3/3/2026

speaker
Operator
Conference Operator

Good day and welcome to the HARO fourth quarter 2025 earnings conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. 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.

speaker
Mike Biega
Vice President, Investor Relations and Communications

Good morning, and welcome to HARO'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 HARO'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. Errol's results may differ materially from those projected. Errol disclaimed 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 Bull, President and Chief Financial Officer, Patrick Sullivan, Chief Commercial Officer, and Amir Choudhary, Chief Scientific Officer. With that, I would like to turn the call over to Mark. Mark?

speaker
Mark Baum
Chief Executive Officer

Good morning, and thank you for joining us. Over the past five years, HERO has undergone a fundamental transformation. Harold now owns one of the largest portfolios of prescription ophthalmic products in the United States market. And we have been the most prolific acquire or 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 five 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 HARO 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 five years from now. However, I can say with nearly absolute certainty that HARO 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 Vivi, iESO, and TriEssence. 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 one or two product candidates from our recent melt pharmaceuticals acquisition, specifically what we are now calling g melt. And yo chill 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 and ocular surgery. and more generally in the lives of so many Americans in need of an alternative to IV and opioid-based medicaments 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 five-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 Vivi is positioned for revenue acceleration and increasing new prescription velocity expanded payer coverage is now in effect. So we are doubling the vivi salesforce 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 nine refills annually, effectively a full year of therapy, this reinforces the durability of the demand for Vivi. 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 Vivi finally becomes a nine-figure revenue product this year. IHESO 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 two and a half million units annually. We're also expecting IESO 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 IESO and legacy anesthesia modalities. This is only going to help us, we believe. We've got to see what the data says. These 2026 activities should further enhance financial performance, and with multiple growth levers now in place, IHESO represents a durable and critical part of our long-term strategy. Triessence 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 and market access. I have asked our talent team to at least double The dedicated triessence 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 triessence 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 triessence appears to be doing, then surgeons are often reticent to change. This is what I mean by the sustainability of the triessence 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 tri-essence is on the move. These elite reps from around the country are hearing about our commitment to this product, and they know that They will also be selling the Gmail to if they can make it onto our team. A lot of folks want to get in on the Gmail, 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 positions at Harrow on the tri essence 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 wring out the value we expect from this exciting and unique group of products. As I discuss more in my letter to stockholders, there are three 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 in the next year as our plans for this portfolio are revealed. A few final points. In 2026, we will also launch two important products by Clovey and BioViz, 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, HARO 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 five-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.

speaker
Andrew Bull
President and Chief Financial Officer

Andrew? 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. The 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 Vivi, 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. IHESO 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 TriEssence and other modest investments we intend to make in this franchise, we are disclosing this revenue separately for the first time. Triacin's 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 triacin's inocular inflammation. Our rare specialty and compounded 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 two 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 IHESO resulted in approximately one and a half quarters of incremental inventory being built across the channels. That inventory is expected to be drawn down largely during Q1. As a result, although we are seeing demand grow for AHISO, similar to the first quarter of 2025, because we are drawing down on Q4 2025 inventory within the channel, we do not anticipate meaningful AHISO revenue in the first quarter. Vivi 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 Vivi 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 Vivi and Triacins, and prepare to support the launches of BioViv and BicloViv. 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 IHESA will lose pass-through status effective April 1, impacting the ASC markets. Approximately 30% of 2025 units were generated in the ASC setting. We've been preparing for this transition through a 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 Biclovin 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 BioViz revenue contribution, which should provide incremental growth. We're anticipating that IHESA will also catch some of the additional tailwinds as a complementary product to BioViz. In addition, beginning in the third quarter, we expect to start to see the impact of our expanded and fully deployed and sales force driving growth for both products. Also starting in the third quarter, we're expecting a pricing improvement for IHESO to go into effect. When you combine that with the continued growth and the in-office expansion, we expect IHESO to 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 revenues 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 B-Buy enterprise and Salesforce, contributions from BioViz and Bicovy, improved IHESL pricing, expanding retina and in-office adoption, and incremental contribution from specialty products. Now I'll turn the call over to Pat Sullivan.

speaker
Patrick Sullivan
Chief Commercial Officer

Thank you, Andrew. Starting with VBI, 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 115% increase in prescribers writing VBI, underscoring strong underlying demand for the product. But there is so much more opportunity for VBI growth in the large and growing U.S. dry eye category. With broader coverage now in place for our Salesforce expansion underway, we expect prescriber growth to continue. Consistent with the data shared in 2024, covered patients averaged approximately nine refills in 2025, effectively a full year of therapy. That level of persistence underscores V-VI'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 VBI sales force by Memorial Day. Expanding our VBI presence among eye care professionals to drive higher prescription volume through 2026. Turning to iHESO. 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 specials represented approximately 70% of fourth-quarter unit volume, underscoring where adoption and clinical traction are strongest. Importantly, we believe we're 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 BioViz in mid-2026, further accelerating IHESO's expansion into new retina counts while deepening penetration within our existing customer base. We are also expanding IHESO into the office-based setting to broad 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 triessence, 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 triathlon 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 workforce 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 PharmaPak Max and PharmaPak 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 DeFi and TriEssence, expanding iHESO 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.

speaker
Amir Choudhary
Chief Scientific Officer

Thanks, Pat. I'd like to turn to our pipeline, which we believe represents a compelling long-term value driver for Harold. 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 GMELT, formerly known as MELT 300, and the ongoing IESO studies. GMELT exemplifies our strategies. 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. GMELT 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 timelines. We view G-MELT as platform-level upside that 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 IHESO. I'm amazed that our team has been so successful with IHESO on retina, given its supporting data was in cataract surgery. I know from my experience developing back-of-the-eye products that retina professionals who are the primary users of IHESO want to see specific data based on procedures they need IHESO 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 AHISO, similar work is underway across the portfolio. High-quality evidence builds clinical confidence, drives utilization, and supports sustained reinvestment in the franchise. For AHISO, 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 AHISO to standard anesthetic approaches, evaluating pain and ocular symptoms with data expected at ASRS this year in July. You can see the code he provided us with on the bottom left of the slide. As for our own HARO-sponsored AHISO study, My team has put together a phase four multi-center randomized trial assessing patient reported pain and safety across approximately 240 patients. We initiated the study in the first quarter of 2026 under the IMD 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 AHISO as a durable long-term growth driver. In summary, HARO'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 HARO for continued growth.

speaker
Mike Biega
Vice President, Investor Relations and Communications

With that, I'll turn it over for questions.

speaker
Operator
Conference Operator

Thank you. If you'd like to ask a question, please press star 1-1. If your question has been answered and you'd like to remove yourself from the queue, please press star 1-1 again. Our first question comes from Chase Knickerbocker with Craig Hallam. Your line is open.

speaker
Chase Knickerbocker
Analyst, Craig-Hallum Capital Group

Good morning, Tim. Appreciate the candid thoughts in the shareholder letter, and thanks for taking the questions here. So, Mark, you kind of mentioned in the letter that you expect kind of continued commercial growth and commercial mix improvement for VBI 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 VBI is in the 2026 guide kind of versus volume? Thanks.

speaker
Mark Baum
Chief Executive Officer

Yeah, so regarding ASP, I think the only, I'll answer the second question first. On ASP and net pricing, you know, 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 with a more sustainable and buoyant net pricing for Vivi, 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 Vivi sales force. In terms of the build and what we're seeing on the ground today for Vivi, 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 VBI on their formulary. And that alone, I think, began a 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 V-VI, and that's how we're set up for this year, and that's what you should expect.

speaker
Chase Knickerbocker
Analyst, Craig-Hallum Capital Group

Helpful, Mark. And just for my second question, another multi-parter, sorry, but just on the triessence phase three cataract announced this morning, you know, 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 triessence 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 and from this label expansion kind of within Cataract for triascents? And then second, I think investors often have kind of question on duration of opportunity with pass-through products in ASE. Can you just remind us or discuss the unique aspects of triascents that may allow for longer-term payment outside the bundle or how you plan to approach pricing there?

speaker
Mark Baum
Chief Executive Officer

Sure. You know, once again, I'll take the second question, the second part first. In terms of reimbursement for the product, TriEssence has 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 tri-essence 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, you know, 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 eyedrop-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 triessence 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 see is that for patients who are using this on label, which is a sub-segment 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, you know, triessence 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.

speaker
Mike Biega
Vice President, Investor Relations and Communications

Very helpful, Mark. Thank you very much.

speaker
Operator
Conference Operator

Thank you. Our next question comes from Timur Ivankov with Cantor Fitzgerald. Your line is open.

speaker
Timur Ivankov
Analyst, Cantor Fitzgerald

Yes, hi, thank you. This is Timur Ivankov on for Steve Seathouse. So first on IHESO, 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 Q226 ASP to be significantly lower? Thank you.

speaker
Mike Biega
Vice President, Investor Relations and Communications

Andrew, you want to take that?

speaker
Andrew Bull
President and Chief Financial Officer

Yeah. 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 Ihesa will be better than what it was in 2025 and in the first part of 2026.

speaker
Timur Ivankov
Analyst, Cantor Fitzgerald

Okay. Okay. Got it. And then the second question is on the triascence 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, you know, to dose the droplets in the treatment arm and the control arm? Thank you.

speaker
Mike Biega
Vice President, Investor Relations and Communications

Amir, can you handle that one?

speaker
Amir Choudhary
Chief Scientific Officer

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

speaker
Timur Ivankov
Analyst, Cantor Fitzgerald

Okay, thank you. I appreciate that.

speaker
Operator
Conference Operator

Thank you. Our next question comes from Mayank Mamthani with B Raleigh Securities. Your line is open.

speaker
Mayank Mamthani
Analyst, B. Riley Securities

Yes, good morning, team. Thanks for taking your questions and I appreciate the helpful go-forward guidance framework. So on VY 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 You know, the growth in the market, obviously, you know, multiple companies investing here on the penetration side, but also when you understand how you're thinking about share gains in both the cash pay and also obviously the commercial mixed markets. And then I have a follow up on iTunes as well.

speaker
Mark Baum
Chief Executive Officer

Sure. Yeah, so we have three goals for Vivi. 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 non-optimal therapies, for whatever reason, whether it's coverage or they're just not aware of Vivi, 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 Vivi offers, including now these enhanced coverage metrics. But in terms of what our goals are, to be clear, the first goal is we believe Vivi will be the number one cyclosporine in the U.S. market. Cyclosporine is the most trusted active ingredient in the dry eye market, and we aim to be the number one 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, you know, we don't care which one you choose, have an inflammatory component to them. And so we aim to be secondarily the number one 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 number one most prescribed dry eye product. Now, for the last couple of years, our competition has had a sales organization. You know, 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 the talent team is doing a great job. And there's just a lot of people that want to join Maria's team and sell Vivi. But in terms of specific market share percentages, We're not giving those goals. I think to be the number one cyclist born 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 number one cycle sport.

speaker
Mike Biega
Vice President, Investor Relations and Communications

Pat, do you want to add to that at all?

speaker
Patrick Sullivan
Chief Commercial Officer

Thanks, Mark. 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 Nevi 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 VBI's presence to really grow this product to be the number one cyclosporine. So, Mark, we're well on our way to building our next phase of growth for VBI.

speaker
Mayank Mamthani
Analyst, B. Riley Securities

And then, obviously, a lot going on here. ASV passed 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, you know, to contextualize its contribution to the guidance. Are you also thinking like Viva, this is a nine-digit revenue contributor for this year or is it more a reasonable target for next year?

speaker
Mark Baum
Chief Executive Officer

Yeah, I don't want to, I don't want to comment on the revenues for that product. I think the only product we've given guidance on specifically is Viva, which is clearly, you know, on the road to nine figures. Um, what I will tell you is this just as a reminder in 2024, we had absolutely zero retina presence. We didn't have a retina Salesforce. 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 called 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 have 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 year and a half, two 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 HARO is. I have to say another thing about iHESO specifically, because it is amazing what Allie 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 iHESO 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 IHESO in the intravitreal injection procedure. And we had all this anecdotal information, you know, doctors would tell us, How it performed you know some doctors had other benefits that they experienced from the product, including efficiency in their workflow. But what what I think you're going to see in the middle of the year, finally, for alley and her team is a data set. that will demonstrate the real difference between IHESO 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, you know, 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 IHESO 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 IHESO. And then, as Andrew said, that coupled with this new packaging format that's specifically for retina and a meaningfully improved price, you know, I think that by the end of next year, you know, you're going to hopefully be surprised at what we think we can generate from this particular product.

speaker
Mayank Mamthani
Analyst, B. Riley Securities

Thank you, Mark. And lastly, very quickly, the OpEx expansion, you know, 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 it a steady state OpEx spend? Andrew, you're trying to get at some point this year. Thanks for taking my question.

speaker
Mark Baum
Chief Executive Officer

Thank you, Mike.

speaker
Mayank Mamthani
Analyst, B. Riley Securities

Andrew, do you want to tackle the OpEx?

speaker
Andrew Bull
President and Chief Financial Officer

Yeah, absolutely. Thanks, Mike. And I want to be sure to note in Q4, in the P&L, there's an $8.5 million charge for acquired and process R&D, which was associated with the acquisition. Those are 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, pardon me. Go ahead. Looking forward at the OPAC spend, and Mike, I'm going to kind of break into the two parts. You've got the SG&A side, which We're adding 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 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 Bevi and Triessence, for that matter. From an R&D perspective, it's 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 triessence 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.

speaker
Mayank Mamthani
Analyst, B. Riley Securities

Glad to thank you.

speaker
Operator
Conference Operator

Thank you. Our next question comes from Lachlan Hanbury-Brown with William Blair. Your line is open.

speaker
Lachlan Hanbury-Brown
Analyst, William Blair

Hey, guys. Thanks for taking the questions. I guess first, would appreciate maybe a little more color on how you're thinking about the ISO 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, you know, looking a year or so out, it will have more than offset that. So, I guess, should we expect maybe a drop in Q2 in unit demand?

speaker
Mark Baum
Chief Executive Officer

Yeah, 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. You know, 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 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 can 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? 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.

speaker
Mike Biega
Vice President, Investor Relations and Communications

Okay. Thanks for that.

speaker
Lachlan Hanbury-Brown
Analyst, William Blair

It's good color. I guess the second question is just on VIVA and the new coverage, Just wondering what you see 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 you know, previously paying cash pay or maybe you'd previously managed to get coverage for them who are now just converting to be, you know, sort of covered more easily?

speaker
Mark Baum
Chief Executive Officer

Yeah, I can't say specifically with numbers, you know, what percentage or what number of patients are converting. You know, I can sort of echo what we've said in the past in that You know, in 2025, there were a lot of patients who we received prescriptions for, but, you know, 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 know, you're talking about, you know, well north of 30 million new covered lives where you have, you know, the best access for Vivi 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.

speaker
Patrick Sullivan
Chief Commercial Officer

Yeah, thanks, Mark. And I think, you know, the core to our next phase of growth for VBI is really around, you know, driving new growth for VBI. We know better is possible when it comes to managing dry disease, as Mark mentioned. And our main focus going forward is ultimately to, you know, win the new-to-brand patients. And I think, you know, 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, 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 suboptimal treatments. VBI 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.

speaker
Mike Biega
Vice President, Investor Relations and Communications

Great. Thanks.

speaker
spk01

Thank you.

speaker
Operator
Conference Operator

Our next question comes from Tom Schrader with BTIG. Your line is open.

speaker
Tom Schrader
Analyst, BTIG

Good morning. Thanks for all the updates. This Fascinating time. On the Vivi Salesforce, after your increase, where does that put you relative to competitors like Mibo? Would you be on an equal playing field? And then just a remedial question on the Melt franchise. Are you still wedded to two 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 two products? Thank you.

speaker
Mark Baum
Chief Executive Officer

Yeah. So, you know, I'll take the first question. In terms of the Levi's Salesforce, I actually, you know, we don't know exactly how many, reps uh you know these competitors have uh out in the field that you know we've heard that you know one of our competitors competitors that has uh you know a pretty sizable market share has upwards of 300 people so we're going to have around 100 ourselves what i can tell you is that our reps are so powerful that one hero rep with vivi is equal to four 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. This is the second phase of our expansion. So this, you know, 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, you know, we're excited to have this sales force 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, you know, 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, 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, you know, 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, You know, 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 Gmail in cataract surgery, but also for other other procedures where, you know, 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, you know, 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 Gmail. 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 and, you know, for endoscopy. It's used in dermatology, plastics, dental, widely used in dental. It's used to deal with claustrophobia and 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 two 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 three different, ultimately be available in a number of different strengths.

speaker
Tom Schrader
Analyst, BTIG

If I can sneak in one follow-up. The new triacids, 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?

speaker
Mark Baum
Chief Executive Officer

It's purely for the eye. You know, we started our company in 2014. Our first sale was with triamcinolone acidenide for injections. And this is a product category and an active ingredient we know really, really well. You know, our compounded formulation, once again, the enthusiasm for triessence for us comes from our experience having sold Trimoxi in well over a 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 eyedrop-free eventually for cataract surgery patients, which is really where the market needs to go.

speaker
Tom Schrader
Analyst, BTIG

Thanks for all the call. Thanks, Tom.

speaker
Operator
Conference Operator

Thank you. Our next question comes from Thomas Flatton with Lake Street Capital Markets. Your line is open.

speaker
Thomas Flatton
Analyst, Lake Street Capital Markets

Hey, good morning, guys. I appreciate you taking the question. Following up on Vivi, with respect to the Salesforce 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 expectations?

speaker
Mark Baum
Chief Executive Officer

I'll take the second one first, and then I'll flip the first to Pat. But, you know, in terms of the Salesforce, actually, pardon me.

speaker
Mike Biega
Vice President, Investor Relations and Communications

Your second, Salesforce expansion, and what else, Thomas?

speaker
Thomas Flatton
Analyst, Lake Street Capital Markets

The ophthalmology versus optometry.

speaker
Mark Baum
Chief Executive Officer

Yeah, ophthalmology. Yeah. So, ophthalmology and optometry, believe it or not, You know, the optometric market is a critical market. I would say that, you know, 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 Salesforce expansion specifically?

speaker
Patrick Sullivan
Chief Commercial Officer

Yeah. 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 V by has done for disease patients to date. And I think 1 of the 1st 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 Salesforce expansion, but it is about DeFi'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, you know, 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 Vivi is poised for significant growth going forward, but it'll be about how we want to put a new Vivi 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 number one goal, of being a number one cyclosporine, a number one 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. Got it.

speaker
Mark Baum
Chief Executive Officer

And Thomas, just as a practical matter, look, we need to get salespeople in these offices. They need to see their BVI 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 HARO V-VI 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 V-VI. And I think you're going to see that throughout the year.

speaker
Thomas Flatton
Analyst, Lake Street Capital Markets

And Mark, to follow up on the last commentary on 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?

speaker
Mark Baum
Chief Executive Officer

Well, right now we are completely focused on two things. One is Amir and his team building this data set. I've put a bounty on him getting that NDA in sooner than he even thinks he's able to get it in. And I'm hopeful that, you know, we can hopefully, you know, we can beat some of these timelines 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, and 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 non-opioid non-IV sedation medicament, the opportunity in ophthalmology is very large. You know, it's billions of dollars per year where our competition is IVs and opioids. I mean, the data, there's a Duke study, there's 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, you know, 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.

speaker
Mike Biega
Vice President, Investor Relations and Communications

Got it. Appreciate it. Thank you.

speaker
Operator
Conference Operator

Thank you. Our next question comes from Jeffrey Cohen with Leidenberg Dallman & Company. Your line is open.

speaker
Jeffrey Cohen
Analyst, Ladenburg Thalmann & Co.

Hey, good morning. Thanks for taking our questions. I guess two from Aaron. Firstly, Mark or Andrew, could you comment any on margins and or tariffs and ramifications throughout 2026, or any net changes that you're seeing now from 25? Andrew, you want to tackle tariffs, margins?

speaker
Andrew Bull
President and Chief Financial Officer

Yeah, Andrew. From 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 re-looked 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 to answer your question more directly, we're not expecting to see any impact on margins as it relates to tariffs this year.

speaker
Jeffrey Cohen
Analyst, Ladenburg Thalmann & Co.

Got it. And then secondly, any commentary on your major expected launch on Bioavis? as far as preparations and commercial organization and how that might look like mid-year?

speaker
Mike Biega
Vice President, Investor Relations and Communications

Andrew, you want to touch on that at all?

speaker
Mark Baum
Chief Executive Officer

Anything you want to add? I think we're ready to go. I think we start realizing revenue and the team's got a very unique strategy. Andrew, do you want to touch on that or Pat?

speaker
Andrew Bull
President and Chief Financial Officer

Yeah, I can touch on a little bit and then hand it over to Pat. The, you know, Jeff, we're really leveraging the existing Retina team with that launch. There's some incremental costs that'll 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 BioViz right away in the middle of this year, which is a Lucentis-referenced biosimilar. And then you may have recently seen the same thing announced. It's entered into a settlement with the innovator drug for ILEA. And so we'll be able to get into the market a little earlier than we expect 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 or new revenues. Pat, do you want to add anything?

speaker
Patrick Sullivan
Chief Commercial Officer

Thanks, Andrew. I think the one thing to add is, you know, as Mark mentioned, you know, we're really excited to get this going. You know, 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've made significant strides in growing our retina business, and this is going to, you know, help us significantly with our presence in 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, you know, we're super excited about BioViz going forward.

speaker
Mike Biega
Vice President, Investor Relations and Communications

Perfect. I have a particular question. Thanks, Jeff.

speaker
Operator
Conference Operator

Thank you.

speaker
spk01

Our next question comes from Yi Chen with HB Wainwright.

speaker
Yi Chen
Analyst, H.C. Wainwright & Co.

Thank you for taking my questions. 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? Thank you.

speaker
Mike Biega
Vice President, Investor Relations and Communications

Yes. Thanks for the question.

speaker
Mark Baum
Chief Executive Officer

You know, 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 uh you know attain the market share that we expect to uh to uh 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 BioViz. 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 is, as Pat said, has a tremendous background in relationships. And this market is going to be successful in helping us get to our goals. But we don't have, you know, you know, we're trying to get about a handful of percentage points of market share, which is what we've said historically.

speaker
Andrew Bull
President and Chief Financial Officer

Thank you. I can add a little bit to 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. We 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 this comprehensive package of products where we totally support the practice and focusing on the patient experience.

speaker
Yi Chen
Analyst, H.C. Wainwright & Co.

Got it. Thank you.

speaker
Operator
Conference Operator

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

speaker
Mark Baum
Chief Executive Officer

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 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 better. 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 Hero. 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.

speaker
Operator
Conference Operator

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

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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