Harrow Health, Inc. (NASDAQ:HROW) Q4 2023 Earnings Call Transcript

The retina market is in the form of the intravitreal injection market, specifically it is a very large market, exceeding 10 million unit opportunities per year. We saw uptake in that market. We were seeing reimbursement happen in that market around the country. But the market is unique and that it is highly concentrated. There are very large groups of potential buyers for these products. And so in the face of those sorts of opportunities in front of us, we thought it was prudent to confirm with CMS that, in fact, our J-code, which is a product-specific permanent J-code, would, in fact, be separately reimbursable in the physician’s office setting. And so as we promised in the last letter to stockholders, we requested a meeting with CMS. We had that meeting on January 9th, and we have been waiting patiently to hear from them.

As we said in the prepared remarks, we were added to the ASP file, the physicians ASP file recently, but we did not know whether or not that confirmed separate payment in the physician’s office. And that happened just yesterday afternoon, which, as I said, is a very important event for the company. Our expectation now is that we will be able to, with this news, open up the market for intravitreal injections that can benefit from unique attributes of IHEEZO and that is going to start here very, very soon, and that it will significantly change, I think, the trajectory for IHEEZO and also, I think, for our company. But IHEEZO is a fantastic product for that application. It’s also obviously used in numerous other ophthalmic interventions, and it’s a very, very exciting opportunity for us.

Mayank Mamtani: Thank you. And lastly, on VEVYE, you put out some good launch metrics. Yet you said it could take up to 18 months for ramp up. So just curious what dynamics in play are here to follow, to get visibility on what peak sales could be? And with that, I’ll hop back in the queue. Thanks for taking my questions.

Mark L. Baum: Thank you, Mayank. First of all, with respect to VEVYE, I want to mention a person, because VEVYE, the team, the commercial effort is being led by a woman named Maria Lloyd. And she is extraordinary. And the effort that she has put into this project is just amazing. So I’m really grateful to everything that she has done. She is very experienced. She was involved in the launch of Restasis. She knows the dry eye market extremely well, and she’s brought a lot of wonderful people into our organization that are working on her team. But as you saw in our recent corporate presentation, all of the numbers, all of the metrics with respect to the VEVYE launch are up into the right, which is fantastic. Importantly, the product is performing extremely well.

In the market, I referenced the social media information that’s out there and publicly available. And so we have very high hopes for that product. As I’ve said for several years, we’ve studied the dry eye market. We know it very well. We’ve compounded 0.1% cyclosporine with our ImprimisRx business now for over five years. And what VEVYE presents to the market is really a complete shift in the cyclosporine market, which is 8 million units strong last year in the U.S. market. So we think we have a product that can dominate the category. And in terms of what the opportunity is, there’s so many patients that have failed other cyclosporine products, whether it’s the 0.05% branded version of cyclosporine or its generic version or even the 0.09% cyclosporine product that is branded and available.

The tolerability profile of those products is very different from the tolerability profile of VEVYE. And so there are a lot of people that have failed those products, and those are candidates to benefit from VEVYE. And in terms of what the size of the market can be, this is a product that gives me far greater confidence that the number that I wrote about a couple of letters to stockholders ago, which was $1 billion in revenue in the aggregate for our product portfolio that can actually be met. I mean that is a real target for us now. The uptake in VEVYE, certainly, this Form 8-K that was filed this morning, this puts us in zone of where we wanted to be. I talked about our revenue getting to $1 billion or more with our product portfolio of certain things went our way, well, the things that we announced today that certainly qualifies as something going our way.

So we’re really excited about that and what Maria and her amazing team are doing with VEVYE.

Operator: The next question comes from Aaron Wukmir with Lake Street Capital Markets. Please go ahead.

Aaron Wukmir: Hey, good morning guys. This is Aaron on the line for Brooks. I appreciate all the color so far. I guess related to Triesence, have there been any more setbacks, I know you had a few comments on the — in the prepared remarks. But I guess if you could just provide a bit more color on sort of inventory timing and how you’re thinking about that and maybe just your confidence there to get that before year-end, that would be helpful?

Mark L. Baum: Sure. Thank you, Aaron. So look, as I said in the letter to stockholders, Triesence was not really being made for more than five years by our manufacturing partner, and the people and the processes that are involved in making that product were kind of dormant and because they weren’t practicing, that knowledge wasn’t being produced. We knew that it was going to be a challenge, reintroducing the product into the market in terms of manufacturing it. But what I can tell you is that the progress that we’ve made in the last six months in particular has given everyone in our organization a very high degree of confidence that we’re going to have success meeting all of the required parameters to make Triesence here very soon.