Harrow, Inc. (HROW) Q4 FY2025 Earnings Call Transcript & Summary

March 3, 2026

NasdaqGM US Health Care Pharmaceuticals Earnings Calls 83 min

Earnings Call Speaker Segments

Operator

Operator
#1

Good day, and welcome to the Harrow Fourth Quarter 2025 Earnings Conference Call. [Operator Instructions] Please note that this call may be recorded. I would now like to turn the call over to Mike Biega, Vice President, Investor Relations and Communications, please go ahead.

Michael Biega

Executives
#2

Good morning, and welcome to Harrow's Fourth Quarter and Full Year 2025 Earnings Conference Call. My name is Mike Biega, Vice President of Investor Relations and Communications, and I'm excited to be introducing today's call. The company's remarks may include forward-looking statements within the meaning of federal securities laws. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond Harrow's control, including risks and uncertainties described from time to time in its SEC filings, such as the risks and uncertainties related to the company's ability to make commercially available its FDA-approved products and compounded formulations and technologies and FDA approval of certain drug candidates in a timely manner or at all. For a list and description of those risks and uncertainties, please see the Risk Factors section of the company's most recent annual report on Form 10-K 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. Joining me on today's call are Mark Baum, Chief Executive Officer; Andrew Boll, President and Chief Financial Officer; Patrick Sullivan, Chief Commercial Officer; and Amir Shojaei, Chief Scientific Officer. With that, I would like to turn the call over to Mark. Mark?

Mark Baum

Executives
#3

Good morning, and thank you for joining us. Over the past 5 years, Harrow has undergone a fundamental transformation. Harrow now owns one of the largest portfolios of prescription ophthalmic products in the United States market, and we have been the most prolific acquirer of ophthalmic pharmaceutical products in the U.S. market, having completed more than a half a dozen transactions, integrating over 15 branded products into our scalable commercial platform that reaches every populated county within the United States and touches with impact nearly every key ophthalmic disease segment. As you'll note in my letter to stockholders, I am proud of the fact that during the last 5 years, hundreds of members of the Harrow family, including my incredible leadership team, drove real economic accomplishment and stockholder value creation, which resulted in a more than 700% appreciation in the Harrow stock price during this period. As a founder and a large Harrow shareholder, I am proud of our track record and the returns we are providing to stockholders who have had the patience to let this team do its thing. But this team isn't done. And frankly, we've only just begun. I can't guarantee where our stock price will be 5 years from now. However, I can say with nearly absolute certainty that Harrow will be a larger and more powerful enterprise, positively impacting the lives of millions of Americans. I resolutely believe that then we will be selling more of every one of our key products like VEVYE, IHEEZO and TRIESENCE. But I predict we will also sell many more units of other products that many stockholders haven't thought too much about. I also predict that we will complete compelling new acquisitions of products and/or businesses structured to appropriately balance risk and potential reward. And finally, I can say confidently that 1 or 2 product candidates from our recent Melt Pharmaceuticals acquisition, specifically what we are now calling G-MELT and YOCHIL will be approved for marketing and that if they are coded and reimbursed in the way that we expect, they will make massive improvements to the standard of care in ocular surgery and more generally, in the lives of so many Americans in need of an alternative to IV and opioid-based medications for sedation and anxiety. It's a very large market. And of course, these assets, as I reflected in my letter to stockholders, should in due course, become our largest revenue products. My bet is that if we do all of that and maybe even a little bit more, patient stockholders should be handsomely rewarded. I invite you to join me for the ride because our best days are absolutely ahead of us. Now let me provide a bit of color on our business as things stand today. We are entering the final phase of our current 5-year plan, and we are doing so with momentum. The portfolio we've assembled, the pipeline we've advanced and the commercial infrastructure we've built were designed for scale. This is not a single product company or a single product story, we are meaningfully diversified and our commercial platform is built for durability, operating leverage and sustained growth. Today, Harrow operates as one Harrow, one strategy, one commercial engine, one unified organization. We have constructed a diversified ophthalmic franchise focused on expanding patient access, improving affordability and delivering strong clinical outcomes. In the fourth quarter of 2025, we saw clear validation of that strategy. For the first time, all of our core growth drivers accelerated simultaneously. That alignment reinforces our confidence and supports our goal of exceeding $250 million in quarterly revenue by the end of 2027. Financially, 2025 was a strong year. We delivered great top line growth and demonstrated operating leverage, underscoring the earnings power embedded in our model as revenue scales. Let me briefly highlight some of the key drivers. VEVYE is positioned for revenue acceleration and increasing new prescription velocity. Expanded payer coverage is now in effect, so we are doubling the VEVYE sales force to ensure that we fully capture the opportunity to build a product with peak sales potential of multiples of last year's numbers. More sales professionals will equal more prescriptions, and this should correlate to increasing profitable revenue growth. Our data backs this up. With covered patients averaging approximately 9 refills annually, effectively a full year of therapy, this reinforces the durability of the demand for VEVYE. As access continues to expand and commercial intensity increases, we expect total prescription growth to continue this year and for many years to come as VEVYE finally becomes a 9-figure revenue product this year. IHEEZO delivered a record quarter, driven by real traction in a growing number of retina specialists' offices. We have broadened our addressable market by focusing on in-office procedures, effectively increasing our procedure volume TAM by more than 2.5 million units annually. We're also expecting IHEEZO price improvements to begin in the second half of this year as we release a new retina-focused packaging format. At around the same time, we expect retina-specific data readouts from studies underway to show from a patient's perspective, the difference between IHEEZO and legacy anesthesia modalities. This is only going to help us, we believe. We got to see what the data says. These 2026 activities should further enhance financial performance and with multiple growth levers now in place, IHEEZO represents a durable and critical part of our long-term strategy. TRIESENCE generated its strongest quarter since relaunch, reflecting accelerating adoption in the very large ocular inflammation market. Based on what I am seeing this quarter with new account trials starting in numerous potentially very large accounts and growing confidence in market access, I have asked our talent team to at least double the dedicated TRIESENCE sales force to deepen penetration in what remains a very large market. Momentum here is early. but it looks meaningful. And because of the origin of the revenue, it is likely highly sustainable. It's not easy to get a product like TRIESENCE added to a surgical treatment protocol. But once you do, and I have seen this happen many times over the years, if the product delivers exceptional outcomes as TRIESENCE appears to be doing, then surgeons are often reticent to change. This is what I mean by the sustainability of the TRIESENCE's momentum. On a related topic, for years, I've spoken about tracking the migration of elite sales representatives. This is nearly a surefire leading indicator of future success. You see sales reps go where they can win, where they can make money and provide for themselves and their families. Well, the word is getting out, the TRIESENCE is on the move. These elite reps from around the country are hearing about our commitment to this product, and they know they will also be selling the G-MELT too, if they can make it on to our team. A lot of folks want to get in on the G-MELT, believe me. So we are seeing a mushrooming inbound interest from some of the most prolific ocular surgery pharmaceutical representatives who want to take these coveted surgical physicians at Harrow on the TRIESENCE's team. This is really good news. Now on to our rare specialty and compounded products. Behind the scenes, believe it or not, we've been planning a few positive surprises for our stockholders from the part of our portfolio they would probably least expect. Yes, our rare specialty and compounded products. This portfolio is now under new sales leadership, and it will benefit from new resources we are providing to finally bring out the value we expect from this exciting and unique group of products. As I discussed more in my letter to stockholders, there are 3 products from within this portfolio that our team has been quietly doing great work on. One product is awaiting a coding decision from CMS, which we expect in April. There are no guarantees. But if this comes through next month, it will open up a very nice, attractive market for this product. Regarding another product in this portfolio, we have a key study underway that we expect to read out later this year. Our entire team is super excited about this opportunity. This is a big one. And based on what we know about this product, we expect the study to be able to highlight the opportunity that we have uncovered. And once the data is announced, it should fuel opening up, as I said, a very sizable and compelling market for this product. In fact, we are also simultaneously working out supply chain issues to ensure that if things work out the way we expect, that we'll be able to supply the market adequately given the historically lower volumes that this product has required. And there is a third product that we expect to be revived from this portfolio to also fill yet another nice but happens to be a smaller market opportunity, but a good one, nevertheless. The bottom line is that I believe our stockholders may be positively surprised throughout the year and into next year as our plans for this portfolio are revealed. A few final points. In 2026, we will also launch 2 important products, BYQLOVI and BYOOVIZ, further expanding our retina and specialty footprint and leveraging our commercial platform. Beyond commercialization, our pipeline continues to advance, and Amir will shortly speak about the great work he and his team are doing. In summary, Harrow is a diversified ophthalmic platform with multiple accelerating growth drivers and increasing operating leverage we have demonstrated the ability to build, integrate and grow and generate a heck of a great return for our patient stockholders as our 5-year track record demonstrates. But as I said at the outset, I really believe that we are still in the early innings of our growth and stockholder value creation story. With that said, I will turn it over to Andrew. Andrew?

Andrew Boll

Executives
#4

Good morning, everyone. I'll begin with our fourth quarter and full year 2025 financial results. For the fourth quarter of 2025, consolidated revenues were $89.1 million, representing 33% year-over-year growth. For the full year, revenue was $272 million, up 36% versus 2024. Growth reflected continued strength across our brand portfolio and expanding commercial execution, particularly in the second half of the year. Adjusted EBITDA was $24.2 million in Q4 and $61.9 million for the full year, reflecting 54% year-over-year growth. This margin expansion demonstrates the operating leverage in our model as revenue scales faster than costs even as we continue investing in commercialization and R&D. In addition, during 2025, we generated just under $44 million of cash from operations, which helped us end the year with $72.9 million in cash and cash equivalents. Overall, 2025 was a year of strong execution, improving profitability and disciplined capital allocation. Moving on to our core growth drivers. Starting with VEVYE, fourth quarter revenues were $25.9 million, up 14% sequentially, bringing full year revenue to $88.7 million, a 216% increase over 2024. Growth reflects expanding demand. IHEEZO generated $35.9 million in Q4 and $81.3 million for the full year, representing 64% quarter-over-quarter growth and 65% year-over-year growth. Performance was driven by increasing penetration across new and existing accounts, particularly in retina. Based on the momentum we are seeing with TRIESENCE and other modest investments we intend to make in this franchise, we are disclosing this revenue separately for the first time. TRIESENCE fourth quarter revenue was $5.1 million, a 36% increase from the third quarter, totaling $9.9 million for the year, a 193% increase from 2024. The growth was primarily driven by accelerating adoption of TRIESENCE in ocular inflammation. Our rare specialty and compounding portfolio generated $22.2 million in Q4 and $92.3 million for the full year. The temporary compounding inventory constraint discussed last quarter is expected to be resolved in the coming weeks, and we expect inventory levels to normalize near the end of the first quarter. We do not anticipate a recurrence of this issue. For 2026, we are approaching guidance with greater transparency and structure and are committed to providing greater insight into the seasonality of our business and how we expect performance to build throughout the year. We expect full year 2026 revenue between $350 million and $365 million. For modeling purposes, we currently expect first half revenue in the range of $133 million to $153 million and the second half revenue in the range of $203 million to $226 million, reflecting the expected phasing of demand, channel dynamics and launch timing across the year. Adjusted EBITDA is expected to be between $80 million to $100 million for the full year, with the majority of the EBITDA generated in the second half of 2026. As in prior years, the second half is expected to be stronger with that weighting being more pronounced in 2026. Historically, quarterly revenue patterns have been consistent, though 2026 will be slightly more second half weighted. Like the past 2 years, the first quarter is expected to be our lowest revenue quarter, primarily due to stocking activity from the fourth quarter and insurance resets and a higher concentration of high deductible plans. We estimated fourth quarter demand for IHEEZO resulted in approximately 1.5 quarters of incremental inventory being built across the channel. That inventory is expected to be drawn down largely during Q1. As a result, although we are seeing demand grow for IHEEZO similar to the first quarter of 2025, because we are drawing down on Q4 2025 inventory within the channel, we do not anticipate meaningful IHEEZO revenue in the first quarter. VEVYE entered the year with expanded coverage effective January 1. While we expect improved access will increasingly drive prescription growth throughout the year, the first quarter typically reflects an increased mix of high deductible plans, which creates near-term pressure for VEVYE and our branded portfolio. The financial impact of the coverage will start to be more pronounced as the year progresses and once our expanded sales force is fully deployed. We typically operate with a disciplined, methodical approach to spend, and we have done that for a reason to protect profitability, drive ROI and preserve strong cash flow. This year, however, we see a clear opportunity to maintain that discipline while increasing the pace and level of investment to expand our revenue base for years to come. As a result, we expect SG&A to increase to approximately $185 million to $205 million in the year as we expand our sales force across our major products and categories, including VEVYE and TRIESENCE, and prepare to support the launches of BYOOVIZ and BYQLOVI. We plan to add roughly 100 new sales roles in the first half of the year, and we'll pair that with increased promotional and marketing investment to drive awareness, adoption and sustained growth in the back half of the year and into 2027. Importantly, even as we invest, we will continue to manage expenses with a careful eye toward profitability and cash flow, holding ourselves accountable to returns and managing the spend accordingly. We also expect R&D expenses to increase this year to approximately $30 million to $35 million as we complete studies required for the Melt product candidates, NDA submissions and as we invest in post-market studies that Amir will discuss later, efforts we believe can support near- and long-term growth across key products. Looking to the second quarter, we expect IHEEZO will lose pass-through status effective April 1, impacting the ASC market. Approximately 30% of 2025 units were generated in the ASC setting. We've been preparing for this transition through our retina pivot in 2024 and the recently announced in-office expansion strategy, which, as Mark said, added about 2.5 million annual procedures to our TAM. The continued growth in retina and the in-office utilization is expected to offset and ultimately exceed the ASC impact. We also plan to launch BYQLOVI in Q2, which will support incremental growth in our specialty portfolio. Now looking at the third quarter. We typically experience some late summer softness due to both doctors, staff and patients going on vacations. The third quarter will include the first full quarter of BYOOVIZ revenue contribution, which should provide incremental growth. We are anticipating that IHEEZO will also catch some of the additional tailwinds as a complementary product to BYOOVIZ. In addition, beginning in the third quarter, we expect to start to see the impact of our expanded and fully deployed VEVYE and TRIESENCE sales force, driving growth for both products. Also starting in the third quarter, we are expecting a pricing improvement for IHEEZO to go into effect. When you combine that with the continued retina growth and the in-office expansion, we expect IHEEZO will have a strong second half of 2026 and position us very well for 2027. The fourth quarter should remain our strongest quarter, driven by demand patterns, stocking activity and patients reaching out-of-pocket maximums. Finally, as Mark discussed in his letter, as we intentionally transition compounded volume to FDA-approved branded alternatives, shifting revenue into our specialty portfolio, we expect compounded revenue to be approximately $60 million to $65 million for the full year, with Q1 the softest quarter as we exit the final stages of the inventory shortage. In summary, we expect a softer first half as we work through channel inventory, absorb the ASC transition and navigate seasonal deductible dynamics. In the second half, we expect meaningful acceleration driven by a fully deployed VEVYE and TRIESENCE sales force, contributions from BYOOVIZ and BYQLOVI, improved IHEEZO pricing, expanding retina and in-office adoption and incremental contribution from specialty products. Now I'll turn the call over to Pat Sullivan.

Patrick Sullivan

Executives
#5

Thank you, Andrew. Starting with VEVYE, we exited 2025 with strong fourth quarter momentum at a clear inflection point as expanded coverage went live. Despite limited coverage throughout 2025, we delivered a 115% increase in prescribers writing VEVYE, underscoring strong underlying demand for the product, but there is so much more opportunity for VEVYE growth in the large and growing U.S. dry eye category. With broader coverage now in place for our sales force expansion underway, we expect prescriber growth to continue. Consistent with the data shared in 2024, covered patients average approximately 9 refills in 2025, effectively a full year of therapy. That level of persistence underscores VEVYE's differentiated clinical profile, rapid onset, sustained efficacy and comfortable on-eye experience without the stinging and burning commonly associated with other treatments. The bottom line, though, is that we do not believe that any product in the category has this level of refill persistence. Since coverage expansion began, we have seen acceleration in new prescription trends despite navigating a challenging period with insurance benefits resetting and high deductible plans, and we expect continued improvement as the year progresses. To fully capitalize on this opportunity, we remain on track to double the VEVYE sales force by Memorial Day, expanding our VEVYE presence among eye care professionals to drive higher prescription volume through 2026. Turning to IHEEZO. This product materially outperformed our expectations in 2025 with an impressive 56% growth in unit demand year-over-year. Growth was driven by our expansion in the new retina practices and deeper utilization within existing accounts. Ordering accounts increased 49% year-over-year and retina specialists represented approximately 70% of fourth quarter unit volume, underscoring where adoption and clinical traction are strongest. Importantly, we believe we are still in the early innings of penetration with significant untapped market opportunity ahead as we continue to expand utilization and drive broader adoption. Looking ahead, in the second half of 2026, we expect a net price improvement, which we expect will further enhance the product's revenue and overall financial profile. Importantly, this comes as we prepare to launch BYOOVIZ in mid-2026, further accelerating IHEEZO's expansion into new retina accounts while deepening penetration within our existing customer base. We are also expanding IHEEZO into the office-based setting to broaden utilization beyond retina. This initiative targets more than 2.5 million anesthesia relevant procedures that already benefit from established reimbursement pathways, reducing access friction. Earlier engagement has been encouraging, supported by a dedicated commercial effort and our existing relationship in the office-based channel. Turning to TRIESENCE. We delivered a record quarter, driven by accelerating momentum in ocular inflammation and continued strength in retina. Despite formally launching in market on October 1, we saw a good portion of the Q4 unit volume come from ocular surgery accounts, and we expect this large market will drive the majority of new volume going forward. Nearly half of the fourth quarter ordering accounts were new and helped drive quarter-over-quarter growth in unit volume. To extend this trajectory, we are in the process of doubling the dedicated TRIESENCE sales force. Based on current trends, we see substantial runway for continued growth in 2026 and beyond. Finally, our rare specialty and compounded portfolio performance rebounded in the fourth quarter as new commercial leadership took hold and execution improved. While we are encouraged by that momentum, I believe there is substantial room to grow this portfolio of everyday workhorse products from current share levels. We are implementing several revenue-generating initiatives tied to these assets, which we expect to detail later this year. In parallel, as Mark discussed in his letter, we are focused on converting compounded utilization into FDA-approved branded products through the launch of PharmaPack Max and PharmaPack Prime, further strengthening the long-term revenue profile of this segment. In closing, each of our core growth drivers accelerated in the fourth quarter, and we entered 2026 with clear commercial momentum. We are scaling the organization to support the trajectory, doubling the sales forces behind VEVYE and TRIESENCE, expanding IHEEZO into the office-based setting and preparing for important launches this year. With strengthened infrastructure, expanding access and a diversified ophthalmic portfolio, we believe we are well positioned to drive sustained growth and delivering increased value to patients and shareholders. With that, I'll turn it over to Amir.

Amir Shojaei

Executives
#6

Thanks, Pat. I'd like to turn to our pipeline, which we believe represents a compelling long-term value driver for Harrow. The next phase of growth is highly focused and capital efficient. We're advancing clinically relevant programs aligned with clear unmet needs in ophthalmology and tightly integrated with our commercial infrastructure and regulatory expertise. While there are several programs on this slide and more that you don't know about yet, I'm only going to focus today on G-MELT, formerly known as MELT-300 and the ongoing IHEEZO studies. G-MELT exemplifies our strategy. It is a fully opioid-free and IV-sparing procedural sedation candidate that has the potential to redefine that standard of care, and I believe has the potential to become our largest product. Today, procedural sedation often requires IV access and uses opioid-based regimens, introducing complexity, staffing burden, monitoring requirements and longer recovery times. G-MELT has the potential to simplify that model. From a development perspective, we initiated the remaining pharmacokinetic work earlier this year and are advancing CMC activities with our CDMO partner. We remain on track for an NDA submission in early 2027, while continuing to evaluate opportunities to accelerate time lines. We view G-MELT as platform-level upside, a differentiated sedation solution with the potential to broadly improve procedural efficiency and create meaningful long-term value in the ophthalmic market and eventually beyond. Pipeline value also comes from expanding the evidence base for marketed products, including IHEEZO. I'm amazed that our team has been so successful with IHEEZO and retina given its supporting data within cataract surgery. I know from my experience developing back-of-the eye products, that retina professionals who are the primary users of IHEEZO want to see specific data based on procedures they need IHEEZO for, namely intravitreal injections. Therefore, we are investing in clinical data generation to support adoption, strength and differentiation and reinforce long-term positioning with both clinicians and payers. While this slide highlights IHEEZO, similar work is underway across the portfolio. High-quality evidence builds clinical confidence, drives utilization and supports sustained reinvestment in the franchise. For IHEEZO, we are sponsoring multiple complementary studies in intravitreal injection procedures. The first and most near-term data is an investigator-initiated randomized trial led by Dr. Sabin Dang comparing IHEEZO to standard anesthetic approaches evaluating pain and ocular symptoms with data expected at ASRS this year in July. You could see the code he provided us with on the bottom left of the slide. As for our own Harrow-sponsored IHEEZO study, my team has put together a Phase IV multicenter randomized trial assessing patient-reported pain and safety across approximately 240 patients. We initiated the study in the first quarter of 2026 under the IND and expect to have data available by the end of 2026. Together, these studies are designed to generate clinically meaningful practice-relevant evidence that supports further and more broad-based adoption, reinforcing IHEEZO as a durable long-term growth driver. In summary, Harrow's pipeline is focused, efficient and impactful. It complements our commercial momentum, expands our addressable markets and creates multiple pathways for long-term value creation. We are building not just individual products, but a sustainable innovation engine that positions Harrow for continued growth. With that, I'll turn it over for questions.

Operator

Operator
#7

[Operator Instructions] our first question comes from Chase Knickerbocker with Craig-Hallum.

Chase Knickerbocker

Analysts
#8

I appreciate the candid thoughts in the shareholder letter. So Mark, you kind of mentioned in the letter that you expect kind of continued commercial growth and commercial mix improvement for VEVYE kind of through the year. What have you seen so far from a commercial mix perspective in Q1? And then can you walk us through what your ASP assumptions or direction of ASP for VEVYE is in the 2026 guide kind of versus volume?

Mark Baum

Executives
#9

Yes. So regarding ASP, I think the only -- I'll answer the second question first. On ASP and net pricing, the only comment that we've made and that we intend to make is regarding the buoyancy and the slight uptick in ASP, which I had forecasted probably a quarter or two late. But nevertheless, as I said in the letter to stockholders, we saw that direction of travel and we eventually got there. So with a more sustainable and buoyant net pricing for VEVYE, that, coupled with some of the things that we're seeing on the commercial side with this new coverage, we have initiated this program to more than double the VEVYE sales force. In terms of the build and what we're seeing on the ground today for VEVYE, as I said also in the letter to stockholders, even in the fourth quarter, we started to see a little bit of momentum build. I think I've said in the past, that CVS had actually sent out letters to thousands and thousands of eye care professionals around the United States, alerting them to the new positioning, the preferred positioning for VEVYE on their formulary. And that alone, I think, began the positive momentum that we're also seeing a little bit in the first quarter. What I can say regarding the first quarter is that typically, it's a weaker period. And we're quite surprised with the new prescription volumes that we're seeing today relative to what we thought we would see, which is to say that the new prescription volumes are meaningfully better than what we thought we would be receiving at this point in the year. So we expect that to build throughout the year. As I said in my prepared remarks, we have data that demonstrates very clearly that more reps in the field for this particular product, given the persistence of the product and the market interest in the product yields more prescriptions. And for us, building those new prescriptions ultimately leads to more and more total prescriptions and more revenue. So we're very much bent towards building volume in VEVYE, and that's how we're set up for this year, and that's what you should expect.

Chase Knickerbocker

Analysts
#10

Helpful, Mark. And just for my second question, another multiparter sorry, but just on the TRIESENCE Phase III cataract announced this morning. Obviously, a large potential volume opportunity. Just a couple of questions to help us understand the magnitude. So what percentage of the cataract market do you think is kind of the sweet spot for TRIESENCE as it relates to kind of the value prop versus the multi-drop regimens that are pretty pervasive today? How should investors kind of think about the TAM expansion from this label expansion kind of within cataract for TRIESENCE? And then second, I think investors often have kind of question on duration of opportunity with pass-through products in the ASC. Can you just remind us or discuss the unique aspects of TRIESENCE that may allow for longer-term payment outside the bundle or how you plan to approach pricing there?

Mark Baum

Executives
#11

Sure. Once again, I'll take the second question -- the second part first. In terms of reimbursement for the product, TRIESENCE is a very unique label in that it is both used in the office setting of care, and it's also used in the hospital and outpatient department setting of care. And as a result of that, and I don't want to go into the nuances of reimbursement policy, but we believe that TRIESENCE will not be limited by a TPT or a temporary pass-through period. And regarding the first part of the question, in terms of what the TAM expansion might be for this study that Amir just received clearance on, I believe, yesterday. I go back to, I think, another comment that I made in my prepared remarks, and that is that our vision for cataract surgery is that in the future, patients in the United States should have an IV-free, opioid-free and even an eye drop-free procedure. That is what I would want my mother to have. That's what I would want anyone that I love to have, not to have to put eye drops in their eye multiple times per day, multiple different eye drop bottles that's assuming you're using an FDA-approved product, of course. And so that should be the ideal, and that's what we're working towards. That's what the G-MELT is about, and that's what this expansion with TRIESENCE is about. It's about putting power in the hands of the surgeon to deliver the anti-inflammatory into the eye so that the patient doesn't need to administer these post-surgical eye drops. What's interesting is anecdotally, what we've seen is that for patients who are using this on label, which is a subsegment of the cataract surgery population, it's those patients who really can't administer eye drops, who have other comorbidities. What we decided to do because those patients are having such exceptional results is to invest in expanding the label so that all cataract surgery patients have access to this therapy. And what's terrific is, as I said, we've got reimbursement. We have an exceptional clinical outcome. And with this amazing study that Amir and his team are going to execute, we're going to have a very broad-based label that will finally give cataract surgeons access to an easy to administer, highly efficacious post-cataract surgery anti-inflammatory that they themselves can inject. And here's the best thing for consumers, for patients. It has the lowest out-of-pocket of any injectable steroid at around $37 per unit. So it's affordable, it's accessible, it's highly efficacious, and we're going to invest for a very small amount of money in a study that will significantly expand the number of patients who will have access to it. And in the United States, by the time this data reads out, that should be about 5 million procedures annually. So it's a very large market opportunity. And as I've said for a couple of years, TRIESENCE is a slow grower. We've got a lot to prove there for sure, but this is a product that in the next couple of years is going to be a meaningful value driver for our stockholders.

Operator

Operator
#12

Our next question comes from Timur Ivannikov with Cantor Fitzgerald.

Timur Ivannikov

Analysts
#13

This is Timur Ivannikov on for Steve Seedhouse. So first, on IHEEZO, I think you mentioned price improvements in the second half of 2026. Could you clarify, is that a price improvement from Q2 '26 or from Q4 '25? And do you expect Q2 '26 ASP to be significantly lower?

Mark Baum

Executives
#14

Andrew, do you want to take that?

Andrew Boll

Executives
#15

Yes. So and just to try to make sure I answer the question correctly, we expect by the time we get to Q3 of 2026, pricing for IHEEZO will be better than what it was in 2025 and in the first part of 2026.

Timur Ivannikov

Analysts
#16

And then second question is on the TRIESENCE cataract trial design. I just wanted to understand the trial a little better. I think you mentioned the trial design versus placebo. Could you talk about the use of droplets -- anti-inflammatory eye droplets in both groups? I mean, are you allowed to dose the droplets in the treatment arm and the control arm?

Mark Baum

Executives
#17

Amir, can you handle that one?

Amir Shojaei

Executives
#18

Yes. I think the protocol design is pretty clear. We're going to have a control arm, which will not get TRIESENCE. And then -- but we do have rescue criteria already built in, and those rescue criteria would allow drops again, per protocol.

Operator

Operator
#19

Our next question comes from Mayank Mamtani with B. Riley Securities.

Mayank Mamtani

Analysts
#20

I appreciate the helpful go-forward guidance framework. So on VEVYE NRx improving and the commercial mix also improving, Mark, are you able to share with us any end of year or second half loaded kind of market share targets that you may have, so we can understand the growth in the market. Obviously, multiple companies investing here on the penetration side, but also want to understand how you're thinking about share gains in both the cash pay and also obviously, the commercial mix markets? And then I have a follow-up on IHEEZO.

Mark Baum

Executives
#21

Sure. Yes. So we have 3 goals for VEVYE. First of all, I just want to say that the dry eye market in the U.S. is as Pat said, a very large market. We believe it still continues to be underpenetrated, and we continue to see data that demonstrates that there are large segments of the dry eye patient population that are receiving products on a monthly basis that burn and sting cause pain, sneeze. I mean the list of these effects are too long. And so when we see that patients are getting access to these nonoptimal therapies for whatever reason, whether it's coverage or they're just not aware of VEVYE, we see that as opportunity to convert those patients to a therapy that doesn't burn and sting and that has all of the positive benefits that VEVYE offers, including now these enhanced coverage metrics. But in terms of what our goals are, to be clear, the first goal is we believe VEVYE will be the #1 cyclosporine in the U.S. market. Cyclosporine is the most trusted active ingredient in the dry eye market, and we aim to be the #1 cyclosporine. Second to that, we believe we can capture the anti-inflammatory market. So any product that actually has an active ingredient and that would be an anti-inflammatory, and we believe all forms of dry eye disease, we don't care which one you choose, have an inflammatory component to them. And so we aim to be secondarily the #1 anti-inflammatory. And then eventually, and it's not going to happen overnight. We think we have the opportunity with this particular product to be the #1 most prescribed dry eye product. Now for the last couple of years, our competition has had a sales organization that even the most inferior products in the market have had much larger sales organizations than we've had. And we are now, as I said, more than doubling our sales force. I think we're more than halfway there. So I'm actually surprised that the talent team is doing a great job. And there's just a lot of people that want to join this Maria's team and sell VEVYE. But in terms of specific market share percentages, we're not giving those goals. I think to be the #1 cyclosporine in the market, we probably need to have just north of 20% market share. So that gives you a sense of what we think is achievable. And by the way, in many markets, we are already there. The problem is, is that we touched historically so few markets with a sales organization of just under 50 people that even if you have better than 20% market share in the Greater Cincinnati area, which happens to be the case, there are many other markets where you just simply don't have that level of market share. So with this enhanced sales force, now numbering close to about 100, we'll touch more markets. We will increase our market share, I believe, and we'll get closer and closer to that goal of being the #1 cyclosporine. Pat, do you want to add to that at all?

Patrick Sullivan

Executives
#22

Thanks, Mark. I think one of the things we're most optimistic about, as we stated in our earnings is the increase in writing that we see -- we saw 115% growth in our writing. And I think, as Mark mentioned, the feedback that we received from our eye care professionals and from their patients is extremely positive around the fact that VEVYE uniquely manages inflammation, how rapid it works and at the same time, is the unique tolerability profile. We are extremely encouraged in our next phase of expansion to cover a much larger portion of the market and increase VEVYE's presence to really grow this product to be the #1 cyclosporine. So Mark, we're well on our way to building our next phase of growth for VEVYE.

Mayank Mamtani

Analysts
#23

And then on IHEEZO, obviously, a lot going on here, ASC pass-through status expiration, but also price per unit improvement that you mentioned. And there's also some data generation activity you noted at ASRS conference middle of the year. I was just curious to contextualize its contribution to the guidance. Are you also thinking like VEVYE, this is a 9-digit revenue contributor for this year? Or is it more a reasonable target for next year?

Mark Baum

Executives
#24

Yes. I don't want to comment on the revenues for that product. I think the only product we've given guidance on specifically is VEVYE, which is clearly on the road to 9 figures. What I will tell you is this, just as a reminder, in 2024, we had absolutely 0 retina presence. We didn't have a retina sales force. We didn't have any products in that market. And only a couple of years ago, did we hire that sales organization. So in really August of 2024, we began what we call the retina pivot, where we were able to attract great people from much larger companies that had tremendous backgrounds in retina, and we built this organization. I remember going to ASRS in Stockholm, nobody knew who Harrow was. They had -- we had no presence in that market. And it's a very tight community, the retina community. And what I can tell you is over the last 1.5 years, 2 years or so, I think if you go to retina professionals now and ask them if they know who Harrow is, they really know who Harrow is. I have to say another thing about IHEEZO specifically because it is amazing what Ali and her team have done, taking a product where the clinical studies supporting the NDA were in cataract surgery, and they have been able to adapt that data to the intravitreal injection market now with more than 70% of the unit volume for IHEEZO in the retina market. What's really exciting is what Amir talked about with the Dang study. What Ali has wanted for well over a year, we've had numerous conversations is specific data related to the performance of IHEEZO in the intravitreal injection procedure. And we had all this anecdotal information, doctors would tell us how it performed. Some doctors had other benefits that they experienced from the product, including efficiency in their workflow. But what I think you're going to see in the middle of the year, finally, for Ali and her team is a data set that will demonstrate the real difference between IHEEZO and these legacy modes of providing these patients with anesthesia for these intravitreal injections. And I have to tell you, if you're a patient getting these injections, the anesthesia and pain control really matters. And we think we have a product, at least anecdotally, we've received tremendous information from accounts that use this product about its performance. And in the middle of the year at ASRS, and he got a late breaker, by the way. I mean it's not easy to get these, but he is going to present this data. And I think that is going to fuel significant demand in the retina market for this product. So in terms of how we -- how IHEEZO fits into our overall guide this year and certainly in 2027, depending on how this data comes out, this is an opportunity, I think, to significantly improve the unit volume demand for IHEEZO. And then as Andrew said that, coupled with this new packaging format that's specifically for retina and a meaningfully improved price, I think that by the end of next year, you're going to hopefully be surprised at what we think we can generate from this particular product.

Mayank Mamtani

Analysts
#25

And lastly, very quickly, the OpEx expansion that you have -- you're seeing your R&D was higher in fourth quarter. Is it sort of a first half loaded kind of dynamic? And is there a steady-state OpEx spend, Andrew, you're trying to get at some point this year?

Mark Baum

Executives
#26

Thank you, Mike. Andrew, do you want to tackle the OpEx?

Andrew Boll

Executives
#27

Yes, absolutely. Thanks, Mayank. And I want to be sure to note, in Q4 in the P&L, there's an $8.5 million charge for acquired in-process R&D, which was associated with the Melt acquisition, was our upfront costs and some of the transaction costs associated with the deal. But none of that acquisition cost was capitalized. It all ran through the P&L and ran through R&D according to GAAP rules. And we also didn't back it out or add it back in, I should say, to the EBITDA number for 2024. But kind of looking forward the adjusted EBITDA -- looking forward at the OpEx spend, and Mayank, I'm going to kind of break it into 2 parts. You've got the SG&A side, which we're adding that sales -- those sales heads right now, we've been adding them aggressively in Q1. We'll continue to add them in Q2. And then we've also been preparing. So we're preparing from a marketing and promotion standpoint, which is also increasing that spend. And we're kind of trying to get ahead of a lot of that as well so that when these people get hired and trained, they're hitting the ground running with VEVYE and TRIESENCE for that matter. From an R&D perspective, a lot of that cost, as you know, is going to be trial dependent. We sort of have a base here of R&D spend year-over-year. But as we put out this announcement this morning regarding the TRIESENCE's IND being accepted and that study picking up. Those costs will kind of show up in the middle part of the year, so Q2, Q3. So we'll have a little bit of a ramp in the middle part of the year and then it should come down a little bit on the R&D side in Q4 as you sort of wrap up those studies along with some of the melt studies.

Operator

Operator
#28

Our next question comes from Lachlan Hanbury-Brown with William Blair.

Lachlan Hanbury-Brown

Analysts
#29

I guess, first, I would appreciate maybe a little more color on how you're thinking about the IHEEZO dynamics in 2026. So you said you think the in-office procedure expansion beyond retina can offset the ASC loss. Is that sort of specifically talking about Q2? Or is that more of a longer term you think looking a year or so out, it will more than offset that. So I guess, should we expect maybe a drop in Q2 in unit demand?

Mark Baum

Executives
#30

Yes. I don't want to be specific about demand in any particular quarter other than to say that in Q4, Q1, Q2, Q3, I think I've said this, we expect demand to continue to increase. So demand continues to increase. That's separate from revenue recognition, but demand for the product does continue to increase. In terms of when we're likely to see the offset from the loss of the ASC units, when I looked at the ASC units specifically, the number of units that we're losing relative to the overall opportunity that we're adding when we add these in-office opportunities with this 2.5 million unit increase to our TAM, it's such a small level of success, and we have a discrete team going into the same customers that are using it in the ASC that don't know that they can use it also in their clinics. Remember, every one of the doctors that's using it in the ASC is a surgeon, but they also only spend a day or two a week in the surgery operating room -- the surgical operating room. The rest of the week, they spend in their office doing procedures. And so it's a simple idea. We're going to the same customers that are using the product satisfactorily in the ASC, and we're saying, "Hey, you're doing more procedures in your office than you're doing in the surgical suite." And it's not for every procedure, but for those procedures where this could be impactful, we're going to the same customers and trying to convert their in-office business. And it's such a small number of units, as I said, that we don't have to really be that successful to fully offset the entirety of what we're losing when we lose the temporary pass-through code. So is that going to happen in the first quarter or the second quarter? No. I doubt it. It should happen throughout the year. And as I said, it's such a small number of units relative to what the overall opportunity is that we can fail and fail and fail again and still end up eating up all of those lost units from the ASC.

Lachlan Hanbury-Brown

Analysts
#31

That's good color. I guess second question is just on VEVYE and the new coverage, just wondering what you're seeing in terms of the patients that are sort of getting scripts filled under that coverage. Are they new-to-brand patients? Or is there a sizable chunk of them who were previously paying cash pay or maybe you previously managed to get coverage for them who are now just converting to be sort of covered more easily?

Mark Baum

Executives
#32

Yes. I can't say specifically with numbers, what percentage or what number of patients are converting. What I can sort of echo what we've said in the past and that in 2025, there were a lot of patients who we received prescriptions for, but -- legal prescriptions, but who were denied access to the product for one reason or another, who chose not to get their prescription filled. And so we're going out to those patients. Now those patients still have legal prescriptions, and we can contact them and make them aware of the existence of coverage and try to capture as many of those as possible. At the same time, there are patients who are paying cash, as you said, so these consignment patients who do have coverage now, but formerly did not, and we can go to them. We know exactly who those folks are as well and convert them. This is a sizable number of people. And you're talking about well north of 30 million new covered lives where you have the best access for VEVYE now. So we have to see how things play out. I think based on what we're seeing in the first quarter, we thought we would not be where we are. We're in a better place than where we thought we would be in terms of new prescriptions. The new-to-brand side of things, I think, is going to come once we get these new bodies out, these new sales reps, you'll have more and more of that new-to-brand. And I can say -- and I don't want to steal Pat's thunder, but Pat, do you want to actually talk about the whole new-to-brand because I know that's really been a focus of yours.

Patrick Sullivan

Executives
#33

Yes. Thanks, Mark. And I think the core to our next phase of growth for VEVYE is really around driving new growth for VEVYE. We know better as possible when it comes to managing dry eye disease, as Mark mentioned. And our main focus going forward is ultimately to win the new-to-brand patients. And I think that's going to be a heavy focus for us. And obviously, beginning of this year in our conversion from CVS, we are really in our expansion and leading up to our expansion, heavily focused on the right patient and working with our physicians and our communication approach to make sure that we are targeting these patients because what we do know is those that are having -- either coming in that are having dry disease symptoms or having unresolved or persistent symptoms on other subdoptimal treatments, VEVYE is the perfect treatment for that. Our goal moving forward is to make sure that we have the right presence with our customers and ultimately target the right patients going forward. So Mark, to your point, new-to-brand for us is a huge focus and will really start to come to life for us as we go to our next phase of expansion.

Operator

Operator
#34

Our next question comes from Tom Shrader with BTIG.

Thomas Shrader

Analysts
#35

On the VEVYE sales force, after your increase, where does that put you relative to competitors like MIEBO? Would you be on an equal playing field? And then just a remedial question on the Melt franchise. Are you still wedded to 2 products? It seems like the first product is the bigger product. It's the combination. Does your compounding business inform you that there really is a need for 2 products?

Mark Baum

Executives
#36

Yes. So I'll take the first question. In terms of the VEVYE sales force, I actually -- we don't know exactly how many reps these competitors have out in the field. We've heard that one of our competitors that has a pretty sizable market share has upwards of 300 people. So we're going to have around 100 ourselves, but what I can tell you is that our reps are so powerful that 1 Harrow rep with VEVYE is equal to 4 of theirs, I'm kidding. But we really do have a terrific sales organization that's well trained and they have an outstanding product to sell. We -- this is the second phase of our expansion. So this -- we had the initial hiring for this product. This is the second phase, taking us up to around 100 territories or so. There very likely could be a slight increase in the number of territories as we see this investment pay off. And so -- but we're excited to have this sales force double -- more than doubling here in the near term. And I'm also pleased with the quality of people we've been able to attract and those that we've continued to retain who are on Maria's team. In terms of Melt and the need for both products, the MKO Melt, which is a compounded formulation that we've sold for a number of years, is -- has really informed the entirety of the development program. One of the nice things about the G-MELT when it is approved, is that we're going to discontinue the compounded version of the product, and we'll hopefully convert all of that business into an FDA-approved and hopefully reimbursable product. It is very hard, as I've said, over the years, to sell compounded medications. They're not FDA approved. They don't have a label, particularly in anesthesia and sedation where an anesthesia professional is going to think twice or three times about whether or not they're going to use a compounded formulation. So when we have an on-label FDA-approved product that is also hopefully reimbursed, this should significantly expand the market opportunity for the G-MELT in cataract surgery, but also for other procedures where a sublingual non-opioid sedation choice can prevail. In terms of why we need also the 210 program, the 210 program addresses a different market segment. And believe it or not, in terms of the total number of units of opportunity for it, based on the expected label, and we still need to discuss that with the FDA and come to a resolution around what ultimately a label might look like for what is now called YOCHIL, that product in terms of unit demand is bigger in unit volume demand, we believe, than even the G-MELT. The G-MELT will be used certainly in cataract surgery, which is what we're studying it for. We also believe it will be used as the compounded product is used in ENT for endoscopy. It's used in dermatology, plastics, dental, widely used in dental. It's used to deal with claustrophobia in MRI tubes. And so that's the experience that we have with the MKO Melt, the compounded version. And our expectation is that the G-MELT when it's approved, eventually will be used in markets outside of ophthalmology, which happen to be even bigger markets than the ophthalmic market. But the answer is yes, we need 2 products. They serve different markets. One is specifically related to anxiety. And it will also, as I said, be available, and I said this, I think, in the letter to stockholders in 3 different -- ultimately be available in a number of different strengths.

Thomas Shrader

Analysts
#37

If I can sneak in one follow-up. The new TRIESENCE, I mean, it seems like it's a much easier product to make and use. Do you think you might expand that outside the eye where that steroid is used? Or is this entirely a formulation for the eye?

Mark Baum

Executives
#38

It's purely for the eye. It's -- we started our company in 2014. Our first sale was with triamcinolone acetonide for injection. And this is a product category, an active ingredient we know really, really well. Our compounded formulation, once again, the enthusiasm for TRIESENCE for us comes from our experience having sold Tri-Moxi in well over 1 million cataract surgeries. So it's a market we know well. It's just -- this product is just going to be for the eye, but we have real high hopes that we can once again create this protocol, which is IV-free, opioid-free and even eye drop-free eventually for cataract surgery patients, which is really where the market needs to go.

Operator

Operator
#39

Our next question comes from Thomas Flaten with Lake Street Capital Markets.

Thomas Flaten

Analysts
#40

Following up on VEVYE, with respect to the sales force expansion, can you talk a little bit about -- and I think you alluded to this, Mark, that it's a lot of new territory, but new territory versus territory splitting because of overload. And then how you see the dynamics between the ophthalmology and optometry community playing into that growth expectation?

Mark Baum

Executives
#41

I'll take the second one first, and then I'll flip the first to Pat. But in terms of the sales force -- actually, pardon me. I think the right -- your second -- sales force expansion and what else, Thomas?

Thomas Flaten

Analysts
#42

The ophthalmology versus optometry.

Mark Baum

Executives
#43

Yes, I'll answer. Yes. So ophthalmology and optometry, believe it or not, the optometric market is a critical market. I would say that I would be slightly biased towards the optometric market. I think now optometrists are writing as many or probably more prescriptions for dry eye medications than ophthalmologists. That's what the data that I'm seeing shows. But Pat, do you want to talk about the sales force expansion specifically?

Patrick Sullivan

Executives
#44

Yes. Thanks, Mark. And I think when we think about the expansion, I mean, this is a real great opportunity for us to look at the great progress that VEVYE has done for dry eye disease patients to date. And I think one of the first things we do is look at this, to your point, you were talking about like basically business interruption versus business continuity. It sounded like your question was around. I think we're taking a very methodical approach to make sure that we are, one, relooking at making sure that this approach going forward. It is sales force expansion, but it is about VEVYE's brand presence and promotional efficiency in front of our customers going forward. This is a very, very active category that is large, growing and active. And for us, like to the prior question by one of your colleagues around playing in that dynamic part of the market where that new to brand is, it's going to take not only having our current territories be very efficient, but also our expansions. We are being very, very thoughtful in how we're, one, putting our footprint together. But I think the key takeaway here is VEVYE is poised for significant growth going forward, but it will be about how we want to put a new VEVYE presence in front of our customers that one is really about differentiation, new to brand and having the right presence that is commensurate with being a #1 -- goal of being the #1 cyclosporine and #1 dry disease treatment. So to your question, very thoughtful on how we'll drive that business to maintain our aims and our growth going forward.

Mark Baum

Executives
#45

Got it. And John, just as a practical matter, look, we need to get salespeople in these offices. They need to see their VEVYE reps more frequently. And that's what this is about. We know where the high-value targets are. We know who's prescribing dry eye disease. We know who is looking for dry eye disease. And this expansion is going to allow more Harrow VEVYE reps to get in those offices far more frequently. And our data demonstrates very clearly that when we do that, we end up with more prescriptions for VEVYE. And I think you're going to see that throughout the year.

Thomas Flaten

Analysts
#46

And Mark, to follow up on the last commentary around Melt being used or MKO being used a lot outside of ophthalmology indications. What can we expect with respect to dealmaking to get Melt appropriately exploited in those opportunities that are outside ophthalmology?

Mark Baum

Executives
#47

Well, right now, we are completely focused on 2 things. One is Amir and his team building this data set. I've put a bounty on him getting that NDA and sooner than he even thinks he's able to get it in. And I'm hopeful that we can hopefully -- we can beat some of these time lines that we've laid out. So it's all about getting the NDA in and getting the data in front of the FDA so that we can hopefully get this approved and then ultimately get it coded for reimbursement. The second thing is that the market, even in ophthalmology, you're talking about 5 million use cases minimally per year. And that's just really cataract surgery. If you tack on glaucoma surgeries and other relevant procedures, you can add another couple of million procedures. So for a reimbursed nonopioid, non-IV sedation medicant, the opportunity in ophthalmology is very large. It's billions of dollars per year where our competition is IVs and opioids. I mean the data -- there was a Duke study, there was a Mayo study, the data is clear. Patients today are getting dosed with fentanyl for sedation during cataract surgery in particular. And so we aim to change that. We've got to build our commercial strategy for the G-MELT, and that is underway. So that's the second component. Other than that, outside of the U.S. market in ophthalmology and getting the studies completed and filing the NDA, if something happens where there's a partnership that is revealed or an opportunity like that, that's revealed, we'll certainly pursue it. But we have such a big revenue opportunity with the G-MELT in ophthalmology that we need to really stay focused on that, and that's what we're going to do.

Operator

Operator
#48

Our next question comes from Jeffrey Cohen with Ladenburg Thalmann & Company.

Jeffrey Cohen

Analysts
#49

I guess two from our end. Firstly, Mark or Andrew, could you comment any on margins and/or tariffs and ratifications throughout 2026 or any net changes that you're seeing now from '25?

Mark Baum

Executives
#50

Andrew, do you want to tackle tariffs, margins?

Andrew Boll

Executives
#51

Yes. Jeff, from what -- yes, on the tariff side, we're not expecting much impact. I think the analysis we did last year was almost in a worst-case scenario when we kind of relooked at things and we're doing that on a continual basis. The analysis we did last year is still holding strong and actually, we're in better shape than we would have been last year in that worst-case scenario around Liberation Day. So not -- to answer your question more directly, we should -- we're not expecting to see any impact on margins as it relates to tariffs this year.

Jeffrey Cohen

Analysts
#52

Got it. And then secondly, any commentary on your midyear expected launch on BYOOVIZ as far as preparations and commercial organization and how that might look like midyear?

Mark Baum

Executives
#53

Andrew, do you want to touch on that at all. Anything you want to add there? We're -- I think we're ready to go. We're -- I think we start realizing revenue. And the team has got a very unique strategy. Andrew, do you want to touch on that or Pat?

Andrew Boll

Executives
#54

Yes, I can touch on a little bit and then hand it over to Pat. The -- Jeff, we're really leveraging the existing retina team with that launch. There's some incremental costs that will go into that. We'll have some variable costs as we get the hub up to help support the product. But we're just -- we're really excited to get that thing going. We've got a great partner in Samsung as well. That's helping us as we prep. This is a very dynamic market. We're going to be getting in with BYOOVIZ right away in the middle of this year, which is the Lucentis reference biosimilar. And then you may have recently seen that Samsung announced they entered into a settlement with the innovator drug for Eylea. And so we'll be able to get into the market a little earlier than we expected with that product as well at the beginning of next year, which will be in January. But from a spend perspective, like I said, we'll leverage most of the existing sales force. There will be some small incremental costs there and maybe some variable costs related to the hub activity for the products, but should be highly, highly accretive to earnings and new revenues. Pat, do you want to add anything?

Patrick Sullivan

Executives
#55

Thanks, Andrew. I think the one thing to add is, as Mark mentioned, we're really excited to get this going. Thinking about back to Mark's comments about the team that we have here, a very deep set of heritage in the retina space. So I think to me, we will capitalize on that very quickly. I think in addition, when you think about our current portfolio, we made significant strides in growing our retina business, and this is going to help us significantly with our presence and growing the value of that franchise. And we are actively right now preparing the market and targeting our business to take off here in the middle of this year. So we're super excited about BYOOVIZ going forward.

Operator

Operator
#56

And next from Yi Chen with H.C. Wainwright.

Yi Chen

Analysts
#57

Could you comment on your marketing strategy for the biosimilar, whether they will have a dedicated sales force and how you are going to present your biosimilar as a differentiated product from other biosimilar competitors?

Mark Baum

Executives
#58

Yes. Thanks for the question. As I think Andrew referenced and as Pat discussed, and I think as you know, it is a highly dynamic market. It is competitive. And we have a unique place in the market with our Lucentis reference biosimilar. And at this point, I really don't want to reveal specifically how we're going to attain the market share that we expect to drive towards. What I have said in the past is that based on our cost in getting into the deal, the level of success that we need to achieve to make this highly profitable is quite low. We're not playing to get 30% market share with BYOOVIZ. We're playing to get a handful of percentage points of market share in this market, which is the largest market in ophthalmology by revenue. And so our expectations are quite modest, and we believe that the strategy that we're going to employ with the team that we have, which, as Pat said, has a tremendous background and relationships and this market is going to be successful in helping us get to our goals. But we don't have -- we're trying to get about a handful of percentage points of market share, which is what we've said historically.

Andrew Boll

Executives
#59

I can add a little bit too. The one big advantage we have compared to everyone else in this market is we have other products that we're selling these doctors. And so it allows us to provide a really comprehensive offering. You can talk about the patient experience with our anesthetic. No one else has that anesthetic in the biosimilars. And so it's more than just the biosimilar products that we're going to be selling. It's the comprehensive package of products where we totally support the practice and focus in on the patient experience.

Operator

Operator
#60

I'm showing no further questions. I'd like to turn the call back over to Mark Baum, CEO, for closing remarks.

Mark Baum

Executives
#61

Well, first, and this is not in my script, I have to say that this call is the longest call I think we've ever had. It was -- reminds me of our recent state of the union. It set a record. And so we're going to definitely work next time to try and make this call a little bit more efficient. So we apologize for the time that this call took, but I think it was worthwhile. And hopefully, anyone who is listening feels a lot more knowledgeable about where this company is and where we're going over the coming quarters and years. Across the portfolio, we're seeing tangible momentum, improved access, expanding adoption and growing commercial execution. We've got a great new commercial leadership team, multiple products are scaling meaningfully, key franchises are gaining depth and we're seeing early signs of inflection where we've been patient and disciplined. And the result is that you own a business with increasing revenue concentration that is in durable high-value assets and that we have multiple pathways with other products for continued growth. I want to thank you for your continued confidence in Harrow. We're building something durable and lasting and valuable, and we believe the most exciting part of our story is still ahead. This will conclude our call. Thank you.

Operator

Operator
#62

Thank you for your participation. You may now disconnect. Everyone, have a great day.

This call discussed

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