Harrow (HROW) Q4 2025 Earnings Call Transcript

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DATE

Tuesday, March 3, 2026 at 8 a.m. ET

CALL PARTICIPANTS

• Chief Executive Officer — Mark L. Baum
• President and Chief Financial Officer — Andrew R. Boll
• Chief Commercial Officer — Patrick Sullivan
• Chief Scientific Officer — Amir Shojaei
• Vice President of Investor Relations and Communications — Michael Biega

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TAKEAWAYS

• Revenue -- $89.1 million for the quarter, a 33% increase year over year.
• Full-Year Revenue -- $272 million, up 36%, reflecting strength across the branded portfolio and improved commercial execution in the second half.
• Adjusted EBITDA -- $24.2 million for the quarter and $61.9 million for the year, representing 54% growth.
• Cash From Operations -- Nearly $44 million generated in 2025; year-end cash and cash equivalents totaled $72.9 million.
• BYOOVIZ Revenue -- $25.9 million in the quarter (up 14% sequentially), $88.7 million for the year (216% year-over-year growth).
• IHEEZO Revenue -- $35.9 million in Q4, $81.3 million for the year, representing 64% quarter over quarter and 65% year-over-year growth.
• TRIESENCE Revenue -- $5.1 million in Q4 (36% sequential growth), $9.9 million for the year, up 193%.
• Rare Specialty and Compounded Portfolio Revenue -- $22.2 million in Q4, $92.3 million for the full year.
• 2026 Revenue Guidance -- $350 million-$365 million, with first half revenue of $133 million-$153 million and second half revenue of $203 million-$226 million expected.
• 2026 Adjusted EBITDA Guidance -- $80 million-$100 million, with majority generated in the second half of the year.
• SG&A Guidance -- Expected to increase to $185 million-$205 million in 2026, driven by sales force expansion and new launches; approximately 100 new sales roles will be added in the first half.
• R&D Expenses Guidance -- Projected to rise to $30 million-$35 million in 2026 for product studies and post-market research.
• Compounded Portfolio Guidance -- Revenue anticipated to be $60 million-$65 million in 2026, with Q1 softest as inventory constraints resolve.
• IHEEZO Dynamics -- Pass-through status loss in April will impact ASC market (30% of 2025 units), but retina and in-office channel expansion is expected to offset and exceed impact.
• VEVYE Commercial Update -- 115% increase in prescribers, coverage expanded as of January 1, and sales force size on track to double by Memorial Day.
• New Product Launch Timing -- BYQLOVI and BYOOVIZ launches planned in 2026 to expand retina and specialty footprint.
• G-MELT and YOCHIL -- NDA submission for G-MELT on track for early 2027; YOCHIL targets a separate, higher unit volume segment.
• TRIESECE Sales Effort -- Dedicated sales force doubling underway; nearly half Q4 ordering accounts were new, with post-cataract label expansion study initiated following IND clearance.

SUMMARY

Management outlined a 2026 revenue range of $350 million-$365 million and forecasted a more pronounced second-half weighting, driven by expanded sales forces, new product launches, and improved access for VEVYE. The company expects operating leverage to continue as both SG&A and R&D spend rise to support sales expansion, with adjusted EBITDA guidance of $80 million-$100 million for the year. Revenue contributions from the compounded portfolio are expected to decrease due to a strategic shift toward FDA-approved branded alternatives, while momentum in retina and in-office channels for IHEEZO is expected to counterbalance ASC headwinds. G-MELT's NDA timeline was reaffirmed for early 2027, and an IND-cleared study to expand TRIESENCE’s label into the cataract market was initiated, targeting a large new patient population.

• Mark L. Baum stated, "For the first time, all of our core growth drivers accelerated simultaneously" and confirmed the target to "exceeding $250 million in quarterly revenue by the end of 2027."
• Andrew R. Boll disclosed that "compounded revenue to be approximately $60 million-$65 million for the full year, with Q1 the softest quarter as we exit the final stages of the inventory shortage."
• "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," according to Andrew R. Boll.
• Amir Shojaei confirmed that a Phase 4, 240-patient IHEEZO trial is underway, with data expected by year-end to support further adoption in intravitreal injection procedures.
• Management guided that the pass-through loss for IHEEZO in ASCs is expected to be fully offset through expansion into a "2.5 million unit" addressable in-office market, referencing a discrete commercial strategy for conversion.

INDUSTRY GLOSSARY

• ASC (Ambulatory Surgery Center): An outpatient healthcare facility where surgeries not requiring hospital admission are performed, referenced for IHEEZO reimbursement and channel dynamics.
• TAM (Total Addressable Market): The total revenue or unit volume opportunity available within a specific drug or procedure area, used when discussing expansion for IHEEZO and G-MELT.
• NDA (New Drug Application): Formal proposal for FDA approval to market a new pharmaceutical; critical for G-MELT’s regulatory timeline.
• Pass-through Status: Temporary Medicare reimbursement allowing separate payment for certain drugs/devices, relevant to expected changes for IHEEZO in the ASC setting.
• IND (Investigational New Drug application): Regulatory submission allowing clinical trial initiation for new drugs in the U.S., referenced for TRIESENCE and IHEEZO studies.

Full Conference Call Transcript

Michael Biega: Good morning. Welcome to Harrow Health, Inc.'s fourth quarter and full year 2025 earnings conference call. My name is Michael Biega, Vice President of Investor Relations and Communications, and I am 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 Health, Inc.'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 Health, Inc.'s results may differ materially from those projected. Harrow Health, Inc. 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 L. Baum, Chief Executive Officer, Andrew R. 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 L. Baum: Good morning. Thank you for joining us. Over the past five years, Harrow Health, Inc. has undergone a fundamental transformation. Harrow Health, Inc. now owns one of the largest portfolios of prescription ophthalmic products in the United States market. 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 will note in my letter to stockholders, I am proud of the fact that during the last five years, hundreds of members of the Harrow Health, Inc. 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 Health, Inc. stock price during this period. As a founder and a large Harrow Health, Inc. 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. This team is not done, and frankly, we have only just begun.

I cannot guarantee where our stock price will be five years from now. However, I can say with nearly absolute certainty that Harrow Health, Inc. 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. I predict we will also sell many more units of other products that many stockholders have not 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.

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 YOCHIL, will be approved for marketing. 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 medicaments for sedation and anxiety. It is a very large market. 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.

Mark L. Baum: 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 have assembled, the pipeline we have advanced, and the commercial infrastructure we have built were designed for scale. This is not a single product company or a single product story. We are meaningfully diversified. Our commercial platform is built for durability, operating leverage, and sustained growth. Today, Harrow Health, Inc. operates as one Harrow Health, Inc., 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.

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. 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 are 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 have to see what the data says. These 2026 activities should further enhance financial performance.

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. Because of the origin of the revenue, it is likely highly sustainable.

It is not easy to get a product like TRIESENCE added to a surgical treatment protocol. 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 momentum. On a related topic, for years, I have 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 that 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 onto 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 positions at Harrow Health, Inc. on the TRIESENCE team. This is really good news.

Mark L. Baum: Now on to our rare specialty and compounded products. Behind the scenes, believe it or not, we have 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 discussed 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. 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 will be able to supply the market adequately given the historically lower volumes that this product has required. 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.

Mark L. Baum: A few final points. In 2026, we will also launch two 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 Health, Inc. 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.

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 R. Boll: Good morning, everyone. I will 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 branded 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.

Andrew R. Boll: Moving on to our core growth drivers. Starting with BYOOVIZ, 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 and ocular 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.

Andrew R. Boll: 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 IHEEZO resulted in approximately one and a half 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.

Andrew R. Boll: 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 win 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, derive 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-$205 million from 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 will 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.

Andrew R. Boll: We also expect R&D expenses to increase this year to approximately $30 million-$35 million as we complete studies required for the 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 have 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.

Andrew R. Boll: 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 tailwind as a complementary product to BYOOVIZ. 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. 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 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 revenue to be approximately $60 million-$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. I will turn the call over to Patrick Sullivan.

Patrick Sullivan: 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. 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 nine 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. 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.

Patrick Sullivan: 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. 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 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. Early engagement has been encouraging, supported by a dedicated commercial effort and our existing relationship in the office-based channel.

Patrick Sullivan: 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. 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 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 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 will turn it over to Amir.

Amir Shojaei: Thanks, Pat. I would like to turn to our pipeline, which we believe represents a compelling long-term value driver for Harrow Health, Inc. The next phase of growth is highly focused and capital efficient. We are 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 do not know about yet, I am only going to focus today on G-MELT, formerly known as MELT-300, and the ongoing IHEEZO study. 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 timelines.

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.

Amir Shojaei: Pipeline value also comes from expanding the evidence base for marketed products, including IHEEZO. I am amazed that our team has been so successful with IHEEZO 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 IHEEZO want to see specific data based on procedures they need IHEEZO for, namely intravitreal injections. 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 can see the quote he provided us with on the bottom left of the slide. For our own Harrow Health, Inc.-sponsored IHEEZO study, my team has put together a Phase 4 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 Health, Inc.'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 Health, Inc. for continued growth. With that, I will turn it over for questions.

Operator: Thank you. If you would like to ask a question, please press star one. If your question has been answered and you would like to remove yourself from the queue, please press star one again. We will now open for questions. Our first question comes from Chase Richard Knickerbocker with Craig-Hallum. Your line is open.

Chase Richard Knickerbocker: Good morning, team. Appreciate the candid thoughts in the shareholder letter and thanks for taking the questions here. Mark, you kind of mentioned in the letter that you expect, you know, kind of continued commercial growth and commercial mix improvement for VVI kind of through the year. What have you seen so far from a commercial mix perspective in Q1? Can you walk us through what your ASP assumptions or direction of ASP for VVI is in the 2026 guide kind of versus volume? Thanks.

Mark L. Baum: Yeah. Regarding ASP, I think I will answer the second question first. On ASP and net pricing, you know, the only comment that we have 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. Nevertheless, as I said in the letter to stockholders, we saw that direction of travel and we eventually got there. With a more sustainable and buoyant net pricing for VVI, that coupled with some of the things that we are seeing on the commercial side with this new coverage, we have initiated this program to more than double the VVI sales force.

In terms of the build and what we are 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 have said in the past that CVS had actually sent out letters to thousands and thousands of eyecare professionals around the United States alerting them to the new positioning, the preferred positioning for VEVYE on their formulary. That alone, I think began the positive momentum that we are also seeing a little bit in the first quarter.

What I can say regarding the first quarter is that typically it is a weaker period and we are quite surprised with, you know, the new prescription volumes that we are 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. 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.

For us, building those new prescriptions, ultimately leads to more and more total prescriptions and more revenue. We are bent towards building volume in VEVYE, and that is how we are set up for this year, and that is what you should expect.

Chase Richard Knickerbocker: Helpful, Mark. Just for my second question, another multipart just on the TRIESENCE Phase 3 cataract announced this morning. You know, obviously a large potential volume opportunity. Just a couple of questions to help us understand the magnitude. What % 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? 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 L. Baum: Sure. You know, once again, I will take the second question, the second part first. In terms of reimbursement for the product, TRIESENCE has a very unique label in that it is both used in the office setting of care, and it is also used in the hospital and outpatient department setting of care. As a result of that, and I do not 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. 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 eye drop-free procedure. That is what I would want my mother to have. That is 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 is assuming you are using an FDA-approved product, of course. That should be the ideal, and that is what we are working towards.

That is what the G-MELT is about, and that is what this expansion with TRIESENCE is about. It is about putting power in the hands of the surgeon to deliver the anti-inflammatory into the eye so that the patient does not need to administer these post-surgical eye drops. What is interesting is, anecdotally, what we see is that for patients who are using this on label, which is a subsegment of the cataract surgery population, it is those patients who really cannot 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.

What is terrific is, as I said, we have got reimbursement. We have an exceptional clinical outcome. With this amazing study that Amir and his team are going to execute, we are 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. Here is the best thing for consumers, for patients: It has the lowest out-of-pocket of any injectable steroid at around $37 per unit.

It is affordable, it is accessible, it is highly efficacious, and we are 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. In the United States, by the time this data reads out, that should be about 5 million procedures annually. It is a very large market opportunity. As I have said for a couple of years, you know, TRIESENCE is a slow grower. We have got a lot to prove there for sure, but this is a product that in the next couple of years is gonna be a meaningful value driver for our stockholders.

Chase Richard Knickerbocker: Very helpful, Mark. Thank you very much.

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

Timur Ivannikov: Yes. Hi, thank you. This is Timur Ivannikov on for Steven James Seedhouse. 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 2026 or from Q4 2025? Do you expect Q2 2026 ASP to be significantly lower? Thank you.

Mark L. Baum: Andrew, you want to take that?

Andrew R. Boll: Yeah. I 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: Okay. Okay, got it. 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 anti-inflammatory eye droplets in both groups? I mean, are you allowed to, you know, dose the droplets in the treatment arm and the control arm? Thank you.

Mark L. Baum: Amir, can you handle that one?

Amir Shojaei: Yeah. Hi. I think the protocol design is pretty clear. We are gonna have a control arm which will not get the TRIESENCE. What we do have rescue criteria already built in. Rescue criteria would allow drops again, per protocol.

Timur Ivannikov: Okay. Thank you. Appreciate that.

Operator: Thank you. Our next question comes from Mayank Mamtani with B. Riley Securities. Your line is open.

Mayank Mamtani: Yes. Good morning, team. Thanks for taking the questions and appreciate the helpful go forward guidance framework. 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, you know, we can understand, you know, the growth in the market? Obviously, you know, multiple companies investing here on the penetration side, but also want to understand how you are thinking about share gains in both the cash pay and also obviously the commercial mix markets. I have a follow-up on IHEEZO.

Mark L. Baum: Sure. Yeah. We have three goals for VEVYE. First of all, I just want to say that the dry eye market in the U.S. is, Pat said, a very large market. We believe it still continues to be under-penetrated, 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.

When we see that patients are getting access to these non-optimal therapies, for whatever reason, whether it is coverage or, they are just not aware of VEVYE, we see that as opportunity, to convert those patients to a therapy that does not burn and sting and that has all of the positive benefits that VEVYE offers, including now these enhanced coverage metrics. In terms of what our goals are, to be clear, the first goal is we believe VEVYE 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 in it that would be an anti-inflammatory. We believe all forms of dry eye disease, you know, we do not care which one you choose, have an inflammatory component to them. We aim to be secondarily the number one anti-inflammatory. Eventually, and it is not gonna happen overnight, we think we have the opportunity with this particular product to be the number one most prescribed dry eye product.

For the last couple of years, our competition has had a sales organization, you know, that even the most inferior products in the market have had much larger sales organizations than we have had. We are now, as I said, more than doubling our sales force. I think we are more than halfway there. I am actually surprised. The talent team is doing a great job. There is just a lot of people that want to join this Maria's team, sell VEVYE. In terms of specific market share percentages, we are not giving those goals. I think to be the number one cyclosporine in the market, we probably need to have just north of 20% market share.

That gives you a sense of what we think is achievable. By the way, in many markets we are already there. The problem 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, you... There are many other markets where you just simply do not have that level of market share. With this enhanced sales force now, numbering close to about 100, we will touch more markets. We will increase our market share, I believe, and we will get closer and closer to that goal of being the number one cyclosporine.

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

Patrick Sullivan: Thanks, Mark. I think, you know, one of the things we are most optimistic about, as we stated in our earnings, is the increase in writing that we see. We saw 115% growth in our writing. I think as Mark mentioned, the feedback that we receive 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 number one cyclosporine.

Mark, we are well on our way to building our next phase of growth for VEVYE.

Mayank Mamtani: On IHEEZO, obviously a lot going on here. ASC pass-through status expiration, but also price per unit improvement that you mentioned. There is also some data generation activity you noted at ASRS conference middle of the year. Was just curious, you know, 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 L. Baum: Yeah, I do not want to comment on the revenues for that product. I think the only product we have given guidance on specifically is VEVYE, which is clearly, you know, on the road to nine figures. What I will tell you is this. Just as a reminder, in 2024, we had absolutely zero retina presence. We did not have a retina sales force. We did not have any products in that market. Only a couple of years ago did we hire that sales organization.

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 Health, Inc. was. We had no presence in that market. It is a very tight community, the retina community. 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 Health, Inc. is, they really know who Harrow Health, Inc. 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 is really exciting is what Amir talked about with the DANG study. What Ali has wanted for well over a year, we have had numerous conversations, is specific data related to the performance of IHEEZO in the intravitreal injection procedure. 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. What I think you are gonna 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. I have to tell you, if you are a patient getting these injections, the anesthesia and pain control really matters. We think we have a product, at least anecdotally, we have received tremendous information from accounts that use this product about its performance.

In the middle of the year at ASRS, and he got a late breaker, by the way. I mean, it is not easy to get these. 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. In terms of 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.

As Andrew said, that coupled with this new packaging format that is specifically for retina and a meaningfully improved price, you know, I think that by the end of next year, you know, you are gonna hopefully be surprised at what we think we can generate from this particular product.

Mayank Mamtani: Thank you, Mark. Lastly, very quickly, the OpEx expansion, you know, you are seeing your R&D was higher in fourth quarter. Is it sort of a first half loaded kind of dynamic? Is it a steady state OpEx spend, Andrew, you are trying to get at some point this year? Thanks for taking my question.

Mark L. Baum: Thank you, Mike. Andrew, do you want to tackle the OpEx?

Andrew R. Boll: Yeah, absolutely. Thanks, Mike. I want to be sure to note in Q4, in the P&L, there is an $8.5 million charge for acquired and processed R&D, which was associated with the Melt acquisition. Those are upfront costs and some of the transaction costs associated with the deal. None of that acquisition cost was capitalized. It all ran through the P&L and ran through R&D according to GAAP rules. We also did not back it out or add it back in, I should say, to the EBITDA number for 2024. Kind of looking forward.

Mark L. Baum: The adjusted.

Andrew R. Boll: The adjusted EBITDA, pardon.

Mark L. Baum: Go ahead.

Andrew R. Boll: The-

Mark L. Baum: Yeah.

Andrew R. Boll: Looking forward at the OpEx spend, Mike, I am gonna kind of break it into two parts. You have got the SG&A side, which we are adding that sales heads right now. We have been adding them aggressively in Q1. We will continue to add them in Q2. We have also been preparing. We are preparing from a marketing and promotion standpoint, which is also increasing that spend. We are kinda trying to get ahead of a lot of that as well, so that when these people get hired and trained, they are hitting the ground running with VEVYE. 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 year of R&D spend year-over-year. As we put out this announcement this morning regarding the TRIESENCE 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. We will 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.

Mayank Mamtani: Got it. Thank you.

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

Lachlan Hanbury-Brown: Hey, guys. Thanks for taking the questions. I guess first, would appreciate maybe a little more color on how you are thinking about the IHEEZO dynamics in 2026. 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? I guess should we expect maybe a drop in Q2 in unit demand?

Mark L. Baum: I do not want to be specific about demand in any particular quarter other than to say that in Q4, Q1, Q2, Q3, I think I have said this, we expect demand to continue to increase. Demand continues to increase. That is separate from revenue recognition, but demand for the product does continue to increase. In terms of when we are 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 are losing relative to the overall opportunity that we are adding when we add these in-office opportunities with this 2.5 million unit increase to our TAM, it is such a small level of success. We have a discrete team going into the same customers that are using it in the ASC that do not know that they can use it also in their clinics. You know, remember, every one of the doctors that is using it in the ASC is a surgeon. They also only spend a day or two a week in the surgical operating room.

The rest of the week, they spend in their office doing procedures. It is a simple idea. We are going to the same customers that are using the product satisfactorily in the ASC. We are saying, "Hey, you are doing more procedures in your office than you are doing in the, in the surgical suite." It is not for every procedure, but for those procedures where this can be impactful, we are going to the same customers and trying to convert their in-office business.

It is such a small number of units, as I said, that we do not have to really be that successful to fully offset the entirety of what we are losing when we lose the temporary pass-through code. Is that gonna happen in the first quarter or the second quarter? No. I doubt it. It should happen throughout the year. As I said, it is 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: Okay. Thanks for that. It is good to call it. I guess second question is just on VEVYE and the new coverage. Just wondering what you are 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, you know, previously paying cash pay or maybe you previously managed to get coverage for them who are now just converting to be, you know, sort of covered more easily?

Mark L. Baum: Yeah. I cannot say specifically with numbers, you know, what % or what number of patients are converting. You know, I can sort of echo what we have said in the past and 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. We are 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 are talking about, you know, well north of $30 million new covered lives where you have, you know, the best access for VEVYE now. We have to see how things play out. I think based on what we are seeing in the first quarter, we thought we would not be where we are.

We are 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 will have more and more of that new to brand. I can, I do not want to steal Pat's thunder, but Pat, do you want to actually talk about the whole new to brand? I know that is really been a focus of yours.

Patrick Sullivan: Thanks, Mark. I think, you know, the core to our next phase of growth for VEVYE is really around, you know, driving new growth for VEVYE. We know better is possible when it comes to managing dry eye disease, as Mark mentioned. Our main focus going forward is ultimately to, you know, win the new-to-brand patients. I think, you know, that is gonna be a heavy focus for us. 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 eye disease symptoms or are having unresolved or persistent symptoms on other suboptimal 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. 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.

Mark L. Baum: Great. Thanks.

Operator: Thank you. Our next question comes from Thomas Eugene Shrader with BTIG. Your line is open.

Thomas Eugene Shrader: Good morning. Thanks for all the updates. This fascinating time. 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? 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 is the combination. Does your compounding business inform you that there really is a need for two products? Thank you.

Mark L. Baum: Yeah. You know, I will take the first question. In terms of the VEVYE sales force, You know, we do not know exactly how many reps, you know, these competitors have out in the field. You know, we have heard that, you know, one of our competitors that has, you know, a pretty sizable market share has upwards of 300 people. We are gonna have around 100 ourselves. What I can tell you is that our reps are so powerful that one Harrow Health, Inc. rep with VEVYE is equal to 4 of theirs. I am kidding. We really do have a terrific sales organization that is well trained, and they have an outstanding product to sell.

This is the second phase of our expansion. 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. You know, we are excited to have these, this sales force more than doubling here in the near term. I am also pleased with the quality of people we have been able to attract, and those that we have, 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 have 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 are gonna discontinue the compounded version of the product, and we will hopefully convert all of that business into, you know, an FDA-approved and hopefully reimbursable product. It is very hard, as I have said over the years, to sell compounded medications. They are not FDA-approved.

They do not have a label, particularly in anesthesia and sedation, where an anesthesia professional is, you know, gonna think twice or three times about whether or not they are gonna use a compounded formulation. 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, you know, and 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.

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 G-MELT. The G-MELT will be used certainly in cataract surgery, which is what we are studying it for. We also believe it will be used, as the compounded product is used in ENT, and you know, for endoscopy. It is used in dermatology, plastics, dental, widely used in dental.

It is used to deal with claustrophobia in MRI tubes. So that is the experience that we have with the MKO Melt, the compounded version. Our expectation is that the G-MELT, when it is approved, eventually will be used in markets outside of ophthalmology, which happen to be even bigger markets than the ophthalmic market. The answer is yes, we need two products. They serve different markets. One is specifically related to anxiety. It will also, as I said, be available. I said this, I think, in the letter to stockholders ultimately be available in a number of different strengths.

Thomas Eugene Shrader: If I can sneak in one follow-up. The new TRIESENCE, I mean, it seems like it is 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 L. Baum: It is purely for the eye. You know, we started our company in 2014. Our first sale was with triamcinolone acetonide for injection. This is a product category and an active ingredient we know really, really well. You know, our compounded formulation, once again, the enthusiasm for TRIESENCE for us comes from our experience having sold Tri-Moxi in, you know, well over 1 million cataract surgery. It is a market we know well. It is 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.

Thomas Eugene Shrader: Great. Thanks for all the color.

Mark L. Baum: Thanks, Tom.

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

Thomas Slayton: Hey, good morning, guys. Appreciate you taking the question. 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 is 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 L. Baum: I will take the second one first, then I will flip the first to Pat. You know, in terms of the sales force. Actually, pardon me. I do not. Your second sales force expansion and what else, Thomas?

Thomas Slayton: The ophthalmology versus optometry component.

Mark L. Baum: Yeah. Ophthalmology. Yeah. 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 is what the data that I am seeing shows. Pat, do you want to talk about the sales force expansion specifically?

Patrick Sullivan: Yeah. Thanks, Mark. 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. I think, you know, one of the first things we do is, you know, 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 are 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 active category that is large, growing and active. 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 is gonna take not only having our current territories be very efficient, but also our expansions. We are being very, very thoughtful in how we are, one, putting our footprint together.

I think the key takeaway here is VEVYE is poised for significant growth going forward, but it will be about how we, one, put a new VEVYE presence in front of our customers. That one is, you know, 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 and number one dry eye disease treatment. To your question, very thoughtful on how we will drive that business to maintain our aims and our growth going forward.

Mark L. Baum: Thomas, 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 is what this is about. We know where the high value targets are. We know who is prescribing dry eye disease. We know who is looking for dry eye disease. This expansion is gonna allow more Harrow Health, Inc. VEVYE reps to get in those offices far more frequently. You know, our data demonstrates very clearly that when we do that, we end up with more prescriptions for VEVYE. I think you are gonna see that throughout the year.

Thomas Slayton: 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 deal making to get MELT, you know, appropriately exploited in those opportunities that are outside ophthalmology?

Mark L. Baum: Well, right now we are completely focused on 2 things. One is Amir and his team building this data set. I have put a bounty on him getting that NDA in sooner than he even thinks he is able to get it in. I am hopeful that, you know, we can hopefully, you know, we can beat some of these timelines that we have laid out. It is 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 know, you are talking about 5 million use cases minimally per year, and that is just really cataract surgery. If you tack on glaucoma surgeries and other relevant procedures, you know, you can add another couple of million procedures. For a reimbursed non-opioid, non-IV sedation medicament, the opportunity in ophthalmology is very large. You know, it is billions of dollars per year where our competition is IVs and opioids. The data, there is a Duke study, there is a Mayo study, the data is clear. Patients today are getting dosed with fentanyl for sedation during cataract surgery in particular. We aim to change that.

We have got to build our commercial strategy for the G-MELT, and that is underway, so that is 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 is a partnership that is revealed or an opportunity like that is revealed, we will certainly pursue it. We have such a big revenue opportunity with the G-MELT in ophthalmology that we need to really stay focused on that, and that is what we are going to do.

Thomas Slayton: Got it. Appreciate it. Thank you.

Operator: Thank you. Our next question comes from Jeffrey Scott Cohen with Ladenburg Thalmann & Company. Your line is open.

Jeffrey Scott Cohen: Hey, good morning. Thanks for taking our questions. I guess 2 from our end. Firstly, Mark or Andrew, could you comment any on margins and/or tariffs and ramifications throughout 2026 or any net changes that you are seeing now from 25?

Mark L. Baum: Andrew, you want to tackle tariffs and margins?

Andrew R. Boll: Yeah. Hey, Jeff.

Jeffrey Scott Cohen: Hey.

Andrew R. Boll: Yeah, on the tariff side, we are not expecting much impact. I think the analysis we did last year was kinda almost in a worst-case scenario when we kind of relooked at things, and we are doing that on a continual basis. The analysis we did last year is still holding strong, and actually we are in better shape than we would have been last year in that worst-case scenario around Liberation Day. To answer your question more directly, we are not expecting to see any impact on margins as it relates to tariffs this year.

Jeffrey Scott Cohen: Got it. 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 L. Baum: Andrew, you want to touch on that at all? Anything you want to add there? I think we are 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?

Andrew R. Boll: I can touch on a little bit and then hand it over to Pat. Jeff, we are really leveraging the existing retina team with that launch. There is some incremental costs that will go into that. We will have some variable costs as we get the hub up to help support the product. We are really excited to get that thing going. We have got a great partner in Samsung as well that is helping us, helping us as we prep. This is a very dynamic market. We are going to be getting in with BYOOVIZ right away in the middle of this year, which is a Lucentis-referenced biosimilar.

Then, you may have recently seen that Samsung announced it is entered into a settlement with the innovator drug for EYLEA. We will 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. From a spend perspective, like I said, we will 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 accretive to earnings on new revenues. Pat, do you want to add anything?

Patrick Sullivan: Thanks, Andrew. I think the one thing to add is, you know, as Mark mentioned, you know, we are 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. 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, you know, help us significantly with our presence in growing the value of that franchise.

We are actively right now preparing the market and targeting our business to take off here in the middle of this year. You know, we are super excited about BYOOVIZ going forward.

Jeffrey Scott Cohen: Terrific. Thanks for taking my questions.

Mark L. Baum: Thanks, Jeff.

Operator: Thank you. Our next question comes from Yi Chen with H.C. Wainwright.

Yi Chen: 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.

Mark L. Baum: Yes. Thanks for the question, Yi. You know, as I think Andrew referenced and as Pat discussed, I think as you know, it is a highly dynamic market. It is competitive, we have a unique place in the market with our Lucentis referenced biosimilar. At this point, I really do not want to reveal specifically how we are going to, you know, 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 are not playing to get 30% market share with BYOOVIZ.

We are playing to get a handful of percentage points of market share in this market, which is the largest market in ophthalmology by revenue. Our expectations are quite modest, and we believe that the strategy that we are going to employ, with the team that we have, which as Pat said, has a tremendous background in relationships, and this market is gonna be successful in helping us get to our goals. We do not have, you know, you know, we are trying to get about a handful of percentage points of market share, which is what we have said historically.

Yi Chen: Got it. Thank you.

Andrew R. Boll: I can add a little bit too. You know, the one big advantage we have compared to everyone else in this market is we have other products that we are selling these doctors. 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. It is more than just the biosimilar products that we are gonna be selling. It is this comprehensive package of products where we totally support the practice and focusing on the patient experience.

Operator: Thank you. I am showing no further questions. I would like to turn the call back over to Mark L. Baum, CEO, for closing remarks.

Mark L. Baum: First, this is not in my script, I have to say that this call is the longest call I think we have ever had. It reminds me of our recent State of the Union. It set a record. We are gonna definitely work next time to try and make this call a little bit more efficient. We apologize for the time that this call took, but I think it was worthwhile. Hopefully, anyone who is listening feels a lot more knowledgeable about where this company is and where we are going over the coming quarters and years. Across the portfolio, we are seeing tangible momentum, improved access, expanding adoption, and growing commercial execution.

We have got a great new commercial leadership team. Multiple products are scaling meaningfully. Key franchises are gaining depth, and we are seeing early signs of inflection where we have been patient and disciplined. 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 Health, Inc. We are 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: Thank you for your participation. You may now disconnect. Everyone, have a great day.

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