Harrow - Q3 2023

Transcript

Operator (participant)

Good afternoon, and welcome to Harrow's third quarter 2023 earnings conference call. My name is Betsy, 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. I would now like to turn the call over to Jamie Webb, Director of Communications and Investor Relations for Harrow.

Jamie Webb (Director of Communications and Investor Relations)

Thank you, operator. Good afternoon, and welcome to Harrow's third quarter 2023 earnings conference call. Before we begin today, let me remind you that the company's remarks may include forward-looking statements within the meaning of federal securities laws. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond Harrow's control, including risks and uncertainties described from time to time in its SEC filings, such as the risks and uncertainties related to the company's ability to make commercially available its FDA-approved products and compounded formulations and technologies and FDA approval of certain drug candidates in a timely manner or at all. For a list and description of these risks and uncertainties, please see the Risk Factors section of the company's most recent Annual Report on Form 10-K and the subsequent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission.

Harrow's results may differ materially from those projected. Harrow disclaims any intention or obligation to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information and is accurate only as of today. Additionally, Harrow will refer to non-GAAP financial metrics, specifically adjusted EBITDA and/or adjusted earnings, as well as core results such as core gross margin, core net income, and core diluted net income per share. A reconciliation of any non-GAAP measures with the most directly comparable GAAP measures is included in the company's earnings release and letter to stockholders, both of which are available on the website. By now, you should have received a copy of the earnings press release. If you have not received a copy, please go to the Investor Relations page of the company's website, www.harrow.com.

Joining me on today's call are Harrow's Chief Executive Officer, Mark L. Baum, and Harrow's Chief Financial Officer, Andrew Boll. With that, I'd like to turn the call over to Mark to go over some prepared remarks prior to the question-and-answer session. Mark?

Mark L. Baum (Founder, Chairman, and CEO)

Thanks, Jamie, and thanks to everyone for joining us on today's call. Before I begin my prepared remarks, I want to take a minute to encourage you to review our third quarter 2023 earnings release, corporate presentation, and letter to stockholders, all of which have been posted to the Investor Relations section of our website, www.harrow.com. Let's jump into it. As you may have seen, we produced record revenues and improved our adjusted gross margins meaningfully. However, this past quarter showed that our ability to create value far exceeds what we actually delivered. So let me be clear, we could have done better. As I have said before, though, we knew that our growth trajectory would not be a linear path upward. It never has been over the past 10 years. We knew that some programs would overperform and some would underperform.

Today, we find ourselves a few months behind our internal development timelines for some of our programs. As we continue, though, to correct course and move our business forward, the reality for Harrow stockholders is simple: We are well-funded. We don't need to access the public equity or debt markets. We're making money. We're paying our bills. We're servicing our creditors, and we're on track to produce another record year of growth and profitability. That only is not bad, it's a place that most companies would like to be. I am proud of what we achieved this past quarter, including record revenues that represented a 50% year-over-year growth rate, as well as a 600 basis point improvement in our core gross margins.

That 50% revenue growth was fueled by our strategic decision to expand into branded pharmaceutical products, and it serves as a solid testimonial and validation of that decision. Without reservation, we could not have produced that level of year-over-year growth with compounded products alone. I'm also pleased with our progress on our IHEEZO launch, which has been tracking ahead of our internal forecast since its May launch. A proof point is the graph we included in our third quarter letter to stockholders, which shows the significant ramp-up in customer unit demand for IHEEZO beginning in September and continuing today. This ramp in customer demand resulted from boots-on-the-ground learnings and strategic tweaks that yielded immediate positive results and a notable increase in IHEEZO units and revenues for September, surpassing our internal targets for 2023.

We are now seeing sizable orders and reorders from high-volume users and many new accounts, both large and small, who are enjoying the many benefits of IHEEZO. And we remain bullish about what the balance of this year will bring, as well as 2024 for IHEEZO. On the other hand, there is no denying that to date, 2023 has presented new challenges. One example is lower than expected Q3 revenues from the Fab Five products and our compounded products. Even though we completed the transfer of four of the five Fab Five products that we acquired earlier this year, namely MAXIDEX, ILEVRO, NEVANAC, and VIGAMOX, we were delayed in beginning marketing and sales detailing efforts. Those efforts, though, have begun, and we are seeing positive data from our awareness campaign, reminding prescribers of the availability of these products and the strong reimbursement support from third-party payers.

Once again, I touched on this in our letter to stockholders. We continue to believe in the high utility of these products and their importance to our branded portfolio, for not only our customer base, but also for Harrow stockholders, because we believe they will provide a reliable stream of income for many years to come. Another Q3 challenge was our compounding business, which underperformed as we invested in improving efficiencies and compliance related to manufacturing, quality systems, the makeup of our sales team, and our analytical testing capabilities, as well as our customer care infrastructure. We have had to invest in efficiency and compliance in the past, and importantly, we have a 100% success record of making these investments and returning the business to historical growth levels. And I am 100% confident that this will happen again.

Investing in the required systems, processes, and protocols to reliably serve a national market requires adherence to a standard and a level of complexity that we comply with, but which few competitors can achieve. I'd also like to update you on the fifth product in the Fab Five. That's TRIESENCE, which I view as the diamond of this group. We had reported last quarter that demo batches had been completed and that we were awaiting results from the first of three process performance qualification batches. Those are PPQ batches for short. While we were not naive about the fact that TRIESENCE is a tricky product to manufacture, which contributes to its out-of-stock status for most of the last five years, we were nevertheless disappointed that our first PPQ batch did not meet all specifications. This is not the end of the story, and frankly, this was not entirely unexpected.

That said, we are working diligently with our contract manufacturer, and we are still committed to having TRIESENCE available next year. We are also making excellent progress on the transfer of the TRIESENCE NDA, or new drug application, and we expect to have that completed soon, which will allow us to reasonably adjust the TRIESENCE pricing for the first time in more than 12 years, thus keeping it in stock and available for eye care professionals and their patients who are awaiting its return. Regarding TRIESENCE market availability, frankly, in our view, it is not a matter of if, but when, and we think that when will be next year. We continue to believe that Harrow's largest future annual market opportunity is VEVYE, the recently FDA-approved patented semifluorinated alkane, or SFA, that contains 0.1% cyclosporine. We're going to be launching it in a few weeks.

VEVYE is a water-free product. It's a topical medication, and once again, it's FDA-approved to treat both the signs and symptoms of dry eye disease. We believe eye care professionals have long awaited a product like VEVYE, a dry eye disease product that can deliver effective, fast, and sustained clinical results for patients without the negative adverse event profiles associated with many of the current pharmaceutical choices. In preparing for the upcoming launch of VEVYE, it has become evident that most ophthalmologists and optometrists believe strongly in the clinical power of cyclosporine as a therapeutic agent. This should not be surprising, given the tens of millions of U.S. patients who have been prescribed cyclosporine during the past 20 years.

However, VEVYE is different from the currently available cyclosporine-based products, not only because of the comfort and the many benefits of its patented delivery vehicle, only the second water-free product in the U.S. market, but also because it offers the highest available concentration of cyclosporine. This puts VEVYE in a class of its own, and I really can't wait to get VEVYE into the hands of the ophthalmic community and their patients, and that day is fast approaching. Before opening the call for questions, I wanted to discuss our financial guidance and our expectations for the remainder of 2023 and 2024.

Many of you know that we have never been big fans of giving public revenue or profitability guidance, but as our partners in this journey, we believe you need a reasonable level of visibility into what we expect to achieve next year, at least as a base case. Therefore, we're updating our guidance for the remainder of 2023 and giving you some direction for what we expect in 2024. Because the progress of our business is about 60 days behind, we're adjusting our 2023 revenue guidance to $129-$136 million.

If we continue to be successful in the execution of a few open 2023 objectives, including IHEEZO sales growing outside the bounds we had anticipated at this stage of the launch, as well as the timing of future milestones unfolding in our favor, we could land toward the higher end of the range. Regardless, our business remains solidly in a growth mode for the balance of our five-year planning cycle, which includes not only the remainder of this year, but 2024, and it will continue through 2027. We are also adjusting our previously issued 2023 adjusted EBITDA guidance to a range of $36-$41 million, primarily because of lower revenue estimates, coupled with increased costs associated with recent acquisitions, needed investments in the preparation for the launch of VEVYE, and one-time integration costs associated with the Santen acquisition.

As for 2024, excluding any contribution from TRIESENCE, we expect our 2024 revenues to be north of $180 million. The magnitude of revenue growth beyond $180 million will depend on many factors, including when we restore TRIESENCE inventory, the acceleration of IHEEZO sales, and how the VEVYE launch goes. Beginning in the first quarter of 2024, we expect moderate revenue growth from our recently acquired FDA-approved products, including the Fab Five and the recovery of our compounding business to historical growth levels. From a cost structure perspective, we expect our operating costs to increase incrementally as we scale our business to grow revenues and invest in the VEVYE launch. We expect to continue investing in our commercial infrastructure while maintaining our leverage ratio. That's debt over adjusted EBITDA, and that should be below 5x.

We expect to close 2024 with a strong balance sheet, with cash increasing significantly during the period. We remain confident in meeting our obligations to Harrow's creditors, and we do not expect to dilute our stockholders unless we find a transformative transaction. But candidly, given where our stock price is, we are less inclined to use equity as a currency. We are happy to answer your questions. I will pause to have our operator pull 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. If at any time your question has been addressed and you would like to withdraw your question, please press star, then two. At this time, we will pause momentarily to assemble our roster. The first question today comes from Brooks O'Neil with Lake Street Capital Markets. Please go ahead.

Brooks O'Neil (Senior Research Analyst)

Good afternoon, Mark, and thanks for all your comments. I have to confess, I have not completed a detailed reading of the stockholder letter, so I might ask you about some things that are highlighted in the letter, and we'll just have to deal with it. But I'd like to start by asking you about the IHEEZO launch. One of the things that seems important is that you have made some adjustments to your plan that have yielded some noticeable improvement in IHEEZO response in the marketplace, and I'm hoping maybe you could at least give us some qualitative color about some of the things that you've changed and what you saw as a result.

Mark L. Baum (Founder, Chairman, and CEO)

Thanks, Brooks. We did make some strategic amendments to the strategy, the launch strategy in late August, and things kind of were implemented by, well, by September. I can't go into the specific tactical details of our strategy, really to our stockholders, but also to, you know, potential competitors. You know, I think the important thing is that we did in fact see this major ramp when we made these changes, and that's important. I know I spoke to a lot of stockholders after the last earnings call, and they wanted to see some numbers that were accurate, and so we provided them.

All I can tell you is that, we not only provided numbers, that I think validate the success of the changes that we made, but importantly, you know, we provided numbers that get us into the fourth quarter. We've seen a continuation of that ramp, and we don't expect that to yield. We think that will continue through the balance of this quarter, and we do expect meaningful growth in IHEEZO unit demand in 2024 and beyond.

Brooks O'Neil (Senior Research Analyst)

Great. Let me switch gears and just ask you a little bit about the weakness in the compounding business and a little bit about the Fab Five. But I know historically, you know, I haven't followed your company for four or five years now. We've seen some variability in the compounding business, and it's always come back. Is there anything that you would describe as materially different this time, or anything that gives you pause about believing that the compounding business remains durable and that the growth opportunity is still there?

Mark L. Baum (Founder, Chairman, and CEO)

Sure. The compounding business discussion that I referred to in this stockholder letter and the issues that, you know, we were addressing are not dissimilar from other issues that we've addressed of a similar kind in the past. So, we were able to overcome those challenges. We made those investments, and as an organization, we improved. Our compounding business is strategically important. It allows us to meet our mission, to make products that are accessible and affordable.

These are cash-pay products. And by far, we're the national leader. There's not even a question. It also gives us credibility when we walk into our customer's offices, and they give us hugs instead of, you know, weird looks because we're making their lives more difficult. It is not an easy business, though. Regulations change, and they're generally getting stricter, and as a result of that, we have to be prepared to absorb those changes, and we do.

We have the people, the processes, and the resources to handle these things. It is, as I referred to in the stockholder letter, it's sort of a superpower that we have that many smaller players do not have. But the reality is that as we move into branded products, we are going to strategically cannibalize compounding units, and that creates a challenge for the overall growth picture of that business. We wanna take cash pay, non-FDA-approved units that we compound, that we have to manufacture, and over time, we would like to exchange those units for our FDA-approved products that we don't have to manufacture, that are reimbursable. And so that shift is taking place. That said, we do have confidence that beginning in 2024, in the first quarter, we will resume our growth in the compounding business.

Brooks O'Neil (Senior Research Analyst)

Okay, that's good. Let me ask you two questions about the debt. And they're a little bit different, but first is, I guess there's some concerns in the marketplace about about B. Riley as a debt issuer, except I, I don't know what the right term is, but any comments on on your observations related to your relationship with with B. Riley Financial as a lender to your business? And then, with the shortfall here in the quarter and outlook for the year, can you just comment a little bit about your outlook for accounts receivable, cash flow, and cash as we get through the fourth quarter?

Mark L. Baum (Founder, Chairman, and CEO)

I'll take the first part of the question, and Andrew, if you'll take the second part, that would be great. But, B. Riley, to be clear, is not a lender to the company.

Brooks O'Neil (Senior Research Analyst)

Okay.

Mark L. Baum (Founder, Chairman, and CEO)

They've banked several transactions for us successfully, I might add. They've produced phenomenal results for us. It's because of that that I can say with confidence we have plenty of cash. We have over $68 million in the bank, and as I said in the stockholder letter, we expect that cash pile to grow during 2024. We're grateful for the work that B. Riley did for us, and they are not a direct lender to us at all. They simply bank the transaction. Andrew, do you want to comment on the second part of the question?

Andrew Boll (President, CFO, and Corporate Secretary)

Sure. Hey, Brooks.

Mark L. Baum (Founder, Chairman, and CEO)

Hi, Andrew.

Andrew Boll (President, CFO, and Corporate Secretary)

On the cash flow, on the cash flow side, and more so just talking about AR in particular, because, you know, we introduced these branded products, we have a different type of AR and receivables cycle than we have seen on the compounding side. And we've also, on the IHEEZO, in particular for our customers buying IHEEZO, we've been able to extend them a additional terms, and that just helps them with their revenue cycle and cash management cycle. For us, what that means is our collections on the branded side are a little bit lengthened out, compared to on the compounding side, it's historically seen.

But just kind of looking out at Q4 and then the aging report in particular, I'm seeing $16 million, over $16 million in AR on the branded side that we should be able to collect this quarter. And then that'll be in addition to the AR and cash receipts we're receiving on the compounding business. And so I think we've gotten through this sort of initial term around the launch with IHEEZO and these branded products, and we should start seeing sort of the AR with the branded products turn a little bit more cash receipts coming in and less of a larger spread on AR compared to revenue going forward.

Brooks O'Neil (Senior Research Analyst)

Great. That's very helpful. Let me just ask you two more, and I, I apologize for asking so many, but it, it's such an interesting time for you and for investors. My first question is: Can you give us any estimate of the peak sales potential of VEVYE? I know it's a unique drug. I know it's got certain clinical characteristics better than the competition. So what do you see is the opportunity with VEVYE, you know, over time?

Mark L. Baum (Founder, Chairman, and CEO)

Sure. Look, we've said in the past that we believe that VEVYE should generate north of $100 million annually in revenues. And, you know, it should and could be much higher. It's not gonna happen overnight. It's gonna take a few years to play out, though. The fact is that the cyclosporine category, if you look at the prescription counts for cyclosporine-based products, we have the opportunity, I believe, to dominate the cyclosporine category. But more than that, we have the opportunity to expand the overall market. When Restasis was the only product in the market and Xiidra came into the market, you had a new and, in some people's view, better product relative to Restasis. The overall market actually expanded.

We believe that a product like VEVYE, the features that it offers, the fact that it works so fast and it provides sustained relief of both signs and symptoms, now going out, 56 weeks. I mean, look at the data that I provided actually in our stockholder letter. It's extraordinary. So we think that VEVYE is gonna expand the market, and as a result, you know, this product should definitely be a nine-figure revenue product annually, and I believe that it could be much higher than that, as we you know, get further into the launch.

Brooks O'Neil (Senior Research Analyst)

Great. I'll ask you more about that offline, but let me just ask one last one, and I appreciate your patience with me. I have some sense that ILEVRO and NEVANAC have had some improving sales in the past month or two. Can you comment on what you're seeing from those two products specifically? And again, thanks for taking my questions.

Mark L. Baum (Founder, Chairman, and CEO)

Thank you, Brooks. Right. So, you know, we said in the stockholder letter that, like, a mission-critical victory for our company was the IHEEZO launch. We needed to provide our stockholders with evidence that we could execute on the IHEEZO launch. I hope if you look at the line graph provided in the letter to stockholders that you will agree that we have, in fact, changed and markedly improved the outlook for IHEEZO sales. And so that was a critical victory that we had to achieve, and I think that we are on our way and things are going in the right direction. As a result, we did decide to not deploy commercial assets at, you know, right away for both ILEVRO and NEVANAC.

So the question is, did we, in fact, deploy those resources? We did. About six weeks ago, seven weeks ago, we began to do exactly what we said we would do. We provided information to prescribers, reminding them not only of the existence of the product, but the incredible insurance coverage for these products. In the letter to stockholders, once again, I actually provided one of our marketing pieces that we use in, on the market access side of things. The good news is that nearly immediately, once again, immediately, as we began to execute on our strategy, we saw improvement in the prescription volumes as an overall share of the topical NSAID market or non-steroidal anti-inflammatory market in the U.S.

And so if you look at the trailing four-week data, I think, you know, we're up on both products, in the mid to high single digits over the last four weeks. And look, it's early, but this is very positive. And so we may be a little bit late, but what we said that we were going to do seems to be working, and I do believe it will continue as we continue to execute the strategy.

Brooks O'Neil (Senior Research Analyst)

Great. Thank you for all that color. I appreciate it very much.

Mark L. Baum (Founder, Chairman, and CEO)

Thanks, Brooks.

Operator (participant)

The next question comes from Jeffrey Cohen with Ladenburg Thalmann. Please go ahead.

Jeffrey Cohen (Managing Director and Director of Equity Research)

Hi, Mark and Andrew, how are you?

Mark L. Baum (Founder, Chairman, and CEO)

Good, Jeff. Good to speak with you.

Jeffrey Cohen (Managing Director and Director of Equity Research)

So, a few questions on our end, I guess. Firstly, talk a little bit about, without getting too much into the weeds, pricing strategy on VEVYE. I did see in your shareholder letter calling out some of the holes that folks meant to identify in the value.

Mark L. Baum (Founder, Chairman, and CEO)

Sure. You know, we have not announced the pricing for VEVYE. What I can tell you is that it will be sort of competitively priced with the other water-free product in the market, which is MIEBO. And so, you know, we'll have more information about the WAC pricing for VEVYE here in the coming weeks as we approach the launch. In terms of the product itself, you know, it is an extraordinary product. Cyclosporine is known to work. We've got the highest concentration of cyclosporine. If you put our product in your eye, if you are prescribed it, and you have put Restasis or other cyclosporine-based products in your eye, you will see that they, it... our product feels completely different. VEVYE is very different from these other products.

And the data is extraordinary. So we have 56-week data that I provided in our letter to stockholders. I would encourage anyone who understands anything about the dry eye disease market to look at that data. It is extraordinary. So we've got great clinical data. We're gonna have a bang-up market access strategy and commercialization strategy that's gonna begin in a couple of weeks. And we're gonna generate our first revenues for VEVYE in the fourth quarter, so in a few weeks.

Jeffrey Cohen (Managing Director and Director of Equity Research)

Okay, got it. And then maybe could you tie that into lessons learned on launches more recently and perhaps some lessons learned on IHEEZO that may carry over to VEVYE and then kind of carry that forward as well to the Fab Five? Sounded like a couple months of marketing and delayed efforts there. Was that intentional as a result of spend parameters from the past quarter, or was it somewhat accidental in which how it came out?

Mark L. Baum (Founder, Chairman, and CEO)

Yeah. So first of all, IHEEZO, you know, IHEEZO is a Buy and Bill product. So the strategy, the market access strategy or the commercialization strategy with IHEEZO is very different than VEVYE. And frankly, they're both different from our approach to the Fab Five and the Santen products. So the strategy with the Fab Five and Santen was to incrementally grow those revenues and to produce streams of cash that would grow over many years. And so, as I said to Brooks, it appears that our strategy of just simply doing a little bit of marketing and some sales detailing around those products is working for the Fab Five, and we think the same will be true for the Santen products.

But in terms of creating significant stockholder value over the long term, it's IHEEZO, it is VEVYE. And, you know, the one product that is similar to IHEEZO is TRIESENCE. So they're both buy and bill products. They're both J-coded products, and so the strategy there, you know, although they are buy and bill products, you know, IHEEZO is a new product and TRIESENCE is not. And so we probably will not need very many resources to get the word out about TRIESENCE, but they're all sort of different. Andrew, do you wanna add to that?

Andrew Boll (President, CFO, and Corporate Secretary)

No, Mark, I think you nailed it.

Jeffrey Cohen (Managing Director and Director of Equity Research)

Got it. Okay. And then a couple more quick ones. You talk about 2024 for launching TRIESENCE after some of the bioavailability work is done. Any narrowing of that to thinking about first half versus second half?

Mark L. Baum (Founder, Chairman, and CEO)

You know, what I can tell you is that our purchase price for TRIESENCE, you know, is $45 million, and it slides down over time, as we do not have inventory. And the purchase price is only triggered, the payment is only triggered once we have inventory. January twentieth, our purchase price goes from $45-$37 million. I can tell you that our partner is working diligently to ensure that the purchase price is $45 million and not $37 million. So they are actively working to create inventory for us, which is a very good thing. We would frankly love to pay $45 million because once we do, we'll have sufficient inventory, assuming we have the NDA, to recover substantially all of our purchase price and, and perhaps even more, depending on how much inventory we have.

So we are really excited about having TRIESENCE sooner rather than later. We don't mind paying more for it because we are highly confident in the market research that we've done around that product. As I said, our expectation, though, is right now that we'll have it in 2024, and our partner would like for us to have it before January 20th of 2024. But what we've said publicly is that we expect to have inventory sometime during the year. I don't wanna be more specific right now, but we're working diligently to make this happen.

Jeffrey Cohen (Managing Director and Director of Equity Research)

Okay, good. And one more, brief one. You had mentioned some, back-end systems. Are you currently using one ERP system, or is that being consolidated as part of the back end? And what's going on as far as leveraging up the, the size of the business on the back end with regard to, to mostly billing?

Mark L. Baum (Founder, Chairman, and CEO)

On the compounding side or on the branded side, or both?

Jeffrey Cohen (Managing Director and Director of Equity Research)

Across the board.

Mark L. Baum (Founder, Chairman, and CEO)

I don't know that we can discuss specific software platforms or ERPs. Andrew, do you wanna tackle that one?

Andrew Boll (President, CFO, and Corporate Secretary)

Jeff, so we're on a single ERP. But we are going through some updates from the CRM perspective and just implementing that additional pieces to the ERP, like within quality and supply chain, for example, and bringing that in on the compounding side and on the branded side. But for the most part, that infrastructure is in place, and we're just kind of scaling off of it.

Jeffrey Cohen (Managing Director and Director of Equity Research)

I got it. Okay. So your comment was basically just scaling up as the size of the business grows.

Andrew Boll (President, CFO, and Corporate Secretary)

That's right.

Jeffrey Cohen (Managing Director and Director of Equity Research)

Perfect. That does it for us. Thanks for taking the questions.

Mark L. Baum (Founder, Chairman, and CEO)

Thank you, Jeff.

Operator (participant)

The next question comes from Mayank Mamtani with B. Riley. Please go ahead.

Mayank Mamtani (Senior Managing Director and Group Head of Healthcare Equity Research)

Good afternoon, team. Thanks for taking our questions. We'll try to keep it short. So two quick ones on IHEEZO. When you say your internal revenue targets for 3Q 2023, could you just clarify that and help me understand the components of your 4Q guide? It looks like the new range is $35-$44 million. And for 2024, it's about $180 million. You know, what's tied to IHEEZO versus maybe some accretion that you might be expecting from the Santen transaction? If you could break down some of those elements. And then I have a quick follow-up on IHEEZO.

Mark L. Baum (Founder, Chairman, and CEO)

Andrew, do you want to cover Q3 confidence, 2023 and Q4, and also the projections in 2024? I think that was it.

Andrew Boll (President, CFO, and Corporate Secretary)

Yeah, I can, I can try. Hey, Mayank, thanks, thanks for the question. So just in regards to confidence, you know, we put out the new range. It is certainly large. We, we realize that. And as Mark kind of mentioned in the letter, there's a couple things that we're working on that, you know, if they go our way, we're going to end up on the higher end of the range. If they get pushed into Q1, you know, we're, we're going to have to capture it in 2024. But we feel pretty confident about the numbers. Anything can happen, obviously, we're halfway through the quarter. But we feel good about the first half and feel good about the potential for the second half.

In regards to the sort of breakdown between your contribution between products from Santen and IHEEZO, you know, we're expecting, you know, that Santen portfolio to continue to perform well. I can kind of talk, let Mark talk about the strategic rationale for that transaction. It's not going to be a big, big driver of revenue in the future. It's going to have incremental impact on the financials, this year and next year, but we think it's going to be positive and it's going to be accretive.

IHEEZO, as we kind of, as Mark's talked about a lot on the call today and in the shareholder letter, that ramp we're seeing, what we saw at the end of last quarter, we should see continue in Q4, and we expect it to continue to increase in 2024. And so contribution from IHEEZO as a major product should just continue next year as we grow revenues. Mark, do you want to comment a little bit more?

Mark L. Baum (Founder, Chairman, and CEO)

Yeah, the, you know, look, the Santen basket, we paid $8 million upfront, is very low risk. It was really connected to rounding out our branded portfolio, allowing us to play a larger role in the prescriber's office, and it's going to produce a great ROI. You know, we paid $8 million for it, but we also paid $8 million for VEVYE upfront. VEVYE, in terms of affecting the overall value of the company, is going to far exceed what you know, we paid for Santen and what we expect from the Santen asset. So, you know, that should give you some scale. We're gonna invest, you know, significantly in VEVYE because the market opportunity is much, much larger for us.

And, you know, I think you know that that's a great place to invest resources.

Mayank Mamtani (Senior Managing Director and Group Head of Healthcare Equity Research)

Maybe I can throw my two questions together. So number one on IHEEZO quickly. On the stockholder letter, you say somewhere that, you know, you're planning to meet with CMS to clarify a billing policy that has historically not allowed for a separate billing in a physician's office. So could you just clarify if that's related to cataract surgery offices specifically? And also, anything specific to your recent efforts with retina offices that is worthy of sharing? What sort of sales metrics you're tracking there that, you know, you are seeing now translate into unit demand and revenues? And then lastly, what you just said about VEVYE, the excitement there.

I know it's early with MIEBO launch with Bausch + Lomb, but they seem to be allocating a lot of resources there. So could you just share, you know, you have an opportunity to learn from what they are doing, going second, and I believe you also show some 12-month data there in your stockholder letter. Could you just put in context the clinical relevance of that chart that you have put in your stockholder letter for VEVYE? And then thanks for those questions.

Mark L. Baum (Founder, Chairman, and CEO)

Sure. Okay, that's a three or a four-part parter, so I'm going to try and tackle it. Andrew, let me know where I fall short. As far as CMS goes, our passthrough is 100% intact in the ASC, in the hospital and outpatient department. We are, as I said in the stockholder letter, we are actively working to ensure that we can extend that passthrough. That decision will not be up to us, it will be up to CMS. But there are other products in this category, in the ophthalmic pharma category, that are buy and bill, that have been able to extend their passthrough. The meeting that we have with CMS is coming up fairly soon, we expect.

I can't really comment on, you know, the specifics of that meeting, but we do seek to just clarify the use of J2403 in the physician's office. That said, we are selling into that market, and reimbursements are happening and, you know, this, I think, will, depending on the outcome of the meeting, I think, you know, have a significant, upward potential, value impact on, on that, that asset, and that's why we're going to be meeting with CMS. So, once again, we don't control that decision-making, but we're excited to meet with CMS in the fairly near term.

In terms of VEVYE and what we can learn from, you know, the MIEBO launch, obviously MIEBO is the other, SFA or semifluorinated alkane product, water-free product to hit the market. I think, you may have even, I believe, put it in your eye. You've experienced it. It's a great product. And Bausch + Lomb, I think, has had, a fairly successful launch. So, we can learn a lot from that experience. We think that there will be many, many prescribers that will want to have cyclosporine on board for their patients. You know, the other product has been sort of marketed for evaporative dry eye, whereas, you know, the concept is that VEVYE would be used for aqueous dry eye.

I would submit to you that if you're a physician and you're seeing a patient, and you have to make a prescribing decision, most physicians, if not all of them, do not know whether a patient is experiencing evaporative or aqueous dry eye. So our hope is that, all things being equal, they will choose to have a product on board, that can perform as our product performs, that also contains Cyclosporine, the highest concentration in the market. In terms of the data set that we presented, if you look at the 12-month sign and symptom improvement data, you're talking about corneal staining data, improvement that is significant out of the gate.

Certainly within four weeks, within one month, you get total corneal fluorescein staining data improving massively, and tear production also improving significantly, as well as the symptoms for the patients, in terms of their dryness scores. So, if you look overall at this data set and you're a prescriber, you can prescribe the highest concentration of cyclosporine in a product that not only works rapidly, but has an extraordinary adverse event profile and importantly, will last a long time in terms of the ability to improve signs and symptoms over a 52-week period. So, we think we're gonna get quite a bit of those prescriptions, certainly in the cyclosporine category. But our overall goal is, as I said earlier, to expand the market.

We think there are a lot of patients and a lot of prescribers that have wanted a product that can perform like VEVYE, and they will soon have it.

Mayank Mamtani (Senior Managing Director and Group Head of Healthcare Equity Research)

Got it. Thanks for taking the question.

Mark L. Baum (Founder, Chairman, and CEO)

Thank you, Mayank.

Operator (participant)

I will now turn the call back over to Mark Baum for closing remarks.

Mark L. Baum (Founder, Chairman, and CEO)

Sure. Thank you, Betsy. You know, I've never been more confident in our prospects. I think the value of our company is far greater today than it ever has been. And we remain on track with a well-structured, disciplined plan that is going to lead to the accomplishment of our goals. Even though we may be a few months behind, the goals will be accomplished. We will get there. This is gonna benefit not only our customers, the prescribers, but patients, our employees, and our valued stockholders. So thanks to everyone for attending today's call and your interest in Harrow. If you have any investor-related questions, please email Jamie Webb at [email protected]. This will conclude our call.

Operator (participant)

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