold. 1, because of what we have, which is Exceptional. So we have a great product, but our enthusiasm is buttressed by the competition that we face. And so 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 redness and you're aggravated and it's hard to work. Speaker 200:42:12And You go to put a product in your eye and 22% of the patients experience Pain when you instill a product in your eye or The adverse event profiles even get worse than that for some of the products that are in development. You're that patient and you need something that soothes your pain. I don't think that these products that live in the so called water world are really helping them. And we have a Totally unique different approach. And as I said, I personally have put an eyesore product in my eye, On my eye and there's just nothing that feels like it. Speaker 200:43:03And having listened to literally hundreds of Interviews of chronic dry eye disease patients, I just think we have something that's going to really benefit them, not on the margin, like Some of the existing products may benefit patients, but we're talking about in a completely new way, something that doesn't Have that burning and stinging doesn't cause to excuse you, 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 and We're going to patiently execute a strategy to make sure patients have access to VIVI. It is a totally new world. It's the water free world. Speaker 600:43:57Got it. And maybe just last one for Andrew, is there sort of a target range for leverage ratio you're trying to get to in the near to medium term? Obviously, It's improved, but is there some is there a sort of range you're working towards, Andrew? Speaker 400:44:16I think that's a good question and thanks for that. It depends is the answer. And I think what I mean by that is We're obviously sort of deal focused in our DNA. And so if there are transactions that we can Transact on and lever into it, we're not going to pass it up. And so that's what I'm saying is we're not going to and it's obviously it's got to be an attractive deal to do that. Speaker 400:44:48But to the current just based on the current leverage ratio, On an annualized basis, I personally would like to see it lower. We're definitely working towards that. I think as you see it in the guidance even our expectation is EBITDA is going to continue to grow throughout the year in order for us to hit the guidance number. But 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. Operator00:45:35The next question is from Jim Romo of Romo Asset Management. Please go ahead. Speaker 700:45:42Thanks. 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 pushes and the pulls, but can you give a little color as to Kind of what decisions your balance sheet decisions you're making, expansion of credit For growth, but just a little color on why your net equity dropped nearly 20% in the quarter or in the first half of the year? Speaker 400:46:22Hey, Jim. Yes, this is Andrew. Happy to talk about that and address it. So on a GAAP basis for the year, we've lost about just under $11,000,000 There are a lot of non cash Impacts related to that such as amortization of the NDAs that we got at the beginning of the call with Jeff. Importantly, Subsequent to quarter end, we also did raised about $69,000,000 of new capital that will increase that debt equity balance Speaker 700:47:00Okay. So A lot of non cash charges in the first half of the year? Speaker 400:47:09That's right. Speaker 700:47:11So What are you writing off? Are these are you is this just kind of amortizing acquisitions or are you actually writing things down? Speaker 400:47:23Sure. So I can go through a couple of examples. A big chunk of that, about $4,700,000 of it So far is amortization of these intangible assets, non cash amortization. There's some investment losses related to our holding in Eaton. And then we also had a debt extinguishment cost of about $5,600,000 Oh, that is essentially non cash or non operating. Speaker 700:47:52Okay. Okay. Well, I'll appreciate that. I'll probably follow-up later. Speaker 200:48:05Thank you, Jim. Speaker 700:48:06Okay. Thank you. Operator00:48:09That is all the time we have for questions today. I will now turn the call back to Mark Baum for closing remarks. Speaker 200:48:17Thank you, operator. The first half of twenty twenty three is proven to be a productive and exciting period for Harrow. Momentum is continuing to build in 2023 and 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. Speaker 200:48:49If you have any investor related Questions, please email jameyweb@jwebbharrowinc .com. Thank you, and this will conclude our call. Operator00:49:04The conference has now concluded. 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