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Citi Healthcare & Medtech Conference

Mar 2, 2023

Joanne Wuensch
Managing Director, Citigroup Inc.

The music has died down, which tells me it's time for us to start the next presentation. I am still Joanne Wuensch from Citibank, and this time we have with us the management team from Pulmonx. Welcome to New York City.

Glen French
President and CEO, Pulmonx

Thank you for having us.

Joanne Wuensch
Managing Director, Citigroup Inc.

You know, it's interesting as I try to follow, or I do follow, the Zephyr valve launch and uptake. You know, we've spent a fair amount of time talking about the eases or obstacles to product adoption, particularly launching a new product during the pandemic. I'd like to sort of start our conversation today from a big picture vantage point. Where are we in terms of the product launch, and where are you maybe in terms of moving some of those obstacles out of the way?

Glen French
President and CEO, Pulmonx

We can take no credit for moving the biggest obstacle out of the way, which was COVID. It's nice to see that we're in a fundamentally different place. I think we talked about that in our 3Q earnings report, how across the second and the 3Q of last year, we had the first uninterrupted six-month window into our business, and we learned a few things, and it modified our strategy and focus as we execute. Taking a step back, as we look at our business, we're building it in three different ways, and we have to be careful the order of operations of these three things. 1 is that we're trying to be very selective on the accounts that we choose to go into.

In the United States, we're targeting on the order of 500 accounts. We're into nearly 300 of those 500 accounts, and we're selecting those accounts based on their capabilities, their geography, the surrounding COPD populations, and very importantly, the sort of key treating physician. As we've talked about in the last couple of quarterly calls, we're very much focused on ensuring that they're getting to a point where they're doing the procedure routinely. What that requires is for them to be doing it efficiently. They're adopting best practices. They're looking into their own networks and ultimately in collaboration with their marketing departments, looking to tap into the referring physicians that are out in the periphery. We estimate 80%-90% of the patients are being managed outside the field of view, if you will, of the treating centers.

Probably 70%, 80% of the patients are coming through referring physicians. The second area of focus is that the COPD physician, the referring physician, we know who they are because the patients themselves have a distinct pharmaceutical fingerprint. We can capture data on the prescribing habits of that combination of drugs, and we can know who's managing the majority of patients in the geography that surrounds our treating centers. Of course, turning that second area on before the treating hospitals are up and running is not practical or logical or rational. We wanna make sure we've got good treating centers.

We try to make sure that the referring physicians both have the information that they need and are introduced and well acquainted with the treating physician because we're talking about referring some of the most fragile patients that these doctors have. We've got a couple 100,000 patients that we've engaged with on through social media on a global basis. About 150,000 of those have opted in to communicate back and forth with us on email.

We have to be very careful if 70%-80% of those patients are gonna go through a referring doc to make sure that we don't create a wave for those referring docs before they understand the magnitude of benefit that we're delivering and the people that are doing the procedure. Those three elements have to be ignited in the proper sequence in a given geography, and we're sort of advancing things in staggered parallel. In certain geographies, we're ahead of others. As we look ahead and as we are primarily currently focused, we're making sure that we've got the right hospitals up and running in a given geography and in parallel than engaging with the referring physicians in that geography.

Joanne Wuensch
Managing Director, Citigroup Inc.

How do you identify the right hospitals in the geography? Is it possible for you to say, "Okay, we trained the physician here, but he or she is not adopting it. We're moving our energy elsewhere"?

Glen French
President and CEO, Pulmonx

Yeah. We're very selective on the hospitals that we are targeting. I think I said 500 hospitals in the United States, which represents something on the order of 8% of U.S. hospitals. Our patients are going to drive by five hospitals on the way to getting to the treating hospital, which is actually very attractive to the treating hospitals. Typically, those hospitals that are doing the procedure have a lung business, if you will. They've got thoracic surgery there. They've got pulmonologists that are there in the hospital. They tend to be closer to 350+ bed hospitals, not, you know, 90-bed hospitals typically. Although we do have in certain geographies like Billings or what have you know, we've got smaller hospitals that are doing the procedure as well.

In any case, that's how we identify the hospital itself, and then we're looking as well for a team that exists in that hospital. Typically, there's an interventional pulmonologist, maybe 500 fellowship-trained interventional pulmonologists, probably a little bit less than that in the United States. We expect about 800 doctors to be ultimately trained to do our procedure. We very much prefer to have a center that's doing many as opposed to two per year. We're pursuing sort of a classical center of excellence approach. We've got, you know, sales reps around the country. Entire country is covered and when we're growing out that base, and we're about roughly two-thirds of the way to getting to the ultimate number of hospitals that we're gonna target.

Joanne Wuensch
Managing Director, Citigroup Inc.

Are there any physicians that you've had to pull back?

Glen French
President and CEO, Pulmonx

Yes.

Joanne Wuensch
Managing Director, Citigroup Inc.

Okay.

Glen French
President and CEO, Pulmonx

Yeah.

Joanne Wuensch
Managing Director, Citigroup Inc.

Talk me through, you train Dr. X in, I don't know, January of 2020, and he or she, you know, are not doing what you think they should be doing. How do you assess, and how do you retrain?

Glen French
President and CEO, Pulmonx

When we assess, we decide whether we want to retrain or whether we're just gonna walk away. Often it's from a doctor, not from a center, because the centers are generally interesting. The only situation where we would walk away from a center would be that we made a bad decision on selecting a doc. They just wanted to get onto our website. They just wanted to tell their colleagues that they were doing the procedure, but they're not really doing the procedure. They happen to be a controlling influence at that specific site, i.e., typically you go, you know, if you're at a teaching hospital or something. You've picked the wrong doc, you just find another one in that center. You know, at the Cleveland Clinic, they've got 10 people that can do this procedure.

You just go to the next person and so forth. It's typically it's not a problem and the person who thought they were gonna do the procedure is not doing it, typically doesn't have a problem. There's relatively few hospitals that we walk away from. There have been some, and the physicians we typically work around. It is super important to us as we have some number of our accounts, about 25% are exactly where we want them to be. There's another. If you take the balance, there's some number of Nearly all of them we're ultimately going to get to the place that we want them to be, but in the immediate term, we have to choose who we want to invest in. I know you asked a question about divestiture.

There's really not that much divesting going on as on an accounts level, but there is in that next group, a very active process going on as to where do we get the best return on our investment of time in terms of that middle group of hospitals that we're trying to take into the most productive cohort.

Joanne Wuensch
Managing Director, Citigroup Inc.

How do you think about the procedure reaching a tipping point?

Glen French
President and CEO, Pulmonx

What do you mean tipping point?

Joanne Wuensch
Managing Director, Citigroup Inc.

Where either the patient is... It's obvious he or she should be doing this, or it's like, the physician that's not trained yet.

Glen French
President and CEO, Pulmonx

Yeah.

Joanne Wuensch
Managing Director, Citigroup Inc.

has what I would call, you know, procedural FOMO. Like, "I need to know how to do this.

Glen French
President and CEO, Pulmonx

Yeah, we're pretty close to, I mean, like I said, we're about two-thirds of the way there to getting the doctors and the sites set up. It's really about the referring physicians and where are they, and at what point does this become, I don't know. I mean, to put it in the most Well, I'm not gonna use this phrase, but I mean, there is a certain element of not only should I be doing this, but is there a consequence to me...

Joanne Wuensch
Managing Director, Citigroup Inc.

Correct.

Glen French
President and CEO, Pulmonx

if this is the standard of care, it's in all the national and global guidelines, and I'm not even talking to my patient about it.

Joanne Wuensch
Managing Director, Citigroup Inc.

Right.

Glen French
President and CEO, Pulmonx

It's an information thing. You know, we go out to physicians, there's some number. Very uncommon for pulmonary specialists, people who have big COPD practice to have not heard about valves. It's quite common in the early conversations to learn that those people don't have complete information. For example, have you ever heard of valves? Yes. Are you referring your patients to a local center to get valves done? No. Why? Well, maybe that they don't know who's doing the procedure. These are among their most fragile patients. They need to know, you know, what information am I gonna get before the procedure in the peri-procedural phase, after the procedure, are you gonna round-trip that patient back to me? You're a pulmonologist, I'm a pulmonologist, am I giving you my patient?

You know, there's that whole conversation. The interventional pulmonologists are subcontractors, so they're not gonna be stealing anyone's patients. They've gotta go through that. The most common reasons why people when we ask them, "Are you referring?" They don't refer, they'll say something like, "Well, I'm waiting for the data to be published." We've got four randomized controlled trials and, you know, one of them was published in The New England Journal, the other three in the American Journal of Respiratory and Critical Care Medicine. That's an information thing. We're waiting for this technology to be recognized in the guidelines. Well, we're in the global guidelines, national guidelines. The rating on the quality of our data is A, which is the highest level randomized controlled trials. We're waiting for this to be reimbursed. Well, it's broadly reimbursed.

99% of patients essentially can get covered. 75% of our patients are Medicare patients. You know, there's no question that people are getting paid for this. They, you know, they'll come up with all kinds of reasons, and I would say the top five reasons are just education. It's like, "Wait a minute, that's done, that's done, that's done." They go, "Oh, well, that's interesting." No, no, there two things. I think once you get that out of the way, it's okay, we're delivering this magnitude of benefit. The best you can do on drugs alone is this.

Joanne Wuensch
Managing Director, Citigroup Inc.

Right.

Glen French
President and CEO, Pulmonx

You know, why not talk to your patient about their interest in turning back the clock some number of years to possibly enable them to do things that don't have them tethered to their couch with oxygen. Maybe get back to walking up to your bedroom. You know, spending time out in the yard with your grandchildren, going to the mall. We've had examples of, you know, one woman said, "My life is my horse, and now I get to go back on my horse." Another woman's a professional musician who had to give it up and now is back in the band. You know, those kinds of things that they can turn back the clock.

It's such that education on the magnitude of benefit, and then as I mentioned before, the introduction to the physician and understanding who's gonna be doing this procedure. 'Cause this patient's fragile. Let's talk about your experience. What could go wrong? What are you gonna do about it? How experienced are you in managing that? What's the probability this patient's gonna come back to me not happy with me because I sent them to you?

Joanne Wuensch
Managing Director, Citigroup Inc.

How do you think about, sort of the other side of the coin, the patient coming in with a, you know, the Google printout saying, "This is what I want.

Glen French
President and CEO, Pulmonx

Yeah.

Joanne Wuensch
Managing Director, Citigroup Inc.

I mean, are you starting to see the push versus the pull aspect of adoption?

Glen French
President and CEO, Pulmonx

20%-30% of our patients on a national basis are going to the treating sites themselves with that Google printout. There is some amount of that. We have a Talk to My Doctor program, they are going to their referring doctor, the referring doctor's going, "Oh, that sounds new. Oh, we gotta wait for that to get published." You know, the patient's like, "Wait a minute, I'm on this website with 100,000 other people, and they all think that this is all taken care of." We have this program called Talk to My Doctor, which is a fully compliant program where the patient says, "Listen, my name is Jane Smith. I'd like you to go to Dr. Jones. Use my name.

Tell him I asked you to come, and go see what you can do to get them some additional information." That's about the warmest lead you could possibly have. Our sales rep follows up on those types of things in that specific geography virtually every time they get in front of the physician. It's a very powerful way to enter. When we, then you know, either us or just the doctors themselves, get connected, the treating physician and the referring physician, you know, 50%-70% of the time patients start to flow.

Joanne Wuensch
Managing Director, Citigroup Inc.

Okay. Do you think that there's a backlog of patients? How do you define backlog, if the answer is yes?

Glen French
President and CEO, Pulmonx

There were always backlogs coming out of COVID waves, which were pretty obvious. The ways that we could very clearly quantify them was that they were patients that were scheduled.

Joanne Wuensch
Managing Director, Citigroup Inc.

Mm-hmm.

Glen French
President and CEO, Pulmonx

Then, you know, the state of Texas says, "All elective procedures stop," or a given hospital said, "If there's any chance that this patient, and I don't care how small, might end up in an ICU bed, we don't want you to do that procedure unless the patient's gonna die tomorrow," type of thing. Those were situations where it's like we could see the scheduled patients-.

Joanne Wuensch
Managing Director, Citigroup Inc.

Mm-hmm.

Glen French
President and CEO, Pulmonx

know that the bump that you'd see, often we would show it in a, in a quarter coming out of a COVID wave.

Joanne Wuensch
Managing Director, Citigroup Inc.

Right.

Glen French
President and CEO, Pulmonx

That's what we viewed as pent-up demand or backlog or whatever. We're now three-quarters away from those types of things shutting down our business. As a result, we have a lot of patients in process. This is not a procedure where you walk in in the morning, and the procedure's done later that day. There could be months between when that patient walks in the front door and when they've gotten through all the pre-testing and ultimately get the procedure. We've got a lot of patients that are in process. We know what's scheduled out in front. We know. We do these quantitative CT analysis software assessments to identify the patients that are most likely to benefit. If there's a green light, we call them a StratX green light. That's software StratX green light.

We can see those StratX green lights accumulating in a given geography. We have calls into our reimbursement services group. We can see those building, which why are they calling to get pre-authorization to have a procedure if they're not planning on having the procedure? We do have certain ways to see what's coming on the horizon. There is no, you know, 1,000 patients or 1 million patients or whatever that are, quote, unquote, "sitting in by themselves in a room waiting to be called for their procedure.

Joanne Wuensch
Managing Director, Citigroup Inc.

Number 223?

Glen French
President and CEO, Pulmonx

Yeah.

Joanne Wuensch
Managing Director, Citigroup Inc.

Okay. All of this, when you put together your 2023 guidance, and we were talking about this after your earnings call, how did you piece it all together? Pulmonx was one of the few companies that gave guidance above the consensus estimate. Most companies safely bracketed it.

Derrick Sung
CFO, Pulmonx

Well, appreciate the question. I mean, I think that the answer is gonna be similar to, you know, what we've always said, which is the guidance that we give is, you know, our best estimate of what we can do and what we feel is achievable at the time that we give it. We feel good about the $63 million-$65 million that we guided to. I mean, I think the components, digging a little deeper into your question, the components of that guidance, you know, first off, I'd say that, our assumption is that the macro environment is really just stable and as it is. There's no assumption one way or the other that the macro environment needs to improve, say, for us to achieve that guidance.

We believe that we can get there primarily, by, you know, driving increased account productivity and throughput through the year. That is something that we think we will be able to do internally, and it is within our control. That's the primary lever, I would say, of guidance, both, you know, to the upside, to the downside as well, which is really, you know, this year we're focusing on driving throughput, driving same-store sales and productivity. We're gonna open up new accounts in the U.S. We've talked about opening up 40 to 50 or so new accounts. Really, our focus is gonna be on driving those same-store sales, and it's gonna be our ability to do that I think drives upside or downside to our range.

Joanne Wuensch
Managing Director, Citigroup Inc.

Okay. I do wanna speak a little bit about, because Zephyr is still new. You touched upon this a little bit.

Glen French
President and CEO, Pulmonx

Mm-hmm.

Joanne Wuensch
Managing Director, Citigroup Inc.

The pathway of the patient getting off of their couch, getting in to get the valve, and getting back to their life. There's a number of touch points that patient needs to go through. If you could just remind us of those steps.

Glen French
President and CEO, Pulmonx

Typically, as I mentioned, they're either gonna go talk to their physician, their, you know, who manages their day-to-day care. More often, you know, the probability that somebody's seeing a pulmonologist goes up with disease severity. We're treating patients with severe emphysema. Though, there's a lot of internal medicine docs, roughly 50% of the patients that are out there are being seen by pulmonologists. That's 70% of patients are gonna go ask that individual, you know, "What do you know about this? I just learned something about it." The rest of the patients are gonna go directly to the source. The University of Chicago is doing a procedure. They're gonna go and start knocking on doors, or they saw something on TV.

They'll go try to get an appointment with the physician that was featured in that. Whether the referring physician starts doing the workup or whether they simply refer to the treating center to start the workup, there's questions that have to be answered. One is that we're treating patients that have severe symptomatic emphysema, and some of those patients may, by the assessment of the physician who's treating, may not yet be sick enough. It's a progressive disease, so if they're not ready for the procedure today, perhaps sometime in the future, they will be. In that case, that's a fairly quick assessment. Their pulmonary function testing, which they'll do, may be stronger than what would be considered normal to do the procedure. We treat patients that. We solve for air trapping in the chest.

Our procedure, imagine you have a one or two liter bottle taking up space in your chest cavity, a fixed, you know, volume, and we're trying to pull that space-occupying inefficient air out of the chest to allow healthier tissue to expand. If the patient's symptomatic and yet they don't have discernible air trapping that is considerably greater than what would be considered to be normal, they're probably not a good candidate. Now, 80% of the patients who have shortness of breath, severe emphysema, are gonna have some kind of air trapping, so that's not a normal stopping point. We have to be sure that these patients are candidates for anesthesia. If they have significant cardiac comorbidities or if their disease is just beyond where we can really reasonably help them, then they're too sick to withstand the insult of the procedure.

Just to put into perspective the insult of the procedure, last year we did five or 10 times as many procedures as the surgical analog, the lung volume reduction, open up the chest. This is not a 1-to-1 kind of thing. We've already lapped the surgery. Now what we're doing is we're going after the great number of patients that aren't candidates for surgery because of the insult. Our procedure can treat a whole array of disease distribution within the lung. Surgery, you have to. It's basically, you can only target on the edges, right? 'Cause you're not gonna go into the middle of someone's lung and take out a baseball-sized chunk of lung tissue. You're targeting a lobe, and you wanna make sure that you can get at where the problem is.

In our case, we can be very surgical in our approach, if you will. whereas with surgery itself, you can only deal with the edges. In any case, there's a number of reasons why somebody would be included or excluded, and a number of tests that allow them to determine whether those patients are good candidates or not.

Joanne Wuensch
Managing Director, Citigroup Inc.

Where does StratX and, I'm sorry, I just flattened.

Glen French
President and CEO, Pulmonx

Chartis.

Joanne Wuensch
Managing Director, Citigroup Inc.

Chartis.

Yeah.

StratX and Chartis. I think I've just combined them. StratX. StratX and Chartis fit into this.

Glen French
President and CEO, Pulmonx

Taking a step back. You know, five or more years ago, everybody we were thinking about treating, we needed to anesthetize and stick a tube down their throat, blow up a balloon at the area that we were gonna target and measure. You know, basically simulate the procedure to understand whether that patient was collateral ventilation negative, meaning didn't have significant communication of air between the target lobe and the adjacent lobe. If we go to a patient who has a lot of collateral ventilation, and we put our valves in in an effort to try to evacuate the target lobe, it just refills through the back channels from the, from the adjacent lobe.

What it was happening was about 50% of the time, this is like five to 10 years ago, 50% of the time the procedure would be done, the patients would be woken up, and they'd be really disappointed. "Sorry, you're collateral ventilation positive. You're not a good candidate." What we did was we said, "Hey, wait a minute. All of these patients are being diagnosed with a CT scan." Basically, at your doctor's office, "I'm really short of breath doing this activity that I used to be able to do routinely.

I can't do it anymore." "Are you a current or former smoker?" "Yes." "Let's do a CT scan." They look at tissue density of the lung relative to normative values for somebody of your age, and if you have considerably less density of your tissue, you're diagnosed as having emphysema. We take that very data from the CT scan, and we run it through this quantitative CT analysis software called StratX, and we're able to rebuild the fissure or tissue division between lobes. If it's at least 80%, we say, "Green light. We're gonna go ahead and schedule a procedure." If it's less than 80%, the odds of them being CV positive is quite high, so it's not worth it. Those patients today, and we can talk about AeriSeal in a moment.

Joanne Wuensch
Managing Director, Citigroup Inc.

Yes.

Glen French
President and CEO, Pulmonx

Those patients today are not candidates for our procedure. The patient gets anesthetized. They go in with a bronchoscope and they do that little balloon catheter. That's Chartis. It's a Chartis catheter. It's connected to effectively a computer. It measures changes in pressure and flow. If the calculated volume of the target lobe is one liter and two liters flows through that Chartis catheter, we know that air is coming from somewhere other than the target lobe, there must be collateral ventilation.

If the amount that flows through is, say, as I said before, let's say there's a liter of air in there, and at 500 cc's of air that flows through the catheter, pressures start to rise in that lobe, that's an indication that that's a CV negative patient, because you would think as you evacuate that space, the pressure in that space is gonna go up. That's a green light. 80% of the time we anesthetize somebody to undergo our valve procedure, we put in valves. 20% of the time today, they're woken up and disappointed to learn that they were CV positive and therefore not good candidates.

Joanne Wuensch
Managing Director, Citigroup Inc.

Do you charge for those two tests?

Glen French
President and CEO, Pulmonx

We do not charge for StratX. Our cost is on the order of $75-$100 a piece. We'll do two or two and a half of those for every patient we treat. We're making in the United States $11,000 a patient at 75% gross margin with whatever, $150 for StratX that we give away.

Joanne Wuensch
Managing Director, Citigroup Inc.

Okay. What about for Chartis?

Glen French
President and CEO, Pulmonx

Chartis, we do charge for. We have the Chartis controller we sell, or we charge a per-use fee. If that patient gets woken up and they are CV positive, they didn't get valves, then they're immediately flipped from an inpatient DRG to an outpatient procedure, and the hospital gets reimbursed for that outpatient diagnostic test, and we get paid. We get paid about $1,000 for the Chartis catheter, and I think on the order of $650 if they rent the use of a Chartis.

Joanne Wuensch
Managing Director, Citigroup Inc.

Okay.

Glen French
President and CEO, Pulmonx

The hospital gets paid for that outpatient procedure.

Joanne Wuensch
Managing Director, Citigroup Inc.

Do you wanna talk about...

Glen French
President and CEO, Pulmonx

AeriSeal?

Joanne Wuensch
Managing Director, Citigroup Inc.

Yeah.

Glen French
President and CEO, Pulmonx

Yeah. Well, it kinda follows, right?

Joanne Wuensch
Managing Director, Citigroup Inc.

Yeah.

Glen French
President and CEO, Pulmonx

80% of the time we anesthetize the patient, we end up placing valves. 20% of the time, the patients get woken up, and they're disappointed. We have a technology called AeriSeal, which is a two-part injectable polymer that we reported on. We put out a press release, I think, in the fourth quarter.

Joanne Wuensch
Managing Director, Citigroup Inc.

Fall.

Glen French
President and CEO, Pulmonx

That or in the fall, yeah. We had some data on a study that's a multi-center, multinational study out of Europe that looks at whether you can do two things. One, can we go into these patients that are, that have, that are essentially Chartis red lights? You know, these patients that we go in, we wanna treat them, we can't treat them because they're CV positive, and use AeriSeal in a procedure to make them CV negative. It's like a tire patch kit. You just, you go, "Oh, we got an interruption here." We can see it on our StratX scan exactly where it is. We know the airways that feed it. We go in with AeriSeal, deliver it into those airways. Will that take a patient that is objectively CV positive and make them CV negative?

The answer that came out of the one. There were two things that were reported basically around the 3Q. One was the interim CONVERT data, which was on the order of 40 patients. It indicated that 80% of the time we can take those patients from CV positive to CV negative. The second question, which makes the first question irrelevant, unless the second question turns the right way, is when you put valves in those patients that you just made CV negative, do they behave the same way as patients did in the prior studies that are the basis for us having the product on the market? The answer is yes.

We saw that in both the interim data from the CONVERT trial, which were reported late last year, and there was a single center study out of Australia that looked at something on the order of 14 patients or something, showed the same thing. It's very encouraging. If this continues to play out, we ultimately are looking to get AeriSeal utilized both outside the United States and in the United States. If in doing so, we would increase our total addressable market by 20%-25%, because now, you know, these patients that we would normally be waking up, we would actually be doing something for them. As I mentioned, how and where we place the AeriSeal is informed by StratX, which we're already doing. It's a little bit different analysis, but it's not inconceivable.

We know that or the plan is that the doctor who's doing the procedures talks to the patient, says, "80% chance we're gonna wake you up, and you're gonna have valves. 20% chance we're gonna put in AeriSeal, and an 80% chance thereafter that that's going to make you ineligible for valves in the future." And they're all... You know, so there's about a 96% chance that the patient's gonna wake up happy, like, "You did something to help me. And I'm CV negative, so let's see how the valves work." Anyway, that's the plan.

Joanne Wuensch
Managing Director, Citigroup Inc.

what is the timing of FDA approval?

Glen French
President and CEO, Pulmonx

We have an IDE trial in front of us, so we expect to enroll our first patient in that IDE trial before the end of this year. You know, we're a few years away from U.S. market entry. We have the CE mark on AeriSeal, and we expect that with this CONVERT-1 trial that we provided interim data on late last year, we'll have all those patients follow followed up and published certainly by next year. We would expect that sometime next year we'll start seeing some revenues coming out of CE mark countries.

Joanne Wuensch
Managing Director, Citigroup Inc.

Where you are internationally, and where do you think you can go internationally?

Glen French
President and CEO, Pulmonx

Well, last year, 60% of our revenue was in the US, 40% was outside the United States. Between 90% and 95% of our global business is spread across six countries. Australia plus four European countries, our largest OUS country is Germany, then France, then the UK, then Australia, then Switzerland. That, you know, we expect that the US will continue to grow faster than international. We estimate maybe 65% of our 2023 revenue will come out of the United States, but we continue to see growth opportunities outside the United States in those markets. We're in about 25 different markets. As I mentioned, the bulk of the business comes out of six countries. 97%-98% of our business is direct.

One of the things that I think differentiates us as a little company, and frankly allows us to stand shoulder to shoulder with any company that's in the interventional pulmonology space is that 97%. We've got it. Our people on the ground. You know, we've got people in China, Australia, Japan, and all the major European countries. We've got a good footprint to take advantage of the opportunity that's out in front of us with the technology that we have, with that which is under development and a cornerstone for any other technologies that we may develop or, you know, put in our bag another way.

Joanne Wuensch
Managing Director, Citigroup Inc.

For you, Derrick. As you think about gross margins, what do you think peak gross margins are for the company? I'm gonna add a little bit more to that. As you add AeriSeal, expand geographically, reach this maybe not tipping point in utilization in the US, how do you think about your need to ramp SG&A?

Derrick Sung
CFO, Pulmonx

Both great questions. I think, I think from a gross margin perspective, we expect we can get into the high seventies at scale. You know, today, this year, we'll be operating around 73%, 74%. You know, we continue to see meaningful gross margin expansion opportunity that's primarily gonna be driven by, increasing our output and driving overhead absorption. You know, we'll be holding sort of production relatively flat through this year and then start ramping up production and utilization again end of this year into next. As we do so, we expect to see, you know, a steady moderate increase in our gross margin to kind of that high seventies range. That's where we think we'll be.

As we build the capacity, I think we'll also demonstrate, or we certainly will plan to demonstrate operating leverage, which maybe is kind of getting to your question on SG&A. This year we're, you know, guiding to growing our revenue 20% on average. We are guiding to grow our cash OPEX spend, that's OPEX excluding stock-based compensation by about 10%. Already this year, you'll be seeing sort of that operating leverage move forward. We're certainly gonna be continuing to grow our SG&As, or our OPEX spend, if you will. Some of it will come in the form of R&D as we continue to ramp up AeriSeal, et cetera.

We expect that our OPEX spend will continue to grow at a meaningfully lower rate than our revenue, and so we'll be seeing some nice operating leverage there.

Joanne Wuensch
Managing Director, Citigroup Inc.

What about R&D?

Derrick Sung
CFO, Pulmonx

Primarily our R&D increase over the next couple of years is going to be the AeriSeal program that Glen talked about. You know, some of the 10% roughly increase in R&D spend this year is gonna be that. I think you'll continue to see our R&D increase on that order over the next couple of years. You know, certainly we'll have other internal projects, you know, internal, external, you know, there's gonna be R&D spend that's going to continue on. I would say for the next couple of years, the R&D growth primarily will be a lot of clinical study, regulatory spend related to the AeriSeal program.

Joanne Wuensch
Managing Director, Citigroup Inc.

Do you have a vision of where you get to cash flow breakeven?

Derrick Sung
CFO, Pulmonx

Yeah, you know, I mean, just rough numbers we've been saying, you know, between, you know, $100 million-$200 million in sort of annualized run rate. If you want to pick a number or call it 150 or so-ish, is where I think we can get there. We burned, you know, we burned $44 million in cash last year. You know, I expect that burn to be flat to down this year, we expect to show and demonstrate cash flow or cash burn leverage moving forward. One of the metrics that we're now reporting to The Street is our Adjusted EBITDA loss. You know, that I think is a clean metric that's for us to look at our operating leverage.

Is it sort of adjusted out some of the non-cash expense? Our Adjusted EBITDA loss last year was around $41 million. Again, our target would be to see that, or demonstrate that that can move down, even this year and over time.

Joanne Wuensch
Managing Director, Citigroup Inc.

Excellent. When we're together a year from now, what do you think we will be talking about?

Derrick Sung
CFO, Pulmonx

Well, we're very confident in the plan that we're on. We see it as a multi-year plan. You know, obviously there's some number of accounts that we've yet to go into that we're gonna have to be bringing up. We see our accounts, even in the pre-COVID phase, taking a solid year to go from, you know, sort of doing their first patient to getting close to being a routine account. We expect that we'll be showing meaningful increased productivity in the accounts that we're in. Obviously, we have always thought of, and we think about new accounts as being very opportunistic. It's not central to our growth strategy. What is central to our growth strategy is same store sales. We measure productivity on average in our accounts across a given quarter.

Those that are established have been up and running for a while. We talked about in the last quarterly call the idea that we delivered, you know, four to five patients per quarter. I think the average in the fourth quarter was 4.8 patients. We would expect to see, on average, those numbers getting into, you know, exiting this year into the sort of five to six patients per quarter in established accounts. Those are the kinds of metrics that I think we would be expecting to see moving in a positive direction.

Joanne Wuensch
Managing Director, Citigroup Inc.

Wonderful. Glen and Derrick, thank you for joining us today.

Glen French
President and CEO, Pulmonx

Thank you very much.

Derrick Sung
CFO, Pulmonx

Thanks, Joanne.

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