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H.C. Wainwright 26th Annual Global Investment Conference 2024

Sep 10, 2024

Moderator

Good morning, everybody, and thank you for joining us for H.C. Wainwright's twenty-sixth Annual Global Investment Conference. My name is Eduardo Martinez. I'm a biotech equity research associate at H.C. Wainwright, and I have the pleasure of presenting Mr. Mark Baum this morning, founder and CEO of Harrow.

Mark Baum
Founder and CEO, Harrow

Harrow.

Moderator

Harrow.

Mark Baum
Founder and CEO, Harrow

Just Harrow.

Moderator

Yeah, just Harrow. Please take it from here.

Mark Baum
Founder and CEO, Harrow

Thank you, Eduardo, and, I want to thank H.C. Wainwright for this platform and, and for your audience. I'm going to run through these slides. I'll try and get through in, I don't know, 12, 15 minutes, so we can have some time for Q&A. We are a publicly listed company on NASDAQ, so this is our safe harbor, and I will be talking about forward-looking statements. I don't know how many of you are familiar with Harrow, but, we are a fast-growing and leading North American eye care pharmaceutical company. We only deal with the eye, we only service the North American market, and we're very, very focused in that regard. We're growing rapidly. In 2022, we had revenues in the high $80 million range, $88 million or so.

In 2023, we were in the $130 million range, and we've given revenue guidance this year that we should do north of $180 million, and that our revenue in the second half of the year is going to be accelerating. The business is really based on three core products and revenue from those core products, IHEEZO, VEVYE, and TRIESENCE. IHEEZO and VEVYE are recently launched products, and they are on track to produce more than $100 million in annual revenue, both of them. TRIESENCE is a product that we acquired from Novartis, and it should relaunch as early as this year, potentially, and we expect that product to produce more than $100 million in annual revenue.

We have a cluster of beautiful products, 14 products, for the anterior segment of the eye or the front of the eye, that we relaunched in Q4 of 2023, and those are sort of meat and potatoes products for ophthalmologists and optometrists around the country. We also have a core business called ImprimisRx. It's a compounding business, and it's a fairly mature business, but it throws off quite a bit of cash for us. Then I'm also going to talk about MELT-300, which is in a pivotal phase III study right now. We expect to have data from that in the fourth quarter of this year and could potentially launch that product in 2026. In the past, we've talked about our core gross margins floating up into the eighties, and we're delivering.

And what I'll also say in closing on this slide is that you can often tell what the prospects are for a pharmaceutical company in particular, if you look at where the talent is going. And if you look at some of the recent hires that we've had, the commercial hires, we are getting really top-notch talent that are leaving very large companies and large portfolios, large responsibilities, and joining little Harrow. So we're really proud of that, and those people are going to help us drive growth, for the long term. This is a visual of all of the products that we have. We now have 17 branded products, believe it or not.

Only a few years ago, we had none, and we've been able to accumulate this very beautifully integrated, well-knitted-together portfolio of both front of the eye and back of the eye products, in addition to our core compounding business. This gives you a peek of how the business has performed financially. You can see that we continue to grow revenues rapidly. We've given guidance that we will exceed $180 million this year, and as I said on the first slide, we expect to have revenues in the second half of the year meaningfully exceed those from the first half of the year as well. Let's talk about products specifically. So IHEEZO is an ocular anesthetic.

If you're going to have any kind of an ocular procedure, whether they're poking a needle into your eye or whether they're cutting into your eye, you want your eye to be anesthetized, so you don't feel the pain. And IHEEZO is the first new ocular anesthetic, that it's FDA approved, in more than a decade. We launched the product last year, and it's used for, as I said, pokings and cuttings, to anesthetize the eye. In particular, I'll focus on the more than 10 million annual intravitreal injections. These are injections to treat age-related macular degeneration, whether it's wet or dry. There are a lot of them in the U.S., and the number of those injections is growing.

What makes our product unique, aside from the clinical benefits of the product, which include rapid onset of anesthesia, predictable duration of anesthesia, and a unique ability to not create a barrier for antisepsis. What also makes it unique is that it is reimbursable. It has a product-specific J-code, J2403. It's separately reimbursable, and it's the only separately reimbursable topical anesthetic in the U.S. market, and it's patented through 2039. The product has been doing very well in terms of the launch. The reorder rate of 87% is exceptional. It's beyond actually what our internal projections were. You see the large jump from Q1 to Q2 in terms of customer unit demand. We expect for customer unit demand to continue to grow in the second half of the year, certainly in 2025 and beyond.

If you think about what our market penetration is, currently, it is nearly de minimis. I mean, it is very, very small, in the 1% range, and so there's a lot of room to grow with IHEEZO, and IHEEZO has also been one of those attractants to the recent commercial hires that we've brought on. VEVYE, anybody in this room have dry eye disease or you do? Have you, have you used, Restasis or any other products in that? You've used VEVYE? Great. Okay, so if you've used Restasis or Cequa or some of the other products, you know that in the past, these, legacy products, sort of the pre-VEVYE launch products, had issues with the time that the product actually produced a benefit, the duration of that benefit, and most importantly, for patients, the, the side effect profile.

These products typically will burn and sting. Products like Xiidra are known to create sort of a bad taste in your mouth, even. When we saw VEVYE, we saw an opportunity to create a category-leading product. And why? Because it works quickly. The effect lasts a long time. We have data going out 56 weeks for this product, and importantly, the tolerability profile is extraordinary in terms of burning and stinging and so on. It has a unique vehicle that delivers 22 times more cyclosporine to the cornea relative to the vehicle in Restasis. And so when you can deliver more of the anti-inflammatory to help an inflammatory condition, you're gonna end up with great, great results.

The refill rates, because financially, you know, first of all, we are really tickled that we're helping so many dry eye patients that have not really had a prescription medication to rely on. But importantly, financially, for our company and our stockholders, the real value of the product is in the refills. Because if I pay a salesperson to get the first prescription and there are no refills, for whatever the reason, it doesn't work, it burns, it stings, and so on, that is a lot of lost opportunity, and the refill rates for VEVYE have been absolutely extraordinary, way beyond our internal projections. You can see that all of the numbers, in terms of total prescriptions, refills, doctors prescribe, everything is up and to the right with VEVYE.

So it's been an extraordinary launch, and we do expect that to pick up momentum. Any of you investors who have access to IQVIA data, including the most recent data, have seen that, you know, we continue to break records with the Vevye launch. So we're excited about that product. This is a product we're going to sell for a long, long time, and I do believe, after having studied this market for many years, that this has category-leading potential. And then finally, TRIESENCE is sort of the third leg to the main stool, is a product that we long admired that Novartis had. We acquired it from Novartis. It had been on drug shortage for north of five years. It had been completely out of stock in the U.S. market for more than two years.

It is a beloved product in ophthalmology. If you talk to any ophthalmologist, surgeons who do vitrectomies, I would dare say that very few would say, "Well, I just don't care about TRIESENCE, and I don't need TRIESENCE." This is a product that they want to have back in stock, and we have been working diligently to do that. In order to do that, because it has been away for so long, you have to demonstrate that you can produce the product reliably in specification, and that involves making three PPQ batches or commercial batches of the drug.

We made a lot of failed batches over the course of a couple of years, but recently, we made our first successful PPQ batch, then we made our second successful PPQ batch, and the week after our most recent earnings call, we made our third PPQ batch, and the initial data from that PPQ batch is positive. It is not over yet. We haven't received final results or all of the data that we need, but the initial results seem positive, and to the extent that that data stays on track and we remain in specification, we expect to be able to relaunch TRIESENCE and hopefully sell all three of the net units from those PPQ batches during the fourth quarter.

I don't believe that's built into our guidance, our revenue guidance for 2024, but we do expect to be able to sell all of that inventory, and it also has a product-specific J-code, and it's a really tough product to make, but we're jazzed about bringing TRIESENCE back, hopefully in 2024. And then we have this cluster of anterior segment products. These are workhorse products that are used as anti-inflammatories, antibacterial medications, and antihistamine, and so on. We actually have the only FDA-approved antifungal in this basket of products. So it's a great workhorse group of products for ophthalmologists and optometrists. It creates a lot of friends in the eye care professional community when you give them access to these products that they need in order to take better care of their patients.

Once again, these are products that we acquired from Santen and Novartis to build this portfolio. Also, ImprimisRx, which is our core compounding business, throws off a lot of cash, serves a lot of ophthalmologists, more than 15,000 U.S. customers. We dispense medications in all 50 states, and it is a more mature business, throws off a lot of cash for us. It actually produced record revenues last quarter of just north of $21 million, and we are expecting growth to be in the 10-plus percent range. It is an important brand and an important product set for many ophthalmologists around the country. Then finally, I wanna talk about MELT- 300. This is a product that was originally a compounded medication. It actually is a compounded medication.

It's a combination of midazolam and ketamine, and it's a sublingual troche. It's delivered under the tongue, for sedation, and we originally used it for cataract surgery, and it was invented by one doctor, one doctor told another doctor, and so on, and we blinked, and we had hundreds of doctors using this compounded medication. We started a company called Melt Pharmaceuticals. We externally funded it. It's externally managed. Harrow owns about 46% of the company. We have a 5% royalty, and the mission of Melt Pharmaceuticals is to get this FDA approved so that it can become reimbursable. What is interesting is that when we were making it for ophthalmologists that were using it for cataract surgery, all of a sudden we started getting calls from dermatologists. We got calls from plastic surgeons.

We even got calls from veterinarians, all sorts of other healthcare professionals that were interested in using this for sedation. And including, we had, you know, folks that owned MRIs and told me that, "Hey, one out of four people that are getting an MRI press the button because they have claustrophobia. They want to get out of the MRI tube." And they were interested as to whether or not this formulation could reduce those exits. And so we're excited because Melt Pharmaceuticals is funded. We're in the midst of a phase III study. They completed a phase II study, and the data was exceptional on sedation. So we are completing this pivotal study, and we expect to have results in the fourth quarter, hopefully at or around the time of our next earnings call.

From a commercial perspective, I want to explain why this is so powerful for us and why I included it in the slide deck. Because we sell the compounded version of this product, and if this product becomes FDA approved, we will stop selling the compounded version, and we'll start selling the FDA-approved version. That will be hopefully reimbursable. Right now, doctors are paying cash for it. This year, we'll probably sell a little over 150,000 of those units, and a pass-through product as an example, typically, those products are in the $600 per unit range, and so it's easy math to multiply-

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