Thank you very much for joining us, day two at the Leerink Conference. I'm Marc Goodman, one of the Biopharma Analysts, and we have Harrow next. Mark Baum, who's the CEO, is gonna do a presentation. I met Mark a few years ago, and just a great entrepreneur and I think he's really building a very interesting company and he's gonna take you through what's been going on there. Thank you very much for joining us.
Thank you, Marc. Thank you. I wanna first thank Leerink for this audience. We really appreciate it. I wanna begin with a question. Which company presenting here at Leerink this week is founder-led, has a five-year revenue CAGR of better than 41%, the fastest-growing company in its space over the last five years, has a five-year adjusted EBITDA CAGR of better than 61%, just reported record revenues, record earnings, record cash from operations, guided to better than 32% year-over-year growth, and its stock is down about 35% in the last week? The answer is the company that we're gonna discuss over the next 20 or so minutes, Harrow Incorporated. We're a publicly traded company. This is our safe harbor. We'll talk about forward-looking statements a bit.
I think the hallmark of our business is that we are a highly diversified provider of ophthalmic disease management solutions. We're certainly not a one-hit wonder company. We have a number of products that address ophthalmic disease management, and this is once again a proof point of our revenue and adjusted EBITDA CAGR over the last five years or so. We have what I believe is the largest portfolio of prescription ophthalmic products in the United States market. All sorts of delivery from injectables, topical, sublinguals in different product categories, buy and bill, over-the-counter, branded, certainly. We, I believe, have one of the largest branded portfolios. Anterior, posterior segments, so the front and the back of the eye, and all sorts of payer types. We play in large markets like dry eye disease. We have redefined ocular anesthesia with our IHEEZO product.
We're the owners of TRIESENCE, which is the only preservative-free injectable corticosteroids. We also have anti-VEGF drugs from a deal that we did recently with Samsung to take on their biosimilars portfolio. We have an incredible pipeline that I'm gonna talk about with our acquisition of Melt Pharmaceuticals. The way that we've built our company, though, is based on access and affordability. A lot of companies talk about access and affordability, but I think if you look at our actions with our Harrow Access for All program as an example, ensuring that every patient in need has access to a Harrow medication for a max out-of-pocket of about $59. These are actions that we are backing up our words with.
We have a very powerful commercial infrastructure that scales and allows us, through acquisitions, to bolt on new products onto the platform so that we can rapidly continue to grow. This is a visual of where our brands play, both in terms of ocular surface disease management, the anterior segment, as well as the posterior segment. Really all parts of the eye, and these are all of our branded products. Let me show you, though, how this has manifested as we've grown the business as a founder-led company, literally from no products and no revenues to where we are today, a company that just reported about $272 million of annual revenue last year and just north of $60 million in adjusted EBITDA.
That was a 54% year-over-year growth in adjusted EBITDA and 36% revenue growth year over year. We have about $73 million in cash as of the end of the year as well. We provided guidance in a new way this year because our business is definitely second half weighted, and we provided the market with not only first half revenue guidance, but also second half revenue guidance, which is unique for us as well as full year adjusted EBITDA guidance. Once again, this is at the midpoint better than 32% or so year-over-year growth. I think I also said in my letter to stockholders that in terms of a bull, bear, and a base case, this was definitely towards the base case, and our goal with this forecast was certainly to exceed our guidance this year.
Let's talk about specific products. Harrow plays in the dry eye disease market. If you know a little bit about the dry eye disease market, you know a couple of things. It's a very large market. More than 30 million Americans suffer from dry eye disease. It is a chronic condition. Harrow owns the only water-free cyclosporine that treats both the signs and symptoms of dry eye disease. Our vehicle, which is called a semifluorinated alkane, delivers 22 x more cyclosporine into the cornea than does the vehicle for what was a perennial $1 billion product called Restasis. The drug really works fast. It provides long-lasting relief. In fact, we have data that demonstrates that VEVYE provides improvement in both the signs and symptoms of dry eye disease going out 56 weeks.
It's very unusual, and there's really no other product in the category that has that kind of durable, lasting effect. I think the hallmark of the product is that when you put it on your eye, the burning and stinging that most of these products provide unfortunately doesn't exist. In fact, our clinical data showed that 99.8% of patients had no or mild instillation pain. We have a great IP portfolio that goes out to 2039. This product is growing rapidly. You have 115% prescriber expansion, amazing refill rates. When you have a chronic disease product, you not only need the first prescription, but you need the refills. What we discussed during our last conference call, and this is a metric that's way out of bounds from what we had originally modeled.
We're actually getting the first prescription, and this is for covered prescriptions and nine refills, and that is nearly an entire year of therapy. We just had a big coverage win with CVS, the largest commercial lives owner in the U.S. with more than 30 million commercial lives. This last bullet, I think is the most critical bullet with respect to VEVYE. We have been, to a certain extent, poor boying it with our commercial organization. We have achieved the level of market share that we have with less than 50 representatives in the U.S. market. That is changing. By Memorial Day, the VEVYE team will be about 100 reps. We have data that shows very clearly more reps covering more territories equals more new prescriptions. More new prescriptions equals more covered prescriptions. More covered prescriptions equals more refills.
When you have that positive snowball, if you will, that compounding effect happens. That is why we believe VEVYE should grow not only this year in terms of total prescriptions, but for many years to come. We also, I think, redefined the ocular anesthesia market with IHEEZO. IHEEZO was the first new branded ocular anesthetic for the U.S. market in about 14 years. It was the first use of chloroprocaine hydrochloride, which is the most power-for-powerful ocular anesthetic. What also makes it unique is that it is the only reimbursable topical anesthetic. It is the only J-code topical anesthetic in the U.S. market. The market size for this product specifically, and this is what we have done, you know, really over the last year or so, is we've focused in on our reimbursement in the office.
Intravitreal injections, various laser procedures, and even punctal plug administration. That number is about 12 million total procedures in the U.S. market, in the office where we have durable reimbursement. The drug works very rapidly. You get reliable anesthetic effect. What is really important is that in the clinical studies with IHEEZO, we were able to demonstrate that no patient who was dosed with IHEEZO required any sort of a rescue or supplemental anesthesia for a procedure. The product is growing rapidly, as you can see. In terms of unit demand, we went from about 128,000 in 2024 to more than 200,000 in 2025. There's a lot more on this slide, but what I really wanna focus in on is the retina market for this product.
The retina market is the key to this market growing, and our sales organization has done a marvelous job growing our IHEEZO unit demand without any retina specific data. What I can tell you is that when you call on retina doctors, they really wanna see your product used for their procedures, and we simply have not had that data to present. We believe that in order for us to go to where we are now, which is about 2.5% market share or so in the intravitreal injection market to where we wanna be, which is about 10% or so, and we hope we can do even much better than that, we really need retina specific data.
Last year we began investing in building those data and there will be a presentation in July at the American Society of Retina Specialists Meeting, the ASRS meeting in Montreal that will read out on IHEEZO versus the traditional standard of care anesthesia for these intravitreal injections. We believe that if that data mirrors what we have seen anecdotally from our customer base, we will finally be able to demonstrate with data to these retina specialists in the U.S. that our product provides not only less pain, but a better patient experience, and that patients prefer IHEEZO when they're getting an intravitreal injection versus what they've traditionally received, which oftentimes is an injection of some subconjunctival lidocaine. With that data, we expect demand for IHEEZO to grow markedly in the back half of the year.
In terms of accelerating growth on the revenue side, there is this retina specific data which I highlighted here in the center, right. Also in the back half of the year, beginning in July, we are expecting improved net pricing. The combination of unlocking the entire in-office market, where once again, we have durable reimbursement, established reimbursement totaling more than 12 million procedures, a new multi-unit package, new data demonstrating, hopefully what we believe will be, the benefits of IHEEZO versus standard of care anesthesia for these intravitreal injections and new improved net pricing that the aggregate of those four factors will lead to not only growth in IHEEZO demand and revenue in the back half of the year, but for years to come. This is a very large market, and it's a market that we continue to have only a tiny share of.
If you're not using IHEEZO, by the way, you're paying for the anesthetic out of a capitated fee. Once again, this is the only reimbursable anesthetic in the U.S. market. We're very interested in ophthalmic surgery. The vision that we have for ophthalmic surgery, to be clear, is IV-free, opioid-free, and even eye drop-free cataract surgery, as an example. I'm gonna talk to you about two products, one product that's approved and one that is a product candidate that reflect how we are furthering that vision of providing IV-free, opioid-free, and eye drop-free cataract surgery. The first is TRIESENCE, which is a tried and true trusted brand as an injectable steroid of triamcinolone acetonide. It is the only preservative-free corticosteroid that's injectable in the U.S. market. It has a product specific J-code.
It has phenomenal reimbursement with more than 96% of lives covered and only 6% of patients requiring a prior authorization. It is reimbursable in all settings of care, not only in the office but also in the surgery center. We have durability of that reimbursement. What's really exciting is that TRIESENCE has traditionally been used as a steroid to control inflammation post-surgery for patients who really were not good candidates for eye drops. We announced a little over a week ago that we were investing in a phase III study to expand the label to cover all of cataract surgery.
We're gonna leverage not only the trust that doctors have in TRIESENCE, not only the clinical experience that they've had, the positive experience that they've had with TRIESENCE to make it available broadly to all cataract surgery patients. We're expecting that data to read out at the end of this year. It is an active versus placebo trial, and we strongly believe that we'll do very well in that study and ultimately be able to expand the label. We also have a next generation prefilled syringe version of TRIESENCE that will come to the market in 2028. TRIESENCE is on the move. We had a record quarter in the fourth quarter of last year for TRIESENCE.
Unit demand is growing even in the first quarter, and we expect unit demand growth to continue quarter after quarter throughout this year and certainly into next year. Once again, instead of a patient following cataract surgery receiving eye drops, we believe that a painless injection of TRIESENCE will obviate or eliminate the need for those eye drops, which is an exciting advancement if you're a patient not having to put those eye drops in your eye. This is a product that I'm really excited about also. There was a study conducted at Duke. Terry Kim did this study at Duke, and I think he surveyed about 3,000 cataract surgeries and found that more than 95% of those cataract surgeries involved the administration of the opioid fentanyl.
There was a study at Mayo that found that better than eight out of 10 cataract surgeries at that institution, once again, there was an administration of fentanyl for sedation during cataract surgery. A few years back, working with an ophthalmologist named Jared Verdoorn, we began to compound a combination of midazolam, ketamine, and ondansetron that was administered sublingually during cataract surgery. It started off with one doctor, and he had a great experience and told his friends, and it grew and grew and grew, and all of a sudden we blinked, and we had more than 800 institutions ordering a compounded, what we called MKO Melt product from us. It was a low-cost solution for sedation during cataract surgery, not FDA-approved. An amazing thing happened.
We started getting calls from owners of MRIs because about 20%-25% of the patients in an MRI tube press the button to get out because they get claustrophobic. We had dermatologists and dentists and ear, nose, and throat doctors calling us, asking about what they had heard was a great compounded sedation medicament called the MKO Melt. Eventually, we said, "Gosh, it would be great if we could get this FDA-approved," and we began to do so. Now we have all of the efficacy studies completed for what we call the G-MELT, which, as this slide reflects, is a fixed dose of midazolam and ketamine. It does not have the ondansetron, and we've studied it in cataract surgery. We were able to demonstrate superiority of the combination versus the individual constituents.
The drug candidate rather is powered by Catalent's Zydis ODT technology, so it goes under the tongue, and it is administered in seconds. Zydis also powers 35 other FDA-approved products. You get quick absorption, fast up, fast down, and you get predictable sedation during cataract surgery, which is what this was studied in. We're very excited about what we call the G-MELT because of not only the cataract surgery market, which you know is around 5 million annual use cases in the United States, but this is a product candidate that we have IP on both domestically and internationally. We're excited about not only the ophthalmic market but also markets outside of ophthalmology, those markets that we've experienced with the compounded version of the drug. Once again, much larger markets than the ophthalmic surgical market.
We're gonna hopefully have the balance of the ancillary studies required to file an NDA completed by this year. We really hope to file the NDA in the first half of 2027 and have it approved and launched in 2028. These are, I think, fairly conservative dates, and we hope we can do better. This is a product candidate that we believe, when approved and J-coded, should become our largest revenue product in the U.S. market for sure. I'll take a couple of minutes and talk about our rare specialty and compounded products. As you can see, there are a lot of products in this category. What I think is exciting, these are sort of workhorse products that we've made available on a $59 basis for anyone who is in need.
Patients don't pay more than $59 out of pocket for these products, which is exciting. Once again, this is part of our commitment to access and affordability. I will highlight, though, on these two top bullets, and as I said in our most recent conference call, within this category, within this product portfolio, there is a coding decision. We have applied for a J-code for one of these products, and we're expecting a coding decision on that product next month. If we're successful with that code, that opens up a market of more than 2 million annual procedures where we will be the only coded reimbursable product to meet the needs of those 2 million ophthalmic procedures for the U.S. market. There are two other products that we intend to relaunch in on-label markets this year.
Very, you know, I would say, pretty large markets. One is a very large market and a well-known market, and another one's slightly smaller. These are great markets where we have a product that is reimbursed on-label, and that we believe we can do very well relaunching. These products are very much a part of, you know, us reaching our revenue goals for next year, and there'll be more to come beginning next month with this, coding decision that we expect in April. In summary, we have a lot of durable revenue drivers within our portfolio.
We have a great pipeline, not only this year when we launch BYOOVIZ and OPUVIZ, our two biosimilars, anti-VEGF products that we brought in from Samsung, but products like the G-MELT that will come in 2028, along with a prefilled syringe version of TRIESENCE. Growth is our hallmark. It's not easy to achieve a five-year revenue CAGR of 41%, a five-year adjusted EBITDA CAGR of better than 61%. You do that through solid commercial execution. There are times, though, where there are hiccups. Not everything is a straight line up, and we continue to grow and learn. I think that our stockholders should expect us to continue to execute with excellence and grow.
You see the near-term commercial launches with BYQLOVI, BYOOVIZ, and OPUVIZ, and an amazing pipeline that we've discussed, including G-MELT. Once again, very, very appreciative of this audience and the opportunity to talk to you about Harrow. I think we have about five and a half minutes or so left if there are any questions.
What's your biggest challenge this year?
Biggest challenge this year, I would say I thought the biggest challenge was going to be recruiting. We are doubling the size of our VEVYE sales team. We're more than doubling the size of our TRIESENCE team. We are building out this rare specialty and compounding team in order to take advantage of what we expect to happen with that portfolio later this year. But I have to say, I think we're gonna meet our recruiting goals early, which is a great thing. I think I said during our conference call that from my perspective, the number one leading indicator for a commercial pharmaceutical company is where the top talent is going. Those people tend to go where they can make money, and they can achieve success. I'm really excited that we've been able to recruit some top talent.
That I thought was gonna be a challenge, but it is not. Then I would say the biggest real challenge is just getting out there and selling and driving revenue growth that meets our stockholders' expectations. I mentioned at the outset, Marc, that our, we've achieved these incredible results, and our stock is down about 35% in the last week. There seems to be an expectation that we should do better. Our entire team should try even harder to meet that.
The biosimilar opportunity a little bit. It's, you know, it's one of those where everybody can't quite get their arms around it.
Yeah. You know, it's a very competitive category. We have both the Lucentis biosimilar that we'll launch here in a few months, and an EYLEA 2 mg. Samsung just settled with Regeneron a matter of a couple of months ago. What I would say is that with our Lucentis biosimilar specifically, you know, that category is really one where net cost recovery at the purchaser level is critical. You know, there are rebates and discounts that really drive volume in that category. You saw that with PAVBLU, which went from zero to hero. It, I think, is gonna be a billion-dollar drug, or it was a billion-dollar drug last year, very close to it, a billion-dollar biosimilar. They did that through net cost recovery.
There are a lot of patients with wet AMD, for example, that are EYLEA non-responders. Lucentis is a very powerful drug, and our biosimilar will be uniquely positioned in the market as really the only product in the category where net cost recovery will actually be available in the market. You know, you'll see that happen here very soon. I think, CIMERLI was recently repriced at a certain level, and I don't think it's selling very well, and the same is true of the brand.
Mark, how big was the TRIESENCE product before it kinda shut down, and you guys restarted?
TRIESENCE traditionally, I think the high water mark in terms of unit volume was a little north of 100,000 units. TRIESENCE was always marketed for visualization during vitrectomy and a little bit of DME, but it was primarily a visualization tool for retina specialists. We actually started our company selling triamcinolone acetonide as an injectable compounded medication. That's probably the active ingredient I know the best 'cause I've been on so many sales calls selling that product myself. We always dreamed of having the brand TRIESENCE. It was such a high-trust product. It had the J-code. It could be used, we believe, more broadly, not only for visualization but also for cataract surgery. There's really only one product in the market that is separately reimbursable for that cataract surgery population.
It doesn't have the best efficacy, and it's fairly hard to administer. In fact, when it's administered, a lot of those units will pop out of where they're poked into. With TRIESENCE, you don't have those challenges. The efficacy is extraordinary. What we've done is really broadened the market opportunity, and I don't know that our stockholders really appreciate that. We've gone from an addressable market of a few hundred thousand annual use cases in the U.S., and when we have this data in cataract surgery, that will have increased by more than 10 x. I can tell you from having been in a lot of cataract surgeries, I think it's gonna do very well.
Doctors will prefer to put the medication in the patient's eye with a patient out-of-pocket of about $37, by the way, and a separately reimbursable product, instead of the patient having to put the medicine in their eye separately post-surgery.
The ASP is relatively high too, I think.
Right. One quick comment. I know we're over, but I will tell you that we can actually lower the WAC price with our new prefilled syringe. We can lower the WAC price and actually make more money. This is a long-term project for us with TRIESENCE in the cataract surgery market. Thank you all.