Conference Transcript - IRIX 2026-06-17

Patrick Mercer, CEO

Good afternoon, everyone Thank you for joining us. My name is Patrick Mercer The president and chief executive officer of Iridex. Also with me today is my chief financial officer Romeo Dijon Appreciate your time and attention today and learning about Iridex. I'm grateful that you could be with us I'm gonna be providing some forward-looking statements. So there's the disclosure with that I'd like to start with our vision and our mission at Iridex. Our vision is to transform laser-based eye care to preserve sight and improve quality of life for patients suffering from ophthalmic conditions globally. Our mission is to deliver innovative, clinically proven, non-invasive laser technologies that safely and effectively treat glaucoma and retinal disorders. And now let's learn a little bit more about Iridex and who we are. Iridex has a long-standing reputation of ophthalmic lasers. The company's been manufacturing and designing lasers since the early 90s. We've really been the technology leader. We have strong clinical credibility. And our global customer base have been really keys to our success. us. Our product portfolio covers two main areas, Retina and Glaucoma, giving us solid reach across two markets. Our Retina business is primarily a capital equipment business, although 22% of that is reoccurring revenue. And our Glaucoma business is a reoccurring revenue business. In 2025, our revenue was $53 million, $30 million from Retina with a 51% direct margin, and $14 million from Glaucomat with a 72% direct margin. One of the things we're proud to announce is that we achieve, Q4, we achieved positive cash flow operations for the first time in the country company's recent history. We were also EBITDA positive for the full year 2025. Let's talk about our retina portfolio. It's one of the broadest in the business. It includes our Pascal pattern laser system, our IQ laser platforms, and our legacy lasers. Now these laser solutions cover both our surgical and medical retina needs. When you look at our delivery devices, our retina disposable probes and all our accessories gives us a full suite of products to use in the space. On the glaucoma side, our Cyclo G6 platform and our full range of micropulse and continuous wave probes are keys to the specialist treating all types of glaucoma disease micropulse tlt in particular is quickly becoming the go-to choice for clinicians because it's safe effective and predictable and repeatable glaucoma is on the rise around the world and our probes offer a great mix of clinical benefits and economic values for practices looking Looking at our global commercial footprint, we have a strong global presence with direct sales in the U.S. and worldwide distribution. We're currently in over 100 countries. This really allows us to scale efficiently while supporting growth in both our capital equipment business and our reoccurring revenue business. Let's dig further into our Retina product overview. you. Our U.S. retina business is aging, especially with Pascal and the IQ platforms. Nearly three-quarters of our systems are approaching five years or approaching end of service. This really creates a significant replacement opportunity for us, which is really timely as we introduce some of our new products like Pascal. Our Pascal system is one of the one of the fastest, most reliable systems out there it offers clinician a full range of tissue sparing laser options these are like sub threshold treatments there are three software options that we we can can be purchased with a pascal system micropulse endpoint management and pslt which is actually a laser glaucoma treatment the software options are safe efficient and they are effective and this is one of the reasons why Pascal is becoming our flagship product out in the marketplace. The global retina market is really big and growing. It's really fueled by the rise in diabetic eye disease and the aging populations. With over 8 million retina laser procedures performed each year and more than 55 million people suffering from diabetic eye disease, it's a real opportunity for us. The demand for really safe, effective treatment is on the rise. The DAME trial, which is mentioned here, it looks to extend visual acuity in the diabetic macular edema patient population. It really is there to, it addresses the economic burden of performing, you know, repeatable pharmaceuticals. Using Micropulse in conjunction with injections would reduce the amount of injections the patient needs. And that's where the real opportunity is. Looking at our Micropulse patented technology, it's clinically proven. The comparison here simply illustrates the difference between continuous wave and Micropulse technology. With our Micropulse technology, there's no scarring. Really how that's achieved is the laser is turned off and on. It's got a 31.3% duty cycle. It allows the tissue to cool before reapplying the energy. So no scarring, no damage to the retina tissue. I mentioned earlier that our retina business is primarily a capital equipment business. That's true, but 22% of it is reoccurring revenue. And those are our endoprobe line, which is really a strong contributor. These products integrate seamlessly into vitrectomy procedures. These single-use devices, they enhance surgeon control while generating reoccurring revenue with each case. Let's talk more about glaucoma. The U.S. market for glaucoma offers a substantial opportunity for us. Iridex is really just scratching the surface. You know, we're doing, you know, 20,000 cases, and the market for moderate patients is 2.1 million. That's a huge opportunity for us. We're seeing more, we're seeing a lot of momentum here. We are seeing more comprehensive doctors use MicroPulse TLT to treat patients earlier in the continuum of care. And, you know, with the Medicare LCD that came out last year, WHICH BASICALLY LIMITED THE REIMBURSEMENT ON MIGS PROCEDURE. IT'S HELPING CREATE EARLY ADOPTION FOR G6 FOR BOTH MILD TO MODERATE AND POST MIGS PATIENTS. AND YOU COMBINE THAT WITH OUR SWEET MANAGEMENT SOFTWARE THAT WE WROTE OUT LAST YEAR, IT PUTS US IN GOOD POSITION FOR 2026 TO ABSTAIN GROWTH GOING FORWARD. INTERNATIONALLY, THE OPPORTUNITY IS EVEN LARGER. with millions of treatable eyes and a large global surgeon base. We estimate about a $700 million probe opportunity in the rest of the world markets alone. As we strengthen our distribution performance and relationships and introduce our enhanced training, we are set up nicely to increase utilization there. One of the things that's unique about our procedure, when you look at the procedures that are done for glaucoma, The unique thing about our treatments is its versatility. It can be done with any of these procedures, stand alone or in conjunction with. Glaucoma is being diagnosed earlier and patients are living longer. Used to, glaucoma would be diagnosed at age 60. The patient would live, you know, maybe to 75 and that was really the treatment life cycle. now it's being diagnosed earlier patients are living longer and we offer probes that can treat glaucoma early stage all the way through the life cycle of the disease another just to stress this is non-incisional procedures our recent prospective data is quite compelling with greater than 50% reduction in IOP over time over a year over 12 months with an more importantly an excellent safety profile what's important here is that when we escalate the dose we can improve efficacy predictably while maintaining extremely low complication rates this reinforces micropulse's tlt's position as one of the safest non-incisional glaucoma therapies available this study by dr crumb is very important it shows that when we look at patients long term we continue to see sustained IOP reduction even after five years and this particular study we saw an average of 32.5% reduction and it more importantly a decrease in drops administered this is an outstanding achievement looking at repeatability this isn't a one-and-done procedure clinical data shows that micropulse and continuous wave treatments can be repeated, providing meaningful, sustained IOP reduction. It's a competitive differentiator for us, and it allows us to manage glaucoma longitudinally across the full disease timeline, something incisional approaches cannot do. There's been a lot of volatility around reimbursement, particularly with the LCD that no longer allows stacking of MIGs. Micropulse TLT is not a MIGs procedure and the LCD actually created a tailwind for us going forward and it supports the early adoption of G6 not just for refractory glaucoma but mild to moderate patients as well. This really broadens the addressable market for us And just to add, I mean, we're seeing this, we're seeing the reimbursement go up every year, and it's a really stable CPT code. The ROI for purchasing a Cyclo G6 laser is 12 months when performing three or more procedures per month. The economics are even more favorable when you're doing the procedures in a hospital. Since my tenure as CEO I reduced the size of the sales force by half while maintaining the same revenue. Tools like MedScout give us granule visibility into where clinicians are doing the procedures, what day they're doing them, and what type of procedures they're doing. This is important because it allows us to to target places where hospitals or ASCs where we could increase utilization, but But it also gives us visibility into large glaucoma users who may or may not be doing MicroPulse and allows us for targeting of them. Let's talk about the financials. Like I mentioned, when I came in, my goal was to right size the company for the revenue. And here's a list of some of the actions we took. We reduced the headcount from 127 to 93. WE RELOCATED OUR GNA TO THE PHILIPPINES, WE INCREASED OUR ASP ON ALL PROBES SOLD IN THE U.S. WE OUTSOURCED OUR PASCAL SERVICE TO A THIRD PARTY AND ONE OF OUR DEVICES AS WELL, PART OF OUR CONTRACT MANUFACTURING, OUR EFFORTS TO OUTSOURCE CONTRACT MANUFACTURING, WHICH IS ONE OF OUR GOALS FOR 26, WHICH WILL GO INTO 27. WE'RE CONTINUING TO DO THAT. Just looking at the financials that we achieved, the charts tells a compelling story. Comparing Q1 2024 to Q1 2026 on a comparable basis, OPEX declined by 2.7 million or 34%. Operating losses improved by 3 million or 90%. We sustained positive adjusted EBITDA in Q1, and cash at quarter-end was $4.6 million. Critically, we are continuing our efforts to outsource all our manufacturing outside of California and to other areas. We are still focused on reducing OPEX, improving our margin, and reporting cash flow positive operations this year. We are reaffirming our guidance of $51 to $53 million in revenue. Adjusted OpEx of 19 to 19.5 million, and positive adjusted cash flow for the full year. We have proven that we're good stewards of capital, and we're going to continue to focus on the keys that got us here over the last year and a half. I want to thank you for your time today, and I'll take any questions now. Okay.

Operator

Yes, sir.

Patrick Mercer, CEO

Yeah, the question was, are we going to continue to focus on selling probes or the hardware? You know, we're using the, on the glaucoma side you're speaking about, we are going to continue to focus the razor, razor blade model. We're not fully saturated on system probes, systems out there. We still have an opportunity for placements as well. But to your point, the whole point behind the targeting that we're using the MedScout software is to drive utilization. We want to drive more probe growth. The opportunity is huge, particularly in the moderate patients. Iridex has been treating late-stage glaucoma for some time. We're well-known there. We have a continuous wave probe for that. But as we move earlier in the continuum of care for treatment of glaucoma, that's where the real driver is for us. Yeah, so the question was, what's the penetration? What's the real growth internationally for our retina equipment? There's a really big opportunity for us outside the U.S. with our new Pascal product that we just released, one I talked about earlier in the presentation. We don't have MDR approval yet in Europe for that product. We're in the process of getting it. We received questions from the notified body. Once we get those approvals, that opens up a huge market in Europe. There's other countries like China that take a couple years to get approval. So there's a large opportunity globally as well, particularly the replacement market that I mentioned in the U.S. is also true outside the U.S. So we still have those options as we introduce the new platforms. Well, we have devices that have been in the market for 20 years, our legacy probes, but particularly we're talking about Pascal and IQ products. They have come out with new features, new advancement. So we are seeing doctors, clinicians that want to upgrade to the Pascal after five years. We only, our service life is seven years. We only want to, at that point, we won't service it anymore anyway. So, and if we do, it's going to cost a lot of money, right? Yeah, I can, yeah, I can talk to you about that. the the LCD the Medicare LCD that comes out for reimbursement our competitors who use MIG devices are no longer allowed to stack those procedures for example they would do a canalplasty and a goniotomy for example and then turn that in to get reimbursed that's cut out it wasn't really there's no proof that that was efficacious for the patient our device has a different mechanism of action we use laser energy we're not incision SO OUR DEVICE IS NOT A MIX PROCEDURE. SO WHAT WE'RE SEEING FROM THIS EACH QUARTER AND COMING OUT OF THE AAO LAST YEAR, IS THAT OUR DEVICE, BECAUSE OF THAT, DOCTORS ARE STARTING TO USE OUR DEVICE MORE EARLIER IN THE CONTINUAL OF CARE. OKAY.

Operator

THANK YOU. NO, GO AHEAD.

Patrick Mercer, CEO

WE WERE TALKING ABOUT THE REIMBURSEMENT, THE LCD.

Operator

YEAH.

Patrick Mercer, CEO

THEY DIDN'T SHUT THEM DOWN. THEY DIDN'T ALLOW STACKING, meaning doing two mixed procedures in a row at the same time stacking means you're going to do a canalplasty for example and then a goniotomy at the patient at the same time now they took a lot of them took a hit during after that yeah I took a tailwind okay great thank you for your time guys I appreciate it