Monogram Orthopaedics Q1 2025 Earnings Call Transcript

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Provided by Quartr
May 14, 2025

There are 7 speakers on the call.

Operator

Good afternoon, everyone, and welcome to the Monogram Technologies first quarter twenty twenty five financial results and business update conference call. A question and answer session will follow the formal presentation. Webcast viewers can submit written questions for the q and a portion of this presentation. As a reminder, this conference's call is being recorded. Before we begin the formal presentation, I would like to remind everyone that statements made on the call and webcast may include predictions, estimates, or other information that might be considered forward looking.

Operator

While these forward looking statements represent our current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially. You are cautioned not to place undue reliance on these forward looking statements, which reflect our opinions only as of the date of this presentation. Please keep in mind that we are not obligating ourselves to revise or publicly release the results of any revision to these forward looking statements in light of new information or future events. Throughout today's discussion, we will attempt to present some important factors relating to our business that may affect our predictions. You should also review our most recent Form 10 k and Form 10 Q for a more complete discussion of these factors and other risks, particularly under the heading risk factors.

Operator

A press release detailing these results was issued today, 05/14/2025, and is available in the investor relations section of the company's website monogramtechnologies.com. Your host today, Ben Saxon, chief executive officer, and Noel Kanopy, chief financial officer, will present results of operations for the first quarter ended 03/31/2025. At this time, I will turn the call over to my Graham chief financial officer, Noel Kanopy.

Speaker 1

Good afternoon, everyone. Great to be here with you this afternoon to go over our q one results and to discuss upcoming, business activity that we're really excited about. We're going to go over the financial data today, then Ben will go over the, FDA clearance overview, our clinical trial update, remind you all of our investment thesis recap, and and the upcoming milestones that we're going to achieve to get there. And then we'll have a a short question session after after all of that. So let's move on to the financial data summary.

Speaker 1

Most importantly, for the three months ended 03/31/2025, we had $13,300,000 of cash, which is reflective of an operating cash flow of $2,300,000 for the core for the quarter, which translates into a monthly cash burn of about $800,000. This is down from last year's monthly burn of about 1.1 to $1,200,000 as we finalize the verification and validation phase of our robotic system development last year. And we've been able to leverage our highly variable cost structure and re and scale down some of those variable costs. We still have 27 full time employees that are supporting our ongoing r and d and getting us ready for achieving the the milestones that we have set out that Ben will go over shortly. As you'll know with our results, from an expense perspective, we've been very cost conscious, and we will continue to do so.

Speaker 1

We forecast a monthly cash burn of about a million dollars a month to keep us going through the milestones and through the remainder of the year. So we have more than a year worth of of cash on the balance sheet, so we're in a good position. As we've stated before, we have no traditional debt and very minimal, short term warrant obligations. So, again, we have a really strong balance sheet that that help will help us continue. In addition to that $1,000,000 per month, cash burn rate, we we do anticipate about $1,200,000 to be spent over the clinical trial time period, which will be in the, you know, six to nine month time frame.

Speaker 1

That that'll that'll be kind of lumpy spend, but that's when that'll go out. Overall, we expect to have cash to capital in the near term, and we're we're bullish for the future. So with that, I'll hand it over to Ben, and he'll give you the updates of the company and and where we're going from here.

Speaker 2

Thank you, Nolan, and thank you everybody for joining today's call. This has been an extremely eventful and rewarding quarter for Monogram. On March 17, we were pleased to announce that we had received five ten k clearance from the FDA for our embossed total TKA system, which was a truly defining milestone for our company's history. This clearance represents the culmination of years of effort, innovation, determination, and technical advancement by our incredible team. We believe our system is well positioned to make a meaningful impact on the future of orthopedic surgery over the years to come.

Speaker 2

In parallel with this clearance, we have applied for our first pilot placement with a major institution in The United States, which will involve approximately four surgeons to start. This program is designed to demonstrate the value proposition with real world clinical performance of the system on live patients and will serve as a platform for demonstrating surgeon training and broader commercial interest. We are not standing still. We have made substantial hardware and software improvements since the July 2024 submission, and we fully intend to launch with these enhancements included. Validation work for those improvements is actively underway.

Speaker 2

To support these efforts, we are actively showcasing the system with key opinion leaders here in Austin, as well as in other geographic areas and preparing for additional placements. While we anticipate a slow and methodical initial rollout, this approach is by design. It ensures we maintain a very high level of service, surgeon support, and importantly, utilization. Once the foundation is set, we anticipate that our commercial growth could accelerate meaningfully. Another major milestone occurred for the company on April 29 when we announced that we had received regular regulatory approval from CDSCO, the Central Drug Standard Control Organization, to initiate our multicenter clinical trial in India in collaboration with Shelby Hospitals.

Speaker 2

This will be the world's first clinical investigation involving autonomous saw based robotic total knee surgeries on live patients. Let me be clear. This is not just a milestone for monogram. It is a watershed moment for the entire field of orthopedic surgery. We are on the brink of performing a revolutionary surgery that will push the limits of automation and surgical robotics.

Speaker 2

While results remain to be seen, we believe this trial will showcase the potential of robotic precision, reduced surgeon fatigue, faster learning curves, and increased operating room efficiency over time, all without compromising safety or accuracy. These achievements are not isolated. They are strategic proof points in our broader investment thesis. We believe orthopedic surgeries will be robotic in the future. We believe that surgeons, patients and hospitals will increasingly demand solutions that are more personalized, more accurate and more efficient.

Speaker 2

So with that, I want to briefly reiterate our rather simple investment thesis. We believe we are at the forefront of a paradigm shift in orthopedic surgery. We are commercializing what we believe is the first autonomous saw based cutting robot for total knee arthroplasty and eventually other applications as well. The system is no longer just a concept. We are now on the cusp of demonstrating its capabilities in live patient cases, which we believe will represent a major inflection point for our company as well as the industry.

Speaker 2

The current market is highly consolidated with one dominant player, Stryker, holding significant market share with its Mako robot. Mako has created enormous value for Stryker by solving a clear clinical problem, enabling patient specific planning and safe efficient bone cuts with haptic boundaries that protect surrounding soft tissues. In our view, it remains the only system on the market that enables efficient, accurate, total knee execution with built in safety boundaries. However, the execution of cuts still relies entirely on the surgeon's hand. We believe this leaves the door open for a next generation solution, autonomous saw based cutting, which could address the same clinical needs while further improving, potentially improving consistency, efficiency and potentially reducing the burden on the surgeon.

Speaker 2

We view this opportunity as highly significant and largely untapped. And we intend to be the company that capitalizes on this. We believe this next slide really underscores the magnitude of the challenge and the opportunity that faces companies operating in orthopedic robotics. The market is undergoing a generational shift. Most new surgeons entering the field are being trained on robotic systems and among fellowship trained programs, Stryker's Mako system currently enjoys an estimated 70% market share.

Speaker 2

That level of early exposure, we believe translates into long term loyalty and entrenched market behavior. What this slide illustrates is the demographic impact or potential demographic impact of that trend. As the current generation of orthopedic surgeons, sixty percent of whom will be over the age of 65 by 02/1931, begin to retire, they will be replaced by a new cohort that is overwhelmingly robotic trained. If we assume that surgeon preferences remain constant and model with no change in adoption behavior, demographic trends alone could result in Stryker gaining up to 9% market share over the next decade without doing anything differently. And this we believe is the opportunity for monogram in our orthopedic space.

Speaker 2

This is the momentum we aim to disrupt with the Emboss surgical system. Our system is designed to be the most advanced robotic platform in orthopedic medicine. It is the only hands free, autonomous, saw based total knee robot cleared by the FDA. While the data is still forthcoming, we believe we have the potential to demonstrate that cutting that is more efficient, accurate, and safe with any than any other robotic system currently on the market. Again, these are not clinical claims, but these are the reasons that we are here.

Speaker 2

We are here to try and develop a robot that executes on those objectives. We expect to perform our first live patient surgeries with the Emboss system sometime later this summer or early this fall. These procedures will represent a key inflection point in validating our product in clinical practice. In closing, I want to acknowledge the incredible efforts of our engineering team, our regulatory team, and clinical teams. The milestones we have achieved this quarter are foundational, not just for Monogram, but for, we believe, the future of orthopedic robotics.

Speaker 2

We wanna thank our investors, partners, employees for their continued belief in our mission. We appreciate you joining today's call, and we look forward to providing more updates as we continue progressing through 2025. With that, I'll turn the call back over to Larry to to help field investor questions.

Operator

Brooks, I think I think Brooks is taking those.

Speaker 2

Perfect.

Speaker 3

Alright. Do we wanna bring up Jason Witz from from Roth Capital

Speaker 4

first? Sure.

Speaker 5

Hi, guys. Can you hear me?

Speaker 2

Yes. How are doing, Jason?

Speaker 5

Hey. Good. Thanks. Nice nice nice regulatory progress this quarter. Maybe if I could just get a little more detail in terms of timelines both in The US and India, both in terms of technical and regulatory hurdles remaining and maybe timelines in terms of when you see them hitting.

Speaker 2

Sure. So right now, we we're in the process of what we've said is that we had a press release when we announced the clinical trial clearance, and we said that we expected to be doing live patient surgeries in India within ninety business days. That timeline remains on track. The the clinical trial system that will be actually performing surgeons surgeries is on its way to India. We we're actively preparing to start patient enrollment.

Speaker 2

So that's a tremendously exciting time for the company, and, we're doing everything we can to to to start our first patient surgeries on a very aggressive time time frame. In The United States, we, our first placement is is underway. It's been through a review committee by the orthopedic surgeons that would be using it, and we're just in the process kind of going through with the with the hospital all of the the logistics that'll be involved. We anticipate that that's a q three story for the company. So sometime either q two, early q three, we anticipate that this will be a reality in the Operating Room and and live live patients will be getting treated with robot.

Speaker 5

Okay. Thank you for that detail. I guess maybe just also, you mentioned Stryker. They're pretty entrenched both in terms of their hip and knee share or specifically knee share for you guys right now. And, obviously, the robotics business is quite well entrenched.

Speaker 5

So maybe just discuss maybe the differentiators that's really what's gonna allow one at Monogram to win, especially those initial placements and how surgeon might go, I guess, in The US and India. Although, you India sounds like it's largely gonna be dependent on Shalvi.

Speaker 2

Sure. Yeah. So and and I should say in parallel, we for India, the commercial launch, we are in the process of getting clearance for the the FDA cleared version of the robot. And I should say the the version of the robot is that is cleared is upgradable will be upgradable to the the next gen version. So we we're eagerly pushing launch overseas as well.

Speaker 2

So in terms of key differentiators versus Mako, I would I would start by saying there would be no higher honor to us for somebody to to say that the monogram system is competitive with Mako. We think there's a huge opportunity for a system that's even comparable, competitive equivalent to Mako. We think that would be a tremendous accomplishment and, you know, sometimes we hear it as a project pejorative. Well, you

Speaker 4

know,

Speaker 2

Mako's better at this or that or whatever. I mean, it it would be incredible to have a system that is frankly competitive with theirs. I I will say that we when we started this project, we thought that that was going to be very difficult to do. The Mako platform is an incredibly robust robot. It does a lot of things really well, and, we thought it would be very difficult to, perform their system.

Speaker 2

I'll say that, I have become increasingly confident that there are technical opportunities to potentially exceed the performance. And I'll just I'll describe areas of focus without actually calling out specific I'll I'll focus more on what what Monogram is aiming to do and and less on what Mako does. But a major focus for us is accuracy. So we we believe that it's it's essential for us to have what we we wanna have the most accurate robot in the world, And we believe the data that's out there on various the accuracy of various systems has some pretty significant flaws. And we we we are working on research to actually quantify what the accuracy of various systems is in literature that will hopefully become published and then compare that to what the accuracy of our system is.

Speaker 2

So that's a big area of focus for us. We another area of focus is, you know, the safety. So we really don't wanna have we want minimal surgeon skill required to actually execute the cuts. We want minimal surgeon fatigue. We don't want the surgeon to be sweaty and tired after doing five knees in a day.

Speaker 2

So we think that's gonna be a significant advantage over time. You know, you don't have to worry about any soft tissue regardless of whether you're a resident or an experienced surgeon. We really want it to be pretty bulletproof in that respect. We we see opportunities around laxity planning. So there's no system on the market, for example, today that does a very good job with, for example, estimating the impact of osteophyte removal, giving surgeons tools to predictive tools to assess the impact of or help guide them, for example, the impact for fixing a flexion contracture, that kind of stuff.

Speaker 2

We think there's opportunities for improved tensioning, more efficient tensioning. We think that the the the number of of joints for Mako, you know, it requires they only have four joints. So for the distal femur and posterior chamfer cuts, it requires a tool change to a right angle adapter that takes time. It's a different tool. A lot of times, that introduces a second blade, which adds cost for the hospital.

Speaker 2

So that's an opportunity. So there's a lot of kind of marginal things around around the fringes. Our our pipeline is vertically vertically streamlined. So the preoperative pipeline is all all AI based, the segmentation algorithm. Our understanding is that Mako for landmark placement relies on the operator and operator skill to place those landmarks, can have a pretty significant impact on system accuracy and how accurate the planned resection is versus the actual resection if the landmark is not well chosen.

Speaker 2

So we our landmark identification is fully automated AI based. So we think over time that's gonna be, you know, just another little small advantage. Where where Mako has some I would say still has some competitive advantage over us is because they have a tool change, their workspace is pretty large. So robot positioning is pretty efficient with Mako. That's been a huge area of focus for us, maximizing the workspace so that it's very quick and efficient to position the robot.

Speaker 2

Getting pretty technical here in a lot of areas, but I will say and I will say that, you you know, the the Mako platform knee, the Stryker Triathlon, it's a it's a fantastic knee. It's got a I think more than twenty years of history. I I believe it has over a million patients with the knee. But we we think that it's versus other players in the market, probably not the most competitive knee on the market. It's a single radius femur, symmetric tibia, and they have a cemented press fit partial knee.

Speaker 2

So we think on the implant side, they've left a lot of opportunity open for comp competition. And and so those and and then when you think about multi application and scaling a system to other clinical applications, hips, shoulders, etcetera, we think that the dex dexterity of our system will really start to shine and and our understanding of active and and autonomous robotics will start to give us a a pretty compelling opportunity. So I would say it would be an incredible compliment to be competitive with them. And then if we if we were able to have a superior system, that would be tremendous. So

Speaker 5

Well, that that's a lot of detail. I really appreciate it. If I could just do one last follow-up and related to that. In terms of your you're now you've been demoing with some KOLs. What are they saying, especially in regards to a lot of the comments you just made in terms of how the how the monograph system is set up?

Speaker 2

Sure. So, you know, when it when we started out so we've been at this for for nine years now. We I would say really developing in earnest. It's been it's been about a five years of real serious engineering development. I would say when we first started bringing surgeons in, you know, the feedback was, you know, well, you know, this is pretty interesting.

Speaker 2

It's too slow. You know, the the planning wasn't dialed in. It you know, it's there was a a sense of you guys are onto something, but there's a lot of work here. I would say over time, you know, we've just continued to make the system better, better, better, faster. I mean, now I would say our feed rates are competitive with manual surgery.

Speaker 2

We can cut exceptionally fast. I think our, like, bone and blade time, which was kind of the biggest barrier, potential barrier to adoption now we're competitive with with any system on the market including manual. So now when surgeons come in, I think, to be honest with you, think some of them have their jaw on the floor. I think they did not fully appreciate how far we've come. I think I think a lot of players in the market potentially haven't appreciated how far we've we've taken this.

Speaker 2

So I think that now the thing that's exciting is that it's it's like, okay. How do you and you brought this up in the past, Jason. How do we now make the implant competitive? Because that's I think I think we can really drive meaningful adoption, let's say, to a certain amount of scale with with the implant platform we have. But I think where this starts to really become the killer app is if it's coupled with a a really compelling implant.

Speaker 2

And so you could just see surgeons sort of getting excited about it and seeing the potential for where this could go and wanting to be involved. So I I would say in terms of surgeons that get it the quickest, it's generally surgeons that have used Mako before. So for them, it's just kind of a very intuitive workflow.

Speaker 5

Great. Thank you. I appreciate all the detail. I will jump back in queue.

Speaker 2

Sure. Thanks, Jason.

Speaker 3

I do wanna bring it. Tom Kerr from Zaxd.

Speaker 4

Hi, guys.

Speaker 2

Tom, how are you?

Speaker 4

Good. You guys just covered a lot, but couple of detailed ones. Are you able to provide more color on the system enhancements that are going on, or is that proprietary? Or, you know, what exactly are you doing to finish it up?

Speaker 2

Sure. So, you know, we we applied to the FDA The robot the let's call it the version of the robot that was cleared, we applied for that in July. So almost hard to believe, but it's, you know, it's it's now May. And we have, subsequent to that submission, made very significant enhancements to the the feed rate of the robot. So we have a completely upgraded end effector, upgraded blade, upgraded there's a whole number of software improvements.

Speaker 2

And so we we have been able to make the cutting much, much faster. So in terms of we, you know, we could launch with the system that's cleared, and that's what we're doing. But we can do what's called a letter to file, which is it's not a whole new submission, but it's just testing internal testing to demonstrate that, for example, upgrading the end effector to the new end effector that we wanna commercialize with, it it is safe and fully tested and get surgeon feedback on that. So that that's actively underway as we speak. In fact, there's a surgeon right right now today in the lab that is using the upgraded hardware.

Speaker 2

And so it's sort of coincidence with getting with getting clearance to actually with from a hospital. So it's not really a a blocker, but it's more of a just a statement that what what we what we're launching with, we think is gonna be pretty competitive right out of the gate.

Speaker 4

Okay. And then just to clarify on a launch domestically, is that still considered some type of trial, or is it a a full commercial launch, or is there a combination of both?

Speaker 2

Sure. So it's we're calling it a a a pilot launch just because, you know, we're we're a small company, and, you know, we have 27 people. And the next step right? So a lot of times in terms of what a surgeon would wanna see to use the system, they would wanna see it in the real world. They nobody wants to be the first to use the robot on on their patients.

Speaker 2

So the the first hospital has been is gonna be with a couple of KOLs that have been with us for quite a while, understand the technology, have seen the evolution of the company. They're gonna do surgeries, And the hospital, you know, there's no benchmark for them, so the hospital needs to evaluate do a value analysis of our system versus other competitive systems on the market before pulling the trigger. And so we're gonna use that as an opportunity to demo the surgeon for surgeons that are interested, that we're actively talking to, be able to bring them in to the Operating Room, see the see the surgery in real life. And as as we tool up with, you know, distributors, sales reps, training, making sure that we have everything we need to provide an excellent standard of care. So, you know, for us to really push on the gas pedal and grow kind of, let's go, say, go parabolic, we really need to make sure that we have all of the infrastructure in place, support in place, take care of our surgeons.

Speaker 2

It's a very the orthopedic market is a lot about customer service. So we don't wanna be in a position where we're not supporting surgeons. We're we're not making sure that they are well taken care of. So our goal is to have very high utilization of the robots that we place. And and so we think that this is the kinda smart way to scale as we as we and we we think we can grow faster overseas initially than in The US, and then we think in The US, we're gonna start to grow faster than in overseas.

Speaker 2

Hope that makes sense. So Yeah. We're starting out in two key geographies here in Austin and then on the East Coast, and then we'll we'll scale from there.

Speaker 4

Got it. And it makes sense. One last quick one. Are there any more actions or interactions with the FDA? I mean, you mentioned a letter to file, but once you get these type of approvals, is it pretty much done with the FDA?

Speaker 2

Yeah. We're done. So it's already cleared. You know, the next interaction with the FDA will be once we have the clinical data from India, we would be submitting that to the FDA and and getting clearance on our next gen system.

Speaker 6

Got it. Makes sense. Okay. Thanks.

Speaker 2

I'll get back in the So and and the system that's cleared is gonna be upgradable to to that version. So it's not like so so really a lot of how our sales funnel works right now is we're showing surgeons, you know, both both versions of the system, and they're they're getting pretty excited about about where this is going.

Speaker 4

That sounds great. Alright. Thanks.

Speaker 2

Sure. Thank you.

Speaker 3

Alright. And just a, a couple other questions that were submitted here. You how should we think about, just capital needs, in light of the upcoming, clinical trial and pilot placements and and commercialization efforts. And you you expect to to raise additional capital in 2025?

Speaker 2

Sure. Yeah. So that's we we actively we've been actively exploring capital opportunities. And, you know, we're gonna in order to really accelerate the business, you know, as Noel said, we have the capital we need to execute the clinical trial and kinda continue in a the growth in a kinda conservative fashion. But to really accelerate the growth, which is exactly what we wanna do, we are gonna need additional capital.

Speaker 2

And so, you know, the we we've been talking to a number of investors and I would say, you know, there's strong interest. I think a lot of folks are starting to see the opportunity. So we're being very thoughtful about who who we partner with, how we partner, and and how how aggressive the ramp would look. But we're gonna continue to validate and derisk the opportunity. The next major derisking milestone is going to be having live patient surgeries under our belt, having those go smoothly and demonstrating that we have a very compelling system.

Speaker 2

So we think that that's a very accretive for the company to to do actually be in the operating room. Once we're in the operating room, I think it's that's really from a derisking perspective, the last hurdle for our company before to validate what we've been working on.

Speaker 3

Alright. And finally, how do you plan to manage balance just between a, you know, more slow, controlled rollout and, the need to drive, commercial traction and and and revenue growth?

Speaker 2

Sure. I think a lot of that's gonna be, you know, access to capital. So, you know, the growth trajectory really does depend a little bit on, like, capital partners and kind of the strategic direction of the company. And so but I will say that we we never will compromise the the quality of service and support that we provide to our surgeons. And we are extremely focused on the utilization of the system.

Speaker 2

So we're not interested in just placing robots without them being used and and well used. So our investment thesis is that the robot effectively is an ATM machine. It's like a cash register. And if we place the system with buy in from surgeons who understand what the value proposition is, And if we can convert a hundred you know, our goal is to convert a % of their business or as much as possible to the robot. We wanna basically be doing every single surgery they do on our system.

Speaker 2

And so that's really the the focus is making sure that we have those key high quality accounts. And and from there, once you have high utilization, it doesn't take too many robots placed robots that are well utilized to start to, you know, ultimately hit breakeven and and go from there. So that's that's our focus.

Speaker 3

Great. Thanks. Yeah, looks like we've set for So, Ben, back to you for any closing remarks.

Speaker 2

Perfect. Well, thanks, everybody. We really appreciate you joining us today, and we look forward to updating you on our progress in in the coming quarter.

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Key Takeaways

  • Monogram ended Q1 with $13.3 million in cash and a reduced monthly burn rate of about $800 K, providing over a year of runway with minimal debt.
  • On March 17, the company received FDA 510(k) clearance for its Emboss autonomous saw-based TKA system and is launching a controlled pilot with four surgeons.
  • Regulatory approval from India’s CDSCO was secured to begin the world’s first live-patient trial of an autonomous robotic total knee arthroplasty, targeting initial surgeries within 90 business days.
  • Monogram is rolling out hardware and software enhancements for faster, more accurate cuts and uses fully automated AI-based planning to compete with entrenched systems like Stryker’s Mako.
  • The company plans a measured commercial rollout to ensure high utilization, will leverage key opinion-leader feedback, and is exploring additional capital raises after live-patient validation.
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Earnings Conference Call
Monogram Orthopaedics Q1 2025
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