Newsfilter article unlocker
Enter Newsfilter article ID in the field below. Example: https://newsfilter.io/articles/39be1bef03e66cdc886c08a2a6319c47
Retrieved article
Good afternoon everyone. Thank you for joining us. My name is Patrick Mercer. I'm the President and Chief Executive Officer of Iridex. Also with me today is my Chief Financial Officer, Romeo Dijon. I appreciate your time and attention today and learning about IrideX. I'm grateful that you could be with us. I'm going to 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 Aerodex. 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 in 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. 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 reoccurrent revenue business in 2025 our revenue was 53 million 30 million from retina with a 51% direct margin and 14 million from glauco man is 72 percent direct margin one of the things we're proud to announce is that we achieve q4 we achieve 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 IR our 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 On 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 glauoma disease. Micropulse TLT in particular is quickly becoming the go-to choice for clinicians because it's safe, effective, and predictable and repeatable. on the rise around the world and our probes offer a great mix of clinical benefits and economic values for practices looking at our global commercial commercial footprint we have a strong global presence with direct sales in the US and worldwide distribution we're currently in over a hundred 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. 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 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 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 retinal laser procedures performed each year and more than 55 million people suffering from diabetic eye diseases, 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, is 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 a 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 micropulses technology. With our micromulces technology, there's no scarring. Really how that's achieved is the laser's 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 primary 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 it these products integrate seamlessly into vitrectomy procedures these single devices, they enhance surgeon control while generating reoccurring revenue with each case. Let's talk more about glaucoma. The US market for glaucoa offers a substantial opportunity for us. We are really, 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 are seeing a lot of momentum here we are seeing more comprehensive doctors use micro pulse TLT to treat patients earlier in the continuum of care and you with the medicare lcd that came out last year which which basically limited the reimbursement on migs procedure it's helping create early adoption for g6 for both mild to moderate and post-mix patients and you combine that with our suite 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, standalone, or in conjunction with. glaucoma is being diagnosed earlier and patients are living longer used to glauoma would be diagnosed at age 60 the patient would live you know maybe 275 and that was really the treatment life cycle life cycle now it's being diagnosed early our patients are living longer and we offer probes that can treat glaucoma early stage all the way through the life cycle of the disease and other 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, 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 micropulses TLT's position as one of the safest non-incisional glaucoma therapies available. This study by Dr. Crum is very important. It shows that when we look at patients long-term, we continue to see sustained IOP reduction even after five years. In this particular study, we saw an average of 32.5% reduction and, 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 seen the reimbursement go up every year and it's really stable CPT code the ROI for purchasing a cyclo g6 laser is 12 months when performing three or 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 salesforce by half while maintaining the same revenue tools like Med Scout 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 ASC's where we could increase utilization 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, I, my goal was to right-size the company for the revenue. And we, 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 the probes sold in the U.S. We outsourced our Pascal service to a third party and one of our devices as well and part of our contract manufacturing, our efforts to outsource contract manufacturing which is one of our goals for 26 which we're going to 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 percent. Operating losses improved by 3 million or 90 percent. 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've been, 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. Thank you. 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 the focus the razor, razor blade model. We're not fully saturated on 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. As we move early 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 US is also true outside the OUS so we still have those options as as we introduce the new platforms we 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 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 incisional, so our device is not a mixed procedure so what we're seeing from this each quarter and coming out of the aeo last year is that our device because of that doctors are starting to use our device more earlier in the continuum of care okay thank you no go ahead we were talking about the reimbursement the LCD yeah 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