Pulmonx Corporation (LUNG) Earnings Call Transcript & Summary

[Audio Gap] Minimally invasive treatment for lung disease. Please welcome to the stage, Steve Williamson, President and Chief Executive Officer; and Mehul Joshi, Chief Financial Officer.

Thanks, Gracia. Appreciate it. Good with that. Welcome, everybody. Thanks for coming out today. I appreciate it. We've got some forward-looking statements we'll be making. The information that you need, you can find in our SEC documents, but I wanted to call that out. Before I get started, right now, there are 500,000 patients in the United States that are suffocating, literally suffocating. Outside the United States, 700,000 patients that are suffocating. They can't get enough oxygen so that they can breathe. And it's not because they can't get the oxygen in, it's that they have trapped air in their lungs that they can't exhale. They can't get that out. So you've got this hyperinflated lobes of the lung that are preventing them from breathing in and taking in more oxygen. Those 1.2 million patients, if treated with Zephyr Valves are a $12 billion market opportunity for us globally right now, $12 billion. This is a number I'll walk you through a little bit more -- this is a number I'll walk you through a little bit more in some future slides here. But the technology itself is broadly reimbursed across not just the United States but outside the United States as well -- to United States, but outside the United States as well is the proper treatment pathway. We've got a great team in place with a lot of experience in the pulmonary space. Our clinical results are exceptional. We have 4 randomized controlled trials, over 100 published pieces of literature that continues to grow. And it's a precision treatment with a proprietary patient selection technology and a minimally invasive treatment. This is done bronchoscopically through a scope. It's -- there's no incisions made on this patient population. Emphysema is very, very bad. I was talking to one of our patients not too long ago. It took her 3 hours to put her sweatpants on. She ran out of breath repeatedly as she was trying to get dressed, walking to the mailbox, can't make it to the mailbox. Difficult to get across the street. You can't go to the kids baseball games. It's very, very debilitating. And as it becomes more and more debilitating, these patients continue to do worse and worse and worse and continue to decondition and get worse and worse. And then their quality of life continues to get worse. A severe emphysema patient has a worse quality of life than a Stage IV cancer patient. So these patients are really in tough shape, and they're looking for a solution. They need a treatment to allow them to breathe again. There's a number of options they can go through. First, they start with medical management. There's a number of different inhalers, pulmonary rehabilitation. Those are kind of on the left side. Once they've failed these, once they've gone through and they've not seen the benefits from them, there's much more invasive options. There's lung volume reduction surgery where they go out and actually excise part of the lung. There's about 400 of those done in the United States a year. So a very, very small patient population and then lung transplants. We actually fall right in the middle. We have a minimally invasive technology that allows them to go in with the bronchoscope, put in these valves that allow the air to escape and then it's fully removable. If it doesn't work for that patient or there's some kind of issue with that patient, they can take those valves out and go down a different path. As far as the treatment process goes, a patient comes in, they receive a full workup. So they go through PFTs, pulmonary function testing. They go through a number of different testing, including a CT scan. That CT scan is then uploaded to us. We provide a report that shows target lobes, what lobe of the lung would be ideal to go after for that physician. They go in and they do what's called a Chartis assessment. They use a small balloon to make sure that, that patient doesn't have collateral ventilation. Collateral ventilation would mean that they actually have a gap between lobes of the lung that allow air to go between those lobes of the lung. If they have that, they're not really a candidate for our procedure right now, they will be in the future from a new product that we're coming with. After that they place Zephyr Valves. And I'll show you one of those looks like because it's a little bit different than probably what you're used to. And then they have a 3-night stay in the hospital and they're sent home. This is the Zephyr Valve. This is what it looks like. You've got what looks like a stent structure. It's a nitinol stent with a -- go ahead and play this with the valve. You see it's a Zephyr Valve inside. That valve allows air to escape that's trapped in the lungs, allows air to escape and then air does not go back in, and I'll show you. If you look in the top left, there's a large valve patient has a lobe that has trapped air in it. You'll see that lobe is very, very large. It's taking up most of the thoracic cavity. But they'll go in and the physician will place through the bronchoscope, several Zephyr Valves. That's what the valve looks like. Typically, it's 3 to 4 valves per patient. As I said, those valves allow air to escape from that hyperinflated lobe of the lung, but no more air to get in. So here, you'll see the air can't get in. And then as we back out, you'll see what happens to that patient is that large hyperinflated lobe that has destroyed lung tissue gets smaller and smaller. It allows the healthy lung tissue to expand and then bring in more air into the healthy lung tissue, which then allows them to perfuse more oxygen and then allows them to go on and be more active. Now it's not going to take 3 hours to put your sweatpants on. It's not going to -- you're not going to be able to not make it to the mailbox. You can go check your mail. You can go to the baseball game. So it's -- that's how the technology works. It's a little bit different. When you think about people that can't breathe, you think that they can't actually get air in their lungs. These patients have liters of air that are trapped in their lungs, and our job is to get that air out. Once they start to see the benefits, once we've reduced the gas trapping, they get better lung function, their breathlessness starts to go away. They see reductions there, their quality of life and their exercise gets better, which then makes better from a health status overall, and they continue to progress. As I mentioned, we have 4 randomized clinical trials. Those clinical trials are really the reason that we are the standard of care. The clinical trials have been done across the globe for many different reasons. Lung function improvement. We see exercise capacity improvement and quality of life improvements across the board. As I said, we're the Gold Level A evidence in 2025. We've been there since 2020. So this is the standard of care for this patient population. Once they've been identified, you see improved survival in these patients. It's the preferred treatment, and they have a number of benefits that come from receiving valves. As far as reimbursement, reimbursement is good. We have coding for both the physician as well as the hospital system. Our coverage payer mix is very strong as well. We have over 95% of patients with commercial insurance are getting coverage. I would say it's probably closer to 98%. So patients that go in are actually getting the treatment and the product is being reimbursed. Medicare reimburses as well. The payment is actually a little bit different. The physician is paid very similar to an advanced bronchoscopy. So just a standard advanced bronchoscopy patient for the physician. It takes -- it doesn't take too much time for the actual procedure itself. The procedure itself typically takes 30 to 45 minutes. The workup that's involved takes a little bit longer, but the actual procedure, the bronchoscopy itself is rather quick. The patient stay, it's a 3-day patient stay. And so because of that, it goes under a DRG. There's 3 different DRGs that this falls under, 163, 164 and 165. Those pay handsomely for the hospitals depending on where they are in the United States. I talked about a $12 billion global opportunity, and we look at this TAM quite a bit. And are there really 500,000 patients out there? We'll do less than 10,000 patients a year is where we are right now. That will continue to grow. But there's this huge, huge unmet need. There's a major patient population. And what we've done is we've actually built this through just a funnel where you've got these patients that have emphysema, then you've got patients with severe emphysema. And that means that it's really affecting their lives in a negative way. If we look at the cause for that severe emphysema, in many cases, it's the severe hyperinflation, which I talked about. They have too much oxygen in different lobes of the lung. Those are the patients that will benefit. Some of these patients can't have this because they're too sick already or there's other comorbidities that are in place that don't make them eligible for the procedure. But based on this, as we work down, we believe there are 500,000-plus patients that are CV negative, that don't have that collateral ventilation that I talked about that can benefit from valve treatment, and that's in the United States. Outside the U.S., it's closer to 700,000. Our strategy to get after these patients is acquisition. We have to go out and we have to acquire these patients and let them know that there is a treatment option for them. We do that through direct-to-patient advertising. We've continued to build that up over the last couple of years. Our results from direct-to-patient advertising have been exceptional. We had 56,000 patients that actually came on to our website and took action. They actually took out a quiz or they called our help line to find a physician that can treat them. So they've actually come in, we have over 1 million patients will actually hit our website, but 56,000 took action when they hit the website to do something. So we continue to do more in direct-to-patient advertising. We do it in targeted areas where we know that there are people that can treat them. When they come through this year, we believe we'll do over 70,000 patients, 70,000 on top of the 56,000 that came in last year. Peer-to-peer education is big for us. Right now, we've got this 56,000 patient population. We've got about 400 hospitals that are doing the procedure right now in the United States. But there's a gap between those, which is the referring physician that's in the marketplace. We need to make sure that those referring physicians are aware of the treatment and aware of what patients would benefit from it and where they need to go. So we're building a bridge between that patient population and the hospital system right now, which is that COPD referring physician. We do that through peer-to-peer education. We've doubled that last year, the amount of peer-to-peer education we did. We'll double that again this year. We've also taken some steps to bring in some sales reps that actually specifically call on those referring physicians to make sure that we build that bridge. And finally, there's a product called LungTrax Detect that I'll talk to you a little bit more about. When I talk about this bridge of getting the COPD physician, this is kind of the tunnel where we actually go -- we don't necessarily need the COPD physician, the referring physician in the community. We can identify patients that are currently in the hospital system by analyzing CT scans that are in their PAC system to find these patients and then move them through the testing process. So we're doing what we can on the acquirer perspective, I think we've seen really, really good results. I think we've done a nice job with really growing patient interest and patient knowledge. Testing: Once those patients are identified, they go through a battery of tests. Those tests are -- sometimes there's probably about 6 of them. And depending on how many -- how the hospital system sets those up, they can take a long period of time or they can be done quickly. We find if there's a navigator in place, a nurse coordinator in place that are really focused on this, they can get those patients through quickly and they get them to treatment. One of the ways we do that also is we've got a new product that we've just recently launched. I mentioned LungTraX Detect. LungTrax Connect is part of LungTrax Detect. And what that does is it's a workflow that comes out for that nursing staff to go through and actually manage that patient through the testing process. And then new account launches. We bring on probably 10 to 11 new accounts a quarter. We'll continue to do that. We do that opportunistically where we see accounts that actually have the opportunity and want to build lung health programs and actually grow and treat these patients. And then finally, treatment, how do we expand our treatment options? We have geographic expansion. We signed a distribution deal with China last year, which has done very well for us. We work direct in China. Now we work through a distributor that has been able to really build up that market. They've brought on a number of different sales reps, and they've done a lot of peer-to-peer education there as well. Japan, we have a clinical trial going on right now. It's our post-approval study. So we have approval and reimbursement in Japan. But before we roll it out more broadly, we have to do a post-approval study of 140 patients. We expect these 140 patients will be completed at the next year in 2026. enrollment will be completed. And there's no submission that goes with that. Once we've completed that enrollment, we just roll out to that patient population. There's 100,000 patients in Japan that we'll be able to capture with this. TAM expansion, AeriSeal is the next-generation product we've got, and I'll walk you through that right here. What this does is it addresses that collateral ventilation. Imagine if we're trying to drain the air out of this room and we put the one-way valve on that door, but somebody opens a window over here, we're not going to be able to get the air out of the room. But if that window -- if we can close that window, which we do with AeriSeal, we put in a small foam that closes that back window that then allows us to get the air out of the room, if you will, get the air out of that lope. And so by closing the collateral ventilation, it opens up another 20% to 25% of the patient population. Those patients are currently already going to the table. They just don't get treated at the time that they're expecting to get valves. So it's not just a broadening of the TAM by 20%, it's actually capturing patients that have already gone through this workup process. They've talked to their doctors and now they've gone through. Now that patient is going to wake up and they will have had a procedure. They'll either have had an AeriSeal procedure or they will have received valves. If they received AeriSeal, they'll be told to come back and receive valve treatment a couple of months later. We now have the LungTrax Detect as well. This is our new product that we recently released. So what this does is it goes into the hospital PAC system, takes data from the hospital PAC system, runs AI on it and identify severe destruction scores in these patients. So what we found is that 15% of the patients that are already in the PAC system in the hospital suffer from severe emphysema undiagnosed. So our ability to go in and actually identify those patients and pull them through so that they can begin workup has been really a major step forward. And this is kind of that tunnel where we don't need to go through the referring physicians that are on the community. These hospital systems already have these patients. They've already done a CT scan on them. They identify them and they can go through. They've already got relationships with them. So we're very excited about this. Our early data here looked pretty good. We had a handful of hospitals that were in our pilot. And from that, we've seen about 500 patients that have been -- potential patients that have been identified. Those go through a workup process, and many of those will fall out. But what we've seen is the StratX reports requests coming from those accounts over 40% increase in the StratX that we're seeing from those accounts. Our first handful of patients that have been identified from LungTraX Detect came through, we've got the next group coming through -- will be coming through as we continue. We're thinking about lung health programs across the board here. I talk to a lot of CEOs of hospitals and what they're looking at, they've got a lot of cancer screening, a lot of lung cancer screening, but we're talking about more comprehensive programs right now and LungTraX Detect really fits in there nicely. In my last 2 seconds, I'll go over the financials quickly. We grew 22% last year. Our guidance this year is 16% to 18%. We were up 20 -- just over 20% in Q1. We mentioned to everybody as we gave guidance that our first half of the year will be more OUS based, and we'll see that flip in the back half of the year as we start to see more and more benefit from this Lungtrax product. And with that, there's our investment highlights again, and thank you very much for your time. I appreciate it.